Ex Parte Schmitz et alDownload PDFPatent Trial and Appeal BoardSep 18, 201412251173 (P.T.A.B. Sep. 18, 2014) Copy Citation 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. 12/251,173 10/14/2008 Klaus-Peter Schmitz TEPH 113 CIP (2) 5107 23579 7590 09/18/2014 Pabst Patent Group LLP 1545 PEACHTREE STREET NE SUITE 320 ATLANTA, GA 30309 EXAMINER SCHALL, MATTHEW WAYNE ART UNIT PAPER NUMBER 3738 MAIL DATE DELIVERY MODE 09/18/2014 PAPER 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. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte KLAUS-PETER SCHMITZ, DETLEF BEHREND, KATRIN STERNBERG, NEILS GRABOW, DAVID P. MARTIN, and SIMON F. WILLIAMS __________ Appeal 2012-007478 Application 12/251,173 Technology Center 3700 __________ Before JEFFREY N. FREDMAN, ULRIKE W. JENKS, and CHRISTOPHER G. PAULRAJ, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal1 under 35 U.S.C. § 134 involving claims to an absorbable biocompatible stent. The Examiner rejected the claims as anticipated and as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. 1 Appellants identify the Real Party in Interest as Tepha, Inc. (see App. Br. 2). Appeal 2012-007478 Application 12/251,173 2 Statement of the Case Background “Stents are currently used in a range of medical applications normally to prevent re-occlusion of a vessel after a procedure to dilate the vessel” (Spec. 1, ll. 15-16). “To address the disadvantages associated with the use of permanent materials in stents and stent coatings, there have been several reports describing the use of absorbable materials to make stents and stent coatings” (Spec. 2, ll. 26-28). The Specification teaches “[a]bsorbable stents and stents coated with absorbable materials have been developed that have improved properties” (Spec. 9, ll. 26-27). The Claims Claims 1-30 are on appeal. Claim 1 is representative and reads as follows: 1. A biocompatible stent comprising a base coat and optionally a top coat, wherein the base coat comprises a blend of poly(4-hydroxybutyrate) (P(4HB)), and poly(lactide) (PLA), and one or more therapeutic, diagnostic or prophylactic agents. The issues A. The Examiner rejected claims 1, 2, 9-16, 19-24, and 26-30 under 35 U.S.C. § 102(e) as anticipated by Hossainy2 (Ans. 4-5). B. The Examiner rejected claims 6 and 7 under 35 U.S.C. § 103(a) as obvious over Hossainy (Ans. 5). 2 Hossainy et al., US 2006/0147412 A1, published Jul. 6, 2006. Appeal 2012-007478 Application 12/251,173 3 C. The Examiner rejected claims 3-5, 8, 17, and 18 under 35 U.S.C. § 103(a) as obvious over Hossainy and Levenberg3 (Ans. 6). D. The Examiner rejected claim 25 under 35 U.S.C. § 103(a) as obvious over Hossainy and Williams4 (Ans. 6-7). A. 35 U.S.C. § 102(e) over Hossainy The Examiner finds that Hossainy discloses an absorbable biocompatible stent or stent coatings comprising a blend of PLLA and P4HB (paragraphs [0010], [0021], [0031], [0088] and [0095]). Hossainy further discloses the stent optionally comprises tacrolimus or rapamycin (paragraph [0062]). Hossainy further discloses coating a stent as described above with a base coat and optionally a top coat, comprising a blend of P4HB and PLLA and a therapeutic agent (paragraphs [0199]-[0205]). Hossainy further discloses concentrations of the agent that include about 2 µg/mm2 (paragraph [0086]). Hossainy further discloses triethylcitrate in a concentration between 0.01 and 10% (paragraphs [0066], [0070] and [0075]). Hossainy further discloses the stent is metallic (paragraph [0018]). Hossainy further discloses balloon expanding the stent (paragraphs [0005] and [0200]). (Ans. 4-5). The issue with respect to this rejection is: Does the evidence of record support the Examiner’s conclusion that Hossainy anticipates the claims? 3 Levenberg et al., US 2005/0031598 A1, published Feb. 10, 2005. 