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 invention I in the reply filed on 9 April 2026 is acknowledged.
Claims 14-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 9 April 2026.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the disruptor mounted on a lid substrate (claim 1), hole in a lid substrate which aligns with a disruptor (claim 1), adhesive structure including a core substrate and having a hole configured to direct fluid (claim 1), electrically conductive material passing through another hole in the adhesive structure (claim 1), conductive trace configured for connection to a voltage/current source or detector (claim 1), barrier layer on an electrode (claim 6), hydrogel layer on an electrode (claim 8), and plurality of working electrodes configured to detect different analytes (claim 9, 10) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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.
Specification
The disclosure is objected to because of the following informalities: The disclosure uses the term “electrode” to refer to both a conductive element and also smaller areas of that element itself – paragraph [0075] as filed recites “The base structure may include a base substrate and a first working electrode 309 that, within the well areas 308, is coated with a compound to detect/sense a particular analyte in the sample, creating a first sensing electrode 310.” As elements 310 are part of element 309 itself, using the term “electrode” to define both renders this description unclear. Similar language is found throughout the disclosure.
Appropriate correction is required.
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.
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.
Claims 1-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “an adhesive structure comprising a core substrate coated with a thin continuous adhesive film on each external surface, wherein the adhesive structure has at least a first hole configured to direct interstitial fluid”; the only disclosure of any “adhesive” in the specification is “An adhesive (not shown) may be applied to the top surface 210 of the channel support structures 204.” (paragraph [0054] as filed) and “s the lid structure 212 is brought down into position over the channel support structures 204, the adhesive (not shown) on the channel support structures 204 may secure the lid structure 212 by contacting the working electrode 214.” (paragraph [0056] as filed). At best, this describes an adhesive layer, not any sort of structure, let alone a substrate separate from the lid substrate and having a hole for fluid transport or a second hole for a conductive material.
Claim 1 further recites “at least one electrically conductive material passing through at least a second hole in the adhesive structure, wherein the at least one electrically conductive material provides a conductive path between the base structure and the lid structure”. As noted above, there is no disclosure of a second hole in an adhesive structure through which anything could pass; further, there is no disclosure of any “conductive material” providing any sort of conductive path between base structure and lid structure; the specification defines conductive paths between electrodes (paragraph [0045] as filed), but there is no disclosure of any electrical communication between base structure or lid structure, or any disclosure even of the lid structure having any element that could participate in conduction or other electrical communication.
Claim 1 further recites “at least one conductive trace configured for external communication to one or more of a voltage/current source and a current detector”; there is no disclosure of any conductive trace for communication with a current detector. At best, the disclosure recites “The magnitude of the current generated may be measured by an ammeter, the measurement of which may directly correlate to the amount (or concentration) of analyte in the collected biological fluid sample.” (paragraph [0046] as filed), with no recitation of how this is achieved, particularly not via a conductive trace that is part of the device itself.
As such, the disclosure of the instant invention does not readily convey possession of an adhesive structure, an electrically conductive material, or a conductive trace at the time the invention was filed.
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 1-13 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 defines “at least one electrically conductive material passing through at least a second hole in the adhesive structure, wherein the at least one electrically conducive material provides a conductive path between the base structure and the lid structure”. As defined in lines 2 and 7 earlier in the claim the lid structure is part of the base structure itself, such that it is unclear how or why the device would also include a conductive material passing through some entirely unrelated other element/structure to allow communication between “the base structure” and a subcomponent of the base structure itself, where the lid structure is inherently in communication with the base structure because it is a part of the base structure. Clarification is required.
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.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-13 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 1 positively recites the human body in “a region of the subject’s skin is exposed to the portion of the at least one disruptor on contact with the lid substrate”; the limitation should be amended to defined what the claimed device is configured to do upon interaction with a human body.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 and 3-13 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Snyder (US 2020/0375510).
