Noven Phamaceuticals, Inc.

Patent Trials and Appeals Board

Feb 23, 2022

2021005027 (P.T.A.B. Feb. 23, 2022)

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. 14/577,028 12/19/2014 Viet Nguyen 041457-1088 1282 22428 7590 02/23/2022 FOLEY & LARDNER LLP 3000 K STREET N.W. SUITE 600 WASHINGTON, DC 20007-5109 EXAMINER PHAN, DOAN THI-THUC ART UNIT PAPER NUMBER 1613 NOTIFICATION DATE DELIVERY MODE 02/23/2022 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): ipdocketing@foley.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte VIET NGUYEN, STEVEN DINH, JUN LLAO, and ROBERT L. LAMBERT Appeal 2021-005027 Application 14/577,028 Technology Center 1600 Before RICHARD M. LEBOVITZ, RYAN H. FLAX, and RACHEL H. TOWNSEND, Administrative Patent Judges. TOWNSEND, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims to a composition of amphetamine for transdermal delivery for obviousness and obviousness-type double patenting. An oral hearing was held on February 10, 2022. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as Noven Pharmaceuticals, Inc. (Appeal Br. 2.) Appeal 2021-005027 Application 14/577,028 2 STATEMENT OF THE CASE Appellant’s Specification states: “Many factors influence the design and performance of transdermal drug delivery compositions. These include . . . the desired rate of drug delivery and therapeutic onset, the desired drug delivery profile, and the intended duration of delivery, among others.” (Spec. ¶ 3.) Appellant’s Specification further states: “Compositions for the transdermal delivery of amphetamine are known, but there remains a need for compositions that exhibit good stability against the formation of degradation products, such as amphetamine reaction products and degradation products.” (Id. ¶ 4.) Appellant’s invention is directed at such a composition. Claim 1, reproduced below, is illustrative of the claimed subject matter: 1. A composition for the transdermal delivery of amphetamine through skin in the form of a flexible finite system for topical application to skin, comprising a polymer matrix comprising a polymer and amphetamine or a pharmaceutically acceptable salt or prodrug thereof, and a backing that comprises polyurethane adjacent the polymer matrix, wherein the polyurethane is a reaction product of an isocyanate and a polyol and is present in an amount effective to control the presence of and/or prevent the formation of phenyl acetone in the polymer matrix. (Appeal Br. 23.) Appeal 2021-005027 Application 14/577,028 3 The prior art relied upon by the Examiner is: Name Reference Date Wright, IV US 2004/0081685 A1 Apr. 29, 2004 Venkatraman et al. US 2005/0048104 A1 Mar. 3, 2005 Kanios et al. US 2006/0078604 A1 Apr. 13, 2006 Marina Nevescanin et al. Analysis of amphetamines illegally produced in Serbia, 73 (7) J. Serb. Chem. Soc., 691-701. 2008 The following grounds of rejection by the Examiner are before us on review: Claims 1, 2, 4-11, 14, 16, 21, and 23 under 35 U.S.C. § 103 as unpatentable over Kanios, Venkatraman, and Nevescanin. Claim 15 under 35 U.S.C. § 103 as unpatentable over Kanios, Venkatraman, Nevescanin, and Wright. Claims 1, 2, 4-11, 14-16, 21, and 23 on the ground of non-statutory obviousness-type double patenting as being unpatentable over claims 1, 2, 4-6, 8, 10-12, 14, 16, and 20 of copending U.S. Application No. 14/206,369, Kanios, Venkatraman, and Nevescanin. Claims 1, 2, 4-11, 14-16, 21, and 23 on the ground of non-statutory obviousness-type double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 8,591,941, Kanios, Venkatraman, and Nevescanin. DISCUSSION Claim 1: Obviousness Rejection The Examiner found that Kanios teaches a transdermal drug delivery system that includes a backing layer that is a single layer or multiple layers Appeal 2021-005027 Application 14/577,028 4 and a polymer matrix drug layer. (Non-Final Action 4-5 (citing Kanios Abstr., ¶¶ 376-378, 380, 382, 386, 387); see also Ans. 21 (citing Kanios Fig. 1, ¶ 349, and Example 3).) The Examiner further found that Kanios teaches the backing layer can comprise polyurethane and that one of the preferred drugs for use in such a system is amphetamine. (Non-Final Action 4-5, 8-9 (citing Kanios ¶¶ 343, 376, 380, 386, Ex. 3); Ans. 21.) Regarding the claim requirement that the backing layer be adjacent the polymer matrix with the drug, the Examiner found that Kanios’ teaching of a single backing layer that can include polyurethane teaches that requirement. (Ans. 21, 22.)2, 3 The Examiner concluded that the transdermal system suggested by Kanios appears to be the same in structure as the transdermal system comprising a polymer material containing a polymer and amphetamine, and a backing that comprises polyurethane adjacent to the polymer matrix of the claimed invention, it would have been reasonably obvious to an ordinary artisan before the effective filing date of the invention that the property of control the presence of and/or prevent the formation of 2 The Examiner relied on the teachings of Venkatraman only for the fact that it was well known in the art that polyurethane used in transdermal systems may be made from a reaction of an isocyanate and a polyol. (Non-Final Action 5.) This is not disputed. 