4 Williams et al., US 6,548,569 B1, issued Apr. 15, 2003. Appeal 2012-007478 Application 12/251,173 4 Findings of Fact 1. The Specification teaches that “the stent is a metallic stent coated with a base coating containing a blend of poly(4-hydroxybutyrate) (P(4HB)) and poly(L-lactide) (PLLA)” (Spec. 6, ll. 21-23). 2. Figure 1 of the Specification shows the structure of poly(4- hydroxybutyrate) as reproduced below: “Figure 1 is the chemical structure of poly(4-hydroxybutyrate) (P(4HB)” (Spec. 8, l. 14). 3. The Specification teaches that “‘Poly( 4-hydroxybutyrate)’ as generally used herein means a homopolymer comprising 4-hydroxybutyrate units. It may be referred to herein as P(4HB)” (Spec. 9, l. 29 to 10, l. 1). 4. Hossainy teaches “polymers containing poly (hydroxyalkanoates) and agents such as diagnostic, prophylactic, therapeutic, ameliorative, and other agents, for use with medical articles. The polymers can be used in medical articles such as, for example, stents” (Hossainy 1 ¶ 10). Appeal 2012-007478 Application 12/251,173 5 5. Hossainy teaches that: The PHA compositions of the present invention include any combination of polymers, copolymers and agents, wherein the combination comprises a hydroxyalkanoate moiety. Polymers comprising hydroxyalkanoate moieties can be biodegradable due to the labile nature of the ester groups that can be present between at least the hydroxyalkanoate moieties. (Hossainy 2 ¶ 20). 6. Hossainy teaches that “[e]xamples of other polymers that can be combined with the PHAs of the present invention include . . . poly(L- lactide)” (Hossainy 3 ¶ 31). 7. Hossainy teaches that the “term ‘PHA’ refers to a polymeric composition that contains a hydroxyalkanoate, which is a hydroxyacid moiety that contains an alkane with hydroxyl and carboxyl functionality” (Hossainy 10 ¶ 88). 8. Hossainy teaches that a “polymer of the present invention can comprise a polymeric carrier having an A-moiety (A), a B-moiety (B), and an optional linkage (L1) connecting A to B” (Hossainy 10 ¶ 91). 9. Hossainy teaches a formula I as shown below where the “the A:B ratio can be less than, greater than, or equal to one; both A and B can be independently selected, and comprise any combination of Appeal 2012-007478 Application 12/251,173 6 monomers such that the polymer has at least one hydroxyalkanoate group . . . and z is an integer not equal to zero” (Hossainy 10 ¶¶ 91-92). 10. Hossainy teaches that in “some embodiments, the composition can comprise . . . 4-hydroxybutyrate” (Hossainy 10 ¶ 95). 11. Hossainy teaches that “B . . . can include a polyol, a polycarboxylic acid, an amino acid, or a combination thereof” (Hossainy 12 ¶ 107). Principles of Law The Examiner bears the initial burden of establishing a prima facie case of anticipation. In re King, 801 F.2d 1324, 1326-27 (Fed. Cir. 1986). Anticipation under 35 U.S.C. § 102 requires that “each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference.” In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999). Analysis Claim Interpretation We begin with claim interpretation since it is a necessary prerequisite for comparing the claim to the prior art. Claim 1 requires the use of a blend of poly(4-hydroxybutyrate) (also called P(4HB)) and poly(lactide) (also called (PLA)) on the stent. The issue presented here is whether poly(4- hydroxybutyrate) is a homopolymer. The Examiner finds that “Appellant has not claimed a homopolymer. Claim 1 requires multiple monomers of P(4HB) and multiple monomers of PLA” (Ans. 8). Appeal 2012-007478 Application 12/251,173 7 Appellants contend that “[p]oly(4-hydroxybutyrate) (P(4HB)) is a polymer made of repeating units of the same monomer, 4- hydroxybutyrate. . . . Thus, P4HB is a homopolymer” (Reply Br. 4). We find that Appellants have the better position. The Specification explicitly defines “Poly( 4-hydroxybutyrate)” to mean “a homopolymer