Ex Parte Hissink et alDownload PDFPatent Trials and Appeals BoardJul 9, 201914695174 - (D) (P.T.A.B. Jul. 9, 2019) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 14/695,174 04/24/2015 27305 7590 07/11/2019 HOW ARD & HOW ARD ATTORNEYS PLLC 450 West Fourth Street Royal Oak, MI 48067 FIRST NAMED INVENTOR Catharina Everdina His sink 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. 060210.00569 7686 EXAMINER BREDEFELD, RACHAEL EV A ART UNIT PAPER NUMBER 1611 NOTIFICATION DATE DELIVERY MODE 07/11/2019 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): IPDocket@HowardandHoward.com dtrost@HowardandHoward.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte CATHARINA EVERDINA HISSINK, THEODORUS ADRIANUS CORNELIUS FLIPSEN, JOHAN ZUIDEMA, and LINDA JOAN GIBCUS Appeal2019-000897 Application 14/695,174 Technology Center 1600 Before JEFFREY N. FRED MAN, DEBORAH KATZ, and JOHN G. NEW, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal 1,2 under 35 U.S.C. § 134(a) involving claims to a hydrophilic biodegradable foam. The Examiner rejected the claims as obvious and indefinite. We have jurisdiction under 35 U.S.C. § 6(b). We affirm but designate our affirmance as a new ground of rejection. 1 Appellants identify the Real Party in Interest as Stryker European Holdings I, LLC (see App. Br. 1 ). 2 We have considered and herein refer to the Specification of Apr. 24, 2015 ("Spec."); Final Office Action of Sept. 8, 2017 ("Final Act."); Appeal Brief of Feb. 14, 2018 ("App. Br."); Examiner's Answer of Sept. 12, 2018 ("Ans."); and Reply Brief of Nov. 9, 2018 ("Reply Br."). Appeal2019-000897 Application 14/695,174 Statement of the Case Background "The need for synthetic absorbable sponges or absorbent foams that can be left in the wound is now well recognized" (Spec. 3: 19-20). Requirements of such foams are a) a high (fluid) absorption capacity, particularly for blood, b) rapid absorption of fluid, c) strength to be readily handled in surgical procedures, d) conformable so as to fit into any topography or space, e) maintenance of mechanical properties, such as resilience, for a specific period of time during or after surgery or after application of the foam, and f) soft so as to avoid injury to sensitive tissues. (Spec. 3 :20-26). "[T]he foam of the invention is comprised of an amorphous hydrophilic soft segment or phase and a crystalline hard segment or phase" (Spec. 4:23-24). "The presence of hydrophilic segment or group in the amorphous phase of the polymer ... provides said foam with required characteristics such as the capacity to absorb aqueous liquids and being readily biodegradable" (Spec. 4:27-30). "[T]he crystalline hard segment or phase must provide the foam with rigidity, keep the foam intact and prevent swelling of the foam when placed in contact with fluids" (Spec. 5:4-6). The Claims Claims 1, 7-9, 12-15, 17, 18, 20-25, and 27-30 are on appeal. Independent claim 17 is representative and reads as follows: 17. Biodegradable absorbent foam, suitable for packing antrums or other cavities of a human or animal body, compnsmg a phase-separated polymer including an amorphous segment and a crystalline segment, said polymer having the formula: 2 Appeal2019-000897 Application 14/695,174 wherein the amorphous segment comprises R, R is selected from one or more aliphatic polyether esters or polyanhydrides, at least one R comprises a hydrophilic segment selected from the group consisting of polyether, polypeptide, poly(vinylalcohol), poly(vinylpyrrolidone ), and po 1 y(hydroxymethy lmethacry late), R' and R" are independently C2-Cs alkylene, optionally substituted with C1-C10 alkyl or C1-C10 alkyl groups substituted with protected S, N, P or O moieties and/or comprising S, N, P or O in the alkylene chain; Z1-Z4 are each urethane, Q1 and Q2 are independently urea, urethane, amide, carbonate, ester or anhydride, n is an integer from 5-500, and p and q are both 1. The Re} ections A. The Examiner rejected claims 1, 7-9, 12-15, 17, 18, 20-25, and 27-30 under 35 U.S.C. § 112, second paragraph for being indefinite (Final Act. 3-4). B. The Examiner rejected claims 17, 18, 20, 23-25, and 27 under 35 U.S.C. § 103(a) as obvious over W0'491 3 and Spaans4 (Final Act. 5-8). 3 Spaans et al., WO 99/64491 Al, published Dec. 16, 1999. 4 Spaans et al., US 2001/0043913 Al, published Nov. 22, 2001. 