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 with traverse of Group II containing claims 7 and 8 in the reply filed on 4/01/2026 is acknowledged. The traversal is on the ground(s) that Group I(claims 1, 2, 3, 4, 6) and Group II share a common special technical feature that distinguish over the Curley(US 20170209579 A1) reference due to the amendments to Group I. This is found persuasive. The requirement is withdrawn and all claims submitted on 4/01/2026 will be examined.
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.
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.
Claim(s) 1-4, and 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Hebb(WO 2016179712 A1) in view of Pozzato(US 8457751 B2).
Regarding claim 1, Hebb discloses a method for blocking or inhibiting the growth of neoplastic cells in a target region of a living organism, said method comprising: treating said neoplastic cells in said target region with said an antitumor drug; and applying electric current waves to said target region for a predefined period of time using a device while said neoplastic cells are being treated with said antitumor drug; wherein the device includes: one or more electrodes; wherein said one or more electrodes are electrodes of the implantable type, said one or more electrodes being adapted to be implanted at or near said target region(The approach of the present invention is referred to as intratumoral modulation therapy or IMT when applied to the treatment of neoplastic disease. I MT is novel in the management of tumors, including tumors of the nervous and somatic system tissues. The present invention may also be used to prevent tumors from forming or recurring(see attached copy, page 11, paragraph 5). In another embodiment the present invention is a method for the treatment of a tumor or cancer in a patient including: (a) implanting at least one electrode adjacent to or within a tumor or a site of the patient suspected of having tumor or cancer cells, the at least one electrode having electrical leads connected thereto; (b) generating continuous alternating or pulsed electric stimulation and applying the electric stimulation through the electrical leads to the at least one electrode adjacent to or within the tumor or the site; and (c) during electric stimulation, treating the patient with a therapeutic agent, radiation, or both the therapeutic agent and radiation, wherein a synergistic effect on the tumor treatment of the combination of the electric stimulation and the therapeutic agent, radiation or both the therapeutic agent and radiation is substantially greater than the effect of each the electric stimulation, therapeutic agent, radiation, or both the therapeutic agent and radiation taken alone(see attached copy, page 7, paragraph 2). Hebb fails to disclose “said electric current waves having a waveform with a fundamental frequency of about 4 MHz distorted by the presence of at least second and third order harmonics; and at least one radiofrequency circuit connected to said one or more electrodes, said at least one radiofrequency circuit being adapted to supply each of said one or more electrodes with one of the current waves having the fundamental frequency of about 4 MHz distorted by the presence of at least second and third order harmonics”.
However, Pozzato teaches “characterized in that said radiofrequency circuit output consists of a current wave of distorted sinusoidal form by the presence of harmonics of at least the second and third order, said current wave circulating in a broadband resonant circuit on the frequency of the pure wave of said distorted sinusoidal form(Summary of the Invention, paragraph 6). The electronic device carrying out the method of the invention is a device in which the resultant wave applied to the electrodes is a wave preferably having a main frequency of 4 MHz and having harmonics of second, third and fourth order(Summary of the Invention, paragraph 9)”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the modulation therapy method of Hebb with the radiofrequency circuit of the electronic device of Pozzato since both references contain electrodes connected to an electronic device with a circuit for controlling parameters. Doing so would specify the frequency waveform modulation that is transmitted to the electrodes during device use.
Regarding claim 2, Hebb in view of Pozzato teaches the method according to claim 1, wherein said waveform is a sinusoidal waveform(Electrodes are composed of clinical grade platinum or platinum/iridium alloy, with square or sinusoidal waves produced by a waveform generator and delivered continuously(see attached copy, page 15, paragraph 2)).
Regarding claim 3, Hebb in view of Pozzato teaches the method according to claim 1, wherein said antitumor drug comprises temozolomide(In another embodiment of the second and third embodiments, the method further comprises treating the patient with a therapeutic agent (including chemotherapeutics) and/or radiation. In one aspect of this embodiment, the therapeutic agent is temozolomide(see attached copy, page 5, paragraph 5)).
Regarding claim 4, Hebb in view of Pozzato teaches the method according to claim 1, wherein said neoplastic cells comprise glioblastoma cells and said target region comprises the central nervous system(In another embodiment of the present invention the tumor or tumor cell is a glial or non-glial tumor cell affecting the nervous or a somatic tumor cell(see attached copy, page 7, paragraph 2). An implantable device to deliver electrical stimulation, including alternating current, within tumor-affected brain regions may exploit the known electrosensitivity of GBM cells while providing targeted, sustained and titratable therapy for the subject patient. Adverse neurological effects may be avoided by focusing the treatment on tumor and tumor-affected regions of the nervous system that are inherently pathological (central nervous system or peripheral nervous system)(see attached copy, page 11, paragraph 5)).
