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 .
Election/Restrictions
Claims 9-13 and 16 and 17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention I and Species B/C, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03 March 2026 of Invention II, Species A, directed to Claim 7 and new Claims 20-22. Claims 1-6, 8, 14, 15, 18, and 19 have been cancelled in the response.
Claims 7 and 20-22 are presently under consideration.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include any reference numbers, although several elements/components of Figs. 1-5 are referred to in the Specification.
Corrected drawing sheets/Figures in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application, including the addition of corresponding reference numbers within the Specification.
Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 20 and 21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
Regarding Claims 20 and 21, the claims contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The claims recite “wherein the bioelectric signal has a current of from 1 mA to 5 mA measured at the electrode-tissue interface” and “wherein the bioelectric signal has a current of from 3 mA to 5 mA measured at the electrode-tissue interface” respectively. However, these limitations were not described in the Specification nor Drawings as originally filed, and therefore is considered to be New Matter. Although examples are given in the Specification of applied current at 3 mA and 5 mA (e.g. Pages 7-8), the Specification does not explicitly describe, “wherein the bioelectric signal has a current of from 1 or 3 mA to 5 mA measured at the electrode-tissue interface” as claimed.
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 7 and 20-22 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.
Regarding Claim 7, the claim recites “which electric signal generator” in Line 5. It is unclear and therefore indefinite if this element is referring to the same or a different electric signal generator recited previously in the claim, and further it is unclear as to what element “which” is referring. For purposes of examination, the Examiner is interpreting this limitation as “wherein the electric signal generator”. Appropriate correction or clarification is required. Claims 20-22 are rejected for depending on independent Claim 7.
Regarding Claim 7, the claim recites “a subject” in multiple lines of the claim (e.g. Line 1, Line 6, Line 10). It is unclear and therefore indefinite if this limitation is referring to the same or different subjects. For purposes of examination, the Examiner is interpreting all of these limitations as referring to the same subject (i.e., “a subject” and “the subject” respectively). Appropriate correction or clarification is required. Claims 20-22 are rejected for depending on Claim 7.
Regarding Claim 7, the claim recites “target tissue” in Line 10. It is unclear and therefore indefinite if this limitation is referring to the same or different “target tissue” previously recited in the claim. For purposes of examination, the Examiner is interpreting this limitation as the same target tissue (i.e. “the target tissue”). Appropriate correction or clarification is required. Claims 20-22 are rejected for depending on independent Claim 7.
Regarding Claim 7, the claim recites “a frequency from 10 Hz to 20 Hz +/-15% and a pulse width from 300 usec to 400 usec +/-15%”. However, it is unclear as to what specific ranges are being claimed. In particular, it is unclear as to whether the +/-15% is referring to the upper range, lower range, or another in between range. Therefore, these limitations are indefinite. For purposes of examination, the Examiner is interpreting these limitations as “a frequency from approximately 10 Hz to 20 Hz and a pulse width from approximately 300 usec to 400 usec”. Appropriate correction or clarification is required. Claims 20-22 are rejected for depending on independent Claim 7.
Regarding Claim 7, the claim recites “a sestrin” and “at least one sestrin” in multiple areas of the claim. It is unclear and therefore indefinite if this limitation is referring to the same or different sestrins, and how many sestrins (one or multiple). Therefore, these limitations are indefinite. For purposes of examination, the Examiner is interpreting each of these limitations as the same “at least one sestrin”. Appropriate correction or clarification is required. Claims 20-22 are rejected for depending on independent Claim 7.
Regarding Claim 7, the claim recites both “upregulate expression and/or release of a sestrin” and “upregulate the expression of at least one sestrin”. It is unclear and therefore indefinite if this limitation is referring to the same or different ‘expression’/’release’. Therefore, these limitations are indefinite. For purposes of examination, the Examiner is interpreting each of these limitations as the same “upregulate expression and/or release of a sestrin” in these instances of these limitations. Appropriate correction or clarification is required. Claims 20-22 are rejected for depending on independent Claim 7.
