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 .
DETAILED ACTION
Applicant’s amendment of 23 June 2026, in which claims 27-41 have been cancelled, and new claims 42-56 have been added, are acknowledged.
Claims 42-56 are pending in the instant application.
Claims 52-56 are withdrawn, as being drawn to a non-elected invention.
Claims 42-51 are examined herein.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 26 January 2026 and 5 March 2026 are acknowledged and considered.
Response to arguments of 23 June 2026
On 23 June 2026, Applicant has added new claims 42-56; of these, claims 52-56 are drawn to a composition/food supplement/nutritional supplement.
Newly added claims 52-56 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: newly added claims 52-56 are drawn to a composition/food supplement/nutritional supplement; claims 27-41, presented for examination on 10/12/2023, were drawn to a method.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, amended claims 52-56 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
Applicant’s amendment of 23 June 2026 necessitated the following new objections and rejections.
Claim objection
Claim 45 is objected to because the text “P53” should read --p53--.
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 42-46 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.
Independent claim 42 recites administering S1PC […] to a subject, and the claim also recites “compared to […] a control subject who has not received the S1PC “. The term “received” is ambiguous, because it is unclear how the subject has “received” or not “received” the therapeutic agent. For example, a subject can receive a compound by mail. For clarity, the claim should state that the control subject is not administered the S1PC or salt thereof.
The same applies to claims 45, 46 which recite a subject “receiving” S1PC, a control “not receiving” S1PC.
Claim 43 is indefinite, because it is unclear what is meant by “the S1PC is an isolated and purified form”. It is unclear what is “an isolated form”, versus perhaps a form that is not isolated? What is a “purified form”? Isolated from what?
Claim 44 is drawn to the method of claim 42, wherein an amount of the trans-isomer and cis-isomer or a salt thereof is 100% and a proportion of the trans-isomer in the S-1- propenylcysteine is from 50 to 100%. Yet, claim 42 does not recite an amount, and does not recite isomers of S1PC. As such, there is insufficient antecedent basis for the recitation “an amount of the trans-isomer and cis-isomer” of claim 44, in claim 42.
Claim 45 is confusing because it recites reducing a level of marker in the subject administered S1PC compared to “a non-senescent control not receiving the S1PC”. What is a “non-senescent control”? It seems that the comparison is between levels of markers in a subject administered S1PC and levels of the same markers in a control subject not administered S1PC. The claim should clearly state that.
In the interest of compact prosecution, claim 45 is interpreted to be drawn to The method of claim 42, wherein reducing the level of senescent cells comprises
(i) reducing a level of at least one senescent cell marker selected from the group consisting of p53, p16, and p21 in the subject administered the S1PC or salt thereof, compared to that in a control subject not administered the S 1PC or salt thereof.
Claim 46 is confusing because it is unclear what is being compared, and in what subject the increasing activation of sirtuin occurs. Claim 46 recites increasing activation of sirtuin in a subject (not defined) compared to “a non-senescent control not receiving the S1PC”. What is a “non-senescent control”? What is actually being compared?
In the interest of compact prosecution, claim 46 is interpreted to be drawn to The method of claim 42, comprising: administering to the subject 0.1 mg/kg per day S-1-propenylcysteine or a salt thereof,
wherein reducing the level of senescent cells comprises (ii) increasing activation of sirtuin or Klotho or increasing a level of NAD+ in the subject administered the S1PC or salt thereof, compared to that in a control subject not administered the S1PC or salt thereof.
Appropriate clarification is required.
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 theinvention, 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 itis most nearly connected, to make and use the same, and shall set forth the best modecontemplated 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 themanner and process of making and using it, in such full, clear, concise, and exact terms as toenable any person skilled in the art to which it pertains, or with which it is most nearlyconnected, to make and use the same, and shall set forth the best mode contemplated by theinventor of carrying out his invention.
Claim 46 is 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. The claimscontain subject matter which was not described in the specification in such a way as toreasonably convey to one skilled in the relevant art that the inventor or a joint inventor,or for pre-AIA the inventor(s), at the time the application was filed, had possession ofthe claimed invention. This is a new matter rejection.
Claim 46 recites administering at least 0.1 mg/kg per day S-1-propenylcysteine or a salt thereof to the subject. The original Specification as filed does not provide support for this limitation.
When an explicit limitation in a claim is not present in the written description whose benefit is sought it must be shown that a person of ordinary skill in the art would have understood at the time of the patent application was filed, that the description required that limitation.
