Ex Parte Cantor et al

Patent Trial and Appeal Board

Apr 29, 2016

12820280 (P.T.A.B. Apr. 29, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/820,280 06/22/2010
32692 7590 05/03/2016
3M INNOVATIVE PROPERTIES COMPANY
PO BOX 33427
ST. PAUL, MN 55133-3427
FIRST NAMED INVENTOR
Adam S. Cantor
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.
56032US040 1886
EXAMINER
GHALI, ISIS AD
ART UNIT PAPER NUMBER
1611
NOTIFICATION DATE DELIVERY MODE
05/03/2016 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):
LegalUSDocketing@mmm.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ADAM S. CANTOR, TERRANCE W. OCHELTREE,
and CYNTHIA A. ROBLES 1
Appeal2013-002877
Application 12/820,280
Technology Center 1600
Before TONI R. SCHEINER, LORA M. GREEN, and ULRIKE W. JENKS,
Administrative Patent Judges.
JENKS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims directed to a
transdermal fentanyl drug delivery device. The Examiner rejects the claims
as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
1 According to Appellants, the Real Party in Interest is are 3M Company and
3M Innovative Properties Company. (Br. 1.)
Appeal2013-002877
Application 12/820,280
STATEMENT OF THE CASE
According to the Specification,
Oral absorption [of fentanyl] is low presumably due to a
high hepatic clearance by first-pass metabolism ....
Transdermal administration of fentanyl can overcome the
drawbacks of frequent dosing needed with the aforementioned
route[] of administration ... [because it can] avoid the peaks
and valleys obtained with pulsatile delivery.
(Spec. 2: 7-13.) Additionally, the Specification explains that "[t]he device
should be designed to make it difficult to accidentally deliver higher dosages
than the intended amount (i.e., avoid dose dumping)." (Spec. 2: 29-30.)
Claims 1-10 are on appeal, and can be found in the Claims Appendix
of the Appeal Brief. Claim 1 is representative of the claims on appeal, and
reads as follows:
1. A transdermal drug delivery composition consisting of:
(a) a copolymer comprising the reaction product of:
(i) one or more A monomers selected from the group
consisting of alkyl acrylates containing 4 to 12 carbon atoms in
the alkyl group and alkyl methacrylates containing 4 to 12
carbon atoms in the alkyl group; and
(ii) one or more ethylenically unsaturated B monomers
copolymerizable with the A monomer;
(b) about 8% to about 30% by weight fentanyl based on the
total weight of the composition; and, optionally,
( c) a component selected from the group consisting of delivery
enhancing adjuvants, tackifiers, plasticizers, and combinations
thereof,
wherein the composition is free of undissolved fentanyl.
Claim 10, the only other independent claim lists a specific selection
for monomers A and B.
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Application 12/820,280
Appellants request review of the Examiner's rejection2 of claims 1-10
over Garbe3 in view of Payne.4
As Appellants do not argue the claims separately, we focus our
analysis on claim 1, and claims 2-10 stand or fall with that claim. 37 C.F.R.
§ 41.37 (c)(l)(iv).
The Examiner finds that "Garbe teaches a transdermal drug delivery
device comprising a backing and a matrix comprising a copolymer, a
softener and a drug. . . . Example on page 19 [of Garbe] teaches copolymer
comprising 55% isooctyl acrylate, 40% hydroxyethyl acrylate and 5%
polymethylmethacrylate, as claimed." (Final Act. 7; Ans. 5.) The Examiner
recognizes that "Garbe teaches the claimed copolymer and teaches 0.01 to
about 30 percent by weight of active agent, and suggested fentanyl,
however, the reference does not exemplify fentanyl." (Ans. 6.) The
Examiner relies on Payne solely for "teaching and showing desirability to
deliver fentanyl transdermally, versus other routes." (Id. at 14.) The
Examiner concludes that "[a]bsent any evidence to the contrary, and based
2 In the Final Action mailed April 27, 2012 the Examiner also rejected
claims 1-10 on the ground of non-statutory obviousness-type double
patenting. The U.S. Patent and Trademark Office mailed a notice of
abandonment on November 23, 2012, for U.S. Application No. 09/965,640,
the application upon which this provisional nonstatutory obviousness-type
double patenting rejection is based. As the application that forms the basis
of this rejection has been abandoned, the contentions presented by
Appellants and the Examiner regarding this rejection are moot.
