DETAILED ACTION
Status of Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-20 are pending.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-8, 10-15, and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Van Herk (US 20090118790 A1, 2009-05-07) in view of John et al. (US 20050043775 A1, 2005-02-24) (hereinafter “John”).
Regarding claims 1-8, 10-15, and 17-20, Van Herk teaches a patch interface, comprising: a substrate with a surface (e.g., [0034], Fig. 2); an interconnect embedded into or coupled to the substrate, the interconnect being configured for attachment of the patch interface to a microcircuit (e.g., [0028], [0034], [0035]; Figs. 1-2); a plurality of microelectrodes attached to or embedded into the surface of the substrate and configured to electrical coupling with the microcircuit via the interconnect; wherein the plurality of microelectrodes are configured to measure signals characterizing skin neural activity in each of a plurality of monitoring sites (e.g., [0031]-[0041], [0046], [0056], [0064], Fig. 2). Note that Van Herk also teaches various electrode configurations, topologies, and functions. See, e.g., [0031]-[0034]. [H1]
Van Herk does not teach use of adhesive. John teaches use of adhesive layer. See, e.g., [0077] [0081]-[0082], Fig. 3 and associated text (Array 300 comprises a substrate 310, a plurality of electrodes 320, and an adhesion layer 330. The adhesion layer 330 is added to electrode array 300 by depositing material to form the layer on the surface of substrate 310 between electrodes 320; The adhesion layer includes a hydrogel or sol-gel construct containing an electrolyte for contacting the skin). [J1] Note that John also teaches use of the adhesive layer as part of various sensors based on electrical and mechanical properties. See, e.g., [0083]-[0089]. [J2]
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings of John with the invention taught by Van Herk such that the invention further comprises an adhesive coupled to the substrate (e.g., [H1], [J1]) (as recited in claim 1); wherein the adhesive is patterned onto the substrate so as to form one or more exposed regions of the substrate, one or more of the plurality of microelectrodes arranged within the one or more exposed regions (e.g., [H1], [J1]) (as recited in claim 2);wherein the adhesive comprises one of an electrically conducting and an ionically conducting component (e.g., [H1], [J1]) (as recited in claim 3); wherein the adhesive provides a macroelectrode function comprising one or more macroelectrodes, the one or more macroelectrodes configured for electrical coupling to at least one of the interconnect and the microcircuit (e.g., [H1], [J2]) (as recited in claim 4); wherein the one or more macroelectrodes provide at least one of a guard function, a reference function, and a counter electrode function for one or more of the microelectrodes (e.g., [H1], [J2]) (as recited in claim 5); wherein the one or more macroelectrodes are shaped and patterned on the substrate surrounding the plurality of microelectrodes to reduce movement artifacts from the signals measured by the plurality of microelectrodes (e.g., [H1], [J2]) (as recited in claim 6); further comprising one or more stretchable electrically conducting traces attached to the substrate, arranged to couple at least one of the plurality of microelectrodes with at least one of the interconnect and the microcircuit (e.g., [H1], [J2]) (as recited in claim 7); wherein the patch interface is configured to not retain a predetermined shape in a free standing state (e.g., [H1], [J2]) (as recited in claim 8); wherein the substrate is formed from a soft pseudo-elastic material and the patch interface is configured to maintain operation when stretched to one of more than 25%, more than 50%, and more than 80% (e.g., [H1], [J2]) (as recited in claim 10); further comprising a sensor coupled with the substrate and configured for electrical coupling with at least one of the interconnect and the microcircuit (e.g., [H1], [J2]) (as recited in claim 11); wherein the sensor comprises at least one of an electrophysiologic sensor, a temperature sensor, a thermal gradient sensor, a barometer, an altimeter, an accelerometer, a gyroscope, a humidity sensor, a magnetometer, an inclinometer, an oximeter, a colorimetric monitor, a sweat analyte sensor, a perfusion sensor, a galvanic skin response sensor, a hydration sensor, an interfacial pressure sensor, a flow sensor, a stretch sensor, and a microphone (e.g., [H1], [J2]) (as recited in claim 12); further comprising a stimulating device arranged along the substrate so as to interface with skin of a subject when the adhesive is attached to the skin of the subject (e.g., [H1], [J2]) (as recited in claim 13); further