Ex Parte Lachaine et alDownload PDFPatent Trials and Appeals BoardMay 15, 201912831546 - (D) (P.T.A.B. May. 15, 2019) 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. 12/831,546 07/07/2010 Martin Lachaine 4186.077US1 2641 153966 7590 05/17/2019 Schwegman Lundberg & Woessner / Elekta, Inc. P.O. Box 2938 Minneapolis, MN 55402 EXAMINER FERNANDEZ, KATHERINE L ART UNIT PAPER NUMBER 3793 NOTIFICATION DATE DELIVERY MODE 05/17/2019 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): uspto@slwip.com slw@blackhillsip.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte MARTIN LACHAINE, SEBASTIEN TREMBLAY, PHILIPPE FORTIER, SERGEI KOPTENKO, and TONY FALCO Appeal 2017-006833 Application 12/831J5461 Technology Center 3700 Before JENNIFER D. BAHR, EDWARD A. BROWN, and BRENT M. DOUGAL, Administrative Patent Judges. BROWN, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Martin Lachaine et al. (“Appellants”) seek review under 35 U.S.C. § 134(a) of the Examiner’s decision rejecting claims 1—12, 19, 21—25, and 30—35.2 We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM-IN-PART. 1 The Appeal Brief identifies Elekta Ltd. as the real party in interest. Appeal Br. 3. 2 Claims 13—18, 20, and 26—29 have been cancelled. Appeal Br. (Claims App.). Appeal 2017-006833 Application 12/831,546 CLAIMED SUBJECT MATTER Appellants’ disclosure “relates to methods and systems for monitoring therapy treatments, and more specifically to observing the effects of radiation and anatomical changes during radiotherapy treatment fractions.” Spec. 12. Claims 1,19, and 23 are independent claims. Claim 1 is illustrative of the claimed subject matter, and reads: 1. A method of monitoring a target tissue in a patient during a radiation treatment, comprising: positioning an ultrasound imaging device such that the ultrasound imaging device is in contact with the patient’s perineum; using the ultrasound imaging device to scan, transperineally, a target tissue in a genitourinary region of the patient to obtain, prior to a radiation fraction, a baseline image of the target tissue and surrounding tissue; delivering the radiation fraction along at least one beam- delivery path to the target tissue using a radiation therapy device, wherein the at least one beam-delivery path is directed to the patient’s anatomy in a non-transperineal direction; simultaneously delivering the radiation fraction while obtaining a plurality of ultrasound images using the ultrasound imaging device, wherein the ultrasound imaging device is positioned to obtain, from at least one transperineal direction, the plurality of ultrasound images, such that the ultrasound imaging device does not intersect the at least one beam-delivery path while obtaining the plurality of ultrasound images; comparing the one or more of the plurality of ultrasound images with the baseline image; and determining intraffactional movement of at least one of the target tissue or the surrounding tissue based on the compared ultrasound images as the radiation fraction is delivered to the patient by the radiation therapy device. Appeal Br. 19 (Claims App.). 2 Appeal 2017-006833 Application 12/831,546 REJECTIONS The Final Office Action includes the following rejections under 35 U.S.C. § 103(a): Claims 1—3, 6, 7, 11, 12, 19, 22—25, 30-323, 34, and 35 are rejected as unpatentable over Fu (US 2007/0015991 Al, published Jan. 18, 2007), Burdette (US 2005/0182316 Al, published Aug. 18, 2005), and Kyle Griffiths et al., Transperineal Ultrasound for Measurement of Prostate Volume: Validation Against Transrectal Ultrasound, 178 J. of Urology 1375—80 (2007) (hereinafter “Griffiths”). Claims 4 and 21 are rejected as unpatentable over Fu, Burdette, Griffiths, and Khamene (US 2005/0251029 Al, published Nov. 10, 2005). Claim 5 is rejected as unpatentable over Fu, Burdette, Griffiths, Khamene, and Allison (US 2008/0021300 Al, published Jan. 24, 2008). Claims 8, 10, and 33 are rejected as unpatentable over Fu, Burdette, Griffiths, and Downey (US 6,254,538 Bl, issued July 3, 2001). Claim 9 is rejected as unpatentable over Fu, Burdette, Griffiths, Downey, and Jianzhou Wu, Effect of Ultrasound Probe on Dose Delivery During Real-time Ultrasound-Guided Tumor Tracking, Proc. of the 28th IEEE EMBS Ann. Inf 1 Conf., pp. 3799-3802 (2006) (hereinafter “Wu”). 3 We note claim 32 depends from claim 9, which is rejected under a different ground listed below. Appeal Br. 25 (Claims App.). 