Warring, Jessica A. et al.Download PDFPatent Trials and Appeals BoardJul 13, 202014866738 - (D) (P.T.A.B. Jul. 13, 2020) 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. 14/866,738 09/25/2015 Jessica A. Warring 101672.0230P5 5689 158673 7590 07/13/2020 BD/Rutan & Tucker, LLP 611 ANTON BLVD SUITE 1400 COSTA MESA, CA 92626 EXAMINER BOSWORTH, KAMI A ART UNIT PAPER NUMBER 3783 NOTIFICATION DATE DELIVERY MODE 07/13/2020 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): ip.docket@bd.com patents@rutan.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JESSICA A. WARRING, AMIR BELSON, and WINFIELD S. FISHER Appeal 2019-001558 Application 14/866,738 Technology Center 3700 Before BENJAMIN D. M. WOOD, JILL D. HILL, and MICHAEL L. WOODS, Administrative Patent Judges. WOOD, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s November 6, 2017 Non-Final Action rejecting claims 1–12. See Non-Final Act. 1. We have jurisdiction under 35 U.S.C. § 6(b). We affirm in part and enter a new ground of rejection. 1 We use the word “Appellant” to refer to the applicant as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as Vascular Pathways, Inc. Appeal Br. 4. Appeal 2019-001558 Application 14/866,738 2 CLAIMED SUBJECT MATTER The claims are directed to an intravenous catheter insertion device. Claim 1, reproduced below, is illustrative of the claimed subject matter: 1 (Original) A catheter insertion device, comprising: a housing; a needle having a proximal end in the housing and a distal end extending from a distal end of the housing in an insertion position; a guide wire having a distal portion disposed in a lumen of the needle in a withdrawn position, the guide wire including a safety tip having a non-coiled configuration in the withdrawn position and a coiled configuration in an advanced position; a sliding member attached to the guide wire, wherein movement of the sliding member translates the guide wire from the withdrawn position to the advanced position; and a catheter disposed coaxially over the needle. REFERENCES Name Reference Date Chuttani US 5,054,501 Oct. 8, 1991 Stocking US 5,704,914 Jan. 6, 1998 Lederman US 2003/0032936 A1 Feb. 13, 2003 Whiting US 8,029,470 B2 Oct. 4, 2011 REJECTIONS Claim 4 is rejected under 35 U.S.C. § 112(a) as failing to comply with the enablement requirement. Claims 1–3, 5, 6, and 10–12 are rejected under 35 U.S.C. § 103 as unpatentable over Stocking and Chuttani. Claim 9 is rejected under 35 U.S.C. § 103 as unpatentable over Stocking, Chuttani, and Lederman. Claims 1, 2, and 9–12 are rejected under 35 U.S.C. § 103 as unpatentable over Stocking and Lederman. Appeal 2019-001558 Application 14/866,738 3 Claim 3 is rejected under 35 U.S.C. § 103 as unpatentable over Stocking, Lederman, and Chuttani. Claims 5, 7, and 8 are rejected under 35 U.S.C. § 103 as unpatentable over Stocking, Lederman, and Whiting. Claims 1, 2, 5, 7, 8, and 10–12 are rejected under 35 U.S.C. § 103 as unpatentable over Stocking and Whiting. Claim 3 is rejected under 35 U.S.C. § 103 as unpatentable over Stocking, Whiting, and Chuttani. Claim 9 is rejected under 35 U.S.C. § 103 as unpatentable over Stocking, Whiting, and Lederman. OPINION Claim 4—Rejected as Failing the Enablement Requirement Claim 4 depends from claim 1 and additionally recites “wherein the safety tip includes a first coil in a first coil plane and a second coil in a second coil plane different from the first coil plane.” App. Br. 41 (Claims App.). The Examiner determines that It is unclear how each of the coils of the multiple coils can be in their own plane. No drawings are provided showing how such a configuration is possible and the specification is silent as to each of this limitation. During previous review, the Examiner interpreted this limitation as describing the configuration of a typical spring or Slinky® wherein the coiling member continuously spirals forming coils that lie on top of one another; however, Applicant’s remarks in the Appeal Brief filed 7/24/2017 contradict that interpretation and explicitly state that Applicant does not believe such a configuration reads upon