Ex Parte HWANG et alDownload PDFPatent Trials and Appeals BoardMay 14, 201914287809 - (D) (P.T.A.B. May. 14, 2019) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 14/287,809 05/27/2014 Julia HWANG 30623 7590 05/16/2019 Mintz Levin/Boston 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 ATTORNEY DOCKET NO. CONFIRMATION NO. 47062-029C02US 8660 EXAMINER One Financial Center OLSON, ERIC Boston, MA 02111 ART UNIT PAPER NUMBER 1623 NOTIFICATION DATE DELIVERY MODE 05/16/2019 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): IPDocketingBOS@mintz.com IPFileroombos@mintz.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JULIA HWANG, DONGLING SU, and JULIUS LOPEZ Appeal2019-000166 Application 14/287,809 Technology Center 1600 Before ULRIKE W. JENKS, TIMOTHY G. MAJORS, and MICHAEL A. VALEK, Administrative Patent Judges. VALEK, Administrative Patent Judge. DECISION ON APPEAL Appellants submit this appeal 1 under 35 U.S.C. § 134 involving claims to an injectable mixture of a hyalauronic acid and a glycosaminoglycan, which have been rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. STATEMENT OF THE CASE Claims 1-3, 7-10, 15-20, 24, 30, and 31 are on appeal, and can be 1 Appellants identify the real party in interest as DePuy Mitek, LLC. Appeal Br. 1. Herein we refer to the Final Office Action mailed January 16, 2018 ("Final Act."), Advisory Office Action mailed April 5, 2018 ("Adv. Act."), Appeal Brief filed June 14, 2018 ("App. Br."), Examiner's Answer mailed August 14, 2018 ("Ans."), and Reply Brief filed October 9, 2018 ("Reply"). Appeal2019-000166 Application 14/287 ,809 found in the Claims Appendix of the Appeal Brief. Claims 1 is the only independent claim and representative of the claims on appeal. It reads as follows: 1. A composition effective for injection in a joint of a patient, comprising: a mixture of a hyalauronic acid and a glycosaminoglycan, wherein the mixture has a viscosity suitable for injection through a syringe within a period of time after the formation of the mixture, the hyaluronic acid has a molecular weight of between about 1.0 MDa and 5.0 MDa, the hyaluronic acid has an amount of the hyaluronic acid present in the composition is between about 1.5% and about 2.5% by weight of the composition, the mixture is disposed in a first chamber of the syringe, the syringe has a second chamber that is separated from the first chamber by a valve, and the syringe has a plunger configured to inject the hyalauronic acid from the second chamber into the first chamber having the glycosaminoglycan disposed therein and thereby form the mixture in the first chamber. App. Br. App'x A. Appellants do not argue any claim separately from claim 1 so claims 2, 3, 7-10, 15-20, 24, 30, and 31 stand or fall with claim 1. 37 C.F.R. § 41.37 (c)(l)(iv). Appellants seek review of Examiner's rejection of claims 1-3, 7-10, 15-20, 24, 30, and 31 under 35 U.S.C. § 103 as unpatentable over Jafari,2 in view ofMichaels. 3 App. Br. 2. 2 Masoud R. Jafari et al., US 2006/0110459 Al, published May 25, 2006 ("Jafari"). 3 Thomas M. Michaels, Jr., Dual Chamber Prefill Syringes, JOURNAL OF PARENTERAL SCIENCE & TECHNOLOGY, Vol. 42, 199-202 (1988) ("Michaels"). 2 Appeal2019-000166 Application 14/287 ,809 The issue is: Does the preponderance of evidence of record support Examiner's conclusion that the combination of Jafari and Michaels renders obvious the claimed compositions? Findings of Fact FF 1. Jafari teaches "triple natural polymer viscoelastic compositions" comprising the combination of sodium hyaluronate (HA), chondroitin sulfate (CS), and glucosamine sulfate (GS) "to form a viscous and elastic sterile solution that can be used as an intraocular and/or intra-articular agent." Jafari ,r 11; see also id. Abst. Jafari teaches that these compositions are "well- suited for joint therapy through intra-articular injection." Id. ,r 19. FF2. Jafari teaches that the HA in its compositions is preferably between about 1.0 MDa and 5.0 MDa and in a concentration from about 1-3% by weight. Jafari ,r 20. FF3. Jafari teaches the preparation of samples of its compositions by connecting a syringe containing a solution of HA and buffer to a second syringe containing a solution of CS, GS, and buffer via a Luer-Lock connector. Jafari ,r,r 25-28. The contents of each syringe are "then thoroughly mixed by alternately pushing plungers of the conjoined syringes until a homogenous mixture" of HA, CS, and GS is obtained. Id. ,r 28. FF4. Michaels is a review article that describes dual chamber prefilled syringes as well as other "package forms [that] have been developed to address the issue of needing two separate containers in order to reconstitute" a drug for administration. Michaels 200, left column, Figs. 1-3. Michaels teaches that