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 .
DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of Group I and the compound of Formula III(a) (specification at page 13) in the reply filed on 6/8/2026 is acknowledged.
Claims 19, 21, 23-25, 29 and 41-42 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/8/2026.
Status of the Claims
Claims 1-3, 10-12, 19, 21, 23-25, 29-33, 35-36 and 41-42 are pending in this application.
Claims 19, 21, 23-25, 29 and 41-42 are withdrawn from consideration as being drawn to a non-elected invention.
Claims 1-3, 10-12, 30-33 and 35-36 are presently under consideration as being drawn to the elected species/invention.
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.
Claims 1-3, 10-12, 30-33 and 35-36 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claim(s) 1-3, 10-12, 30-33 and 35-36 are directed to a naturally occurring product. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
The rationale for this determination is explained below:
The claims are drawn to a compound of Formula I, and compositions comprising the same.
As evidenced by Imai et al. (Nature Chemical Biology volume 18, pages1236-1244 (2022)) the elected species corresponds to evybactin (see Fig. 1 of Imai et al., and the structure of the elected species on page 13 of the instant specification), which is a naturally occurring DNA gyrase inhibitor.
The Office has prepared interim guidance (2014 Interim Guidance on Patent Subject Matter Eligibility) (Federal Register/Vol. 79, No. 241, Dec. 16, 2014) for use by USPTO personnel under 35 U.S.C. 101 in view of recent U.S. Supreme Court decisions. The 2014 Interim Eligibility Guidance supersedes the March 4, 2014 Process for Subject Matter Eligibility Analysis of Claims Reciting or Involving Laws of Nature/Natural Principles, Natural Phenomena, and/or Natural Products.
The current Interim Guidance provides subject eligibility test or products and processes (See Flow Chart, p. 74621):
Step 1: The instant claims are directed to a statutory patent-eligible subject matter category, a naturally occurring product.
Step 2A: The claims involve a judicial exception, a product of nature.
Specifically, the claims are drawn to the naturally occurring DNA gyrase inhibitor evybactin.
Step 2B: The claims do not recite additional elements that amount to significantly more that the judicial exception.
Markedly different characteristics can be expressed as the product's structure, function, and/or other properties and is evaluated based on what is recited in the claim. In accordance with this analysis, a product that is purified or isolated will be eligible when there is a resultant change in characteristics sufficient to show a marked difference from the products naturally occurring counterpart.
The Applicants have not shown a marked difference from the products naturally occurring counterpart.
Although one of ordinary skill in the art would construe the limitations “a composition comprising the compound and at least one excipient, carrier or diluent”, “in form suitable for topical administration, systemic administration, etc.” and “wherein the carrier, excipient or diluent is an agriculturally acceptable…” to mean a composition suitable for pharmaceutical or agricultural use and possibly for human administration, this does not render the claim markedly different from what exists in nature. Myriad clarified that not every change to a product will result in a marked difference, and that the mere recitation of particular words (e.g., “isolated”) in the claims does not automatically confer eligibility. Id. at 2119. See also Mayo, 132 S. Ct. at 1294 (eligibility does not “depend simply on the draftsman’s art”). The instant claims do not show any additional ingredients for the composition that imparts markedly different characteristic from any naturally occurring counterparts.
Claims 1-3 and 10-12 do not require any additional agents/ingredients besides evybactin, which is a naturally occurring DNA gyrase inhibitor.
With respect to claims 30-33, “pharmaceutically or agriculturally acceptable carriers, excipients or diluents” include water, which is naturally occurring.
With respect to claims 35-36, the MPEP 2113 states that product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. In the instant case, as discussed above, evybactin (i.e. the elected species) is naturally occurring.
Therefore, the claims are drawn to a judicial exception and are considered patent ineligible.
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 1-3, 10-12 and 35-36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ferreira et al. (Int J Syst Evol Microbiol. 2013 May;63(Pt 5):1853-1858), as evidenced by Imai et al. (Nature Chemical Biology volume 18, pages 1236-1244 (2022)).
With respect to claims 1-3 and 10-12 Ferreira et al. teach that P. noenieputensis is a subspecies of the genus Photorhabdus (Title; abstract, passim).
As evidenced by Imai et al., evybactin (depicted below), which corresponds to the elected species, is produced by P. noenieputensis (Fig. 1).
With respect to claims 35-36, the MPEP 2113 states that product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. In the instant case, as discussed above, Imai et al. teach evybactin. Thus, the claims are anticipated.