Regarding Claims 7 and 20-22, the claims recite all of “at least one bioelectric signal”, “a signal”, and “the bioelectric signal”. It is unclear and therefore indefinite if this limitation is referring to the same or different signals, and how many signals (one or multiple). Therefore, these limitations are indefinite. For purposes of examination, the Examiner is interpreting each of these limitations as the same “at least one bioelectric signal”. Appropriate correction or clarification is required. Claims 20-22 are rejected for depending on independent Claim 7.
Regarding Claims 20 and 21, the claims recite “wherein the bioelectric signal has a current of from 1 mA to 5 mA measured at the electrode-tissue interface” and “wherein the bioelectric signal has a current of from 3 mA to 5 mA measured at the electrode-tissue interface”. Firstly, the “electrode-tissue interface” lacks antecedent basis in the claims, and it is unclear as to where this region is referring. Furthermore, it is unclear as to what is intended by the limitation “measured”, whether this is an active step or referring to the applied signal, since this limitation is not described in the Specification nor Drawings as originally filed (see 35 U.S.C. 112(a) rejections above). For purposes of examination, the Examiner is interpreting these limitations as “wherein the bioelectric signal has a current of from 1 mA to 5 mA
Regarding Claim 22, the claim recites “a frequency from 20 Hz +/-15% and a pulse width from 400 usec to 400 usec +/-15%”. However, it is unclear as to what specific ranges are being claimed. In particular, it is unclear as to whether the +/-15% is referring to the upper range, lower range, or another in between range, in particular since Claim 22 depends from Claim 7, which recites different ranges. Therefore, these limitations are indefinite. For purposes of examination, the Examiner is interpreting this limitation as “a frequency of approximately 20 Hz and a pulse width of approximately 400 usec”. Appropriate correction or clarification is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 7 and 20-22 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Regarding Claim 7, the claim recites “target tissue of a subject comprising living cells so as to upregulate expression and/or release of a sestrin by the living cells”. However, this limitation appears to be claiming human tissue/cells and claims a naturally occurring biological process. Therefore, these limitations encompass a human organism, which is excluded from the scope of patentable subject matter under 35 U.S.C. 101. These limitations should be amended/rewritten to include “configured to” language, thereby directing the applied bioelectric signal to be configured to perform a specific method step using tangible structural elements of the electric signal generator. Claims 20-22 are rejected for depending on Claim 7.
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.
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.
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.
Claims 7 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Simon et al. (US Publication No. 2019/0240486) in view of Keilhack et al. (US Publication No. 2018/0289717).
Regarding Claims 7 and 22, Simon et al. discloses a method of treating a subject for muscle atrophy (Paragraph 0019, 0157-0158, 0160), Alzheimer's disease (Abstract, Paragraph 0018, 0028, 0050, 0130), Parkinson's disease (Abstract, Paragraph 0018, 0028, 0050, 0130), dementia (Paragraph 0018, 0019, 0134, 0227), cognitive impairment (Abstract, Paragraph 0018, 0028, 0050, 0134, 0227), aging (Paragraph 0161, 0167, 0199), and/or inflammation (Abstract, Paragraph 0002, 0022-0025, 0065-0068, 0130) comprising:
an electric signal generator (impulse/signal generator 310, Fig. 1; Paragraph 0074-0077, 0082) and electrodes (31, 30, 29, Figs. 3A-C, 5-7; Paragraph 0111, 0112, 0125), which electric signal generator (impulse/signal generator 310, Fig. 1; Paragraph 0074-0077, 0082) is programmed to produce at least one bioelectric signal that stimulates target tissue of a subject comprising living cells (Paragraph 0028-0030, 0037, 0050-0051; Abstract) so as to upregulate expression and/or release of a protein/gene expression pathway by the living cells (“treatment relates to stimulation of the vagus nerve to reduce neuroinflammation, wherein pathways involving anti-inflammatory cytokines, the retinoic acid signaling