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 Objections
The claims are objected to because they include reference characters which are not enclosed within parentheses. See Claim 11.
Reference characters corresponding to elements recited in the detailed description of the drawings and used in conjunction with the recitation of the same element or group of elements in the claims should be enclosed within parentheses so as to avoid confusion with other numbers or characters which may appear in the claims. See MPEP § 608.01(m).
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 6, 9-17 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 6 recites “the at least one circuit”. There is insufficient antecedent basis for this limitation.
Claim 9 recites “the base metalized layer”. There is insufficient antecedent basis for this limitation.
Claim 9 recites “base layer substrate”. There is insufficient antecedent basis for this limitation.
Claim 10 (11-17 by reference) recites “the at least one circuit”. There is insufficient antecedent basis for this limitation.
Claim 11 recites “the base metalized layer”. There is insufficient antecedent basis for this limitation.
Claim 12 (13-17 by reference) recites “an electrically-conductive pad” twice. While applicant uses references markers (560 and 562) , Examiner notes that while reference numbers help readability of the claims, claims must generally be complete in words. One should not have to rely on direct incorporation by reference to drawing elements or figures. The presence of reference numbers in a claim does not change the legal scope of that claim.
Claim 13 recites “the base metalized layer”. There is insufficient antecedent basis for this limitation.
Claim 13 recites “respective contact pads”. There is insufficient antecedent basis for this limitation.
Claim 14 (15-17 by reference) recites “a middle layer circuit” twice. While applicant uses references markers, Examiner notes that while reference numbers help readability of the claims, claims must generally be complete in words. One should not have to rely on direct incorporation by reference to drawing elements or figures. The presence of reference numbers in a claim does not change the legal scope of that claim. Examiner also notes that Claim 12 already recites “middle layer circuits”.
Claim 14 (15-17 by reference) recites “a contact pad” twice. While applicant uses references markers, Examiner notes that while reference numbers help readability of the claims, claims must generally be complete in words. One should not have to rely on direct incorporation by reference to drawing elements or figures. The presence of reference numbers in a claim does not change the legal scope of that claim. Is Applicant referring to conductive pads recited in claim 12?
Claim 16 (17 by reference) recites multiple limitations reciting “a contact pad” and “the contact pad and contact pad”. While applicant uses references markers, Examiner notes that while reference numbers help readability of the claims, claims must generally be complete in words. One should not have to rely on direct incorporation by reference to drawing elements or figures. Examiner also notes that Claim 14 already recites “a contact pad”.
Claim 16 (17 by reference) recites “a middle layer circuit” twice. While applicant uses references markers, Examiner notes that while reference numbers help readability of the claims, claims must generally be complete in words. One should not have to rely on direct incorporation by reference to drawing elements or figures. The presence of reference numbers in a claim does not change the legal scope of that claim. Examiner also notes that Claim 12 and 14 already recites “middle layer circuits”.
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.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Peterson et al. (WO 2018/118061 A1 – cited by Applicant), hereinafter Peterson.
Regarding Claim 1, Peterson teaches: A multi-layer sensor assembly (500) for use as a subcutaneous analyte sensor in a continuous monitoring system, the multi-layer sensor assembly comprising:
a distal end portion (502), the distal end portion comprising:
a first working electrode (530);
a counter electrode (532);
a second working electrode (533); and
a reference electrode (534);
a proximal end portion (501), the proximal end portion comprising a plurality of electrically conductive pads (590); and
a middle portion (503),
whereby the electrodes (530, 532, 533, 534) communicate electrically with the contact pads (590) through the middle portion [Peterson - paragraph 0191; figure 42 elements 500-503, 590 and 130-134].
Regarding Claim 2, Peterson teaches: The multi-layer sensor assembly of claim 1, wherein each of the distal end portion (502) and the middle portion (503) has a width of approximately 279 microns [Peterson – paragraph 0195].
