Ex Parte Okada et al

Patent Trial and Appeal BoardMar 8, 2019

13983166 (P.T.A.B. Mar. 8, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 13/983, 166 09/11/2013 513 7590 03/12/2019 WENDEROTH, LIND & PONACK, L.L.P. 1030 15th Street, N.W., Suite 400 East Washington, DC 20005-1503 FIRST NAMED INVENTOR Yasuaki Okada 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. 2013-1142A 2973 EXAMINER ALAWADI, SARAH ART UNIT PAPER NUMBER 1619 NOTIFICATION DATE DELIVERY MODE 03/12/2019 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): eoa@wenderoth.com kmiller@wenderoth.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte YASUAKI OKADA, KATSUHIRO OKADA, MASATO NISHIMURA, YUJI KA WAHARADA, HIROO MAEDA, KAZUMITSU YAMAMOTO, and MASA Y ASU TANAKA 1 Appeal2018-000301 Application 13/983,166 Technology Center 1600 Before RICHARD M. LEBOVITZ, TA WEN CHANG, and RYAN H. FLAX, Administrative Patent Judges. FLAX, Administrative Patent Judge. DECISION ON APPEAL 1 Appellants identify the Real Party in Interest as "NITTO DENKO CORPORATION." Br. 2. Appeal2018-000301 Application 13/983,166 This is a decision under 35 U.S.C. Â§ 134(a) involving claims directed to a transdermal drug-delivery patch. Claims 1, 3, 6, 7, 10, 11, 13, and 21 are on appeal as rejected under 35 U.S.C. Â§ 103. We have jurisdiction under 35 U.S.C. Â§ 6(b). We affirm. STATEMENT OF THE CASE Independent claim 1 is representative and is reproduced below: 1. A patch preparation comprising a support and an adhesive layer formed on one surface of the support, wherein the adhesive layer comprises (i) 2-(4-ethyl-l-piperazinyl)-4-(4-fluorophenyl)- 5, 6, 7 ,8,9, 10-hexahydrocycloocta[b ]pyridine or a physiologically acceptable acid addition salt thereof, (ii) an acrylic polymer, (iii) lactic acid, (iv) sesame oil, (v) (v-1) not more than one additive selected from the group consisting of 2-mercapto benzimidazole, 2, 6-di-tert- butyl-4-methylpheno l and propyl gallate and (v-2) a filler which 1s magnesmm aluminometasilicate, and ( vi) an organic liquid component that is a fatty acid ester formed from a fatty acid having a carbon number of 8 to 18 and a monohydric alcohol having a carbon number of 1 to 18, wherein the adhesive layer is a non-aqueous adhesive layer, and the content of the lactic acid in 100 wt% of the adhesive layer is 1-10 wt%, the content of the additive (v-1) in 100 wt% of the adhesive layer is 0.3 - 10 wt% and the content 2 Appeal2018-000301 Application 13/983,166 ratio of the sesame oil and the organic liquid component is 1: 1- 1 :6 by weight ratio. Br. 19 (Claims Appendix). The following rejections are appealed: Claims 1, 3, 6, 7, 10, 11, and 13 stand rejected under 35 U.S.C. Â§ 103 (a) over Maeda, 2 Sharma, 3 Ishii, 4 and Ameyama, 5 as evidenced by Fuji, 6 Ton-That,7 and Okada. 8 Final Action 3. Claim 21 stand rejected under 35 U.S.C. Â§ I03(a) over Maeda, Sharma, Ishii, Ameyama, and Funakoshi, 9 as evidenced by Fuji, Ton-That, and Okada. Id. at 10. Claims 1, 3, 6, 7, 10, 11, 13, and 21 stand rejected for obviousness- type double patenting over claims 1-8 of Maeda' 121, 10 in view of Sharma, Ishii, and Funakoshi, as evidenced by Fuji, Ton-That. Id. at 12. DISCUSSION "[T]he examiner bears the initial burden, on review of the prior art or on any other ground, of presenting aprimafacie case ofunpatentability. If that burden is met, the burden of coming forward with evidence or argument shifts to the applicant." In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). 2 US 2009/0169605 Al (published July 2, 2009) ("Maeda"). 3 US 5,229,130 (issued July 20, 1993) ("Sharma"). 4 US 2007 /0219286 Al (published Sept. 20, 2007) ("Ishii"). 5 US 2008/0299183 Al (published Dec. 4, 2008) ("Ameyama"). 6 Fuji Chemical Industry Co., LTD., The Specialty Excipient NeusilinÂ® (2009) ("Fuji"). 7 US 2006/0009588 Al (published Jan. 12, 2006) ("Ton-That"). 8 US 2010/0318042 Al (published Dec. 16, 2010) ("Okada"). 9 US 2010/0068248 Al (published Mar. 18, 2010) ("Funakoshi"). 10 US 8,354,121 B2 (issued Jan. 15, 2013) ("Maeda '121 "). 