PerkinElmer Health Sciences, Inc.

Patent Trials and Appeals BoardMay 11, 2021

2020004368 (P.T.A.B. May. 11, 2021)

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. 15/970,366 05/03/2018 Brian Chan 9888-11CT 1037 15308 7590 05/11/2021 MYERS BIGEL, P.A. PO Box 37428 Raleigh, NC 27627 EXAMINER KASTURE, DNYANESH G ART UNIT PAPER NUMBER 3746 NOTIFICATION DATE DELIVERY MODE 05/11/2021 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): myersbigel_pair@firsttofile.com uspto@myersbigel.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte BRIAN CHAN __________ Appeal 2020-004368 Application 15/970,366 Technology Center 3700 __________ Before CHARLES N. GREENHUT, MICHAEL L. HOELTER, and ANNETTE R. REIMERS, Administrative Patent Judges. GREENHUT, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 1–16. See Final Act. 1. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM and designate our affirmance of the rejections of claims 1–16 under 35 U.S.C. § 103 as NEW GROUNDS 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 PerkinElmer Health Sciences, Inc. See Appeal Br. 2. Appeal 2020-004368 Application 15/970,366 2 STATEMENT OF THE CASE The claims are directed to a peristaltic pump and a method for pumping fluid using a peristaltic pump. Claim 1, reproduced below, is illustrative of the claimed subject matter: 1. A peristaltic pump for pumping a fluid, the peristaltic pump comprising: a flexible tube having inner and outer tubular opposed walls, the inner wall defining a through passage to receive the fluid; and at least one roller having an outer contact surface; wherein the peristaltic pump is configured to compress the flexible tube with the contact surface of the roller to thereby force the fluid through the through passage; and wherein at least the contact surface of the roller is formed of borosilicate glass, the peristaltic pump further comprising: a roller carrier; and a roller axle pin coupling the roller to the roller carrier; wherein the roller axle pin is formed of borosilicate glass and the roller axle pin is stationary with respect to the roller carrier and the roller is rotatable about the roller axle pin. Appeal 2020-004368 Application 15/970,366 3 REFERENCES The prior art relied upon by the Examiner is: Name Reference Date Buttery US 3,446,152 May 27, 1969 Latham (“Allen”)2 US 3,565,286 Feb. 23, 1971 Galea US 3,999,891 Dec. 28, 1976 Obara US 6,345,915 B1 Feb. 12, 2002 Payne US 2003/0086735 A1 May 8, 2003 Masters US 2008/0115599 A1 May 22, 2008 REJECTIONS Claims 1–4, 6–8, 11–13, 15, and 16 are rejected under 35 U.S.C. § 103 as being unpatentable over Masters, Allen, and (Payne alone or Payne and Obara).3 Final Act. 2. Claims 1–4, 6–8, 11–13, 15, and 16 are rejected under 35 U.S.C. § 103 as being unpatentable over Masters, Allen, Payne, and Buttery.4 Final Act. 7. 2 For this reference, the Examiner refers to the first name, Allen, rather than the surname, of the inventor, which is Latham. See Final Act., passim. Appellant, likewise, refers to the first name of the inventor to identify this reference. See Appeal Br., passim. For consistency, we shall also refer to this reference as “Allen” hereinafter. 3 Although paragraph 4 for the statement of this rejection does not indicate the combination of Payne and Obara as an alternative to Payne alone, paragraphs 12 and 13 of the body of the rejection indicate that is the case. See Final Act. 2, 4. 4 Although paragraph 26 for the statement of this rejection does not indicate the combination Payne and Buttery as an alternative to Payne alone, paragraphs 34 and 35 for the body of the rejection indicate that is the case. See Final Act. 7–8. Because the combination of Masters, Allen, and Payne was already made in the previous rejection, we do not list this combination Appeal 2020-004368 Application 15/970,366 4 Claims 1, 2, 4–8, 11, and 13–16 are rejected under 35 U.S.C. § 103 as being unpatentable over Masters, Allen, and (Obara or Buttery).5 Final Act. 11. Claims 9 and 10 are rejected under 35 U.S.C. § 103 as being unpatentable over Masters, Allen, (Payne alone or Payne and