Ex Parte Barry et alDownload PDFPatent Trial and Appeal BoardMay 26, 201711833717 (P.T.A.B. May. 26, 2017) 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. 11/833,717 08/03/2007 James J. BARRY 2001.1358104 8372 11050 7590 05/31/2017 SEAGER, TUFTE & WICKHEM, LLP 100 South 5th Street Suite 600 Minneapolis, MN 55402 EXAMINER RIDER, LANCE W ART UNIT PAPER NUMBER 1618 NOTIFICATION DATE DELIVERY MODE 05/31/2017 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): BSC.USPTO@stwiplaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JAMES J. BARRY and MARIA PALASIS Appeal 2016-003444 Application H/833,7171 Technology Center 1600 Before RICHARD M. LEBOVITZ, FRANCISCO C. PRATS, and DEVON ZASTROW NEWMAN, Administrative Patent Judges. PRATS, Administrative Patent Judge. DECISION ON APPEAL This appeal under 35 U.S.C. § 134(a) involves claims to a dilation catheter that has an expandable balloon coated with a coating that contains the drug paclitaxel. The Examiner rejected the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We affirm the Examiner’s rejections except as to one claim. 1 Appellants identify the assignee, Boston Scientific Scimed, Inc., a subsidiary of Boston Scientific Corporation, as the real party in interest. App. Br. 3. Appeal 2016-003444 Application 11/833,717 STATEMENT OF THE CASE The Examiner entered and maintained the following rejections: (1) Claims 30-38, 40-43, and 73—76, under 35 U.S.C. § 103(a), as being obvious over Lambert2 and Sollott3 (Final Act. 7 (entered June 5, 2014); Ans. 2); and (2) Claims 30-32, 34—37, 39-43, and 73—76, under 35 U.S.C. § 103(a) as being obvious over Sollott or Axel4 combined with Macke5 (Final Act. 9; Ans. 5).6 Claim 30 is representative and reads as follows (App. Br. 23): 30. A dilation catheter comprising a shaft and an expandable balloon mounted on the shaft, said balloon having a drug coating layer thereon comprising paclitaxel. 2 WO 94/21308 A1 (published Sept. 29, 1994). 3 Steven J. Sollott et al., Taxol Inhibits Neointimal Smooth Muscle Cell Accumulation after Angioplasty in the Rat, 95 Journal of Clinical Investigation, Inc. 1869-1876 (1995). 4 Dorothea I. Axel et al., Paclitaxel Inhibits Arterial Smooth Muscle Cell Proliferation and Migration in Vitro and in Vivo Using Local Drug Delivery, 96 Circulation 636—645 (1997). The Examiner cited, as we do, to the version of the article on the web at: http://circ.ahajoumals.Org/content/96/2/636.long. 5 P. Macke Consigny et al., Local Delivery of an Antiproliferative Drug with Use of Hydrogel-coated Angioplasty Balloons, 5 Journal of Vascular and Interventional Radiology 553-560 (1994). 6 In the Answer, the Examiner includes claims 77—84 in both obviousness rejections at issue herein. Ans. 2, 5. Claims 77—84 have been canceled, however. See After-Final Amendment filed October 20, 2014; see also Advisory Action entered November 5, 2014 (entering After-Final Amendment). 2 Appeal 2016-003444 Application 11/833,717 OBVIOUSNESS— LAMBERT AND SOLLOTT The Examiner’s Prima Facie Case In rejecting claims 30-38, 40-43, and 73—76 over Lambert and Sollott, the Examiner cited Lambert as disclosing devices, including balloons, for localized drug delivery, the devices being coated with anti proliferative drugs. Non-Final Act. 7 (entered November 15, 2013). The Examiner found that Lambert differs from the rejected claims in that “Lambert does not teach further including the specific hydrophilic anti proliferative drug taxol, [also known as paclitaxel,] to coat the balloon catheters.” Id.1 To address that deficiency, the Examiner cited Sollott as teaching “the use of the drug taxol to inhibit smooth muscle accumulation after angioplasty,” and in particular teaching that “that taxol functions as an ant[i] proliferative agent in . . . balloon catheterized rats and inhibits VSCM [vascular smooth muscle cell] migration and proliferation.” Id. Based on the references’ combined teachings, the Examiner concluded that an ordinary artisan would have considered it obvious to “use an effective amount of a known hydrophilic anti-proliferative drug used for treating proliferation (restenosis) of tissues caused by balloon catheterization as taught by Sollot[t] in the methods of making hydrophilic anti-proliferative coated balloon catheters of Lambert.” Id. at 8. The Examiner reasoned that applying paclitaxel to a balloon catheter would have been “merely the use of a known hydrophilic anti-proliferative drug useful for treating local 7 It is undisputed that the terms “paclitaxel” and “taxol” refer to the same compound. 