DETAILED ACTION
A complete action on the merits of pending claims 1-8 appears below.
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 .
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 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.
Claim Rejections - 35 USC § 112
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.
Claims 1-8 are 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 pre-AIA the applicant regards as the invention.
Claims 1, 2 and 4 recite DAMP which is an acronym that is not defined in the claims; therefore, the scope of the claim is not defined. Claims 5-8 are rejected as being dependent on claims 1 and 2.
Claim 3 recites “electrodes capable of delivering both electroporation and electrolysis and radiofrequency and microwave type pulse modulation”. This requires some punctuation or something to determine what is being talked about. Both is used, which typically refers to two things, but it is a list of four things which all are separated by ands. For examination, if the electrodes can supply different kinds of frequencies it will be seen to read on the limitation.
Claim 5 recites “where the permeabilization is not done by means of electroporation but by sonoporation or cryoablation or other means of cell permeabilization”. Claim 3 from which claim 5 depends has limitations for controlling electroporation. As stated in the applicant’s specification in par. [0047], “Electroporation is the permeabilization of the cell membrane by a pulsed electric field…”. Therefore, if electroporation is happening it causes permeabilization.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 5 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 5 states permeabilization is not done by electroporation. However, claim 3, from which claim 5 depends, requires electroporation. Electroporation causes permeabilization, so controlling electroporation and having permeabilization not caused by electroporation cannot happen. Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
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.
Claims 1 and 3-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lugnani US 20200222102.
Regarding claims 1 and 3, Lugnani teaches a) a plurality of electrodes configured for delivering electroporation and electrolysis to target tissue (par. [0055] electroporation and electrolysis created between electrode pairs); b) a thermal modulation unit integrated able to heat and/or cool and designed to adjust the temperature of the target tissue during ablation (par. [0086] cooling the device to prevent carbonization); c) a controller programmed to synchronize electroporation, electrolysis, and thermal inputs (par. [0079] combination of cryosurgery with electroporation and electrolysis) based either on real-time feedback from the tissue or generic tissue data to induce a specified ablation mode or immune response in a volume(s) of interest (par. [0129] feedback sensors relying on sensors including temperature sensors); wherein the controller adjusts parameters including voltage, current, total charge, pulse modulation, and thermal energy (par. [0073] controlling charge, current voltage and time, par. [0085] controlling the cryogenic temperatures in conjunction with electrolysis) to achieve desired immune outcomes through the ablation mode and in turn the modulation of cytokine release and DAMP activation in the volume(s) of interest (this is what happens during ablation procedures since cytokine release is an inflamitory response); and d) a user interface for clinicians to plan the treatment, input data, select parameters and monitor the treatment (par. [0138] controller functions off inputs by the user).
Regarding claim 4, Lugnani teaches wherein the thermal energy is applied selectively based on the tissue type and the desired depth of ablation, and is controlled to prevent overheating (par. [0086] cooling the device to prevent carbonization) while maximizing the release of heat shock proteins and other immunostimulatory DAMPs to planned areas (par. [0068] different ablation methods, the act of ablation releases heat shock protiens).
Regarding claim 5, Lugnani teaches where the permeabilization is not done by means of electroporation but by sonoporation or cryoablation or other means of cell permeabilization (see 112s above, however if it read as cryoablation adds to permeabilization par. [0084] cryosurgery increases permeability).
Regarding claim 6, Lugnani teaches where the electrode configuration includes options for both invasive and non-invasive application, for flexibility in treating both superficial and deep-seated tumors (par. [0053] minimally invasive surgeries and par. [0162] exposed liver surgery via incision).
Regarding claim 7, Lugnani teaches further comprising the step of administering adjunctive immunotherapeutic agents concurrently with the ablation procedure to synergize with the induced immune responses, including checkpoint inhibitors, cancer vaccines, cell fragment binding and presenting compounds, cytokine therapy, monoclonal antibodies, adoptive cell transfer, oncolytic virus therapy, cancer growth inhibitors, bispecific antibodies, immune system modulators, CAR T-Cell therapy, tumor-infiltrating lymphocytes (TIL) therapy, dendritic cell vaccines, immune agonists, immune adjuvants, toll-like receptor agonists, interferons, interleukins, or combinations thereof (par. [0056] using during electroporation cell toxic compounds additionally cytokine are released as an inflammatory response).
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 2 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Lugnani in view of Manucherhabadi US 20210315639.
Regarding claims 2 and 8, Lugnani teaches comprising: a) planning the procedure by means of computational modeling in conjunction with previously acquired tomography datasets and an immune-oncological treatment plan (par. [0072] preselected volume, par. [0082] predetermined electrolysis, par. [0086] preselected cooling of tissue); resulting in a map of ablation types or cell death types including pyroptosis, necroptosis, apoptosis, necrosis, ferroptosis, or combinations thereof or immune responses including DAMP release, cytokine release, antigen presentation, programmed lysis, delayed responses, activation of cytotoxic T lymphocytes, tumor micro environment (TME) disruption, T-cell activation, NK cell activation, or combinations thereof desired for one or more volumes of interest to achieve the planned immunological effect (par. [0056] using during electroporation cell toxic compounds additionally cytokine are released as an inflammatory response); b) applying permeabilization, including electroporation and electrolysis through a set of electrodes to a target tissue area (par. [0079] combination of cryosurgery with electroporation and electrolysis) with voltages and energies and pulse shapes that computationally approximate the planed ablation map of the volume(s) of interest (par. [0073]); c) concurrently adding thermal energy using electric pulse modulation to the target tissue to enhance the effects of electroporation and electrolysis (par. [0079] combination of cryosurgery with electroporation and electrolysis); d) adjusting the parameters of electroporation, electrolysis, and thermal energy dynamically, based on the sensor readings (par. [0073] controlling charge, current voltage and time, par. [0085] controlling the cryogenic temperatures in conjunction with electrolysis) including impedance and temperature and including treatment combination and repetition timings adapted to the immunological response as measured by suitable imaging (par. [0054] thermal imaging of tissue site).
Lugnani does not explicitly teach where the device is used for oncology and where blood testing is used.
Manucherhabadi, in an analogous method, teaches blood pressure and heart rate are used as tracked biomarkers during the procedure (par. [0188]) and that the electroporation devices can be used on any kinds of cells including cancer cells (par. [0128]).
It would have been obvious to one of ordinary skill in the art at the time the device was effectively filed to modify the method of Lugnani to be used on cancer cells, as in Manucherhabadi. Electroporation is a known interventional oncology method in the art (par. [0002]).
Conclusion
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/R.T.C./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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