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 .
Information Disclosure Statement
The information disclosure statement(s) filed 05/30/2024 has/have been considered by the Examiner.
Response to Arguments
Claim Rejections - 35 USC § 112
Applicant’s arguments, filed 04/29/2026, with respect to 35 USC § 112(a) rejection have been fully considered and are persuasive. The 35 USC § 112(a) rejection of 10/02/2026 has been withdrawn.
Claim Rejections - 35 USC § 102/103
Applicant’s arguments with respect to claim(s) 1, 3-10, 14-21, 23, 31 and 33 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Claim(s) 1, 3-10, 14-17, 20-21, 23, 31 and 33 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Smith (US 20210379362 A1 – hereinafter Smith).
Re. claim 1, Smith teaches a method of treating diabetes in a subject having diabetes (paragraph 0006 – “One aspect of the invention is directed to a first method of preventing or minimizing damage from an autoimmune disease in a target region of a subject's body”; paragraph 0008 – “In some instances of the first method, the autoimmune disease is type 1 diabetes…”) comprising:
applying an alternating electric field to a target site of the subject (paragaph 0008 – “…and the plurality of electrodes is positioned with respect to the subject's body so that the alternating electric field is imposed in a liver or a pancreas…”),
for a period of time (paragraph 0006 – “The first method comprises positioning a plurality of electrodes in or on the subject's body positioned with respect to the target region so that application of an AC voltage between the plurality of electrodes will impose an alternating electric field through tissue that is being attacked by the autoimmune disease in the target region; and applying an AC voltage between the plurality of electrodes for an interval of time, such that an alternating electric field is imposed through the tissue for the interval of time”),
the alternating electric field having a frequency and field strength (paragraph 0014 – “The alternating electric field with the first orientation has a frequency and a field strength such that when the alternating electric field with the first orientation is imposed in the tissue, the alternating electric field with the first orientation inhibits proliferation of T cells in the tissue”).
Smith does not expressly teach wherein FGF21 is increased in the subject after applying the alternating electric field to the target site of the subject, however, the recited limitation is considered to comprise an intended result of the stimulation and not to comprise a positively recited step of the method (see MPEP 2111.04. I). In other words, Smith as stated above meets all the positively recited steps of the claimed invention and thus should inherently yield any intended results, unless the claims are incomplete for failing to include aspects that are essential to achieving the claimed intended results.
Re. claim 3, Smith further teaches wherein the target site identified as being tumor-free (paragaph 0021 – “Optionally, in any of the instances of the first or second methods described above, the tissue is tumor-free”).
Re. claim 4, Smith further teaches wherein the subject is tumor-free (paragaph 0021 – “Optionally, in any of the instances of the first or second methods described above, the tissue is tumor-free”).
Re. claim 5, Smith further teaches wherein the target site comprises hepatocytes (paragraph 0008 teaches delivering AC fields to the liver, paragraph 0008 – “In some instances of the first method, the autoimmune disease is type 1 diabetes, and the plurality of electrodes is positioned with respect to the subject's body so that the alternating electric field is imposed in a liver or a pancreas”; paragraph 0033 – “In some instances of the third method, the tissue is located in an organ selected from the group consisting of heart, pancreas, liver, lung, kidney, brain, and intestine”; paragraphs 0131-0132 detail treatment of Nonalcoholic fatty liver disease [NAFLD] using AC fields).
Re. claim 6, Smith further teaches wherein the target site is the subject's liver (paragraph 0008 teaches delivering AC fields to the liver, paragraph 0008 – “In some instances of the first method, the autoimmune disease is type 1 diabetes, and the plurality of electrodes is positioned with respect to the subject's body so that the alternating electric field is imposed in a liver or a pancreas”; paragraph 0033 – “In some instances of the third method, the tissue is located in an organ selected from the group consisting of heart, pancreas, liver, lung, kidney, brain, and intestine”; paragraphs 0131-0132 detail treatment of Nonalcoholic fatty liver disease [NAFLD] using AC fields).
Re. claim 7, Smith further teaches wherein the target site is the subject's torso (treatment is delivered to the liver and pancreas, which are known to be located in the human torso, paragraph 0008 – “In some instances of the first method, the autoimmune disease is type 1 diabetes, and the plurality of electrodes is positioned with respect to the subject's body so that the alternating electric field is imposed in a liver or a pancreas”; paragraph 0033 – “In some instances of the third method, the tissue is located in an organ selected from the group consisting of heart, pancreas, liver, lung, kidney, brain, and intestine”; see also figure 12).