3 Appeal 2016-003444 Application 11/833,717 proliferation in a method of making balloon catheters used for localized delivery of drugs that requires just such hydrophilic antiproliferative compounds.” Id- Analysis As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992): [T]he examiner bears the initial burden ... of presenting a prima facie case of unpatentability. . . . After evidence or argument is submitted by the applicant in response, patentability is determined on the totality of the record, by a preponderance of evidence with due consideration to persuasiveness of argument. We select claim 30 as representative of the rejected claims. 37 C.F.R. § 41,37(c)(l)(iv). Appellants do not persuade us that a preponderance of the evidence fails to support the Examiner’s conclusion that the balloon catheter recited in claim 30 would have been obvious to an ordinary artisan in view of Lambert and Sollott. Lambert discloses that “balloon angioplasty induced vascular injury resulting in smooth muscle proliferation contributes to a restenosis rate in excess of forty percent, leading to repeat angioplasty and bypass surgery. Despite numerous basic and clinical research efforts employing antiproliferative, antiplatelet, and antiinflammatory drugs given systemically, no effective therapy has been found in humans.” Lambert 1 (citations omitted). Lambert discloses that “[kjinetic studies of drugs delivered locally into the vessel wall to date have shown that elution of drug from the vessel wall is rapid, thus diminishing the effectiveness of the drug.” Id. To address those issues, Lambert discloses that polyurethane coatings “on prosthetic articles can be swelled (without significantly dissolving the 4 Appeal 2016-003444 Application 11/833,717 polymer) so that substantial quantities of biologically active compounds can be incorporated within the interstices of the polymer. Swelling of the polyurethane allows drug uptake throughout the matrix which provides higher drug content than surface binding techniques.” Lambert 3. Lambert discloses: Upon long term exposure of a prosthetic article to physiological conditions, the biologically active compound is slowly released by the treated polymer. The biologically active compound is, therefore, released and concentrated only at the site where it is desired, i.e., where the prosthetic article is positioned. When the target tissue is in contact with the polyurethane, the biologically active compound distributes in the tissue by passive diffusion. Increasing the lipid solubility of the compound slows release from the polyurethane, and increases the tissue retention. More lipid soluble compounds are, therefore, preferred agents for use in the practice of the present invention. Id. Lambert discloses that biologically active compounds suitable in its coatings include “antiproliferative compounds (e.g., colchicine, sphingosine[)] . . . .” Id. at 5. Lambert discloses that a variety of different prosthetic articles are useful in its invention, including “metallic stents, such as vascular, biliary or ureteral stents, heart valves, metallic prostheses, prosthetic joints, pacemakers, catheters, balloon coatings, ocular implants, contact lenses, and the like.” Id. at 6 (emphasis added). Although Lambert does not describe using paclitaxel as one of the antiproliferative compounds it applies to devices, Sollott discloses that application of paclitaxel to the artery wall, in an animal model of post- 5 Appeal 2016-003444 Application 11/833,717 angioplasty restenosis prevents vascular smooth muscle cell (VSMC) proliferation: In vivo, taxol prevented medial VSMC proliferation and the neointimal VSMC accumulation in the rat carotid artery after balloon dilatation and endothelial denudation injury. This effect occurred at plasma levels approximately two orders of magnitude lower than that used clinically to treat human malignancy (peak levels achieved in this model were ~ 50-60 nM). Taxol may therefore be of therapeutic value in preventing human restenosis with minimal toxicity. Sollott 1869. Given Lambert’s teaching that it was desirable to coat prosthetic devices, such as balloon catheters, with antiproliferative drugs to treat and/or prevent post-angioplasty restenosis by delivering the drugs directly to the walls of blood vessels, and further given Sollott’s disclosure that paclitaxel prevented restenosis-associated VSMC proliferation in an animal model, thus, suggesting its use in humans, we discern no error in the Examiner’s finding that an ordinary artisan had good reason to use paclitaxel in a coating applied to a prosthetic device, such as a balloon catheter, meeting the corresponding limitation of claim 30. We, therefore, also agree with the Examiner that the balloon catheter recited in Appellants’ claim 30 would have been prima facie obvious. Appellants’ arguments do not