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 .
This is the first Office action on the merits of the claims.
All citations to the Manual of Patent Examining Procedure (MPEP) refer to Revision 01.2024, which was released in November 2024.
Status of the Claims
Claims 1-20, as originally filed 07 June 2023, are pending.
Claim Objections
Claims 15-16 are objected to because of the following minor informality: The capital letters in “Cystic Fibrosis” need to be lowercase. Generally, capital letters are reserved for the beginning of a claim, for abbreviations, and for proper nouns. Appropriate correction is required.
Claim Rejections - 35 U.S.C. 112(a)
The following is a quotation of 35 U.S.C. 112(a):
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.
Claims 7-20 are rejected under 35 U.S.C. 112(a) for lack of enablement.
The test of enablement is whether one skilled in the art could make and use the claimed invention from the disclosures in the specification coupled with information known in the art without undue experimentation (United States v. Telectronics, 8 USPQ2d 1217 (Fed. Cir. 1988)). MPEP § 2164.01. Whether undue experimentation is needed is not based upon a single factor but rather is a conclusion reached by weighing many factors. MPEP § 2164.01(a). These factors were outlined in In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988) and include the following: (1) the breadth of the claims; (2) the nature of the invention; (3) the state of the prior art; (4) the level of one of ordinary skill; (5) the level of predictability in the art; (6) the amount of direction provided by the inventor; (7) the existence of any working examples; and (8) the quantity of experimentation necessary needed to practice the claimed invention based on the content of the disclosure. MPEP § 2164.01(a).
There is no requirement in any of claims 7-20 that effective amounts of the adjuvant and the antibiotic, respectively, are administered to the subject. Applicant’s specification does not reasonably provide enablement for treating a gram-negative bacterial biofilm (or any other condition encompassed by the preamble of claim 7) by administering negligible or otherwise ineffective amounts of the adjuvant/antibiotic combination. In sum, a person having ordinary skill in the art could not practice the full scope of Applicant’s invention, as recited in claims 7-20, without first engaging in undue experimentation.
Claim Rejections - 35 U.S.C. 112(b)
The following is a quotation of 35 U.S.C. 112(b):
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter that the inventors regard as the invention.
Regarding claim 1, the chemical structure set forth in this claim defines various discrete compounds. In other words, the defined structure is not merely part of a molecule; instead, it represents the entire molecule. Thus, the structure is closed to additional (unrecited) elements or features. This conflicts with the transitional phrase <comprising>, which “is inclusive or open-ended and does not exclude additional, unrecited elements.” MPEP § 2111.03(I). Consequently, claim 1 and all claims depending thereon are indefinite.
Regarding claim 6, the following limitation is unclear: “wherein the antibiotic comprises colistin, polymyxin B, or a mixture thereof.” Emphasis added. It is important to recognize that “[a]lthough the term ‘Markush claim’ is used throughout the MPEP, any claim that recites alternatively usable members, regardless of format, should be treated as a Markush claim.” MPEP § 2117(I). Claim 6 improperly recites the transitional phrase <comprises> in connection with the Markush group. This renders claim 6 indefinite. MPEP § 2173.05(h)(I) (“If a Markush grouping requires a material selected from an open list of alternatives (e.g., selected from the group ‘comprising’ or ‘consisting essentially of’ the recited alternatives), the claim should generally be rejected under 35 U.S.C. 112(b) as indefinite because it is unclear what other alternatives are intended to be encompassed by the claim.”).
Regarding claim 7, the effect of the preamble, if any, cannot be ascertained to a reasonable degree of certainty for the following reason: None of the active (manipulative) steps recited in the body of claim 7 relates to the “subject” recited in the preamble. Applicant is alerted that the body of claim 7 is suggestive of a laboratory procedure, as opposed to a medical procedure, because it does not expressly require administration of the composition to the subject.
In further regard to claim 7, the patient population is unclear. Is it any subject, regardless of medical status? If not, how does a person having ordinary skill in the art distinguish (i) subjects who are in need of inhibition of “gram negative bacteria biofilm production, virulence factor production, pyocyanin production, or quorum sensing” from (ii) subjects who are not? For example, does the subject even have to have an infection? MPEP § 2173.04 (“a genus claim that could be interpreted in such a way that it is not clear which species are covered would be indefinite (e.g., because there is more than one reasonable interpretation of what species are included in the claim)”).
In further regard to claim 7, there is no antecedent basis for the following limitation: “a compound of claim 5.” The examiner notes that claim 5 is directed is directed to a composition. Applicant is referred to MPEP § 2173.05(e) (lack of antecedent basis).
Regarding claim 10, what is “AmA”? This abbreviation is not defined in the claim and, therefore, is unclear. Secondly, it is unclear how the functional limitation recited in this claim further limits the composition. How must the composition of claim 5 be further defined to inhibit AmA in a cationic antibiotic peptide resistance pathway? A person having ordinary skill in the art, even after reviewing the specification of the present application, would not be able to answer that question with reasonable certainty. MPEP § 2173.05(g) (“the use of functional language in a claim may fail ‘to provide a clear-cut indication of the scope of the subject matter embraced by the claim’ and thus be indefinite”).
Regarding claim 11, how can a subject be both a human and an animal?
Regarding claim 12, the genus of the Markush group is directed to “an infection.” However, the following recited members of that Markush group are not classes, types, or species of infection: “dental plaque,” “burn,” “wound,” “is immunocompromised,” and “is immunosuppressed.” This conflict renders the claim indefinite.
