Ex Parte MARGULIES et alDownload PDFPatent Trial and Appeal BoardFeb 11, 201611766298 (P.T.A.B. Feb. 11, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 111766,298 06/21/2007 24239 7590 02/16/2016 MOORE & VAN ALLEN PLLC P.O. BOX 13706 3015 Carrington Mill Boulevard, Suite 400 Research Triangle Park, NC 27709 FIRST NAMED INVENTOR BARRY JOSEPH MARGULIES 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. 026228-171.05-036 9117 EXAMINER HIRT,ERINE ART UNIT PAPER NUMBER 1616 NOTIFICATION DATE DELIVERY MODE 02/16/2016 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): iplaw@mvalaw.com usptomail@mvalaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte BARRY JOSEPH MARGULIES and TORY PATRICIA JOHNSON1 Appeal2013-008879 Application 11/766,298 Technology Center 1600 Before JEFFREYN. FREDMAN, ULRIKE W. JENKS, and RICHARD J. SMITH, Administrative Patent Judges. SMITH, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to an implantable drug delivery device and a method for treating or controlling a herpes virus. (Appeal Br. 25-28.) We have jurisdiction under 35 U.S.C. § 6(b ). We affirm. 1 According to Appellants, the real party in interest is Towson University. (Appeal Br. 3.) Appeal2013-008879 Application 11/766,298 STATEMENT OF THE CASE "Despite the efficacy of ACV2 in the treatment ofHSV-1,3 patient compliance and bioavailability are still major issues and, therefore, maintenance of the requisite levels of drug in the patient is a potential problem." (Spec. 4, i-f 11.) "Thus, it would be advantageous to provide an effective alternative for delivering an antiviral drug such as ACV that employs the use of a controlled release delivery device." (Spec. 5, i-f 13.) Claims on Appeal Claims 1, 2, 4--18, and 20-32 are on appeal. Independent claim 1 and dependent claim 10 are illustrative and read as follows (emphasis added): 1. An implantable solid drug delivery device for positioning near the site of infection to provide an initial burst and long term delivery of therapeutic compound to local tissue, the device comprising: a solid substrate having an uncovered surface and a geometric shape for implantation \'l1ithin a subject, \'I/herein the solid substrate comprises a silicone or silicone containing material and at least one therapeutic compound, and wherein the therapeutic compound is dissolved, dispersed or impregnated into at least the outer surface of the solid substrate, and wherein the therapeutic compound is at least one compound selected from acyclovir, valacyclovir and functional analogue thereof and wherein the uncovered surface of the substrate provides for the initial burst of the therapeutic compound and long term delivery into local tissue thereby exhibiting primarily local drug release instead of systemic. 2 ACV refers to acyclovir. (Spec. 3, i-f 8.) 3 HSV refers to herpes simplex virus. HSV-1 refers to herpes simplex virus type-I. (Spec. 2, i-fi-13, 5.) 2 Appeal2013-008879 Application 11/766,298 10. The drug delivery device of claim 1, wherein the subject is infected HSV-1, HSV 2 or VZV. 4 Examiner's Rejections 1. Claims 1, 2, 4--8, 11-18, 20-24, and 26-31 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Martinod,5 Gillis, 6 and Wong.7 (Ans. 3.) 2. Claims 9, 10, 25, and 32 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Martinod, Gillis, Wong, Tyring,8 and Yanagihara.9 (Id.) Appellants have presented arguments for the patentability of claims 1, 2, 4--8, 11-18, 20-24, and 26-31 as a group. (Appeal Br. 10-22.) Therefore, we limit our discussion to claim 1 as representative of those claims. Appellants have presented arguments for the patentability of claims 9, 10, 25, and 32 as a group. (Appeal Br. 22-23.) Therefore, we limit our discussion to claim 10 as representative of those claims. FINDINGS OF FACT We adopt the Examiner's findings and analysis concerning the scope and content of the prior art. The following findings are included for emphasis and reference convenience. 4 VZV refers to Varicella-Zoster virus. (Spec. 15, i-f 68.) 5 Martinod, et al., US 2005/0129728 Al, published June 16, 2005. 6 Gillis, et al., US 2001/0041870 Al, published Nov. 15, 2001. 7 Wong, et al., US Patent No. 6,692,759 Bl, issued Feb. 17, 2004. 