MANUAL OF PATENT EXAMINING PROCEDURE
`
`2141
`
`reduction to practice.” Justus v. Appenzeller, 177 USPQ
`332, 340-41 (Bd. Pat. Inter. 1971).
`
`2141 Examination Guidelines for Determining
`Obviousness Under 35 U.S.C. 103 [R-9]
`
`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.
`(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.
`(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).
`(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.
`(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.
`(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.
`EXAMINATION GUIDELINES FOR
`DETERMINING OBVIOUSNESS UNDER 35 U.S.C.
`103
`
`These guidelines are intended to assist Office personnel
`to make a proper determination of obviousness under 35
`U.S.C. 103, and to provide an appropriate supporting
`rationale in view of the recent decision by the Supreme
`Court in KSR International Co. v. Teleflex Inc. (KSR),
`550 U.S. 398, 82 USPQ2d 1385 (2007). The guidelines
`are based on the Office’s current understanding of the
`law, and are believed to be fully consistent with the
`binding precedent of the Supreme Court. **> The KSR
`decision reinforced earlier decisions that validated a more
`flexible approach to providing reasons for obviousness.
`However, the Supreme Court’s pronouncement in KSR
`has clearly undermined the continued viability of cases
`such as In re Lee, 277 F.3d 1338 (Fed. Cir. 2002), insofar
`as Lee appears to require a strict basis in record evidence
`as a reason to modify the prior art. As the Federal Circuit
`has explained:
`
`At the time [of the decision in In re Lee], we
`required the PTO to identify record evidence of a
`teaching, suggestion, or motivation to combine
`references because “[o]mission of a relevant factor
`required by precedent is both legal error and
`arbitrary agency action.” However, this did not
`preclude examiners from employing common sense.
`More recently [in DyStar Textilfarben GmbH v.
`C.H. Patrick Co., 464 F.3d 1356, 1366
`
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`

`MANUAL OF PATENT EXAMINING PROCEDURE
`
`Court stated that there are “[t]hree cases decided after
`Graham [that] illustrate this doctrine.” Id. at ___, 82
`USPQ2d at 1395. (1) “In United States v. Adams,
`. . . [t]he Court recognized that when a patent claims a
`structure already known in the prior art that is altered by
`the mere substitution of one element for another known
`in the field, the combination must do more than yield a
`predictable result.” Id. at ___, 82 USPQ2d at 1395. (2)
`“In Anderson’s-Black Rock, Inc. v. Pavement Salvage
`Co., . . . [t]he two [pre-existing elements] in combination
`did no more than they would in separate, sequential
`operation.” Id. at ___, 82 USPQ2d at 1395. (3) “[I]n
`Sakraida v. AG Pro, Inc., the Court derived . . . the
`conclusion that when a patent simply arranges old
`elements with each performing the same function it had
`been known to perform and yields no more than one
`would expect from such an arrangement, the combination
`is obvious.” Id. at ___, 82 USPQ2d at 1395-96 (Internal
`quotations omitted.). The principles underlining these
`cases are instructive when the question is whether a patent
`application claiming the combination of elements of prior
`art would have been obvious. The Supreme Court further
`stated that:
`
`When a work is available in one field of endeavor,
`design incentives and other market forces can
`prompt variations of it, either in the same field or a
`different one. If a person of ordinary skill can
`implement a predictable variation, § 103 likely bars
`its patentability. For the same reason, if a technique
`has been used to improve one device, and a person
`of ordinary skill in the art would recognize that it
`would improve similar devices in the same way,
`using the technique is obvious unless its actual
`application is beyond his or her skill. Id. at ___, 82
`USPQ2d at 1396.
`
`When considering obviousness of a combination of known
`elements, the operative question is thus “whether the
`improvement is more than the predictable use of prior art
`elements according to their established functions.” Id .
`at ___, 82 USPQ2d at 1396.
`
`> T
`
`he Supreme Court’s flexible approach to the obviousness
`inquiry is reflected in numerous pre- KSR decisions; see
`MPEP § 2144. That section provides many lines of
`reasoning to support a determination of obviousness based
`upon earlier legal precedent that had condoned the use of
`particular examples of what may be considered common
`sense or ordinary routine practice (e.g., making integral,
`changes in shape, making adjustable). Thus, the type of
`reasoning sanctioned by the opinion in KSR has long been
`a part of the patent examination process.
