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==[[MPEP 2141|2141 35 U.S.C. 103; the Graham Factual Inquiries]]==
==[[MPEP 2141|2141 35 U.S.C. 103; the Graham Factual Inquiries]]==


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{{Statute|35 U.S.C. 103. Conditions for patentability; non-obvious subject matter.}}
35 U.S.C. 103. Conditions for patentability; non-obvious subject matter.
(a) A patent may not be obtained though the invention is not  
 
(a)A patent may not be obtained though the invention is not  
identically disclosed or described as set forth in section 102 of this  
identically disclosed or described as set forth in section 102 of this  
title, if the differences between the subject matter sought to be patented  
title, if the differences between the subject matter sought to be patented  
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which the invention was made.
which the invention was made.


(b)
(b)(1)Notwithstanding subsection (a), and upon timely election  
<p style="padding-left: +20px;">(1) Notwithstanding subsection (a), and upon timely election  
by the applicant for patent to proceed under this subsection, a  
by the applicant for patent to proceed under this subsection, a  
biotechnological process using or resulting in a composition of  
biotechnological process using or resulting in a composition of  
matter that is novel under section 102 and nonobvious under subsection  
matter that is novel under section 102 and nonobvious under subsection  
(a) of this section shall be considered nonobvious if-</p>
(a) of this section shall be considered nonobvious if-


<p style="padding-left: +40px;">(A) claims to the process and the composition of matter  
(A)claims to the process and the composition of matter  
are contained in either the same application for patent or in separate  
are contained in either the same application for patent or in separate  
applications having the same effective filing date; and</p>
applications having the same effective filing date; and


<p style="padding-left: +40px;">(B) the composition of matter, and the process at the time  
(B)the composition of matter, and the process at the time  
it was invented, were owned by the same person or subject to an  
it was invented, were owned by the same person or subject to an  
obligation of assignment to the same person.</p>
obligation of assignment to the same person.


<p style="padding-left: +20px;">(2) A patent issued on a process under paragraph (1)-</p>
(2)A patent issued on a process under paragraph (1)-


<p style="padding-left: +40px;">(A) shall also contain the claims to the composition of  
(A)shall also contain the claims to the composition of  
matter used in or made by that process, or</p>
matter used in or made by that process, or


<p style="padding-left: +40px;">(B) shall, if such composition of matter is claimed in  
(B)shall, if such composition of matter is claimed in  
another patent, be set to expire on the same date as such other  
another patent, be set to expire on the same date as such other  
patent, notwithstanding section 154.</p>
patent, notwithstanding section 154.
 
(3)For purposes of paragraph (1), the term “biotechnological
process” means-
 
 
 


<p style="padding-left: +20px;">(3) For purposes of paragraph (1), the term “biotechnological
process” means-</p>


<p style="padding-left: +40px;">(A) a process of genetically altering or otherwise  
(A)a process of genetically altering or otherwise  
inducing a single- or multi-celled organism to-</p>
inducing a single- or multi-celled organism to-


<p style="padding-left: +60px;">(i) express an exogenous nucleotide sequence,</p>
(i)express an exogenous nucleotide sequence,


<p style="padding-left: +60px;">(ii) inhibit, eliminate, augment, or alter expression  
(ii)inhibit, eliminate, augment, or alter expression  
of an endogenous nucleotide sequence, or</p>
of an endogenous nucleotide sequence, or


<p style="padding-left: +60px;">(iii) express a specific physiological characteristic  
(iii)express a specific physiological characteristic  
not naturally associated with said organism;</p>
not naturally associated with said organism;


<p style="padding-left: +40px;">(B) cell fusion procedures yielding a cell line that  
(B)cell fusion procedures yielding a cell line that  
expresses a specific protein, such as a monoclonal antibody; and</p>
expresses a specific protein, such as a monoclonal antibody; and


<p style="padding-left: +40px;">(C) a method of using a product produced by a process  
(C)a method of using a product produced by a process  
defined by subparagraph (A) or (B), or a combination of subparagraphs  
defined by subparagraph (A) or (B), or a combination of subparagraphs  
(A) and (B).</p>
(A) and (B).
 


