Ex Parte Beddingfield et alDownload PDFPatent Trial and Appeal BoardFeb 28, 201912627809 (P.T.A.B. Feb. 28, 2019) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 12/627,809 11/30/2009 51957 7590 03/04/2019 ALLERGAN, INC. 2525 DUPONT DRIVE, T2-7H IRVINE, CA 92612-1599 FIRST NAMED INVENTOR Frederick C. Beddingfield 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 ATTORNEY DOCKET NO. CONFIRMATION NO. 18485 (AP) 4763 EXAMINER SOROUSH, LAYLA ART UNIT PAPER NUMBER 1627 NOTIFICATION DATE DELIVERY MODE 03/04/2019 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): patents_ip@allergan.com pair_allergan@firsttofile.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte FREDERICK C. BEDDINGFIELD, JOHN G. WALT, CHRISTINE SOMOGYI, CRETAN PUJARA, and JULIE ALBRIGHT 1 Appeal2018-004121 Application 12/627,809 Technology Center 1600 Before RYAN H. FLAX, RACHEL H. TOWNSEND, and CYNTHIA M. HARDMAN, Administrative Patent Judges. HARDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims directed to a method of enhancing eyelash growth and a kit for same, which have been rejected as obvious and for obviousness-type double patenting. We have jurisdiction under 35 U.S.C. § 6(b ). 1 Appellants identify the real party in interest as Allergan, Inc. (Appeal Br., 1.) Herein we reference the Nov. 30, 2009 Specification ("Spec."); Aug. 23, 2016 Non-Final Office Action ("Office Action"); June 22, 2017 Appeal Brief ("Appeal Br."); Jan. 11, 2018 Examiner's Answer ("Answer"); and Mar. 5, 2018 Reply Brief ("Reply Br."). Appeal2018-004121 Application 12/627,809 We affirm the obviousness rejections as to all pending claims, but designate our affirmance as New Grounds of Rejection. We reverse the obviousness-type double patenting rejections. STATEMENT OF THE CASE The Specification discloses that bimatoprost is widely used as an ophthalmic preparation (bimatoprost ophthalmic solution 0.03%) for the treatment of ocular hypertension and open-angle glaucoma. (Spec. 1.) In clinical trials and later in broad scale use, it became apparent that bimatoprost increases eyelash growth. (Id.) Appellants' claimed invention is directed to the topical application, with an applicator to the upper eyelid margin, of a 0.03% bimatoprost solution. Claims 22-26, 28-32, and 34--48 are on appeal. Claim 22 is illustrative and reads as follows: 22. A kit for enhancing the growth of eyelashes in a target treatment area in a person, the kit comprising: an eyelash growth enhancing composition, wherein the eyelash growth enhancing composition comprises a 0.03% w/v bimatoprost solution in a sterile dispensing container; a delivery system separate from the eyelash growth enhancing composition, comprising one or more sets of two sterile applicator brushes having filaments, wherein each of the one or more sets of two sterile applicator brushes are packaged together in a sheath, and wherein the filaments are configured to deliver a single drop of 0.03% w/v to the upper eyelid so that when a single drop of bimatoprost solution from the separate sterile dispensing container is applied to the filaments, the sterile applicator brush delivers about 1 % to about 9% of the drop of bimatoprost solution to the target treatment area. (Appeal Br. 9.) 2 Appeal2018-004121 Application 12/627,809 The Examiner rejected claims 22-26, 28-32, 34, 35, 37--42, and 44-- 48 under 35 U.S.C. § I03(a) as obvious over the combination of Brinkenhoff2 in view of Fitjer3 and Remington. 4 The Examiner rejected claims 36 and 43 under 35 U.S.C. § I03(a) as obvious over the combination of Brinkenhoff, Fitjer, and Remington, in further view of Alderson. 5 The Examiner rejected claims 22-26, 28-32, 34, 35, 37--42, and 44-- 48 on the ground of nonstatutory obviousness-type double patenting as unpatentable over claims 1-17 of Warner '484, 6 claims 1-20 of Ahluwalia '931,7 claims 1-20 of Ahluwalia '733, 8 and claims 1-20 of Ahluwalia '183. 9 ANALYSIS Obviousness Because the same issues are dispositive for both obviousness rejections, we discuss them together. Principles of Law "[T]he examiner bears the initial burden, on review of the prior art or on any other ground, of presenting aprimafacie case ofunpatentability. If 2 Brinkenhoff et al., US 2007/0160562 Al, published July 12, 2007. 3 Fitjer, H., US 4,982,838, issued Jan. 8, 1991. 