BFKW, LLCDownload PDFPatent Trials and Appeals BoardSep 13, 20212021002880 (P.T.A.B. Sep. 13, 2021) 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. 15/019,497 02/09/2016 Randal S. Baker BAK04 P-122C 5617 15671 7590 09/13/2021 Gardner, Linn, Burkhart & Ondersma LLP 2900 Charlevoix Dr., SE, Suite 300 Grand Rapids, MI 49546 EXAMINER PINDERSKI, JACQUELINE M ART UNIT PAPER NUMBER 3785 NOTIFICATION DATE DELIVERY MODE 09/13/2021 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): Vredeveld@gardner-linn.com clark@gardner-linn.com patents@gardner-linn.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte RANDAL S. BAKER and JAMES A. FOOTE Appeal 2021-002880 Application 15/019,497 Technology Center 3700 Before CHARLES N. GREENHUT, MICHELLE R. OSINSKI, and JEREMY M. PLENZLER, Administrative Patent Judges. GREENHUT, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 1–13, 16–24 and 49–59. See Final Act. 1. We have jurisdiction under 35 U.S.C. § 6(b). An oral hearing was conducted August 23, 2021. We AFFIRM. 1 We use the term “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as BFKW, LLC. Appeal Br. 3. Appeal 2021-002880 Application 15/019,497 2 CLAIMED SUBJECT MATTER The claims are directed to a method and device for treating metabolic disease. Claim 1, reproduced below, is illustrative of the claimed subject matter: 1. An organic method of treating metabolic disease in a patient having a metabolic disease, comprising: deploying a device having a member with a surface that is shaped to a portion of the gastrointestinal tract of the patient; applying stress with the surface of the deployed device to the portion of the gastrointestinal tract to thereby treat the metabolic disease and produce satiety in the patient; and titrating the stress applied with the surface of the deployed device, including titrating the stress according to activity of the patient to regulate caloric intake, wherein said titrating the stress comprises titrating the stress applied based on the patient's activity to avoid satiety from the applied stress interfering with the patient’s consumption of calories if the patient does not have significant excess body mass. REFERENCES The prior art relied upon by the Examiner is: Name Reference Date Forsell US 2001/0011543 A1 Aug. 9, 2001 Saadat US 2005/0192629 A1 Sept. 1, 2005 Baker US 2007/0293716 A1 Dec. 20, 2007 Birk US 2012/0203061 A1 Aug. 9, 2012 Dixon Health Outcomes of Severely ObeseType 2 Diabetic Subjects 1 Year After Laparoscopic Adjustable Gastric Banding Feb. 2002 Appeal 2021-002880 Application 15/019,497 3 REJECTIONS Claims 1–11, 13, 16–24, and 49 are rejected under 35 U.S.C. § 103 as being unpatentable over Birk, Dixon and Forsell. Final Act. 3. Claim 12 is rejected under 35 U.S.C. § 103 as being unpatentable over Birk, Dixon and Forsell, and Baker and Saadat. Final Act. 10. Claims 50–59 are rejected under 35 U.S.C. § 103 as being unpatentable over Birk and Dixon. Final Act. 11. OPINION The rejection of independent claims 1 and 50 The Examiner rejected independent claim 1 based on the combination of Birk, Dixon, and Forsell. Final Act. 3–5. In that rejection Birk was essentially relied on for the basic device used in the method and basic aspects of its operation. Final Act. 3. There is no structural distinction asserted between the device used to practice Appellant’s invention and that of Birk. Rather, Appellant is attempting to secure claims directed to new uses of the Birk device. Hearing Transcript 5–6. The Examiner cites Dixon as linking obesity, the condition with which Birk is concerned, with type 2 diabeties—a metabolic disease. Final Act. 3–4; Birk paras. 3–4. Appellant does not raise any issues concerning the Examiner’s reliance on Dixon in this regard and Appellant’s Specification appears to acknowledge this relationship was known. Spec. 3:7. The Examiner relies on Birk for the general ability to titrate the applied stress. Final Act. 3 (citing Birk para. 1082). The Examiner’s reliance on Birk in that regard is not disputed. The 2 “A variation of the above embodiments would be to allow the device to be adjustable via an adjustment element. This adjustability could be in the length, shape, angle or stiffness of the cardiac 12, esophageal 36, connecting Appeal 2021-002880 Application 15/019,497 4 Examiner relies on Forsell for the titrating step to specifically be “according to activity of the patient to regulate caloric intake.” Final Act. 4 (citing Forsell para. 38). The Examiner reasons that it would have been obvious to incorporate that teaching of Forsell into Birk “in order to help treat patients suffering from heartburn and reflux disease.” Final