Ex Parte Grant et alDownload PDFPatent Trial and Appeal BoardMay 22, 201812562978 (P.T.A.B. May. 22, 2018) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 12/562,978 09/18/2009 321 7590 05/24/2018 SENNIGER POWERS LLP 100 NORTH BROADWAY 17THFLOOR ST LOUIS, MO 63102 FIRST NAMED INVENTOR Sheila Ann Grant 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. UM007092.l (07UMC092) CONFIRMATION NO. 5402 EXAMINER CABRAL, ROBERTS ART UNIT PAPER NUMBER 1618 NOTIFICATION DATE DELIVERY MODE 05/24/2018 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): uspatents@senniger.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte SHEILA ANN GRANT, COREY RENEE DEEKEN, BRUCE JOHN RAMSHA W, SHARON LIEBE BACHMAN, ARCHANA RAMASWAMY, and NICOLE MARIE FEARING Appeal2017-005182 1 Application 12/562,978 Technology Center 1600 Before JEFFREY N. FRED MAN, ULRIKE W. JENKS, and TIMOTHY G. MAJORS, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal2 under 35 U.S.C. § 134(a) involving claims to a bionanocomposite. The Examiner rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part but designate our affirmance as a new ground of rejection and enter additional new grounds of rejection. 1 Our Decision refers to Appellants' Appeal Brief ("Appeal Br.," filed May 16, 2016) and Reply Brief ("Reply Br.," filed Jan. 30, 2017), and the Examiner's Non-Final Office Actions ("Non-Final Act. 2015," mailed Jan. 15, 2015; "Non-Final Act. 2013," mailed Oct. 3, 2013), Final Office Actions ("Final Act. 2014," mailed June 12, 2014; "Final Act. 2015," mailed Oct. 15, 2015) and Answer ("Ans.," mailed Nov. 28, 2016). 2 Appellants identify the real party in interest as The Curators of the University of Missouri (see App. Br. 2). Appeal2017-005182 Application 12/562,978 Statement of the Case Background "Hernias are by definition a breakdown of the tough connective tissue that encases the abdominal musculature, known as fascia" (Spec. i-f 3). "To help decrease the rate of hernia recurrence, a prosthetic mesh material is utilized to repair the hernia defect. The role of mesh in these repairs is to provide a tension-free bridge between the fascial defects and/or reinforcement of the fascia" (Spec. i-f 4). Prior prosthetic mesh materials may shrink and lead to a recurrence of the hernia or chronic pain due to nerve entrapment (Spec. i-f 5). The Specification teaches that newer "soft tissue repair materials have utilized collagen scaffolds, but purified collagen is mechanically weak and chemically crosslinked collagen has inadequate biocompatibility" (Spec. i-f 6). The Specification concludes "there is a need to provide a new and improved implant material that combats the problems of mesh shrinkage, infection, and recurrences, while promoting tissue integration and improving the overall biocompatibility when used in soft tissue repair" (Spec. i-f 7). The Claims Claims 2, 5, 8, 9, 11, 12, 14, 18-20, 22, 23, 37, 42, 43, 69, 85-87, and 89-91 are on appeal. Claim 2 is representative and reads as follows: 2. A bionanocomposite comprising: a decellularized tissue, and a nanomaterial functionalized with surface functional groups capable of bonding with the tissue, wherein the nanomaterial is crosslinked with the decellularized tissue and the decellularized tissue has a tensile strength measured at yield ranging from 16 MPa to 25 MPa. 2 Appeal2017-005182 Application 12/562,978 The Issues 3 A. The Examiner rejected claims 2, 5, 8, 9, 11, 12, 18-20, 37, 42, 43, 69, and 89 under 35 U.S.C. § 103(a) as obvious over Atala, 4 Oswal, 5 Hafemann, 6 and Haidekker7 (Non-Final Act. 2013 2-7). B. The Examiner rejected claims 12, 14, and 90 under 35 U.S.C. § 103(a) as obvious over Atala, Oswal, Hafemann, Haidekker, and Dixon8 (Non-Final Act. 2013 7-8). C. The Examiner rejected claims 85-87 under 35 U.S.C. § 103(a) as obvious over Atala, Oswal, Hafemann, Haidekker, and Lee9 (Non-Final Act. 2013 10-12). D. The Examiner rejected claims 2, 5, 8, 9, 11, 18, 22, 23, 87, and 89 under 35 U.S.C. § 103(a) as obvious over Atala, Oswal, and Xu 10 (Non- Final Act. 2013 12-13). 3 We note that claims 51 and 54 were withdrawn from consideration as non- elected without traverse in a response filed Nov. 28, 2011. 4 Atala et al., US 2006/0257377 Al, published Nov. 16, 2006. 5 Oswal et al., Biochemical Characterization of Decellularized and Cross- Linked Bovine Pericardium, 16 J. Heart Valve Disease 165-74 (2007). 6 Hafemann et al., Cross-linking by l-ethyl-3-(3-dimethylaminopropyl)- carbodiimide (EDC) of a collagen/elastin membrane meant to be used as a dermal substitute: effects on physical, biochemical and biological features in vitro, 12 J. Materials Sci. Materials in Medicine 437--46 (2001). 