DETAILED ACTION
This action is pursuant to the claims filed on December 26, 2024. Claims 1-12 are pending. A first action on the merits of claims 1-12 is as follows.
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 . 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 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.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4 and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Masuda (WO 2020/196097).
In regards to independent claim 1, Masuda discloses a biological sensor (stick on biosensor 100 in Fig. 1) to be attached to a living body (a stick-on biosensor 100 that is brought into contact with a living body as a subject to measure biological information), the biological sensor comprising:
a sensor body (an electronic device 150 comprising a substrate 135, battery 160 in Fig. 1) configured to obtain biological information ([0081]-[0083]: the electronic device 150 is configured to process biological signal acquired via an electrode);
an electrode (electrode/probe 140) connected to the sensory body (electrode/probe 140 is connected to the device 150 via wiring 130 and is configured to acquire biological signal, [0083]);
a first layer member (cover layer 170, [0086]) including a housing (a protrusion 170B) that forms a housing space in which the sensor body is housed (a recess 170C as shown in Fig. 2 is shown formed by cover layer 170 and houses the electronic device 150), the electrode being disposed on a lower surface of the first layer member (the electrode 140 is disposed below layer 170 as shown in Fig. 2); and
a second layer member (base material layer 120 and its pressure sensitive adhesive layer 110) that is attached to the lower surface of the first layer member so as to expose the electrode and cover the sensor body (the base material layer 120 covers the bottom surface of the device 150 and exposes the electrode 140 via hole 113), wherein
at least a part of a connection portion (circuit unit 130) that is provided between the first layer member and the second layer member so as to overlap with a part of the electrode (the circuit unit 130 is between the layers 120 and 170) and connects the electrode to the sensor body is provided so as to be disposed in the housing in a plan view of the biological sensor (a small portion of the wiring 131 of the circuit unit 130 is disposed in the housing 130 as shown in exemplary Fig. 2).
In regards to claim 2, Masuda further discloses wherein the housing has a flexural rigidity that is higher than that of portions of the first layer member, the portions of the first layer member being other than the housing (the cross sectional area of the sensor 100 shows that the housing portion 170C has a thickness greater than the thickness of the cover 170 where the electrode 140 is disposed on; therefore, the rigidity of the housing portion 170C is greater than the layer 170 where the electrode 140 is disposed on).
In regards to claim 3, Masuda further discloses wherein the housing is formed into a dome shape (protrusion 170C is inherently has a roof/vault).
In regards to claim 4, Masuda further discloses wherein the housing includes a projection in a center region of the biological sensor (the protrusion 170C is at a center of cover 170 as shown in Fig. 1), the projection protecting in a direction away from the living body (the protrusion 170C protects in a direction away from the skin); a tilted portion that is formed so as to be tilted from the projection toward both ends of the biological sensor (the cover 170 comprises a curved portion that extends from the protrusion 170B to the 170A), wherein at least the part of the connection portion is provided so as to be disposed in the tilted portion in a plane view of the biological sensor (a portion of the wiring 131 of the circuit unit 130 adjacently positioned to substrate 135 is disposed in the curved portion that extends from the protrusion 170B to the cover portion 170A as shown in exemplary Fig. 2).
In regards to claim 6, Masuda further discloses wherein the second layer member includes a second adhesive layer at a surface opposite to the first layer member (the base material layer 120 comprises a pressure-sensitive adhesive layer 110 as shown in Fig. 2).
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 5 and 7-12 are rejected under 35 U.S.C. 103 as being unpatentable over Masuda and further in view of as applied to claim 1 above, and further in view of Kumar et al. (hereinafter ‘Kumar’, U.S. PGPub. No. 2011/0279963).
In regards to claims 5 and 7-12, Masuda discloses the invention substantially as claimed in claim 1 and discussed above.
Masuda further discloses the first layer member arrangement as claimed in claim 5.
Kumar teaches a patch sensor similar to Masuda (see 900 in Figs. 9A-9B, [0095]). Specifically, Kumar teaches a multi-layer arrangement that can be sequentially removed such that a plurality of adhesives of the respective multi-layer arrangement can be peeled over a period of time to use new adhesive of the plurality of adhesives ([0095]). Specifically, Kumar teaches a first base (layer 901) including a housing space in which the sensor body is housed and an opening of the housing space (general dome-shaped profile of the layer 901 to accommodate electronics 108), a first adhesive layer that is provided at a surface of the first base (the adhesive 962 along the layer 901), the surface of the first base being opposite to a cover member (note that this is broadly claimed and that the adhesive 962 is positioned opposite to the upper surface of layer 902), and to which an electrode is attached (the examiner notes that all structures are directly and indirectly attached, including the electrodes 124 and 126 to the layer 902 and the adhesive 962), and the cover member (layer 902) includes a housing space in which the sensor body is housed (the general dome-shaped profile of layer 902 accommodates the layer 901 and the electronics 108) and an opening of the housing space (the dome-shaped profile of layer 902 has an opening along the lower surface to accommodate layer 901 and the electronics 108), and an upper adhesive layer (the adhesive 962 of the layer 902) that attaches the cover member (902) and the first base to each other (901) since the upper adhesive layer (962) allows for the cover member to be disposed on and attached to the first base when attached to the skin. Given that the first base of Kumar is equivalent to the first layer member (e.g. cover layer 170) of Masuda, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the first layer member of Masuda and incorporate a plurality of members/layers and its respective adhesive layer as taught by Kumar such that each layer is capable of being peeled away so that new adhesive can be used to assist adhesion to the skin over a period of time ([0095]).
The examiner notes that the combination of Masuda/Kumar results in an attachment surface to a living body that is formed by the electrode (electrode/probe 140 of Masuda in Fig. 2), the second layer member (base material layer 120 and the pressure-sensitive adhesive layer 110 of Masuda in Fig. 2) and the first layer member (the additional layer 902 that is disposed above the layer 901 that forms a contact with via adhesive 962 of Kumar which is equivalent to the layer 120 of Masuda), thus meeting claims 7-12.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EUNHWA KIM whose telephone number is (571)270-1265. The examiner can normally be reached 9AM-5:30PM.
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, JOSEPH STOKLOSA can be reached at (571) 272-1213. 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.
/EUN HWA KIM/Primary Examiner, Art Unit 3794 6/25/2026
Prosecution Insights