Gruenenthal GmbH

Patent Trials and Appeals Board

Jan 12, 2022

2021005256 (P.T.A.B. Jan. 12, 2022)

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. 15/245,855 08/24/2016 Klaus SCHIENE 107101-240 KGB 9804 27384 7590 01/12/2022 Briscoe, Kurt G. Norris McLaughlin, PA 7 Times Square, 21st Floor New York, NY 10036-6524 EXAMINER CRUZ, KATHRIEN ANN ART UNIT PAPER NUMBER 1627 NOTIFICATION DATE DELIVERY MODE 01/12/2022 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): mgonzalez@norris-law.com nmanfredi@norris-law.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte KLAUS SCHIENE and PETRA BLOMS-FUNKE Appeal 2021-005256 Application 15/245,855 Technology Center 1600 ____________ Before RICHARD M. LEBOVITZ, JEFFREY N. FREDMAN, and ULRIKE W. JENKS, Administrative Patent Judges. LEBOVITZ, Administrative Patent Judge. DECISION ON APPEAL The Examiner rejected claims 1, 2, 5-10, 16, 18, 19, 22-26, 30, 33- 37, 40-44, 52, and 53 under 35 U.S.C. § 103 as obvious. Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject the claims. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM, but designate the rejection of claims 1, 40, 44, and 53 as a new ground of rejection pursuant to 37 C.F.R. § 41.50(b). 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as Grünenthal GmbH. Appeal Br. 1. Appeal 2021-005256 Application 15/245,855 2 STATEMENT OF THE CASE The Examiner rejected claims 1, 2, 5-10, 16, 18, 19, 22-26, 30, 33- 37, 40-44, 52, and 53 as follows: 1. Claims 1, 2, 5-10, 22-26, 30, 33-37, 40-43, 52, and 53 under 35 U.S.C. § 103(a) as obvious in view of Buschmann et al. (US 6,344,558 B1, issued Feb. 5, 2002) (“Buschmann”), Wilder-Smith et al. (“Postoperative Sensitization and Pain After Cesarean Delivery and Effects of Single IM doses of Tramadol and Diclofenac Alone and in Combination,” Anesth. Analg, 2003, 97: 526-533) (“Wilder-Smith”), and Garcia-Alonso et al. (“Comparative study of the efficacy of dipyrone, diclofenac sodium and pethidine in acute renal colic,” Eur. J. Clin. Pharmacol., 1991, 40:543-546) (“Garcia-Alonso”). Final Act. 2. 2. Claim 44 under 35 U.S.C. § 103(a) as obvious in view of Buschmann, Wilder-Smith, Garcia-Alonso and Ward et al. (“The analgesic effects of caffeine in headache,” Pain, 1991, 44(2): 151-155) (“Ward”). Final Act. 2-3. Claims 1 and 53 are representative of the appealed claims and reproduced below: 1. A composition comprising: (a) at least one 3-(3-Dimethylamino-l-ethyl-2-methyl-propyl)- phenol compound corresponding to formula (I), or a solvate or an acid addition salt thereof, and Appeal 2021-005256 Application 15/245,855 3 (b) one or more non-steroidal anti-inflammatory drugs (NSAIDs) selected from the group consisting of Diclofenac, Diclofenac-Sodium, Ibuprofen, Metamizol, Metamizol-Sodium, and Ketoprofen. 53. A composition comprising a synergistic combination of: (a) at least one 3-(3-Dimethylamino-l-ethyl-2-methyl-propyl)- phenol compound corresponding to formula (I), or a solvate or an acid addition salt thereof, and (b) one or more non-steroidal anti-inflammatory drugs (NSAIDs) selected from the group consisting of Diclofenac, Diclofenac-Sodium, Ibuprofen, Metamizol, Metamizol-Sodium, and Ketoprofen. An oral hearing was held by video conference on December 15, 2021. A transcript of the hearing will be entered into the rejection in due course. REJECTIONS BASED ON BUSCHMANN, WILDER-SMITH, AND GARCIA-ALONSO The claims are directed to a composition comprising (a) at least one 3- (3-Dimethylamino-l-ethyl-2-methyl-propyl)-phenol compound and (b) one or more non-steroidal anti-inflammatory drugs (NSAIDs) selected from the group consisting of Diclofenac, Diclofenac-Sodium, Ibuprofen, Metamizol, Metamizol-Sodium, and Ketoprofen. 3-(3-Dimethylamino-l-ethyl-2-methyl-propyl)-phenol is also known as “tapentadol.” Appeal Br. 7. The term “tapentadol” is used throughout this Appeal 2021-005256 Application 15/245,855 4 Decision to refer to the claimed compound. The Specification discloses that tapentadol exists in four different stereoisomers. Spec. ¶ 10. Claims 1 and 53 do not limit tapentadol to one of the four specific stereoisomers described in the Specification. The Examiner found that Buschmann discloses that tapentadol is useful for the treatment of pain. Final Act. 11. The Examiner further found that tapentadol has an analgesic effect “which is significantly enhanced compared with an analgesic, tramadol.” Id. The