DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Claims 1-10, 12-15, 18, 21, 24, 27, 30, 33, 36, 39, 40, 42-48 and 50 are pending upon entry of amendment filed on 12/9/25.
Claim 1-10, 12-15, 18, 21, 24, 27, 30, 33, 36, 39, 40, 42-48 and 50 are under consideration in the instant application.
3. IN light of Applicant’s response and amendment filed on 12/9/25, the rejections of record have been withdrawn. The currently amended claims require D90 value of particle sizes of emulsion reconstituted after 6 month storage at 5oC as lyophilized formulation is 1000nm of less for the emulsion recited in claim 1 of the instant application.
4. The following new ground of rejection is necessitated by Applicants’ amendment filed on 12/9/25.
5 The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
6. Claims 1-10, 12-15, 18, 21, 24, 27, 30, 33, 36, 39-40, 42-48 and 50 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for a lyophilized emulsion having D 90 value of particle sizes of emulsion reconstituted after 6 month storage at 5oC as lyophilized formulation is 1000nm of less of a lyophilized formulation comprising (4E, 8E, 12E, 16E, 20E)-N-{2-[{4-[(2-amino-4{[(3S)-1-hydroxyhexam-3-yl]amino}-6-methylpyrimidin-5-yl)methyl]benzyl}(methyl)amino]ethyl}-4,8,12,17,21,25-hexamethylhexacosa-4,8,12,16,20,24-hexaenamide (compound A), squalane, antioxidant A and an excipient A at ratio of 1:225:500, respectively as in Tables 1-3 does not reasonably provide enablement for more.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use of the invention commensurate in scope with these claims.
The specification does not enable one of skill in the art to practice the invention as claimed without undue experimentation. Factors to be considered in determining whether undue experimentation is required to practice the claimed invention are summarized In re Wands (858 F2d 731, 737, 8 USPQ2d 1400, 1404 (Fed.Cir.1988)). The factors most relevant to this rejection are the scope of the claim, the amount of direction or guidance provided, the lack of sufficient working examples, the unpredictability in the art and the amount of experimentation required to enable one of the skilled in the art to practice the claimed invention.
There is insufficient guidance in the specification as filed as to how the skilled artisan would use D 90 value of particle sizes of emulsion reconstituted after 6 month storage at 5oC as lyophilized formulation is 1000nm of less as currently amended.
Examples 1-3 as in p. 31-40 exhibit less than 1000 particles in Table 6 of the instant application in p. 37. No examples disclose particle quantitation studies as currently amended in claim 1 of the instant application.
The claims of the instant application is a lyophilized formulation comprising (4E, 8E, 12E, 16E, 20E)-N-{2-[{4-[(2-amino-4{[(3S)-1-hydroxyhexam-3-yl]amino}-6-methylpyrimidin-5-yl)methyl]benzyl}(methyl)amino]ethyl}-4,8,12,17,21,25-hexamethylhexacosa-4,8,12,16,20,24-hexaenamide (compound A), squalane, antioxidant A and an excipient A. Given that having D 90 value of particle sizes of emulsion reconstituted after 6 month storage at 5oC as lyophilized formulation is 1000nm of less is critical, the currently amended claims is not commensurate with the full scope of the claimed invention.
As such, the particular weight ratio disclosed in Tables 1-3 cannot be extrapolated any unspecified concentration ranges encompassed by the claimed invention.
The specification fails to provide sufficient guidance to direct a person of skilled in the art to make and achieve the intended use of the claimed invention without undue experimentation. The specification discloses specific ratios of excipients, antioxidants with compound A but the formulations encompassed by the claims have not been tested for D90 values. It is unpredictable to develop lyophilized emulsions of compound A having D90 value and one exemplary formulation with specified ratios disclosed in the example cannot be extrapolated to various formulations encompassed by the claimed invention.
To summarize, reasonable correlation must exist between the scope of the claims and scope of the enablement set forth. In view or the quantity of experimentation necessary, the limited working example, the unpredictability of the art, the lack of sufficient guidance in the specification, and the breath of the claims, it would take undue trials and errors to practice the claimed invention.
7. No claims are allowable.
8. 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.
9. Any inquiry concerning this communication or earlier communications from the examiner should be directed to YUNSOO KIM whose telephone number is (571)272-3176. The examiner can normally be reached Mon-Fri 8:30-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached on 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Yunsoo Kim
Patent Examiner
Technology Center 1600
January 7, 2026
/YUNSOO KIM/Primary Examiner, Art Unit 1641