8 Tyring, et al., Valacyclovir for Herpes Simplex Virus Infection: Long-Term Safety and Sustained Efficacy after 20 Years' Experience with Acyclovir, 2002 J. INFECTIOUS DISEASES 186 (Supp. 1), S40-S46. 9 Yanagihara, et al., NEW HORIZONS INF ACIAL NERVE RESEARCH AND FACIAL EXPRESSION 191-93 (Kugler Pub.) (1998). 3 Appeal2013-008879 Application 11/766,298 FF 1. The Examiner finds that Martinod teaches that the sustained release implant is "preferably of the form of a matrix or an uncovered or covered rod." (Ans. 4, quoting Martinod i-f 15.) FF 2. The Examiner finds that Martinod teaches that the implant is made from silicon/silicon based polymers and has an "initial burst" (an initial first order release/rapid initial release of active agent). (Id., citing Martinod i-fi-1 10, 11, 15, 19.) FF 3. The Examiner finds that Martinod teaches that the implant includes "a pharmaceutically active composition carried in or on the silicone support rod." (Id. at 6, quoting Martinod i-f 11.) FF 4. The Examiner finds that Gillis states that the guides for placing implants, as taught by Gillis, are useful with any implant/drug delivery device. (Id. at 7, citing Gillis i-f 26.) FF 5. The Examiner finds that Wong teaches implants useful for administering ACV. (Id. at 8-9, citing Wong, col. 8, 1. 60.) FF 6. The Examiner finds that Tyring teaches the use of acyclovir and valacyclovir for the treatment/control of herpes viral infections. (Final Act. 10).10 ISSUE NO. 1 Whether a preponderance of evidence of record supports the Examiner's conclusion that claim 1 is obvious based on Martinod, Gillis, and Wong. 10 Office Action dated July 27, 2012. 4 Appeal2013-008879 Application 11/766,298 ANALYSIS The Examiner concluded that claim 1 would have been obvious to one of ordinary skill in the art based on Martinod, Gillis, and Wong. (Final Act. 3-8.) Based on the Examiner's findings and analysis, we find that the Examiner has satisfied the burden of showing "some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). The Examiner has therefore established a prima facie case of obviousness and, as discussed below, Appellants have not overcome that prima facie case. Systemic Versus Local Delivery Appellants argue that Martinod does not teach or suggest the invention because it teaches the systemic delivery of drugs, rather than local drug release as recited in the concluding "wherein" clause of claim 1. (Appeal Br. 10-11.) We are not persuaded by this argument. First, as noted by the Examiner, local versus systemic drug release is related to where the infection is located, and an implant placed near the site of an infection will primarily release the drug to the local tissue. (Ans. 4.) Stated another way, the "wherein" clause merely states the result of the limitations in the claim (e.g., uncovered surface, therapeutic compound "into at least the outer surface of the solid substrate"), and thus adds nothing to the patentability or substance of the claim. See Texas Instruments Inc. v. U.S. Int 'l Trade Comm 'n, 988 F.2d 1165, 1172 (Fed. Cir. 1993). Second, to the extent that the concluding wherein clause might be deemed to have patentable weight, the claim itself states that the "local drug release" is exhibited by "the initial burst of the therapeutic compound and long term delivery into local tissue." 5 Appeal2013-008879 Application 11/766,298 (Appeal Br. 25.) However, that "initial burst" is taught by Martinod (FF 1- 3), and the "wherein" limitation is thus satisfied by Martinod. Teachings of References Appellants argue that an "uncovered" rod is only mentioned once in Martinod, and "there is not a single example or further discussion relating to an uncovered implant." (Appeal Br. 13.) However, this argument fails to take into account that a prior art reference may be read for all that it teaches, including uses beyond its primary purpose. See In re Mouttet, 686 F .3d 1322, 1331 (Fed. Cir. 2012). Appellants also argue that the devices of Martinod and Gillis are not combinable. (Appeal Br. 15-17.) However, prior art need not be physically combinable; the test for obviousness is what the references would have suggested to a person of ordinary skill in the art. See In re Keller, 642 F.2d 413, 425 (CCPA 1981) (citing cases). Acyclovir and Hindsight Appellants also argue with respect