Ex Parte Seher et alDownload PDFPatent Trial and Appeal BoardSep 5, 201711996810 (P.T.A.B. Sep. 5, 2017) Copy Citation 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. 11/996,810 01/25/2008 Jens-Peter Seher 2005P02196WOUS 1924 38107 7590 09/07/2017 PTTTT TPS TNTFT T FfTTTAT PROPFRTY fr STANDARDS EXAMINER 465 Columbus Avenue FOSTER, CHRISTINE E Suite 340 Valhalla, NY 10595 ART UNIT PAPER NUMBER 1678 NOTIFICATION DATE DELIVERY MODE 09/07/2017 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): marianne. fox @ philips, com debbie.henn @philips .com patti.demichele@philips.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JENS-PETER SEHER and MALCOLM G. PLUSKAL Appeal 2016-006450 Application 11/996,8101 Technology Center 1600 Before ERIC B. GRIMES, TIMOTHY G. MAJORS, and DAVID COTTA, Administrative Patent Judges. COTTA, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a cardiac monitoring method. The Examiner rejected the claims on appeal as under 35 U.S.C. § 112 as indefinite, under 35 U.S.C. § 102(a) as anticipated, and under 35 U.S.C. § 103(a) as obvious. We affirm. STATEMENT OF THE CASE The Specification discloses that cardiac markers including brain natriuretic peptide (BNP) and N-terminal pro-BNP (NT-proBNP) “are 1 According to Appellants, the real party in interest is Koninklijke Philips Electronics N.V. App. Br. 1. Appeal 2016-006450 Application 11/996,810 secreted by the patient’s body during cardiac stress, and hence correlate with cardiac stress.” Spec. 1. “[T]he assayed level of cardiac marker is useful in detecting the presence of heart failure, determining its severity, and estimating prognosis. By monitoring cardiac marker levels in blood serum during treatment, the effectiveness of the treatment can be assessed.” Id. The Specification further discloses that “[sjynthetic therapeutic agents, such as nesiritide, which correspond to cardiac markers have shown substantial promise and demonstrated clinical success” in treating cardiac diseases. Id. at 1—2. “However, a therapeutic agent which is a synthetic form of a cardiac marker or is otherwise mimetic of a cardiac marker typically interferes with the blood assay of the natural cardiac marker.” Id. at 2. Typically, when BNP is secreted from myocardial cells, a precursor protein is cleaved into a signal peptide and an intermediate proBNP protein. Id. at 4. “The intermediate proBNP may in turn be cleaved into a physiologically active form of BNP, and a physiologically inactive form of NT-proBNP.” Id. (internal references omitted). According to Appellants’ method “[a]t least an inactive natriuretic peptide and an active natriuretic peptide are assayed in a biological sample taken from a patient.” Id. at 2. “The administered therapeutic agent substantially interferes with the active natriuretic peptide assay but does not substantially interfere with the inactive natriuretic peptide assay.” Id. Kinetics of the administered therapeutic agent are determined based on the active peptide assay and cardiac diagnostic information is determined based on the inactive peptide assay. Id. 2-3. 2 Appeal 2016-006450 Application 11/996,810 Claims 23—25, 28, 31, 32, 34 and 35 are on appeal. Independent claims 23, 25 and 34 are illustrative and read as follows (limitations at issue emphasized): 23. A cardiac monitoring method comprising: for each of a plurality of treatment times over a treatment period, performing operations including: administering a therapeutic agent including a synthetic BNP to a patient, taking a blood sample from the patient before administering the therapeutic agent, taking a blood sample from the patient after administering the therapeutic agent wherein the blood sample from the patient after administering the therapeutic agent and the blood sample from the patient before administering the therapeutic agent are taken 2- 10 minutes apart, assaying BNP in the blood sample taken from the patient before administering the therapeutic agent to generate a BNP assay performed before the administering, assaying BNP in the blood sample taken from the patient after administering the therapeutic agent to generate a BNP assay performed after the administering, assaying NT-proBNP in at least one of (i) the blood sample taken from the patient before administering the therapeutic agent and (ii) the blood sample taken from the patient after administering the therapeutic agent to generate an NT-proBNP assay, and determining an uptake of the administered therapeutic agent based on an increase of the BNP assay performed after the administering compared with the BNP assay performed before the administering; and determining cardiac diagnostic information based on a trend of the NT-proBNP assays generated over the treatment period. 