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 Figure 1 is difficult to understand and some of the text is difficult to read. As published one cannot identify the difference in the various tumor microenvironment. 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 Objections
Claim 6 is objected to because of the following informalities: the claim does not end in a period. It is assumed the semi-colon should be replaced with a period. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim 18 is 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. Claim 18 states the data relating to the staging of the tumor are selected form spike count, evoked compound action potential shape or area, firing rate and spike shape. The disclosure does not provide any specific insight into how the spike count, evoked compound action potential shape or area, firing rate and spike shape correlates to a stage. The disclosure states language similar to the claims and does not provide any insight into how the total number of action potentials (spike count), or any other recited action potential characteristics, correlate to a tumor/cancer stage.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 21 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 21, the phrase "e.g.," renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention.
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.
Claim(s) 1-4, 6, 8, 13, and 19-21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pilcher et al (US Publication 2017/0312021).
Referring to Claim 1, Pilcher et al teaches a method for the treatment of a cancer in a subject, or for adjuvating the treatment of cancer in a subject comprising the following steps: i) implanting a neural interface (NI) on at least one target nerve of the tumor microenvironment (TME) of a tumor mass of said cancer, and at least one stimulator connected to said NI in subject in need of such treatment (e.g. Paragraphs [0168] and [0169] discloses the neuromodulation assembly is implanted and Figure 13 NI 120 and stimulator 130 and Paragraph [0134]); ii) performing a neuromodulation protocol to said nerve using said neural interface in order to reduce the tumor mass or the metabolic activity of said cancer (e.g. Paragraphs [0108], [0109], [0111], and [0169]).
Referring to Claim 2, Pilcher et al teaches the method according to claim 1, wherein said neuromodulation protocol consists of stimulating or inhibiting said target nerve (e.g. Paragraph [0169]).
Referring to Claim 3, Pilcher et al teaches the method according to claim 1, wherein said stimulator is implanted in a subcutaneous cavity (e.g. Paragraph [0168] discloses implanting the assembly and Paragraph [0065] discloses neuromodulation within the abdominal cavity).
Referring to Claim 4, Pilcher et al teaches the method according to claim 1, wherein said target nerve is determined by characterization of the parasympathetic, sympathetic and/or sensory innervation of the tumor microenvironment (TME) for primary and metastatic tumor masses of said cancer (e.g. Paragraph [0115] discloses characterizing the tumor microenvironment and targeting SNS nerves proximal the tumor).
Referring to Claim 6, Pilcher et al teaches the method for according to claim 1, further comprising prior to step 1) the following steps: a) acquiring data about the staging of the cancer of said subject (e.g. Paragraph [0108] discloses PET scan before neuromodulation); b) defining the tumor microenvironment (TME) innervation profile of each tumor mass of said cancer (e.g. Figure 2 and Paragraph [0115] discloses obtaining a baseline of the microenvironment).
Referring to Claim 8, Pilcher et al teaches a method for the treatment of a cancer in a subject, or for adjuvating the treatment of cancer in a subject, comprising the following steps: i) acquiring data about the staging of the cancer of said subject before the treatment (e.g. Paragraph [0108] discloses PET scan before neuromodulation); ii) defining the tumor microenvironment (TME) innervation profile of each tumor mass of said cancer (e.g. Figure 2 and Paragraph [0115] discloses obtaining a baseline of the microenvironment); iii) implanting a neural interface (NI) on all the nerves of the tumor microenvironment (TME) of each tumor mass of said cancer, and their stimulators connected to said NI (e.g. Paragraphs [0168] and [0169] discloses the neuromodulation assembly is implanted and Figure 13 NI 120 and stimulator 130 and Paragraph [0134] and Paragraph [0163]); iv) performing a neuromodulation protocol using said neural interface in order to reduce the tumor mass or the metabolic activity of said cancer (e.g. Paragraphs [0108], [0109], [0111], and [0169]).
Referring to Claim 13, Pilcher et al teaches the method according to claim 1, wherein said neural interface (NI) is configured in order to provide an electric stimulus to said target nerve and/or to allow the bidirectional communication between said tumor masses and nerves (e.g. Paragraphs [0048], and [0169]-[0170] discloses delivery of electrical stimulus (neurostimulation) to target nerve ).
