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
Applicant’s election without traverse of Group I and Species IV in the reply filed on July 23, 2026 is acknowledged.
Claims 7-9 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 23, 2026.
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).
Status of the Claims
Claims 1-20 are pending in the application. Claims 7-9 and 20 are withdrawn, and claims 1-6 and 10-19 are being examined herein.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
The disclosure is objected to because of the following informalities:
In para. [0014] and [0035] of the instant US PGPub, “Polyethylene, terephthalate” should read “Polyethylene terephthalate”.
In para. [0014] and [0035] of the instant US PGPub, “polymide” is a typo and it is unclear whether it is supposed to mean polyamide or polyimide. There is no support for either.
In para. [0014] and [0035] of the instant US PGPub, “polyvinylpyrollidone” should read “polyvinylpyrrolidone”.
Appropriate correction is required.
Claim Objections
Claims 2-6 and 10-12 are objected to because of the following informalities: in line 1 of each claim, “device” should read “oxygen sensor device”. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: in line 1, “interdigitated” should read “interdigitated electrode”. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: in line 2, “an oxygen sensor device” should read “the oxygen sensor device”. Appropriate correction is required.
Claims 14-19 are objected to because of the following informalities: in line 1 of each claim, “system” should read “oxygen sensor system”. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: in line 1, “the PCM” should read “the solid-state PCM”. Appropriate correction is required.
Claim 15 is objected to because of the following informalities:
In line 3, “Polyethylene, terephthalate” should read “Polyethylene terephthalate”.
In line 4, “polymide” is a typo.
Appropriate correction is required.
Claim 17 is objected to because of the following informalities: in line 2, “polyvinylpyrollidone” should read “polyvinylpyrrolidone”. Appropriate correction is required.
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 1-6 and 10-19 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 recites the limitation “the electrode” in line 3 of the claim. It is unclear whether this recitation refers to the previously recited “a Clark-type sensor electrode” or “thin-film electrode leads” in line 2 of the claim. For the purpose of examination, Examiner interprets “the electrode” to refer to one of the “thin-film electrode leads”. Claims 2-6 and 10-19 are rejected as dependent thereon.
Claim 2 recites the limitation “the electrode” in line 1 of the claim. It is unclear whether this recitation refers to the previously recited “a Clark-type sensor electrode” or “thin-film electrode leads” in line 2 of claim 1. For the purpose of examination, Examiner interprets “the electrode” to refer to one of the “thin-film electrode leads”.
Claim 3 recites the limitation “the Clark-type sensor electrode includes a working electrode” in lines 1-2 of the claim. It is unclear whether the “working electrode” is one of the previously recited “thin-film electrode leads” in line 2 of claim 1 or in addition to it. For the purpose of examination, Examiner interprets it to be the former.
Claim 4 recites the limitation “the Clark-type sensor electrode includes a counter electrode” in lines 1-2 of the claim. It is unclear whether the “counter electrode” is one of the previously recited “thin-film electrode leads” in line 2 of claim 1 or in addition to it. For the purpose of examination, Examiner interprets it to be the former.
Claim 5 recites the limitation “the Clark-type sensor electrode includes a reference electrode” in lines 1-2 of the claim. It is unclear whether the “reference electrode” is one of the previously recited “thin-film electrode leads” in line 2 of claim 1 or in addition to it. For the purpose of examination, Examiner interprets it to be the former.
Claim 6 recites the limitation “electrodes” in line 2 of the claim. It is unclear whether this recitation is the same as or different from the previously recited “a Clark-type sensor electrode” and/or “thin-film electrode leads” in line 2 of claim 1. For the purpose of examination, Examiner interprets “electrodes” to be the same as “thin-film electrode leads”.
Claim 6 recites the limitation “a PCM” in line 2 of the claim. It is unclear whether this recitation is the same as or different from the previously recited “a solid-state proton conductive matrix (PCM)” in lines 2-3 of claim 1. For the purpose of examination, Examiner interprets them to be the same.
Claim 10 recites the limitation “the electrode” in line 1 of the claim. It is unclear whether this recitation refers to the previously recited “a Clark-type sensor electrode” or “thin-film electrode leads” in line 2 of claim 1. For the purpose of examination, Examiner interprets “the electrode” to refer to “a Clark-type sensor electrode”.
Claim 13 recites the limitation “the electrode” in line 3 of the claim. It is unclear whether this recitation refers to the previously recited “a Clark-type sensor electrode” or “thin-film electrode leads” in line 2 of claim 1. For the purpose of examination, Examiner interprets “the electrode” to refer to “a Clark-type sensor electrode”. Claims 14-19 are rejected as dependent thereon.
