Ex Parte Rice et al

Patent Trial and Appeal Board

Mar 29, 2017

12581597 (P.T.A.B. Mar. 29, 2017)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
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APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
12/581,597 10/19/2009 Charles Rice 48062-84468 2911
21888 7590 03/31/2017
THOMPSON OORT TRN T T P
EXAMINER
ONE US BANK PLAZA HORNING, MICHELLE S
SUITE 3500
ST LOUIS, MO 63101 ART UNIT PAPER NUMBER
1648
NOTIFICATION DATE DELIVERY MODE
03/31/2017 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):
IPDOCKET@THOMPSONCOBURN.COM
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte CHARLES RICE, MATTHEW J. EVANS,
BRETT D. LINDENBACH, and CHRISTOPHER JONES
Appeal 2016-000139
Application 12/581,5971
Technology Center 1600
Before DONALD E. ADAMS, ELIZABETH A. LaVIER, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
LaVIER, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellants seek review of the
Examiner’s rejection of claims 12, 14—16 and 23—29. We have jurisdiction
under 35 U.S.C. § 6(b). For the reasons set forth below, we AFFIRM.
BACKGROUND
The Specification relates to recombinant hepatitis C viruses (HCV),
including methods for producing infectious recombinant HCV for use in
anti-HCV therapies and diagnostics. Spec. 14. Claim 12 is illustrative:
1 Appellants state the real party in interest is the Rockefeller University.
Appeal Br. 2.
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Application 12/581,597
12. An isolated chimeric HCV variant vims with enhanced
capacity to produce infectious vims produced by a method
comprising:
a) obtaining a culture of cells with chimeric HCV genomes
that efficiently replicate intracellularly but produce moderate to
undetectable levels of infectious vims particles, wherein said
chimeric HCV genomes comprise:(i) a stmctural core, El and
E2 genes and nonstmctural p7 and NS2 genes from a first HCV
strain; and (ii) nonstmctural NS3, NS4A, NS4B, NS5A, and
NS5B genes from HCV strain JFH-1;
b) passaging said culture from (a);
c) selecting a passaged cell culture from (b) where infectious
vims production has occurred; and
d) selecting the chimeric HCV variant vims that is an infectious
HCV with enhanced capacity to produce infectious vims in
comparison to the chimeric HCV genomes of step (a).
Appeal Br. 17—18 (Claims Appendix).
REJECTION MAINTAINED ON APPEAL
Claims 12, 14—16, and 23—29 stand rejected under 35 U.S.C. § 112,
first paragraph, as failing to comply with the written description
requirement. Ans. 2.
DISCUSSION
The Examiner finds that claim 12
encompass[es] an enormity of differential HCV variant vimses
wherein any mutation or mutation(s) may occur at any position
along the chimeric HCV genome of step a). Variants
comprising one or more mutations at any position(s) of any of
the region of the chimeric vims (core, El, E2, NS3, etc.) are
encompassed by the claims.
Final Action 6. Only certain genes are limited as being from HCV strain
JFH-1 (i.e., NS3, NS4A, NS4B, NS5A, and NS5B); the other recited genes
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can be from any HCV strain. Final Action 6. The Examiner further finds
that claim 12 “require[s] that the claimed HCV variant virus possesses an
enhanced capacity to produce infectious virus and that the HCV variant virus
is infectious,” and notes that the Specification uses “infectious” as
“referring] to the ability of a virus to enter and replicate in a cell and to
produce viral particles.” Id. (discussing Spec. 135).
The Examiner explains that the Specification includes the following
working example regarding the nature of the variants:
the following mutations which occur across different regions of
the genome correlating to different HCV proteins: H2476L
mutation in the NS5B protein, a SI 107T mutation in the NS3
protein, a K12N mutation in the core protein, an 1348S
mutation or A269T mutation in the El protein; see para. 44 and
Examples. Also, it is noted that only chimera J6/JFH and
H77/JFH are provided by the instant specification; see
Examples including Example 12 and Fig. 9.
Final Action 6—7.