Referring to Claim 19, Pilcher et al teaches the method according to claim 1, wherein said cancer is selected from the group consisting of central nervous system cancer, pancreatic cancer, prostate cancer, breast cancer, colon cancer, rectum cancer, skin cancer, liver cancer, cervical cancer, lung cancer, ovarian cancer, bladder cancer, bone cancer, stomach cancer, urogenital cancer, esophageal cancer, mesothelial cells and combinations thereof (e.g. Paragraph [0051] discloses bone cancer).
Referring to Claim 20, Pilcher et al teaches the method according to claim 1, further comprising a step of administering one or more neoplastic disease therapeutic and/or palliative therapies, optionally comprising the administration of one or more anti-cancer agent (e.g. Paragraphs [0111], [0117], [0119] and [0121] discloses including drug delivery).
Referring to Claim 21, Pilcher et al teaches the method according to claim 20, wherein said one or more anti-cancer agent is selected from the group consisting of cytokines, chemokines, growth factors, a photosensitizing agents, toxins, anti-cancer antibiotics, chemotherapeutic compounds, radionuclides, angiogenesis inhibitors, signaling modulators, anti-metabolites, anti-cancer vaccines, anti-cancer oligopeptides, mitosis inhibitor proteins, antimitotic oligopeptides, anti-cancer antibodies (e.g., single-chain antibodies), anti-cancer antibiotics, immunotherapeutic agents, bacteria and combinations thereof (e.g. Paragraphs [0111] and [0117]).
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) 5 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pilcher et al (US Publication 2017/0312021) in view of Baeket al (US Publication 2014/0330264).
Referring to Claim 5, Pilcher et al teaches the method of claim 4, wherein said target nerve is determined by combining imaging information with physiological and/or neural information.
Baek et al teaches that it is known to use PET imaging along physiological information (Warburg effect) that cancer consumes/binds to more glucose molecules than non-cancerous cells as set forth in Paragraphs [0030] to provide improved location of the target tissue to be treated. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Pilcher et al, with PET imaging along physiological information (Warburg effect) that cancer consumes/binds to more glucose molecules than non-cancerous cells as taught by Baek et al, since such a modification would provide the predictable results of improved location of the target tissue to be treated.
Referring to Claim 9, Pilcher et al teaches the method according to claim 1, except wherein said metabolic activity is the glucose consumption of said cancer, as measured by positron emission tomography (PET).
Baek et al teaches that it is known to use PET imaging along physiological information (Warburg effect) that cancer consumes/binds to more glucose molecules than non-cancerous cells as set forth in Paragraphs [0030] to provide improved location of the target tissue to be treated. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Pilcher et al, with said metabolic activity is the glucose consumption of said cancer, as measured by positron emission tomography (PET) as taught by Baek et al, since such a modification would provide the predictable results of improved location of the target tissue to be treated.
Claim(s) 7, 10 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pilcher et al (US Publication 2017/0312021) in view of Schwab et al (US Publication 2017/0100588).
Referring to Claim 7, Pilcher et al teaches a method for the treatment of a cancer in a subject, or for adjuvating the treatment of cancer in a subject, comprising the following steps: i) acquiring data about the staging of the cancer of said subject before the treatment (e.g. Paragraph [0108] discloses PET scan before neuromodulation); ii) defining the tumor microenvironment (TME) innervation profile of each tumor mass of said cancer (e.g. Figure 2 and Paragraph [0115] discloses obtaining a baseline of the microenvironment); iii) implanting a neural interface (NI) on at least one target nerve of the tumor microenvironment (TME) of a tumor mass of said cancer, and at least one stimulator connected to said NI (e.g. Paragraphs [0168] and [0169] discloses the neuromodulation assembly is implanted and Figure 13 NI 120 and stimulator 130 and Paragraph [0134]); iv) performing a neuromodulation protocol using said neural interface with neuromodulation parameters related to the tumor staging before the treatment (e.g. Paragraphs [0108], [0109], [0111], and [0169]); v) comparing data about the staging of the cancer of said subject before and after the treatment (e.g. Paragraph [0108] discloses analysis of PET scan before and after neuromodulation); vi):determining: a) if no reduction of said tumor mass or the metabolic activity has been achieved; or b) if reduction of said tumor mass or the metabolic activity has been achieved (e.g. Paragraph [0103] assessing the efficacy of the neuromodulation treatment). However, Pilcher et al does not explicitly disclose if no reduction changing the neuromodulation parameter and if reduction not changing the neuromodulation parameters.
