UPSPRING LTD.Download PDFPatent Trials and Appeals BoardOct 25, 20212021001296 (P.T.A.B. Oct. 25, 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. 13/654,312 10/17/2012 Julie JUMONVILLE 155.0002-US02 9121 92049 7590 10/25/2021 J.A. Lindeman & Co. PLLC 3190 Fairview Park Drive Suite 1070 Falls Church, VA 22042 EXAMINER JARRETT, LORE RAMILLANO ART UNIT PAPER NUMBER 1797 NOTIFICATION DATE DELIVERY MODE 10/25/2021 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): jeff.lindeman@jalindeman.com mail@jalindeman.com yamini.anand@clarivate.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JULIE JUMONVILLE, ELIZABETH SMITH, and MATTHEW POPE Appeal 2021-001296 Application 13/654,312 Technology Center 1700 Before BEVERLY A. FRANKLIN, DEBRA L. DENNETT, and MERRELL C. CASHION, JR., Administrative Patent Judges. DENNETT, Administrative Patent Judge. DECISION ON APPEAL1 STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), Appellant2 appeals from the Examiner’s decision to reject claims 65–75, which constitute all the claims 1 In our Decision, we refer to the Specification (“Spec.”) of Application 13/654,312 filed Oct. 17, 2012 (“the ’312 App.”); the Non-Final Office Action dated Jan. 7, 2020 (“Non-Final Act.”); the Appeal Brief filed July 8, 2020 (“Appeal Br.”); the Examiner’s Answer dated Oct. 20, 2020 (“Ans.”), and the Reply Brief filed Dec. 11, 2020 (“Reply Br.”). 2 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 UpSpring LLC. Appeal Br. 2. Appeal 2021-001296 Application 13/654,312 2 pending in this application. See Final Act. 1. A video telephonic hearing was held on October 4, 2021, a transcript of which has been entered into the record. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. CLAIMED SUBJECT MATTER The invention relates generally to detecting a target analyte in a sample of breast milk, and methods of protecting a nursing infant from exposure to a target analyte present in breast milk. Spec. ¶¶ 13, 22. Claim 65, reproduced below from the Claims Appendix of the Appeal Brief, illustrates the claimed subject matter: 65. A method of testing a human breast milk sample for the presence of alcohol, said method comprising the step of: contacting an alcohol test reagent in a sampling portion of a test strip with a human breast milk sample for a period of time to allow any alcohol present in the breast milk sample to react with the alcohol test reagent and induce a detectable change in the alcohol test reagent at the sampling portion, which is indicative of the presence of alcohol in the human breast milk sample. REFERENCES The Examiner relies on the following prior art in rejecting the claims: Name Reference Date Toranto et al. (“Toranto”) US 2003/0175993 A1 Sept. 18, 2003 A.C. Hansen et al., Measurement of alcohol in saliva with a test strip, 151 Ugeskr Laeger 300–02 (Jan. 30, 1989) (“Hansen”)(English Abstract) P.H. Dickson et al., The Routine Analysis of Breast Milk for Drugs of Abuse in a Clinical Toxicology Laboratory, 39 J. Forensic Sci. 207–214 (Jan. 1994) (“Dickson”) E. Ho et al., Alcohol and Breast Feeding: Calculation of Time to Zero Appeal 2021-001296 Application 13/654,312 3 Level in Milk, 80 Biol Neonate 219–222 (2001) (“Ho”) REJECTIONS The Examiner maintains and Appellant appeals the rejection of claims 65–75 under 35 U.S.C. § 103(a) as obvious over Dickson in view of Hansen, Toranto, and Ho. Non-Final Act. 3; Appeal Br. 6. OPINION During patent examination, a claim is given its broadest reasonable construction “in light of the specification as it would be interpreted by one of ordinary skill in the art.” In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364 (Fed Cir. 2004). We need consider only one term here: alcohol. Appellant does not differentiate between the terms “alcohol,” “ethanol alcohol,” and “ethanol” in the Specification. See Spec. ¶¶ 1, 3, 4, 73. Dickson refers to “ethanol” (p. 207, first ¶), Hansen refers to “alcohol” (Hansen, Abstract), Toranto refers to “alcohol” and “ethanol,” Ho refers to “ethanol” and “alcohol” (Ho, Abstract, 219). We construe “alcohol” in the claims to refer to ethyl alcohol that may be consumed by a breast-feeding mother. We review the appealed rejection for error based upon the issues identified by