the limitation of claim 4 (see the top of page 15 and the bottom of page 23). If this configuration is not what is intended by the Appeal 2019-001558 Application 14/866,738 4 limitation of claim 4, then it is unclear how one could make and/or use the invention. Final Act. 3–4. Appellant responds that “any three points of a coil can define a plane, or ‘coil plane.’” Appeal Br. 9. Referring to an annotated version of Figure 25B of the Specification, Appellant asserts that “the first coil plane can be defined by three adjacent points of the first coil,” and “the second coil plane can be defined by three similarly adjacent points of the second coil.” Id. Section 112 requires a written description to enable “those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation.”’ Koito Mfg. Co., Ltd. v. Turn-Key-Tech, LLC, 381 F.3d 1142, 1155 (Fed. Cir. 2004) (citation omitted). Whether undue experimentation is needed is not a single, simple factual determination, but is a conclusion reached by weighing many factual considerations. In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988). The Wands factors include: (a) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims. Id. “[T]he PTO bears an initial burden of setting forth a reasonable explanation as to why it believes that the scope of protection provided by that claim is not adequately enabled by the description of the invention provided in the specification of the application.” In re Wright, 999 F.2d 1557, 1561–62 (Fed. Cir. 1993). The Examiner has not made any findings regarding whether undue experimentation is required for one of ordinary skill in the art to make and use the invention of claim 10, much less considered any of the Wands Appeal 2019-001558 Application 14/866,738 5 factors. Therefore, the Examiner has not established a prima facie case of lack of enablement, and we do not sustain this rejection. NEW GROUND OF REJECTION UNDER 37 C.F.R. § 41.50(b) Claim 4—Rejected Under 35 U.S.C. § 112(a) as Failing the Written Description Requirement To satisfy the written description requirement, a disclosure must reasonably convey to one skilled in the art that the applicant had possession of the subject matter in question when the application was filed. Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). Determining possession requires an objective inquiry into the “four corners of the specification from the perspective of a person of ordinary skill in the art.” Id. at 1351. Although we agree with the Examiner that claim 4 should be rejected under 35 U.S.C. § 112(a), the proper basis to do so is under the written- description requirement. We are unable to discern any disclosure in the Specification for a coil configuration that includes a first coil in a first coil plane and a second coil in a second coil plane that is parallel to the first coil plane. For example, Figure 4B depicts a first and second coil in the same plane rather than each in separate, parallel planes. Spec. ¶ 52, Fig. 4B. Figures 25A and 25B depict two coils that are three dimensional, and thus cannot be said to be “in” a two-dimensional plane, as claim 4 requires. Appellant contends that a “coil plane” can be defined by any three points on each of the coils depicted in Figure 25B. Appeal Br. 12. But the Specification does not support this contention—the Specification does not appear to use the term “coil plane,” much less define it as any three randomly selected points on a coil. Such a definition would mean little, as Appeal 2019-001558 Application 14/866,738 6 there would be an infinite number of possible planes that could be defined by the selection of any three of an infinite number of points on each coil. For the above reasons, we determine that claim 4 is not adequately described by the Specification. Claims 1–3, 5, 6, and 10–12—Rejected as Unpatentable over Stocking and Chuttani The Examiner relies on Stocking to teach independent claim 1 substantially as claimed, but acknowledges that Stocking does not teach that the guidewire has a safety tip having a non-coiled configuration in the withdrawn position and a coiled