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 .
Response to Amendment
The amendment filed 2025 November 7 containing newly amended claims 1, 3, 5-8, 13, 15-18, 21-24, 26, and 27 is examined on the merits. The 35 U.S.C. 112 rejection over claims 1, 3, 6, 7, 8, 16,17, 25, and 26 is overcome because claim 1 recites a complex (a compound as defined in the specification, page 11, lines 6-9) formed by the reaction of a C3-10-alkyl-NH2 with a β-lactam ring that also contains an isotope. The 35 U.S.C. 102 rejections are overcome because none of the cited references describe the preparation of an isotopically labelled C3-10- alkyl-NH-C(O)-C-C-N compound.
Claim Objections
Claims 13, 22, and 24 are objected to because of the following informalities.
Claims 13 and 24 each recite an intended use, “suitable as an internal standard and/or calibrator in mass spectrometry measurements”. This intended use does not limit the usage of the derivatized antibiotic substance or the stabilized antibiotic substance recited in the respective claims.
Claim 22 recites the text “for more for more” (line 2). It appears this text should be –-for more--.
Appropriate correction is required.
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.
Claims 13, 15, 18, and 21-24 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.
In claims 13, 15, and 21-24, the metes and bounds of an antibiotic substance are unclear. DESHPANDE (Current Science, 2004, 87 (12), 1684-1695) describes various antibiotics: penicillin, 6-APA, cephalosporin C, desacetylcephalosporanic acid; imipenem; meropnem, aztreonam, norcardicin (page 1685, figure 1; page 1686, figure 2; page 1687, figure 3). Do applicants mean that the antibiotic is limited to cephalosporin C? Even though antibiotics are recited in the specification, they do not limit the claims (page 13, line 4-23).
It is unclear how an antibiotic substance is derivatized. The claims do not recite how an antibiotic substance is derivatized and is suitable as an internal standard and/or calibrator for mass spectrometry measurements. What structural features make a derivatized antibiotic suitable for the intended use recited in claims 13?
The term “stabilized” in claim 15, 18, and 21-24 is a relative term which renders the claim indefinite. The term “stabilized” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Neither the claims nor the specification define what is meant when an antibiotic is stabilized. What structural features make a derivatized antibiotic suitable for the intended use recited in claims 24?
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A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 22 recites the broad recitation “for more than 12 hours”, and the claim also recites the terms “for more than [24 hours, 48 hours, 7 days, 2 weeks, 4 weeks, 2 months, 3 months, 4 months, 5 months, or 6 months]”, which are a narrower statement of the range/limitation. Please note that more each limitation is a more narrow limitation of the preceding limitation, As one example, the limitations “for more than [48 hours, 7 days, 2 weeks, 4 weeks, 2 months, 3 months, 4 months, 5 months, or 6 months]” are each a narrower range of “for more than 24 hours”.
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Conclusion
Claims 1, 3, 6, 7, 8, 16,17, 26, and 27 are allowed. Claims 13, 15, 18, and 21-24 are not allowable.
The following is a statement of reasons for the indication of allowable subject matter: LEVINE (US 4316882, issued 1982 February 23, cited in previous action) describes four compounds (column 7, line 24 to column 8, line 2; column 10, lines 10-65). In these compounds, an NH-[propyl, ethyl, butyl, or pentyl] group is attached to a carbonyl group. The compounds are prepared when a penicillin reacts with n-propyl amine, ethyl amine, n-butyl amine, or n-pentyl amine respectively. Compositions are described (column 8, lines 46-52; column 9, line 32 to column 10, line 4). These compounds are not prior art because they are not isotopically labeled.
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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.
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/NOBLE E JARRELL/Primary Examiner, Art Unit 1699