Appellant and in light of the arguments and evidence produced thereon. Cf. Ex parte Frye, 2010 WL 889747, *4 (BPAI 2010) (precedential) (cited with approval in In re Jung, 637 F.3d 1356, 1365 (Fed. Cir. 2011) (“[I]t has long been the Board’s practice to require an applicant to identify the alleged error in the examiner’s rejections.”). After considering the evidence presented in this Appeal and each of Appellant’s contentions, we are not persuaded that reversible error has been identified, and we affirm Appeal 2021-001296 Application 13/654,312 4 the Examiner’s § 103 rejections for the reasons expressed in the Non-Final Office Action and the Answer. We add the following primarily for emphasis. Appellant argues the rejected claims as a group. Appeal Br. 6–14. We select claim 65 as representative of the group. Claims 66–75 stand or fall with claim 65. 37 C.F.R. § 41.37(c)(1)(iv). Regarding claim 65, the Examiner finds that Dickson explicitly discloses testing breast milk for the presence of alcohol. Final Act. 4; Ans. 4. The Examiner finds that Hansen and Toranto disclose using a test strip to test body fluids such as saliva for the presence of alcohol. Final Act. 4; Ans. 5–10. The Examiner finds that Toranto’s definition of “samples” to be tested include biological samples such as plasma, serum, saliva, urine, lachrymal fluid, cell lysates and the like. Ans. 9 (citing Toranto ¶ 67). The Examiner finds that Ho discloses the importance of detecting alcohol in breast milk because alcohol was known to enter breast milk and was documented to produce adverse effects on a nursing infant. Final Act. 4. The Examiner finds that one of ordinary skill in the art at the time of the invention would have been motivated to combine Dickson’s disclosure of testing breast milk for the presence of alcohol with Hansen’s and Toranto’s disclosures of test strips to test other body fluids for the presence of alcohol, motivated by Ho’s disclosure of the importance of detecting the presence of alcohol in breast milk. Id. at 4–5. The Examiner determines that it would have been obvious to one of ordinary skill in the art at the time of the invention to have substituted a test strip as disclosed in Hansen and Toranto to test for the presence of alcohol in breast milk, as disclosed in Appeal 2021-001296 Application 13/654,312 5 Dickson, as this would be a substitution of one known element for another to yield predictable results. Ans. 6–10. Appellant argues that Dickson “reports the use of breast milk specimens in the clinical toxicology laboratory for the screening and confirmation of drugs of abuse.” Appeal Br. 8 (quoting Dickson, 207). Appellant argues that ethanol was detected in only one case reported in Dickson, and was tested by gas chromatography, thus alcohol was not the subject of the analysis reported by Dickson. Id. at 8–9. Appellant argues that neither Hansen nor Toranto teach detecting alcohol in human breast milk, but rather teach detecting it in saliva. Id. at 10–11. Appellant argues that the Examiner fails to show that the results of a saliva-based test strip assessing blood alcohol levels is comparable to a laboratory gas chromatograph test of breast milk. Id. at 12. Appellant argues that Hansen’s disclosure of variability in results with test strips “undermines the Examiner’s conclusion that one of ordinary skill would have combined the teachings of Dickson, Hanse and Toranto.” Id. Finally, Appellant argues that “Ho does not speak of the ‘importance of detecting alcohol in breast milk’ as the Examiner states.” Id. Appellant’s arguments are not persuasive of reversible error by the Examiner in rejecting claim 65 as obvious over Dickson in view of Hansen, Toranto, and Ho. “During patent examination . . . , the concept of prima facie obviousness establishes the framework for the obviousness determination and the burdens the parties face.” ACCO Brands Corp. v. Fellowes, Inc., 813 F.3d 1361, 1365 (Fed. Cir. 2016); see also In re Brandt, 886 F.3d 1171, 1176 (Fed. Cir. 2018) (describing the prima facie framework as well). Appeal 2021-001296 Application 13/654,312 6 “Under this framework, the patent examiner must first set forth a prima facie case, supported by evidence, showing why the claims at issue