Obara), and Galea.6 Final Act. 15. Claims 9 and 10 are rejected under 35 U.S.C. § 103 as being unpatentable over Masters, Allen, Payne, Buttery, and Galea. Final Act. 16. Claims 9 and 10 are rejected under 35 U.S.C. § 103 as being unpatentable over Masters, Allen, (Obara or Buttery), and Galea. Final Act. 17. OPINION Obviousness over Masters, Allen, and (Payne alone or Payne and Obara) Appellant focuses only on the following limitations of independent claim 1 (and similar limitations recited in independent claim 8): at least the contact surface of the roller is formed of borosilicate glass, the peristaltic pump further comprising: a roller carrier; and a roller axle pin coupling the roller to the roller carrier; wherein the roller axle pin is formed of borosilicate glass and the roller axle pin is stationary with respect to the roller carrier and the roller is rotatable about the roller axle pin. (i.e., the combination of Masters, Allen, Payne, and Buttery) again for this rejection. 5 Although paragraph 48 for the statement of this rejection does not indicate Buttery as an alternative to Obara, paragraphs 56 and 57 of the body of the rejection indicate that is the case. See Final Act. 11, 13. 6 The alternatives in the cited art discussed in the above footnotes are applicable for all rejections of claims 9 and 10 because the rejections of these claims are dependent on the rejections of parent claim 1 above. Appeal 2020-004368 Application 15/970,366 5 Appeal Br. 4. Accordingly, claim 1 is representative of claims 2–4, 6–8, 11– 13, 15, and 16 pursuant to 37 C.F.R. § 41.37(c)(1)(iv)(2018). See Appeal Br. 4–6. Appellant first contends that “the Action provides no basis for assuming that all of the elements of the roller including the axle pin of Masters teach or suggest that the roller axle pin, which is stationary with respect to the roller carrier, are formed of glass or borosilicate glass.” Appeal Br. 4. We understand that this argument is in response to the Examiner’s statement that “Masters implies that all elements of the roller which includes the axle pin is made of glass (borosilicate glass in view of Payne).” See id. (quoting Final Act. 4). Thereafter, Appellant argues that “the Action does not meet the requirements for inherency, and that there is no apparent reason to require that the axle pin of Allen as applied to Masters be formed of glass (or the same material of the roller).” Id. at 5. To the extent Appellant is arguing that the Examiner is incorrect in asserting that Masters inherently discloses a roller axle pin formed of glass or borosilicate glass, we agree. However, this argument is inconsequential because in the Answer, the Examiner clarifies the earlier statement by stating that “Masters doesn’t teach away from other elements like the axle pin (shown to be stationary by the Allen reference) being also made of glass.” Ans. 19 (emphasis added). In other words, the Examiner’s position is not that Masters inherently discloses a roller axle pin formed of glass or borosilicate glass, but rather, that it would have been obvious to modify Masters’ pump to include an axle pin made of glass or borosilicate glass (as further discussed below). This is further evident that the Examiner supplements the teachings of Allen and Payne with the teachings of Masters by stating that Appeal 2020-004368 Application 15/970,366 6 paragraphs 127 and 150 of Masters disclose that other components can be made of glass. See id. Consequently, Appellant’s contention does not address the rejection. In the same vein of argument above, Appellant contends that “nothing in Masters, Allen or Payne discloses or suggests that the roller axle pin is formed of borosilicate glass.” Appeal Br. 5. Appellant does not elaborate, but we note that as a precursor to this argument, Appellant asserts that “Payne is cited as allegedly disclosing pressing rollers that are formed of borosilicate glass.” Id. It seems to us that Appellant is arguing that the combination of Masters, Allen, and Payne is deficient because Payne does not disclose an axle pin made of borosilicate