Virginia Ursin et al.

Patent Trials and Appeals Board

Sep 16, 2020

13551602 - (D) (P.T.A.B. Sep. 16, 2020)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/551,602 07/17/2012 Virginia Ursin MONS:044USD1 2049
73905 7590 09/16/2020
DENTONS US LLP
P.O. BOX 061080
CHICAGO, IL 60606-1080
EXAMINER
DUBOIS, PHILIP A
ART UNIT PAPER NUMBER
1791
NOTIFICATION DATE DELIVERY MODE
09/16/2020 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
patents.us@dentons.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte VIRGINIA URSIN, BYRON FROMAN, JENNIFER SIMMONS,
THOMAS J. LAROSA, FENGGAO DONG, and STEVEN SCREEN
Appeal 2020-000052
Application 13/551,602
Technology Center 1700
Before LINDA M. GAUDETTE, N. WHITNEY WILSON, and
BRIAN D. RANGE, Administrative Patent Judges.
RANGE, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 53, 56–61, 63, and 64. We have
jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. Appellant identifies the real party in interest as Bayer
CropScience, Inc. which is the parent company of assignee Monsanto
Technology LLC. Appeal Br. 3.
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CLAIMED SUBJECT MATTER2
Appellant describes the invention as relating to improvement of fatty
acid profiles using desaturase enzymes and nucleic acids encoding such
desaturase enzymes. Spec. 2:9–12.3 For example, the Specification explains
that stearidonic acid (“SDA”) efficiently raises eicosapentaenoic acid
(“EPA”) levels in humans and that EPA provides health benefits. Spec. 3:4–
6; 4:6–7. The Specification explains that producing, for example, SDA in
plants would benefit public health. Id. at 6:19–7. Appellant’s invention thus
seeks to encode nucleic acids of soybean plants (i.e., genetically modify the
plants) to produce beneficial polyunsaturated fatty acids. Id. at 2:14–18.
Claim 53 is illustrative:
53. An endogenous soybean seed oil comprising ALA
(alpha-linolenic acid), SDA (stearidonic acid), and GLA
(gamma-linolenic acid), wherein the ratio of SDA/GLA in said
endogenous soybean seed oil is at least about 2.0.

REJECTIONS
The Examiner maintains the following rejections on appeal:
A. Claims 53, 56–61, 63, and 64 under 35 U.S.C. § 101 as patent
ineligible because the claims recite a judicial exception without
significantly more. Ans. 3.

2 In this Decision, we refer to the Final Office Action dated June 15, 2018
(“Final Act.”), the Appeal Brief filed February 8, 2019 (“Appeal Br.”), the
Examiner’s Answer dated July 29, 2019 (“Ans.”), and the Reply Brief filed
September 30, 2019 (“Reply Br.”).
3 Our citations are to the “Unmarked Substitute Specification” dated October
22, 2012 (“Spec.”)
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B. Claims 53, 56–61, 63, and 64 under 35 U.S.C. § 112 as not enabled.
Id. at 7.

OPINION
Rejection 1, § 101 eligibility. With respect to this rejection, both the
Appellant and the Examiner focus on the sole independent claim on appeal,
claim 53. We also focus on claim 53 below, and as explained below, our
assessment of that claim is sufficient to resolve the appeal of this rejection.
A. The Examiner’s Rejection
The Examiner rejects claims 53, 56–61, 63, and 64 under 35 U.S.C. § 101
as patent ineligible because the claims recite a judicial exception without
significantly more. Ans. 3. In particular, the Examiner determines that the claims
are “directed to an endongenous soybean seed oil comprising alpha-linolenic,
steariodonic, and gamma-lionlenic fatty acids.” Ans. 3. The Examiner
determines that “these fatty acid themselves are naturally occurring and when
bound to glycerol molecules also form naturally occurring molecules.” Id.
B. Principles of Law
An invention is patent-eligible if it claims a “new and useful process,
machine, manufacture, or composition of matter.” 35 U.S.C. § 101. The U.S.
Supreme Court, however, has long interpreted 35 U.S.C. § 101 to include
implicit exceptions: “[l]aws of nature, natural phenomena, and abstract
ideas” are not patentable. E.g., Alice Corp. v. CLS Bank Int’l, 573 U.S. 208,
216 (2014).
In determining whether a claim falls within an excluded category, we
are guided by the Court’s two-part framework, described in Mayo and Alice.
Id. at 217–18 (citing Mayo Collaborative Servs. v. Prometheus Labs., Inc.,
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566 U.S. 66, 75–77 (2012)). In accordance with that framework, we first
determine what concept the claim is “directed to.” See Alice, 573 U.S. at 219
(“On their face, the claims before us are drawn to the concept of
intermediated settlement, i.e., the use of a third party to mitigate settlement
risk.”); see also Bilski v. Kappos, 561 U.S. 593, 611 (2010) (“Claims 1 and 4
in petitioners’ application explain the basic concept of hedging, or protecting
against risk.”).
If the claim is “directed to” patent ineligible matter, we turn to the
second part of the Alice and Mayo framework, where “we must examine the
elements of the claim to determine whether it contains an ‘inventive
concept’ sufficient to ‘transform’ the claimed abstract idea into a patent-
eligible application.” Alice, 573 U.S. at 221 (quotation marks omitted).
In January 2019, the U.S. Patent and Trademark Office (USPTO)
published revised guidance on the application of § 101. 2019 Revised Patent
Subject Matter Eligibility Guidance, 84 Fed. Reg. 50 (Jan. 7, 2019)
(“2019 Revised Guidance”).4 Consistent5 with the 2019 Revised Guidance
and the October 2019 Update, we first look to whether the claim recites:

4 In response to received public comments, the Office issued further
guidance on October 17, 2019, clarifying the 2019 Revised Guidance.
USPTO, October 2019 Update: Subject Matter Eligibility (the “October
2019 Update”) (available at
https://www.uspto.gov/sites/default/files/documents/peg_oct_2019_update.p
df).
5 Our reviewing court has explained that the 2019 Revised Guidance “cannot
modify or supplant the Supreme Court’s law regarding patent eligibility, or
[our reviewing court’s] interpretation and application thereof.” In re Rudy,
956 F.3d 1379, 183 (Fed. Cir. 2020). Our decision, therefore, is based upon
applicable statute and precedent of the United States Supreme Court and the
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(1) any judicial exceptions, including certain groupings of abstract
ideas (i.e., mathematical concepts, certain methods of organizing
human activity such as a fundamental economic practice, or mental
processes) (“Step 2A, Prong One”); and
(2) additional elements that integrate the judicial exception into a
practical application (see MPEP § 2106.05(a)–(c), (e)–(h) (9th ed.
Rev. 08.2017, Jan. 2018)) (“Step 2A, Prong Two”).6
2019 Revised Guidance, 84 Fed. Reg. at 52–55.
Consistent with the guidance, only if a claim (1) recites a judicial
exception and (2) does not integrate that exception into a practical
application, do we then look, under Step 2B, to whether the claim:
(3) adds a specific limitation beyond the judicial exception that is not
“well-understood, routine, conventional” in the field (see MPEP
§ 2106.05(d)); or
(4) simply appends well-understood, routine, conventional activities
previously known to the industry, specified at a high level of
generality, to the judicial exception.
2019 Revised Guidance, 84 Fed. Reg. at 52–56.

