Ex Parte MalininDownload PDFPatent Trial and Appeal BoardJul 30, 201814937206 (P.T.A.B. Jul. 30, 2018) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 14/937,206 11/10/2015 Theodore Malinin 30448 7590 08/01/2018 AKERMANLLP P.O. BOX 3188 WEST PALM BEACH, FL 33402-3188 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. 11150-3 (305071) 1001 EXAMINER HAGOPIAN, CASEY SHEA ART UNIT PAPER NUMBER 1617 NOTIFICATION DATE DELIVERY MODE 08/01/2018 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): ip@akerman.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte THEODORE MALININ1 Appeal2018-002414 Application 14/937,206 Technology Center 1600 Before JOHN G. NEW, TA WEN CHANG, and TIMOTHY G. MAJORS, Administrative Patent Judges. CHANG, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) involving claims to a composition comprising cartilage microparticles in a solution comprising povidone iodine, configured to harden upon desiccation into a bioactive implant, which have been rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 Appellant identifies the Real Party in Interest as the inventor, Theodore Malinin. (Appeal Br. 2.) Appeal2018-002414 Application 14/937,206 STATEMENT OF THE CASE The Specification states that, "[ d]espite advances in the understanding in the treatment and repair of bone and cartilage defects, there is still a need for bioactive implants that are biocompatible, non-inflammatory, osteogenic, and chondrogenic, and can be replaced by a subject's natural bone and cartilage." (Spec. ,r 3.) The Specification states that "[t]he present application relates to bioactive implants, methods of making bioactive implants, and methods of using bioactive implants to treat or repair bone or cartilage defects" (Id. ,r 1) and discloses, among other things, "a composition comprising cartilage microparticles in a povidone iodine solution, wherein the size of the cartilage microparticles is from about 50 µm to about 900 µm, and wherein the composition hardens upon desiccation into a bioactive implant." (Id. ,r 77.) Claims 1, 2, 5, 6, 8, and 21 are on appeal. Claim 1 is illustrative and reproduced below: 1. A composition, comprising: cartilage microparticles in a solution comprising povidone iodine, wherein the size of the cartilage microparticles is from about 50 µm to about 900 µm, and wherein the composition is configured to harden upon desiccation into a bioactive implant. (Appeal Br. A-1 (Claims App.).) The Examiner rejects claims 1, 2, 6, 8, and 21 under 35 U.S.C. § 103 as being unpatentable over Atala,2 Darouiche, 3 and Bemard. 4 (Ans. 4.) 2 Atala et al., U.S. Patent No. 5,516,532, issued May 14, 1996. 3 Darouiche, U.S. Patent No. 5,756,145, issued May 26, 1998. 4 David Bernard, Povidone-Iodine Prevents Infection in Prosthetic Implants, 2011 OUTPATIENT SURGERY MAGAZINE, http://www. outpatientsurgery .net/newsletter/ eweekly /2011 /03/08/povidone- i odine-prevents-infection-in-prosthetic-implants 2 Appeal2018-002414 Application 14/937,206 The Examiner rejects claims 1, 2, 6, and 8 under 35 U.S.C. § 103 as being unpatentable over Shi, 5 Darouiche, and Bernard. (Ans. 6.) The Examiner rejects claims 1, 2, 5, 6, and 8 under 35 U.S.C. § 103 as being unpatentable over Yayon, 6 Darouiche, and Bernard. (Ans. 9.) DISCUSSION Issue The Examiner has rejected claims 1, 2, 6, and 8 under 35 U.S.C. § 103 as being unpatentable over the combination of (a) Atala, Shi, or Ya yon and (b) Darouiche and Bernard. The Examiner has rejected claim 5 under 35 U.S.C. § 103 as being unpatentable over Yayon, Darouiche, and Bernard. The Examiner has rejected claim 21 under 35 U.S.C. § 103 as being unpatentable over Atala, Darouiche, and Bernard. The same issues are dispositive for all of the rejections; we therefore discuss them together. The Examiner finds that Atala teaches "injectable compositions comprising cartilage or bone microparticles ranging from 80 to 200 microns," which is "injected into the patient and then subsequently hardens." (Ans. 4.) The Examiner finds that Atala's compositions "further contain polymeric carriers and/or other pharmaceutically acceptable materials for injection including polyvinylpyrrolidone, water, saline or buffer." (Id.) The Examiner finds that Shi teaches chondrogenic "implantable compositions comprising a plurality of cartilage particles and a biocompatible carrier for the treatment of cartilage defects," wherein the biocompatible carriers may be, for instance, aqueous buffered solution, 5 Shi et al., US 2014/0134212 Al, published May 15, 2014. 