Durect Corporation

Patent Trials and Appeals Board

Jan 28, 2022

2021004948 (P.T.A.B. Jan. 28, 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. 16/281,026 02/20/2019 Adrian Neil Verity DURE-055CON8 8463 111104 7590 01/28/2022 DURECT CORPORATION BOZICEVIC, FIELD & FRANCIS & LLP 201 REDWOOD SHORES PARKWAY SUITE 200 REDWOOD CITY, CA 94065 EXAMINER ALAWADI, SARAH ART UNIT PAPER NUMBER 1619 NOTIFICATION DATE DELIVERY MODE 01/28/2022 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): docket@bozpat.com patents@durect.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE _________________ BEFORE THE PATENT TRIAL AND APPEAL BOARD _________________ Ex parte ADRIAN NEIL VERITY _________________ Appeal 2021-004948 Application 16/281,026 Technology Center 1600 _________________ Before DEBORAH KATZ, ULRIKE W. JENKS, and TAWEN CHANG, Administrative Patent Judges. KATZ, Administrative Patent Judge. DECISION ON APPEAL Appellant1 seeks our review2, under 35 U.S.C. § 134(a), of the Examiner’s decision to reject claims 182-184 and 196. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 We use the word “Appellant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party-in-interest as Durect Corporation. (Appeal Br. 3.) 2 We consider the Final Office Action issued June 12, 2020 (“Final Act.”), the Appeal Brief filed March 10, 2021 (“Appeal Br.”), the Examiner’s Answer issued on June 17, 2021 (“Ans.”), and the Reply Brief filed August 16, 2021 (“Reply Br.”). Appeal 2021-004948 Application 16/281,026 2 Appellant’s Specification is directed to controlled drug delivery systems for providing a localized anesthetic effect. (Spec. ¶ 1.) Appellant’s claim 182 recites: A method for providing an anesthetic effect at a surgical wound in a subject, comprising administering a controlled delivery composition into the surgical wound, wherein the controlled delivery composition comprises: bupivacaine free base present in an amount ranging from 2 wt% to 5 wt%, based on weight of the controlled delivery composition; a polyorthoester; and an organic solvent comprising dimethyl sulfoxide and glyceryl triacetate that is present in an amount ranging from 15 wt% to 50 wt%, based on weight of the controlled delivery composition, wherein the administering provides a sustained local anesthetic effect at the wound having a duration of at least 48 hours after the administration. (Appeal Br. 34.) The Examiner rejected claims 182-184 and 196 under 35 U.S.C. § 103(a) over Gibson (U.S. Patent Application Publication 2004/0101557, published May 27, 2004). (See Final Act. 2-6; see Advisory Action, issued September 25, 2020.) Findings of Fact 1. Gibson teaches liquid, high viscosity materials suitable for the delivery of biologically active substances in a controlled fashion. (See Gibson, ¶ 3, abstract.) 2. Gibson teaches administering high viscosity liquid carrier material (“HVLCM”) directly to a wound. (See Gibson ¶ 127; see Final Act. 3-4.) Appeal 2021-004948 Application 16/281,026 3 3. Gibson teaches that HVLCM can be mixed with a viscosity lowering solvent to form a lower viscosity liquid carrier material (“LVLCM”), which is then mixed with the biologically active agent to be administered. (See Gibson ¶ 77; see Final Act. 3-4.) 4. Gibson teaches adding “particularly suitable solvents” that can be used to form a LVLCM include dimethyl sulfoxide and triacetin. (See Gibson ¶¶ 77-78, claim 5; see Final Act. 4.) 5. Gibson teaches that dimethyl sulfoxide and triacetin can be used in combination as a solvent. (See Gibson ¶ 78; see Final Act. 4.) 6. Triacetin is another name for glyceryl triacetate. (See Final Act. 3; see Appeal Br. 3.) 7. Gibson teaches additives that can be used to lengthen the delivery time for an active ingredient, making the composition suitable for treatment of disorders or conditions response to longer term administration. (See Gibson ¶ 103; see Final Act. 4.) 8. Gibson teaches that suitable biodegradable polymers include polyorthoesters. (See Gibson ¶¶ 103, 108; see Final Act. 4.) 9. Gibson exemplifies the anesthetic bupivacaine as a biologically active agent. (See Gibson Examples A, B, I, J, K, Fig. 1, and Claim 58; see Ans. 7.) 10. Gibson teaches specific compositions that release bupivacaine for at least 24 hours. (See Gibson Fig. 1; see Final Act. 4.) Appeal 2021-004948 Application 16/281,026 4 Analysis The Examiner finds that even though Gibson does not specifically teach the claimed methods, that is, Gibson does not anticipate the claimed methods, it would have been prima facie obvious to arrive at the instantly claimed invention for providing an anesthetic effect by administering bupivacaine with a solvent including triacetin and dimethylsulfoxide and polyorthoester controlled delivery polymers to treat a wound site since Gibson teaches each component as being useful in making a sustained release anesthetic composition for treating wounds. (Final Act. 5.) The Examiner cites KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 401 (2007), in