13472938 (P.T.A.B. Aug. 29, 2018)

Ex Parte Jay

Patent Trial and Appeal BoardAug 29, 2018

13472938 (P.T.A.B. Aug. 29, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 13/472,938 05/16/2012 51414 7590 08/31/2018 GOODWIN PROCTER LLP PATENT ADMINISTRATOR 100 Northern A venue BOSTON, MA 02210 FIRST NAMED INVENTOR Gregory D. Jay 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. LUB-006Cl 4541 EXAMINER HELM, CARAL YNNE E ART UNIT PAPER NUMBER 1615 NOTIFICATION DATE DELIVERY MODE 08/31/2018 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): PA TENTBOS@GOODWINPROCTER.COM PSOUSA-ATWOOD@GOODWINPROCTER.COM GLENN .WILLIAMS@GOODWINPROCTER.COM PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte GREGORY D. JA Y 1 Appeal2017-000692 Application 13/472,938 Technology Center 1600 Before RICHARD M. LEBOVITZ, JOHN G. NEW, and TA WEN CHANG, Administrative Patent Judges. CHANG, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. Â§ 134(a) involving claims to an implantable non-diarthrodial device, which have been rejected as obvious. We have jurisdiction under 35 U.S.C. Â§ 6(b ). We AFFIRM. STATEMENT OF THE CASE The Specification teaches "coating the surface of a biocompatible device with a tribonectin" and teaches that the tribonectin may be lubricin or a biologically active fragment thereof. (Spec. 2; see also id. at 3--4.) The 1 Appellant identifies the Real Party in Interest as LUBRIS LLC. (Appeal Br. 2.) Appeal2017-000692 Application 13/472,938 Specification states that, "[i]n addition to serving as a lubricating composition, a tribonectin ... can be coated onto the surface of a biocompatible device to prevent the growth of microbes on the device, or their attachment to the device." (Id. at 8: 15-18.) Claims 42, 43, 45--47, 49, and 50 are on appeal. Claim 42 is illustrative and reproduced below: 42. An implantable non-diarthrodial device resistant to attachment of cells on its surface, the device being selected from the group consisting of a stent, intraocular lens, dialysis graft, pacemaker lead, implantable defibrillator, suture, suture anchor, staple, clamp, screw, plate, shunt, bone pin, hemostatic barrier, anastomosis device, intraluminal device, angioplasty device, and vascular support, and comprising a surface, and a coating on at least a portion thereof comprising a recombinantly produced, glycosylated lubricin protein having the amino acid sequence of Figure 1 (Sequence ID NO: 1 ), or a biologically active, microbial colony-inhibiting fragment thereof comprising multiple glycosylated repeats of the sequence KEP APTT (Sequence ID NO: 3), in an amount sufficient to inhibit attachment of microbial cells onto said coating. (Appeal Br. 21 (Claims App.).) The Examiner rejects claims 42, 43, 45--47, 49, and 50 under pre-AIA 35 U.S.C. Â§ I03(a) as being unpatentable over Thurmond,2 Malaviya, 3 and Jay, 4 as evidenced by Sun. 5 (Final Act. 2-3.) 2 Thurmond II et al., US 2009/0318746 Al, published Dec. 24, 2009. 3 Malaviya et al., US 7,819,918 B2, issued Oct. 26, 2010. 4 Jay, US 6,960,562 B2, issued Nov. 1, 2005. 5 Yulong Sun et al., Expression and Mapping of Lubricin in Canine Flexor Tendon, 24 J. ORTHOPAEDIC RES. 1861 (2006). 2 Appeal2017-000692 Application 13/472,938 The Examiner rejects claims 42, 43, 45--47, 49, and 50 under pre-AIA 35 U.S.C. Â§ I03(a) as being unpatentable over Lenz, 6 Malaviya, and Jay, as evidenced by Sun. (Final Act. 5.) DISCUSSION Issue The Examiner has rejected claims 42, 43, 45--47, 49, and 50 as obvious over Malaviya, Jay, and either Thurmond or Lenz, as evidenced by Sun. The same issues are dispositive for both rejections; we therefore discuss them together. The Examiner finds that both Thurmond and Lenz teach devices, including implantable, non-diarthrodial devices such as stents and/or sutures, that are provided with a lubricant coating. (Final Act. 3, 5.) The Examiner finds that Thurmond and Lenz teach that suitable lubricating or coating material include, e.g., hyaluronic acid. (Id.) The Examiner finds that Thurmond and Lenz do not explicitly teach a lubricant coating comprising lubricin. (Id.) The Examiner finds, however, that Malaviya teaches "biological lubricants and this set includes hyaluronic acid as well as lubricin." (Id.) The Examiner also finds that Jay teaches lubricating polypeptides including lubricin, as well as the lubricin amino acid sequence recited in the claims, and further teaches that such polypeptides are preferably glycosylated and recombinant. (Id. at 3, 5---6.) Finally, the Examiner finds that Jay teaches using a coating solution of its 6 Lenz, US 2004/0167615 Al, published Aug. 26, 2004. 