(c)


<p style="padding-left: +20px;">(1) Subject matter developed by another person, which  
(c)(1) Subject matter developed by another person, which  
qualifies as prior art only under one or more of subsections (e), (f),  
qualifies as prior art only under one or more of subsections (e), (f),  
and (g) of section 102 of this title, shall not preclude patentability  
and (g) of section 102 of this title, shall not preclude patentability  
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were, at the time the claimed invention was made, owned by  
were, at the time the claimed invention was made, owned by  
the same person or subject to an obligation of assignment to the  
the same person or subject to an obligation of assignment to the  
same person.</p>
same person.


<p style="padding-left: +20px;">(2) For purposes of this subsection, subject matter developed  
(2)For purposes of this subsection, subject matter developed  
by another person and a claimed invention shall be deemed  
by another person and a claimed invention shall be deemed  
to have been owned by the same person or subject to an obligation  
to have been owned by the same person or subject to an obligation  
of assignment to the same person if —</p>
of assignment to the same person if —  


<p style="padding-left: +40px;">(A) the claimed invention was made by or on behalf of  
(A)the claimed invention was made by or on behalf of  
parties to a joint research agreement that was in effect on or before  
parties to a joint research agreement that was in effect on or before  
the date the claimed invention was made;</p>
the date the claimed invention was made;


<p style="padding-left: +40px;">(B) the claimed invention was made as a result of  
(B)the claimed invention was made as a result of  
activities undertaken within the scope of the joint research agreement;  
activities undertaken within the scope of the joint research agreement;  
and</p>
and  


<p style="padding-left: +40px;">(C)the application for patent for the claimed invention  
(C)the application for patent for the claimed invention  
discloses or is amended to disclose the names of the parties to the  
discloses or is amended to disclose the names of the parties to the  
joint research agreement.</p>
joint research agreement.  


<p style="padding-left: +20px;">(3) For purposes of paragraph (2), the term “joint  
(3)For purposes of paragraph (2), the term “joint  
research agreement” means a written contract, grant, or cooperative  
research agreement” means a written contract, grant, or cooperative  
agreement entered into by two or more persons or entities for  
agreement entered into by two or more persons or entities for  
the performance of experimental, developmental, or research  
the performance of experimental, developmental, or research  
work in the field of the claimed invention.</p>
work in the field of the claimed invention.
|}




'''I. STANDARD OF PATENTABILITY TO BE APPLIED IN OBVIOUSNESS REJECTIONS'''
 
I. STANDARD OF PATENTABILITY TO  
BE APPLIED IN OBVIOUSNESS REJECTIONS
 


Patent examiners carry the responsibility of making  
Patent examiners carry the responsibility of making  
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sought to be patented. As indicia of obviousness or nonobviousness,  
sought to be patented. As indicia of obviousness or nonobviousness,  
these inquires may have relevancy. . .  
these inquires may have relevancy. . .  


This in not to say, however, that there will not be difficulties  
This in not to say, however, that there will not be difficulties  
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for determining obviousness are as follows:
for determining obviousness are as follows:


# Determining the scope and contents of the prior art
(A)Determining the scope and contents of the  
# Ascertaining the differences between the prior art and the claims in issue
prior art;
# Resolving the level of ordinary skill in the pertinent art and
 
# Evaluating evidence of secondary considerations.
(B)Ascertaining the differences between the  
prior art and the claims in issue;
 
(C)Resolving the level of ordinary skill in the  
pertinent art; and  
 
(D)Evaluating evidence of secondary considerations.
 


The Supreme Court reaffirmed and relied upon the  
The Supreme Court reaffirmed and relied upon the  
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patentability under 35 U.S.C. 103 set forth in Graham.  
patentability under 35 U.S.C. 103 set forth in Graham.  
See below for a detailed discussion of each of  
See below for a detailed discussion of each of  
the Graham factual inquiries. It should be noted that  
the Graham factual inquiries. It should be noted that  
the Supreme Court’s application of the Graham test to  
the Supreme Court’s application of the Graham test to  
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156 USPQ 406 (Ct. Cl. 1967).
156 USPQ 406 (Ct. Cl. 1967).


