DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Rejections under 35 USC 112
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 5-10, 12-14 and 16-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Havenstrite (US 20150234204 A1).
Regarding claim 1, Havenstrite teaches a method of manufacturing an accommodating intraocular lens (a contact lens; abstract; P0051), the method comprising: molding an optical component having at least a central portion formed of an optically clear silicone material (the contact lens is a shaped or molded lens, and is comprised of a silicone core which is optically clear; fig 1B; P0145, P0193); molding a second component, the second component comprising a silicone material (a silicone-containing layer is applied to the surface of the lens, thereby molding to its shape; fig 1B; P0156); activating surfaces of the optical component and surfaces of the second component in a plasma chamber (the surfaces of the lens are activated to react with the surface of the hydrophilic polymer in a plasma chamber; P0224-0225); and covalently bonding together without adhesive the optical component and the second component to form a lens capsule having an internal chamber (the silicone-containing layer covalently bonds to the silicone core lens, without adhesives, and form a contact lens which is functionally a capsule having an internal lens core forming an optical chamber contained by exterior layers; fig 1B; P0174).
Regarding claim 2, Havenstrite teaches applying a vacuum pressure within the plasma chamber during the activating (the plasma chamber is a vacuum plasma chamber with a vacuum applied to the lens during the activation process; P0225).
Regarding claim 3, Havenstrite teaches the vacuum pressure is between 0.01 mbar and 1 mbar (the vacuum pressure is 200 mTorr which is ~0.26 mbar which is between 0.01 mbar and 1 mbar; P0225).
Regarding claim 5, Havenstrite teaches supplying a gas to the plasma chamber during the activating (gas is supplied to the plasma chamber during treatment; P0226).
Regarding claim 6, Havenstrite teaches the gas is Argon, atmospheric air, or oxygen (the gas used is oxygen gas; P0226).
Regarding claim 7, Havenstrite teaches the gas is supplied with or without applying vacuum pressure to the plasma chamber (the plasma chamber is a vacuum plasma chamber with a vacuum applied to the lens during the activation process; P0225).
Regarding claim 8, Havenstrite teaches the gas comprises 70%-100% oxygen (the gas is oxygen gas indicating 100% oxygen gas; P0226).
Regarding claim 9, Havenstrite teaches holding the optical component and the second component within a fixture during the covalently bonding (a holding device acts as a fixture which holds the lens having the layer thereon; P0241).
Regarding claim 10, Havenstrite teaches the fixture is designed to apply an amount of compression between the surfaces of the optical component and the surfaces of the second component (because the silicone-containing layer is applied to the surface of the lens, the holding device will inherently apply an amount of compression between the silicone-containing layer and the lens with the silicon core when holding and contacting the lens; P0241).
Regarding claim 12, Havenstrite teaches the fixture is designed to hold the optical component and the second component in contact with one another without applying compressive force on the optical component and the second component (because the silicone-containing layer is applied to the surface of the lens, the holding device will inherently apply an amount of compression between the silicone-containing layer and the lens with the silicon core when holding and contacting the lens; where the holding device is indicated not to apply a force; P0241).
Regarding claim 13, Havenstrite teaches the fixture is formed of a material that does not bond to the optical component or the second component during covalently bonding (the holding device is comprised of metal and does not bond with the lens or the silicone containing layer; P0241).
Regarding claim 14, Havenstrite teaches the fixture is a high-heat resistant material (the holding device is comprised of metal and used in a plasma chamber indicating high-heat resistance; P0225).
Regarding claim 16, Havenstrite teaches the fixture comprises a first surface contacting the optical component and a second surface contacting the second component (the metal lens holding device has first and second surfaces contacting the lens core and the hydrophilic external layer respectively; P0241, P0225).
Regarding claim 17, Havenstrite teaches the first surface and the second surface are modified to prevent bonding to optical component and the second component, respectively (the holding device is comprised of metal and does not bond with the lens or the silicone containing layer; P0241).
