Ex Parte Altenschopfer et al

Patent Trial and Appeal Board

Jan 21, 2016

12508522 (P.T.A.B. Jan. 21, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/508,522 07/23/2009
20350 7590 01/25/2016
KILPATRICK TOWNSEND & STOCKTON LLP
TWO EMBARCADERO CENTER
EIGHTH FLOOR
SAN FRANCISCO, CA 94111-3834
Peter Altenschopfer
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.
95069-000200US-857422 8176
EXAMINER
TRAN, SUSAN T
ART UNIT PAPER NUMBER
1615
NOTIFICATION DATE DELIVERY MODE
01125/2016 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):
ipefiling@kilpatricktownsend.com
j lhice@kilpatrick.foundationip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte PETER AL TENSCHOPFER and
ADAM CHARLES WATKINSON
Appeal2013-007331
Application 12/508,522
Technology Center 1600
Before DONALD E. ADAMS, DEMETRA J. MILLS, and
ERIC B. GRIMES, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL 1
This appeal under 35 U.S.C. § 134(a) involves claims 1-32 (Reply Br.
3). 2 Examiner entered rejections under the enablement provision of
35 U.S.C. § 112, first paragraph, 35 U.S.C. § 102(b), 35 U.S.C. § 103(a),
and obviousness-type double patenting. We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM-IN-PART.
1 Appellants identify the Real Party in Interest as "Strakan International
Limited" (App. Br. 3).
2 Pending claims 33-35 stand withdrawn from consideration (Reply Br. 3).
Appeal2013-007331
Application 12/508,522
STATEMENT OF THE CASE
The claims are directed "to transdermal patches comprising
granisetron" (Spec. 1). Claims 1, 20-23, and 31 are representative and
reproduced in the Claims Appendix of Appellants' Brief.
Claim 31 stands rejected under the enablement provision of 35 U.S.C.
§ 112, first paragraph.
Claims 1-32 stand rejected under 35 U.S.C. § 102(b) as anticipated by
Effing. 3
Claim 31 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Effing and Sanger. 4
Claims 1-32 stand rejected under the judicially created doctrine of
obviousness-type double patenting as being unpatentable over the claim of
Altenschopfer. 5
Obviousness-type Double Patenting:
Appellants acknowledge the obviousness-type double patenting
rejection and contend that they "will file a terminal disclaimer upon
resolution of all other issues in this case" (Reply Br. 5; see App. Br. 6; Ans.
10). In sum, Appellants waived appeal of this rejection. Accordingly, we
decline to address the merits of the obviousness-type double patenting
rejection.
3 Effing, WO 98/53815, published Dec. 3, 1998.
4 Sanger et al., WO 94/01095, published Jan. 20, 1994.
5 Altenschopfer et al., US 7,608,282 B2, issued Oct. 27, 2009.
2
Appeal2013-007331
Application 12/508,522
Enablement:
ISSUE
Does the evidence of record support Examiner's conclusion that
undue experimentation would be required to practice the claimed invention?
ANALYSIS
Appellants' claim 31 is directed to a patch (see Appellants' claim 31).
We note that Appellants' claim 31 recites a number of conditions for which
the claimed patch is intended to treat or provide prophylaxis (id.). The
intended use of the patch, however, does not limit Appellants' claimed
patch. Therefore, we are not persuaded by Examiner's assertion that
Appellants' Specification "does not reasonably provide enablement for a
method for the treatment and/or prophylaxis of a patient having, or
susceptible to, a condition" set forth in Appellants' claim 31 (Ans. 5; see
Reply Br. 6 ("If the patch is acknowledged to be enabled, how can the use of
such patch for the treatment of conditions which are known in the art to be
responsive to the same active ingredient, granisetron, not also be enabled?");
see App. Br. 7).
CONCLUSION OF LAW
The evidence of record fails to support Examiner's conclusion that
undue experimentation would be required to practice the claimed invention.
The rejection of claim 31 under the enablement provision of 35 U.S.C.
§ 112, first paragraph is reversed.
3
Appeal2013-007331
Application 12/508,522
Anticipation:
ISSUE
Does the preponderance of evidence on this record support
Examiner's finding that Effing teaches Appellants' claimed invention?
FACTUAL FINDINGS (FF)
FF 1. Effing "relates to a transdermal drug delivery device for the delivery
of tropisetron or granisetron" (Effing 1: 5---6; see Ans. 8).
FF 2. Effing teaches that "the drug is present[] in an amount by weight of
about 1 to about 25 percent, preferably about 4 to 15 percent, by weight
based on the total weight of the adhesive layer" (Effing 5: 28-30; Ans. 8; cf
Spec. 9 ("Levels of granisetron may be up to about 10% by weight")).
FF 3. Effing exemplifies a transdermal patch comprising hydroxyethyl
acrylate (HEA) and tropisetron (Effing 13: 16-28; id. at 9: 13; Ans. 12;
Spec. 6: 3--4 ("Particularly preferred acrylates are ... , especially
hydroxyethylacrylate (HEA)")).
FF 4. "Stability testing of [Effing' s] formulation [comprising HEA]
revealed [] a decrease in the drug content of more than 10% within 4 weeks
of storage" (Effing 13: 27-28).
FF 5. Effing's examples 1 and 2 relate to a patch comprising tropisetron,
iso-octylacrylate (IOA) and N-vinyl-2-pyrrolidone (NVP), with or without
ELVACITEâ„¢, see Effing's examples 2 and 1 respectively (Effing 11: 1-
27).
4
Appeal2013-007331
Application 12/508,522
Claim 1:
ANALYSIS
Effing teaches and exemplifies an adhesive patch suitable for the
transdermal administration of granisetron to a subject in need thereof, that
comprises: (1) HEA, an acrylic adhesive containing non-acidic hydroxyl
moieties, and (2) a physiologically effective amount of granisetron loaded in
the acrylic adhesive (FF 1-3). In this regard, Appellants recognize that a
person of ordinary skill in this art would have realized that because Effing
teaches "adhesive patches containing either tropisetron or granisetron []