3 Appeal2017-000692 Application 13/472,938 lubricating polypeptides at a concentration of 250 Âµg/ml, which the Examiner finds would be antimicrobial. (Id. at 4, 6.) The Examiner concludes that it would be obvious for a skilled artisan to use a lubricant coating comprising Jay's recombinant lubricin having the claimed amino acid sequence, either alone or in combination with hyaluronic acid, on a stent and/or suture of Thurmond and/or Lenz. (Id. at 4, 6.) Citing Kerkhoven, the Examiner concludes that a lubricant coating comprising hyaluronic acid and lubricin would be obvious because Thurmond and Lenz suggest hyaluronic acid for this purpose, both hyaluronic acid and lubricin were known as biological lubricants according to Malaviya, and "'[i]t 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 to be used for the very same purpose."' (Id. ( citing In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980).) Alternatively, the Examiner concludes that a lubricant coating comprising lubricin would have been obvious because Thurmond and Lenz suggest hyaluronic acid for such a purpose and the substitution of lubricin having the claimed amino acid sequence, which is also known as a biological lubricant, constitutes a "simple substitution of one known element for another to yield a predictable result." (Final Act. 4, 6-7.) The Examiner further finds that it would have been obvious to include lubricin in recombinant form in a concentration of 250 Âµg/ml, which would be antimicrobial, because Jay exemplifies such a concentration and teaches that recombinant lubricin is preferred. (Id. at 4--5, 7.) Appellant contends that the references do not teach all the limitations of the claims because they do not teach using lubricin as an antimicrobial 4 Appeal2017-000692 Application 13/472,938 coating for a non-diarthrodial device. (Appeal Br. 9; see also id. at 10-11, 15-1 7.) Appellant also contends that a skilled artisan would have no motivation to combine the cited references to arrive at the claimed invention, because none of the prior art relates to antimicrobial coating and because it would not have been obvious to substitute Jay's lubricin for the hyaluronic acid of Thurmond and Lenz. (Appeal Br. 10, 11, 12-14, 17.) Appellant further contends that the Examiner's rejection is based on improper hindsight. (Appeal Br. 10; see also id. at 11, 15.) Finally, Appellant contends that the claimed subject matter is non-obvious because it exhibits unexpected results. (Appeal Br. 17-18.) The issues with respect to these rejections are (1) whether a skilled artisan would have had reason to combine the cited prior art to arrive at the claimed invention and, if so, (2) whether Appellant has provided evidence of unexpected results that, when considered together with evidence of obviousness, suffices to support a conclusion of non-obviousness. Findings of Fact 1. The Specification states that the tribonectin is preferably "present in an amount sufficient to reduce microbial growth on the surface of the device when used with a mammal." (Spec. 2; see also id. at 3--4.) The Specification teaches that "[t]he concentration of tribonectin in the coating may be, e.g., between 0.1 Âµg/ml to 1.0 mg/ml" and that the concentration is preferably 0.2 mg/ml. (Spec. 2; see also id. at 3--4, 16: 19- 20:8 (example where catheters were contacted with lubricin solution at concentration of 200 Âµg/ml).) 5 Appeal2017-000692 Application 13/472,938 2. The Specification teaches that the coating of the biocompatible device may include a lubricant and teaches that the lubricant is preferably hyaluronic acid. (Id. at 2-3; see also id. at 5, 15:26-16:13.) 3. Thurmond teaches that [ m ]edical devices can be coated with hydrophilic, lubricant, and optionally echogenic coatings. Such coated devices can thus be slippery when wet, yet non-slippery when dry, and optionally echogenic. The coated devices can be provided in a dry state, so as to be non-slippery for ease of handling and preparation. Once the device is wetted, before or during a medical procedure, it can become slippery so as to protect the patient and can reduce friction and damage to surrounding tissue. A device that has an echogenic coating can be readily distinguished from surrounding tissue or fluid when observed by ultrasound imaging. (Thurmond ,r 5; see also id. ,r 30 (stating that medical device can have coating that is abrasion resistant, lubricant, echogenic and biocompatible ); see also id. ,r,r 55-56.) 