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 .
Priority
This application is a 371 of PCT/US2022/071479 (03/31/2022)
PCT/US2022/071479 has PRO 63/170,936 (04/05/2021).
Drawings
The drawings filed 10/3/23 are objected to for not conforming to the requirements of 37 CFR 1.84(u)(1) (“View numbers must be preceded by the abbreviation “FIG.” Where only a single view is used in an application to illustrate the claimed invention, it must not be numbered and the abbreviation “FIG.” must not appear.”). MPEP 608.02.
Election/Restrictions
Applicant's election without traverse of Group II, claims 13-26, in the reply filed on 3/12/26 is acknowledged.
Applicant also elected the following species:
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.
As detailed in the following rejections, the generic claim encompassing the elected species was not found patentable. Therefore, the provisional election of species is given effect, the examination is restricted to the elected species only, and claims not reading on the elected species are held withdrawn. MPEP 803.02; Ex parte Ohsaka, 2 USPQ2d 1460, 1461 (Bd. Pat. App. lnt. 1987). Claim 22 not reading on the elected species is withdrawn.
Should applicant, in response to this rejection of the Markush-type claim, overcome the rejection through amendment, the amended Markush-type claim will be reexamined to the extent necessary to determine patentability of the Markush-type claim. See MPEP 803.02.
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.
Claims 13-21, 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Krause et al. (US20180015100) in view of Lin et al. (Antimicrobial Agents and Chemotherapy, Feb. 1995, p. 359–361).
Krause teaches antibiotic combination of a ceftibuten with clavulanate (beta-lactamase inhibitor) at a dose of 1800 mg/day ceftibuten ([0111]: “In some embodiments, ceftibuten is administered orally at a total daily dose of 800 to 1800 mg, such as a total daily dose of 900 to 1200 mg, e.g. given as 300-400 mg BID or TID, and clavulanate is administered orally at a total daily dose of 250 to 750 mg, such as a total daily dose of 375 to 562.5 mg, e.g. given 100-250 mg or 125 to 187.5 mg BID or TID. This supports a finding that the specific combination of ceftibuten+clavulanate is superior to other existing orally-bioavailable cephalosporin+β-lactamase inhibitor combinations, and is likely to meet its PK/PD target and be efficacious.”). Krause teaches that ceftibuten is approved at a dose of 400 mg ([0112]).
Krause does not teach a single dose of greater than 400 mg.
Lin teaches the “pharmacokinetics and dose proportionality of ceftibuten were evaluated in healthy male volunteers receiving single oral doses of 200, 400, and 800 mg of ceftibuten” (Abstract) and that there was dose proportionality up to 800 mg (p. 360-361, Figs. 1-2).
One of ordinary skill in the art would have readily considered increasing the single dose by up to the 1800 mg/day as taught by Krause. One of ordinary skill in the art would have had a reasonable expectation of success in view of Lin’s teaching that such a dose would be proportional and result in a predictable response. With each of the claims, the level of skill in the art is very high such that one of ordinary skill in the art would consider routine the combination of elements from the teaching of the art. One of ordinary skill in the art would have recognized that the results of the combination would be predictable due to the well-known nature and optimizations routinely performed in the art. Thus, one of ordinary skill in the art would have arrived at the invention as claimed before the effective filing date with a reasonable expectation of success.
Regarding claims 25-26 specifying the amount once or twice per day, Krause teaches BID (twice a day) which one of ordinary skill in the art would have considered and arrived at the claimed invention.
Thus, claims 13-21, 25-26 are rendered obvious.
Claims 13-21, 23-26 are rejected under 35 U.S.C. 103 as being unpatentable over Krause et al. (US20180015100) in view of Lin et al. (Antimicrobial Agents and Chemotherapy, Feb. 1995, p. 359–361) as applied to claims 13-21, 25-26 above and further in view of Hecker et al. (US20180002351).
Regarding claims Krause does not teach the elected species lactamase inhibitor of the elected species.
Hecker teaches beta-lactamase inhibitors combined with antibiotics with a preferred embodiment of ceftibuten (Abstract, claims 1 and 36, [0344]). Hecker teaches the species of 26 and 27 (claim 36, p. 83):
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which are isomers of the elected species such that one of ordinary skill in the art would have had an expectation that they would share the same utility. MPEP 2144.09. In this case based on the disclosure of Hecker one of ordinary skill in the art would have considered Hecker’s small genus of
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in view of compounds 26 and 27 and readily envisioned the elected species. Thus, one of ordinary skill in the art would have considered substituting the beta-lactamase inhibitor of modified Hecker for Krause’s and had a reasonable expectation of success due to the well-known nature of the need for such a combination in an antibiotic as well as the fact the Hecker teaches the combination with ceftibuten as a preferred embodiment. Therefore, one of ordinary skill in the art would have arrived at the claimed invention with a reasonable expectation of success and the claims are prima facie obvious.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT H HAVLIN whose telephone number is (571)272-9066. The examiner can normally be reached 9am - 6pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached at (571) 270-5293. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT H HAVLIN/Primary Patent Examiner, Art Unit 1626
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