MPEP 2106: Difference between revisions

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==[[MPEP 2106|2106 Patent Subject Matter Eligibility]]==
==[[MPEP 2106|2106 Patent Subject Matter Eligibility]]==


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There are two criteria for determining subject matter eligibility and both must be satisfied. The claimed invention:
T o determine the subject matter eligibility the following two steps are conducted:




(1) must be directed to one of the four statutory categories, and
'''Step 1: Determining that the invention is directed to one of the four statutory categories, which are as follows''':




(2) must not be wholly directed to subject matter encompassing a judicially recognized exception.
i. '''Process''' – an act, or a series of acts or steps.It is an act, or a series of acts,  
 
 
I. THE FOUR CATEGORIES OF STATUTORY SUBJECT MATTER
 
Identifying that the claim is directed to one of the four patent-eligible subject matter
categories forms the first step in determining the subject matter eligibility.
 
 
The four categories of statutory subject matter are as follows:
 
i. Process – an act, or a series of acts or steps.It is an act, or a series of acts,  
performed upon the subject-matter to be transformed and reduced to a different state or thing
performed upon the subject-matter to be transformed and reduced to a different state or thing




ii. Machine – a concrete thing, consisting of parts, or of certain devices and combination of devices.
ii. '''Machine''' – a concrete thing, consisting of parts, or of certain devices and combination of devices.
This includes every mechanical device or combination of  
This includes every mechanical device or combination of  
mechanical powers and devices to perform some function and produce a certain effect or result.
mechanical powers and devices to perform some function and produce a certain effect or result.




iii. Manufacture – an article produced from raw or prepared materials by  
iii. '''Manufacture''' – an article produced from raw or prepared materials by  
giving to these materials new forms,qualities, properties, or combinations, whether by hand labor or by machinery
giving to these materials new forms,qualities, properties, or combinations, whether by hand labor or by machinery




iv. Composition of matter – all compositions of two or more substances and all composite articles, whether they be the results of chemical union, or of mechanical mixture, or whether they be gases, fluids, powders or solids,
iv. '''Composition of matter''' – all compositions of two or more substances and all composite articles, whether they be the results of chemical union, or of mechanical mixture, or whether they be gases, fluids, powders or solids,




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'''STEP II. JUDICIAL EXCEPTIONS TO THE FOUR CATEGORIES'''
 
'''Step- 2: Determining that the invention is not wholly directed to subject matter encompassing a judicially recognized exception'''.


Judicially recognized exception are as follows:
Judicially recognized exception are as follows:
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A “practical application” relates to how a judicially recognized exception is applied in a real world product or a process,and not merely to the result achieved by the invention.When subject matter has been reduced to a particular practical application having a real world use, the claimed practical application is evidence that the subject matter is not abstract (e.g., not purely mental) and does not encompass substantially all uses (preemption) of a law of nature or a physical phenomenon.
A “practical application” relates to how a judicially recognized exception is applied in a real world product or a process,and not merely to the result achieved by the invention.When subject matter has been reduced to a particular practical application having a real world use, the claimed practical application is evidence that the subject matter is not abstract (e.g., not purely mental) and does not encompass substantially all uses (preemption) of a law of nature or a physical phenomenon.


A. Practical Application of Machines, Manufactures,and Compositions of Matter (Products)
'''A. Practical Application of Machines, Manufactures,and Compositions of Matter (Products)'''


If the claimed product falls within one of the three product categories of invention and does not recite judicially excepted subject matter, e.g., a law of nature, a physical phenomenon, or an abstract idea, it qualifies as eligible subject matter. If a judicial exception is recited in the claim, it must be determined if the judicially excepted subject matter has been practically applied in the product.
If the claimed product falls within one of the three product categories of invention and does not recite judicially excepted subject matter, e.g., a law of nature, a physical phenomenon, or an abstract idea, it qualifies as eligible subject matter. If a judicial exception is recited in the claim, it must be determined if the judicially excepted subject matter has been practically applied in the product.
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A process claim, to be statutory under 35 U.S.C. 101 , must be limited to a particular practical application. This ensures that the process is not simply claiming an abstract idea, or substantially all practical uses of (preempting) a law of nature, or a physical phenomenon.  
A process claim, to be statutory under 35 U.S.C. 101 , must be limited to a particular practical application. This ensures that the process is not simply claiming an abstract idea, or substantially all practical uses of (preempting) a law of nature, or a physical phenomenon.  


A claim that attempts to patent an abstract idea is ineligible subject matter under 35 U.S.C. 101 . The abstract idea exception has deep roots in the Supreme Court’s jurisprudence. The recitation of some structure, such as a machine, or the recitation of some transformative component will in most cases limit the claim to such an application. However, not all such recitations necessarily save the claim.  Moreover,the fact that the steps of a claim might occur in the ‘‘real world’’ does not necessarily save it from a 35 U.S.C. 101 rejection.  
A claim that attempts to patent an abstract idea is ineligible subject matter under 35 U.S.C. 101 . The recitation of some structure, such as a machine, or the recitation of some transformative component will in most cases limit the claim to such an application. However, not all such recitations necessarily save the claim.  Moreover,the fact that the steps of a claim might occur in the ‘‘real world’’ does not necessarily save it from a 35 U.S.C. 101 rejection.  


1. Factors To Be Considered in an Abstract Idea Determination of a Method Claim
'''1. Factors To Be Considered in an Abstract Idea Determination of a Method Claim'''


a) A machine or a transformation test:
'''a) A machine or a transformation test:'''


“The machine-or-transformation test is a useful and important clue, and investigative tool, for determining whether some claimed inventions are processes under §101.” If so, the claims are less likely to be drawn to an abstract idea; if not, they are more likely to be so drawn.  
“The machine-or-transformation test is a useful and important clue, and investigative tool, for determining whether some claimed inventions are processes under §101.” If so, the claims are less likely to be drawn to an abstract idea; if not, they are more likely to be so drawn.  
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With respect to these factors, a “machine” is a concrete thing, consisting of parts, or of certain devices and combination of devices.This includes every mechanical device or combination of mechanical powers and devices to perform some function and produce a certain effect or result. This definition is interpreted broadly to include electrical, electronic,optical, acoustic, and other such devices that accomplish a function to achieve a certain result. An “apparatus” does not have a significantly different meaning from a machine and can include a machine or group of machines or a totality of means by which a designated function or specific task is executed.
With respect to these factors, a “machine” is a concrete thing, consisting of parts, or of certain devices and combination of devices.This includes every mechanical device or combination of mechanical powers and devices to perform some function and produce a certain effect or result. This definition is interpreted broadly to include electrical, electronic,optical, acoustic, and other such devices that accomplish a function to achieve a certain result. An “apparatus” does not have a significantly different meaning from a machine and can include a machine or group of machines or a totality of means by which a designated function or specific task is executed.


For the machine or transformation test following factors have to be considered:
'''For the machine or transformation test following factors have to be considered:'''


1- The particularity or generality of the elements of the machine or apparatus:  
'''1- The particularity or generality of the elements of the machine or apparatus:'''


The degree to which the machine in the claim can be specifically identified (not any and all machines). Incorporation of a  
The degree to which the machine in the claim can be specifically identified (not any and all machines). Incorporation of a  
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1- a computer aids the method,  
1- a computer aids the method,  
2- the extent to which a computer aids the method, or  
2- the extent to which a computer aids the method, or  
3- the significance of a computer to the performance of the method.
3- the significance of a computer to the performance of the method.


To qualify as a particular machine under the test,the claim must clearly convey that the computer is programmed to perform the steps of the method because such programming, in effect, creates a special purpose computer limited to the use of the particularly claimed combination of elements (i.e., the programmed instructions) performing the particularly claimed combination of functions. If the claim is so abstract and sweeping that performing the process as claimed would cover substantially all practical applications of a judicial exception, such as a mathematical algorithm, the claim would not satisfy the test as the machine would not be sufficiently particular.
To qualify as a particular machine under the test,the claim must clearly convey that the computer is programmed to perform the steps of the method because such programming, in effect, creates a special purpose computer limited to the use of the particularly claimed combination of elements (i.e., the programmed instructions) performing the particularly claimed combination of functions. If the claim is so abstract and sweeping that performing the process as claimed would cover substantially all practical applications of a judicial exception, such as a mathematical algorithm, the claim would not satisfy the test as the machine would not be sufficiently particular.


2- Whether the machine or apparatus implements the steps of the method.  
'''2- Whether the machine or apparatus implements the steps of the method.'''


Integral use of a machine or apparatus to achieve performance of the method weighs toward eligibility, as compared to where the machine or apparatus is merely an object on which the method operates, which weighs against eligibility.  
Integral use of a machine or apparatus to achieve performance of the method weighs toward eligibility, as compared to where the machine or apparatus is merely an object on which the method operates, which weighs against eligibility.  


3- Whether its involvement is extra solution activity or a field-of-use, i.e., the extent to which (or how) the machine or apparatus imposes meaningful limits on the execution of the claimed method steps. Use of a machine or apparatus that contributes only nominally or insignificantly to the execution of the claimed method(e.g., in a data gathering step or in a field-of-use limitation) would weigh against eligibility.  
'''3- Whether its involvement is extra solution activity or a field-of-use''', i.e., the extent to which (or how) the machine or apparatus imposes meaningful limits on the execution of the claimed method steps. Use of a machine or apparatus that contributes only nominally or insignificantly to the execution of the claimed method(e.g., in a data gathering step or in a field-of-use limitation) would weigh against eligibility.  




'''(b) Whether performance of the claimed method results in or otherwise  
'''(b) Whether performance of the claimed method results in or otherwise involves a transformation of a particular article'''
involves a transformation of a particular article'''


“Transformation and reduction of an article ‘to a different state or thing’ is the clue to patentability of a process claim that does not include particular machines. If such a transformation exists, the claims are less likely to be drawn to an abstract idea; if not, they are more likely to be so drawn.
“Transformation and reduction of an article ‘to a different state or thing’ is the clue to patentability of a process claim that does not include particular machines. If such a transformation exists, the claims are less likely to be drawn to an abstract idea; if not, they are more likely to be so drawn.
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An “article” includes a physical object or substance. The physical object or substance must be particular, meaning it can be specifically identified. An article can also be electronic data that represents a physical object or substance. For the test, the data should be more than an abstract value. Data can be specifically identified by indicating what the data represents, the particular type or nature of the data, and/or how or from where the data was obtained.
An “article” includes a physical object or substance. The physical object or substance must be particular, meaning it can be specifically identified. An article can also be electronic data that represents a physical object or substance. For the test, the data should be more than an abstract value. Data can be specifically identified by indicating what the data represents, the particular type or nature of the data, and/or how or from where the data was obtained.