Regarding claim 18, Havenstrite teaches the first surface and the second surface are modified by coating or by laser texturing (when the holding device contacts the lens core, the surface will be coated with material of the silicone layer; P0241).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Havenstrite (US 20150234204 A1) as applied to claim 1, further in view of LeBoeuf (US 5882421 A).
Regarding claim 4, Havenstrite is silent to wherein a process power of the plasma chamber during the activating is between 270-300W.
LeBoeuf, in the same field of endeavor, polymer shaping, teaches a process power of the plasma chamber during the activating is between 270-300W (a plasma chamber is used to activate polymers for an intraocular lens, and operates at 300 Watts; abstract; col 4, lines 29-33). It would have been obvious at the time of the invention to have modified the invention of Havenstrite to include wherein a process power of the plasma chamber during the activating is between 270-300W for the purpose of reducing tackiness as taught by LeBoeuf (col.4, lines 37-40).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Havenstrite (US 20150234204 A1) as applied to claim 10, further in view of Beekman (US 6460399 B1).
Regarding claim 11, Havenstrite does not disclose wherein the amount of compression
is between 30-100 gf.
Beekman, in the same field of endeavor, fixing devices for compression, teaches an amount of compression is between 30-100 gf (a holding mechanism exhibits compression force of 0.5 newton, which is about 51 gf; col 7, lines 8-29).
It would have been obvious at the time of the invention to have modified the invention of Havenstrite to include wherein the amount of compression is between 30-100 gf as taught by Beekman to gain the advantages of controlled pressure for uniform pressure distribution, optimizing contact area, elimination of air bubbles, and consistent bonding results.
Further, it would have been obvious to one having ordinary skill in the art to have determined the optimum value of a cause effective variable such as compression force through routine experimentation in the absence of a showing of criticality in the claimed force. In re Woodruff, 16 USPQ2d 1934, 1936 (Fed. Cir. 1990).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Havenstrite (US 20150234204 A1) as applied to claim 13, further in view of Katz (US 20060103924 A1).
Regarding claim 15, Havenstrite is silent to a fixture being polytetrafluoroethylene (PTFE).
Katz, in the same field of endeavor, optical devices, teaches the fixture is polytetrafluoroethylene (PTFE) (a lens holder comprises PTFE; fig.12; P0082).
It would have been obvious at the time of the invention to have modified the invention of Havenstrite to include wherein the fixture is polytetrafluoroethylene "PTFE" as taught by Katz to gain the advantages of nonstick properties, chemical inertness, high temperature resistance, high biocompatibility, and high durability. Further, the selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Havenstrite (US 20150234204 A1) as applied to claim 16, further in view of Kohn (US 20110212819 A1).
Regarding claims 19-20, Havenstrite discloses holding the optical component and the second component relative to one another (the holding device holds the lens and the silicone containing layer against each other; P0241) but is silent to the first surface is on a fixture lid and the second surface is on a fixture base, wherein the fixture lid and the fixture base are configured to mate with one another and the fixture lid comprises a pin and the fixture base comprises a helical groove, wherein the pin rides within the helical groove as the fixture lid is locked with the fixture base.
Kohn, in the same field of endeavor, fixing devices, teaches a first surface is on a fixture lid and a second surface is on a fixture base, wherein the fixture lid and the fixture base are configured to mate with one another (a fixture includes a lid and a base which mate with each other via a thread 24 and pin 20; fig 1; P0017-0018), and the fixture lid comprises a pin and the fixture base comprises a helical groove, wherein the pin rides within the helical groove as the fixture lid is locked with the fixture base (the lid component comprises a thread pin 20 and the base comprises a helical shaped thread 24 where the pin 20 rides within the thread to lock the fixture together).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the fixture of Havenstrite with the mechanism of Kohn to arrive at the claimed invention for the purpose of simplifying the handling and use of the fixture as taught by Kohn (P0003-4).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERICA H FUNK whose telephone number is (571)272-3785. The examiner can normally be reached Monday-Friday 8:00-5:00pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alison Hindenlang can be reached on (571) 270-7001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERICA HARTSELL FUNK/Examiner, Art Unit 1741