Ex Parte Boland et alDownload PDFPatent Trial and Appeal BoardJul 15, 201310556878 (P.T.A.B. Jul. 15, 2013) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte EDWARD J. BOLAND and JOE MCDONOUGH __________ Appeal 2012-002857 Application 10/556,878 Technology Center 1600 __________ Before DEMETRA J. MILLS, ERIC GRIMES, and JEFFREY N. FREDMAN, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal 1 under 35 U.S.C. § 134 involving claims to an enantiomerically pure phenothiazine compound. The Examiner rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm- in-part. 1 Appellants identify the Real Parties in Interest as Board of Regents, The University of Texas System and Southwest Research Institute (see App. Br. 2). Appeal 2012-002857 Application 10/556,878 2 Statement of the Case Background “The invention provides surprisingly effective methods for inhibiting osteoclasts, reducing bone loss and treating conditions such as periodontitis and osteoporosis by administering a phenothiazine enantiomer, preferably the (+) enantiomer of promethazine” (Spec. 1). The Claims Claims 46-50, 52, and 53 are on appeal. Claims 46, 52, and 53 are representative and read as follows: 46. A medicament comprising: a phenothiazine compound consisting of a purified phenothiazine enantiomer having the structure: where R1, R2, and R3 independently are in each occurrence hydrogen, a hydroxyl radical, an alkoxy radical having a branched or unbranched alkyl radical having a total of from 1 to 6 carbon atoms inclusive, an acyloxy radical having a branched or unbranched alkyl radical having from 1 to 6 carbon atoms inclusive, a substituted alkyl radical having from 1 to 6 carbon atoms inclusive, a substituted or an unsubstituted phenyl radical or a substituted or an unsubstituted benzyl radical, where the substituted radicals have a substituent of hydroxyl radicals, halogens, ammonium, sulfonium, phosphonium, alkyl radicals having from about 1 to 6 carbon atoms inclusive, cyclic alkylene groups, or heterocyclic alkylene groups in which a heterocyclic atom is nitrogen or sulfur, or X is a branched alkyl radical having a chiral carbon atom and from 2 to 5 carbon atoms, a branched alkenyl group having a Appeal 2012-002857 Application 10/556,878 3 chiral carbon atom and from 3 to 5 carbon atoms; and R 4 is N-(R 5 )2 or S-R 5 ; R 5 independently is in each occurrence hydrogen, alkyl radicals having from 1 to 4 carbon atoms inclusive, and alkenyl radical having from 2 to 4 carbon atoms, cyclic alkylene groups and heterocyclic alkylene groups having a heterocyclic atom of nitrogen or sulfur, with the proviso that said purified enantiomer is enantiomerically resolved at the chiral atom; and a pharmaceutically acceptable carrier, with the proviso that when said compound is promethazine that said carrier is an implantable matrix, a transdermal delivery device, or a controlled release carrier. 52. The medicament of claim 46 wherein said purified phenothiazine enantiomer is a (+) enantiomer of promethazine. 53. The medicament of claim 46 further comprising a second anti- osteoclastic or anti-osteoporotic agent. The issues A. The Examiner rejected claims 46-50 and 52 under 35 U.S.C. § 103(a) over Tattersall, 2 Ponder, 3 and admitted prior art (Ans. 5-6). B. The Examiner rejected claims 46-50 and 52 under 35 U.S.C. § 103(a) over Borsy 4 and Tattersall (Ans. 8-9). C. The Examiner rejected claim 53 under 35 U.S.C. § 103(a) over Tattersall, Ponder, admitted prior art, and Slaga 5 (Ans. 7-8). 2 Tattersall, F., WO 97/02824 A1, published Jan. 30, 1997. 3 Ponder et al., Resolution of promethazine, ethopropazine, trimeprazine and trimipramine enantiomers on selected chiral stationary phases using high-performance liquid chromatography, 692 J. CHROMATOGRAPHY A 173-182 (1995). 4 Borsy et al., Studies on Promethazine, 15 ACTA PHYSIOLOGICA 339-343 (1959). 5 Slaga et al., US 6,451,341 B1, issued Sep. 17, 2002. Appeal 2012-002857 Application 10/556,878 4 D. The Examiner rejected claim 53 under 35 U.S.C. § 103(a) over Borsy, Tattersall, and Slaga (Ans. 10). A. 35 U.S.C. § 103(a) over Tattersall, Ponder and Admitted Prior Art The Examiner finds that “[w]hile Tattersall teaches that promethazine is a preferred antihistamine compound, and that the antihistamine compound may exist as its enantiomer, Tattersall does not specifically teach that the promethazine consists of its „purified enantiomer‟” (Ans. 5). The Examiner finds that “Ponder et al teach that resolution of phenothiazines, including promethazine, is known” (id.). The Examiner finds that “Applicant‟s