“Transformation” of an article means that the “article”has changed to a different state or thing. Changing to a different state or thing usually means more than simply using an article or changing the location of an article. A new or different function or use can be evidence that an article has been transformed. Manufactures and compositions of matter are the result of transforming raw materials into something new with a different function or use. Purely mental processes in which thoughts or human based actions are “changed” are not considered an eligible transformation. For data, mere "manipulation of basic mathematical constructs [i.e,] the paradigmatic 'abstract idea'," has not been deemed a transformation.  However, transformation of electronic data has been found when the nature of the data has been changed such that it has a different function or is suitable for a different use.  
“Transformation” of an article means that the “article” has changed to a different state or thing. Changing to a different state or thing usually means more than simply using an article or changing the location of an article. A new or different function or use can be evidence that an article has been transformed. Manufactures and compositions of matter are the result of transforming raw materials into something new with a different function or use. Purely mental processes in which thoughts or human based actions are “changed” are not considered an eligible transformation. For data, mere "manipulation of basic mathematical constructs i.e, the paradigmatic 'abstract idea'," has not been deemed a transformation.  However, transformation of electronic data has been found when the nature of the data has been changed such that it has a different function or is suitable for a different use.  


Where a transformation occurs, the following factors are relevant:
Where a transformation occurs, the following factors are relevant:
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(e) Whether its involvement is extra solution activity or a field-of-use, i.e., the extent to which (or how)  
(e) Whether its involvement is extra solution activity or a field-of-use, i.e., the extent to which (or how)  
the transformation imposes meaningful limits on the execution of the claimed method steps.
the transformation imposes meaningful limits on the execution of the claimed method steps.A transformation that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would weigh against eligibility.
A transformation that contributes only nominally or insignificantly to the execution of the claimed  
method (e.g., in a data gathering step or in a field-of-use limitation) would weigh against eligibility.


'''(c) Whether performance of the claimed method involves an application of a law of nature,  
'''(c) Whether performance of the claimed method involves an application of a law of nature,  
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(a) The particularity or generality of the application.
(a) The particularity or generality of the application.
Application of a law of nature having broad applicability across many fields of endeavor weighs against  
Application of a law of nature having broad applicability across many fields of endeavor weighs against  
eligibility,such as where the claim generically recites an effect of the law of nature or claims  
eligibility,such as where the claim generically recites an effect of the law of nature or claims  
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(b) Whether the claimed method recites an application of a law of nature solely involving subjective determinations;e.g., ways to think about the law of nature. Application of a law of nature to a particular way of thinking about,or reacting to, a law of nature would weigh against eligibility.  
(b) Whether the claimed method recites an application of a law of nature solely involving subjective determinations;e.g., ways to think about the law of nature. Application of a law of nature to a particular way of thinking about,or reacting to, a law of nature would weigh against eligibility.  


(c) Whether its involvement is extrasolution activity or afield-of-use, i.e., the extent to which (or how) theapplication imposes meaningful limits on the executionof the claimed method steps. An application of the lawof nature that contributes only nominally or insignificantlyto the execution of the claimed method (e.g., in a datagathering step or in a field-of-use limitation) would weighagainst eligibility.
(c) Whether its involvement is extra solution activity or a field-of-use, i.e., the extent to which (or how) the application imposes meaningful limits on the execution of the claimed method steps. An application of the law of nature that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would weigh against eligibility.
(d) Whether a general concept (which could also berecognized in such terms as a principle, theory, planor scheme) is involved in executing the steps of themethod
 
The presence of such a general concept can be a clue thatthe claim is drawn to an abstract idea. Where a generalconcept is present, the following factors are relevant:
(d) Whether a general concept (which could also be recognized in such terms as a principle, theory, plan or scheme) is involved in executing the steps of the method
(a) The extent to which use of the concept, as expressedin the method, would preempt its use in other fields; i.e.,that the claim would effectively grant a monopoly overthe concept. Bilski v. Kappos, 561 U.S. ___, ___, 130 S.Ct. 3218, 3231, 95 USPQ2d 1001, ___ (2010).
The presence of such a general concept can be a clue that the claim is drawn to an abstract idea. Where a general concept is present, the following factors are relevant:
(b) The extent to which the claim is so abstract andsweeping as to cover both known and unknown uses ofthe concept, and be performed through any existing orfuture-devised machinery, or even without any apparatus. Gottschalk v. Benson, 409 U.S. 63, 68, 175 USPQ 673,___ (1972) (stating “[h]ere the process' claim is so abstractand sweeping as to cover both known and unknown usesof the BCD to pure binary conversion. The end use may(1) vary from the operation of a train to verification ofdrivers' licenses to researching the law books forprecedents and (2) be performed through any existingmachinery or future-devised machinery or without anyapparatus”).
 
(c) The extent to which the claim would effectively coverall possible solutions to a particular problem; i.e., that theclaim is a statement of the problem versus a descriptionof a particular solution to the problem. See The TelephoneCases, 126 U.S. 1, 161-162 (1888) (discussing Tilghmanv. Proctor, 102 U.S. 707 (1880)(“‘The claim of the patent[in Tilghman] is not for a mere principle.’ . . . In that casethere was a problem. Find a way, if you can, to combineeach atom of water with an atom of acid. If you can dothat, then you can reach this important result of resolvingthe neutral fats into glycerine and acids. And Tilghman'ssolution of it was: Heat the water under such pressure thatthe water shall not pass into steam. This was his process;and he claimed, and the court justly allowed, great latitudein its application.”)).
(a) The extent to which use of the concept, as expressed in the method, would preempt its use in other fields; i.e.,that the claim would effectively grant a monopoly over the concept.
(d) Whether the concept is disembodied or whether it isinstantiated; i.e., implemented, in some tangible way. Aconcept that is well-instantiated weighs in favor ofeligibility.
 
(b) The extent to which the claim is so abstract and sweeping as to cover both known and unknown uses of the concept, and be performed through any existing or future-devised machinery, or even without any apparatus. Gottschalk v. Benson, 409 U.S. 63, 68, 175 USPQ 673,___ (1972) (stating “here the process' claim is so abstract and sweeping as to cover both known and unknown uses of the BCD to pure binary conversion. The end use may(1) vary from the operation of a train to verification of drivers' licenses to researching the law books for precedents and (2) be performed through any existing machinery or future-devised machinery or without any apparatus”).
 
(c) The extent to which the claim would effectively coverall possible solutions to a particular problem; i.e., that the claim is a statement of the problem versus a description of a particular solution to the problem.  
 
For example in The TelephoneCases, 126 U.S. 1, 161-162 (1888) (discussing Tilghmanv. Proctor, 102 U.S. 707 (1880)(“‘The claim of the patent[in Tilghman] is not for a mere principle.’ . . . In that case there was a problem. Find a way, if you can, to combine each atom of water with an atom of acid. If you can do that, then you can reach this important result of resolving the neutral fats into glycerine and acids.  
 
(d) Whether the concept is disembodied or whether it is instantiated; i.e., implemented, in some tangible way. A concept that is well-instantiated weighs in favor of eligibility.
 
(e) The mechanism(s) by which the steps are implemented; e.g., whether the performance of the process is observable and verifiable rather than subjective or imperceptible. Steps that are observable and verifiable weigh in favor of eligibility.
 
(f) Examples of general concepts include, but are not limited to:
 
• Basic economic practices or theories (e.g., hedging,insurance, financial transactions, marketing);
 
• Basic legal theories (e.g., contracts, dispute resolution, rules of law);
 
• Mathematical concepts (e.g., algorithms, spatial relationships, geometry);
 
• Mental activity (e.g., forming a judgment,observation, evaluation, or opinion);
 
• Interpersonal interactions or relationships (e.g.,conversing, dating);
 
• Teaching concepts (e.g., memorization, repetition);
 
• Human behavior (e.g., exercising, wearing clothing,following rules or instructions);
 
• Instructing ‘‘how business should be conducted.’
 
 
 
'''2. Making the Determination of Eligibility'''
 
Each of the factors relevant to the particular patent application should be weighed to determine whether the method is claiming an abstract idea by covering a general concept, or combination of concepts, or whether the method is limited to a particular practical application of the concept.
 
The presence or absence of a single factor will not be determinative as the relevant factors need to be considered and weighed to make a proper determination as to whether the claim as a whole is drawn to an abstract idea such that the claim would effectively grant a monopoly over an abstract idea and be ineligible for patent protection.
 
If the factors indicate that the method claim is not merely covering an abstract idea, the claim is eligible for patent protection under 35 U.S.C. 101 and must be further evaluated for patentability under all of the statutory requirements, including utility and double patenting (35U.S.C. 101 ); novelty (35 U.S.C. 102); non-obviousness( 35 U.S.C. 103 ); and definiteness and adequate description, enablement, and best mode (35 U.S.C. 112).
 
35 U.S.C. 101 is merely a coarse filter and thus a determination of eligibility under 35 U.S.C. 101 is only a threshold question for patentability. 35 U.S.C. 102, 103, and 112 are typically the primary tools for evaluating patentability unless the claim is truly abstract.
 
If the factors indicate that the method claim is attempting to cover an abstract idea, the examiner will reject the claim under 35 U.S.C. 101 , providing clear rationale supporting the determination that an abstract idea has been claimed, such that the examiner establishes a prima facie case of patent-ineligibility. The conclusion made by the examiner must be based on the evidence as a whole.In making a rejection or if presenting reasons for allowance when appropriate, the examiner should specifically point out the factors that are relied upon in making the determination. If a claim is rejected under 35 U.S.C. 101 on the basis that it is drawn to an abstract idea,the applicant then has the opportunity to explain why the claimed method is not drawn to an abstract idea.Specifically identifying the factors used in the analysis will allow the applicant to make specific arguments in response to the rejection if the applicant believes that the conclusion that the claim is directed to an abstract idea is in error.
 
 
3. Establish on the Record a Prima Facie Case
 
USPTO personnel should review the totality of the evidence (e.g., the specification, claims, relevant prior art) before reaching a conclusion with regard to whether the claimed invention sets forth patent eligible subject matter. USPTO personnel must weigh the determinations made above to reach a conclusion as to whether it is more likely than not that the claimed invention as a whole either falls outside of one of the enumerated statutory classes or within one of the exceptions to statutory subject matter.The examiner bears the initial burden … of presenting a prima facie case of un-patentability.
 
After USPTO personnel identify and explain in the record the reasons why a claim is for an abstract idea, physical phenomenon, or law of nature with no practical application, then the burden shifts to the applicant to either amend the claim or make a showing of why the claim is eligible for patent protection.
 
 
===2106.01 Subject Matter Eligibility Analysis of Process Claims Involving Laws of Nature [R-9]===
 
 
Process claims having a natural principle as a limiting element or step should be evaluated by determining whether the claim includes additional elements/steps or a combination of elements/steps that integrate the natural principle into the claimed invention such that the natural principle is practically applied, and are sufficient to ensure that the claim amounts to significantly more than the natural principle itself.
 
If the claim as a whole satisfies this inquiry, the claim is directed to patent-eligible subject matter. If the claim as a whole does not satisfy this inquiry, it should be rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
 
'''ESSENTIAL INQUIRIES FOR SUBJECT MATTER ELIGIBILITY UNDER 35 U.S.C. 101'''
 
After determining what applicant invented and establishing the broadest reasonable interpretation of the claimed invention, conduct the following three inquiries on the claim as a whole to determine whether the claim is drawn to patent-eligible subject matter. Further details regarding each inquiry are provided below.
 