Claim 13 recites the limitation “the oxygen sensor electrode” in lines 5-6 of the claim. It is unclear whether this recitation refers to the previously recited “a Clark-type sensor electrode” in line 2 of claim 1 or the “oxygen sensor device” in line 2 of claim 13. For the purpose of examination, Examiner interprets “the oxygen sensor electrode” to refer to the “oxygen sensor device”. Claims 14-19 are rejected as dependent thereon.
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.
Claims 1-6 and 10-19 are rejected under 35 U.S.C. 103 as being unpatentable over Reed et al. (US 2018/0325386 A1) (provided in Applicant’s IDS filed on September 29, 2025) in view of McLaughlin et al., Microfabricated solid-state dissolved oxygen sensor, Sensors and Actuators B: Chemical, Vol. 83, Issues 1-3, pp. 138-148 (2002) (hereinafter “McLaughlin”) (provided in Applicant’s IDS filed on September 29, 2025).
Regarding claim 1, Reed teaches an oxygen sensor device (an oxygen sensor 26, Reed, Fig. 1A, para. [0044]), comprising:
a Clark-type sensor electrode comprising thin-film electrode leads overlaid with a solid- state proton conductive matrix (PCM) (the oxygen sensor 26 includes a Clark-type sensor comprising thin-film electrode leads overlaid with a solid-state proton conductive matrix, Reed, Fig. 1A, para. [0044]).
Reed teaches that the electrodes are for real-time quantification of chemistry and electrophysiology of the body and are implantable into the body via a probe (Reed, abstract, para. [0036]). Reed teaches that the thin-film electrode leads include a working electrode, counter electrode, and reference electrode (Reed, Figs. 1A & 9, para. [0026], [0044]). Reed teaches that the current response of the oxygen sensor is proportional to the oxygen concentration (Reed, Figs. 9-10, para. [0026]-[0027]). Reed fails to teach wherein at least one dimension of the electrode is less than 25µm.
McLaughlin teaches a microfabricated oxygen concentration sensor consisting of a microfabricated thin-film electrode matrix overlaid with a solid-state proton conductive matrix (McLaughlin, abstract). McLaughlin teaches that each element of the Clark-type oxygen sensor test matrix consists of a working, reference, and counter electrode set, where the working electrode diameter may be 10 or 20 µm (McLaughlin, Figs. 1-2, pg. 138, left column, last paragraph, right column, first paragraph). McLaughlin teaches that the current responses of the 10 and 20 µm diameter working electrodes with respect to dissolved oxygen concentrations are linear as expected (McLaughlin, Figs. 6, 9, 11, pg. 141, right column, second paragraph, pg. 144, left column, last paragraph, pg. 145, left column, last paragraph, right column, first paragraph). McLaughlin teaches this microfabricated Clark-type oxygen sensor is able to be used in delicate biological media such as blood, and the sensor’s response and performance is linear and consistent with theoretical models (McLaughlin, pg. 139, right column, last paragraph, pg. 147, left column, last paragraph).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the size of the working electrode of Reed be 10 or 20 µm as taught by McLaughlin in order to yield the predictable result of a microfabricated Clark-type oxygen sensor that is able to be implanted in a body and has current responses that are proportional to oxygen concentration.
Regarding claim 2, Modified Reed teaches wherein the electrode comprises an ultramicroelectrode (the working electrode has a size of 10 or 20 µm, Reed, Fig. 9, McLaughlin, pg. 138, left column, last paragraph, right column, first paragraph, see modification supra). According to Applicant’s instant specification, ultramicroelectrodes have been widely defined by the electrochemical community as being electrodes that possess at least one dimension that is less than 25 µm in size (see para. [0046] of the instant US PGPub).
Regarding claim 3, Modified Reed teaches wherein the Clark-type sensor electrode includes a working electrode (the thin-film electrode leads of the Clark-type oxygen sensor 26 include a working electrode, Reed, Figs. 1A & 9, para. [0026], [0044]).
Regarding claim 4, Modified Reed teaches wherein the Clark-type sensor electrode includes a counter electrode (the thin-film electrode leads of the Clark-type oxygen sensor 26 include a counter electrode, Reed, Figs. 1A & 9, para. [0026], [0044]).
Regarding claim 5, Modified Reed teaches wherein the Clark-type sensor electrode includes a reference electrode (the thin-film electrode leads of the Clark-type oxygen sensor 26 include a reference electrode, Reed, Figs. 1A & 9, para. [0026], [0044]).