25. A cardiac monitoring method comprising: 3 Appeal 2016-006450 Application 11/996,810 administering a therapeutic agent to a patient wherein the therapeutic agent includes a synthetic BNP; performing repeated assays of BNP, the repeated assays being performed on first and second blood samples taken before and a predetermined time after the administering or at two different predetermined times after the administering; performing an assay of NT-proBNP on at least one of the first and second blood samples; determining uptake of the administered therapeutic agent based on an increase in BNP between the repeated assays of BNP, wherein a time interval separating the taking of the first and second blood samples is 2-10 minutes; and assessing cardiac diagnostic information based on at least the assay of NT-proBNP. 34. A cardiac monitoring method comprising: administering a therapeutic agent to a patient wherein the therapeutic agent includes a synthetic form of an active natriuretic peptide wherein the active natriuretic peptide is selected from the group consisting of BNP and ANP; performing repeated assays of the active natriuretic peptide, the repeated assays being performed on first and second blood samples taken before and a predetermined time after the administering or at two different predetermined times after the administering', performing an assay of an inactive form of the active natriuretic peptide on at least one of the first and second blood samples wherein the inactive form of the active natriuretic peptide is NT-proBNP which is the inactive form of BNP or NT-proANP which is the inactive form of ANP; determining uptake of the administered therapeutic agent based on an increase in the active natriuretic peptide between the repeated assays of the active natriuretic peptide, wherein a time interval separating the taking of the first and second blood samples is effective for the change in active natriuretic peptide between the repeated assays to be a measure of uptake of the administered therapeutic agent', and assessing cardiac diagnostic information based on the assay of the inactive form of the active natriuretic peptide. 4 Appeal 2016-006450 Application 11/996,810 App. Br. 23—25. The claims stand rejected as follows: Claim 34 was rejected under 35 U.S.C. § 112(b) as indefinite for failing to particularly point out and distinctly claim the subject matter which the inventors regard as the invention. Claim 34 was rejected under 35 U.S.C. § 102(a) as anticipated by Miller.2 Claim 34 was rejected under 35 U.S.C. § 103(a) as obvious over the combination of Fitzgerald3 and Troughton.4 Claim 35 was rejected under 35 U.S.C. § 103(a) as obvious over the combination of Fitzgerald, Troughton and Schreiner.5 Claims 23—25, 28, 31, 32, 34, and 35 were rejected under 35 U.S.C. § 103(a) as obvious over the combination of Fitzgerald, Troughton, Schreiner, and Yoshimura.6 2 Miller et al., Biomarker Responses During and After Treatment with Nesiritide Infusion in Patients with Decompensated Chronic Heart Failure, 51(3) Clinical Chemistry 1-9 (“Miller”). 3 Fitzgerald et al., Utility of B-Type Natriuretic Peptide and ProBNP in Evaluation of Patients Receiving Natrecor Therapy (UBET Study), Abstract No. 1049-112, Journal of the American College of Cardiology, 43(5si): 171A-172A (2004) (“Fitzgerald”). 4 Troughton et al., Treatment of Heart Failure Guided by Plasma Aminoterminal Brain Natriuretic Peptide (N-BNP) Concentrations, 355(9210) The Lancet 1126-1130 (2000) (“Troughton”). 5 Schreiner US Pub. No. 2004/0077537 Al, published Apr. 22, 2004 (“Schreiner”). 6 Yoshimura et al., Hemodynamic, Renal, and Hormonal Responses to Brain Natriuretic Peptide Infusion in Patients With Congestive Heart Failure, 84 Circulation 1581-1588 (1991) (“Yoshimura”). 