3 The Examiner relied on Nevescanin as allegedly teaching that phenyl acetone is a recognized degradation product or impurity of amphetamine and finding that “it would have been reasonably obvious and predictive that the backing containing polyurethane . . . would also be capable of minimizing the degradation of amphetamine in the matrix from oxidizing (interaction with oxygen from air/moisture) to the degradation product or impurity of phenyl acetone.” (See Non-Final Action 7-8.) We do not agree with the Examiner’s findings in this regard, but do not need to rely on those findings in affirming the Examiner’s rejection. Appeal 2021-005027 Application 14/577,028 5 phenyl acetone in the polymer matrix as claimed would have been implicit. (Non-Final Action 5-6.) We agree with the Examiner’s findings as set forth above regarding Kanios and the conclusion of obviousness. Kanios teaches a transdermal drug delivery system where the polymeric backing layer can control the delivery rate of the transdermal drug delivery system. (Kanios Abstr.) Kanios provides a list of polymeric materials that are suitable for use as the backing material, which includes polyurethane. (Id. ¶ 376.) Kanios teaches with respect to the backing layer that one or more polymers may be used in a single layer or multiple layers (id. ¶¶ 377, 378, 380, 382) and demonstrates backing layers in a transdermal system where polyurethane is combined with ethylene vinyl alcohol (Kanios Example 2) and where polyurethane was used by itself (id. at Example 3). Kanios reported the drug flux rate for such a system where the drug polymer matrix was formed directly over the backing layer. (Id. at Table 3.) Kanios states that the selection of the backing layer material can be made to tailor the delivery rate (Kanios ¶ 391). Kanios explains: As demonstrated in the examples, employing a backing layer with a lower moisture vapor transmission rate, the flux of the drug increased. When the moisture vapor transmission rate was increased, the flux of the drug decreased. Thus, it is believed that by varying the moisture vapor transmission rate, the delivery rate of the drug from the transdermal device can be tailored. (Id.) It is noted that the flux rate of the drug in the polyurethane only backing layer is 0.32 micrograms per square centimeter per hour (μg/cm2/hr), while the combined polyurethane and ethylene vinyl alcohol backing layer flux rate is 0.93 μg/cm2/hr. (Id. at Table 3.) Kanios teaches Appeal 2021-005027 Application 14/577,028 6 that a drug delivery rate of about 0.01 mg to about 100 mg of active agent per day is within the scope of its invention (id. ¶ 407). There is no indication by Kanios that the 0.32 μg/cm2/hr drug delivery rate with a polyurethane only backing adjacent to a drug layer is not capable of achieving the disclosed per day delivery rate of about 0.01 mg to about 100 mg of active agent. Moreover, Kanios describes that having the backing layer affixed to the drug polymer matrix layer is part of a most preferred embodiment of the invention. (Id. ¶ 349 (referencing Fig. 1).) Whether or not Kanios prefers polyurethane to be adjacent to the polymer matrix, it nevertheless teaches such a structure. Merck & Co. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989) (“[D]isclos[ing] a multitude of effective combinations does not render any particular formulation less obvious. This is especially true because the claimed composition is used for the identical purpose taught by the prior art.”). Thus, we do not find Appellant’s argument that “Kanios does not disclose or suggest that the polyurethane layer should be adjacent the drug-containing polymer matrix layer” (Appeal Br. 9) persuasive.4, 5 4 We note further that Kanios teaches that ethylene vinyl alcohol can be laminated or coextruded with polyurethane. (Kanios ¶ 386.) In a system in which there is coextrusion, the polyurethane would necessarily be in a mixture that was adjacent to the drug layer. Although Kanios may indicate that a preferred backing material is a layer of ethylene vinyl alcohol combined with polyurethane (Kanios ¶ 386; Appeal Br. 9), such does not preclude meeting the claimed “backing that comprises polyurethane adjacent the polymer matrix.” 