observations made with respect to tropisetron [] would be equally applicable
to granisetron" (App. Br. 8). Thus, an exemplification of a patch containing
tropisetron is also an exemplification of a patch containing granisetron.
For the foregoing reason we are not persuaded by Appellants'
contention that Effing fails to disclose an "acrylic adhesive contain[ing]
'non-acidic hydroxyl moieties"' (App. Br. 8; cf FF 3).
Appellants' claim 1 does not require a particular level of stability,
therefore, we are not persuaded by Appellants' contentions regarding
Effing's stability results for the patch exemplified in Effing's Example 7
(see App. Br. 8-9; Reply Br. 7-8; FF 4).
Claim 20:
Appellants' claim 20 depends from and further limits the patch of
claim 1 to require that no crystallization is observed after one month storage
at room temperature and pressure (see Appellants' claim 20).
Appellants failed to present persuasive evidence or argument to
support a finding that Effing' s patch, comprising granisetron and HEA, will
5
Appeal2013-007331
Application 12/508,522
not inherently exhibit the absence of crystallization after one month storage
at room temperature and pressure (cf App. Br. 9 ("claim 20, further
distinguishes over Effing by requiring that 'no crystallization is observed
after one month storage at room temperature and pressure"')).
Claims 21and22:
Appellants' claims 21 and 22 depend from and further limit the patch
of claim 1 to require that the granisetron content of the patch remains
substantially unchanged when stored at 25°C or 40°C, respectively, for at
least six weeks (see Appellants' claims 21 and 22).
We recognize, but are not persuaded by, Examiner's reliance on
Effing's Examples 1 and 2 to support a finding that Effing's "device shows
stability at storage conditions under 25°C and 40°C after 4 weeks" (Ans. 8;
see generally FF 5). Examiner failed to establish an evidentiary basis on this
record to support a conclusion that the adhesive of Effing's Examples 1 and
2 contain non-acidic hydroxyl moieties, as required by Appellants' claims 21
and 22 (see Ans. 8; FF 5; cf App. Br. 8; Ans. 12). Therefore, Examiner
failed to establish a factual basis on this record to support a finding that the
stability of the products disclosed in Effing' s Examples 1 and 2 are within
the scope of Appellants' claimed invention.
Examiner did, however, establish that the product of Effing's
Example 7 is within the scope of Appellants' claimed invention. The
stability of the product disclosed in Effing's Example 7, however, is outside
the scope of the stability requirements set forth in Appellants' claims 21 and
22 (see Appellants' claims 21 and 22; see Reply Br. 7-8; cf FF 4).
6
Appeal2013-007331
Application 12/508,522
Claims 23 and 31:
Appellants' claims 23 and 31 are directed the patch of claim 1.
Claims 23 and 31 additionally recite various intended uses for the claimed
patch. The intended uses recited in claims 23 and 31 are "for the treatment
of conditions which are known in the art to be responsive to [] granisetron"
(Reply Br. 6).
Having found that Effing anticipates the patch of Appellants' claim 1,
we are not persuaded by Appellants' contention and/ or intimation that a
recitation of the intended use of the claimed patch, which does not place
additional structural limitations on the claimed patch, renders the patch set
forth in Appellants' claims 23 and 31 novel in view of Effing.
CONCLUSION OF LAW
The preponderance of evidence on this record supports Examiner's
finding that Effing teaches Appellants' claimed invention as it relates to
claims 1, 20, 23, and 31. The rejection of claims 1, 20, 23, and 31 under
35 U.S.C. § 102(b) as being anticipated by Effing is affirmed. Claims 2-19
and 32 are not separately argued and fall with claim 1. Claims 24--30 are not
separately argued and fall with claim 23.
The preponderance of evidence on this record fails to support
Examiner's finding that Effing teaches Appellants' claimed invention as it
relates to claims 21 and 22. The rejection of claims 21 and 22 under
35 U.S.C. § 102(b) as being anticipated by Effing is reversed.
7
Appeal2013-007331
Application 12/508,522
Obviousness:
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 6. Examiner relies on Effing as set forth above (Ans. 10).
FF 7. Examiner relies on Sanger to disclose "the use of 5-HT 3 receptor
antagonist[, which include granisetron,] for the treatment of visceral pain
and migraine (abstract)" (id.).
ANALYSIS
Based on the combination of Effing and Sanger, Examiner concludes
that, at the time Appellants' invention was made, it would have been prima
facie obvious "to modify the teaching of Effing for the treatment of migraine
to obtain the claimed invention" (Ans. 10). Having found that Effing
anticipates the subject matter of Appellants' claim 31, we find that Effing
makes obvious the subject matter of Appellants' claim 31. Connell v. Sears,
Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir. 1983) ("anticipation is the
epitome of obviousness").
For the foregoing reasons we are not persuaded by Appellants'
contention that "Sanger is unable to cure the deficiencies of Effing" (App.
Br. 1 O; Reply Br. 8).
Appellants' claim 31 does not require a particular level of stability,
therefore, we are not persuaded by Appellants' contentions regarding
Effing's stability results for the patch exemplified in Effing's Example 7
(see App. Br. 11; see Reply Br. 8-9; FF 4).
8
Appeal2013-007331
Application 12/508,522
CONCLUSION OF LAW
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness. The rejection of claim 31 under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Effing and Sanger is
affirmed.
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. § 1.136(a).
AFFIRMED-IN-PART
cdc
9