4. Thurmond teaches that the medical device may be, among other things, a stent. (Id. ,r 11; see also id. ,r 55 (stating that "coating can have beneficial characteristics for use on the surface of devices such as biomedical implants"), ,r 69 (suggesting that surgical instruments such as suture holders may be provided with a lubricant and optionally echogenic coating), ,r,r 73, 78-94 (stating that sutures can be coated), ,r 152 (ureteral pigtail stent), ,r,r 158-160 (stent).) 5. Thurmond teaches that examples of compositions that can be used to form a lubricant coating include "silicon based polymers, hyaluronic acid, poly(acrylates), polyether polyurethanes, and others known to those skilled in the art." (Id. ,r 43.) 6 Appeal2017-000692 Application 13/472,938 6. Thurmond teaches that "[ t ]he composition of the coating can be varied to control lubricity, swelling, flexibility, and resistance to removal by wet abrasion" and that "[t]hese characteristics of the coating can thus be adjusted for various substrates and applications." (Id. ,r 59.) 7. Lenz teaches "[a] stent compris[ing] a plurality of serpentine circumferential bands and a plurality of connector columns" arranged in a specified manner. (Lenz Abstract.) 8. Lenz teaches that stents may be provided with "various bio- compatible coatings to enhance various properties of the stent," such as lubricant coatings. (Id. ,r,r 30, 32.) 9. Lenz teaches that suitable polymer coating materials include, among others, hyaluronic acid. (Id. ,r 37.) 10. Malaviya teaches "[ a ]n implantable tissue repair device [having] a cover and tissue regeneration material." (Mala vi ya Abstract; see also id. at 1: 13-15 ( stating that "invention relates generally to surgical devices or implants for repairing and regenerating damaged or diseased fibrocartilage"), 5:64---6:2 (illustrating cartilage repair device, particularly a meniscal repair device, but stating that "it should be understood that the principles of the present invention may be applied to other repair devices, such as those designed to be implanted to repair defects in fibrocartilage other than the meniscus").) 11. Malaviya teaches that the cover of its invention comprises inner and outer groups of laminae ofbiocompatible material and that these laminae and the mass of tissue regeneration material may comprise, among other things, a biological lubricant. (Malaviya 6:38--42, 7:35-39, 11 :51-54; 7 Appeal2017-000692 Application 13/472,938 see also id. at 13:33-38 (stating that "[u]se of the implant of the present invention may be accompanied by use of a biological lubricant").) 12. Malaviya teaches that biological lubricants include hyaluronic acid, lubricin, and tribonectins, among others. (Id. at 10: 14--38.) 13. Jay discloses tribonectin, a lubricating polypeptide containing "at least one repeat of an amino acid sequence which is at least 50% identical to KEP APTT" and contains at least one 0-linked lubricating moiety, preferably B(l-3)Gal-GalNAc moiety. (Id. at Abstract, 1 :42--47 .) 14. Jay teaches that the tribonectin is preferably a recombinant or chemically synthesized lubricating polypeptide and further teaches that [ fJor example, a tribonectin includes a substantially pure polypeptide the amino acid sequence of which includes at least one repeats but less than 7 6 repeats. . . . The amino acid sequence of each subunit is at least 50% identical to [KEP APTT]. . . . Preferably, the amino acid sequence of the subunit is identical to [KEP APTT]. (Id. at 2:65-3:9; see also id. at 16:48-56.) 15. Jay teaches that [a] tribonectin includes an 0-linked oligosaccharide, e.g., an N- acetylgalactosamine and galactose in the form [sic] beta (1-3)Gal- GalNAC. For example, KEPAPTT (SEQ IDN0:3) and XXTTTX (SEQ ID N0:4) repeat domains are glycosylated by beta (1-3)Gal- GalNAC (which may at times be capped with NeuAc in the form of B (1-3) Gal-GalNACNeuAc. The term "glycosylated" with respect to a polypeptide means that a carbohydrate moiety is present at one or more sites of the polypeptide molecule. For example, at least 10%, preferably at least 20%, more preferably at least 30%, and most preferably at least 40% of the tribonectin is glycosylated. Up to 50% or more of the tribonectin can be glycosylated. (Id. at 4: 12-24.) 