configuration in an advanced position. Non-Final Act. 4 (citing Stocking, 5:1–5, Figs.1–4). The Examiner further finds that Chuttani teaches a guide wire having a safety tip having a non- coiled configuration in a withdrawn position and a could configuration in an advanced position, “for the purpose of cannulating tubular or vascular organs to allow the passage of devices into these organs for diagnosis and treatment.” Id. at 5 (citing Chuttani, 2:24–26, 5:23–26, Figs. 1–6). The Examiner determines that it would have been obvious to one of ordinary skill in the art “to modify Stocking to include the guide wire with a safety tip, as taught by Chuttani, for the purpose of cannulating tubular or vascular organs to allow the passage of devices into these organs for diagnosis and treatment.” Id. at 5 (citing Chuttani, 2:24–26, 5:23–26). In response, Appellant argues that the helix formed at the end of Chuttani’s guide wire is for a different purpose than Stocking’s guide wire. Appeal Br. 15. That is, according to Appellant, Stocking’s guide wire is “used to guide the catheter a short distance within a blood vessel,” whereas the helix at the end of Chuttani’s guide wire is used to navigate the spiral Appeal 2019-001558 Application 14/866,738 7 folds of the cystic duct that lead to the ball bladder. Id. at 15–16 (citing Stocking, 6:1–49, 8:26–33, Chuttani, 2:24–26, 5:23–46, 4:36–46). The Examiner responds that: Appellant’s arguments focus on Chuttani’s disclosed use within the cystic duct, but Chuttani does not disclose only use in the cystic duct but also explicitly discloses use in “tubular and vascular organs” (see Col 2, Lines 24–26); one of ordinary skill understands that blood vessels are both “tubular organs” and “vascular organs”. Therefore, Chuttani discloses use in blood vessels, like those of Stocking. Ans. 8. We do not sustain this rejection. Although the Examiner is correct that the invention “generally” relates to use in “tubular or vascular organs,” Chuttani teaches using the coils on its guidewire (the specific structure that the Examiner proposes combining with Stocking) for a more specialized purpose: to help maneuver Chuttani’s guidewire through spiraled channels, particularly the “valves of Heister” in the cystic duct. Chuttani 5:10–19. We are not persuaded that one of ordinary skill in the art would have been motivated to include Chuttani’s coiled structure in a device not intended for use in an organ with spiral channels. Claim 9—Rejected as Unpatentable over Stocking, Chuttani, and Lederman Claim 9 depends on claim 1. Appeal Br. 42. This rejection relies on the Examiner’s unpersuasive determination that one of ordinary skill in the art would have combined Chuttani’s helical guide-wire structure with Stocking’s guide wire. Lederman is not relied upon to cure this deficiency. Accordingly, we do not sustain the Examiner’s rejection of claim 9 as unpatentable over Stocking, Chuttani, and Lederman. Appeal 2019-001558 Application 14/866,738 8 Claims 1, 2, and 9–12—Rejected as Unpatentable over Stocking and Lederman Appellant argues claims 1, 2, and 9–12 as a group. Appeal Br. 24–31. We select claim 1 as representative of the group, and decide the appeal of these claims on the basis of claim 1 alone. 37 C.F.R. § 41.37(c)(1)(iv). The Examiner relies on Stocking to teach the structure of claim 1, except for the claimed safety tip having a non-coiled configuration in the withdrawn position and a coiled configuration in an advanced position. Non-Final Act. 7–8 (citing Stocking, 5:1–5, Figs. 1–4). For the missing limitation, the Examiner relies on Lederman’s guide wire 24 and its distal end pigtail 42. Id. at 8 (citing Lederman ¶¶ 26, 38, Figs. 1, 2). The Examiner finds that Lederman teaches that distal end pigtail 42 has “a non- coiled configuration in a withdrawn position (inherently based on the diameter of the guide wire and the diameter of the lumen it resides within) and a coiled configuration in an advanced position” for the purpose of “providing a capture for the catheter it resides within and for the purpose of reducing the risk of the