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Re. claim 8, Smith further teaches administering a diabetes therapeutic to the subject (paragraph 0006 – “One aspect of the invention is directed to a first method of preventing or minimizing damage from an autoimmune disease in a target region of a subject's body”; paragraph 0008 – “In some instances of the first method, the autoimmune disease is type 1 diabetes, and the plurality of electrodes is positioned with respect to the subject's body so that the alternating electric field is imposed in a liver or a pancreas”).
Re. claim 9, Smith further teaches wherein the subject is not diagnosed with liver cancer (paragraph 0033 – “In some instances of the third method, the tissue is located in an organ selected from the group consisting of heart, pancreas, liver, lung, kidney, brain, and intestine”; paragaph 0021 – “Optionally, in any of the instances of the first or second methods described above, the tissue is tumor-free”).
Re. claim 10, Smith further teaches wherein the subject has not been diagnosed with a tumor (paragaph 0021 – “Optionally, in any of the instances of the first or second methods described above, the tissue is tumor-free”).
Re. claim 14, Smith further teaches wherein the alternating electric field has a frequency between 50 kHz and 10 MHz (paragraph 0021 – “Optionally, in any of the instances of the first or second methods described above, the alternating electric field has a frequency of about 200 kHz. Optionally, in any of the instances of the first or second methods described above, the alternating electric field has a frequency between 50 and 500 kHz”; paragraph 0080 – “For example, the frequency of the AEFs that are used to treat autoimmune diseases may be between 100 and 300 kHz, between 50 and 500 kHz, or between 25 kHz and 1 MHz”).
Re. claim 15, Smith further teaches wherein the frequency of the alternating electric fields is about 200 kHz (paragraph 0021 – “Optionally, in any of the instances of the first or second methods described above, the alternating electric field has a frequency of about 200 kHz”).
Re. claim 16, Smith further teaches wherein the alternating electric field has a field strength is between 0.5 V/cm and 10 V/cm (paragraph 0021 – “Optionally, in any of the instances of the first or second methods described above, the alternating electric field has a field strength between 1 and 5 V/cm RMS”).
Re. claim 17, Smith further teaches wherein the field strength is about 1 V/cm (paragraph 0021 – “Optionally, in any of the instances of the first or second methods described above, the alternating electric field has a field strength between 1 and 5 V/cm RMS”; paragraph 0129 – “…the alternating electric field has a field strength of at least 1 V/cm in at least a portion of the target region”).
Re. claim 20, Smith further teaches wherein a magnetic field is not applied to the subject (Smith disclosure does not contain any support for applying magnetic fields to the subject).
Re. claim 21, Smith teaches a method of increasing one or more of FGF21 or blood glucose uptake in a subject having diabetes comprising:
applying an alternating electric field to a target site of the subject (paragaph 0008 – “…and the plurality of electrodes is positioned with respect to the subject's body so that the alternating electric field is imposed in a liver or a pancreas…”),
for a period of time (paragraph 0006 – “The first method comprises positioning a plurality of electrodes in or on the subject's body positioned with respect to the target region so that application of an AC voltage between the plurality of electrodes will impose an alternating electric field through tissue that is being attacked by the autoimmune disease in the target region; and applying an AC voltage between the plurality of electrodes for an interval of time, such that an alternating electric field is imposed through the tissue for the interval of time”),
the alternating electric field having a frequency and field strength (paragraph 0014 – “The alternating electric field with the first orientation has a frequency and a field strength such that when the alternating electric field with the first orientation is imposed in the tissue, the alternating electric field with the first orientation inhibits proliferation of T cells in the tissue”).
Smith does not expressly teach wherein FGF21 or blood glucose uptake is increased in the subject after applying the alternating electric field to the target site of the subject, however, the recited limitation is considered to comprise an intended result of the stimulation and not to comprise a positively recited step of the method (see MPEP 2111.04. I). In other words, Smith as stated above meets all the positively recited steps of the claimed invention and thus should inherently yield any intended results, unless the claims are incomplete for failing to include aspects that are essential to achieving the claimed intended results.