Regarding claim 1, Snyder discloses a transdermal sampling and analysis device comprising:
a base structure comprising:
at least one disruptor mounted on a base substrate (element 304), wherein the at least one disruptor is configured to generate a localized heat capable of altering permeability characteristics of a subject's skin (paragraphs [0031], [0036], [0046]); and
a first electrode array (element 306);
a lid structure (element 314) comprising:
a lid substrate (element 316) having at least one hole configured to align with a portion of the at least one disruptor (paragraph [0036]), wherein a region of the subject's skin is exposed to the portion of the at least one disruptor on contact with the lid substrate (paragraph [0036]); and
a second electrode array (element 318);
an adhesive structure comprising a core substrate coated with a thin continuous adhesive film on each external surface, wherein the adhesive structure has at least a first hole configured to direct interstitial fluid collected from the subject's skin to at least one of the first electrode array and the second electrode array (element 310); paragraph [0047]);
at least one electrically conductive material passing through at least a second hole in the adhesive structure, wherein the at least one electrically conductive material provides a conductive path between the base structure and the lid structure (paragraphs [0046]-[0049]); and
at least one conductive trace configured for external connection to one or more of a voltage/current source and a current detector (paragraph [0036]).
Regarding claim 3, Snyder further discloses that the second electrode array comprises at least one working electrode (paragraph [0042], [0048]).
Regarding claim 4, Snyder further discloses that the at least one working electrode comprises a plurality of working electrodes each including a sensing layer configured to detect a distinct analyte (paragraph [0036], [0037], [0042]).
Regarding claim 5, Snyder further discloses that the sensing layer of at least one of the plurality of working electrodes comprises at least one cofactor (paragraph [0053]).
Regarding claim 6, Snyder further discloses that at least one of the plurality of working electrodes is coated with an anti-interferent barrier layer (paragraph [0073]).
Regarding claim 7, Snyder further discloses that the anti- interferent barrier layer comprises alginate (paragraph [0006]).
Regarding claim 8, Snyder further discloses that each sensing layer comprises an enzyme immobilized within a hydrogel, wherein the enzyme causes a reaction to determine levels of a target analyte in the collected interstitial fluid (paragraphs [0026], [0033]).
Regarding claim 9, Snyder further discloses that the plurality of working electrodes comprises a first working electrode configured to detect glucose, and a second working electrode configured to detect an analyte selected from alcohol or lactate (paragraphs [0026], [0033], [0053]).
Regarding claim 10, Snyder further discloses that the plurality of working electrodes includes: a first working electrode comprising a glucose oxidase sensing layer; and a second working electrode comprising an oxidoreductase sensing layer (paragraphs [0026], [0033], [0053], [0072]).
Regarding claim 11, Snyder further discloses that the oxidoreductase is selected from alcohol dehydrogenases or lactate dehydrogenases (paragraph [0072]).
Regarding claim 12, Snyder further discloses that the base structure and the lid structure are aligned such that the first electrode array is positioned directly opposite the second electrode array (figure 2).
Regarding claim 13, Snyder further discloses that the at least one disruptor has a serpentine configuration (figures 1A, 1B).
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.
Claim 2 is/are rejected under 35 U.S.C. 103 as being obvious over Snyder in view of Vidalis (US 2014/0275895).
The applied reference Snyder has a common assignee and inventors with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
Regarding claim 2, Snyder does not disclose that the first electrode array comprises at least one combined counter/reference electrode; Snyder discloses counter and reference electrodes (paragraph [0036]) but does not explicitly disclose combining them. Vidalis teaches a similar transdermal sensing and analysis device (abstract) which includes a combined counter/reference electrode (paragraph [0216]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the device of Snyder with a combined counter/reference electrode, as taught by Vidalis, in order to allow the functionality of both while minimizing the size of the device.
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAREN E TOTH whose telephone number is (571)272-6824. The examiner can normally be reached Mon - Fri 9a-6p.
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/KAREN E TOTH/Examiner, Art Unit 3791
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