3 Appeal2019-000897 Application 14/695,174 C. The Examiner rejected claims 1, 7-9, 12-15, 17, 18, 20-25, 27, and 28 under 35 U.S.C. § 103(a) as obvious over W0'491, Spaans, and Cohn5 (Final Act. 8-12). D. The Examiner rejected claims 1, 7-9, 12-15, 17, 18, 20-25, and 27-30 under 35 U.S.C. § 103(a) as obvious over W0'491, Spaans, Cohn, and Evans6 (Final Act. 12-13). A. 3 5 U.S. C. 112, second paragraph The Examiner finds indefinite the phrase "R' and R" are independently C2-Cs alkylene, optionally substituted with C1-C10 alkyl or C1-C10 alkyl groups substituted with protected S, N, P or O moieties and/or comprising S, N, P or O in the alkylene chain" (Final Act. 3). The Examiner finds "the 'comprising' language in the above limitations is open-ended and the metes and bounds of the limitations are unclear. It is not clear what else the alkylene groups could comprise (i.e., more carbon atoms outside the range)" (id.). Appellants contend "a person of ordinary skill in the art would readily understand the claimed limitation, particularly in view of the specification (see Page 5, lines 20-23; and Page 26, lines 20-23)" (App. Br. 21 ). Appellants contend that the term "comprising" allows for inclusion of additional atoms in the alkylene chain, e.g., heteroatoms that are not S, N, P, or 0. See App. Br. 22. Appellants contend "inclusion of additional carbon atoms in the alkylene chain of the of the C3 alkyl group such that the number of carbon atoms exceeds the C1-C10 range ( e.g. 1000 carbon atoms) would 5 Cohn et al., EP 0295055 A2, published Dec. 14, 1988. 6 Evans et al., US 2003/0236573 Al, published Dec. 25, 2003. 4 Appeal2019-000897 Application 14/695,174 be understood by a person of ordinary skill in the art to be outside the C1- C10 range and therefore not within the scope of claims 1 and 17" (id.). We are persuaded by Appellants' argument. The plain meaning of the claim does not allow for more carbon atoms outside the claimed range. We reverse this rejection. B.-D. Obviousness Because the same issue of the combining the prior art is relevant to each of these rejections, we will consider these rejections together. The Examiner finds "WO' 491 teaches biomedical polyurethanes and their use as porous shaped, biodegradable implants" (Final Act. 5). The Examiner finds W0'491 teaches a "50/50 E-caprolactone/L-lactide prepolymer initiated with butanediol and extended with BDI-BDO-BDI- BDO-BDI" wherein BDI is 1,4-butanediisocyanate and BDO is 1,4- butanediol (id.). The Examiner finds the synthesis results in "a polymer meeting all the limitations recited in instant claims 17 and 24 ... with the only difference being that W0'491 does not explicitly teach its polyurethanes have an amorphous segment that comprises a hydrophilic segment selected from ... polyether" (Final Act. 5-6). The Examiner finds Spaans teaches "macroporous biomedical polyurethane-amide based materials" including a soft polyester phase. (Final Act. 6). The Examiner finds Spaans teaches "[ s Jui table preferred monomers for the polyester are equimolar amounts of E-caprolacton[ e] and L-lactide (paragraph 0036) and suitable diisocyanates include small blocks of diisocyanate terminated diol (BDl-butanediol-BDI) (paragraph 0038)" (id.). The Examiner finds the "polyester can also be combined with a 5 Appeal2019-000897 Application 14/695,174 polyol, such as a polyether-polyol, in order to modify the properties thereof (biodegradability, phase separation, hydrophilicity, mechanical properties, etc.). Preferably low molecular weight polyols are used (MW from 500- 3000, based on ethylene and/or propylene glycol)" (id.). The Examiner concludes: [I]t would have been obvious to an artisan of ordinary skill at the time the invention was made to include polyethylene glycol (polyether) ... in the polyester segments ofW0'491 's polyurethanes. A skilled artisan would have been motivated to do so since Spaans et al teach low molecular weight glycols can be combined with its polyesters to modify properties such as biodegradability, phase separation, hydrophilicity, and mechanical properties. (Final Act. 6). The issue with respect to this rejection is: Does a preponderance of the evidence of record support the Examiner's conclusion that the prior art renders the claims obvious? Findings of Fact ("FF'') 1. W0'491 teaches biomedical polyurethanes "processed into porous shaped bodies, e.g., as implants" (W0'491 1:18-20). 