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 .
Status of the Claims
Claims 1-20 are pending.
Claims 7-20 are withdrawn.
Priority
Applicant’s claim for benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. This application is a national stage entry of and claims priority to Application Serial No. PCT/IB2021/000916, filed 12/29/2021. Acknowledgment is made of applicant's claim for foreign priority, however, that applicant has not filed a certified copy of the PCT application as required by 37 CFR 1.55.
Information Disclosure Statement
All references from IDS(s) received on 06/28/2024 and 11/18/2025 have been considered unless marked with a strikethrough.
Elections/Restrictions
Applicant’s election of Group I with traverse in the reply filed on 8/12/2026 is acknowledged.
Applicant’s election of mannitol as diluent, sodium croscarmellose as disintegrant, sucralose as sweetener, and HPMC as binder with traverse in the reply filed on 8/12/2026 is acknowledged.
The grounds for traversal are the Applicant argues that the claims are linked by a common inventive concept and share a common special technical feature. Further, the Applicant argues that the art cited by the Examiner fails to teach a zwitterion of fexofenadine. The Examiner argues that the art does not explicitly teach the form of fexofenadine and with the other art that will be used in the rejection below, it would be obvious that the broad term fexofenadine may include a fexofenadine zwitterion. Therefore, unity is broken.
Claims 7-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as
being drawn to a nonelected products and methods of using, there being no allowable generic or linking claim.
No anticipatory art was found of the elected species, so the Examiner expanded the species pursuant to MPEP 803.02. The expanded species is described in the rejection. No anticipatory art was found however is rejected in an obviousness-type 103 rejection below.
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.
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.
Claims 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Beijing University of Chemical Technology (CN105997910A; cited in IDS filed 6/28/2024; “BCT”) in further view of Chrzan, K. et al. (US8933097B2 (2015); cited in IDS filed 6/28/2024; “Chrzan”).
This rejection applies to the expanded species of mannitol as diluent, starch as disintegrant, sucrose as sweetener, and HPMC as binder.
BCT teaches a method of preparing a spray-dried (Claim 6, step 3) product of fexofenadine hydrochloride including adding in a taste masking preparation including additives that may include mannitol (Claim 3), starch (Claim 3), hydroxypropylmethyl cellulose (HPMC) (Claim 2), and a sweetener such as sucrose (Claim 3), as required by instant claims 1-6, respectively. BCT teaches the composition may have a pH between 5-11 (Claim 8, Step 3), encompassing the limitation as required by instant claim 4.
BCT fails to teach an example where the fexofenadine is a dihydrate zwitterion.
Chrzan teaches a pharmaceutical suspension of fexofenadine zwitterionic dihydrate (Claim 1). Chrzan teaches the pharmaceutical suspension pH between 5.8-7, and includes a wetting agent, a suspending agent, such as hydroxyethylcellulose, a sweetener, such as sucrose, and a preservative (Claim 1), as required by the instant claims.
Chrzan fails to teach the suspension in spray-dried form. However, it would be obvious to extract the process of preparing the formulation of fexofenadine, as taught by BCT, and substitute the form of fexofenadine for its dihydrate zwitterion, as taught by Chrzan.
The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down inGraham.
Examples of 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.
Applying KSR example rationale (B), it would have been prima facie obvious to extract the process of preparing the formulation of fexofenadine, as taught by BCT, and substitute the form of fexofenadine for its dihydrate zwitterion, as taught by Chrzan. A person skilled in the art would be motivated to do so because both BCT and Chrzan teach similar formulations and additives and use the composition for similar purposes, such as its use as an antihistamine. Therefore, claims 1-6 would be obvious to a person skilled in the art at the time.
Conclusion
Claims 1-6 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLA MARIA BAUER whose telephone number is (703)756-1269. The examiner can normally be reached Monday-Friday 7:30-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clint Brooks can be reached at (571) 270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/N.M.B./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