The Specification discloses [0038] that it is preferable to ingest 0.001 to 10 mg/kg of S-1-propenylcysteine or a salt thereof per day, and it is more preferable to ingest 0.1 to 1 mg/kg per day. In addition, a daily dose can be optionally divided into 2 to 4 times for ingestion.
The limitation " at least 0.1 mg/kg per day S-1-propenylcysteine or a salt thereof “in claim 46 does not meet the written description requirement because the phrase “at least” has no upper limit and causes the claim to read literally on embodiments outside the actual range disclosed in the Specification. This is new matter and does not have support in the specification. In re Wertheim, 541 F.2d 257, 191 USPQ90 (CCPA 1976). Cancellation of the new matter is required.
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 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.
Claims 42-49, 51 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Suzuki et al. (WO 2019/235597, published 12 December 2019, cited in IDS, US 2021/0228521 used as English equivalent, cited in IDS), as evidenced by Zhang et al. (Nature Neuroscience 2019, 22, 719-728, cited in PTO-892 of 23 January 2026), Michan et al. (The Journal of Neuroscience 2010, 30 (29), 9695-9707, cited in IDS), and Imai et al. (Trends Cell Biol. 2014, 24 (8), 464-471, cited in IDS).
Suzuki teaches (US 2021/0228521, [0048]-[0050]) a method of preventing, treating, or ameliorating a neurodegenerative disease comprising administering S-1-propenylcysteine or a salt thereof to a subject in need thereof. Suzuki teaches [0059] that the total of the trans-isomer and the cis-isomer is 100% in S-1-propenylcysteine, and the proportion of the trans-isomer is from 50% to 100%, as in instant claims 44.
Suzuki teaches [0088] that the daily intake of S1PC is 0.1 to 2.7 mg/kg, which is within the range in instant claim 46.
Suzuki teaches (claim 20) that the neurodegenerative disease is selected from Alzheimer's disease, Parkinson's disease, Huntington's disease, amyotrophic lateral sclerosis, muscular dystrophy, heart failure, dilated cardiomyopathy, infectious disease, autoimmune disease, obesity, diabetes, arteriosclerosis, or steatohepatitis.
Thus, Suzki teaches administering S-1-propenylcysteine or a salt thereof to a subject who suffers from Alzheimer's disease, Parkinson's disease, Huntington's disease, amyotrophic lateral sclerosis, muscular dystrophy, heart failure, dilated cardiomyopathy, infectious disease, autoimmune disease, obesity, diabetes, arteriosclerosis, or steatohepatitis, to prevent or treat said disease.
Even though Suzuki does not specifically teach that administering S-1-propenylcysteine suppresses senescent cells/reduces levels of senescent cells in the Alzheimer’s patient in the method of treatment, as in instant claims, and suppresses cells expressing p16 genes, as in claim 45, 49, such suppressing of senescent cells inherently occurs in the method of treating Alzheimer’s disease with S-1-propenylcysteine, as evidenced by Zhang et al. (Nature Neuroscience 2019, 22, 719-728, cited in PTO-892 of 23 January 2026). Zhang teaches that cellular senescence is involved in the pathogenesis of Ab plaques and associated with cognitive impairment in AD. Zhang teaches (Abstract) that, in the brains of patients with AD and in AD mouse models, Aβ plaque-associated cells exhibit a senescence-like phenotype characterized by the upregulation of p16/INK4/CDKN2A proteins.
While Suzuki does not teach that administration of S-1-propenylcysteine or a salt thereof to a subject who suffers from Alzheimer's disease activates or enhances the expression of sirtuins or Klotho, or increases NAD+, as in instant claim 46, suppresses or delays cellular senescence, as in instant claims, and suppresses cells expressing p16 in the subject, as in instant claims 45, 49, these processes inherently occur upon administration of S-1-propenylcysteine or a salt thereof.
Administration of the same therapeutic agent, S-1-propenylcysteine or a salt thereof, to the same patient population, patients suffering from Alzheimer’s disease, will inherently have the same effect on the expression of sirtuins, Klotho, NAD+, and cell senescence in the body of the patient.
Even though Suzuki does not specifically teach that administering S-1-propenylcysteine enhances the expression of sirtuins in the Alzheimer’s patient in the method of treatment, as in instant claim 46, such increase in expression of sirtuins inherently occurs in the method of treating Alzheimer’s disease with S-1-propenylcysteine, as evidenced by Michan et al. (The Journal of Neuroscience 2010, 30 (29), 9695-9707, cited in IDS). Michan teaches that SIRT1 is essential for normal cognitive function and synaptic plasticity; that cognitive functions including immediate memory, spatial learning are impaired in SIRT1 knockout mice; that overexpression of SIRT1 is observed to exhibit ordered synaptic plasticity and memory; and that SIRT1 acts on normal learning, memory and synaptic plasticity.
