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 Objections
Claims 1 and 7 are objected to because of the following informalities:
Claim 1: “to at least covering” should read as “to at least cover”
Claim 7: ““silver, a combination thereof” should read instead as “silver, or a combination thereof””
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.
Claim 8 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.
Re. Claim 8: Claim 8 possesses multiple issues of indefiniteness.
It is unclear what is “the other surface of the substrate.” Claim 1 requires that a substrate is formed on “one surface” of the substrate. If the substrate can be considered a very thin piece of material with negligible depth, then one planar face of the substrate may possess multiple surfaces which are defined as subsets of the face; thus, the choice is not binary, and the limitation “other surface of the substrate” is not well-defined. If the substrate can be considered a material having depth (e.g., as a rectangular prism), then the substrate comprises at least 3 other planar faces. That is, if a claimed surface is interpretable as the entirety of a planar face, then the substrate in this interpretation also does not possess a binary choice of surfaces for substrate since at least three other planar surfaces exist; thus, the limitation “other surface of the substrate” remains indefinite.
The claim recites a “second sensing region” but a “first sensing region” is not defined earlier in the claims. It is unclear how many sensing regions are required.
The claim recites a “second insulation layer” but a “first insulation layer” is not defined earlier in the claims. It is unclear how many sensing regions are required.
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.
Claims 1 and 2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
Wang et al. (US 20180199873 A1) (disclosed by Applicant) (hereinafter – Wang).
Re. Claim 1: A method for manufacturing an implantable micro-biosensor adapted to be implanted under skin of a body to continuously monitor a physiological parameter of an analyte in a biological fluid of the body (Paragraph 0135: “Moreover, the continuous analyte sensor 110 may be implanted as at least one of the following types of flexible analyte sensors: an implantable glucose sensor, a transcutaneous glucose sensor, implanted in a host vessel or extracorporeally, a subcutaneous sensor, a refillable subcutaneous sensor, an intravascular sensor;” Paragraph 0171: “Although certain sensor configurations and methods of manufacture are described herein, it should be understood that any of a variety of known sensor configurations can be employed with the analyte sensor systems and methods of manufacture described herein…;” Paragraph 0262: “The sensor 700 illustrated in FIG. 7 can be manufactured using a variety of techniques as described herein…”),
the method comprising the steps of:
A) providing a substrate which includes an implanting end portion, which is elongated in a longitudinal direction and which is to be implanted under the skin (Fig. 7: elongated core 702 is a substrate which comprises the sensor 700 intended to be implanted under the skin);
B) forming on one surface of the substrate a first electrode which is used as a counter electrode (Fig. 7: counter electrode 706), and
which includes a front portion and a rear portion both disposed at the implanting end portion, wherein the front portion extends along the longitudinal direction, and the rear portion extends along the longitudinal direction and away from the front portion (Fig 7: see ends of counter electrode 706 in the longitudinal direction),
and
a sensing section of the first electrode at least including the front portion (Fig. 7: a sensing membrane 508 is deposited over the entirety of counter electrode 706);
C) forming on the one surface of the substrate a second electrode which is spaced apart from the first electrode (Fig. 7: working electrode 704 is smaller and spaced apart from counter electrode 706), and
which includes a sensing section disposed at the implanting end portion and having an area less than that of the sensing section of the first electrode (Fig. 7: the corresponding area of the working electrode covered by sensing membrane 508 is smaller than the section of sensing membrane 508 covering counter electrode 706);
D) forming on the substrate a third electrode which includes a sensing section disposed at the implanting end portion (Paragraph 0254: “In aggregate, core 702 and the conductive features formed thereon (e.g., one or more working electrodes…;” Examiner notes that “one or more” discloses at least a second working electrode formed on the core 702); and
E) applying a chemical reagent layer to at least covering the sensing section of the third electrode so as to permit the third electrode to selectively cooperate with the first electrode or the first and second electrodes to measure a physiological signal in response to the physiological parameter of the analyte (Paragraph 0254: “A membrane 508 may be disposed on the core 702 covering at least the working electrode 704…” see previous citation of Paragraph 0254 contemplating plural working electrodes; Paragraph 0101: As a non-limiting example, in an electrochemical glucose sensor, a working electrode measures hydrogen peroxide, H2O2, at its electroactive surface. The hydrogen peroxide is produced by the enzyme-catalyzed reaction of the analyte detected, which reacts with the electroactive surface to create a detectable electric current;” Examiner is interpreting “selectively cooperate” as being encompassed by the purely positive case – that is, the membrane 508 of allows underlying electrodes to cooperate to measure a physiological signal).
Re. Claim 2: Wang teaches the invention according to claim 1. Wang further teaches the invention wherein in step C), the second electrode is used as a reference electrode or another working electrode (see discussion of Paragraph 0254 in rejection of claim 1 – more than one working electrode is contemplated by Wang).
Claims 3-8 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
U.S. Patent No. 12,364,418 B2 (hereinafter – the ‘418 patent)
Murase et al. (U.S. 20160116429 A1) (hereinafter – Murase)
Cheng et al. (US 20200337605 A1) (hereinafter – Cheng)
Hoss et al. (US 20100230285 A1) (hereinafter – Hoss).
The ‘418 patent is a commonly-assigned patent, where claim 16 of the patent recites limitations that are either identical or encompassing those of claim 3 of the present application; however, the independent claim of the patent application differs in reciting limitations which are not suggested by the prior art, such as:
“A) providing a substrate which includes an implanting end portion, which is elongated in a longitudinal direction…
B) forming on one surface of the substrate a first electrode which is used as a counter electrode which includes a front portion and a rear portion both disposed at the implanting end portion, wherein the front portion extends along the longitudinal direction, and the rear portion extends along the longitudinal direction and away from the front portion…
C) forming on the one surface of the substrate a second electrode which is spaced apart from the first electrode, and which includes a sensing section disposed at the implanting end portion and having an area less than that of the sensing section of the first electrode.”
Murase and Hoss are prior art references used in rejecting the ‘418 patent in previous Office Actions; however, neither Murase and Hoss teach the limitation of “converting the precursor material disposed at the other one of the two areas to a reference electrode material so as to form the sensing section of the second electrode” as recited in claim 3.
Cheng is the closest prior art of reference regarding claim 5 (see Figs. 4A-4E). However, Cheng does not teach the limitations of:
“b2) subjecting the backing material layer to patterning so as to divide the backing material layer into two areas which are separated from each other and which are free of electrical connection, one of the two areas being used for forming the first electrode, and the other one of the two areas being used for forming the second electrode; and
b3) applying a reference electrode material on the other one of the two areas so as to form the sensing section of the second electrode.”
The manufacturing process shown through, particularly Figs. 4B-4F utilize masking to sequentially deposit material onto a layer 220, but to form separate electrodes shown in Fig. 4C; however, it is not clear that the layer above 220 in Fig. 4B is formed through patterning in order to divide material into two separate areas, with the most detail provided at Paragraph 0045; as best understood, electroplating and deposition of a seed layer are used to form the layer directly below layer 240 which is the closest component interpretable as a “back material.” Furthermore, the device of Cheng is directed to temperature sensing, and not electrochemical sensing as in the present application.
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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/JUSTIN XU/Primary Examiner, Art Unit 3791
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