2021002200 (P.T.A.B. Dec. 2, 2021)

Keith G. Lurie

Patent Trials and Appeals BoardDec 2, 2021

2021002200 (P.T.A.B. Dec. 2, 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. 15/689,670 08/29/2017 Keith G. Lurie 085921-1055929 (000561US) 6727 20350 7590 12/02/2021 Kilpatrick Townsend & Stockton LLP - West Coast Mailstop: IP Docketing - 22 1100 Peachtree Street Suite 2800 Atlanta, GA 30309 EXAMINER LOUIS, LATOYA M ART UNIT PAPER NUMBER 3785 NOTIFICATION DATE DELIVERY MODE 12/02/2021 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): KTSDocketing2@kilpatrick.foundationip.com ipefiling@kilpatricktownsend.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte KEITH G. LURIE, KANCHANA SANJAYA GUNESEKERA KARUNARATNE, JOSEPH MANNO, and JOHN P. GRIMM __________ Appeal 2021-002200 Application 15/689,6701 Technology Center 3700 __________ Before CHARLES N. GREENHUT, MICHAEL L. HOELTER, and ANNETTE R. REIMERS, Administrative Patent Judges. REIMERS, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), Appellant2 appeals from the Examiner’s decision to reject claims 1–15 and 24. Claims 16–23 have been 1 Appellant identifies the following U.S. Patent Application as related to the present Appeal: 15/160,492 (Appeal No. 2021-000010; decision rendered July 2, 2021). See Appeal Brief (“Appeal Br.”) 3, filed Sept. 16, 2020. 2 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 Keith G. Lurie. Appeal Br. 3. Appeal 2021-002200 Application 15/689,670 2 canceled. Appeal Br. 15 (Claims App.). We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM and designate our affirmance of the rejection of claims 1–15 and 24 under 35 U.S.C. § 103 as a NEW GROUND OF REJECTION pursuant to 37 C.F.R. § 41.50(b). CLAIMED SUBJECT MATTER The claimed subject matter is “directed toward systems and methods of administering CPR to a patient in a head and thorax up position.” Spec. ¶ 4.3 Claims 1, 9, and 24 are independent. Claim 1 is illustrative of the claimed subject matter and recites: 1. A method for performing cardiopulmonary resuscitation (CPR), comprising: positioning an individual on an elevation device in a stable selected position to elevate the individual’s heart and head, the stable selected position comprising a relationship between the individual’s head, neck, and chest, the elevation device comprising: a base; and an upper support movably coupled to the base, wherein the upper support is configured to receive and support the individual’s upper back, shoulders, and head; elevating at least a portion of the upper support to elevate the head of the individual relative to the heart by a distance in the range from about 7 cm to about 27 cm; and performing active compression-decompression CPR while elevating the head relative to the heart. Appeal Br. 12 (Claims App.). 3 Specification (“Spec.”), filed Aug. 29, 2017. Appeal 2021-002200 Application 15/689,670 3 THE REJECTIONS I. Claims 1, 2, and 5 stand rejected under 35 U.S.C. § 103 as unpatentable over Reinhold (US 4,060,079, issued Nov. 29, 1977) and Cantrell (US 2004/0116840 A1, published June 17, 2004). II. Claims 3, 4, 7, and 8 stand rejected under 35 U.S.C. § 103 as unpatentable over Reinhold, Cantrell, and Soderberg (US 8,752,220 B2, issued June 17, 2014). III. Claim 6 stands rejected under 35 U.S.C. § 103 as unpatentable over Reinhold, Cantrell, and Wilson (US 2009/0308400 A1, published Dec. 17, 2009). IV. Claims 9–11, 15, and 24 stand rejected under 35 U.S.C. § 103 as unpatentable over Reinhold, Cantrell, and Voss (US 2012/0330200 A1, published Dec. 27, 2012). V. Claims 12 and 13 stand rejected under 35 U.S.C. § 103 as unpatentable over Reinhold, Cantrell, Voss, and Soderberg. VI. Claim 14 stands rejected under 35 U.S.C. § 103 as unpatentable over Reinhold, Cantrell, Voss, and McDaniel (US 2006/0162077 A1, published July 27, 2006). VII. Claim 1 stands rejected on the ground of nonstatutory double patenting as unpatentable over claim 1 of Lurie (US 9,750,661 B2, issued Sept. 5, 2017). ANALYSIS Rejection I – Obviousness over Reinhold and Cantrell Appellant does not offer arguments in favor of dependent claims 2 and 5 separate from those presented for independent claim 1. Appeal Br. 5– Appeal 2021-002200 Application 15/689,670 4 8. We select claim 1 as the representative claim, and claims 2 and 5 stand or fall with claim 1. 