Ex Parte Quick et alDownload PDFPatent Trial and Appeal BoardSep 4, 201813749241 (P.T.A.B. Sep. 4, 2018) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 13/749,241 01/24/2013 96000 7590 09/06/2018 C. R. Bard, Inc./BBS Intellectual Property Department 1415 W. 3rd St. Tempe, AZ 85281 FIRST NAMED INVENTOR Richard L. Quick 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. 297-PDD-10-181 US CON 3887 EXAMINER ABOUELELA, MAY A ART UNIT PAPER NUMBER 3736 NOTIFICATION DATE DELIVERY MODE 09/06/2018 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): raust@austiplaw.com BBSIP.Docket@crbard.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte RICHARD L. QUICK, FRANK R. LOUW, PAUL LUBOCK, and MARTIN V. SHABAZ Appeal2017-008293 1 Application 13/749,241 Technology Center 3700 Before DONALD E. ADAMS, FRANCISCO C. PRATS, and TIMOTHY G. MAJORS, Administrative Patent Judges. PRATS, Administrative Patent Judge. DECISION ON APPEAL This appeal under 35 U.S.C. § 134(a) involves claims to tissue biopsy devices and methods for using them. The Examiner rejected the claims as anticipated and for obviousness. We have jurisdiction under 35 U.S.C. § 6(b)(l). We affirm. STATEMENT OF THE CASE The following rejections are before us for review: (1) Claims 52-55, 59, 74, 77, and 78, under 35 U.S.C. § 102(b) as 1 The real party in interest is SenoRx, Inc. Appeal Br. 3. Appeal2017-008293 Application 13/749,241 anticipated by Burbank2 (Final Act. 2-7); (2) Claims 56, 57, 75, and 76, under 35 U.S.C. § 103(a) as obvious over Burbank (id. at 7-8), and (3) Claims 58 and 79, under 35 U.S.C. § 103(a) as obvious over Burbank and Ryan3 (id. at 8-10). 4 Claim 52 is illustrative, and reads as follows: 52. A tissue biopsy device for accessing and severing a tissue specimen from supporting tissue at a target site within a patient, comprising: a. an elongated probe member which has a longitudinal axis, an inner lumen extending therein, a tissue penetrating distal tip, and a tissue receiving aperture proximal to the tissue penetrating distal tip and defined at least in part by a longitudinally oriented tissue cutting edge; and b. an elongated tissue cutting member disposed within the inner lumen of the elongated probe member and configured for cutting movements therein, which has a distal tip with a distal tissue cutting edge having an arcuate shape that is at least in part diagonally oriented at an acute cutting angle with respect to the longitudinally oriented tissue cutting edge defining in part the tissue receiving aperture of the elongated probe member, and which is configured to be connected to at least one drive unit configured to rotationally oscillate the elongated tissue cutting member side-to-side such that with the rotational oscillation of the elongated tissue cutting member a point of intersection of the distal tissue cutting edge of the elongated tissue 2 US 5,526,822 (issued June 18, 1996). 3 US 5,285,795 (issued Feb. 15, 1994). 4 The Examiner withdrew the rejection of claims 71-73 over Burbank and Ryan. Ans. 2. 2 Appeal2017-008293 Application 13/749,241 Appeal Br. 42--43. cutting member is longitudinally advanced with respect to the longitudinally oriented tissue cutting edge at the tissue receiving aperture of the elongated probe member when the elongated tissue cutting member is rotated in a first direction, and the point of intersection of the distal tissue cutting edge of the elongated tissue cutting member is longitudinally retreated with respect to the longitudinally oriented tissue cutting edge at the tissue receiving aperture of the elongated probe member when the elongated tissue cutting member is rotated in a second direction opposite the first direction. ANTICIPATION-CLAIM 52 The Examiner's Prima Facie Case In determining that Burbank describes a device anticipating Appellants' claim 52, the Examiner cited Burbank's Figure 4 as showing an element corresponding to the outer elongated probe member of Appellants' claimed device, that is, element "a" of claim 52. Final Act. 2-3. As to the inner elongated tissue cutting member, element "b" of claim 52, disposed within the lumen of element "a," the Examiner cited Figure 6A of Burbank as describing the arcuate shape and diagonal orientation of the distal tip of the claimed cutting member, and cited Figures 13A and 13C, and related disclosures in column 18 of Burbank as meeting claim 52's configurational limitations relating to rotational motion and cutting edge position. Id. at 3. Analysis As stated inJn re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992): [T]he examiner bears the initial burden ... of presenting a primafacie case ofunpatentability .... 