Accordingly, we dismiss the appeal with respect to this rejection.
3 Garbe et al., WO 96/08229, published Mar. 21, 1996.
4 Payne et al., Quality of life and cancer pain: satisfaction and side effects
with transdermalfentanyl versus oral morphine, 16 J. Clin. Oncol. 1588-93
(1998) (Abstract only).
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Application 12/820,280
upon the teachings of the prior art, there would have been a reasonable
expectation of success in practicing the instantly claimed invention" based
on the teachings of Garbe." (Id. at 7-8.)
The issue is: Does the preponderance of evidence of record support
the Examiner's conclusion that the combination of references would have
suggested formulating fentanyl into the transdermal delivery system of
Garbe?
Findings of Fact
We adopt the Examiner's findings and analysis concerning the scope
and content of the prior art. The following facts are repeated for reference
convemence.
FF 1. Garbe teaches a transdermal drug delivery device, comprising:
( 1) a backing;
(2) a matrix adhered to one side of the backing and comprising
(a) a copolymer comprising
(i) one or more A monomers selected from the
group consisting of alkyl acrylates containing 4 to
10 carbon atoms in the alkyl group and alkyl
methacrylates containing 4 to 10 carbon atoms in
the alkyl group; and
(ii) optionally one or more ethylenically
unsaturated B monomers copolymerizable with the
A monomer; and
(iii) a macromonomer, preferably a substantially
linear macromonomer, copolymerizable with the A
and B monomers defined above and having a
molecular weight in the range 500-500,000;
(b) a softener dissolved in the copolymer; and, ( c) if the
softener is not therapeutically effective, a therapeutically
effective amount of a drug.
(Garbe 2: 5-19.)
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Application 12/820,280
FF2. Garbe teaches the preparation containing isooctyl acrylate,
hydroxyethyl acrylate, and polymethylmethacrylate macromonomer
(Garbe 19: 1-19; see Ans. 5 (Garbe teaches "copolymer comprising
55% isooctyl acrylate, 40% hydroxyethyl acrylate and 5%
polymethylmethacrylate").)
FF3. Garbe teaches that suitable drugs include fentanyl. (Garbe 12: 28.)
FF4. Garbe teaches that "certain drug substances function as softeners,
including nicotine." (Id. at 9: 12-13.)
FF5. Garbe teaches that the "transdermal drug delivery device that allows
dissolution of drug and relatively heavy loading with oily excipients,
maintains contact with the skin, and can be removed cleanly from the
skin. The pressure sensitive skin adhesives of the invention provide
these advantages and in addition adhere to the skin." (Id. at 3: 11-15.)
FF6. Garbe teaches that
a drug is present in a transdermal device of the invention in an
amount of about 0.01 to about 30 percent by weight based on
the total weight of the matrix. In a preferred embodiment the
drug is substantially fully dissolved, and the matrix is
substantially free of solid undissolved drug.
(Id. at 13: 16-20.)
Principle of Law
"The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results."
KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). "If the claim
extends to what is obvious, it is invalid under§ 103." Id. at 419 (2007).
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Application 12/820,280
Analysis
The Examiner rejects claim 1 as obvious based on the combination of
Garbe and Payne (Final Act. 5-10; Ans. 4--7). We adopt the Examiner's
findings of fact, reasoning regarding the scope and content of the prior art,
and responses to argument (see Final Act. 10-16; see also Ans. 8-15), and
agree that the claims are rendered obvious by Garbe and Payne. We address
Appellants' arguments below.
Appellants contend that "[ f]entanyl and nicotine ... are entirely
different from the standpoint of transdermal delivery," citing Naik5 in
support (Br. 3). "Given the known solubility issues associated with fentanyl,
a person of ordinary skill, based upon Garbe, would not have expected
amounts of about 8 to about 30% fentanyl to be incorporated without
undissolved fentanyl." (Br. 4.)