37 C.F.R. § 41.37(c)(1)(iv) (2019). As to claim 1, the Examiner finds that Reinhold discloses a method for performing cardiopulmonary resuscitation comprising positioning an individual on an elevation device in a stable selected position to elevate the individual’s heart and head in which the elevation device has a base (frame member 18) and an upper support (sub-frame 32) movably coupled to the base, wherein the upper support is configured to receive and support the individual’s upper back, shoulders, and head. Final Act. 3 (citing Reinhold Fig. 5).4 The Examiner acknowledges that Reinhold “does not specifically disclose performing active compression decompression CPR while elevating the head relative to the heart.” Id. The Examiner, however, finds that Cantrell teaches this missing limitation. Id. In particular, the Examiner finds that “Cantrell teaches performing active decompression CPR . . . while elevating the head relative to the heart.” Id. (citing Cantrell ¶¶ 7, 67). The Examiner concludes that it would have been obvious to an ordinarily skilled artisan to modify the method of Reinhold to “include active CPR . . . performed while elevating the user’s head to provide the advantage of . . . enhanced blood return from the head as disclosed by Cantrell.” Id. (citing Cantrell ¶ 67). The Examiner also acknowledges that the modified Reinhold device “does not specifically disclose elevating at least a portion of the upper support to further elevate the head of the individual relative to the heart by a distance in the range from about 7 cm to about 27 cm.” Id. at 4. The Examiner, however, concludes that it would have been obvious to an ordinarily skilled artisan “to have modified the upper support of the 4 Final Office Action (“Final Act.”), dated Apr. 16, 2020. Appeal 2021-002200 Application 15/689,670 5 modified Reinhold” by elevating “the head of the individual relative to the heart by a distance in the range from about 7 cm to about 27 cm as such would be considered a design choice fully implementable by one having ordinary skill in the art and would provide the advantage of enhanced accommodation of users of different sizes.” Final Act. 4. The Examiner also concludes that “it has been held than where the general conditions of a claim are known it is not inventive to determine optimum or workable ranges by routine experimentation.” Id. Appellant contends that Reinhold stresses that its arrangement of components, as shown in Figure 2 for a patient in the supine position, i.e., the flat position, “is important so as to provide ‘a relatively unyielding support of the patient’s back area sufficient to effect cardiac compression through the application of periodic mechanical downward forces on the chest area of the patient.’” Appeal Br. 6 (citing Reinhold 2:14–25, 3:35–37, claim 6, Fig. 2). Appellant argues that “[t]here is nothing within the Reinhold reference that teaches or suggests that such unyielding support is possible when the back section of the device is in the raised position as shown in FIG. 5.” Id. As such, Appellant concludes that “the Reinhold device as disclosed is not capable of being used in a method for the performance of head up CPR as presently claimed.” Id.; see also id. at 6–7 (arguing that “[a]s Reinhold indicates that its frame needs to be in the lowered patient treatment and transporting position in order for the back area to be sufficiently supported to effect chest compressions,” the combination of Reinhold and Cantrell fails to disclose “performing active compression- Appeal 2021-002200 Application 15/689,670 6 decompression CPR while elevating the head relative to the heart’ as recited in claim 1”); Reply Br. 2.5 Appellant’s contention is unpersuasive. In reference to column 2, lines, 14 through 25, Reinhold, at best, discloses that the device is designed to engage a horizontal surface, such as a floor, for proper support and to engage and support a patient thereon in a supine position to “provide[] for [] relatively unyielding support of the patient’s back area sufficient to effect cardiac compression” during CPR administration. See Reinhold 2:14–25 (emphasis added); see also id. at Abstract. The Supreme Court has emphasized that “the [obviousness] analysis need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). As noted by the Court in KSR, “[a] person of ordinary skill is also a person of ordinary creativity, not an automaton.” Id. at 421. “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” Id. at 416. Here, assuming for the sake of argument that Reinhold’s device lacks comparable support for the administration of CPR in the elevated position of Figure 5, nothing in the record shows that providing additional support to Reinhold’s device, when elevated in the position of Figure 5, to have adequate support for conducting CPR, would involve more than routine engineering efforts. For example, it appears to us that providing a stronger material for components such as the strut 36 of Reinhold’s device, or adding 5 Reply Brief (“Reply Br.”), filed Feb. 8, 2021. Appeal 2021-002200 Application 15/689,670 7 an additional component such as another strut, to the extent such would be necessary, is a matter of providing simple mechanical reinforcement within the skills of an ordinary artisan and the results