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 .
Response to Remarks and Amendments
Applicant’s remarks and amendments filed December 12, 2025 have been entered. All rejections and objections not explicitly maintained herein are withdrawn. The rejections below constitute the full set of rejections being applied to the instant claims.
With respect to the rejection of claim 11 under 35 USC 112(b), the rejection is withdrawn in view of Applicant’s amendment to correct the dependency of the claim.
With respect to the rejection of claims 7-9 under 35 USC 112(b), the rejection is withdrawn in view of Applicant’s amendment to delete the recitations of “preferably” and “more preferably.”
With respect to the rejection of claims 1, 3-9, 11-15, 17-18 and 20-21 under 35 USC 102(a)(1), the rejection is withdrawn in view of Applicant’s amendment to import a requirement for a dosage of the administered rifabutin. Applicant notes that Chromy et al. does not teach such a dosage. Accordingly, the rejection is withdrawn.
With respect to the rejection of claims 1, 3-9, 11-15, 17-18 and 20-24 for double patenting over the claims of US Patent 11,701,346, Applicants have requested that the rejection be held in abeyance. Since the conflicting claims still overlap with the claimed dosage, the rejection still applies over the claimed invention as amended and the rejection is maintained herein.
Status of Claims
Currently, claims 1, 3-9, 11-15, 17-18 and 20-24 are pending in the instant application and under consideration herein.
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.
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.
Claim(s) 1, 3-9, 11-15, 17-18 and 20-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chromy et al., Future Microbiology, Vol. 7, No. 8, (2012) in view of WO 2014/152332 (“the ‘332 publication”).
Determining the scope and contents of the prior art
Chromy et al. teach the use of rifabutin to treat Acinetobacter baumannii isolated from US soldiers and marines, which reads on the requirement for treating humans. The reference teaches the use of the method for treating wound infections (which reads on the claimed skin or surgical site infection). According to the prior art, the three tested rifamycin compounds, which necessarily includes rifabutin, were found to be effective at preventing growth and preventing cellular respiration of MDRAb and select agent surrogate bacteria when evaluated in growth prevention assays, highlighting the potential for repurposing.
Ascertaining the differences between the prior art and the claims at issue
The difference between the instant invention and the prior art is that the prior art does not teach a particular dosage for the rifabutin administration.
Resolving the level of ordinary skill in the pertinent art
To this end, it is noted that MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.’" KSR, 550 U.S. at ___, 82 USPQ2d at 1396. Exemplary 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."
The ‘332 publication relates to the treatment of infections comprising administering antibiotics. In particular, the reference describes treatment of a bacterial infection comprising administering a therapeutically effective amount which is from 0.01 mg/kg to about 7 mg/kg (or 10 mg/day to 600 mg/day) (paragraphs [0020] - [0021]). In particular, the reference describes a more specific range of 0.1mg/kg to 5 mg/kg (paragraph [0067]). Most specifically, 0.1 mg/kg is disclosed as required by the instant claims (paragraph [0064]). Rifabutin is specifically disclosed as the antibiotic to be administered (paragraph [0074]). Accordingly, it would not have been considered inventive for the skilled artisan to follow the explicit suggestion of the prior art to treat bacterial infections with dosages of 0.1 mg/kg to 5 mg/kg of rifabutin. Doing so would have been obvious because a person of ordinary skill in the art would recognize that the active ingredient was known for the claimed therapeutic use of treating infection, and the particular dosage recited in the instant claims was also described in the art.
Further, MPEP 2144.05(I) provides that "[A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). See also In re Harris, 409 F.3d 1339, 74 USPQ2d 1951 (Fed. Cir. 2005) (claimed alloy held obvious over prior art alloy that taught ranges of weight percentages overlapping, and in most instances completely encompassing, claimed ranges; furthermore, narrower ranges taught by reference overlapped all but one range in claimed invention). Thus, the prior art ranges render the dosages of the instant claims obvious.
Accordingly, based on the teachings of the MPEP and KSR above, by employing the rationale in (B), (D), (E) or (G) above, it would have been obvious for one of ordinary skill in the art to use rifabutin for its known purpose at its art-described dosage in view of the combined teachings of Chromy and the ‘332 publication. There would have been a reasonable expectation of success in the claimed treatment since the same Compound was already known in the art for the treatment of bacterial infection, including Acinetobacter infection specifically, and the art also disclosed the particular dosage range to be used. The instantly claimed invention would have therefore been obvious to a person of ordinary skill before the filing of the instantly claimed invention.
Double Patenting
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 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); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(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 §§ 706.02(l)(1) - 706.02(l)(3) 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 eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 3-9, 11-15, 17-18 and 20-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-18 of U.S. Patent 11,701,346 (“the ‘346 patent”).
The ‘346 patent claims recite a method for treating a mammalian subject infected with Acinetobacter, specifically Acinetobacter baumannii (reference claim 2), comprising administering rifabutin “co-administered with colistin but not with another therapeutically active agent.” Although it is noted that the instantly claimed invention recites the administration of rifabutin as the sole therapeutically active agent for Acinetobacter treatment, or that the rifabutin is not co-administered with any other therapeutic for treating the same infection, the overlap in scope is based on the interpretation of the term “co-administered” in the instant claims and reference claims. The term “co-administered” is not defined in the instant claims or specification based on a particularly limited amount of lag time such that substances would not be considered “co-administered” if administered with a particular amount of time between administrations. Dependent claims in the reference patent recite a time lag of “at least about 4 h” between administration of rifabutin and colistin. This amount of lag time reads on each substance being separately administered, 4 hours apart, such that the separate administration of rifabutin on this dosing schedule reads on the instant claims. This interpretation is further confirmed by the dependent claims in the instant application, which recite for example “at least about 4 h” between administration of rifabutin and any additional therapeutic for the treatment of the same infection. Since this is exactly the amount of time recited in the reference claims, and the reference claims further teach the required dosage of 60 to 600mg rifabutin as well as the treatment of a human patient, the claims are anticipated.
Since the patented and copending claims anticipate the examined claims, a double patenting rejection is appropriate.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alicia L. Otton whose telephone number is (571)270-7683. The examiner can normally be reached on Monday - Thursday, 8:00-6:00.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mr. Fereydoun Sajjadi can be reached on 571-272-0699. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ALICIA L OTTON/Primary Examiner, Art Unit 1699
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