3 Appeal 2017-006833 Application 12/831,546 ANALYSIS Obviousness over Fu, Burdette, and Griffiths (Claims 1—3, 6, 7, 11, 12, 19, 22—25, 30—32, 34, and 35) Claims 1—3, 6, 7, 11, 12, 30—32, and 35 Examiner’s Rejection The Examiner finds that Fu discloses all limitations of claim 1 except for: (a) the ultrasound imaging device is in contact with the patient’s perineum and scans transperineally; (b) the soft tissue region scanned by the ultrasound imaging device is a genitourinary region; and (c) the ultrasound imaging device is positioned to obtain, from at least one transperineal direction, a plurality of ultrasound images, such that the ultrasound imaging device does not intersect the at least one radiation beam-delivery path while obtaining the ultrasound images. Final Act. 2—4. The Examiner relies on Burdette as disclosing external beam radiation therapy, comprising localizing an ultrasound probe (imaging device 100) to target the radiation beam to regions of the prostate. Id. at 4 (citing Burdette 28—31, Fig. 1). During this therapy, target volume 110 is within the ultrasound probe’s field of view 101. Id. at 4—5 (citing Burdette 130).4 The Examiner finds that because the prostate lies in the patient’s genitourinary region, the ultrasound probe inherently scans that region. Id. at 5. The Examiner notes that ultrasound imaging device 100 is positioned to obtain, from at least one transrectal direction, the plurality of ultrasound images, such that the ultrasound imaging device does not intersect the at least one 4 Burdette describes, “[f]or the example of FIG. 1, the target volume 110 would be a patient’s prostate or a portion thereof.” Burdette 129 (boldface omitted). 4 Appeal 2017-006833 Application 12/831,546 beam-delivery path (i.e., from the radiation therapy device (LINAC 250)) while obtaining the ultrasound images. Id. (citing Burdette, Fig. 1). The Examiner concludes that it would have been obvious to one of ordinary skill in the art to have Fu’s ultrasound imaging device: (a) scan a genitourinary region; (b) image a soft tissue region comprising the prostate; and (c) be positioned to obtain, from at least one transrectal direction, the plurality of ultrasound images, such that the ultrasound imaging device does not intersect the at least one beam-delivery path while obtaining the plurality of ultrasound images, as taught by Burdette, to treat prostate lesions. Id. The Examiner determines, however, that Fu and Burdette do not disclose that: (a) the ultrasound imaging device is in contact with the patient’s perineum; (b) the ultrasound imaging device scans transperineally; and (c) the plurality of ultrasound images are obtained from at least one transperineal direction. Id. The Examiner relies on Griffiths as teaching imaging the prostate using transperineal ultrasound by placing a transducer at the base of the scrotum. Id. at 6 (citing Griffiths, Abstract, p. 1376, left col. (“Prostate Ultrasound”), Fig. 1). The Examiner determines that transperineal ultrasound provides an accurate and less invasive alternative to transrectal imaging means. Id. (citing Griffiths, Abstract, p. 1375, right col.). The Examiner concludes that it would have been obvious to have the ultrasound imaging device of Fu and Burdette in contact with a patient’s perineum to scan transperineally and obtain the ultrasound images from at least one transperineal direction, as taught by Griffiths, “to provide an accurate and minimally invasive prostate imaging means.” Id. The Examiner also concludes that it would have been obvious to substitute the transrectal ultrasound imaging probe for imaging the prostate of Fu and 5 Appeal 2017-006833 Application 12/831,546 Burdette with a transperineal ultrasound imaging probe for imaging the prostate, as taught by Griffiths, “as the substitution of one known ultrasound imaging probe for imaging the prostate for another yields predictable results to one of ordinary skill in the art.” Id. Regarding the modification of Fu and Burdette, the Examiner acknowledges that Griffiths does not disclose positioning the ultrasound imaging device to not intersect at least one radiation beam-delivery path. Adv. Act. (dated June 13, 2016) (Cont. sheet). The Examiner explains, however, that Fu and Burdette teach the claim limitations reciting radiation therapy and that Griffiths is relied on to teach using an ultrasound imaging device positioned “from at least one transperineal position” as an alternative to transrectal imaging. Id. The Examiner submits that in modifying the combination of