Court of Appeals for the Federal Circuit. This decision applies the 2019
Revised Guidance in a manner consistent with statute and precedent.
6 This evaluation is performed by (a) identifying whether there are any
additional elements recited in the claim beyond the judicial exception, and
(b) evaluating those additional elements individually and in combination to
determine whether the claim as a whole integrates the exception into a
practical application. See 2019 Revised Guidance - Section III(A)(2), 84
Fed. Reg. 54–55.
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C. Guidance Step 1: Does independent claim 53 fall within a
statutory category?
Pursuant to 35 U.S.C. § 101 and consistent with Step 1 of the
Guidance, we first consider whether the claimed subject matter falls within
the four statutory categories explicitly set forth in § 101: “[p]rocess,
machine, manufacture, or composition of matter.” 2019 Revised Guidance,
84 Fed. Reg. at 53–54; see also 35 U.S.C. § 101. Here, the Examiner does
not dispute that each claim on appeal falls within a statutory category.
D. Guidance Step 2A Prong 1: Does independent claim 53 recite
a judicial exception?
Pursuant to the U.S. Supreme Court’s Mayo and Alice framework and
consistent with the next step of the Guidance, we consider whether claim 53
recites a judicial exception. 2019 Revised Guidance, 84 Fed. Reg. at 51. The
Examiner determines that ALA, SDA, and GLA are each essential
polyunsaturated fatty acids that are found in nature. Ans. 5. Appellant does
not dispute this point. See, e.g., Spec. 4:15–5:16 (discussing natural sources
of polyunsaturated fatty acids). Thus, claim 53 recites natural phenomena
(i.e., a naturally occurring things) which are a judicial exception to patent
eligibility. Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S.
576, 589–90 (2013) (referring to “[t]he rule against patents on naturally
occurring things”).
E. Guidance Step 2A Prong 2: Are the claims “directed to” the
recited judicial exception?
Because claim 53 (and thus all claims on appeal) recites an abstract
idea, we now determine, pursuant to the precedent of the U.S. Supreme
Court and our reviewing court and consistent with the Guidance, whether the
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recited judicial exception is integrated into a practical application. 2019
Revised Guidance, 84 Fed. Reg. at 51. According to the Guidance, when a
claim recites a judicial exception and fails to integrate the exception into a
practical application, the claim is “directed to” the judicial exception. Id.
The claim may integrate the judicial exception when, for example, it reflects
an improvement to technology or a technical field. Id. at 55.
Here, as we explain above, the Examiner determined that claim 53 is
directed to a natural phenomenon. Ans. 3–6, 12–13. We disagree. As
Appellant explains, the claimed soybean oil is produced only by transgenic
(i.e., genetically modified) soybeans. Appeal Br. 8. Data in Appellant’s
Specification, for example, confirms that nontransgenic soybean oil does not
contain SDA or GLA in detectable amounts. Id.; see also Spec. 36–38. The
Examiner, thus, has not established that claim 53’s recited endogenous
soybean seed oil is natural. Indeed, the Examiner appears to admit as much.
See, e.g., Ans. 13 (“the endogenous soybean seed oil recited in the claims is
not an exact replica of what occurs in nature”).
The Examiner takes the position that the subject matter of claim 53 is
nonetheless not patent eligible because it is merely a mixture of naturally
occurring molecules. The U.S. Supreme Court has explained that “[t]he rule
against patents on naturally occurring things is not without limits, however,
for all inventions at some level embody, use, reflect, rest upon, or apply laws
of nature, natural phenomena, or abstract ideas, and too broad an
interpretation of this exclusionary principle could eviscerate patent law.”
Ass’n for Molecular Pathology, 569 U.S. at 589–90 (internal quotes and
citation omitted).
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The Federal Circuit’s recent decision in Natural Alternatives Int’l v.
Creative Compounds, LLC, 918 F.3d 1338 (Fed. Cir. 2019) is illustrative.
Reply Br. 7. In Natural Alternatives, one of the product claims at issue
recited “A human dietary supplement, comprising a beta-alanine in a unit
dosage of between about 0.4 grams to 16 grams, wherein the supplement
provides a unit dosage of beta-alanine.” Natural Alternatives Int’l, 918 F.3d
at 1348. The court explained the test for evaluating eligibility of claims
made form a natural product as follows: “[a] claim to a manufacture or
composition of matter made from a natural product is not directed to the
natural product where it has different characteristics and ‘the potential for
significant utility.’” Id. (quoting Diamond v. Chakrabarty, 447 U.S. 303,
310 (1980)). Based on this test, our reviewing court determined that
although “beta-alanine is a natural product, the Product Claims are not
directed to beta-alanine.” Id.
Here, claim 53 has different characteristics than any natural oil of
record. The Examiner has not identified any natural oil comprising ALA,
SDA, and GLA with the recited SDA/GLA ratio. Moreover, as we have held
previously, the phrase “endogenous soybean oil imparts structural features to
the oil as recited in claim 53.” Ex Parte Ursin, Appeal 2016-000817, 4
(PTAB July 31, 2017). The claim is thus directed to an oil with
characteristics different than even an artificial mixture comprising ALA,
SDA, and GLA. Also, Appellant explains the utility of the recited oil
