Ex Parte Ryan et alDownload PDFPatent Trial and Appeal BoardJul 26, 201813362278 (P.T.A.B. Jul. 26, 2018) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 13/362,278 01/31/2012 Shawn Ryan 30636 7590 07/26/2018 FAY KAPLUN & MARCIN, LLP 150 BROADWAY, SUITE 702 NEW YORK, NY 10038 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. 10121/14102 3014 EXAMINER CERIONI, DANIEL LEE ART UNIT PAPER NUMBER 3736 MAIL DATE DELIVERY MODE 07/26/2018 PAPER 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. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte SHAWN RYAN, CAROLINE GAUDET, KAYLA BURNIM, ANDREW WHITNEY, and BARRY WEITZNER Appeal2017-004570 Application 13/362,278 Technology Center 3700 Before ELIZABETH A. LA VIER, RICHARD J. SMITH, and TIMOTHY G. MAJORS, Administrative Patent Judges. MAJORS, Administrative Patent Judge. DECISION ON APPEAL Appellants 1 submit this appeal under 35 U.S.C. § 134 involving claims to a stylet for insertion into a biopsy needle, and to a related biopsy device. The Examiner rejected the claims as indefinite and for obviousness. We have jurisdiction under 35 U.S.C. § 6(b ). We AFFIRM. 1 Appellants identify the Real Party in Interest as Boston Scientific Scimed, Inc. App. Br. 2. Appeal2017-004570 Application 13/362,278 STATEMENT OF THE CASE Appellants' "invention relates to devices for needle biopsies and, in particular, relates to a biopsy device including improved distal tip features for tissue acquisition." Spec. ,r 6. Claims 1--4, 19, and 22-26 are on appeal. Claims 1 and 19, the independent claims on appeal, are illustrative and are reproduced below: 1. A stylet for insertion into a biopsy needle, comprising: a coil at a distal end thereof such that advancement of the stylet relative to the needle moves the coil from a closed configuration in the needle to a tissue collecting configuration in which the coil extends distally past the distal end of the needle; and an actuating mechanism including a housing and a piston extending therethrough, a distal end of the piston coupled to a proximal end of the stylet such that movement of the piston distally relative to the housing moves the stylet from the closed configuration to the tissue collecting configuration, the actuating mechanism including a releasable, pivotable lever fixing the stylet in the tissue collecting configuration and a biasing element received in the housing to bias the stylet toward the closed configuration so that, when the lever is pivoted to release the piston, the stylet reverts to the closed configuration and is drawn proximally into the needle. 19. A biopsy device, comprising: a needle extending longitudinally from a proximal end to a distal end and including a channel extending therethrough; a stylet sized and shaped for slidable insertion through the channel of the needle, the sty let including a coil at a distal end thereof such that rotation of the stylet relative to the needle moves the coil from a closed configuration in the channel to a tissue collecting configuration in which the coil extends distally past a distal end of the needle to be inserted into a target tissue; and an actuating mechanism including a housing and a piston extending therethrough, a distal end of the piston coupled to a 2 Appeal2017-004570 Application 13/362,278 proximal end of the stylet such that movement of the piston distally relative to the housing moves the stylet from the closed configuration to the tissue collecting configuration, the actuating mechanism including a releasable, pivotable lever fixing the stylet in the tissue collecting configuration and a biasing element received in the housing to bias the stylet toward the closed configuration so that, when the lever is pivoted to release the piston, the stylet reverts to the closed configuration and is drawn proximally into the needle. Claims App. 2 The claims stand rejected as follows: Claims 1--4, 24, and 26 under 35 U.S.C. § 112, second paragraph (pre- AIA), for indefiniteness. Final Act. 3 3--4. Claims 1--4, 19, and 22-26 under 35 U.S.C. § I03(a) as obvious over Jans sens 4 and Sauer. 5 Final Act. 4--10. Only those arguments made by Appellants in the Appeal Brief and properly presented in the Reply Brief have been considered in this Decision. Arguments not so presented in the Briefs are waived. See 37 C.F.R. § 4I.37(c)(l)(iv) (2015); see also Ex parte Borden, 93 USPQ2d 1473, 1474 (BP AI 2010) (informative) ("Any bases for asserting error, whether factual or legal, that are not raised in the principal brief are waived"). 