would have been obvious in light of the prior art.” ACCO Brands, 813 F.3d at 1365. The burden then shifts to the applicant “to provide evidence, in the prior art or beyond it, or argument sufficient to rebut the examiner’s evidence.” Id. at 1365–66. A final determination on obviousness is reached by weighing the evidence establishing the prima facie case with the rebuttal evidence. Id. at 1366. If obviousness is shown by a preponderance of the evidence after such weighing, the claims at issue are unpatentable. Id. We must consider a prior art reference “not only for what it expressly teaches, but also for what it fairly suggests.” Bradium Techs. LLC v. Iancu, 923 F.3d 1032, 1049 (Fed. Cir. 2019) (quoting In re Baird, 16 F.3d 380, 383 (Fed. Cir. 1994). “What a reference teaches is a question of fact.” Baird, 16 F.3d at 382 (citing In re Beattie, 974 F.2d 1309, 1311 (Fed. Cir. 1992)). The art cited by the Examiner establishes that, at the time of the invention, these facts were known: (1) alcohol consumed by a mother passes readily into her breast milk; (2) consumption of breast milk containing alcohol can produce adverse effects on a nursing infant; (3) one could test for the presence of alcohol in breast milk; and (4) the presence of alcohol in numerous body fluids could be detected by a simple test strip method. Specifically regarding fact (1), Ho teaches that “[a]lcohol consumed by a mother passes readily into her breast milk at levels reaching concentrations similar to those found in maternal blood.” Ho, 219, right column. Dickson discloses that ethanol was detected in a breast milk sample from a mother with a history of ethanol and cocaine use. Dickson, 207 first ¶, 208 last ¶. Appeal 2021-001296 Application 13/654,312 7 Regarding fact (2), Ho teaches that adverse effects of alcohol on suckling infants include impairment of motor development, changes in sleep patterns, decrease in milk intake, and risk of hypoglycemia from alcohol. Ho, 219 last ¶ and Table 1. Dickson discloses that a mother with a history of ethanol and cocaine use, and in whose breast milk ethanol, cocaine, and other drugs were detected, gave birth to an infant with multiple medical problems. Dickson, 208 last ¶. The mother’s breast feeding of the infant during hospital visits was thought to contribute to the infants symptoms. Id., 211 Discussion. Dickson teaches fact (3), testing for the presence of ethanol in breast milk by gas chromatography. Dickson, 208 last ¶ and Table 1. Hansen teaches fact (4), using test strips to detect the presence of alcohol in saliva. Hansen, Abstract. Toranto also teaches fact (4), using test strips to detect analytes such as alcohol in, inter alia, “[b]iological samples includ[ing] blood products (e.g., plasma and serum), saliva, urine, lachrymal fluid, cell lysates and the like.” Toranto, ¶¶ 7, 11, 67. The question then becomes whether “ one of ordinary skill in the art at the time of the invention would have been motivated to combine the teachings in Dickson, Hansen, Toranto, and Ho?” “[W]hether there is a reason to combine prior art references is a question of fact.” Kinetic Concepts, Inc. v. Smith & Nephew, Inc., 688 F.3d 1342, 1367 (Fed. Cir. 2012) (citing Transocean Offshore Deepwater Drilling, Inc. v. Maersk Contractors USA, Inc., 617 F.3d 1296, 1303 (Fed. Cir. 2010) . “Evidence of a motivation to combine prior art references ‘may flow from the prior art references themselves, the knowledge of one of ordinary skill in the art, or, in some cases, from the nature of the problem to be solved.’” Medichem, Appeal 2021-001296 Application 13/654,312 8 S.A. v. Rolabo, S.L., 437 F.3d 1157, 1164 (Fed. Cir. 2006) (quoting Brown & Williamson Tobacco Corp. v. Philip Morris Inc., 229 F.3d 1120, 1125 (Fed.Cir.2000). We look not at “what the individual references themselves suggest but rather what the combination of disclosures taken as a whole would suggest to one of ordinary skill in the art.” In re McLaughlin, 443 F.2d 1392, 1395 (CCPA 1971). We do not consider whether the inventions in the references could be physically combined. In re Sneed, 710 F.2d 1544, 1550 (Fed. Cir. 1983) (“[I]t is not necessary that the inventions of the references be physically combinable to render obvious the invention under review.”). In making this assessment, we take into account “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). Based on Ho and Dickson, the ordinarily skilled artisan at the time of the invention would have been motivated to detect the presence of alcohol in breast milk to prevent potential harm to a nursing infant. “One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings.” Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323 (Fed. Cir. 2005). Using test strips to detect the presence of alcohol and other analytes in biological fluids such as blood and saliva was known, as shown by Hansen and Toranto.3 Hansen, Abstract; Toranto, ¶¶ 7, 11, 67. Our reviewing court has repeatedly held that 3 Even if, as Appellant argues, variability in Hansen’s test results might not cause one of ordinary skill in the art to consider substituting test strips for Appeal 2021-001296 Application 13/654,312 9 [A]n implicit motivation to combine exists not only when a suggestion may be gleaned from the prior art as a whole, but when the “improvement” is technology-independent and the combination of references results in a product or process that is more desirable, for example because it is stronger, cheaper, cleaner, faster, lighter, smaller, more durable, or more efficient. Because the desire to enhance commercial opportunities by improving a product or process is universal—and even common-sensical—we have held that there exists in these situations a motivation to combine prior art references even absent any hint of suggestion in the references themselves. In such situations, the proper question is whether the ordinary artisan possesses knowledge and skills rendering him capable of combining the prior art references. Dystar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1368 (Fed. Cir. 2006). The improvement would have been to substitute one testing methodology (gas chromatography in Dickson) with a faster, cheaper, and readily available testing methodology (test strips in Hansen and Toranto). Substituting one known element (testing a fluid biological sample by gas chromatography) for another known element (testing a fluid biological sample by test strips) would have yielded a predictable result of detecting the presence or absence of alcohol in human breast milk. Gas chromatography is a much more complicated form of testing than the test strip method, but it is equivalent to the test strip method in terms of detecting whether alcohol is present in a biological fluid sample, as required by claim 65. The ordinarily skilled artisan would have had the knowledge and skills to employ the test strip methodology in place of using a gas chromatograph. Dickson’s testing (see Appeal Br. 11), Toranto also teaches use of test strips for detecting the presence of alcohol in biological samples. Appeal 2021-001296 Application 13/654,312 10 See KSR, 550 U.S. at 421 (“A person of ordinary skill is also a person of ordinary creativity, not an automaton.”). “Express suggestion to substitute one equivalent for another need not be present to render such substitution obvious.” In re Fout, 675 F.2d 297, 301 (CCPA 1982). During the hearing of this case, Appellant’s counsel argued that the state of the art at the time of filing indicated that the concentration of alcohol in breast milk correlated to blood alcohol concentration. Hearing Tr. 7, ll. 6–10. Appellant argues that it was reversible error to look at saliva based blood alcohol tests. Id. 10, ll. 9–10. However, Hansen states that concentration of alcohol in saliva “meticulously” follows the concentration of alcohol in blood (Hansen, Abstract), and Toranto’s analyte detection system tests saliva to determine alcohol concentration in blood (Toranto ¶¶ 6, 10). In addition, Ho states “[a]lcohol consumed by a mother passes readily into her breast mild at levels reaching concentrations similar to those found in maternal blood.” Ho, 219. This suggests that the ordinarily skilled artisan would have been motivated to combine the prior art references as the Examiner did. At the hearing, Appellant’s counsel also argued that an example in the Specification indicated that the results of testing saliva and breast milk were quite different. Hearing