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 .
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 (i.e., changing from AIA to pre-AIA ) 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.
Notice of Amendment
In response to the amendment(s) filed on 2/17/26, amended claim(s) 1, 17, 19, and 21, and canceled claims 16 is/are acknowledged. The following new and/or reiterated ground(s) of rejection is/are set forth:
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “an array of mechanomyography sensors … configured to detect mechanomyography signals from the body to which the apparatus is applied” in claim 1, which corresponds to “one or more of acoustic sensors, accelerometers, piezoelectric sensors and force sensors” (see page 3, lines 21-22 of Applicant’s specification as originally filed); “a pressure bias system configured to provide a variation in contact pressure of the mechanomyography sensors spatially distributed across the substrate to the body surface to allow the mechanomyography sensors to detect mechanomyography signals at different levels of applied contact pressure,” in claim 1, which corresponds to “a plurality of platforms on the substrate at different heights relative to the reference plane of the substrate” (see page 2, lines 32-34 of Applicant’s specification a originally filed); and “means for adjusting the tightness of the substrate around the body,” in claim 8, which corresponds to “one or more of a fastener and an inflatable chamber” (see page 3, lines 15-16 of Applicant’s specification as originally filed).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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(s) 1-4, 6-11, 13, 17-19, and 21-22 is/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.
For claim 1, the claim language “a substrate” and “a pressure bias system configured to provide a variation in contact pressure of the mechanomyography sensors to the body surface to receive mechanomyography signals at different levels of applied contact pressure” is ambiguous. The claim language “a pressure bias system configured to provide a variation in contact pressure of the mechanomyography sensors to the body surface to receive mechanomyography signals at different levels of applied contact pressure” invokes 35 U.S.C. 112(f) and corresponds to “a plurality of platforms on the substrate at different heights relative to the reference plane of the substrate” (see 35 U.S.C. 112 invocation above). Therefore, it is unclear whether the same substrate is being referred to or if the claim has a scope that covers two different substrates. The claim is examined under the former interpretation.
Dependent claim(s) 1-4, 6-11, 13, 17-19, and 21-22 fail to cure the ambiguity of independent claim 1, thus claim(s) 1-4, 6-11, 13, 17-19, and 21-22 is/are rejected under 35 U.S.C. 112(b).
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.
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.
Claim(s) 1-4, 6-9, 11, 13, 17-19, and 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2020/0114148 to Wybo et al. (hereinafter “Wybo”) in view of U.S. Patent No. 9,763,590 to Rood et al. (hereinafter “Rood”).
For claim 1, Wybo discloses an apparatus configured for application to a surface of a body (Abstract), the apparatus comprising:
an array of mechanomyography sensors (50) (Fig. 2) (para [0033]-[0034]) spatially distributed across a substrate (32) (Fig. 2) (para [0030]), each mechanomyography sensor configured to detect mechanomyography signals from the body to which the apparatus is applied (para [0034] and [0038]);
a pressure bias system configured to provide a variation in contact pressure of the mechanomyography sensors spatially distributed across the substrate to the body surface to allow the mechanomyography sensor to detect mechanomyography signals at different levels of applied contact pressure (para [0032] and [0119]-[0121]); and
processing circuitry (28/38) (Figs. 1-2) (para [0028] and [0030]) configured to process the mechanomyography signals detected from the body at different levels of applied contact pressure to determine activity associated with one or more muscles located within the body (para [0079]-[0080]).
Wybo does not disclose the specific structure of the 35 U.S.C. 112(f) invocation for the “pressure bias system configured to provide a variation in contact pressure of the mechanomyography sensors to the body surface to receive mechanomyography signals at different levels of applied contact pressure” being “a plurality of platforms on the substrate at different heights relative to the reference plane of the substrate.”
However, Rood teaches a plurality of platforms (22 and 24) (Fig. 9) (col. 20, lines 3-7) on a substrate (12) (Fig. 9) (col. 18, lines 30-36) at different heights relative to the reference plane of the substrate (as can be seen in Fig. 9) (also see col. 20, lines 3-7).
It would have been obvious to a skilled artisan to modify Wybo to include a plurality of platforms on the substrate at different heights relative to the reference plane of the substrate, in view of the teachings of Rood, for the obvious advantage of aiding in the application of the electrode to a patient’s skin, especially in the application area is not flat.
For claim 2, Wybo, as modified, further discloses wherein the pressure bias system is configured to (Examiner’s Note: functional language, i.e., capable of): (a) spatially modulate the applied pressure across the sensor array; or (b) temporally modulate the applied pressure of at least some of the mechanomyography sensors in the sensor array (para [0032] and [0119]-[0121] of Wybo).
For claim 3, Wybo, as modified, further discloses wherein the spatial modulation of applied pressure is effected by a plurality of the mechanomyography sensors in the sensor array being distributed at different distances from and orthogonal to a reference plane of the substrate (Examiner’s Note: the other alternative being relied upon) (alternatively, see para [0032] and [0119]-[0121] of Wybo).
For claim 4, Wybo, as modified, further discloses wherein the pressure bias system comprises a plurality of platforms on the substrate at different heights relative to the reference plane of the substrate (see col. 20, lines 3-7 of Rood), each platform bearing at least one mechanomyography sensor of the sensor array (see Fig. 16 of Rood).
For claim 6, Wybo, as modified, further discloses wherein the temporal modulation of applied pressure is effected by at least some of the mechanomyography sensors having an adjustable height relative to a reference plane of the substrate (para [0032] and [0119]-[0121] of Wybo).
For claim 7, Wybo, as modified, fruther discloses wherein the pressure bias system comprises one or more actuators or inflatable elements configured for (Examiner’s Note: functional language, i.e., capable of) adjusting the height of at least one mechanomyography sensor relative to the reference plane of the substrate (see para [0032] and [0119]-[0121] of Wybo).
For claim 8, Wybo further discloses wherein the substrate is configured to be worn around the body (as can be seen in Fig. 2), and wherein the pressure bias system comprises means for adjusting the tightness of the substrate around the body (see para [0032] and [0119]-[0121] of Wybo) and optionally, wherein the substrate comprises a plurality of rigid substrate portions linked together by flexible and/or stretchable connectors (Examiner’s Note: this claim language optional).
For claim 9, Wybo further discloses wherein the means for adjusting the tightness of the substrate around the body comprise one or more of a fastener and an inflatable chamber attached to the substrate (see para [0032] and [0119]-[0121] of Wybo).
For claim 11, Wybo further discloses (a) an array of pressure sensors, each pressure sensor configured to provide an indication of the contact pressure of a respective mechanomyography sensor as applied to the body surface (para [0034]); and/or (b) an array of electromyography electrodes disposed on the substrate, each electromyography electrode configured to detect electromyography signals from the body to which the apparatus is applied.
For claim 13, Wybo further discloses wherein: (a) the array is a two-dimensional array (Fig. 3); (b) the array is a regular array; and/or (c) the sensors of the array have a spacing of no more than 5mm, 10mm, 15mm or 20mm.
For claim 17, Wybo further discloses wherein the determined activity associated with the one or more muscles within the body comprises at least one of muscle activity, neural activity, neuronal activity and cerebral activity (para [0079]-[0081]).
For claim 18, Wybo further disclose wherein the determined muscle activity comprises one or more biomechanical properties of the muscles (Examiner’s Note: the other alternative being relied upon) (alternatively, see para [0027] of Wybo).
For claim 19, Wybo further discloses wherein: (a) the processing circuitry is configured to process the detected mechanomyography signals to determine activity associated with one or more muscles located at different corresponding depths within the body; and/or (b) the processor circuitry is configured to process the detected mechanomyography signals to detect the frequency response of one or more muscles (para [0075], [0080], and [0084]-[0085]) at different levels of applied contact pressure (para [0034]).
For claim 21, Wybo further discloses an array of pressure sensors (para [0034]), each pressure sensor configured to provide an indication of the contact pressure of a respective mechanomyography sensor as applied to the body surface (para [0034]), wherein the processing circuitry is configured to associate mechanomyography signals received from the mechanomyography sensors with pressure signals received from respective pressure sensors (para [0034]).
For claim 22, Wybo further discloses wherein: (a) the processing circuity is configured to associate the mechanomyography signals with the pressure signals by synchronizing read-out of the mechanomyography sensors with read-out of the respective pressure sensors (para [0034]); and/or (b) the processing circuitry is configured to fuse the mechanomyography signals with the pressure signals (para [0034]).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wybo in view of Rood, and further in view of U.S. Patent Application Publication No. 2014/0334083 to Bailey.
For claim 10, Wybo and Rood do not expressly disclose wherein the substrate comprises a plurality of rigid substrate portions linked together by flexible and/or stretchable connectors.
However, Bailey teaches wherein the substrate comprises a plurality of rigid substrate portions linked together by flexible and/or stretchable connectors (para [0060]) (see more generally para [0060]-[0069]).
It would have been obvious to a skilled artisan to modify Wybo wherein the substrate comprises a plurality of rigid substrate portions linked together by flexible and/or stretchable connectors, in view of the teachings of Bailey, for the obvious advantage of making Wybo’s device accommodate different patient anatomy sizes.
Response to Arguments
Applicant’s arguments filed 2/17/26 have been fully considered.
With respect to the 112 rejections, the claim language still invokes 35 U.S.C. 112(f) and therefore there is still ambiguity regarding the number of substrates being claimed.
With respect to the 103 rejections, Wybo reads on the broadest, reasonable interpretation of “determine activity associated with one or more muscles,” as now recited in claim 1. Para [0079]-[0080] describes processing the “MMG output signal” (where “MMG” stands for “mechanomyography,” see para [0038]) to determine if there is a muscle response that has been induced by the artificially created stimulus. This muscle response reads on the “activity associated with one or more muscles.” Fig. 2 shows the MMG output signal (i.e., reference numeral “52”) is part of element 34 and there are multiple elements 34 spatially distributed across the body as shown in Fig. 1. Para [0121] of Wybo teaches “selective actuation” that reads on the pressure levels that are varied according to the broadest, reasonable interpretation of the claim language.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL LEE CERIONI whose telephone number is (313) 446-4818. The examiner can normally be reached M - F 8:00 AM - 5:00 PM PT.
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, Jennifer Robertson can be reached at (571) 272-5001. 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.
/DANIEL L CERIONI/Primary Examiner, Art Unit 3791