2 We refer to the claims as included in the corrected Claims Appendix, which was submitted on January 11, 2016. 3 Final Office Action dated March 13, 2015. 4 Janssens, US 2003/0114773 Al, published June 19, 2003. 5 Sauer, US 2007/0167868 Al, published July 19, 2007. 3 Appeal2017-004570 Application 13/362,278 INDEFINITENESS As the Examiner explains, claim 1 is drawn to "a stylet," yet other aspects of the claim recite elements of a biopsy device and/ or actuating mechanism, which are not part of the sty let. Final Act. 3--4. Hence, the Examiner concludes, the claims are unclear and indefinite under § 112, second paragraph. Id. Regarding claim 26, which depends from claim 19, the Examiner concludes the claim is unclear whether the recited "lever biased toward a locked position" relates to a function of the "biasing element," the "lever," or some other feature. Here too, the Examiner concludes the claim is indefinite. Id. at 4. As the Examiner notes, Appellants provide no argument in response to the rejection of claims 1--4, 24, and 26 for indefiniteness. Ans. 9. Because Appellants failed to contest the rejection, it is summarily affirmed. 6 Hyattv. Dudas, 551 F.3d 1307, 1314 (Fed. Cir. 2008) ("When the appellant fails to contest a ground of rejection to the Board, ... the Board may treat any argument with respect to that ground of rejection as waived ... [and] the PTO may affirm the rejection of the group of claims that the examiner rejected on that ground without considering the merits of those rejections."). 6 It appears the Examiner and Appellants have discussed proposed claim amendments as potentially traversing the rejection under§ 112, second paragraph. See Interview Summary and Adv. Act. ( dated Sept. 17, 2015). But those amended claims are not before us on appeal. 4 Appeal2017-004570 Application 13/362,278 OBVIOUSNESS Issue Has the Examiner established by a preponderance of the evidence on this record that claims 1--4, 19, and 22-26 would have been obvious over Janssens and Sauer?7 Findings of Fact (FF) The Examiner's findings of fact and statement of the rejection are provided at pages 4--10 of the Final Office Action. See also Ans. 2-8 and 10-15 (Response to Argument). The following findings are provided for emphasis and convenient reference. FF 1. Janssens teaches a "[d]evice for taking a tissue sample ... characterized in that it comprises a spirally shaped tissue-receiving element." Janssens Abstract. More specifically, Janssens describes a "spirally shaped tissue-receiving element ... and a cutting element" that cooperatively provide a cutting function. Id.; see also id. at Figs. 1-3 (showing spiral tissue-receiving element (2) within cylindrical element (4)), Figs. 13-14 (illustrating steps of tissue removal by the spirally shaped tissue-receiving element and cylindrical element), ,r,r 40, 61---62. FF 2. Janssens teaches that the device comprising the spirally shaped tissue-receiving element and cylindrical element "may be made as a biopsy needle" and "can be operated manually as well as by means of an 7 Although we have affirmed the rejection for indefiniteness (as discussed above), we review the obviousness rejection nonetheless. See Ex parte Tanksley, 26 USPQ2d 1384, 1387 (BPAI 1991) (exercising discretion to reach art rejections despite indefiniteness where nature of case permitted). 5 Appeal2017-004570 Application 13/362,278 appropriate apparatus." Id. ,r,r 50-51; see also id. ,r 68 ("the cylindrical element 4 is made as a hollow needle, more particularly a biopsy needle"). FF. 3. Janssens teaches that the device/apparatus may include various driving means within a housing to axially shift and/or rotate the cylindrical element and tissue-receiving element. See, e.g., id. ,r,r 51-54, Fig. 6 (showing, inter alia, device (1), housing (13), extremity (18) of portion (3) of the tissue-receiving element (2), and driving mechanism (15) for axial movement of the tissue-receiving element (2) and related structures (3, 18)). FF 4. Sauer relates to a "medical diagnostic instrument for the ergonomic effective and safe harvesting of specimen at targeted remote tissue sites[, which] includes a pistol grip style handle with a hand activated lever and a specialized elongated flexible double tube needle shaft." Sauer Abstract. Sauer teaches that the "ergonomic device ... enables enhancement of obtaining larger core biopsy tissue samples ... [and] enables enhancement of obtaining tissue samples using a traditional needle or needle with indwelling stylet." Id. ,r,r 16-17; see also id. at Figs. 4A--4B ( showing exploded view of a fine needle aspiration instrument with handle halves (22 and 24) separated, and showing lever (32) and its attached band drive (34) and lever spring (36)), ,r,r 74--75 (description of Figs. 4A--4B). FF 5. Figure 3 of Sauer is reproduced below. 