7 Haidekker et al., Influence of gold nanoparticles on collagen fibril morphology quantified using transmission electron microscopy and image analysis, 6 BMC Medical Imaging 1-7 (2006). 8 Dixon et al., US 4,813,964, issued Mar. 21, 1989. 9 Lee et al., Amine-functionalized gold nanoparticles as non-cytotoxic and efficient intracellular siRNA delivery carriers, 364 Int. J. Pharmaceutics 94-- 101 (2008). 10 Xu et al., Biodegradable electrospun poly(L-lactide) fibers containing antibacterial silver nanoparticles, 42 European Polymer J. 2081-7 (2006). 3 Appeal2017-005182 Application 12/562,978 E. The Examiner rejected claims 2, 5, 8, 9, 11, 12, 18-20, 37, 42, 43, 69, 89, and 91 under 35 U.S.C. § 103(a) as obvious over Atala, Oswal, Hafeman, Haidekker, Walter, 11 and Zeeman 12 (Non-Final Act. 2015 5-11). A. 35 US.C. § 103(a) over Atala, Oswal, Hafemann, and Haidekker The issue with respect to this rejection is: Does the evidence of record support the Examiner's conclusion that the cited prior art suggests decellularized tissue that "has a tensile strength measured at yield ranging from 16 MPa to 25 MPa" as required by claim 2? Findings of Fact 1. Atala teaches "producing an artificial composite tissue construct ... using a first biocompatable structural matrix having sufficient rigidity to provide structural support" where the "structural matrix can be ... a decellularized substrate" (Atala i-fi-18, 10). 2. Atala teaches "scaffolds comprising a biodegradable synthetic polymer and a naturally derived collagen matrix" (Atala i-f 137). 3. Atala teaches the "scaffolds can be created by functionalizing the scaffold to incorporate ... nanoparticles" (Atala i-f 116). 4. Haidekker teaches: "Recent work has focused on functionalized gold nanoparticles as crosslinking agents for collagen and as a facilitator for cell migration and ingrowth" (Haidekker 2, col. 1 ). Haidekker teaches "the nanoparticles bind either by nonspecific hydrogen absorption to the fibrils or by NH2/COOH cross-links" (Haidekker 5, col. 1 ). 11 Walter et al., US 5,863,297, issued Jan. 26, 1999. 12 Zeeman et al., Successive epoxy and carbodiimide cross-linking of dermal sheep collagen, 20 Biomaterials 921-31 (1999). 4 Appeal2017-005182 Application 12/562,978 5. Hafeman teaches "various methods are available for the crosslinking of collagen based materials" (Hafeman 438, col. 1 ). 6. Oswal teaches "to decellularize bovine pericardium and to compare the biomechanical properties of fresh and decellularized bovine pericardia to those treated with different concentrations of glutaraldehyde (GA)" (Oswal 165, abstract). 7. Table II of Oswal is reproduced, in part, below: fJ .. ~~~~u( ph;;~~·~: ~-b~p~~- r ~ ~ .. :re .. ~J- 0,.1 ~:i3~t:o..172·: o.7el:::.t:0.4-S.3' (\::~k~g~:,n pha~e :~:h>p("' {\Jt-1~ {(~.::?~-J} U~02J::t:n .. J1{ 03J2H·:tU.·:}U~J Tr:.~:n ::;:~ ::.-i ~}n .::tn::::~=:~ ;.\(1~_~e~ ( l\·'~ .~\:1) n --~-f;.~·8 ::H.t 7:~~:;" } A)·~~::~ J.Ci,? l .. J Table II shows tensile strength for 0.05% GA-treated decellularized pericardium as 13.082±4.537 and for 0.5% GA-treated decellularized pericardium as 13.570±3.206 (see Oswal 170, table II). Principles of Law [In Patel], [w]e vacated the Board's finding ofaprimafacie case based solely on the closeness of the prior art reference's disclosed range because "the ranges d[id] not overlap and the prior art d[id] not teach that a broader range would be appropriate." Id. at 1009. Patel recognized, however, that prima facie rejections may be appropriate "where there is a teaching in the prior art that the end points of the prior art range are approximate, or can be flexibly applied." Id. at 1010. In re Brandt, 886 F.3d 1171, 1177 (Fed. Cir. 2018) (citing In re Patel, 566 Fed. Appx. 1005 (Fed. Cir. 2014)). 