1. Is the claimed invention directed to a process,defined as an act, or a series of acts or steps?
 
Under this analysis, the claim must be drawn to a process.
A process is defined as an act, or a series of acts or steps.
Process claims are sometimes called method claims.




C. Determine Whether the Claimed Invention
- If no, this analysis is not applicable.
Falls Within 35 U.S.C. 101 Judicial
Exceptions – Laws of Nature, Natural
Phenomena and Abstract Ideas


Determining whether the claim falls within one of
- If yes, proceed to Inquiry 2.
the four enumerated categories of patentable subject
matter recited in 35 U.S.C. 101 (i.e., process,
machine, manufacture, or composition of matter) does
not end the analysis because claims directed to nothing
more than abstract ideas (such as mathematical
algorithms), natural phenomena, and laws of nature
are not eligible for patent protection.


While abstract ideas, natural phenomena, and laws
of nature are not eligible for patenting, methods and
products employing abstract ideas, natural phenomena,
and laws of nature to perform a real-world function
may well be. In evaluating whether a claim meets
the requirements of section 101, the claim must be
considered as a whole to determine whether it is for a
particular application of an abstract idea, natural phenomenon,
or law of nature, and not for the abstract
idea, natural phenomenon, or law of nature itself.


1.Determine Whether the Claimed Invention
2. Does the claim focus on use of a law of nature,a natural phenomenon, or naturally occurring relation or correlation (collectively referred to as a natural principle herein)? (Is the natural principle a limiting feature of the claim?)
Covers Either a 35 U.S.C. 101 Judicial
Exception or a Practical Application of a 35
U.S.C. 101 Judicial Exception


USPTO personnel must ascertain the scope of the  
A natural principle is the handiwork of nature and occurs without the hand of man.  
claim to determine whether it covers either a 35
For example, the disinfecting property of sunlight is a natural principle.  
U.S.C. 101 judicial exception or a practical application
The relationship between blood glucose levels and diabetes is a natural principle.  
of a 35 U.S.C. 101 judicial exception. The conclusion
A correlation that occurs naturally when a man-made product, such as a drug, interacts with a naturally occurring substance, such as blood, is also considered a natural principle because, while it takes a human action to trigger a manifestation of the correlation,the correlation exists in principle apart from any human action.  
that a particular claim includes a 35 U.S.C.  
101 judicial exception does not end the inquiry
because the practical application of a judicial exception
may qualify for patent protection. “It is now commonplace
that an application of a law of nature or
mathematical formula to a known structure or process
may well be deserving of patent protection.” Diehr,  
450 U.S. at 187, 209 USPQ at 8 (emphasis in original);
accord Flook, 437 U.S. at 590, 198 USPQ at
197; Benson, 409 U.S. at 67, 175 USPQ at 675. Thus,
“[w]hile a scientific truth, or the mathematical expression
of it, is not a patentable invention, a novel and
useful structure created with the aid of knowledge of
scientific truth may be.” Diehr, 450 U.S. at 188, 209
USPQ at 8-9 (quoting Mackay, 306 U.S. at 94); see
also Corning v. Burden, 56 U.S. (15 How.) 252, 268,
14 L.Ed. 683 (1854)(“It is for the discovery or invention
of some practical method or means of producing
a beneficial result or effect, that a patent is granted . .
.”).


2.Determine Whether the Claimed Invention is  
For this analysis, a claim focuses on a natural principle when the natural principle is a limiting element or step.
a Practical Application of an Abstract Idea,
Law of Nature, or Natural Phenomenon (35
U.S.C. 101 Judicial Exceptions)


For claims including such excluded subject matter
In that case, the claim must be analyzed (in Inquiry 3) to ensure that the claim is directed to a practical application of the natural principle that amounts to substantially more than the natural principle itself. So, for instance, a claim that recites a correlation used to make a diagnosis focuses on a natural principle and would require further analysis under Inquiry 3.
to be eligible for patent protection, the claim must be  
for a practical application of the abstract idea, law of
nature, or natural phenomenon. Diehr, 450 U.S. at
187, 209 USPQ at 8 (“application of a law of nature or
mathematical formula to a known structure or process
may well be deserving of patent protection.”); Benson,
409 U.S. at 71, 175 USPQ at 676 (rejecting formula
claim because it “has no substantial practical
application”).  


A claimed invention is directed to a practical application
If a natural principle is not a limitation of the claim, the claim does not focus on the use of a natural principle and requires no further analysis under this procedure. If the claim focuses on an abstract idea, such as steps that can be performed entirely in one’s mind, methods of controlling human activity, or mere plans for performing an action, refer to MPEP § 2106 to evaluate eligibility.
of a 35 U.S.C. 101 judicial exception when it:


(A)“transforms” an article or physical object to a
- If no, this analysis is complete,and the claim should be analyzed to determine if an abstract idea is claimed (see MPEP § 2106).
different state or thing; or


(B)otherwise produces a useful, concrete and
- If yes,proceed to Inquiry 3.
tangible result, based on the factors discussed below.


(1)Practical Application by Physical Transformation
3. Does the claim include additional elements/steps or a combination of elements/steps that integrate the natural principle into the claimed invention such that the natural principle is practically applied, and are sufficient to ensure that the claim amounts to significantly more than the natural principle itself? (Is it more than a law of nature plus the general instruction to simply “apply it”?)


A claim that focuses on use of a natural principle must also include additional elements or steps to show that the inventor has practically applied, or added something significant to, the natural principle itself.


USPTO personnel first shall review the claim and
To show integration, the additional elements or steps must relate to the natural principle in a significant way to impose a meaningful limit on the claim scope.  The claim cannot cover the natural principle itself such that it is effectively standing alone. A bare statement of a naturally occurring correlation,albeit a newly discovered natural correlation or very narrowly confined correlation, would fail this inquiry.
determine if it provides a transformation or reduction
of an article to a different state or thing. If USPTO
personnel find such a transformation or reduction,
USPTO personnel shall end the inquiry and find that
the claim meets the statutory requirement of 35
U.S.C. 101. If USPTO personnel do not find such a  
transformation or reduction, they must determine
whether the claimed invention produces a useful, concrete,
and tangible result.


(2)Practical Application That Produces a
It is not necessary that every recited element or step integrate or relate to the natural principle as long as it is applied in some practical manner. However, there must be at least one additional element or step that applies,relies on or uses the natural principle so that the claim amounts to significantly more than the natural principle itself.
Useful, Concrete, and Tangible Result


For purposes of an eligibility analysis, a physical
Elements or steps that do not integrate the natural principle and are merely appended to it would not be sufficient. For example, a claim to diagnosing an infection that recites the step of correlating the presence of a certain bacterium in a person’s blood with a particular type of bacterial infection with the additional step of recording the diagnosis on a chart would not be eligible because the step of recording the diagnosis on the chart is extra-solution activity that is unrelated to the correlation and does not integrate the correlation into the invention.
transformation “is not an invariable requirement, but
merely one example of how a mathematical algorithm
[or law of nature] may bring about a useful application.”
AT&T, 172 F.3d at 1358-59, 50 USPQ2d at
1452. If USPTO personnel determine that the claim
does not entail the transformation of an article, then
USPTO personnel shall review the claim to determine
it produces a useful, tangible, and concrete result. In
making this determination, the focus is not on
whether
the steps taken to achieve a particular result
are useful, tangible, and concrete, but rather on  
whether the final result achieved by the claimed
invention is “useful, tangible, and concrete.” In other
words, the claim must be examined to see if it
includes anything more than a 35 U.S.C. 101 judicial
exception. If the claim is directed to a practical application
of a 35 U.S.C. 101 judicial exception, USPTO
personnel must then determine whether the claim preempts
the judicial exception. If USPTO personnel do
not find such a practical application, then USPTO personnel
have determined that the claim is nonstatutory.


In determining whether a claim provides a practical
Along with integration, the additional steps must be sufficient to ensure that the claim amounts to significantly more than the natural principle itself by including one or more elements or steps that limit the scope of the claim and do more than generally describe the natural principle with generalized instructions to “apply it.”
application of a 35 U.S.C. 101 judicial exception that
produces a useful, tangible, and concrete result,
USPTO personnel should consider and weigh the following
factors:


a)“USEFUL RESULT”
The additional elements or steps must narrow the scope of the claim such that others are not foreclosed from using the natural principle (a basic tool of scientific and technological work) for future innovation.


For an invention to be “useful” it must satisfy the
Elements or steps that are well-understood, purely conventional,and routinely taken by others in order to apply the natural principle, or that only limit the use to a particular technological environment (field-of-use), would not be sufficiently specific. A claim with steps that add something of significance to the natural laws themselves would be eligible because it would confine its reach to particular patent-eligible applications of those laws, such as a typical patent on a new drug (including associated method claims) or a new way of using an existing drug.
utility requirement of section 101. The USPTO’s official
interpretation of the utility requirement provides
that the utility of an invention has to be (i) specific,
(ii) substantial and (iii) credible. MPEP § 2107 and
Fisher, 421 F.3d at 1372, 76 USPQ2d at 1230 (citing
the Utility Guidelines with approval for interpretation
of “specific” and “substantial”). In addition, when the
examiner has reason to believe that the claim is not
for a practical application that produces a useful
result, the claim should be rejected, thus requiring the
applicant to distinguish the claim from the three 35
U.S.C. 101 judicial exceptions to patentable subject
matter by specifically reciting in the claim the practical
application. In such cases, statements in the specification
describing a practical application may not be  
sufficient to satisfy the requirements for section 101with respect to the claimed invention. Likewise, a
claim that can be read so broadly as to include statutory
and nonstatutory subject matter must be amended
to limit the claim to a practical application. In other
words, if the specification discloses a practical application
of a section 101 judicial exception, but the
claim is broader than the disclosure such that it does
not require a practical application, then the claim must
be rejected.


b)“TANGIBLE RESULT”
In other words, the claim must be limited so that it does not preempt the natural principle being recited by covering every substantial practical application of that principle.The process must have additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself.


The tangible requirement does not necessarily
mean that a claim must either be tied to a particular
machine or apparatus or must operate to change articles
or materials to a different state or thing. However,
the tangible requirement does require that the claim
must recite more than a 35 U.S.C. 101 judicial exception,
in that the process claim must set forth a practical
application of that judicial exception to produce a
real-world result. Benson, 409
U.S. at 71-72,
175
USPQ
at 676-77 (invention ineligible because
had “no substantial practical application.”). “[A]n
application of a law of nature or mathematical formula
to a … process may well be deserving of patent
protection.” Diehr, 450 U.S. at 187, 209 USPQ at 8
(emphasis added); see also Corning, 56 U.S. (15
How.) at 268, 14 L.Ed. 683 (“It is for the discovery or
invention of some practical method or means of producing
a beneficial result or effect, that a patent is
granted . . .”). In other words, the opposite meaning of
“tangible” is “abstract.”


c)“CONCRETE RESULT”
- If no, the claim is not patent-eligible and should be rejected.