Regarding Claim 3, Peterson teaches: The multi-layer sensor assembly of claim 1, further comprising a sensing layer formed over each of the first working electrode (530) and the second working electrode (533), the sensing layer comprising:
a base coating layer, the base coating layer comprising:
poly-2-hydroxyethyl methacrylate (PHEMA); and
glucose oxidase and/or glucose dehydrogenase on the first working electrode only;
a second coating layer disposed directly on the base coating layer, the second coating layer comprising:
PHEMA; and
a plurality of microspheres from polydimethylsiloxane (PDMS); and
a top coating layer disposed directly on the second coating layer, the top coating layer comprising:
PHEMA; and
Catalase [Peterson - paragraph 0192].
Regarding Claim 4, Peterson teaches: The multi-layer sensor assembly of claim 1,
the reference electrode (534) comprising:
a silver-silver chloride (AgCl) layer; and
a hydrogel membrane covering the AgCl layer; and
the counter electrode (532) comprising a hydrogel membrane [Peterson - paragraph 0193].
Regarding Claim 5, Peterson teaches: A multi-layer sensor assembly (500) for use as a subcutaneous analyte sensor in a continuous monitoring system, the multi-layer sensor assembly comprising:
an electrically insulating base layer (510), the base layer comprising:
a base proximal end portion (514);
a base distal end portion (516); and
a base middle portion (518) between the base proximal end portion and the base distal end portion;
an electrically insulating middle layer (550) disposed over the base layer, the middle layer comprising:
a middle layer proximal end portion (554);
a middle layer distal end portion (556); and
a middle layer middle portion (558) between the middle layer proximal end portion and the middle layer distal end portion; and
an electrically insulating top layer (580) disposed over the middle layer and having a size and shape corresponding to the middle layer and the base layer, the top layer comprising:
a top layer proximal end portion (582);
a top layer distal end portion (584); and
a top layer middle portion (586) between the top layer proximal end portion and the top layer distal end portion [Peterson – paragraph 0191-0195; figure 43].
Regarding Claim 6, Peterson teaches: The multi-layer sensor assembly (500) of claim 5, the base layer (510) further comprising:
a base metalized layer (520) disposed on the base layer defining at least one circuit (522);
the at least one circuit (522) extending longitudinally along the base layer; and
at least one electrically-conductive contact pad (524) formed at the base proximal end portion (514) in the at least one circuit (522); and
at least one electrically conductive contact pad (526) formed at the base distal end (516) in the at least one circuit (522) [Peterson – paragraph 0194-0198].
Regarding Claim 7, Peterson teaches: The multi-layer sensor assembly (500) of claim 5, the base layer (510) further comprising an electrically-insulating base layer substrate (512) made of polyimide and having a thickness between 7.5 μm and 12.5 μm [Peterson – paragraph 0197].
Regarding Claim 8, Peterson teaches: The multi-layer sensor assembly (500) of claim 7, wherein the base layer substrate (512) is formed by spin coating polyimide on a glass plate [Peterson – paragraph 0197-0199].
Regarding Claim 9, Peterson teaches: The multi-layer sensor assembly (500) of claim 5, wherein the base metalized layer (520) is formed by:
depositing a first part of chromium at 200±150 Å thick directly onto base layer substrate (512);
depositing a second part of gold 1000±150 Å thick directly onto the chromium; and
depositing a third part of chromium at 200±150 Å thick directly onto the gold [Peterson – paragraph 0059; 0200].
Regarding Claim 10, Peterson teaches: The multi-layer sensor assembly (500) of claim 5, the middle layer (550) further comprising an electrically insulating middle layer substrate (552) defining a plurality of middle layer through openings (564) with side walls extending to the base layer (510), wherein each middle layer through opening communicates electrically with a respective electrically-conductive contact pad (524, 526) of the at least one circuit (522) [Peterson – paragraph 0202-0205].
Regarding Claim 11, Peterson teaches: The multi-layer sensor assembly (500) of claim 10, wherein the middle layer substrate (552) is made of polyimide that is coated onto the base layer 510 and base metallized layer (520) and has a thickness between 7.5 μm and 12.5 μm [Peterson – paragraph 0201].
Regarding Claim 12, Peterson teaches: The multi-layer sensor assembly (500) of claim 10, the middle layer (550) further comprising:
a middle metalized layer (570) disposed onto the middle layer substrate (552) and side walls of the through openings (564) to define at least two middle layer circuits (572);
each middle layer circuit (572) comprises:
an electrically-conductive pad (560) formed at the middle layer proximal end portion (554);
an electrically-conductive pad (562) formed the middle layer distal end portion (556);
an electrically-conductive trace (574) electrically coupling the pad (560) with the pad (562); and
at least one or more additional electrically conductive pads (560, 562) in electrical contact with the through openings (564) [Peterson - paragraph 0195-0205].
Regarding Claim 13, Peterson teaches: The multi-layer sensor assembly (500) of claim 12, wherein the middle metalized layer (570) is deposited on a top surface (550 a), on sidewalls of the through openings (564), and onto at least a part of the base metalized layer (520), thereby creating electrical continuity between the base metallized layer (520) and respective contact pads (560, 562) [Peterson – paragraph 0202-0205].
Regarding Claim 14, Peterson teaches: The multi-layer sensor assembly (500) of claim 12, the middle layer proximal end portion (554) further comprising:
a middle layer circuit (572 a) that includes a contact pad (560 b);
a middle layer circuit (572 b) that includes a contact pad (560 c);
a contact pad (560 a) that defines two through openings (564 a); and
a contact pad (560 b) that defines two through openings (564 b) [Peterson – paragraph 0201-0206].
Regarding Claim 15, Peterson teaches: The multi-layer sensor assembly (500) of claim 14, wherein the contact pads (560 a, 560 b) each have electrical continuity to the base metallized layer (520) at the contact pads (524 a, 524 b) respectively [Peterson – paragraph 0202-0205].
Regarding Claim 16, Peterson teaches: The multi-layer sensor assembly (500) of claim 14, the middle layer distal end portion (556) further comprising:
a contact pad (562 a);
a contact pad (562 b) comprising a through opening (564 c) having electrical continuity to the based metallized layer (520) at the contact pad (526 b);
a contact pad (562 c);
a contact pad (562 d);
a middle layer circuit (572 a) comprising the contact pad (562 a);
a middle layer circuit (572 b) comprising the contact pad (562 c),
wherein the contact pad (562 b) and contact pad (562 d) are isolated from the middle layer circuits (572 a, 572 b) [Peterson – paragraph 0201-0206].
Regarding Claim 17, Peterson teaches: The multi-layer sensor assembly (500) of claim 16, wherein the contact pad (562 a) is segmented to three contact pad portions (562 a 1, 562 a 2, 562 a 3) to prevent cracking and delamination of an Ag/AgCl layer [Peterson – paragraph 0204].
Regarding Claim 18, Peterson teches: The multi-layer sensor assembly (500) of claim 5, the top layer (580) further comprising:
a plurality of contact openings (590) on the top layer proximal end portion (501); and
a plurality of sensor wells (592) on the top layer distal end portion (502) [Peterson - paragraph 0195; 0253-0254].
Regarding Claim 19, Peterson teaches: The multi-layer sensor assembly (500) of claim 18, wherein
the plurality of contact openings (590) coincide with electrically-conductive pads (560) of the middle layer (550); and
the plurality of sensor wells (592) coincide with electrically-conductive pads (562) of the middle layer (550) [Peterson – paragraph 0195].
Regarding Claim 20, Peterson teaches: A multi-layer sensor assembly (500) for use as a subcutaneous analyte sensor in a continuous monitoring system, the multi-layer sensor assembly comprising:
a distal end portion (502), the distal end portion comprising:
a first working electrode (530);
a counter electrode (532);
a second working electrode (533); and
a reference electrode (534);
a proximal end portion (501), the proximal end portion comprising a plurality of electrically conductive pads (590); and
a middle portion (503), whereby the electrodes (530, 532, 533, 534) communicate electrically with the contact pads (590) through the middle portion;
a base layer (510);
a middle layer (550) disposed over the base layer; and
a top layer (580) disposed over the middle layer [Peterson - paragraph 0191-0205; figures 42-49].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAY B SHAH whose telephone number is (571)272-0686. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson can be reached at 571-272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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JAY SHAH
Primary Examiner
Art Unit 3791
/JAY B SHAH/Primary Examiner, Art Unit 3791
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