guide wire puncturing or damaging tissue.” Id. (citing Lederman ¶¶ 26, 38, Figs. 1, 2). The Examiner determines that it would have been obvious to one of ordinary skill in the art to modify Stocking’s guide wire to include Lederman’s guide-wire pigtail “for the purpose of providing a capture for the catheter it resides within and for the purpose of reducing the risk of the guide wire puncturing or damaging tissue.” Id. (citing Lederman ¶ 38). We have reviewed each of Appellant’s arguments for patentability of claim 1, but find them unpersuasive of Examiner error. Accordingly, we sustain the Examiner’s rejection of claim 1 as unpatentable over Stocking Appeal 2019-001558 Application 14/866,738 9 and Lederman for essentially those reasons expressed in the Non-Final Action and Answer. We add the following primarily for emphasis. Appellant argues that “there is no evidence to support the Examiner’s assertion that the Lederman guide wire inherently has a non-coiled configuration in a withdrawn position.” Appeal Br. 26. In response, the Examiner points to Lederman Paragraphs 26 and 35 and Figures 2–5 as teaching this limitation. Ans. 19. According to the Examiner: Para 26 states that “guide wire 24 has been inserted into guide wire lumen 12 via guide collar 22”, . . . and that this is done so “snugly” and Fig 2–5 clearly show that guide wire lumen 12 is of a diameter significantly smaller than the radius of curvature of the distal end 42 when it is in its pigtail shape and that the difference between the outer diameter of the guide wire 24 and the inner diameter of the lumen 12 is so small that the coil configuration of the distal end 42 could not be maintained when drawn into the lumen 12. Therefore, one of ordinary skill would understand that the distal end 42 of Lederman’s guide wire 24 must be uncoiled when it is within the lumen 12, i.e. when it is in “a withdrawn position.” Id. Appellant responds that “the non-coiled configuration of the pigtail is an Examiner-asserted inherent feature of the pigtail,” which therefore “must be necessarily present in Lederman,” but Lederman “simply does not show the alleged non-coiled configuration of the pigtail is necessarily present.” Reply Br. 15. This argument is not persuasive. First, we disagree with Appellant that the Examiner is relying on the doctrine of inherency with respect to the non-coiled configuration. Instead, the Examiner relies on record evidence: Paragraphs 26 and 35, and Figures 2–5, of Lederman. Ans. 19. In stating that Lederman’s guide wire 24 and safety tip 42 have “a non-coiled Appeal 2019-001558 Application 14/866,738 10 configuration in a withdrawn position (inherently based on the diameter of the guide wire and the diameter of the lumen it resides within),” the Examiner simply means that guide wire lumen 12 is too small for Lederman’s pigtail to fit inside of unless the guide wire is in a non-coiled configuration. See id. at 18–19. Second, we agree with the Examiner that one can reasonably infer from paragraph 26 of Lederman that distal pigtail end 42 of guide wire 24 is inserted through guide collar 22, then through into the proximal end of guide wire lumen 12, finally “emerging from the distal end 20 of catheter 10.” Lederman ¶ 26. Because guide wire 24 fits “snugly” into guide wire lumen 12 (Lederman ¶ 35), it is reasonable to infer that the pigtail must be “maintained in a straightened configuration” while it is still in guide wire lumen 12 and before it emerges from the distal end of catheter 10. Ans. 19. Appellant notes that after describing the insertion of the guide wire into the guide wire lumen, paragraph 26 of Lederman teaches that “the distal end 42 of guide wire 24 optionally may be coiled to form a ‘pigtail.’” Appeal Br. 28 (quoting Lederman ¶ 26). Appellant reads this as a process step, i.e., that “in a first step, the guide wire can be inserted into the guide wire lumen and, in a second step, the guide wire can be coiled to form a pigtail.” Id. We disagree with this reading of Lederman. We do not read paragraph 26 of Lederman as describing the manufacturing steps for the