3 Appeal2018-000301 Application 13/983,166 Arguments made by Appellants in the Appeal Brief (no Reply Brief was submitted) have been considered in this Decision; arguments not so- presented in the Brief are waived. See 37 C.F.R. Â§ 4I.37(c)(l)(iv) (2015); see also Ex parte Borden, 93 USPQ2d 1473, 1474 (BPAI 2010) (informative) ("Any bases for asserting error, whether factual or legal, that are not raised in the principal brief are waived."). As applicable to the rejections on appeal and Appellants' arguments there-over, "[t]he 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). Put another way, "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." Id. "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. If the claim extends to what is obvious, it is invalid underÂ§ 103." Id. at 419. "[T]he question is whether there is something in the prior art as a whole to suggest the desirability, and thus the obviousness, of making the combination, not whether there is something in the prior art as a whole to suggest that the combination is the most desirable combination available." In re Fulton, 391 F.3d 1195, 1200 (Fed. Cir. 2004) (citation omitted). "Patents [ and published applications] are part of the literature of the art and are relevant for all they contain." In re Young, 927 F.2d 588, 591 (Fed. Cir. 1991 ). That the prior art "discloses a multitude of effective 4 Appeal2018-000301 Application 13/983,166 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." Merck & Co. Inc. v. Biocraft Labs. Inc., 874 F.2d 804, 807 (Fed. Cir. 1989). "The criterion [for determining obviousness] ... is not the number of references, but what they would have meant to a person of ordinary skill in the field of the invention." In re Gorman, 933 F.2d 982, 986 (Fed. Cir. 1991) (reliance on thirteen references to support obviousness rejection does not of itself weigh against conclusion of obviousness). Appellants argue the two obviousness rejections together, addressing only independent claim 1 specifically. Therefore, we address the obviousness rejections and Appellants' arguments similarly. The Examiner determined the claims would have been obvious over the prior art combination of Maeda, Sharma, Ishii, and Ameyama, and also looking to Fuji, Ton-That, and Okada, and in the case of claim 21 also adding Funakoshi. Final Action 3-11, 17-20 and Answer 2-13 ( collectively citing Maeda abstract, ,r,r 6, 11-13, 24--29, 32-34, 36, 37, 49-52, Example 1, claims 1, 3-7; citing Sharma in its entirety, but specifically at abstract, 2:1- 3:68, 4:19, 5:40-50, claim 1; citing Ishii abstract, ,r,r 17, 39, 58, 73, 74; citing Ameyama ,r,r 11, 13, 24, 25, 55; citing Fuji generally; citing Ton-That generally; citing Okada ,r,r 48, 49; citing Funakoshi generally); see also Maeda ,r,r 2, 35; Ishii ,r,r 4, 6, 7, 11, 13, 19, 76, 82, 88, 94, 99, 100; Ameyama abstract, ,r,r 37, 38; Ton-That ,r,r 7, 12, 13; Okada ,r,r 44, 45; Fuji 2; Funakoshi abstract, ,r,r 29, 31, 32, 37 (each disclosing relevant materials, components, and additives for transdermal patches). 5 Appeal2018-000301 Application 13/983,166 The Examiner determined that Maeda disclosed a transdermal patch having an adhesive with the claimed drug (Compound A) ( claimed component i), with the claimed acrylic polymer ( claimed component ii), with permeation enhancers including the claimed lactic acid ( claimed component iii), as well as olive and soybean oils, and with other fillers or additives such as BHT. Final Action 3-11, 17-20 and Answer 2-13. The Examiner determined that it would have been obvious to use sesame oil ( as in claimed component iv), rather than Maeda's soybean or olive oils, as an additional permeation enhancer with Maeda' s lactic acid (in the claimed amounts), as suggested by Sharma, because the list of permeation enhancers described in both publications significantly overlap, as does, in a general fashion, the drug delivered. Id. The Examiner further determined that it would have been obvious to use magnesium aluminometasilicate ( claimed component v-2), also called Neusilin, as Maeda's filler component, as suggested by Ishii, Fuji, and Ton-That. Id. Further, the Examiner determined that it would have been obvious to use 2-ethylhexylacrylate/acrylic acid/N-vinyl-2-pyrrolidone copolymer, as suggested by