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
The preliminary amendment filed 04/23/2023, amended claims 2-17.
Claims 1-17 are pending and examined on the merits herein.
Priority
This application claims the following priority:
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Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: Fig. 3B. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. 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.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
See paragraphs [0089]-[0121] of the specification, for example.
Claim Objections
Claims 2, 44, and 10 are objected to because of the following informalities:
-In claims 2, the term “activator” should be inserted following “SIRT1,” at the end of line 1 of the claim.
-In claim 4, since B-[2-Methoxy-5-[(1E)-3-oxo-3-(3,4,5-trimethoxyphenyl)-1-propen-1-yl]phenyl]boronic acid is YK-3-237, YK-3-237 should be placed in parenthesis following the chemical name, and “or YK-3-237” should be deleted.
-In claim 9, line 2, the term “to,” prior to “sperm” should be replaced with - -with- -.
-In claim 10, line 2, the term “further” should be deleted.
Appropriate correction is required.
Note: If claim 1 is found allowable, claim 16 may be objected to under 37 CFR 1.75 as being a substantial duplicate of claim 1. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP§ 608.01(m).
Claim Rejections - 35 USC § 112(b)
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 11-13 and 15-16 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 11, the term "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
As such, the preferred embodiments following “preferably” are interpreted as exemplary, and as not further limiting the claim.
-Regarding claim 13, the phrase "in particular" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
As such, the preferred embodiment following “in particular” is interpreted as exemplary, and as not further limiting the claim.
-In claim 13, the term “maximum” in relation to “tyrosine phosphorylation,” is a relative term which render the claims indefinite. The term “maximum” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For example, it is not clear what baseline, threshold, or measurement, is being applied to distinguish maximum tyrosine phosphorylation from phosphorylation that is not maximum.
In view of compact prosecution, for the purpose of applying prior art, line 2 of claim 13 is interpreted as , “wherein it induces tyrosine phosphorylation. . .”
-Regarding claim 15, the phrases "particularly" and “more particularly” render the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
As such, the preferred embodiments following “particularly” are interpreted as exemplary, and as not further limiting the claim.
-In claim 16, the phrase “Pharmaceutical compound comprising the SIRT1 activator,” renders the claim indefinite. The instant specification teaches the SIRT1 activator as a compound. Thus, it is not clear if a) claim 16 is a substantial duplicate of claim 1, and the pharmaceutical compound is the SIRT1 activator of claim 1, or b) the recited pharmaceutical compound comprises the base of an SIRT1 activator, but can comprise additional groups, or if the pharmaceutical compound can be a conjugate of one or more compounds and an SIRT1 activator. Thus, the metes and bounds of the “pharmaceutical compound” are unclear.
In view of compact prosecution, for the purpose of applying prior art, this claim is interpreted as “Pharmaceutical compound is the SIRT1 activator of claim 1.”
All other claims not specifically recited are rejected for depending from an indefinite claim and failing to cure the deficiency.
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 1-9 and 13-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kumar (How much successful are the medicinal chemists in modulation of SIRT1: A critical review, Eur. Jn. of Med. Chem., published 2016, IDS of 04/23/2023).
Regarding claims 1 and 16, Kumar teaches the following SIRT1 activators:
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(pg. 49);
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(pg. 50).
Regarding claims 2-4, Kumar teaches an increase in SIRT1 activity at the concentration of 10uM YK-3-237. (pg. 49).
Regarding claims 1, 5, 8-9, 14, and 15, the “for use” phrases are interpreted as intended use recitations. Regarding claims 6-7, the wherein clauses further limit the intended use recitations in claim 5. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. Since the prior art compound is capable of performing the intended use, it meets these claim limitations; the intended use of the SIRT1 activator is being considered to the extent that it limits the structure of the composition, but it is not treated as a process of using claim. See MPEP 2112.01 and 2111.02.
Regarding claim 13, the claim recites a property of the SIRT1 activator compounds and an intended use. Since Kumar teaches the instantly claimed preferred compound in the instantly claimed concentration, it would necessarily have this effect. See MPEP 2112.02. And since the compounds taught by Kumar are capable of performing the intended use, the intended use limitations are also met.
Regarding claim 17, since Kumar teaches these compounds as therapeutics, these compounds would necessarily be contained, meet the limitation of “kit” (abstract).
Claims 1, 5-9, and 13-17 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by US 2017/0035724 to Chen (published 2017, PTO-892).
Regarding claims 1 and 16, Chen teaches mammalian SIRT1 activators of formula (I) as extending life span and/or treating a disease, such as Alzheimer’s disease (title, abstract, pgs. 3-4, claims 7, 9).
Regarding claims 1, 5, 8-9, 14, and 15, the “for use” phrases are interpreted as intended use recitations. Regarding claim 6-7, the wherein clauses further limit the intended use recitation in claim 5. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. Since the prior art SIRT1 activator compound is capable of performing the intended use, then it meets these claim limitations; the intended use of the composition is being considered to the extent that it limits the structure of the composition, but it is not treated as a process of using claim. See MPEP 2112.01 and 2111.02.
Regarding claim 13, the claim recites a property of the compounds and an intended use. Since Chen teaches the instantly claimed preferred compound, it would necessarily have this effect. See MPEP 2112.02. And since the compounds taught by Chen are capable of performing the intended use, the intended use limitation is also met.
Regarding claim 17, since Chen teaches these compounds as therapeutics and teaches administering the compounds, these compounds would necessarily be contained, i.e., meet the limitations of a kit (abstract; pgs. 3-4, 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 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.