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.
Claim(s) 1-3, 10-12, 30-31, 33 and 35-36 are rejected under 35 U.S.C. 103 as being unpatentable over Ferreira et al. (Int J Syst Evol Microbiol. 2013 May;63(Pt 5):1853-1858) in view of Muangpat et al. (PLoS ONE 15(6): e0234129, 2020).
The teachings of Ferreira et al. with respect to claims 1-3, 10-12 and 35-36 have been discussed above.
Ferreira et al. do not teach a composition comprising evybactin and a pharmaceutically acceptable carrier, excipient or diluent.
Muangpat et al. teach that “[B]iological compounds from natural or bacterial resources are one such alternative approach. Xenorhabdus and Photorhabdus, the symbiotic bacteria associated with entomopathogenic nematodes (EPNs), have been reported to be bacterial resources for the production of antimicrobial compounds. Their cell suspension and metabolite compound activities effectively inhibit the growth of Staphylococcus pyogenes and S. aureus, Bacillus subtilis, Botrytis cinerea, Escherichia coli, Klebsiella pneumoniae, Enterobacter coloacae, Fusicladium effusum, Bacillus anthracis, Phytophthora capsici, and Rhizoctonia solani” (page 2, 1st para).
It would have been obvious to one of ordinary skill in the art to make a composition comprising evybactin and a pharmaceutically acceptable carrier, excipient or diluent in order to administer said composition to subjects suffering from infection caused by, for e.g., S. aureus, E. Coli, etc.
The skilled artisan would have been motivated, with a reasonable expectation of success, because Muangpat et al. teach that cell suspension and metabolite compounds from Photorhabdus (e.g. avybactin) are antimicrobial against S. aureus, E. Coli, etc.
With respect to claim 33, the skilled artisan would have been motivated to discover the optimal route of administration by normal optimization procedures known in the pharmaceutical art.
Claim(s) 1-3, 10-12, 30-33 and 35-36 are rejected under 35 U.S.C. 103 as being unpatentable over Ferreira et al. (Int J Syst Evol Microbiol. 2013 May;63(Pt 5):1853-1858) in view of da Silva et al. (Parasit Vectors. 2020 Jul 29;13(1):376).
The teachings of Ferreira et al. with respect to claims 1-3, 10-12 and 35-36 have been discussed above.
Ferreira et al. do not teach a composition comprising evybactin and a pharmaceutically acceptable carrier, excipient or diluent.
da Silva et al. teach that “[T]he study of bacterial species of the genera Xenorhabdus and Photorhabdus has been the target of several research groups, aiming at their use in agricultural, pharmaceutical and industrial products. The interest in studying these bacteria is justified by some evidence available in the literature, such as: (i) having genes that are capable of encoding low molecular weight secondary toxins and metabolites with insecticide activities, antibiotic, antifungals, and antiparasitic; (ii) laboratory research points to the success of these bacteria in pest control; (iii) Photorhabdus luminescens releases toxins with activities in the insect intestinal epithelium” (page 3, left column, 4th para).
It would have been obvious to one of ordinary skill in the art to make a pharmaceutical composition comprising evybactin and a pharmaceutically acceptable carrier, excipient or diluent in order to administer said composition to subjects in the form of an antibiotic, antifungal antiparasitic, etc.
The skilled artisan would have been motivated, with a reasonable expectation of success, because da Silva et al. teach that toxins and metabolites from Photorhabdus (e.g. avybactin) have antibiotic, antifungals, and antiparasitic activities.
Furthermore, it would have been obvious to one of ordinary skill in the art to make an agricultural composition comprising evybactin and an agriculturally acceptable carrier, excipient or diluent because da Silva et al. teach that bacterial species of the genus Photorhabdus (e.g. avybactin) have been the target of several research groups, aiming at their use in agricultural products.
The skilled artisan would have been motivated, with a reasonable expectation of success, because da Silva et al. teach that laboratory research points to the success of these bacteria in pest control.
With respect to claim 33, the skilled artisan would have been motivated to discover the optimal route of administration by normal optimization procedures known in the pharmaceutical art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SERGIO COFFA whose telephone number is (571)270-3022. The examiner can normally be reached M-F: 6AM-4PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MELISSA FISHER can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SERGIO COFFA Ph.D./
Primary Examiner
Art Unit 1658
/SERGIO COFFA/Primary Examiner, Art Unit 1658
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