Regarding claims 17-20, there is no antecedent basis for the following phrase: “is administered.” The examiner notes that claim 7 does not recite a step of administering. Applicant is referred to MPEP § 2173.05(e) (lack of antecedent basis).
Claim Rejections - 35 U.S.C. 102(a)
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102(a) that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless
(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; or
(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3 and 5-20 are rejected under 35 U.S.C. 102(a)(1) and/or 35 U.S.C. 102(a)(2) as being anticipated by Bassler (US 9,751,851 B2).
Bassler is directed to “molecules and compositions that inhibit gram negative bacteria and their uses.” Title.
In Table 2 (column 34), Bassler discloses the following chemical structure, which is referred to therein as Compound 10:
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Compound 10 anticipates claims 1 and 2 of the present application.
In column 80 (lines 20-25), Bassler discloses the following chemical structure, which is referred to therein as Compound S63:
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Compound S63 anticipates claims 1-3 of the present application.
Regarding claims 5 and 6, Bassler discloses: “The compound or compound compositions of the invention may be administered alone or in combination with other compounds, such as adjuvants. In one embodiment the compounds may be administered in combination with one or more antibiotics, for example, gentamicin, tobramycin, colistin, and fluoroquinolins. Combinations may be administered either concomitantly, e.g., as an admixture, separately but simultaneously or concurrently; or sequentially. This includes presentations in which the combined agents are administered together as a therapeutic mixture, and also procedures in which the combined agents are administered separately but simultaneously, e.g., as through separate intravenous lines into the same individual.” (Emphasis added) Column 12, lines 28-40.
Regarding claim 7, Applicant is referred to claim 4 of Bassler. See also Bassler at column 3, lines 58-61 (“It is contemplated that the use of the compounds or the composition of the invention inhibits quorum sensing and production of a biofilm or virulence factor, preferably pyocyanin.”).
Regarding claims 8 and 9, Applicant is referred to claims 5 and 6 of Bassler.
Regarding claim 10, Applicant is referred to claim 7 of Bassler. In the alternative, Applicant is referred to MPEP § 2112.01(II), which states in relevant part: “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.”
Regarding claim 11, Applicant is referred to claim 8 of Bassler.
Regarding claim 12, Applicant is referred to claim 9 of Bassler.
Regarding claim 13, Applicant is referred to claim 10 of Bassler.
Regarding claims 14-16, Applicant is referred to claims 11-13 of Bassler.
Regarding claim 17, Applicant is referred to claims 14-16 of Bassler.
Regarding claims 18-20, Applicant is referred to claims 19-21 of Bassler.
Claims 1-17 are rejected under 35 U.S.C. 102(a)(1) and/or 35 U.S.C. 102(a)(2) as being anticipated by Miller Conrad (WO 2022/036208 A1).
Miller Conrad is directed to “antibacterial adjuvants and applications thereof.” Title.
On page 12, Miller Conrad discloses the following chemical structure, which is referred to therein as Compound S4:
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Compound S4 anticipates claims 1-3 of the present application.
On page 17, Miller Conrad discloses the following chemical structure, which is referred to therein as Compound S28:
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Compound S28 anticipates claim 1 of the present application, when R is Formula (III).
On page 14 (line 9), Miller Conrad discloses the following compound: 6-Bromo-N-(2-(trifluoromethyl)pyridin-4-yl)-hexanamide, which is referred therein as Compound S12. The examiner notes that the correct chemical structure of Compound S12 is:
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Compound S12 anticipates claims 1-4 of the present application.
Regarding claims 5 and 6, Miller Conrad discloses: “The CAP [(cationic antimicrobial peptides)] and compound of formula I can be administered as a single composition or as separate compositions.” Page 6; see also page 25 claim 13. Miller Conrad identifies colistin as a preferred CAP. Page 25 at claim 8; page 27 at claim 28.
Regarding claims 7-11, Applicant is referred to claims 20-27 of Miller Conrad (pages 26-27).
Regarding claims 12-17, Applicant is referred to page 1 (lines 19-32) and page 2 (lines 1-8) of Miller Conrad.
Claim Rejections - Double Patenting (Non-Statutory)
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminalDisclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/ eTD-info-I.jsp.
Claims 1-20 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-19 of co-pending Application No. 18/021,284 (as preliminarily amended on 14 February 2023).
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following: Formula (I) of conflicting claims 1 and 7 of the ’284 Application overlaps the compounds defined by claim 1 of the present application. Conflicting claim 7 is further directed to a treatment for a gram-negative bacterial infection, and the treatment specified therein includes both the compound of Formula (I) and a cationic antimicrobial protein (CAP), the latter of which qualifies as an antibiotic. See also conflicting claim 8 (“wherein the CAP is colistin”). Additionally, conflicting claim 13 requires that the compound of Formula (I) and the CAP are in the same composition. Finally, conflicting claim 12 identifies the gram-negative bacteria as P. aeruginosa. These observations establish that the conflicting claims collectively overlap the claims of the present application. Therefore, the present claims are not patentably distinguishable over conflicting claims 1-19 of the ’284 Application.
This is a provisional rejection because the conflicting claims have not been patented.
Conclusion
Claims 1-20 are rejected.
Claims 15-16 are also objected to.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER ANTHOPOLOS whose telephone number is 571-270-5989. The examiner can normally be reached on Monday – Friday (9:00 am – 5:00 pm). If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany P. Barham, can be reached on Monday – Friday (9:00 am – 5:00 pm) at 571-272-6175. The fax number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.A./
20 March 2026
/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611