Ex Parte Boukhny et alDownload PDFPatent Trial and Appeal BoardMar 7, 201711584996 (P.T.A.B. Mar. 7, 2017) Copy Citation 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. 11/584,996 10/23/2006 Mikhail Boukhny PAT903106-US-NP 6704 26356 ALCON IP LEGAL 7590 03/09/2017 EXAMINER SZPIRA, JULIE ANN 6201 SOUTH FREEWAY FORT WORTH, TX 76134 ART UNIT PAPER NUMBER 3731 NOTIFICATION DATE DELIVERY MODE 03/09/2017 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): patent, docketing @ alcon.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte MIKHAIL BOUKHNY, JAMES CHON, DAVID DOWNER, and STEVE VAN NOY1 Appeal 2015-003495 Application 11/584,996 Technology Center 3700 Before TONI R. SCHEINER, MELANIE L. McCOLLUM, and ERICA A. FRANKLIN, Administrative Patent Judges. McCOLLUM, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to an intraocular lens delivery system. The Examiner has rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. STATEMENT OF THE CASE Claims 1—29 are on appeal (App. Br. 9). Claims 1 and 8 are illustrative and read as follows: 1. An intraocular lens delivery system comprising: an injector body; a plunger slidably movable within the injector body; 1 Appellants identify the real party in interest as Novartis AG (App. Br. 2). Appeal 2015-003495 Application 11/584,996 a nozzle portion on a distal end of the injector body, the nozzle portion having a hollow interior adapted for receiving an intraocular lens; a heater integrated with the intraocular lens delivery system adapted to heat the intraocular lens while the intraocular lens is external to an eye; and an indicator on the injector body operable to be illuminated to display a visible indication to deliver the intraocular lens into the eye while the intraocular lens is external to the eye when the heater has heated the intraocular lens to a predetermined temperature range. 8. The intraocular lens delivery system of claim 1 further comprising a controller for regulating the temperature of the intraocular lens. Claims 1—7, 11—22, and 26—28 stand rejected under 35 U.S.C. § 103(a) as obvious over Van Gent (US 4,955,889, Sept. 11, 1990) in view of Callahan et al. (US 2003/0033013 Al, Feb. 13, 2003) and Flom et al. (US 4,053,953, Oct. 18, 1977) (Final Act. 2). Claims 8—10, 23—25, and 29 stand rejected under 35 U.S.C. § 103(a) as obvious over Van Gent in view of Callahan, Flom, and Ludin et al. (US 6,193,683 Bl, Feb. 27, 2001) (Final Act. 5). I In rejecting claim 1, inter alia, the Examiner relies on Van Gent for disclosing an intraocular lens (IOL) delivery system comprising: an injector body (22) and a polymer plunger (26 ... ) slidably movable within the injector body[;] ... a polymer nozzle portion (34 . . . ) on a distal end of the injector body . . . , the nozzle portion . . . having a hollow interior . . . adapted for receiving an intraocular lens . . . ; a heater . . . integrated with the intraocular lens delivery system, . . . adapted to heat the intraocular lens . . . ; [and] an indicator on the injector body operable to display a visible indication when the heater has heated the intraocular lens to a predetermined temperature range ( ... the shape change of 2 Appeal 2015-003495 Application 11/584,996 part 44 is the “indicator” since it is a visual indication of the heater heating the lens to a predetermined temperature range). (Final Act. 2—3.) The Examiner acknowledges that Van Gent “fails to disclose the heating of the lens being external to the eye and the indicator being illuminated” {id. at 3). The Examiner relies on Callahan for teaching “heating ... a lens prior to insertion of the device within the eye” {id.). The Examiner concludes that it would have been obvious “to heat the lens prior to inserting the lens into the eye to allow for the lens to deform to a small diameter configuration to minimize the delivery profile of the lens, and thus reduce the size of the corneal incision” {id. at 3 4). The Examiner relies on Flom for teaching “a visual indicator being illuminated to denote the correct positioning of an IOL” {id. at 4). The Examiner concludes: It would have been obvious to one having ordinary skill in the art at the time the invention was made to use an illuminated signal as taught by Flom et al. in combination with the IOL delivery system disclosed by Van Gent in view of Callahan et al. as using an illuminated signal would provide a reliable and less subjective way to sense if a lens was in the correct position for delivery. {Id.) Findings of Fact 1. Van Gent discloses an apparatus for inserting an intraocular lens into an eye, the apparatus including “[cjarrying element 44 . . . made of a shape memory alloy which is programmed or has a composition to release the IOL 12 at the temperature within eye” (Van Gent, col. 5,11. 