DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Claims 1-9, 11-13 and 16-18 are examined herein.
Claims 10, 14, 15 and 19-21 are withdrawn (see restriction/election below).
Priority
This application is filed 07/13/2023 and claims the benefit of domestic priority as below:
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Information Disclosure Statements
Two IDS(s) received on 10/17/2023, and 01/14/2024 have been considered unless marked with a strikethrough.
Election/Restrictions
Applicant elects group I - claims 1-18, drawn to a compound of Formula I, salts and pharmaceutical compositions thereof, without traverse in the reply filed on 01/28/2026 is acknowledged.
Claims 19-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method of use, there being no allowable generic or linking claim.
While it is acknowledged that restriction requirements in applications entering the U.S. national phase under 35 USC § 371 do not require a showing of search burden, the present claims nevertheless present issues that would also be applicable under standard U.S. examination practice.
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Applicant’s election of species of the compound FA-CP elected in the reply filed on 1/28/2026 is acknowledged.
Claims 1-9 and 16-18 read on the elected species.
If the elected specie was not identified in the prior arts, the elected specie would be allowable if an independent claim were drafted with that specie alone, and Examiner expanded the search to additional species of the genus per MPEP 802.03.
The elected specie is not identified in the prior art; thus, Examiner expanded his search to other species in the genus, and claims 11-13 read on the expanded specie as well. Accordingly, claims 10, 14 and 15 are withdrawn as not reading on the expanded species.
Claims 1-9, 11-13 and 16-18 read on the elected and extended species and will be examined on their merits. With respect to the elected/extended specie, the species are rejected under 102 and 103 below.
Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because:
The Figure 3 (A) is not clearly distinct between FA-CP and Fusidic acid. See 37 CFR 1.84(l) and (q).
Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
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, 3-6, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhao et. al (CN 105924488 A, English Machine Translation attached, pub’d 07/09/2016).
With respect to claims 1, 3-6, and 18, Zhao disclose antibacterial compounds including WU-FA-09, WU-FA-10, WU-FA-11, WU-FA-13, WU-FA-18, and WU-FA-19 (paragraph [0061-[0076]). These compounds fall within the scope of the instant claimed compounds. Zhao further teaches these compounds are useful as antibiotic agents.
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Zhao further teaches that such compounds can be prepared in the form of powders, tablets, capsules, suspensions, liquids, emulsions, oral preparations, granules, sprays, ointments, eye drops, disinfectants, etc. (paragraph [0043]). Preparations for the such forms are understood in the pharmaceutic field as formulated compositions produced though compounding. Accordingly, this disclosure reasonably convey that the active compound is combined with additional components in such preparations, thereby forming pharmaceutical compositions. Claim 18 recites that “a pharmaceutical composition comprising a compound of claim 1 and a pharmaceutically acceptable excipient.” The specification does not disclosure a specific information of a pharmaceutically acceptable excipient, thus this interpretation is consistent with the broadest reasonable interpretation standard applied during patent examination (see MPEP 2111). Accordingly, in the view the specification’s disclosure of Zhao that the compounds should prepare through drug compounding into preparation such as spray, ointments, tablets and eye drops, the disclosure reasonably encompasses pharmaceutical compositions comprising the compound of claim 1 together with pharmaceutically acceptable excipients as recited in claim 18.
Claim Rejections - 35 USC § 103
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 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.
Claims 1, 2, 6, 11-13, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Zhao et. al (CN 105924488A1, WIPO English Machine Translation, pub’d 07/09/2016, cited in IDS).
Claims 1, 3-6 and 18 are rejected under 35 USC § 102(a)(1) as anticipated by Zhao. These 103 rejections are expanded additional limitations for claims 2, 11-13, and 16 that would have been obvious, but not directly disclosed by Zhao.
With respect to claim 1, 2, 6, 11-13, and 16, Zhao teaches compounds sharing the core structure with Formula I as set forth above, including WU-FA-13 that is a compound of formula I wherein G1 is ORx wherein Rx is H; G2 is H; J1 is CRcRd (i.e., Rc is H and Rd is Halo), R1 is -OC(=O)(C1-C6)alkyl, R2 and R3 are hydroxy, as required in claims 1 and 3-6 explained above.
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Zhao fails to teach a structural example wherein both Rc and Rd are both bromo or iodine substituents at position J1.
However, Zhao does teach in the generic disclosure that the terminal olefin may be substitute with halogen (i.e., bromine, chlorine, and fluorine), methoxy, trifluoromethyl group or mixture on both Rc and Rd position (claims 1-3). For examples, Zhao cites that “R1 is a chlorine atom, R2 is a chlorine atom”, and “R1 is a fluorine atom, R2 is a bromine atom”. R1 is the same position as Rc, and R2 is the same position as Rd (claim 1 and 3). Thus, Zhao teaches that the substitution at the terminal olefin position is permitted and encompasses both halogens as bromine or iodine within the genus, as required in the instant claims 2, 11-13, and 16. Zhao further teaches the compounds for use in antibiotics (paragraph [0011]).
The MPEP states that compounds with structural similarity are expected to have similar properties. A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. “An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties.” In rePayne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). See In rePapesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963) (discussed in more detail below) and In reDillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990). See MPEP 2144.09(I).
The references is directed to the same field of endeavor and address related to the application. The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham.
Examples of rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Applying KSR example rationale (E), it would have been prima facie obvious to extract the structure and substitute different halogens or dichloro- on the J position in Formular I taught by Zhao. Zhao does not restrict substitution at that position and expressly contemplates halogen substitution, thereby providing a reason to pursue such modification with a reasonable expectation of success. Therefore, claims 1, 2, 6, 11-13, and 16 would be obvious to a person skilled in the art at the time.
Claim Objections
Claims 7-9 and 17 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. (see MPEP 707.07(j))
Conclusion
Claims 1-6, 11-13, 16 and 18 are rejected.
Claims 7-9 and 17 are objected to.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEONG JONG KIM whose telephone number is (571)272-6918. The examiner can normally be reached 7:00am-3:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton A. Brooks can be reached at 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEONG JONG KIM/Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621