'''II. BASIC CONSIDERATIONS WHICH APPLY TO OBVIOUSNESS REJECTIONS'''
 
 
II. BASIC CONSIDERATIONS WHICH  
APPLY TO OBVIOUSNESS REJECTIONS  


When applying 35 U.S.C. 103, the following tenets  
When applying 35 U.S.C. 103, the following tenets  
of patent law must be adhered to:
of patent law must be adhered to:


# The claimed invention must be considered as a whole
(A)The claimed invention must be considered as  
# The references must be considered as a whole and must suggest the desirability and thus the obviousness of making the combination
a whole;
# The references must be viewed without the benefit of impermissible hindsight vision afforded by the claimed invention and  
 
# Reasonable expectation of success is the standard with which obviousness is determined.
(B)The references must be considered as a whole  
and must suggest the desirability and thus the obviousness  
of making the combination;
 
(C)The references must be viewed without the  
benefit of impermissible hindsight vision afforded by  
the claimed invention; and  
 
(D)Reasonable expectation of success is the standard  
with which obviousness is determined.
 
Hodosh v. Block Drug Co., Inc., 786 F.2d 1136,
1143 n.5, 229 USPQ 182, 187 n.5 (Fed. Cir. 1986).
 


Hodosh v. Block Drug Co., Inc., 786 F.2d 1136, 1143 n.5, 229 USPQ 182, 187 n.5 (Fed. Cir. 1986).


'''III. OBJECTIVE EVIDENCE MUST BE CONSIDERED'''
III. OBJECTIVE EVIDENCE MUST BE  
CONSIDERED


Objective evidence or secondary considerations  
Objective evidence or secondary considerations  
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determination on patentability is made on the  
determination on patentability is made on the  
entire record. In re Oetiker, 977 F.2d 1443, 1446,  
entire record. In re Oetiker, 977 F.2d 1443, 1446,  
24 USPQ2d 1443, 1445 (Fed. Cir. 1992). However,  
24  
USPQ2d 1443, 1445 (Fed. Cir. 1992). However,  
evidence developed after the patent grant in response  
evidence developed after the patent grant in response  
to challenge to the patent validity’s should not be  
to challenge to the patent validity’s should not be  
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be relevant to the patent validity inquiry).
be relevant to the patent validity inquiry).


See [[MPEP 716|MPEP § 716 - § 716.06]] for a discussion of  
See MPEP § 716 - § 716.06 for a discussion of  
objective evidence and its role in the final legal determination  
objective evidence and its role in the final legal determination  
of whether a claimed invention would have  
of whether a claimed invention would have  
been obvious under 35 U.S.C. 103.
been obvious under 35 U.S.C. 103.


===2141.01 Scope and Content of the Prior Art===
2141.01Scope and Content of the Prior  
Art [R-3]


'''I. PRIOR ART AVAILABLE UNDER 35 U.S.C. 102 IS AVAILABLE UNDER 35 U.S.C. 103'''
I.PRIOR ART AVAILABLE UNDER 35 U.S.C.  
102 IS AVAILABLE UNDER 35  
U.S.C. 103


“Before answering Graham’s ‘content’ inquiry, it  
“Before answering Graham’s ‘content’ inquiry, it  
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1593, 1597 (Fed. Cir.), cert. denied, 481 U.S. 1052  
1593, 1597 (Fed. Cir.), cert. denied, 481 U.S. 1052  
(1987). Subject matter that is prior art under  
(1987). Subject matter that is prior art under  
35 U.S.C. 102 can be used to support a rejection  
35  
U.S.C. 102 can be used to support a rejection  
under section 103. Ex parte Andresen, 212 USPQ 100,  
under section 103. Ex parte Andresen, 212 USPQ 100,  
102 (Bd. Pat. App. & Inter. 1981) (“it appears to us  
102 (Bd. Pat. App. & Inter. 1981) (“it appears to us  
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102(a), 102(b), 102(e), etc. depending on the type of  
102(a), 102(b), 102(e), etc. depending on the type of  
prior art reference used and its publication or issue  
prior art reference used and its publication or issue  
date. For instance, an obviousness rejection over a  
date. For instance, an obviousness rejection over a  
U.S. patent which was issued more than 1 year before  
U.S. patent which was issued more than 1 year before  
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For an overview of what constitutes prior art under  
For an overview of what constitutes prior art under  
35 U.S.C. 102, see [[MPEP 901|MPEP § 901 - § 901.06(d)]] and  
35  
[[MPEP 2121|§ 2121]] - [[MPEP 2129|§ 2129]].
U.S.C. 102, see MPEP § 901 - § 901.06(d) and  
§
2121 - § 2129.