5 Appeal2017-005182 Application 12/562,978 Analysis Appellants contend "a person of ordinary skill in the art would not have had any cogent technical reason to substitute the biocompatible lower tensile strength structures of Atala with the cytotoxic structures having higher tensile strength of Oswal having a maximum tensile strength of 13 .57 MPa" (App. Br. 7). Appellants also contend "the tensile strength is affected by the density of crosslinks and therefore the density of nanoparticles in the bionanocomposite. This relationship was also not recognized by the combined teachings" (App. Br. 8; cf App. Resp. 3/3/2014 at 9 "the lower tensile strength disclosed in Oswal does not overlap the required tensile strength range of 16-25 MP. There is also no reason provided by Oswal or any of the other cited references that such a tensile strength would be advantageous.") The Examiner13 responds "[t]his argument is not persuasive because it ignores that Oswal otherwise teaches tensile strength that encompass the claimed range. For instance, Table I shows untreated decellularized pericardium having a tensile strength of 14/342 ± 4.437" (Final Act. 2014 at 4). The Examiner, in the Answer, also argues "'it is desirable that a biodegradable implant designed for tissue ingrowth have mechanical properties similar to those of the tissue into which it is placed' Id. at page 10." However, this argument cites to the Non-Final Act. 2015 which is itself citing to the Walter reference that is not relied upon by the Examiner in this 13 We note that the rejections, scattered in several previous Non-Final actions, combined with the brevity and summary nature of the Examiner's responses the various actions and Answer, makes it more difficult to accurately determine the Examiner's position regarding each of the separate rejections. 6 Appeal2017-005182 Application 12/562,978 rejection. If the citation of a prior art reference is necessary to support a rejection, the reference must be included in the statement of rejection. In re Hoch, 428 F.2d 1341, 1342 n.3 (CCPA 1970) ("Where a reference is relied on to support a rejection whether or not in a 'minor capacity,' there would appear to be no excuse for not positively including the reference in the statement of the rejection.") We find that Appellants have the better position in this rejection. We agree with Appellants that there are not necessarily any overlapping teachings because Oswal does not teach tensile strengths of 16 to 25 MP, but rather teaches that the standard deviation of their measured tensile strengths for decellularized and crosslinked tissues had values of either 13.082±4.537 or 13.570±3.206. However, the Examiner has not established that any particular measured value fell within the claimed range, because the standard deviation simply quantifies "a measure of the dispersion of a frequency distribution" 14 and does not necessarily indicate particular values that Oswal measured for the tensile strength distribution. More importantly, in this rejection the Examiner has provided no evidence or reason to optimize the tissue composites to obtain the required tensile strength of 16 to 25 MP. Therefore, this rejection lacks "a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does." KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). 14 https://www.merriam-webster.com/dictionary/standard%20deviation? utm_campaign =sd&utm_medium=serp&utm_source=j sonld 7 Appeal2017-005182 Application 12/562,978 Conclusion of Law The evidence of record does not support the Examiner's conclusion that the cited prior art suggests decellularized tissue that "has a tensile strength measured at yield ranging from 16 MPa to 25 MPa" as required by claim 2. B.-D. 35 US.C. § 103(a) over Atala, Oswal, Hafemann, and Haidekker with one of Dixon, Lee, or Xu The Examiner relies upon Oswal for each of these rejections to teach the tensile strength limitation of independent claim 2 (see Non-Final Act. 2013 2-13). Having reversed the obviousness rejection of claim 2 for the reasons given above, we also find that the further combinations with Dixon, Lee, or Xu do not render the rejected claims obvious for the same reason. E. US.C. § 103(a) as obvious over Atala, Oswal, Hafeman, Haidekker, Walter, and Zeeman The issue with respect to this rejection is: Does the evidence of record support the Examiner's conclusion that the cited prior art suggests decellularized tissue crosslinked with a nanomaterial with "a tensile strength measured at yield ranging from 16 MPa to 25 MPa" as required by claim 2? Findings of Fact 8. Atala teaches "Nanoparticles (e.g., QD, image enhancing agents) can be easily bound to matrices, and also embedded within nanofibers of electrospun matrices" (Atala i-f 132). 9. Hafeman teaches the "(EDC) mixed with N- hydroxysuccinimide (NHS), on the other hand, cross-links the collagen matrix by the formation of isopeptides without being incorporated itself. In 8 Appeal2017-005182 Application 12/562,978 this way stable covalent linkages are produced directly between activated side-groups of the collagen precluding the release of toxic monomers upon depolymerization" (Hafeman 438, col. 1 ). 