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 .
Response to Amendment
The amendment filed November 20th, 2025 has been entered. Claims 1, 3, 5-7, 9, and 11-12 remain pending in the application. Claims 2, 4, 8 and 10 have been cancelled.
Response to Arguments
Applicant's arguments filed November 20th, 2025 have been fully considered but they are not persuasive.
Applicant’s arguments, see Pages 7-8, regarding the body electrodes of Yakovlev not being used as EEG electrodes, the electrodes being used for stimulation treatment, and that the electrodes are not subdermal electrodes, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The examiner has relied upon Flaherty to discloses the EEG electrodes as claimed by the applicant, and therefore in combination with the teachings of coating electrodes that are inserted subdermally as taught by Yakovlev, would result in EEG electrodes coated with a coagulant, a conductive gel, and a local anesthetic.
In response to applicant's argument, see Page 8, that the electrode for an EEG as taught by Flaherty would not be combined with the coated electrodes as taught by Yakovlev, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
In response to applicant's argument, see Page 9-10, that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Lastly, applicant’s arguments regarding the Bibian reference are moot as Bibian was not used in the rejection. Therefore, claims 1, 3, 5, 6, 7, 9 and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Flaherty et al. (US 20060173259) herein referred to as Flaherty in view of Yakovlev et al. (US 20200101291) herein referred to as Yakovlev.
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.
Claim 9 is 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 9 recites the limitation "the coagulant" in line 1. There is insufficient antecedent basis for this limitation in the claim.
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 6 and 12 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. Claims 6 and 12 repeat the same subject matter as disclosed in amended claims 1 and 7 respectively. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1, 3, 5, 6, 7, 9 and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Flaherty et al. (US 20060173259) herein referred to as Flaherty in view of Yakovlev et al. (US 20200101291) herein referred to as Yakovlev.
Regarding claim 1, Flaherty discloses a subdermal electroencephalogram (EEG) electrode (the system includes a sensor, electrode array 210 that has been inserted into a brain 250 (seen as being subdermal) of patient 500, Paragraph [0063], electrode configurations are applicable on both the inside to cranium, in on or near the peripheral nerves and on the surface of the scalp (electrodes penetrate into the skin, which is seen as being subdermal) such as to record electroencephalogram signals (EEGs), Paragraph [0063]),
comprising: an electrode head in communication with an external differential amplifier (Figure 20 depicts the electrode inputs the signal to the differential amplifier, the differential amplifier works such that if one input is grounded, the other may be on “virtual ground”, Paragraph [0174]);
and at least one point extending from the electrode head and adapted to be embedded in a patient's scalp (sensor 200 with multiple projections 211 that have one or more electrodes such as electrode 212 at each tip, Figure 9, Paragraph [0137], electrode configurations are applicable on both the inside to cranium, in on or near the peripheral nerves and on the surface of the scalp such as to record electroencephalogram signals (EEGs), Paragraph [0063]).
However, Flaherty does not explicitly disclose wherein the at least one point is coated with a coagulant, a conductive gel, and a local anesthetic.
Yakovlev discloses wherein the at least one point is coated with a coagulant, a conductive gel, and a local anesthetic (electrodes can further be coated with drug eluting agents, the agents may include epinephrine (seen as a coagulant), Paragraph [0221], electrodes can further be coated with drug eluting agents, the agents may include anesthetics, examples may include lidocaine (seen as a local anesthetic), Paragraph [0221], conductive gels can be used to ensure good contact between the conduction electrodes and tissue, Paragraph [0266]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Flaherty to incorporate
the teachings of Yakovlev by including electrodes with at least one point coated with a coagulant, a conductive gel and a local anesthetic. The motivation to include a coagulant and a local anesthetic being to prevent or otherwise reduce inflammation infection, pain, and/or other adverse effects (Yakovlev, Paragraph [0221]). The motivation to include a conductive gel being to ensure good contact between the conduction electrodes and tissue (Yakovlev, Paragraph [0266]).
Regarding claim 3, Flaherty in view of Yakovlev discloses the subdermal EEG electrode of claim 1.
However, Flaherty does not explicitly disclose wherein the coagulant comprises epinephrine.
Yakovlev discloses wherein the coagulant comprises epinephrine (electrodes can further be coated with drug eluting agents, the agents may include epinephrine (seen as a coagulant), Paragraph [0221]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Flaherty to incorporate
the teachings of Yakovlev by including electrodes with at least one point coated with a coagulant comprising epinephrine. The motivation to do so being to prevent or otherwise reduce inflammation infection, pain, and/or other adverse effects (Yakovlev, Paragraph [0221]).
Regarding claim 5, Flaherty in view of Yakovlev discloses the subdermal EEG electrode of claim 4.
However, Flaherty does not explicitly disclose wherein the local anesthetic comprises lidocaine.
Yakovlev discloses wherein the local anesthetic comprises lidocaine (electrodes can further be coated with drug eluting agents, the agents may include anesthetics, examples may include lidocaine (seen as a local anesthetic), Paragraph [0221]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Flaherty to incorporate
the teachings of Yakovlev by including electrodes with at least one point coated with a local anesthetic comprising lidocaine. The motivation to do so being to prevent or otherwise reduce inflammation infection, pain, and/or other adverse effects (Yakovlev, Paragraph [0221]).