Fu and Burdette to position the ultrasound imaging device at the base of the scrotum (i.e., “from at least one transperineal direction”), as taught by Griffiths, the ultrasound imaging device would not intersect the at least one beam-delivery path while obtaining the plurality of ultrasound images. Id. Appellants ’ Contentions Appellants contend that the Examiner has invoked the doctrine of inherency to establish obviousness by relying on the notion that the claim element of “non-intersecting ‘would naturally follow as a result of the taught positioning.’” Appeal Br. 12 (citing Adv. Act. (Cont. Sheet)). Appellants submit that to rely on inherency in an obviousness analysis, “the limitation at issue necessarily must be present, or the natural result of the combination of elements explicitly disclosed by the prior art.” Id. (citing Par Pharm., Inc. v. Twi Pharm., Inc., 773 F.3d 1186, 1195—96 (Fed. Cir. 2014)). Appellants 6 Appeal 2017-006833 Application 12/831,546 assert that “inherency may not be established by probabilities or possibilities, and that the mere fact that a certain thing may result from a given set of circumstances is not sufficient.” Id. (citing Par Pharm. at 1196). Appellants contend that the Examiner has not established that “Griffiths ’ disclosure of placing the transducer at the base of the scrotum would necessarily or must result in the claimed limitation that the ultrasound imaging device does not intersect the at least one beam-delivery path while obtaining the plurality of ultrasound images.” Id. Appellants state, various situations may exist that would affect the intersecting between the beam-delivery path and the ultrasound image device, such as the angle through which radiation beam is delivered, the relative location between the ultrasound imaging device and the radiation source, the rotational trajectory of the gentry [sic], the movement of the patient table, etc. Id. at 12—13. Appellants submit, “merely placing a transducer at the base of the scrotum, without considering the interaction between the transducer and the beam-delivering device of the radiotherapy system, would not necessarily result in the non-intersecting feature recited in claim 1.” Id. at 13. Appellants contend that, at best, the transducer positioning taught by Griffiths may lead to the claimed result, which is insufficient to support inherent obviousness. Id. The Examiner submits that Fu teaches delivering radiation beams from different angles, and, as such, at least one beam-delivery path would not intersect with the ultrasound imaging device positioned transrectally, as at least one beam-delivery path would be delivered above the ultrasound imaging device. Adv. Act. (Cont. sheet) (citing Full 50-51). The Examiner finds that Fu discloses “a radiation system wherein ‘a radiation source (e.g., a LINAC) is mounted on the gantry in such a way that it rotates 7 Appeal 2017-006833 Application 12/831,546 in a plane corresponding to an axial slice of the patient. Radiation is then delivered from several positions on the circular plane of rotation.’” Ans. 15 (boldface omitted). The Examiner adds that Fu and Burdette are both concerned with targeted accurate delivery of radiation beams to the anatomy while avoiding surrounding healthy tissue. Id. at 15—16 (citing Fu Tflf 4, 25, 33; Burdette Tflf 4—5, 28). The Examiner states: the taught positioning of the ultrasound imaging device at the base of the scrotum in the above combined reference would necessarily result in the ultrasound imaging device not intersecting the at least one beam-delivery path while obtaining the plurality of ultrasound images since the beam-delivery path of Fu is delivered in an axial plane around the target tissue region, and as such, targeted delivery of radiation in an axial plane around a prostate region would necessarily not intersect an ultrasound probe that is positioned outside the body (i.e. outside the prostate region) at the base of the scrotum. That is, an ultrasound imaging device positioned at the base of the sc[r]otum outside the prostate region would necessarily not intersect at least one beam-delivery path of radiation beams delivered in an axial plane covering the prostate region that is inside the body, as radiation beams delivered in an axial manner targeting the prostate region inside the body would not intersect the base of the scrotum region that is outside the body. Ans. 16—17 (boldface omitted). The Examiner provides a modified version of