8 Appeal2017-000692 Application 13/472,938 16. Jay teaches the amino acid sequence of human megakaryocyte stimulating factor (MSF). (Id. at Table 1.) Appellant has not disputed that this amino acid sequence is identical to the claimed SEQ ID NO: 1. 17. Jay teaches that lubricating polypeptides may be a full-length MSF polypeptide or is an MSF polypeptide that is less than 1404 residues in length, e.g., it has the amino acid sequence of naturally-occurring MSF ... but lacks at least 5, 10, 15, 20, or 24 amino acids of naturally-occuring MSF." (Id. at 16:56-61; see also id. 4:39-43 (stating that tribonectin may contain a polypeptide having an amino acid sequence that is at least 50% identical to the sequence of residues 200-1140, inclusive, of the MSF amino acid sequence disclosed in Jay's Table I).) 18. Jay teaches that a tribonectin may be used as a boundary lubricant between mammalian tissue and a medical device such as a prosthetic implant and that its tribonectin composition may be in a form "suitable for the inhibition of tissue adhesion." (Id. at 5:21-28.) 19. Jay teaches that its invention "encompasses a biocompatible composition containing a tribonectin in a form suitable for the inhibition of tissue adhesion formation." (Id. at 5:25-29.) Jay further teaches that [a] method inhibiting adhesion formation between a first surface and a second surface in a mammal is carried out by placing a tribonectin between the first and second surfaces in an amount sufficient to prevent adhesion of the surfaces in the mammal. For example, one or both of the surfaces is a mammalian tissue, and a tribonectin placed between them prevents formation of adhesions during the healing process. Alternatively the first or the second surface ( or both) is an artificial device such as an orthopedic implant. Tissues to be treated include those injured by surgical incision or trauma. 9 Appeal2017-000692 Application 13/472,938 (Id. at 5:47-56.) 20. Jay teaches that "[t]ribonectins are also used to coat artificial limbs and joints prior to implantation into a mammal." (Id. at 16:43--44.) 21. Jay teaches using tribonectin at a concentration in the range of 20-500 Âµg/ml in a volume of approximately 0.1-2 ml per injection, including an example where 1 ml of tribonectin at a concentration of 250 Âµg/ml was injected into a knee joint. (Id. at 16:7-13; see also id. at Tables 5-7 (lubricants including tribonectin tested at concentrations of 250 Âµg/ml).) 22. Sun teaches that "[l]ubricin has many distinct biological functions, including lubrication, antiadhesion, and cytoprotection in cartilage, tendons, and other tissues." (Sun Abstract.) 23. Sun teaches that lubricin's "best-known physical characteristic is its excellent boundary lubricating ability." (Id. at 1861, left column.) 24. Sun teaches that lubricin is also known as megakaryocyte stimulating factor (MSF). (Id.) 25. Sun teaches that human lubricin contains repeating KEPAPTT/P sequences. (Id. at 1864, left column.) Analysis Appellant does not separately argue the claims with respect to any of the rejections. (Appeal Br. 5 (stating that all claims rise and fall together).) Accordingly, we limit our analysis to claim 42. Except as otherwise noted, we adopt the Examiner's findings, analysis, and conclusions with respect to claim 42, including with regard to the scope and content of, and motivation to modify or combine, the prior art, as set forth in the Final Action and 10 Appeal2017-000692 Application 13/472,938 Answer. (Final Act. 2-10; Ans. 2-7; FF1-FF25.) We address Appellant's arguments below. Appellant first contends that "[ n Jone of the above references teach that lubricin may be used as a coating for non-diarthrodial device nor that such a coating would or could impart antimicrobial properties, as required by the claims," and that "the Examiner has ignored the antimicrobial limitation, the very purpose of the invention." (Appeal Br. 9; see also id. at 5, 10-11, 15-17, Reply Br. 2.) We are not persuaded. As the Examiner explained, Thurmond