`
`(Fed.Cir.2006)], we explained that that use of
`common sense does not require a “specific hint or
`suggestion in a particular reference,” only a reasoned
`explanation that avoids conclusory generalizations.
`
`Perfect Web Technologies, Inc. v. InfoUSA, Inc., 587
`F.3d 1324, 1329 (Fed. Cir. 2009) (citations omitted).
`
`< T
`
`hese guidelines do not constitute substantive rule making
`and hence do not have the force and effect of law. They
`have been developed as a matter of internal Office
`management and are not intended to create any right or
`benefit, substantive or procedural, enforceable by any
`party against the Office. Rejections will continue to be
`based upon the substantive law, and it is these rejections
`that are appealable. Consequently, any failure by Office
`personnel to follow the guidelines is neither appealable
`nor petitionable.
`
`I. The KSR Decision and Principles of the Law of
`Obviousness
`
`The Supreme Court in KSR reaffirmed the familiar
`framework for determining obviousness as set forth in
`Graham v. John Deere Co. (383 U.S. 1, 148 USPQ 459
`(1966)), but stated that the Federal Circuit had erred by
`applying the teaching-suggestion-motivation (TSM) test
`in an overly rigid and formalistic way. KSR, 550 U.S. at
`___, 82 USPQ2d at 1391. Specifically, the Supreme Court
`stated that the Federal Circuit had erred in four ways: (1)
`“by holding that courts and patent examiners should look
`only to the problem the patentee was trying to solve ”
`( Id. at ___, 82 USPQ2d at 1397); (2) by assuming “that
`a person of ordinary skill attempting to solve a problem
`will be led only to those elements of prior art designed to
`solve the same problem” ( Id.); (3) by concluding “that a
`patent claim cannot be proved obvious merely by showing
`that the combination of elements was ‘obvious to try’”
`( Id.); and (4) by overemphasizing “the risk of courts and
`patent examiners falling prey to hindsight bias” and as a
`result applying “[r]igid preventative rules that deny
`factfinders recourse to common sense” ( Id. ).
`
`In KSR, the Supreme Court particularly emphasized “the
`need for caution in granting a patent based on the
`combination of elements found in the prior art,” Id. at
`___, 82 USPQ2d at 1395, and discussed circumstances
`in which a patent might be determined to be obvious.
`Importantly, the Supreme Court reaffirmed principles
`based on its precedent that “[t]he combination of familiar
`elements according to known methods is likely to be
`obvious when it does no more than yield predictable
`results.” Id. at ___, 82 USPQ2d at 1395. The Supreme
`
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`2100-112
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`

`

`MANUAL OF PATENT EXAMINING PROCEDURE
`
` Office Personnel As Factfinders
`
`Office personnel fulfill the critical role of factfinder when
`resolving the Graham inquiries. It must be remembered
`that while the ultimate determination of obviousness is a
`legal conclusion, the underlying Graham inquiries are
`factual. When making an obviousness rejection, Office
`personnel must therefore ensure that the written record
`includes findings of fact concerning the state of the art
`and the teachings of the references applied. In certain
`circumstances, it may also be important to include explicit
`findings as to how a person of ordinary skill would have
`understood prior art teachings, or what a person of
`ordinary skill would have known or could have done.
`Factual findings made by Office personnel are the
`necessary underpinnings to establish obviousness.
`
`Once the findings of fact are articulated, Office personnel
`must provide an explanation to support an obviousness
`rejection under 35 U.S.C. 103. 35 U.S.C. 132 requires
`that the applicant be notified of the reasons for the
`rejection of the claim so that he or she can decide how
`best to proceed. Clearly setting forth findings of fact and
`the rationale(s) to support a rejection in an Office action
`leads to the prompt resolution of issues pertinent to
`patentability.
`
`In short, the focus when making a determination of
`obviousness should be on what a person of ordinary skill
`in the pertinent art would have known at the time of the
`invention, and on what such a person would have
`reasonably expected to have been able to do in view of
`that knowledge. This is so regardless of whether the
`source of that knowledge and ability was documentary
`prior art, general knowledge in the art, or common sense.
`What follows is a discussion of the Graham factual
`inquiries.
`
`A. Determining the Scope and Content of the Prior
`Art
`
`In determining the scope and content of the prior art,
`Office personnel must first obtain a
`thorough
`understanding of the invention disclosed and claimed in
`the application under examination by reading the
`specification, including the claims, to understand what
`the applicant has invented. See MPEP § 904. The scope
`of the claimed invention must be clearly determined by
`giving the claims the “broadest reasonable interpretation
`consistent with the specification.” See Phillips v. AWH
`Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed.