Another consideration is whether the invention produces
- If yes,the claim is patent-eligible, and the analysis is complete.
a “concrete” result. Usually, this question arises
when a result cannot be assured. In other words, the  
process must have a result that can be substantially
repeatable or the process must substantially produce
the same result again. In re Swartz, 232 F.3d 862, 864,
56 USPQ2d 1703, 1704 (Fed. Cir. 2000) (where
asserted result produced by the claimed invention is
“irreproducible” claim should be rejected under section
101). The opposite of “concrete” is unrepeatable
or unpredictable. Resolving this question is dependent
on the level of skill in the art. For example, if the  
claimed invention is for a process which requires a
particular skill, to determine whether that process is  
substantially repeatable will necessarily require a
determination of the level of skill of the ordinary artisan
in that field. An appropriate rejection under
35
U.S.C. 101 should be accompanied by a lack of
enablement rejection under 35 U.S.C. 112, paragraph
1, where the invention cannot operate as intended
without undue experimentation. See infra.


SAMPLE ANALYSIS


3.Determine Whether the Claimed Invention
Sample Claim Drawn to a Patent-Eligible PracticalApplication - Diamond v. Diehr
Preempts a 35 U.S.C. 101 Judicial Exception
(Abstract Idea, Law of Nature, or Natural
Phenomenon)


Even when a claim applies a mathematical formula,
1. A method of operating a rubber-molding press for precision molded compounds with the aid of a digital computer, comprising:
for example, as part of a seemingly patentable process,
USPTO personnel must ensure that it does not in
reality “seek[] patent protection for that formula in the
abstract.” Diehr, 450 U.S. at 191, 209 USPQ at 10.
“Phenomena of nature, though just discovered, mental
processes, abstract intellectual concepts are not patentable,
as they are the basic tools of scientific and
technological work.” Benson, 409 U.S. at 67, 175
USPQ at 675. One may not patent a process that comprises
every “substantial practical application” of an
abstract idea, because such a patent “in practical
effect would be a patent on the [abstract idea] itself.”
Benson, 409 U.S. at 71-72, 175 USPQ at 676; cf.
Diehr, 450 U.S. at 187, 209 USPQ at 8 (stressing that
the patent applicants in that case did “not seek to pre-
empt the use of [an] equation,” but instead sought
only to “foreclose from others the use of that equation
in conjunction with all of the other steps in their
claimed process”). “To hold otherwise would allow a
competent draftsman to evade the recognized limitations
on the type of subject matter eligible for patent
protection.” Diehr, 450 U.S. at 192, 209 USPQ at 10.
Thus, a claim that recites a computer that solely calculates
a mathematical formula (see Benson) or a computer
disk that solely stores a mathematical formula is
not directed to the type of subject matter eligible for
patent protection. If USPTO personnel determine that
the claimed invention preempts a 35 U.S.C. 101 judicial
exception, they must identify the abstraction, law
of nature, or natural phenomenon and explain why the
claim covers every substantial practical application
thereof.


D.Establish on the Record a Prima Facie Case
providing said computer with a data base for said press including at least,


USPTO personnel should review the totality of the
natural logarithm conversion data (ln),
evidence (e.g., the specification, claims, relevant prior
art) before reaching a conclusion with regard to
whether the claimed invention sets forth patent eligible
subject matter. USPTO personnel must weigh the
determinations made above to reach a conclusion as
to whether it is more likely than not that the claimed
invention as a whole either falls outside of one of the
enumerated statutory classes or within one of the
exceptions to statutory subject matter. “The examiner
bears the initial burden … of presenting a prima faciecase of unpatentability.” In re Oetiker, 977 F.2d 1443,
1445, 24 USPQ2d 1443, 1444 (Fed. Cir. 1992). If the
record as a whole suggests that it is more likely than
not that the claimed invention would be considered a
practical application of an abstract idea, natural phenomenon,
or law of nature, then USPTO personnel
should not reject the claim.


After USPTO personnel identify and explain in the  
the activation energy constant (C) unique to each batch of said compound being molded, and
record the reasons why a claim is for an abstract idea
with no practical application, then the burden shifts to  
the applicant to either amend the claim or make a
showing of why the claim is eligible for patent protection.
See, e.g., In re Brana, 51 F.3d 1560, 1566, 34
USPQ2d 1436, 1441 (Fed. Cir. 1995); see generally
MPEP § 2107 (Utility Guidelines).


For further discussion of case law defining the line
a constant (x)dependent upon the geometry of the particular mold of the press,
between eligible and ineligible subject matter, as well
as a summary of improper tests for subject matter eligibility,  
see Annex II and Annex III of Interim Guidelines
for Examination of Patent Applications for
Patent Subject Matter Eligibility, 1300 Off. Gaz. Pat.
Office 142 (Nov. 22, 2005)(Patent Subject Matter Eligibility
Interim Guidelines).


V.EVALUATE APPLICATION FOR COMPLIANCE
initiating an interval timer in said computer upon the closure of the press for monitoring the elapsed time of said closure,
WITH 35 U.S.C. 112


A.Determine Whether the Claimed Invention
constantly determining the temperature (Z) of the mold at a location closely adjacent to the mold cavity in the press during molding,
Complies with 35 U.S.C. 112, Second
Paragraph Requirements (MPEP § 2171)


The second paragraph of 35 U.S.C. 112 contains
constantly providing the computer with the temperature (Z),
two separate and distinct requirements: (A) that the  
claim(s) set forth the subject matter applicants regard
as the invention, and (B) that the claim(s) particularly
point out and distinctly claim the invention.


An application will be deficient under the first
repetitively calculating in the computer, at frequent intervals during each cure, the Arrhenius equation for reaction time during the cure,  
requirement of 35 U.S.C. 112, second paragraph when
evidence including admissions, other than in the  
application as filed, shows that an applicant has stated
what he or she regards the invention to be different
from what is claimed (see MPEP § 2171- § 2172.01).


An application fails to comply with the second
which is ln v = CZ + x where v is the total required cure time,
requirement of 35 U.S.C. 112, second paragraph when
the claims do not set out and define the invention with
a reasonable degree of precision and particularity. In
this regard, the definiteness of the language must be
analyzed, not in a vacuum, but always in light of the
teachings of the disclosure as it would be interpreted
by one of ordinary skill in the art. Applicant’s claims,
interpreted in light of the disclosure, must reasonably
apprise a person of ordinary skill in the art of the
invention.


The scope of a “means” limitation is defined as the  
repetitively comparing in the computer at said frequent intervals during the cure each said calculation of the total required cure time calculated with the Arrhenius equation and said elapsed time,
corresponding structure or material set forth in the  
written description and equivalents thereof. See
MPEP § 2181 through § 2186. See MPEP § 2173 et
seq. for a discussion of a variety of issues pertaining
to the 35 U.S.C. 112, second paragraph requirement
that the claims particularly point out and distinctly
claim the invention.


B.Determine Whether the Claimed Invention
and opening the press automatically when a said comparison indicates equivalence.
Complies with 35 U.S.C. 112, First Paragraph
Requirements


The first paragraph of 35 U.S.C. 112 contains
The above claim was found to be a patent- eligible practical application in Diamond v. Diehr, 450 U.S. 175(1981).  
three separate and distinct requirements:


(A)adequate written description,  
Recently, the Supreme Court looked back to this claim as an example of a patent-eligible practical application as explained in the following excerpt from Mayo:


(B)enablement, and
The Court pointed out that the basic mathematical equation, like a law of nature, was not patentable.


(C)best mode.
But it found the overall process patent eligible because of the way the additional steps of the process integrated the equation into the process as a whole.  
Those steps included “installing rubber in a press, closing the mold, constantly determining the temperature of the mold, constantly recalculating the appropriate cure time through the use of the formula and a digital computer, and automatically opening the press at the proper time.”


1.Adequate Written Description
It no where suggested that all these steps, or at least the combination of those steps, were in context obvious,already in use, or purely conventional.  
And so the patentees did not “seek to pre-empt the use of the equation,” but sought “only to foreclose from others the use of that equation in conjunction with all of the other steps in their claimed process.”


For the written description requirement, an applicant’s
These other steps apparently added to the formula something that in terms of patent law’s objectives had significance—they transformed the process into an inventive application of the formula.  
specification must reasonably convey to those
skilled in the art that the applicant was in possession
of the claimed invention as of the date of invention.
Regents of the University of California v. Eli Lilly &
Co., 119 F.3d 1559, 1566-67, 43 USPQ2d 1398,
1404-05 (Fed. Cir. 1997); Hyatt v. Boone, 146
F.3d 1348, 1354, 47 USPQ2d 1128, 1132 (Fed. Cir.
1998). The claimed invention subject matter need not
be described literally, i.e., using the same terms, in
order for the disclosure to satisfy the description
requirement. Software aspects of inventions , for
example, may be described functionally. See Robotic
Vision Sys. v. View Eng’g, Inc., 112 F.3d 1163, 1166,
42 USPQ2d 1619, 1622-23 (Fed. Cir. 1997); Fonar
Corp. v. General Electric Co., 107 F.3d 1543, 1549,
41 USPQ2d 1801, 1805 (Fed. Cir. 1997); In re Hayes
Microcomputer Prods., Inc., 982 F.2d 1527, 1537-38,
25 USPQ2d 1241, 1248-49 (Fed. Cir. 1992). See
MPEP § 2163 for further guidance with respect to the  
evaluation of a patent application for compliance with
the written description requirement.


2.Enabling Disclosure


An applicant’s specification must enable a person
This claim would pass Inquiries 1-3 in the above analysis as it is a process that includes the Arrhenius equation as a limitation,
skilled in the art to make and use the claimed invention
with additional steps that integrate the Arrhenius equation into the process and are
without undue experimentation. The fact that  
sufficient to narrow the scope of the claim so that others are not foreclosed from using
experimentation is complex, however, will not make
the Arrhenius equation in different applications
it undue if a person of skill in the art typically engages
in such complex experimentation.


See MPEP § 2164 et seq. for detailed guidance
with regard to the enablement requirement of 35
U.S.C. 112, first paragraph.


3.Best Mode (MPEP § 2165)
'''Sample Claim Drawn to Ineligible Subject Matter - Mayo v. Prometheus'''


Determining compliance with the best mode
1. A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastro intestinal disorder, comprising:  
requirement requires a two-prong inquiry:


(1)at the time the application was filed, did the
(a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastro intestinal disorder; and
inventor possess a best mode for practicing the invention;  
and  


(2)if the inventor did possess a best mode, does
(b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,
the written description disclose the best mode such
that a person skilled in the art could practice it.


See MPEP § 2165 et seq. for additional guidance.
wherein the level of 6-thioguanine less than about 230 pmol per 8x108 red blood cells indicates
Deficiencies related to disclosure of the best mode for
a need to increase the amount of said drug subsequently administered to said subject and
carrying out the claimed invention are not usually
encountered during examination of an application
because evidence to support such a deficiency is seldom
in the record. Fonar, 107 F.3d at 1548-49, 41
USPQ2d at 1804-05.