54—56, col. 6,11. 59-62, & Fig. 2). 3 Appeal 2015-003495 Application 11/584,996 2. In particular, Van Gent discloses: The shape memory alloy from which carrying element 44 is made is such that at the temperature within the eye 14, the carrying chamber 44 reverts to its original shape and opens up, i.e., side flaps 46 and 48 separate, to allow IOL 12 to be separated or released from carrying element 44. A heating system 50 may optionally be included to heat carrying element 44 to a temperature equal to or greater than the transition temperature of carrying element 44. {Id. at col. 7,11. 12-20, & Figs. 1 & 4.) 3. Callahan discloses a “deformable artificial intraocular lens” (Callahan | 8). 4. Callahan also discloses: The lens 10 is warmed, or heated, prior to rolling or deforming. . . . When the lens is cooled to about room temperature, or dehydrates, the lens becomes brittle. In certain embodiments, the temperature of the lens 10 [is] reduced prior to inserting the lens 10 into an incision of the eye. When the lens 10 is re hydrated, or warmed, as it will be by the fluid present in the eye, the lens 10 will unroll by itself. (Id. 1114.) 5. In describing rolling the lens, Callahan states: “The lens 10 was just removed from a vial containing a balanced salt solution, BSS, which was heated to approximately 100 degrees F. The lens 10 must be rolled immediately after removal from the warm BSS, since the material becomes stiff when cooled or dehydrated.” {Id. 140.) 6. Flom “relates to an artificial intraocular lens for implantation in the posterior chamber of the eye to obviate aphakia, the lens including retaining means” (Flom, col. 1,11. 16—18). 4 Appeal 2015-003495 Application 11/584,996 7. Flom discloses that “[pjrotruding from the bottom of the retaining ring 320 are three posts 321 - 323, which serve to attach the retaining ring 320 to the lens 300” {id. at col. 22,11. 30-32, & Fig. 35). 8. Flom also discloses that “lens 300 and retaining ring 320 . . . are adapted to form part of an electrical circuit, the electrical circuit in turn providing an extra-ocular confirmation signal to indicate that the posts and lens are properly operatively engaged” {id. at col. 24,11. 21—26, & Fig. 36). 9. In particular, Flom discloses that, “[i]f both posts 321 and 322 are operatively engaged with the split ring 306 [of the lens], electrical contact is established between them and the electrical circuit is completed through the posts 321, 322 and split ring 306 to light light emitting diode 345” {id. at col. 24,11. 27 & 60-64, & Figs. 36 & 40). Analysis Appellants argue that the applied references fail to teach or suggest “an indicator on the injector body operable to be illuminated to display a visible indication to deliver the intraocular lens into the eye while the intraocular lens is external to the eye when the heater has heated the intraocular lens to a predetermined temperature range,” as recited in claim 1 (App. Br. 9—11 & 38). We agree. The Examiner relies on the shape change of Van Gent’s carrying element 44 to be “an indicator [that is] operable to display a visible indication when the heater has heated the intraocular lens to a predetermined temperature range” (Final Act. 3). However, as acknowledged by the Examiner, Van Gent does not disclose that this “indicator” is operable to be illuminated to display the visible indication {id.). 5 Appeal 2015-003495 Application 11/584,996 As noted by the Examiner, Callahan teaches “heating ... a lens prior to insertion of the device within the eye” (Final Act. 3; see also Findings of Fact (FF) 4—5). However, the Examiner does not rely on, nor did we find, Callahan to disclose the claimed indicator. Flom discloses an indicator that is operable to be illuminated to display a visible indication (FF 9). However, as noted by Appellants (App. Br. 10), Flom’s indicator provides “an extra-ocular confirmation signal to indicate that the posts [of the retaining ring] and [the] lens are properly operatively engaged” (FF 7—8). Flom does not disclose that the indicator displays a visible indication “when the heater has heated the intraocular lens to a predetermined temperature range” (App. Br. 10). As a result, we agree with Appellants that incorporating Flom’s indicator