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 .
Response to Amendment
The Amendments filed December 18, 2024 have been entered. Currently, claim 6 has been amended, claims 7-10 have been newly added, and claims 1-20 are pending in the application.
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 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Hughes (U.S. Application No. 20160120433 A1), and further in view of Perez (E.P. Application No. 3261712B1), and as evidenced by MatWeb (“Overview of materials for Styrene-Butadiene Copolymer, SBC”) henceforth referred to as MatWeb.
Regarding independent claim 1, Hughes discloses a biological sensor (100) (pa. 0080, 0094 & Fig. 1A), comprising:
a sensor body (120) configured to obtain biological information (via contact electrode traces 311, 312 which are connected to electrodes 350, pa. 0100, 0122 & Figs. 1B, 3B). Examiner is interpreting a sensor body as a conductive structure able to receive and transmit electric signals;
an electrode (350) connected (electrically) to the sensor body (pa. 0113);
a first layer member (combination of upper housing member 140, battery holder 150, upper gasket 370, flexible body 110, and lower gasket 360) including a cover member (140) that includes a housing space (space between the upper gasket and the cover member which holds the sensor body, the battery holder, and batteries 160) in which the sensor body is housed (pa. 0096 & Fig. 1B), the electrode being disposed on a lower surface of the first layer member (see Figs. 3B, 6A); and
a second layer member (combination of lower housing member 145 and lower surface of the flexible body which includes adhesive layer 340 that is applied to wings portions 130, 131 of a bottom surface of bottom substrate layer 330, pa. 0119 & Fig. 3B) that is attached to the lower surface of the first layer member so as to expose the electrode and cover the sensor body (see Fig. 6A).
Lastly, Hughes discloses the cover is made of a water-resistant plastic (pa. 0126).
Examiner notes that the claim language is broad and does not prohibit the first layer and the second layer from sharing structural components.
However, Hughes does not disclose wherein a tensile modulus of the cover member is 1.5 MPa or less and a relative dielectric constant of the cover member is 2.2 or less.
Perez, in the same field of endeavor, teaches a patch device (110) comprising a housing (111) sealed so that it is waterproof or water-resistant, wherein the housing may be molded from polymeric materials such as styrene-butadiene co-polymers (pa. 0503 & Fig. 1A).
It is known to one of ordinary skill in the art that a styrene-butadiene co-polymer has inherent material properties such as a tensile modulus of 1.61 - 27.6 MPa and a dielectric constant of 2.50 (MatWeb).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the water-resistant material of the cover of Hughes with the water-resistant styrene-butadiene co-polymer material taught by Perez since they are known both variants in the art and they would both yield the same predictable results of waterproofing the electrical components housed inside the biological sensor.
Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to have a cover with a dielectric constant of 2.2 or less, 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 claims 2-3, Hughes discloses the cover is made of a water-resistant plastic (pa. 0126).
However, Hughes does not disclose wherein the cover member includes a thermoplastic elastomer, wherein the thermoplastic elastomer is a styrene-based thermoplastic elastomer.
Perez, in the same field of endeavor, teaches a patch device (110) comprising a housing (111) sealed so that it is waterproof or water-resistant, wherein the housing may be molded from polymeric materials such as styrene-butadiene co-polymers (pa. 0503 & Fig. 1A).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the water-resistant material of the cover of Hughes with the water-resistant styrene-butadiene co-polymer material taught by Perez since they are known both variants in the art and they would both yield the same predictable results of waterproofing the electrical components housed inside the biological sensor.
Regarding claim 4, Hughes/Perez combination discloses wherein
the first layer member includes
a first base (combination of the battery holder 150, upper gasket 370, and flexible body 110) including a through-hole (see two holes for retaining batteries 160 in Fig. 1B) at a position corresponding to the housing space (Hughes, see Fig. 1B), and
a first adhesive layer (adhesive surface 340 of the flexible body) that is provided at a surface of the first base, the surface of the first base facing a living body, and to which the electrode is attached (Hughes, pa. 0131 & Figs. 3B, 6A), and
an upper adhesive layer (adhesive surface provided on the top gasket 370 and bottom gasket 360) that attaches the cover member and the first base to each other (Hughes, pa. 0125).
Regarding claim 5, Hughes/Perez combination discloses wherein the second layer member includes a second adhesive layer (adhesive surface 340 of the flexible body) at a surface opposite to the first layer member (Hughes, pa. 0131 & Figs. 3B, 6A).
Regarding claims 6-10, Hughes/Perez combination discloses wherein an attachment surface to a living body is formed by the first layer member, the electrode, and the second layer member (Hughes, see Figs. 1B, 6a, 7).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Libbus (US 20150250405 A1) teaches a plurality of electrodes connected to the patch capable of electrically coupling to the patient.
Netzsch “SBR: Styrene-butadiene rubber” teaches the Young’s Modulus of Styrene butadiene rubber (SBR) is between 2-10 MPa.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANA VERUSKA GUERRERO ROSARIO whose telephone number is (571)272-6976. The examiner can normally be reached Monday - Thursday 7:00 - 4:30 PM EST.
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.
/A.V.G./Examiner, Art Unit 3794 /Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794
Prosecution Insights