2. W0'491 teaches "porous 50/50 copoly(E-caprolactone/L-lactide) materials were used for the reconstruction of meniscal lesions .... [H]owever ... the degradation rate was somewhat too high. New meniscal tissue, the so called fibrocartilage, is formed after an induction time of 10 to 20 weeks" (W0'491 1:21-32). 3. W0'491 teaches "[a]n important feature of these polyurethanes is that they owe their good mechanical properties to the phase separated morphology. Because the soft segments ( e.g. polyesters, polycarbonates or 6 Appeal2019-000897 Application 14/695,174 polyethers) are chemically incompatible with the hard segments (urethane, urea or amide moieties) phase separation occurs" (W0'491 4:11-16). 4. W0'491 teaches a polyurethane formed by chain-extending a polycaprolactone (50/50 L-lactide and E-caprolactone) with a BDI-BDO- BDI-BDO-BDI block (see W0'491 8:26-33; 11:3-6). 5. Spaans teaches "macroporous biomedical polyurethane-amide based materials, having good mechanical properties, that can be prepared by an easy in-situ foam generating process" (Spaans ,-J 22). 6. Spaans teaches the material "is applicable to various types of implants in the human or animal body, such as for meniscal reconstruction, but also for other types of implants, including artificial skin, nerve guides, vascular prostheses and medical devices such as wound dressings" (Spaans ,-J 31 ). 7. Spaans teaches: The nature of the application determines the level of biodegradability, which is mainly determined by the nature of the polyester prepolymer. Generally a material is considered biodegradable in case it degrades into non-toxic components within a reasonable period of time. Degradation can be determined by following the mechanical properties of the material as function of the time. For meniscal repair material it is preferred that the mechanical properties as indicated earlier, are maintained for a certain period of time, for example at least three months, following which they start to drop. (Spaans ,-J 32). 8. Spaans teaches "the polyurethane of the invention comprises in the most general form chain extended isocyanate terminated polyester prepolymer units, the said chain extension being based on least one dicarboxylic acid or a hydroxy-carboxylic acid, resulting in urethaneamide segments" (Spaans ,-J 33). 7 Appeal2019-000897 Application 14/695,174 9. Spaans teaches the material may include a linear random copolyester having about equimolar amounts of E-caprolactone and L-Lactide, endcapped with isocyanate terminated materials, such as diisocyanate terminated diol (BDI-butanediol-BDI) (Spaans ,i,i 36, 38). 10. Spaans teaches: It is possible to combine the polyester with a polyol, such as a polyether-polyol, in order to modify the properties thereof (biodegra[ da ]bility, phase separation, hydrophilicity, mechanical properties). This polyol may either be included in the polyester itself, or may be mixed with the polyester, prior to endcapping. Preferably low molecular weight polyols are used (Mw from 500 to 3000, based on ethylene and/or propylene glycol). (Spaans ,i 39). 11. Cohn teaches polymeric materials for bioabsorbable surgical articles including sutures, vascular grafts, wound and bum coverings, textile structures, and other forms of support (Cohn Abst.; 3:60-65). 12. Cohn teaches the polymeric materials include "multiblock copolymers obtained through the polyesterification of[] a-hydroxycarboxylic acid in the presence of hydroxyl-ended poly(alkylene glycol) chains of various molecular weights .... A preferred poly(alkylene glycol) is poly( ethylene glycol), preferably in the 600-6000 molecular weight range" (Cohn 3:53- 57). 13. Cohn teaches polyethylene glycol-lactic acid block copolymers containing 18-71 % polyethylene glycol (Cohn 10:5-45, Table I). 14. Cohn teaches "the developed copolymers ... show a substantial decrease in stiffness and a large increase in the elongation at break. Of special interest were highly flexible PELA polymers, exhibiting an 8 Appeal2019-000897 Application 14/695,174 elastomeric-like behavior, with a modulus of 5 MPa and elongation at break of900%" (Cohn 10:53-57). 15. Evans teaches an implant "comprising collagen and other bio- resorbable materials, where the implant may also be used for therapy delivery" (Evans, Abst.). 