'''II. SUBSTANTIVE CONTENT OF THE PRIOR ART'''
II.SUBSTANTIVE CONTENT OF THE PRIOR  
ART


See [[MPEP 2121|§ 2121]] - [[MPEP 2129|§ 2129]] for case law relating to  
See MPEP § 2121 - § 2129 for case law relating to  
the substantive content of the prior art (e.g., availability  
the substantive content of the prior art (e.g., availability  
of inoperative devices, extent to which prior art  
of inoperative devices, extent to which prior art  
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embodiments, admissions, etc.).
embodiments, admissions, etc.).


'''III. CONTENT OF THE PRIOR ART IS DETERMINED AT THE TIME THE INVENTION WAS MADE TO AVOID HINDSIGHT'''
III.CONTENT OF THE PRIOR ART IS DETERMINED  
AT THE TIME THE INVENTION  
WAS MADE TO AVOID HINDSIGHT


The requirement “at the time the invention was  
The requirement “at the time the invention was  
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denied, 469 U.S. 851 (1984).  
denied, 469 U.S. 851 (1984).  


'''IV. 35 U.S.C. 103(c) — EVIDENCE REQUIRED TO SHOW CONDITIONS OF 35 U.S.C. 103 (c) APPLY'''
IV.35 U.S.C. 103(c) — EVIDENCE REQUIRED  
TO SHOW CONDITIONS OF 35 U.S.C. 103  
(c) APPLY


An applicant who wants to avail himself or herself  
An applicant who wants to avail himself or herself  
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of section 102. See MPEP § 706.02(l)(1). See also In  
of section 102. See MPEP § 706.02(l)(1). See also In  
re Bartfeld, 925 F.2d 1450, 1453-54, 17  
re Bartfeld, 925 F.2d 1450, 1453-54, 17  
USPQ2d 1885, 1888 (Fed. Cir. 1991) (Applicant attempted to  
USPQ2d  
1885, 1888 (Fed. Cir. 1991) (Applicant attempted to  
overcome a 35 U.S.C. 102(e)/103 rejection with a terminal  
overcome a 35 U.S.C. 102(e)/103 rejection with a terminal  
disclaimer by alleging that the public policy  
disclaimer by alleging that the public policy  
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“secret” prior art in obviousness determinations. The  
“secret” prior art in obviousness determinations. The  
court rejected this argument, holding “We may not  
court rejected this argument, holding “We may not  
disregard the unambiguous exclusion of § 102(e)  
disregard the unambiguous exclusion of §
102(e)  
from the statute’s purview.”).
from the statute’s purview.”).


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or a joint research agreement.
or a joint research agreement.


====2141.01(a) Analogous and Nonanalogous Art====


'''I. TO RELY ON A REFERENCE UNDER 35 U.S.C. 103, IT MUST BE ANALOGOUS PRIOR ART'''
 
 
 
2141.01(a)Analogous and Nonanalogous
Art [R-3]
 
 
 
I. TO RELY ON A REFERENCE UNDER  
35 U.S.C. 103, IT MUST BE ANALOGOUS  
PRIOR ART


The examiner must determine what is “analogous  
The examiner must determine what is “analogous  
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problem with which the inventor is involved).  
problem with which the inventor is involved).  


'''II. PTO CLASSIFICATION IS SOME EVIDENCE OF ANALOGY, BUT SIMILARITIES AND DIFFERENCES IN STRUCTURE AND FUNCTION CARRY MORE WEIGHT'''
 
 
II. PTO CLASSIFICATION IS SOME EVIDENCE  
OF ANALOGY, BUT SIMILARITIES  
AND DIFFERENCES IN STRUC-
TURE AND FUNCTION CARRY MORE  
WEIGHT


While Patent Office classification of references and  
While Patent Office classification of references and  
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underground formation anomalies.).
underground formation anomalies.).


'''III. ANALOGY IN THE CHEMICAL ARTS'''
 
 
III. ANALOGY IN THE CHEMICAL ARTS


See, for example, Ex parte Bland, 3 USPQ2d 1103  
See, for example, Ex parte Bland, 3 USPQ2d 1103  
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would  
would  
have been pertinent to the problems in the  
have been pertinent to the problems in the  
other references and the invention at hand.); Stratoflex,  
other references and the invention at hand.); Stratoflex,  
Inc. v. Aeroquip Corp., 713 F.2d 1530, 218 USPQ  
Inc. v. Aeroquip Corp., 713 F.2d 1530, 218 USPQ  
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would include the dye arts in general.).
would include the dye arts in general.).


