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 .
Claims Status
Claims 1,2,5,7,8,10,15,22,24,25,26,29,32-35,38,45,47 and 52 are pending and under current examination.
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 15, 25, 26,29,32-35,38,45, 47 and 52 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being 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.
Claims 15, 25, 26, 29,35, 38, recites 0.5 Ca, or hydrate thereof; or 0.5 Ca hydrate. Here, it is unclear what a 0.5 Ca hydrate or 0.5 Ca is referring to and whether this encompasses 0.5% of calcium ions or whether the compound is present also in a hydrate form.
The metes and bounds for a 0.5 Ca hydrate or 0.5 Ca for the alternative to the compound in the claims renders the scope of claims 26,29,32-35,38,45,47 and 52 indefinite. Furthermore, regarding claims 29 and 38 it is unclear if the hydrate is meant to be the compound present or if a 0.5 Ca hydrate is in the alternative or not since there is no “or” presented in the claims.
Claim 47 has deleted the claim number that the claim is meant to depend from rendering the scope of the claim uncertain.
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 1-2, 5,15, 24,25,26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,3,5,6,8,15,16,17,20 of copending Application No 18/864210 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and the claims of Application ’210 claim oral composition comprising a SSD (spray dried dispersion) of orforglipron (claimed compound) in overlapping mg amounts. Both the instant claims and that of Application ‘210 recite the presence of a pH modifier which is inclusive of sodium bicarbonate. Both the instant claims and that of Application ‘210 contain an overlapping size range inclusive of 5-113 microns in diameter. Both the instant claims and that of Application ‘210 contain a pH modifier in overlapping mg amounts. The SSD in both Applications is a PVP-VA polymer present in overlapping amounts.
The difference between the instant claims and that of Application ‘210 is that the instant claims recite a tablet. However, the oral formulation of Application ‘210 at claim 1 is a genus of any orally acceptable form which is inclusive of tablets, capsules and liquids and thus renders obvious a tablet dosage form. Note that instant clam 1 does not require any disintegrants present of which Application ‘210 does not claim as the remainder of the claims of Application ‘210 are directed to capsule formulations.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Statement of Reasons for allowance
Yoshino (US10858356) appears to be the closest prior art which teaches GLP-1R receptor agonists which can comprise tablet formulations, see claim 13-14 (encompassing structures as claimed see instant spec at page 2). However, Yoshino does not teach particle sizes, that there is a spray dried dispersion or the amounts of pH adjuster and disintegrant present.
Yoshino (20190225604-IDS) teaches tablet formulations (paragraph 0305) which may further contain GLP1R agonists (see paragraph [0298] and also structure at paragraph [0427], however there is no spray dried dispersion, particle size of the claimed compound or amount of excipient present.
Accordingly, the instant claims appear to be free of the art which are to spray dried dispersions comprising orforglipron (claimed compound).
Claims 7,8, 10 and 22 are allowable.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH ALAWADI whose telephone number is (571)270-7678. The examiner can normally be reached Monday-Friday 10:00am-6:30pm EST.
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SARAH ALAWADI
Primary Examiner
Art Unit 1619
Prosecution Insights