(Appeal Br. 8), and the Examiner does not persuasively refute this cited
utility. Claim 53 is therefore directed to subject matter akin to the dietary
supplement of Natural Alternatives Int’l, which was held by the Federal
Circuit to be patent eligible.
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The Examiner compares claim 53 to the patent ineligible claims of
Funk Bros. Seed Co. v. Kalo Innoculant Co., 333 U.S. 127 (1948). The Funk
Bros. decision is distinguishable. In Funk Bros., the Court held that claims
directed to a mixture of two natural bacteria were not patent eligible. Id. at
131. The Court emphasized that the combination provided no improvement
in any way to the bacteria’s natural function. Id. The present fact pattern is
different; the preponderance of the evidence supports that claim 53’s oil
provides benefits over other, different sources of ALA, SDA, and GLA.
Appeal Br. 8; Reply Br. 6. Merely blending naturally occurring ALA, SDA,
and GLA does not produce the recited oil at all because such a blend would
not have the structural characteristics of an “endogenous soybean oil.” Ex
Parte Ursin, Appeal 2016-000817 at 4. Indeed, one benefit of the recited oil
is that soy plants manufacture the oil.
The Examiner also compares claim 53 to the patent ineligible claims
of Ass’n for Molecular Pathology, 569 U.S. 576. That decision holds that
certain naturally occurring, isolated DNA segments were not patent eligible.
Id. at 593–594. The Court stated, however, that cDNA “does not present the
same obstacles to patentability” because it is not naturally occurring. Id. at
594–595. The oil of claim 53 is not naturally occurring and cannot be
acquired by merely isolating an oil from nature. Claim 53’s oil is thus more
similar to the cDNA of Ass’n for Molecular Pathology than the isolated
natural DNA. Reply Br. 8.
Because the Examiner has not established that claim 53 and the claims
depending from claim 53 are directed to a natural phenomenon or other
judicial exception, we do not sustain the Examiner’s rejection under Section
101.
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Rejection 2, Enablement. The Examiner rejects claims 53, 56–61, 63,
and 64 under 35 U.S.C. § 112 as not enabled. Ans. 7. Enablement is a
question of law based upon underlying factual findings. In re Wright, 999
F.2d 1557, 1561 (Fed. Cir. 1993). Our reviewing court has explained the
examiner’s burden in rejecting a claim as not meeting the enablement
requirement by stating, “the PTO bears an initial burden of setting forth a
reasonable explanation as to why it believes that the scope of protection
provided by that claim is not adequately enabled by the description of the
invention provided in the specification of the application.” Id. at 1561–2
(Fed. Cir. 1993). Once the examiner has weighed all the evidence and
established a reasonable basis to question the enablement provided for the
claimed invention, the burden falls on applicant to present persuasive
arguments, supported by suitable proofs where necessary, that one skilled in
the art would be able to make and use the claimed invention using the
application as a guide. In re Brandstadter, 484 F.2d 1395, 1406−07 (CCPA
1973).
Here, the Examiner determines that claim 53’s recitation of an
“endogenous soybean seed oil” is “indicative of the rest of the fatty acids /
triglycerides present in the oil claimed.” Ans. 8. This position is consistent
with our prior decision concerning this claim language. Ex Parte Ursin,
Appeal 2016-000817 at 4. The Examiner then determines that different
genetic manipulations will result in different oil compositions and that
Appellant’s Specification is not sufficient to enable a person of ordinary skill
in the art to arrive at all compositions within the scope of the claims. Ans. 8.
The Examiner further determines that for each possible different endogenous
oil that could result from genetic manipulation, a person of skill in the art
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would have to engage in undue experimentation to ensure the specific fatty
acids and ratios recited in claim 53. Id. at 16.
Appellant argues Section 112’s enablement is satisfied so long as “the
Specification discloses at least one method for making and using the claimed
invention that bears a reasonable correlation to the entire scope of the
claim.” Appeal Br. 17 (citations omitted). Appellant further argues that the
Specification discloses multiple of examples within the scope of the claims
(id. at 17–18), and the Examiner does not dispute this point (Ans. 16
(agreeing that the Specification provides “a number of examples” to arrive at
endogenous oils within the scope of Appellant’s claims). The Examiner and
the Appellant’s respective positions thus present us with the question of
whether or not the Specification’s examples bear a reasonable correlation to
the entire scope of claim 53.7 See In re Fisher, 427 F.2d 833, 839 (CCPA
1970) (“[35 U.S.C. § 112] requires that the scope of the claims must bear a
reasonable correlation to the scope of enablement provided by the
specification”).
To assess this question, we first consider several precedential
decisions where the “reasonable correlation” standard was or was not met.
First, in In re Fischer, the court addressed a claim reciting a hormone
preparation having a potency of “at least 1 International Unit of ACTH per
milligram.” Id. at 835. The court determined that the field was unpredictable,
and the appellant had not enabled preparation having potencies much greater
than 2.3. Id. at 839–840. The court thus affirmed the Board’s rejection based

