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 .
STATUS OF APPLICATION
Examiner Wecker previously corresponded with Attorney Henschel regarding examiner’s amendments to place the application for allowance, however, upon further consideration by the office it was determined that a 35 USC 101 rejection was needed, and such a rejection is further detailed below.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-19, in the reply filed on 11/05/2025 is acknowledged and Claim 20 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/05/2025.
Claim Objections
Regarding Claims 1 and 10, claims 1 and 10 recite “cancer cells of the first batch” , and these claims should be reworded to clarify that the first batch is the first batch of cancer cells.
In addition, claims 1 and 10 should be reworded to clarify that the first and second percentages are percentages of ciliated cancer cells.
EXAMINER’S AMENDMENT
An examiner’s amendment to the record appears below. Should the changes and/or additions be unacceptable to applicant, an amendment may be filed as provided by 37 CFR 1.312. To ensure consideration of such an amendment, it MUST be submitted no later than the payment of the issue fee.
Authorization for this examiner’s amendment was given in an interview with Rouget Henschel on 12/01/2025.
Claim 1 (currently amended):
A method of determining susceptibility of cancer cells of a subject to treatment with alternating electric fields, the method comprising:
applying alternating electric fields to a first batch of cancer cells obtained or derived from a subject;
ascertaining, after applying the alternating electric fields to the first batch of cancer cells, a first percentage of the cancer cells of the first batch that are ciliated;
ascertaining a second percentage of a second batch of cancer cells obtained or derived from the subject that are ciliated, wherein the second batch of cancer cells was not exposed to alternating electric fields prior to ascertaining the second percentage; and
determining that the cancer cells of the subject are susceptible to treatment with alternating electric fields if the first percentage of ciliated cancer cells is lower than the second percentage of ciliated cancer cells.
Claim 10 (currently amended): A method of reducing the viability of cancer cells of a subject, comprising:
applying alternating electric fields to a first batch of cancer cells obtained or derived from a subject;
ascertaining, after applying the alternating electric fields to the first batch of cancer cells, a first percentage of the cancer cells of the first batch that are ciliated;
ascertaining a second percentage of a second batch of cancer cells obtained or derived from the subject that are ciliated, wherein the second batch of cancer cells was not exposed to alternating electric fields prior to ascertaining the second percentage; and applying alternating electric fields to either the first or second batch of cancer cells if the first percentage of ciliated cancer cells is lower than the second percentage of ciliated cancer cells.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-19 rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 1 recites “determining that the cancer cells of the subject are susceptible to treatment with alternating electric fields if the first percentage is lower than the second percentage” and “ascertaining, after applying the alternating electric fields to the first batch, a first percentage of the cancer cells of the first batch that are ciliated”.
This judicial exception is not integrated into a practical application because of the following:
Step 1: Claim 1 is a method.
Step 2A, prong 1: Claim 1 recites “determining that the cancer cells of the subject are susceptible to treatment with alternating electric fields if the first percentage is lower than the second percentage” and “ascertaining, after applying the alternating electric fields to the first batch, a first percentage of the cancer cells of the first batch that are ciliated” and “determining that the cancer cells of the subject are susceptible to treatment with alternating electric fields if the first percentage is lower than the second percentage” and “ascertaining, after applying the alternating electric fields to the first batch, a first percentage of the cancer cells of the first batch that are ciliated”.
Step 2A, prong 2: The abstract ideas determine if the cancer cells are susceptible to treatment with an AC field and once the determination is made, then no action is taken and therefore there is no particular practical application. The steps of alternating the fields and then ascertaining the % of cancer cells are just be data gathering, which is insignificant pre-solution activity, which is not a particular practical application (and further the idea of alternating the electric fields is known as will be detailed below).
Step 2B: Claim 1 recites that the “ascertaining” steps are used to determine if the cancer cells are susceptible to AC field treatment. If the determination is negative no action is taken and if the determination is positive it is not clear what action is taken with the patient (i.e. when the cells would be a candidate for AC field treatment, not sure how this related to the patient) and then evaluating the additional elements (i.e. applying the alternating currents to the cells aside from the abstract idea) are well known in the art (as will be detailed below).
Therefore claims 1-9 are rejected under 35 USC 101.
In addition, regarding claims 10-19, the following applies:
Step 1: Claim 1 is a method.
Step 2A, prong 1: Claim 10 recites “ascertaining, after applying the alternating electric fields to the first batch, a first percentage of the cancer cells of the first batch that are ciliated” and “applying alternating electric fields to the cancer cells if the first percentage is lower than the second percentage” (invoking a comparison) and for the ascertaining steps above the ascertaining steps could be viewed as simply imaging through a microscope and then determining whether or not to apply alternating electric fields based on each ascertaining step.