Tr. 9, l. 21–10, l. 8. But we consider what the prior art cited by the Examiner taught to one of skill in the art, not what Appellant’s application taught to one of skill in the art. We are persuaded that the Examiner establishes a prima facie case of obviousness of claim 65 over the cited art. “Once a prima facie case of obviousness has been established, the burden shifts to the applicant to come forward with evidence of nonobviousness to overcome the prima facie case.” In re Huang, 100 F.3d 135, 139 (Fed. Cir. 1996). Objective Appeal 2021-001296 Application 13/654,312 11 evidence of nonobviousness (also called “secondary considerations”) includes commercial success, long felt but unsolved needs, and failure of others. Graham v. John Deere Co., 383 U.S. 1, 17 (1966). “Evidence rising out of the so-called ‘secondary considerations’ must always when present be considered en route to a determination of obviousness.” Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 1538 (Fed. Cir. 1983). If a showing of such objective indicia is made, the presumption of unpatentability created by the Examiner’s identification of a prima facie case of obviousness dissolves and all of the evidence must be weighed together to reach a final conclusion regarding the obviousness of the claim in question. In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). “[P]atentability is determined on the totality of the record, by a preponderance of evidence with due consideration to persuasiveness of argument.” Id. Appellant contends that commercial success of its Milkscreen Test for Alcohol in Breast Milk is evidence that rebuts the Examiner’s obviousness rejection. Appeal Br. 14. “In the ex parte process of examining a patent application, . . . the [Examiner] lacks the means or resources to gather evidence which supports or refutes the applicant’s assertion that the sales constitute commercial success.” In re Huang, 100 F.3d 135, 139 (Fed. Cir. 1996) (citing Ex parte Remark, 15 USPQ2D 1498, 1503 (BPAI 1990) (evidentiary routine of shifting burdens in civil proceedings inappropriate in ex parte prosecution proceedings because examiner has no available means for adducing evidence)). Thus, the Examiner (and Board) must rely upon Appellant to provide hard evidence of commercial success. Id. Appeal 2021-001296 Application 13/654,312 12 Appellant provides a declaration from Lisa Raper Williamson. Williamson Declaration dated Mar. 12, 2019 (“Williamson Decl.”). Ms. Williamson is a co-founder and current CEO of UpSpring, the assignee of the ’312 Application. Id., ¶ 3. According to the declaration, UpSpring “created a brand new market category” of test kits (¶ 4) which it began marketing on Amazon.com in 2007 (¶ 6). Competitors are asserted to have “recognized the financial opportunities that existed in the market that UpSpring created and began to sell lower quality, knock-off products” since 2016.” ¶¶ 8–9. The declaration provides a graph showing quarterly marketing spend ranging widely (from $0 to $50,000 then back to $0) from 2007 to 2011, and less widely (from $10,000 to $30,000) in the following period up to the third quarter of 2018. ¶ 7. The graph, which also illustrates revenue, shows no revenue from sales of products on Amazon.com until the second quarter of 2014, and steady increase in such sales since then, with marketing spend (apparently not limited to Amazon.com) generally decreasing as sales revenue increased. ¶ 7. The graph shows $300,000 in quarterly sales of UpSpring product before any sales were made on Amazon.com. ¶ 7. As of the third quarter of 2018, UpSpring’s sales of the product on Amazon.com appear to account for well less than half of the revenue from the product. A table is provided in the declaration that lists UpSpring’s products and what are asserted to be competing products, when such products were available on Amazon.com, the estimated unit sales, and the estimated monthly retail revenue. ¶ 10. The table does not provide any indication of the dates of the estimated unit sales—whether when first available on Amazon.com, at the time the declaration was prepared, or some other date— Appeal 2021-001296 Application 13/654,312 13 or when the estimated monthly retail revenue figures