to Wong that "acyclovir" is "found in the list of hundreds of compounds" and that there is no guidance for adding acyclovir to a silicon polymeric material. (Appeal Br. 17.) Appellants also argue that the Examiner is using "impermissible hindsight." (Id. at 19.) We are not persuaded. Claim 1 is directed to a "drug delivery device," and Wong teaches that acyclovir can be used in its drug delivery implants. (FF 5.) Furthermore, the Examiner makes clear that Wong was not cited for teaching a polymeric material made of silicone. (Ans. 8.) Rather, as explained by the Examiner, Wong teaches implants made of biocompatible and non-biodegradable polymers, and silicone based polymers are well known in the art to be biocompatible and non- 6 Appeal2013-008879 Application 11/766,298 biodegradable polymers useful for forming drug delivery implants. (Id.) Finally, rather than using hindsight) the Examiner points to specific disclosures in the prior art that describe the limitations of AppeHants' claimed device. (Final Act. 3-8; Ans. 3-10.) \Ve therefore find that the Examiner's obviousness conclusion is based on sufficiently articulated reasoning that overcomes any concerns about hindsight bias. See KSR, 550 U.S. at 418. Test Results Appellants also argue that test results from the Specification indicate that the uncovered rod was surprisingly more effective in releasing therapeutic compound than the covered rod. (Appeal Br. 20-21.) Those results do not appear to be unexpected given that a covered rod covers the drug and an uncovered rod does not. (See Spec. i-f 23 and FIG. 1 A-E.) In any event, Appellants do not establish that a person of ordinary skill in the art would have found the test results unexpected. See Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1371 (Fed. Cir. 2007). CONCLUSION OF LAW A preponderance of evidence of record supports the Examiner's conclusion that claim 1 is obvious under 35 U.S.C. § 103(a). Furthermore, Appellants have not provided sufficient evidence of unexpected results that, when weighed with the evidence favoring obviousness, shows that the drug delivery device of claim 1 would have been nonobvious. Claims 2, 4--8, 11-18, 20-24, and 26-31 were not argued separately and therefore fall with claim 1. 37 C.F.R. § 41.37(c)(l)(iv). 7 Appeal2013-008879 Application 11/766,298 ISSUE NO. 2 Whether a preponderance of evidence of record supports the Examiner's conclusion that claim 10 is obvious based on Martinod, Gillis, Wong, Tyring, and Yanagihara. ANALYSIS The Examiner concluded that it would have been obvious to use the drug delivery device taught by Martinod, Gillis, and Wong for local treatment of alphaherpes viruses, specifically HSV-1, HSV-2, and VZV, because the use of antivirals such as ACV to treat those viruses was known in the prior art (e.g., Tyring). (Final Act. 10.) In light of the above discussion and the Examiner's findings regarding the treatment of herpes (e.g., FF 6), we conclude that the Examiner has established a prima facie case of obviousness and that Appellants have not overcome that prima facie case. Appellants' initial argument relates to "the need for so many cited references" as evidencing nonobviousness. (Appeal Br. 22.) However, the mere number of references used does not weigh against a conclusion of obviousness. In re Gorman, 933 F.2d 982, 986 (Fed. Cir. 1991). Appellants also argue that Tyring teaches the use of oral (systemic) delivery of acyclovir or valacyclovir, and that there is no reason to think that administering acyclovir or valacyclovir to the spot of infection would be effective. (Id. at 22-23.) However, we find that the combined teachings of the references would have suggested the use of a drug delivery device, as recited in claim 1, with a subject infected with HSV-1, HSV-2, or VZV, as recited in claim 10. See Keller, 642 F.2d at 425. 8 Appeal2013-008879 Application 11/766,298 CONCLUSION OF LAW A preponderance of evidence of record supports the Examiner's conclusion that claim 10 is obvious under 35 U.S.C. § 103(a). Claims 9, 25, and 32 were not argued separately and therefore fall with claim 10. 37 C.F.R. § 41.37(c)(l)(iv). SUMMARY We affirm the rejection of all claims on appeal. 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