DETAILED ACTION
Pending Claims
Claims 9-25 are pending.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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 .
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 Rejections - 35 USC § 112, 1st paragraph (a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 9-12 and 14-25 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The instant application is a national stage application. A preliminary amendment was filed on May 30, 2023. The amendment removed the following limitation from the independent embodiment (see original claim 1) and moved it to a dependent claim (see new claim 13): “wherein the copolymer is incapable of dissolving at 1.0% (w/v) in water at 20°C and capable of dissolving at 0.1% (w/v) or more in boiling water”. As a result, the claimed invention now embraces copolymers that do not satisfy this property. However, the international application linked to the instant national stage application only supports copolymers that satisfy this property. This is a new matter rejection.
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 9, 10, 12, 14, 15, 17, 18, 20, 21, 23, and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yoshioka et al. (JP 2011-052055 A).
Regarding claims 9, 10, and 12, Yoshioka et al. disclose the following copolymer of structure (4):
PNG
media_image1.png
182
596
media_image1.png
Greyscale
(see paragraphs 0025-0026). This anticipates the modifier/copolymer set forth in claims (9, 10 & 12).
Regarding claims 14, 15, 17, 18, 20, 21, 23, and 24, Yoshioka et al. disclose: (14 & 15) a silicone hydrogel composition, comprising: the copolymer and a base composition, wherein a content of the copolymer is from 0.05 part by mass to 2 parts by mass with respect to 100 parts by mass of the base composition (paragraphs 0033 & 0049); (17 & 18) a silicone hydrogel, which is obtained by curing the silicone hydrogel composition (paragraphs 0043 & 0049); (20 & 21) an ophthalmic device, comprising the silicone hydrogel (paragraphs 0044 & 0054-0055); and (23 & 24) wherein the ophthalmic device is a soft contact lens (paragraphs 0028-0029).
Claim 9 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Iso et al. (US 2018/0244911 A1).
Claim 9 is rejected under 35 U.S.C. 102(a)(2) as being anticipated by Iso et al. (US 2018/0244911 A1).
Regarding claim 9, synthesis example 6 of Iso et al. anticipates claim (9) (see Table 1; see also paragraphs 0135 & 0138).
Claim Rejections - 35 USC § 102/103
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.
Claim 13 is rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Yoshioka et al. (JP 2011-052055 A).
Regarding claim 13, the teachings of Yoshioka et al. are as set forth above and incorporated herein. They fail to explicitly disclose that: (13) the copolymer is incapable of dissolving at 1.0% (w/v) in water at 20°C and capable of dissolving at 0.1% (w/v) or more in boiling water. However, the skilled artisan would have expected the copolymer of Yoshioka et al. to satisfy this property because the teachings of Yoshioka et al. satisfy all of the material/chemical limitations of the claimed invention. At the very least, the skilled artisan would have expected the teachings of Yoshioka et al. to obviously embrace embodiments capable of satisfying this property because the teachings of Yoshioka et al. satisfy all of the material/chemical limitations of the claimed invention.
Therefore if not anticipated by Yoshioka et al., the skilled artisan would have expected the teachings of Yoshioka et al. to obviously embrace embodiments capable of satisfying the instantly claimed property because the teachings of Yoshioka et al. satisfy all of the material/chemical limitations of the claimed invention.
Claim 13 is rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Iso et al. (US 2018/0244911 A1).
Claim 13 is rejected under 35 U.S.C. 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Iso et al. (US 2018/0244911 A1).
Regarding claim 13, the teachings of Iso et al. are as set forth above and incorporated herein. They fail to explicitly disclose that: (13) the copolymer is incapable of dissolving at 1.0% (w/v) in water at 20°C and capable of dissolving at 0.1% (w/v) or more in boiling water. However, the skilled artisan would have expected the copolymer of Iso et al. to satisfy this property because the teachings of Iso et al. satisfy all of the material/chemical limitations of the claimed invention. At the very least, the skilled artisan would have expected the teachings of Iso et al. to obviously embrace embodiments capable of satisfying this property because the teachings of Iso et al. satisfy all of the material/chemical limitations of the claimed invention.
Therefore if not anticipated by Iso et al., the skilled artisan would have expected the teachings of Iso et al. to obviously embrace embodiments capable of satisfying the instantly claimed property because the teachings of Iso et al. satisfy all of the material/chemical limitations of the claimed invention.
Claim Rejections - 35 USC § 103
Claims 10 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Iso et al. (US 2018/0244911 A1).
Regarding claims 10 and 12, the teachings of Iso et al. are as set forth above and incorporated herein. Their synthesis example 6, derived from a “MPC” A-unit and a “TRIS” B-unit (see Table 1), fails to: (10 & 12) further contain a constituent unit based on a thermally reactive monomer or a photoreactive monomer "c". However, the general teachings of Iso et al. contemplate the use of multiple A-units (see paragraphs 0033-0034). These include a “MPC” unit represented by formula (A2) and reactive monomers (A3)-(A6) (see paragraphs 0034-0057).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare the copolymer of Iso et al. with an additional thermally reactive monomer or a photoreactive monomer "c" because: (a) synthesis example 6 of Iso et al. is derived from a “MPC” A-unit and a “TRIS” B-unit; (b) the general teachings of Iso et al. contemplate the use of multiple A-units; and (c) the multiple A-units of Iso et al. include a “MPC” unit represented by formula (A2) and reactive monomers (A3)-(A6).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 9-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9-21 of copending Application No. 18/039,567 (US 2024/0010777 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claims 9, 10, 12, and 13 are anticipated by the copolymer featured in the method of copending claims 9-21.
Claim 11 is anticipated by the copolymer featured in the method of copending claims 10-18, 20, and 21.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Aside from the ODP rejection, claim 11 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 1st paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claims 16, 19, 22, and 25 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 1st paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Yoshioka et al. (JP 2011-052055 A) and Iso et al. (US 2018/0244911 A1) fail to teach or suggest the instantly claimed modifier/copolymer, wherein the monomer "c" is glycidyl methacrylate, methacryloyloxybenzophenone, or 4-(4-azidobenzoyloxymethyl)vinylbenzene.
International Search Report
The international search report cited one X-reference. The US-equivalent publication of the X-reference has been applied as prior art.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL J FEELY whose telephone number is (571)272-1086. The examiner can normally be reached Monday-Friday 8am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Randy Gulakowski can be reached at (571)272-1302. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHAEL J FEELY/Primary Examiner, Art Unit 1766
January 9, 2026