Act. 4 (citing Forsell para. 38). The Examiner relies on substantially similar fact findings and reasoning with regard to claim 50, the other independent claim before us. Claim 50, however, does not recite a titrating step, and the Examiner did not rely on Forsell in the rejection of claim 50. Appellant separately argues each independent claim. The motivation for incorporating Forsell’s teachings Initially Appellant makes a somewhat tangential attack on the Examiner’s stated motivation for combining the references, in that Appellant does not actually address the motivation stated by the Examiner of treating “heartburn and reflux.” Rather, Appellant asserts that one seeking to treat obesity, as is the case with Birk, would not seek to “regulate caloric intake to avoid satiety” in the manner Appellant sought. Appeal Br. 9. This argument does not address the Examiner’s proposed reason for combining the teachings of Forsell with Birk. See 37 C.F.R. § 41.37(c)(1)(iv) (“The arguments shall explain why the examiner erred . . .”). Appellant makes no assertion that a patient suffering from, or having a history of, obesity or metabolic disease, would or could not additionally, or at another time, also 25, and/or fixation elements 31. Adjustability may be a desirable feature, whether manual or automated.” Appeal 2021-002880 Application 15/019,497 5 suffer from heartburn or reflux, and therefore benefit from a method of treating such ailments. It is well-settled that it is not necessary for the prior art to serve the same purpose as that disclosed in Appellants’ Specification in order to support the conclusion that the claimed subject matter would have been obvious. See In re Lintner, 458 F.2d 1013, 1016 (CCPA 1972); see also KSR Int’l. v. Teleflex, 550 U.S. 398, 419 (2007) (“[N]either the particular motivation nor the avowed purpose of the [Appellants] controls” in an obviousness analysis.) “[A]ny need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed” KSR Int’l. v. Teleflex 550 U.S. at 420; In re Beattie, 974 F.2d 1309, 1312 (Fed. Cir. 1992) (“As long as some motivation or suggestion to combine the references is provided by the prior art taken as a whole, the law does not require that the references be combined for the reasons contemplated by the inventor.”). Here, the Examiner’s position that one would have been motivated to make the proposed combination in order to be able to treat heartburn or reflux stands uncontroverted. To the extent Appellant is arguing the statement of purpose “to regulate caloric intake” must be an expressly stated goal of the prior art because it is recited in the claim, we first note that claim 1 does not actually include any language indicating that the “regulat[ion of] caloric intake” must always be “to avoid satiety.” Claim 1 uses the open-ended transitional phrase “comprises” to define a further aspect of the “titrating the stress.” According to the language following the term “comprises,” the avoidance of satiety must only be an aspect of titrating “if the patient does not have significant excess body mass.” We will discuss issues related to contingent Appeal 2021-002880 Application 15/019,497 6 limitations and intended purposes or results in greater detail where we address Appellant’s arguments more directly related to those issues. See Appeal Br. 12–14; Reply Br. 5–6. Appellant’s argument that (the heartburn/reflux embodiment) of Forsell teaches away from Birk (Appeal Br. 9) is unpersuasive because Forsell clearly and undisputedly teaches alternatives and it is well-settled that “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 . . .” In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). Appellant’s argument that “Forsell could not treat obesity and reflux in the same paitent at the same time,” (Reply Br. 2) apparently refers to the exact same moment in time (Reply Br. 4). The Examiner does not actually attempt to assert Forsell could be used in such a manner. To the extent this is an argument that the heartburn/reflux embodiment of Forsell would be incompatible with Birk’s obesity treatment, Appellant does not apprise us of any reason why both conditions could not be treated at different instances over the same or sequential time periods while the device is implanted. Again, as noted above, there is nothing of record to suggest a patient suffering from, or having a history of, obesity or metabolic disease would or could not additionally, or at another time, also suffer from heartburn or reflux, and therefore benefit from a method of treating such ailments. Analogousness Appellant next contends that Forsell, or at least the portion of Forsell directed to