6 Yayon et al., US 2010/0274362 Al, published Oct. 28, 2010. 3 Appeal2018-002414 Application 14/937,206 hydroxyethyl starch, or polyvinylpyrrolidone. (Id. at 7.) The Examiner finds that Shi's "particles hav[ing] an average of diameter of about 0.1 mm [] to about 25 mm," which overlaps with the claimed size of the cartilage microparticles in claim 1 and renders that limitation prima facie obvious. (Id. at 7-8.) The Examiner finds that Shi's composition is capable of performing the intended use in claim 1 regarding "harden[ing] upon desiccation into a bioactive implant." (Id.) The Examiner finds that Y ayon teaches "chondrogenic mixtures, such as gels or pastes, comprising cartilage particles and other components such as growth factors for repairing chondral defects," which "may also be applied to constructs for implantation." (Id. at 9-10.) The Examiner finds that Y ayon teaches that the cartilage particles "may be combined with a carrier such as PBS, saline, collagen, polymers, etc." and that constructs for implantation may be "rehydrated in solution such as saline prior to implantation." (Id. at 10.) The Examiner finds that Yayon's cartilage particles have a particle size within a range of about 10 microns to about 210 microns, which overlaps with the claimed size of the cartilage microparticles in claim 1 and renders that limitation prima facie obvious. (Id. at 10-11.) The Examiner finds that Atala, Shi, and Y ayon do not disclose povidone iodine. The Examiner finds, however, that Darouiche teaches implants comprising an antimicrobial coating layer, which provides extended protection against infection. (Id. at 4--5; see also id. at 8, 11.) The Examiner finds that Darouiche teaches povidone-iodine as an antimicrobial agent. (Id. at 5; see also id. at 8, 11.) The Examiner finds that Bernard similarly teaches that "povidone-iodine in and around a surgical site prior to 4 Appeal2018-002414 Application 14/937,206 closing can significantly and effectively reduce post-op infection rates." (Id. at 5; see also id. at 8, 11.) The Examiner concludes that a skilled artisan would have reason to include povidone-iodine in the compositions of Atala, Shi, or Yayon with a reasonable expectation of success at arriving at the claimed invention, because Darouiche and Bernard teach that "the inclusion of an antimicrobial/antiseptic such as povidone iodine is effective in reducing post-op infections over a period of time" and because Atala, Shi, Ya yon, and Darouiche are all drawn to implantable devices/compositions for orthopedic purposes. (Id. at 5; see also id. at 9, 11.) Appellant contends that Examiner's prior art combinations are improper because Darouiche teaches away from the claimed invention. (Appeal Br. 9-10.) Appellant further contends that it would not have been obvious to a skilled artisan to add povidone iodine to the compositions of Atala, Shi, or Y ayon because neither Darouiche nor Bernard deals with a composition, much less one that would subsequently harden into an implant. (Id. at 10-12.) Appellant contends that the Examiner's rejections are instead based on impermissible hindsight. The issues with respect to these rejections are whether a skilled artisan would have had a reason to combine Atala, Shi, or Y ayon with Darouiche and Bernard, with a reasonable expectation of success at arriving at the claimed invention. Findings of Fact 1. The Specification defines solution as a homogeneous mixture of two or more substances. A solution may exist in any phase. For example, a solution can be a homogeneous 5 Appeal2018-002414 Application 14/937,206 mixture composed of only one phase, wherein a solute (such as, e.g., HES, non-solubilized HES, polyvinyl pyrrolidone (PVP), povidone iodine, bone collagen, tendon collagen, albumin, or a combination thereof) is dissolved in a solvent (such as, e.g., water, saline, alcohol, DMSO, or a combination thereof). (Spec. ,r 140; see also id. ,r 202 (describing examples of solutes including PVP), ,r 205 ( describing examples of solvents including water, saline, DMSO, and phosphate-buffered saline (PBS)).) 