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 4 and 8 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 4 recites the limitation “a second adhesive layer” in line 2. Given that a first adhesive layer is not recited in claim 1, upon which claim 4 depends, there is insufficient antecedent basis for this limitation in the claim, and the scope of the claim is unclear. For examination purposes, claim 4 will be read as depending upon claim 3, which recites a first adhesive layer. Dependent claim 8 is necessarily rejected as depending upon a rejected base claim.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 3-5, and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US PGPub No. 2018/0360341), hereinafter Wang, in view of Kitagawa et al. (US Patent No. 4,947,846), hereinafter Kitagawa.
Regarding claim 1, Wang teaches a biological sensor to be attached to a living body (Fig. 7: sensor module 2), the biological sensor comprising:
a sensor body configured to obtain biological information (Fig. 7 and par. 0075: “a sensor die (e.g., heart monitor sensing die) on the first side 10 can process the signals transduced by the ECG electrode or pad 82”);
an electrode connected to the sensor body (Fig. 9: ECG pads 82);
a cover member including a housing space in which the sensor body is housed and an opening of the housing space (Fig. 10: first cover 53 housing sensor components),
a moisture permeability of the cover member being 350 g/(m2⋅day) or less (par. 0077: “The first cover 53 may comprise a first cover layer 54 (e.g., a foam material such as SCF®) and a protective layer 93 (e.g., white polyethylene terephthalate (PET)”);
a first base that is provided so as to face the opening of the cover member (Fig. 1: conformal layers 52);
and a second layer member attached to a surface of the first base opposite to that facing the cover member so as to expose the electrode and cover the sensor body (Figs. 9A-10: second cover 55 having windows to expose electrodes 82 and covering sensor components on substrate 4).
Wang does not explicitly teach wherein the first base includes a jutting-out portion in at least a part of an outer peripheral portion of the first base, the jutting-out portion projecting beyond outer peripheral portions of the cover member and the second layer member, a moisture permeability of the first base being 3,600 g/(m2⋅day) or less, and a tensile strength of the first base at a strain of 20% being 5.0N/10mm or less. However, in an analogous art, Kitagawa teaches a biological sensor with a first waterproof base (Figs. 6-7: waterproof ring-shaped sheet 37) having a jutting-out portion in at least a part of an outer peripheral portion of the first base, the jutting-out portion projecting beyond outer peripheral portions of the rest of the sensor device (Figs. 6-7: adhesive sheet 3 projecting beyond rest of sensor device) and having high moisture permeability and low tensile strength (col 4, lines 64-66: “The adhesive sheet 3 is made of a material such as non-woven fabric or the like which is excellent in terms of gas permeability and water permeability”). Kitagawa teaches that the disclosed adhesive ring with high moisture permeability and low tensile strength provides a better adaptation to the human body than an impermeable and inflexible material (col 4, lines 16-19: “using non-woven fabric as an adhesive sheet 3 provides a better adaptation to the human body and is preferable in that it improves gas permeability and water permeability”), while the inner portion continues to provide necessary waterproofing for the sensor to prevent short circuits (col 5, lines 3-12: “when a warm or cold bath test is performed with the adhesive sheet 3 and the sheet 37 stuck to the human body, even if water (including warm water) penetrates from the outside to the inside by capillary action along the adhesive sheet 3, water permeation is prevented by the non-permeable sheet 37, water penetration to the portion of sponge 5 is prevented, and the electrical connection between the conductive gel in the sponge and the outside water is prevented”).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the sensor of Wang by providing an adhesive ring with high moisture permeability and low tensile strength projecting beyond the outer peripheral portions of the sensor device, as taught by Kitagawa, in order to provide better adaptation to the human body while preventing short circuits, as taught by Kitagawa.
Kitagawa teaches high moisture permeability and low tensile strength for the first base (adhesive sheet) but does not explicitly teach the upper limits of 3,600 g/(m2⋅day) or 5.0 N/10 mm at a strain of 20%, respectively. However, given that most non-woven fabrics exhibit a similar range of moisture permeability and tensile strength, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to select a particular non-woven fabric with properties falling within the claimed range, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 3, the combination teaches the device of claim 1 as described previously. Wang further teaches further comprising: a first adhesive layer that is provided at a surface of the first base, the surface of the first base facing the living body, and to which the electrode is attached (Figs. 10 and 16B: adhesive layer 56 attached to electrode 82); and an upper adhesive layer that attaches the cover member and the first base to each other (Fig. 10: adhesive layer 58 attaching base 52 and cover 53).
Regarding claim 4, the combination teaches the device of claim 3 as described previously. Wang further teaches wherein the second layer member includes a second adhesive layer at a surface opposite to the first base (Fig. 10: tape 78; par. 0077: “the tape 78 can be used to adhere the sensor module to the user's body”).
Regarding claims 5 and 7-8, the combination teaches the devices of claims 1 and 3-4 as described previously. The combination further teaches wherein an attachment surface to the living body is formed by the electrode, the first base, and the second layer member (see Wang at Figs. 9A and 10: electrode pads 82, tape 78; and Kitagawa at Figs. 6-7: adhesive sheet 3).
Claims 2 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Kitagawa and further in view of Garai et al. (US PGPub No. 2020/0337642), hereinafter Garai.
Regarding claim 2, Wang in view of Kitagawa teaches the device of claim 1 as described previously. The combination does not explicitly teach wherein the first base includes a polyurethane-based thermoplastic elastomer. However, in an analogous art, Garai teaches a biological sensor with an adhesive including a polyurethane-based thermoplastic elastomer (par. 0128: “The adhesive patch 18 may be composed of a flexible and breathable material with one or more adhesive layers, such as cloth, a bandage-like material, and the like. For example, suitable materials could include polyurethane, polyethylene, polyester, polypropylene, polytetrafluoroethylene (PTFE), or other polymers, to which one or more adhesive layers are applied”). In light of Garai’s teaching, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to include a polyurethane-based thermoplastic elastomer in the first base, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. See also Ballas Liquidating Co. v. Allied industries of Kansas, Inc. (DC Kans) 205 USPQ 331.
Regarding claim 6, the combination teaches the device of claim 2 as described previously. Wang and Kitagawa further teach the limitations of claim 6 for the same reasons set forth in the rejection of claims 5 and 7-8.
Conclusion
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/D.E.L./Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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