'''IV. ANALOGY IN THE MECHANICAL ARTS'''
 
 
IV. ANALOGY IN THE MECHANICAL  
ARTS


See, for example, In re Oetiker, 977 F.2d 1443,  
See, for example, In re Oetiker, 977 F.2d 1443,  
24 USPQ2d 1443 (Fed. Cir. 1992) (Applicant claimed  
24  
an improvement in a hose clamp which differed from  
USPQ2d 1443 (Fed. Cir. 1992) (Applicant claimed  
an  
improvement in a hose clamp which differed from  
the prior art in the presence of a preassembly “hook”  
the prior art in the presence of a preassembly “hook”  
which maintained the preassembly condition of the  
which maintained the preassembly condition of the  
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need for a simple holding means to enable frequent,  
need for a simple holding means to enable frequent,  
secure attachment and easy removal of a marker pen  
secure attachment and easy removal of a marker pen  
to and from a pen arm, and one skilled in the pen art  
to and from a pen arm, and one skilled in the pen art  
trying to solve that problem would have looked to the  
trying to solve that problem would have looked to the  
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materials to accomplish their respective purposes.).
materials to accomplish their respective purposes.).


'''V. ANALOGY IN THE ELECTRICAL ARTS'''
 
 
 
V. ANALOGY IN THE ELECTRICAL  
ARTS


See, for example, Wang Laboratories, Inc. v.  
See, for example, Wang Laboratories, Inc. v.  
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were in an analogous art.).
were in an analogous art.).


'''VI. EXAMPLES OF ANALOGY IN THE DESIGN ARTS'''
 
 
VI. EXAMPLES OF ANALOGY IN THE  
DESIGN ARTS


See MPEP § 1504.03 for a discussion of the relevant  
See MPEP § 1504.03 for a discussion of the relevant  
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at 1400.).  
at 1400.).  


===2141.02 Differences Between Prior Art and Claimed Invention===
2141.02Differences Between Prior Art  
and Claimed Invention [R-5]


Ascertaining the differences between the prior art  
Ascertaining the differences between the prior art  
and the claims at issue requires interpreting the claim  
and the claims at issue requires interpreting the claim  
language, and considering both the invention and the  
language, and considering both the invention and the  
prior art references as a whole. See MPEP § 2111 - § 2116.01 for case law pertaining to claim interpretation.
prior art references as a whole. See MPEP § 2111 -  


'''I.THE CLAIMED INVENTION AS A WHOLE MUST BE CONSIDERED'''
 
 
 
 
§
2116.01 for case law pertaining to claim interpretation.
 
 
I.THE CLAIMED INVENTION AS A  
WHOLE MUST BE CONSIDERED


In determining the differences between the prior art  
In determining the differences between the prior art  
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product.).  
product.).  


'''II.DISTILLING THE INVENTION DOWN TO A “GIST” OR “THRUST” OF AN INVENTION DISREGARDS “AS A WHOLE” REQUIREMENT'''
II.DISTILLING THE INVENTION DOWN  
TO A “GIST” OR “THRUST” OF AN INVENTION  
DISREGARDS “AS A WHOLE”  
REQUIREMENT


Distilling an invention down to the “gist” or  
Distilling an invention down to the “gist” or  
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word solution to a problem).
word solution to a problem).


'''III.DISCOVERING SOURCE/CAUSE OF A PROBLEM IS PART OF “AS A WHOLE” INQUIRY'''
III.DISCOVERING SOURCE/CAUSE OF A  
PROBLEM IS PART OF “AS A WHOLE”  
INQUIRY


“[A] patentable invention may lie in the discovery  
“[A] patentable invention may lie in the discovery  
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identified. This is part of the ‘subject matter as a  
identified. This is part of the ‘subject matter as a  
whole’ which should always be considered in determining  
whole’ which should always be considered in determining  
the obviousness of an invention under 35 U.S.C. § 103.” In re Sponnoble, 405 F.2d 578, 585,  
the obviousness of an invention under 35  
 
 
 
 
 
U.S.C. § 103.” In re Sponnoble, 405 F.2d 578, 585,  
160 USPQ 237, 243 (CCPA 1969). However, “discovery  
160 USPQ 237, 243 (CCPA 1969). However, “discovery  
of the cause of a problem . . does not always result  
of the cause of a problem . . does not always result  
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problem.
problem.