4 REMINGTON: THE SCIENCE AND PRACTICE OF PHARMACY, Vol. 1, (19th ed. 1995). 5 Alderson et al., US 7,223,724 Bl, issued May 29, 2007. 6 Warner et al., US 9,149,484 B2, issued Oct. 6, 2015. 7 Ahluwalia et al., US 9,226,931 B2, issued Jan. 5, 2016. 8 Ahluwalia et al., US 8,758,733 B2, issued June 24, 2014. 9 Ahluwalia et al., US 9,216,183 B2, issued Dec. 22, 2015. 3 Appeal2018-004121 Application 12/627,809 that burden is met, the burden of coming forward with evidence or argument shifts to the applicant." In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). "The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,416 (2007). "In determining whether the subject matter of a patent claim is obvious, neither the particular motivation nor the avowed purpose of the patentee controls. What matters is the objective reach of the claim. If the claim extends to what is obvious, it is invalid under§ 103." Id. at 419. The obviousness analysis "can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418. Analysis The Examiner found that Brinkenhoff teaches a delivery device for administration of hair-promoting cosmetic agent such as Lumigan (bimatoprost 0.03%) [0046], furthermore, a method for stimulating the growth of natural eyelashes (length, thickness, and/ or number of eyelashes-reads on darkness) in a human subject which comprises: applying to the base of the eyelash bimatoprost (abstract). (Office Action 5.) The Examiner further found that "[t]he delivery device may be a hollow eyeliner brush that, in a manner similar to that of a ball point pen, dispenses with one click a precise quantity (reads on a drop) of the preparation into the brush-bristles at the tip [ of] the eyeliner brush [0041]." (Id. at 6.) The Examiner further found that "Brinkenhoff teaches [0041] the quantitative control, thereby reducing the risk of excess active ingredient going into the eye ( where it can affect the intraocular pressure, cause redness, and/or change the color of the iris)." (Answer 10.) 4 Appeal2018-004121 Application 12/627,809 According to the Examiner, Brinkenhoff's teachings "provide[] motivation to modify dosage amounts, i.e. a single drop, depending on the condition to be treated." (Id. at 11.) The Examiner acknowledged that Brinkenhoff fails to specify the kit dispensing agent as sterile or the brushes as disposable. To remedy these deficiencies, the Examiner relied on Fitjer, which "teaches disposable mascara tester for the hygienic testing of cosmetic materials." (Id. at 5.) According to the Examiner, a skilled artisan would have been motivated to use a disposable tester for hygienic reasons, with a reasonable expectation of success of producing a hygienic product. (Id.) The Examiner further acknowledged that Brinkenhoff fails to specify that the kit comprises applicator brushes packaged separately, and that the applicators are enclosed in a first, second, and third box with instructions. (Id.) The Examiner found that "the mere placement of such a formulation into a package would have been within the general knowledge of one of ordinary skill in the art," and that the subject matter printed on the label or package insert is "not covered by patent laws," and "represents no more than a statement of intended use and does not impart any physical or otherwise material limitation to the claimed package that is either not present in the prior art or made obvious by the teachings of the prior art." (Id. at 5---6.) We adopt the Examiner's findings of fact and reasoning regarding the scope and content of the prior art. (Office Action 2-9; Answer 3---6.) We agree that (1) claims 22-26, 28-32, 34, 35, 37--42, and 44--48 are unpatentable as obvious over Brinkenhoff in view of Fitjer and Remington, and (2) claims 36 and 43 are unpatentable as obvious over Brinkenhoff, 5 Appeal2018-004121 Application 12/627,809 Fitjer, and Remington, in further view of Alderson, although for somewhat different reasoning than that proffered by the Examiner. We address this reasoning in the context of Appellants' arguments below. Appellants acknowledge that "Brinkenhoff discloses administering Lumigan® (containing 0.03% bimatoprost) once a day to eyelids using a specialized eyeliner brush," and "that '[a]ll 6 patients experienced a significant and noticeable increase in the length of their eyelashes."' (Appeal Br. 5 (citing Brinkenhoff,I,I 46, 47, and 