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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 February 3, 2026 has been entered.
Response to Amendment
The amendment filed February 3, 2026 has been entered. Claims 1, 7, 13 have been amended. Claims 3, 9, 14 were previously canceled. Currently, claims 1-2, 4-8, 10-13 and 16-20 are pending for examination.
Response to Arguments
Applicant's arguments filed February 3, 2026 with respect to claim 13 under 35 U.S.C. 103 have been fully considered but they are not persuasive. Applicant’s arguments directed to the prior art rejection of claim 13 as being unpatentable over Kaynan et al. (US 2020/0016339) in view of Nagel et al. (US 2021/0282479) are primarily directed to the prior art preventing the number of cells that initially get infected, and not that the alternating electric field (AEF) had any effect on cells already infected (p. 7). In response to this argument, Kaynan et al. states, “AEFs can inhibit viral infection, applying AEFs can prevent the damage made by infection of new cells (alteration of cell's functions, cell death or transformation), stop viral multiplication and spread, and avoid its ramifications on the wellbeing of the infected person.” ([0039]) and further differentiates this primary purpose with another, “AEF-based anti-viral therapy may also be used for the protection of uninfected healthy individuals from a threatening infection” ([0040]). Therefore it is clear that Kaynan et al. discloses in paragraph [0039] that the AEF has an effect on cells already infected.
With regard to applicant’s arguments directed to Nagel et al. (p. 7), the current rejection of claim 13 now depends on the prior art teaching that lentivirus and coronavirus are similar enough viruses to contemplate the same kind of treatment procedures, and that it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the methods of Kaynan et al. (directed to lentivirus) to treat coronavirus.
Furthermore, applicant’s argument that Kaynan et al. fails to disclose or teach inhibition of viral multiplication or viral replication occurs in a cell because the prior art discloses inhibiting viral infection (p. 8), this argument is unpersuasive as applicant’s own claim 19 appears to equate these two terms as the same. Furthermore, unlike the other independent claims, claim 13 is not directed to viral replication within the cell, but broadly recites, “inhibits replication of the coronavirus, thereby treating the subject infected with the coronavirus”. What happens at a cellular level is not currently claimed.
Applicant’s arguments, see page 6, filed February 3, 2026, with respect to the rejection(s) of claim(s) 1-2, 4-8, 10-12 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Nicacio et al. (US 2021/0228895).
During the course of prosecution history, claim 1 was amended to recite, exposing the cell infected with coronavirus “to a single electrical field, wherein the single electrical field is an alternating electric field for a period of time”, claim 7 was amended to recite, exposing a cell infected with coronavirus “to a single field, wherein the single field is an alternating electric field for a period of time”, and claim 13 was amended to recite, “applying a single field, wherein the single field is an alternating electric field for a period of time” (see 05/09/25 claim amendment). While it is understood this limitation was made to overcome Nicacio et al. (US 2021/0228895), after further review this specific claim amendment does not exclude prior art that uses an electromagnetic-based system such as Nicacio et al. as the prior art states this electromagnetic-based system can be used to create an electrical field with alternating current qualities for exposing to a cell ([0035], [0056]).
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 1-2, 4-8, 10-13 and 16-20 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.
During the course of prosecution history, claim 1 was amended to recite, “exposing the cell infected with coronavirus to a single electrical field, wherein the single electrical field is an alternating electric field for a period of time” (see 05/09/25 claim amendment). The wording of this claim is now ambiguous as it is unclear if “for a period of time” is directed to the, “exposing the cell infected with coronavirus to a single electrical field” or directed to the characterization of, “wherein the single electrical field is an alternating electric field”.
Claims 8, 10-12 are rejected to for being dependent on and for failing to remedy the deficiencies of claim 1.
During the course of prosecution history, claim 7 was amended to recite, “exposing a cell infected with coronavirus to a single field, wherein the single field is an alternating electric field for a period of time” (see 05/09/25 claim amendment). The wording of this claim is now ambiguous as it is unclear if “for a period of time” is directed to the, “exposing the cell infected with coronavirus to a single field” or directed to the characterization of, “wherein the single field is an alternating electric field”.
Claims 2, 4-6 are rejected to for being dependent on and for failing to remedy the deficiencies of claim 7.
