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 .
Amendment
This action is in response to the Amendment filed on 6/29/2026.
Claims 1 ,2, 4, 9-17, 21-24, 53 and 82-84 are pending.
Response to Arguments
Applicant's arguments filed 6/29/2026 have been fully considered.
CLAIM REJECTIONS UNDER 35 U.S.C. 102 U.S. Patent Application Publication No. 2010/0331758 to Davalos et al. ("Davalos"), U.S. Patent Application Publication No. 2013/0108667 to Soikum et al. ("Soikum").
Davalos
Applicant argues that Independent claims 1 and 13 have been amended to recite, in part, "applying a low intensity alternating electric field to the target site of the subject" (emphasis added).they state that Davalos describes irreversible electroporation (IRE), not an alternating electric field, but rather short electric pulses. Applicant submits that one of ordinary skill in the art would understand that these short electric pulses are not the same as the claimed low intensity alternating electric fields. Rather, the low intensity alternating electric fields of the current invention are known to be continuous electric fields, NOT short electric pulses. Thus, the short electric pulses described in Davalos are not low intensity alternating electric fields. Therefore, Davalos fails to teach every element of the claims.
Davalos also fails to teach a "low intensity" alternating electric field. The intensity in the irreversible electroporation as taught in Davalos is much higher than the claimed low intensity alternating electric field. Applicant asserts that it is well known in the art that irreversible electroporation as taught in Davalos uses a high intensity field strength which would not be considered "low- intensity." In fact, the Office Action compares the claimed alternating electric field to Davalos' teaching of using about 500 V/cm to about 1500 V/cm. (see Office Action, top of page 3). One of ordinary skill in the art would understand that 500 V/cm to about 1500 V/cm is high intensity, not low intensity. Furthermore, the current specification describes the low intensity alternating electric fields as being, for example, 1-3 V/cm or less than 10 V/cm (see Specification, background section and para [0064]) which are significantly lower than the 500 V/cm to about 1500 V/cm taught in Davalos. Davalos fails to teach a low intensity alternating electric field.
Applicant’s arguments are not persuasive for the following reasons.
While applicant argues that the claims as recited require “a low intensity alternating current” and that applicant’s specification (e.g. [0064]) states that low intensity alternating electrode fields as being 1-3V/cm or less than 10V/cm, the claims does not recite any specific value and there is no special definition in the specifications for “low intensity electric field” as being at these levels. These values are merely examples because Applicant’s own originally filed specifications and claim 84 (which is dependent on claim 1) state the field strength as being at least 1V/cm (e.g. [0094] of the applicant’s originally filed specifications) leaving the upper range open ended. Thus 50V/cm is considered as a “low intensity” alternating current. Therefore, the rejections have been maintained.
Soikum
Independent claim 53 has been amended to recite, in part, "wherein the step of introducing the nanoparticle begins at a given time and wherein the step of applying the alternating electric field ends at least 12 hours after the given time."
Upon view of applicant’s arguments in view of the amended claims and upon further search and consideration, the rejections have been withdrawn.
DOUBLE PATENTING
Applicants request that the double patenting rejection be held in abeyance. Therefore, the double patenting rejections have been maintained.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
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)(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.
Claims 1, 2, 4, 9-12-17, 21-24 and 82-84 are rejected under 35 U.S.C. 102(a)(1) as being by anticipated Davalos et al (U.S. Patent Application Publication Number: US 2010/0331758 A1, hereinafter “Davalos”- PREVIOUSLY CITED).