glass. Once again, Appellant does not address the rejection. The Examiner finds that Masters discloses a roller (roller 820). Final Act. 3 (citing Masters ¶ 149, Fig. 8C). Indeed, Masters discloses “rollers 820 rotate about their own axis.” Masters ¶ 149. The Examiner states that although “it is possible [as seen in the figures] that the projecting portions on the carrier are axle pins of the rollers,” the Examiner concedes that Masters “does not explicitly disclose [an] axle pin coupling the roller to the carrier” and relies on Allen for this aspect of the claimed subject matter. Final Act. 3. Allen discloses “roller pin 219 has the rollers, e.g., roller 201 rotatably mounted on it” and that there are “two end plates 217 and 218 in which [the] roller pin 219 is firmly mounted.” Allen 6:25–27. Thus, Allen discloses a roller axle pin coupled to a roller of a roller carrier, in which the roller axle pin is stationary with respect to the roller carrier and the roller is rotatable about the roller axle pin. As recognized by Appellant (Appeal Br. 5), the Examiner relies on Payne for disclosing rollers made of borosilicate Appeal 2020-004368 Application 15/970,366 7 glass. See Final Act. 4. Thus, the Examiner did not rely on Masters, Allen, or Payne, individually, for disclosing a roller axle pin made of borosilicate glass. In other words, we agree with Appellant that each of Masters, Allen, and Payne alone does not disclose a roller pin made of borosilicate glass. Nonetheless, the combination Masters and Allen would have suggested to an ordinary artisan to couple an axle pin to a roller and the combination of Masters and Payne would have suggested to an ordinary artisan to make at least a roller made of borosilicate glass. As the Examiner correctly points out, Masters discloses that multiple components in its pump can be made of glass. See Ans. 19 (citing Masters ¶¶ 127, 150). Thus, if Masters’ roller, which is made of glass (Masters ¶ 150), is modified to be made of borosilicate glass (Payne ¶ 31), and is further modified to be held by an axle pin (Allen at 6:25–27), and Masters discloses that other components can be made of glass (Masters ¶ 127), it seems to us that this combination of teachings would suggest to a skilled artisan to modify an axle pin that is added to or part of Masters’ pump, to be made of borosilicate glass as well because the axle pin and the roller are coupled to each other and would benefit similarly from such modification. There does not appear to be any reasons of record against making both of these components (a roller and its axle pin), which are coupled to each other, of the same material. Thus, Appellant’s argument does not apprise us of Examiner error. Appellant further argues that because “Payne relates to a roller for allowing UV light to pass through to cure [sic, ink] in a printer” and Payne “does not relate to peristaltic pumps,” “one skilled in the art would not look to Payne for borosilicate glass.” Appeal Br. 5. Appeal 2020-004368 Application 15/970,366 8 The Examiner correctly responds that “[t]he roller of Payne serves the same purpose of applying pressure, just like the roller of Masters applies pressure.” Ans. 20. We are mindful that the Examiner references the first prong of the test for analogous art, by asserting that Payne and Masters are in the same field of endeavor. Id. Here, we note that Payne discloses rollers 18 and 19, which are similar structures to the rollers 820 of Masters. See Payne Figs. 1, 3; Masters Figs. 1–3. Further, Masters’ rollers 820 are used to apply pressure to the fluid in tubes 710a–710i. Masters, ¶ 149, Figs. 8A–8C. Because Payne’s rollers 18, 19 also apply pressure to a fluid, i.e., toner 12 onto paper 16 (see Payne ¶ 27, Fig. 1). Thus, Payne’s rollers 18, 19 and Masters’ rollers 820 also have the same basic functions. We thus agree with the Examiner that Payne and Masters are in the same field of endeavor. See MPEP § 2141.01(a)(IV) (discussing references being in the same field of endeavor because the disclosed devices have the same structure with the same function (citing