Regarding claim 6, Hebb discloses a method for blocking or inhibiting the growth of neoplastic cells in a target region of a living organism, said method comprising: treating said neoplastic cells in said target region with an antitumor drug; and applying electric current waves to said target region for a predefined period of time using a device after treating said neoplastic cells with said antitumor drug, wherein the device includes: one or more electrodes; wherein said one or more electrodes are electrodes of the implantable type, said one or more electrodes being adapted to be implanted at or near said target region(The approach of the present invention is referred to as intratumoral modulation therapy or IMT when applied to the treatment of neoplastic disease. I MT is novel in the management of tumors, including tumors of the nervous and somatic system tissues. The present invention may also be used to prevent tumors from forming or recurring(see attached copy, page 11, paragraph 5). In another embodiment the present invention is a method for the treatment of a tumor or cancer in a patient including: (a) implanting at least one electrode adjacent to or within a tumor or a site of the patient suspected of having tumor or cancer cells, the at least one electrode having electrical leads connected thereto; (b) generating continuous alternating or pulsed electric stimulation and applying the electric stimulation through the electrical leads to the at least one electrode adjacent to or within the tumor or the site; and (c) during electric stimulation, treating the patient with a therapeutic agent, radiation, or both the therapeutic agent and radiation, wherein a synergistic effect on the tumor treatment of the combination of the electric stimulation and the therapeutic agent, radiation or both the therapeutic agent and radiation is substantially greater than the effect of each the electric stimulation, therapeutic agent, radiation, or both the therapeutic agent and radiation taken alone(see attached copy, page 7, paragraph 2). Hebb fails to disclose “said electric current waves having a waveform with a fundamental frequency of about 4 MHz distorted by the presence of at least second and third order harmonics, and at least one radiofrequency circuit connected to said one or more electrodes, said at least one radiofrequency circuit being adapted to supply each of said one or more electrodes with one of the current waves having the fundamental frequency of about 4 MHz distorted by the presence of at least second and third order harmonics”.
However, Pozzato teaches “characterized in that said radiofrequency circuit output consists of a current wave of distorted sinusoidal form by the presence of harmonics of at least the second and third order, said current wave circulating in a broadband resonant circuit on the frequency of the pure wave of said distorted sinusoidal form(Summary of the Invention, paragraph 6). The electronic device carrying out the method of the invention is a device in which the resultant wave applied to the electrodes is a wave preferably having a main frequency of 4 MHz and having harmonics of second, third and fourth order(Summary of the Invention, paragraph 9)”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the modulation therapy method of Hebb with the radiofrequency circuit of the electronic device of Pozzato since both references contain electrodes connected to an electronic device with a circuit for controlling parameters. Doing so would specify the frequency waveform modulation that is transmitted to the electrodes during device use.
Regarding claim 7, Hebb discloses a device configured to block or inhibit the growth of neoplastic cells in a target region of a living organism, said device comprising: one or more electrodes, wherein said one or more electrodes are electrodes of the implantable type, said one or more electrodes being adapted to be implanted at or near said target region(The approach of the present invention is referred to as intratumoral modulation therapy or IMT when applied to the treatment of neoplastic disease. I MT is novel in the management of tumors, including tumors of the nervous and somatic system tissues. The present invention may also be used to prevent tumors from forming or recurring(see attached copy, page 11, paragraph 5). In another embodiment the present invention is a method for the treatment of a tumor or cancer in a patient including: (a) implanting at least one electrode adjacent to or within a tumor or a site of the patient suspected of having tumor or cancer cells, the at least one electrode having electrical leads connected thereto; (b) generating continuous alternating or pulsed electric stimulation and applying the electric stimulation through the electrical leads to the at least one electrode adjacent to or within the tumor or the site; and (c) during electric stimulation, treating the patient with a therapeutic agent, radiation, or both the therapeutic agent and radiation, wherein a synergistic effect on the tumor treatment of the combination of the electric stimulation and the therapeutic agent, radiation or both the therapeutic agent and radiation is substantially greater than the effect of each the electric stimulation, therapeutic agent, radiation, or both the therapeutic agent and radiation taken alone(see attached copy, page 7, paragraph 2). The method according to any one of claims 1 -16, wherein prior to step (a) the method comprises providing a device, the device including the at least one electrode to deliver the electric stimulus and one or more reference electrodes that are implanted in proximity to the at least one electrode that delivers the electric stimulus(see attached copy, page 25, claim 17)). Hebb fails to disclose “said device being configured to generate electric current waves having a waveform with a fundamental frequency of about 4 MHz distorted by the presence of at least second and third order harmonics, and at least one radiofrequency circuit connected to said one or more electrodes, said at least one radiofrequency circuit being adapted to supply each of said one or more electrodes with a current wave having a fundamental frequency of about 4 MHz distorted by the presence of at least second and third order harmonics”.
However, Pozzato teaches “characterized in that said radiofrequency circuit output consists of a current wave of distorted sinusoidal form by the presence of harmonics of at least the second and third order, said current wave circulating in a broadband resonant circuit on the frequency of the pure wave of said distorted sinusoidal form(Summary of the Invention, paragraph 6). The electronic device carrying out the method of the invention is a device in which the resultant wave applied to the electrodes is a wave preferably having a main frequency of 4 MHz and having harmonics of second, third and fourth order(Summary of the Invention, paragraph 9)”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the modulation therapy method of Hebb with the radiofrequency circuit of the electronic device of Pozzato since both references contain electrodes connected to an electronic device with a circuit for controlling parameters. Doing so would specify the frequency waveform modulation that is transmitted to the electrodes during device use.
Regarding claim 8, Hebb in view of Pozzato teaches the device according to claim 7, wherein said waveform is a sinusoidal waveform(Electrodes are composed of clinical grade platinum or platinum/iridium alloy, with square or sinusoidal waves produced by a waveform generator and delivered continuously(see attached copy, page 15, paragraph 2)).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIA CATHERINE ANTHONY whose telephone number is (703)756-4514. The examiner can normally be reached 7:30 am - 4:30 pm, EST, M-F.
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/MARIA CATHERINE ANTHONY/Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796
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