Burdette Figure 1, in which the relationship between an “Ultrasound Imager Unit” positioned at the base of a patient’s scrotum and a radiation treatment delivery area (“between the longitudinal broken lines”) targeting prostate region 110 is depicted. Ans. 17. The Examiner determines that, as disclosed by Fu, the radiation beam-delivery path would be rotated in an axial plane (i.e., about the x-axis shown in modified Fig. 1) around the prostate region. Id. The 8 Appeal 2017-006833 Application 12/831,546 Examiner submits that this figure shows that the ultrasound imaging device of the combination does not intersect the at least one beam-delivery path. Id. Appellants contend that the Examiner mischaracterizes the limitation “at least one beam-delivery path” in stating, “as long as there exists one beam-delivery path, among the plurality of paths through which radiation is delivered, that does not intersect the probe, then the combination of references discloses the claim language.” Appeal Br. 13. Particularly, Appellants contend that claim 1 instead recites, “‘delivering the radiation fraction along at least one beam-delivery path to the target tissue using a radiation therapy device,’ and ‘such that the ultrasound imaging device does not intersect the at least one beam-delivery path while obtaining the plurality of ultrasound images.’” Id. This claim language means that “the ultrasound imaging device does not intersect ‘the at least one beam-delivery path,’ not at least one of the beam-delivery paths.” Id. at 13—14. Therefore, “claim 1 requires that none of the at least one beam-delivery path intersects with the ultrasound imaging device,” not “[t]he possibility that there may be one beam-delivery path not intersecting while there are many other beam- delivery paths intersecting.” Id. at 14 (emphasis added). Appellants’ construction of “at least one beam-delivery path” is consistent with the Specification. See, e.g., Spec. 7 (“radiation beams are typically directed at the patient from multiple intersecting directions, and the probe must not be in the path of the radiation beam, which would cause attenuation of the radiation, and potentially increase the skin dose to the patient”), 10 (“securing a diagnostic imaging device about the patient such that the diagnostic imaging device does not intersect the beam-delivery path'1'’), and 12 (“the diagnostic imaging device can be secured into a brace, 9 Appeal 2017-006833 Application 12/831,546 thereby ensuring that the diagnostic imaging device does not intersect the beam-delivery path'1'’) (emphasis added). These passages support Appellants’ construction as requiring “that none of the at least one beam-delivery path intersects with the ultrasound imaging device.” Id. at 14. Returning to Appellants’ contention that the Examiner has not established inherency, the Examiner also states, “the ultrasound imaging device is positioned such that the ultrasound imaging device does not intersect with the radiation treatment beams (i.e. all beam-delivery paths)” in the combination. Ans. 18. This statement appears to consider a construction of “at least one beam-delivery path” that is consistent with Appellants’. However, we are still persuaded by Appellants that the Examiner has not established, with sufficient evidence, that the applied combination would necessarily result in the limitation that “the ultrasound imaging device does not intersect the at least one beam-delivery path while obtaining the plurality of ultrasound images,” as recited in claim 1. The rejection relies partly on the finding that Burdette’s ultrasound imaging device is positioned such that it does not intersect the at least one beam-delivery path from LfNAC 250 while obtaining the ultrasound images. Final Act. 5. The Examiner concludes that it would have been obvious to position Fu’s ultrasound imaging device to obtain, from at least one transrectal direction, the plurality of ultrasound images, such that the ultrasound imaging device does not intersect the at least one beam-delivery path while obtaining the plurality of ultrasound images. Id. However, Appellants explain that Burdette’s transrectal ultrasound probe is described as being used “prior to delivering the radiation treatment.” Reply Br. 3^4. 