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 .
Response to Amendment
The amendment filed 3/12/2026 has been entered. Claims 1-5, 7-10, 12, 13, 16, 17 and 18 remain pending in the application. Applicant’s amendments to the Claims have addressed every objection and 112(b) rejection previously set forth in the Office Action mailed 12/16/2025.
Response to Arguments
Applicant's arguments filed 3/12/2026 have been fully considered.
The prior art rejections are no longer applied to the instant claims due to the amended language of claim 1 regarding biopolymer particles.
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 1-5, 7-10, 12-13, and 16-18 are 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.
Claim 1 recites “wherein the tangential diafiltration is performed without a prior complexation of the high molecular weight adenosine-based coenzyme with bio-polymer particles.”
The original disclosure does not provide any of the following:
The specification does not expressly state the negative limitation (As an example “the method comprising filtering in absence of complexation”)
The specification does not describe a reason to exclude a prior complexation (As an example “complexation occurrence is detrimental in the following ways”)
The specification does not describe alternative elements (As an example “purifying high molecular wight adenosine-based enzyme can be achieved by X, Y, Z, and complexation”)
In so doing, alternative elements may be explicitly excluded in the claims.
MPEP 2163 states “The introduction of claim changes which involve narrowing the claims by introducing elements or limitations which are not supported by the as-filed disclosure is a violation of the written description requirement of 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph.”
Claims 2-5, 7-10, 12-13, and 16-18 depend on Claim 1, and therefore are also rejected.
Conclusion
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 MARRIAH ELLINGTON whose telephone number is (703)756-1061. The examiner can normally be reached Monday - Friday, 9:00 am - 4:00 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ben Lebron can be reached at (571) 272-0475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARRIAH ELLINGTON/
Examiner
Art Unit 1773
/BENJAMIN L LEBRON/Supervisory Patent Examiner, Art Unit 1773
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