system, and/or neurotrophic factors are enhanced, and/or pathways involving pro-inflammatory cytokines are inhibited”; Paragraph 0002; “ a method for treating a neurodegenerative disorder in a patient comprises applying energy transcustaneously through an outer skin surface of the patient to generate an electrical impulse at or near a selected nerve, such as the vagus nerve, within the patient. The electrical impulse is sufficient to inhibit inflammation in the patient and treat the neurodegenerative disorder. In some embodiments, the electrical impulse is sufficient to inhibit and/or block the release of pro-inflammatory cytokines, such as TNF-alpha. In other embodiments, the electrical impulse is sufficient to increase the anti-inflammatory competence of certain cytokines to thereby offset or reduce the effect of pro-inflammatory cytokines”, Paragraph 0029; “Inflammation and the immune system play a significant role in AD pathogenesis. The inflammatory components in AD include microglia and astrocytes, the complement system, and various inflammatory mediators (including cytokines and chemokines). Microglia are the resident immune cell types of the central nervous system, and in AD, microglia may cause damage by secretion of neurotoxins. When microglia become activated during inflammation, they also secrete a variety of inflammatory mediators including cytokines (TNF and interleukins IL-1β and IL-6) and chemokines (macrophage inflammatory protein MIP-1a, monocyte chemoattractant protein MCP-1 and interferon inducible protein IP-10) that promote the inflammatory state.”, Paragraph 0139; see also Paragraph 0013, 0021, 0022-0025, 0037, 0065-0070, 0072, 0073, 0150, Fig. 8),
wherein the bioelectric signal comprises a signal having a biphasic constant current (biphasic or polyphasic current, Paragraph 0079; see Fig 2) having a frequency from 15 to 35 Hz (Paragraph 0035), 15 to 50 Hz (Paragraph 0083), or specifically about 25 Hz (Paragraph 0083) or 20 Hz (Paragraph 00156), and a pulse width from 20 usec to 1000 usec (Paragraph 0083) to stimulate target tissue comprising living cells of a subject to modulate upregulate the expression and/or release of a protein/gene expression pathway by the living cells (Paragraph 0002, 0013, 0021, 0022-0025, 0037, 0065-0070, 0072, 0073, 0150, Fig. 8), the method comprising:
administering the bioelectric signal to the living cells (Paragraph 0028-0030, 0037, 0050-0051; Abstract) via the electrodes (31, 30, 29, Figs. 3A-C, 5-7; Paragraph 0111, 0112, 0125) for about 20 minutes (Paragraph 0126) or 30 minutes (Paragraph 00156), or from 1-200 minutes (Paragraph 0156, 0188, 0219, 0227), so as to upregulate the expression and/or release of a protein/gene expression pathway by the living cells by the living cells and thus treat the muscle atrophy (Paragraph 0019, 0157-0158, 0160), Alzheimer's disease (Abstract, Paragraph 0018, 0028, 0050, 0130), Parkinson's disease (Abstract, Paragraph 0018, 0028, 0050, 0130), dementia (Paragraph 0018, 0019, 0134, 0227), cognitive impairment (Abstract, Paragraph 0018, 0028, 0050, 0134, 0227), aging (Paragraph 0161, 0167, 0199), and/or inflammation (Abstract, Paragraph 0002, 0022-0025, 0065-0068, 0130).
Simon et al. does not explicitly disclose wherein the upregulation of the expression and/or release of a protein/gene expression pathway by the living cells is specifically a sestrin. Keilhack et al. teaches a method of treating a subject for cancer, Alzheimer’s disease, Parkinson’s disease, muscle degeneration, and age-related disorders (Paragraph 0012, 0334, 0367) comprising applying treatment protocols for regulating biological pathways including specifically sestrins (sestrins, SESN1, Paragraph 0012, 0079, 0410, 0417-0418, 0424; Table 4A-4C).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to including upregulation of the expression and/or release of a protein/gene expression pathway by the living cells to be specifically a sestrin, as taught by Keilhack et al., in the method disclosed by Simon et al., since sestrins are known to be involved in the treatment of cancer, Alzheimer’s disease, Parkinson’s disease, muscle degeneration, and age-related disorders (see Keilhack et al., Paragraph 0012, 0334, 0367), and the stimulation protocols/methods disclosed by Simon et al. would likely also involve sestrins, since nearly identical stimulation protocols are used (see Simon et al., Paragraph 0035, 0083, 00156, 0188; see Fig. 2).
