Ex Parte Cantor et al

Patent Trial and Appeal BoardNov 20, 2012

09965610 (P.T.A.B. Nov. 20, 2012)

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 __________ Appeal 2011-009532 Application 09/965,610 Technology Center 1600 __________ Before TONI R. SCHEINER, LORA M. GREEN, and ULRIKE W. JENKS, Administrative Patent Judges. GREEN, Administrative Patent Judge. DECISION ON APPEAL This is a decision on appeal under 35 U.S.C. § 134 from the Examiner‟s rejection of claims 1-9, 16-18, 28, 29, 35, 36, 39-47, 52-54, and 92-103. 1 We have jurisdiction under 35 U.S.C. § 6(b). 1 Claims 48-51 and 55-91 are also pending, but stand withdrawn from consideration (App. Br. 1). Appeal 2011-009532 Application 09/965,610 2 STATEMENT OF THE CASE Claim 1 is representative of the claims on appeal, and reads as follows: 1. A transdermal drug delivery composition consisting essentially of: (a) a copolymer comprising (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; and (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. The following grounds of rejection are before us for review: I. Claims 1-5, 35, 39-42, 52, 53, and 92-97 stand rejected under 35 U.S.C. § 102(b) as being anticipated by Miranda 2 (Ans. 4). As Appellants do not argue the claims separately, we focus our analysis on claim 1, and claims 2-5, 35, 39-42, 52, 53, and 92-97 stand or fall with that claim. 37 C.F.R. § 41.37(c)(1)(vii). II. Claims 1-9, 16-18, 28, 29, 35, 36, 39-47, 52-54, and 92-103 stand rejected under 35 U.S.C. § 103(a) as being rendered obvious by the combination of Miranda and Garbe 3 (Ans. 5). Again, as Appellants do not argue the claims separately, we focus our 2 Miranda et al., US 5,474,783, issued Dec. 12, 1995. 3 Garbe et al., WO 96/08229, published March 21, 1996. Appeal 2011-009532 Application 09/965,610 3 analysis on claim 1, and claims 2-9, 16-18, 28, 29, 35, 36, 39-47, 52-54, and 92-103 stand or fall with that claim. We affirm. ANALYSIS “The present invention relates to a transdermal drug delivery composition containing fentanyl” (Spec. 1). The Specification teaches that “[t]ransdermal drug delivery devices are designed to deliver a therapeutically effective amount of drug across the skin of a patient” (id.). Specifically, according to the Specification, the invention “provides a method of providing sustained analgesia to a mammal comprising delivering fentanyl to a mammal via a transdermal drug delivery device in an amount of about 0.5 to about 5.0 mg/day thereby causing the serum concentration of fentanyl in the mammal to be about 0.2 to about 10 ng/mL for a period of time from about 4 to about 14 days” (id. at 3). The Specification lists a number of properties that the device should include, such as sufficient skin flux (id. at 2-3). One of the drug delivery compositions taught by the Specification is a “copolymer of alkyl (meth)acrylate A monomers in which the alkyl group has 4 to 12 carbon atoms and ethylenically unsaturated B monomers that are copolymerizable therewith” (id. at 4). The Specification teaches further that polysiloxanes are also a suitable type of polymer for use in the pressure sensitive adhesive composition, and that the polymers may be used alone, or in combination (id. at 7). According to the Specification, “[i]n a preferred Appeal 2011-009532 Application 09/965,610 4 embodiment the composition . . . further comprises an adjuvant that enhances the transdermal delivery of fentanyl” (id. at 6). We cannot find, nor do Appellants point to, any specific definition in the Specification as to what components are included or excluded by the use of the transitional phrase “consisting essentially of.” The Examiner rejects claim 1 as anticipated by Miranda (Ans. 4-5). We adopt the Examiner‟s findings as our own, and highlight the following teachings of Miranda. Miranda relates “to a transdermal drug delivery composition wherein a blend of polymers is utilized to affect the rate of drug delivery from the composition” (Miranda, col. 1, ll. 23-26). Miranda teaches that the “invention is premised on the discovery that the transdermal permeation rate of a drug from the multiple polymer adhesive system can be selectively modulated by adjusting the solubility of the drug in the device” (id. at col. 6, ll. 15-18). According to Miranda: Generally, a monolithic system comprises a drug dispersed or dissolved in a matrix comprising a homogeneous polymeric material of, illustratively, silicone adhesive, silicone rubber, acrylic adhesive, polyethylene, polyisobutylene, polyvinyl chloride, nylon, or the like. The drug is dissolved in the polymeric matrix until its saturation concentration is reached. Any additional drug, remains dispersed within the matrix. As drug is removed from the surface of the matrix, more of the drug diffuses out of the interior in response to the decreased concentration at the surface. The release rate is therefore not constant over time, but instead gradually decreases as the drug concentration decreases. (Id. at col. 2, ll. 4-16.) Miranda thus discloses “a transdermal drug delivery system wherein a blend of at least two polymers having different solubility Appeal 2011-009532 Application 09/965,610 5 parameters adjusts the solubility of a drug in the polymeric blend and thereby modulates the delivery of the drug from the system and through the dermis” (id. at col. 3, ll. 38-42). Miranda teaches further: In a particularly preferred embodiment of the invention, the multiple polymer adhesive system comprises a blend of an acrylic pressure-sensitive adhesive and a silicone pressure- sensitive adhesive. The acrylic-based polymer and silicone- based polymer are preferably in a ratio by weight, respectively, from about 2:98 to about 96:4, more preferably from about 2:98 to about 90:10, and even more preferably about 2:98 to about 86:14. The amount of acrylic-based polymer (hereinafter referred to broadly as a polyacrylate) and silicone-based polymer (hereinafter referred to broadly as a polysiloxane) is selected to modify the saturation concentration of the drug in the multiple polymer