50).) Appellants contend, however, that "Brinkenhoff discloses neither how the eyeliner [brush] is configured nor that one drop of Lumigan® per day is applied to the eyelids." (Id.) Appellants also dispute that Brinkenhoff s disclosure of a delivery device which dispenses with one click a precise quantity of a preparation into the brush-bristles at the tip of an eyeliner brush "reads on a drop" of bimatoprost solution. (Id.) Appellants further contend that [a]s a measurement for dosing control, both claims 22 and 30 require that the filaments of an applicator brush be configured in a manner such that a single drop of 0.03% w/v bimatoprost solution be delivered to the upper eyelid but only about 1 % to 9% of the drop of the bimatoprost solution be delivered to the target treatment area. (Id. at 4.) They contend that "Brinkenhoff does not teach or suggest such requirement." (Id.) We agree with the Examiner that Brinkenhoff s disclosure of dispensing "a precise quantity of the preparation into the brush-bristles" (Brinkenhoff,I 41) "reads on a drop." (Answer 4, 9-10.) During prosecution, terms in patent claims are given their broadest reasonable interpretation in view of the specification. Cuozzo Speed Tech., LLC v. Lee, 6 Appeal2018-004121 Application 12/627,809 136 S. Ct. 2131, 2145 (2016). Claims 22 and 30 contain no limitations directed to the size of the "drop" or the dosage ofbimatoprost included in the drop. Thus, there is no basis to distinguish the precise quantity of product that Brinkenhoff is able to dispense, including one drop, into the brush bristles from the "drop" recited in these claims. To the extent Appellants seek to equate the term "drop" in claims 22 and 30 with "one drop of Lumigan® per day" (Appeal Br. 5) or with a particular "dosing requirement" (id. at 6), such constructions must be rejected. These claims do not contain any such requirements. Although the Specification notes that Lumigan® (bimatoprost 0.03%) contains 9 µg of bimatoprost in a 30 µl drop (see Spec. 7, 11. 23-26), particular embodiments appearing in the written description cannot be read into the claims. See Phillips v. AWH Corp., 415 F.3d 1303, 1323 (Fed. Cir. 2005). Indeed, as set forth in the specification, the dose of 0.03% w/v bimatoprost in a drop can vary (see, e.g., Spec. 8, 11. 7-8), and thus the size of the drop can vary. Accordingly, we agree with the Examiner that Brinkenhoff's disclosure that the device dispenses a precise quantity of the preparation into the brush bristles reads on a "drop," as that term is used in claims 22 and 30. The Examiner did not specifically address whether the filaments of Brinkenhoff' s brush are configured such that only about 1 % to about 9% of the drop of bimatoprost solution dispensed onto the brush is delivered to the target treatment area. Appellants assert that Brinkenhoff "teaches using the delivery device to deliver the exact amount provide[ d] by one click rather than a portion thereof." (Reply Br. 2.) We are not persuaded by Appellants' argument. We see nothing in Brinkenhoff that indicates that the entire 7 Appeal2018-004121 Application 12/627,809 amount of product dispensed onto the bristles by one click is delivered to the eyelid, nor does Brinkenhoff teach away from its specialized eyeliner brush bristles delivering only a portion of the amount dispensed thereon. Indeed, we are not aware of eyeliner brushes in which all of the liquid product applied is dispensed when the brush contacts a surface onto which the product is to be transferred. That is, the bristles of such brushes retain some portion of the liquid product dispensed onto them. We find that Brinkenhoff s bristles on its hollow eyeliner brush would function in the expected manner and retain some portion of the liquid dispensed thereon. Furthermore, in the absence of evidence to the contrary, we conclude that the amount of the drop delivered would be within the range claimed. We so conclude based on the fact that Appellants' Specification fails to disclose any structural features that serve to distinguish the filaments on its applicator brush from the filaments that make up the bristles on Brinkenhoff s disclosed hollow eyeliner brush-both are understood to be conventional applicator brushes. It is noted that the PTO does not have the facilities to perform tests on the prior art and claimed invention. "Where .. . the claimed and prior art products are identical or substantially identical .. . the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. ... [The] fairness [ of the burden-shifting] is evidenced by the PTO' s inability to manufacture products or to obtain and compare prior art products." In re Best, 562 F.2d 1252, 1255 (CCPA 1977). Additionally, we note that Appellants have not demonstrated that the claimed range of deposited bimatoprost is critical to the claimed invention. 