and Lenz teach that a non-diarthrodial, implantable device (e.g., a stent) may comprise a lubricant coating, and Malaviya and Jay teach that lubricin is a biological lubricant. (Final Act. 3-7.) Thus, the combination of references suggests that lubricin may be used as a coating for a non-diarthrodial device. To the extent Appellant's argument is that no single reference teaches lubricin may be used as a coating for non-diarthrodial device, we note that "[ n ]on-obviousness cannot be established by attacking references individually where the rejection is based upon the teachings of a combination of references" and that references "must be read, not in isolation, but for what [they] fairly teach[] in combination with the prior art as a whole." In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986). Appellants also argue that the references do not disclose that a lubricin coating would or could impart antimicrobial properties. However, "[ t ]he general principle that a newly-discovered property of the prior art cannot support a patent on that same art is not avoided if the patentee explicitly claims that property." Abbott Labs. v. Baxter Pharm. Products, Inc., 471 F.3d 1363, 1368 (Fed. Cir. 2006); see also Catalina Mktg. Int'!, 11 Appeal2017-000692 Application 13/472,938 Inc. v. Coo/savings.com, Inc., 289 F.3d 801, 809 (Fed. Cir. 2002) ("[T]he patentability of apparatus or composition claims depends on the claimed structure, not on the use or purpose of that structure."). Moreover, "'where the Patent Office has reason to believe that a functional limitation asserted to be critical for establishing novelty in the claimed subject matter may, in fact, be an inherent characteristic of the prior art, it possesses the authority to require the applicant to prove that the subject matter shown to be in the prior art does not possess the characteristic relied on."' In re Best, 562 F.2d 1252, 1254--55, (CCPA 1977) (quoting In re Swinehart, 439 F.2d 210, 212-13 (CCPA 1971)). In this case, the limitations in claim 42 relating to "resistant to attachment of cells on ... surface," "microbial colony-inhibiting," and "inhibit attachment of microbial cells onto said coating" are functional limitations. The Examiner also has shown that the prior art renders obvious a device that has identical or substantially identical structure to the claimed device (i.e., an implantable, non-diarthrodial device comprising a coating comprising the claimed lubricin protein in the claimed amount). We thus find that the burden has shifted to Appellant to show that the device rendered obvious by the prior art does not necessarily or inherently possess the alleged antimicrobial characteristics of the claimed product. This Appellant has not done. Citing In re Rijckaert, 9 F.3d 1531 (Fed. Cir. 1993), Appellant contends that "obviousness cannot be predicated on what is not known at the time an invention is made, even if the inherency of a certain feature is later established." (Reply Br. 5.) In this case, however, the obviousness rejection is not predicated on what is not known at the time an invention is made. 12 Appeal2017-000692 Application 13/472,938 Rather, it is predicated on the known lubricant properties of lubricin. Appellant also contends that "[ t ]he fact that a certain result or characteristic may occur or be present in the prior art is not sufficient to establish the inherency of that result or characteristic" and that "the closest known structure that is necessarily present in the prior art is a hyaluronic acid coated device which would not have inherently possessed the newly recognized antimicrobial activity of the claimed invention." (Reply Br. 5.) While Appellant is correct that a property must be necessarily present in order to be considered inherent to a structure, Appellant misapprehend the law of inherency when he suggests that inherency requires a structure to be "necessarily present" in the prior art. Rather, the relevant question is whether a result or characteristic ( e.g., antimicrobial activity) is necessarily present in a structure rendered obvious by the prior art. Appellant similarly contends that a skilled artisan would have no motivation to combine the cited references to arrive at the claimed invention, because none of the prior art relates to antimicrobial coating. (Appeal Br. IO; see also