Ameyama, for Maeda's acrylic polymer. Id. Further, the Examiner determined that for Maeda' s disclosed BHT component ( claimed component v-1), it would have been obvious to use 0.3-10 wt%, as taught by Okada. Id. Regarding claim 21, the Examiner determined that it would have been obvious to use a crosslinking agent, such as the isocyanate compound diisocyanate, as taught by Funakoshi, in a patch as disclosed by Maeda. Id. 6 Appeal2018-000301 Application 13/983,166 The cited prior art references are directed to transdermal patches and their components. The Examiner's position is that the modifications made to Maeda' s transdermal patch, as noted above, would have been obvious because the substituted or added components were disclosed in the cited prior art as, essentially, known and conventional components of transdermal patches and/or equivalent to components of Maeda's patch. We discern no error in the Examiner's determinations. The combined patch components would have been useful for their known properties and their functions as taught in the references. We address Appellants' arguments below. Appellants argue Maeda fails to disclose sesame oil and the amounts thereof, as claimed, and also fails to disclose magnesium aluminometasilicate and the amounts thereof, as claimed. Br. 5---6. Appellants argue that the Examiner's determination that substituting sesame oil, as disclosed by Sharma, for the soybean or olive oils disclosed by Maeda, for a penetration enhancer would not have been an obvious, simple substitution. Id. at 6-7. Although acknowledging that Maeda discloses a list of penetration enhancers, including olive oil, soybean oil, and lactic acid, useful for pairing with the antipsychotic drug of Composition A ( as claimed) in an amount ranging from about 0.01-about 50% by weight, and acknowledging that Sharma discloses a list of permeation enhancers, including vegetable oils such as sesame oil, olive oil, and soybean oil, useful for pairing with a variety of pharmaceuticals, including antipsychotics, Appellants argue that the evidence shows that the skilled artisan would not have had a reasonable expectation of successfully replacing Maeda's olive or soybean oils with Sharma's sesame oil as a penetration enhancer for 7 Appeal2018-000301 Application 13/983,166 Composition A because "penetration enhancer potencies appear to be drug specific" according to Williams. 11 Br. 6-9. Appellants' argument is not persuasive. We note that the lists of permeation enhancers in Maeda and Sharma overlap, where Maeda lists some vegetable-based oils ( olive oil and soybean oil) as permeation enhancers and Sharma focuses on vegetable-based oils as permeation enhancers, like Maeda listing olive oil and soybean oil, but also listing sesame oil, as options. See Maeda ,r,r 12, 32; Sharma 2:30-3:3. Also, Maeda's disclosed drug, the penetration of which is to be enhanced, is Compound A, which is an antipsychotic; Sharma lists antipsychotics as a type of drug that's permeation can be enhanced by sesame oil. See Maeda ,r 2; Sharma 4:6-30. Maeda discloses that it's preferred permeation enhancer is lactic acid (0.01-10 wt%) and that its patch can have more than one permeation enhancer. See, e.g., Maeda ,r 12, claim 5. The thrust of Appellants' argument is that replacing Maeda's olive or soybean oils with Sharma's sesame oil would not have been expected to work because Williams indicated that the performance of penetration enhancers is drug-specific. While Williams does make this statement, as quoted by Appellants, the claim does not recite a specific level of penetration enhancing performance and a more complete quote of the relevant portion of Williams is: It is difficult to select rationally a penetration enhancer for a given permeant. Penetration enhancer potencies appear to be drug specific, or at best may be predictive for a series of 11 Adrian C. Williams & Brian W. Barry, Penetration Enhancers, 56 Aov. DRUG DELIVERY REV. 603-18, 615 (2004) ("Williams"). 