teaching the treatment of heartburn and reflux disease, should be considered nonanalogous art. Appeal Br. 10–12. Appellant does not cite, and Appeal 2021-002880 Application 15/019,497 7 we are not aware of any, authority for treating only a portion of a reference as nonanalogous art. Indeed, the presence of different embodiments in the same reference evinces the fact that one skilled in the art would consider the subject matter associated with those embodiments analogous. In any case, Forsell clearly satisfies the structure and function test associated with the field of endeavor prong of the analogous art inquiry. There is no dispute that the device Forsell employs for treating obesity is structurally identical to that used for treating heartburn or reflux. The distinction Appellant attempts to draw between the methods of Forsell are rooted more in their intended use rather than actual function. In both methods the manipulative steps associated with the devices are essentially the same: [0035] In accordance with another aspect of the present invention there is provided a method of controlling the food flow in the stomach or esophagus of a patient, comprising: (a) Surgically implanting in the patient an adjustable restriction device engaging the patient's stomach or esophagus to form a stoma opening in the stomach or esophagus. (b) Surgically implanting in the patient an adjustment device which adjusts the restriction device and a sensor for sensing at least one physical parameter associated with the patient. And (c) controlling the adjustment device to adjust the restriction device to change the size of the stoma opening in response to the sensor sensing a change in the physical parameter. The fact that different control settings can be applied in order to put the device to a different use (compare Forsell para. 36 with para. 38) does not significantly alter the functioning of the device or method itself. The device and method still function according to the same basic principles outlined in paragraph 35. That minor modifications can be made to Forsell’s control algorithm to produce different in vivo results to treat different conditions Appeal 2021-002880 Application 15/019,497 8 does not demonstrate a significant functional difference in Forsell’s method of treating heartburn or reflux such that a skilled artisan would regard those teachings as irrelevant in the context of treating obesity or metabolic disorders. Contingent limitations Appellant’s next two arguments (Appeal Br. 12–14) ultimately depend on the same underlying issue: what is the effect of “if” in claim 1 where the claim recites the condition: “if the patient does not have significant excess body mass.” Although the Examiner cites MPEP § 2173.05(h) (Ans. 20), no rejection under § 112(b) is presently before us for review. However, we note that we do have some question as to precisely which clause the conditional “if” language in claim 1 refers back to as being contingent upon the condition being satisfied. The most likely possible contingent clauses are the ones that begin: “titrating the stress applied . . .”; “titrating the stress according to activity . . . ”; or “wherein said titrating the stress comprises . . .” Although we would certainly recommend clarification of this language in any further prosecution, we can briefly consider each alternative without seeking further clarification at this time and the chosen construction is not ultimately determinative of the outcome of the prior-art rejections before us. Interpreting contingencies in claim language is covered in MPEP § 2111.04 which discusses Ex parte Schulhauser, Appeal 2013-007847 (PTAB April 28, 2016) (precedential). Schulhauser (as quoted in MPEP § 2111.04) states: “[i]f the condition for performing a contingent step is not satisfied, the performance recited by the step need not be carried out in order for the claimed method to be performed.” Schulhauser at 10. Appeal 2021-002880 Application 15/019,497 9 As mentioned, the “condition for performing a contingent step” in claim 1 is: “the patient does not have significant excess body mass.” When using Birk’s device, it would seem that condition is likely to go unsatisfied because Birk is concerned specifically and primarily with treating obesity. We must then consider what the contingent step that “need not be carried out” is then in claim 1. If the contingent step depending on the “if” condition being satisfied is the entire “titrating the stress applied . . .” clause then the claim would seem to be clearly met by Birk and Dixon, and Forsell would not appear to be needed for the rejection. The Examiner does not appear to