Schwab et al teaches it is known to use a closed-loop system to adjust electrical treatment parameters in response to sensor readings as set forth in Figure 5 and Paragraphs [0061]-[0062] to provide adjusting the therapy signals, when necessary, to improve the subject’s cancer symptoms. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Pilcher et al, with a closed-loop system to adjust electrical treatment parameters in response to sensor readings as taught by Schwab et al, since such a modification would provide the predictable results of adjusting the therapy signals, when necessary, to improve the subject’s cancer symptoms.
Referring to Claim 10, Pilcher et al teaches the method according to claim 1, wherein said neuromodulation protocol uses the following parameters for stimulating said target nerve: stimulation is a monopolar, bipolar or tripolar stimulation (e.g. Paragraphs [0095] and [0119]). However, Pilcher et al does not disclose said neuromodulation protocol uses: biphasic rectangular, sinusoidal, trapezoidal, triangular pulses or a combination thereof, with: an amplitude in a range from 1 to 10 mA; and/or a frequency in a range from 1 to 100 Hz; pulse width is in a range from 0.01 to 3 ms. Schwab et al teaches that it is known to use a square wave with an amplitude in in a range from 1 to 10 mA; and/or a frequency in a range from 1 to 100 Hz; pulse width is in a range from 0.01 to 3 ms as set forth in Paragraphs [0049-0051] to provide increasing activity of the neural target site to increase activity of the patient's intact sympathetic circuitry to suppress the patient's immune function (e.g. Paragraph [0037]). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Pilcher et al, with a square wave with an amplitude in in a range from 1 to 10 mA; and/or a frequency in a range from 1 to 100 Hz; pulse width is in a range from 0.01 to 3 ms as taught by Schwab et al, since such a modification would provide the predictable results of increasing activity of the neural target site to increase activity of the patient's intact sympathetic circuitry to suppress the patient's immune function.
Referring to Claim 11, Pilcher et al teaches the method according to claim 1, wherein said neuromodulation protocol uses the following parameters for inhibiting said target nerve: stimulation is a monopolar, bipolar or tripolar stimulation (e.g. Paragraphs [0095] and [0119]). However, Pilcher et al does not disclose said neuromodulation protocol uses: biphasic sinusoidal, square, trapezoidal, triangular waveforms or a combination thereof with: an amplitude in a range from 1 to 10 mA; and/or a frequency in a range from 1 to 100 kHz; pulse width is in a range from 0.01 to 3 ms.
Schwab et al teaches that it is known to use a square wave with an amplitude in in a range from 1 to 10 mA; and/or a frequency in a range from 1 to 100 kHz; pulse width is in a range from 0.01 to 3 ms as set forth in Paragraphs [0049-0051] to provide decreasing immune activity resulting from a hyperactive immune system to improve symptoms caused by the abnormal immune systems (e.g. Paragraph [0013]). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method] as taught by Pilcher et al, with a square wave with an amplitude in in a range from 1 to 10 mA; and/or a frequency in a range from 1 to 100 kHz; pulse width is in a range from 0.01 to 3 ms as taught by Schwab et al, since such a modification would provide the predictable results of decreasing immune activity resulting from a hyperactive immune system to improve symptoms caused by the abnormal immune systems.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pilcher et al (US Publication 2017/0312021) in view of Pardasani et al (US Publication 2018/0333141).
Referring to Claim 12, Pilcher et al teaches the method according to claim 6, except wherein said data about the staging of the cancer of said subject have been obtained by performing a tumor biopsy and/or imaging, optionally by means of magnetic resonance imaging (MRI), computed tomography (CT) and positron emission tomography (PET) scans.
Pardasani et al teaches that it is known to use MRI in staging of cancer as set forth in Paragraph [0003] to provide improved visualization of the tissue for improved staging. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Pilcher et al, with MRI in staging of cancer as taught by Pardasani et al, since such a modification would provide the predictable results of improved visualization of the tissue for improved staging.
Claim(s) 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pilcher et al (US Publication 2017/0312021) in view of Mrva (US Patent 7,797,058).
