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 papers filed January 29, 2026. Applicant’s reply to the restriction/election requirement of December 18, 2025 has been entered. Claim 14 has been amended. Claims 1-20 are pending in the application.
Priority
Applicant’s claim for the benefit as a continuation of prior-filed U.S. Patent Application No. 17/051,665, filed October 29, 2020, which claims the benefit of prior-filed WIPO International Application No. PCT/US2018/061915, filed November 20, 2018 under 35 U.S.C. 365(c), which claims the benefit of prior-filed U.S. Provisional Patent Application No. 62/743,779, filed October 10, 2018 under 35 U.S.C. 119(e), is hereby acknowledged.
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-13, is acknowledged. Applicant’s elections of i) “change in glaucoma biomarker concentration” as the species of parameter determined by measuring the wavelength and intensity of reflected light, ii) “comprises nanopores” as the species of nanopore status on the biomarker-sensing region, iii) “present” as the species of metal film status, iv) “inner surface” as the species of location of the nanopores comprising the drug, and v) “open ends” as the species of status of the ends of the nanopores are all also acknowledged. The Examiner has determined that claims 1, 5-7, and 9-13 read on the elected subject matter.
The traversal is on the following grounds:
1. “restriction requirements are optional”
2. there is not “an undue burden on the Examiner”, and
3. “Applicant should not be required to incur the additional costs associated with the filing of multiple divisional applications”.
These grounds for traversal are not found persuasive for the following reasons:
1. A restriction requirement has been imposed on this application and remains in effect.
2. There is an undue burden because the identified groups are directed to independent and distinct inventions, and these groups of inventions have acquired a separate status in the art in view of their different classification.
3. The cost of a divisional application is not the proper standard for determining whether any particular restriction requirement is proper. Indeed, the U.S. Congress has seen fit to enact 35 USC 121 into law, and this law should properly be followed, and the law is not controlled by the cost of filing a divisional application.
Accordingly, claims 2-4, 8, and 14-20 are hereby withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected subject matter, there being no allowable generic or linking claim. The restriction requirement is still deemed proper, maintained, and is therefore made FINAL.
Applicant timely traversed the restriction requirement in the reply filed on January 29, 2026. Claims 1, 5-7, and 9-13 are currently under examination.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 5-7, and 9-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
The present claims appear to be directed to a non-statutory “use” of a contact lens. The claims are directed to “a method of using a contact lens in a wearer’s eye”, but the claims do not define a set of requisite active steps that must be performed by the hand of man. Indeed, it is noted that the claim requires “exposing the contact lens to a light source” and “measuring wavelength and intensity of light from the light source reflected from the contact lens”. The claims place no limits whatsoever on the light source, on the manner of “exposing”, and on the manner of “measuring”. Indeed, ‘exposing the contact lens to a light source” and “measuring wavelength and intensity of light from a light source reflected from the contact lens” are not necessarily active steps that must be performed by the hand of man. Indeed, the wearer of the contact lens may stand in a lit room of a building or in the outdoor sunshine and be exposed to a light source without there being any active step requiring the hand of man. Likewise, “measuring wavelength and intensity of light from a light source reflected from the contact lens” is something that could be done passively, even mentally, without a requisite active step by the hand of man. For example, color is an index of the wavelength of visible light, and brightness is an index of the intensity. One could make these determinations merely by passively observing and thinking. Similarly, “determining intraocular pressure” and “determining glaucoma biomarker concentration” are abstractions that do not require an active step by the hand of man, but could be accomplished merely by data input to a computer, or merely thinking. In effect, the claims are directed to a non-statutory “use”, even if the “use” is for a particular contact lens, i.e. one that contains a nanoporous film with human IL-12p70 antibodies and a gold film.
***Applicant is advised that in the United States, patent method claims should be properly defined by a requisite set of concrete active steps that must be performed by the hand of man to accomplish a specific purpose, e.g. making something in particular, or e.g. treating something in particular.
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, and 9-11 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, and 9-13 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 is directed to “a method of using a contact lens in a wearer’s eye”, which appears to involve “exposing the contact lens to a light source” and “measuring the wavelength and intensity of light from the light source reflected from the contact lens in the wearer’s eye”, and from the latter determining “glaucoma biomarker concentration”, which renders the claim indefinite for the following reasons:
1. Claim 1 never properly defines what the method is actually is for or is intended to accomplish. Claim 1 appears to be nothing more than a non-statutory “use” claim. One of ordinary skill in the art cannot definitively ascertain what is necessarily being made, or what is necessarily being treated, or what is necessarily being accomplished by the method, and thus cannot definitively ascertain the metes and bounds of the claimed subject matter.
