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
Status of Application
1. Receipt of the Request for Continued Examination (RCE) under 37 C.F.R. 1.114, the Amendment and Applicants’ Arguments/Remarks, all filed 26 August 2025 are acknowledged.
Claims 1, 3, 5-12, 14, 16-20, 22, and 24-28 are currently pending. Claims 2, 4, 13, 15, 21, and 23 are cancelled. Claims 6, 12, 17, 20, and 25 are currently amended. Claims 1, 3, 5-12, 14, 16-20, 22, and 24-28 are examined on the merits within.
Continued Examination Under 37 C.F.R. 1.114
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 26 August 2025 has been entered.
Withdrawn Objections/Rejections
3. Applicant’s arguments, filed 26 August 2025, with respect to the claim objections have been fully considered and are persuasive. The objections of claims 6, 12, 17, 20, and 25 have been withdrawn. The 35 U.S.C. 112(a) Rejection of claim 3 has been withdrawn in view of support in the specification, specifically paragraph [0034], describing the components of AC3, and paragraph [0043] stating AC3 may be present in amounts of 10 to 100µg/mL.
Maintained Rejections
Claim Rejections – 35 U.S.C. 112(a): New Matter
4. 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.
5. Claims 1, 3, 5-12, 14, 16-20, 22, and 24-28 are again 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 claim(s) 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.
6. Claim 1 recites “30-50% w/w bisdemethoxycurcumin”. The previous filed claims, specification, and drawings do not provide support for the specific lower endpoint of 30%. The only values mentioned in the specification are 20-50% w/w bisdemethoxycurcumin. It is unclear where the value of 30% was derived from. With respect to changing numerical range limitations, the analysis must take into account which ranges one skilled in the art would consider inherently supported by the discussion in the original disclosure. In the decision in In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976), the ranges described in the original specification included a range of "25%- 60%" and specific examples of "36%" and "50%." A corresponding new claim limitation to "at least 35%" did not meet the description requirement because the phrase "at least" had no upper limit and caused the claim to read literally on embodiments outside the "25% to 60%" range, however a limitation to "between 35% and 60%" did meet the description requirement. See MPEP 2163.05. Thus the claims lack sufficient written description for this limitation.
Response to Arguments
Applicant's arguments filed 26 August 2025 have been fully considered but they are not persuasive.
7. Applicants argued, “Applicants have submitted a representative specification of the product AC3 complex as additional evidence in a Declaration under 35 U.S.C. 1.132 showing that the lower range of the BDMC is 30%.”
The Declaration under 37 CFR 1.132 filed 26 August 2025 is insufficient to overcome the rejection of claims 1, 3, 5-12, 14, 16-20, 22, and 24-28 based upon 35 U.S.C. 112(a) New Matter as set forth in the last Office action because:
Support for an amendment must be found within the claims, drawings or specification. A declaration cannot provide support for material that is not disclosed. The lower endpoint of 30% bisdemethoxycurcumin was not found recited in the specification, claims, or drawings. There must be explicit/implicit support for an amendment. Since this value was not recited within the application there is no explicit support. Nor is there information in the specification where support for 30% can be derived, i.e., such as claim 3 wherein paragraph [0034] describes the components of AC3, and paragraph [0043] states AC3 may be present in amounts of 10 to 100µg/mL, which overcame the 35 U.S.C. 112(a) Rejection of claim 3.
MPEP 2163 States: While there is no in haec verba requirement, newly added claims or claim limitations must be supported in the specification through express, implicit, or inherent disclosure. An amendment to correct an obvious error does not constitute new matter where the ordinary artisan would not only recognize the existence of the error in the specification, but also recognize the appropriate correction. In re Oda, 443 F.2d 1200, 170 USPQ 268 (CCPA 1971).
With respect to newly added or amended claims, applicant should show support in the original disclosure for the new or amended claims.
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Thus this rejection is maintained.
Conclusion
8. All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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.
Correspondence
9. No claims are allowed at this time.
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA WORSHAM whose telephone number is (571)270-7434. The examiner can normally be reached Monday-Friday (8-5).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Wax can be reached on 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JESSICA WORSHAM/Primary Examiner, Art Unit 1615