'''IV.APPLICANTS ALLEGING DISCOVERY OF A SOURCE OF A PROBLEM MUST PROVIDE SUBSTANTIATING EVIDENCE'''
IV.APPLICANTS ALLEGING DISCOVERY  
OF A SOURCE OF A PROBLEM MUST  
PROVIDE SUBSTANTIATING EVI-
DENCE


Applicants who allege they discovered the source  
Applicants who allege they discovered the source  
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problem of manual clearinghouse operations.).
problem of manual clearinghouse operations.).


'''V.DISCLOSED INHERENT PROPERTIES ARE PART OF “AS A WHOLE” INQUIRY'''
V.DISCLOSED INHERENT PROPERTIES  
ARE PART OF “AS A WHOLE” INQUIRY


“In determining whether the invention as a whole  
“In determining whether the invention as a whole  
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volume to contractor ratio, and therefore the parameter  
volume to contractor ratio, and therefore the parameter  
optimized was not recognized in the art to be a  
optimized was not recognized in the art to be a  
result-effective variable.). See also In re Papesch, 315  
result-effective variable.). See also In re Papesch, 315  
F.2d 381, 391, 137 USPQ 43, 51 (CCPA 1963)  
F.2d 381, 391, 137 USPQ 43, 51 (CCPA 1963)  
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rejections based on inherency.
rejections based on inherency.


'''VI.PRIOR ART MUST BE CONSIDERED IN ITS ENTIRETY, INCLUDING DISCLOSURES THAT TEACH AWAY FROM THE CLAIMS'''
VI.PRIOR ART MUST BE CONSIDERED IN  
ITS ENTIRETY, INCLUDING DISCLOSURES  
THAT TEACH AWAY FROM THE  
CLAIMS


A prior art reference must be considered in its  
A prior art reference must be considered in its  
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does not criticize, discredit, or otherwise discourage  
does not criticize, discredit, or otherwise discourage  
the solution claimed….” In re Fulton,  
the solution claimed….” In re Fulton,  
391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed.  
391  
F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed.  
Cir. 2004). See also MPEP § 2123.
Cir. 2004). See also MPEP § 2123.


===2141.03 Level of Ordinary Skill in the Art===
2141.03Level of Ordinary Skill in the  
Art [R-2]


'''FACTORS TO CONSIDER IN DETERMINING LEVEL OF ORDINARY SKILL'''
FACTORS TO CONSIDER IN DETERMINING  
LEVEL OF ORDINARY SKILL  


“Factors that may be considered in determining  
“Factors that may be considered in determining  
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ordinary skill in the art”).
ordinary skill in the art”).


'''SPECIFYING A PARTICULAR LEVEL OF SKILL IS NOT NECESSARY WHERE THE PRIOR ART ITSELF REFLECTS AN APPROPRIATE LEVEL'''
 
 
 
 
SPECIFYING A PARTICULAR LEVEL OF  
SKILL IS NOT NECESSARY WHERE THE PRIOR  
ART ITSELF REFLECTS AN APPROPRIATE  
LEVEL


If the only facts of record pertaining to the level of  
If the only facts of record pertaining to the level of  
Line 930: Line 1,080:
2001).
2001).


'''ASCERTAINING LEVEL OF ORDINARY SKILL IS NECESSARY TO MAINTAIN OBJECTIVITY'''
ASCERTAINING LEVEL OF ORDINARY SKILL  
IS NECESSARY TO MAINTAIN OBJECTIVITY


“The importance of resolving the level of ordinary  
“The importance of resolving the level of ordinary  
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218 USPQ 865 (Fed. Cir. 1983), cert. denied, 464  
218 USPQ 865 (Fed. Cir. 1983), cert. denied, 464  
U.S. 1043 (1984).
U.S. 1043 (1984).
<noinclude>{{MPEP Section|2138|2100|2142}}</noinclude>
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