Regarding claim 6, Modified Reed teaches titanium/gold, titanium/platinum, chromium/gold, nickel/gold or silver/silver-chloride electrodes overlaid with a PCM constructed from Nafion (titanium/gold or titanium/platinum electrodes overlaid with the PCM constructed from Nafion, Reed, Figs. 8-9, para. [0044]).
Regarding claim 10, Modified Reed teaches wherein the electrode comprises an interdigitated (IDE) geometry (the thin-film electrode leads of the Clark-type oxygen sensor 26 comprise an interdigitated electrode geometry, Reed, Figs. 1A & 8-9, para. [0025]-[0026], [0044]).
Regarding claim 11, Modified Reed teaches wherein the device is configured to measure dissolved oxygen concentration (the oxygen sensor 26 measures oxygen level in brain tissue oxygen, Reed, Figs. 1A & 9, para. [0030], [0036]).
Furthermore, the limitation “measure dissolved oxygen concentration” is interpreted as intended use and/or functional language. The Courts have held that the manner in which a claimed apparatus is intended to be employed does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex parte Masham, 2 USPQ2d 1647 (BPAI 1987). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. See MPEP § 2114. The oxygen sensor disclosed by Modified Reed teaches all of the structural limitations of the claim and thus is configured for and capable of measuring dissolved oxygen concentration as mapped supra.
Regarding claim 12, Modified Reed teaches wherein the device is configured to measure brain tissue oxygen (PBTO2) (the oxygen sensor 26 measures oxygen level in brain tissue oxygen, Reed, Figs. 1A & 9, para. [0030], [0036]).
Furthermore, the limitation “measure brain tissue oxygen (PBTO2)” is interpreted as intended use and/or functional language. The Courts have held that the manner in which a claimed apparatus is intended to be employed does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex parte Masham, 2 USPQ2d 1647 (BPAI 1987). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. See MPEP § 2114. The oxygen sensor disclosed by Modified Reed teaches all of the structural limitations of the claim and thus is configured for and capable of measuring brain tissue oxygen as mapped supra.
Regarding claim 13, Modified Reed teaches an oxygen sensor system (a probe device 10, Reed, Figs. 1A-3, para. [0037]), comprising:
an oxygen sensor device as described in claim 1 (the oxygen sensor 26, Reed, Figs. 1A & 3, para. [0038], [0044], see rejection of claim 1 supra);
a sensing window above the electrode (the probe body 34 is partially cut away to reveal the oxygen sensor 26, Reed, Figs. 1A & 3, para. [0020], [0038]);
at least one contact pad (connector pads 20, Reed, Fig. 1A, para. [0045]); and
at least one lead line electrically connecting the at least one contact pad to the oxygen sensor electrode (at least one lead 18 used to connect the oxygen sensor 26 with the connector pads 20, Reed, Fig. 1A, para. [0044]-[0045]).
Regarding claim 14, Modified Reed teaches a protective layer overlaying the PCM (the PCM can be coated or overlaid with a protective layer, Reed, Figs. 1A & 9-10, para. [0044]).
Regarding claim 15, Modified Reed teaches wherein the protective layer comprises polydimethylsiloxane (PDMS), Polyetheretherketone (PEEK), Polytetrafluoroethylene (PTFE), Polypropylene (PP), Polystyrene (PS), Polyurethane, Polycarbonate (PC), Polyethylene, terephthalate (PET), Polymethyl methacrylate (PMMA), polymide, or Parylene-C (the protective layer is polydimethylsiloxane (PDMS), Reed, Figs. 1A & 9-10, para. [0044]).
Regarding claim 16, Modified Reed teaches an adhesion promoting compound (an adhesion promoting compound, Reed, Fig. 1A, para. [0044]).
Regarding claim 17, Modified Reed teaches wherein the adhesion promoting compound comprises polyvinylpyrollidone (PVP) or SU-8 (the adhesion promoting compound is polyvinylpyrollidone (PVP), Reed, Fig. 1A, para. [0044]).
Regarding claim 18, Modified Reed teaches a substrate (a substrate, Reed, Fig. 1A, para. [0044]).
Regarding claim 19, Modified Reed teaches wherein the substrate comprises Kapton, glass, ceramic, silicon, or dielectric on silicon (the substrate comprises Kapton, Reed, Figs. 1A & 10, para. [0027], [0044]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VIVIAN A TRAN whose telephone number is (571)272-3232. The examiner can normally be reached Mon - Fri 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Lin can be reached at (571) 272-8902. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/V.T./ Examiner, Art Unit 1794
/JAMES LIN/ Supervisory Patent Examiner, Art Unit 1794
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