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 .
Election/Restrictions
Applicant’s election without traverse of Species B in the reply filed on 7/9/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 1-4 and 10-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species, there being no allowable generic or linking claim.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6/27/2024 was filed is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities: Please review the continuity data in the first paragraph and ensure it is up to date. As an example, US 18/122,304 is now US Patent No. 12,064,624.
Appropriate correction is required.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 18/122,304, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Specifically, the parent application does not provide support for selectively reducing an electric field magnitude emanating from one or more different electrode elements during respective periods of time while alternating electric fields are applied, accepting feedback that indicates whether peripheral nerve stimulation is occurring during each of the respective different periods of time, and determining whether reducing the electric field magnitude from a given one or more of the electrode elements reduces the peripheral nerve stimulation. While the parent application discloses completely turning off electrode elements, claim 5 requires merely reducing the magnitude of the emanating electric field. Therefore, claim 5 requires that the electric filed remain emanating, but that the field must be reduced. Therefore, turning off the electrode elements is not the same as reducing an electric field magnitude as currently recited in claim 5. As additional evidence, the applicant did not traverse the Restriction Requirement that laid out how turning off the electrode elements and reducing the magnitude emanating from the electrode elements are distinct and mutually-exclusive Species.
While par. 0048 of the parent application discusses that a field strength of other areas away from the tumor may be of a reduced magnitude, this is accomplished by selectively turning on/off certain electrode elements, and no discussion of reducing the electric field emanating from specific electrode elements is disclosed.
Finaly, par. 0056 of the parent application discusses using different sized electrodes to reduce PNS, this paragraph makes clear that the smaller electrodes do not sacrifice intensity/magnitude, and as such, the magnitude of the electric field is not reduced.
Given the evidence, the current claims 5-9 have an effective filing date of 6/27/2024.
Additionally, although the ADS indicates the current application is a DIVISIONAL of Application No. 18/122,304, this cannot be true because of the lack of support, as described above. Furthermore, NO RESTRICTION REQUIREMENT was ever mailed by the Examiner in the parent application.
This application repeats a substantial portion of prior Application No. 18/122,304 and adds disclosure not presented in the prior application. Because this application names the inventor or at least one joint inventor named in the prior application, it may constitute a continuation-in-part of the prior application. Should applicant desire to claim the benefit of the filing date of the prior application, attention is directed to 35 U.S.C. 120, 37 CFR 1.78, and MPEP § 211 et seq. The presentation of a benefit claim may result in an additional fee under 37 CFR 1.17(w)(1) or (2) being required, if the earliest filing date for which benefit is claimed under 35 U.S.C. 120, 121, 365(c), or 386(c) and 1.78(d) in the application is more than six years before the actual filing date of the application.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 5-9 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Specifically, the original specification does not provide support for selectively reducing an electric field magnitude emanating from one or more different electrode elements during respective periods of time while alternating electric fields are applied, accepting feedback that indicates whether peripheral nerve stimulation is occurring during each of the respective different periods of time, and determining whether reducing the electric field magnitude from a given one or more of the electrode elements reduces the peripheral nerve stimulation. While the parent application discloses completely turning off electrode elements, claim 5 requires merely reducing the magnitude of the emanating electric field. Therefore, claim 5 requires that the electric filed remain emanating, but that the field must be reduced. Therefore, turning off the electrode elements is not the same as reducing an electric field magnitude as currently recited in claim 5. As additional evidence, the applicant did not traverse the Restriction Requirement that laid out how turning off the electrode elements and reducing the magnitude emanating from the electrode elements are distinct and mutually-exclusive Species.
While par. 0048 of the parent application discusses that a field strength of other areas away from the tumor may be of a reduced magnitude, this is accomplished by selectively turning on/off certain electrode elements, and no discussion of reducing the electric field emanating from specific electrode elements is disclosed.
Finaly, par. 0056 of the parent application discusses using different sized electrodes to reduce PNS, this paragraph makes clear that the smaller electrodes do not sacrifice intensity/magnitude, and as such, the magnitude of the electric field is not reduced.
As per MPEP 2163 I.A., despite these being original claims, issues of adequate written description may arise even for original claims, for example, when an aspect of the claimed invention has not been described with sufficient particularity such that one skilled in the art would recognize that the inventor had possession of the claimed invention at the time of filing. Given the evidence described above, it does not appear that the applicant described with claimed invention with any sort of particularity in the original specification that would indicate that they had possession of the claimed invention at the time of filing.
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 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over Travers et al. (US 2021/0177492, hereinafter Travers).
Regarding claims 5-8, Travers discloses a method of reducing peripheral nerve stimulation (“PNS”) in a subject being treated using alternating electric fields (see par. 0074). Travers discloses slowly adjusting power levels in various arrays of electrode elements to determine power levels that will cause PNS (i.e, feedback must be received to determine when PNS occurs for each of a plurality of arrays tested at different times, such that the occurrence of PNS is input from the subject). In order to adjust the power level of the field, some sort of field intensity monitor must exist.
While Travers specifically only disclose slowly adjusting power levels up to determine when PNS occurs, the Examiner believes that one of ordinary skill in the art would understand that one could also start with a high amplitude and slowly decrease the power levels to determine the magnitudes necessary to reduce peripheral nerve stimulation, and this would not change the overall purpose of Travers. Alternatively, if, while adjusting upward, it became unclear if PNS was being detected, to lower the magnitude to double check whether a previous magnitude was safe or not. Therefore, it would have been obvious to one of ordinary skill in the art before the applicant’s effective filing date to modify Travers to reduce the magnitude of electrode elements in order to determine the power levels necessary to stimulate a peripheral nerve for the reasons/rationale outlined above, in order to avoid PNS, as required by Travers in par. 0074.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Travers in view of Travers et al. (US 2016/0022986, hereinafter Travers et al.)
Travers, as described and modified above, discloses the applicant’s basic invention, but is silent as to turning off electrode elements if a leakage current is detected. Travers et al. is analogous art that also discloses delivering alternating electric fields to a subject. Travers et al. further discloses turning off electrode elements if a leakage current is detected (par. 0024,0029, 0081). Therefore, it would have been obvious to one of ordinary skill in the art before the applicant’s effective filing date to modify Travers to turn off electrode elements if a leakage current is detected as taught by Travers et al. in order to prevent tissue damage to the patient (par. 0024 of Travers et al. for motivation).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See attached PTO-892, specifically US 2005/0209640 and US 2018/0050200, both of which disclose delivering alternating electric fields to a patient to treat tumors.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric D Bertram whose telephone number is (571)272-3446. The examiner can normally be reached Monday-Friday 8am-6pm Central Time.
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 McDonald can be reached at 571-270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Eric D. Bertram/Primary Examiner, Art Unit 3796
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