6 Appeal2017-004570 Application 13/362,278 z;;;:?xt~: "-~L~.,._',,. ~~';;'-', (/'"" ) ... 1() -,~~''' !() ,.-·-=t:\~:~:-:?,, ,;,l:'A ., i~w~: .. , )~1·~" :::'.-~).::··· .. ·.·::::::•::::\i~/ ,~;::~a~i~·,\:~:>--· ... '"'·'··'·"-··· 1:,.• ~<· ,.,.),.:,....,,,,.,:_~' ··. '-·''-~··,~· -~/f~ ··:\?\\ \ \ \\''v~.:'_'·~~~\)~,~ r ~ .,. ,. , , ,., .,. ~ '--··-·J~t.A Figure 3 is a perspective view of aspiration instrument ( 10) without the right handle portion (22), so that various internal mechanisms of the instrument can be better seen. Id. ,r 72. Figure 3 depicts, among other structures, lever (32) (attached at cylindrical pivot (32A)), band drive (34), and lever spring (36). Sauer discloses, and Figure 3 shows, lever spring (36) attached at one end by way of hook (36A) to spring post (32C) of lever (32), and at the other end to lever spring post (24F). Id. Sauer teaches "spring 36 is of a commercially available spring material such as stainless steel and operates in accordance with common extension spring principles." Id.; see also Ans. 13-14 (Examiner's annotated versions of Sauer' s Fig. 12, illustrating corresponding movement of lever (32) and lever spring (36)). FF 6. Figure 14C of Sauer is reproduced below. 7 Appeal2017-004570 Application 13/362,278 ?{) ........ .~:~·:S { \ ···._:)~t .. ~ Figure 14C is a perspective view of the aspiration instrument (like shown in Fig. 3), with additional components removed for clarity. Id. ,r 96. Figure 14C shows, inter alia, lever (32), band drive (34) including drive tang opening (34B) encompassing drive tang (56). Id. Sauer teaches: With the pivot 32A of the lever 32 stationary and the lever partially rotated back shown by arrow 114, the tab 32B of the lever 32 is engaged with the lever tab opening 34A of the band drive 34. The drive tang opening 34B encompasses the drive tang 56 and advances the grater tube 54 (not shown) via the drive tang 56 along with the cover tube 58 partially outside the flex sheath 64. Id.; see also id. at Fig. 14D (showing the instrument with the lever rotated fully back as shown by arrow (116)), ,r 97 (disclosing that, with lever (32) rotated fully back, drive tang (56) advances the grater tube (54) and cover tube (58) "completely outside" the flex sheath (64)). 8 Appeal2017-004570 Application 13/362,278 Analysis Claim 1 The Examiner finds that Janssens teaches a stylet and biopsy needle as recited in claim 1, as well as an actuating mechanism and piston for moving the stylet from a closed configuration to a tissue collecting configuration. Final Act. 6. The Examiner finds, however, that Janssens does not expressly disclose an actuating mechanism with a "releasable, pivotable lever" and "biasing element" with the characteristics required in claim 1, so the Examiner turns to Sauer. Id. According to the Examiner, Sauer teaches an actuating mechanism with the claimed features. Id. at 6-7. And the Examiner concludes it would have been obvious to use the actuating mechanism of Sauer with the device of Janssens "to provide for a large lever that is ergonomic and easy to grasp and thereby make operation of the invention of Janssens easier." Id. at 7. Except as stated below, we agree with and adopt the Examiner's findings of fact, reasoning, and conclusion of obviousness on this record. Final Act. 4--10; see also Ans. 2-8 and 10-15 (Response to Argument). We address Appellants' arguments below. Appellants argue that the combination of Janssens and Sauer fails to disclose all the limitations of claim 1. App. Br. 4. First, Appellants argue Sauer "does not teach ... 