2. Claim 1 does not disclose a definitive set of active method steps that must be performed by the hand of man and that properly defines the method for which they seek U.S. Patent protection. It appears the contact lens is in a wearer’s eye, and thus is presumably not being handled or actively manipulated by the hand of man. Moreover, ‘exposing the contact lens to a light source” and “measuring wavelength and intensity of light from a light source reflected from the contact lens” are not necessarily active steps that must be performed by the hand of man. Indeed, the wearer of the contact lens may stand in a lit room in a building or in the outdoor sunshine and be exposed to a light source without there being any active step requiring the hand of man. Likewise, “measuring wavelength and intensity of light from a light source reflected from the contact lens” is something that could be done passively, even mentally, without a requisite active step by the hand of man. For example, color is an index of the wavelength of visible light, and brightness is an index of the intensity. One could make these determinations merely by passively observing and thinking. Similarly, “determining intraocular pressure” and “determining glaucoma biomarker concentration” are abstractions that do not require an active step by the hand of man, but could be accomplished merely by thinking. In the United States, a method claim is properly defined by the requisite set of active steps that must be performed by the hand of man. Hence, one of ordinary skill in the art cannot definitively ascertain the metes and bounds of the claimed subject matter.
3. 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?
4. One of ordinary skill in the art cannot definitively ascertain whether the wavelength and/or intensity of the light to which the contact lens is exposed and the wavelength and/or intensity of the light which the contact lens reflects must be the same, must be different, or could be either the same or different.
5. The “glaucoma biomarker” is not defined by the claim. One of ordinary skill in the art cannot definitively ascertain the metes and bounds of “glaucoma biomarker”.
6. One of ordinary skill in the art cannot definitively ascertain how to determine “intraocular pressure” and/or “glaucoma biomarker concentration” from the wavelength and intensity of light reflected from the contact lens, and whether the required steps are the same for all wavelengths and intensities of light. The claim does not properly define the metes and bounds of the claimed subject matter. Indeed, the claim does not define the required steps or places any limits whatsoever on the manner of determining these parameters.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 9 and 10 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 9, which depends from claim 5, and ultimately from claim 1, stipulates in a wherein clause that “the biomarker-sensing region of the nanoporous film comprises nanopores”. One of ordinary skill in the art would understand from claim 1 that the nanoporous film comprises nanopores. Hence, claim 9 does not further limit claim 5 from which it depends.
Claim 10, which depends from claim 5, and ultimately from claim 1, stipulates in a wherein clause that “the biomarker is indicative of a disease or condition, and wherein the antibody is absorptive towards the biomarker”. Claims 1 and 5 already provide that the biomarker is specifically a glaucoma biomarker, and that the antibodies are absorptive towards the biomarker, i.e. in this case a biomarker for glaucoma. Hence, claim 9 appears to be broader in scope than claim 5 from which it depends.
Claim Rejections - 35 USC § 103 (I and II)
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.
I. Claims 1, 5-7, and 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (U.S. Patent Application Pub. No. 2010/0113901), in view of Etzkorn et al. (U.S. Patent Application Pub. No. 2014/0088381), and Gupta et al. (Clin Opthalmol. 2017; 11: 411-416).
I. Applicant Claims
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.
I. Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
Zhang et al. disclose a method of detecting a bioanalyte concentration in tears comprising exposing a 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 the surface of a substrate, which is integrated with a disposable contact lens (abstract; paragraphs 0002, 0024-0029, 0050, 0053, 0056, 0069, 0070, 0073, 0074, 0076, 0077, 0083-0085, 0087, 0094, 0095).
Etzkorn et al. disclose a contact lens integrated with a microporous film on the surface containing antibodies that can bind to a biomarker present in tear fluid and thus can be employed to detect the biomarker concentration in the tears of a subject wearing the contact lens, and thus that can disclose a particular health state of the subject (abstract; paragraphs 0002, 0035-0037, 0043, 0044, 0046, 0056).
Gupta et al. disclose that a change in the cytokine IL-12p70 concentration in tear fluid is a biomarker for glaucoma.
I. Ascertainment of the Difference Between the Scope of the Prior Art and the Claims (MPEP §2141.02)
Zhang et al. do not explicitly disclose that the nanopores contain human IL-12p70 antibodies, and that a change in the cytokine IL-12p70 concentration in tear fluid is a biomarker for glaucoma. These deficiencies are cured by the teachings of Etzkorn et al. and Gupta et al.
I. Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious for one of ordinary skill in the art at the time the present application was filed to combine the respective teachings of Zhang et al., Etzkorn et al. and Gupta et al., outlined supra, to devise Applicant’s presently claimed “use”.