5 Appeal 2016-006450 Application 11/996,810 INDEFINITENESS OF CLAIM 34 Claim 34 includes the limitation “wherein a time interval separating the taking of the first and second blood samples is effective for the change in active natriuretic peptide between the repeated assays to be a measure of uptake of the administered therapeutic agent.” The Examiner finds that the Specification “does not clearly set forth what specific times would be ‘effective for the change in BNP between the repeated assays to be a measure of uptake of the administered therapeutic agent’” and “[a]s a result, the metes and bounds of the claims are unclear.” Ans. 2. In addition the Examiner finds that the claimed time interval “would also depend on other variables that may vary and which are not specified in the claim” and that this would “lead to ambiguity in assessing infringement[] since the same time interval could be a measure of drug uptake or not depending on the treatment regimen.” Id. at 3. We are not persuaded. “[I]t is well-established that the determination whether a claim is invalid as indefinite ‘depends on whether those skilled in the art would understand the scope of the claim when the claim is read in light of the specification.’” Atmel Corp. v. Information Storage Devices Inc., 198 F.3d 1374, 1378 (Fed. Cir. 1999) (quoting North Am. Vaccine, Inc. v. American Cyanamid Co., 7 F.3d 1571, 1579 (Fed. Cir. 1993)). Here, the person of ordinary skill in the art would understand the claims to encompass any time interval between samples that allows one to determine uptake. While the time interval encompassed may be quite broad, this does not render the claim indefinite. In re Miller, 441 F.2d 689, 693 (CCPA 1971) (“breadth is not to be equated with indefmiteness.”) Similarly the potential for the interval to vary based on treatment regimen does not render the claim 6 Appeal 2016-006450 Application 11/996,810 indefinite absent evidence, which the Examiner has not presented, that the skilled artisan would be unable to determine an “effective” “time interval” for a given treatment regimen. See, Exxon Research and Eng ’g Co. v. United States, 265 F.3d 1371, 1379 (Fed. Cir. 2001) (“Provided that the claims are enabled, and no undue experimentation is required, the fact that some experimentation may be necessary to determine the scope of the claims does not render the claims indefinite.”). Accordingly we reverse the Examiner’s rejection of claim 34 as indefinite. OBVIOUSNESS OF CLAIMS 23-25, 28, 31, 32, 34, AND 35 OVER FITZGERALD, TROUGHTON, SCHREINER AND YOSHIMURA In finding claims 23—25, 28, 31, 32, 34, and 35 obvious, the Examiner found that Fitzgerald disclosed methods of administering Natrecor® (nesiritide) as a bolus to patients followed by an infusion. Ans. 6, 12. Serial blood samples were obtained from the patients “at baseline (i.e., before administering) as well as at 1 hour and 48 hour[s]” after administration of the bolus as well as “at 12 hour[s] post infusion.” Id. Fitzgerald also disclosed assaying both BNP and NT-proBNP in the blood samples. Id. at 6—7. Fitzgerald reports that “one hour following bolus dose of Natrecor®, the average concentrations of BNP increased about three-fold.” Id. at 7. The Examiner acknowledged that Fitzgerald did not teach “using their determined NT-proBNP levels for the purpose of assessing cardiac diagnostic information.” Id. at 9. The Examiner found, however, that “NT- proBNP was well known in the prior art to be a cardiac disease marker, as taught for example by Troughton.” Id. The Examiner thus concluded that it would have been obvious “to employ the available NT-proBNP information 7 Appeal 2016-006450 Application 11/996,810 as determined by Fitzgerald et al. for the purpose of providing information relevant to a patient’s cardiac status and prognosis.” Id. at 9-10. With respect to the requirement that the time interval be “about 2—10 minutes” between assays, the Examiner found that Yoshimura “performed serial measurements of BNP immediately before infusion, and every 15 minutes after the initiation of the infusion” and that Yoshimura disclosed that “BNP was already substantially elevated at 15 minutes.” Final Act. 18.7 The Examiner thus concluded that it would have been obvious to modify the method of Fitzgerald, which takes an assay 1 hour after administration of the bolus, to take an assay about 2—10 minutes after administration. Id. The Examiner explained that time was a result effective variable and “out of the course of routine optimization . . . one would be motivated to complete the BNP analysis as quickly as possible,” which is particularly desirable “in an outpatient setting ... so that the patients could complete their appointment and go home more quickly.” Id.', Ans. 27. The Examiner reasoned that the skilled artisan would have had a reasonable expectation of success because “Yoshimura et al. indicate that BNP was already substantially elevated at 15 minutes, and so one skilled in the art would have reasonably expected that BNP increase in response to BNP administration would also be present and detectable even earlier, e.g. at 10 minutes.” Final Act. 18. We adopt the Examiner’s findings of fact and reasoning regarding the scope and content of the prior art (Ans. 3—23; Final Act. 7—24) and agree that the claims would have been obvious over Fitzgerald, Troughton, Yoshimura, and Schreiner. We address Appellants’ arguments below. 