However, the Examiner finds that “[t]he instant specification fails to
disclose a sufficient number of representative species for the claimed HCV
chimeric variants.” Id. at 7. Further, the Examiner finds that “the
specification fails to provide sufficient correlations between the entire
structure of the claimed chimeric variants to the functions required by the
claims, including being infectious or having an enhanced capacity to
produce infectious virus.” Id. Noting that minor structural differences can
yield “substantially different biological or pharmacological activities,” such
as the substitution of certain amino acids causing loss of function, the
Examiner finds that “the large number of sequences encompassed by the
current claims may or may not possess an enhanced capability for infection.”
Id. (citing Baker et al., Protein Structure Predication and Structural
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Genomics, Science (2001) Vol. 294, No. 5540, pages 93—96; Attwood, T.,
The Babel of Bioinformatics, Science (2000) Vol. 290, no. 5491, pages
471—473). Thus, the Examiner concludes that the ordinarily skilled artisan
“cannot envision the detailed structure of a genus of compounds that are
contemplated in the invention” and “would not have recognized that
applicant was in possession of the claimed invention as presently claimed.”
Id. at 7—8.
As Appellants point out, claim 12 is a product-by-process claim.
Appeal Br. 5. Appellants argue the Examiner misapplied the law applicable
to product-by-process claims (see id. at 4—7), and as a result, “discounted the
process steps of claim 12” (id. at 6). According to Appellants, the
Examiner’s findings regarding the insufficiency of the Specification in
describing the structure of the claimed variants and their correlation to the
recited function are “irrelevant.” Id. at 7. Appellants highlight the working
example in their Specification (see id. at 8 (discussing Spec. Example 12,
Fig. 9)), and assert that the maturity of the existing knowledge in the art,
namely the “availability of HCV sequences necessary to practice the
invention as claimed” (id. at 10), means that “nothing more than routine
recombinant DNA procedures such as those referenced in the specification
would be required to construct the chimeric HCV genomes used in the first
process step of the claims” (id. (citing Spec. 22:6—10)). Conducting the
remaining process steps would likewise be routine, according to Appellants
(id. at 10), and thus “[o]ne of ordinary skill in the art would recognize that
the Applicants were in possession of each of the recited process steps and
were thus in possession of the genus of products obtained by performing
those process steps” (id. at 11).
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Application 12/581,597
The written description requirement applies to all claims, product-by­
process claims included. Cf. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d
1336, 1345 (Fed. Cir. 2010) (en banc) (confirming that written description is
a separate requirement from enablement under § 112, first paragraph, and
observing that “[ejvery patent must describe an invention”). That claim 12
is drafted in product-by-process format does not negate the fact that claim 12
encompasses a broad genus of products, not a particular product. A claimed
genus may be adequately described by disclosure of a representative number
of species, common structural features, or other means of “precise
definition.” Ariad Pharm., Inc. v. EliLilly & Co., 598 F.3d 1336, 1350
(Fed. Cir. 2010) (en banc). Also, “functional claim language can meet the
written description requirement when the art has established a correlation
between structure and function.” Id. (citation omitted).
Step (d) of claim 12, the “selecting” step, draws a distinction between
the selected virus of step (d) and the chimeric genomes from step (a):
d) selecting the chimeric HCV variant virus that is an infectious
HCV with enhanced capacity to produce infectious virus in
comparison to the chimeric HCV genomes of step (a).
Appeal Br. 18 (Claims App’x). Accordingly, the infectious virus of step (d)
of claim 12 is functionally different than the chimeric HCV of step (a). See
Final Action 6 (citing Spec. Tflf 117—118). Further, as the Examiner explains,
Appellants’ “[Specification discloses that the selected chimeric variant
virus with an enhanced capacity to produce infectious virus of step d is
structurally different than the chimeric HCV of step a.” Id.', see also Reply
Br. 5 (“[T]he selection step will cull out those mutations that are detrimental
or have no effect, leaving only the desired mutations that result in an
enhanced capacity to produce infectious virus.” (discussing Spec. 1116)).
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Thus, although not recited expressly in claim 12, some mutational event(s)
must occur between step (a) and step (d) to arrive at the claimed “HCV
variant virus with enhanced capacity to produce infectious virus.”
