Ex Parte Lee et al

Patent Trial and Appeal Board

Sep 7, 2016

13879638 (P.T.A.B. Sep. 7, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/879,638 04/16/2013
23347 7590 09/09/2016
GLAXOSMITHKLINE
GLOBAL PATENTS
FIVE MOORE DR., PO BOX 13398
MAIL STOP: 5.5A
FIRST NAMED INVENTOR
Kevin Lee
RESEARCH TRIANGLE PARK, NC 27709-3398
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.
PB64375US 2769
EXAMINER
MCDONALD, JENNIFER SUE PITRAK
ART UNIT PAPER NUMBER
1674
NOTIFICATION DATE DELIVERY MODE
09/09/2016 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):
USCIPRTP@GSK.COM
laura.m.mccullen@gsk.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte KEVIN LEE and DAVID FRANCIS TOUGH 1
Appeal2015-002743
Application 13/879,638
Technology Center 1600
Before DONALD E. ADAMS, LORA M. GREEN, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
MAJORS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to methods
comprising administration of an inhibitor of the protein SPl 10, which have
been rejected for failing to satisfy the written description requirement and as
anticipated. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
STATEMENT OF THE CASE
According to the Specification, "[b ]romodomain containing proteins
have been implicated in disease processes including cancer, inflammation
and viral replication. The development of inhibitors to bromodomains is
1 Appellants identify the Real Party in Interest as Glaxo Group Limited. (Br.
3.)
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Application 13/879,638
thus an attractive means for controlling gene expression." (Spec. 2, 11. 17-
20.) Appellants disclose "an inhibitor of a human bromodomain is
preferably used, more particularly an inhibitor of [bromodomain-containing
protein] SPl 10, particularly an inhibitor compound." (Id. at 5, 11. 23-24.)
Claims 1 and 2 are on appeal. Claim 1 is illustrative:
1. A method of treating autoimmune and inflammatory diseases
and conditions which comprises inhibiting the bromodomain-
containing protein SP 110 in a mammal.
(Br. 11 (Claims App'x).)
The claims stand rejected as follows:
Claims 1 and 2 under 35 U.S.C. § 112, first paragraph, for failure to
comply with the written description requirement.
Claims 1and2 as anticipated under 35 U.S.C. § 102(e) by Bentwich.2
I - WRITTEN DESCRIPTION
Issue
Has the Examiner established, by a preponderance of the evidence,
that Claims 1 and 2 fail to satisfy the written description requirement
of§ 112, first paragraph?
Findings of Fact (FF)
FF 1. Appellants' disclose
the term "inhibitor" can be any compound or treatment capable
of inhibiting the expression and/or function of the bromodomain-
containing protein, i.e., any compound or treatment that inhibits
transcription of the gene, RNA maturation, RNA translation,
2 Bentwich, US 8,163,896 Bl, issued Apr. 24, 2012 ("Bentwich").
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post-translational modification of the protein, binding of the
protein to an acetylated lysine target and the like.
(Spec. 6, 1. 32 through 7, 1. l; see also, id. at 7, 1. 4 through 8, 1. 18 (listing
categories of potential inhibitors including, inter alia, nucleic acids,
polypeptides, and natural or synthetic chemical compounds).)
FF 2. The Examiner finds:
The claims are directed to in vivo methods of treating an
immensely broad genus of diseases and conditions by generically
inhibiting SP 110 in a mammal. The agents capable of inhibiting
SPllO include those that directly inhibit SPl 10, known and
unknown, and those that indirectly inhibit SPllO, known and
unknown.
(Ans. 2.) The Examiner further finds "[t]he instant claims require inhibiting
SPl 10 expression and/or function by any means .... The claimed means of
inhibiting SP 110 are essentially unlimited." (Id. at 5-6.)
FF 3. The Examiner finds "[t]he Specification provides evidence that
siRNAs targeted to SPl 10 inhibit SPl 10 in vitro." (Id. at 3 (emphasis
removed).) According to the Examiner, "[t]he specification provides long
lists of potential SPl 10 inhibitors .... [but] [t]he only confirmed functional
SP 110 inhibitors actually disclosed in the instant specification were siRNAs
targeted to SPl 10." (Id. at 6.)
FF 4. The Examiner finds
The instant disclosure invites those of ordinary skill in the art to
1) determine diseases and conditions that can be treated or
prevented by inhibiting SPllO, 2) determine what agents are
useful in the claimed therapeutic methods, and 3) determine
therapeutically effective amounts of such agents. Finally,
Applicant's claims would exclude others from treating any
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number of diseases or conditions with any agent that
inadvertently inhibits SP 110.
(Id. at 8.)