embodiment depicted in Figures 1–5, but rather as describing the embodiment itself. Thus, Lederman uses “coiled” as an adjective to describe an optional version of the distal end 42, rather than a verb describing how it is made. Appeal 2019-001558 Application 14/866,738 11 Appellant also takes issue with the Examiner’s reason to combine Lederman’s pigtail with Stocking’s guide wire, i.e., to “reduc[e] the risk of the guide wire puncturing or damaging tissue.” Non-Final Act. 8. Appellant notes that “the tissue at reduced risk of being punctured is expressly heart tissue,” and therefore “a person of ordinary skill in the art would not predictably arrive at the claimed catheter insertion device with a reasonable expectation of success.” Reply Br. 15 (emphasis added by Appellant). This argument is unpersuasive. First, Lederman teaches that pigtail 42 at the distal end of guide wire 24 reduces the risk of guide wire 24 puncturing or damaging “tissue within the body of a subject,” not just heart tissue. Lederman ¶ 38. Second, even if Lederman’s teaching was limited to protecting heart tissue, Appellant does not explain why it would have been beyond ordinary skill to realize that other kinds of tissue need protection from accidental puncture, and would be protected therefrom by a pigtail at the distal end of the guide wire. “A person of ordinary skill is also a person of ordinary creativity, not an automaton.” KSR Int’l. Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007). Claim 3—Rejected as Unpatentable over Stocking, Lederman, and Chuttani Claim 3 depends from claim 1 and additionally recites “wherein the guide wire has a first portion having a first diameter and a second portion having a second diameter less than the first diameter, and wherein the safety tip is formed in the second portion.” Appeal Br. 41 (Claims App.). The Examiner relies on “the proximal end of section 15” as corresponding to the “first portion having a first diameter,” and on “the distal end of section 15” as corresponding to the “second portion having a second diameter” less than the first diameter. Non-Final Act. 9, 10 (citing Chuttani, 3: 46–65, Figs. 1, Appeal 2019-001558 Application 14/866,738 12 2). The Examiner determines that it would have been obvious to one of ordinary skill in the art “to modify Stocking/Lederman to include the guidewire as one with two diameters, the smaller of the diameters being where a safety tip is formed, as taught by Chuttani, for the purpose of imparting the distal end of the guide wire with increased flexibility.” Id. at 10 (citing Chuttani, 3:58–60). We have reviewed each of Appellant’s arguments for patentability of claim 1, but find them unpersuasive of Examiner error. Accordingly, we sustain the Examiner’s rejection of claim 1 as unpatentable over Stocking and Lederman for essentially those reasons expressed in the Non-Final Action and Answer. We add the following primarily for emphasis. Appellant argues, inter alia, that Lederman’s guide wire needs “sufficient rigidity to transmit torque applied thereto ‘to assist manipulation of the catheter into apposition with the target structure, such as the wall of a heart.’” Appeal Br. 32–33 (quoting Lederman ¶ 38). According to Appellant, “[i]t is contradictory for the Examiner to assert a first modification of Stocking’s catheter assembly with the sufficiently rigid, torquable guide wire of Lederman and subsequently assert a second modification thereto to impart increased flexibility to the torquable guide wire.” Id. at 33. The Examiner responds that Lederman teaches to use materials of sufficient flexibility for its guide wire, and thus “Lederman discloses that the guide wire is already flexible . . . even before modification by Chuttani.” Ans. 24 (citing Lederman ¶ 32). Appellant’s argument is not persuasive of Examiner error. First, as the Examiner notes, Lederman encourages the use of flexible materials (Lederman ¶ 32), so the Examiner’s proposed modification to enhance the Appeal 2019-001558 Application 14/866,738 13 guide wire’s flexibility is fully compatible with Lederman. Second, the