Zhang et al. disclose a method of detecting a bioanalyte concentration in tears comprising exposing a 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 the surface of a substrate, which is integrated with a disposable contact lens; wherein a shift in the intensity and/or wavelength of the light from the contact lens is indicative of a change in concentration of the bioanalyte in tear fluid. Since Etzkorn et al. disclose a contact lens integrated with a microporous film on the surface containing antibodies that can bind to a biomarker present in tear fluid and thus can be employed to detect the biomarker concentration in the tears of a subject wearing the contact lens, and thus that can disclose a particular health state of the subject; and since Gupta et al. disclose that a change in the cytokine IL-12p70 concentration in tear fluid is a biomarker for glaucoma; one of ordinary skill in the art would thus be motivated to integrate human IL-12p70 antibodies in the microporous film of the Zhang et al. contact lens, and to detect the level of binding of the cytokine IL-12p70 in tear fluid to the human IL-12p70 antibodies in the microporous film by a shift in the wavelength and intensity of the light source reflected from the contact lens, with the reasonable expectation that the resulting method can be “used” to detect a glaucoma biomarker concentration in tears.
In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
II. Claims 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (U.S. Patent Application Pub. No. 2010/0113901), in view of Etzkorn et al. (U.S. Patent Application Pub. No. 2014/0088381), Gupta et al. (Clin Opthalmol. 2017; 11: 411-416), and Jazayeri et al. (Sensing and Bio-sensing Research. 2018; 9: 17-22).
II. Applicant Claims
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 antibodies “absorptive” to the glaucoma biomarker, and further comprises a gold film on the nanoporous film; and wherein the said antibody is functionalized to the nanoporous film via the gold film with EDC/NHS chemistry.
II. Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
Zhang et al. disclose a method of detecting a bioanalyte concentration in tears comprising exposing a 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 the surface of a substrate, which is integrated with a disposable contact lens (abstract; paragraphs 0002, 0024-0029, 0050, 0053, 0056, 0069, 0070, 0073, 0074, 0076, 0077, 0083-0085, 0087, 0094, 0095).
Etzkorn et al. disclose a contact lens integrated with a microporous film on the surface containing antibodies that can bind to a biomarker present in tear fluid and thus can be employed to detect the biomarker concentration in the tears of a subject wearing the contact lens, and thus that can disclose a particular health state of the subject (abstract; paragraphs 0002, 0035-0037, 0043, 0044, 0046, 0056).
Gupta et al. disclose that a change in the cytokine IL-12p70 concentration in tear fluid is a biomarker for glaucoma.
Jazayeri et al. disclose that antibodies can be covalently conjugated to gold nanoparticles via EDC/NHS chemistry, and that gold nanoparticle-antibody conjugates have advantages such as increased stability and decreased immunogenicity.
II. Ascertainment of the Difference Between the Scope of the Prior Art and the Claims (MPEP §2141.02)
Zhang et al. do not explicitly disclose that the nanopores contain human IL-12p70 antibodies conjugated to gold nanoparticles, and that a change in the cytokine IL-12p70 concentration in tear fluid is a biomarker for glaucoma. These deficiencies are cured by the teachings of Etzkorn et al. and Gupta et al.
II. Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious for one of ordinary skill in the art at the time the present application was filed to combine the respective teachings of Zhang et al., Etzkorn et al., Gupta et al., and Jazayeri et al., outlined supra, to devise Applicant’s presently claimed “use”.
Zhang et al. disclose a method of detecting a bioanalyte concentration in tears comprising exposing a 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 the surface of a substrate, which is integrated with a disposable contact lens; wherein a shift in the intensity and/or wavelength of the light from the contact lens is indicative of a change in concentration of the bioanalyte in tear fluid. Since Etzkorn et al. disclose a contact lens integrated with a microporous film on the surface containing antibodies that can bind to a biomarker present in tear fluid and thus can be employed to detect the biomarker concentration in the tears of a subject wearing the contact lens, and thus that can disclose a particular health state of the subject; since Gupta et al. disclose that a change in the cytokine IL-12p70 concentration in tear fluid is a biomarker for glaucoma; and since Jazayeri et al. disclose that antibodies can be covalently conjugated to gold nanoparticles via EDC/NHS chemistry, and that gold nanoparticle-antibody conjugates have advantages such as increased stability and decreased immunogenicity; one of ordinary skill in the art would thus be motivated to integrate gold nanoparticles covalently conjugated to human IL-12p70 antibodies via EDC/NHS chemistry to the microporous film of the Zhang et al. contact lens, and to detect the level of binding of the cytokine IL-12p70 in tear fluid to the human IL-12p70 antibodies in the microporous film by a shift in the wavelength and intensity of the light source reflected from the contact lens, with the reasonable expectation that the resulting method can be “used” to detect a glaucoma biomarker concentration in tears.
In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
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
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