VI.DETERMINE WHETHER THE CLAIMED
wherein the level of 6-thioguanine greater than about 400 pmol per 8x108 red blood cells
INVENTION COMPLIES WITH 35 U.S.C.  
indicates a need to decrease the amount of said drug subsequently administered to said subject.
102 AND 103


Reviewing a claimed invention for compliance with
The above claim was found to be ineligible in Mayo. The Supreme Court determined that the claim focused on use of a law of nature that was given weight during prosecution of the claim – specifically the relationships between concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will prove ineffective or cause harm. The Court analyzed the claim as follows:
35 U.S.C. 102 and 103 begins with a comparison of
the claimed subject matter to what is known in the  
prior art. See MPEP § 2131 - § 2146 for specific guidance
on patentability determinations under 35 U.S.C.
§ 102 and 103. If no differences are found between
the claimed invention and the prior art, then the
claimed invention lacks novelty and is to be rejected
by USPTO personnel under 35 U.S.C. 102. Once differences
are identified between the claimed invention
and the prior art, those differences must be assessed
and resolved in light of the knowledge possessed by a  
person of ordinary skill in the art. Against this backdrop,
one must determine whether the invention
would have been obvious at the time the invention
was made. If not, the claimed invention satisfies
35 U.S.C. 103.


VII.CLEARLY COMMUNICATE FINDINGS,  
The question before us is whether the claims do significantly more than simply describe these natural relations. To put the matter more precisely, do the patent claims add enough to their statements of the correlations to allow the processes they describe to qualify as patent-eligible processes that apply natural laws? We believe that the answer to this question is no.
CONCLUSIONS AND THEIR BASES


Once USPTO personnel have concluded the  
The upshot is that the three steps simply tell doctors to gather data from which they may draw an inference in light of the correlations. To put the matter more succinctly, the claims inform a relevant audience about certain laws of nature; any additional steps consist of well understood, routine,conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately. For these reasons we believe that the steps are not sufficient to transform un-patentable natural correlations into patentable applications of those regularities.
above analyses of the claimed invention under all the  
statutory provisions, including 35 U.S.C. 101, 112,  
102 and 103, they should review all the proposed
rejections and their bases to confirm that they are  
able to set forth a prima facie case of unpatentability.
Only then should any rejection be imposed in an
Office action. The Office action should clearly communicate
the findings, conclusions and reasons which
support them.


This claim would pass Inquiries 1-2 and fail Inquiry 3. It is a process claim that includes a natural principle that was construed as a limiting feature of a claim during prosecution - the natural principle being the naturally occurring relationships noted above, which are a consequence of the ways in which thiopurine compounds are metabolized by the body.


Guidelines Flowchart
The Court emphasized that while it takes a human action to trigger a manifestation of this relation in a particular person, the relation itself exists in principle apart from any human action. The additional steps integrate the relationship into the process as the administering step involves the thiopurine drug,
the determining step establishes the thiopurine drug level and the wherein clauses set forth the critical levels.


The steps are not sufficient, however,to narrow the application such that others could still make use of the naturally occurring relationship in other practical applications. The claim essentially sets forth a law of nature with generalized instructions to apply it.


===2106.01Computer-Related Nonstatutory Subject Matter [R-5]===


Descriptive material can be characterized as
Making a Rejection
either “functional descriptive material” or “nonfunctional
descriptive material.” In this context, “functional
descriptive material” consists of data structures
and computer programs which impart functionality
when employed as a computer component. (The definition
of “data structure” is “a physical or logical relationship
among data elements, designed to support
specific data manipulation functions.” The New IEEE
Standard Dictionary of Electrical and Electronics
Terms 308 (5th ed. 1993).) “Nonfunctional descriptive
material” includes but is not limited to music, literary
works, and a compilation or mere arrangement
of data.


Both types of “descriptive material” are nonstatutory
After performing the appropriate Inquiries, a claim that fails Inquiry 3 should be rejected under 35 U.S.C. 101 as not being drawn to patent-eligible subject matter.  
when claimed as descriptive material per se, 33
F.3d at 1360, 31 USPQ2d at 1759. When functional
descriptive material is recorded on some computer-
readable medium, it becomes structurally and functionally
interrelated to the medium and will be statutory
in most cases since use of technology permits the
function of the descriptive material to be realized.
Compare In re Lowry, 32 F.3d 1579, 1583-84, 32
USPQ2d 1031, 1035 (Fed. Cir. 1994)(discussing patentable
weight of data structure limitations in the context
of a statutory claim to a data structure stored on a
computer readable medium that increases computer
efficiency) and Warmerdam, 33 F.3d at 1360-61, 31
USPQ2d at 1759 (claim to computer having a specific
data structure stored in memory held statutory product-
by-process claim) with Warmerdam, 33
F.3d at
1361, 31 USPQ2d at 1760 (claim to a data structure
per se held nonstatutory).  


When nonfunctional descriptive material is
When making the rejection,  
recorded on some computer-readable medium, in a
computer or on an electromagnetic carrier signal, it is
not statutory since no requisite functionality is present
to satisfy the practical application requirement.
Merely claiming nonfunctional descriptive material,
i.e., abstract ideas, stored on a computer-readable
medium, in a computer, or on an electromagnetic carrier
signal, does not make it statutory. See Diehr, 450
U.S. at 185-86, 209 USPQ at 8 (noting that the claims
for an algorithm in Benson were unpatentable as
abstract ideas because “[t]he sole practical application
of the algorithm was in connection with the programming
of a general purpose computer.”). Such a result
would exalt form over substance. In re Sarkar, 588
F.2d 1330, 1333, 200 USPQ 132, 137 (CCPA 1978)
(“[E]ach invention must be evaluated as claimed; yet
semantogenic considerations preclude a determination
based solely on words appearing in the claims. In the
final analysis under § 101, the claimed invention, as a
whole, must be evaluated for what it is.”) (quoted
with approval in Abele, 684 F.2d at 907, 214 USPQ at
687). See also In re Johnson, 589 F.2d 1070, 1077,
200 USPQ 199, 206 (CCPA 1978) (“form of the claim
is often an exercise in drafting”). Thus, nonstatutory
music is not a computer component, and it does not
become statutory by merely recording it on a compact
disk. Protection for this type of work is provided
under the copyright law.


When nonfunctional descriptive material is
- identify the natural principle,
recorded on some computer-readable medium, in a
computer or on an electromagnetic carrier signal, it is
not statutory and should be rejected under 35 U.S.C.
101. In addition, USPTO personnel should inquire
whether there should be a rejection under 35 U.S.C.
102 or 103. USPTO personnel should determine
whether the claimed nonfunctional descriptive material
be given patentable weight. USPTO personnel
must consider all claim limitations
when determining
patentability of an invention over the prior art.
 
In re
Gulack,
703 F.2d 1381, 1385, 217 USPQ 401, 403-04
(Fed. Cir. 1983). USPTO personnel may not disregard
claim limitations comprised of printed matter.
 
See
Gulack,
703 F.2d at 1384, 217 USPQ at 403;
 
see also
Diehr,
 
450 U.S. at 191, 209 USPQ at 10. However,
USPTO personnel need not give patentable weight to
printed matter absent a
new and unobvious functional
relationship between the printed matter and
the
substrate. See In re Lowry, 32 F.3d 1579, 1583-84,
32 USPQ2d 1031, 1035 (Fed. Cir. 1994); In re Ngai,
367 F.3d 1336, 70 USPQ2d 1862 (Fed. Cir. 2004).


- identify that the claim is effectively directed to a natural principle itself, and


I.FUNCTIONAL DESCRIPTIVE MATERIAL:
- explain the reason(s) that the additional claim features or combination of features,
“DATA STRUCTURES” REPRESENTING
when the claim is taken as a whole, fail to integrate the natural principle into the claimed
DESCRIPTIVE MATERIAL PER SEOR COMPUTER PROGRAMS REPRESENTING
invention so that the natural principle is practically applied, and/or
COMPUTER LISTINGS PER SE


Data structures not claimed as embodied in computer-
- fail to be sufficient to ensure that the claim amounts to significantly more than the natural principle itself.
readable media are descriptive material per seand are not statutory because they are not capable of
causing functional change in the computer. See, e.g.,
Warmerdam, 33
F.3d at 1361, 31 USPQ2d at 1760
(claim to a data structure per se held nonstatutory).
Such claimed data structures do not define any structural
and functional interrelationships between the  
data structure and other claimed aspects of the invention
which permit the data structure’s functionality to
be realized. In contrast, a claimed computer-readable
medium encoded with a data structure defines structural
and functional interrelationships between the
data structure and the computer software and hardware
components which permit the data structure’s
functionality to be realized, and is thus statutory.


Similarly, computer programs claimed as computer
listings per se, i.e., the descriptions or expressions of
the programs, are not physical “things.” They are neither
computer components nor statutory processes, as
they are
not “acts” being performed. Such claimed
computer programs do not define any structural and
functional interrelationships between the computer
program and other claimed elements of a computer
which permit the computer program’s functionality to
be realized. In contrast, a claimed computer-readable
medium encoded with a computer program is a computer
element which defines structural and functional
interrelationships between the computer program and
the rest of the computer which permit the computer
program’s functionality to be realized, and is thus statutory.
See Lowry, 32 F.3d at 1583-84, 32 USPQ2d at
1035. Accordingly, it is important to distinguish
claims that define descriptive material per se from
claims that define statutory inventions.


Computer programs are often recited as part of a
A sample rejection of the following claim could read as follows:
claim. USPTO personnel should determine whether
the computer program is being claimed as part of an
otherwise statutory manufacture or machine. In such a
case, the claim remains statutory irrespective of the
fact that a computer program is included in the claim.
The same result occurs when a computer program is
used in a computerized process where the computer
executes the instructions set forth in the computer
program. Only when the claimed invention taken as a
whole is directed to a mere program listing, i.e., to
only its description or expression, is it descriptive
material per se and hence nonstatutory.


Since a computer program is merely a set of  
Claim 1. A method of determining effective dosage of insulin to a patient, comprising the steps of administering a dose of insulin to a patient, testing the patient’s blood for the blood sugar level, and evaluating whether the insulin dosage is effective based on the blood sugar level.
instructions capable of being executed by a computer,  
the computer program itself is not a process and
USPTO personnel should treat a claim for a computer
program, without the computer-readable medium
needed to realize the computer program’s functionality,  
as nonstatutory functional descriptive material.
When a computer program is claimed in a process
where the computer is executing the computer program’s
instructions, USPTO personnel should treat
the claim as a process claim. See paragraph IV.B.2(b),
below. When a computer program is recited in conjunction
with a physical structure, such as a computer
memory, USPTO personnel should treat the claim as a
product claim. See paragraph IV.B.2(a), below.


II.NONFUNCTIONAL DESCRIPTIVE MATERIAL
'''Analysis:'''




Nonfunctional descriptive material that does not
The claim passes Inquiry 1 because it is drawn to a process.
constitute a statutory process, machine, manufacture,
or composition of matter and should be rejected under
35 U.S.C. 101. Certain types of descriptive material,
such as music, literature, art, photographs, and mere
arrangements or compilations of facts or data, without
any functional interrelationship is not a process,
machine, manufacture, or composition of matter.
USPTO personnel should be prudent in applying the
foregoing guidance. Nonfunctional descriptive material
may be claimed in combination with other functional
descriptive multi-media material on a
computer-readable medium to provide the necessary
functional and structural interrelationship to satisfy
the requirements of 35 U.S.C. 101. The presence of
the claimed nonfunctional descriptive material is not
necessarily determinative of nonstatutory subject matter.
For example, a computer that recognizes a particular
grouping or sequence of musical notes read from
memory and thereafter causes another defined series
of notes to be played, requires a functional interrelationship
among that data and the computing processes
performed when utilizing that data. As such, a claim  
to that computer is statutory subject matter because it  
implements a statutory process.


