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 .
DETAILED ACTION
This action is in response to Applicant’s amendment filed July 7, 2026 in reply to the First Office Action on the Merits mailed April 29, 2026. Claims 1 and 5 have been amended; claims 3, 6, and 10 have been canceled; and claim 21 has been newly added. Claims 2, 4, 8, and 14-20 have been withdrawn. Claims 1, 5, 7, 9, 11-13, and 21 are under examination in the application.
Withdrawal of Prior Claim Rejections - 35 USC § 101
Claim 1 has been satisfactorily amended. Therefore, the 35 USC 101 rejection presented in the First Office Action on the Merits mailed April 29, 2026 is hereby withdrawn.
Withdrawal of Prior Claim Rejections - 35 USC § 112(d)
Claim 10 has been canceled; and Applicant’s argument with respect to claim 9 is accepted. Therefore, the 35 USC 112(d) rejection presented in the First Office Action on the Merits mailed April 29, 2026 is hereby withdrawn.
Withdrawal of Prior Claim Rejections - 35 USC § 103 (I and II)
Neither Zhang et al. (U.S. Patent Application Pub. No. 2010/0113901), Etzkorn et al. (U.S. Patent Application Pub. No. 2014/0088381), nor Gupta et al. (Clin Opthalmol. 2017; 11: 411-416) appear to disclose determining the intraocular pressure and/or the glaucoma biomarker concentration or change in concentration in a wearer’s eye by determining the shift in the wavelength of the light from the light source that is reflected from a contact lens in the wearer’s eye, as now stipulated in newly amended claim 1. Therefore, the 35 USC 103 rejection presented in the First Office Action on the Merits mailed April 29, 2026 is hereby withdrawn.
Obviousness-Type 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 1, 5, 7, 9, 11, and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9-12, and 14-16 of U.S. Patent No. 11,947,195.
Applicant claims a method of “using” a contact lens comprising exposing the contact lens to a light source and measuring the wavelength and intensity of the light source reflected from the contact lens; wherein the contact lens comprises a nanoporous film on an inner surface comprising human IL-12p70 antibodies “absorptive” to the glaucoma biomarker IL-12p70f, and wherein the light measured can be used to determine intraocular pressure or glaucoma biomarker concentration.
Claims 1, 9-12, and 14-16 of U.S. Patent No. 11,947,195 disclose method of “using” a contact lens comprising exposing the contact lens to a light source and measuring the wavelength and intensity of the light source reflected from the contact lens; wherein the contact lens comprises a nanoporous film on an inner surface comprising anodic aluminum oxide (AAO) and human IL-12p70 antibodies “absorptive” to the glaucoma biomarker IL-12p70f, and wherein the light measured can be used to determine intraocular pressure or glaucoma biomarker concentration.
Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims do not exclude the AAO element.
Claim Rejections - 35 USC § 112(b)
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, 7, 9, 11-13, and 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 remains indefinite because one of ordinary skill in the art cannot definitively ascertain the metes and bounds of “light”, i.e. “a light source” or “the light source”. For example, is “light” limited to the visible light spectrum, e.g. red light, or e.g. blue light? Or, rather, does “light” include visible light, infrared light, and UV light? Or, rather, does “light” include the entire EM spectrum, from radio waves to gamma rays? Or what?
Applicant contends that this issue is about breadth, and that “breadth is not indefiniteness”. However, this issue is not about breadth at all. The issue here is that there are multiple different reasonable interpretations for the term “light”. One interpretation is that “light” is strictly limited to the visible light spectrum. Another interpretation is that “light” includes the visible spectrum, as well as IR and UV, but that radio is not considered “light”, and gamma rays are not considered “light”. Another interpretation is that “light” is essentially synonymous with EM waves generally, and refers to the entire EM spectrum, from radio waves to gamma rays.
Claims 5, 7, 9, 11-13, and 21 are indefinite for depending from an indefinite claim.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID BROWE whose telephone number is (571)270-1320. The examiner can normally be reached Monday - Friday, 9:30 AM to 6 PM EST.
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/DAVID BROWE/Primary Examiner, Art Unit 1617