Principles of Law
"[T]he test [for adequate written description] requires an objective
inquiry into the four comers of the specification from the perspective of a
person of ordinary skill in the art. Based on that inquiry, the specification
must describe an invention understandable to that skilled artisan and show
that the inventor actually invented the invention claimed." Ariad Pharms.,
Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en bane).
Where claims to a genus are involved, "[ o ]ne needs to show that one
has truly invented the genus, i.e., that one has conceived and described
sufficient representative species encompassing the breadth of the genus.
Otherwise, one has only a research plan, leaving it to others to explore the
unknown contours of the claimed genus." Abb Vie Deutschland GmbH &
Co. v. Janssen Biotech, Inc., 759 F.3d 1285, 1300 (Fed. Cir. 2014).
Analysis
Appellants have not separately argued the patentability of claims 1
and 2 over the Examiner's written description rejection. We thus select
claim 1 as representative.
Appellants argue the Specification provides disclosure showing
possession of the invention as broadly as claimed. According to Appellants,
"[t]he specification describes how to screen for inhibitors and provides
evidence that SP 110 can be inhibited ... [and further] list[ s] diseases and
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conditions which are immunoinflammatory and autoimmune, thus
complying with the written description." (Br. 9.) In response to the
Examiner's findings concerning the absence of detail about compounds that
actually inhibit SP 110, Appellants argue they "are not claiming a genus of
compounds ... [but instead] a method of treatment and not the inhibitors per
se." (Id.) Also, Appellants contend, the disclosure is sufficient because they
have described "screening techniques" and "si[RNA] inhibitors as an
example of a suitable therapeutic." (Id.)
Appellants' arguments are unpersuasive. Claim 1 is directed to an "an
immensely broad genus" and is reasonably interpreted as covering any and
all methods of inhibiting SPl 10 - now known or later discovered. (Ans. 2-
3; FF 1, 2, 4.) As discussed further below, we agree with the Examiner that
Appellants' disclosure is not sufficient to support the breadth of such a
claim. (FF 2--4.)
We reject as unpersuasive Appellants' argument that they have
satisfied the written description requirement because they are claiming a
method of treatment, not the compounds that inhibit the SP 110 protein. (Br.
9.) On this point, the Federal Circuit's precedents are instructive. For
example, in Rochester, the Court considered whether method claims
(analogous to those here) satisfied the written description requirement, and
held that
[ r ]egardless whether a compound is claimed per se or a method
is claimed that entails the use of the compound, the inventor
cannot lay claim to that subject matter unless he can provide a
description of the compound sufficient to distinguish infringing
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compounds from non-infringing compounds, or infringing
methods from non-infringing methods.
University of Rochester v. G.D. Searle & Co., 358 F.3d 916, 926 (Fed. Cir.
2004). 3 The Federal Circuit proceeded to affirm the grant of summary
judgment of invalidity because the specification lacked sufficient description
of compounds for carrying out the claimed methods. Id. at 929.
Appellants' argument fares no better here than the similar argument
rejected in Rochester. Indeed, Appellants' claims are broader than those
held invalid in Rochester, which recited a method of "administering a non-
steroidal compound that selectively inhibits activity of the PGHS-2 gene
product." (Id. at 918.) Present claim 1, in contrast, does not specify a type
of compound that inhibits the gene product. In any event, Appellants cannot
avoid the written description requirement by, in effect, claiming a method
that would cover the administration of any compound or therapy when the
Specification fails to provide sufficient disclosure of representative
compounds and therapies that inhibit the SP 110 protein.
So too, Appellants' argument that they have described one type of
inhibitor (siRNAs) does not overcome the written description rejection. (Br.
9; FF 3.) The description of one species as inhibiting SP 110 in in vitro
testing is insufficient to show possession of the broad genus that is claimed
here. AbbVie, 759 F.3d at 1299-1300 ("analogizing the genus to a plot of
land, if the disclosed species only abide in a comer of the genus, one has not
3 See also, Ariad, 598 F.3d at 1354, (rejecting Ariad's argument that
"because there is no term in the asserted claims that corresponds to the
molecules, it is entitled to claim the methods without describing the
molecules.")
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described the genus sufficiently to show that the inventor invented, or had
possession of, the genus. He only described a portion of it.") Nor are we
persuaded by Appellants' argument that the description is sufficient because
the Specification discloses screening techniques. (Br. 9.) Appellants'
generic disclosure of screening techniques (see, e.g., Spec. 19 (describing
binding or competition assays) "leav[ es] it to others to explore the unknown
contours of the claimed genus." AbbVie, 759 F.3d at 1300. At best, this
provides a research plan for seeking out undisclosed or unknown SP 110
inhibitors. (Cf FF 4.) It does not, however, show possession by Appellants
of any and all methods of inhibiting the SP 110 protein.
