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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]]== | ||
<noinclude | <noinclude>__TOC__</noinclude> | ||
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 | ||
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- | (a) of this section shall be considered nonobvious if- | ||
(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 | applications having the same effective filing date; and | ||
(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. | obligation of assignment to the same person. | ||
(2)A patent issued on a process under paragraph (1)- | |||
(A)shall also contain the claims to the composition of | |||
matter used in or made by that process, or | matter used in or made by that process, or | ||
(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. | patent, notwithstanding section 154. | ||
(3)For purposes of paragraph (1), the term “biotechnological | |||
process” means- | |||
(A)a process of genetically altering or otherwise | |||
inducing a single- or multi-celled organism to- | inducing a single- or multi-celled organism to- | ||
(i)express an exogenous nucleotide sequence, | |||
(ii)inhibit, eliminate, augment, or alter expression | |||
of an endogenous nucleotide sequence, or | of an endogenous nucleotide sequence, or | ||
(iii)express a specific physiological characteristic | |||
not naturally associated with said organism; | not naturally associated with said organism; | ||
(B)cell fusion procedures yielding a cell line that | |||
expresses a specific protein, such as a monoclonal antibody; and | expresses a specific protein, such as a monoclonal antibody; and | ||
(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). | (A) and (B). | ||
(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. | same person. | ||
(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 — | of assignment to the same person if — | ||
(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; | the date the claimed invention was made; | ||
(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 | and | ||
(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. | joint research agreement. | ||
(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. | work in the field of the claimed invention. | ||
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: | ||
(A)Determining the scope and contents of the | |||
prior art; | |||
(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 | |||
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: | ||
(A)The claimed invention must be considered as | |||
a whole; | |||
(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). | |||
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 | 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. | ||
2141.01Scope 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 | |||
“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 | ||
Line 262: | Line 311: | ||
For an overview of what constitutes prior art under | For an overview of what constitutes prior art under | ||
35 U.S.C. 102, see | 35 | ||
U.S.C. 102, see MPEP § 901 - § 901.06(d) and | |||
§ | |||
2121 - § 2129. | |||
II.SUBSTANTIVE CONTENT OF THE PRIOR | |||
ART | |||
See | 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 | |||
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 | |||
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 [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 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 | |||
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 | |||
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 | |||
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 | |||
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.). | ||
2141.02Differences 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 - | prior art references as a whole. See MPEP § 2111 - | ||
§ | |||
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 | |||
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 | |||
“[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 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 | |||
“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 | |||
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. | ||
2141.03Level of Ordinary Skill in the | |||
Art [R-2] | |||
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 | |||
If the only facts of record pertaining to the level of | If the only facts of record pertaining to the level of | ||
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2001). | 2001). | ||
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). | ||