Examiner found that Buschmann does not describe the combination of tapentadol and one of the NSAIDs recited in the claims. Id. at 12. However, the Examiner found that Wilder-Smith discloses that tramadol and diclofenac, one of the recited NSAIDs, resulted in improved analgesia as compared to monotherapy with each alone. Id. The Examiner found it would have been obvious to one of ordinary skill in the art to substitute tapentadol for tramadol in Wilder- Smith’s combination “because Buschmann teaches that tapentadol has [an] analgesic effect which is significantly enhanced compared with . . . tramadol and Smith teaches that the combination of tramadol and diclofenac resulted in [an] improved analgesia effect.” Id. The Examiner also found that that the claimed combination of tapentadol and diclofenac would be more effective than tramadol and diclofenac because Buschmann discloses that tapentadol is more effective as an analgesic than tramadol. Id. at 12-13. The Examiner also cited Garcia-Alonso for its teaching that dipyrone and diclofenac are art recognized NSAIDs, which have similar analgesic effects. Final Act. 12. Dipyrone is also known as “metamizole,” which is one of the NSAIDs listed in claims 1 and 53. Appeal 2021-005256 Application 15/245,855 5 Appellant’s arguments are mainly directed to claim 53, which recites a composition comprising a “synergistic combination” of tapentadol. Appellant cited evidence in the Specification that the administration of a combination of tapentadol and the NSAIDs recited in the claim exhibit a “supraadditive” effect, which Appellant argues is also synergistic. Appeal Br. 8-10, 20 (citing data in Tables 1 and 2 on pages 19-20 of the Specification). Appellant argues that it would not have been obvious to one of ordinary skill in the art that the combination of tapentadol and diclofenac would have enhanced analgesic effects and synergy. Id. at 11, 12-13. Appellant cites the disclosure in Wilder-Smith of additive effects when tramadol and NSAID are administered as a combination and not synergy as claimed. Id. at 14-17. Appellant further cites the disclosure in the Satyanarayana reference2 that tramadol and naproxen showed “‘supra- additive or synergistic interaction,’” but in contrast, the combination of tapentadol and naproxen is shown in the Specification to be only additive. Id. at 18 (emphasis omitted). This data, Appellant contends, disproves the Examiner’s theory that because tapentadol was shown to be superior to tramadol, it would be reasonably expected to “to show an even greater synergy when combined with naproxen.” Id. In contrast, Appellant states, the combination of tapentadol and naproxen “did not exhibit any synergy at all, but instead only a conventional additive effect.” Id. Thus, Appellant contends synergism between tapentadol and one of the claimed NSAIDs would have been unpredictable. Id. at 19. 2 Satyanarayana et al., Progress in Neuro-Psychopharmacology & Biological Psychiatry, 2004, 28:641-649. Appeal 2021-005256 Application 15/245,855 6 The Examiner responded that the results were insufficient to demonstrate synergy. Ans. 9. The Examiner identified a several objections to the data in the Specification relied upon by Appellant to establish synergy. We summarize the Examiner’s arguments as follows:3 First, Tables 1 and 2 of the Specification, which are cited by Appellant as establishing synergy for the claimed subject matter, describe administration of the stereoisomer (1R,2R)-3-(3-Dimethylamino-1-ethyl-2- methyl-propyl)phenol, but the claim is not limited to a specific stereoisomer of tapentadol, let alone this specific stereoisomer. Ans. 10. Second, a “composition” of tapentadol and one of the recited NSAIDs is claimed, but the examples in Table 1 and 2 of the Specification did not administer a composition, but instead administered tapentadol intravenously (i.v.) and the NSAID intraperitoneally (i.p.). Id. Third, the dosages employed in Tables 1 and 2 to demonstrate synergy are not commensurate in scope with the claim. Id. Each of these concerns are addressed below, along with Appellant’s response to them. 3 The Examiner cited additional objections to the data which are not addressed in this Decision. We have not addressed them because we find they are not supported by a preponderance of the evidence and/or the Examiner did not have sufficient basis to find the