have advanced such a position and such an interpretation seems the least likely of the three options discussed above in the context of claim 1 so we need not discuss it further for purposes of this review. The contingent step at the very least includes: to avoid satiety from the applied stress interfering with the patient's consumption of calories because, grammatically, this immediately precedes the condition and contextually it naturally follows from the subject matter of the present application that “if the patient does not have excess body mass” one would want “to avoid satiety” so as not to cause insufficient low caloric intake. Contextually, it is conceivable that one may still want to “titrat[e] the stress applied based on the patient’s activity” in both cases where the patient does and does not have significant excess body mass. However, grammatically, there being no punctuation offsetting this clause from that following, it would seem that the contingency mentioned above should also include: wherein said titrating the stress comprises titrating the stress applied based on the patient's activity Appeal 2021-002880 Application 15/019,497 10 Appellant’s arguments on page 9 of the Brief (“[the prior art] does not disclose titrating the stress according to activity of the patient to regulate caloric intake to avoid satiety”) seem to indicate Appellant believes that claim 1 should be interpreted such that “regulat[ion] of caloric intake” results in “avoid[ing] satiety.” Under such an interpretation it would seem that the clause: including titrating the stress according to activity of the patient to regulate caloric intake should additionally be included as part of the contingent step for purposes of the conditional language analysis because one would seemingly only want to achieve the end of avoiding satiety “if the patient does not have significant excess body mass.” However, as the claim does not contain any express language indicating the recited caloric regulation must be to avoid satiety, we think the claim is better construed to regard avoiding satiety as one possible effect of more broadly “regulat[ing] caloric intake.” In other words, we see nothing in the claim language or Specification requiring or suggesting that the term “regulate” should be limited to only cover downregulation of caloric intake in all situations. In this context it would seem one may want to upregulate or downregulate caloric intake based on activity level and it is only when the patient does not have significant excess body mass that such regulation need be downregulation (“to avoid satiety”). This construction is the one that appears to be advanced by the Examiner, and is in Appellant’s best interest, narrowing the claim somewhat, for purposes of the conditional language analysis. Thus, under the best interpretation of claim 1, the contingent step that “need not be carried out” if the condition precedent (“the patient does not have significant excess body mass”) is satisfied is: Appeal 2021-002880 Application 15/019,497 11 wherein said titrating the stress comprises titrating the stress applied based on the patient's activity to avoid satiety from the applied stress interfering with the patient's consumption of calories Regarding the condition precedent, claim 1 makes no mention of anything further that is required when treating a patient with excess body mass, i.e., if the condition is not satisfied. Claim 1 also does not include any language limiting the scope of subject matter covered by claim 1 to methods performed on patients not having excess body mass. Contra Hearing Transcript at 9. We also do not discern any language in claim 1 to indicate that the method is first used to treat a patient with obesity, then subsequently used to treat a patient that no longer exhibits excess body mass. Contra Hearing Transcript at 9. Thus, we are in agreement with the Examiner (Ans. 20) that in order to demonstrate the obviousness of the claimed method, the cited prior art need not necessarily show at least: wherein said titrating the stress comprises titrating the stress applied based on the patient's activity to avoid satiety from the applied stress interfering with the patient's consumption of calories Ans. 20. It is enough for that purpose that Birk teaches deploying the device in patients suffering from obesity, that Dixon demonstrates obesity is linked to metabolic diseases, and that it would have been obvious to modify Birk in view of Forsell to titrate the stress applied by the device based on the patient’s activity (e.g., eating or sleeping) in order to, also or instead, treat heartburn or reflux. Appeal 2021-002880 