16. Evans teaches the implant "is generally fabricated from one or more biocompatible materials ( e.g. polymer)" and "may contain a depot of material (e.g., calcium salts, collagens, cytokines, drugs, etc.) for assisting the in-growth of cells and act as a carrier for other constituents" (Evans ,-J 80). Principles of Law "In determining whether the subject matter of a patent claim is obvious, neither the particular motivation nor the avowed purpose of the patentee controls. What matters is the objective reach of the claim. If the claim extends to what is obvious, it is invalid under § 103." KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398,419 (2007). Analysis We adopt the Examiner's findings of fact and conclusion of law (Final Act. 5-13; FFs 1-16), and agree that the combination ofW0'491, Spaans, Cohn, and Evans renders the claims obvious. However, as our reasoning differs with respect to claims 18 and 21, we designate our affirmance as a new ground of rejection. We address Appellants' arguments below. Claims 17, 20, 23-25, and 27: W0'491 and Spaans Appellants contend "[i]nclusion of the hydrophilic segment of Spaans '914 in the polyurethane implant of [W0'491] would render the implant of 9 Appeal2019-000897 Application 14/695,174 [WO' 491] inoperable as a nerve guide, meniscal reconstruction material, artificial skin and/or artificial vein because the resultant implant would degrade too quickly" (App. Br. 9, emphasis omitted). Appellants contend "in order for the polyurethane implant to be suitable as a nerve guide, etc., the implant of [WO' 491] must have a degradation rate suitable for fibrocartilage induction ... [ and] cannot degrade more quickly than 10 weeks or it would be inoperable for its intended purpose" (App. Br. 10). Appellants contend that "in the context of the implant of [W0'491], the inclusion of a hydrophilic segment such as the polyether of Spaans '913 would necessarily lead to 1) the implant degrading more quickly than the intended 10 to 20 weeks required for fibrocartilage induction; and 2) increased swelling of the implant" (App. Br. 11 ). We do not find this argument persuasive because nothing in the prior art teaches that the proposed modification would have resulted in an "inoperable" biodegradable foam or a phase-separated polymer with undesirable properties. See In re Urbanski, 809 F.3d 1237, 1244 (Fed. Cir. 2016). Spaans teaches that phase-separated polyurethane-amide-polyesters are applicable to various types of implants, including meniscal implants, nerve guides, and wound dressings (FF 6). Spaans teaches the nature of application determines the level of biodegradability (FF 7). Spaans teaches that biodegradability is determined by the polyester, and that a polyol may be added to the polyester to modify biodegradability and hydrophilicity (FFs 7, 10). W0'491 and Spaans suggest that the combination of crystalline polyurethane and amorphous polyester-polyol can be varied in order to adjust the properties of the biodegradable implant. See Urbanski, 809 F.3d at 1242. Here, we conclude that one of ordinary skill in the art would have 10 Appeal2019-000897 Application 14/695,174 had a reason to modify the biodegradability of the implant depending on the nature of the application, e.g., as a wound dressing rather than a meniscal reconstruction material. Appellants contend "that one of ordinary skill in the art could not combine the teachings of [W0'491] and [Spaans] with any degree of predictability and would therefore not combine the teachings with a reasonable expectation of success" (App. Br. 16). Appellants contend that "[W0'491] discloses a polyurethane implant comprising a urethane-based hard segment and polyester-based soft segment" in contrast to Spaans' "polymer having urethane-amide-based hard segments" (App. Br. 14-15). Appellants contend "because the polyurethane implant of [W0'491] does not contain urethane-amide hard segments, one of ordinary skill in the art would readily understand that the teachings of Spaans '913 pertaining to the inclusion of a hydrophilic segment are not applicable to the implant of [W0'491]" (App. Br. 16). We find this argument unpersuasive because "obviousness cannot be avoided simply by a showing of some degree of unpredictability in the art so long as there was a reasonable probability of success." Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364 (Fed. Cir. 2007). Both W0'491 and Spaans are directed to biodegradable implants made of phase-separated polymers incorporating polyurethane and polyester-based segments. Indeed, Spaans expressly cites to W0'491 (see Spaans ,-J,-J 20, 21) and describes modifying the phase-separated polymer to provide improved implants (see FFs 5, 7). Spaans teaches predictable modifications to biodegradability by modifying the polyester, including combining the polyester with a polyol (FFs 7, 10). Because the combination ofW0'491 11 Appeal2019-000897 Application 14/695,174 and Spaans is "the predictable use of prior art elements according to their established functions," we are not persuaded that the Examiner erred in concluding that claims 17, 20, 23-25, and 27 are unpatentable over the prior art. See KSR, 550 U.S. at 417. Claims 1, 7-9, 12-15, 22, and 28: W0'491, Spaans, and Cohn The Examiner finds "W0'491 does not explicitly teach its polyurethanes have an amorphous segment that comprises polyethylene glycol in a content of 1-80 wt% and a number average molecular weight of 150 to 4000 g/mol" (Final Act. 8-9). The Examiner finds "[ o ]ne would have been motivated to incorporate polyethylene glycol at a molecular weight of 500-3000 since Spaan et al similar polyurethanes as discussed in W0'491 used for the same purpose" (Final Act. 9). The Examiner finds "[a] skilled artisan would [] have a reasonable expectation of success to add the amounts of polyethylene glycol disclosed in Cohn et al depending on the desired flexibility and elastomeric behavior ofW0'491 's polyurethanes" (Final Act. 10). Appellants repeat their arguments as to the combination ofW0'491 and Spaans, discussed with respect to claims 17, 20, 23-25, and 27 (App. Br. 17). Appellants contend "Cohn teaches a poly( a-hydroxy-carboxylic acid)/poly( oxyalkylene) (hereinafter 'PELA') polymer and not a polyurethane" (App. Br. 18). Appellants contend "the PELA polymer of Cohn does not even contain any hard segments as described in [WO' 491] or Spaans '913 because the poly( a-hydroxy-carboxylic acid) segment is a polyester (i.e., a soft segment, as described in [W0'491] and Spaans '913) and not a polyurethane" (id.). Appellants contend "[b Jecause Cohn has no such hard segments, the teachings of Cohn provide no degree of 12 Appeal2019-000897 Application 14/695,174 predictability regarding how the incorporation of PEG in particular amounts will impact the polyurethane implant of [W0'491]" (id.). We find Appellants' argument unpersuasive because "[n]on- obviousness cannot be established by attacking references individually where the rejection is based upon the teachings of a combination of references. . . . [The reference] must be read, not in isolation, but for what it fairly teaches in combination with the prior art as a whole." In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986). Here, Cohn teaches molecular weights and amounts of PEG for use in biodegradable implants in combination with W0'491 and Spaans (see FFs 11-13). The PEG is incorporated into a lactic-acid containing polyester, similar to that of W0'491 and Spaans (see FFs 2, 4, 9). Spaans teaches the predictable effects of adding PEG, with a similar molecular weight, to the polyurethane- polyester implant ofW0'491 to modify the properties of biodegradability, phase separation, hydrophilicity, and mechanical properties (FF 10). Accordingly, as discussed above, the combined prior art teaches the predictable use of prior art elements according to their established functions, and we are not persuaded that the Examiner erred in concluding claims 1, 7- 9, 12-15, and 28 are unpatentable over the prior art. Claims 18 and 21 Appellants contend "[t]he Examiner has not cited any disclosure in any reference that describes a fragmentation time of 1 to 10 days" as recited by claims 18 and 21 (App. Br. 12). Appellants contend "one of ordinary skill in the art would not be able to predict to any degree whether the PEG of Spaans '913 would impact the degradation time of the polyurethane implant 13 Appeal2019-000897 Application 14/695,174 of [WO' 491] to the amount necessary for a complete fragmentation time of 1 to 10 days" (App. Br. 13). The Examiner finds that, with respect to claims 18 and 21, limitations directed to the foam's fragmentation time "would naturally flow from all the suggested features ofW0'491 's polyurethanes and polyethers discussed in Spaans et al and therefore, would be obvious" (Final Act. 7, 11). We do not agree with the Examiner's reasoning. As shown by Appellants' Specification and the prior art, phase-separated polymers