specification admits that resolution of phenothiazines, including promethazine, is known” (id.). The Examiner finds it obvious to “use a purified enantiomer of promethazine in the medicament of Tattersall . . . it would be within the purview of the skilled artisan to select the purified enantiomer of a phenothiazine, such as promethazine, by routine experimentation, in order to optimize the efficacy of the resultant medicament” (id. at 6). The issues with respect to this rejection are: (i) Does the evidence of record support the Examiner‟s conclusion that Tattersall, Ponder, and admitted prior art render the claims prima facie obvious? (ii) If so, have Appellants presented evidence of secondary considerations, that when weighed with the evidence of obviousness, is sufficient to support a conclusion of non-obviousness? Appeal 2012-002857 Application 10/556,878 5 Findings of Fact 1. Tattersall teaches that “[s]uitable antihistamines of use in the present invention include . . . promethazine . . . . A further sub-class of compound with antihistamine and pronounced anti-muscarinic activity are phenothiazines and related compounds. Promethazine is the archetypal phenothiazine” (Tattersall 44, ll. 3-9). 2. Tattersall teaches that the “compounds of use in this invention may have one or more asymmetric centres and can therefore exist as enantiomers and possibly as diastereoisomers. It is to be understood that the present invention relates to the use of all such isomers and mixtures thereof” (Tattersall 43, ll. 10-13). 3. Tattersall teaches “administration by trans-dermal patches” (Tattersall 45, ll. 9-10). 4. Tattersall teaches that the novel composition can be coated or otherwise compounded to provide a dosage form affording the advantage of prolonged action. For example, the tablet or pill can comprise an inner dosage and an outer dosage component, the latter being in the form of an envelope over the former. The two components can be separated by an enteric layer which serves to resist disintegration in the stomach and permits the inner component to pass intact into the duodenum or to be delayed in release. (Tattersall 45, ll. 25-31.) 5. Tattersall teaches that the “Examples disclosed herein produce predominently the preferred isomers. The unfavoured isomers are also produced as minor components. If desired they may be isolated and employed to prepare the various stereoisomers in conventional manner, for Appeal 2012-002857 Application 10/556,878 6 example chromatography using an appropriate chiral column” (Tattersall 58, l. 12 to 59, l. 2). 6. Ponder teaches that the “separation of the enantiomers of three phenothiazines and a dibenzazepine were investigated on several different chiral stationary phases without the use of derivatization or column switching. The phenothiazines selected were promethazine, ethopropazine and trimeprazine” (Ponder 173, abstract). 7, Ponder teaches that “promethazine enantiomers were successfully separated on the CARNU column with a resolution of at least 1.0 (baseline Rs = 1.50) using a wide variety of mobile phases” (Ponder 175, col. 2). 8. Figure 1 of Ponder is reproduced in part below: “Fig. 1. Chemical structures of chiral compounds used in this study” (Ponder 176, figure 1 legend). 9. Ponder teaches “[s]ince there was little distinction between the bioactivity of each enantiomer of the compounds used in this study, it was possible that the highly protein bound nature of these compounds in vivo Appeal 2012-002857 Application 10/556,878 7 meant that there would be no distinction by protein CSP [chiral stationary phase]” (Ponder 182, col. 1). Principles of Law “In proceedings before the Patent and Trademark Office, the Examiner bears the burden of establishing a prima facie case of obviousness based upon the prior art.” In re Fritch, 972 F.2d 1260, 1265 (Fed. Cir. 1992). “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). “If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability.” Id. at 417. “[E]vidence rising out of the so-called „secondary considerations' must always when present be considered en route to a determination of obviousness.” Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 1538 (Fed. Cir. 1983). Analysis Claim 46 Tattersall teaches promethazine as an antihistamine medicament (FF 1) which may be enantiomers (FF 2). Tattersall teaches dosage forms including transdermal (FF 3) and controlled release (FF 4). Ponder teaches separation of promethazine into two enantiomers (FF 7-8) which have similar biological activity (FF 9). Applying the KSR standard of obviousness to the findings of fact, we conclude that the person of ordinary creativity would have predictably Appeal 2012-002857 Application 10/556,878 8 recognized that either enantiomeric form would function as an antihistamine, and would have been suitable for use as a medicament in either a transdermal delivery device or controlled release carrier (FF 2-4). Such a combination is merely a “predictable use of prior art elements according to their established functions.” KSR, 550 U.S. at 417. Appellants contend that “one upon skill of the art upon reading Ponder would have no motivation to exact enantiomer separations for the purpose of producing a medication since it is clearly taught there is no meaningful difference in bioactivity between the enantiomers” (App. Br. 9). We are not persuaded. In KSR, the Supreme Court rejected the rigid application of the teaching, suggestion, and motivation test argued by Appellants, stating that The principles underlying [earlier] cases are instructive when the question is whether a patent claiming the combination of elements of prior art is obvious. When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability. 550 U.S. at 417. Ponder teaches that both the (+) and (-) forms of promethazine have similar bioactivity (FF 9) so the ordinary artisan would have recognized that these two compounds are equivalents, and that the ordinary artisan would reasonably select the use of either enantiomer as well as the racemic form as known equivalents. See KSR, 550 U.S. at 416 (“[W]hen a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the Appeal 2012-002857 Application 10/556,878 9 field, the combination must do more than yield a predictable result.”) Here, the substitution of either enantiomerically pure form of promethazine for each other or for the racemic mixture as antihistamines expressly falls into this equivalence situation based on the express teaching of equivalence by Ponder (FF 9). Appellants contend that “Ponder is thus submitted to not motivate the combination as required to support the outstanding rejection, but instead teach away from the prior art combination” (App. Br. 9). We are not persuaded. A teaching away requires a reference to actually criticize, discredit, or otherwise discourage the claimed solution. See In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004) (“The prior art‟s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed”). Appellants do not identify, and we do not find, any teaching in Tattersall or Ponder which criticizes or discourages the use of any form of promethazine. Indeed, rather than criticize any form of promethazine, Ponder teaches that the different forms of promethazine are equivalent (FF 9). Appellants contend that for “treatment of osteoporosis the (+) enantiomer achieved greater than 90% inhibition of bone resorbtion at 10 -7 M. This is two orders of magnitude lower than the concentration required by the racemic mixture” (App. Br. 10-11). Appellants contend that “[s]imilar to atorvastatin at issue in Pfizer, the claimed compositions provide unexpected superiority over the racemic mixture” (id. at 10). Appeal 2012-002857 Application 10/556,878 10 While we agree with Appellants that the result demonstrated for (+) promethazine constitutes an unexpected result, claim 46 is not limited to (+) promethazine. Claim 46 broadly encompasses a variety of phenothiazine compounds including the (-) enantiomer of promethazine. Even when claim 46 is interpreted as modified by Appellants‟ election, 6 the claim encompasses phenothiazine enantiomers with the formula of claim 46 where R 1 and/or R 2 and/or R 3 is hydrogen or hydroxyl or alkoxy; R 4 is N-(R 5 )2 or S-R 5 where R 5 is hydrogen, alkyl or heteroalkyl chain. Consequently, the evidence for a single enantiomer in the broader elected group and even more so in the much broader genus of claim 46 is not commensurate with the degree of protection sought. See In re Harris, 409 F.3d 1339, 1344 (Fed. Cir. 2005) (Unexpected results must also be “commensurate in scope with the degree of protection sought by the claimed subject matter.”). See also In re Tiffin, 448 F.2d 791, 792 (CCPA 1971) (“objective evidence of non-obviousness must be commensurate in scope with the claims which the evidence is offered to support”)(evidence showing commercial success of thermoplastic foam “cups” used in vending machines was not commensurate in scope with claims directed to thermoplastic foam “containers” broadly). Claim 52 While Appellants do not separately argue claim 52, this claim is limited to the (+) promethazine, the specific form that Appellants argue has been shown to provide unexpectedly superior results (Appeal Br. 10-11). Since we find the evidence for (+) promethazine constitutes an unexpected 6 See Response to Election/Restriction, filed Sep. 17, 2008. Appeal 2012-002857 Application 10/556,878 11 result sufficient, when considered with the prima facie case of obviousness, to result in a conclusion that the invention of claim 52 is non-obvious, we will reverse the rejection over this claim. Conclusion of Law (i) The evidence of record supports the Examiner‟s conclusion that Tattersall, Ponder, and admitted prior art render the claims prima facie obvious. (ii) Appellants have not presented evidence of secondary considerations, that when weighed with the evidence of obviousness, is sufficient to support a conclusion of non-obviousness for claim 46, but have presented sufficient evidence to support a conclusion of non-obviousness for claim 52. B. Borsy and Tattersall The Examiner finds that “Borsy et al disclose a preparation of (+)- promethazine dissolved in physiological saline (i.e., a pharmaceutically acceptable carrier) (see page 340). The preparations are administered and tested for toxicity and antihistaminic activity” (Ans. 8). The Examiner finds that “Tattersall teaches pharmaceutical compositions . . . . The antihistamine is preferably promethazine (page 44) and can exist as its enantiomer” (id.). The Examiner finds that Tattersall teaches the compounds may be administered by controlled release, or by transdermal patches (id. at 8-9). The Examiner finds it obvious to “administer (+)-promethazine by a transdermal patch or a controlled release oral carrier . . . . One skilled in the art would be motivated . . . because Tattersall et al fairly teach and suggest that suitable dosage forms of compositions comprising phenothiazines such Appeal 2012-002857 Application 10/556,878 12 as promethazine include transdermal patches and oral carriers which provide a delayed release” (id. at 9). The issues with respect to this rejection are: (i) Does the evidence of record support the Examiner‟s conclusion that Borsy and Tattersall render prima facie obvious a purified enantiomer of promethazine in an implantable matrix, a transdermal delivery device or a controlled release carrier? (ii) If so, have Appellants presented evidence of secondary considerations, that when weighed with the evidence of obviousness, is sufficient to support a conclusion of non-obviousness? Findings of Fact 10. Table IV of Borsy is reproduced below: “The ED50 of the isomers investigated are shown in Table IV” (Borsy 343). 11. Borsy teaches that “the toxicity and antihistaminic activity as well as the anaesthesia potentiating effect of the optical isomers of promethazine have been investigated, as compared to the racemic form” (Borsy 339). 12. Borsy teaches that Appeal 2012-002857 Application 10/556,878 13 the optical antipods of promethazine do not reveal such differences in activity as is usual with other kinds of drugs . . . . The observation that the optical isomers of promethazine differ neither in antihistiminic effect nor in central nervous action indicates that the sensitivity to the individual optical isomers of the peripheral histamine receptors is the same as that of the central nervous system (Borsy 343). Analysis Claim 46 Borsy teaches the equivalence of three different enantiomeric forms of promethazine as antihistamines, the (+), (-), and racemic mixtures all function as antihistamines (FF 10-12). Tattersall teaches promethazine as an antihistamine medicament (FF 1) which may be enantiomers (FF 2). Tattersall teaches dosage forms including transdermal (FF 3) and controlled release (FF 4). Applying the KSR standard of obviousness to the findings of fact, we conclude that the person of ordinary creativity would have predictably recognized that either enantiomeric form would function as an antihistamine (FF 10-12), and would have been suitable for use as a medicament in either a transdermal delivery device or controlled release carrier (FF 2-4). Such a combination is merely a “predictable use of prior art elements according to their established functions.” KSR, 550 U.S. at 417. Appellants contend that “there must be some motivation found in the prior art or general knowledge in the art to purify enantiomers of promethazine for use in a medicament. Not only does not such motivation Appeal 2012-002857 Application 10/556,878 14 exist, but Borsy teaches away from the combination as „superfluous‟” (App. Br. 13). We