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 .
Response to Amendment
The amendment filed July 27, 2026 has been entered. Claims 1, 7 and 13 have been entered. Claims 3, 9 and 14 are canceled. Currently, claims 1-2, 4-8, 10-13, 15-20 are pending for examination.
Response to Arguments
Applicant's arguments filed July 27, 2026 have been fully considered but they are not persuasive.
Applicant argues on pages 7-8 that Nicacio et al. (US 2021/0228895) does not disclose the limitation of, “exposing the cell infected with coronavirus to a single field for a period of time” as recited in claims 1, 7 and 13, because the prior art discloses an electromagnetic signal, and the applicant reasons an electromagnetic signal therefore comprises two fields- an alternating electric field and a magnetic field. In response, the arguments of counsel cannot take the place of evidence in the record. In re Schulze 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re Geisler, 116 F.3d 1465, 43 USPQ 2d 1362 (Fed Cir. 1997). The prior art does not disclose two fields being applied to the cell infected with coronavirus. Instead, Nicacio et al. states a single “specialized AC current” is produced via conduction ring 106 ([0056]), this conduction ring 106 either worn by the user (fig. 4a, 5a) or connected to the user via adhesive pad 138 (fig. 9a) to expose a cell infected with coronavirus ([0069], [0078]) and further details the acceptable frequency range for this one field ([0059]). Nicacio et al. additionally provides statements regarding delivery of a single electric field to living tissue ([0071]), the resultant effects of delivering a single electric field ([0075]) and the history of application of an electric field ([0046-0054]). No where does the prior art disclose details or reference an additional magnetic field being applied to a cell infected with coronavirus. Assuming arguendo the cell infected with coronavirus is exposed to another field besides the electric field, it is noted that claims 1, 7 and 13 recite the transitional phrase “comprising”, which is synonymous with “including,” “containing,” or “characterized by,” is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004).
Applicant’s arguments on pages 10-11 directed to Nicacio et al. are unpersuasive for the same reasons as addressed above.
Applicant argues on pages 11-13 that Kaynan et al. (US 2020/0016399) in view of Nagel et al. (US 2021/0282479) do not disclose the claimed invention of, “applying a single field to a target site of the subject for a period of time, wherein the single field is an alternating electric field… wherein the target site comprises one or more coronavirus infected cells” because neither reference discloses applying an alternating electric field to a cell infected with coronavirus. Applicant further argues there is no motivation to combine Kaynan et al. in view of the teachings of Nagel et al. because the prior is concerned with treating the cell with an alternating electric field “to see how it affects the infectivity of the virus while the purpose of the treatment is Nagel is to treat the virus with an alternating electric field to see how it affects the infectivity” (p. 12). As stated in the Response to Arguments in the previous Office action, Kaynan et al. states, that alternating electric fields (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]). Kaynan et al. additionally states benefits of this treatment include, “Halting the continuous cycles of viral infection would seize the spread within and prevent the progression of the disease” ([0042]) suggesting that not only is Kaynan et al. focused on treating a cell to see how it affects the infectivity of the virus as argued by the applicant but it is also focused on treating and halting continuous cycles of infected cells. As indicated in the previous Office action’s rejection of claim 13, 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.
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 field for a period of time, wherein the single field is an alternating electric 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]), “specialized AC current” [0056], “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 for a period of time (“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 (“specialized AC current” [0056]), 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 field to a target site of the subject (fig. 9A) for a period of time, wherein the single field is an alternating electric 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]; “specialized AC current” [0056]), 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 to a target site of the subject for a period of time ([0035]), wherein the single electrical field is an alternating electric field ([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
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 ERICA S LEE whose telephone number is (571)270-1480. The examiner can normally be reached M-F 8-7pm, flex.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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