Even though Suzuki does not specifically teach that administering S-1-propenylcysteine increases NAD+ in the Alzheimer’s patient in the method of treatment, as in instant claim 46, such increase in NAD+ inherently occurs in the method of treating Alzheimer’s disease with S-1-propenylcysteine, as evidenced by Michan et al. (The Journal of Neuroscience 2010, 30 (29), 9695-9707, cited in IDS) and Imai et al. (Trends Cell Biol. 2014, 24 (8), 464-471, cited in IDS). Michai is as above. Imai teaches that NAD+ functions as a coenzyme for dehydrogenases and a substrate for sirtuins in living bodies; an increase in NAD+ amount enhances sirtuin activity. Thus, Michan and Imai teach the link between cognitive function, sirtuin expression and NAD+ amount. Improved cognitive function (that occurs in the treatment of AD) correlates with enhanced expression of sirtuins, and an increase in NAD+ amount.
As such, a method of instant claims 42-49, 51 is anticipated by Suzuki.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 42, 46, 50 are rejected under 35 U.S.C. 103 as being unpatentable over Suzuki et al. (WO 2019/235597, published 12 December 2019, cited in IDS, US 2021/0228521 used as English equivalent, cited in IDS), in view of Imai et al. (Trends Cell Biol. 2014, 24 (8), 464-471, cited in IDS).
Suzuki teaches (US 2021/0228521, [0048]-[0050]) a method of preventing, treating, or ameliorating a neurodegenerative disease comprising administering S-1-propenylcysteine or a salt thereof to a subject in need thereof.
Suzuki teaches (claim 20) that the neurodegenerative disease is, for example, amyotrophic lateral sclerosis, muscular dystrophy, heart failure, dilated cardiomyopathy, infectious disease, autoimmune disease, obesity, diabetes, arteriosclerosis, or steatohepatitis, which are not cognitive or memory disorders, as in instant claim 50.
Thus, Suzki teaches administering S-1-propenylcysteine or a salt thereof to a subject who suffers from amyotrophic lateral sclerosis, muscular dystrophy, heart failure, dilated cardiomyopathy, infectious disease, autoimmune disease, obesity, diabetes, arteriosclerosis, or steatohepatitis, to prevent or treat said disease.
Suzuki teaches [0088] that the daily intake of S1PC is 0.1 to 2.7 mg/kg, which is within the range in instant claim 46.
The patient population in Suzuki includes patients in need to reduce senescent cells, which accumulate with aging.
Imai teaches that NAD+ levels decline during aging. Imai teaches that NAD+ functions as a coenzyme for dehydrogenases and a substrate for sirtuins in living bodies; an increase in NAD+ amount enhances sirtuin activity. Thus, Imai teaches the link between aging/senescence, sirtuin expression and NAD+ amount.
It would have been obvious to administer S-1-propenylcysteine or a salt thereof to a subpopulation of patients of Suzuki, namely aging patients suffering from a neurodegenerative disease such as amyotrophic lateral sclerosis, muscular dystrophy, heart failure, dilated cardiomyopathy, infectious disease, autoimmune disease, obesity, diabetes, arteriosclerosis, or steatohepatitis, with the expectation of achieving therapeutic effect. Even though Suzuki does not specifically teach that administering S-1-propenylcysteine suppresses senescent cells/reduces levels of senescent cells in the patients in the method of treatment, as in instant claims, such suppressing of senescent cells inherently occurs in the method of treating said aging patients with S-1-propenylcysteine.
Administration of the same therapeutic agent, S-1-propenylcysteine or a salt thereof, to the same patient population, aging patients suffering from a neurodegenerative disorder taught by Suzki, will inherently have the same effect on the expression of sirtuins, Klotho, NAD+, and cell senescence in the body of the patient.
Conclusion
Claims 42-51 are rejected.
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 IRINA NEAGU whose telephone number is (571)270-5908. The examiner can normally be reached Mon-Fri 8-5.
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, JEFFREY S. LUNDGREN can be reached at (571)272-5541. 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.
/IRINA NEAGU/Primary Examiner, Art Unit 1629
Prosecution Insights