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 .
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 and dependent claims thereof 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 1: The term “substantially” in claim 1 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Thus, the degree to which an insulating sheath covers a corresponding electrically conductive core is rendered indefinite.
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.
Claims 1, 3, 5, and 6 are rejected under 35 U.S.C. 103 as being unpatentable over:
Duvall et al. (US 20230293060 A1) (hereinafter – Duvall) in view of
Brister et al. (US 20170360341 A1) (hereinafter – Brister).
Re. Claim 1: Duvall teaches an invasive multi-electrode electrochemical sensor, comprising:
a substrate (see annotated Fig. 14D below: a first interpretation of a “substrate” may be only the paddle-shaped portion shown in Fig. 14D and each analogous part in each other figure; see annotated Fig. 15C below: a second interpretation of a “substrate” can be interpreted as the base layer 110 shown in Fig. 4A and each analogous part shown in each other figure; see annotated figures below);
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Annotated Fig. 14B: First interpretation of “substrate”
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Annotated Fig. 15C: Second interpretation of “substrate”
a plurality of wire electrodes (Abstract: “The coaxial analyte sensors can include one or more co-extruded wire electrodes with a substrate;” see any figure providing more than one electrode),
wherein each said wire electrode comprises an electrically conductive core and an insulating sheath (Figs. 15A-15D; Paragraph 0221: “The sensor assembly 1500 can be made by co-extruding the suitable conductive materials with the insulating polymer of the substrate;” similarly shown in Figs. 16A-16D and described in Paragraph 0222; similarly shown in Figs. 17A-17D and described in Paragraph 0226),
each said insulating sheath substantially covers a corresponding one of the electrically conductive cores while exposing a proximal end and a distal end of the corresponding one of the electrically conductive cores (see figures 15C, 15D, 16C, 16D, 17C, 17D),
each said wire electrode has a substrate section (see annotated Fig. 14D per Examiner’s first interpretation of a “substrate;” Fig. 14D shows wires of electrodes on the paddle-shaped portion, thus forming a section of wires located on a portion of the device identified as a substrate; see also each analogous part in each other figure; see annotated Fig. 15C per Examiner’s second interpretation of “a substrate;” Figs. 15C, 15D show a portion of each electrode which extending from, e.g., substrate 1510, which allows portions of wires covered by substrate 1510 to read on a “substrate section;” see each analogous part in Figs. 16C, 16D, 17C, 17D) and
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Annotated Fig. 14B: First interpretation of “substrate section” and “invasion section”
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Annotated Fig. 15C: Second interpretation of “substrate section” and “invasion section”
an invasion section (see annotated figures above),
the proximal end and the distal end of the electrically conductive core of each said wire electrode are located at the substrate section and the invasion section of the each said wire electrode respectively (see annotated Fig. 14D above: a first interpretation of an “invasion section” can be the entire portion of the wire electrodes which are not on the paddle-shaped portion shown in Figs. 14D; see also each analogous part in each other figure; see annotated Fig. 15C above: per Examiner’s second interpretation of a substrate, Figs. 15C, 15D show a portion of each electrode which extending from, e.g., substrate 1510, which allows portions of wires not by substrate 1510 to read on an “invasion section”),
the substrate section of each said wire electrode is provided on the substrate, the invasion section of each said wire electrode extends outward from an edge of the substrate (see annotated figures above).
Duvall does not teach the invention comprising:
an axle,
the invasion sections of the wire electrodes being wound around the axle spirally,
the axle having a terminal end protruding beyond the distal ends of the invasion sections.
Duvall teaches, at most, that wire electrodes are patterned in a spiral pattern within a substrate with no central element (Figs. 15A, 15B) or within a substrate around an electrode (Figs. 16A-17B). Thus, Duvall does not teach invasion sections of all wire electrodes being wound around an axle (emphasis added). As best understood, the electrodes shown in the cited figures remain longitudinal (i.e., unwound), and their cross-section displays a spiral pattern.
The concept of wrapping electrodes around an “axle” is not considered novel. Brister teaches analogous art in the technology of electrode-based analyte sensors (Abstract). Brister further teaches the invention further comprising:
an axle (Fig. 1B: central core 16),
the invasion sections of the wire electrodes being wound around the axle spirally (Fig. 1B: electrodes 18, 20 helically wound or twisted about core 16),
the axle having a terminal end protruding beyond the distal ends of the invasion sections (Fig. 1B: at least some portion of the central core 16 extends beyond electrodes 18, 20).