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 1, 5-10, and 13-17 are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0035724 to Chen (published 2017, PTO-892) in view of Koivisto (Chronic Pyruvate Supplementation Increases Exploratory Activity and Brain Energy Reserves in Young and Middle-Aged Mice, Frontiers in Aging Neuroscience, published 2016, PTO-892), as evidenced by US 10,470,798 to Navarrete Solano (published 2019, PTO-892),
Chen is applied to claims 1, 5-9, and 13-17, as discussed above, and incorporated herein.
Regarding claim 10, while Chen teaches SIRT1 activators, it differs from that of instant claim 10 in that it does not teach sperm promoters and/or enhancers.
Koivisto teaches that chronic pyruvate supplementation increases exploratory activity and brain energy reserves in young and middle aged mice (title). Koivisto teaches that pyruvate supplementation counteracts aging-related behavior impairment related to explorative activity, and improved spatial learning (abstract; pg. 12, Conclusion). In summary, pyruvate supplementation is beneficial against aging related cognitive impairment and inactivity (pg. 12, Conclusion).
As evidenced by Navarrete Solano (US 10,470,798, published 2019, PTO-892), pyruvate is an energy source for sperm (Col. 31-32, claims 1, 3, and 19).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to add pyruvate to the methods of Chen, to predictably arrive instant claim 10. One of ordinary skill in the art would have been motivated to make such an addition, with a reasonable expectation of success, because:
-the methods of Chen and the methods of Koivisto are both directed toward a method of treating aging, especially brain/cognitive aging, and
-"It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). MPEP 2144.06
As such, an artisan having ordinary skill in the art would have been motivated to make such an addition to predictably arrive at a more potent method of treating aging, especially cognitive related aging.
Claims 1-9 and 11-17 are rejected under 35 U.S.C. 103 as being unpatentable over Kumar (How much successful are the medicinal chemists in modulation of SIRT1: A critical review, Eur. Jn. of Med. Chem., published 2016, IDS of 04/23/2023) in view of Coussens (SIRT1 Deficiency Attenuates Spermatogenesis and Germ Cell Function, PLOSone, published 2008, PTO-892), Bell (SIRT1 is required in the male germ cell for differentiation and fecundity in mice, The Company Biologists, published 2014, PTO-892), and Ritta (In Vitro Effect of Gamma-Aminobutyric Acid on Bovine Spermatozoa Capacitation, Molec Reproduc and Develop, published 2004, PTO-892).
Kumar is applied to claims 1-9 and 13-17, as discussed above and incorporated herein.
Regarding claims 11-12, while Kumar teaches SIRT1 activators, it differs from that of claims 11-12 in that it does not teach sperm media or sperm media comprising spermatozoa.
Coussens teaches that SIRT1 deficiency attenuates spermatogenesis and germ cell function (title, abstract).
Initial investigations of SIRT1 deficient mice reveal a phenotype that includes reduced lifespan, small size, and in increased frequency of abnormal sperm. SIRT1 deficiency markedly attenuates spermatogenesis. Numbers of mature sperm and spermatogenic precursors, as early as d15.5 of development, are significantly reduced in numbers (abstract; pgs. 6-7, Discussion).
Bell teaches that SIRT1 is required in the male germ cell for differentiation and fecundity in mice (title; pg. 3501, Fig. 6). Mice lacking SIRT1 in male germ cells display decreased sperm counts, and many of their spermatozoa have aberrant morphology and increased DNA lesions (pg. 3501, “Discussion”). Bell states, “It will be interesting to test whether restoring SIRT1 activity pharmacologically can prolong the reproductive lifespan of male mice, and if so, whether human reproduction might be impacted by activating or inhibiting this sirtuin protein in the male germ line” (pg. 3502, Col. 1, 1st full paragraph).
Ritta teaches adding GABA to a spermatozoa medium to increase the percentage of capacitated spermatozoa (abstract). To study the effects of drugs on spermatozoa, semen is placed in a medium with diluted 1:1 in egg yolk-triextender. Semen aliquots are washed in 4 ml of Biggers, Whitten, and Wittingham (BWW) medium, and the sperm suspension is centrifuged in plastic tubes. Aliquots of this suspension are mixed with an equal volume of BWW alone, BWW with GABA, GABA agonists, or antagonists. Sperm motility is monitored before and after incubations with the different compounds. The effects of these compounds are then measured (pgs. 479-481,”Materials and Methods”).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to add the SIRT1 activators taught by Kumar to the sperm media comprising spermatozoa of Ritta, to arrive at instant claims 11-12. One of ordinary skill in the art would have been motivated to make such an addition, with a reasonable expectation of success, because:
-Coussens teaches that initial investigations of SIRT1 deficient mice reveal a phenotype that includes reduced lifespan, small size, and increased frequency of abnormal sperm,
-Bell teaches that mice lacking SIRT1 in male germ cells display decreased sperm counts, and many of their spermatozoa have aberrant morphology and increased DNA lesions, and teaches that “It will be interesting to test whether restoring SirT1 activity pharmacologically can prolong the reproductive lifespan of male mice, and if so, whether human reproduction might be impacted by activating or inhibiting this sirtuin protein in the male germ line,”
-Ritta teaches a sperm media comprising spermatozoa for use in determining the activity/function of sperm following the addition of pharmacological agents, and
-Kumar teaches SIRT1 activators known in the art.
As such, an ordinary skilled artisan would have been motivated to make such an addition to predictably arrive at a means of determining the effects of known SIRT1 activators on sperm, especially in regard to sperm count and quality of sperm for reproductive purposes.
Conclusion
No claims are allowed.
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/LAUREN WELLS/Examiner, Art Unit 1622