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 .
The first inventor to file provisions of the Leahy-Smith America Invents Act (AIA ) apply to any application for patent, and to any patent issuing thereon, that contains or contained at any time—
(A) a claim to a claimed invention that has an effective filing date on or after March 16, 2013 wherein the effective filing date is:
(i) if subparagraph (ii) does not apply, the actual filing date of the patent or the application for the patent containing a claim to the invention; or
(ii) the filing date of the earliest application for which the patent or application is entitled, as to such invention, to a right of priority under 35 U.S.C. 119, 365(a), or 365(b) or to the benefit of an earlier filing date under 35 U.S.C. 120, 121, or 365(c); or
(B) a specific reference under 35 U.S.C. 120 , 121, or 365(c), to any patent or application that contains or contained at any time a claim as defined in paragraph (A), above.
Status of the Claims
Claim(s) 1-13 and 17-21 is/are pending. Claim(s) 3, 12-13, and 19 is/are withdrawn. Claim(s) 14-16 and 22-23 is/are canceled.
Allowable Subject Matter
Claim(s) 1-13 and 17-21 are allowable over the prior art and would be allowable if the below rejections are addressed.
The prior art lacks a composite light adjustable intraocular lens having an acrylic insert, a silicone-based light adjustable lens, haptics, an adhesion promoter, where the adhesion promoter has the formula detailed in instant claim 1, which includes a dialkylsiloxy pendant group having the noted “R6” group that is one of vinyloxy, allyl, and allyloxy.
Election/Restriction
This application contains claims directed to the following patentably distinct species.
Species of haptic attachment type
Species 1-1: attached to the acrylic intraocular insert (separate elements) (e.g. claim 2)
Species 1-2: part of the acrylic intraocular insert (integrally formed) (e.g. claim 2)
Species of optical power of the acrylic intraocular insert
Species 2-1: zero (e.g. claim 3)
Species 2-2: non-zero (e.g. claim 4)
Species of location of the adhesion promoter
Species 3-1: dispersed in the acrylic intraocular insert (e.g. claims 11, 17)
Species 3-2: dispersed in the adhesion layer between the acrylic intraocular insert and the light adjustable lens (e.g. claim 12)
Species 3-3: dispersed in the light adjustable lens (e.g. claim 13)
Species of location of ultraviolet absorbing layer
Species 4-1: at a distal surface of the light adjustable lens (e.g. claim 19)
Species 4-2: dispersed throughout the acrylic intraocular insert (e.g. claim 20)
each species within its group is of a different design than the other species within its group
The species are independent or distinct because each species within its group is of a different design than the other species within its group. Here, Species 1-1 and 1-2 are mutually exclusive designs. Species 2-1 and 2-2 are mutually exclusive designs. Species 3-1, 3-2, and 3-3 represent different designs as they are distinct locations for the adhesion promoter. Species 4-1, 4-2, and 4-3 represent different designs as they are distinct locations for the UV-absorber. In addition, these species are not obvious variants of each other based on the current record.
Applicant is required under 35 U.S.C. 121 to elect a single disclosed species, or a single grouping of patentably indistinct species, for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable. Currently, claim 1 is generic.
There is a serious search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply: The species require a different field of search (e.g. searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected species or grouping of patentably indistinct species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered nonresponsive unless accompanied by an election.
The election may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the election of species requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected species or grouping of patentably indistinct species.
Should applicant traverse on the ground that the species, or groupings of patentably indistinct species from which election is required, are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing them to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the species unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other species.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141.
During a telephone conversation with Gergely Zimanyi on 6/4/2026 a provisional election was made without traverse to prosecute the invention of Species 1-2, 2-2, 3-1, and 4-2, claims 1-2, 4-11, 17-18, and 20-21. Affirmation of this election must be made by applicant in replying to this Office action. Claims 3, 12-13, and 19 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Information Disclosure Statement
The information disclosure statement filed 1/14/2026 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because FOR citations numbers 1, 6, and 7 were not provided in English or with an English equivalent. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
All non-lined through citations were considered.
The information disclosure statement filed 1/30/2025 fails to comply with the provisions of 37 CFR 1.98(a)(4) because it lacks the appropriate size fee assertion. It has been placed in the application file, but the information referred to therein has not been considered as to the merits.