using a traditional syringe to manually combine a diluent in one container with a lyophilized drug in another is disadvantageous because it "requires considerable manipulation by pharmacy or clinical personnel as well as 3 Appeal2019-000166 Application 14/287 ,809 observance of sterile technique throughout." Id. at 199, right column. According to Michaels, "[a] logical development in the evolution of a combination package" is a dual chamber syringe. Id. at 200, right column. Michaels teaches that "syringes with two chambers have been in use and on the market for some time" and "have been used for liquid drugs where two compounds are often administered together, but cannot be mixed prior to injection." Id. FF5. Michaels depicts configurations of exemplary dual chamber syringes in Figures 3 and 5. Michaels 200 (Fig. 3), 202 (Fig. 5). These figures show syringes with two chambers separated by a "by-pass" or "valving plunger stopper" that allows the contents of one chamber to be injected into the other chamber through operation of the plunger. Id. Analysis Examiner finds that Jafari teaches a mixture of hyalauronic acid (i.e., HA) and a glycosaminoglycan (i.e., CS), as claimed. Final Act. 4--5. While noting that Jafari "does not specifically disclose an apparatus which is a multi-chambered syringe containing the mixture," id. at 4, Examiner determines that the "makeshift two-syringe mixing setup described by Jafari" is "functionally equivalent" to the dual chamber by-pass syringe taught in Michaels. Adv. Act. 2-3. Accordingly, Examiner finds that a skilled artisan would be motivated to place Jafari's mixture of HA and CS in a dual-chambered syringe, as taught in Michaels, to provide a composition that is "stable and easy to use." Final Act. 5---6. Appellants do not dispute Examiner's finding that Jafari teaches an injectable mixture of hyalauronic acid and a glycosaminoglycan, as claimed. See App. Br. 2 (describing Jafari's teachings). Instead, Appellants urge that 4 Appeal2019-000166 Application 14/287 ,809 Examiner's stated rationale for placing that mixture in a dual chamber syringe, as taught in Michaels, is "insufficient." App Br. 4--5. Appellants further contend that doing so "would render Jafari unsatisfactory for its intended purpose" and "impermissibly change Jafari's principle of operation." See id. at 5-7. We are not persuaded by Appellants' arguments and agree with Examiner's statement of the rejection and responses to Appellants' arguments in both the Answer and Final Action. We further address each of Appellants' arguments below. We disagree with Appellants' argument that the rationale Examiner articulated for placing Jafari's mixture in a dual chamber syringe is insufficient. As Examiner has explained, Jafari teaches an HA solution in the chamber of one syringe and a CS/GS solution in the chamber of second syringe that are mixed together by operation of the syringes' plungers. Final Act. 5; FF3. In other words, Jafari teaches a mixture formed by using a plunger to inject a hyalauronic acid solution in one chamber into a second chamber containing a glucosaminoglycan solution. Michaels describes a dual chamber syringe as a "logical development in the evolution of a combination package" because it is easier to use and less prone to error than manually mixing separate components through the manipulation of separate syringes and vials immediately prior to injection. FF4. Accordingly, the record supports Examiner's stated rationale for using a dual chamber syringe because doing so would promote both "stability," by storing the components of the mixture separately until it is time to mix and inject them, and "ease of use." Final Act. 6. 5 Appeal2019-000166 Application 14/287 ,809 In addition, we agree with Examiner's determination that a dual chamber syringe is "functionally equivalent" to the two syringe setup described in Jafari. Adv. Act. 2-3. Jafari uses two separate containers to combine its components into a mixture with suitable viscosity for injection. Michaels expressly teaches that a dual chamber syringe is another package form that has been "developed to address the issue of needing two separate containers" to prepare a drug for injection. Thus, the prior art teaches that a dual chamber syringe performs the same function as the two-syringe setup taught in Jafari, further demonstrating that it would have been obvious to use a dual chamber syringe to prepare the claimed mixture. See In re Mayne, 104 F.3d 1339, 1343 (Fed. Cir. 1997) (affirming obviousness determination premised on finding that prior art structure is the "functional equivalent" of that claimed). We also disagree with Appellants' arguments that using dual chamber syringe, as taught in Michael, "would render Jafari unsatisfactory