Regarding claim 6, Flaherty in view of Yakovlev discloses the subdermal EEG electrode of claim 4.
However, Flaherty does not explicitly disclose wherein the at least one point is coated with a conductive gel.
Yakovlev discloses wherein the at least one point is coated with a conductive gel, (conductive gels can be used to ensure good contact between the conduction electrodes and tissue, Paragraph [0266]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Flaherty to incorporate
the teachings of Yakovlev by including electrodes with at least one point coated with a conductive gel. The motivation to include a conductive gel being to ensure good contact between the conduction electrodes and tissue (Yakovlev, Paragraph [0266]).
Regarding claim 7, Flaherty in view of Yakovlev discloses a plurality of electrodes, each of the electrodes being a subdermal EEG electrode according to claim 1.
Flaherty further discloses an EEG system, comprising: a support structure that is adapted to cover at least predetermined areas on the patient's head wherein, when the plurality of electrodes are mounted on the support structure and the support structure is mounted on the patient's head (Fig. 6 illustrates a portion of the biological system including a sensor (comprises the electrode array) and a through-the-skin connector for mounting on the skull, (seen as the support structure for mounting the electrodes), Paragraph [0025]),
the electrodes are distributed around the patient's head (multiple sensor components can be implanted entirely in the brain or at an extracranial location, or the multiple discrete sensor components can be placed in any combination of locations, Paragraph [0063], additional sensors can be incorporated into one or more discrete components of the system (seen as multiple electrode sensors distributed around the patients head), Paragraph [0195])
and are capable of detecting electrical signals that are representative of the patient's electrical brain activity (each electrode 212 may be used to detect the firing of one or more neurons, as well as other cellular signals such as those from clusters of neurons, examples of detected signals include, neuron spikes, electrocorticogram signals, local field potential signals, electroencephalogram signals, and other signals, Paragraph [0069]).
However, Flaherty does not explicitly disclose wherein the at least one point is coated with a conductive gel and a local anesthetic.
Yakovlev discloses wherein the at least one point is coated with a conductive gel and a local anesthetic (electrodes can further be coated with drug eluting agents, the agents may include anesthetics, examples may include lidocaine (seen as a local anesthetic), Paragraph [0221], conductive gels can be used to ensure good contact between the conduction electrodes and tissue, Paragraph [0266]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Flaherty to incorporate
the teachings of Yakovlev by including electrodes with at least one point coated with a conductive gel and a local anesthetic. The motivation to include a local anesthetic being to prevent or otherwise reduce inflammation infection, pain, and/or other adverse effects (Yakovlev, Paragraph [0221]). The motivation to include a conductive gel being to ensure good contact between the conduction electrodes and tissue (Yakovlev, Paragraph [0266]).
Regarding claim 9, Flaherty in view of Yakovlev discloses the EEG system of claim 7.
However, Flaherty does not explicitly disclose wherein the coagulant comprises epinephrine.
Yakovlev discloses wherein the coagulant comprises epinephrine (electrodes can further be coated with drug eluting agents, the agents may include epinephrine (seen as a coagulant), Paragraph [0221]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Flaherty in view of Yakovlev to incorporate the teachings of Yakovlev by including electrodes with at least one point coated with a coagulant comprising epinephrine. The motivation to do so being to prevent or otherwise reduce inflammation infection, pain, and/or other adverse effects (Yakovlev, Paragraph [0221]).
Regarding claim 11, Flaherty in view of Yakovlev discloses the EEG system of claim 10.
However, Flaherty does not explicitly disclose wherein the local anesthetic comprises lidocaine.
Yakovlev discloses wherein the local anesthetic comprises lidocaine (electrodes can further be coated with drug eluting agents, the agents may include anesthetics, examples may include lidocaine (seen as a local anesthetic), Paragraph [0221]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Flaherty in view of Yakovlev to incorporate the teachings of Yakovlev by including electrodes with at least one point coated with a local anesthetic comprising lidocaine. The motivation to do so being to prevent or otherwise reduce inflammation infection, pain, and/or other adverse effects (Yakovlev, Paragraph [0221]).
Regarding claim 12, Flaherty in view of Yakovlev discloses the EEG system of claim 10.
However, Flaherty does not explicitly disclose wherein the at least one point of each of the electrodes is coated with a conductive gel.
Yakovlev discloses wherein the at least one point is coated with a conductive gel, (conductive gels can be used to ensure good contact between the conduction electrodes and tissue, Paragraph [0266]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Flaherty to incorporate
the teachings of Yakovlev by including electrodes with at least one point coated with a conductive gel. The motivation to include a conductive gel being to ensure good contact between the conduction electrodes and tissue (Yakovlev, Paragraph [0266]).
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Dana Stumpfoll whose telephone number is (703)756-4669. The examiner can normally be reached 9-5 pm (CT), M-F.
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/D.S./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794