In re Deminski, 796 F.2d 436 (Fed. Cir. 1986); In re Bigio, 381 F.3d 1320, 1325–26 (Fed. Cir. 2004)). Towards this end, we note that a device’s function is not necessarily confined by the article worked upon for purposes of the field of endeavor test. In Bigio, “the court applied the ‘field of endeavor test’ for analogous art and determined that the references were within the field of applicant’s endeavor and hence was analogous art because toothbrushes are structurally similar to small brushes for hair, and a toothbrush could be used to brush facial hair.” MPEP § 2141.01(a)(IV) (quoting Bigio at 1326; emphasis added). See also MPEP § 904.01(c) (“The determination of what arts are analogous to a particular claimed invention is at times difficult. It depends upon the necessary essential function or utility of the subject matter covered by the claims, and Appeal 2020-004368 Application 15/970,366 9 not upon what it is called by the applicant.”). Here, Payne’s rollers 18, 19 could be used to apply pressure to a fluid or a tube much in the same manner as required by claim 1 (“compress the flexible tube with the contact surface of the roller”). See also Spec., Fig. 2 (showing Appellant’s tubular roller 170 applying pressure to flexible tube 150 having fluid therein). Thus, this similar intended use is further indicative that Payne and Masters are in the same field of endeavor. Concerning the Examiner’s alternative combination of Masters, Allen, Payne, and Obara, Appellant contends that “[t]he configuration in Figure 7 of Obara does not relate to rollers, and therefore, Obara does not disclose an axle pin for a roller for a peristaltic pump.” Appeal Br. 5. According to Appellant, “[o]ne of ordinary skill would not look to the shaft of Figure 7 of Obara for rollers for a peristaltic pump” and thus, “Obara is . . . nonanalogous art.” Id. The Examiner responds that Obara is analogous art because Obara and Masters are in the same field of endeavor. Ans. 19–20. According to the Examiner, Obara and Masters disclose “SIMILAR STRUCTURES” having similar functions, e.g., Obara’s bearing body 22 and shaft 23 “achieve the same effect of allowing relative rotation therebetween to occur, just like the roller/axle pin combination of Masters allows relative rotation therebetween to occur.” Id. We do not agree with the Examiner that Obara and Masters are in the same field of endeavor. The Examiner focuses on only two similar structures that accomplish a single similar function although there are many structures in Masters’ more complex pump that are not present in Obara’s simple bearing. Nonetheless, Obara is analogous art under the second prong of the test for analogous art, namely, that Obara is reasonably pertinent to Appeal 2020-004368 Application 15/970,366 10 the particular problem with which Appellant is involved. See In re Clay, 966 F.2d 656, 658 (Fed. Cir. 1992). Appellant’s Specification discloses that conventional peristaltic pumps have components that “may be formed of stainless steel.” Spec. ¶ 3. The Specification then discloses that the fluid in the peristaltic pumps “is corrosive or caustic to stainless steel.” Id. at ¶ 11. Obara discloses that according to the roller bearing 1 of the invention, since the heat resistance and the anti-corrosion of the inner ring 2 and the outer ring 3 are increased, correspondingly when the ball 5 and the retainer 4 are made of the material superior in the heat resistance or anti-corrosion, these can be used stably even in a high temperature or highly corrosive environment. Obara 4:5–11 (emphases added). Thus, Obara is analogous art because Obara is reasonably pertinent to the particular problem with which Appellant is involved, namely, corrosion of components of a device, in particular those typically formed from stainless steel (Obara col. 1, ll. 25–26). We also note that the Examiner relies on Obara only for disclosing an axle pin made of borosilicate glass, rather than for an axle pin that is stationary. Final Act. 4. Allen already discloses an axle pin that is stationary, as discussed above. We further note