8 Appeal2018-000301 Application 13/983,166 permeants with similar physico-chemical properties ( such as similar partition coefficients, molecular weights and solubilities). Some broad generic trends are apparent, such as the use of hydrocarbon monoterpenes for lipophilic permeants, but the level of enhancement expected for these agents is unpredictable. Williams 615. Thus, Williams is not as absolute as to the unpredictability of permeation enhancer performance or selection as suggested by Appellants. Williams teaches that similar permeation enhancing materials can be predicted to behave similarly and identifies the existence of broad trends, such as the fact that lipophilic permeants (like vegetable oils) would be expected to similarly enhance permeation, even if the level of enhancement could vary. In view of this statement, Appellants did not provide adequate evidence that sesame oil would act differently than the other vegetable-based oils on Sharma' s list. Thus, we are not persuaded the evidence supports Appellants' arguments. As for Appellants' argument that Maeda does not disclose magnesium aluminometasilicate, the Examiner does not cite Maeda for such a teaching, but determined that it would have been obvious to add Neusilin to Maeda's patch based on the cited prior art combination (Neusilin was a common, commercially available pharmaceutical excipient for over 50 years, with a wide variety of uses, as taught by Fuji). "Non-obviousness cannot be established by attacking references individually where the rejection is based upon the teachings of a combination of references. . . . [The reference] must be read, not in isolation, but for what it fairly teaches in combination with the prior art as a whole." In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 9 Appeal2018-000301 Application 13/983,166 1986). Maeda was not cited for teaching this component and the argument that it does not do so is not persuasive. Appellants also argue that Ishii either teaches away from its combination with Maeda or, if not so explicit, would not have provided the skilled artisan with a reasonable expectation of success in using Maeda's disclosed lactic acid ( 1-10 wt%) and Ishii' s disclosed magnesium aluminometasilicate (Neusilin), because Ishii warns that exceeding 5,000 ppm B-hydroxypropionic acid (salt) (0.5 wt% per solid content of the polymer), detrimentally affects the crosslinking in the adhesive and results in either hardness instability or drug-absorption instability. Br. 10-12 (citing Ishii ,r,r 7, 11, 13, 19). Appellants' position is that lactic acid is a type of oxycarboxylic acid and B-hydroxypropionic acid (salt) is a type of oxycarboxylic acid and, therefore, Ishii's warnings with respect to the latter would also implicate the former; thus, the amounts of lactic acid taught by Maeda would be too much for use with Ishii's Neusilin as Maeda's filler. Id. This argument is not persuasive. Ishii does not teach away from using Neusilin as a filler in Maeda's patch. A "teaching away" requires a reference to actually criticize, discredit, or otherwise discourage the claimed solution. See In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). Here, Ishii suggests that it may be desirable to limit an amount of /J-hydroxypropionic acid (salt) to 5,000 ppm or less, but it teaches using 0.01-20% Neusilin, as well as also adding additional lactic acid as a pH adjuster ( as well as adding other relevant components such as olive, sesame, and soybean oils as permeation enhancers, and BHT as an antioxidant). Ishii 10 Appeal2018-000301 Application 13/983,166 ,r,r 73-74, 94, 99, 100. Ishii does not criticize or discredit combining lactic acid and N eusilin, (particularly with the other components), or the use of Neusilin as a filler, as claimed. Appellants also argue that the Examiner's obviousness rejections are premised on improper hindsight, based on picking and choosing components from the prior art references to reconstruct Appellants' claims. Br. 12. In particular, Appellants argue that, without hindsight, selecting Sharma' s sesame oil for Maeda's Compound A patch (as a substitute for Maeda's olive or soybean oils, would not have been obvious. Id. at 12-14. Further, Appellants argue that Maeda does not teach an amount of dibutylhydroxytouline (2,6-di-tert-butyl-4-methylphenol or "BHT") as an