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’s election without traverse of Group III (claims 15-22, 25-27 and 38-39) and species i (a volatile liquid) in the reply filed on 6/22/2026 is acknowledged.
Group I, II and IV (claims 1, 4-7, 12-13, 28, 31 and 33-35) and species ii (compressed gas, claims 17-18) are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 6/22/2026.
Response to Amendment
The amendment filed on 6/22/2026 has been entered. Claim(s) 17-18, 21, 26-28 and 38-39 is/are currently amended. Claim(s) 2-3, 8-11, 14, 23-24, 29-30, 32 and 36-37 has/have been cancelled. Claim(s) 1, 4-7, 12-13, 15-22, 25-28, 31, 33-35 and 38-39 is/are pending with claim(s) 1, 4-7, 12-13, 17-18, 28, 31 and 33-35 withdrawn from consideration. Claim(s) 15-16, 19-22, 25-27 and 38-39 is/are under examination in this office action.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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) 15-16, 19-22, 25-27 and 38-39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Purandare et al (US 20160002278 A1).
Regarding claims 15-16, 19-22, 25-27 and 38-39, Purandare teaches a pharmaceutical composition in the form of a foam for rectal administration comprising fidaxomicin and optionally one or more pharmaceutically acceptable excipients [0031].
Suitable excipients include a vehicle, foaming agents, propellants, thickening agents, and emulsifiers [0055, 0100].
The vehicle includes aqueous vehicle, ethanol, ethanol, propylene glycol, glycerol, polyethyleneglycol, polypropylene glycol [0056], which read on the claimed liquid component.
The foaming agents read on the claimed foaming agent.
The propellants include HFA 134a [0068], which is 1,1,1,2-tetrafluoroethane and reads on the claimed volatile liquid bubble-forming component as specified in claims 16 and 19-22 (H134A).
The thickening agents include xanthan gum and guar gum [0065], which read on the claimed bio- adhesive as specified in claim 39.
Fidaxomicin is art recognized as an antibiotic agent, which reads on the claimed therapeutic agent as specified in claims 25-26.
The emulsifiers include cetyl alcohol [0103], which reads on the recited cetyl alcohol in claim 38.
It would have been obvious to one of ordinary skill in the art at the time of filing to select the above compounds as the excipients in Prrandare’s composition, as they are expressly disclosed as being useful in this capacity. It has been established that selection of a known material based on its suitability for its intended use is prima facie obvious (Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945)). See MPEP 2144.07.
The recited “the composition forms a foam after administering to a targeted area in the patient's body” in claim 27 is a property of the product. “Products of identical chemical composition cannot have mutually exclusive properties." 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. “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990)). See MPEP 2112.01. Since the prior art teaches the same product as the current invention, the recited property is expected to be present. Nonetheless, Purandare teaches that the pharmaceutical composition forms a foam in rectal area [0031].
The recited “for treating a gastrointestinal infection” represents a statement of intended use that imparts no additional structure beyond the claimed product and need not be taught by the prior art to read on the claimed invention. See MPEP 2111.02(III). Nonetheless, Purandare teaches that the pharmaceutical composition is for treating rectal infections [abstract], which is a gastrointestinal infection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIANGTIAN XU whose telephone number is (571)270-1621. The examiner can normally be reached Monday-Thursday.
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, Robert Jones can be reached on (571) 270-7733. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JIANGTIAN XU/Primary Examiner, Art Unit 1762
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