2. Atala teaches that"[ v ]esicouretal reflux is a condition wherein there is an abnormal development of the ureteral bud as it enters the bladder during embryologic development." (Atala 1:10-12.) 3. Atala teaches that the condition has been treated by endoscopically injecting, e.g., polytetrafluoroethylene paste, bovine dermal collagen preparations, or a paste of silicone microparticles suspended in hydrogel, but that such prior art treatments have drawbacks such as migration of the polytetrafluoroethylene paste or silicone particles and loss of volume of the collagen implant. (Id. at 1 :48-2 :22 and 2 :26-61.) 4. Atala teaches that "[t ]he ideal implant material [ for treating vesicouretal reflux] should be non-migratory, non-antigenic, able to be delivered endoscopically, and should conserve its volume." (Id. at 2:23-25; see also id. at 3:20-22 and 4:31-33.) 5. Atala teaches a method for making an injectable "non- immunogenic cartilage and bone preparation and use thereof as a bulking agent." (Id. at Title, 1 :6-9; see also id. at Abstract.) 6. Atala teaches grinding cartilage and/or bone to a particle size ranging from 80 to 200 microns. (Id. at 5:29-31; see also id. at claim 1.) 7. Atala teaches that its "non-immunogenic demineralized bone and cartilage suspension ... can be mixed with polymeric carriers and/or 6 Appeal2018-002414 Application 14/937,206 other pharmaceutically acceptable materials for injection," including "suitable polymeric carriers [ such as] polyvinylpyrrolidone (PVP), hyaluronic acid, fibrin, glue, saline, alginate, and other polymers forming a hydrogel." (Id. at 4:38--45; see also id. at 8:28-33 (teaching that the demineralized particulate organic "matrix material can be suspended in an aqueous solution such as phosphate buffered saline or mixed with a polymeric material" and that, "[i]n the latter case, the matrix and polymer is preferably dissolved in water, saline, buffer or polymeric solution to form a suspension"), claims 3 and 4 ). 8. Atala teaches mixing an alginate solution with its demineralized particulate organic matrix derived from cartilage and/or bone to form an alginate suspension, which is injected into a patient prior to hardening of the suspension "due to the presence in vivo of physiological concentrations of calcium ions to form a hydrogel." (Id. at 6:25-31.) 9. Atala teaches that, "[i]n one embodiment, the time to solidification of the polymeric-matrix suspension may be manipulated by varying the concentration of calcium as well as the temperature at which the chondrocytes are added to the alginate" and further teaches that "[ s ]olidification of the alginate impedes its migration until after it is degraded." (Id. at 8:52-58; see also id. at claim 6.) 10. Shi teaches that "cartilage particles derived from human adult donors can be useful for repairing cartilage defects in subjects in need thereof." (Shi ,r 43.) 11. Shi teaches "[ c ]ompositions comprising a plurality of cartilage particles ... and a biocompatible carrier." (Shi Abstract; see also id. ,r,r 6, 13-16, claims 1 and 17.) 7 Appeal2018-002414 Application 14/937,206 12. Shi teaches that the biocompatible carrier may comprise DMSO. (Id. ,I,I 10, 23, 54, and 88; claim 12.) 13. Shi teaches that the cartilage particles can be made in desired shapes including spheres and that, "[i]n some embodiments, the cartilage particles have an average diameter from about 0.1 mm to about 25 mm." (Id. ,r,r 9, 21, and 47--48; claims 7 and 25.) 14. Shi teaches that the cartilage compositions of its invention may be administered locally to a subject, surgically implanted in the subject, or administered in a minimally invasive procedure such as arthroscopy. (Id. i195.) 15. Yayon teaches applying mixtures comprising cartilage particles and biocompatible carrier to repair chondral defects, including via implantation at the defect site. (Yayon Abstract, ,r,r 77-84, 94, 107, and 109; see also id. ,r,r 9, 4 7.) Y ayon also teaches that the cartilage particle mixtures may be applied to constructs made of cancellous bone and the construct rehydrated in a solution such as saline prior to implantation. (Id. ,r,r 77-87.) 