3 Appeal2017-008293 Application 13/749,241 After evidence or argument is submitted by the applicant in response, patentability is determined on the totality of the record, by a preponderance of evidence with due consideration to persuasiveness of argument. In the present case, having carefully considered all of the arguments and evidence advanced by Appellants and the Examiner, Appellants do not persuade us that the preponderance of the evidence fails to support the Examiner's determination Burbank describes a device having all of the features required by Appellants' claim 52. In particular, Appellants do not persuade us (see Appeal Br. 20-27; Reply Br. 5-11) that the inner cutting member of Burbank's device fails to include a distal tip with a diagonally oriented, arcuate shaped, cutting edge that is configured to rotationally oscillate, as claim 52 requires. As Appellants explain (Appeal Br. 19-20), Appellants' Figures 19 and 20, reproduced below, illustrate the device recited in Appellants' claim 52: FIG. 20 4 Appeal2017-008293 Application 13/749,241 Figure 20 shows, as to element "a" of claim 52, elongated probe member 86, which has a longitudinal axis 94, an inner lumen extending therein, a tissue penetrating distal tip (pointed structure adjacent to reference number 94), and a tissue receiving aperture 92 proximal to the tissue penetrating distal tip, defined at least in part by longitudinally oriented tissue cuttings edge 90, 91. Figure 20 also shows the distal tip 83 of inner tissue cutting member, element "b" of claim 52, disposed within the inner lumen of elongated probe 86. Figure 20 also includes arrows showing the oscillating rotational motion of the inner tissue cutting member within the outer probe member, which results the advance and retreat of the intersection point between the cutting edge 84 of the inner member and the longitudinal cutting edge 90, 91 of the outer member. Figure 19 shows, as to element "b" of claim 52, the "distal cutting section 82 has a beveled, needle-like distal tip 83 with a sharpened opposed edges 84 and 85 which facilitate cutting of the tissue specimen when the cutting member 80 is moved within the outer tubular member or cannula 86." Spec. ,r 44. Burbank's Figure 6A, is reproduced below: 5 Appeal2017-008293 Application 13/749,241 Burbank's Figure 6A shows "hollow outer piercing needle 44 in position to pierce a tissue sample 132 which is to be sampled" (Burbank 14:3-5), as well as hollow inner cutting member 68 disposed therein, having a diagonally oriented distal tip, identified by the Examiner as corresponding to element "b" of Appellants' claim 52. Burbank's Figure 13A is reproduced below: FIG~13A \ 68 Burbank's Figure 13A shows an alternate cutting action for the cutting mechanism previously described in connection with FIGS. lK--6. The cutting action described in FIGS. lK--6 was a linear slicing of the tissue which had prolapsed into the tissue receiving port 46 by the coaxial linear motion of the cannular inner cutter 68 through the hollow outer piercing needle 44. FIGS. 13A and 13B illustrate the same structure comprising the cannular inner cutter 68 and the hollow outer piercing needle 44. However, the cutting action is modified. As shown by arrows 410 and 412, the cannular inner cutter 68 is capable of rotational motion 6 Appeal2017-008293 Application 13/749,241 within the hollow piercing needle 44 as well as translational motion along their common longitudinal axis. The cannular inner cutter 68 rotational motion is controlled by cutter drive motor 80 and the linear motion along the longitudinal axis is controlled by the linear driver 88. A combination of these two actions provides the cutting action necessary to sever a tissue sample which has prolapsed into