During the course of prosecution history, claim 13 was amended to recite, “applying a single field, wherein the single field is an alternating electric field for a period of time” (see 05/09/25 claim amendment). The wording of this claim is now ambiguous as it is unclear if “for a period of time” is directed to the, “applying a single field” or directed to the characterization of, “wherein the single field is an alternating electric field to a target site of the subject”.
Claims 15-20 are rejected to for being dependent on and for failing to remedy the deficiencies of claim 13.
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 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.
Claim(s) 1-2, 4, 6-8, 10, 12-13, 15, 17, 19-20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Nicacio et al. (US 2021/0228895).
Regarding claim 1, Nicacio et al. discloses a method of inhibiting a coronavirus from replicating in a cell infected with coronavirus comprising: exposing the cell infected with coronavirus to a single electrical field (“FIG. 9A depicts an implementation wherein the wire is connected directly to an individual by a TENS pad or TENS-like pad and wherein the device is powered by an electrical source using a grounded plug.” [0036]; “Additionally, portable device 100 may comprise at least one wire 116 and an electrode 118 to carry the electrical signal to a location near the cells to be treated.” [0056]), wherein the single electrical field is an alternating electric field for a period of time, the alternating electric field having a frequency and field strength ([0059], [0072]), wherein the frequency and field strength of the alternating electric field inhibits coronavirus replication in the cell infected with coronavirus (“shut down protein production in an infected cell to block pathogen replication” [0045]; “In certain implementations, the “cells” are infected by a virus and inhibition of cell growth includes prevention of further infection of cells by the virus.” [0069]; [0078]), wherein the coronavirus is SARS-CoV-2 ([0078]).
Regarding claim 2, Nicacio et al. discloses wherein the cell is in a subject ([0040]).
Regarding claim 4, Nicacio et al. discloses wherein the alternating electric field has a frequency of between 50 kHz and 1 MHz ([0059], [0072]).
Regarding claim 6, Nicacio et al. discloses wherein the alternating electric field is multidirectional ([0033]).
Regarding claim 7, Nicacio et al. discloses a method of reducing coronavirus copy number per cell comprising: exposing a cell infected with coronavirus to a single field (“FIG. 9A depicts an implementation wherein the wire is connected directly to an individual by a TENS pad or TENS-like pad and wherein the device is powered by an electrical source using a grounded plug.” [0036]; “Additionally, portable device 100 may comprise at least one wire 116 and an electrode 118 to carry the electrical signal to a location near the cells to be treated.” [0056]), wherein the single field is an alternating electric field for a period of time, the alternating electric field having a frequency and field strength ([0059], [0072]), wherein the frequency and field strength of the alternating electric field inhibits replication of the coronavirus in the cell infected with coronavirus, thereby reducing coronavirus copy number in the cell (“shut down protein production in an infected cell to block pathogen replication” [0045]; “In certain implementations, the “cells” are infected by a virus and inhibition of cell growth includes prevention of further infection of cells by the virus.” [0069]; [0078]), wherein the coronavirus is SARS-CoV-2 ([0078]).
Regarding claim 8, Nicacio et al. discloses wherein the cell is in a subject ([0040]).
Regarding claim 10, Nicacio et al. discloses wherein the alternating electric field has a frequency of between 50 kHz and 1 MHz ([0059], [0072]).
Regarding claim 12, Nicacio et al. discloses wherein the alternating electric field is multidirectional ([0033]).
Regarding claim 13, Nicacio et al. discloses a method of treating a subject infected with coronavirus comprising: applying a single electrical field (“FIG. 9A depicts an implementation wherein the wire is connected directly to an individual by a TENS pad or TENS-like pad and wherein the device is powered by an electrical source using a grounded plug.” [0036]; “Additionally, portable device 100 may comprise at least one wire 116 and an electrode 118 to carry the electrical signal to a location near the cells to be treated.” [0056]), wherein the single electrical field is an alternating electric field to a target site of the subject (fig. 9A) for a period of time, the alternating electric field having a frequency and field strength ([0059], [0072]), wherein the target site comprises one or more coronavirus infected cells ([0078]), wherein the alternating electric field inhibits coronavirus replication of the coronavirus, thereby treating the subject infected with the coronavirus (“inhibiting the growth of proliferating cells or viruses in living tissue” [0012]; “shut down protein production in an infected cell to block pathogen replication” [0045]; “In certain implementations, the “cells” are infected by a virus and inhibition of cell growth includes prevention of further infection of cells by the virus.” [0069]; [0078]), wherein the coronavirus is SARS-CoV-2 ([0078]).