comprising a feedback sensor coupled with the stimulating device, the feedback sensor being configured to monitor interaction of the stimulating device with the skin of the subject during activation of the stimulating device (e.g., [H1], [J2]) (as recited in claim 14); a module, comprising: a housing; a circuit board comprising one or more microcircuits, the circuit board coupled to the housing; and one or more module interconnects coupled to one or more of the microcircuits, the one or more module interconnects being configured for placement and coupling of the module onto a patch interface; the one or more microcircuits being configured to determine spatial readings of skin neural activity in each of a plurality of monitoring sites, the spatial readings being determined utilizing signals measured by one or more of a plurality of microelectrodes attached to or embedded into a surface of a substrate of the patch interface (e.g., [H1], [J2]) (as recited in claim 15); wherein the one or more microcircuits comprise two or more processing banks interface (e.g., [H1], [J2]) (as recited in claim 17); wherein a first one of the two or more processing banks is coupled to a first subset of the plurality of microelectrodes; and a second one of the two or more processing banks is coupled to a second subset of the plurality of microelectrodes interface (e.g., [H1], [J2]) (as recited in claim 18); wherein the first subset of the plurality of microelectrodes and the second subset of the plurality of microelectrodes are attached to or embedded into respective distinct portions of the substrate to interact with different regions of neural innervation of a subject when the patch interface is attached to skin of the subject interface (e.g., [H1], [J2]) (as recited in claim 19); wherein the first subset of the plurality of microelectrodes and the second subset of the plurality of microelectrodes are configured to interact with different neural structures of a subject when the patch interface is attached to skin of the subject interface (e.g., [H1], [J2]) (as recited in claim 20) in order to enhance the effectiveness of the treatment.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Van Herk in view of John, as applied to claims 8, and further in view of Sessions (US 3805769 A, 1974-04-23).
Regarding claim 9, Van Herk teaches a patch interface, except a temporary stiffening member. Sessions teaches a flexible electrode patch comprising a protective cover assembly configured to be stripped off at the time of use, said protective cover assembly being stiffer than the electrode structure (col. 2, lines 10-45; col. 3, lines 25-40; Figures 2 and 3). [S1]
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings of Sessions with the invention taught by Van Herk in view of John such that the invention further comprises a temporary stiffening member attached to the substrate, the temporary stiffening member configured to provide retention of the shape of the patch interface prior to attachment to a subject, the stiffening member being removable from the substrate after attachment to the subject (e.g., [H1], [J2], [S1]) (as recited in claim 9) in order to improve the usability of the invention.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Van Herk in view of John, as applied to claims 15, and further in view of Del Mar (US 6605046 B1, 2003-08-12).
Regarding claim 16, Van Herk teaches a patch interface, except a hermetically seal. Del Mar teaches a hermetically seal (col. 7 lines 35-65, col. 8 lines 10-20; Figures 1, 4-6). [D1]
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings of Del Mar with the invention taught by Van Herk in view of John such that the invention further comprises a temporary stiffening member attached to the substrate, the temporary stiffening member configured to provide retention of the shape of the patch interface prior to attachment to a subject, the stiffening member being removable from the substrate after attachment to the subject (e.g., [H1], [J2], [S1]) (as recited in claim 16) in order to improve the reliability of the invention.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12193842 B2. Although the language of the claims at issue are not identical, the claims are not patentably distinct from each other because they are directed to the same invention.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SCOTT T LUAN whose telephone number is (571)270-1860. The examiner can normally be reached on 9am-5pm, M-F (generally).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gary Jackson, can be reached on 571-272-4697. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Scott Luan
/SCOTT LUAN/Primary Examiner, Art Unit 3792
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