for its intended purpose" or "impermissibly change Jafari' s principle of operation." App. Br. at 5-7. Appellants contend that Jafari requires the formation of a "homogenous mixture" that is "not ... possible" to achieve in Michaels' prefilled syringe. Id. at 6; see also Reply 5 (arguing that modifying "Jafari in view of Michaels as proposed by the Examiner ... would adversely affect stability and usability of Jafari's composition"). We are unpersuaded by those arguments for several reasons. First, there is nothing in the record that supports Appellants' argument that a skilled artisan would consider it impossible to use a dual chamber syringe to house, mix and inject Jafari's compositions. To the contrary, Jafari teaches that its mixtures are prepared by constituting the HA and 6 Appeal2019-000166 Application 14/287 ,809 CS/GS in separate chambers and then mixing them together, which is the same principle of operation of the dual chamber syringes taught in Michaels. See FF5. Moreover, Appellants further contend that Hecht4 teaches that the individual components of Jafari's mixture can be "stored separately for long periods," whereas the mixture of HA, CS, and GS cannot be. Reply 4--5. That is the scenario, i.e., one where two liquid drugs are administered together, but cannot be mixed in advance, in which Michaels teaches dual chamber syringes have been successfully employed. FF4. Second, the unsupported attorney argument Appellants offer regarding "shelf-life stability" and "homogenous" mixing is not premised on any limitation in Appellants' claims. See App. Br. 6. Claim 1 merely requires a "mixture" with a "viscosity suitable for injection," which is precisely what Jafari teaches and what Michaels indicates a dual chamber syringe is capable of delivering. Third, even if maintaining a homogenous mixture over an extended period of time was of concern for one of skill seeking to employ a dual chamber syringe, "[ o ]bviousness does not require absolute predictability of success ... all that is required is a reasonable expectation of success." In re Drage, 695 F.3d 1334, 1338 (Fed. Cir. 2012) (quoting In re Kubin, 561 F.3d 1351, 1360 (Fed. Cir. 2009)). As explained above, the record supports that dual chamber syringes were amongst the "'known options within [the] technical grasp"' of a skilled artisan. See In re Translogic Technology, Inc., 504 F.3d 1249, 1262 (Fed. Cir. 2007) (quoting KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398 (2007)); FF4-FF5. Appellants have not identified, much less 4 Gerald Hecht et al., U.S. Patent No. 5,409,904 ("Hecht"). 7 Appeal2019-000166 Application 14/287 ,809 claimed, any particular modification that is not taught in the cited prior art that they contend must be made to successfully utilize the claimed mixture in a dual chamber syringe. Moreover, even if some routine optimization was required, we agree with Examiner that it would be obvious for a skilled artisan to do such to provide Jafari's mixture in a dual chamber syringe. See Ans. 7 (referring to potential multi-chamber configurations one of skill could consider "to determine how best to dispense it"). Finally, Appellants' arguments are largely premised on the assumption that those of ordinary skill in the art would limit themselves to the specific procedure the authors of Jafari used to prepare their test samples without exercising any of their own critical thought to provide the same mixture in a dual chamber syringe. Such arguments fail because "[a] person of ordinary skill is ... a person of ordinary creativity, not an automaton." See KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007); see also In re Sovish, 769 F.2d 738, 743 (Fed. Cir. 1985) (rejecting non-obviousness argument that "presumes stupidity rather than skill" from the skilled artisan). An appropriate obviousness analysis takes "account of the inferences and creative steps that a person of ordinary skill in the art would employ" to use Jafari's mixture in a dual chamber syringe, e.g., shaking the syringe to achieve a homogenous mixture prior to injecting it. See Trans logic, 504 F.3d at 1262 (internal quotations omitted) (affirming obviousness determination premised on one of ordinary skill adapting a generally known option to the particular application taught in the primary reference). For all these reasons, Appellants' arguments fail to persuade us that Examiner erred in rejecting claims 1-3, 7-10, 15-20, 24, 30, and 31. We therefore affirm. 8 Appeal2019-000166 Application 14/287 ,809 SUMMARY We affirm the rejection of claims 1-3, 7-10, 15-20, 24, 30, and 31 under 35 U.S.C. § 103 as unpatentable over Jafari and Michaels. 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 9 Copy with citationCopy as parenthetical citation