Appellants direct us to no structural characterization of the types of
mutations that can give rise to a virus with the functional attributes that
would be selected in step (d) aside from the single working example (see
discussion supra', see also Spec. 144, || 118—119 (Example 12), Fig. 9)).
We agree with the Examiner that this one working example is insufficient to
support the entire genus as claimed. See Final Action 7. To be sure, claim
12 recites the structure of a virus insofar as it recites the genes comprising
the viral genome in step (a), but this recitation gives no information about
the location or type of mutation(s) within those genes that yield the claimed
variant virus. See Ans. 7 (finding that the Specification “fails to make clear
as to what common structural features would result in an enhanced capacity
to produce infectious virus, structural features including required motifs,
mutations at what specific position(s) and/or region(s) of the genome as well
as what structural features would be detrimental to the viral life cycle”).
Likewise, Appellants do not explain how knowledge in the prior art, such as
the availability of sequence data for various HCV strains in the prior art (see
Appeal Br. 10), would have guided the ordinarily skilled artisan in
understanding what type of mutational events in those known strains, or
mixtures of strains, might give rise to a variant virus within the scope of
claim 12.2
2 Contrary to Appellants’ suggestion that the Examiner’s structure-driven
analyses are “irrelevant” (Appeal Br. 7), the MPEP counsels that, even with
respect to a product-by-process claim to a single species, the written
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Appellants also fail to direct us to a satisfactory functional
description. Appellants maintain that
[u]pon completion of the steps set forth in the claimed
process[], one skilled in the art would also be able to determine
that a chimeric HCV having an enhanced capacity to produce
infectious virus had been produced via methods disclosed in the
specification, thus recognizing possession of the product-by­
process.
Reply Br. 11. This reasoning is circular, and demonstrates that one must
practice the claimed invention before one can describe it or understand its
bounds. Cf. Ariad, 598 F.3d at 1350 (“[Mjerely drawing a fence around the
outer limits of a purported genus is not an adequate substitute for describing
a variety of materials constituting the genus and showing that one has
invented a genus and not just a species.”); Regents of the Univ. of Cal. v. Eli
Lilly & Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997) (“The description
description requirement may not be satisfied if it is unclear “that the product
is produced by [the] process,” or where the specification discloses “a partial
structure without additional characterization of the product.” MPEP
§ 2163(II)(A)(3)(a)(i) (2015) (citing Amgen, Inc. v. Chugai Pharm. Co., 927
F.2d 1200, 1206 (Fed. Cir. 1991)). These potential pitfalls are amplified, not
obviated, for genus claims, as the Specification must contain adequate
disclosure that the genus (not just an individual product) is produced by the
process. Appellants highlight the Specification’s disclosure that “mutations
that enhance some aspect of the viral life cycle, such as infectious virus
production, will have a selective advantage and should therefore spread
through the culture.” Reply Br. 5 (citing Spec. 1116). But this does not
inform the ordinarily skilled artisan about the nature (structural or otherwise)
of the genus of products, or even the likelihood of producing them. See Ans.
7 (“[T]he instant specification supports an uncertainty in view of what
mutations in a chimeric HCV variant would successfully lead to the required
functional property as claimed following the process steps, including
passaging and selecting.”).
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requirement of the patent statute requires a description of an invention, not
an indication of a result that one might achieve if one made that invention.”)
(citation omitted). We discern no “correlation between structure and
function,” Ariad, 598 F.3d at 1350, nor any other description that would
provide the ordinarily skilled artisan with “notice of the boundaries of the
right to exclude,” id. at 1348.
In short, the Specification does not adequately describe how the
recited process results in the claimed genus of products. Claim 12 is “only a
research plan, leaving [] to others to explore the unknown contours of the
claimed genus.” AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech,
Inc., 759 F.3d 1285, 1300 (Fed. Cir. 2014) (citing Ariad, 598 F.3d at 1353).
Accordingly, we affirm the Examiner’s rejection of claim 12. Claims 14—16
and 23—29, which are not argued separately (see Appeal Br. 3), fall with
claim 12. See 37 C.F.R. § 41.37(c)(l)(iv).
CONCLUSION
The rejection of claims 12, 14—16, and 23—29 is affirmed for the
reasons of record and those described herein.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv).
AFFIRMED
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