are not persuaded. As we already noted, the Supreme Court rejected the rigid application of the teaching, suggestion, and motivation test argued by Appellants. Borsy teaches that both the (+) and (-) forms of promethazine have similar bioactivity (FF 10-12) so the ordinary artisan would have recognized that these two compounds are equivalents, and the ordinary artisan would reasonably select the use of either enantiomer as well as the racemic form as known equivalents. See KSR, 550 U.S. at 417 (“[W]hen a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result.”) Also, Appellants do not identify, and we do not find, any teaching in Tattersall or Borsy which criticizes or discourages the use of any form of promethazine. Indeed, rather than criticize any form of promethazine, Borsy teaches that the different forms of promethazine are equivalent (FF 10-12). A teaching that separation into optical isomers is “superfluous” does not discredit or criticize their use, but simply recognizes the equivalent function of each enantiomer. Appellants similarly rely upon the unexpected results regarding (+) promethazine, contending that these “data provide experimental evidence that the purified isomers of the claimed compounds have advantages and superiority over the racemate that could not have been predicted from the limited disclosures of Tattersall and Ponder [sic, Borsy], thus, rebutting any prima facie case of obviousness” (App. Br. 14). Appeal 2012-002857 Application 10/556,878 15 We are not persuaded. As we discussed above, the evidence for a single enantiomer in the broader elected group and even more so in the much broader genus of claim 46 is not commensurate with the degree of protection sought. See In re Harris, 409 F.3d at 1344 (Unexpected results must also be “commensurate in scope with the degree of protection sought by the claimed subject matter.”) Claim 52 As we discussed above, claim 52 is limited to the (+) promethazine. Since we find the evidence for (+) promethazine constitutes an unexpected result sufficient, when considered with the prima facie case of obviousness, to result in a conclusion that the invention of claim 52 is non-obvious, we will reverse the rejection over this claim. Conclusion of Law (i) The evidence of record supports the Examiner‟s conclusion that Borsy and Tattersall render prima facie obvious a purified enantiomer of promethazine in an implantable matrix, a transdermal delivery device or a controlled release carrier. (ii) Appellants have not presented evidence of secondary considerations, that when weighed with the evidence of obviousness, is sufficient to support a conclusion of non-obviousness for claim 46, but Appellants have presented evidence that is sufficient to support a conclusion of non-obviousness for claim 52. C. and D. Tattersall, Ponder, admitted prior art, Borsy and Slaga The Examiner finds that the “invention of Tattersall is delineated above (see paragraph 8). Tattersall further teaches that the compositions may Appeal 2012-002857 Application 10/556,878 16 comprise tableting compositions such as dicalcium phosphate” (Ans. 7). The Examiner finds that Slaga teaches that “deficiencies in calcium have been associated with accelerated bone loss resulting in health problems such as osteoporosis, and dicalcium phosphate is a source of calcium which functions in almost all aspects of metabolism, and also aids in the manufacturing (tableting) process” (Ans. 7). The Examiner finds it obvious “to select the use of dicalcium phosphate in combination with a phenothiazine . . . . One skilled in the art would be motivated to do so because the selection of dicalcium phosphate provides the benefits of anti-osteoporotic activity in addition to being a tableting aid” (id.). The issue with respect to these rejections is: Does the evidence of record support the Examiner‟s conclusion that Tattersall and either Ponder, admitted prior art or Borsy, both combinations in view of Slaga render obvious a purified enantiomer of promethazine in combination with dicalcium phosphate? Findings of Fact 13. Tattersall teaches that for “preparing solid compositions such as tablets, the principal active ingredient is mixed with a pharmaceutical carrier, e.g. conventional tableting ingredients such as . . . dicalcium phosphate” (Tattersall 45, ll. 11-14). 