MPEP 2106

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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.