Ex Parte Sahatjian et al

Patent Trial and Appeal BoardApr 15, 2016

13053461 (P.T.A.B. Apr. 15, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 13/053,461 03/22/2011 121974 7590 04/19/2016 KACVINSKY DAISAK BLUNI PLLC America's Cup Building 50 Doaks Lane Marblehead, MA 01945 FIRST NAMED INVENTOR Ronald A. Sahatjian 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. 10527-0658002 I 02-261 (D 8287 EXAMINER WEISBERG, AMY REGINA ART UNIT PAPER NUMBER 3731 NOTIFICATION DATE DELIVERY MODE 04/19/2016 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): kddocketing@cpaglobal.com bbonneville@kdbfirm.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte RONALD A. SAHATJIAN, FRANCISCA TAN, PATRICK T. MATHER, CHANGDENG LIU, and QING GE Appeal2014-002709 Application 13/053,461 Technology Center 3700 Before JOHN C. KERINS, BRANDON J. WARNER, and LEE L. STEPINA, Administrative Patent Judges. STEPINA, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF CASE Appellants appeal under 35 U.S.C. Â§ 134 from a rejection of claims 2- 17, 19-25, and 38--40. We have jurisdiction under 35 U.S.C. Â§ 6(b). We affirm. The claims are directed to a method of treating a mammal using an endoprosthesis. Claim 23, reproduced below, is illustrative of the claimed subject matter: Appeal2014-002709 Application 13/053,461 23. A method of treating a cavity or lumen in a mammal, the method comprising: implanting, into the lumen or cavity of the mammal, an endoprosthesis comprising a tubular member having a coating comprising a polymeric material including a reaction product of a polyol, an isocyanate and a silsesquioxane having at least two pendent hydroxyl groups. REFERENCES The prior art relied upon by the Examiner in rejecting the claims on appeal is: Ding Hubbell Schottman us 6,099,562 US 6,958,212 Bl US 7 ,008,979 B2 Aug. 8,2000 Oct. 25, 2005 Mar. 7, 2006 Fu et al., Nanoscale reinforcement of polyhedral oligiomeric silsesquioxane (POSS) in polyurethane elastomer, Polym Int. 49:437--440 (2000) (hereinafter "Fu"). R.L. Hudson, http://www.rlhudson.com/O-Ring%20Book/P041.html (Jan. 31, 2001 )(hereinafter "Hudson"). REJECTIONS (I) Claims 2--4, 9, 12-17, 23-25, 38, and 39 are rejected under 35 U.S.C. Â§ 103(a) as unpatentable over Ding and Fu. (II) Claims 5 and 40 are rejected under 35 U.S.C. 103(a) as unpatentable over Ding, Fu, and Schottman. (III) Claims 6 and 7 are rejected under 35 U.S.C. 103(a) as unpatentable over Ding, Fu, and Hubbell. (IV) Claims 8, 10, 11, and 19-22 are rejected under 35 U.S.C. 103(a) as unpatentable over Ding, Fu, and Hudson. 2 Appeal2014-002709 Application 13/053,461 OPINION Rejection(!) The Examiner finds that Ding discloses most of the features recited in claim 1 and teaches the use of generic polyurethane thermoplastic elastomers, but "fails to disclose specifically the coating being made from a reaction product of a polyol, an isocyanate and a silsesquioxane having at least two pendent hydroxyl groups." Final Act. 3. The Examiner finds that Fu teaches a method of making a polyurethane elastomer and a method involving a reaction of "a POSS,[lJ an isocyanate, and a polyol (PTMG)." Final Act. 3. The Examiner determines that it would have been obvious "to substitute the nonspecific polyurethane elastomer of Ding to be the more specific method of making such a compound as taught by Fu, as the incorporation of POSS molecularly reinforces the hard segment and improves mechanical and physical properties of segmented polyurethane (PU)." Final Act. 3 (referring to Fu 437). The Examiner finds that the combination of Ding and Fu does not explicitly teach at least two pendent hydroxyl groups. Final Act. 3. However, the Examiner further finds that "creating derivatives by substituting different functional groups is within the realm of this invention, furthermore the addition of hydroxyl groups is well known in polymer chemistry, for example as to provide increase[ d] water solubility." Final Act. 3 (referring to Fu 437--438, Fig. D). Appellants argue that Ding discloses a polyurethane coating, but there are a vast number of known polyurethanes, "and the Examiner has not properly established that Ding would have made it obvious to a person of ordinary skill in the art to select any particular polyurethane for his 1 POSS means "polyhedral oligomeric silsesquioxane." Fu, Abstract. 3 Appeal2014-002709 Application 13/053,461 undercoating." Appeal Br. 2. Appellants assert, "the Examiner has not established that Fu's allegedly advantageous properties would be advantageous in Ding's prostheses." Appeal Br. 2. In this regard, Appellants state, "absent evidence to the contrary, it is entirely possible that a person of ordinary skill in the art might have considered such properties to be detrimental for the undercoat of Ding' s prostheses." Appeal Br. 3; see also Reply Br. 3--4 arguing that the Examiner has not established that a person of skill in the art would have recognized Fu's polymer as providing a benefit. In response, the Examiner states that Ding discloses a generic polyurethane, and Fu teaches an improved composition of polyurethane that provides