The claim passes Inquiry 2 because a naturally occurring correlation between insulin and blood glucose levels is a limitation of the claim.


===2106.02 Mathematical Algorithms [R-5]===
The claim does not pass Inquiry 3 because, although the additional steps integrate or make use of the correlation in the process by administering insulin in one step and testing for the correlation in another step, the steps are not sufficient to ensure that the claim amounts to significantly more than the correlation itself since every application of the correlation would require an administration of insulin and testing of blood to observe the relationship between insulin and blood glucose levels.


Claims to processes that do nothing more than
'''The rejection:'''
solve mathematical problems or manipulate abstract
ideas or concepts are complex to analyze and are
addressed herein.


If the “acts” of a claimed process manipulate only
Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter because it is not a patent-eligible practical application of a law of nature.  
numbers, abstract concepts or ideas, or signals representing
any of the foregoing, the acts are not being
applied to appropriate subject matter. Gottschalk v.
Benson, 409 U.S. 63, 71 - 72, 175 USPQ 673, 676
(1972). Thus, a process consisting solely of mathematical
operations, i.e., converting one set of numbers
into another set of numbers, does not manipulate
appropriate subject matter and thus cannot constitute
a statutory process.


In practical terms, claims define nonstatutory processes
The claim is directed to a naturally occurring correlation between insulin and blood glucose levels. The combination of steps recited in the claim taken as a whole, including the steps of administering insulin to a patient and testing blood sugar levels, are not sufficient to qualify as a patent-eligible practical application as the claim covers every substantial practical application of the correlation.
if they:


– consist solely of mathematical operations without
Evaluating a Response
some claimed practical application (i.e., executing
a “mathematical algorithm”); or


– simply manipulate abstract ideas, e.g., a bid
A proper response to a rejection based on failure to claim patent-eligible subject matter would be an amendment adding additional steps/features or amending existing steps/features that integrate the natural principle into the process (by practically applying or making use of the principle) and are sufficient to limit the application of the natural principle to more than the principle itself + steps that do more than simply “apply it” at a high level of generality.  
(Schrader, 22 F.3d at 293-94, 30 USPQ2d at 1458-
59) or a bubble hierarchy (Warmerdam, 33 F.3d at
1360, 31 USPQ2d at 1759), without some claimed
practical application.


Cf. Alappat, 33 F.3d at 1543 n.19, 31 USPQ2d at
Examples of both eligible and ineligible hypothetical claims follow. It would also be proper for the applicant to present persuasive arguments that the additional steps add something significantly more to the claim than merely describing the natural principle. A showing that the steps are not routine, well-known or conventional could be persuasive.
1556 n.19 in which the Federal Circuit recognized the
confusion:


The Supreme Court has not been clear . . . as to
For example, a claim that uses the natural disinfecting properties of sunlight would require additional steps beyond exposing an item requiring disinfection to sunlight. The additional steps could involve constructing a sanitizing device that uses ultraviolet light for disinfection with steps that integrate the ultraviolet light into the device and are sufficient to confine the use of the ultraviolet light to a particular application (not so broad as to cover all practical ways of applying ultraviolet light).
whether such subject matter is excluded from the scope of
101 because it represents laws of nature, natural phenomena,
or abstract ideas. See Diehr, 450 U.S. at 186 (viewed
mathematical algorithm as a law of nature); Gottschalk v.
Benson, 409 U.S. 63, 71-72 (1972) (treated mathematical
algorithm as an “idea”). The Supreme Court also has not
been clear as to exactly what kind of mathematical subject
matter may not be patented. The Supreme Court has used,
among others, the terms “mathematical algorithm,”
“mathematical formula,” and “mathematical equation” to  
describe types of mathematical subject matter not entitled
to patent protection standing alone. The Supreme Court
has not set forth, however, any consistent or clear explanation
of what it intended by such terms or how these
terms are related, if at all.


Certain mathematical algorithms have been held to
A claim that sets forth the relationship between blood glucose levels and the incidence of diabetes would require additional steps that do significantly more to apply this principle than conventional blood sample testing or diagnostic activity based on recognizing a threshold blood glucose level. Such additional steps could involve a testing technique or treatment steps that would not be conventional or routine.
be nonstatutory because they represent a mathematical
definition of a law of nature or a natural phenomenon.
For example, a mathematical algorithm
representing the formula E = mc2 is a “law of nature”
— it defines a “fundamental scientific truth” (i.e., the  
relationship between energy and mass). To comprehend
how the law of nature relates to any object, one
invariably has to perform certain steps (e.g., multiplying
a number representing the mass of an object by
the square of a number representing the speed of
light). In such a case, a claimed process which consists
solely of the steps that one must follow to solve..
the mathematical representation of E = mc2 is indistinguishable
from the law of nature and would “preempt”
the law of nature. A patent cannot be granted
on such a process.

Latest revision as of 22:44, May 31, 2020

← MPEP 2105 ↑ MPEP 2100 MPEP 2107 →


2106 Patent Subject Matter Eligibility[edit | edit source]

T o determine the subject matter eligibility the following two steps are conducted:


Step 1: Determining that the invention is directed to one of the four statutory categories, which are as follows:


i. Process – an act, or a series of acts or steps.It is an act, or a series of acts, performed upon the subject-matter to be transformed and reduced to a different state or thing


ii. Machine – a concrete thing, consisting of parts, or of certain devices and combination of devices. This includes every mechanical device or combination of mechanical powers and devices to perform some function and produce a certain effect or result.


iii. Manufacture – an article produced from raw or prepared materials by giving to these materials new forms,qualities, properties, or combinations, whether by hand labor or by machinery


iv. Composition of matter – all compositions of two or more substances and all composite articles, whether they be the results of chemical union, or of mechanical mixture, or whether they be gases, fluids, powders or solids,


Examples of Non statutory categories:

i. Transitory forms of signal transmission for example, a propagating electrical or electromagnetic signal per se

ii. a naturally occurring organism,

iii. a human per se,

iv. a legal contractual agreement between two parties

v. a game defined as a set of rules

vi. a computer program per se

vii. a company

viii. a mere arrangement of printed matter

Patentability of a claim covering both statutory and non- statutory embodiments

A claim that covers both statutory and non-statutory embodiments (under the broadest reasonable interpretation of the claim when read in light of the specification and in view of one skilled in the art) embraces subject matter that is not eligible for patent protection and therefore is directed to non-statutory subject matter. Such claims fail the first step and should be rejected under 35 U.S.C. 101, for at least this reason.

If the claimed invention is clearly not within one of the four categories, it is not patent eligible. However, when the claim fails under Step 1 and it appears from applicant’s disclosure that the claim could be amended to be directed to a statutory category, Step 2 should still be conducted.


Step- 2: Determining that the invention is not wholly directed to subject matter encompassing a judicially recognized exception.

Judicially recognized exception are as follows:

1- laws of nature,

2- physical phenomena, and

3- abstract ideas

While abstract ideas, physical phenomena, and laws of nature are not eligible for patenting, methods and products employing abstract ideas, physical phenomena, and laws of nature to perform a real-world function may well be.

A claim that is limited to a particular practical application of a judicially recognized exception is eligible for patent protection.

A “practical application” relates to how a judicially recognized exception is applied in a real world product or a process,and not merely to the result achieved by the invention.When subject matter has been reduced to a particular practical application having a real world use, the claimed practical application is evidence that the subject matter is not abstract (e.g., not purely mental) and does not encompass substantially all uses (preemption) of a law of nature or a physical phenomenon.

A. Practical Application of Machines, Manufactures,and Compositions of Matter (Products)

If the claimed product falls within one of the three product categories of invention and does not recite judicially excepted subject matter, e.g., a law of nature, a physical phenomenon, or an abstract idea, it qualifies as eligible subject matter. If a judicial exception is recited in the claim, it must be determined if the judicially excepted subject matter has been practically applied in the product.


ELIGIBILITY TESTS ON PRODUCTS FOR PATENTABILITY

1- TANGIBLE EMBODIMENT:

Eligible machines, manufactures, and compositions of matter are non-naturally occurring products typically formed of tangible elements or parts that embody a particular or specific, tangible practical application of the invention. Thus, for these product categories, a particular practical application is often self-evident based on the claim limitations that define the tangible embodiment.This is because an idea that is tangibly applied to a structure is no longer abstract, and a law of nature or physical phenomenon that is practically applied to a structure is limited to that particular application of the concept. For example, a cup is the tangible application of the abstract idea of containing a liquid and is one limited embodiment of that idea (which is no longer abstract). As another example, a magnetic door latch is the tangible application of the concept of magnetism and does not wholly embrace the concept of magnetism but, rather, is one limited application of the concept.

A claim that includes terms that imply that the invention is directed to a product, but fails to include tangible limitations in accordance with its broadest reasonable interpretation is not limited to a practical application, but rather wholly embraces or encompasses the concept upon which the invention is based. This is impermissible as such claim coverage would extend to every way of applying the abstract idea, law of nature or physical phenomenon.

2- OCCURRENCE OF PREEMPTION

Once a practical application has been established, the limited occurrence of preemption must be evaluated to determine whether the claim impermissibly covers substantially all practical applications of the judicially excepted subject matter. If so, the claim is not patent-eligible. If the claim covers only a particular practical application of the judicially excepted subject matter, it is patent eligible.


B. Practical Application of Processes (Methods)


A process claim, to be statutory under 35 U.S.C. 101 , must be limited to a particular practical application. This ensures that the process is not simply claiming an abstract idea, or substantially all practical uses of (preempting) a law of nature, or a physical phenomenon.

A claim that attempts to patent an abstract idea is ineligible subject matter under 35 U.S.C. 101 . The recitation of some structure, such as a machine, or the recitation of some transformative component will in most cases limit the claim to such an application. However, not all such recitations necessarily save the claim. Moreover,the fact that the steps of a claim might occur in the ‘‘real world’’ does not necessarily save it from a 35 U.S.C. 101 rejection.

1. Factors To Be Considered in an Abstract Idea Determination of a Method Claim

a) A machine or a transformation test:

“The machine-or-transformation test is a useful and important clue, and investigative tool, for determining whether some claimed inventions are processes under §101.” If so, the claims are less likely to be drawn to an abstract idea; if not, they are more likely to be so drawn.

With respect to these factors, a “machine” is a concrete thing, consisting of parts, or of certain devices and combination of devices.This includes every mechanical device or combination of mechanical powers and devices to perform some function and produce a certain effect or result. This definition is interpreted broadly to include electrical, electronic,optical, acoustic, and other such devices that accomplish a function to achieve a certain result. An “apparatus” does not have a significantly different meaning from a machine and can include a machine or group of machines or a totality of means by which a designated function or specific task is executed.