10. Walter teaches "it is desirable that a biodegradable implant designed for tissue ingrowth have mechanical properties similar to those of the tissue into which it is placed" (Walter 2:4--6). 11. Walter teaches it "is desirable that the implant materials be porous to facilitate tissue ingrowth. In general, the implant materials of this invention preferably have a Young's modulus between about 0.1 and about 200 MPa at room temperature" (Walter 4: 12-16). 12. Zeeman teaches: "Cross-linking of collagen-based materials is an effective method to modify the stability towards enzymatic degradation and to optimize the mechanical properties" (Zeeman 921, col. 1 ). 13. Zeeman teaches "cross-linking reagents for collagen based biomaterials ... It has been shown that these reagents are effective cross- linkers for pericardium, vascular grafts and porcine aortic heart valves" (Zeeman 926, col. 2). Principles of Law When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103. KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007). 9 Appeal2017-005182 Application 12/562,978 Analysis Claim 2 Atala teaches "artificial composite tissue construct ... using a first biocompatible structural matrix" that includes decellularized tissue (FF 1 ). Atala teaches that the tissue construct may be composed of collagen (FF 2) and functionalized with nanoparticles (FF 3, 8). Atala does not teach how the nanoparticles are associated with the decellularized tissue nor the tensile strength of the decellularized tissue (see, e.g., Non-Final Act. 2015 7). Haidekker teaches incorporation of gold nanoparticles into collagen scaffolds by crosslinking to serve "as a facilitator for cell migration and ingrowth" (FF 4), while Hafeman teaches that a variety of crosslinking methods, including nontoxic methods, were available to the ordinary artisan (FF 5, 9). Zeeman explains one reason to use crosslinking is because: "Cross-linking of collagen-based materials is an effective method to modify the stability towards enzymatic degradation and to optimize the mechanical properties" (FF 12). While Atala exemplifies tensile strengths for blood vessels that are less than 1.2 MPa (see Atala i-f 205 and Fig. 5) and scaffolds that were less 8.33 MPa or less (see Atala i-f 286, Table 1), Walter expressly teaches a range of tensile strengths between 0.1and200 MPa (FF 11) because "it is desirable that a biodegradable implant designed for tissue ingrowth have mechanical properties similar to those of the tissue into which it is placed" (FF 10). Thus, we agree with the Examiner's conclusion that the ordinary artisan would have found it obvious, at the time the invention was made, to modify Atala's tissue construct by crosslinking with nanoparticles because 10 Appeal2017-005182 Application 12/562,978 Haidekker explains that nanoparticles improve tissue constructs by facilitating cell migration and ingrowth (FF 4) and Zeeman explains that crosslinking improves stability and mechanical properties of tissue constructs (FF 12). In addition, the ordinary artisan would have found it obvious to modify the construct of Atala, Haidekker, and Zeeman with the claimed tensile strength range of 16 to 25 MPa based on the overlapping range suggested by Walter, because Walter provides a reason to optimize the construct to have "mechanical properties similar to those of the tissue into which it is placed" (FF 10) and because: In cases involving overlapping ranges, we and our predecessor court have consistently held that even a slight overlap in range establishes a prima facie case of obviousness . . . Selecting a narrow range from within a somewhat broader range disclosed in a prior art reference is no less obvious than identifying a range that simply overlaps a disclosed range. In fact, when, as here, the claimed ranges are completely encompassed by the prior art, the conclusion is even more compelling than in cases of mere overlap. The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages. In re Peterson, 315 F.3d 1325, 1329, 1330 (Fed. Cir. 2003). Appellants provide no evidence rebutting this obviousness case. Appellants contend the Walter patent is directed to polymeric scaffolds and not to decellularized tissue, so a person of ordinary skill in the art would have expected that the mechanical properties would have been very different. Moreover, a person of ordinary skill in the art would not have contemplated Walter's teachings when developing the claims bionanocomposite, and would not have had a reasonable expectation that incorporating mechanical 11 Appeal2017-005182 Application 12/562,978 properties