16. Y ayon teaches that the cartilage particles may have a size within a range from about 5 microns to about 212 microns. (Id. ,r 96; see also id. at claim 8 ( cartilage particle size ranging from about 10 microns to about 210 microns).) 1 7. Y ayon teaches that the biocompatible carrier used in its invention may comprise, e.g., phosphate buffer saline (PBS) solution or saline solution and that the carrier can have different viscosities depending on the desired consistency of the cartilage particle mixture. (Id. ,r,r 107-108; see also id. ,r 79, claim 3 7.) 8 Appeal2018-002414 Application 14/937,206 18. Yayon teaches that "factors facilitating retention of the cartilage particles within [a] construct throughout a range of motion include, but are not limited to ... moisture content of the construct and/or cartilage particles." (Id. ,r 98.) 19. Darouiche teaches that "there is a need for a durable antimicrobial coated orthopedic implant or medical device that can remain in vivo for extended periods of time without losing its antimicrobial efficacy" and "a resilient antimicrobial coated orthopedic implant that can be inserted into bone with minimal sloughing of the antimicrobial layer from the surface of the device." (Darouiche 2:47-53.) 20. Darouiche teaches "[a] medical implant, such as an orthopedic implant, having a first antimicrobial coating layer and a second protective layer" formed over the antimicrobial coating layer. (Darouiche Abstract; see also id. at 1:8-15, 3:8-15.) 21. Darouiche teaches that "[ t ]he antimicrobial coating layer preferably comprises an antimicrobial solution comprising an antimicrobial agent and a polyvinyl moiety dissolved in an acid solution applied to at least a portion of the surfaces of [a] medical implant." (Id. at 3:33-36.) 22. Darouiche teaches that "antimicrobial agent as used in [its] invention means antibiotics, antiseptics, disinfectants and other synthetic moieties, and combinations thereof, that are soluble in organic solvents." (Id. at 4:28-33; see also id at 3:37--41.) 23. Darouiche teaches that examples of antiseptics and disinfectants that may be used include "iodine and iodophores (i.e. povidone-iodine )." (Id. at 4:58---65.) 9 Appeal2018-002414 Application 14/937,206 24. Bernard describes a study in which a 3-step antiseptic procedure is practiced in total hip and knee replacement surgeries, wherein a wound is soaked with a diluted povidone-iodine solution for three minutes after placing the implant, the site is soaked with saline, and the skin surrounding the incision is painted with a 10% povidone-iodine solution. (Bernard 1.) 25. Bernard teaches that povidone-iodine prevents infection in prosthetic implants. (Id. at Title.) In particular, Bernard teaches that "povidone-iodine in and around a joint replacement surgical site before closing can significantly and effectively reduce post-op infection rates." (Id.) 26. Bernard teaches that "[p ]ovidone-iodine is 'safe, inexpensive, simple to use and readily available within most operating rooms"' and "'effective on many types of bacteria."' (Id.) Analysis We agree with the Examiner on this record that claim 1 is rendered obvious over the combinations of (a) Atala, Shi, or Yayon, and (b) Darouiche and Bernard. Only those arguments made by Appellant in the briefs have been considered in this decision. Arguments not presented in the briefs are waived. See 37 C.F.R. § 4I.37(c)(l)(iv). Atala, Shi, and Y ayon each teaches a composition comprising cartilage microparticles wherein the size of the microparticles is encompassed by or overlaps the range of the claimed microparticle size (FF5-FF6, FFl 1, FF13, and FF15-16), and "[a] prima facie case of obviousness typically exists when the ranges of a claimed composition 10 Appeal2018-002414 Application 14/937,206 overlap the ranges disclosed in the prior art." In re Peterson, 315 F.3d 1325, 1329--30 (Fed. Cir. 2003). Likewise, Atala, Shi, and Y ayon each suggests that the composition may be in the form of a solution as defined by the Specification (i.e., a homogeneous mixture of two or more substances). (FFI.) In particular, Atala teaches that its cartilage composition can be mixed with polymeric carriers and/or other pharmaceutically acceptable materials for injection, such as PVP and saline. (FF7 .) Shi and Yayon similarly teach that their cartilage compositions may comprise biocompatible carrier( s) such as