Application 15/019,497 12 If the contingent limitation is the entirety of the clause beginning, “including titrating the stress . . .”, no further analysis of claim 1 need be conducted. If instead the contingent limitation is regarded, as we think most appropriate, as beginning with the “wherein said titrating . . .” language quoted above, the only question that would then remain with regard to claim 1 relates to the language “to regulate caloric intake.” Inherency Appellant mentions the “to regulate caloric intake” limitation only tangentially on page 12 of the Brief, focusing instead on the “to avoid satiety” language in that section of the Brief, but returns the focus to the “to regulate caloric intake” language in the Reply Brief. Reply Br 5. To the extent the limitation is outside of the contingent clause and always required by claim 1, the issue with regard to the “to regulate caloric intake language” of claim 1 is essentially the same as the sole issue raised with regard to claim 50 where Appellant asserts the Examiner has not established that the prior art teaches “increasing motility of the gastrointestinal tract of the patient.” Appeal Br. 14–17. Although the Examiner does not appear to cite or quote from relevant authorities for support, the Examiner’s analysis of this issue (Ans. 19, 21–22) is exactly correct. The patent laws include express provisions indicating that claims directed to processes may permissibly be directed to new uses of known processes, materials, or apparatus. 35 U.S.C. § 100. However, jurisprudence on the subject has long recognized a distinction between a new “use,” where that use consists of a series of manipulative steps in a process, and the mere discovery of latent or inherent properties, or results, naturally present in, or Appeal 2021-002880 Application 15/019,497 13 flowing from, known or existing processes or apparatus. See, e.g., cases cited at MPEP § 2112.02(II). When the issue arises, each case must be examined on its own facts to determine whether a claim directed to a process is, in fact, directed to a new use of the type contemplated in § 100, or instead amounts to appending newly discovered properties or results to a known or obvious process. Claims 1 and 50, in their present form, involve the latter. Of particular relevance here are cases involving claims in which the only distinguishing limitation involves “efficacy” or some other result occurring in vivo because the recitations at issue here, “to regulate caloric intake” and “increasing motility of the gastrointestinal tract of the patient,” amount not to manipulative steps undertaken by the practitioner of the methods, but to results naturally and inherently flowing from the actual manipulative steps that must be undertaken to practice the recited methods. Ans. 19, 21–22. While new uses of known processes may be patentable, newly discovered results of known processes do not, without more, render a process patentable. See Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc. 246 F.3d 1368, 1376–1377 (Fed. Cir. 2001) (“[E]xpressions of intended efficacy and reduced toxicity are non-limiting”). There is a strong policy incentive behind this jurisprudence. Congress, with § 103, and before that the U.S. Supreme Court, has recognized it is undesirable to grant patent monopolies on obvious combinations that serve to withdraw subject matter from the public and diminish the resources available to skilled artisans. Great A. & P. Tea Co. v. Supermarket Equip. Corp., 340 U.S. 147 (1950) (discussed with approval in Graham v. John Deere Co. of Kansas City, 383 U.S. 1 (1966)). Above, we have discussed the reasons why processes including all of the manipulative steps recited in claims 1 and 50 would have been obvious. Appeal 2021-002880 Application 15/019,497 14 The purpose of both Appellant’s method and Forsell’s is to titrate stress on the stomach caused by the implanted device according to patient activity. The distinction lies not in the process but in the results of that titration: caloric regulation versus heartburn or reflux mitigation. The Examiner’s position with respect to claim 1 is that the act of “titrating the stress according to activity of the patient” in the manner disclosed in Forsell would, despite being intended to mitigate heartburn or reflux, inherently serve “to regulate caloric intake.” Ans. 19. Appellant’s own Specifiation supports the Examiner’s position in this regard, stating (with emphasis added), “[t]itration could be affected by adjusting the pressure on a portion of the GI tract and the amount of time that the pressure is increased. This causes a neurohormonal response to