the tissue receiving port 46. The rotational motion may be continuous or oscillatory, as shown in FIG. 13C. Burbank 18:9-27. We acknowledge, as Appellants contend (Appeal Br. 21-22), that Figure 13A of Burbank depicts the inner cutting member 68 as having a blunt circle-shaped distal end, rather than the beveled configuration that provides the diagonally oriented, arcuate shaped, cutting edges 84 and 85, shown in Appellants' Figure 19 and recited in Appellants' claim 52. As seen above, however, and as the Examiner found, Figure 6A of Burbank shows the inner cutting member 68 as having the same beveled configuration shown in Appellants' Figure 19. Burbank does not include a perspective view of the device shown in Figure 6A comparable to the perspective view of Appellants' Figure 19. Nonetheless, Burbank consistently depicts the distal end of the inner cutting member 68 as having the same beveled configuration that provides the diagonally oriented, arcuate shaped, pair of cutting edges 84 and 85, shown in Appellants' Figure 19. See Burbank Figs. 6A---6H; see also Spec. ,r 44 ( explaining as to Appellants' Figure 19 that the "distal cutting section 82 has a beveled, needle-like distal tip 83 with a sharpened opposed edges 84 and 85"). Appellants, therefore, do not persuade us (see Appeal Br. 25) that the Examiner erred in finding that the diagonally oriented distal end of inner cutting member 68 of the device shown in Burbank's Figure 6A includes the 7 Appeal2017-008293 Application 13/749,241 diagonally oriented, arcuate shaped, cutting edge required by Appellants' claim 52. We acknowledge, as Appellants contend (see id.), that Appellants' Figure 19 includes a notation of the cutting angle theta between the inner diagonal cutting edge and outer longitudinal edge. Appellants' claim 52, however, does not recite any specific limitation as to the cutting angle of the inner element, other than the diagonally oriented acute cutting angle, which as discussed above, is shown in Figure 6A of Burbank. Appellants, moreover, fail to explain with any particularity how or why the Examiner erred in finding that Burbank's device has the arcuate shaped, cutting edge required by Appellants' claim 52, given that Burbank's device has the same beveled end shown in Appellants' own disclosure at Figure 19 as providing those elements. As noted above, moreover, Burbank discloses that the oscillating rotational motion of the inner member 68 described in column 18 in relation to Figure 13A (Burbank 18:26-36) is "an alternate cutting action/or the cutting mechanism previously described in connection with FIGS JK-6." Id. at 18:9-11 (emphasis added). Accordingly, contrary to Appellants' contention that Burbank's disclosures regarding the oscillating rotational motion of its inner cutting member 68 relate only to the embodiment shown in Figure 13A (Appeal Br. 23-24, 26; Reply Br. 8-11), Burbank states expressly that the oscillating rotational cutting action described in column 18 is "for the cutting mechanism previously described in connection with FIGS lK---6." Id. at 18:10-11. In sum, as discussed above, Burbank states expressly that the oscillating rotational cutting action described in column 18 is for the cutting 8 Appeal2017-008293 Application 13/749,241 mechanism described in connection with its Figure 6, and Figure 6A of Burbank depicts the distal end of the inner cutting member 68 as having the same beveled configuration that provides a diagonally oriented, arcuate shaped, pair of cutting edges shown in Appellants' Figure 19. Accordingly, Appellants do not persuade us (see Appeal Br. 23-24) that the Examiner erred in finding that the oscillating rotational motion described in Burbank would result in the scissoring action recited in claim 52, in which the intersection point of the inner cutting member and outer longitudinal cutting member advances and retreats. The preponderance of the evidence, thus, supports the Examiner's determination that Burbank describes a device having an inner cutting member with a distal tip that includes a diagonally oriented, arcuate shaped, cutting edge that is configured to rotationally oscillate, in the manner required by Appellants' claim 52. Because