Obviousness Under 35 USC 103 › newsletter › 2016 › Documents › IPSA2016 › … ·...

Obviousness Under 35 USC 103

July 11, 2016

Peter Corless, Member

IP Summer Academy 2016


Boston, Massachusetts

July 11 – 22, 2016


© 2016 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved.

Outline

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WHAT IS OBVIOUSNESS UNDER 35 USC 103?

• Introduction

•35 USC 103(a), 103(b), and 103(c)

•How does a USPTO examiner, district court judge, ITC judge, or USPTO judge establish a prima

facie case of obviousness?



July 11 – 22, 2016



I. Introduction

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• Three basic patentability requirements: usefulness (35 USC 101); novelty (35 USC 102); and

nonobviousness (35 USC 103)

•Novelty involves applying an objective standard

– Does a single reference describe everything in a claim?

•Nonobviousness involves applying what amounts to a subjective standard

– Would the modification of a single reference or the combination of two or more references have rendered

the subject matter recited in a claim obvious to one of ordinary skill in the art at the time of the invention?



July 11 – 22, 2016



II. 35 USC 103(a)

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• [Filing Date Pre-March 16, 2013]

•35 U.S.C. 103 Conditions for patentability; non-obvious subject matter.

– (a) A patent may not be obtained though the invention is not identically disclosed or described as set forth

in section 102 of this title, if the differences between the subject matter sought to be patented and the prior

art are such that the subject matter as a whole would have been obvious at the time the invention was

made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall

not be negatived by the manner in which the invention was made.



July 11 – 22, 2016



35 USC 103(a)

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• For 103(a), the analysis is similar as for a basic inventive step rejection.

• First, are the cited references proper prior art?

– Particularly important when the references are systems or non-publications

• Second, would the cited reference, or combination of cited references, have taught or

suggested the claimed subject matter to one of ordinary skill in the art?

– Must determine who a person of ordinary skill in the art at the time of the invention is



July 11 – 22, 2016



35 USC 103(a)

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• In 103(a): “Patentability shall not be negatived by the manner in which the invention was

made.”

• The “flash of genius” test does not apply

• The inventor’s mental state is not relevant to the question of nonobviousness

• It is the hypothetical “person of ordinary skill in the art” that is the measure



July 11 – 22, 2016



35 USC 103(b)

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[Filing Date Prior to March 16]

(b) (1) Notwithstanding subsection (a), and upon timely election by the applicant for patent to proceed under this subsection, a biotechnological process using or resulting in a composition of matter that is novel under section 102 and nonobvious under subsection (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 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 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

(B) shall, if such composition of matter is claimed in another patent, be set to expire on the same date as such other patent, notwithstanding section 154.



July 11 – 22, 2016



35 USC 103(b) (continued)

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35 U.S.C. § 103(b) (continued)

(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-

(i) express an exogenous nucleotide sequence,

(ii) inhibit, eliminate, augment, or alter expression of an endogenous nucleotide sequence, or

(iii) express a specific physiological characteristic 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

(C) a method of using a product produced by a process defined by subparagraph (A) or (B), or a combination of subparagraphs (A) and (B).



July 11 – 22, 2016



35 USC 103(c)

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The text of 103(c) is as follows:

35 U.S.C. 103 Conditions for patentability; non-obvious subject matter.

(c)(1) Subject matter developed by another person, which 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

under this section where the subject matter and the claimed invention were, at the time the

claimed invention was made, owned by the same person or subject to an obligation of

assignment to the same person.

[Post March 16, see 102(c)]



July 11 – 22, 2016



35 USC 103(c)

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The text of 103(c) (continued):

(c)(2) For purposes of this subsection, subject matter developed by another person and a claimed invention shall be deemed to have been owned by the same person or subject to an obligation 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 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; and

(C) the application for patent for the claimed invention discloses or is amended to

disclose the names of the parties to the joint research agreement.