comprising 4-hydroxybutyrate units” and further states that it may be referred to herein as P(4HB) (FF 3). This express definition in the Specification controls the meaning of poly(4-hydroxybutyrate). See Phillips v. AWH Corp., 415 F.3d 1303, 1316 (Fed. Cir. 2005) (“[O]ur cases recognize that the specification may reveal a special definition given to a claim term by the patentee that differs from the meaning it would otherwise possess. In such cases, the inventor’s lexicography governs.”) Hossainy The Examiner finds that “[e]ven if the claim language was viewed to require a homopolymer of P(4HB), the disclosure of Hossainy rejects this as well. Even considering the embodiments of paragraphs [0091]-[0094], the polymer is comprised of monomers (see paragraph [0092], line 3) of any combination of the list of paragraph [0095], which includes P(4HB)” (Ans. 8-9). We agree with Appellants that Hossainy does not teach a homopolymer comprising 4-hydroxybutyrate units (see, e.g., Reply Br. 4). While Hossainy teaches stents with polymer blends (FF 4-5), where one of the polymers may be PLA (FF 6), and where one of the polymers may comprise 4-hydroxybutyrate (FF 10), there is no teaching in Hossainy to form homopolymers that comprises repeat units of only 4-hydroxybutyrate. Appeal 2012-007478 Application 12/251,173 8 The Examiner’s reliance on paragraphs [91]-[95] of Hossainy is not persuasive. In those paragraphs, Hossainy teaches hydroxyalkanoate polymers composed of two moieties, an “A” and a “B” moiety (FF 8) which is necessarily a copolymer that requires the presence of both the “A” and “B” moieties, since z cannot equal zero (FF 9). While Hossainy teaches that the “A” moiety can be composed of 4-hydroxybutyrate (FF 10), Hossainy further teaches that “B . . . can include a polyol, a polycarboxylic acid, an amino acid, or a combination thereof” (Hossainy 12 ¶ 107; FF 11). The Examiner has not identified any teaching in Hossiany that both the “A” and “B” moieties may be 4-hydroxybutyrate, thereby forming a homopolymer. Rather, the Examiner selectively picked a single moiety identified for the copolymer taught by Hossiany in order to assert that the claimed stent comprising a homopolymer coating is anticipated. To the extent that there may be some suggestion in Hossainy, unidentified by the Examiner, to select 4-hydroxybutyrate as both the “A” and “B” moieties, the Court has stated that an anticipatory reference under 35 U.S.C. § 102 “must clearly and unequivocally disclose the claimed compound or direct those skilled in the art to the compound without any need for picking, choosing, and combining various disclosures not directly related to each other by the teachings of the cited reference.” In re Arkley, 455 F.2d 586, 587-588 (CCPA 1972). Conclusion of Law The evidence of record does not support the Examiner’s conclusion that Hossainy anticipates the claims. Appeal 2012-007478 Application 12/251,173 9 B.-D. 35 U.S.C. § 103(a) These rejections rely upon the underlying anticipation rejection over Hossainy. Having reversed the rejection of claim 1, we also necessarily reverse these obviousness rejections because none of the additionally cited prior art is relied upon to teach the poly(4-hydroxybutyrate) homopolymer as required by independent claim 1, upon which all of the rejected claims depend. SUMMARY In summary, we reverse the rejection of claims 1, 2, 9-16, 19-24, and 26-30 under 35 U.S.C. § 102(e) as anticipated by Hossainy. We reverse the rejection of claims 6 and 7 under 35 U.S.C. § 103(a) as obvious over Hossainy. We reverse the rejection of claims 3-5, 8, 17, and 18 under 35 U.S.C. § 103(a) as obvious over Hossainy and Levenberg. We reverse the rejection of claim 25 under 35 U.S.C. § 103(a) as obvious over Hossainy and Williams. REVERSED tc Copy with citationCopy as parenthetical citation