Ex Parte LI et al

Patent Trial and Appeal Board

Aug 23, 2016

13013139 (P.T.A.B. Aug. 23, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/013, 139 01125/2011
26691 7590 08/23/2016
POTTER ANDERSON & CORROON LLP
ATTN: JANETE. REED, PH.D.
P.O. BOX 951
WILMINGTON, DE 19899-0951
FIRST NAMED INVENTOR
Bailin Li
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
PHI 3707+ (35290-041) 8178
EXAMINER
KOV ALENKO, MYKOLA V
ART UNIT PAPER NUMBER
1662
MAILDATE DELIVERY MODE
08/23/2016 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte BAILIN LI and KEVIN A. FENGLER
Appeal2014-007516
Application 13/013,139 1
Technology Center 1600
Before FRANCISCO C. PRATS, MELANIE L. McCOLLUM, and
RYAN H. FLAX, Administrative Patent Judges.
FLAX, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134(a) involving
claims directed to an isolated labeled polynucleotide that discriminates
between soybean plants tolerant to or susceptible to herbicides. Claims 1, 2,
5, 6, and 28-33 are on appeal as rejected under 35 U.S.C. §§ 101 and 112,
first paragraph. We have jurisdiction under 35 U.S.C. § 6(b ).
We reverse.
1 The Real Party in Interest is E. I. du Pont de Nemours and Company. App.
Br. 3.
Appeal2014-007516
Application 13/013,139
STATEMENT OF THE CASE
The Specification discloses two variants of a full length cDNA of a
soybean gene (i.e., Glymal 9g 1940.1 ), the differences between which
determine whether a soybean plant is tolerant of herbicides or susceptible to
herbicides. Spec. 1-2. The cDNA of the soybean tolerant of herbicides is
identified in the Specification as SEQ ID NO: 124 and the cDNA of the
soybean susceptible thereto is identified as SEQ ID NO: 125. Spec. 9.
These two sequences are set forth at Figure 5B, which also identifies the
nucleotide differences, or SNPs, between them which account for the
difference in herbicide tolerance/susceptibility phenotype. See, e.g., Spec.
138-39 (Table 23) and Figure 5B.
The Specification describes using nucleotide sequence primers and/or
probes, for example, to identify and distinguish between these two genetic
sequences and, therefore, the respective phenotypes. See, e.g., Spec. 8-9,
29-30, 137-39 (Example 10), and Figure 2. The Specification describes
labeling such primers or probes, e.g., radioactively or fluorescently, so as to
be able to detect the polynucleotide and hybridized duplex thereby. See,
e.g., Spec. 19, 29-30, 32-37. Finally, the Specification describes using the
genetic detection capability to identify soybean plants with the desired
tolerance or susceptibility phenotypes and perpetuating such traits via
segregation and introgression. Spec. 14.
The appealed claims can be found in the Claims Appendix of the
Appeal Brief. Claims 1, 28, and 31 are independent claims. Claim 1 is
representative reads as follows:
1. An isolated labeled polynucleotide, wherein the
polynucleotide discriminates between a soybean that displays
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Application 13/013,139
tolerance and a soybean that displays susceptibility to one or
more herbicides, and wherein the polynucleotide detects at least
one SNP within a genomic sequence set forth in SEQ ID NO:
124 or SEQ ID NO: 125.
App. Br. 20 (Claims App'x).
The following rejections are on appeal: 2
Claims 1, 2, 5, and 6 stand rejected under 35 U.S.C. § 101. Final
Action 3.
Claims 1, 2, 5, 6, and 28-33 stand rejected under 35 U.S.C. § 112,
first paragraph, as failing under the written description requirement. Final
Action 6.
Claims 1, 2, 5, 6, and 28-33 stand rejected under 35 U.S.C. § 112,
first paragraph, as not enabled. Final Action 10.
DISCUSSION
The rejection of claims j, 2, 5, and 6 under 35 U.S.C. § jQj.
The Examiner determined that the claims read on a product of nature
because "[t]he claimed labeled isolated polynucleotide [],would read on
polynucleotides naturally occurring in [a] soybean genome," and"[ o ]ne
skilled in the art would have recognized that radioactive isotopes, such as for
example C 14, occur naturally and get incorporated in biological molecules,
such as polynucleotides, without the hand of man." Ans. 2-3. The
Examiner's determination is premised on an incorrect interpretation of the
claims.
2 Rejections under 35 U.S.C. § 112, second paragraph, and§ 103(a) were
withdrawn by the Examiner in the Advisory Action dated Oct. 16, 2013.