that would have been obvious do not necessarily possess the characteristics of the claimed product, e.g., a fragmentation time of 1-10 days. Although the prior art does not teach the claimed fragmentation time, the prior art does teach the general conditions of the claims. See In re Aller, 220 F.2d 454,456 (CCPA 1955). Particularly, Spaans teaches "[t]he nature of the application determines the level of biodegradability," which in tum is determined by the polyester prepolymer as modified by the polyether-polyol (FFs 7, 8, 10). Spaans teaches "a material is considered biodegradable in case it degrades ... within a reasonable period of time" and that the material may be used as a wound dressing (FFs 6, 7). Accordingly, Spaans suggests preparing a material for a wound dressing that degrades within a reasonable period of time for a wound dressing as opposed to a meniscal repair implant. Because Spaans teaches the modifications that would have been within the capabilities of one skilled in the art, discovering the optimum or workable ranges of biodegradability for a wound dressing by routine experimentation is not inventive. Aller, 220 F.2d at 456. Here, Appellants do not distinguish the claimed polymer from those in the prior art. Appellants have not established any criticality between the 14 Appeal2019-000897 Application 14/695,174 claimed combination of components of the polymer and the fragmentation of the foam. See Aller, 220 F.2d at 456. Appellants have not established that the fragmentation time of the claimed polymer is different in kind and not merely in degree from the prior art polymer. See id. Accordingly, we conclude that Appellants have not overcome prima facie obviousness in view of the prior art. Because our reasoning differs from that of the Examiner, we designate our affirmance as a New Ground of Rejection to provide Appellants a fair opportunity to address these teachings and new position. Claims 29 and 30: WO '491, Spaans, Cohn, and Evans Appellants contend that "Evans fails to disclose a phase-separated polymer of formula (I)" (App. Br. 19). Appellants contend "[b Jecause Evans fails to disclose a phase-separated polymer including an amorphous segment and a crystalline segment, Evans cannot cure the deficiencies of [W0'491], Spaans '913, and Cohn described above" (App. Br. 19-20). We find Appellants' argument unpersuasive as it addresses Evans individually, and not the prior art as a whole. As discussed above, the combination ofW0'491, Spaans, and Cohn teaches the phase-separated polymer of claim 1, from which claims 29 and 30 depend. Evans teaches a biodegradable implant containing a drug substance or a collagen ( a hemostatic component) (FFs 15, 16). We agree with the Examiner that: A skilled artisan would have been motivated to [include a drug or hemostatic component] since Evans et al suggest the addition of drugs and collagen would assist the in-growth of cells within polymeric implants and thus, a skilled artisan would have a reasonable expectation that such benefits would also apply to the biomedical implants of WO' 491 15 Appeal2019-000897 Application 14/695,174 (Final Act. 13). Accordingly, the combined prior art teaches the predictable use of prior art elements according to their established functions, and we are not persuaded that the Examiner erred in rejecting claims 29 and 30. Conclusion of Law A preponderance of the evidence of record support the Examiner's conclusion W0'491, Spaans, Cohn, and Evans render the claims obvious. SUMMARY In summary, we reverse the rejection of claims 1, 7-9, 12-15, 17-18, 20-25, and 27-30 under 35 U.S.C. § 112, second paragraph as being indefinite. We affirm the rejection of claims 17, 18, 20, 23-25, and 27 under 35 U.S.C. § 103(a) over W0'491 and Spaans. We affirm the rejection of claims 1, 7-9, 12-15, 21, 22, and 2 8 under 35 U.S.C. § 103(a) over W0'491, Spaans, and Cohn. We affirm the rejection of claims 29 and 30 under 35 U.S.C. § 103(a) over W0'491, Spaans, Cohn, and Evans. Because we rely on an optimization rationale that was not relied upon by the Examiner, we designate our affirmance as a new ground 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: 16 Appeal2019-000897 Application 14/695,174 (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 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; 37 C.F.R. § 41.50(b) 17 Copy with citationCopy as parenthetical citation