from the Walter disclosure would have been advantageous for the claimed bionanocomposites. (App. Br. 11 ). We find this argument unpersuasive because Walter generally teaches that the ordinary artisan would have reason to optimize the mechanical properties of a tissue construct to match the properties of the target tissue, and Walter teaches a range for implant materials that overlaps the claimed range, while Atala teaches tissue constructs designed for implantation that would reasonably benefit from optimization of tensile strength as suggested by Walter (FF 1-3, 10, 11). "Non-obviousness cannot be established by attacking references individually where the rejection is based upon the teachings of a combination of references." In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986). We also are not persuaded by Appellants' argument that "Zeeman, like Walter provides a significantly different material from the decellularized tissue required by the claims. Thus, a person of ordinary skill in the art would not have had a reasonable expectation that Zeeman's teachings would have provided an advantageous bionanocomposite" (App. Br. 11 ). The Examiner relies upon Zeeman solely for the general teaching that crosslinking of collagen materials designed for in vivo use improves stability and allows optimization of mechanical properties (see FF 12). Zeeman's "crosslinking reagents for collagen based biomaterials" (FF13) is in the same field of endeavor and pertinent to the use of crosslinked nanoparticles to collagen taught by Haidekker for cell ingrowth on scaffolds (FF 4) as well as the collagen scaffolds of Atala (FF 2). 12 Appeal2017-005182 Application 12/562,978 Claim 91 Appellants recite the limitations of claim 91, but do not identify any specific reason why claim 91 is unobvious. A general allegation that the cited prior art does not teach any of the instant claim limitations is no more than merely pointing out the claim limitations. A statement which merely points out what a claim recites will not be considered an argument for separate patentability of the claim. 37 C.F.R. § 41.37(c)(l)(iv). As our reviewing court held, "the Board reasonably interpreted Rule 41.3 7 to require more substantive arguments in an appeal brief than a mere recitation of the claim elements and a naked assertion that the corresponding elements were not found in the prior art." In re Lovin, 652 F.3d 1349, 1357 (Fed Cir 2011). Conclusion of Law The evidence of record supports the Examiner's conclusion that the cited prior art suggests decellularized tissue crosslinked with a nanomaterial with "a tensile strength measured at yield ranging from 16 MPa to 25 MPa" as required by claim 2. New Grounds of Rejection Under the provisions of 37 C.F.R. § 41.50(b ), we enter the following new ground of rejection. Claims 14, 22, 23, 85-87, and 90 are rejected under 35 U.S.C. § 103(a) as obvious over Atala, Oswal, Hafeman, Haidekker, Walter, Zeeman further with Dixon, Xu, and Lee. 13 Appeal2017-005182 Application 12/562,978 Findings of Fact 14. Atala, Oswal, Hafeman, Haidekker, Walter, and Zeeman teach the limitations of the rejected claims as discussed above. 15. Atala, Oswal, Hafeman, Haidekker, Walter, and Zeeman do not teach the use of porcine tissue as required by claims 14 and 90, silver nanomaterials as required by claims 22 and 23, or amine-functionalization as required by claims 85 and 86. 16. Dixon teaches an "implant material comprising appropriately sized graft of sterilized bovine or porcine or other anisotropic mammalian diaphragm which has been cross-linked" (Dixon 2:35-39). 1 7. Dixon teaches these materials have "been found to be more effective in restoring the function of degenerated flexor tendon pulleys and has been found to be effective for a longer period of time than was the case with any prior art xenogeneic tissue" (Dixon 2:39-43). 18. Xu teaches: "Polymer biomaterials are usually utilized as implanted medical devices ... As a powerful antimicrobial agent, silver is believed to fit all of antimicrobial methods above and has been widely used in kinds of materials, especially in medical materials" (Xu 2081, col. 1-2). 19. Lee teaches Gold nanoparticles chemically modified with primary and quaternary amine moieties were ionically interacted with plasmid DNA, and they exhibited more efficient intracellular delivery than the conventional transfection agents ... Furthermore, it was suggested that gold nanoparticles could be functionalized with various antibodies, peptides, and small molecular ligands to achieve a target cell-specific uptake, endosome escape, and nuclear localization for efficient gene delivery. (Lee 94, col. 2). 