Finally, the disclosure of myriad hypothetically treatable
inflammatory or autoimmune conditions does not overcome the rejection.
The broadest reasonable interpretation of claim 1 requires only inhibiting the
SP 110 protein in a mammal. Moreover, although the Specification lists an
extensive number of conditions (e.g., everything from arthritis to
schizophrenia), Appellants have not cited in the Specification sufficient
disclosure concerning treatment of these conditions. (See, e.g., Spec. 16-18;
Ans. 6.) Here again, Appellants' leave it others to complete an unfinished
invention.
Conclusion of Law
We conclude the Examiner established, by a preponderance of the
evidence, that claim 1 fails to satisfy the written description requirement of
§ 112, first paragraph.
Claim 2 has not been argued separately and thus falls with claim 1.
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II - ANTICIPATION
Issue
Has the Examiner established, by a preponderance of the evidence,
that Bentwich teaches Appellants' claimed invention?
Findings of Fact (FF)
FF 5. Bentwich teaches "GAM3229 is a novel bioinformatically
detected regulatory, non protein coding, micro RNA (miRNA) gene."
(Bentwich, col. 5330, 11. 7-8.) Bentwich teaches "GAM3229 gene, herein
GAM GENE, and GAM3229 target gene, herein designated TARGET
GENE, are human genes contained in the human genome." (Id. at col. 5330,
11. 11-13.)
FF 6. Bentwich teaches a "function of GAM3229 is therefore
inhibition of Sp 110 nuclear body protein ... , a gene which is involved in
transduction of interferon action. Accordingly, utilities of GAM3229
include diagnosis, prevention and treatment of diseases and clinical
conditions associated with SPl 10." (Id. at col. 5532, 11. 3-8; see also, id.
col. 5532, 11. 9-32.)
FF 7. The Examiner finds
Bentwich teaches that GAM3229 inhibits SPllO and that
GAM3229 is useful to prevent and treat diseases and conditions
associated with SPl 10. To use GAM3229 to treat or prevent a
disease or condition, GAM3229 must be administered.
Bentwich discloses a species of the instant claims.
(Ans. 10.)
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Analysis
We select claim 1 as representative.
Appellants argue that Bentwich is long and "difficult to understand."
(Br. 9-10.) Appellants further contend they "cannot find in [Bentwich] any
evidence presented for either an ability to inhibit SP 110 or what the
consequences of inhibiting SPl 10 would be." (Id. at 10.) We are not,
however, persuaded that the cited portions of Bentwich do not teach
inhibiting the SP 110 protein. (FF 5-7.) Bentwich expressly discloses that a
"function of GAM3229 is the[] inhibition of Spl 10 nuclear body protein."
(FF 6.) This disclosure in an issued patent is presumed enabling. In re
Antor Media Corp., 689 F.3d 1282, 1288 (Fed. Cir. 2012) ("[A] prior art
publication cited by an Examiner is presumptively enabling barring any
showing to the contrary by a patent applicant.")
We are also not persuaded by Appellants' suggestion that Bentwich is
deficient for not specifying the diseases or clinical conditions associated
with SPl 10. (Br. 10.)4 The broadest reasonable interpretation of claim 1
does not require treatment of any specific disease or condition. 5
4 Bentwich does teach that SP 110 "is involved in transduction of interferon
action" and the Specification, citing the prior art, states that "IFN-y
[interferon gamma] ... has been implicated in a number of
autoimmune/inflammatory diseases." (FF 6; Spec. 23, 11. 8-9.)
5 If Appellants regard treatment of a particular disease or condition as their
invention, in prosecution they may revise claims and pursue more precise
claim coverage. Cf In re Zletz, 893 F.2d 319, 322 (Fed. Cir. 1989) ("An
essential purpose of patent examination is to fashion claims that are precise,
clear, correct, and unambiguous. Only in this way can uncertainties of claim
scope be removed, as much as possible, during the administrative process.")
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For these reasons, we agree that claim 1 is anticipated.
Conclusion of Law
We conclude that the Examiner established, by a preponderance of the
evidence, that claim 1 is anticipated under § 102( e) by Bentwich.
Claim 2 has not been argued separately and thus falls with claim 1.
SUMMARY
We affirm the rejection of claims 1 and 2 under 35 U.S.C. § 112, first
paragraph for failure to satisfy the written description requirement.
We affirm the rejection of claims 1and2 under 35 U.S.C. § 102(e) by
Bentwich.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § l.136(a).
AFFIRMED
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