14690791 - (D) (P.T.A.B. Aug. 3, 2020)

Ala Moradian et al.

Patent Trials and Appeals BoardAug 3, 2020

14690791 - (D) (P.T.A.B. Aug. 3, 2020)

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. 14/690,791 04/20/2015 Ala Moradian P05273 (6639-000262-US) 1091 23702 7590 08/03/2020 Bausch & Lomb Incorporated 1400 North Goodman Street Rochester, NY 14609 EXAMINER LAUER, CHRISTINA C ART UNIT PAPER NUMBER 3771 NOTIFICATION DATE DELIVERY MODE 08/03/2020 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): patents@bausch.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte ALA MORADIAN, BRIAN D. MCCARY, TOH SENG GOH, and MATTHEW J. FITZGERALD ____________ Appeal 2019-000434 Application 14/690,791 Technology Center 3700 ____________ Before CHARLES N. GREENHUT, BENJAMIN D. M. WOOD, and BRANDON J. WARNER, Administrative Patent Judges. WARNER, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 1, 2, 4–6, and 10, which are all the pending claims. Appeal Br. 2. We have jurisdiction over the appeal under 35 U.S.C. § 6(b). We REVERSE. 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 Bausch & Lomb Incorporated. Appeal Br. 2. Appeal 2019-000434 Application 14/690,791 2 CLAIMED SUBJECT MATTER Appellant’s disclosed invention “relates to ultrasonic needles used in surgery, particularly ophthalmic surgery,” and more specifically “relates to ultrasonic needles formed of non-metal materials or a combination of materials.” Spec. ¶ 1. Claim 1, reproduced below with emphasis added, is the sole independent claim and is representative of the subject matter on appeal. 1. A phacoemulsification needle comprising: a hub for connection to an ultrasonic handpiece; an elongated shaft formed with the hub and extending from the hub wherein a distal end of the shaft breaks-up tissue when the distal end is caused to be vibrated by the handpiece; and wherein the hub and the shaft are formed of a material having a density of less than 2000 kg/m3. EVIDENCE The Examiner relies on the following evidence in rejecting the claims on appeal: Worst US 2003/0139809 A1 July 24, 2003 Mouser US 2006/0094627 A1 May 4, 2006 Gilkey US 2009/0312775 A1 Dec. 17, 2009 Gomez US 2010/0036388 A1 Feb. 11, 2010 Moore US 2010/0160852 A1 June 24, 2010 Clayton US 2016/0302816 A1 Oct. 20, 2016 Wernz EP 2 011 458 A1 Jan. 7, 2009 Appeal 2019-000434 Application 14/690,791 3 REJECTIONS The following rejections are before us for review: I. Claims 1, 5, and 6 stand rejected under 35 U.S.C. § 103 as being unpatentable over Moore, Gilkey, and Mouser. Non- Final Act. 4–5. II. Claim 2 stands rejected under 35 U.S.C. § 103 as being unpatentable over Moore, Gilkey, Mouser, and Worst. Id. at 5–6. III. Claim 4 stands rejected under 35 U.S.C. § 103 as being unpatentable over Moore, Gilkey, Mouser, and Wernz. Id. at 6. IV. Claim 10 stands rejected under 35 U.S.C. § 103 as being unpatentable over Moore, Gilkey, Mouser, and Gomez. Id. at 7–8. V. Claims 1 and 5 stand rejected under 35 U.S.C. § 103 as being unpatentable over Moore and Clayton. Id. at 8–9. VI. Claim 2 stands rejected under 35 U.S.C. § 103 as being unpatentable over Moore, Clayton, and Worst. Id. at 9. VII. Claim 4 stands rejected under 35 U.S.C. § 103 as being unpatentable over Moore, Clayton, and Wernz. Id. at 9–10. VIII. Claim 6 stands rejected under 35 U.S.C. § 103 as being unpatentable over Moore, Clayton, Gilkey, and Mouser. Id. at 10–11. IX. Claim 10 stands rejected under 35 U.S.C. § 103 as being unpatentable over Moore, Clayton, and Gomez. Id. at 11–12. Appeal 2019-000434 Application 14/690,791 4 ANALYSIS Rejections I–IV – Based on Moore, Gilkey, and Mouser Appellant’s claims relate to phacoemulsification (or “phaco”) needles used in ultrasonic ophthalmic surgery by vibrating the needle in the eye tissue. Spec. ¶¶ 18–20. Independent claim 1 recites, in relevant part, a phacoemulsification needle comprising a hub (to connect to an ultrasonic handpiece) and shaft both “formed of a material having a density of less than 2000 kg/m3.” Appeal Br., Claims App. Appellant’s disclosure indicates this material may be polyether ether ketone (“PEEK”) or some other plastic. See Spec. ¶¶ 57, 83. In Rejections I–IV, the Examiner determines that the cited art establishes a known equivalence between titanium and PEEK as suitable materials for a hub and a shaft of a phaco needle. In particular, in each of these rejections, the Examiner concludes that the combination of Moore, Gilkey, and Mouser renders obvious the decision to form the phaco needle out of PEEK rather than some other known material, such as titanium. The Examiner relies on Moore for its disclosure that it is possible for phaco needles to be made of materials other than metal. Non-Final Act. 4. Recognizing that Moore fails to teach any density limitation for the phaco needle material, the Examiner turns to Gilkey’s disclosure of an endoscopic suturing needle formed from PEEK. Id. at 5. The Examiner then looks to Mouser, a cleaning tank with ultrasonic transducers formed from PEEK, for the position that PEEK may be ultrasonically vibrated. Id. Appellant persuasively argues, however, that cited prior art does not disclose a phacoemulsification needle formed of a material having a density of less than 2000 kg/m3 or explain