14 Appeal2017-005182 Application 12/562,978 Analysis The ordinary artisan would have found it obvious, at the time the invention was made, to substitute known equivalents such as the porcine collagen implant material of Dixon for the naturally derived collagen of Atala (FF 2, 16). See In re Mehta, 347 F.2d 859, 863 (CCPA 1965) ("No invention can be seen in obvious equivalents of the prior art."). We also agree with the Examiner's reasoning that "[m]otivation for the modification is found in Dixon's express teaching that the use of diaphragm tissue demonstrates is more effective over a longer period of time than the prior art" (Non-Final Act. 2013 at 8; FF 17). The ordinary artisan would also have found it obvious to use silver nanoparticles in the implanted artificial tissue scaffolds of Atala because silver is a powerful antimicrobial agent that "has been widely used in kinds of materials, especially in medical materials" (FF 18). We agree with the Examiner's reasoning that "a skilled artisan would have found motivation and/or suggestion to incorporate silver nanoparticles in a tissue construction ... so as to imbue the tissue construct with antimicrobial properties" (Non- Final Act. 2013 at 12). Lastly, the ordinary artisan would have found it obvious, at the time the invention was made, to use amine functionalized gold particles as taught by Lee (FF 19) because Lee's amine functionalization allows for binding of gold nanoparticles to desired materials as taught by Haidekker (FF 4 "functionalized gold nanoparticles as crosslinking agents for collagen and as a facilitator for cell migration and ingrowth") who explains "the nanoparticles bind either by nonspecific hydrogen absorption to the fibrils or by NH2/COOH cross-links" (FF 4). 15 Appeal2017-005182 Application 12/562,978 SUMMARY In summary, we reverse the rejection of claims 2, 5, 8, 9, 11, 12, 18- 20, 37, 42, 43, 69, and 89 under 35 U.S.C. § 103(a) as obvious over Atala, Oswal, Hafemann, and Haidekker. We reverse the rejection of claims 12, 14, and 90 under 35 U.S.C. § 103(a) as obvious over Atala, Oswal, Hafemann, Haidekker, and Dixon. We reverse the rejection of claims 85-87 under 35 U.S.C. § 103(a) as obvious over Atala, Oswal, Hafemann, Haidekker, and Lee. We reverse the rejection of claims 2, 5, 8, 9, 11, 18, 22, 23, 87, and 89 under 35 U.S.C. § 103(a) as obvious over Atala, Oswal, and Xu. We affirm the rejection of claim 2 under 35 U.S.C. § 103(a) as obvious over Atala, Oswal, Hafeman, Haidekker, Walter, and Zeeman. Claims 5, 8, 9, 11, 12, 18-20, 37, 42, 43, 69, 89, and 91 fall with claim 2. We enter a new ground of rejection of claims 14, 22, 23, 85-87, and 90 over Atala, Oswal, Hafeman, Haidekker, Walter, Zeeman, Dixon, Xu, and Lee, pursuant to 37 C.F.R. § 41.50(b). Section 41.50(b) provides "[a] new ground of rejection pursuant to this paragraph shall not be considered final for judicial review." Section 41.50(b) also provides: When the Board enters such a non-final decision, the appellant, within two months from the date of the decision, must exercise one of the following two options with respect to the new ground of rejection to avoid termination of the appeal as to the rejected claims: ( 1) Reopen prosecution. Submit an appropriate amendment of the claims so rejected or new Evidence relating to the claims so rejected, or both, and have the matter reconsidered by the examiner, in which event the prosecution will be remanded to the examiner. The new ground of rejection 16 Appeal2017-005182 Application 12/562,978 is binding upon the examiner unless an amendment or new Evidence not previously of Record is made which, in the opinion of the examiner, overcomes the new ground of rejection designated in the decision. Should the examiner reject the claims, appellant may again appeal to the Board pursuant to this subpart. (2) Request rehearing. Request that the proceeding be reheard under§ 41.52 by the Board upon the same Record. The request for rehearing must address any new ground of rejection and state with particularity the points believed to have been misapprehended or overlooked in entering the new ground of rejection and also state all other grounds upon which rehearing is sought. Further guidance on responding to a new ground of rejection can be found in the Manual of Patent Examining Procedure§ 1214.01. AFFIRMED-IN-PART; 37 C.F.R. § 41.50(b) 17 Copy with citationCopy as parenthetical citation