7 Office Action mailed September 3, 2015 (“Final Act.”). 8 Appeal 2016-006450 Application 11/996,810 Appellants argue each of the independent claims separately. Accordingly, we will separately address each of the independent claims. Claim 23 Appellants argue that Fitzgerald discloses performing an assay during rather than after administering BNP, and thus does not meet the claim requirement for determining uptake based on an increase in a BNP assay performed after administration. App. Br. 14; Reply Br. 5—6. Appellants contend that “the claims are limited to ‘after the administering’, which does not encompass ‘during the administering’, whether during a single bolus or during a bolus/infusion administration.” Reply Br. 5—6. We are not persuaded. “[A]s an initial matter, the PTO applies to the verbiage of the proposed claims the broadest reasonable meaning of the words in their ordinary usage as they would be understood by one of ordinary skill in the art, taking into account whatever enlightenment by way of definitions or otherwise that may be afforded by the written description contained in the applicant’s specification.” In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997). As Zletz notes “during patent prosecution when claims can be amended, ambiguities should be recognized, scope and breadth of language explored, and clarification imposed.” In re Zletz, 893 F.2d 319, 321 (Fed. Cir. 1989). Here, claim 23 does not require that administration of the synthetic BNP be completed before the assay is conducted. It simply requires “taking a blood sample from the patient after administering the therapeutic agent” and “determining an uptake of the administered therapeutic agent based on an increase of the BNP assay performed after the administering . . . .” 9 Appeal 2016-006450 Application 11/996,810 Accordingly, we agree with the Examiner that “the claims do not require ‘after the administering’ to mean after all administration of drug has been stopped.” Ans. 24. In Fitzgerald, Natrecor® was administered first as a 2 pg/kg bolus, followed by an infusion of 0.01 pg/kg/min for 24, 36, or 48 hours. Fitzgerald Methods. We agree with the Examiner that an assay conducted during the 0.01 pg/kg/min infusion, but after the 2 pg/kg bolus was administered “reads on ‘after the administering’ since Natrecor® had already been administered, even if the entire treatment regimen was not yet concluded.” Ans. 24. As the Examiner explained “BNP measurements made during the infusion would still be considered ‘after the administering’ since they were after the bolus dose; and the claims do not exclude subsequent or repeated administration.” Id. Appellants argue that the Examiner erred in concluding that it was obvious to discover the optimum time between assays as a result of routine optimization. As support, Appellants assert that the 2—10 minute interval recited in claim 23 is critical, “especially when compared with the 30 minute time interval of Yoshimura.” App. Br. 15. Appellants contend that the Specification establishes criticality by disclosing: The difference in [C]BNP+nesintide level measured by the first and second repetitions is a measure of the uptake of the nesiritide. The terminal half-life of nesiritide in the bloodstream is typically about 20 minutes, while the onset of therapeutic action is about 15 minutes, and the therapeutic action is sustained over about 24 hours in typical cardiac patients. The first and second repetitions can be separated by, for example, about 2-10 minutes. 10 Appeal 2016-006450 Application 11/996,810 App. Br. 15—16 (citing Spec. p. 7). Appellants further contend that the 2—10 minute interval recited in claim 23 is “less than the half-life of nesiritide; whereas, the 30 min time interval of Yoshimura is greater than the half-life of nesiritide” and thus “[t]he criticality of the 2-10 min interval is thus established.” Id. at 16. We are not persuaded. As an initial matter, Yoshimura discloses that BNP measurements are taken “15 minutes before, immediately before the infusion, and every 15 minutes after the initiation of the infusion for 60 minutes.” Yoshimura 1582. Appellants’ argument that Yoshimura’s time between assays is 30 minutes relies on construing “after administering” to require that all infusion of active agent has ceased. As discussed above, we do not construe the claims to require that all