8 Appeal2018-004121 Application 12/627,809 Further, even if Brinkenhoff can be read to require that the entire amount of product dispensed onto the bristles be applied to the eyelid, a person of ordinary skill in the art would have been motivated to modify the device to apply only the exact amount of product needed for treatment, regardless of how much product is initially dispensed onto the brush. This is demonstrated by Brinkenhoff's teaching of achieving "quantitative control," to "reduc[ e] the risk of excess active ingredient going into the eye ... or onto the skin of the eyelids." (Brinkenhoff,I 41; see also KSR Int'! Co., 550 U.S. at 421 ("A person of ordinary skill is also a person of ordinary creativity, not an automaton.").) Appellants additionally assert that "rather than teaching delivering a small portion, much less the specified 1 % to 9%, of applied one drop bimatoprost solution to the target treatment area, Brinkenhoff teaches retaining to the target area as much of the applied solution as possible." (Appeal Br. 6 (citing Brinkenhoff,I,I 14 and 27).) Appellants' argument is not persuasive. While Brinkenhoff is concerned with ensuring that the medication once applied does not stray to unintended areas and indicates that "more viscous" preparations provide for such a result, that does not address the quantitative control in application of the product to the target area in the first instance. As noted above, we discern no structural differences between the brush disclosed in Brinkenhoff for dispensing liquid and the brush for this same purpose as claimed and as disclosed in Appellants' Specification. Appellants have not separately argued the dependent claims. (See, e.g., Appeal Br. 7 ("Brinkenhoff cannot be said to teach or suggest the mode and manner of administration as claimed in claims 20 [sic] and 30 and in the 9 Appeal2018-004121 Application 12/627,809 dependent claims.").) Separately arguing a claim requires "more substantive arguments in an appeal brief than a mere recitation of the claim elements and a naked assertion that the corresponding elements were not found in the prior art" In re Lovin, 652 F.3d 1349, 1356-57 (Fed. Cir. 2011), Accordingly, the dependent claims fall with independent clairns 22 and 30. 37 C.F.R. § 4L37(c)(1)(iv). In sum, we affirm the Examiner's rejection of claims 22-26, 28-32, 34, 35, 37--42, and 44--48 as obvious over the combination ofBrinkenhoff in view of Fitjer and Remington, and claims 36 and 43 as obvious over the combination of Brinkenhoff, Fitjer, and Remington, in further view of Alderson, but designate our affirmance as New Grounds of Rejection. Because our statement of the rejections differs somewhat from that of the Examiner, particularly with respect to whether Brinkenhoff s brush are configured such that only about 1 % to about 9% of the drop of bimatoprost solution dispensed onto the brush is delivered to the target treatment area, designating these rejections as New Grounds under 37 C.F.R. § 4I.50(b) provides Appellants with a full and fair opportunity to react to the rejections. Obviousness-Type Double Patenting We address of each of the four separate double patenting rejections below. Principles of Law The doctrine of obviousness-type double patenting is designed to prevent an inventor from securing a second, later-expiring patent for the same invention (and obvious variants thereof) claimed in an earlier, 10 Appeal2018-004121 Application 12/627,809 commonly-owned patent. Abb Vie Inc. v. Mathilda and Terrence Kennedy Inst. of Rheumatology Trust, 764 F.3d 1366, 1373 (Fed. Cir. 2014). In evaluating whether claims under examination should be rejected for obviousness-type double patenting, the Examiner must determine, in an analysis comparable to that under 35 U.S.C. § 103, whether one of ordinary skill