stabilizer, and the Examiner improperly relies on Okada's teaching of BHT as an antioxidant, which is insufficient because there is only a passing reference to BHT in Okada and Okada's drug is methyl salicylate, not Compound A. Id. at 15-16. This argument is not persuasive. Any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning, but so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made and does not include knowledge gleaned only from applicant's disclosure, such a reconstruction is proper. In re McLaughlin, 443 F.2d 1392, 1395 (CCPA 1971). Here, the Examiner has relied upon only what is disclosed in the prior art, identifying motivation to modify or combine as suggested by the prior art's teachings. The appropriateness of combining Sharma's sesame oil with Maeda's permeation enhancer mix is discussed above. As for BHT, Maeda discloses 11 Appeal2018-000301 Application 13/983,166 incorporating it in a patch, and Okada teaches it is useful as an antioxidant in patches; that the drugs being delivered in Maeda and Okada are not identical is not determinative because both publications describe the component as useful in a patch. The Examiner's double patenting rejection is over the issued patent, i.e., Maeda '121, of the published Maeda application, discussed above; this publication and patent share the same specification and disclosure. Final Action 12-13. Maeda' 121 's claims recite the subject matter discussed above as disclosed by Maeda with respect to claim 1, that is, a patch ( called a "tape" in the claims) including, inter alia, Compound A, an acrylic polymer, lactic acid as a first permeation enhancer, and olive oil and/or soybean oil as a second permeation enhancer. As the Examiner notes, Maeda '121 's claims are written as "comprising" claims, meaning they must include the recited elements, but can also include other obvious components (it would have been obvious to include other components). Id. at 13. The Examiner cited the other prior art, discussed above, as teaching and suggesting such additional, obvious components of the claimed Maeda '121 patch, as discussed above (e.g., sesame oil (a known penetration enhancer) as Maeda '121 's disclosed/ claimed second penetration enhancer, BHT ( a known transdermal patch antioxidant additive) as Maeda '121 's stabilizer, Neusilin (a known filler) as Maeda' 121 's filler material). Id. at 13-17. Again, as with the obviousness rejection discussed above, we discern no error in this rejection. Regarding the double patenting rejection over Maeda '121, Appellants argue the Examiner has improperly imported limitations into Maeda '121 's 12 Appeal2018-000301 Application 13/983,166 claims when comparing them to the appealed claims. Br. 16. Specifically, Appellants argue that the Examiner has relied on Maeda ' 121 's claims inclusion of the "comprising" transition term to pull not-recited elements disclosed in Maeda '121 's specification, such as fillers and stabilizing agents as in the appealed claims, into the patent's claims. Id. at 16-17. Also, Appellants argue that Maeda' 121 does not claim sesame oil, BHT, or aluminometasilicate and the Examiner relies on Sharma, Ishii, and Okada, as in the obviousness rejections, which suffer from the issues discussed above. Id. at 17. This argument is not persuasive. We do not conclude that the Examiner is improperly importing limitations into Maeda '121 's claims to meet the appealed claims' subject matter; instead, the Examiner has merely identified that Maeda' 121 's claims are not restrictive of the claimed patch's components and that it would have been obvious to add or substitute conventionally used transdermal patch components as taught and suggested in the other cited prior art. We, therefore, find no error in the Examiner's obviousness type double patenting rejection and rationale for the same reasons we likewise found no error in the obviousness rejections, as discussed above. 13 Appeal2018-000301 Application 13/983,166 SUMMARY The obviousness rejections under 35 U.S.C. Â§ 103 are each affirmed. The double patenting rejection 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. Â§ 1.136(a)(l)(iv). AFFIRMED 14