It would have been obvious to one having skill in the art before the effective filing date to have modified Duvall to include the use of a central core (i.e., an axle) and wrapping electrodes around such an axle as taught by Brister, the motivation being that the central core may be formed of a material not limited to solely electrode materials (Paragraph 0330: “The central core 16 can be… a support made of insulating material”), which allows for further flexibility in constructing a tool for inserting the sensing electrodes of Duvall into a body.
Re. Claim 3: Duvall as modified by Brister teaches the invention according to claim 1. Brister, in teaching further detail regarding the incorporated structure, further teaches the invention wherein the terminal end is solid (see citations of claim 1 – the central core 16 is formed from a solid material).
Re. Claim 5: Duvall as modified by Brister teaches the invention according to claim 1. Duvall further teaches the invention further comprising a cover plate provided on the substrate such that the substrate sections of the wire electrodes are at least partially fixed between the cover plate and the substrate (Fig. 5K: interspersed insulating layer 532 can be interpreted as cover a cover plate provided on substrate sections of electrodes (i.e., portions overlying the paddle shape shown in Fig. 14C, or, in Examiner’s second interpretation, the substrate 510 itself) which partially fixes wire electrodes between 532 and substrate 510, as shown at Fig. 5G; Fig. 7B: see second side 704 comprising insulating layer 732 over top each electrode shown at Fig. 7C; see analogous structures in remaining figures; alternatively or additionally – Fig. 3A: see any portion of mounting unit 314 provided over top of substrate sections (not shown) of analyte sensor 334).
Re. Claim 6: Duvall as modified by Brister teaches the invention according to claim 1.
In Examiner’s first interpretation of an “invasion section” (e.g., the non-paddle section of the device depicted in Fig. 14B), Duvall teaches that the “overall length of the sensor is dependent on the requirements of the wearable/inserter but are generally between 15 mm and 25 mm” (Paragraph 0165). Thus, Duvall, in Examiner’s first interpretation, teaches an invasion section which is “greater than 10 mm” as required by claim 6.
In Examiner’s second interpretation of an “invasion section” (e.g., exposed electrodes past substrate 1510 shown in Fig. 15C), Duvall is silent regarding the length of these sections. However, Applicant’s disclosure is silent regarding criticality or unexpected results of requiring an “a length for which each of the invasion sections extends outward from the edge is greater than 10 mm.” Since Duvall already suggests that the overall sensor length is dependent on the requirements of the wearable/inserter (Paragraph 0165), it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the lengths of invasion sections to be at the claimed lengths since the length of a sensor is a result-effective variable (i.e., an overall length including the length of an invasion section entering tissue), and it has been held that, where the general conditions of a claim are disclosed in the prior art, discovering an optimum value of a result-effective variable involves only routine skill in the art. See In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Claims 2 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over:
Duvall et al. (US 20230293060 A1) (hereinafter – Duvall) in view of
Brister et al. (US 20170360341 A1) (hereinafter – Brister) in further view of
Duhamel et al. (US 20230277762 A1) (hereinafter -- Duhamel).
Re. Claim 2: Duvall as modified by Brister teaches the invention according to claim 1, but does not teach the invention wherein the terminal end is pointed.
Duhamel teaches analogous art in the technology of analyte monitoring (Abstract). Duhamel further teaches the invention wherein the terminal end is pointed (Paragraph 0135: “FIGS. 15(A-C) show various embodiments of sensors wherein the electrodes are… wrapped around the needle or cannula”).
It would have been obvious to one having skill in the art before the effective filing date to have modified Duvall as modified by Brister to utilize a needle as a central core, the motivation being that Duhamel suggests that such a structure may be useful for introducing the sensor into a patient for integrated sensors (Paragraph 0135; Abstract: “… the delivery methods include… a microneedle array…”).
Re. Claim 4: Duvall as modified by Brister teaches the invention according to claim 1, but does not teach the invention wherein the terminal end is pointed.
Duhamel further teaches the invention wherein the terminal end is pointed (Paragraph 0135: “FIGS. 15(A-C) show various embodiments of sensors wherein the electrodes are… wrapped around the needle or cannula”).
It would have been obvious to one having skill in the art before the effective filing date to have modified Duvall as modified by Brister to utilize a cannula as a central core, the motivation being that doing so creates a method of delivering a analyte sensing electrode structure with an integrated insulin delivery and monitoring system (Abstract).
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.
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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.
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/JUSTIN XU/Primary Examiner, Art Unit 3791