persuade us to the contrary. Appellants contend that both Lambert and Sollott focus on sustained release of the drug at the site of angioplasty. App. Br. 9-11 (citing Lambert 3, Sollott 1875). Appellants contend that, while Lambert does briefly mention coating balloons alongside a number of other devices, balloons “will not provide sustained release of bioactive agents as clearly wanted by 6 Appeal 2016-003444 Application 11/833,717 Lambert et al. They are not prosthetic devices and they are not implanted in a body, as are stents, the focus of all of the Lambert et al.’s examples, as well as the rest of the disclosure.” App. Br. 12; see also Reply Br. 3^4. It is well settled, however, that “in a section 103 inquiry, the fact that a specific [embodiment] is taught to be preferred is not controlling, since all disclosures of the prior art, including unpreferred embodiments, must be considered.” Merck v. Biocraft, 874 F.2d 804, 807 (Fed. Cir. 1989) (internal quotations and citation omitted; emphasis added). Thus, although Lambert and Sollott may have focused on sustained release and implanted devices other than balloons, those facts do not negate Lambert’s express teachings (Lambert 6, 21 (claim 8)) that balloons are among the devices that may be coated with antiproliferative drugs. Indeed, it would be improper to ignore Lambert’s express disclosure of coating balloons, based solely on the fact that the cited references’ examples might have focused elsewhere. See In re Mills, 470 F.2d 649, 651 (CCPA 1972) (“All the disclosures in a reference must be evaluated, including nonpreferred embodiments, and a reference is not limited to the disclosure of specific working examples.”) (citations omitted; emphasis added). As to Appellants’ teaching away arguments (App. Br. 12—13; Reply Br. 3—4), a “reference does not teach away ... if it merely expresses a general preference for an alternative invention but does not criticize, discredit, or otherwise discourage investigation into the invention claimed.” DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1327 (Fed. Cir. 2009) (internal quotations and citation omitted). Appellants identify no specific teaching in either cited reference that criticizes or discredits coating a balloon catheter with an antiproliferative 7 Appeal 2016-003444 Application 11/833,717 drug such as paclitaxel. Directly to the contrary, as noted above, Lambert expressly teaches that its drug-containing coatings may be applied to balloons and catheters. Lambert 6, 21. In sum, for the reasons discussed, Appellants do not persuade us that the Examiner failed to make a prima facie case that the balloon catheter of claim 30 would have been obvious to an ordinary artisan in view of Lambert and Sollott. Because Appellants advance no objective evidence of nonobviousness, we affirm the Examiner’s rejection of claim 30 over those references. Claims 30—37, 40-43, and 73—76 fall with claim 30 because they were not argued separately. 37 C.F.R. § 41.37(c)(l)(iv). Claim 38 recites “[a] dilation catheter as in claim 30 wherein the balloon further comprises a polymeric modulating layer over the drug coating layer that modulates the release rate in the body of the paclitaxel from the drug coating.” App. Br. 24. Appellants contend that the Examiner “has not pointed to any disclosure in either Lambert et al. or Sollot et al.” corresponding to the claimed two-layer coating. App. Br. 13. The Examiner responds: Lambert teaches embodiments where the system is a substrate that is coated with polyurethane where the biologically active compound is found inside and throughout the entire thickness of an applied polyurethane polymer coating that controls the release rate of the drug. (See page 4 lines 1- 23.) This appears to also read on a polymer layer over the drug that controls the release rate of the drug. Lambert also teaches incubating the coated devices in 5% albumin polymer, which modulates release of the drug. (See examples 2.) Ans. 5. 8 Appeal 2016-003444 Application 11/833,717 We find that Appellants have the better position. Claim 38 requires the device to be coated with two distinct layers with a specific arrangement: “[1] a polymeric modulating layer over [2] the drug coating layer.” App. Br. 24 (emphasis added). Thus, although we note Lambert’s disclosure that its coating methods allow the drug to permeate “throughout the entire thickness of the polyurethane coating” layer (Lambert 4), claim 3 8 requires an additional coating over the drug-containing layer. The Examiner does not persuade us, therefore, that Lambert’s description of its coating on page 4 of the reference meets the requirements of claim 38. In addition, while we note Lambert’s