Re. claim 23, Smith teaches a method of increasing brain-derived neurotrophic factor (BDNF) in a subject having diabetes comprising:
applying an alternating electric field to a target site of the subject (paragaph 0008 – “…and the plurality of electrodes is positioned with respect to the subject's body so that the alternating electric field is imposed in a liver or a pancreas…”),
for a period of time (paragraph 0006 – “The first method comprises positioning a plurality of electrodes in or on the subject's body positioned with respect to the target region so that application of an AC voltage between the plurality of electrodes will impose an alternating electric field through tissue that is being attacked by the autoimmune disease in the target region; and applying an AC voltage between the plurality of electrodes for an interval of time, such that an alternating electric field is imposed through the tissue for the interval of time”),
the alternating electric field having a frequency and field strength (paragraph 0014 – “The alternating electric field with the first orientation has a frequency and a field strength such that when the alternating electric field with the first orientation is imposed in the tissue, the alternating electric field with the first orientation inhibits proliferation of T cells in the tissue”).
Smith does not expressly teach wherein FGF21 and BDNF are increased in the subject after applying the alternating electric field to the target site of the subject, however, the recited limitation is considered to comprise an intended result of the stimulation and not to comprise a positively recited step of the method (see MPEP 2111.04. I). In other words, Smith as stated above meets all the positively recited steps of the claimed invention and thus should inherently yield any intended results, unless the claims are incomplete for failing to include aspects that are essential to achieving the claimed intended results.
Re. claim 31, Smith further teaches administering a diabetes therapeutic to the subject (paragraph 0006 – “One aspect of the invention is directed to a first method of preventing or minimizing damage from an autoimmune disease in a target region of a subject's body”; paragraph 0008 – “In some instances of the first method, the autoimmune disease is type 1 diabetes, and the plurality of electrodes is positioned with respect to the subject's body so that the alternating electric field is imposed in a liver or a pancreas”).
Re. claim 33, Smith further teaches wherein the subject is not diagnosed with a tumor (paragaph 0021 – “Optionally, in any of the instances of the first or second methods described above, the tissue is tumor-free”).
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.
Claim(s) 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US 20210379362 A1 – hereinafter Smith) in view of Harel (US 20040249421 A1 – hereinafter Harel).
Re. claim 18, Smith teaches the method of claim 8 as stated above, but does not expressly teach wherein the diabetes therapeutic is metformin, a sulfonylurea, a glinide, a thiazolidinedione, a GLP-1 receptor agonist, or an SGLT2 inhibitor.
Harel teaches a similar system for treating diabetes using electric fields (abstract – “A method of glucose level control comprising, providing at least one electrode adapted to apply an electric field to a pancreas; and applying an electric field to the pancreas using said at least one electrode…”), and further teaches the known technique of administering a diabetes therapeutic to the subject, wherein the diabetes therapeutic is metformin (paragraph 503 – “A series of experiments was carried out on a human volunteer patient. The patient is a 45 year old female with a one year history of type II diabetes. The patient is of Indian extraction, 71 Kg in weight, {fraction (1/61)} Meters in height and is treated with Gliclazide 80 mg and Metformin 500 mg twice a day”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the diabetes treatment method of Smith, to incorporate the Metformin diabetes therapeutic as taught by Harel, since such modification would predictably result in reducing blood sugar to treat type-II diabetes.
Re. claim 19, Smith teaches the diabetes treatment method of claim 1 as stated above, but does not expressly teach wherein the subject having diabetes has type 2 diabetes.
Harel teaches a similar system for treating diabetes using electric fields (abstract – “A method of glucose level control comprising, providing at least one electrode adapted to apply an electric field to a pancreas; and applying an electric field to the pancreas using said at least one electrode…”), and further teaches the known technique of administering a diabetes therapeutic to the subject to treat type II diabetes (paragraph 503 – “A series of experiments was carried out on a human volunteer patient. The patient is a 45 year old female with a one year history of type II diabetes. The patient is of Indian extraction, 71 Kg in weight, {fraction (1/61)} Meters in height and is treated with Gliclazide 80 mg and Metformin 500 mg twice a day”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the diabetes treatment method of Smith, to incorporate the Metformin diabetes therapeutic to treat type II diabetes as taught by Harel, since such modification would predictably result in reducing blood sugar to treat type-II diabetes.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anh-Khoa N. Dinh whose telephone number is (571)272-7041. The examiner can normally be reached Mon-Fri 7:00am-4:00pm EST.
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/ANH-KHOA N DINH/Examiner, Art Unit 3796
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