would be predictable. Appellant argues that “Cantrell fails to teach active decompression” and instead, teaches “passive” decompression. Appeal Br. 6 (citing Cantrell ¶ 41). This argument is also unpersuasive. The Specification does not define “active decompression.” Spec., passim. The Examiner takes the position that “during active compression, a CPR device pushes down on a patient’s chest while during active decompression, the device actively lifts up the chest wall (instead of allowing the user’s chest wall to bounce back up on its own).” Ans. 12.6 Consequently, it is reasonable for the Examiner to find that “[t]he device of Cantrell actively decompresses the chest by using a spring to forcefully pull up on the chest to expand the chest wall beyond the normal diastole position.” Id. (citing Cantrell ¶ 40). We thus are unpersuaded by Appellant’s contention to the contrary. Appellant argues that “while the Cantrell reference generally discloses that its electrical compression device 40 may be used with the head elevated above the heart, the reference does not describe any corresponding structure to support the patient in such a position.” Appeal Br. 6. This argument improperly attacks the references individually. “Non- obviousness cannot be established by attacking references individually where the rejection is based upon the teachings of a combination of references. [The reference] must be read, not in isolation, but for what it fairly teaches in combination with the prior art as a whole.” In re Merck & 6 Examiner’s Answer (“Ans.”), dated Dec. 8, 2020. Appeal 2021-002200 Application 15/689,670 8 Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986) (citation omitted). Here, the Examiner relies on Reinhold, rather than Cantrell, for disclosing a device with structure allowing the head to be elevated above the heart. Final Act. 3. Appellant contends that the claimed “elevation of the head relative to the heart during the performance of CPR is not a mere design choice, but is instead a critical feature that improves the survival outcomes of CPR.” Appeal Br. 7; see also Reply Br. 3. Appellant argues that “elevation of the head relative to the heart also provides the unexpected benefit of increas[ing] blood flow to the brain as compare[d] to CPR flat, despite the effects of gravity on the blood flow.” Appeal Br. 7 (citing Spec. ¶ 128); see also id. (arguing that paragraphs 70 and 71 of the Specification disclose that “elevating the head relative to the heart by a distance in the range from about 7 cm to about 27 cm results in ‘lower right-atrial pressures while increasing cerebral perfusion pressure, cerebral output, and systolic blood pressure SBP compared to CPR administered to an individual in the supine position’”); Reply Br. 3. As such, Appellant argues that “the elevation of the head relative to the heart by a distance in the range from about 7 cm to about 27 cm provides unexpected and critical life-saving benefits and is not a mere design choice as suggested by the Examiner.” Appeal Br. 7; see also Reply Br. 3. As an initial matter, we agree with Appellant that the Examiner’s rationale concerning design choice to “provide the advantage of enhanced accommodation of users of different sizes” is faulty. See Final Act. 4. First, if there is an advantage (enhanced accommodation of different sizes) for the proposed modification, then it would not be a “design choice.” Second, it appears to us that “enhanced accommodation of users of different sizes” would involve different surface areas of the device, rather than having Appeal 2021-002200 Application 15/689,670 9 different ranges of head and heart elevation. Nonetheless, the Examiner provides an alternative rationale for the proposed modification, namely that “it is not inventive to determine optimum or workable ranges by routine experimentation,” and Appellant does not address this alternative rationale. See Final Act. 4; see also Ans. 13; Appeal Br, Reply Br., passim. As discussed above, the Examiner indicates Cantrell’s teaching of active CPR “while elevating the user’s head to provide the advantage of . . . enhanced blood return from the head.” Final Act. 3 (citing Cantrell ¶ 67). Indeed, Cantrell discloses that “a significant benefit of positioning the victim at various angles is that the head of the victim is not required to be at the same horizontal level as the heart. The head may now be elevated above the heart, thereby enhancing blood return from the head.” Cantrell ¶ 67. Cantrell goes on to state that “[s]ince CPR elevates intra cranial pressure, . . . elevation of the head may help reduce this undesired effect.” Id. Thus, Cantrell here teaches that elevation of the head is a result-effective variable in regard to enhancing blood return from the head or reducing the undesired effect of elevated intra cranial pressure during CPR. See In re Aller, 220 F.2d 454, 456 (CCPA 1955) (“[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”). “[T]he discovery of an optimum value of a variable in a known process is usually obvious.” Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1368 (Fed. Cir. 2007). The rationale for determining the optimal parameters for prior art result-effective variables “flows from the ‘normal desire of scientists or artisans to improve upon what is already generally known.’” Id. (quoting In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003)). Appeal 2021-002200 Application 15/689,670 10 In this case, Appellant does not identify any secondary considerations, such as unexpected results. The evidence of obviousness based on routine optimization of elevating the head during CPR as disclosed by Cantrell outweighs the evidence of nonobviousness on the record presently before us. Appellant directs our attention to paragraphs 70, 71, and 128 of the Specification for its argument that the range of head and heart elevation recited in claim 1 provides unexpected results. Appeal Br. 7; see also Reply Br. 3. However, as correctly noted by the Examiner, “the recitation of the range of 7 to 27 cm is not found in [Appellant’s] disclosure” and paragraph 71 of the Specification “discloses various ranges for the head of 10-30 cm and heart 3[-]8 cm resulting in a wide possibility of differences[, but no] specificity or criticality is provided for the range of 7 to 27 cm.” Ans. 13. In other words, even if there is criticality in elevating the head above the heart, the Specification does not appear to disclose criticality for the range of 7 to 27 cm compared to an elevation of, for example, 6 to 28 cm. In summary, and based on the record presented, we sustain the Examiner’s rejection of claim 1 as unpatentable over Reinhold and Cantrell. We further sustain the rejection of claims 2 and 5, which fall with claim 1. 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. Rejections II and III – Obviousness over Reinhold, Cantrell, and either Soderberg or Wilson Claims 3, 4, and 6–8 depend from claim 1. Appeal Br. 12–13 (Claims App.). In regard to these claims, Appellant relies on the arguments Appeal 2021-002200 Application 15/689,670 11 presented for claim 1. Appeal Br. 8 see also Reply Br. 3–4. As we find no deficiencies in the Examiner’s rejection of claim 1, we likewise sustain the Examiner’s rejection of claims 3, 4, and 6–8, for reasons similar to those discussed above for claim 1, as unpatentable over the various combinations of cited prior art. Because we designate our affirmance of the rejection of claim 1 as including a new ground of rejection, we likewise designate the rejection of these claims as including a new ground. Rejection IV – Obviousness over Reinhold, Cantrell, and Voss Claims 9–11 and 15 Appellant does not offer arguments in favor of dependent claims 10, 11, and 15 separate from those presented for independent claim 9. Appeal Br. 8–9. We select claim 9 as the representative claim, and claims 10, 11, and 15 stand or fall with claim 9. Claim 9 recites similar claim language as that of claim 1, namely, “elevating at least a portion of the upper support relative to the base to elevate the head of the individual relative to the heart by a distance in the range from about 7 cm to about 27 cm” and “performing CPR by repeatedly compressing the chest.” Appeal Br. 14 (Claims App.); see also id. at 8 (pointing out that the limitations of claim 9 are similar to those of claim 1). In regard to these limitations, Appellant contends that, “[a]s such, claim 9 is believed to be distinguishable over the combination of Reinhold and Cantrell for similar reasons as claim 1.” Appeal Br. 8; see also Reply Br. 4. Appellant’s arguments are unpersuasive for the same reasons discussed above for claim 1. Claim 9 further recites “regulating an intrathoracic pressure of the individual using an impedance threshold device while elevating the head Appeal 2021-002200 Application 15/689,670 12 relative to the heart.” Appeal Br. 14 (Claims App.); see also id. at 9. As to claim 9, the Examiner makes similar findings as discussed above for claim 1 but acknowledges that the combination of Reinhold and Cantrell “does not specifically disclose regulating an intrathoracic pressure using an impedance threshold device while performing the elevated CPR.” Final Act. 7–8. The Examiner, however, finds that “Voss teaches an impedance threshold device for use during CPR for creating negative pressure within the chest during the relaxation phase as regulation.” Id. at 8 (citing Voss ¶ 106). The Examiner concludes that it would have been obvious to an ordinarily skilled artisan to modify the method of Reinhold and Cantrell, by using a chest compression device “with an impedance threshold device as taught by Voss to provide the advantage of enhanced treatment for victims in need.” Id. Appellant contends that “there is nothing within Voss to inform a person of skill in the art how the use of an ITD [(impedance threshold device)] during head up CPR would enhance treatment of a patient, as Voss fails to teach or suggest the use of an ITD to regulate an intrathoracic pressure of the individual while elevating the head relative to the heart as presently claimed.” Appeal Br. 9; see also Reply Br. 4–6. This contention is unpersuasive because once again, Appellant improperly attacks the references individually. The Examiner relies on the teachings of Voss for using an impedance device during CPR and on the teachings of Cantrell for elevating the head relative to the heart during CPR. Final Act. 7–8; see also Ans. 14. See In re Merck & Co., 800 F.2d at 1097. We also are not persuaded the Examiner engages in impermissible hindsight in combining the teachings of the references. See Reply Br. 5–6. The Examiner cites specific teachings in the references themselves, not Appellant’s disclosure, in support of the Examiner’s articulated reasoning Appeal 2021-002200 Application 15/689,670 13 for combining the references as proposed in the rejection. See Final Act. 7– 8; see also Ans. 14. We further are not persuaded of Examiner error, because Appellant has not made a showing that the Examiner’s rationales were outside of the knowledge within the level of ordinary skill in the art at the time the claimed invention was made or were gleaned only from Appellant’s disclosure. See Reply Br. 5–6. For these reasons, we sustain the Examiner’s rejection of claim 9 as unpatentable over Reinhold, Cantrell, and Voss. We further sustain the rejection of claims 10, 11, and 15, which fall with claim 9. As we set forth reasoning as discussed above for claim 1–– which is also relied upon for claim 9––which may differ from or supplement the Examiner’s reasoning, we designate our affirmance of this rejection as including a new ground of rejection. Claim 24 Claim 24 recites similar subject matter as that of claims 1 and 9 discussed above. Appeal Br. 15 (Claims App); see also id. at 9. Because of the similarly claimed subject matter, Appellant contends that “[a]s such, claim 24 is believed to be distinguishable over the combination of Reinhold and Cantrell for similar reasons as claims 1 and 9.” Appeal Br. 10; see also Reply Br. 6. As we find no deficiencies in the Examiner’s rejection of claims 1 and 9, we likewise sustain the Examiner’s rejection of claim 24, for reasons similar to those discussed above for claims 1 and 9, as unpatentable over Reinhold, Cantrell, and Voss. For similar reasons discussed above, we also designate our affirmance of this rejection as including a new ground of rejection. Appeal 2021-002200 Application 15/689,670 14 Rejections V and VI – Obviousness over Reinhold, Cantrell, Voss, and either Soderberg or McDaniel Claims 12–14 depend from claim 9, either directly or indirectly. Appeal Br. 14–15 (Claims App.). In regard to these claims, Appellant relies on the arguments presented for claim 9. Appeal Br. 10; see also Reply Br. 6–7. As we find no deficiencies in the Examiner’s rejection of claim 9, we likewise sustain the Examiner’s rejection of claims 12–14, for reasons similar to those discussed above for claim 9, as unpatentable over the various combinations of cited prior art. Because we designate our affirmance of the rejection of claim 9 as including a new ground of rejection, we likewise designate the rejection of these claims as including a new ground. Rejection VII – Nonstatutory Double Patenting Claim 1 is rejected on the ground of nonstatutory double patenting. Final Act. 13. Appellant states that it “requests that the Office hold this rejection in abeyance until this application is otherwise in condition for allowance.” Appeal Br. 10; see also Reply Br. 7. Thus, Appellant does not present arguments directed to the rejection and has waived any such arguments. Accordingly, the rejection is summarily affirmed. Appeal 2021-002200 Application 15/689,670 15 CONCLUSION In summary: Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed New Ground 1, 2, 5 103 Reinhold, Cantrell 1, 2, 5 3, 4, 7, 8 103 Reinhold, Cantrell, Soderberg 3, 4, 7, 8 6 103 Reinhold, Cantrell, Wilson 6 9–11, 15, 24 103 Reinhold, Cantrell, Voss 9–11, 15, 24 12, 13 103 Reinhold, Cantrell, Voss, Soderberg 12, 13 14 103 Reinhold, Cantrell, Voss, McDaniel 14 1 Nonstatutory Double Patenting U.S. 9,750,661 Lurie 1 Overall Outcome 1 1–15, 24 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: 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: Appeal 2021-002200 Application 15/689,670 16 (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)