disclosure that the drug release rate from a coated stent was tested in a 5% bovine serum albumin solution (Lambert 11—12), we are not persuaded that Lambert suggests providing its devices with an outer coating composed of albumin. We, therefore, reverse the Examiner’s rejection of claim 38 over Lambert and Sollott. OBVIOUSNESS— SOLLOT, AXEL, AND MACKE The Examiner’s Prima Facie Case In rejecting claims 30-32, 34—37, 39-43, and 73—76 for obviousness over either Sollott or Axel in combination with Macke, the Examiner cited Sollott and Axel as teaching the use of paclitaxel to inhibit post-angioplasty smooth muscle cell proliferation. Non-Final Act. 8—9. The Examiner found that Sollott and Axel differed from the rejected claims in that “[njeither Sollot[t] nor Axel teach that the hydrophobic ant[i] proliferative drug paclitaxel can be coated onto the surface of the angioplasty balloon and delivered in this manner.” Id. at 9. 9 Appeal 2016-003444 Application 11/833,717 To address that deficiency, the Examiner cited Macke as disclosing “balloon catheters comprising a hydrophobic ant[i] proliferative drug RG- 50872 on the surface of the balloon formed by pipetting the solubilized drug onto the surface of the balloon.” Non-Final Act 9. Based on the references’ teachings, the Examiner reasoned: It would have been prima facie obvious to one of ordinary skill in the art to provide an antiproliferative (such as paclitaxel) as a dried coating on the surface of an angioplasty balloon as taught by Macke. The skilled artisan would have been motivated to make this combination in order to deliver the antiproliferative agent directly to the site being affected at the time of damage when angioplasty was performed in order to inhibit unwanted proliferation immediately and without the necessity for any further intervention. The skilled artisan would have had a predictable expectation of success in this combination. Sollot[t] and [Axel] teach using inflated balloons for delivery of the VSCM antiproliferative taxol to prevent VSCM proliferation. Macke teaches that one can deliver such a hydrophobic VSCM antiproliferative as a coating placed directly on an angioplasty balloon catheter. This is merely the use of a known method of delivering a hydrophobic ant[i] proliferative drug on an angioplasty catheter in a method of angioplasty that requires the use of a hydrophobic ant[i] proliferative drug. Id. at 10. Analysis We again select claim 30 as representative of the claims subject to this ground of rejection. 37 C.F.R. § 41.37(c)(l)(iv). Appellants do not persuade us that a preponderance of the evidence fails to support the Examiner’s conclusion that the balloon catheter recited in claim 30 would have been obvious to an ordinary artisan in view of either Sollott or Axel, in combination with Macke. 10 Appeal 2016-003444 Application 11/833,717 Macke discloses that a majority of post-angioplasty restenosis is caused by proliferation of smooth muscle cells in the artery wall. Macke 553. Macke, therefore, undertook a study to “determine the feasibility of using hydrogel-coated angioplasty balloons to deliver drugs that inhibit vascular smooth muscle cell (VSMC) proliferation.” Id. Macke used the antiproliferative drug RG-50872 in its study. Id. Macke applied to balloon catheters either a hydrogel coating or a silicone coating, and permeated the coatings with RG-50872. Id. at 555. Macke tested the release rate of the drug by immersing the coated balloons in culture medium. Id. Macke found that “the hydrogel-coating on angioplasty balloons can take up and release sufficient RG-50872 to significantly inhibit smooth muscle cell proliferation. Further in vivo experiments are needed to determine if hydrogel-coated balloons can deliver sufficient RG-50872 to the arterial wall to affect VSMC proliferation.” Id. at 553. Macke, however, was “unable to determine the amount of drug released by the silicone-coated balloons because the amount was insufficient to inhibit VSMC proliferation in our bioassay.” Id. at 559. Although Macke does not describe coating its balloon catheters with paclitaxel as required by claim 30, Sollott, as noted above, discloses that application of paclitaxel to the artery wall, in an animal model of post angioplasty restenosis prevents vascular smooth muscle cell (VSMC) proliferation: In vivo, taxol prevented medial VSMC proliferation and the neointimal VSMC accumulation in the rat carotid artery after balloon dilatation and endothelial denudation injury. . . . Taxol 11 Appeal 2016-003444 Application 11/833,717 may therefore be of therapeutic value in preventing human restenosis with minimal toxicity. Sollott 1869. Axel similarly discloses that local application