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 .
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.
Election/Restrictions
Applicant’s election without traverse of Group II; Species B in the reply filed on January 5, 2026 is acknowledged.
Claims 6-9, 13-15, 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Inventions and Species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on January 5, 2026.
Examiner’s note: Applicant attempts to point out that claims 1-5, 16 were missing from the invention groups and presumes this is a typographical error. It was not. Claim 1 is a linking claim which links the inventions of Groups I, II, III. Claims 2-5, 16 are not part of the restrictable inventions of Groups I, II, and III. Claims 2-5, 16 are drawn to other aspects/features of claim 1 and therefore get examined (absent any Species election) with the election of any of Groups I, II, or III.
Information Disclosure Statement
The information disclosure statement(s) filed on September 29, 2023 have/has been acknowledged and considered by the examiner. Initialed copies of supplied IDS(s) forms are included in this correspondence.
Drawings
The drawings are objected to because:
Figures 4A, B do not comply with CFR 1.84(l) - the character of the numbers/letters/lines of the axes, regression equations, and legend are not clean durable and dark.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1-5, 10-12, 16 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.
As to claim 1, the claim recites “predicate contact lens” which is unclear what Applicant intends by “predicate” (MPEP 2173.05(b)). Those of ordinary skill in the art generally understand a predicate contact lens to be relative to FDA consideration and/or approval1, however the metes and bounds are unclear whether such language functionally or structurally defines the contact lens. Applicant’s abstract/specification states the predicate lens can be any scleral or normal contact lens. The claim appears to include lenses irrespective of any FDA consideration/approval, thus Examiner will essentially read-out the term and consider the claim drawn to any contact lens.
Claims 2-5, 10-12, 16 are rejected as dependent upon claim 1.
As to claim 3, the claim recites “the predicate lens is a habitual contact lens” which is subjective/relative (MPEP 2173.05(b)). What habit constitutes “habitual” appears entirely subjective. For purposes of compact prosecution, Examiner will consider claim 3 redundant to the claim 1 predicate contact lens.
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 rejected under 35 U.S.C. 102(a1)/(a2) as being anticipated by Legerton et al. (US 2022/0317476 - Legerton).
As to claim 1, Legerton teaches a method for determining an offset position and a rotation angle of a wavefront-customized for a wavefront-customized contact lens (Legerton Fig. 11; Fig. 13; para. [0078]), the method comprising
placing predicate contact lens on a patient’s eye (Legerton Fig. 11 - 1102; Fig. 13 - 1302);
measuring an offset position (Legerton Fig. 11 - 1108; Fig. 13 - 1310, 1312; para. [0076]) and rotation angle (Legerton Fig. 11 - 1110; para. [0077]).
As to claim 3, Legerton teaches all the limitations of the instant invention as detailed above with respect to claim 1, and Legerton further teaches the predicate contact lens is a habitual lens used by the patient (Legerton Fig. 11 - 1102; Fig. 13 - 1302).
As to claim 4, Legerton teaches all the limitations of the instant invention as detailed above with respect to claim 1, and Legerton further teaches determining a corneal vertex location by measuring and calibrating one or more front surface Purkinje reflections from the patient’s eye (Legerton Fig. 4; para. [0055]).
As to claim 5, Legerton teaches all the limitations of the instant invention as detailed above with respect to claim 1, and Legerton further teaches both the predicate contact lens and the wavefront-customized contact lens are scleral contact lenses (Legerton para. [0064]).
Claim Rejections - 35 USC § 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.
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.
Claims 3, 16 are rejected under 35 U.S.C. 103 as being unpatentable over Legerton as applied to claim 1 above, and further in view of Kim et al. (US 2012/0188508 - Kim).
As to claim 3, Legerton teaches all the limitations of the instant invention as detailed above with respect to claim 1, and while Legerton teaches capturing the eye/contact image with a camera (Legerton Fig. 9 - 914A,B) but doesn’t specify the camera is one of aberrometer, corneal topographer, OCT, or Scheimpflug. In the same field of endeavor Kim teaches aberrometer, corneal topographer for determining contact lens fitting (Kim Fig. 6 - 10, 50; para. [0032]-[0034]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use an aberrometer or topographer since, as taught by Kim, such devices are well known in the art for the purpose of imaging the eye for contact lens fitting data (Kim para. [0002]).
As to claim 16, Legerton teaches all the limitations of the instant invention as detailed above with respect to claim 1, and while Legerton teaches capturing the eye/contact image with a camera (Legerton Fig. 9 - 914A,B) but doesn’t specify the camera is a corneal topographer combined with a wavefront aberrometer. In the same field of endeavor Kim teaches a corneal topographer combined with a wavefront aberrometer for determining contact lens fitting (Kim Fig. 6 - 10, 50; para. [0032]-[0034]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use an aberrometer or topographer since, as taught by Kim, such devices are well known in the art for the purpose of imaging the eye for contact lens fitting data (Kim para. [0002]).
Allowable Subject Matter
Claims 10-12 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd 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:
As to claims 10-12, although the prior art teaches methods for determining offset and rotation of contact lenses, the prior art taken either singularly or in combination fails to anticipate or fairly suggest the limitations of claim(s) 10, in such a manner that a rejection under 35 U.S.C. §102 or §103 would be proper, including all the numerical and structural limitations recited together in combination with the totality of particular features/limitations recited therein.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Xiao et al. (US 12,446,772); Legerton et al. (US 11,762,219); Heavyside et al. (US 10,901,238; 2018/0210230); ven der Steen et al. (US 11,576,574; 2019/0274543); Kim et al. (US 8,727,534); Svochak et al. (US 8,696,117); Anan et al. (US 5,686,981); Klyce (US 5,293,533); Ticak et al. (A Comparison of Three Methods to Increase Scleral Contact Lens On-Eye Stability)2; Wang et al. (IOL tilt and decentration estimation from 3 dimensional reconstruction of OCT image)3 are cited as additional examples of calculating offset and rotation for contact lens fitting.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARY W WILKES whose telephone number is (571)270-7540. The examiner can normally be reached M-F 8-4 (Pacific).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ricky Mack can be reached at 571-272-2333. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZACHARY W WILKES/Primary Examiner, Art Unit 2872 January 21, 2026
1 https://en.wikipedia.org/wiki/Federal_Food,_Drug,_and_Cosmetic_Act
2 Ticak A, Marsack; et al. A Comparison of Three Methods to Increase Scleral Contact Lens On-Eye Stability. Eye Contact Lens. 2015 Nov;41(6):386-90. doi: 10.1097/ICL.0000000000000145. PMID: 25943050; PMCID: PMC4630135.
3 Wang X, Dong J, Wang X, Wu Q. IOL tilt and decentration estimation from 3 dimensional reconstruction of OCT image. PLoS One. 2013;8(3):e59109. doi: 10.1371/journal.pone.0059109. Epub 2013 Mar 15. PMID: 23554982; PMCID: PMC3598664.