10 Appeal 2017-006833 Application 12/831,546 Appellants contend that a person of ordinary skill in the art would not have been motivated to replace Burdette’s transrectal ultrasound probe with a transperineal probe in view of Griffiths. Reply Br. 5—6. As for Fu, Appellants contend that the Examiner’s conclusion that radiation beams emitted from a radiation head that rotates in the axial plane must not intersect the ultrasound probe placed at the base of the patient’s scrotum relies on the assumption that the radiation beams must also be confined within the same axial plane. Id. at 4. Appellants contend this assumption is unfounded because radiation beams are generally cone- shaped, such that as a radiation beam travels farther away from its source, the beam cross-section of the beam becomes larger. Id. Therefore, Appellants contend, even if the radiation head (source) rotates in an axial plane crossing the prostate region (“inside” the patient body), the radiation beams emitted from the radiation head may not be confined within the same axial plane. Id. at 4—5. Appellants submit that the extent to which the radiation beams reach outside the axial plane depends on, for example, the shape of the beams, the distance between the radiation head and target area, and the “thickness” of the axial plane, and depending on the distance between the axial plane and the ultrasound probe, the radiation beams may, or may not, intersect the probe. Id. at 5. In other words, Appellants contend, the radiation beams do not necessarily avoid intersecting the ultrasound probe in the Examiner’s hypothetical configuration. Id. We are persuaded that the Examiner has not established, with sufficient evidence, that the combination of teachings, as applied to claim 1, would meet each method limitation. 11 Appeal 2017-006833 Application 12/831,546 For the foregoing reasons, we do not sustain the rejection of claim 1, or of claims 2, 3, 6, 7, 11, 12, 30-32, and 35 depending therefrom, as unpatentable over Fu, Burdette, and Griffiths. Claims 19. 22—25. and 34 In contrast to claim 1, claims 19 and 23 are directed to an apparatus and a system, respectively. See Appeal Br. 22—24 (Claims App.). For claims 19 and 23, the Examiner construes “[t]he specific positioning of the ultrasound imaging device with reference to the patient and the beam- delivery path is viewed as an intended use of the device.” Ans. 18—19 (emphasis added). The Examiner determines that, because the ultrasound imaging device of the combination “may, or is capable of being positioned in the claimed manner such that the ultrasound imaging device does not intersect one or more beam-delivery paths of the radiation fraction,” the combination meets the corresponding limitation in claims 19 and 23. Id. at 19. Appellants contend that the Examiner incorrectly alleges that the specific positioning of the ultrasound imaging device recited in claims 19 and 23 is an intended use. Reply Br. 7. Appellants appear to contend that the Examiner’s position is an improper new ground of rejection. Id. We note, however, this issue is a petitionable matter, and thus, not an appealable matter, and so it is not properly before us. See 37 C.F.R. § 41.40 (“Failure of appellant to timely file such a petition will constitute a waiver of any arguments that a rejection must be designated as a new ground of rejection.”). According to Appellants, the Examiner “lowered the standard from ‘necessarily must be present’ to ‘may or capable of being present’ by 12 Appeal 2017-006833 Application 12/831,546 demoting the structural limitation recited in claims 19 and 23 to ‘intended use’ without providing any rationale of doing so.” Reply Br. 7—8. Appellants contend that claim 19 recites an ultrasound imaging device and a brace for holding the ultrasound imaging device and positioning the ultrasound imaging device {id. at 8), and claim 19 requires that the ultrasound imaging device to be positioned in a specific manner that “from at least one transperineal direction” “such that the ultrasound imaging device does not intersect, while obtaining the plurality of ultrasound images, a beam- delivery path along which a radiation fraction is delivered to the patient during the radiation therapy by a radiation therapy device.” Id. (emphasis added). Appellants submit that “the recited manner of positioning requires particular configuration(s) of the ultrasound imaging device, as well as the brace, and is not an intended use.” Id. Similarly, Appellants contend, “claim 23 recites that the ultrasound imaging device is ‘configured to be positioned . . . wherein the ultrasound imaging device does not intersect the one or more beam-delivery paths of the radiation fraction