`Cir. 2005) and MPEP § 2111. Once the scope of the
`claimed invention is determined, Office personnel must
`then determine what to search for and where to search.
`
`< I
`
`I. The Basic Factual Inquiries of Graham v. John
`Deere Co.
`
`An invention that would have been obvious to a person
`of ordinary skill at the time of the invention is not
`patentable. See 35 U.S.C. 103(a). As reiterated by the
`Supreme Court in KSR, the framework for the objective
`analysis for determining obviousness under 35 U.S.C.
`103 is stated in Graham v. John Deere Co., 383 U.S. 1,
`148 USPQ 459 (1966). Obviousness is a question of law
`based on underlying factual inquiries. The factual inquiries
`enunciated by the Court are as follows:
`(A) **>Determining the scope and content of< the
`prior art; and
`(B) Ascertaining the differences between the claimed
`invention and the prior art; and
`(C) Resolving the level of ordinary skill in the
`pertinent art.
`Objective evidence relevant to the issue of obviousness
`must be evaluated by Office personnel. Id. at 17-18, 148
`USPQ at 467. Such evidence, sometimes referred to as
`“secondary considerations,” may include evidence of
`commercial success, long-felt but unsolved needs, failure
`of others, and unexpected results. The evidence may be
`included in the specification as filed, accompany the
`application on filing, or be provided in a timely manner
`at some other point during the prosecution. The weight
`to be given any objective evidence is made on a
`case-by-case basis. The mere fact that an applicant has
`presented evidence does not mean that the evidence is
`dispositive of the issue of obviousness.
`
`The question of obviousness must be resolved on the basis
`of these factual determinations. While each case is
`different and must be decided on its own facts, the
`Graham factors, including secondary considerations when
`present, are the controlling inquiries in any obviousness
`analysis. The Graham factors were reaffirmed and relied
`upon by the Supreme Court in its consideration and
`determination of obviousness in the fact situation
`presented in KSR, 550 U.S. at ___, 82 USPQ2d at 1391
`(2007). The Supreme Court has utilized the Graham
`factors in each of its obviousness decisions since Graham.
`See Sakraida v. Ag Pro, Inc., 425 U.S. 273, 189 USPQ
`reh’g denied, 426 U.S. 955 (1976); Dann v.
`449,
`Johnston, 425 U.S. 219, 189 USPQ 257 (1976); and
`Anderson’s-Black Rock, Inc. v. Pavement Salvage Co.,
`396 U.S. 57, 163 USPQ 673 (1969). As stated by the
`Supreme Court in KSR, “While the sequence of these
`questions might be reordered in any particular case, the
`[ Graham] factors continue to define the inquiry that
`controls.” KSR, 550 U.S. at ___, 82 USPQ2d at 1391.
`
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`

`

`MANUAL OF PATENT EXAMINING PROCEDURE
`
`1. What To Search For:
`
`The search should cover the claimed subject matter and
`should also cover the disclosed features which might
`reasonably be expected to be claimed. See MPEP §
`904.02. Although a rejection need not be based on a
`teaching or suggestion to combine, a preferred search will
`be directed to finding references that provide such a
`teaching or suggestion if they exist.
`
`2. Where To Search:
`
`Office personnel should continue to follow the general
`search guidelines set forth in MPEP § 904 to § 904.03
`regarding search of the prior art. Office personnel are
`reminded that, for purposes of 35 U.S.C. 103, prior art
`can be either in the field of applicant’s endeavor or be
`reasonably pertinent to the particular problem with which
`the applicant was concerned. Furthermore, prior art that
`is in a field of endeavor other than that of the applicant
`(as noted by the Court in KSR, “[w]hen a work is
`available in one field of endeavor, design incentives and
`other market forces can prompt variations of it, either in
`the same field or a different one,” 550 U.S. at ___, 82
`USPQ2d at 1396 (emphasis added)), or solves a problem
`which is different from that which the applicant was trying
`to solve, may also be considered for the purposes of 35
`U.S.C. 103. (The Court in KSR stated that “[t]he first
`error…in this case was…holding that courts and patent
`examiners should look only to the problem the patentee
`was trying to solve. The Court of Appeals failed to
`recognize that the problem motivating the patentee may
`be only one of many addressed by the patent’s subject
`matter…The second error [was]…that a person of
`ordinary skill attempting to solve a problem will be led
`only to those elements of prior art designed to solve the
`same problem.” 550 U.S. at ___, 82 USPQ2d at 1397.