into the apparatus of Van Gent in view of Callahan would not result in an apparatus having the claimed indicator (id. at 10 & 12). The Examiner argues: The combination of references is simply using Flom et al. to disclose the visual indicator portion of the delivery device, rather than implanting of the whole system. Given that Van Gent in view of Callahan et al. teaches a visual indicator, the substitution of the illuminated indicator disclosed by Flom et al. is an obvious variant of a display and would be within ordinary knowledge of one skilled in the art. (Final Act. 9.) We are not persuaded. Consistent with our prior Decision in this case,2 we agree with the Examiner that Van Gent discloses a shape change, which provides a visible 2 Appeal No. 2011-005666, Decision dated August 10, 2012. 6 Appeal 2015-003495 Application 11/584,996 indication when the heater has heated the intraocular lens to a predetermined temperature (FF 1—2). However, the stated purpose of this shape change is “to allow IOL 12 to be separated or released from carrying element 44” (FF 2), not to act as an indicator. Therefore, we do not agree with the Examiner that it would have been obvious to substitute Van Gent’s shape change for Flom’s illuminated indicator. Instead, given that the Examiner has not shown that Van Gent or Flom teaches or suggests the need for a visible indication when the heater has heated the intraocular lens to a predetermined temperature range, we conclude that the Examiner has not adequately explained how the applied references teach or suggest the indicator of claim 1. Claim 14 also recites “an indicator . . . operable to be illuminated to display a visible indication to deliver the intraocular lens into the eye while the intraocular lens is external to the eye when the heater has heated the intraocular lens to a predetermined temperature range” (App. Br. 40). Therefore, for the reasons discussed above, we also conclude that the Examiner has not adequately shown how the applied references teach or suggest the indicator of claim 14. Conclusion The Examiner has not set forth a prima facie case that the combined teachings of Van Gent, Callahan, and Flom suggest the systems of claims 1 and 14. We therefore reverse the obviousness rejection of claims 1 and 14 and of claims 2—7, 11—13, 15—22, and 26—28, which directly or indirectly depend from either claim 1 or claim 14. 7 Appeal 2015-003495 Application 11/584,996 II In rejecting claim 8, inter alia, the Examiner relies on Van Gent, Callahan, and Flom as discussed above (Final Act. 5). The Examiner finds that “Van Gent strongly suggests that the temperature increase is monitored[], but fails to explicitly teach it further comprising a controller” {id.). The Examiner relies on Ludin for teaching “a power level controller (38, figure 1), an interface (32) between the heater (28) and the controller (38), wherein the interface provides feedback to the controller ... so that the controller can operate the heater to maintain the intraocular lens within a desired temperature range” {id.). The Examiner concludes that it would have been obvious “to provide the invention of Van Gent in view of Callahan and Flom et al. with a controller as taught by Ludin et al. since Ludin et al. state that such a modification would allow the user to control the power supplied to the distal end” {id. at 5—6). Analysis Claims 8—10 and 23—25 directly or indirectly depend from claims 1 or 14 (App. Br. 39 & 41). The Examiner does not rely on Ludin for teaching or suggesting the claimed indicator (Final Act. 5). Therefore, for at least the reasons discussed above, the Examiner has not set forth a prima facie case that Van Gent, Callahan, Flom, and Ludin suggest the systems of these claims. Similarly, we conclude that the Examiner had not adequately explained why the applied references suggest modifying Van Gent’s device to include a “controller [that] is adapted to . . . generate a signal to illuminate 8 Appeal 2015-003495 Application 11/584,996 [an] indicator ... in response to the temperature of the intraocular lens having been regulated such that the intraocular lens has been heated to a predetermined temperature range,” as recited in claim 29. Conclusion The Examiner has not set forth a prima facie case that the combined teachings of Van Gent, Callahan, Flom, and Ludin suggest the systems of claims 8—10, 23—25, and 29. We therefore reverse the obviousness rejection of these claims. REVERSED 9 Copy with citationCopy as parenthetical citation