7 The dependent claims are narrower than independent claim 53. The
Examiner does not present any reason why one of the dependent claims
would not be enabled if claim 53 were enabled.
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on enablement. Id.; see also MagSil Corp. v. Hitachi Global Storage Techs.,
Inc., 687 F.3d 1377, 1381–85 (Fed. Cir. 2012) (affirming summary
judgment of invalidity for lack of enablement where claim recited “change
in the resistance by at least 10%” but Specification stated that artisans hoped
to achieve 24% but only taught how to achieve 11.8%).
A second decision addressing the required scope of enablement is In
re Hogan, 559 F.2d 595 (CCPA 1977). There, a 1953 patent application
enabled making and using the claims’ recited “solid polymer” in crystalline
form. Id. at 606. By 1962, a later publication disclosed an amorphous form
of the solid polymer. Id. at 605. The 1953 application did not enable making
and using this amorphous form. Id. at 606. The court nonetheless held that
the 1953 application satisfied the Section 112 enablement requirement. Id. at
606–07. The court explained that a patent application’s claims may not be
tested in light of a later existing state of the art because doing so would place
too high a burden on patentees and “wreck havoc” on the patent system. Id.
at 606; see also Chiron Corp. v. Genentech, Inc., 363 F.3d 1247, 1255 (“the
enablement requirement does not extend to technology that arises after the
time of filing”).
A third exemplary decision is Plant Genetic Systems, N.V. v. Dekalb
Genetics Corp., 315 F.3d 1335 (Fed. Cir. 2003). Our reviewing court
affirmed the district court’s determination that claims directed to certain
genetically modified plant cells did not satisfy the enablement requirement.
Id. at 1338, 1346. The claims’ breadth encompassed both monocot and dicot
flowering plants, but all of the specification’s examples were dicots. Id. at
1338, 1341. The court concluded that the law did not support a broad scope
of coverage (covering monocots) and a lower standard of enablement (no
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enablement of modified monocots). Id. 1341–42. The court, thus, upheld the
district court’s conclusion that the claim was invalid based on lack of
enablement. Id. at 1344; see also In re Vaeck, 947 F.2d 488 (Fed. Cir. 1991)
(affirming enablement rejection where claim encompassed a large and
diverse group of bacteria but specification only explained genetic
transformation of one bacteria strain).
On balance, the fact pattern here is more akin to the facts of In re
Hogan than the facts of In re Fischer or Plant Genetic Systems, N.V. The
Examiner’s rejection is based on the future possibility of genetic
modifications leading to an endogenous soybean oil within the scope of
claim 53 that the Specification does not presently enable. The record,
however, lacks evidence that technology to reach such a hypothetical oil
exists or that such a hypothetical oil is presently known or desirable. This is,
for example, different than In re Fischer where the concept of higher
potencies was known and desired at the time of the application and different
than Plant Genetic Systems, N.V. where the concept of genetically modifying
monocots was known and desired at the time of the application.
A weighing of the Wands factors further supports our analysis. In In
re Wands, our reviewing court set forth eight factors for addressing
enablement:
(1) the quantity of experimentation necessary,
(2) the amount of direction or guidance presented,
(3) the presence or absence of working examples,
(4) the nature of the invention,
(5) the state of the prior art,
(6) the relative skill of those in the art,
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(7) the predictability or unpredictability of the art,
(8) and the breadth of the claims.
In re Wands, 858 F.2d 731, 738 (Fed. Cir. 1988); see also Cephalon, Inc. v.
Watson Pharm. Inc., 707 F.3d 1330, 1336 (Fed. Cir. 2013) (“These [Wands]
factors while illustrative are not mandatory.”).
Here, factors (1), (2), (3), and (6) support enablement because the
Specification provides specific guidance as to several working examples that
allow practicing the claimed invention without undue experimentation and
the relative skill of those in the art is high. Factors (4) and (7) weigh
somewhat against enablement because the invention is in a difficult and
unpredictable field. See In re Fisher, 427 F.2d at 839 (indicating that cases
involving “chemical reactions and physiological activity” more often
involve unpredictable factors). Factor (5) is neutral because neither the
Examiner nor the Appellant address the state of relevant prior art relative to
enablement. Factor (8) is neutral in that claim 53 is narrow by being
restricted to endogenous soybean seed oil comprising specific fatty acids but
broad by being open to various other components within the oil.
Weighing the Wands factors, we determine that, on balance, the
Specification here is sufficient to satisfy the enablement requirement. We,
therefore, do not sustain the Examiner’s rejection of claim 53 and claims
depending from claim 53.

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CONCLUSION
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
53, 56–61,
63, 64
101 Eligibility 53, 56–61,
63, 64
53, 56–61,
63, 64
112 Enablement 53, 56–61,
63, 64
Overall
Outcome
53, 56–61,
63, 64

REVERSED