that Obara’s device has at least one component that rotates relative to another component, similar to the roller and axle pin of Masters. See Obara 3:2 (disclosing roller bearing 1), 5:41 (disclosing bearing body 22). But even if Obara’s corresponding pin rotates as opposed to being stationary, the corrosion problem as discussed above by Obara does not relate to whether the pin rotates. As such, we are unpersuaded by Appellant’s contention that “[o]ne of ordinary skill would not look to the shaft of Figure 7 of Obara for rollers for a peristaltic pump.” Appeal Br. 5. Consequently, Appellant does not apprise us of Examiner error. Appeal 2020-004368 Application 15/970,366 11 Accordingly, for these reasons, we sustain the Examiner’s rejection of claims 1–4, 6–8, 11–13, 15, and 16 as unpatentable over the combination of Masters, Allen, and Payne and over the combination of Masters, Allen, Payne, and Obara. As we set forth reasoning, which may differ from or supplement the Examiner’s reasoning, we designate our affirmance of this rejection as including a new ground of rejection under 37 C.F.R. § 41.50(b) to afford Appellant the procedural options for response associated therewith. Obviousness over Masters, Allen, Payne, and Buttery In regard to this alternative rejection, Appellant points out that “in [c]laims 1 and 8, the roller axle pin is stationary with respect to the roller carrier and the roller is rotatable about the roller axle pin.” Appeal Br. 6. Appellant states that “Buttery proposes a mounting configuration in which rotation of the shaft 2[67] causes the shaft 13 and sleeve 17 to rotate as a unit.” Id. (citing Buttery 2:68–69). Appellant contends that “the shaft 13 in Buttery is rotatably mounted, and one of ordinary skill looking to suitable mounting techniques would not look to the impeller of Buttery for mounting the fixed roller axle pin in the current peristaltic pump configuration.” Id. As such, Appellant argues that “[t]herefore, there is no apparent reason to use glass material of the impeller axle pin of Buttery with the axle of Allen.” Id. These arguments are unpersuasive in that they do not address the rejection. In this alternative rejection, the Examiner once again (as discussed 7 Appellant refers to Buttery’s “shaft 22.” Appeal Br. 6. However, Buttery identifies item 22 as a helical compression spring and item 26 as a shaft. Buttery 2:52, 69. We thus understand that Appellant is referring to Buttery’s “shaft 26” instead. Appeal 2020-004368 Application 15/970,366 12 above) finds that: (1) Masters discloses a roller, (2) Allen discloses an axle pin for coupling a roller to a carrier in which the axle pin is stationary relative to the roller, and (3) Payne discloses rollers made of borosilicate glass. Final Act. 7–8. Here, rather than Obara, the Examiner relies on Buttery only for disclosing an axle pin made of borosilicate glass, rather than for an axle pin that is stationary. Id. at 8. Toward this end, Buttery discloses “a pump for pumping corrosive liquids.” Buttery 2:18–19. Buttery further discloses that “[t]he housing 1, impeller 12 and impeller shaft 11 are each formed from glass preferably[,] borosilicate glass” (id. at 2:32–34) and that “[t]he shaft 13 is received in sleeve 17” (id. at 2:43–44). Figure 1 of Buttery shows shaft 13 is an extension of impeller shaft 11. The Examiner explains that “[t]he sleeve 17 can be designated as part of a composite shaft which includes [shaft 26].” Ans. 21. Thus, Buttery at least discloses a “pin” (impeller shaft 11, shaft 13, and shaft 26 together), which holds sleeve 17 and the pin is made of borosilicate glass, apparently for the purpose of withstanding corrosive liquids. As such, Buttery discloses a corresponding pin for holding a component (sleeve), much in the same manner as Allen’s roller pin 219 is for holding its roller 201. Buttery, similar to Obara as discussed above, is reasonably pertinent to Appellant’s problem of corrosion, and thus is analogous art under the second prong of the test.8 As discussed above for Obara, the corrosion problem does not depend on 8 The