id. at 11, Reply Br. 2.) Appellant contends that it would not have been obvious to substitute Jay's lubricin for the hyaluronic acid of Thurmond and Len. First, Appellant argues that "the purpose of the coatings in the references (lubrication) and the purpose of the lubricin coating in applicant[']s invention (antimicrobial activity by resisting cell attachment) are very different. (Appeal Br. 12-13.) Appellant also contends that "[t]here is no structural or mechanistic similarity between lubricin and the prior art hyaluronic acid coating that would motivate one having skill in the 13 Appeal2017-000692 Application 13/472,938 art to substitute one for the other."7 (Id. at 13-14; see also id. at 17, Reply Br. 3.) Appellant further contends that "the only context in which hyaluronic acid is believed to provide lubrication, and the only biological context where hyaluronic acid and lubricin coexist, is within the [diarthrodial] joint," and the Examiner has not shown why a skilled artisan "would have expected both hyaluronic acid and lubricin to have lubricating ability in the context of coating for a non-diarthrodial device, ... let alone been motivated to substitute one for the other." (Reply Br. 3--4; Appeal Br. 14.) We are not persuaded. "In determining whether the subject matter of a patent claim is obvious, neither the particular motivation nor the avowed purpose of the patentee controls. . . . [ A ]ny need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398, 419-20 (2007). Thus, the fact that a skilled artisan may be motivated to apply lubricin as a coating on an implantable device to provide lubrication rather than antimicrobial activity does not render claim 42 non-obvious, so long as the resulting device meets all the limitations of the claim either expressly or inherently. As to Appellant's argument that "[t]here is no structural or mechanistic similarity between lubricin and the prior art hyaluronic acid coating that would motivate one having skill in the art to substitute one for the other," we agree with the Examiner that the prior art recognizes hyaluronic acid and lubricin as functional equivalents for purposes of acting 7 Appellant contends that "[t]he only context in which HA is believed to provide lubrication is within the diarthrodialjoint." (Appeal Br. 14.) 14 Appeal2017-000692 Application 13/472,938 as biological lubricants. Substituting one for the other is thus prima facie obvious even without express suggestion for the substitution. In re Fout, 675 F.2d 297,301 (CCPA 1982). Contrary to Appellant's contention, functional equivalency does not require structural similarity. See, e.g., id. at 301 ( explaining that it is prima facie obvious to substitute evaporative distillation for aqueous extraction as a method for separating caffeine from oil when both are known in the prior art as such). To the extent Appellant's argument is that a skilled artisan would have considered lubricin to be a superior biological lubricant than hyaluronic acid at the time of the invention (Appeal Br. 13 (stating that lubricin is one of the most efficient lubricant known to man while hyaluronic acid lubricates no better than saline)), such knowledge would have merely provided a reason (i.e., superior lubricating ability) for a skilled artisan to substitute lubricin for hyaluronic acid. Appellant argues that the Examiner has not shown why a skilled artisan would have expected hyaluronic acid and lubricin to have lubricating ability in coating a non-diarthrodial device, or be motivated to substitute one for the other in such a context, given that Malaviya relates to devices to be used in the diarthrodialjoint. (Appeal Br. 14; Reply Br. 3--4.) We are not persuaded. While Malaviya generally relates to devices for repairing fibrocartilage, it describes hyaluronic acid and lubricin simply as biological lubricants without limiting their applicability to within the diarthrodial joint. (Mala vi ya 10: 14--3 8.) Appellant's contention that hyaluronic acid is believed to provide lubrication only within the diarthrodial joint is also contradicted by Thurmond, which describes hyaluronic acid as a composition that can be used to form a lubricant coating for medical devices 15 Appeal2017-000692 Application 13/472,938 generally. 8 (FF5.) Finally, "expectation of success need only be reasonable, not absolute." Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364 (Fed. Cir. 2007). We find that, absent evidence to the contrary, a skilled artisan would have a reasonable expectation that a compound useful as a biological lubricant in the diarthrodial joint would be similarly useful in a non- diarthrodial context. Appellant further contends that the Examination's citation of the prior art "necessarily is based solely on applicant's specification" because "none of the applied references mentions antimicrobial activity or teaches anything about it in any way" while "[a] person of skill in the art seeking to impart antimicrobial activity to an implantable device of course necessarily would seek prior art literature disclosing something about antimicrobial activity." (Appeal Br. 10; see also id. at 11, 15, Reply Br. 2.) We are not persuaded. "Any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning, but so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made and does not include knowledge gleaned only from applicant's disclosure, such a reconstruction is proper." In re McLaughlin, 443 F.2d 1392, 1395, 170 USPQ 209, 212 8 As part of this argument, Appellant also contends that Lenz "provides no guidance whatsoever as to why [hyaluronic acid] should be included in the coating it discloses." (Appeal Br. 14.) While we agree that Lenz does not explicitly discloses including hyaluronic acid in a coating for its lubricant property, we find that the combination of Lenz and Mala vi ya would have suggested as much to a skilled artisan: Lenz teaches that stents may be provided with coatings including lubricant coatings and, separately, that suitable polymer coating materials include hyaluronic acid (FF8, FF9), while Malaviya teaches that hyaluronic acid is a biological lubricant (FF12). 16 Appeal2017-000692 Application 13/472,938 ( CCP A 1971). In this case, as discussed above, it is not necessary to show that a skilled artisan would have combined the references in order to achieve an antimicrobial coating for an implantable device: "[ A ]ny need or problem known in the field of endeavor at the time of invention," such as the desirability of a lubricating coating for implantable medical devices, "can provide a reason for combining the elements in the manner claimed." KSR, 550 U.S. at 419--20. To the extent Appellant's argument is that the prior art references are not analogous art, we also disagree. The cited references are in the field of Appellant's endeavor - i.e., the field of implantable medical devices. In re Clay, 966 F.2d 656, 658-59, 23 USPQ2d 1058, 1060 (Fed. Cir. 1992) ("Two criteria have evolved for determining whether prior art is analogous: (1) whether the art is from the same field of endeavor, regardless of the problem addressed, and (2) if the reference is not within the field of the inventor's endeavor, whether the reference still is reasonably pertinent to the particular problem with which the inventor is involved."). Finally, Appellant contends that, in any event, the claimed subject matter is non-obvious because it "possesses a new and unexpected property (antimicrobial activity) that was neither inherently present nor recognized in the prior art." (Appeal Br. 17-18; see also Reply Br. 2, 4.) We are not persuaded for the reasons already discussed above. To the extent that Appellant's argument is that the claimed subject matter exhibits unexpected results, moreover, we further note "it is well settled that unexpected results must be established by factual evidence. 'Mere argument or conclusory statements in the specification does not suffice."' In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997) (quoting In re De Blauwe, 736 F.2d 699, 705 17 Appeal2017-000692 Application 13/472,938 (Fed. Cir. 1984)). Here, Appellant has provided only attorney argument and no persuasive evidence that the alleged antimicrobial activity of lubricin is unexpected rather than, at best, unknown at the time of the invention. Accordingly, we affirm the Examiner's rejection of claim 42. Claims 43, 45--47, 49, and 50, which are not separately argued, fall with claim 42. See App. Br. 5; 37 C.F.R. Â§ 4I.37(c)(l)(iv). SUMMARY For the reasons above, we affirm the Examiner's decision rejecting claims 42, 43, 45--47, 49, and 50. 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. Â§ 1.136(a). AFFIRMED 18