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 .
Election/Restrictions
Claims 12-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3/11/2026.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1-3,5,7 and 11 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Altman (WO 2017/040849).
Altman discloses glucose sensors, comprising a first layer of crosslinked hemoglobin-albumin (meeting heme-protein of claim 7 and antioxidants of claim 5), glucose oxidase and an oxygen detecting dye configured to reversibly bind oxygen and emit light when oxygen is bound (meeting chromogenic chromophore). See entire disclosure, especially abstract, [0572]-[0580] and claims, especially claim 60. Regarding claim 3, the sensor includes a HEMA polymer, EDGMA crosslinking agent and UV initiator. See [0544],[0567] and claims 130 and 139. Regarding claim 11, the nanosensor is a nanogel provided as an emulsion. See [0472] and [0545].
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(s) 1-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over March et al. (US 2002/0007113) in view of Puge et al. (US 2017/0299892) in view of Chauhan et al. (US 2020/0156336).
March teaches an ocular analyte sensor for detecting glucose, the lens including a receptor moiety of glycose oxidase and detectable moiety including cyanine dyes (meeting chromophore of claim 5). See entire disclosure, including abstract and claims, especially 1,3-5 and 16.
March is silent with respect to use of a heme-protein and the specific crosslinked polymer components recited in claim 3-4 and antioxidants of claim 5.
Puge is used primarily for its disclosure within on the use of hemoglobin as an absorptive material in contact lenses to enhance oxygen in tear fluid was well known in the art before the time of the claimed invention. See entire disclosure, especially abstract and claims 1,7-8. Puge teaches that a contact lens located on the eye can decrease the levels of oxygen in the fluid of the eye. See [0002] and [0008]. Since March and Pugh are both generally related in their teachings of contact lenses one of ordinary skill in the art would have a high expectation of success in adding hemoglobin to the lens of March. Reason to make such a substitution would be to provide enhanced levels of oxygen to tear fluid under the eye.
Chauhan is used primarily for the disclosure within that contact lenses produced from HEMA, EGDMA crosslinker, TPO initiator (meeting claims 3-4) vitamin E used as a diffusion layer (reading on α-tocopherol antioxidant of claim 5) and carotene colorant solubilized in a micro-emulsion or liposome (meeting emulsifier recited in claim 12) were well known to be used in contact lenses before the time of the claimed invention. See entire disclosure, especially abstract,[0041],[0046],[0135]-[0136],[0152] and claims 1,9-14. The contact lenses were pigmented by colorant and provided selective light blocking of harmful UV rays. See Fig 1a-d,[0002]-[0009]. Regarding claim 6, the amount of vitamin E was from 5 to 40 wt% in the lens, the data point of 5 is within the claimed range. See [0046]. Regarding the amounts of initiator, monomer and crosslinker in claim 4, Chauhan while exemplifying use of these three components appears silent on the exact amounts claimed. However, Chauhan teaches that increasing the amount of photo initiator increases polymerization and when more than 1% was used a turbid HEMA monomer mixture with a loss of more than 50% transmission, rendering it less desirable as a UV blocking lens [0152]. One of ordinary skill would understand that increasing the amount of EGDMA increases the degree of crosslinking. Therefore, the preparation of crosslinked polymer hydrogel lens having variable amount of initiator, monomer and crosslinker is within the level of skill of one having ordinary skill in the art at the time of the invention to produce a lens with the desired properties. It has also been held that the mere selection of proportions and ranges is not patentable absent a showing of criticality. See In re Russell, 439 F.2d 1228 169 USPQ 426 (CCPA 1971). Since the references are generally related in their teachings on contact lenses one of ordinary skill in the art would have a high expectation of success in substituting the contact lens materials of Chauhan (HEMA, EGDMA, TPO), colorants (carotene) and diffusion barrier (vitamin E) with a high expectation of success. Reason to make such a modification would be to provide light protection over certain damaging wavelengths to the contact lens of March.
Thus the claimed invention would have been prima facie obvious since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES W ROGERS whose telephone number is (571)272-7838. The examiner can normally be reached 9:30-6:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAMES W ROGERS/Primary Examiner, Art Unit 1618
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