adhesive system in order to affect the rate of delivery of the drug from the system and through the skin. (Id. at col. 8, ll. 30-43.) Miranda also teaches that “enhancers” may also be used (id. at col. 12, ll. 55-60). Appellants argue that the claims are “directed towards transdermal drug delivery composition for delivering fentanyl „consisting essentially of‟ an acrylate copolymer, [and] fentanyl” (App. Br. 2). Miranda, Appellants assert, requires at least two polymers having different solubility parameters, such as a polyacrylate adhesive and a polysiloxane adhesive (id.). Appellants assert that “Miranda criticizes compositions that include only a single adhesive polymer (e.g., col. 2, lines 4-16), and states that the second adhesive polymer modulates the release of the drug from the adhesive composition (col. 6, lines 16-19 and col. 8, lines 30-43)” (id.). Appeal 2011-009532 Application 09/965,610 6 Appellants note that the “consisting essentially of” language in the claim limits its scope to the ingredients listed, and to those ingredients that do not materially affect the basic and novel characteristics of the composition (id. at 3). Appellants argue that basic and novel characteristics of the claimed composition are drawn to the transdermal delivery of fentanyl, and that the “entire reason Miranda includes the polysiloxanes is to affect the drug delivery characteristics of the composition” (id. at 3-4). According to Appellants, “[a]n ingredient may „affect‟ the transdermal drug delivery properties of the composition either positively or negatively” (id. at 3). Appellants argue that it is “irrelevant” that the instant Specification discloses polysiloxanes, “because merely listing them says nothing about whether they affect the transdermal drug delivery characteristics of an acrylate-containing composition” (id. at 4). Thus, Appellants assert: The only evidence of record on the issue of whether Miranda's polysiloxanes would affect the drug delivery properties of an acrylate-containing transdermal drug delivery composition is what Miranda says-and Miranda makes absolutely clear that the polysiloxanes, when added in the amounts Miranda instructs, do, in fact, affect the transdermal drug delivery properties of the composition. The Examiner has produced no evidence to the contrary. The “consisting essentially of” language included in each of Appellants' claims, therefore, plainly excludes Miranda‟s polysiloxanes because, based upon what Miranda itself discloses, the additional presence of such polysiloxanes would affect the drug delivery characteristics of Appellants‟ acrylate copolymer-based, transdermal drug delivery compositions. (Id.) Appeal 2011-009532 Application 09/965,610 7 We have carefully considered Appellants‟ arguments, but do not find them convincing. “[D]uring examination proceedings, claims are given their broadest reasonable interpretation consistent with the specification.” In re Hyatt, 211 F.3d 1367, 1372 (Fed. Cir. 2000). The “phrase „consisting essentially of‟ limits the scope of a claim to the specified ingredients and those that do not materially affect the basic and novel characteristic(s) of a composition.” In re Herz, 537 F.2d 549, 551-52 (CCPA 1976) (emphasis added); see also PPG Indus., Inc. v. Guardian Indus. Corp., 156 F.3d 1351, 1354 (Fed. Cir 1998). Appellant bears the burden of establishing that the basic and novel characteristics of the claimed invention would be materially affected by, or at least reasonably expected to be materially affected by, any component or step of an applied reference that is argued to be excluded by a “consisting essentially of” transitional phrase used in the claims. See In re De Lajarte, 337 F.2d 870, 873-74 (CCPA 1964); Ex parte Hoffman, 12 USPQ2d 1061, 1063-64 (BPAI 1989). Here, Appellants have not defined “consisting essentially of” in the Specification. The Specification also acknowledges that there is a need to find a balance among the desired properties of the device, as they can sometimes be mutually exclusive (Spec. 2). As the Specification (id. at 6), as well as claim 1, contemplate the addition of enhancers, we decline to interpret “consisting essentially of” as narrowly as Appellants would like us to—that is, as excluding any component that might affect the delivery of fentanyl, either positively or negatively, in any amount or in any way. Rather, we interpret the “basic and novel properties,” in view of the teachings of the Specification, as the ability of the composition to perform Appeal 2011-009532 Application 09/965,610 8 the function of transdermal drug delivery. And given that interpretation of the phrase “consisting essentially of,” we agree with the Examiner that Miranda anticipates claim 1. We would like to further note that we do not agree with Appellants argument that the disclosure in the instant Specification that polysiloxanes may be included in the composition is “irrelevant.” It is in context of Appellants‟ Specification, and not the disclosure of Miranda, that the terms of the claim are interpreted. And the instant Specification does not support the interpretation of “consisting essentially of” advanced by Appellants. As to the rejection over Miranda and Garbe, we note that we have already found that claim 1 is anticipated by Miranda, and again Appellants do not argue the claims separately (see, e.g., App. Br. 4-5). Thus, as “„anticipation is the epitome of obviousness,‟” In re McDaniel, 293 F.3d 1379, 1385 (Fed. Cir. 2002), we affirm the rejection or the reasons set forth above as to the anticipation rejection of claim 1 SUMMARY We affirm the rejection of claims 1 as being anticipated by Miranda. Claims 2-5, 35, 39-42, 52, 53, and 92-97 fall with claim 1. We also affirm the rejection of claim 1 as being rendered obvious by the combination of Miranda and Garbe. Again, as Appellants do not argue the claims separately, claims 2-9, 16-18, 28, 29, 35, 36, 39-47, 52-54, and 92-103 fall with claim 1. Appeal 2011-009532 Application 09/965,610 9 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 cdc