DETAILED ACTION
Claims 1-23 are pending. Of these, claims 13-23 are withdrawn as directed to a nonelected invention. Therefore, claims 1-12 are under consideration on the merits.
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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9/7/23 was filed prior to the mailing date of a first Action on the merits. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, it was considered by the Examiner.
Restriction
Applicant’s election of Group I, claims 1-12, is acknowledged. Applicant did not point to any alleged deficiencies in the restriction requirement. Therefore, the election has been treated as having been made without traverse. The restriction requirement is still considered proper and is made FINAL.
Applicant’s election of hydroxypropyl methyl cellulose acetate succinate as the species of stabilizing agent is acknowledged. Applicant did not point to any alleged deficiencies in the election of species requirement. Therefore, the election has been treated as having been made without traverse. The election of species requirement is still considered proper and is made FINAL.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 5-6 and 8-11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 5 recites “API” and “stabilizing excipients,” but these ingredients are already recited by claim 1, and it is unclear whether the same or different API and stabilizing excipients are being referred to. Clarification is required. It is suggested that “API” and “stabilizing excipients” be preceded by “the” to make it clear that the same “API” and “stabilizing excipients” are being referred to. Since dependent claims 6 and 8-11 do not clarify the point of confusion, they are also rejected.
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.
Claims 1-5 and 7-11 are rejected under 35 U.S.C. 103 as unpatentable over Schenck et al. (US Pat. Pub. 2020/0261365; of record in IDS) in view of Palzer (Chemical Engineering Science 60 (2005) 3959-3968).
As to claims 1-5 and 7-11, Schenck discloses a process for preparing a pharmaceutical composition comprising particles comprising an active (API) and a stabilizing excipient, the process comprising introducing a solvent stream containing the API dissolved in a solvent along with a stabilizing excipient into anti-solvent to form a co-precipitated material, wherein the stabilizing excipient may be hydroxypropyl methyl cellulose acetate succinate, which is the elected species of stabilizing excipient of claims 1, 5, and 8-10 (paragraphs 25, 33). Schenck further teaches drying the co-precipitated material as recited by claim 1 by evaporating the solvent using thin film evaporation as recited by claim 2 (paragraphs 21 and 35-41).
As to claim 7, the thin film evaporation removes the solvent as recited by claim 7, and the process also is carried out at increased temperature as recited by claim 7 (see the working examples which use a temperature of 60 degrees Celsius).
Regarding claims 3-4, the particles of the co-precipitated material may be an amorphous or crystalline dispersion (paragraph 24).
As to claim 11, Schenck discloses compressing the particles into tablets (paragraph 42).
As to claims 1-5 and 7-11, Schenck does not further expressly disclose that the drying/annealing step for the co-precipitated material occurs above its wetted glass transition temperature as recited by claims 1-2, or that the co-precipitated amorphous dispersion undergoes a greater level of densification relative to a process that does not anneal above the wetted glass transition temperature as recited by claim 4.
Palzer is directed to a discussion on the effect of glass transition on the agglomeration of wetted amorphous powders (Abstract). Palzer discloses that as the temperature during processing rises beyond its glass transition temperature, the caking/stickiness of the powder decreases (Section 3.2 and Figure 3).
As to claims 1-5 and 7-11, it would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to modify the Schenck process by annealing the co-precipitated particles above their wetted glass transition temperature, because Palzer teaches that doing so will reduce caking, which the skilled artisan would recognize would be advantageous in improving their flowability properties when they are being processed such as by compressing them into tablets.
The resulting process will result in the co-precipitated amorphous dispersion undergoing densification and at a higher level relative to a process that does not anneal above the wetted glass transition temperature as recited by claim 4 because it is made by a process comprising the same steps recited by the claims. The U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the countless ways that an Applicant may present previously unmeasured characteristics. When, as here, the prior art appears to contain the same ingredients that are disclosed by Applicants' own specification as suitable for use in the invention, a prima facie case of obviousness has been established, and the burden is properly shifted to Applicants to demonstrate otherwise. See MPEP 2112.01.
Claim 6 is rejected under 35 U.S.C. 103 as unpatentable over Schenck et al. (US Pat. Pub. 2020/0261365; of record in IDS) in view of Palzer (Chemical Engineering Science 60 (2005) 3959-3968) as applied to claims 1-5 and 7-11 above, and further in view of McClain (WO2012/092504).
The teachings of Schenck and Palzer are relied upon as discussed above, and Schenck further teaches that the solvent and anti-solvent are mixed using a rotor stator device (paragraph 33), but Schenck does not further expressly specify that the rotor stator device is in-line as recited by claim 6.
McClain discloses that high shear mixers disperse one phase such as a liquid into another phase such as another liquid with which it normally would be immiscible, and that such mixers can be used to create granular products (paragraph 374). McClain further teaches that one example of a high shear mixer is an inline rotor-stator mixer, and that ultra high shear inline mixers can produce particles of an exceptionally narrow particle size distribution (paragraphs 378-382)
It would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to modify the process of Schenck and Balakrishnan as combined supra by selecting an in-line rotor stator as the type of rotor stator mixer used to produce the co-precipitated particles, because Schenck discloses that a rotor stator mixer is suitable for use in the method taught therein but does not identify any specific type of rotor stator mixer that should be used, which would have motivated the skilled artisan to search the art for information on a suitable mixer which would have led to McClain which teaches that inline rotor-stator mixers are a type of rotor-stator mixers that are known to be useful in generating particles and that an ultra high shear inline mixer advantageously allows for exceptional control over the size distribution of the particles, such that the skilled artisan reasonably would have expected that said inline rotor stator mixers could be used as the type of rotor stator mixer in the Schenck process.
Claim 12 is rejected under 35 U.S.C. 103 as unpatentable over Schenck et al. (US Pat. Pub. 2020/0261365; of record in IDS) in view of Palzer (Chemical Engineering Science 60 (2005) 3959-3968) as applied to claims 1-5 and 7-11 above, and further in view of Balakrishnan et al. (US Pat. Pub. 2017/0190763).
The teachings of Schenck and Palzer are relied upon as discussed above, but they do not further expressly disclose that the API is ulonivirine.
Balakrishnan discloses that MK-8507 (synonymous with “ulonivirine”) as a known anti-HIV compound (paragraph 259).
It would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to modify the process of Schenck and Balakrishnan as combined supra by selecting ulonivirine as the API, because Schenck does not limit the identity of the API, and Balakrishnan discloses that ulonivirine was a known API at the time of the effective filing date of the present invention, such that the skilled artisan would have been motivated to select ulonivirine in order to generate with a reasonable expectation of success in generating co-precipitated particles of ulonivirine stabilized with an excipient that could be used to formulate the API as a tablet for oraladministration.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GAREN GOTFREDSON whose telephone number is (571)270-3468. The examiner can normally be reached on M-F 9AM-6PM.
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/GAREN GOTFREDSON/Examiner, Art Unit 1619
/ANNA R FALKOWITZ/ Primary Examiner, Art Unit 1600