For the machine or transformation test following factors have to be considered:

1- The particularity or generality of the elements of the machine or apparatus:

The degree to which the machine in the claim can be specifically identified (not any and all machines). Incorporation of a particular machine or apparatus into the claimed method steps weighs toward eligibility.

In case of computer implemented processes the “machine” is often disclosed as a general purpose computer. In these cases, the general purpose computer may be sufficiently“particular” when programmed to perform the process steps. Such programming creates a new machine because a general purpose computer, in effect, becomes a special purpose computer once it is programmed to perform particular functions pursuant to instructions from program software.

However, "adding a'computer-aided' limitation to a claim covering an abstract concept, without more, is insufficient to render a patent claim eligible where the claims are silent as to how

1- a computer aids the method,

2- the extent to which a computer aids the method, or

3- the significance of a computer to the performance of the method.


To qualify as a particular machine under the test,the claim must clearly convey that the computer is programmed to perform the steps of the method because such programming, in effect, creates a special purpose computer limited to the use of the particularly claimed combination of elements (i.e., the programmed instructions) performing the particularly claimed combination of functions. If the claim is so abstract and sweeping that performing the process as claimed would cover substantially all practical applications of a judicial exception, such as a mathematical algorithm, the claim would not satisfy the test as the machine would not be sufficiently particular.

2- Whether the machine or apparatus implements the steps of the method.

Integral use of a machine or apparatus to achieve performance of the method weighs toward eligibility, as compared to where the machine or apparatus is merely an object on which the method operates, which weighs against eligibility.

3- Whether its involvement is extra solution activity or a field-of-use, i.e., the extent to which (or how) the machine or apparatus imposes meaningful limits on the execution of the claimed method steps. Use of a machine or apparatus that contributes only nominally or insignificantly to the execution of the claimed method(e.g., in a data gathering step or in a field-of-use limitation) would weigh against eligibility.


(b) Whether performance of the claimed method results in or otherwise involves a transformation of a particular article

“Transformation and reduction of an article ‘to a different state or thing’ is the clue to patentability of a process claim that does not include particular machines. If such a transformation exists, the claims are less likely to be drawn to an abstract idea; if not, they are more likely to be so drawn.

An “article” includes a physical object or substance. The physical object or substance must be particular, meaning it can be specifically identified. An article can also be electronic data that represents a physical object or substance. For the test, the data should be more than an abstract value. Data can be specifically identified by indicating what the data represents, the particular type or nature of the data, and/or how or from where the data was obtained.

“Transformation” of an article means that the “article” has changed to a different state or thing. Changing to a different state or thing usually means more than simply using an article or changing the location of an article. A new or different function or use can be evidence that an article has been transformed. Manufactures and compositions of matter are the result of transforming raw materials into something new with a different function or use. Purely mental processes in which thoughts or human based actions are “changed” are not considered an eligible transformation. For data, mere "manipulation of basic mathematical constructs i.e, the paradigmatic 'abstract idea'," has not been deemed a transformation. However, transformation of electronic data has been found when the nature of the data has been changed such that it has a different function or is suitable for a different use.

Where a transformation occurs, the following factors are relevant:

(a) The particularity or generality of the transformation: A more particular transformation would weigh in favor of eligibility.

(b) The degree to which the recited article is particular i.e., can be specifically identified (not any and all articles).A transformation applied to a generically recited article would weigh against eligibility.

(c) The nature of the transformation in terms of the type or extent of change in state or thing, for instance by having a different function or use, which would weigh toward eligibility, compared to merely having a different location,which would weigh against eligibility.

(d) The nature of the article transformed, i.e., whether it is an object or substance, weighing toward eligibility,compared to a concept such as a contractual obligation or mental judgment, which would weigh against eligibility.

(e) Whether its involvement is extra solution activity or a field-of-use, i.e., the extent to which (or how) the transformation imposes meaningful limits on the execution of the claimed method steps.A transformation that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would weigh against eligibility.

(c) Whether performance of the claimed method involves an application of a law of nature, even in the absence of a particular machine, apparatus, or transformation:

An application of a law of nature may represent patent-eligible subject matter even in the absence of a particular machine, apparatus, or transformation.

Where such an application is present, the following factors are relevant:

(a) The particularity or generality of the application.

Application of a law of nature having broad applicability across many fields of endeavor weighs against eligibility,such as where the claim generically recites an effect of the law of nature or claims every mode of accomplishing that effect, such that the claim would monopolize a natural force or patent a scientific fact.

For instance in O'Reilly v. Morse,56 U.S. 62 (1853) "the use of electromagnetism for transmitting signals at a distance was considered un-patentable.

(b) Whether the claimed method recites an application of a law of nature solely involving subjective determinations;e.g., ways to think about the law of nature. Application of a law of nature to a particular way of thinking about,or reacting to, a law of nature would weigh against eligibility.

(c) Whether its involvement is extra solution activity or a field-of-use, i.e., the extent to which (or how) the application imposes meaningful limits on the execution of the claimed method steps. An application of the law of nature that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would weigh against eligibility.

(d) Whether a general concept (which could also be recognized in such terms as a principle, theory, plan or scheme) is involved in executing the steps of the method The presence of such a general concept can be a clue that the claim is drawn to an abstract idea. Where a general concept is present, the following factors are relevant:

(a) The extent to which use of the concept, as expressed in the method, would preempt its use in other fields; i.e.,that the claim would effectively grant a monopoly over the concept.

(b) The extent to which the claim is so abstract and sweeping as to cover both known and unknown uses of the concept, and be performed through any existing or future-devised machinery, or even without any apparatus. Gottschalk v. Benson, 409 U.S. 63, 68, 175 USPQ 673,___ (1972) (stating “here the process' claim is so abstract and sweeping as to cover both known and unknown uses of the BCD to pure binary conversion. The end use may(1) vary from the operation of a train to verification of drivers' licenses to researching the law books for precedents and (2) be performed through any existing machinery or future-devised machinery or without any apparatus”).

(c) The extent to which the claim would effectively coverall possible solutions to a particular problem; i.e., that the claim is a statement of the problem versus a description of a particular solution to the problem.

For example in The TelephoneCases, 126 U.S. 1, 161-162 (1888) (discussing Tilghmanv. Proctor, 102 U.S. 707 (1880)(“‘The claim of the patent[in Tilghman] is not for a mere principle.’ . . . In that case there was a problem. Find a way, if you can, to combine each atom of water with an atom of acid. If you can do that, then you can reach this important result of resolving the neutral fats into glycerine and acids.

(d) Whether the concept is disembodied or whether it is instantiated; i.e., implemented, in some tangible way. A concept that is well-instantiated weighs in favor of eligibility.

(e) The mechanism(s) by which the steps are implemented; e.g., whether the performance of the process is observable and verifiable rather than subjective or imperceptible. Steps that are observable and verifiable weigh in favor of eligibility.

(f) Examples of general concepts include, but are not limited to:

• Basic economic practices or theories (e.g., hedging,insurance, financial transactions, marketing);

• Basic legal theories (e.g., contracts, dispute resolution, rules of law);

• Mathematical concepts (e.g., algorithms, spatial relationships, geometry);

• Mental activity (e.g., forming a judgment,observation, evaluation, or opinion);

• Interpersonal interactions or relationships (e.g.,conversing, dating);

• Teaching concepts (e.g., memorization, repetition);

• Human behavior (e.g., exercising, wearing clothing,following rules or instructions);

• Instructing ‘‘how business should be conducted.’


2. Making the Determination of Eligibility

Each of the factors relevant to the particular patent application should be weighed to determine whether the method is claiming an abstract idea by covering a general concept, or combination of concepts, or whether the method is limited to a particular practical application of the concept.

The presence or absence of a single factor will not be determinative as the relevant factors need to be considered and weighed to make a proper determination as to whether the claim as a whole is drawn to an abstract idea such that the claim would effectively grant a monopoly over an abstract idea and be ineligible for patent protection.

If the factors indicate that the method claim is not merely covering an abstract idea, the claim is eligible for patent protection under 35 U.S.C. 101 and must be further evaluated for patentability under all of the statutory requirements, including utility and double patenting (35U.S.C. 101 ); novelty (35 U.S.C. 102); non-obviousness( 35 U.S.C. 103 ); and definiteness and adequate description, enablement, and best mode (35 U.S.C. 112).

35 U.S.C. 101 is merely a coarse filter and thus a determination of eligibility under 35 U.S.C. 101 is only a threshold question for patentability. 35 U.S.C. 102, 103, and 112 are typically the primary tools for evaluating patentability unless the claim is truly abstract.

If the factors indicate that the method claim is attempting to cover an abstract idea, the examiner will reject the claim under 35 U.S.C. 101 , providing clear rationale supporting the determination that an abstract idea has been claimed, such that the examiner establishes a prima facie case of patent-ineligibility. The conclusion made by the examiner must be based on the evidence as a whole.In making a rejection or if presenting reasons for allowance when appropriate, the examiner should specifically point out the factors that are relied upon in making the determination. If a claim is rejected under 35 U.S.C. 101 on the basis that it is drawn to an abstract idea,the applicant then has the opportunity to explain why the claimed method is not drawn to an abstract idea.Specifically identifying the factors used in the analysis will allow the applicant to make specific arguments in response to the rejection if the applicant believes that the conclusion that the claim is directed to an abstract idea is in error.


3. Establish on the Record a Prima Facie Case

USPTO personnel should review the totality of the evidence (e.g., the specification, claims, relevant prior art) before reaching a conclusion with regard to whether the claimed invention sets forth patent eligible subject matter. USPTO personnel must weigh the determinations made above to reach a conclusion as to whether it is more likely than not that the claimed invention as a whole either falls outside of one of the enumerated statutory classes or within one of the exceptions to statutory subject matter.The examiner bears the initial burden … of presenting a prima facie case of un-patentability.

After USPTO personnel identify and explain in the record the reasons why a claim is for an abstract idea, physical phenomenon, or law of nature with no practical application, then the burden shifts to the applicant to either amend the claim or make a showing of why the claim is eligible for patent protection.


2106.01 Subject Matter Eligibility Analysis of Process Claims Involving Laws of Nature [R-9][edit | edit source]

Process claims having a natural principle as a limiting element or step should be evaluated by determining whether the claim includes additional elements/steps or a combination of elements/steps that integrate the natural principle into the claimed invention such that the natural principle is practically applied, and are sufficient to ensure that the claim amounts to significantly more than the natural principle itself.

If the claim as a whole satisfies this inquiry, the claim is directed to patent-eligible subject matter. If the claim as a whole does not satisfy this inquiry, it should be rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.

ESSENTIAL INQUIRIES FOR SUBJECT MATTER ELIGIBILITY UNDER 35 U.S.C. 101

After determining what applicant invented and establishing the broadest reasonable interpretation of the claimed invention, conduct the following three inquiries on the claim as a whole to determine whether the claim is drawn to patent-eligible subject matter. Further details regarding each inquiry are provided below.