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"[T]he person of ordinary skill in the art is deemed to read the claim
term not only in the context of the particular claim in which the disputed
term appears, but in the context of the entire patent, including the
specification .... To begin with, the context in which a term is used in the
asserted claim can be highly instructive." Phillips v. AWH Corp., 415 F.3d
1303, 1313-14 (Fed. Cir. 2005); see also id. at 1316 ("The Patent and
Trademark Office ('PTO') determines the scope of claims in patent
applications not solely on the basis of the claim language, but upon giving
claims their broadest reasonable construction 'in light of the specification as
it would be interpreted by one of ordinary skill in the art."') (quoting In re
Am. Acad. of Science Tech Center, 367 F.3d 1359, 1364 (Fed. Cir. 2004); cf
In re Royka. 490 F.2d 981, 984 (CCPA 1974) (reversing a Board decision, in
part, for ignoring the specification in determining the claims' broadest
reasonable interpretation).
We agree with Appellants (see App. Br. 8-10) that the claim term
"labeled polynucleotide" is properly interpreted to require intentional
tagging of the polynucleotidefor detection. The way this term is used
throughout the Specification corresponds to such a meaning. See, e.g., Spec.
19; 29-30, 32-37. A naturally occurring polynucleotide would not have
such an intentionally applied tag. The Examiner, moreover, does not direct
us to any clear or specific evidence showing that labeled polynucleotides
have been either detected in nature, or isolated therefrom.
For the above reasons, we reverse the§ 101 rejection of the claims.
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Application 13/013,139
The rejection of claims 1, 2, 5, 6, and 28-33 under 35 U.S. C. § 112,
first paragraph, as failing under the written description requirement.
The Examiner conceded, "Appellant describes isolated nucleic acids
of the full length SEQ ID NO: 124, SEQ ID NO: 125, as well as two
additional species that fall within the claimed genus" and "Appellant
describes eight [actually twelve] nucleic acid sequences of polynucleotide
markers that can detect at least one SNP within variants of SEQ ID NO 124
and 125" at, e.g., Example 10. Ans. 4, 13.
However, the Examiner determined the full subject matter
encompassed by the claims is not described by the Specification because the
claims "do not limit the length of the polynucleotide nor do they require that
the region recognized by it be located within the sequences of SEQ ID NO:
124 or SEQ ID NO: 125" and "[b]ecause SEQ ID NO's 124 and 125 are
both 3920 nucleotides long, and because the claimed SNPs are distributed
throughout the sequence of SEQ ID NO's 124 and 125, the potential genus
of markers encompassed by the claims is [too] large." Ans. 11-12.
Appellants contend the Specification's disclosure, per Examiner's
concessions supra, provides sufficient disclosure for a person of ordinary
skill in the art to identify the invention and "design" the claimed
polynucleotides. App. Br. 11; Reply Br. 9-10. Appellants argue the claim
language "wherein the polynucleotide detects at least one SNP," invokes the
very types of detection for which the Specification provides disclosure and
guidance. Reply Br. 9. Essentially, Appellants' argument is that the
Specification described detecting either SEQ ID NO: 124 or 125, which
determines herbicide tolerance or susceptibility, and the 12 SNPs defining
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the phenotype-expressing differences therebetween, which amounts to a
disclosure of possession of the claimed invention. We find Appellants'
arguments persuasive.
The Federal Circuit explains, "[f]or generic claims, we have set forth
a number of factors for evaluating the adequacy of the disclosure, including
'the existing knowledge in the particular field, the extent and content of the
prior art, the maturity of the science or technology, [and] the predictability
of the aspect at issue."' Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co.,
598 F.3d 1336, 1351 (Fed. Cir. 2010) (en bane) (quoting Capon v. Eshhar,
418 F.3d 1349, 1359 (Fed. Cir. 2005). The court also advised that the
"doctrine never created a heightened requirement to provide a nucleotide-by-
nucleotide recitation of the entire genus of claimed genetic material; it has
always expressly permitted the disclosure of structural features common to
the members of the genus." Id. at 1352.
Here, Appellants have gone to substantial lengths to illustrate the
genetic differences (structural features) between herbicide-tolerant and
herbicide-susceptible soybean plants, which they identify as definitively
represented in SEQ ID NO: 124 and SEQ ID NO: 125. Identifying genetic
sequences was well known as of the application date and the Specification
undisputedly describes several known ways of doing so, e.g., via labeled
probes and primers. With the knowledge of the sought genetic sequences (or
defining portions thereof) in hand, the skilled artisan can find them. So long
as such a polynucleotide can distinguish between the aforementioned genetic
sequences and also identify an SNP between them, it would be recognized
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by a person of ordinary skill in the art as the claimed invention, regardless of
how long or short the isolated polynucleotide. 3
For the above reasons we find the preponderance of the evidence
supports Appellants' contentions and, so, we reverse the rejection of the
claims for lack of written description.
The rejection of claims 1, 2, 5, 6, and 28-33 under 35 U.S. C. § 112,
first paragraph, as not enabled.
The Examiner determined the Specification,
while being enabling for isolated nucleotide sequences of SEQ
ID NO: 124 and 125; and polynucleotide markers recognizing at
least one SNP within those sequences, does not reasonably
provide enablement for polynucleotide markers capable of
discriminating between a soybean that displays tolerance to one
or more herbicides and a soybean that displays susceptibility to
one or more herbicides; nor does specification reasonably
provide enablement for the methods of selecting herbicide
tolerant or susceptible plants, or introgressing herbicide
resistance into a soybean plant. The specification does not
enable any person skilled in the art to which it pertains, or with
which it is most nearly connected, to make and use the invention
commensurate in scope with these claims.