Regarding claim 15, Nicacio et al. discloses wherein the alternating electric field has a frequency of between 50 kHz and 1 MHz ([0059], [0072]).
Regarding claim 17, Nicacio et al. discloses wherein cells not infected with a coronavirus are not damaged ([0070]).
Regarding claim 19, Nicacio et al. discloses wherein the viability of the cells at the target site is maintained and viral replication or viral infection is decreased ([0045]).
Regarding claim 20, Nicacio et al. discloses wherein the alternating electric field is multidirectional ([0033]).
Claim Rejections - 35 USC § 103
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.
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.
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.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nicacio et al. (US 2021/0228895).
Regarding claim 16, Nicacio et al. discloses cancer situations involving the lungs ([0076]) but does not expressly disclose coronavirus as it relates to the lungs. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to treat a respiratory disease, such as coronavirus, at the lungs since it is the organ responsible for respiration ([0023], [0088]).
Claim(s) 5, 11, 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nicacio et al. (US 2021/0228895) in view of Schmidt et al. (US 2019/0117969).
Regarding claims 5, 11 and 18, Nicacio et al. does not expressly disclose wherein the alternating electric field strength has a field strength of at least 1 V/cm root mean square (RMS). Schmidt et al. teaches a similar treatment system wherein the alternating electric fields have a field strength of at last 1 V/cm RMS ([0033-0034]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use an electric field strength above 1 V/cm RMS since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim(s) 13, 15-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaynan et al. (US 2020/0016339) in view of Nagel et al. (US 2021/0282479).
Regarding claim 13, Kaynan et al. discloses a method of treating a subject infected with coronavirus comprising: applying a single electrical field ([0035]), wherein the single electrical field is an alternating electric field to a target site of the subject for a period of time ([0036]), the alternating electric field having a frequency and field strength ([0005]), wherein the target site comprises one or more virus infected cells ([0035]), wherein the alternating electric field inhibits virus replication of the virus ([0035], [0039]), thereby treating the subject infected with the virus ([0039]).
Kaynan et al. does not expressly disclose wherein the target site comprises one or more coronavirus infected cells, wherein the alternating electric field inhibits coronavirus replication of the coronavirus, thereby treating the subject infected with the coronavirus, wherein the coronavirus is SARS-CoV-2. Instead, Kaynan et al. teaches the specific virus infecting the subject is lentivirus, but also acknowledges different viruses can be treated with the single field, alternating electric field ([0034]). Nagel et al. teaches it is known in the art that a treatment to affect lentivirus ([0055]) can also be used to treat coronavirus ([0158], [0394]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kaynan et al. and try applying the lentivirus-intended, single field, alternating electric field to a target site comprising one or more coronavirus infected cells to try to inhibit replication of the coronavirus, thereby treating a subject infected with coronavirus such as SARS-CoV-2, as Nagel et al. states it is known in the art to apply the same treatment procedure to both lentivirus and coronavirus, the results of such a modification being reasonably predictable and would not alter the overall operation of the device.
Regarding claim 15, Kaynan et al. discloses wherein the alternating electric field has a frequency of between 50 kHz and 1 MHz ([0036]).
Regarding claim 16, Kaynan et al. discloses wherein the target site of the subject is the lungs ([0035], [0037]).
Regarding claim 17, Kaynan et al. discloses wherein cells not infected with a coronavirus are not damaged ([0037]).
Regarding claim 18, Kaynan et al. discloses wherein the alternating electric field strength has a field strength of at least 1 V/cm root mean square (RMS) ([0010]).
Regarding claim 19, Kaynan et al. discloses wherein the viability of the cells at the target site is maintained and viral replication or viral infection is decreased ([0039]).
Regarding claim 20, Kaynan et al. discloses wherein the alternating electric field is multidirectional ([0025]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERICA S LEE whose telephone number is (571)270-1480. The examiner can normally be reached M-F 8-7pm, flex.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERICA S LEE/Primary Examiner, Art Unit 3796
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