Ex Parte DellDownload PDFPatent Trials and Appeals BoardMay 8, 201912515817 - (D) (P.T.A.B. May. 8, 2019) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 12/515,817 05/21/2009 Alberto A. Fernandez Dell 'Oca 76960 7590 05/08/2019 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. 10139/14002 2897 EXAMINER COLELLO, ERIN L ART UNIT PAPER NUMBER 3771 MAIL DATE DELIVERY MODE 05/08/2019 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 ALBERTO A. FERNANDEZ DELL'OCA Appeal2017-009824 Application 12/515,817 1 Technology Center 3700 Before FRANCISCO C. PRATS, ELIZABETH A. LA VIER, and RYAN H. FLAX, Administrative Patent Judges. PRATS, Administrative Patent Judge. DECISION ON APPEAL This appeal under 35 U.S.C. § 134(a) involves claims to a device for creating a tunnel through soft tissue. The Examiner rejected the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b ). We reverse. 1 Appellant states that the real party in interest is "DePuy Synthes Products, Inc. Johnson & Johnson, Inc. is the parent corporation ofDePuy Synthes Products, Inc." Appeal Br. 2. Appeal2017-009824 Application 12/515,817 STATEMENT OF THE CASE Appellant's invention "relates to orthopedics, and more particularly to a device able for dissecting soft tissues surrounding bone to create space for the minimally invasive insertion of an implant adjacent to the bone." Spec. iT 1. Appellant's claim 1, reproduced below, illustrates the appealed subject matter: 1. A device for creating a tunnel through soft tissue, compnsmg: an elongated insertion member including a lumen extending therethrough to a distal opening, the elongated insertion member being sized to be inserted into the body via an opening of no more than 35 mm diameter, the lumen including a distal lumen section extending from the distal opening to a proximal lumen section which extends to a first shoulder, the distal lumen section having a smaller diameter than the proximal lumen section, the proximal lumen section having a smaller diameter than the first shoulder; a tunneling member received in the lumen for movement between an insertion configuration in which a tissue penetrating distal tip is received within the lumen and a tunneling configuration in which the distal tip extends distally from the distal opening by a desired distance, the tunneling member configured and designed to create the tunnel that is maintained after the tunneling member is removed therefrom, the tunneling member including a distal portion having a diameter corresponding to the distal lumen section, a proximal portion having a diameter corresponding to the proximal lumen section, and a second shoulder configured to engage the first shoulder to prevent the tunneling member from extending distally beyond a predetermined distance; and a handle coupled to a proximal end of the insertion member, the handle remaining outside the body and including a 2 Appeal2017-009824 Application 12/515,817 first actuator for moving the tunneling member between the insertion and tunneling configurations. Appeal Br. 16. DISCUSSION Appellant seeks review of seven rejections for obviousness entered by the Examiner. See id. at 4. In the first obviousness rejection, the Examiner rejected claims 1-5 over Gellman2 and Smith. 3 Final Act. 2-6. 4 In rejecting claims 1-5 over Gellman and Smith, the Examiner found that Gellman taught a device having nearly all of the features required by the rejected claims. Id. at 2-3. In particular, the Examiner found, Gellman' s "elongated insertion member includes a lumen having different sections that have different diameters and that the tunneling member has different sections with different diameters that correspond to the different sections of the insertion member but fails to explicitly disclose the specific configuration claimed." Id. at 3. The Examiner cited Smith as evidence that Appellant's claimed device would have been obvious to a skilled artisan, despite the difference in configuration between Gellman' s device and Appellant's claimed device. Id. at 3--4. In particular, the Examiner cited Smith as disclosing a device with an outer elongated insertion member having a lumen, "where the lumen includes a distal lumen section extending from the distal opening to a 2 US 2005/0090706 Al (published Apr. 28, 2005). 3 US 5,515,861 (issued May 14, 1996). 4 Final Office Action ( entered Sept. 1, 2016). 3 Appeal2017-009824 Application 12/515,817 proximal lumen section which extends to a first shoulder, the distal lumen section having a smaller diameter than the proximal lumen section, the proximal lumen section having a smaller diameter than the first shoulder." Id. Based on the references' combined teachings, the Examiner reasoned that it would have been obvious to modify Gellman's device to have first and second lumens, with the distal lumen having a reduced size as compared to the proximal lumen, as recited in Appellant's claims: [I]t would have been obvious to one of ordinary skill in the art at the time the invention was made to modify portion Ref 26 of the insertion member structure of Gellman to include a channel similar to the channel (Ref 22 of Smith) in order to allow portion Ref 3 6 of the tunneling member to be constant! y surrounded by the channel (similar to the portion of the plunger/inner member of Smith between the flanges Ref 38 and 42, which constantly lies within the channel Ref 22 during forward/backward movement) such that the portion Ref 3 6 moves back and forth within the channel and therefore provides a stable structure with more stability during movement of the inner/tunneling member as suggested by Smith. Id. at 5. As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992): [T]he examiner bears the initial burden ... of presenting a primafacie case ofunpatentability .... 