determining that this modification represents nothing more than “the predictable use of prior art elements according to their established functions.” (See id.) Appellant does not dispute that Gibson teaches each element of the pending claims but argues, in general, that one of skill in the art would have to resort to undue “picking and choosing from at least millions of possible combinations (billions and billions if genera are considered)” to arrive at the claimed methods. (Appeal Br. 10.) Appellant argues further that the claimed elements are non-preferred selections from Gibson and that the reference provides insufficient guidance to reasonably expect to achieve a sustained local anesthetic effect at the wound having a duration of at least 48 hours after the administration. (See id.) According to Appellant, to arrive at the claimed method, one would have to contemplate seven different steps, resulting in over 158 million options. (See Appeal Br. 9, n. 2; see Reply Br. 2.) Appeal 2021-004948 Application 16/281,026 5 At the outset, we note that “picking and choosing may be entirely proper in the making of a 103, obviousness rejection, where the applicant must be afforded an opportunity to rebut with objective evidence any inference of obviousness which may arise from the similarity of the subject matter which he claims to the prior art.” In re Arkley, 455 F.2d 586, 587-88 (CCPA 1972). Appellant does not direct us to any objective evidence of non-obviousness in the briefs before us. Furthermore, we disagree with Appellant’s characterization of Gibson. For example, Appellant argues that to arrive at the claimed methods, Gibson would require a skilled artisan to choose to use an optional additive and to select a polyorthoester, which is not a preferred additive, as the optional additive from a long list of optional additives. (See Appeal Br. 12-15, citing Gibson ¶¶ 101-121.) Although Gibson devotes 20 paragraphs to the topic of additives, this disclosure is not a simple listing devoid of explanation. Rather, Gibson explains the uses of different additives, stating for example, that “[t]he addition of additives can also be used to lengthen the delivery time for the active ingredient, making the composition suitable for treatment of disorders or conditions responsive to longer term administration.” (Gibson ¶ 103.) Gibson provides “[s]uitable additives in this regard” including polymeric additives, such as cellulosic polymers and biodegradable polymers. Suitable cellulosic polymers include cellulose acetates, cellulose ethers, and cellulose acetate butyrates. Suitable biodegradable polymers include polylactones, polyanhydrides, and polyorthoesters, in Appeal 2021-004948 Application 16/281,026 6 particular, polylactic acid, polyglycolic acid, polycaprolactone, and copolymers thereof. (Gibson ¶ 103 (emphasis added).) Thus, in contrast to Appellant’s characterization of Gibson as providing no guidance in regard to 20 paragraphs of additives, Gibson teaches that one could lengthen delivery time, as desired given the claimed effective duration of 48 hours, using any of a list of 9 suitable polymers. Appellant argues that none of the examples or preferred embodiments presented in Gibson use polyorthoester as an additive or a polymer with dimethyl sulfoxide or glyceryl triacetate. (See Appeal Br. 15, 22.) This argument is unpersuasive because “[a]ll the disclosures in a reference must be evaluated, including nonpreferred embodiments . . . and a reference is not limited to the disclosure of specific working examples.” In re Mills, 470 F.2d 649, 651 (CCPA 1972). That a reference “discloses a multitude of effective combinations does not render any particular formulation less obvious.” Merck & Co. Inc. v. Biocraft Laboratories, Inc., 874 F.2d 804, 807 (Fed. Cir. 1989). Appellant argues further that picking two solvents (dimethyl sulfoxide and triacetin) from a “long list of genera and 45 solvent options” would involve picking from 900 possible combinations. (Appeal Br. 15-16.) Gibson teaches that HVLCM can be mixed with other solvents to form a lower viscosity liquid carrier material (“LVLCM”) and provides an admittedly lengthy list of such solvents, including dimethyl sulfoxide and triacetin. (See Gibson ¶ 77.) Gibson also teaches that “combinations thereof” of the listed solvents can be used. (Id.) In the following paragraph, Appeal 2021-004948 Application 16/281,026 7 though, Gibson teaches that “[p]articularly suitable solvents” include triacetin and dimethyl sulfoxide. (Gibson ¶ 78.) Appellant argues that paragraph 78 merely states that particularly suitable individual solvents include triacetin and dimethyl sulfoxide, but does not indicate a combination of these solvents. (See Appeal Br. 16.) We disagree in light of the express teaching in the prior paragraph that triacetin and dimethyl sulfoxide can be combined. (See Gibson ¶ 77.) Appellant acknowledges this teaching in paragraph 77, but argues that this only applies to the “longer list of