Appellants do not persuade us, therefore, that the Examiner erred in determining that Burbank describes a device having all of the features required by claim 52, we affirm the Examiner's rejection of claim 52 as anticipated by Burbank. ANTICIPATION-CLAIMS 53 AND 54 In contending that the Examiner erred in determining (see Final Act. 4) that Burbank anticipates claims 53 and 54, Appellants rely entirely on their arguments as to claim 52, discussed above. See Appeal Br. 27. As discussed above, however, we find those arguments unpersuasive. Accordingly, because Appellants do not identify, nor do we discern, error in the Examiner's determination that Burbank anticipates claims 53 and 54, we affirm the Examiner's rejection of claims 53 and 54 over Burbank. 9 Appeal2017-008293 Application 13/749,241 ANTICIPATION-CLAIM 55 In contending that the Examiner erred in determining (see Final Act. 4) that Burbank anticipates claim 55, Appellants contend that the inner cutting cannula shown in Figure 13A of Burbank fails to include the first and second distal cutting edges required by claim 55. Appeal Br. 27-28. In particular, Appellants contend, the distal end of the inner cutting cannula shown in Figure 13A of Burbank is circular, "which by plain definition has only one side." Id. at 28. As the Examiner contends, however (Ans. 5-6), and as discussed above, Figure 6A of Burbank depicts the distal end of the inner cutting member 68 as having the same beveled configuration that provides the diagonally oriented, arcuate shaped, pair of first and second cutting edges 84 and 85, shown in Appellants' Figure 19. See Burbank Fig. 6A; see also Spec. ,r 44 (explaining as to Appellants' Figure 19 that the "distal cutting section 82 has a beveled, needle-like distal tip 83 with a sharpened opposed edges 84 and 85"); Appeal Br. 8-9 (identifying cutting edges 84 and 85 as corresponding to first and second cutting edges of claim 55). Accordingly, because Appellants do not explain specifically why the Examiner erred in finding that the cutting device shown in Figure 6A of Burbank includes the first and second cutting edges required by Appellants' claim 55, we affirm the Examiner's rejection of claim 55 as anticipated by Burbank. ANTICIPATION-CLAIM 59 In contending that the Examiner erred in determining (see Final Act. 4--5) that Burbank anticipates claim 59, Appellants rely entirely on their 10 Appeal2017-008293 Application 13/749,241 arguments as to claim 55, discussed above. See Appeal Br. 29. As discussed above, however, we find those arguments unpersuasive. Accordingly, because Appellants do not identify, nor do we discern, error in the Examiner's determination that Burbank anticipates claim 59, we affirm the Examiner's rejection of claim 59 over Burbank. ANTICIPATION-CLAIM 74 In contending that the Examiner erred in determining (see Final Act. 5---6) that Burbank anticipates claim 7 4, Appellants contend, similar to their contention in relation to claim 55 discussed above, that the inner cutting cannula shown in Figure 13A of Burbank fails to include the first and second distal cutting edges required by claim 74. Appeal Br. 30. In particular, Appellants contend, the distal end of the inner cutting cannula shown in Figure 13A of Burbank is circular, "which by definition has only one side." Id. As the Examiner contends, however (Ans. 5---6), and as discussed above, Figure 6A of Burbank depicts the distal end of the inner cutting member 68 as having the same beveled configuration that provides the diagonally oriented, arcuate shaped, pair of first and second cutting edges 84 and 85, shown in Appellants' Figure 19. See Burbank Fig. 6A; see also Spec. ,r 44 ( explaining as to Appellants' Figure 19 that the "distal cutting section 82 has a beveled, needle-like distal tip 83 with a sharpened opposed edges 84 and 85"); Appeal Br. 13 (identifying cutting edges 84 and 85 as corresponding to first and second cutting edges of claim 74). In sum, because Appellants do not explain specifically why the Examiner erred in finding that the cutting device shown in Figure 6A of Burbank includes the first and second cutting edges required by Appellants' 11 Appeal2017-008293 Application 13/749,241 claim 