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 . Claims 1-10 are currently pending.
Drawings
The drawings are objected to because Figures 1-4A are blurry and it’s difficult to make out which elements are which. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 10 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. The sensing value in line four of claim 10 is not given any real detail in the original disclosure for the skilled artisan before the effective filing date to understand what is being claimed. Raw signals are obtained by bioelectrodes, as is well-known in the EEG, ECG, EMG sensing arts (and shown in the prior art of record), which is then processed either remotely or on-board to some extent. The sensing value could in theory be the processed signal, but there is no mention in the original disclosure what it actually is. Metrics and scales also exist to quantify results and find correlations, of the obtained bio-signals, where a sensing value could be attached to those signals, but again there is no suggestion or direction found in the disclosure if that is or isn’t the case.
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 10 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.
In claim 10 line four, there is mention of a sensing value but it is unclear what is meant by this. It is assumed that it is simply the raw signal from the bioelectrode at which point is processed to some extent into the biosignal, but if that is not the case the skilled artisan is not clear on what is being claimed.
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.
Claims 1 and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Park US 2021/0244304 (hereinafter Park).
Regarding claim 1, Park discloses a bioelectrode, comprising: a substrate (110, [0080], [0103]); and an electrode part formed on the substrate (Figure 1), wherein the electrode part includes a channel having a bilayer structure of a first channel including a first material and a second channel including a second material different from the first material ((Figure 6 at elements 121-122, [0063], [0069], and wherein the first material and the second material include a biocompatible material ([0002][0056][0067][0073]-[0074][0080]-[0081] which details that the conductive polymer PEDOT:PSS is biocompatible and that the other layer is gold).
Regarding claim 5, Park discloses that the constituent material of the substrate includes parylene-C (0082][0103]).
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 non-obviousness.
Claims 2-4, 6-7, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Park in view of Yen et al. “A Graphene-PEDOT:PSS Modified Paper-Based Aptasensor for Electrochemical Impedance Spectroscopy Detection of Tumor Marker” Sensors 2020, 20, 1372. March 2020 (hereinafter Yen).
Regarding claims 2 and 4, Park discloses that the first material includes PEDOT:PSS (0063] which details the polymer itself but in [0067] mentions that the other material is a metal). Park teaches that the contacts/conductors 130/140 can be made of the same metal nanowires as the electrode part or they can be made of graphene, showing the material equivalence, there is no explicit mention of graphene being used as the second material in the bilayer channel.
Yen teaches a PEDTOS:PSS and graphene bilayer channel (Introduction paragraph three, sections 2.2-2.3 also teach this combination of electrode materials for the bilayer). Yen further shows the same order of graphene to PEDOT:PSS with respect to the substrate (see Scheme 1 under the Fabrication section 2.3). Therefore, it would have been obvious to the skilled artisan before the effective filing date to utilize the graphene layer as taught by Yen in lieu of the metal nanowires of Park as they are art recognized equivalents where graphene also has the added benefit of being transparent and exhibiting superior electrical and thermal qualities.
Regarding claim 3, Park discloses the channel configuration while Yen teaches the material choice however neither explicitly disclose the arrangement of the PEDOT:PSS and graphene as claimed. Park does detail that either material can be directly deposited onto the substrate ([0112]-[0113]), but again does not detail those materials arranged on the substrate in that order. However given the lack of criticality for the order, and that both materials are biocompatible, known to be deposited directly onto a substrate, and are both over 95% transparent, it would have been obvious to simply rearrange the materials (PEDOT:PSS/graphene) of Yen with the device/channels of Park as predictable results would have ensued (utilizing transparent, conductive, biocompatible materials to obtain bio signals)
Regarding claims 6-7 and 9, Park discloses the substrate, electrode part, and channels as mentioned above (see rejected claim 1), but is silent on the bio-receptor. Yen teaches a bio-receptor formed on the electrode part (sections 2.2-2.4), with the bio-receptor being an aptamer capable of binding to a predefined target molecule (abstract, sections 2.4 which details a carcinoembryonic antigen, CEA). Yen further teaches that the bio-receptor is fixed to the channel of the electrode part (Figure 1 which shows the aptamer fixed to the graphene-PEDOT:PSS electrode part). Therefore, it would have been obvious to the skilled artisan before the effective filing date to utilize the aptamer as taught by Yen with the device of Park in order to increase sensitivity for desired molecule detection.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Park in view of Yen, and in further view of Pusomjit et al. “Impedimetric determination of cortisol using screen-printed electrode with aptamer-modified magnetic beads” Microchimica Acta (2021) 188: 41. January 2021 (hereinafter Pusomjit).
Regarding claim 8, Park as modified by Yen discloses the base device and the bio-receptor (CEA), but are silent on it targeting a cortisol molecule. Pusomjit teaches an electrochemical sensor with an electrode part (Figure 1) that includes a aptamer that is to bind to a target molecule including a cortisol molecule (Abstract, Introduction sections which details cortisol being the targeted molecule). It would have been obvious to the skilled artisan before the effective filing date to utilize the bio-receptor as taught by Pusomjit with the device of Park and Yen in order to allow targeting of other molecules using a known method to yield a predictable result (detection of a different but similarly well-known biomarker).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Park in view of Zhu et al. US Publication 2022/0340726 (hereinafter Zhu).
Regarding claim 10, Park discloses the bioelectrode (as mentioned above in rejected claim 1), and details that the biosignal can include at least one of electrocardiography (ECG),electroencephalography (EEG), and electromyography (EMG) (see [0008]), and further teaches a measuring device linked to the bioelectrode and configured to measure a biosignal based on a sensing value from the bioelectrode ([0070]). Park does not explicitly detail that the EEG/EMG signal is being measured constantly however it would be a first to see a single EMG/EEG point instead of a constant signal over some amount of time.
Zhu teaches a stretchable, sensing electrode that include an electrode part configured to continuously monitor ECG/EMG signals ([0064][0066]). It would have been obvious to the skilled artisan before the effective filing date to utilize the constant monitoring as taught by Zhu with the EEG/EMG sensing of Park as predictable results would have ensued (sensing to afford diagnosis of muscle behavior or abnormal activity).
Conclusion
Any inquiry concerning this communication or earlier communications from the
examiner should be directed to Brian M Antiskay whose telephone number is (571)270-5179. The examiner can normally be reached M-F 10am-6pm EST.
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/BRIAN M ANTISKAY/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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