Step 2A, prong 2: The abstract ideas determine if the cancer cells are susceptible to treatment with an AC field and once the determination is made, then no action is taken and therefore there is no particular practical application. The steps of alternating the fields and then ascertaining the % of cancer cells are just be data gathering, which is insignificant pre-solution activity, which is not a particular practical application (and further the idea of alternating the electric fields is known as will be detailed below).
Step 2B: Claim 10 recites that the “ascertaining” steps are used to determine if the cancer cells are susceptible to AC field treatment. If the determination is negative no action is taken and if the determination is positive it is not clear what action is taken with the patient (i.e. when the cells would be a candidate for AC field treatment, not sure how this related to the patient) and then evaluating the additional elements (i.e. applying the alternating currents to the cells aside from the abstract idea) are well known in the art (as will be detailed below).
Furthermore, examiner Wecker notes that office policy states that abstracts ideas may be ideas themselves and that one specific example of an abstract idea is the idea of comparing new and stored information (such as the estimated level of a gas in a breath sample) and using rules to identify options (such as whether or not the subject is eligible to be provided with a tobacco product, based on the above gas level value). In addition, the examiner notes that (per the July 2015 Interim Eligibility Guidance with regards to USC 101 rejections) states that abstracts ideas may be ideas themselves and that other specific examples of an abstract idea include comparing information regarding a sample or test subject (such as the level of the gas in a breath sample) to a control or target data and collecting and comparing known data ((such as the level of the gas in a breath sample using a known diagnostic test or assay.
Therefore claims 1-19 are ineligible.
Citation of Relevant art
The closest prior art, Patel et al (US PGPub 2021/799640) discloses methods of determining susceptibility of cancer cells of a subject to treatment with alternating electric fields (see abstract). Specifically, Patel et al teaches that the viability of cancer cells (e.g., glioblastoma cells) can be reduced by administering mannose to the cancer cells; and applying an alternating electric field with a frequency between 100 and 500 kHz to the cancer cells. Further, susceptibility to treatment with an alternating electric field can be determined by measuring uptake of a PKM2 probe before and after treatment with an alternating electric field (see abstract).
In addition, Marc (US PGPub 2012/289955) discloses an apparatus and method for selectively heating a biological target within a treatment region of a subject is disclosed. The method includes administering to the subject a dielectric heating modulator that becomes associated with the biological target. The method also includes positioning the treatment region between first and second electrodes connected to a generator, and activating the generator to apply an alternating electric field between the first and second electrodes and across the treatment region to thereby heat the treatment region. The dielectric heating modulator causes the biological target to heat at a faster rate than non-targets within the treatment region, which preferably results in the killing of the biological target (see abstract).
Allowable Subject Matter
Claims 1-19 would in condition for allowance if the 101 issues and claim objections cited above were resolved.
The following is an examiner’s statement of reasons for allowance: The closest prior art, Patel et al (US PGPub 2021/799640) discloses methods of determining susceptibility of cancer cells of a subject to treatment with alternating electric fields (see abstract). Specifically, Patel et al teaches that the viability of cancer cells (e.g., glioblastoma cells) can be reduced by administering mannose to the cancer cells; and applying an alternating electric field with a frequency between 100 and 500 kHz to the cancer cells. Further, susceptibility to treatment with an alternating electric field can be determined by measuring uptake of a PKM2 probe before and after treatment with an alternating electric field (see abstract).
In addition, Marc (US PGPub 2012/0289955) discloses an apparatus and method for selectively heating a biological target within a treatment region of a subject is disclosed. The method includes administering to the subject a dielectric heating modulator that becomes associated with the biological target. The method also includes positioning the treatment region between first and second electrodes connected to a generator, and activating the generator to apply an alternating electric field between the first and second electrodes and across the treatment region to thereby heat the treatment region. The dielectric heating modulator causes the biological target to heat at a faster rate than non-targets within the treatment region, which preferably results in the killing of the biological target (see abstract).
However, neither Patel et al nor Marc (alone or in combination) teaches A method of determining susceptibility of cancer cells of a subject to treatment with alternating electric fields, the method comprising: ascertaining, after applying the alternating electric fields to the first batch of cancer cells, a first percentage of the cancer cells of the first batch that are ciliated; ascertaining a second percentage of a second batch of cancer cells obtained or derived from the subject that are ciliated, wherein the second batch of cancer cells was not exposed to alternating electric fields prior to ascertaining the second percentage; and determining that the cancer cells of the subject are susceptible to treatment with alternating electric fields if the first percentage of ciliated cancer cells is lower than the second percentage of ciliated cancer cells (as claimed in claims 1 and 10).
Furthermore, claims 2-9 and 11-19 are also in condition for allowance, per their dependence from claims 1 and 10.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER WECKER whose telephone number is (571)270-1109. The examiner can normally be reached 9:30AM - 6 PM EST M-F.
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/JENNIFER WECKER/Primary Examiner, Art Unit 1797