Novartis AG

Patent Trials and Appeals BoardApr 14, 2021

2020005590 (P.T.A.B. Apr. 14, 2021)

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. 15/073,878 03/18/2016 Alireza Mirsepassi PAT056570-US-NP 9551 26356 7590 04/14/2021 ALCON INC. C/O ALCON RESEARCH LLC IP LEGAL 6201 SOUTH FREEWAY FORT WORTH, TX 76134 EXAMINER LAWSON, MATTHEW JAMES ART UNIT PAPER NUMBER 3775 NOTIFICATION DATE DELIVERY MODE 04/14/2021 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): alcon_pair@firsttofile.com patent.docketing@alcon.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte ALIREZA MIRSEPASSI, MICHAEL JAMES PAPAC, BARRY L. WHEATLEY, and CHENGUANG DIAO ____________ Appeal 2020-005590 Application 15/073,8781 Technology Center 3700 ____________ Before JAMES P. CALVE, CYNTHIA L. MURPHY, and BRUCE T. WIEDER, Administrative Patent Judges. WIEDER, Administrative Patent Judge. DECISION ON APPEAL This is a decision on appeal under 35 U.S.C. § 134 from the Examiner’s final rejection of claims 1–20. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real parties in interest as Novartis AG and Alcon Inc. (Appeal Br. 2.) Appeal 2020-005590 Application 15/073,878 2 CLAIMED SUBJECT MATTER Appellant’s invention relates to an illuminated ophthalmic cannula. (Spec., Title.) Claim 1 is the sole independent claim on appeal. It recites (emphasis added): 1. An ophthalmic cannula assembly comprising: a cannula including an outer cannula surface and an inner cylindrical bore that defines a longitudinal axis and an inner radius, the cannula defining a cannula length measured parallel to the longitudinal axis; a hub adjoining a proximal end of the cannula, the cannula and hub configured to be received onto a trocar piercing device to be inserted into an eye and further configured to hold an incision, created by the trocar piercing device during the insertion process, open during an ophthalmic procedure to allow repeated removal and insertion of instruments through the incision; an optical fiber attached to the outer cannula surface for at least a portion of the cannula length; a cover material that covers at least a portion of the optical fiber and that is in contact with the outer cannula surface; and a light diffuser at a distal tip of the optical fiber. REJECTIONS Claims 1, 4–7, 9, 10, 15, 18, and 20 are rejected under 35 U.S.C. § 103 as unpatentable in view of Bhadri (US 2011/0282160 A1, pub. Nov. 17, 2011) and Ryan, Jr. (US 5,916,149, iss. June 29, 1999). Claims 2, 3, 11, 12, 14, 16, and 17 are rejected under 35 U.S.C. § 103 as unpatentable in view of Bhadri, Ryan, Jr., and Auld (US 2013/0079598 A1, pub. Mar. 28, 2013). Appeal 2020-005590 Application 15/073,878 3 Claims 8 and 13 are rejected under 35 U.S.C. § 103 as unpatentable in view of Bhadri, Ryan, Jr., and Yeik (US 7,492,987 B2, iss. Feb. 17, 2009). Claim 19 is rejected under 35 U.S.C. § 103 as unpatentable in view of Bhadri, Ryan, Jr., and Schaller (US 2012/0035425 A1, pub. Feb. 9, 2012). Claim 20 is rejected under 35 U.S.C. § 103 as unpatentable in view of Bhadri, Ryan, Jr., and Vayser (US 2013/0267786 A1, pub. Oct. 10, 2013). ANALYSIS Obviousness is a legal conclusion involving a determination of underlying facts. Under § 103, the scope and content of the prior art are to be determined; differences between the prior art and the claims at issue are to be ascertained; and the level of ordinary skill in the pertinent art resolved. Against this background, the obviousness or nonobviousness of the subject matter is determined. Such secondary considerations as commercial success, long felt but unsolved needs, failure of others, etc., might be utilized to give light to the circumstances surrounding the origin of the subject matter sought to be patented. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007) (quoting Graham v. John Deere Co. of Kansas City, 383 U.S. 1, 17–18 (1966)). “[R]ejections on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.” Id. at 418 (brackets in original) (quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)). With regard to the scope and content of the prior art, the Examiner finds that Bhadri discloses an ophthalmic cannula assembly (Final Action 3), but Appeal 2020-005590 Application 15/073,878 4 fail[s] to expressly teach or disclose an optical fiber attached to the outer cannula surface for at least a portion of the cannula length, a cover material that covers at least a portion of the optical fiber and that is in contact with the outer cannula surface; and