With respect to size fees, the Examiner notes the 7/3/2024 IDS includes 49 citations and the 8/20/2024 and 12/19/2024 IDSs include 3 additional citations for a total of 52 citations prior to the start of the size fees. Thus, no size fee will be needed until Applicant files an IDS that results in the cumulative number of citations being 100 or more (or 200 or more).
Product By Process
The Examiner recognizes claims 8, 10, and 21 as a "product-by-process" claims. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (see MPEP 2113).
As a product claim, Examiner has determined claims 8, 10, and 21 require the composite light adjustable lens to comprise the following structural elements in addition to those in the claims from which they depend:
Claim 8: the silicone-based light adjustable lens comprising: a first polymer matrix; and a refraction modulating composition, dispersed in the first polymer matrix
Claim 10: the light adjustable lens comprising: a photoinitiator
Claim 21: the acrylic intraocular insert of claim 1.
Each process in claim 21 is a product-by-process process.
In the prior art rejection in this Office action, Examiner considers claims 8, 10, and 21 to be met when a reference teaches these structural limitations.
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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. 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 USPTO internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application will determine 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1 and 4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 19 of copending Application No. 19/387,189. Although the claims at issue are not identical, they are not patentably distinct from each other because the prior claims contain the limitations claimed by the current Application as indicated in the noted claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-2, 4-11, 17-18, and 18-21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1’s chemical formula is obscured by another chemical formula. The latter is shown here in the box.
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Claim 1 Formula (as shown)
It appears that Applicant has amended former claim 14 (see 5/15/2024 claim set) into claim 1 and the pendant group image has been overlayed on the overall formula image.
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Prior claim 14 Main Formula (see 5/15/2024 claim set)
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Prior claim 14 Pendant Group (see 5/15/2024 claim set)
Therefore, for purposes of examination the Examiner considers the formula of claim 1 to be met when the main formula and pendant group formula is as previously found in claim 14 (5/15/2024 claim set).
Claim 1 recites “such as (-CH2)n, where n=1 through 10”. It is unclear if this limitation is required or not because of the “such as” language, which makes the following limitation optional.
Claim 18 recites the limitation "the silicon-carbon covalent bonds". There is insufficient antecedent basis for this limitation in the claim. For purposes of examination the Examiner notes this language is being interpreted as “silicon-carbon covalent bonds”.
Claim(s) 2, 4-11, 17, and 20-21 are rejected as dependent from a rejected claim.
Relevant Prior Art
US 2010/0211170 to Liao teaches an intraocular lens of an acrylate polymer and a vinyldialkylsiloxy pendant group (e.g. abstract, [0103]). Liao lacks a pendant group where the claimed R6 group is one of vinyloxy, allyl, and allyloxy.
US 6,013,855 to McPherson, et al teaches methacryloxypropyltris(vinyldimethylsiloxy)silane is used as an adhesive (coupling agent) (e.g. column 8, line 53 to column 9, line 36) in implantable devices (e.g. column 5, lines 15-22).
US 2014/0358226 A1 to Cohen teaches a composite light adjustable intraocular lens having an acrylic lens and a silicone light adjustable lens attached to the acrylic lens (e.g. abstract, [0036], [0037]).
US 2016/0339657 A1 to Grubbs teaches a light adjustable lens having haptics (e.g. Figure 4A) and the silicone light adjustable lens having an ultraviolet absorbing layer at a distal surface of the silicone light adjustable lens (e.g. [0054], light-adjustable lens has UV absorber layer #310; [0049]-[0050], the light adjustable lens is silicon; [0054] at the posterior surface).
US 4,666,640 to Neefe teaches acrylic materials for lenses (e.g. column 3, lines 29-52).
US 6,450,642 B1 to Jethmalani, et al teaches silicone materials for lenses (e.g. column 5, lines 5-17).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LESLIE A LOPEZ whose telephone number is (571)270-7044. The examiner can normally be reached 8:30 AM - 5:30 PM, MST.
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, THOMAS BARRETT can be reached at (571)272-4746. 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.
/LESLIE A LOPEZ/Primary Examiner, Art Unit 3774 6/12/2026
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