Ex Parte Zerbe et al

Patent Trial and Appeal Board

Jan 26, 2017

13292590 (P.T.A.B. Jan. 26, 2017)

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.
13/292,590 11/09/2011 Horst Georg ZERBE 20111766 3737
513 7590 01/30/2017
WENDEROTH, LIND & PONACK, L.L.P.
1030 15th Street, N.W.,
Suite 400 East
EXAMINER
ROBERTS, LEZAH
Washington, DC 20005-1503 ART UNIT PAPER NUMBER
1612
NOTIFICATION DATE DELIVERY MODE
01/30/2017 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):
ddalecki@wenderoth.com
eoa@ wenderoth. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte HORST GEORG ZERBE, JIAN-HWA GUO, and
ANTHONY SERINO1
Appeal 2015-007223
Application 13/292,590
Technology Center 1600
Before RICHARD J. SMITH, RYAN H. FLAX, and
RACHEL H. TOWNSEND, 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 a film comprising a pharmaceutically active ingredient
Claims 10-14, 16—28, 30-34, and 36-49 are on appeal as rejected under
35 U.S.C. § 103(a) and for obviousness-type double patenting. We have
jurisdiction under 35 U.S.C. § 6(b).
We affirm.
1 We understand the Real Party in Interest to be LTS LOHMANN
THERAPIE-SYSTEME AG. Br. 2.
Appeal 2015-007223
Application 13/292,590
STATEMENT OF THE CASE
The appealed claims can be found in the Claims Appendix of the
Appeal Brief. Claims 10, 28, and 45 are independent claims; claim 10 is
representative and reads as follows:
10. A film comprising:
i. at least one water-soluble polymer,
11. at least one polyalcohol, and
iii. at least one pharmaceutically active ingredient selected
from the group consisting of narcotics that are capable of being
delivered via the mucous membrane,
wherein the at least one pharmaceutically active ingredient is
incorporated into the film.
Br. 23 (Claims App’x).2
The following rejections are on appeal:
Claims 10-20, 22 40, and 42-49 stand rejected under 35 U.S.C.
§ 103(a) over Majeti,3 Acharya,4 Kizawa,5 and Sunshine.6 Ans. 3.
2 The Claims Appendix does not continue the consecutive pagination of the
Appeal Brief of which it is a part. We refer to the Claims Appendix herein
by the continued consecutive pagination based on counting.
3 U.S. Patent No. 5,599,554 (issued to Satyanarayana Majeti on Feb. 4,
1997) (hereinafter “Majeti”).
4 U.S. Patent No. 5,686,094 (issued to Ramesh N. Acharya on Nov. 11,
1997) (hereinafter “Acharya”).
5 U.S. Patent No. 4,517,173 (issued to Hidenori Kizawa et al. on May 14,
1985) (hereinafter “Kizawa”).
6 U.S. Patent No. 4,486,436 (issued to Abraham Sunshine on Dec. 4, 1984)
(hereinafter “Sunshine”).
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Application 13/292,590
Claims 21 and 41 stand rejected under 35 U.S.C. § 103(a) over Majeti,
Acharya, Kizawa, Sunshine, and Hill.7 Id. at 5.
Claims 10-14, 16—28, and 30-46 stand rejected on the ground of
nonstatutory obviousness-type double patenting over the claims of Zerbe.8
Id. at 6.
We adopt the Examiner’s findings of fact, reasoning on scope and
content of the prior art, and conclusions set out in the Final Action and
Answer. The findings of fact set forth below are provided only to highlight
certain evidence of record.
FINDINGS OF FACT
FF1. Majeti disclosed “a transdermally or transmucosally
administrable composition for the treatment o[f] nicotine craving or
smoking withdrawal symptoms comprising nicotine and caffeine or
caffeine equivalent.” Majeti Abstract; see also Ans. 3—5 and 7—13
(discussing Majeti).
FF2. Majeti disclosed a film for “use in with the oral mucosa,”
comprising “[wjater soluble or water swellable polymers . . .
[including] polyvinyl alcohol [and] cellulose derivatives [such as] . . .
hydroxypropyl cellulose,” and “a glycol plasticizer,” such as
propylene glycol and polyethylene glycol, which forms a “reservoir
layer . . . forming film walls or matrixes which allow the nicotine and
7 U.S. Patent No. 5,032,387 (issued to Ira D. Hill et al. on July 16, 1991)
(hereinafter “Hill”).
