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 .
Amended claims 1-8, 22-24 and new independent claim 25 are pending.
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.
Previously presented rejection of claims 1-8, 22, 23-25 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 is maintained for reasons of record.
Applicants arguments and the Affidavit were considered.
According to Applicant, the term
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defines the structure of the starting material compound.
Further Applicant points to Examples of
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in the specification. Page 5-8.
That one of skill in the art would understand what the functional term
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means was explicitly acknowledged in the previous action, bottom of page 3..
As to referring to specification at page 5-6 for the starting material
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, Examiner notes that
Examples are not explicit definition
Further, consider one of the Applicant cited examples of
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at page 8, the first structure.
As pointed out by the Examiner in previous action at page 4, line 7, one of skill in the art would at once recognize that there is no functionality in nabumetone molecular structure that could be reacted with N-protected amino alkyl chloroformate as required for the first step in the claimed method. That is, the first step in the claimed method raises issues because of lack of explicit structural information for the starting material reactant defined as
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. Applicant response to this issue is found at page 7/17 of the Affidavit, according to which FIG H, teaches how to ‘create’ the
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Invoking starting materials and intermediates ‘created’ by such chemical and biochemical methods (metabolites and prodrugs) as argued at Applicant Remarks 07/16/2025 bottom of page 8, suitable for the claimed method would be inconsistent with the 112-2 requirement of ‘particularly pointing out and distinctly claiming the subject’. Applicant also speculates on chemistry possibilities (see page 14/17) to make the intermediates necessary for the claimed method. The argument that Examiner need to ignore claim language and limitation is against Examination guidelines on claim interpretation. Consider for example, the reaction of meloxicam at FIG.1C with the N-protected alkyl chloroformate. No reagent is even speculated here or in any working example to support why one of skill in the art would anticipate that the reaction would occur at NH and not at OH in meloxicam. At the minimum Applicant could point out, for example prior art citations for regiospecific acylation reaction of meloxicam.
The missing elements (missing steps) and open-ended comprising language pointed out in the previous actions (plural), directly relate to the applicants argument that Examiner need to import any explicit or implicit subject matter from the specification to interpret claim. Pointing out steps for ‘creating’ necessary intermediates buried in the specification would not be persuasive for this Examiner. See previous action, page 5 Van Genus and Zietz citations.
Similarly, with respect to absence of other process parameters pointed out in the previous action such as reagents, terms such intermediates, cannabinoid etc., Applicant turns to examples (not working examples) in the specification. Again, Examples are not explicit definitions.
As to claim 24 pointed out by the Examiner as lacking antecedent basis because compound IV-b has non-cannabinoid (right hand portion) in the pictured structure, Applicant points to the Affidavit.
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While it is known that cannabigerol is a cannabinoid, cannabigerol has two phenolic OH groups. As such paragraphs 68-71 implies the need for derivatization of cannabigerol to ‘create’ starting materials and intermediates needed for the claimed method. Such language here in the affidavit, ‘derivative’, ‘would be’ ‘could be’ are indefinite and do not help with defining the metes and bounds of the claims. For example, the term ‘derivative’ implies more than what are positively recited (in claims). Similarly, language at paragraph 39 with regards to lumiracoxib and meloxicam is at best confusing, not only because meloxicam does not have an amino group, but also it is unclear what part of lumiracoxib (the NH or carboxylic acid) reacts with N-protected amino alkyl chloroformate. It is interesting to note that the while many of the cox-2 inhibitors (see claim 25 and also see Zarghi teaching of record) are carboxylic acids, the disclosure in the specification is limited to one working example, conjugation of celecoxib, a sulfonamide cox-2 inhibitor, for which a patent has been issued.
New claim 25 recites the specific starting materials for cox-inhibitors and cannabinoids for otherwise same method of claim 1. For reasons explained here and in rejections of record for claim 1, clarity with regards to these starting materials and intermediates of claimed method of claim 25 is also vague and indefinite.
For suggestion see Office action 04/25/2025 bottom of page 4, and top of page 5:
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.
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.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached on (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