a light diffuser at a distal tip of the optical fiber. (Id. at 4.) The Examiner finds that Ryan, Jr. discloses an ophthalmic cannula assembly including an outer cannula surface and an inner cylindrical bore. The Examiner finds that Ryan, Jr. also discloses an optical fiber (21) attached to the outer cannula surface for at least a portion of the cannula length . . . ; a cover material (47 + 71) that covers at least a portion of the optical fiber and that is in contact with the outer cannula surface; and a light diffuser (31) at a distal tip of the optical fiber. The optical fiber, cover material and light diffuser working in concert to achieve an illumination filed [sic] that is broad in the area in which it illuminates and prevent light from impinging upon the light source and target area [sic, from impinging upon a predetermined area] (see Abstract). (Id. at 4–5.) The Examiner also determines that “positioning the optical fiber on the outer surface of the cannula as taught by Ryan would not defeat the purpose or intent of Bhadri. Both devices are constructed such that the illumination source is integral with the cannula.” (Answer 4.) Thus, the Examiner determines that it would have been obvious to one of ordinary skill in the art at the time of filing to have constructed the ophthalmic cannula assembly of Bhadri et al. to include the optical fiber, cover material and light diffuser of Ryan, Jr. as the element [sic] provide a targeted illumination filed [sic] and avoid impinging light onto the targeted field. (Final Action 5.) Appellant argues that “there is no motivation in the Bhadri and Ryan references to combine Bhadri and Ryan in the way suggested by the Appeal 2020-005590 Application 15/073,878 5 Examiner. Applicant respectfully notes Bhadri teaches illumination sources that are internal to the cannula. Bhadri emphasizes his solution is ‘self- contained’ throughout the Bhadri specification (e.g., see Bhadri, [0049]).” (Appeal Br. 5.) Specifically, Appellant argues that “[s]ince the Bhadri illumination source is internal, Bhadri is able to send light directly down the interior of the cannula shaft” and that “[t]here would be no reason for a person skilled in the art reviewing the Bhadri reference to seek out ways to mount an optical fiber to the outside of the Bhadri cannula.” (Id.) Appellant also quotes from the disclosure in Bhadri that “[t]he light source 108 contained in the infusion cannula system 100 provides certain benefits over currently available fiber optic systems, such as not being tethered to a separate light source to generate the light directed down the fiber optic. Thus, the light source 108 allows for a self-contained system.” (Id. (quoting Bhadri ¶ 53).) Appellant argues that one “skilled in the art tasked with combining Bhadri and Ryan (without the benefit of Applicant’s Specification) would try to make the illumination source internal to the Ryan device.” (Id. at 6.) Bhadri discloses a cannula having a housing, a first and second lumen, and a light emitting diode “positionable within the housing and configured to direct light through the second lumen to the surgical sight.” (Bhadri, Abstract.) Bhadri explains that [c]hallenges of known infusion and/or fiber-optic light cannulas include obtaining sufficient illumination of the inside of the eyeball at the surgical site . . . [and] the heat emitted from the light source of fiber-optic systems, the short operating life of the light sources, and the fragility of the fiber optics of such systems. Appeal 2020-005590 Application 15/073,878 6 (Id. ¶ 48.) As noted above, Bhadri discloses that containing the light source in the cannula system “provides certain benefits over currently available fiber optic systems, such as not being tethered to a separate light source to generate the light directed down the fiber optic.” (Id. ¶ 53.)2 Ryan, Jr. discloses an illumination and surgical device for ophthalmic surgery and the like includes an optical fiber having a proximal end and a distal end and a connector disposed at the proximal end of the optical fiber. The connector is adapted for connection to a source of illumination and for holding the proximal end of the optical fiber in position to accept light from the illumination source. A handpiece is disposed generally at the distal end of the optical fiber and has a handpiece body and a surgical tool extending distally from the handpiece body. The optical fiber extends generally through the handpiece. . . . A structure