`Federal Circuit case law prior to the Supreme Court’s
`decision in KSR is generally in accord with these
`statements by the KSR Court. See e.g., In re Dillon, 919
`F.2d 688, 693, 16 USPQ2d 1897, 1902 (Fed. Cir. 1990)
`( en banc) (“[I]t is not necessary in order to establish a
`prima facie case of obviousness that both a structural
`similarity between a claimed and prior art compound (or
`a key component of a composition) be shown and that
`there be a suggestion in or expectation from the prior
`art that the claimed compound or composition will have
`the same or a similar utility as one newly discovered by
`applicant”);
`In re Lintner, 458 F.2d 1013, 1018, 173
`USPQ 560, 562 (CCPA 1972) (“The fact that [applicant]
`uses sugar for a different purpose does not alter the
`conclusion that its use in a prior art composition would
`be prima facie obvious from the purpose disclosed in the
`references.”).).
`
`For a discussion of what constitutes prior art, see MPEP
`§ 901 to § 901.06(d) and § 2121 to § 2129.
`
`B. Ascertaining the Differences Between the Claimed
`Invention and the Prior Art
`
`the claimed
`the differences between
`Ascertaining
`invention and the prior art requires interpreting the claim
`language, see MPEP § 2111, and considering both the
`invention and the prior art as a whole. See MPEP §
`2141.02.
`
`C. Resolving the Level of Ordinary Skill in the Art
`
`Any obviousness rejection should include, either explicitly
`or implicitly in view of the prior art applied, an indication
`of the level of ordinary skill. A finding as to the level of
`ordinary skill may be used as a partial basis for a
`resolution of the issue of obviousness.
`
`The person of ordinary skill in the art is a hypothetical
`person who is presumed to have known the relevant art
`at the time of the invention. Factors that may be
`considered in determining the level of ordinary skill in
`the art may include: (1) “type of problems encountered
`in the art;” (2) “prior art solutions to those problems;” (3)
`“rapidity with which innovations are made;” (4)
`“sophistication of the technology; and” (5) “educational
`level of active workers in the field.>" In re GPAC, 57
`F.3d 1573, 1579, 35 USPQ2d 1116, 1121 (Fed. Cir. 1995).
`"<In a given case, every factor may not be present, and
`one or more factors may predominate.”**> Id.. See
`also< Custom Accessories, Inc. v. Jeffrey-Allan Industries,
`Inc., 807 F.2d 955, 962, 1 USPQ2d 1196, 1201 (Fed. Cir.
`1986); Environmental Designs, Ltd. V. Union Oil Co.,
`713 F.2d 693, 696, 218 USPQ 865, 868 (Fed. Cir. 1983).
`
`“A person of ordinary skill in the art is also a person of
`ordinary creativity, not an automaton.” KSR, 550 U.S. at
`___, 82 USPQ2d at 1397. “[I]n many cases a person of
`ordinary skill will be able to fit the teachings of multiple
`patents together like pieces of a puzzle.” Id. Office
`personnel may also take into account “the inferences and
`creative steps that a person of ordinary skill in the art
`would employ.” Id. at ___, 82 USPQ2d at 1396.
`
`In addition to the factors above, Office personnel may
`rely on their own technical expertise to describe the
`knowledge and skills of a person of ordinary skill in the
`art. The Federal Circuit has stated that examiners and
`administrative patent judges on the Board are “persons
`of scientific competence in the fields in which they work”
`and that their findings are “informed by their scientific
`knowledge, as to the meaning of prior art references to
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`MANUAL OF PATENT EXAMINING PROCEDURE
`
`persons of ordinary skill in the art.” In re Berg , 320 F.3d
`1310, 1315, 65 USPQ2d 2003, 2007 (Fed. Cir. 2003).>
`In addition, examiners “are assumed to have some
`expertise in interpreting the references and to be familiar
`from their work with the level of skill in the art .”
`PowerOasis, Inc. v. T-Mobile USA, Inc., 522 F.3d 1299
`(Fed. Cir. 2008) (quoting Am. Hoist & Derrick Co. v.
`Sowa &Sons, 725 F.2d 1350, 1359 (Fed. Cir. 1984). See
`MPEP § 2141 for a discussion of the level of ordinary
`skill. <
`
`III. RATIONALES TO SUPPORT REJECTIONS
`UNDER 35 U.S.C. 103
`
`Once the Graham factual inquiries are resolved, Office
`personnel must determine whether the claimed invention
`would have been obvious to one of ordinary skill in the
`art.