reinforcement and improved mechanical properties of segmented polyurethane, and "one of ordinary skill would seek to utilize this for a medical device as to incorporate the improved qualities." Ans. 5. Fu teaches that "[ s ]egmented polyurethane (PU) based elastomers have versatile mechanical and thermophysical properties due to the formation of microphase separation from the thermodynamic incompatibility (immiscibility) of solid-like hard segments and rubbery soft segment sequences." Fu 437. Fu discloses "a unique class of PU containing polyhedral oligomeric silsesquioxane (POSS) cages pendent to the polymer chain. The purpose of this POSS incorporation is to molecularly reinforce the hard segment and improve mechanical and physical properties of PU." Fu 437. Fu also discloses that POSS molecules have been "successfully incorporated in different polymers" and "[t]hese hybrid polymers show improved properties such as higher T g, increased oxygen permeability, reduced flammability and enhanced mechanical strength." Fu 437. Accordingly, Fu discloses advantages, such as providing improved 4 Appeal2014-002709 Application 13/053,461 mechanical properties, resulting from incorporating POSS in PU. As for whether the Examiner has established that the advantages specified by Fu would be recognized by a person of skill in the art as advantageous in Ding, "the [obviousness] analysis need not seek out precise teachings directed to the specific subject matter of the challenged claim, for [an examiner] can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). The advantages of incorporating POSS in PU touted by Fu provide rational underpinnings to the Examiner's reasoning for modifying Ding. Thus, we are not persuaded by Appellants' arguments on this point. According to Appellants, Ding uses its coating to store and release a biologically active material, and "Fu provides no indication whatsoever that his polymer could be used to appropriately store and release a therapeutic agent when used in Ding's prostheses." Appeal Br. 2. Appellants further argue "the Examiner has not properly established [that] either Ding [or] Fu would have provided a person of ordinary skill in the art with a reasonable expectation of success for the Examiner's proposed Ding/Fu combination." Appeal Br. 3; see also Reply Br. 4. As for whether Fu indicates that its polymer could be used for the storage and release of a therapeutic agent, the Examiner's modification to Ding does not eliminate the use of polyurethane, but instead uses a hybrid of polyurethane and POSS as disclosed by Fu. Further, "[o]bviousness does not require absolute predictability of success." In re 0 'Farrell, 853 F.3d 894 (Fed. Cir. 1988). "For obviousness underÂ§ 103, all that is required is a reasonable expectation of success." 0 'Farrell, 853 F.3d 894 (citing In re Langi, 759 F.2d 887, 897 (Fed. Cir. 1985); and In re Clinton, 527 F.2d 1226, 1228 (CCPA 1976)). In the present case, Ding would continue to use 5 Appeal2014-002709 Application 13/053,461 polyurethane as it does in its unmodified state, albeit with the Examiner's proposed modification, and Appellants do not provide any persuasive evidence as to how this modification would interfere with the polyurethane's ability to store and release a therapeutic agent. Accordingly, we are not persuaded by Appellants' arguments on this point. In the Reply Brief, Appellants assert the Examiner mischaracterized Appellants' arguments and the record (see Reply Br. 1-2). Appellants further assert the Examiner did not use the term "Official Notice" in the Final Office Action and therefore, contrary to the Examiner's statement on page 6 of the Answer, Appellants have not conceded to the taking of official notice by the Examiner. Reply Br. 2. We are not persuaded by Appellants' arguments on these points inasmuch as the teachings in Fu provide rational underpinnings for the Examiner's reason to combine Ding and Fu. Although we agree with Appellants that the Examiner did not take official notice in the Final Office Action (see Ans. 5---6 referring to a taking of official notice), Appellants provide no persuasive argument as to why the Examiner's.finding of fact that "the use of an improved composition only requires routine skill in the art" is incorrect. See Reply Br. 3; see also Ans. 5. Indeed, Fu explicitly teaches improving the mechanical and physical properties of PU. See Fu 437 (Introduction). We have considered all of Appellants' arguments but find them unpersuasive. Accordingly, we sustain the Examiner's rejection of claim 23 and claims 2--4, 9, 12-17, 24, 25, 38, and 39 depending therefrom as unpatentable over Ding and Fu. 6 Appeal2014-002709 Application 13/053,461 Rejections (11)-(IV) Appellants do not make separate arguments against any of Rejections (II}-(IV). See Appeal Br. 3. Accordingly, we sustain these rejections for the same reasons discussed above regarding Rejection (I). DECISION The Examiner's decision to reject claims 2-17, 19-25, and 38--40 is affirmed. 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). See 37 C.F.R. Â§ 1.136(a)(l )(iv). AFFIRMED 7