8 U.S. Patent No. 5,948,430 (issued to Horst Georg Zerbe et al. on Sept. 7,
1999) (hereinafter “Zerbe”).
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caffeine or caffeine equivalent to pass by diffusion.” Majeti 4:55—5:9,
6:51—65 (Example 1); see also Ans. 3—5 and 7—13 (discussing Majeti).
FF3. Acharya disclosed “a carrier or coating of active
compositions, such as pharmaceuticals and the like . . . having a shape
suitable for insertion into the mouth.” Acharya Abstract; see also
Ans. 3—5 and 7—13 (discussing Acharya).
FF4. Acharya disclosed materials that dissolve or disintegrate
after contact with saliva (e.g., tablets, lozenges, candies, suppositories,
or the like) that deliver active compositions, “provided as a . . . film or
laminate . . . [where] the active composition is contained in an inert
matrix,” comprising “cellulose polymers . . . such as . . .
hydroxypropyl cellulose, hydroxymethyl cellulose,” and “cosolvents
e.g. glycerol, propylene glycol, or polyethylene glycols, in varying
proportion to affect the formation of the polymeric hydrogel,” and
“medicinal agents includ[ing inter alia] . . . codeine phosphate.”
Acharya 1:56-64, 5:1-2, 5:4A-54, 7:39-8:21, 10:2-6, 12:18-22; see
also Ans. 3—5 and 7—13 (discussing Acharya).
FF5. Kizawa disclosed “[a] mucous membrane-adhering film
preparation wherein the film consists of two layers. One layer of the
film consists of the pharmaceutical agents and water-soluble high
polymer material.” Kizawa Abstract; see also Ans. 3^4 and 13
(discussing Kizawa).
FF6. Kizawa disclosed the film includes “[ujseful pharmaceutical
agents [such as]. . . narcotic agents such as lidocain and
procainehydrochloride, [and] cough curing agents such as codeine
phosphate,” and “a water-soluble cellulose derivative such as
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Application 13/292,590
hydroxypropyl cellulose (hereinafter abbreviated as ‘HPC’), methyl
cellulose,” a “[copolymer with] . . . poly vinyl [sic] alcohol,” and a
“plasticizer [such as] . . . polyethylene glycol (macrogol),
propyleneglycol, glycerine.” Kizawa 2:34—58, 3:5—15, 4:3—6; see also
Ans. 3^4 and 13 (discussing Kizawa).
FF7. Sunshine disclosed “compositions comprising caffeine
together with ... a selected narcotic analgesic.” Sunshine Abstract;
see also Ans. 3, 5, and 13—14 (discussing Sunshine).
FF8. Sunshine disclosed combining “the selected narcotic
analgesic . . . with any oral nontoxic pharmaceutically acceptable inert
carrier,” which can include “disintegrating agents” and “binders [such
as] . . . methylcellulose [and] polyethylene glycol.” Sunshine 21:8—
36; see also Ans. 3, 5, and 13—14 (discussing Sunshine).
FF9. Hill disclosed “an oral hygiene preparation,” which could
include “Carbowaxes ® (polyethylene glycols)” and “[v]iscosity
control agents . . . such as . . . methyl cellulose,” and “conventional
flavoring components [such as] . . . vanillin,” and “at least one
humectant [such as] . . . glycerine . . . and propylene glycol.” Hill
Abstract, 4:17—18, 6:58—60, 7:1—11, 7:41—45; see also Ans. 5—6 and
14 (discussing Hill).
FF10. Zerbe claimed, at its originally granted claims 1 and 10, “[a]
monolayer film . . . comprising] at least one water-soluble polymer
... a polyalcohol... [a] pharmaceutically ingredient. . . which
rapidly softens and completely disintegrates in the oral environment”
where “the pharmaceutically active ingredient is ... a narcotic.”
Zerbe claims 1 and 10; see also Ans. 6 and 14—15 (discussing Zerbe).