74, we affirm the Examiner's rejection of claim 74 as anticipated by Burbank. ANTICIPATION-CLAIM 77 In contending that the Examiner erred in determining (see Final Act. 6) that Burbank anticipates claim 77, Appellants rely entirely on their arguments as to claim 52, discussed above. See Appeal Br. 31. As discussed above, however, we find those arguments unpersuasive. Accordingly, because Appellants do not identify, nor do we discern, error in the Examiner's determination that Burbank anticipates claim 77, we affirm the Examiner's rejection of claim 77 over Burbank. ANTICIPATION-CLAIM 78 In contending that the Examiner erred in determining (see Final Act. 6-7) that Burbank anticipates claim 78, Appellants contend, similar to their contention in relation to claim 52 discussed above, that the distal end of the inner cutting cannula shown in Figure 13A of Burbank is blunt and circular, and therefore would not provide the scissoring action recited in claim 78, in which the intersection point of the inner cutting member and outer longitudinal cutting member advances and retreats. Appeal Br. 31-33. As discussed above in relation to claim 52, however, Burbank states expressly that the oscillating rotational cutting action described in column 18 is for the cutting mechanism described in connection with its Figure 6 (Burbank 18:9-11), and Figure 6A of Burbank depicts the distal end of the inner cutting member 68 as having a same beveled configuration that provides a diagonally oriented, arcuate shaped, pair of cutting edges shown in Appellants' Figure 19. 12 Appeal2017-008293 Application 13/749,241 Because Burbank thus describes applying the same oscillating rotational motion to components having the same shape and relative orientations as claimed by Appellants, Appellants do not persuade us that the Examiner erred in finding that the oscillating rotational motion described in Burbank would result in the scissoring action recited in claim 78, in which the intersection point of the inner cutting member and outer longitudinal cutting member advances and retreats. We, therefore, affirm the Examiner's rejection of claim 78 as anticipated by Burbank. OBVIOUSNESS-CLAIMS 56, 57, 75, AND 76 In rejecting claims 56, 57, 75, and 76 for obviousness over Burbank, the Examiner determined that it would have been obvious to configure the distal cutting edge of Burbank's device to have a cutting angle within the ranges recited in claims 56, 57, 75, and 76. Final Act. 8. In contending that the Examiner erred in determining that claims 56, 57, 75, and 76 would have been obvious over Burbank, Appellants rely entirely on their arguments as to claim 52, discussed above. See Appeal Br. 34--35. As discussed above, however, we find those arguments unpersuasive. Accordingly, because Appellants do not identify, nor do we discern, error in the Examiner's determination that Burbank renders obvious the devices recited in claims 56, 57, 75, and 76, we affirm the Examiner's obviousness rejection of claims 56, 57, 75, and 76 over Burbank. OBVIOUSNESS-CLAIMS 58 AND 79 In rejecting claims 58 and 79 for obviousness over Burbank and Ryan, the Examiner determined that it would have been obvious in view of Ryan to configure the distal cutting edge of Burbank's device to have an outward 13 Appeal2017-008293 Application 13/749,241 flare as recited in claims 58 and 79, and to also have the beveled tip and distal slot recited in claim 79. Final Act. 9-10. In contending that the Examiner erred in determining that claims 58 and 79 would have been obvious over Burbank and Ryan, Appellants rely entirely on their arguments as to claims 52, 54, and 7 4, discussed above. See Appeal Br. 36, 40. As discussed above, however, we find those arguments unpersuasive. Accordingly, because Appellants do not identify, nor do we discern, error in the Examiner's determination that the combination of Burbank and Ryan renders obvious the device recited in claim 58, and the process recited in claim 79, we affirm the Examiner's obviousness rejection of claims 58 and 79 over Burbank and Ryan. SUMMARY For the reason discussed, we affirm each of the Examiner's rejections. TIME PERIOD 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