DMSO, PBS, or saline. (FF11-FF12, FF15, and FFl 7.) The Specification discloses PVP as an example of a solute and DMSO, PBS, and saline as examples of solvents for the claimed solution. (FPL) Atala, Shi, and Y ayon do not disclose a composition comprising povidone iodine, as required by claim 1. However, Darouiche and Bernard teach that it is desirable to prevent infection when using implants and that povidone iodine is an antiseptic that is effective on many types of bacteria and that prevents infection in prosthetic implants. (FF19--FF26.) Given that Atala, Shi, and Y ayon all relate to composition useful as implant material (FF5, FF8, FFlO, and FF15), we find that the disclosures in Darouiche and Bernard would provide a skilled artisan with a reason to include povidone iodine in the compositions of Atala, Shi, and Yayon, i.e., in order to prevent infection when the compositions are implanted in a patient. Finally, we agree with the Examiner that the limitation that the composition be "configured to harden upon desiccation into a bioactive implant" may be reasonably interpreted as an intended use and therefore encompasses any structure capable of performing the recited function. 11 Appeal2018-002414 Application 14/937,206 See In re Swinehart, 439 F.2d 210,213 (CCPA 1971) ("'Functional' terminology may render a claim quite broad ... [;] a claim employing such language covers any and all embodiments which perform the recited function."); see also Schreiber, 128 F.3d at 1478-79 (prior art apparatus meeting all claimed structural limitations found anticipatory because it was inherently capable of functioning in accordance with claimed intended use). In this case, the prior art suggests compositions having identical or substantially identical ingredients as the claimed compositions. We thus find that the Examiner has established a prima facie case that the compositions rendered obvious by the combination of (a) Atala, Shi, or Yayon and (b) Darouiche and Bernard are capable of "harden[ing] upon desiccation into a bioactive implant." In re Best, 562 F.2d 1252, 1255 ( CCP A 1977) ( citations and footnote omitted) ("Where ... the claimed and prior art products are identical or substantially identical ... the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product."). Appellant contends that none of the primary references (Atala, Shi, and Yayon) "disclose[s] 'cartilage microparticles in a solution comprising povidone iodine," much less that such a "cartilage particle / povidone iodine composition could ... be dessicated to harden into a 'bioactive implant," as required by claim 1. (Appeal Br. 7.) Appellant also contend that Darouiche teaches a metallic implant rather than compositions such as those taught by Atala, Shi, or Yayon," that Darouiche mentions povidone-iodine as only "one of a laundry list of ... antimicrobial coatings that could be used," that Darouiche requires a protective coating layer in addition to the antimicrobial coating layer, and that povidone iodine is only added to and then rinsed out 12 Appeal2018-002414 Application 14/937,206 of a wound in Bernard, or painted on the skin surrounding a wound. (Id. at 7-8.) Accordingly, Appellant contends that it would not have been obvious to modify Atala, Shi, or Yayon in light ofDarouiche and Bernard to arrive at the claimed invention with a reasonable expectation of success, because none of the prior art teaches that povidone iodine should or could be added to a composition that includes cartilage microparticles or is configured to harden upon desiccation into a bioactive implant, as required by claim 1. (Id. at 9, 11-12; see also Reply Br. 4---6.) We are not persuaded. The gravamen of Appellant's argument is that there is no explicit teaching that povidone iodine should or could be added to the type of compositions described in Atala, Shi, and Yayon (i.e., a composition comprising cartilage microparticles ). However, a combination may be obvious even if there are no "precise teachings directed to the specific subject matter of the challenged claim," because an obviousness analysis "can take into account ... the inference 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). As discussed above, Atala, Shi, and Y ayon all teach compositions that may be used in implants, and Darouiche