data inadequate on the stated ground. The summarized arguments provide Appellant with a clear understanding of why the Examiner found the data insufficient. Any additional arguments/objections set forth by the Examiner in the Answer, which are not addressed here, are not considered to be a sufficient objection to the evidence and have not been considered in this Decision. Appeal 2021-005256 Application 15/245,855 7 DISCUSSION The Examiner’s finding that it would have been obvious to combine tapentadol and one of the NSAIDs recited in the rejected claims is supported by a preponderance of the evidence because each were known in the prior to have analgesic activity. “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition which is to be used for the very same purpose . . . [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980). Although the evidence supports the Examiner’s finding of the obviousness of combining tapentadol with one of the claimed NSAID analgesics, Appellant provided sufficient evidence (as explained above) that synergism between the compounds, as recited in claim 53 only, would not have been predictable. See Appeal Br. 14-19. Appellant relies on the data shown in Tables 1 and 2 of the Specification to establish synergy of tapentadol and an NSAID of the claims. The data disclosed in Tables 1 and 2 are described in the Specification as being analyzed in accordance with the Tallarida reference.4 Spec. ¶ 87. “The application route was intravenous (i.v.) for (1R,2R)-3-(3-Dimethylamino-1- ethyl-2-methyl-propyl)-phenol (A) and intraperitoneal (i.p.)” for the NSAIDs. Spec. ¶¶ 89, 92. The tables show that a single ratio between one stereoisomer of tapentadol ((1R,2R)-3-(3-Dimethylamino-1-ethyl-2-methyl-propyl)-phenol) and ibuprofen, diclofenac-sodium, ketoprofen, and metamizol-sodium 4 Tallarida et al., “Statistical Analysis of Drug-Drug and Site-Site Interactions with Isobolograms,” 1989, Life Sciences, 45:947-961. Appeal 2021-005256 Application 15/245,855 8 (representative of all four claimed NSAIDs) showed “supraadditive” interactions having a statistical significance of “p<0.001.” Spec. 19-20 (¶¶ 90, 93). The Specification discloses that “the combination studies demonstrate significant synergistic interaction of (1R,2R)-3-(3- Dimethylamino-1-ethyl-2-methyl-propyl)-phenol with both NSAIDs, Diclofenac-Sodium and Ibuprofen.” Spec. ¶ 89. The Specification also discloses that “[t]he combination studies demonstrate significant synergistic interaction of (1R,2R)-3-(3-Dimethylamino-1-ethyl-2-methyl-propyl)phenol with both NSAIDs Ketoprofen and Metamizol sodium.” Id. ¶ 92. In contrast, the same tapentadol stereoisomer only showed additive effects when combined with naproxen, another NSAID, but not an NSAID in the scope of the rejected claims. Id. ¶ 93. Thus, not all NSAIDs gave synergistic results when combined with the single tested tapentadol stereoisomer. “One way for a patent applicant to rebut a prima facie case of obviousness is to make a showing of ‘unexpected results,’ i.e., to show that the claimed invention exhibits some superior property or advantage that a person of ordinary skill in the relevant art would have found surprising or unexpected.” In re Soni, 54 F.3d 746, 750 (Fed. Cir. 1995). “The evidence presented to rebut a prima facie case of obviousness must be commensurate in scope with the claims to which it pertains.” In re Dill, 604 F.2d 1356, 1361 (CCPA 1979); see also In re Kao, 639 F.3d 1057, 1068 (Fed. Cir. 2011) (“If an applicant demonstrates that an embodiment has an unexpected result and provides an adequate basis to support the conclusion that other embodiments falling within the claim will behave in the same manner, this will generally establish that the evidence is commensurate with [the] scope of the claims.”). Appeal 2021-005256 Application 15/245,855 9 The data shown in Tables 1 and 2 of the Specification is not commensurate with the full scope of claim 53. First, as indicated by the Examiner, the claim is directed to a tapentadol compound, which includes any one or all of the stereoisomers disclosed in the Specification, but all the examples in Tables 1 and 2 used a single stereoisomer. Appellant has not shown that the three other stereoisomers of tapentadol disclosed in the Specification, which have different spatial configurations, would also exhibit synergism when combined with one of the