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 .
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.
Claim 9 and dependent claims 10-15 and 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.
Amendments to claims and applicants arguments are not persuasive.
The active ingredients in the claimed method are:
2-(3,4-dihydroxyphenyl)chromenylium-3,5,7-triol
2-(3,4,5-trihydroxylphenyl)chromenylium-3,5,7-triol
a compound in which 2 to 15 molecules of (2R,3R)-2-(3,4-dihydroxyphenyl)-3,4-dihydro-2H-chromene-3,5,7-triol condensed by
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The active ingredients are critical and essential limitations of the claims. The chemical structure of these compounds are unclear.
The phrase/term/name for the compounds (A) and (B) appear ~2 dozen times in the specification. But no structural formulae for these are found.
Applicants response, for example with respect to tetramer, the elected species, linearly condensed compound (C) is revealing and discussed below:
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Based on the above it is clear that the recurring unit here is
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How the above monomeric unit relates to
(2R,3R)-2-(3,4-dihydroxyphenyl)-3,4-dihydro-2H-chromene-3,5,7-triol
is mind boggling,
because
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means that
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wherein the dotted line corresponding to the 2 position attached to rest of the molecule.
There is nothing in
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indicative of presence of
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moiety (even after any condensation).
The Catechin molecule (undergoing condensation as per Applicant) is known in the art as having the following chemical structure
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contradicting the structures for Catechin in Applicants arguments here (and for rejection under 35 USC § 103).
Note that the tetramer is the elected species.
Further the base claims also requires salts of the recited ingredients. The compounds being phenols what salts protection sought for is unclear.
Dependent claims do not solve the problem of the base claims.
A patent search cannot be done for the claims.
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 9-15 and 16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for (the elected) compound, does not reasonably provide enablement for the salt, hydrate of the monomers and multimers of the active ingredients of the active agents. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
Applicants arguments are not persuasive.
Applicant’s Remarks that the there is no
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simply overlooks the fact there is no evidence for making any of the active ingredient compounds without hydrate molecules.
As taught in the cited West reference, it is unpredictable whether these compounds even if makeable would hydrates is not predictable. Applicant simply ignores the reference cited by the Examiner.
Likewise there is no enabling disclosure with respect to salts of recited (phenolic) compounds. Because phenols are weakly acidic (having higher pKa values than carboxylic acids), traditional stable salt formation via simple proton transfer is more challenging and often requires strong bases or specialized counterions. That such salts even if makeable, could cross fatty cell membranes for the intended pharmacological effect is questionable as it defies commonly understood (medicinal) chemistry principles.
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.
Claims 9-15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Tamura US 11147791 (= WO2018101231); Osakabe, Exp Biol Mad Vol. 227(1):51-56, 2002; Kozai, Antioxidants and Redox Signalling Volume 21, Number 6, 2014; Kozikowski, J. Org. Chem. 2003, 68, 1641-1658 and Magrone, Front. Immunol., 08 June 2017.
Applicants arguments focus (Remarks page 4) on the (elected species) tetramer.
According to Applicant, Tamura does not disclose the tetramer:
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Applicant is correct, but the above has nothing to do with the recited active ingredients in the base claims. For more on this see section under 35 USC § 112b.
Applicant also points to Figs 8, 9 and 13-15 and asserts unexpected results. Given the explanation as to the dimer and trimer with respect to their chemical structures, it is unclear whether compounds of Figures 8-9 have anything to do with the results in these figures and compounds as recited.
To be persuasive, establishing that the compounds in Fig 8, dimer, trimer and tetramer are not the same compounds of the cited Tamura 11147791 = WO2018101231 (titled Composition containing polyphenol for sympathetic nerve activation):
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Further placing on record the relationship among the tetramer cinnamtannin A2, as in the post-filing date Koizumi, Relationship between hemodynamic alteration and sympathetic nerve activation following a single oral dose of cinnamtannin A2, Free Radical Research (2021), 55(5), 491-498, the Tamura tetramer cinnamtannin A2 and the instant tetramer would help facilitate prosecution.
THIS ACTION IS MADE FINAL. 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.
Even though, Remarks 09/03/2026 at page 12 says
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Attempts to reach the above noted
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are not successful. Also see page 2 of office action filed 03/03/2026.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NIZAL S CHANDRAKUMAR whose telephone number is (571)272-6202. The examiner can normally be reached M-F 8-5 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, Andrew Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NIZAL S CHANDRAKUMAR/Primary Examiner, Art Unit 1625
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