Regarding claim 1, Davalos teaches a method comprising
a. introducing a conductive nanoparticle (e.g. [0012], [0056], claims 1,15: administering nanoparticles to the subject in an amount sufficient to permit at least some of the nanoparticles to come in close proximity to neoplastic cells) to a target site in the subject; and
b. applying a low intensity alternating electric field to the target site of the subject (e.g. [0113] claims 1, 15: multiple electrical pulses into the neoplasia at about 500 V/cm to about 1500 V/cm in 90 microsecond or less pulses, Note: the claims do not recite any specific parameter ranges and applicant’s originally field specifications describe the field strength as being at least 1V/cm (e.g. [0094] of the applicant’s originally field specifications) leaving the upper range open ended),
wherein the conductivity in the target site is increased (e.g. [0012]: nanoparticles of the methods of the invention, including conductive nanoparticles of varying shape, can enhance pulsed electric field therapies by lowering the electric field threshold).
Regarding claims 2 and 4, Davalos teaches that the current density and/or power loss density in the target site of the subject to the alternating current is altered and that the impedance in the target site is lowered (Note: Since Davalos teaches the claimed steps a and b and also teaches applying an alternating current to a tumor site and stimulation parameters that meets the ranges claimed in claims 83 and 84 (e.g. [0120]: frequency of 0-100 MHz and current electric field strength is 500 V/cm to about 1500 V/cm therefore at least 1V/cm RMS as claimed in claims 83 and 84 and [0094] of the originally filed specifications), Davalos teaches the limitations as claimed).
Regarding claims 9 and 11, Davalos teaches that the alternating electric field is a tumor-treating field and that the wherein the target site is a tumor target site (e.g. Abstract, claims 1, 4, 5, 15).
Regarding claim 10, Davalos teaches that the nanoparticles are nanoparticles that increase tissue permittivity (e.g. [0012]).
Regarding claim 12, Davalos teaches that the altered electric impedance in the tumor target site of the subject to the alternating current results in an increased mitotic effect of the alternating electric field in the tumor target site (Note: Since Davalos teaches the claimed steps a and b and also teaches applying an alternating current to a tumor site and stimulation parameters that meets the ranges claimed in claims 83 and 84 (e.g. [0120]: frequency of 0-100 MHz and current electric field strength is 500 V/cm to about 1500 V/cm therefore at least 1V/cm RMS as claimed in claims 83 and 84), Davalos teaches the limitations as claimed).
Regarding claim 24, Davalos teaches the nanoparticle is introduced into a tumor, a cancer cell or a tumor cell (e.g. [0008]-[0012]: Nanoparticles offer a promising solution for treatment of neoplasias because of their size (about 1 to about 1,000 nm) and ability to diffuse through extracellular spaces).
Regarding claim 82, Davalos teaches the alternating electric fields are induced non- invasively (e.g. [0073]: the device, or a portion of it, is flexible. A flexible device is advantageous for use in accessing tumors non-invasively).
Regarding claim 83, Davalos teaches the alternating electric field is applied at a frequency between 100 kHz and 1 MHz (e.g. [0120] Frequency of pulse signal: 0-100 MHz).
Regarding claim 84, Davalos teaches the alternating electric field has a field strength of at least 1 V/cm RMS (e.g. claim 1: multiple electrical pulses into the neoplasia at about 500 V/cm to about 1500 V/cm).
Regarding claims 13 and 15, Davalos teaches a method of increasing the efficacy of an alternating electric field in a target site of a subject, the method comprising:
a. introducing a conductive nanoparticle (e.g. [0012], [0056]) to a target site in the subject (e.g. claims 1, 15: administering nanoparticles to the subject in an amount sufficient to permit at least some of the nanoparticles to come in close proximity to neoplastic cells);
b. applying a low intensity alternating electric field to the target site of the subject (e.g. [0113] claims 1, 15: multiple electrical pulses into the neoplasia at about 500 V/cm to about 1500 V/cm in 90 microsecond or less pulses),
wherein the efficacy of the alternating electric field in the target site of the subject is increased (e.g. [0012]: nanoparticles of the methods of the invention, including conductive nanoparticles of varying shape, can enhance pulsed electric field therapies by lowering the electric field threshold).