Examiner is not proposing combining Lederman’s teaching that its pigtail be able to transmit torque, but rather that it be able to protect tissue from accidental puncture. Appellant does not point to any teaching in Stocking suggesting the need for its guide wire to transmit torque. Claims 5, 7, and 8—Rejected as Unpatentable over Stocking, Lederman, and Whiting Claims 5, 7, and 8 ultimately depend from claim 1. Appeal Brief 41– 42 (Claims App.). Appellant does not address with any specificity the Examiner’s rejection of claims 5, 7, and 8 as unpatentable over Stocking, Lederman, and Whiting. Id. at 33–34. Accordingly, for the reasons stated above with respect to the Examiner’s rejection of claim 1 as unpatentable over Stocking and Lederman, we sustain this rejection. Claims 1, 2, 5, 7, 8, and 10–12—Rejected as Unpatentable over Stocking and Whiting The Examiner finds that Stocking discloses all of the limitations of claim 1 except that it does not disclose that the guidewire has a safety tip having a non-coiled configuration in the withdrawn position and a coiled configuration in an advanced position. Non-Final Act. 13–14 (citing Stocking, 5:1–5, Figs. 1–4). The Examiner relies on Whiting for this limitation. Id. at 14 (citing Whiting, 18:19–37, Fig. 2). The Examiner finds that Whiting teaches a guide wire 18 including safety tip 19 having a non- coiled configuration in a withdrawn position and a coiled configuration in an advanced position. Id. According to the Examiner, it would have been obvious to one of ordinary skill in the art to modify Stocking to include Whiting’s safety tip “for the purpose of forming an anchoring structure Appeal 2019-001558 Application 14/866,738 14 allowing the guidewire to stay in place when the conduits received thereover are removed.” Id. (citing Whiting, 18:19–37). Appellant responds, inter alia, that “the anchoring structure of Whiting configured for anchoring in the left atrium of the heart would not be suitable for disposition inside of a blood vessel lumen, as taught by Stocking.” Appeal Br. 36. We agree. In Stocking, guide wire 32 is designed to retract when introducer needle 27 is retracted. Stocking, 5:1–5, 6:37–39. We are not persuaded that one of ordinary skill in the art would be motivated to form an anchoring structure to impede this retraction. Accordingly, we do not sustain this rejection. Remaining Rejections The Examiner’s rejection of claims 3 as unpatentable over Stocking, Whiting, and Chuttani; and of claim 9 as unpatentable over Stocking, Whiting, and Lederman; rely on the Examiner’s erroneous determination that claim 1, from which claims 3 and 9 depend, is unpatentable over Stocking and Whiting. Non-Final Act. 16–17. Neither Chuttani nor Lederman are relied on to cure this deficiency. Therefore, for the reasons stated above, we do not sustain these rejections. DECISION The following table summarizes our disposition of the rejections at issue in this appeal: Appeal 2019-001558 Application 14/866,738 15 Claims Rejected 35 U.S.C. § Reference(s)/ Basis Affirmed Reversed New Ground 4 112(a) Enablement 4 4 112(a) Written Description 4 1–3, 5, 6, 10–12 103 Stocking, Chuttani 1–3, 5, 6, 10–12 9 103 Stocking, Chuttani, Lederman 9 1, 2, 9–12 103 Stocking, Lederman 1, 2, 9–12 3 103 Stocking, Lederman, Chuttani 3 5, 7, 8 103 Stocking, Lederman, Whiting 5, 7, 8 1, 2, 5, 7, 8, 10–12 103 Stocking, Whiting 1, 2, 5, 7, 8, 10–12 3 103 Stocking, Whiting, Chuttani 3 9 103 Stocking, Whiting, Lederman 9 Overall Outcome 1, 2, 3, 5, 7–12 6 4 FINALITY OF DECISION This decision contains a new ground of rejection under 37 C.F.R. § 41.50(b). 37 C.F.R. § 41.50(b) provides “[a] new ground of rejection pursuant to this paragraph shall not be considered final for judicial review.” 37 C.F.R. § 41.50(b) also provides that Appellants, WITHIN TWO MONTHS FROM THE DATE OF THE DECISION, “must exercise one of Appeal 2019-001558 Application 14/866,738 16 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.” 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 IN PART; 37 C.F.R. § 41.50(b) Copy with citationCopy as parenthetical citation