administration of active agent be completed before the assay is conducted. Accordingly, we consider the measurement time between assays in Yoshimura to be 15 minutes, not 30 minutes. The passage from the Specification cited by Appellants does not establish the criticality of measuring BNP 2—10 minutes after administration. To the contrary, the Specification states that the “first and second repetitions can be separated by, for example, about 2—10 minutes.” Spec. 7 (emphasis added). By using the words “for example,” the Specification suggests that other time intervals can be used. Similarly, while the Specification discloses the half-life of nesiritide to be about 20 minutes, it does not single out any particular time in relation to that half-life as being critical for performing the second assay. Id. Appellants argue that neither Fitzgerald nor Yoshimura discloses determining an uptake of the administered agent. App. Br. 16. We are not persuaded. 11 Appeal 2016-006450 Application 11/996,810 As disclosed in the Specification determining uptake of an administered agent, like nesiritide, involves monitoring BNP concentration and identifying a difference between assays taken before and after administration. Spec. 9 (“To derive the kinetic information on nesiritide uptake, the difference between the first assay 30 levels for the two blood samples drawn on a given treatment date is recorded. This difference is indicative of the uptake of nesiritide into the bloodstream.”); see also, Spec. 10 (“BNP monitoring provides kinetic information on nesiritide uptake.”). Fitzgerald monitored BNP levels and observed increases in the measured BNP concentration in blood following administration of Natrecor®. Fitzgerald Results. Fitzgerald thus determined uptake of Natrecor® into the bloodstream. Appellants argue that modifying the timing of the assays performed in Fitzgerald would change the principle of operation, because Fitzgerald is “not directed to measuring uptake of a therapeutic agent including synthetic BNP, but rather is directed to monitoring its extended treatment including an initial bolus followed by an infusion which runs for at least 24 hours.” App. Br. 16. We are not persuaded because, as discussed above, Fitzgerald does measure uptake of a therapeutic agent. Accordingly, we affirm the Examiner’s rejection of claim 23. Claim 25 Appellants’ arguments with respect to claim 25 are similar to their arguments with respect to claim 23. Appellants thus argue None of the references disclose repeated assays of BNP ... performed on first and second blood samples taken before and a predetermined time after the administering or at two different predetermined times after the administering wherein a time 12 Appeal 2016-006450 Application 11/996,810 interval separating the taking of the first and second blood samples is 2-10 minutes. App. Br. 17. We are not persuaded for the reasons discussed in connection with claim 23. In addition to arguments paralleling those made with respect to claim 23, Appellants argue that Fitzgerald does not determine uptake “based on an increase in BNP between the repeated assays of BNP” because Fitzgerald reports that “[f]ollowing the bolus dose, average BNP concentration trended down during the infusion.” App. Br. 17. Appellants assert that Yoshimura similarly “demonstrates [that] BNP level decreases in between 30 min and 45 min.” Id. We are not persuaded because both Fitzgerald and Yoshimura observed initial increases in BNP levels. See, Fitzgerald Results (“One hour following a bolus dose of Natrecor, the average concentrations of BNP increased about three fold.”); Yoshimura 1584 (“After the beginning of BNP infusion, plasma BNP levels promptly increased . . .”). Accordingly, we affirm the Examiner’s rejection of claim 25. Claim 34 Appellants’ arguments with respect to claim 34 are the same as their arguments with respect to claim 25. App. Br. 18 (“Applicability of the arguments directed to claim 25 to the above-underscored limitations of claim 34 are readily apparent and are not repeated here.”). Accordingly, we affirm the Examiner’s rejection of claim 34 for the reasons discussed in connection with claim 25. Claims 24, 28, 31, 32, and 35 13 Appeal 2016-006450 Application 11/996,810 Dependent claims 24, 28, 31, 32, and 35 were not argued separately. Accordingly, claims 24 and 31 fall with claim 23, claims 28 and 32 fall with claim 25, and claim 35 falls with claim 34. OBVIOUSNESS OF CLAIM 34 OVER FITZGERALD AND TROUGHTON Appellants argue that claim 34 is patentably distinct over the combination of Fitzgerald