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 .
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 11, and 15-19 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Hendricks (U.S. Patent Application Publication No. 2024/0165419) hereinafter referred to as Hendricks.
Regarding claim 1, Hendricks teaches a computer-implemented method for treatment planning for delivering tumor treating fields to a subject (¶[0002]), the method comprising:
obtaining a plurality of treatment locations for delivering tumor treating fields to a subject, each treatment location comprising a plurality of transducer locations for delivering tumor treating fields to the subject (¶[0087], Fig. 1B, Fig. 4);
for each treatment location, delivering tumor treating fields to the subject using transducers located on the subject (Fig. 12); and
recording data from delivering tumor treating fields to the subject (Fig. 12, ¶[0093]); and
selecting, based on the data recorded from delivering tumor treating fields to the subject, at least one of the treatment locations for further delivering tumor treating fields to the subject (Fig. 13A-B, updating parameters includes locations, ¶[0087]).
Regarding claim 2, Hendricks teaches the method of claim 1.
Hendricks further teaches wherein the plurality of treatment locations are generated by a computer-implemented method based on at least one medical image of the subject (Fig. 13A, cross-sectional imaging data, ¶[0046], Fig. 3A-D).
Regarding claim 11, Hendricks teaches the method of claim 1.
Hendricks further teaches wherein, for each treatment location, the data recorded from delivering tumor treating fields to the subject comprises measured voltages and measured currents from delivering tumor treating fields to the subject (¶¶[0093-0095]).
Regarding claim 15, Hendricks teaches the method of claim 1.
Hendricks teaches further comprising processing the data recorded for each treatment location to obtain processed data, wherein selecting at least one of the treatment locations for further delivering tumor treating fields to the subject is based on the processed data (¶[0095]).
Regarding claim 16, Hendricks teaches the method of claim 1.
Hendricks further teaches wherein further delivering tumor treating fields to the subject is for a time period to receive a full dosage of tumor treating fields (¶[0004], ¶[0036]).
Regarding claim 17, the claim is directed to a method comprising substantially the same subject matter as claim 1 and is rejected under substantially the same sections of Hendricks.
Regarding claim 18, Hendricks teaches the method of claim 17.
Hendricks further teaches wherein locating the plurality of transducers on the subject comprises affixing plurality of transducers to the subject (¶[0092] implanted).
Regarding claim 19, Hendricks teaches the method of claim 17.
Hendricks further teaches wherein locating the plurality of transducers on the subject comprises placing the plurality of transducers on the subject but not affixing the plurality of transducers to the subject (¶[0092] implanted, placement must occur before fixation, this claim does not require that fixation never occurs).
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) 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hendricks as applied to claims 1 and 17 above, and further in view of Isakovic (U.S. Patent Application Publication No. 2024/0139537) hereinafter referred to as Isakovic.
Regardings claim 3-4, Hendricks teaches the method of claim 1.
Hendricks does not teach wherein the plurality of treatment locations are selected from a database of treatment locations based on attributes of the subject or wherein the attributes of the subject comprise one or more of gender, race, age, height, weight, medical history, daily activity, or job type.
Attention is brought to the Isakovic reference, which teaches an electrical stimulation treatment including a plurality of treatment locations selected from a database of treatment locations (¶[0018] placement map, ¶[0127], Fig. 4) based on attributes of the subject (¶[0179] suitable or unsuitable for the subject) or wherein the attributes of the subject comprise one or more of gender, race, age, height, weight, medical history, daily activity, or job type (Fig. 9, medical history from personal folder).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the treatment planning of Hendricks to include personalized treatment locations, as taught by Isakovic, because personalized therapy optimizes treatment for an individual (Isakovic ¶[0088]).
Claim(s) 5-10 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hendricks as applied to claims 1 and 17 above, and further in view of Valcke (U.S. Patent Application Publication No. 2021/0038892) hereinafter referred to as Valcke.
Regarding claim 5, Hendricks teaches the method of claim 1.
Hendricks does not teach wherein, for each treatment location, the tumor treating fields are delivered for approximately 30 minutes to approximately 6 hours.
Attention is drawn to the Valcke reference, which teaches wherein, for each treatment location, the tumor treating fields are delivered for approximately 30 minutes to approximately 6 hours (¶[0173]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the TTF treatment of Hendricks to include a time limit, as taught by Valcke, to solve a long felt need to avoid overstimulation and adapt stimulation according to each particular tissue (Valcke ¶[0013]).
