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 .
Election/Restrictions
Applicant elected, without traverse, Group I (Claims 1-11), drawn to a compound, for examination. In addition, Applicant elected the following species for examination: Formula (XII); claims 1-10 read on the elected species. Claims 1-11 are hereby examined on the merits. Claims 12-37 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 13th April 2026.
Priority
This application filed 10/27/2023 is a National Stage entry of PCT/US22/26504 , International Filing Date: 04/27/2022, Claims Priority from Provisional Application 63270777, filed 10/22/2021, Claims Priority from Provisional Application 63180348 , filed 04/27/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/10/2025 is in compliance with the
provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the
examiner.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon (natural product) without significantly more. The claim(s) recite(s) the judicial exception of a compound represented by Formula (I). This judicial exception is not integrated into a practical application because there is no difference in substance from the claimed composition of Formula (I) and Colistin. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. See the following analysis.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Yes, the claim is directed to a composition.
Step 2A: Is the claim directed to a law of nature, a natural phenomenon (product of nature) or
abstract idea?
Prong One: Does the claim recite an abstract idea, law of nature or natural phenomenon? Yes,
the claim recites a composition. Under the broadest reasonable interpretation, the claimed
compound of Formula (I), is Colistin, a naturally occurring antibiotic isolated from strains of Paenibacillus polymyxa (Velkov et al).
Prong Two: Does the claim recite additional elements that integrate the judicial exception into a
practical application? No, the additional elements in the claim do not integrate the judicial exceptions
into a practical application. The claim is directed only to the composition and to the function
incorporated by the composition.
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 rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tony Velkov et al., hereinafter Velkov (Tony Velkov et al., J. Med. Chem. 2010, 53, 1898–1916).
Regarding claim 1, Velcov teaches the chemical structure of Colistin, (i.e. Formula (I) which meets the limitations of claim 1.
PNG
media_image1.png
316
612
media_image1.png
Greyscale
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.
Claim(s) 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Pamela Brown et al., hereinafter Brown (Pamela Brown et al., Development of new polymyxin derivatives for multi-drug resistant Gram-negative infections, The Journal of Antibiotics (2017) 70, 386–394) as evidenced by JUN’ICHI SHOJI et al., hereinafter Shoji (JUN’ICHI SHOJI et al., The Journal of Antibiotics, 1977, 30 (12), 10351041).
The teachings of Velkov have been set forth above.
Applicant elected species of Formula (XII) i.e. biphenyl macrolacin (see below)
PNG
media_image2.png
277
504
media_image2.png
Greyscale
Regarding claim 1, Brown teaches that members of the polymyxin family are isolated from strains of Paenibacillus polymyxa, and the Polymyxins contain a heptapeptide core (see page 386, ‘Natural Polymyxins and related natural products’, lines 1-4). Embodiments of the specification disclose Macrolacin to comprise Ser at position 3, Leu at position 6, Ile at position 7 and Leu at position 10 (see Fig 2D). Brown teaches Polymyxin E, characterized by D-Leu at position 6 (page 387, 1st paragraph); at position 7, in place of L-leucine, the isoleucine-7 variant, and D-Ser at position 3. Brown teaches that in thevariant of Polymyxin T, Thr-10 is replaced by Leucine (see Table 1, page 387). Notably, Brown teaches that biphenylacyl N-terminus (Figure 8; FADDI-003) show increased activity compared with Colistin against Polymyxin-resistant strains of Pseudomonas and FADDI-003 shows lower clearance, and volume of distribution, and longer half-lives compared with Colistin (see Monash lipopeptides, 1st paragraph, page 392).
Obviousness can be established by combining or modifying the teachings of the prior art to
produce the claimed invention where there is some teaching, suggestion, or motivation to do so. In re
Kahn, 441 F.3d 977, 986, 78 USPQ2d 1329, 1335 (Fed. Cir. 2006) (discussing rationale underlying the
motivation-suggestion-teaching test as a guard against using hindsight in an obviousness analysis).
Consequently, it would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to modify the clinically used Polymyxin E (Colistin) to generate variants, drawing from structurally related polymyxins (see structurally related polymyxins in Table 1, page 387)to generate the compound that is instantly claimed. One motivated to do so, would have a reasonable expectation of success, as Brown specifically teaches substitutions at positions 3, 6, 7 and 10 in the core heptapeptide and biphenylacyl N-terminus (Figure 8; FADDI-003) for increased anti-microbial activity (see Monash lipopeptides, 1st paragraph, page 392).
. Thus, one would have recognized, that applying the teaching of Brown would have yielded predictable results and improved the anti-microbial function of the composition. See MPEP §2143.
Regarding claims 2-10, the obviousness rationale has been noted above.
Regarding claim 11, embodiments of the specification disclose pharmaceutical composition as comprising at least one compound of the invention (see page 16, last line). Accordingly, the rejection under claims 1-10, apply to the instant claim.
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARCHANA VARADARAJ whose telephone number is (571)272-2366. The examiner can normally be reached Monday-Friday 10:00am-5:00pm.
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, Melissa Fisher can be reached at 5712707430. 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.
/ARCHANA VARADARAJ/Examiner, Art Unit 1658
/Melissa L Fisher/Supervisory Patent Examiner, Art Unit 1658
Prosecution Insights