of paclitaxel in an animal model of restenosis prevents VSMC proliferation. Axel 1 (“[I]n 20 male New Zealand White rabbits, intimal plaques were produced by electrical stimulation. In 10 animals, paclitaxel was locally applied by use of microporous balloons. Histologically, the intima wall area, wall thickness, and degree of stenosis were reduced significantly in paclitaxel- treated animals compared with controls.”). Axel discloses that the “long-lasting effect after just several minutes’ exposure time makes this lipophilic substance a promising candidate for local antiproliferative therapy of restenosis.” Id. at 2; see also id. at 6 (drug applied at plaque site for about 30 seconds); id. at 12 (significant effect seen 28 days after paclitaxel application). Given the disclosures by Sollott and Axel that paclitaxel has significant antiproliferative activity against VSMCs in animal models of restenosis, we agree with the Examiner that an ordinary artisan applying a VSMC antiproliferative drug to a balloon catheter, as taught by Macke, would have been prompted to apply paclitaxel to a balloon catheter, as required by claim 30. We, therefore, also agree with the Examiner that the balloon catheter recited in claim 30 would have been prima facie obvious to an ordinary artisan in view of Macke, combined with either Sollott or Axel, and are unpersuaded that the Examiner’s prima facie case lacks sufficient rational underpinnings. 12 Appeal 2016-003444 Application 11/833,717 We acknowledge the differences, identified by Appellants, in chemical structure between the RG-50872, used in Macke, and paclitaxel. See App. Br. 16—17; Reply Br. 7—8. We acknowledge also that neither Sollott nor Axel describes coating a balloon with paclitaxel. App. Br. 17, 19. That the disclosures in the cited references differ from the subject matter recited in claim 30 does not demonstrate that the claimed subject matter would have been unobvious. Dann v. Johnston, 425 U.S. 219, 230 (1976) (“[T]he mere existence of differences between the prior art and an invention does not establish the invention’s nonobviousness.”). Appellants contend that the unpredictability in the chemical arts and the many factors involved in successful drug delivery demonstrate that the teachings in the cited references are insufficient to suggest using paclitaxel in a balloon catheter coating. App. Br. 18—19; Reply Br. 7—8. Appellants do not, however, identify any specific evidence of record suggesting that formulation of a balloon coating containing paclitaxel would have been beyond the skill of an ordinary artisan viewing the cited references, particularly given Macke’s express disclosure of how to make a hydrogel coating that contains an antiproliferative drug. As Appellants contend (Reply Br. 7—8), and as noted above, Macke discloses that further experiments were needed to determine whether the balloons could deliver sufficient drug in vivo. Macke, nonetheless, expressly taught that sufficient drug was released in its in vitro experiments (Macke 553), and both Sollott and Axel, as discussed above, taught that topical delivery of paclitaxel was sufficient to inhibit VSMC proliferation in animal models. Appellants, therefore, do not persuade us that the combined teachings of the cited references fail to provide a reason for, and a 13 Appeal 2016-003444 Application 11/833,717 reasonable expectation of success in, applying a paclitaxel-containing coating to a balloon catheter, as recited in claim 30. It is well settled, moreover, that “[ojbviousness does not require absolute predictability of success. . . . For obviousness under § 103, all that is required is a reasonable expectation of success.” In re O’Farrell, 853 F.2d 894, 903—04 (Fed. Cir. 1988); accord, In re Kubin, 561 F.3d 1351, 1359-61 (Fed. Cir. 2009). Thus, that unpredictability exists in the field of drug delivery and the chemical arts does not, by itself, demonstrate that all inventions in those fields are unobvious. To that end, contrary to Appellants’ suggestion that Macke is uniquely interested in RG-50872 (App. Br. 18; Reply Br. 6—7), Macke suggests that its study has more general applicability to the delivery of antiproliferative drugs for treating restenosis. See Macke 553 (purpose of study was to “determine the feasibility of using hydrogel-coated angioplasty balloons to deliver drugs that inhibit vascular smooth muscle cell (VSMC) proliferation”). Indeed, Macke states further that the “overall objective of this study was to determine if this hydrogel coating was capable of storing and releasing water-insoluble (dimethyl sulfoxide [DMSO]-soluble) agents that could be used to inhibit intimal VSMC hyperplasia after angioplasty.” Id. at 