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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/06/2025, 03/04/2026 and 04/17/2026 were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-7 and 12-13 in the reply filed on 04/17/2026 is acknowledged.
Claims 8-11 and 14-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/17/2026.
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.
Claim 3 is 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.
Claim 3 recites “wherein said characteristic peaks are selected from a group consisting of 6.4 …” A degree of variation is not defined by the claim.
Para. [0096] of the specification states:
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It is clear that a “certain degree of variability” is present, but the specification offers both +/- 0.2 degrees and +/- 0.5 degrees of variability as interpretations. Accordingly, it is unclear what degree of variability, if any, is present in the peaks of claim 3 which is therefore indefinite. The broadest reasonable interpretation is +/- 0.5 degrees of variability and is applied herein for examination purposes.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-7 and 12 is/are rejected under 35 U.S.C. 102((a)(1)/(a)(2)) as being anticipated by US4812561A to Hamashima et al. as evidenced by PubChem CID 5282242.
Hamashima et al. discloses a crystalline form of ceftibuten (see PubChem CID 5282242 structure and p. 9, 2.4.2, which shows that the compound referred to as 7432-S by Hamashima et al. at Col. 1, line 8 is equivalent to ceftibuten of the instant claims) with characteristic peaks at at least 10.15, 15.65 and 16.25 degrees 2-theta. See Table 2, Col. 2. At least these peaks lie within the ranges of peaks 10.2, 15.5 and 16.1 degrees 2-theta +/- 0.5 degree 2-theta recited in claims 2 and 3. Note that even if the narrower interpretation suggested by instant Para. [0096] of +/- 0.2 degrees 2-theta were applied, the peaks would still lie within the range of those claimed. With respect to claims 4-6, Col. 2, lines 43-48 describe the crystalline hydrate as containing 96 to 100% (especially 99.0 to 99.8%) of the cis-geometric isomer. The crystalline hydrate comprising a portion of the cis isomer necessarily includes other components and therefore reads on the pharmaceutical composition of claims 4-6. With respect to claim 7, the form is referred to as a hydrate at at least Col. 2, line 21. With respect to claim 12, Example 11 discloses a pharmaceutical composition comprising the hydrate with crystalline cellulose and other excipients (Col. 8-9, lines 62-8).
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.
Claim(s) 1-7 and 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over US4812561A to Hamashima et al. as evidenced by PubChem CID 5282242.
Hamashima et al. discloses a crystalline form of ceftibuten (see PubChem CID 5282242 structure and p. 9, 2.4.2, which shows that the compound referred to as 7432-S by Hamashima et al. at Col. 1, line 8 is equivalent to ceftibuten of the instant claims) with characteristic peaks at at least 10.15, 15.65 and 16.25 degrees 2-theta. See Table 2, Col. 2. At least these peaks lie within the range of peaks 10.2, 15.5 and 16.1 degrees 2-theta +/- 0.5 degree 2-theta recited in claims 2 and 3. Note that even if the narrower interpretation suggested by instant Para. [0096] of +/- 0.2 degrees 2-theta were applied, the peaks would still lie within those claimed. With respect to claims 4-6, Col. 2, lines 43-48 describe the crystalline hydrate as containing 96 to 100% (especially 99.0 to 99.8%) of the cis-geometric isomer. The crystalline hydrate comprising a portion of the cis isomer necessarily includes other components and therefore reads on the pharmaceutical composition of claims 4-6. With respect to claim 7, the form is referred to as a hydrate at at least Col. 2, line 21. With respect to claim 12, Example 11 discloses a pharmaceutical composition comprising the hydrate with crystalline cellulose and other excipients (Col. 8-9, lines 62-8).
Hamashima et al. does not disclose the combination of the crystalline form with a beta-lactamase inhibitor as required by claim 13.
Stewart et al. teaches “Novel cephalosporin/β-lactamase inhibitor combinations have been developed and demonstrate good in vitro activity against ESBL-producing isolates. A pooled analysis of in vitro activity of existing oral cephalosporin/clavulanate combinations in ESBL-producing Enterobacteriaceae has shown MIC50s of 0.5–1, 0.125–1 and 0.25 mg/L for cefpodoxime, ceftibuten and cefixime, respectively. A novel cyclic boronic acid β-lactamase inhibitor, QPX7728, was able to produce MIC50 values of 0.5 and ≤0.06 mg/L when paired with cefpodoxime and ceftibuten, respectively. Other novel combinations, cefpodoxime/ETX0282 and ceftibuten/VNRX7145, have also demonstrated excellent activity against ESBL producers. Clinical trials are now awaited.” Because a combination of ceftibuten and QPX7728 has been shown to produce an MIC50 value of ≤0.06 mg/L and a combination of ceftibuten and VNRX7145 has demonstrated “excellent activity against ESBL producers”, it would have been obvious to a PHOSITA to combine the crystal form of ceftibuten taught by Hamashima et al. with one of the beta-lactamase inhibitors taught by Stewart et al. such as QPX7728 or VNRX7125. There would have been a reasonable expectation of success that the combination would show similar efficacy given that the active ingredients are the same and a specific polymorph such as that taught by Hamashima et al. would be expected to have the same or similar biological activity.
Conclusion
Claims 1-7 and 12-13 are rejected.
Claims 8-11 and 14-24 are withdrawn.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JED A KUCHARCZK whose telephone number is (571)270-5206. The examiner can normally be reached Mon-Fri 7:30 to 5.
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/JED A KUCHARCZK/ Examiner, Art Unit 1623
/VALERIE RODRIGUEZ-GARCIA/ Primary Examiner, Art Unit 1621
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