We are not persuaded. Garbe teaches a transdermal delivery system
and suggests fentanyl as one of the drugs for use in the system (FF1-FF6).
We find nothing in Naik that suggests a composition containing 8-30%
fentanyl would not be soluble. We agree with the Examiner that merely
demonstrating that fentanyl and nicotine have different pharmacochemical
and pharmacokinetic properties does not indicate that they "cannot be
delivered transdermally using the same polymer. It is known that different
drugs have different solubility and it is known that fentanyl can be delivered
transdermally." (Ans. 12.) As further pointed out by the Examiner, "Garbe
teaches formulation comprising copolymer suitable to deliver different drugs
having different properties including [different] solubility." (Ans. 12.) We
5 Naik et al., Transdermal drug delivery: overcoming the skin's barrier
function, 3 PSTT 318-326 (2000).
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Application 12/820,280
agree with the Examiner that Garbe teaches a transdermal drug delivery
device that allows for the dissolution of the drug (FF5) so that the matrix is
substantially free of solid undissolved drug (FF6). The Examiner explains
that the dissolution of the drug "it is not only suitable for highly soluble
drugs, but also less soluble drugs, since the formulation assists in drug
dissolution. In other words, the drug does not need to be soluble, rather the
copolymer will dissolute [sic] the drug." (Ans. 12.) The Examiner looks to
the teaching of Payne for the use of a transdermal delivery system
containing fentanyl for the purpose of pain management. Concluding that
one of ordinary skill in the art would have been motivated to formulate
Garbe' s transdermal device with fentanyl, as already suggested by Garbe
itself (FF2), "because Payne teaches that transdermal fentanyl patches
satisfy patients in need of pain management." (Final Act. 9.)
We recognize, but are not persuaded by, Appellants argument that
nicotine and fentanyl have different pharmacokinetic properties. Naik lists
the various drugs that have "acceptable (but rather confined) parameter
ranges for currently marketed transdermal agents. The net result is that
although there are many transdermal candidates (i.e. drugs that would
benefit from this mode of delivery), only a limited number possess the ideal
physicochemical properties" and fentanyl as well as nicotine are listed by
Naik as meeting these narrow limitations (Naik 320-321 ). Thus, there is
nothing in Naik to dissuade the ordinary artisan from using fentanyl in a
transdermal patch as already suggest by Garbe (FF3).
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Application 12/820,280
Appellants contend that reliance on Payne "is irrelevant because its
fentanyl patch has an entirely different architecture [see Venkatramann6]
from the patch that is the subject of Applicant's claims." (Br. 4.)
We are not persuaded. The Examiner looks to Payne solely to
establish that administering fentanyl via a transdermal route is desirable
"because transdermal fentanyl patches provide lower frequency and reduced
impact of side effects." (Final Act. 9, 15 ("Payne is relied upon for ...
solely teaching and showing desirability to deliver fentanyl transdermally,
versus other routes, to alleviate pain").) Knowing that the transdermal route
of fentanyl administration produces less side effects provides motivation to
also formulate Garbe's transdermal delivery composition with fentanyl, as
already suggested by Garbe (FF2), with a reasonable expectation of success
(Final Act. 9). We do not agree with Appellants position that Payne's
teaching is irrelevant just because the Duragesic depot patch, a liquid
reservoir patch is "structurally distinct from monolithic acrylate copolymer
patches." (Br. 5.)
We conclude that the evidence cited by the Examiner supports a prima
facie case of obviousness with respect to claim 1, and Appellants have not
provided sufficient rebuttal evidence or evidence of secondary
considerations that outweighs the evidence supporting the prima facie case.
As Appellants do not argue the claims separately, claims 2-10 fall with
claim 1. 37 C.F.R. § 41.37 (c)(l)(iv).
6 Venkatraman et al., US 2004/0213832 Al, published Oct. 28, 2004.
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SUMMARY
We affirm the rejection of claim 1under35 U.S.C. § 103(a) over
Garbe in view of Payne. Claims 2-10 were not separately argued and fall
with claim 1.
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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