claimed NSAIDs. Second, only one ratio was shown for each combination. As explained in the Specification, :“the ratio of A and Diclofenac-Sodium can be calculated to be 1:77.5, the ratio of A to Ibuprofen to be 1:73.8” and “[t]he ratio of A and (+)-Naproxen used in the experiments was 1:87.3, the ratio of A and Ketoprofen 1:119 and the ratio of A and Metamizol-Sodium was 1:46.9.” Spec. ¶¶ 91, 94. Third, as also indicated by the Examiner, the claim is directed to a composition that comprises the tapentadol and NSAID, but the claimed compounds were not administered as a single composition, but rather separately by different routes, tapentadol by i.v. and the NSAID by i.p.. With respect to the first objection to the data because all examples only use (1R,2R)-3-(3-Dimethylamino-1-ethyl-2-methyl-propyl)phenol (“the 1R, 2R enantiomer”), Appellant argues “the tested members are structurally close to and, therefore, representative of the non-tested members.” Reply Br. 11. Citing Tallarida, Appellant argues that persons of ordinary skill in the art “would understand that a multitude of different weight ratios of Appeal 2021-005256 Application 15/245,855 10 tapentadol with each of the recited NSAID species would have been expected to synergize.” Appeal Br. 8. As evidence, Appellant cites to Figure 4(a) of Tallarida which is a graph showing points along a diagonal line which are additive, and points below the line which are superadditive, and points above the line which are subadditive regions. Id. Appellant concludes that “once Appellant demonstrated that component (a) [tapentadol] and component (b) [one of the recited NSAIDs] synergized at the specific ratios calculated, persons skilled in the art would have expected that many other weight ratios falling below the line of additivity would also have been synergistic.” Appeal Br. 10. Appellant contends, with regard to the objection that the compounds were administered by different administration routes, that “person skilled in this art would understand that the demonstrated synergy, while achieved using different administration routes, occurs in vivo because active ingredients (a) and (b) simultaneously come to be present in the blood in a quantity that brings about a synergistic interaction between them.” Id. at 9. Appellant states it should not matter how the compounds are introduced into the body “as long as the proper blood concentrations of both active ingredients are simultaneously achieved.” Id. Appellant further argues that there is no reason presented by the Examiner that “a person skilled in the art should not be able to formulate the respective active ingredients into a single formulation that would provide the blood concentrations of each active ingredient that are necessary to yield the desired synergy.” Id. at 10. Appellant contends that once synergy was demonstrated, “it is merely a routine matter to formulate the two active ingredients into a single composition to reproduce the synergy demonstrated.” Id. Appeal 2021-005256 Application 15/245,855 11 Appellant also argues that “reasonable assurance against overclaiming is provided in claim 53 by virtue of the ‘synergistic’ requirement so any non- synergistic species are expressly excluded.” Reply Br. 11. We have considered these arguments but are not persuaded that they establish synergistic and unexpected results for the full scope of the claim. Although claim 53 is directed to a “synergistic combination,” which would exclude non-synergistic species as indicated by Appellant, such language does not alleviate Appellant’s burden to demonstrate that the synergistic results are representative of the full scope of the claim. In the Application of Kollman, 595 F.2d 48 (CCPA 1979), independent claim 1 was directed to a “synergistic herbicidal composition” comprising two herbicidal compounds in a weight ratio of “about 1:10 to about 20:1.” Id. at 51. Id. Dependent claims recited narrower ranges and more specific herbicidal compounds. Appellant relied on examples in the Specification as evidence of synergy. Id. at 51-52. The court stated that, with respect to the broader ratio ranges recited in claim 1 and certain of its dependents, “even if each of the examples showed the presence of an unexpected result, those examples would not provide an adequate basis for concluding that the great numbers of compositions recited in generic claims 1, 