is disposed at the distal end of the optical fiber for dispersing light passing from the illumination source through the cable to broaden the area on which the light impinges. (Ryan, Jr. col. 2, ll. 28–54 (emphasis added).) Ryan, Jr. discloses an embodiment with surgical scissors including an elongated support shaft with a handle mounted on the proximal end of the shaft and the scissor blades on the distal end of the shaft. (Id., at col. 5, ll. 53–57.) A fiber cannula is secured to the support shaft to hold the optical fiber in position adjacent to the scissor blades to allow light to be delivered to the blades. (Id. at col. 5, ll. 62–65; see also id. Fig. 6B.) 2 Although not addressed by either Appellant or the Examiner, we note that Bhadri discloses that “[i]n some embodiments a fiber optic light source can be provided to augment the LED 108.” (Bhadri ¶ 83.) But Bhadri does not explain the physical relation between Bhadri’s cannula system and the fiber optic light source. We decline to address its potential relevance in the first instance. Appeal 2020-005590 Application 15/073,878 7 In short, both Bhadri and Ryan, Jr. disclose providing illumination to a surgical area via a surgical device. However, we disagree with the Examiner that both the Bhadri and Ryan, Jr. “devices are constructed such that the illumination source is integral with the cannula.” (Answer 4.) Ryan, Jr. discloses that the optical fiber “dispers[es] light passing from an illumination source through the cable.” (Ryan, Jr., Abstract.) Ryan, Jr. also discloses that “the optical fiber cable 17 terminates proximally in illumination connector 15 in such a manner that it is exposed to illuminating light from the light source.” (Id. at col. 3, ll. 49–52.) In other words, the light/illumination source that connects to the illumination connector is not integral with the cannula. We agree with the Examiner that Ryan Jr.’s “optical fiber, cover material and light diffuser work[] in concert to achieve an illumination filed [sic].” (Final Action 5.) But the Examiner does not sufficiently explain why one of ordinary skill in the art would have modified Bhadri’s self-contained illuminated cannula by including the optical fiber, cover material, and diffuser of Ryan (and its associated illumination connector and external light source). Moreover, it is unclear if the Examiner’ proposed modification of Bhadri adds the external light source and optical fiber of Ryan to Bhadri, or substitutes the external light source and optical fiber of Ryan for Bhadri’s self-contained light source. (See Ryan, Jr. at col. 3, ll. 32–34; see also Bhadri, Title (“Self Contained Illuminated Infusion Cannula Systems and Methods and Devices” (emphasis added)).) Therefore, we reverse the rejection of claim 1. For the same reason, we reverse the rejection of claims 4–6, 7, 9, 10, 15, 18, and 20. The additional art cited in the rejections of dependent claims 2, 3, 8, 11–14, 16, Appeal 2020-005590 Application 15/073,878 8 17, 19, and 203 does not remedy the above noted deficiency. Therefore, we also reverse these rejections of claims 2, 3, 8, 11–14, 16, 17, 19, and 20. CONCLUSION The Examiner’s rejections of claims 1–20 under 35 U.S.C. § 103 are reversed. Specifically: Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 4–7, 9, 10, 15, 18, 20 103 Bhadri, Ryan, Jr. 1, 4–7, 9, 10, 15, 18, 20 2, 3, 11, 12, 14, 16, 17 103 Bhadri, Ryan, Jr., Auld 2, 3, 11, 12, 14, 16, 17 8, 13 103 Bhadri, Ryan, Jr., Yeik 8, 13 19 103 Bhadri, Ryan, Jr., Schaller 19 3 Claim 20 depends from claim 1 and recites “wherein an outer periphery of the hub includes at least two gripping flats.” The Examiner rejects claim 20 in view of Bhadri and Ryan, Jr. and finds that “Bhadri, et al. disclose that an outer periphery if [sic] the hub includes at least two gripping surfaces (considered the top and bottom surface of the hub).” (Final Action 8.) The Examiner also rejects claim 20 in view of Bhadri, Ryan, Jr. and Vayser and finds that “Bhadri et al. in view of Ryan, Jr. discloses the claimed invention except for an outer periphery of the hub includes at least two gripping flats. Vayser et al. disclose that an outer periphery of a hub includes at least two gripping flats (¶70).” (Final Action 16–17.) In view of our decision, we need not resolve these apparently conflicting findings. Appeal 2020-005590 Application 15/073,878 9 Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 20 103 Bhadri, Ryan, Jr., Vayser 20 Overall Outcome 1–20 REVERSED