5 The Examiner also found that Kanios teaches that both layers in a multilayer backing layer can include polyurethane. (See Non-Final Action 5.) We need not rely on this finding in affirming the Examiner’s rejection. However, we do agree with the Examiner that Kanios teaches that polyurethane is an especially preferred material for the secondary layer of the backing material. (Kanios ¶ 380.) In addition, Kanios teaches that the Appeal 2021-005027 Application 14/577,028 7 Although in its demonstrative examples, Kanios teaches the drug present was clonidine, we note that Kanios teaches that clonidine is but one of the 50 specifically listed low molecular weight “[d]rugs usable in practicing the invention.” (Kanios ¶ 343.) The list also includes “amphetamine, d-amphetamine, l-amphetamine, d,1-amphetamine, methaphetamine.” (Id.) Claim 1 requires amphetamine or a pharmaceutically acceptable salt or prodrug of it. An expressed preference for certain embodiments within a disclosed genus does not teach away from the rest of the embodiments within the disclosed genus. In re Susi, 440 F.2d 442, 445 (CCPA 1971). The fact that a number of low molecular weight drugs are disclosed as being suitable for use in the drug delivery system of Kanios would not have made any one of them less obvious to include in that delivery system. See Merck, 874 F.2d at 807. And for this reason, we do not find Appellant’s argument that Kanios provides “a general disclosure of drugs that can be delivered” (Appeal Br. 9), or that Kanios “does not disclose any specific amphetamine compositions” (id. at 10) to be persuasive of nonobviousness. Appellant’s argument that “persons of ordinary skill in the art would not have known or expected that providing an amphetamine-containing polymer matrix with a backing comprising polyurethane adjacent to the amphetamine-containing polymer matrix could control (reduce or prevent) the formation of phenyl acetone in the amphetamine-containing polymer secondary layer “can be used on one or both sides of the primary layer.” (Kanios ¶ 382.) Thus, Kanios suggests a backing layer in which polyurethane is used on both sides of a primary layer and such a backing material would result in a polyurethane layer being adjacent to the drug polymer matrix layer. Appeal 2021-005027 Application 14/577,028 8 matrix” (Appeal Br. 11) is not persuasive that the composition claimed is not obvious. Appellant’s Specification teaches that the amount of polyurethane that is effective to control and/or prevent the formation of phenyl acetone in the polymer matrix is 0.01 to one hundred times the amount of amphetamine. (Spec. ¶ 7.) Given that broad range, we conclude that Kanios’ description of a transdermal delivery device having a polyurethane backing layer and a drug-polymer matrix layer in which the drug is present in the system at between about 0.1% to about 50% is sufficient to render obvious the effective amount limitation. In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (“Where . . . the claimed and prior art products are identical or substantially identical . . . the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. § 102, on ‘prima facie obviousness’ under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO’s inability to manufacture products or to obtain and compare prior art products.” (internal citation and footnote omitted)). That the prior art does not recognize the inherent result of reducing or preventing the formation of phenyl acetone in the amphetamine-containing polymer matrix is insufficient to establish that the claimed transdermal system suggested by Kanios would not have resulted in controlling phenyl acetone formation. In re Pearson, 494 F.2d 1399, 1402 (CCPA 1974) (“[T]erms [that] merely set forth . . .a property inherent in, an otherwise old composition . . . do not differentiate the claimed composition from those known in the prior art.”); see also Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347 (Fed. Cir. 1999) (“[T]he discovery of a previously unappreciated Appeal 2021-005027 Application 14/577,028 9 property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer”). Appellant’s argument that the result is “surprising and unexpected” (Appeal Br. 17) is insufficient to rebut the Examiner’s obviousness determination because the prevention of the formation of phenyl acetone would have been a property of the delivery system comprising amphetamine and polyurethane described in Kanios. Kanios teaches that a polyurethane backing layer has a higher moisture vapor transmission rate than a polyester and ethylene vinyl acetate backing layer and a higher moisture vapor transmission rate than a polyurethane and ethylene vinyl alcohol backing layer (Kanios ¶ 391 and Table 3) and thus results in a lower drug flux than those systems in which the backing layer has a lower moisture vapor transmission rate and states that “similar drug modulation can be achieved with other active agents” (id. ¶ 415). Thus, Kanios describes a polyurethane only backing layer with a drug polymer matrix that includes any one of the low molecular weight drugs enumerated in paragraph 343. And, Kanios suggests the lower drug flux with a polyurethane only backing layer would be achieved with any one of the low molecular weight drugs enumerated in paragraph 343. (Id. ¶¶ 415, 391, 343.) “In determining whether the subject matter of a patent claim is obvious, neither the particular motivation nor the avowed purpose of the patentee controls. What matters is the objective reach of the claim.