Regarding claims 6-10/20, Hendricks teaches the method of claim 1.
Hendricks does not teach wherein, for each treatment location, the tumor treating fields are delivered until at least one measured electrical parameter related to delivering tumor treating fields to the subject reaches a steady state for a predetermined time period, wherein the at least one measured electrical parameter is current or voltage.
Attention is drawn to the Valcke reference, which teaches wherein, for each treatment location, the tumor treating fields are delivered until at least one measured electrical parameter related to delivering tumor treating fields to the subject reaches a steady state for a predetermined time period, wherein the at least one measured electrical parameter is current or voltage (¶¶[0123-0125] tissue impedance is calculated from voltage in a typical measurement, ¶[0121]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the TTF treatment of Hendricks to include a steady state parameter test, as taught by Valcke, to solve a long felt need to avoid overstimulation and adapt stimulation according to each particular tissue (Valcke ¶[0013]).
Hendricks as modified does not teach wherein the predetermined time period is between approximately 1 minute and approximately 15 minutes, wherein the steady state for the measured electrical parameter is reached when the measured electrical parameter is constant without substantial ringing for the predetermined time period, wherein the steady state for the measured electrical parameter is reached when the measured electrical parameter is within approximately 0.2% to approximately 2% of a constant value for the predetermined time period, wherein the steady state for the measured electrical parameter is reached when at least one of: a measured current is within approximately 0.02 amps to approximately 0.2 amps of a constant value for the predetermined time period, or a measured voltage is within approximately 0.02 volts to approximately 0.2 volts of a constant value for the predetermined time period.
However, Applicant appears to disclose no criticality to these parameter ranges.
Therefore, as the teaching in Valcke motivates limiting stimulation to only which is necessary, it would nevertheless have been obvious to arrive at the claimed stimulation ending thresholds, because courts have held that generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim(s)12-13 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hendricks as applied to claims 1 and 17 above, and further in view of Mason et al. (U.S. Patent Application Publication No. 2021/0134458) hereinafter referred to as Mason.
Regarding claims 12-13, Hendricks teaches the method of claim 1.
Hendricks does not teach wherein, for each treatment location, the data recorded from delivering tumor treating fields to the subject comprises subjective data obtained from the subject regarding delivering tumor treating fields to the subject, wherein the subjective data includes at least one of: ability of the subject or a caregiver to affix the transducers to the subject, comfort of the subject while wearing the transducers, ability of the subject to move while the transducers are affixed to the subject, or ability of the subject or a caregiver to remove the transducers from the subject.
Attention is drawn to the Mason reference, which teaches wherein, for each treatment location, the data recorded from delivering tumor treating fields to the subject comprises subjective data obtained from the subject regarding delivering tumor treating fields to the subject (¶[0051] electromagnetic neurostimulation), wherein the subjective data includes at least one of: ability of the subject or a caregiver to affix the transducers to the subject, comfort of the subject while wearing the transducers, ability of the subject to move while the transducers are affixed to the subject, or ability of the subject or a caregiver to remove the transducers from the subject (¶[0097], ¶[0138], ¶[0151]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify data collected by the system of Hendricks to include subjective data from the subject of the treatment, as taught by Mason, for improved patient compliance (Mason ¶[0153]).
Claim(s)14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hendricks as applied to claims 1 and 17 above, and further in view of Tran (U.S. Patent Application Publication No. 2014/0143064) hereinafter referred to as Tran.
Regarding claim 14, Hendricks teaches the method of claim 1.
Hendricks does not teach wherein, for each treatment location, the data recorded from delivering tumor treating fields to the subject comprises subjective data regarding states of the transducers after the transducers are removed from the subject.
Attention is brought to the Tran reference, which teaches subjective data regarding states of the transducers after the transducers are removed from the subject (¶[0327]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the data collection of Hendricks to include subjective data, such as the wear state of transducer couplings taught by Tran, for replacing old worn out contact surfaces to improve coupling (Tran ¶[0327]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Patent Application Publication No. 2017/0266438 to Sano et al. teaches a maximum steady state voltage potential achievable in a cell membrane during electrical stimulation for treating tumors.
U.S. Patent Application Publication No. 2022/0347461 to Campean et al. teaches measuring properties to determine contact integrity (brittle, broken, wet, dry, loose, etc.).
U.S. Patent Application Publication No. 2019/0314631 to Wong et al. teaches databases of imaging information including tissue electrical properties.
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/AMANDA L STEINBERG/Examiner, Art Unit 3792
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