1. Is the claimed invention directed to a process,defined as an act, or a series of acts or steps?

Under this analysis, the claim must be drawn to a process. A process is defined as an act, or a series of acts or steps. Process claims are sometimes called method claims.


- If no, this analysis is not applicable.

- If yes, proceed to Inquiry 2.


2. Does the claim focus on use of a law of nature,a natural phenomenon, or naturally occurring relation or correlation (collectively referred to as a natural principle herein)? (Is the natural principle a limiting feature of the claim?)

A natural principle is the handiwork of nature and occurs without the hand of man. For example, the disinfecting property of sunlight is a natural principle. The relationship between blood glucose levels and diabetes is a natural principle. A correlation that occurs naturally when a man-made product, such as a drug, interacts with a naturally occurring substance, such as blood, is also considered a natural principle because, while it takes a human action to trigger a manifestation of the correlation,the correlation exists in principle apart from any human action.

For this analysis, a claim focuses on a natural principle when the natural principle is a limiting element or step.

In that case, the claim must be analyzed (in Inquiry 3) to ensure that the claim is directed to a practical application of the natural principle that amounts to substantially more than the natural principle itself. So, for instance, a claim that recites a correlation used to make a diagnosis focuses on a natural principle and would require further analysis under Inquiry 3.

If a natural principle is not a limitation of the claim, the claim does not focus on the use of a natural principle and requires no further analysis under this procedure. If the claim focuses on an abstract idea, such as steps that can be performed entirely in one’s mind, methods of controlling human activity, or mere plans for performing an action, refer to MPEP § 2106 to evaluate eligibility.

- If no, this analysis is complete,and the claim should be analyzed to determine if an abstract idea is claimed (see MPEP § 2106).

- If yes,proceed to Inquiry 3.

3. Does the claim include additional elements/steps or a combination of elements/steps that integrate the natural principle into the claimed invention such that the natural principle is practically applied, and are sufficient to ensure that the claim amounts to significantly more than the natural principle itself? (Is it more than a law of nature plus the general instruction to simply “apply it”?)

A claim that focuses on use of a natural principle must also include additional elements or steps to show that the inventor has practically applied, or added something significant to, the natural principle itself.

To show integration, the additional elements or steps must relate to the natural principle in a significant way to impose a meaningful limit on the claim scope. The claim cannot cover the natural principle itself such that it is effectively standing alone. A bare statement of a naturally occurring correlation,albeit a newly discovered natural correlation or very narrowly confined correlation, would fail this inquiry.

It is not necessary that every recited element or step integrate or relate to the natural principle as long as it is applied in some practical manner. However, there must be at least one additional element or step that applies,relies on or uses the natural principle so that the claim amounts to significantly more than the natural principle itself.

Elements or steps that do not integrate the natural principle and are merely appended to it would not be sufficient. For example, a claim to diagnosing an infection that recites the step of correlating the presence of a certain bacterium in a person’s blood with a particular type of bacterial infection with the additional step of recording the diagnosis on a chart would not be eligible because the step of recording the diagnosis on the chart is extra-solution activity that is unrelated to the correlation and does not integrate the correlation into the invention.

Along with integration, the additional steps must be sufficient to ensure that the claim amounts to significantly more than the natural principle itself by including one or more elements or steps that limit the scope of the claim and do more than generally describe the natural principle with generalized instructions to “apply it.”

The additional elements or steps must narrow the scope of the claim such that others are not foreclosed from using the natural principle (a basic tool of scientific and technological work) for future innovation.

Elements or steps that are well-understood, purely conventional,and routinely taken by others in order to apply the natural principle, or that only limit the use to a particular technological environment (field-of-use), would not be sufficiently specific. A claim with steps that add something of significance to the natural laws themselves would be eligible because it would confine its reach to particular patent-eligible applications of those laws, such as a typical patent on a new drug (including associated method claims) or a new way of using an existing drug.

In other words, the claim must be limited so that it does not preempt the natural principle being recited by covering every substantial practical application of that principle.The process must have additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself.


- If no, the claim is not patent-eligible and should be rejected.

- If yes,the claim is patent-eligible, and the analysis is complete.

SAMPLE ANALYSIS

Sample Claim Drawn to a Patent-Eligible PracticalApplication - Diamond v. Diehr

1. A method of operating a rubber-molding press for precision molded compounds with the aid of a digital computer, comprising:

providing said computer with a data base for said press including at least,

natural logarithm conversion data (ln),

the activation energy constant (C) unique to each batch of said compound being molded, and

a constant (x)dependent upon the geometry of the particular mold of the press,

initiating an interval timer in said computer upon the closure of the press for monitoring the elapsed time of said closure,

constantly determining the temperature (Z) of the mold at a location closely adjacent to the mold cavity in the press during molding,

constantly providing the computer with the temperature (Z),

repetitively calculating in the computer, at frequent intervals during each cure, the Arrhenius equation for reaction time during the cure,

which is ln v = CZ + x where v is the total required cure time,

repetitively comparing in the computer at said frequent intervals during the cure each said calculation of the total required cure time calculated with the Arrhenius equation and said elapsed time,

and opening the press automatically when a said comparison indicates equivalence.

The above claim was found to be a patent- eligible practical application in Diamond v. Diehr, 450 U.S. 175(1981).

Recently, the Supreme Court looked back to this claim as an example of a patent-eligible practical application as explained in the following excerpt from Mayo:

The Court pointed out that the basic mathematical equation, like a law of nature, was not patentable.

But it found the overall process patent eligible because of the way the additional steps of the process integrated the equation into the process as a whole. Those steps included “installing rubber in a press, closing the mold, constantly determining the temperature of the mold, constantly recalculating the appropriate cure time through the use of the formula and a digital computer, and automatically opening the press at the proper time.”

It no where suggested that all these steps, or at least the combination of those steps, were in context obvious,already in use, or purely conventional. And so the patentees did not “seek to pre-empt the use of the equation,” but sought “only to foreclose from others the use of that equation in conjunction with all of the other steps in their claimed process.”

These other steps apparently added to the formula something that in terms of patent law’s objectives had significance—they transformed the process into an inventive application of the formula.


This claim would pass Inquiries 1-3 in the above analysis as it is a process that includes the Arrhenius equation as a limitation, with additional steps that integrate the Arrhenius equation into the process and are sufficient to narrow the scope of the claim so that others are not foreclosed from using the Arrhenius equation in different applications


Sample Claim Drawn to Ineligible Subject Matter - Mayo v. Prometheus

1. A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastro intestinal disorder, comprising:

(a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastro intestinal disorder; and

(b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,

wherein the level of 6-thioguanine less than about 230 pmol per 8x108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and

wherein the level of 6-thioguanine greater than about 400 pmol per 8x108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

The above claim was found to be ineligible in Mayo. The Supreme Court determined that the claim focused on use of a law of nature that was given weight during prosecution of the claim – specifically the relationships between concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will prove ineffective or cause harm. The Court analyzed the claim as follows:

The question before us is whether the claims do significantly more than simply describe these natural relations. To put the matter more precisely, do the patent claims add enough to their statements of the correlations to allow the processes they describe to qualify as patent-eligible processes that apply natural laws? We believe that the answer to this question is no.

The upshot is that the three steps simply tell doctors to gather data from which they may draw an inference in light of the correlations. To put the matter more succinctly, the claims inform a relevant audience about certain laws of nature; any additional steps consist of well understood, routine,conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately. For these reasons we believe that the steps are not sufficient to transform un-patentable natural correlations into patentable applications of those regularities.

This claim would pass Inquiries 1-2 and fail Inquiry 3. It is a process claim that includes a natural principle that was construed as a limiting feature of a claim during prosecution - the natural principle being the naturally occurring relationships noted above, which are a consequence of the ways in which thiopurine compounds are metabolized by the body.

The Court emphasized that while it takes a human action to trigger a manifestation of this relation in a particular person, the relation itself exists in principle apart from any human action. The additional steps integrate the relationship into the process as the administering step involves the thiopurine drug, the determining step establishes the thiopurine drug level and the wherein clauses set forth the critical levels.

The steps are not sufficient, however,to narrow the application such that others could still make use of the naturally occurring relationship in other practical applications. The claim essentially sets forth a law of nature with generalized instructions to apply it.


Making a Rejection

After performing the appropriate Inquiries, a claim that fails Inquiry 3 should be rejected under 35 U.S.C. 101 as not being drawn to patent-eligible subject matter.

When making the rejection,

- identify the natural principle,

- identify that the claim is effectively directed to a natural principle itself, and

- explain the reason(s) that the additional claim features or combination of features, when the claim is taken as a whole, fail to integrate the natural principle into the claimed invention so that the natural principle is practically applied, and/or

- fail to be sufficient to ensure that the claim amounts to significantly more than the natural principle itself.


A sample rejection of the following claim could read as follows:

Claim 1. A method of determining effective dosage of insulin to a patient, comprising the steps of administering a dose of insulin to a patient, testing the patient’s blood for the blood sugar level, and evaluating whether the insulin dosage is effective based on the blood sugar level.

Analysis:


The claim passes Inquiry 1 because it is drawn to a process.

The claim passes Inquiry 2 because a naturally occurring correlation between insulin and blood glucose levels is a limitation of the claim.

The claim does not pass Inquiry 3 because, although the additional steps integrate or make use of the correlation in the process by administering insulin in one step and testing for the correlation in another step, the steps are not sufficient to ensure that the claim amounts to significantly more than the correlation itself since every application of the correlation would require an administration of insulin and testing of blood to observe the relationship between insulin and blood glucose levels.

The rejection:

Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter because it is not a patent-eligible practical application of a law of nature.

The claim is directed to a naturally occurring correlation between insulin and blood glucose levels. The combination of steps recited in the claim taken as a whole, including the steps of administering insulin to a patient and testing blood sugar levels, are not sufficient to qualify as a patent-eligible practical application as the claim covers every substantial practical application of the correlation.

Evaluating a Response

A proper response to a rejection based on failure to claim patent-eligible subject matter would be an amendment adding additional steps/features or amending existing steps/features that integrate the natural principle into the process (by practically applying or making use of the principle) and are sufficient to limit the application of the natural principle to more than the principle itself + steps that do more than simply “apply it” at a high level of generality.

Examples of both eligible and ineligible hypothetical claims follow. It would also be proper for the applicant to present persuasive arguments that the additional steps add something significantly more to the claim than merely describing the natural principle. A showing that the steps are not routine, well-known or conventional could be persuasive.

For example, a claim that uses the natural disinfecting properties of sunlight would require additional steps beyond exposing an item requiring disinfection to sunlight. The additional steps could involve constructing a sanitizing device that uses ultraviolet light for disinfection with steps that integrate the ultraviolet light into the device and are sufficient to confine the use of the ultraviolet light to a particular application (not so broad as to cover all practical ways of applying ultraviolet light).

A claim that sets forth the relationship between blood glucose levels and the incidence of diabetes would require additional steps that do significantly more to apply this principle than conventional blood sample testing or diagnostic activity based on recognizing a threshold blood glucose level. Such additional steps could involve a testing technique or treatment steps that would not be conventional or routine.

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