July 11 – 22, 2016



35 USC 103(c)

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The text of 103(c) (continued):

(c)(3) For purposes of paragraph (2), the term "joint research agreement" means a written contract, grant, or cooperative agreement entered into by two or more persons or entities for the performance of experimental, developmental, or research work in the field of the claimed invention.



July 11 – 22, 2016



35 USC 103(c)

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•35 U.S.C. § 103(c) – Some history

– 103(c) was amended in December 2004 for implementation of the Cooperative Research and Technology

Enhancement Act of 2004 (CREATE Act)

• 103(c)(1) is effectively the old 103(c)

• 103(c)(2) and 103(c)(3) were added to implement the CREATE Act provisions



July 11 – 22, 2016



35 USC 103(c)

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•35 U.S.C. § 103(c) – Some history

– The CREATE Act was a legislative response to the reality of corporate research and development

partnerships in addition it reversed the treatment of "Secret Prior Art" resulting from the 1997 CAFC decision

in OddzOn Products Inc. v. Just Toys Inc., 122 F.3d 1396 (Fed. Cir 1977)

– The rules were created to implement the CREATE Act



July 11 – 22, 2016



35 USC 103(c)

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•CREATE Act

– Relates to collaborative research projects

– Adversely impacted academic/non-profit research institutes

• because common ownership was impossible in many instances

– Addresses non-commonly owned shared inventions/information

• commonly owned matter was exempted by previous 103(c); now 103(c)(1)

– Non-commonly owned work not associated with a joint research agreement remains potential prior art



July 11 – 22, 2016



35 USC 103 Post AIA

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[Post March 16, 2013]

A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in Section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be

negated by the manner in which the invention was made.



July 11 – 22, 2016



III. How does a USPTO examiner establish a prima facie case of

obviousness?

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•Burden on Examiner to Create Prima Facie Case of Obviousness

• First, what does “prima facie” mean?

• It literally means “at first sight” or “on the face of it”.

• It is used here to mean a legal presumption of obviousness that arises from a basic showing of

facts that support a finding/conclusion of obviousness which will control unless proven untrue

by applicant.



July 11 – 22, 2016




obviousness

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• The initial burden is on the examiner and if the Examiner does not establish prima facie case,

no need to rebut MPEP 2142. The examiner must follow Graham v. John Deere,

383 U.S. 1, 148 USPQ 459 (1966):

•Considerations:

– Scope and content of the prior art

– Differences between the prior art and the claimed invention

– The level of ordinary skill

– Secondary considerations (e.g., surprising activity, commercial success)



July 11 – 22, 2016




obviousness

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• Scope and content of the prior art

– MPEP 706.02(j) is consistent, and indicates that “the relevant teachings of the prior art relied upon” must be

set forth in an Office action and “preferably with reference to the relevant column or page number(s) and

line number(s) where appropriate” PTO has deemphasized the need for actual support in the documents.

*KSR



July 11 – 22, 2016




obviousness

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•Differences between the prior art and the claimed invention

– MPEP 706.02(j) also indicates that the examiner should set forth “the proposed modification of the applied

reference(s) necessary to arrive at the claimed subject matter”



July 11 – 22, 2016




obviousness

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• The level of ordinary skill

• Educational level of people of ordinary skill in the art, for example – See MPEP 2141.03.

• Judge, jury members, and common laymen typically are not ones of ordinary skill.

•MPEP 706.02(j) indicates that the examiner should set forth “an explanation why one of

ordinary skill in the art at the time the invention was made would have been motivated to

make the proposed modification”



July 11 – 22, 2016




obviousness

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• Secondary considerations

– So-called “secondary considerations” must be considered if presented, but

– they only relate to nonobviousness and will not be considered until novelty is established.

– This is not part of the examiner’s burden. Applicant can present these to rebut.