would have considered the examined claims merely an obvious variation of an invention claimed in an earlier patent. See In re Braat, 93 7 F.2d 589, 592-93 (Fed. Cir. 1991). Analysis Having carefully considered the evidence and arguments presented by Appellants and the Examiner, we do not sustain the Examiner's double patenting rejections. We begin our analysis with the rejection over Warner '484. The Examiner found that claims 1-17 of Warner '484 "disclose a composition for growing hair in a kit with an applicator for application to the skin a therapeutically effective amount of a composition of bimatoprost." (Office Action 9-10.) However, as Appellants pointed out, Warner '484 claims a composition comprising about 0.3% w/w to about 4% w/w bimatoprost. (Appeal Br. 7.) In contrast, the rejected claims recite 0.03% bimatoprost w/v solution. The Examiner has not explained why a person of ordinary skill in the art would have considered the claims at issue here, which recite a much lower concentration of bimatoprost, to be an obvious variation of the invention recited in the Warner '484 patent claims, which require a much higher concentration ofbimatoprost. Accordingly, we do not sustain the double patenting rejection over claims 1-17 of Warner '484. 11 Appeal2018-004121 Application 12/627,809 With respect to the claims of the Ahluwalia patents, the Examiner found that they "disclose method[ s] of increasing hair growth in chemotherapy patients, the method[ s] comprising applying a therapeutically effective amount of a composition of bimatoprost resulting in eyelashes that are longer, thicker or darker compared to patients receiving no treatment." (Office Action 10-11.) The Examiner reasoned that "[i]t would have been obvious to one of ordinary skill in the art at the time the invention was made to incorporate said bimatoprost to enhance growth of eyelashes." (Id.) Appellants acknowledge that the claims of the reference patents teach methods of hair growth, including by administration of 0.03% w/v bimatoprost. (Appeal Br. 8.) They argue, however, that (Id.) none of the claims of the reference patents teaches or suggests that the filaments of an applicator brush be configured in a manner such that a single drop of 0.03% w/v bimatoprost solution be delivered to the upper eyelid but only about 1 % to 9% of the drop of the bimatoprost solution be delivered to the target treatment area, as required by claims 22 and 30. The Examiner responded that although the claims do[] not describe an applicator, the same specifications describe sterile single-use-per eye applicator and applied to the upper eyelid margin. The Examiner maintains that the application must occur to the eyelid, as recited in the claims and therefore, an applicator for use of transfer of the drug to the area of treatment is obvious. (Answer 11.) As noted above, the Examiner bears the burden of presenting a prima facie case ofunpatentability. The claims of Ahluwalia' 183, Ahluwalia '931, and Ahluwalia '733 do not recite applicators. Instead, the 12 Appeal2018-004121 Application 12/627,809 Examiner turns to the Ahluwalia specifications for their purported recitation of sterile single-use-per eye applicators. As an initial matter, although the Ahluwalia '183 specification discloses such applicators (see col. 15, 11. 13- 16), the Examiner has not established that the Ahluwalia '931 and Ahluwalia '733 specifications disclose such applicators. And we find that they do not. Further, we conclude that the Examiner has improperly used the Ahluwalia '183 specification as prior art in concluding that the claims on appeal are not patentably distinct from the Ahluwalia claims. "As a general rule, obviousness-type double patenting determinations tum on a comparison between a patentee's earlier and later claims, with the earlier patent's written description considered only to the extent necessary to construe its claims." Eli Lilly and Co. v. Teva Parenteral Medicines, Inc., 689 F.3d 1368, 1378- 79 (Fed. Cir. 2012). The Examiner has not asserted that the Ahluwalia patent specifications are being consulted for construing any particular claim term. The Examiner appears to be basing the obviousness-type double patenting rejections on the ground that the purported conflicting patent claims encompass the rejected claims. (Answer 11 (noting that