while obtaining the plurality of ultrasound images.’” Id. Appellants assert that “this recited configuration of the ultrasound imaging device is tied to the structure and function of the claimed system, and is not merely an intended use.” Id. at 8—9. Appellants’ contentions are not persuasive. The Examiner finds that Fu discloses that the ultrasound imaging device is attached to a brace (robotic arm 910). Final Act. 8 (citing Fu 72). We do not agree with Appellants’ contention that claim 19 requires “the ultrasound imaging device to be positioned in a specific manner.” Rather, claim 19 recites “a brace for holding the ultrasound imaging device and for positioning the ultrasound 13 Appeal 2017-006833 Application 12/831,546 imaging device between the patient’s legs and in contact with the patient’s perineum.” We construe this language as requiring the ultrasound imaging device to be capable of the recited positioning. Appellants do not, however, provide persuasive argument as to why Fu’s robotic arm would not be capable of meeting the claimed function of the brace in claim 19 when combined with Burdette and Griffiths. As noted, Appellants acknowledge that the transducer positioning taught by Griffiths may lead to the claimed “non-intersecting” feature. Appeal Br. 13. Claim 23 recites “an ultrasound imaging device configured to be positioned between the patient’s legs and in contact with the patient’s perineum.” Appeal Br. 22—23 (emphasis added). Appellants do not apprise us of error in the Examiner’s finding that Griffiths teaches imaging the prostate using transperineal ultrasound by placing a transducer at the base of the scrotum. Final Act. 6. And again, Appellants acknowledge that the transducer positioning taught by Griffiths may lead to the claimed “non intersecting” feature. Appeal Br. 13. As for “the structure and function of the claimed system,” we note neither claim 19 nor claim 23 positively recites the radiation source as an element of the claimed invention. Consequently, for these claims, whether the limitations of the ultrasound imaging device not intersecting the beam- delivery paths are met appears to depend on the radiation source with which the apparatus or system is used, and thus, not only on the ultrasound imaging device. We are not persuaded by Appellants’ contentions presented for claims 19 and 23 that the Examiner’s proposed combination would be unable to meet the limitations of these apparatus claims. 14 Appeal 2017-006833 Application 12/831,546 For these reasons, we sustain the rejection of claims 19 and 23, and of claims 22, 24, 25, and 34 depending therefrom, as unpatentable over Fu, Burdette, and Griffiths. Obviousness over Fu, Burdette, Griffiths, and one of more of Khamene, Allison, Downey, and Wu (Claims 4, 5, 8—10, 21 and 33) Claims 4, 5, and 8—10 depend from claim 1. Appeal Br. 20-21 (Claims App.). The Examiner’s reliance on: Khamene to reject claim 4 (Final Act. 10—11); Khamene and Allison to reject claim 5 (id. at 11); Downey to reject claims 8 and 10 (id. at 12—13); and Downey and Wu to reject claim 9 (id. at 13—14) fails to cure the deficiencies of the rejection of claim 1. Accordingly, we do not sustain the rejections of claims 4, 5, and 8— 10 for the same reasons as for claim 1. For dependent claims 21 and 33, Appellants contend that Khamene and Downey fail to cure the deficiencies of the rejection of parent claim 19. Appeal Br. 15—17. However, as we find no deficiencies in the rejection of claim 19, we also sustain the rejections of claim 21 and 33. DECISION We affirm the rejection of claims 19, 22—25, and 34, and reverse the rejection of claims 1—3, 6,1, 11, 12, 30-32, and 35, under 35 U.S.C. § 103(a) as unpatentable over Fu, Burdette, and Griffiths. We affirm the rejection of claim 21, and reverse the rejection of claim 4, under 35 U.S.C. § 103(a) as unpatentable over Fu, Burdette, Griffiths, and Khamene. 15 Appeal 2017-006833 Application 12/831,546 We reverse the rejection of claim 5 under 35 U.S.C. § 103(a) as unpatentable over Fu, Burdette, Griffiths, Khamene, and Allison. We affirm the rejection of claim 33, and reverse the rejection of claims 8 and 10, under 35 U.S.C. § 103(a) as unpatentable over Fu, Burdette, Griffiths, and Downey. We reverse the rejection of claim 9 under 35 U.S.C. § 103(a) as unpatentable over Fu, Burdette, Griffiths, Downey, and Wu. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv). AFFIRMED-IN-PART 16 Copy with citationCopy as parenthetical citation