3-5 and 9-15 would behave in the same way.” Id. at 55. Furthermore, with respect to certain narrower claims which recited narrower ranges of ratios, the court also found the data insufficient. The Kollman court explained: We feel that the unobviousness of a broader claimed range can, in certain instances, be proven by a narrower range of data. Often, one having ordinary skill in the art may be able to ascertain a trend in the exemplified data which would allow him to reasonably extend the probative value thereof. The proof, Appeal 2021-005256 Application 15/245,855 12 thus considered, might then be sufficient to rebut a PTO holding of prima facie obviousness. Kollman, 595 F.2d at 56. The court acknowledged that synergy was shown in the Specification (id. at 54), but did not find it sufficient to overcome the obviousness rejection because the data was not sufficient to show synergy for the “broader claimed range” of the claim. Thus, while the claim excluded non- synergistic combinations because of the recitation of a “synergistic herbicidal composition,” Kollman still required Appellant to show that the full range of ratios recited in the claim provided adequate synergy to rebut prima facie obviousness. The examples in the Specification only uses the 1R, 2R enantiomer, but the claim is not restricted to this compound. Appellant argues that “the tested members are structurally close to and, therefore, representative of the non-tested members.” Reply Br. 11. We take notice of the fact that enantiomers contain the same type and number of atoms, but differ in their three-dimensional structure. Appellant has not provided objective evidence that each of the four different enantiomeric configurations would provide the same type of synergy shown by the one enantiomer tested. An argument made by counsel in a brief does not substitute for evidence lacking in the record. Estee Lauder, Inc. v. L’Oréal, S.A., 129 F.3d 588, 595 (Fed. Cir. 1997). Appellant also argues that the skilled worker would understand “that a multitude of different weight ratios of tapentadol with each of the recited NSAID species would have been expected to synergize.” Appeal Br. 8. Appellant bases this argument on graph by Tallarida showing that synergistic data points fall below a line of additivity on a graph. Id. The Appeal 2021-005256 Application 15/245,855 13 graph reproduced by Tallarida does not indicate that every single point below the line represents an actual superadditive combination of two species of compounds. For example, a point below the line and close to the origin for both axes might not have sufficient amounts of either species to show any therapeutic efficacy at all. Consistently, Tallarida shows an example of upward concave curve of a “superadditive set of dose combinations” which represent a subset of the points below the line. Tallarida 957 (Fig. 7). Tallarida explains: “It does not follow, however, that all combinations within the sector can be said to be potentiating or superadditive with this same p value.” Id. Appellant’s explanation does not address the full disclosure in Tallarida. Appellant has not provided an adequate explanation, supported by objective evidence, that the one data point for each of the synergistic combinations in Table 1 and 2 of the Specification shows a trend in the data that all ratios outside these values would also provide synergy. See Kollman; Kao, 639 F.3d at 1068. The claim is directed to a composition comprising tapentadol and an NSAID selected from a specific list of NSAIDs. The data reported in Tables 1 and 2 of the Specification were not obtained with a single composition as claimed, but with one compound administered intravenously and the other, intraperitoneally. Appellant contends this data is sufficient to demonstrate synergy of the claimed composition because the two active ingredients “come to be present in the blood in a quantity that brings about a synergistic interaction between them.” Reply Br. 9. Appellant’s argument is not persuasive because there is no data to indicate that the two active ingredients, administered by different routes, would reach the blood in amounts effective at the same time to achieve Appeal 2021-005256 Application 15/245,855 14 synergy. The data in the Specification discloses that the compounds were administered in such a way, including by different routes of administration, that “the combination” of them “corresponds to the timepoint of the peak effect of the respective compound.” Spec. ¶ 89. Appellant has not provided objective evidence that this effect would be observed with a composition within the scope of the claim which is administered at the same time by the same mode of administration. Appellant also argues that it would be routine to make a composition to reproduce the synergy. Reply Br. 10. This argument is not supported by objective evidence.5 Appellant has not established that a single composition, when given together, could achieve the blood concentrations of each active ingredient that are necessary to yield the desired synergy. Id. The burden is on Appellant to do so because Appellant seeks to rebut the prima facie case of obviousness for the full scope of the claim. We further note, that as explained in Soni, 54 F.3d at 751, an applicant must state the results are unexpected: [W]hen an applicant demonstrates substantially improved results, as Soni did here, and states that the results were unexpected, this should suffice to establish unexpected results in the absence of evidence to the contrary. 5 “An applicant cannot prove unexpected results with attorney argument and bare statements without objective evidentiary support. See In re Lindner, 59 C.C.P.A. 920, 457 F.2d 506, 508 (CCPA 1972); In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997) (“attorney argument [is] not the kind of factual evidence that is required to rebut a prima facie case of obviousness”); In re Soni, 54 F.3d 746, 750 (Fed. Cir. 1995) (“It is well settled that unexpected results must be established by factual evidence. Mere argument or conclusory statements ... [do] not suffice.”) (quoting In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984)).” CFMT, Inc. v. Yieldup Intern. Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003).” Appeal 2021-005256 Application 15/245,855 15 We have not been directed to a statement by the applicant for a patent that the results are “unexpected” by one of ordinary skill in the art. The statement was made the attorney of record, but not by applicant or one of ordinary skill in the art. For the foregoing reasons, the rejection of claim 53 is affirmed. The same rationale applies to independent claims 1 and 40, and separately argued claim 44 (Appeal Br. 26). The rejection of claim 1, 40, 44, and 53 are designated as new grounds of rejection pursuant to 37 C.F.R. § 41.50(b) because, while the same references are cited, we have expanded on the evidence and reasoning of the Examiner. However, the rejection of dependent claims 2, 5-10, 16, 18, 19, 22-26, 30, 33-37, 41-43, and 52 are affirmed and not designated as new grounds because Appellant did not argue them separately. Appellant did not present arguments that the Examiner erred in rejecting the dependent claims.6 6 We review the appealed rejections for reversible error based on the arguments and evidence the Appellant provide for each issue Appellant identifies. 37 C.F.R. § 41.37(c)(1)(iv); Ex parte Frye, 94 USPQ2d 1072, 1075 (BPAI 2010) (precedential) (cited with approval in In re Jung, 637 F.3d 1356, 1365 (Fed. Cir. 2011) (explaining that even if the Examiner had failed to make a prima facie case, “it has long been the Board’s practice to require an applicant to identify the alleged error in the examiner’s rejections”)). Appeal 2021-005256 Application 15/245,855 16 CONCLUSION In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed New Ground 1, 2, 5- 10, 22- 26, 30, 33-37, 40-43, 52, 53 103 Buschmann, Wilder-Smith, Garcia-Alonso 2, 5-10, 22-26, 30, 33- 37, 41- 43, 52 1, 40, 53 44 103 Buschmann, Wilder-Smith, Garcia-Alonso, Ward 44 Overall Outcome 2, 5-10, 22-26, 30, 33- 37, 41- 43, 52 1, 40, 44, 53 TIME PERIOD FOR RESPONSE This decision contains a new ground of rejection pursuant to 37 C.F.R. § 41.50(b). 37 C.F.R. § 41.50(b) provides “[a] new ground of rejection pursuant to this paragraph shall not be considered final for judicial review.” 37 C.F.R. § 41.50(b) also provides that 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 Appeal 2021-005256 Application 15/245,855 17 examiner, in which event the proceeding will be remanded to the examiner. . . . (2) Request rehearing. Request that the proceeding be reheard under § 41.52 by the Board upon the same Record. . . . 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)