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 KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), although the Supreme Court emphasized "an expansive and flexible approach" when analyzing the issue of obviousness (id. at 415), the Court also reaffirmed the 4 Appeal2017-009824 Application 12/515,817 importance of determining "whether there was an apparent reason to combine the known elements in the fashion claimed by the patent at issue." Id. at 418. Thus, even under the flexible analysis outlined in KSR, "[i]n determining whether obviousness is established by combining the teachings of the prior art, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art." In re GPAC Inc., 57 F.3d 1573, 1581 (Fed. Cir. 1995) (internal quotations and citations omitted). In other words, even post-KSR, "obviousness concerns whether a skilled artisan not only could have made but would have been motivated to make the combinations or modifications of prior art to arrive at the claimed invention." Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015). In the present case, having considered all of the arguments and evidence advanced by Appellant and the Examiner, Appellant persuades us that preponderant evidence does not support the Examiner's conclusion of obviousness. In particular, Appellant persuades us (see Appeal Br. 9-10) that the Examiner has not explained sufficiently why the cited references would have motivated a skilled artisan to modify Gellman's device to have the configuration of lumens disclosed in Smith. Gellman discloses "guide member placement devices" (Gellman ,r 165) that enable a physician to deploy a guidewire in a patient, which in tum allows the physician to introduce a sling into the patient for the purpose of stabilizing the patient's urethral floor, to treat urinary incontinence (see id. ,r,r 184--195). 5 Appeal2017-009824 Application 12/515,817 Figure 2 of Gellman shows the guidewire placement device, which has a handle 10, with the handle including a tapered distal section 26, which secures the shaft that is inserted into the patient's body to the handle. See id. at Fig. 2; id. ,I 174. As noted above, the Examiner's position is that a skilled artisan would have been motivated to modify the distal tapered section 26 of the handle of Gellman' s device to have a channel as seen in Smith's device, because the modification would "provide[] a stable structure with more stability during movement of the inner/tunneling member as suggested by Smith." Final Act. 5; Ans. 6. We are not persuaded that the Examiner has identified a sufficient evidentiary basis for making the posited modification to Gellman's device. In particular, we are not persuaded that the Examiner has identified, or explained sufficiently, which teachings in the cited references suggest that providing Gellman' s device with the configuration of Smith's apparatus would have rendered Gellman's device more stable. Smith discloses a "single tissue extraction tool for extracting core tissue samples from paraffin embedded tissue and placing them into another paraffin block single-handedly." Smith 1 :42--44. Smith discloses that the tissue extraction tool is a hollow syringe-like apparatus with an outer portion and an inner plunger portion with "a distal end having a circular tapered aperture with a cutting edge." Id. at 1 :46--47. Smith explains that the tissue extraction tool "cuts the tissue sample cleanly in a circular disc shape, approximately 1 to 10 mm in diameter, depending on technician/pathologist preference. The tissue sample is 6 Appeal2017-009824 Application 12/515,817 removed from a paraffin bed by pulling the tool out of the paraffin bed." Id. at 1:56-60. After the paraffin-embedded tissue sample is extracted from the first bed of paraffin, "the tissue extraction tool with the tissue core in a tip is placed in another paraffin bed by pressing a plunger. The plunger forces the tissue core out of the tip of the tool into the [second] paraffin bed." Id. at 1:60-63. As the Examiner found, Smith's device includes a distal portion with a distal lumen that is narrower than the proximal lumen, with the plunger portion slidingly engaged in the distal lumen. See id. at Figs. 1, 4; id. at 1:47-50 ("A solid plunger has an external diameter sufficient to be disposed in sliding contact with an inner surface of the hollow cannula."). We, thus, acknowledge the teachings in Smith of a tissue sample manipulating device having a lumen configuration consistent with Appellant's claims. We are not persuaded, however, that the Examiner has identified the specific teachings in Smith, or Gellman for that matter, supporting the Examiner's finding that modifying Gellman according to Smith's teachings would make Gellman's device more stable. Absent a sufficient evidentiary basis, or reasoned technical explanation, supporting the Examiner's posited modification of Gellman, we are constrained to reverse the Examiner's rejection of claims 1-5 over Gellman and Smith. Each of the Examiner's remaining rejections relies on the combination of Gellman and Smith, discussed above, with further prior art references cited to show the obviousness of additional features recited in the rejected claims. See Final Act. 6-17. Because each of those rejections relies on the combination of Gellman and Smith, which we find deficient for the reasons 7 Appeal2017-009824 Application 12/515,817 discussed above, we are constrained to reverse the Examiner's remaining rejections as well. CONCLUSION For the reasons discussed, we reverse each of the Examiner's obviousness rejections. REVERSED 8 Copy with citationCopy as parenthetical citation