`
`The obviousness analysis cannot be confined by . .
`. overemphasis on the importance of published
`articles and
`the explicit content of
`issued
`patents. . . . . In many fields it may be that there is
`little discussion of obvious
`techniques or
`combinations, and it often may be the case that
`market demand, rather than scientific literature, will
`drive design trends. KSR , 550 U.S. at ___, 82
`USPQ2d at 1396.
`
`Prior art is not limited just to the references being applied,
`but includes the understanding of one of ordinary skill in
`the art. The prior art reference (or references when
`combined) need not teach or suggest all the claim
`limitations, however, Office personnel must explain why
`the difference(s) between the prior art and the claimed
`invention would have been obvious to one of ordinary
`skill in the art. The “mere existence of differences between
`the prior art and an invention does not establish the
`invention’s nonobviousness.” Dann v. Johnston, 425 U.S.
`219, 230, 189 USPQ 257, 261 (1976). The gap between
`the prior art and the claimed invention may not be “so
`great as to render the [claim] nonobvious to one
`reasonably skilled in the art.” Id . In determining
`obviousness, neither the particular motivation to make
`the claimed invention nor the problem the inventor is
`solving controls. The proper analysis is whether the
`claimed invention would have been obvious to one of
`ordinary skill in the art after consideration of all the facts.
`See 35 U.S.C. 103(a). Factors other than the disclosures
`of the cited prior art may provide a basis for concluding
`that it would have been obvious to one of ordinary skill
`in the art to bridge the gap. The rationales discussed below
`outline reasoning that may be applied to find obviousness
`in such cases.
`
`If the search of the prior art and the resolution of the
`Graham factual inquiries reveal that an obviousness
`rejection may
`be made
`using
`the
`familiar
`teaching-suggestion-motivation (TSM) rationale, then
`such a rejection should be made. Although the Supreme
`KSR cautioned against an overly rigid
`Court in
`application of TSM, it also recognized that TSM was one
`of a number of valid rationales that could be used to
`determine obviousness. (According to the Supreme Court,
`establishment of the TSM approach to the question of
`obviousness “captured a helpful insight.” 550 U.S. at ___,
`82 USPQ2d at 1396 (citing In re Bergel, 292 F.2d 955,
`956-57, 130 USPQ 206, 207-208 (1961)). Furthermore,
`the Court explained that “[t]here is no necessary
`inconsistency between the idea underlying the TSM test
`and the Graham analysis.” 550 U.S. at ___, 82 USPQ2d
`at 1396. The Supreme Court also commented that the
`Federal Circuit “no doubt has applied the test in accord
`with these principles [set forth in KSR] in many cases.”
`550 U.S. at ___, 82 USPQ2d at 1396). Office personnel
`should also consider whether one or more of the other
`rationales set forth below support a conclusion of
`obviousness. The Court in KSR identified a number of
`rationales to support a conclusion of obviousness which
`are consistent with the proper “functional approach” to
`the determination of obviousness as laid down in
`Graham. KSR, 550 U.S. at ___, 82 USPQ2d at 1395-97.
`Note that the list of rationales provided below is not
`intended to be an all-inclusive list. Other rationales to
`support a conclusion of obviousness may be relied upon
`by Office personnel.
`
`The key to supporting any rejection under 35 U.S.C. 103
`is the clear articulation of the reason(s) why the claimed
`invention would have been obvious. The Supreme Court
`in KSR noted that the analysis supporting a rejection
`under 35 U.S.C. 103 should be made explicit. The Court
`quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329,
`1336 (Fed. Cir. 2006), stated that “‘[R]ejections on
`obviousness cannot be sustained by mere conclusory
`statements; instead, there must be some articulated
`reasoning with some rational underpinning to support the
`legal conclusion of obviousness.’” KSR, 550 U.S. at ___,
`82 USPQ2d at 1396. Exemplary rationales that may
`support a conclusion of obviousness include:
`(A) Combining prior art elements according to
`known methods to yield predictable results;
`(B) Simple substitution of one known element for
`another to obtain predictable results;
`(C) Use of known technique to improve similar
`devices (methods, or products) in the same way;
`(D) Applying a known technique to a known device
`(method, or product) ready for improvement to yield
`predictable results;
`
`2100-115
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`