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FF11. Zerbe claims, at its reexamined claims 13 and 16, “[a]
monolayer film . . . comprising]... at least one water-soluble
polymer ... a polyalcohol... at least one . . . pharmaceutical
ingredient. . . which rapidly softens and completely disintegrates in
the oral environment” where “the pharmaceutically active ingredient
is ... a narcotic.” Zerbe claims 13 and 16; see also Ans. 6 and 14—15
(discussing Zerbe).
DISCUSSION
Obviousness Rejections
Each of Majeti, Acharya, Kizawa, and Hill disclose the combination
of a water-soluble polymer and a polyalcohol for the purpose of carrying and
delivering a pharmaceutical and that these components can be the same as
those disclosed in the Specification (at 3—5) and recited by the appealed
claims.9 FF1—FF9. Acharya, Kizawa, and Sunshine disclose that the
pharmaceutical component carried by such a polymer combination can be a
narcotic, e.g., codeine phosphate. FF4, FF6—FF8. Majeti, Acharya, and
Kizawa disclose that the combination of materials can be produced as a film.
FF2, FF4—FF6. Acharya is clear that these materials can be fashioned to
dissolve or disintegrate (rapidly), e.g., as tablets, lozenges, candies,
suppositories, or the like. FF4. Majeti, Acharya, Kizawa, and Sunshine are
clear that these materials can be fashioned to deliver the pharmaceutical
(e.g., a narcotic) orally and to the mucous membranes. FF1—FF8.
9 Except with respect to claims 21, 26, 41, and 43, that we address below, we
select claim 10 as representative with the remaining claims falling with
claim 10. See 37 C.F.R. § 41.37(c)(l)(iv).
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These references are analogous art as they are each in the same field
of endeavor as one another and the claimed invention—polymeric oral or
mucous membrane pharmaceutical carriers and delivery systems. See In re
Clay, 966 F.2d 656, 658—59 (Fed. Cir. 1992). As the Supreme Court
explained in KSR, “when a patent claims a structure already known in the
prior art that is altered by the mere substitution of one element for another
known in the field, the combination must do more than yield a predictable
result.” KSR Int’l v. Teleflex Inc., 550 U.S. 398, 416 (2007); see also id. at
417 (“[W]hen a patent ‘simply arranges old elements with each performing
the same function it had been known to perform’ and yields no more than
one would expect from such an arrangement, the combination is obvious.”)
(quoting Sakraida v. Ag Pro, Inc., 425 U.S. 273, 282 (1976)). Furthermore,
picking one of a finite number of known solutions to a known problem is
obvious. KSR, 550 U.S. at 421.
Here the prior art combination cited by the Examiner establishes a
prima facie case that the appealed claims would have been obvious.
Appellants’ arguments do not persuade us that a preponderance of the
evidence fails to support the Examiner’s determination that the film defined
by claim 10 would have been prima facie obvious over Majeti, Acharya,
Kizawa, and Sunshine, and in the case of claims 21 and 41, also Hill. We
address Appellants’ arguments below.
Appellants argue the final rejection is premised on improper hindsight
reasoning because the Examiner used the Applicants’ disclosure as a guide
to pick and choose components from the prior art. This argument is not
persuasive. The Examiner relies on the disclosures of the prior art and their
suggested materials for a polymeric drug delivery film. No improper
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hindsight was necessary or evidenced in the Examiner’s analysis or
reasoning.
Appellants argue there would have been no expectation of
successfully combining the references because Acharya merely lists codeine
as one of many drugs and Majeti requires both nicotine and caffeine and the
skilled artisan could not expect to replace both of these with a narcotic. This
argument is not persuasive. Even though the Examiner focuses on Acharya,
more than one of the references disclosed using a narcotic as the
pharmaceutical agent in a polymeric film, made of the materials recited by
the appealed claims, for the purpose of delivering the drug to the mouth or
mucous membrane. FF3—FF8. There would have been no reason to expect
anything other than success in combining such materials and narcotic active
ingredients, rather than the caffeine and nicotine active ingredients taught in
Majeti, for mucosal delivery by way of a film as taught in Majeti.