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 419 (2007). “Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention.” In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991); In re Prindle, 297 F.2d 251, 254 (CCPA 1962). “The fact that Appeal 2021-005027 Application 14/577,028 10 appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious.” Ex parte Obiaya, 227 USPQ 58, 60 (BPAI 1985); see also Persion Pharms. LLC v. Alvogen Malta Ops. Ltd., 945 F.3d 1184, 1191 (Fed. Cir. 2019), GE Co. v. Jewel Incandescent Lamp Co., 326 U.S. 242, 248-49 (1945). We also do not find persuasive Appellant’s argument that the “rejections should be reversed under Honeywell [International v. Mexichem Amanco Holding, 865 F.3d 1348 (Fed. Cir. 2017)]” (Appeal Br. 13). We find that case is distinguishable on its facts. In Honeywell, the issue involved whether it would have been obvious to combine compound x with compounds within the genus z based on the following facts: (1) the prior art taught compound y to be used with various compounds within the genus z and (2) another prior art reference disclosed drawbacks to using compound x even though it had some advantages, without any information concerning compounds within the genus z. Honeywell, 865 F.3d at 1350-52. The facts before us, however, are different. Kanios teaches Example 3 having a backing layer made only of polyurethane that is adjacent to, preferably, a clonidine drug matrix layer and states that, alternatively, amphetamine is also a low molecular weight drug that could be used in the invention (Kanios ¶ 343). Kanios also explains that the Examples, which are Examples 1-3, demonstrate the effect of variations in the occlusiveness of the backing layer in controlling the flux rate of the drug (id. ¶ 415) which is the invention (see, e.g., id. ¶ 391, Abstr.) and explains that, “[w]hile the Examples are directed to formulations using clonidine, it should be understood that similar drug modulation can be achieved with other active Appeal 2021-005027 Application 14/577,028 11 agents” (id. ¶ 415). In other words, in terms similar to the discussion of Honeywell above, Kanios teaches compound x can be combined with compound y, while also teaching compounds similar to x have been combined with compound y. Furthermore, Appellant’s reliance on data in the Specification to establish the claimed transdermal system achieves unexpected results (Appeal Br. 16-17) is unavailing. The data does establish that a polyurethane film that forms the backing layer or that is laminated with a polyester film to form the backing layer does control phenyl acetone production more than (1) a polyester film, (2) an ethyl vinyl acetate film, and (3) an aluminum vapor-coated polyester film. (Spec. ¶ 75.) The structure having the polyurethane film results in 0.1% phenyl acetone content after 1 month storage, and the laminated polyurethane polyester film results in 0.2% phenyl acetone content after 1 month storage. (Id.) First, we note as to the backing layer that is laminated, the Specification does not state whether the polyurethane film is laminated to the polyester film such that the polyurethane layer is positioned next to the drug matrix. Thus, it is not clear that the polyurethane is required to be adjacent to the drug matrix as required by the claim to provide the stability to amphetamine. Second, as noted above, Kanios teaches both a polyurethane only backing and a preferred backing material that is ethylene vinyl alcohol copolymer laminated or coextruded with polyurethane, as well as teaching that a secondary layer may be provided on one or both sides of the primary backing layer (Kanios ¶ 382) where “polyurethane is an especially preferred material for the secondary layer” (id. ¶ 380) and suggests using such a system in conjunction with amphetamine. For this reason, as explained above, we find that the Appeal 2021-005027 Application 14/577,028 12 claimed embodiment is within the scope of Kanios. And, as already explained, the recognition of latent properties in an otherwise obvious composition art cannot render the invention nonobvious. In re Prindle, 297 F.2d at 254. Thus, we do not find the evidence relied upon establishes non- obviousness. Adapt Pharma Operations Ltd. v. Teva Pharms USA, Inc., Appeal No. 2020-2106, slip op. 25 (Feb 10, 2022) (noting that objective indicia must always be considered when presented, but “they do not necessarily control the obviousness determination”); Persion Pharms., 945 F.3d at 1194 (finding no error in the district court’s conclusion of obviousness even when presented with secondary considerations). In light of the foregoing, we affirm the Examiner’s rejection of claim 1 as being obvious from Kanios. We need not designate our affirmance as a new ground of rejection because in affirming a multiple reference rejection under 35 U.S.C. § 103, the Board may rely on fewer than all of the references relied on by the Examiner in an obviousness rationale. In re Bush, 296 F.2d 491, 496 (CCPA 1961). Claims 2, 4-11, 14, 16, 21, and 23 have not been argued separately and therefore fall with claim 1. 