Referring to Claim 14, Pilcher et al teaches the method according to claim 1, except wherein said neural interface (NI) is placed around the target nerve.
Mrva et al teaches that it is known to use a neurostimulator comprising a nerve cuff electrode (placed around the target nerve) connected to encapsulated wires to connect the nerve cuff with the stimulator (pulse generator) and as set forth in Figure 1 and Column 2 lines 58-Column3 line 4 to provide a structure that makes good contact with the nerve and provides a reliable connection for transmitting stimulation signals. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Pilcher et al, with said neural interface (NI) is placed around the target nerve as taught by Mrva et al, since such a modification would provide the predictable results of a structure that makes good contact with the nerve.
Referring to Claim 15, Pilcher et al teaches the method according to claim 1, except wherein said neural interface (NI) is connected to said stimulator by means of encapsulated lead wires or wireless connection, and optionally radiofrequency coupling (RF coupling), bluetooth low energy (BLE) and/or ultrasounds.
Mrva et al teaches that it is known to use a neurostimulator comprising a nerve cuff electrode (placed around the target nerve) connected to encapsulated wires to connect the nerve cuff with the stimulator (pulse generator) as set forth in Figure 1 and Column 2 lines 58-Column3 line 4 to provide a structure that makes good contact with the nerve and provides a reliable connection for transmitting stimulation signals. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Pilcher et al, with wherein said neural interface (NI) is connected to said stimulator by means of encapsulated lead wires or wireless connection, and optionally radiofrequency coupling (RF coupling), bluetooth low energy (BLE) and/or ultrasounds as taught by Mrva et al, since such a modification would provide the predictable results of a reliable connection for transmitting stimulation signals.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pilcher et al (US Publication 2017/0312021) in view of Bullock et al (US Publication 2022/0280779).
Referring to Claim 16, Pilcher et al teaches the method according to claim 1, wherein said stimulator is current-controlled and delivers current pulses to said target nerve through the neural interface (NI) exploiting a capacitive, faradaic or pseudo faradaic charge injection mechanism.
Bullock et al teaches that it is known to use capacitive charge injection as set forth in Paragraphs [0009] and [0207] to provide delivery of charge without releasing chemical into the tissue that has the potential to cause harm. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Pilcher et al, with stimulation using capacitive charge injection as taught by Bullock et al, since such a modification would provide the predictable results of delivery of charge without releasing chemical into the tissue that has the potential to cause harm.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pilcher et al (US Publication 2017/0312021) in view of Ciofani et al (US Publication 2012/0121712).
Referring to Claim 17, Pilcher et al teaches the method according to claim 1, except wherein said neural interface (NI) comprises or consists of a nanostructured material suitable to be used as nano transductor to convert external energy into electrical potential, optionally wherein said external energy is near infrared light (NIR) in the range from 700 to 900 nm, ultrasound, laser, radiofrequency, magnetic field or a combination thereof.
Ciofani et al teaches that it is known to use a nanotransducer to receive ultrasound and convert it into electrical stimulus as set forth in Figure 1 and Paragraphs [0001], [0015], and [0027] to provide a reduction in size, without the need for a battery, while providing for powers that can be adapted to the patient’s needs (e.g. Paragraph [0026]). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Pilcher et al, with a nanotransducer to receive ultrasound and convert it into electrical stimulus as taught by Ciofani et al, since such a modification would provide the predictable results of a reduction in size, without the need for a battery, while providing for powers that can be adapted to the patient’s needs.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pilcher et al (US Publication 2017/0312021).
Referring to Claim 18, Pilcher et al teaches the method according to claim 6, except wherein said data relating to the staging of the tumor are selected from spike count, evoked compound action potential shape or area, firing rate and spike shape.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method as taught by Pilcher et al, with a data relating to the staging of the tumor are selected from spike count, evoked compound action potential shape or area, firing rate and spike shape since it was known in the art that data relating to the staging of the tumor are selected from spike count, evoked compound action potential shape or area, firing rate and spike shape is used to provide the predictable results of determining stage of cancer.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to William J Levicky whose telephone number is (571)270-3983. The examiner can normally be reached Monday-Thursday 8AM-5PM EST.
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/WILLIAM J LEVICKY/Primary Examiner, Art Unit 3796