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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 4 July 2024 and 15 October 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group I drawn to a granule comprising progerinin in the reply filed on 17 May 2026 is acknowledged.
Claims 10-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 17 May 2026.
Applicant's election with traverse of mannitol as the species of excipient, sodium croscarmellose as the species of disintegrant, magnesium stearate as the species of lubricant, and a species of formulation in the form of granules in the reply filed on 17 May 2026 is acknowledged. The traversal is on the ground(s) that the listed species are merely exemplary of the recited additive categories. This is not found persuasive. As discussed in MPEP 1893.03(d), the standard for restriction and election of species requirements in applications filed under 35 U.S.C. 371 is the unity of invention standard. As the instantly claimed species do not share a special technical feature as defined in PCT Rules 13.1 and 13.2, the election of species requirement is proper.
The requirement is still deemed proper and is therefore made FINAL.
Claims 5 and 8-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 17 May 2026.
Claims 1-4 and 6-7 are examined on the merits 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.
Claims 1-4 and 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Kannusamy et al. (WO 2015/124995) in view of Park et al. (WO 2018/199633 cited on Applicant’s IDS filed 4 July 2024) and Nekkanti et al. (US 2011/0177161).
The instant claims are drawn to a granule comprising progerinin, the granule comprising:
20 to 40 wt% of progerinin;
5 to 15 wt% of hydroxypropyl methylcellulose (HPMC);
1 to 10 wt% of D-α-tocopherol polyethylene glycol succinate (TPGS);
mannitol;
sodium croscarmellose; and
magnesium stearate
wherein the progerinin is drug particles formed via wet type ball milling with an average particle diameter (D50) of 100 nm to 200 nm. As so summarized, the invention reads on instant claims 1-4 and 6-7 and Applicant’s elected species.
Kannusamy et al. teach solid compositions of rivaroxaban (Abstract), in particular granular compositions comprising rivaroxaban (Pg. 4 lines 9-19). Kannusamy et al. teach in Example 1(b) a granular composition (Ingredients 1-12 of table on pg. 11) comprising:
5 wt% rivaroxaban;
5 wt% HPMC;
-
-
croscarmellose sodium; and
magnesium stearate.
Kannusamy et al. further teach the rivaroxaban in a micronized form having a size (D50) of 0.1 to 10µm (Pg. 5 lines 5-7) corresponding to 100 to 10000 nm, overlapping with the instantly claimed range. The recitation of “drug particles formed via wet type ball milling” is a product by process limitation and does not impose further structural limitation on the granules (see MPEP 2113), as such the micronized active ingredient of Kannusamy et al. reads on the instantly claimed drug particles.
Kannusamy et al. additionally teach the active ingredient in a weight ratio of rivaroxaban to excipient in the range of 1:2 to 1:8 (Pg. 4 lines 30-31), corresponding to 11 wt% to 33 wt%; and HPMC in the amount of up to 22 wt% (Pg. 5 lines 25-30), overlapping with the instantly claimed ranges of active ingredient and HPMC.
As such, Kannusamy et al. teach a granule comprising 20 to 40 wt% of an active ingredient, 5 to 15 wt% HPMC, sodium croscarmellose; and magnesium stearate, wherein the active ingredient is drug particles with an average particle diameter (D50) of 100 nm to 200 nm.
The granule of Kannusamy et al. differs from the instantly claimed granule in the following ways:
the granules of Kannusamy et al. do not comprise progerinin;
the granules of Kannusamy et al. do not comprise 1 to 10 wt% TPGS; and
the granules of Kannusamy et al. do not comprise mannitol.
Yet, as to 1: Kannusamy et al. teach rivaroxaban as a water insoluble drug (Pg. 1 lines 15-16) and the granules as improving the bioavailability of rivaroxaban (Pg. 3 lines 20-23).
Park et al. teach pharmaceutical compositions for treating aging-related diseases (Abstract) comprising progerinin (Formula I), further teaching progerinin as a water insoluble drug (Par. [20]) and granular compositions being a suitable form for progerinin (Par. [33]).
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the granule of Kannusamy et al. to include progerinin as taught by Park et al. It would have been obvious to substitute one water insoluble active agent suitable for delivery via granules for another to obtain the predictable result of a granule composition for treating aging related diseases with improved bioavailability, with a reasonable expectation of success.
As to 2: Kannusamy et al. further teach the granules comprising sodium lauryl sulfate (Table on pg. 11), additionally teaching sodium lauryl sulfate as a suitable surfactant for the granular composition and the composition comprising up to 10 wt% surfactant (Pg. 6 lines 1-5), overlapping with the instantly claimed range of TPGS.
Nekkanti et al. teach solid pharmaceutical compositions (Abstract) comprising the S isomer of DRF 1042 (Par. [0001]), which is a poorly water-soluble drug (Par. [0036]), in the form of granules (Par. [0171]). Nekkanti et al. further teach TPGS as a suitable surfactant for the compositions (Par. [0078]).
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the composition of Kannusamy et al. to include TPGS as taught by Nekkanti et al. It would have been obvious to substitute one surfactant suitable for granular compositions of poorly water-soluble drugs for another to obtain the predictable result of a granular composition of a drug, with a reasonable expectation of success.
And, as to 3: Kannusamy et al. further teach the granules comprising lactose (Table on pg. 11) and both mannitol and lactose as suitable water-soluble diluents (Pg. 5 lines 20-22).
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the composition of Kannusamy et al. to include mannitol. It would have been obvious to substitute one suitable water-soluble diluent for another to obtain the predictable result of a granular composition of a drug, with a reasonable expectation of success.
Based on all of the foregoing, claims 1-4 and 6-7 are rejected as prima facie obvious.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Paul Hoerner whose telephone number is (571)270-0259. The examiner can normally be reached Monday - Friday 9:00am - 5:00pm eastern.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached at (571)272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/PAUL HOERNER/Examiner, Art Unit 1611
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