Examiner finds that Buttery and Masters are in the same field of endeavor for the first prong of the analogous art test, without elaboration. Ans. 20. However, we note that Buttery discloses a “pump for pumping corrosive liquids” (Buttery 2:19–20) and thus, apparently has more common components to those of Masters as opposed to those of Payne, which we discussed above. Appeal 2020-004368 Application 15/970,366 13 whether Buttery’s corresponding pin rotates. Consequently, Appellant does not apprise us of Examiner error. Accordingly, for these reasons, we sustain the Examiner’s rejection of claims 1–4, 6–8, 11–13, 15, and 16 as unpatentable over the combination of Masters, Allen, Payne, and Buttery. As we set forth reasoning, which may differ from or supplement the Examiner’s reasoning, we also designate our affirmance of this rejection as including a new ground of rejection. Obviousness over Masters, Allen, and (Obara or Buttery) Appellant argues that the combination of “Masters, Allen, Obara and Buttery do not disclose the recitations of independent Claims 1 and 8 for at least the reasons discuss above.” Appeal Br. 6. In other words, for this alternative rejection, Appellant relies on the arguments presented for the first two rejections discussed above. As we find those arguments unpersuasive for the reasons discussed above, we likewise sustain the Examiner’s rejection of claims 1, 2, 4–8, 11, and 13–16 as unpatentable over the combination of Masters, Allen, and Obara, and over the combination of Masters, Allen, and Payne. Once again, we designate our affirmance of this rejection as including a new ground of rejection. Obviousness over Masters, Allen, (Payne alone or Payne and Obara), and Galea Obviousness over Masters, Allen, Payne, Buttery, and Galea Obviousness over Masters, Allen, (Obara or Buttery), and Galea Appellant does not provide substantive arguments for these rejections and relies on arguments presented for parent claims 1 and 8. Appeal Br. 7. As we find no deficiencies in the Examiner’s rejection of claims 1 and 8, we Appeal 2020-004368 Application 15/970,366 14 likewise sustain the Examiner’s rejections of claims 9 and 10 over the variously indicated combinations of cited art. Because the affirmances of these rejections rely on the rejections of parent claims 1 and 8 above, we also designate our affirmances of these rejections as including a new ground of rejection. CONCLUSION The Examiner’s rejections of claims 1–16 under 35 U.S.C. § 103(a), as being obvious, are affirmed, under 37 C.F.R. § 41.50(b). Appeal 2020-004368 Application 15/970,366 15 DECISION SUMMARY In summary: FINALITY OF DECISION This decision contains a new ground of rejection 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: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed New Ground 1–4, 6–8, 11–13, 15, 16 103 Masters, Allen, (Payne alone or Payne and Obara) 1–4, 6–8, 11–13, 15, 16 1–4, 6–8, 11–13, 15, 16 1–4, 6–8, 11–13, 15, 16 103 Masters, Allen, Payne, Buttery 1–4, 6–8, 11–13, 15, 16 1–4, 6–8, 11–13, 15, 16 1, 2, 4–8, 11, 13– 16 103 Masters, Allen, (Obara or Buttery) 1, 2, 4–8, 11, 13– 16 1, 2, 4–8, 11, 13–16 9, 10 103 Masters, Allen, (Payne alone or Payne and Obara), Galea 9, 10 9, 10 9, 10 103 Masters, Allen, Payne, Buttery, Galea 9, 10 9, 10 9, 10 103 Masters, Allen, (Obara or Buttery), Galea 9, 10 9, 10 Overall Outcome 1–16 1–16 Appeal 2020-004368 Application 15/970,366 16 When the Board enters such a non-final decision, the Appellant, within two months from the date of the decision, must exercise one of the following two options with respect to the new ground of rejection to avoid termination of the appeal as to the rejected claims: (1) Reopen prosecution. Submit an appropriate amendment of the claims so rejected or new Evidence relating to the claims so rejected, or both, and have the matter reconsidered by the examiner, in which event the prosecution will be remanded to the examiner. The new ground of rejection 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. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED; 37 C.F.R. § 41.50(b)