37 C.F.R. § 41.37(c)(1)(iv). Claim 15: Obviousness Rejection The Examiner found that Wright teaches a backing layer used in a transdermal drug delivery system that includes a polymer matrix containing a drug like Kanios, and that Wright, like Kanios teaches the backing layer can be polyurethane, but Kanios teaches additionally that the polyurethane can be in fiber form. (Non-Final Action 15 (citing Wright Abstr. and ¶¶ 29- 33); Ans. 33-34.) The Examiner therefore found that it would have been Appeal 2021-005027 Application 14/577,028 13 obvious to have used a fiber form of polyurethane in the system of Kanios because Wright teaches such materials are “biocompatible and avoid irritation to the skin or mucosa, as well as, provide the added advantage of serving as a protective cover for the therapeutic agent in the matrix.” (Non- Final Action 16 (citing Wright ¶ 32).) We agree with the Examiner’s findings and conclusion of obviousness. It is obvious to those skilled in the art to substitute one known equivalent for another. See In re Omeprazole Patent Litigation, 483 F.3d 1364, 1374 (Fed. Cir. 2007) (“[T]his court finds no . . . error in [the] conclusion that it would have been obvious to one skilled in the art to substitute one ARC [alkaline reactive compound] for another.”); see also Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC, 683 F.3d 1356, 1364 (Fed. Cir. 2012). “Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put into the last opening in a jig-saw puzzle. It is not invention.” Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 335 (1945). In light of the foregoing, we do not find persuasive Appellant’s argument that because “Wright does not teach or suggest that backing layers comprising non- woven polyurethane fibers are more biocompatible or better at avoiding skin irritation or provide a better protective cover than the other types of backing materials it discloses” or that it is “the most preferred” backing material (Appeal Br. 19), the record does not support the Examiner’s conclusion of obviousness. We affirm the Examiner’s rejection of claim 15 as being obvious from Kanios and Wright. Appeal 2021-005027 Application 14/577,028 14 Obviousness-Type Double Patenting Appellant argues that the rejection for obviousness-type double patenting over the ’369 patent application claims should be reversed because Kanios, Venkatraman, and Nevescanin does not make obvious a polyurethane-containing backing layer as set forth in the claim 1 on appeal. (Appeal Br. 20.) However, for the reasons discussed above, we agree with the Examiner that Kanios does make obvious the polyurethane-containing backing layer as set forth in claim 1 on appeal. Thus, we affirm the Examiner’s rejection of claims 1, 2, 4-11, 14-16, 21, and 23 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4-6, 8, 10-12, 14, 16, and 20 of copending Application No. 14/206,369 in view of Kanios, Venkatraman, and Nevescanin. Appellant argues that the Examiner’s rejection for obviousness-type double patenting over the ’941 patent claims should be reversed because the ’941 patent does not recite which of the layers of the backing layer, polyester or polyurethane, should be adjacent the carrier layer. (Appeal Br. 21.) We do not find this argument persuasive as the transdermal system of the ’941 patent claim is a genus of two possibilities, i.e., either the polyester layer is next to the carrier layer or the polyurethane is next to the carrier layer. And for the reasons discussed above regarding the Examples described in the Specification, Appellant has not established the species now claimed is patentably distinct from the alternative embodiment embraced by the ’941 patent claims. Thus, we affirm the Examiner’s rejection of claims 1, 2, 4-11, 14-16, 21, and 23 on the ground of nonstatutory double patenting as being Appeal 2021-005027 Application 14/577,028 15 unpatentable over claims 1-15 of U.S. Patent 8591941 in view of Kanios, Venkatraman, and Nevescanin. DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 2, 4-11, 14, 16, 21, 23 103 Kanios, Venkatraman, Nevescanin 1, 2, 4-11, 14, 16, 21, 23 15 103 Kanios, Venkatraman, Nevescanin, Wright 15 1, 2, 4-11, 14-16, 21, 23 Obviousness-Type Double Patenting: U.S. Application No. 14/206,369, Kanios, Venkatraman, and Nevescanin 1, 2, 4-11, 14-16, 21, 23 1, 2, 4-11, 14-16, 21, 23 Obviousness-Type Double Patenting: US 8,591,941, Kanios, Venkatraman, and Nevescanin 1, 2, 4-11, 14-16, 21, 23 Overall Outcome 1, 2, 4-11, 14-16, 21, 23 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). See 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED