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 .
Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because FIGS. 1-2 and 11-15 fail to comply with line and shading requirements of 37 C.F.R. 1.84 (1 and m) and thus do not possess satisfactory reproduction characteristics as required by those sections. See MPEP 608.02. Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
Claim Rejections - 35 USC § 102
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.
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.
Claims 1, 3-4, 6-21 and 29-31 are rejected under 35 U.S.C. 102(a)(1) and/or (a)(2) as being clearly anticipated by US 2024/0017074 A1 to Mihajlovic et al. (hereinafter “Mihajlovic”).
Regarding Claims 1 and 30-31, Mihajlovic teaches a device, comprising:
a power source (implicitly disclosed in the following portions which show current generated and delivered via electrodes);
a plurality of pairs of electrodes (e.g. pair 14 and pair 34) having a plurality of current paths (e.g. 18 and 38), wherein each pair of electrodes is electrically connected to the power source (implicitly true), wherein each pair of electrodes is adapted to apply a current delivered from the power source in a respective current path of the plurality of current paths in order to stimulate a subcutaneous target (e.g. 50; also see e.g. Paras. 4, 91, 161) within a subject, wherein the plurality of current paths have a plurality of first waveforms (e.g. 16 and 36) with a plurality of first frequencies (e.g. “X kHz” and “Y kHz”; see e.g. FIG. 1 and Paras. 116-117), wherein the plurality of current paths overlap at an interference point (e.g. 50) having a second waveform (e.g. 52) with a second frequency (e.g. “X-Y Hz”; see e.g. FIG. 1 and Paras. 116-117), wherein the second waveform is result of a summation of electrical fields of the current delivered via each pair of electrodes (see e.g. FIG. 1 and Paras. 116-117); and
a controller (e.g. control unit 160; see e.g. Paras. 136-143), wherein the controller is communicatively connected to the power source (implicitly true), wherein the controller is configured to send control signals in order to control the current delivered from the power source to each pair of electrodes in order to create a stimulation pattern for each electrode pair (see e.g. Paras. 136-143), wherein the controller is further configured to control the current delivered to each pair of electrodes such that each of the plurality of first frequencies is higher than the second frequency (see e.g. Para. 118: “The beat frequency may be much lower than the first and second frequencies”; note that the “beat frequency” referred to here is the “X-Y” frequency which is equivalent to Applicant’s claimed “second frequency,” whereas the “first and second frequencies” are the “X” and “Y” frequencies, respectively, which are collectively equivalent to Applicant’s claimed “plurality of first frequencies”) and such that the second waveform includes discrete interference pulses delivered with periods of quiescence between the interference pulses (see e.g. Para. 13: “quiescent activation” and Para. 97: “sequences of pulses being provided in plural periods separated by “off time” when no stimulation is provided”).
Regarding Claim 3, see e.g. Paras. 79, 151, 193.
Regarding Claim 4, see e.g. Para. 47 and FIGS. 3a-g.
Regarding Claims 6-16, see e.g. Paras. 144-146.
Regarding Claims 17-20, see e.g. FIGS. 3f, 3g, Paras. 188-198.
Regarding Claim 21, see e.g. Paras. 93-96, 199.
Regarding Claim 29, see e.g. Paras. 18, 91, 161.
Claim Rejections - 35 USC § 103
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.
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 2, 5, 22-24 and 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Mihajlovic.
Regarding Claims 2, 22-24 and 27, Mihajlovic fails to specify the exact stimulation parameter range(s) and electrode size and spacing parameters recited in these claims. However, it would have been obvious to one of ordinary skill in the art as of the filing date of Applicant’s invention to engage in routine experimentation to discover the optimal stimulation parameters and electrode size and spacing parameters based upon various factors known and understood to those skilled in the art, such as the patient’s particular condition and severity of the condition, other patient health factors, etc. See MPEP § 2144.05(II)(A)( “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”) (citing In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
Regarding Claim 5, Mihajlovic notes that the interferential signal waveform can have a similar shape as existing typical biphasic waveforms in existing stimulation devices (see e.g. Paras. 47, 169). Biphasic waveforms with an interphase gap were extraordinarily well known in electrical stimulation devices. It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Mihajlovic to provide an interferential waveform with an interphase gap, as is well known in the art, because it would involve a merely simple substitution of one known waveform shape for another to obtain predictable results.
Regarding Claim 28, Mihajlovic teaches that the device may be “mounted at the skin of the body” (see e.g. Para. 27), but fails to specify an adhesive layer to achieve this. However, the use of an adhesive layer to mount stimulation devices to the skin was extraordinary well known in the electrical stimulation arts. It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Mihajlovic to achieve the skin mounting using an adhesive layer since this was an extremely well known technique to achieve this purpose.
Claims 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Mihajlovic in view of US 2021/0052884 A1 to Jashek et al. (hereinafter “Jashek”).
Regarding Claims 25-26, Mihajlovic fails to teach a resistive sensor or an impedance sensor for activating a switch. Another reference, Jashek, teaches an analogous stimulation device in which sensing resistance or impedance can be used to switch the device into stimulation mode (see e.g. Paras. 126 and 172). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Mihajlovic to further include a resistive sensor and/or an impedance sensor for activating a switch, as seen in Jashek, because it would advantageously enhance safety by only allowing stimulation once the device is in the desired configuration.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN R DOWNEY whose telephone number is (571)270-7247. The examiner can normally be reached Monday-Friday 8:30am-5:00pm ET.
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, NIKETA PATEL can be reached at (571)-272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOHN R DOWNEY/Primary Examiner, Art Unit 3792
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