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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/25/2026 has been entered.
Terminal Disclaimer
The terminal disclaimer filed on 03/25/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of 12,048,691 has been reviewed and is accepted. The terminal disclaimer has been recorded.
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.
Claims 1, 2, 12, 14-24 and 27-31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jain et al. WO 2018112372 A1.
This rejection has been withdrawn in view of the Amendment filed 03/25/2026.
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.
Claims 1, 2, 12, 14-24 and 27-31 are rejected under 35 U.S.C. 103 as being unpatentable over Jain et al. WO 2018112372 A1, in view of Tablet Formulation reference (10/2017).
Jain teaches a tablet core comprising at least 65% tebipenem pivoxil HBr and tableting excipients. See abstract, and page 7. Tablet comprises 300 mg of tebipenem pivoxil in tablet weight of about 500 mg is found in page 12, paragraph 0054. The claimed diluent, binder, disintegrant and glidant in the claimed amount is found in pages 8-9 and Examples. The claimed method of treatment is found in pages 12-14. Tablet comprising tebipenem pivoxil, crospovidone (PVPP XL- 10), monohydrate lactose, and microcrystalline cellulose (Avicel PH102) is found in paragraph 0076.
It is noted that Jain teaches tablet excipients including mannitol. However, avoiding the use of mannitol in tablet formulation is known common and known in the art. See the teaching in the Tablet Formulation reference. Powdered mannitol shows higher sticking propensity as compared to granular mannitol. It was shown that diluting the mannitol blend with microcrystalline cellulose and 1% magnesium stearate decreased the sticking propensity of the blend. Based on the literature, it was concluded that to resolve the sticking and flowability issue, scientists needed to replace or reduce the amount of mannitol from the original formulation of Compound XY. In order to replace or reduce the amount of mannitol, scientists conducted several formulation trials to identify appropriate diluents. The goal was to use direct compression process and have the blend show good flowability because this was expected to resolve the challenge of weight variation. A common blend approach was chosen to manufacture 5-mg, 10-mg, and 25-mg tablets. In order to use common blend approach, tablet weight of the 25-mg formulation was increased to 300 mg. The percentage of crospovidone and magnesium stearate was kept the same. The tablet blends were manufactured using diluents like Prosolv SMCC 90, Avicel PH102, Avicel PH200.
Thus, it would have been prima facie obvious to one of ordinary skill in the art to optimize the tablet formulation in Jain in view of the teaching of the Tablet Formulation reference to exclude the use of mannitol with the expectation to obtain a tablet with improved stability, flowability, and compressibility.
Claims 13, 18-24 and 27-31 are rejected under 35 U.S.C. 103 as being unpatentable over Jain et al. WO 2018112372 A1, in view of in view of Tablet Formulation reference (10/2017), and further in view of Bonnaud et al. WO 2018145089 A1 and Karaborni US 2020/0291022 A1.
Jain is relied upon for the reasons stated above. Atli is silent with respect to the crystalline form of tebipenem pivoxil.
Bonnaud teaches a tebipenem pivoxil is known to come in crystalline Form B. See page 7.
Karaborni teaches crystalline hydrate of compound for the treatment of bacterial infection, the crystalline has particles size of less than 40µm is found in paragraph 0086. Compound includes tebipenem is found in paragraph 0140.
Thus, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to, by routine experimentation select crystalline Form A or Form B in view of the teaching of Bonnaud and Karaborni to obtain the claimed invention. This is because Bonnaud teaches tebipenem pivoxil in crystalline form, namely, Form B is known and desirable in the art. See page 1.
Claims 1, 2, 12-24 and 27-31 are rejected under 35 U.S.C. 103 as being unpatentable over Bhiwgade et al. US 2008/0069879 A1, in view of Jain et al. WO 2018112372 A1 in view of Tablet Formulation reference (10/2017) and Karaborni US 2020/0291022 A1.
Bhiwgade teaches a stable solid dosage form of pivoxil comprising up to about 80% cefditoren pivoxil and tablet excipients. See abstract and paragraphs 0025-0029. Tablet exhibits at least 90% dissolution in less than 5 minutes is found in Table 3.
Bhiwgade does not expressly teach putting pivoxil in a solid composition of the claimed invention.
Jain teaches a tablet core comprising at least 65% tebipenem pivoxil HBr and tableting excipients. See abstract, and page 7. Tablet comprises 300 mg of tebipenem pivoxil in tablet weight of about 500 mg is found in page 12, paragraph 0054. The claimed diluent, binder, disintegrant and glidant in the claimed amount is found in pages 8-9 and Examples. The claimed method of treatment is found in pages 12-14.
The cited references do not teach tebipenem particle size.
Thus, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to, by routine experimentation optimize the composition of Bhiwgade to include tebipenem pivoxil crystalline for in view of the teaching of Jain and Karaborni with the expectation to obtain a tebipenem tablet useful for the treatment of bacterial infections in a subject in need thereof. the claimed invention. This is because Karaborni teaches tebipenem pivoxil in crystalline form is known and desirable in the art, and this is because Jain teaches the use of tebipenem pivoxil is useful for a wide variety of bacterial infections.
Response to Arguments
Applicant’s arguments filed 03/25/2026 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSAN T TRAN whose telephone number is (571)272-0606. The examiner can normally be reached Monday-Friday, 8:30 am-5:30 pm.
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/SUSAN T TRAN/Primary Examiner, Art Unit 1615