Appellants argue the Examiner has not used the broadest reasonable
interpretation of the claim language in referencing the Specification’s
disclosure of a list of drugs suitable for its invention, which includes
narcotics and other drugs that overlap with the drug lists of the prior art
references. This argument is not persuasive. There is no evidence
suggesting the Examiner has not given the claim language its broadest
reasonable interpretation. Ans. 12. To the contrary, the Examiner looked to
the Specification to understand the meaning and context of the term
“narcotic,” and found no special definition was given and determined that
lidocaine, labeled by the prior art as a narcotic, would meet the limitation,
but even if it did not, Acharya’s (and, we note, Kizawa’s and Sunshine’s)
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disclosure of codeine phosphate would meet the limitation. Adv. Act. 2.10
“[A] claim must be read in view of the specification of which it is a part.”
Renishaw PLC v. Marposs Societa per Azioni, 158 F.3d 1243, 1248 (Fed.
Cir. 1998).
Furthermore, we also do not find anything improper in the Examiner’s
consulting the Specification to better understand the claimed invention.
Adv. Act. 2; Ans. 12. The Examiner determined from the Specification that
no specific tailoring was disclosed to make the film especially suited for use
with narcotics, as opposed to the many other active ingredients listed in the
Specification (Ans. 12; Spec. 5), which supported the Examiner’s conclusion
of obviousness in substituting a medicinal agent listed in Acharya, such as
lidocaine or codeine phosphate, for the nicotine and caffeine of Majeti into
the film of Majeti, that includes the same film ingredients for mucosal
delivery of the drug as claimed. We note the Specification evidences a lack
of criticality to the particular pharmaceutical used. We also note that the
Sunshine reference discloses combining a narcotic with caffeine, which
evidences that a narcotic could be added to the film disclosed by Majeti.
FF7-FF8.
Appellants argue the Examiner has improperly relied on inherency
regarding claims 26 and 43 (directed to “rapidly dissolving” limitation) and
contend there was no reason to expect the film materials of the prior art
references to “rapidly dissolve,” as required by claims 26 and 43. This
argument is not persuasive. As the Examiner found, the cited prior art
discloses the same water soluble polymers and polyalcohols, in substantially
10 Advisory Action, dated Oct. 9, 2014.
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the same amounts, as disclosed in the Appellants’ Specification as suitable
to carry and deliver narcotics. Ans. 12—13. Thus, if the Specification’s
disclosed materials rapidly dissolve, those of the prior art would likewise be
expected to do so. This expectation is confirmed by the disclosure of
Acharya, which indicates that its drug carrier/delivery products composed of
water soluble polymers and polyalcohols carrying narcotics can be
fabricated as products that dissolve or disintegrate quickly, e.g., as tablets,
lozenges, candies, suppositories, or the like. FF4.
Appellants argue claims 21 and 41 are patentable for the same reasons
argued for other claims. For the same reasons discussed above, this
argument is not persuasive.
Double Patenting Rejection
Appellants’ arguments also do not persuade us that the Examiner was
incorrect in determining that the appealed claims 10-14, 16—28, and 30-46
are unpatentable over the claims of Zerbe.11 We address Appellants’
arguments below.
Appellants argue that the double patenting rejection fails because the
Examiner has not addressed their prior traversal of the rejection. Appellants
also argue that the appealed claims do not require a surfactant (which is
alleged to be different from a polyalcohol), which is required by the claims
of Zerbe. Appellants’ arguments are not persuasive.
Zerbe claims a film with a water soluble polymer, a polyalcohol, and a
pharmaceutical agent (claim 13). FF10. Zerbe also claims that the
11 Claim 10 is representative with the remaining claims falling therewith.
See 37 C.F.R. § 41.37(c)(l)(iv).
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pharmaceutical agent can be a narcotic (claims 10 and 16). FF10-FF11.
Whether Zerbe’s claims also include a surfactant is not determinative
because the Appellants’ claims are fashioned as inclusive, open-ended
claims by nature of their use of the transition term “comprising.” A film
having a water soluble polymer, a polyalcohol, and a narcotic, with or
without a surfactant, such as defined by the Zerbe claims, renders the
appealed claims obvious.
SUMMARY
The rejection of claims 10-20, 22-40, and 42-49 under 35 U.S.C.
§ 103(a) over Majeti, Acharya, Kizawa, and Sunshine is affirmed.
The rejection of claims 21 and 41 under 35 U.S.C. § 103(a) over
Majeti, Acharya, Kizawa, Sunshine, and Hill is affirmed.
The rejection of claims 10—14, 16—28, and 30-46 for nonstatutory
obviousness-type double patenting over the claims of Zerbe 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
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