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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2026 May 15 has been entered. Newly amended claims 1-3, 5-9, and 13-16 are examined on the merits.
Claim Objections
Claims 2, 3, and 5 are objected to because of the following informalities:
In claims 2, 3, and 5, the language “claim 1, and a pharmaceutically acceptable salt” should be --claim 1, or a pharmaceutically acceptable salt— because a pharmaceutically acceptable salt, hydrate, or solvent mixture thereof are each alternative forms of a compound of claim 1;
in claim 2, the language “compounds have the following structures of formula (I-3)” does not agree with the preamble of the claim, which is “The compound of claim 1”; and
in claim 3, the language “compounds have the following structures of formula (I-6)” does not agree with the preamble of the claim, which is “The compound of claim 1”.
In each claim the specified language should be stated in singular tense.
Application of this idea to claim 2 could result in changing the language “compounds have the following structures of formula (I-3)” to --compound having the following structure of formula (I-3)--.
Application of this idea to claim 3 could result in changing the language “compounds have the following structures of formula (I-6)” to --compound having the following structure of formula (I-6)--.
In claim 3, the language “wherein each group is defined as in claim 1” is extraneous because variable R2 is assumed to have the same limitations as in claim 1 unless it is further limited.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 2 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. In the specification, formula (I-3) is the following structural formula. When these two formulae are compared, formula (I-3) of the specification does not provide support for the claimed formula (I-3) due to the substituents attached to the 3-position of the β-lactam ring. In the specification formula (I-3), a =CH-R group is attached to the 3-position. In the claim 2 formula (I-3), the 3-position is substituted with -OR and -CH2OR group moieties. Due to the substitution pattern being different in each formula, claim 2 contains new matter.
PNG
media_image1.png
184
250
media_image1.png
Greyscale
Specification formula (I-3)
PNG
media_image2.png
160
142
media_image2.png
Greyscale
Claim 2 formula (-3)
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by PAGILIARIN (WO 2013017548, published 2023 February 7). Pagliarin describes compound 6 (page 11), a compound in which the following examined definitions apply: R2 is OMe; R3 is H; R4 is O-C(O)-Me in which R is methyl.
PNG
media_image3.png
230
672
media_image3.png
Greyscale
Conclusion
Claims 1 and 2 are not allowed. Claims 13-16 are allowable.
Claims 6-9 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: PAGILIARIN (WO 2013017548, published 2023 February 7) describes compound 6 (page 11), a compound in which the following examined definitions apply: R2 is OMe; R3 is H; R4 is O-C(O)-Me in which R is methyl. This compound does not anticipate or render obvious a compound of claims 2, 3, 5, or 13 because a combination of variables R3 and R4 is [H, O-C(O)-Me] is not permitted in these claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOBLE E JARRELL whose telephone number is (571)272-9077. The examiner can normally be reached 9:00 AM to 5:00 PM.
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, Fereydoun Sajjadi can be reached at 571-272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NOBLE E JARRELL/Primary Examiner, Art Unit 1699
Prosecution Insights