'a releasable, pivotable lever' fixing a stylet in a tissue collecting configuration, as recited in claim 1." Id. According to Appellants, "movement of the grater tube 54 and cover tube 5 8 [ of Sauer] proximally and distally depends on the positioning of the spring button 70 and the needle control tube 68, not on the actuation of the lever 32." Id. Appellants contend it is "the spring lock button 70 of Sauer, which fixes the 9 Appeal2017-004570 Application 13/362,278 stylet, ... [as] it locks around the band drive 34 to prevent movement of the cover tube 58, grater tube 54 and needle tip 52." Reply Br. 3--4; see also App. Br. 4--5. Thus, Appellants argue, "Sauer does not teach or suggest a lever that would control any longitudinal movement of a tissue collecting device between a tissue collecting configuration and a closed configuration wherein the tissue collecting device is withdrawn into a lumen of a needle." App. Br. 5; Reply Br. 4. Second, Appellants argue Sauer does not teach claim 1 's "biasing element." App. Br. 5-6. According to Appellants, "Sauer never teaches or suggests that the lever spring 36 biases its tissue collective device (the grater tube 54) toward any particular configuration." Id. Appellants contend, "Sauer only shows that the spring is connected to a spring post of the lever and a lever spring post of the left handle portion 24." Id. ("Sauer describes only a connection mechanism of different portions of the lever"); see also Reply Br. 4 ("in its description of the movement of the lever in paragraphs [0095]-[0097], describing the movement of the lever from a rotated fully forward position to the rotated fully back position, Sauer consistently describes the pivot 32A as remaining stationary"). Appellants' arguments are unpersuasive. As to Appellants' first argument, we agree with the Examiner on this record that the combination of Janssens and Sauer teaches or suggests the "releasable, pivotable lever" with the features claimed. As described above (FF 4--6), Sauer discloses an ergonomic pistol-grip lever (32) that, when squeezed, moves grater and cover tubes (54 and 56, which the Examiner equates with a stylet) distally. Ans. 4, 11-12. When the lever is released, the grater tube and cover tube move proximally - withdrawing the "sty let" to the closed configuration as 10 Appeal2017-004570 Application 13/362,278 the Examiner explains. Ans. 4. Thus, contrary to Appellants' contentions, the lever of Sauer does control the longitudinal movement of a tissue collecting device. FF 6; Sauer ,r,r 96-97. The fact that other structures ( e.g., spring button) may also facilitate movement of the alleged sty let does not demonstrate that Sauer' s lever ( and associated structures, such as the lever spring and band drive) lacks the features and functionality of claim 1. Insofar as Appellants contend structures other than Sauer's lever.fix the stylet in the tissue collecting position, we disagree. Reply Br. 3--4; App. Br. 4--5. Appellants appear to interpret "fixing" in claim 1 as requiring "locking." Reply Br. 3--4 (explaining that Sauer's spring lock button (70) "locks around the band drive 34 to prevent movement"). But we are unpersuaded "fixing" is that narrow. To the contrary, as the Examiner notes, "the term 'fixing' does not have an explicit definition in Applicants' specification" and, thus, "fixing" is interpreted as "'to hold or direct stead[i]ly."' Ans. 11 (citing a Merriam-Webster.com online dictionary definition in support of this plain meaning). Accordingly, as the Examiner explains, "[a] user holding the lever 32 [of Sauer] stead[i]ly in the position shown in Fig. 14D will result in stylet 54, 58 remaining steady in the extended position." Ans. 11. Appellants provide no persuasive rebuttal to the Examiner on these points. For these reasons, we agree with the Examiner on this record that Appellants are arguing limitations that are not required in claim 1. Id. at 12 ("Appellants' arguments are not commensurate 11 Appeal2017-004570 Application 13/362,278 with the claim language of claim 1 and 19, which solely require a lever fixing a stylet, which is shown in Figs. 14A-D of Sauer"). 8 Appellants' second argument fares no better in overcoming the evidence of obviousness on this record. Appellants contend Sauer' s lever spring is not a "biasing element as recited in claim 1." App. Br. 6. But Appellants' Specification indicates that a biasing element may be a spring or numerous other possible structures. Spec. ,r 12 ("It will be understood by those of skill in the art that the spring may be any biasing element that biases the piston 130, and thereby the stylet 102, toward the closed configuration"). 