Regarding claims 14, 16 and 17, Davalos teaches that the magnitude of the current density of the alternating field is increased in the target site, the impedance in the target site is lowered and conductivity of the target site is increased (Note: Since Davalos teaches the claimed steps a and b and also teaches applying a low intensity alternating current to a tumor site and stimulation parameters in the ranges disclosed in the specifications of the application (e.g. [0120]: frequency of 0-100 MHz and current electric field strength is 500 V/cm to about 1500 V/cm therefore at least 1V/cm RMS), Davalos teaches the limitations as claimed in claims 14, 16 and 17).
Regarding claims 21 and 22, Davalos teaches that the low intensity alternating electric field is a tumor-treating field and that the target site is a tumor target site (e.g. Abstract, claims 1, 4, 5, 15).
Regarding claim 23, Davalos teaches the increased efficacy of the low intensity alternating electric field in the target site results in an increased anti-mitotic effect of the low intensity alternating electric field in the target site. (Note: Since Davalos teaches the claimed steps a and b and also teaches applying a low intensity alternating current to a tumor site and stimulation parameters in the ranges disclosed in the specifications of the application (e.g. [0120]: frequency of 0-100 MHz and current electric field strength is 500 V/cm to about 1500 V/cm therefore at least 1V/cm RMS), Davalos teaches the limitations as claimed).
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 1, 2, 4, 9-17, 21-24, and 82-84 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent Number:11833362. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1 and 11 of the current application are directed to methods comprising the steps of a. introducing a conductive nanoparticle to a target site in the subject; and b. applying a low intensity alternating electric field to the target site of the subject which is similar to the claim 1 of U.S. Patent Number:11833362 which also comprises the same steps. Further dependent claims of the current application are similar to the dependent claims 2-14 of U.S. Patent Number:11833362.
Claims 1, 2, 4, 9-17, 21-24, and 82-84 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent Number:12397167. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1 and 11 of the current application are directed to methods comprising the steps of a. introducing a conductive nanoparticle to a target site in the subject; and b. applying a low intensity alternating electric field to the target site of the subject which is similar to the claim 1 of U.S. Patent Number:12397167 which also comprises the same steps. Further dependent claims of the current application are similar to the dependent claims 2-13 of U.S. Patent Number:12397167.
Claim 53 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent Number:12076556. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 53 of the current application is directed to a method comprising the steps of applying a low intensity alternating electric field to the cell for a period of time, wherein application of the alternating electric field increases permeability of the cell membrane; and introducing the nanoparticle to the cell, wherein the increased permeability of the cell membrane enables the nanoparticle to cross the cell membrane which is similar to the claim 1 of U.S. Patent Number:12076556 which also comprises the same steps.
While no prior art rejection has been applied for independent claim 53, it is not indicated as allowable due to the double patenting rejection discussed above.
In claim 53, no prior art was found teaching individually, or suggesting in combination, all of the features of the applicants' invention, specifically “the step of introducing the nanoparticle begins at a given time and wherein the step of applying the alternating electric field ends at least 12 hours after the given time” in combination with the recited steps of the claimed invention.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Sano et al (U.S. Patent Application Publication Number: US 2017/0266438 A1, hereinafter “Sano”) teaches a method of treating a subject suffering from an aberrant cell growth, comprising: implanting an electrode into or adjacent the aberrant growth region within the body of a subject, and causing multiple electrical pulses that are unipolar or bipolar wave form of a rectangular pulse, ramp, decaying exponential, or sine wave to be emitted from the electrode into the aberrant cell growth region to generate an electric field, wherein the electric field strengths generated within the aberrant cell growth region are selective to kill, slow the growth rate of, halt migration of, or prevent the transport of blood and nutrients to aberrant cells while preserving healthy cells.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MALLIKA DIPAYAN FAIRCHILD whose telephone number is (571)270-7043. The examiner can normally be reached Monday- Friday 8 am-5pm EST.
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/MALLIKA D FAIRCHILD/Primary Examiner, Art Unit 3792
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