for each product were ascertained. ¶ 10. The table also does not provide any evidence of sales of allegedly competing product other than those made on Amazon.com. According to the declaration, the total amount of UpSpring’s and competitors’ products sold on Amazon.com through the fourth quarter of 2018 is approximately $3,038,546. ¶ 10. No evidence is provided in support of this estimate. The Williamson Declaration is the only evidence of commercial success proffered by Appellant. Upon careful review of the declaration, Appellant has not provided sufficient hard evidence from which we can determine whether the test kit sold by UpSpring is commercially successful in the market. No information is provided regarding the relevant market other than Amazon.com, although the declaration indicates that the majority of UpSpring’s sales are not made via Amazon.com. See Williamson Decl. ¶¶ 7, 10. No evidence is provided to indicate that sales via Amazon.com are representative of the entire market for such test kits. But even assuming that Appellant has sufficiently demonstrated commercial success, “that success is relevant in the obviousness context only if there is proof that the sales were a direct result of the unique characteristics of the claimed invention—as opposed to other economic and commercial factors unrelated to the quality of the patented subject matter.” Huang, 100 F.3d at 140 (citing Cable Elec. Prods., Inc. v. Genmark, Inc., 770 F.2d 1015, 1027 (Fed. Cir. 1985)). “[A] nexus is required between the sales and the merits of the claimed invention.” Id. Appellant proffers a declaration from its attorney that purports to include a claim chart demonstrating how UpSpring’s Milkscreen test Appeal 2021-001296 Application 13/654,312 14 “practices the claimed invention.” Declaration of Jeffrey A. Lindeman, Ph.D. dated Mar. 13, 2019 (“Lindeman Decl.”), ¶ 3. For each limitation in claim 654, the claim chart states “Yes, product, DIRECTIONS FOR USE.” Id., Ex. 1. The directions for use of the Milkscreen product as well as for all “competitor” products identified in the Lindeman Declaration are the same as those disclosed in Toranto. Compare Lindeman Decl., Exs. 1–6, with Toranto ¶¶ 150, 156, 163. The chemicals used in the Milkscreen test are the same as those taught in Toranto. See Hearing Tr. 9, ll. 16–20; Toranto ¶¶ 13, 160; Appeal Br. 24 (Claims App.). The Lindeman Declaration is insufficient to establish that sales of the Milkscreen product was driven by the merits of the claimed method, as opposed to methods in the prior art, some other unclaimed property, or by the availability and marketing of the test kit itself. See Huang, 100 F.3d at 140. No evidence is proffered to show that the steps in the claimed method resulted in any sales of the test kits, or that sales would not have been made had the test kit included different instructions for use. In addition, marketing spend shown in the Williamson Declaration suggests that initial sales were tied closely to marketing spend, and not necessarily to any unique quality of the test kit, much less to the claimed method. To the extent any nexus between commercial success and the claimed method is shown, it is relatively weak. We contrast this with the strong showing of prima facie obviousness made by the Examiner. On the totality of the record before us, we sustain the rejection of claim 65 as obvious over 4 The claim chart does not address pending claims 74 and 75. Appeal 2021-001296 Application 13/654,312 15 the combination of Dickson, Hansen, Toranto, and Ho. In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992) (“[P]atentability is determined on the totality of the record, by a preponderance of evidence with due consideration to persuasiveness of argument.”). For the reasons above, we also sustain the rejection of claims 66–75, not argued separately by Appellant. 37 C.F.R. § 41.37(c)(1)(iv). CONCLUSION The Examiner’s decision to reject claims 65–75 is sustained. More specifically, DECISION SUMMARY Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 65–75 103(a) Dickson, Hansen, Toranto, Ho 65–75 TIME PERIOD FOR 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)(1)(iv). AFFIRMED Copy with citationCopy as parenthetical citation