July 11 – 22, 2016




obviousness

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• The examiner also must follow the MPEP (706.02(j) and 2143):

– No longer required but still often used--some teaching, suggestion, or motivation (either in the references

themselves or in the knowledge generally available to one of ordinary skill in the art) to modify the

reference or to combine reference teachings

– A reasonable expectation of success

– The prior art references may teach or suggest all of the claim limitations which would be strong evidence,

but no longer necessary

– KSR Int'l Co. v. Teleflex, Inc., 550 U.S. 398 (2007)



July 11 – 22, 2016




obviousness

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•Motivation

– Must be found in the prior art and not based on applicant’s disclosure.

– Express written motivation to combine does not have to appear in the relied-upon references.

– Examiner must provide explanation and cannot simply conclude that there is motivation or assert that a

substitution would have been within the ordinary skill of the art.

– Three possible sources for the teaching, suggestion, or motivation to modify or combine are:

• nature of problem to be solved

• prior art teachings

• knowledge of persons of ordinary skill in the art



July 11 – 22, 2016




obviousness

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•Reasonable expectation of success

– Must be found in the prior art and not based on applicant’s disclosure.

– Determined at the time the invention was made.

– Usually not an issue in mechanical/electrical, but can be an issue in chemical/biotech.

•All claim limitations

– All words in a claim must be considered.



July 11 – 22, 2016




obviousness

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• There are two basic types of obviousness rejections:

– A single prior art reference is used (less typical)

• Must have been clear to a person of ordinary skill to change what the reference teaches to that which is claimed –

a matter of standard design choice or technique

– Two or more prior art references are combined (more typical)

• A primary reference teaches most of what is claimed, and a secondary reference supplies the missing element(s)

or step(s)



July 11 – 22, 2016




obviousness

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•Obvious to try is not the test. For biotech inventions, see In re Kubin, 561 F.3d 1351 (Fed. Cir.

2009)



July 11 – 22, 2016



Obviousness in U.S. District Court and USITC litigation

• In some ways the procedure is the same as during prosecution

– Accused infringer bears burden of providing a prima facie case of invalidity

– If, and only if, the accused infringer has provided a prima facie case of invalidity, patentee must rebut it

• Unlike at the USPTO, expert testimony on whether the invention would have been obvious to a person of

ordinary skill in the art at the time of the invention is almost always involved

-- May also involve testimony from witnesses on the state of prior art systems at the time of the invention

--especially for computer and method claims, more non-publication prior art appears

• Standard of proof is clear and convincing evidence

-- Patents presumed valid

– a high burden

– Harder to overturn on appeal as it is a question of fact

• Secondary considerations of nonobviousness are often important

• Presumption of validity has different weight with juries, bench trials, and at the ITC



July 11 – 22, 2016



Obviousness in Post-Grant Reviews

•As always, the party challenging validity bears the burden of presenting the evidence for

invalidity

•Difference from litigation—standard of proof for demonstrating invalidity is preponderance of

evidence

– Much lower

– Only publications can be used as prior art

– Less discovery than litigation, but there is some

– Broadest possible interpretation of claims is used



July 11 – 22, 2016



Cases to be aware of

•KSR Int'l Co. v. Teleflex, Inc., 550 U.S. 398 (2007)

• I/P Engine Inc. v. AOL Inc (Fed. Cir. 2014)

--The majority reversed a jury verdict, finding “common sense” would have suggested the

technique in the claim, retaining a query for use in filtering

•Allergan v. Apotex 754 F.3d 952 (Fed. Cir. 2014)

– the Federal Circuit reversed the district court’s decision for clear error, concluding that the district court

missed the probative facts pointing to motivation and the reasonable expectation of success in making

compounds of similar structure and activity as those in the art.

Bristol-Myers Squibb Company v. Teva Pharmaceuticals USA, Inc., 752 F.3d 967 (Fed. Cir. 2014)

the Federal Circuit panel affirmed a lower court finding that BMS’s patent covering the Hep-B drug entecavir is

invalid as obvious

Sanofi-Aventis v. Glenmark 748 F.3d 1354 (Fed. Cir. 2014)

“Synergy” of patented combination that was only recognized after the application filing can still be used to

prove non-obviousness


Thank you!

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