Furthermore, Simon et al. discloses administering the bioelectric signal to the living cells (Paragraph 0028-0030, 0037, 0050-0051; Abstract) via the electrodes (31, 30, 29, Figs. 3A-C, 5-7; Paragraph 0111, 0112, 0125) for about 20 minutes (Paragraph 0126) or 30 minutes (Paragraph 00156), or from 1-200 minutes (Paragraph 0156, 0188, 0219, 0227), wherein the bioelectric signal comprises a signal having a biphasic constant current having a frequency from 15 to 35 Hz (Paragraph 0035), 15 to 50 Hz (Paragraph 0083), or specifically about 25 Hz (Paragraph 0083) or 20 Hz (Paragraph 00156), and a pulse width from 20 usec to 1000 usec (Paragraph 0083) to stimulate target tissue comprising living cells of a subject to modulate upregulate the expression and/or release of a protein/gene expression pathway by the living cells (Paragraph 0002, 0013, 0021, 0022-0025, 0037, 0065-0070, 0072, 0073, 0150, Fig. 8). However, Simon et al. does not explicitly disclose the bioelectric signal has specifically a frequency from 10 Hz to 20 Hz +/-15% and a pulse width from 300 usec to 400 usec +/-15%, with a duration of 5 minutes to about an hour. It is noted that these limitations are indefinite as described above (see 35 U.S.C. 112(b) rejections above).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to specifically configure the signal to have a frequency from 10 Hz to 20 Hz +/-15% and a pulse width from 300 usec to 400 usec +/-15%, with a duration of 5 minutes to about an hour, since similar and overlapping ranges as disclosed by Simon et al., to provide the treatment for the same disorders disclosed by Simon et al. including muscle atrophy (Paragraph 0019, 0157-0158, 0160), Alzheimer's disease (Abstract, Paragraph 0018, 0028, 0050, 0130), Parkinson's disease (Abstract, Paragraph 0018, 0028, 0050, 0130), dementia (Paragraph 0018, 0019, 0134, 0227), cognitive impairment (Abstract, Paragraph 0018, 0028, 0050, 0134, 0227), aging (Paragraph 0161, 0167, 0199), and/or inflammation (Abstract, Paragraph 0002, 0022-0025, 0065-0068, 0130), and 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. Titanium Metals Corp. of Americav. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985).
Claims 20 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Simon et al. (US Publication No. 2019/0240486) in view of Keilhack et al. (US Publication No. 2018/0289717), further in view of Yazicioglu et al. (US Publication No. 2020/0306534).
Regarding Claims 20 and 21, Simon et al. discloses the method further wherein the bioelectric signal induces a current in the tissue (Abstract; Paragraph 0033, 0051, 0080; Fig. 2; Claims 1-2). However, neither Simon et al. nor Keilhack et al. discloses wherein the bioelectric signal has a current of from 1 mA to 5 mA measured at the electrode-tissue interface, specifically from 3 mA to 5 mA. It is noted that these limitations are indefinite and contain New Matter (see 35 U.S.C. 112(a) and 112(b) rejections above). Yazicioglu et al. teaches a method of treating a patient comprising an electric signal generator (60, 101, Fig. 4, 8; Paragraph 0105) and electrodes (15, 10, Figs. 4, 8; Paragraph 0105, 0107; Fig. 1), wherein a bioelectric signal applied to the patient has a current of approximately 0.5 to 2 mA measured at the electrode-tissue interface (Paragraph 0068) to activate tissue/cells.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to specifically configure the signal in the method disclosed by Simon et al. in view of Keilhack et al. to have a current of from 1 mA to 5 mA measured at the electrode-tissue interface, specifically from 3 mA to 5 mA, since similar and overlapping ranges as taught by Yazicioglu et al. for treatment/activation of tissue, and 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. Titanium Metals Corp. of Americav. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAMELA M BAYS whose telephone number is (571)270-7852. The examiner can normally be reached 9:00am - 6:00pm EST.
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, Jennifer McDonald can be reached at 571-270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/PAMELA M. BAYS/Primary Examiner, Art Unit 3796