because the reference patents describe that the bimatoprost is applied to the eyelid, "an applicator [ as claimed] for use of transfer of the drug to the area of treatment is obvious").) However, "obviousness is not demonstrated merely by showing that an earlier expiring patent dominates a later expiring patent." AbbVie Inc., 764 F.3d at 1378-79. The fact that there is overlap between the two sets of claims, in that both recite the application of bimatoprost to the eyelids for eyelash growth, is not dispositive of whether the additional 13 Appeal2018-004121 Application 12/627,809 requirements of the claims on appeal, e.g., the delivery system including sterile applicator brushes having filaments configured to deliver about 1 % to about 9% of a drop of solution to the target treatment area, are merely patentably indistinct variants of the reference patent claims. Application of bimatoprost to the eyelids can be achieved in any number of manners, including by swabbing with a cotton swab, or squeezing a drop of bimatoprost from the container onto the eyelid. It is not apparent, nor has the Examiner made the case, that there is a limited class of applicators that are usable to apply bimatoprost solution to the eyelids. In a case such as this one, where the rejected claims overlap in scope with claims in a potentially conflicting patent, and one cannot at once envisage each member of a limited class (i.e., means of applying bimatoprost solution to eyelids), the Examiner is required to analyze the claims of the application for obviousness. (SeeMPEP § 804II.B.1 (citingAbbVielnc., 764F.3d 1366).) Here, in connection with the double patenting rejections, the Examiner has failed to identify the missing elements from the reference patent claims as being in the prior art. Moreover, in connection with these rejections, the Examiner has failed on this record to establish some reason that would have led one of ordinary skill in the art to modify the invention of the reference patents to make the invention on appeal, with a reasonable expectation of success. Thus, we do not sustain the Examiner's obviousness-type double patenting rejections. 14 Appeal2018-004121 Application 12/627,809 SUMMARY We affirm the Examiner's rejections of claims 22-26, 28-32, 34, 35, 37--42, and 44--48 as obvious over Brinkenhoff in view ofFitjer and Remington, and claims 36 and 43 as obvious over Brinkenhoff, Fitjer, and Remington, in further view of Alderson. However, because our reasoning with respect to the obviousness rejections differs to some degree from the Examiner's regarding the configuration of the bristles in Brinkenhoff s device, we designate our affirmance of both obviousness rejections as New Grounds of Rejection. We reverse the rejections of claims 22-26, 28-32, 34, 35, 37--42, and 44--48 for obviousness-type double patenting. TIME PERIOD FOR RESPONSE This decision contains new grounds of rejection pursuant to 37 C.F.R. § 4I.50(b). 37 C.F.R. § 4I.50(b) provides that "[a] new ground of rejection pursuant to this paragraph shall not be considered final for judicial review." 37 C.F.R. § 4I.50(b) also provides that Appellants, WITHIN TWO MONTHS FROM THE DATE OF THE DECISION, must exercise one of the following two options with respect to the new grounds 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 .... (2) Request rehearing. Request that the proceeding be reheard under § 41.52 by the Board upon the same Record .... 15 Appeal2018-004121 Application 12/627,809 Should Appellants elect to prosecute further before the Examiner pursuant to 3 7 C.F .R. § 41.50(b )(1 ), in order to preserve the right to seek review under 35 U.S.C. §§ 141 or 145 with respect to the affirmed rejection, the effective date of the affirmance is deferred until conclusion of the prosecution before the Examiner unless, as a mere incident to the limited prosecution, the affirmed rejection is overcome. If Appellants elect prosecution before the Examiner and this does not result in allowance of the application, abandonment, or a second appeal, this case should be returned to the Patent Trial and Appeal Board for final action on the affirmed rejection, including any timely request for rehearing thereof. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED; 37 C.F.R. § 4I.50(b) 16 Copy with citationCopy as parenthetical citation