regulate caloric intake and intestinal transit time . . . ” Spec. 8:1-3. It is true, and Appellant and the Examiner seem to agree, that Forsell does not expressly disclose caloric regulation as the purpose or result of the stress regulation dictating the opening size of the stoma during the heartburn or reflux treatment, only the obesity treatment. Ans. 19; Reply Br. 5–6; Forsell para. 18. However, the Examiner articulates a sound technical basis for the conclusion that reversing the process used in the obesity treatment would ultimately have the reverse effect, thereby inherently upregulating caloric intake, whether intended, desirable, known to happen or not. Ans. 19. On the record presently before us, the Examiner has articulated a reasonable basis to conclude that if reducing the stoma opening causes satiety (Forsell paras. 18, 36), enlarging the stoma opening (Forsell para. 38) Appeal 2021-002880 Application 15/019,497 15 would inherently “[up]regulate caloric intake” to thereby, “avoid satiety[3]” at least to some degree. The Examiner makes similar and reasonable findings with regard to claim 50 in that, based on Appellant’s own Specification4 and arguments, no further manipulative steps beyond those recited in claim 50 have been identified as needing to be performed to achieve the recited result of “increasing motility in the gastrointestinal tract of the patient.” Indeed, if there were additional steps required, the claim runs the risk of being incomplete. See, e.g., In re Mayhew, 527 F.2d 1229, 1233 (CCPA 1976) (Method claims lacked an enabling disclosure for omitting a step, without which, the invention as claimed could not produce the claimed product). The Examiner’s position is that Appellant may have recognized something quite interesting about Birk’s process when used in a patient with metabolic 3 To the extent “avoid[ing] satiety” may be required by claim 1 in light of the conditional language. 4 Appellant asserts it is improper to look to Appellant’s own Specification for proof of inherency. Appeal Br. 17; Reply Br. 10. We disagree. “The perceived problem with combining references using hindsight to render a claimed invention obvious is that it ‘simply takes the inventor’s disclosure as a blueprint for piecing together the prior art to defeat patentability.’ This fear of hindsight recreation in the context of obviousness determinations, however, is not applicable in the context of inherency. There is simply no basis in our law to support the proposition that the source of proof for inherency must be found in the prior art and cannot be found in a patentee’s own disclosure or other source.” Elan Pharmaceuticals, Inc. v. Mayo Foundation, 304 F.3d 1221 (Fed. Cir. 2002) (citation omitted), J. Dyk, dissenting (vacated at 314 F.3d 1299 (Fed. Cir. 2002) (en banc), superseded by 346 F.3d 1051); see also, In re Thorpe, 777 F.2d 695, 697–99 (Fed. Cir. 1985) (admissions in an applicant’s own specification indicating that the applicant’s claim distinguish from the prior art by merely reciting latent properties or characteristics of an old product, may be used against an applicant to reject those claims.) Appeal 2021-002880 Application 15/019,497 16 disease as suggested by Dixon, in that it can increase motility of the gastrointestinal tract of the patient. However, such a discovery, without more, does not amount to inventing a new and nonobvious process within the meaning of that term as it is used in 35 U.S.C. § 100. In re Cruciferous Sprout Litigation, 301 F.3d 1343, 1351 (Fed. Cir. 2002). Thus, in the context of both claim 1 and claim 50 the Examiner has set forth a reasonable basis to shift the burden to Appellant to come forward with technical reasoning or evidence demonstrating error in the Examiner’s positions. MPEP § 2112(IV), (V) (Appellant is in the best position to provide technical reasoning or evidence to show error in the Examiner’s inherency determinations). This burden is not carried merely by pointing out Forsell lacks express disclosure of the supposedly inherent subject matter as Appellant has done. On the record presently before us, the Examiner’s inherency positions stand without any meaningful rebuttal. CONCLUSION For the foregoing reasons, the Examiner’s rejections are AFFIRMED. Appeal 2021-002880 Application 15/019,497 17 DECISION SUMMARY Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1–11, 13, 16–24, 49 103 Birk, Dixon, Forsell 1–11, 13, 16–24, 49 12 103 Birk, Dixon, Forsell, Baker, Saadat 12 50–59 103 Birk, Dixon 50–59 Overall Outcome 1–13, 16– 24, 49–59 RESPONSE 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 Copy with citationCopy as parenthetical citation