8 To the extent the Examiner implies that consideration of intrinsic evidence to reach the broadest reasonable interpretation ("BRI") of claims undergoing examination is inappropriate ("Although claims of issued patents are interpreted in light of the specification, prosecution history, prior art, and other claims, this is not the mode of claim interpretation to be applied during examination." (Ans. 10)), the Examiner is incorrect. BRI must, for example, still account for, and be consistent with, the specification. See, e.g., Microsoft Corp. v. Proxyconn, Inc., 789 F.3d 1292, 1298 (Fed. Cir. 2016) (holding that, even under BRI, the Patent Office cannot construe claims "so broadly that its constructions are unreasonable under general claim construction principles"); In re Smith Int 'l, Inc., 871 F.3d 1375, 1382-83 (Fed. Cir. 2017) (holding that the BRI is "not simply an interpretation that is not inconsistent with the specification"). Nevertheless, we are persuaded the Examiner arrived at the correct conclusion as to the BRI of "fixing," a term which appears nowhere in the Specification. The Specification also does not use the word "fix," and the word "fixed" is used just once in a manner unrelated to the lever. Spec. ,r 11 ("The proximal end of the sty let 102 is fixed to the piston ... "). Conversely, when "locking" was the meaning intended, that term was specifically used in the Specification. Id. ,r 13 ("The spring ... urges the piston 130 against the engaging element 158, locking the device in the tissue sampling configuration"); see also claim 26 ("wherein the lever biased toward a locked position ... the lever is automatically pivoted to lock the stylet"). 12 Appeal2017-004570 Application 13/362,278 Moreover, the Examiner has shown persuasively- with the help of annotated drawings - how Sauer' s spring works to bias the sty let toward the closed configuration as recited in claim 1. Ans. 12-14. In short, as Sauer's lever (32) is pulled, lever spring (36) is put under tension and stretches. Id. at 13. When the lever is released, the spring will contract to its pre-extended state, moving the lever back to its forward position. Id. at 14; see also FF 4---6. The Examiner explains that this is how the skilled artisan would understand the lever spring's operation in Sauer, and Sauer is consistent in describing its spring as operating in accordance with these basic principles. Ans. 15; FF 4; Sauer ,r 72. And, as already discussed, when Sauer's lever moves to the forward position, the alleged "stylet" is drawn proximally into a closed configuration. FF 4---6; Ans. 4. Appellants point out that Sauer's lever is connected to a pivot (32A), which remains stationary. Reply Br. 4. This argument misses the point. The lever itself moves. See Ans. 12-14 (annotated drawings). So does the lever spring. Id. And when that spring contracts, it pulls on the spring post (32C) at the upper portion of the lever - urging that post and upper portion downward and the lever's bottom portion (i.e., the handle portion) forward. Id.; see also FF 4---6. These two portions, thus, rotate around the pivot. That the lever's pivot itself remains stationary does not demonstrate error with the rejection on appeal. Claim 19 The Examiner provides substantially the same findings and reasoning in support of the conclusion that claim 19 would have been obvious over Janssens and Sauer. Final Act. 8-10; Ans. 5-7. Appellants do not provide separate argument on claim 19, instead arguing " [ fJ or at least similar reasons 13 Appeal2017-004570 Application 13/362,278 as discussed above with respect to claim 1, Janssen[s] and Sauer, taken alone or in combination, do not disclose or suggest a releasable, pivotable lever or a biasing element as recited in Applicant's claim 1." App. Br. 6. We again agree with the Examiner on this record and find Appellants' arguments unpersuasive as explained above. Conclusion of Law The preponderance of the evidence supports the Examiner's conclusion that claims 1 and 19 would have been obvious over Janssens and Sauer. Claims 2--4 and 22-26 have not been argued separately and, therefore, fall with claims 1 and 19. See 37 C.F.R. § 4I.37(c)(l)(iv). SUMMARY We affirm the rejection of claims 1--4, 24, and 26 for indefiniteness. We further affirm the rejection of claims 1--4, 19, and 22-26 for obviousness. 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). AFFIRMED 14 Copy with citationCopy as parenthetical citation