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 .
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.
Current Status of 17/975,028
This Office Action is in response to the amended claims of October 27th 2025.
Claims 4 is original; claim 1, 3, 5, 16 and 18 currently are amended; and claim 2, 5, 17 and 19 were previously presented.
Claims 1-5, and 16-19 are examined on merits.
Examiner have withdrawn 112(b) and 103 rejections on record.
New 102 and 103 rejections are made due to applicant claim amendments.
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).
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. The application is the national stage filing of PCT/CN2021/128232. The effective filing date is 11/02/2021.
Response to Arguments
Examiner acknowledges the receipt of applicant’s claim amendments and remarks of October 27th 2025. Examiner have reviewed these remarks and amendments.
Regarding 112(b) indefinite rejection, applicant deleted the term “includes” from claims 3 and 18, rendering moot 112(b) indefinite rejection. Therefore 112(b) rejection is withdrawn.
Regarding 103 rejection.
Applicant responded by
Amending claims 1 and 16 by including the limitation “dihydroberberine or a pharmaceutically acceptable salt, acid, or ester thereof is formulated in a facial mask composition, a functionalized cream composition, a functionalized essence, a skin care composition, or a make-up composition for local application on skin”
Applicant argues
Buchannan developed transdermal formulation of dihydroberberine, to increase berberine levels over oral administration to achieve health benefits including lipid and cholesterol reductions and improved insulin sensitivity. Buchanan does not teach local administration on the skin.
Examiner’s response
Examiner agrees with applicant, the prior art of Buchannan does not teach local application for dihydroberberine on skins surface. Therefore 103 rejection is withdrawn.
Response to Amendment
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.
Claims 16-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by PIETRA DANIELE (WO-2013084162-A2).
PIETRA DANIELE teaches dihydroberberine have anti-radical effect (page 5 lines 15-20 ) and effect mitochondrial dehydrogenase activity and have beneficial effect in the treatment of skin regeneration and repair dysfunctions (page 14, lines 15-30) in human(page 36 line 1-26). Daniele further teaches dihydroberberine used in anti-aging (claim 18) cosmetic product (page 14, lines 15-30) and formulated in gels and creams thus anticipating claims 16 and 18.
Claim 17 are directed to the ability of the composition to “mitigate and prevent skin aging is achieved through inhibiting progerin” examiner interpret this as inherent properties of the composition. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01(I) and (II).
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).
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 1-5 and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over:
PIETRA DANIELE (WO-2013084162-A2)
In view of
Anisel et.al. “PHARMACEUTICAL DOSAGE FORMS AND DRUG DELIVERY SYSTEMS” 7th edition, 1999.
1. Determining the scope and contents of the prior art
PIETRA DANIELE teaches dihydroberberine have anti-radical effect (page 5 lines 15-20 ) and effect mitochondrial dehydrogenase activity and have beneficial effect in the treatment of skin regeneration and repair dysfunctions (page 14, lines 15-30) in human(page 36 line 1-26) (claim 4). Daniele further teaches dihydroberberine used in anti-aging (claims 3, 18) cosmetic product (page 14, lines 15-30) and formulated in gels and creams (claims 16 and 5) thus teaching claims 1,3-5,16 and 18.
Claim 2 and 17 are directed to the ability of the composition to “mitigate and prevent skin aging is achieved through inhibiting progerin” examiner interpret this as inherent properties of the composition. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01(I) and (II).
Anisel et.al. teaches dosages (examiner interpret this as concentration) of pharmaceuticals are routinely optimized (Anisel et.al. page 50).
2. Ascertaining the differences between the prior art and the claims at issue.
Daniel does not teach 2-2000mg of dosage of dihydroberberine.
Anisel et.al. does not teach dosage of dihydroberberine.
3. Resolving the level of ordinary skill in the pertinent art.
The level of ordinary skill is an artisan who have sufficient background in anti-aging research.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1 and 19 are directed to concentration of dihydroberberine. Examiner interprets these attributes as variables the artisan would normally be expected to routinely optimize. For example, Anisel et.al. teaches dosages (examiner interpret this as concentration) of pharmaceuticals are routinely optimized (Anisel et.al. page 50). Generally, concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such attributes are critical. The specification does not indicate the dosage and frequency of the dosage to be critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05(II)(A).
Applicants are encouraged to provide evidences for secondary consideration. Evidence for secondary consideration can be in the form of surprising/unexpected results.
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).
Conclusion
No claims are allowable as written.
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 Rehana Ismail whose telephone number is (703)756-4776. The examiner can normally be reached Monday-Friday 9:00am-5:00pm.
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/R.I./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625