554 (emphasis added). In that regard, we note Sollotf s disclosure that the paclitaxel composition it used was provided in a DMSO carrier (Sollott 1870), as well as Axel’s disclosure that the paclitaxel composition it used was in a lipoid, i.e. lipid-based, carrier (Axel 3). Given these teachings that paclitaxel was an antiproliferative drug having the type of solubility shown by Macke to be releasable from a balloon catheter using its hydrogel coating, 14 Appeal 2016-003444 Application 11/833,717 Appellants do not persuade us that an ordinary artisan lacked a reason for, or a reasonable expectation of success in, applying a paclitaxel-containing coating to a balloon catheter, as recited in claim 30. In sum, for the reasons discussed, Appellants do not persuade us that the Examiner erred in determining that the balloon catheter of claim 30 would have been obvious to an ordinary artisan in view of either Sollott or Axel, combined with Macke. Because Appellants advance no objective evidence of nonobviousness, we affirm the Examiner’s rejection of claim 30 over those references. Claims 31, 32, 34—37, 39, and 73 fall with claim 30 because they were not argued separately. 37 C.F.R. § 41(c)(l)(iv). Appellants argue that claims 40 and 74 are separately patentable from the remaining claims because the Examiner erred in finding that the cited references describe drying the paclitaxel coating. App. Br. 20-21. In particular, Appellants contend, although Macke describes applying its drug to a balloon in a DMSO vehicle, Macke does not “indicate that the DMSO totally evaporates. Moreover, removing excess fluid from the surface does not mean that the resulting surface is dry. The term ‘excess fluid’ is a relative term. It is possible to remove ‘excess fluid’ from a surface and still not have a dried surface or layer.” Id. at 21 (internal quotations in original). The Examiner responds that “the polymer surface of the balloons are treated with DMSO (a volatile solvent) and taxol over 10 minutes (allowing for evaporation of DMSO), then deflated (i.e. squeezed, which removes further fluid from the polymer), and this excess fluid is then removed from the surface.” Ans. 9—10. We find that the Examiner has the better position here. The disclosure at issue in Macke reads as follows: 15 Appeal 2016-003444 Application 11/833,717 The application of RG-50872 or DMSO vehicle [control] to the surfaces of these balloons was performed in a laminar flow hood to maintain sterility. Briefly, the balloon tip of each catheter was passed through and supported by a horizontally placed sterile tube held in place by a tubing clamp attached to a ring stand. The balloon was inflated to 2 atm, and two 5-pL aliquots of RG-50872 (40 mmol/L) or DMSO vehicle (100%) were then applied to the surface of each balloon with a micropipette. Over the next 10 minutes, the micropipette was used to spread the fluid over the surface of the balloon while the balloon was rotated within the horizontally placed tube. On completion of the coating, the balloon was deflated and any excess fluid was removed from the surface of the balloon with the micropipette. All balloons were used immediately after drug application. Macke 555. As the Supreme Court has noted, “the [obviousness] analysis need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR Int 7 v. Teleflex Inc., 550 U.S. 398, 418 (2007). In the present case, although Macke does not expressly state that the coating was entirely dried, Macke teaches that excess fluid was removed from the balloons, and the balloons were maintained in an open air environment for an amount of time that undisputedly would allow evaporation of at least some of the DMSO. Accordingly, we find that an ordinary artisan would have reasonably inferred that it would be acceptable to dry the drug-containing coating of Macke’s balloons without affecting taxol efficacy. Because Appellants, therefore, do not persuade us that the Examiner erred in concluding that the cited references render obvious the subject matter recited in claims 40 and 74, we also affirm the Examiner’s 16 Appeal 2016-003444 Application 11/833,717 rejection of those claims, and their dependents, over Sollott or Axel, combined with Macke. SUMMARY We affirm the Examiner’s rejection of claims 30—37, 40-43, and 73— 76 for obviousness over Lambert and Sollott. We reverse the Examiner’s rejection of claim 38 for obviousness over Lambert and Sollott. We affirm the Examiner’s rejection of claims 30—32, 34—37, 39-43, and 73—76 for obviousness over either Sollott or Axel, in combination with Macke. TIME PERIOD 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-IN-PART 17 Copy with citationCopy as parenthetical citation