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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/26/2026 has been entered.
Response to Amendment
Claims 33, 73, and 74 have been amended, and claims 75-76 have been added. Claims 33, 35, 38, and 64-76 remain pending.
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 33, 35, 38, and 64-76 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “low intensity” in claim 33 is a relative term which renders the claim indefinite. The term “low intensity” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
At [0024] of Applicant’s instant Specification, it is recited that “an "alternating electric field" or "alternating electric fields" refers to a very-low-intensity, directional, intermediate-frequency alternating electrical fields delivered to a subject, a sample obtained from a subject or to a specific location within a subject or patient”. This is the only reference made to a low intensity, and does not provide a specific range for how the claim term “low intensity” as meant to be specifically applied. Claims 73-76 (especially claims 75-76) further specify a particular strength which the electric fields must have, however it is not clear if claim 33 is meant to be interpreted to have such a field strength without a specific limitation drawn towards the field strength. Since it is not clear how the claim limitation is meant to be interpreted or if specific boundaries are meant to be applied to the intensity of the fields, claim 33 is considered to be indefinite and Examiner has understood the claim to require electric fields with field strengths suitably low for safe use with human subjects.
Claims 35, 38, and 64-76 are indefinite based on their dependency on, and thus requirements of the indefinite limitations of, indefinite claim 33.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 33, 35, and 38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of U.S. Patent No. 11,529,511 in view of Dev et al. (US 20040092860, henceforth Dev) and Wenger et al. (US 20170120041, henceforth Wenger).
Regarding claim 33, claims 1 (which claim 4 depends on and thus requires) and 4 of the ‘511 patent discloses a method for reducing the viability of a cell (“reduces viability of the cancer cells.” Since the ‘511 patent is for cancer cells, cancer cells are species of cells, and since species anticipate genuses, this anticipates the claim limitation), the method comprising: applying a first alternating electric field at a first frequency to the cell for a first period of time, wherein application of the first alternating electric field at the first frequency to the cell for the first period of time increases permeability of the cell membrane of the cell (“the method comprising: applying a first alternating electric field at a first frequency to the cancer cells for a first period of time, wherein application of the first alternating electric field at the first frequency to the cancer cells for the first period of time increases permeability of cell membranes of the cancer cells”) wherein the first frequency is between 50 kHz and 350 kHz (“the first frequency is between 75 kHz and 175 kHz”, claim 4, this range is fully within the range of 50 kHz and 350 kHz and thus anticipates the claimed range); introducing a vector to the cell (“introducing a substance to the cancer cells”, see below), wherein the increased permeability of the cell membranes enables the vector to cross the cell membrane (“wherein the increased permeability of the cell membranes enables the substance to cross the cell membranes”); and applying a second alternating electric field at a second frequency to the cell for a second period of time, wherein the second frequency is different from the first frequency, and wherein the second alternating electric field at the second frequency reduces viability of the cell (“and applying a second alternating electric field at a second frequency to the cancer cells for a second period of time, wherein the second frequency is different from the first frequency, and wherein the second alternating electric field at the second frequency reduces viability of the cancer cells.”).
Claim 4 of the ‘511 patent does not disclose that the substance to be introduced into the cell was a vector. Dev teaches that a substance which can be introduced into a cell can be a vector ([0080]) and that it can be a vector for the benefit of incorporating a gene for a selectable marker into a cell so that affected cells can be identified ([0080]).
Claim 4 of the cited patent as modified by Dev does not explicitly claim that the first alternating electric field and the second alternating electric field are low intensity fields. Wenger teaches alternating electric fields used for tumor treatment to be low intensity ([0002]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had arranged the alternating electric fields of claim 4 of the cited patent as modified by Dev be low intensity as Wenger teaches this to be the standard convention known in the art ([0002]).
Regarding claim 35, claim 1 (which claim 4 depends on and thus requires) of the ‘511 patent as modified by Dev discloses that the cell is a cancer cell (“cancer cells”).
Regarding claim 38, claim 4 of the ‘511 patent with the modification from Dev as in claim 33 above discloses that the second frequency is between 75 kHz and 300 kHz (“the second frequency is between 100 kHz and 300 kHz”, this range is fully within the range of 75 kHz and 300 kHz and thus anticipates the claimed range).
Regarding claim 73, claim 6 of the ‘511 patent with the modification from Dev as in claim 33 above discloses that the first alternating electric field has a field strength of at least 1 V/cm RMS (“wherein the first alternating electric field has a field strength of at least 1 V/cm RMS.”).
Response to Arguments
Applicant’s arguments, see pgs. 7 and 8 of Applicant’s Remarks, filed 05/26/2026, with respect to the previously relied upon combination of Dev and Palti have been fully considered and are persuasive. The rejection of claims 33, 35, 38, and 64-76 under 35 U.S.C. 103 has been withdrawn.
In particular, the argument regarding the differing modalities of treatment between Dev and Palti, particularly where Dev relies on increased cell viability while Palti acts to decrease cell viability, is persuasive for the reasons provided in Applicant’s Remarks at pgs. 7 and 8.
The Double Patenting rejection did not have any specific arguments provided as to its traversal, and thus the Double Patenting rejection is maintained.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL J MARRISON whose telephone number is (703)756-1927. The examiner can normally be reached M-F 7:00a-3:30p ET.
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/SAMUEL J MARRISON/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