3 Similarly, Example 4 of the Written Description Training Materials (Rev.
1, Mar. 25, 2008) (http://www.uspto.gov/web/menu/written.pdf) (pages 13-
16) explains that, in the context of expressed sequence tags, open
"comprising" language including unnamed nucleotides flanking a sequence
recited a claim does not lack descriptive support because each member of
the genus necessarily contains the named sequence, and because adding any
desired sequence would be within the knowledge and skill in the art. Here,
the skilled artisan would similarly understand the claimed subject.
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See Ans. 6. The Examiner also determined "[t]he claims rest on an implicit
teaching that a single SNP would be a sufficient indicator of herbicide
tolerance or susceptibility." Ans. 8. Finally, the Examiner determined "the
range of herbicides encompassed by the claims is not limited to PPO
inhibitors. The claims encompass mesotrione and isoxazole herbicides (both
HPPD inhibitors) or 'one or more' unspecified herbicide. Yet the working
examples teach specific SNPs only for the PPO inhibitors." Ans. 8.
The Examiner bears the burden of establishing that practicing the full
scope of the claimed subject matter would have required undue
experimentation. In re Wright, 999 F.2d 1557, 1561-62 (Fed. Cir. 1993)
("[T]he 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.").
The appealed claims do not require determining the herbicide
tolerance or susceptibility of a plant based on identification of a single SNP
and such an interpretation is not reasonable. The claims recite an isolated
labeled polynucleotide that can discriminate between an herbicide-tolerant
and herbicide-susceptible soybean plant and can also detect at least one SNP
in SEQ ID NO: 124 or SEQ ID NO: 125. These are two separately recited,
albeit related, properties of the polynucleotide. As long as an isolated
labeled polynucleotide can do each, it falls within the scope of the claims.
The Examiner concedes the Specification is "enabling for isolated
nucleotide sequences of SEQ ID NO: 124 and 125," which suffices as
enabling the claims because these polynucleotides are disclosed as
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designating a soybean plant as herbicide-tolerant or herbicide-susceptible.
Knowing the controlling gene and its key variations, developing
complementary probes or primers thereto (see, e.g., Spec. 116 (discussing
designing Taqman® probe markers to distinguish between tolerant versus
susceptible alleles)) was undisputedly well within the purview of the skilled
artisan, even without the extensive disclosure of the Specification. And, we
note the Specification discloses a series of examples illustrating the
inventors' stepwise fashion, logic, and rationale in working from identifying
soybean plants with herbicide tolerance or susceptibility, to identifying the
genes responsible for the phenotype, to identifying the variations (SNPs) in
those genes responsible for the phenotype, to using this genetic information
to propagate the phenotypes in subsequent generations. Spec. 90-145
(Examples 1-12).
Finally, the Examiner's criticism of the working examples as relating
to a single type of herbicide is unconvincing. The discussion of the working
examples begins by studying several types of herbicides (e.g., Example 1 's
mesotrione and isoxazole, which are HPPD-inhibitors, and Example 3's
sulfentrazone, which is a PPO inhibitor), but eventually focuses on PPO
inhibitors. The same research reported for the PPO-type herbicides could
also be conducted for HPPD-type or other type herbicides and, moreover,
Appellants explain (App. Br. 16-17) the data relating to PPO tolerance or
susceptibility is also likely applicable to HPPD tolerance/susceptibility
because of co-localization of relevant genetic markers.
In any event, "[i]t is well settled that patent applicants are not required
to disclose every species encompassed by their claims, even in an
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unpredictable art." In re Angstadt, 537 F.2d 498, 502---03 (CCPA 1976).
Although the disclosure must provide enablement commensurate with the
scope of the claims, "[t ]he enablement requirement is met if the description
enables any mode of making and using the invention." Johns Hopkins Univ.
v. Cellpro Inc., 152 F.3d 1342, 1361 (Fed. Cir. 1998) (quoting Engel Indus.,
Inc. v. Lodiformer Co., 946 F.2d 1528, 1533 (Fed. Cir. 1991)).
Because the preponderance of the evidence supports Appellants'
contention that, given the scope of the claims, level of skill in the art, and
guidance provided by the Specification, any experimentation required to
practice the present claims would be routine, we reverse the enablement
rejection of the claims.
SUMMARY
The rejection of claims 1, 2, 5, and 6 under 35 U.S.C. § 101 as
directed to non-statutory subject matter is reversed.
The rejection of claims 1, 2, 5, 6, and 28-33 under 35 U.S.C. § 112,
first paragraph, as failing to comply with the written description requirement
is reversed.
The rejection of claims 1, 2, 5, 6, and 28-33 under 35 U.S.C. § 112,
first paragraph, as not enabled is reversed
REVERSED
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