solvent . . . .” (Appeal Br. 17.) This argument is unpersuasive because triacetin and dimethyl sulfoxide are listed in both paragraphs. Appellant argues that even given the smaller number of choices in paragraph 78, the Examiner fails to identify a reason why one of ordinary skill in the art would use the combination of dimethyl sulfoxide and triacetin out of the 105 possible combinations presented. (See Appeal Br. 18-19, 21- 22.) This argument is unpersuasive because Gibson presents these combinations as equivalent ingredients in a controlled drug delivery composition and Appellant does not direct us to evidence of a criticality or of unexpected results achieved with the claimed combination. Thus, the inclusion of dimethyl sulfoxide and triacetin in a composition for controlled delivery of a drug would have been obvious. “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition which is to be used for the very same purpose.” In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980). Appeal 2021-004948 Application 16/281,026 8 Appellant also argues that because Gibson reportedly teaches at least 200 drug options, the choice of bupivacaine would have required picking and choosing. (See Appeal Br. 19-21; Reply Br. 3-6.) Again, this argument is unpersuasive because Gibson presents each drug, including bupivacaine, as being a biologically active substance to be used with the controlled release compositions disclosed. Not only is bupivacaine disclosed, it is specifically highlighted in the examples and claims of Gibson. (See Gibson ¶¶ 146, 147, 154-56, Examples A, B, I, J, K, and claim 58; see Ans. 7.) Accordingly, we are not persuaded that the Examiner erred in relying on the teaching of bupivacaine in Gibson. Appellant cites In re Baird, 16 F.3d 380 (Fed. Cir. 1994), to argue that obviousness is not established when a claimed element is found to be only encompassed by a combination of elements from a large set of possibilities. (See Appeal Br. 11, 26.) In Baird, however, the large set of possibilities was the description of a genus of compounds, not the express recitation of the claimed compound as in the instant case. See Baird, 16 F.3d at 382 (“The fact that a claimed compound may be encompassed by a disclosed generic formula does not by itself render that compound obvious.”). We are persuaded that Gibson provides sufficient disclosure of the claimed compounds, along with sufficient and express reason that one of ordinary skill in the art would have chosen them, to render the claimed methods obvious. We agree with the Examiner that Merck & Co. v. Biocraft Lab'ys, Inc., 874 F.2d 804, 807 (Fed. Cir. 1989), is more instructive of the facts before us. Merck explains that when a patent discloses a multitude of effective combinations, a particular formulation is no less obvious when it is Appeal 2021-004948 Application 16/281,026 9 used for the same purpose taught by the prior art. Here, the combination of components recited in Appellant’s claimed methods is taught in Gibson to achieve the same result - a duration of anesthetic effect at a surgical wound from a controlled delivery composition. Appellant cites to several non-precedential Board opinions as being “analogous.” (Appeal Br. 22-27.) Appellant acknowledges that we are not bound by these holdings, but argues that they are informative if the facts before us are “uniquely match[ed]” with the facts then at issue. (Appeal Br. 26-27, quoting MPEP §2106.07(a)(I).) Even if prior non-precedential Board decisions were binding on us under such a standard, Appellant does not persuade us that any of these non-precedential cases presents facts uniquely matched to the facts before us now. For example, Appellant does not indicate that any of these cases addresses claims related to those currently before us or prior art related to Gibson. Accordingly, Appellant fails to persuade that we are bound to any of these prior Board decisions over the findings of facts and determinations we present here. Appellant’s arguments that Gibson fails to provide sufficient reason for one of ordinary skill in the art to choose the recited components of the claimed method, requiring too much picking and choosing, does not persuade us that the Examiner failed to present a prima facie case for obviousness. Accordingly, we affirm the rejection of claim 182. Dependent Claims Appellant argues that the Examiner erred in rejecting claims 183, 184, and 196 because of the asserted need to pick and choose from Gibson to Appeal 2021-004948 Application 16/281,026 10 arrive at the specifically recited anesthetic effects. (See Appeal Br. 31-32.) As discussed above, this argument is unpersuasive. Accordingly, we affirm the Examiner’s rejection of these claims. Conclusion Upon consideration of the record and for the reasons given, we affirm the Examiner’s rejection. In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 182-184, 196 103(a) Gibson 182-184, 196 No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136. AFFIRMED