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 .
Applicant’s amendments filed 2/3/2026 have been entered.
The outstanding rejections under 35 USC 112 is withdrawn in view of the amendments filed 2/3/2026. The claims are now recited the aspect ratio of the excipients.
Claims 1-12, 14-28 are pending.
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.
Claim(s) 1-12, 14-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO2009/020198 (‘198), English translation by Google is also provided, in view of Handbook of Pharmaceutical Handbook, 2009, 6th Ed, pages 129-133, 364-369, herein after referred as Handbook and Horio et al., International Journal of Pharmaceutics, 473 (2014) 572-578.
‘198 teaches the herein claimed compound (see page 6 second compound on the third row). ‘198 teaches a genus of compounds including the herein claimed compounds as suitable in treating human papillomavirus infection (see English translation page 3/21, line 21). ‘198 teaches the pharmaceutical dosage forms the compounds can be formulated as tablet or suppository (see English translation page 7/21, line 28-29). ‘198 teaches polysorbate 80 can be used as the surfactants (see English translation page 7/21, line 40). ‘198 teaches crystalline cellulose and other hydroxyalkyl cellulose (see page 7/21, lines 40-41).
‘198 does not expressly the shape of the cellulose to have the herein claimed aspect ratio of 1.8 or above. ‘198 does not expressly teach the method of making the composition.
Handbook teaches that microcrystalline cellulose can be used binder/diluent for tablets. And have approximate column-like shape (see page 130). Handbook teaches lactose hydrate has approximately round shape and it is commonly used as diluent in tablets (see page 365-366 for example, especially section 7).
Horio et al. teaches the aspect ratio of the microcrystalline cellulose in commercial grade, in which the aspect ratio for all of the different types of microcrystalline cellulose is 1.8 or above (see page 574, Table 1).
It would have been obvious to one of ordinary skill in the art at employ lactose hydrate and microcrystalline cellulose in making the composition.
One of ordinary skill in the art would have been motivated to employ lactose hydrate and microcrystalline cellulose in making the composition. The examiner notes that both excipients are known to be useful in formulating tablets. In addition, they are suitable with the herein claimed compounds. The microcrystalline cellulose is well-known to have the aspect ratio of 1.8 or above. Incorporating them into the composition would be reasonably expected to be successful.
As for the void recited in the claims, the examiner notes that when the microcrystalline cellulose is elongated and the other excipients are spherical, space (or void) would be inevitbably created when they are mixed together. Furthermore, the simply mixing the granules and the making a solid core and then coating it with the coating materials is routinely perform by one of ordinary skill in the art. And hence, a simply mixing is obvious as being within the purview of skilled artisan, especially when the herein claimed excipients are well-known to be compatible with the active compound.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-12, 14-28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 37-43, 45-54, 56-70, 72-79 of copending Application No. 17/605,747 (‘747) (reference application) in view of ‘198. Although the claims at issue are not identical, they are not patentably distinct from each other because ‘747 teaches the composition with the herein claimed active agent, the same crystalline cellulose with the same aspect ratio and the weight ratio (see for example claim 37). ‘747 teaches the coating of the composition and also the method of preparing the composition (see claim 38 and 64).
‘747 does not expressly teach the method of treating human papillomavirus infection.
‘198 teaches the use of the herein claimed agent for treating human papillomavirus infection.
It would have been obvious to one of ordinary skill in the art at the time of filing to employ the composition of ‘747 to treat human papillomavirus infection.
One of ordinary skill in the art would have been motivated to employ the composition of ‘747 to treat human papillomavirus infection since the herein claimed compounds are well-known to be effective in treating human papillomavirus infection. Employing the composition containing the same compounds to treat human papillomavirus would be reasonably expected to be useful.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed 2/3/2026 averring the presence of unexpected benefits of the shape of the excipients, have been fully considered but they are not persuasive. The examiner notes that tt is applicant’s burden to demonstrate unexpected results over the prior art. See MPEP 716.02, also 716.02 (a) - (g). Furthermore, the unexpected results should be demonstrated with evidence that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance. Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992). Moreover, evidence as to any unexpected benefits must be "clear and convincing" In re Lohr, 137 USPQ 548 (CCPA 1963), and be of a scope reasonably commensurate with the scope of the subject matter claimed, In re Linder, 173 USPQ 356 (CCPA 1972). In the instant case, the specification does not disclose any evidence or data comparing the shape of the crystalline cellulose particles and its effect on the pharmacokinetic and stability of the composition. It is not clear how the shape of the excipients would be critical to the invention.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAN MING R HUI whose telephone number is (571)272-0626. The examiner can normally be reached Mon - Fri 9:30-5:30.
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, Kortney Klinkel can be reached at 571-270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAN MING R HUI/Primary Examiner, Art Unit 1627
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