14. Slaga teaches that “Dicalcium phosphate dihydrate is source of calcium and phosphorus which functions in almost all aspects of metabolism, and also aids in the manufacturing (tableting) process” (Slaga, col. 15, ll. 37-40). Appeal 2012-002857 Application 10/556,878 17 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, 550 U.S. at 419. Analysis As discussed above, Tattersall and Ponder teach formation of a medicament including controlled release carriers using promethazine enantiomers (FF 1-9). Borsy also teaches treatment with promethazine enantiomers (FF 10-12). Tattersall also teaches that when forming such tablets, tableting ingredients such as dicalcium phosphate may be selected (FF 13). Slaga teaches that dicalcium phosphate is a desirable component to incorporate since it “aids in the manufacturing (tableting) process” (Slaga, col. 15, ll. 37-40; FF 14). Applying the KSR standard of obviousness to the findings of fact, we conclude that an ordinary artisan would have reasonably found it obvious to incorporate the use of dicalcium phosphate of Slaga into the tablets of Tattersall and Ponder, or Tattersall and Borsy, since Tattersall teaches the use of dicalcium phosphate (FF 13) and Slaga teaches that dicalcium phosphate aids in tablet manufacture (FF 14). Such a combination is merely a “predictable use of prior art elements according to their established functions.” KSR, 550 U.S. at 417. Appeal 2012-002857 Application 10/556,878 18 Appellants contend that “Tattersall teaches promethazine is an antihistamine and nowhere teaches it having anti-osteoclastic or anti- osteoporotic activity” (App. Br. 12). Appellants contend that there is no more motivation to include an anti-osteoporotic than any other class of compounds (e.g. anti-emetic, vitamin, etc.) and leaves one of skill in the art with an infinite number of possible things to potentially combine with no motivation, rhyme or reason that the resultant substance would operate as anything other than an aggregation to treat bone loss (id.). We are not persuaded. The Examiner notes that one reason to select the dicalcium phosphate of Slaga, a component taught by Tattersall (FF 13) is that dicalcium phosphate is a tableting aid (FF 14; Ans. 7). That the prior art has a different reason or motivation to use the dicalcium phosphate of Slaga and Tattersall is of no moment as long as there is a reason to make the combination. See In re Kemps, 97 F.3d 1427, 1430 (Fed. Cir. 1996)(“[T]he motivation in the prior art to combine the references does not have to be identical to that of the applicant to establish obviousness.”). Appellants contend that “[a]bsent hindsight resort to the instant specification one of skill in the art would wholly lack a motivation to combine promethazine with an anti-osteoporotic agent” (App. Br. 12). While we are fully aware that hindsight bias often plagues determinations of obviousness, Graham v. John Deere Co., 383 U.S. 1, 36 (1966), we are also mindful that the Supreme Court has clearly stated that “if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the Appeal 2012-002857 Application 10/556,878 19 same way, using the technique is obvious unless its actual application is beyond his or her skill.” KSR, 550 U.S. at 417. In this case, we conclude that the person of ordinary skill would have recognized that the use of dicalcium phosphate with the promethazine compound of Tattersall, Ponder (or Borsy), and Slaga would improve the tableting process as taught by Slaga (FF 14). Conclusion of Law The evidence of record supports the Examiner‟s conclusion that Tattersall and either Ponder, admitted prior art or Borsy, both combinations in view of Slaga render obvious a purified enantiomer of promethazine in combination with dicalcium phosphate. SUMMARY In summary, we affirm the rejection of claim 46 under 35 U.S.C. § 103(a) over Tattersall, Ponder, and admitted prior art. Pursuant to 37 C.F.R. § 41.37(c)(1), we also affirm the rejection of claims 47-50, as these claims were not argued separately. We reverse the rejection of claim 52 under 35 U.S.C. § 103(a) over Tattersall, Ponder, and admitted prior art. We affirm the rejection of claims 46 under 35 U.S.C. § 103(a) over Borsy and Tattersall. Pursuant to 37 C.F.R. § 41.37(c)(1), we also affirm the rejection of claims 47-50, as these claims were not argued separately. We reverse the rejection of claim 52 under 35 U.S.C. § 103(a) over Borsy and Tattersall. Appeal 2012-002857 Application 10/556,878 20 We affirm the rejection of claim 53 under 35 U.S.C. § 103(a) over Tattersall, Ponder, admitted prior art, and Slaga. We affirm the rejection of claim 53 under 35 U.S.C. § 103(a) over Borsy, Tattersall, and Slaga. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED-IN-PART cdc Copy with citationCopy as parenthetical citation