and Bernard both teach that antiseptics such as povidone-iodine are useful as an antimicrobial agent in orthopedic implants and implantation procedures. (FF5, FF8, FFlO, FF15, and FF19-FF26.) Given these teachings, we find that a person of ordinary skill and creativity in the art at issue would have had an adequate reason to include povidone-iodine as an antimicrobial agent in the implant compositions of Atala, Shi, and Y ayon in order to reduce infection in implants. This is particularly the case because Bernard teaches that 13 Appeal2018-002414 Application 14/937,206 povidone-iodine is "'safe, inexpensive, simple to use[,] ... readily available"' and "'effective on many types of bacteria. "'7 (FF26.) As to Appellant's argument that Darouiche mentions povidone-iodine as only "one of a laundry list of ... antimicrobial coatings that could be used" (Appeal Br. 7-8), we note that "disclos[ing] a multitude of effective combinations does not render any particular formulation less obvious." Merck & Co. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989). Furthermore, as discussed above, Bernard discloses specific advantages of using povidone-iodine as an antiseptic in implant procedures. Finally, with respect to Appellant's argument that there is no suggestion in the prior art that the claimed "cartilage particle / povidone iodine composition could ... be dessicated to harden into a 'bioactive implant" (Appeal Br. 7 and 9), we reiterate that the limitation that the composition be "configured to harden upon desiccation into a bioactive implant" is reasonably interpreted as an intended result. As the Supreme Court has held, "[i]n 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 7 We note that while Darouiche specifically discusses coating metallic implants and Bernard discusses using povidone-iodine on skin and wounds, the combination of these references suggest that povidone-iodine may be used in the body and in or on different compositions and/or surfaces. (See Darouiche 7:64---66 (stating that medical devices amenable to coating by antimicrobial combinations are generally composed of metallic material); 8: 15-29 (suggesting that antimicrobial coating of its invention may be applied to miscellaneous surfaces including, e.g., hospital floors and kitchen counters).) 14 Appeal2018-002414 Application 14/937,206 reason for combining the elements in the manner claimed." KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398, 419-20 (2007). Appellant further contends that Darouiche teaches away from the combination, because the "inventive aspect" of Darouiche requires a protective coating layer over the antimicrobial layer. (Appeal Br. 9-10; see also id. at 12, Reply Br. 2--4.) We are not persuaded. "[A] reference will teach away when it suggests that the developments flowing from its disclosures are unlikely to produce the objective of the applicant's invention." Syntex (US.A.) LLC v. Apotex, Inc., 407 F.3d 1371, 1380 (Fed. Cir. 2005). In this case, Darouiche at most teaches that a protective coating is desirable when an antimicrobial agent is coated onto an implant and thus subject to, e.g., sloughing off and leaching. Such a teaching does not suggest, however, that an antimicrobial agent included as an integral part of an implant composition would not perform its antimicrobial function without a protective coating. Finally, Appellant contends that the Examiner's rejection is based on impermissible hindsight reconstruction. (Appeal Br. 12; Reply Br. 5, 6.) 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 (CCPA 1971). As we have discussed, a skilled artisan would have reason to combine the cited prior art references to arrive at the claimed invention, without reference to knowledge gleaned only from Appellant's disclosure. 15 Appeal2018-002414 Application 14/937,206 Accordingly, we affirm the Examiner's rejection of claim 1 as obvious over the combination of (a) Atala, Shi, or Ya yon and (b) Darouiche and Bernard. Claims 2, 5, 6, 8, and 21, which are not separately argued, fall with claim 1. 37 C.F.R. § 4I.37(c)(l)(iv). SUMMARY For the reasons above, we affirm the Examiner's decision rejecting claims 1, 2, 5, 6, 8, and 21. 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 16 Copy with citationCopy as parenthetical citation