and Troughton for the reasons provided in connection with the larger combination of Fitzgerald, Troughton, Schreiner, and Yoshimura. App. Br. 19. Accordingly, we affirm the Examiner’s rejection of claim 34 for the reasons provided above. OBVIOUSNESS OF CLAIM 35 OVER FITZGERALD, TROUGHTON AND SCHREINER Appellants argue that claim 35 is patentably distinct over the combination of Fitzgerald, Troughton and Schreiner for the reasons provided in connection with the larger combination of Fitzgerald, Troughton, Schreiner, and Yoshimura. App. Br. 19. Accordingly, we affirm the Examiner’s rejection of claim 35 for the reasons provided above. ANTICIPATION OF CLAIM 34 BY MILLER Miller discloses a study in which patients were administered a bolus of nesiritide at 2 pg/kg over 1—2 minutes followed by continuous infusion at 0.01 pg/kg per minute over at least 24 hours. Miller 2. Miller discloses measuring NT-proBNP and BNP “before, at 6 and 24 h during, and at 6 h after infusion.” Id. at 1 (Methods). The Examiner found that Miller disclosed all of the limitations of claim 34. Final Act. 5—7. We adopt the Examiner’s findings of fact and reasoning regarding the scope and content of the prior art (Ans. 3—5, and 20-23; Final Act. 5—7, 24— 14 Appeal 2016-006450 Application 11/996,810 25) and agree that claim 34 is anticipated by Miller. We address Appellants’ arguments below. Appellants argue that the assays in Miller were performed even less frequently than in Fitzgerald and “[t]hus, Miller is seen to have the same deficiencies as Fitzgerald.” App. Br. 20. We are not persuaded because, as discussed above, claim 34 encompasses performing an assay after a bolus of nesiritide has been administered, but while infusion still continues. Appellants argue that the assay performed after administering the 24- hour nesiritide infusion is “lower than the baseline assay performed before administering the infusion.” Id. Appellants thus argue that “Miller does not anticipate, or even fairly suggest (as per claim 34) determining uptake of the administered therapeutic agent [nesiritide in Miller] based on an increase in the active natriuretic peptide [BNP in Miller] between the repeated assays of the active natriuretic peptide.” Id. We are not persuaded because Miller teaches that “[statistically significant increases from baseline were noted in BNP during the nesiritide infusion.” Miller 3; see also, id. at Figs. IB and 2B (showing increase in BNP level as compared to baseline 6 hours and 24 hours after administration). Appellants argue that the time interval between the first and second blood samples is so long that it would not be “effective for the change in active natriuretic peptide between the repeated assays to be a measure of uptake of the administered therapeutic agent.” App. Br. 20. We are not persuaded. As discussed above in connection with obviousness, determining uptake involves monitoring BNP and identifying a difference between assays taken before and after administration. Miller does this, observing an 15 Appeal 2016-006450 Application 11/996,810 increase in BNP level measured 6 hours after administration as compared to the level measured before administration. There is nothing in the claim language that requires the time interval to be any particular unit of time. Rather, the time interval in claim 34 is defined in functional terms. Appellants have not persuaded us that the measurements described in Miller would not be effective in performing the claimed function of measuring uptake. Accordingly, we affirm the Examiner’s rejection of claim 34 as anticipated by Miller. SUMMARY For the reasons set forth herein, we reverse the Examiner rejection of claim 34 under 35 U.S.C. § 112(b) as indefinite for failing to particularly point out and distinctly claim the subject matter which the inventors regard as the invention. For the reasons above and those set forth in the Examiner’s Answer and Final Action, we affirm: the Examiner’s rejection of claims 23—25, 28, 31, 32, 34, and 35 under 35 U.S.C. § 103 (a) as obvious over the combination of Fitzgerald, Troughton, Schreiner, and Yoshimura; the Examiner’s rejection of claim 34 under 35 U.S.C. § 103(a) as obvious over the combination of Fitzgerald and Troughton; the Examiner’s rejection of claim 35 under 35 U.S.C. § 103 (a) as obvious over the combination of Fitzgerald, Troughton and Schreiner; and the Examiner’s rejection of claim 34 under 35 U.S.C. § 102(a) as anticipated by Miller. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(1). AFFIRMED 16 Copy with citationCopy as parenthetical citation