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 .
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 following features must be shown or the feature(s) canceled from the claim(s):
Claim 1: “a counter electrode provided above the supporting seat and provided in a first fixed state;” Examiner notes that while page 8 of Applicant’s Specification states “the second needle-shaped body 4 is provided with a reference electrode/counter electrode,” the counter electrode claimed is not indicated by a reference number or otherwise identifiable in the figures.
Claim 1: “an outer surface of the elastic object is provided with a working electrode, the working electrode is electrically insulated from the counter electrode;” the working electrode claimed is not indicated by a reference number or otherwise identifiable in the figures.
Claim 2: “an area surrounded by an inner side wall of the soluble needle-shaped body adjacent to the needle tip is less than a cross-sectional area of the free end;” Examiner notes that Applicant’s Fig. 2 shows a “soluble needle-shaped body 5” deforming to reveal a second needle-shaped body 4 and spring 3 encased beneath; however, the soluble needle-shaped body 5 is not depicted as containing an inner side wall having features as claimed.
Claim 3: “further comprising a reference electrode, wherein the reference electrode is provided corresponding to the working electrode and the counter electrode to form a three-electrode system;” the reference electrode claimed is not indicated by a reference number or otherwise identifiable in the figures, particularly separately from the working electrode.
Claim 10: “wherein the specific enzyme is provided on the working electrode adjacent to the free end of the elastic object;” the placement of the enzyme adjacent to a free end of the elastic object is not indicated by a reference number or otherwise identifiable in the figures.
Claim 11: see limitations recited mutatis mutandis as those of claim 1 in manufacturing limitations;
Claim 12: ““providing the working electrode at a position of the free end of the elastic object… providing the specific enzyme on the working electrode adjacent to the free end of the elastic object… providing the counter electrode in the first fixed state above the bearing surface;”
Claim 13: Examiner first notes that drawing objections to limitations verbatim those of claim 12 are also herein objected in claim 12; claim 13 further recites “making the working electrode and the counter electrode be externally connected separately by connecting paste;” such a paste is not indicated by a reference number or otherwise identifiable in the figures.
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.
Claim Objections
Claim 18 is objected to because of the following informalities:
“a manufacturing is as follows” should read as “the manufacturing method for the soluble material is as follows:”
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 12-15 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.
Re. Claim 12: Claim 12 recites “extruding the free end of the elastic object by the soluble needle-shaped body to compress the free end.” It is unclear how a process of extrusion of the elastic object occurs if the prior steps require the working electrode (positioned at the free end of the elastic object) is wrapped by the soluble needle-shaped body. As best understood, extrusion requires forcing material through a die. It is unclear how an elastic object may is extruded through a needle-shaped body having a cavity since such a body is not described as having an outlet or hole through which the elastic object is extruded through.”
Re. Claim 13: Claim 13 recites a “second needle-shaped body.” It is unclear how many needle-shaped bodies are required by the claim since a first needle-shaped body is not required earlier in claim 13 or claims from which claim 13 depends upon.
Re. Claim 14: Claim 14 requires electrodes “formed by coating [various materials].” However, the claim does not recite what element is being coated. While a reference electrode is stated as formed on the surface of the second needle-shaped body, the step of “coating silver/silver chloride slurry” is not directed to applying the coating on any particular structural element recited in the claim. A similar issue is found in the recitation “the working electrode and the counter electrode are formed by coating…”
Re. Claim 15: Claim 15 requires evaporating or sputtering material, but does not describe what structure such materials are evaporated or sputtered onto, similar to the issue indefiniteness of coating in claim 14.
Allowable Subject Matter
Claims 1 and 11 do not possess prior art rejections; should Applicant amend the claims and/or obviate the objection to the drawings, such claims would be in condition for allowability.
The following is an examiner’s statement of reasons for allowance, pending negation of drawing objections:
Each independent claim requires the following features, summarily:
A counter electrode provided above a supporting seat.
An elastic object having a natural state and compressed state (i.e., a spring).
An outer surface of the elastic object is provided with an enzymatic working electrode.
A soluble needle-shaped body fixed on the supporting seat and completely wrapping the counter electrode and the elastic object from an outside, and the soluble needle-shaped body has an inner cavity structure configured to enable the elastic object to be in the compressed state.
The closest prior arts of record are as follows:
Rong et al. (US 20130245412 A1) (hereinafter – Rong)
Chapin et al. (US 20220401024 A1) (hereinafter – Chapin)
Hanssen et al. (US 20150068028 A1) (hereinafter – Hanssen)
Durand et al. (US 20180264255 A1) (hereinafter – Durand)
Shen et al. (CN 110448305 A) (citing SEARCH translation) (hereinafter – Shen)
Thomas et al. (US 20210161437 A1) (hereinafter – Thomas)
Simpson et al. (US 20140107450 A1) (hereinafter – Simpson)
Fedder et al. (US 20130131482 A1) (hereinafter – Fedder)
The concept of three-electrode systems comprising a helically-wound electrode and enzyme layers are known from the following arts, wherein each art is deficient for reasons which follow:
Rong teaches helically wound dual counter/reference electrode around a working electrode (Figs. 2A-2C; Paragraph 0212), and enzymes provided on at least one of the electrodes (Paragraph 0212; Figs. 6A-6C) but is deficient in reciting elements of points b) and d).
Chapin teaches a micro-spring and micro-needle (Figs. 4A-4B) including embodiments having a three-electrode system (Paragraph 0059), but is deficient in reciting elements of points c) and d).
Hanssen teaches a three-electrode biosensor (Paragraph 0018, 0026) with a biocompatible layer which is biocompatible placed on the electrodes (Paragraph 0058) and an enzyme placed in the sensor (Paragraph 0111), but is deficient in reciting elements of points b) and d).
Durand teaches a needle introducer having a dissolvable substance to cause a microwire electrode to detach from the introducer body (Paragraph 0080), but is deficient in reciting elements of points a), c), and d).
Shen teaches a micro-needle electrode sensor having enzymatic layers, counter electrodes, reference electrodes, and working electrodes, and further states “the counter electrode and the reference electrode in a spiral form is wound on the working electrode is the second penetrant film coated on said electrode layer” (Page 3; Fig. 4), but is deficient in reciting elements of points b) and d).
The concept of a dissolvable introducer for an electrode system is known from the following arts, wherein each art is deficient for reasons which follow:
Thomas teaches an analyte monitoring system which “may incorporate a dermal dissolving sharp or introducer” (Paragraph 0827), but is deficient in reciting each necessary element of points a)-c).
Simpson teaches an electrode-based unit having an electrode with an enzymatic membrane covering (Paragraph 0008, Paragraph 0117) and a piercing element covering said electrode (Paragraph 0008: “a piercing element comprising a material that rapidly dissolves upon insertion into the host, the piercing element abutting the sensor tip and being capable of piercing tissue”), but is deficient in reciting each necessary element of points a)-c).
Fedder teaches a flexible electrode array and teaches “dissolvable, biodegradable, and biocompatible needles that encase the electrodes and facilitate their delivery into tissue” (Paragraph 0003), but is deficient in reciting each necessary element of points a)-c).
The combination of elements a)-d) is not suggested or obvious in light of the prior arts of reference.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Each dependent claim would be allowable for the same reasons as those of the independent claims notwithstanding drawing objections and rejections under 35 U.S.C. 112(b).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN XU whose telephone number is (571)272-6617. The examiner can normally be reached Mon-Fri 7:30-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at (571) 272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JUSTIN XU/Primary Examiner, Art Unit 3791
Prosecution Insights