how the cited art could be combined to Appeal 2019-000434 Application 14/690,791 5 form a phaco needle as claimed. Appellant asserts that “[c]laiming a phaco needle necessarily requires the material forming the needle to be appropriate for ultrasonically contacting solid, even hard tissue,” as is done during phacoemulsification. Reply Br. 2. We agree. Turning to the art cited by the Examiner, we observe that Appellant’s disclosure states that, although some prior disclosures have speculated that phaco needles could be formed from non-metal materials, “[i]n practice, non-metal phaco needles essentially do not exist.” Spec. ¶ 4. Our review of the record before us reveals that Moore falls into this category of art—that is, it speculates that phaco needles may be made of some material other than titanium, but it gives “no specificity or guidance regarding material selection criteria” to withstand ultrasonic vibration and contact with solid tissue. Id.; see also Moore ¶ 17. And while Gilkey and Mouser disclose that PEEK may be used as a material for items other than phaco needles, neither teach that PEEK could be used to ultrasonically vibrate and emulsify solid tissue. In particular, Gilkey discloses a different kind of needle made of PEEK; Gilkey’s needle does not undergo vibration, let alone the ultrasonic vibration Appellant describes during phacoemulsification. And Mouser’s ultrasonic transducers formed of PEEK only contact and vibrate fluids, not solid tissues like the phaco needle that Appellant claims. In short, we agree with Appellant that the art cited by the Examiner fails to teach that PEEK—or some other material having a density of less than 2000 kg/m3—would be an acceptable material for a phaco needle as claimed. Rejections based on obviousness must rest on a factual basis; in making such a rejection, the Examiner has the initial burden of supplying the Appeal 2019-000434 Application 14/690,791 6 requisite factual basis and may not, because of doubts that the invention is patentable, resort to speculation, unfounded assumptions, or hindsight reconstruction to supply deficiencies in the factual basis. See In re Warner, 379 F.2d 1011, 1017 (CCPA 1967). Because of the deficiencies in the factual findings relied on by the Examiner in making Rejections I–IV, we do not sustain them. Rejections V–IX – Based on Moore and Clayton (Optimization) As previously observed above, independent claim 1 recites, in relevant part, a phacoemulsification needle comprising a hub and shaft both “formed of a material having a density of less than 2000 kg/m3.” Appeal Br., Claims App. In Rejections V–IX, the Examiner relies on a combination of Moore, discussed above, and Clayton, which indicates a high stiffness-to-density ratio as a characteristic of a titanium needle. Based on this teaching in Clayton, the Examiner concludes that, because PEEK has a lower density than titanium, “it would have been obvious . . . to use a material with the claimed density, for the purpose of the needle having a high stiffness to density ratio.” Non-Final Act. 8. Building on Rejections I–IV discussed previously, Examiner further notes that “where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art.” Id. at 9 (citing In re Aller, 220 F.2d 454, 456 (CCPA 1955)). We note, as a preliminary matter, that we have reversed the Examiner’s Rejections I–IV due to the deficiencies in the prior art cited, including the Examiner’s reliance on Moore to show alternative, non-metal Appeal 2019-000434 Application 14/690,791 7 materials for phaco needles. Thus, a condition precedent to a discussion of optimization—whether the prior art discloses the general condition claimed—is not present here. The Examiner’s rejections relying on this optimization analysis are deficient for this reason, and we do not sustain them. We reverse Rejections V–IX for another reason as well. Appellant persuasively argues that, although Clayton discloses a high stiffness-to- density ratio as a characteristic of a titanium needle, and although Appellants claim a phaco needle with a hub and shaft of a lower density than titanium, “it does not necessarily follow that a low density material will have a high stiffness to density ratio.” Appeal Br. 6. In fact, Appellant’s claimed invention “teaches the desirability to minimize both stiffness and density, essentially teaching away from Clayton.” Id.; see Spec. ¶¶ 40–41. We agree with Appellant that the combination of Moore and Clayton fails to teach the specific condition Appellant claims—a phaco needle with a hub and shaft both “formed of a material having a density of less than 2000 kg/m3.” Because Rejections V–IX all include this error, we do not sustain them. DECISION We REVERSE the Examiner’s rejections of claims 1, 2, 4–6, and 10. Appeal 2019-000434 Application 14/690,791 8 CONCLUSION In summary: Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 5, 6 103 Moore, Gilkey, Mouser 1, 5, 6 2 103 Moore, Gilkey, Mouser, Worst 2 4 103 Moore, Gilkey, Mouser, Wernz 4 10 103 Moore, Gilkey, Mouser, Gomez 10 1, 5 103 Moore, Clayton 1, 5 2 103 Moore, Clayton, Worst 2 4 103 Moore, Clayton, Wernz 4 6 103 Moore, Clayton, Gilkey, Mouser 6 10 103 Moore, Clayton, Gomez 10 Overall Outcome 1, 2, 4–6, 10 REVERSED