DETAILED ACTION
Claims 1-10 and 12-21 are pending.
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
The instant application filed 7/12/2024 is a National Stage entry of PCT/CN2023/071689, with an International Filing Date of 1/10/2023, and claims foreign priority to 202210039840.3, filed 1/13/2022 and claims foreign priority to 202310016976.7, filed 1/5/2023.
Information Disclosure Statement
The Information Disclosure Statements (IDS) submitted on 7/12/2024, 6/12/2026, and 6/15/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the Information Disclosure Statements are being considered by the Examiner.
Claim Objections
Claims 3, 4, 7, 8, 9, 10 objected to because of the following informalities: these are independent claims and all have confusing language by stating, “of compound I as claimed in claim 1.” Applicant simply is claiming “of compound I.” Applicant could reintroduce the formula of compound I, or simply truncate “as claimed in claim 1,” as it is clear what the structure is already. Appropriate correction is required.
Claim 20 refers to “claims 4,” this should be fixed to “claim 4.”
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 1-10 and 12-21 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.
Claim 1 states, “for example, the salt is an acid addition salt of compound I with any one of the following acids…”
Regarding claim 1, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Claim 1 states, “for example, the salt is an acid addition salt of compound I with any one of the following acids…”
Claim 1 states, “tartaric acid (comprising L-tartaric acid or R-tartaric acid).”
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation “tartaric acid”, and the claim also recites “L-tartaric acid or R-tartaric acid” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 2 states, “The salt as claimed in claim 1, wherein a hydrochloride of compound I is an acid addition salt of compound I with hydrochloric acid, wherein preferably, the molar ratio of compound I to the hydrochloric acid is 1:(0.9-1.2); preferably, a sulfate of compound I is an acid addition salt of compound I with sulfuric acid, wherein preferably, the molar ratio of compound I to the sulfuric acid is 1:(0.4-0.6); preferably, a p-toluenesulfonate of compound I is an acid addition salt of compound I with p- toluenesulfonic acid, wherein preferably, the molar ratio of compound I to the p-toluenesulfonic acid is 1:(0.9-1.2);….”
Firstly, this claim states the salt as claimed in claim 1, then lists multiple salt forms with different acids. This claim is improperly written. If Applicant wants to claim all the salts in this claim, they should use a Markush Group. Applicant could simply write, “the salt as claimed in claim 1 selected from a hydrochloride of compound I, a sulfate of compound I, ….”
Claim 2 states, “The salt as claimed in claim 1, wherein a hydrochloride of compound I is an acid addition salt of compound I with hydrochloric acid, wherein preferably, the molar ratio of compound I to the hydrochloric acid is 1:(0.9-1.2).”
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 2 recites the broad recitation “a hydrochloride of compound I” (this is the genus of any ratio), and the claim also recites “the molar ratio of compound I to the hydrochloric acid is 1:(0.9-1.2)” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Applicant could correct this in multiple ways, one would be to claim “The salt as claimed in claim 1, is a hydrochloride salt of compound I which is an acid addition salt of compound I with hydrochloric acid, wherein the molar ratio of compound I to the hydrochloric acid is 1:(0.9-1.2).”
The complete fix of all the 112(b) problems with claim 2 could be, “Claim 2, the salt as claimed in claim 1 selected from the group consisting of a hydrochloride of compound I, a sulfate of compound I, a p-toluenesulfonate of compound I, a maleate of compound I, an oxalate of compound I, a camphorsulfonate of compound I, a 2-hydroxyethanesulfonate of compound I,…
Then state for each compound, “wherein the hydrochloride salt of compound I is an acid addition salt of compound I with hydrochloric acid, wherein the molar ratio of compound I to the hydrochloric acid is 1:(0.9-1.2).”
Alternatively, Applicant could separate out the salts into separate dependent claims, or into separate wherein clauses in new dependent claims.
Claim 2 states “preferably” 23 times, all of which result in a broad range and narrow range being claimed, this should be corrected.
Claim 3 states, “preferably” 4 times, to indicate alternative identification characteristics of the free base crystal form of compound I. This claim is confusing, as the “preferably” is not the proper way to delineate different ways to characterize the free base. Moreover each “preferred” characterization seems to have different scope. This claim might better be written as 4 distinct claims. Claim 3 would be “3. A free base crystal form of compound I as claimed in claim 1.”
New dependent claim, “X. The free base crystal form of claim 3, wherein the free base crystal form is Form I.” Then more new claims dependent on claim 3 could be used to capture the peaks and the Figures.
Claim 4 has the same problems as Claim 3, using preferably leads to broad and narrow limitations in the same claim, this is both for the different salts and the different characterizations.
Claim 4 also used the phrase “for example.” Regarding claim 4, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 5 has the same problems as Claim 3, using preferably leads to broad and narrow limitations in the same claim, this is both for the different salts and the different characterizations.
Claim 6 has the same problems as Claim 3, using preferably leads to broad and narrow limitations in the same claim, this is both for the different salts and the different characterizations.
Claim 7 uses “preferably” two times, which leads to broad and narrow limitations in the same claim, this language makes the claim indefinite as to what is required by the claim as the preferential language could be seen as optional.
Claim 8 uses “preferably”, which leads to broad and narrow limitations in the same claim, this language makes the claim indefinite as to what is required by the claim as the preferential language could be seen as optional.
Claim 9 uses “preferably”, which leads to broad and narrow limitations in the same claim, this language makes the claim indefinite as to what is required by the claim as the preferential language could be seen as optional.
Claim 12 uses “preferably”, which leads to broad and narrow limitations in the same claim, this language makes the claim indefinite as to what is required by the claim as the preferential language could be seen as optional.
Claim 13 uses “preferably”, which leads to broad and narrow limitations in the same claim, this language makes the claim indefinite as to what is required by the claim as the preferential language could be seen as optional.
Claim 14 uses “preferably”, which leads to broad and narrow limitations in the same claim, this language makes the claim indefinite as to what is required by the claim as the preferential language could be seen as optional.
Claim 15 uses “preferably”, which leads to broad and narrow limitations in the same claim, this language makes the claim indefinite as to what is required by the claim as the preferential language could be seen as optional.
Claim 16 uses “preferably”, which leads to broad and narrow limitations in the same claim, this language makes the claim indefinite as to what is required by the claim as the preferential language could be seen as optional.
Claim 17 uses “preferably”, which leads to broad and narrow limitations in the same claim, this language makes the claim indefinite as to what is required by the claim as the preferential language could be seen as optional.
Claim 18 uses “preferably”, which leads to broad and narrow limitations in the same claim, this language makes the claim indefinite as to what is required by the claim as the preferential language could be seen as optional.
Claim 19 uses “preferably”, which leads to broad and narrow limitations in the same claim, this language makes the claim indefinite as to what is required by the claim as the preferential language could be seen as optional.
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.
Application 18/005,165
Claims 1-10 and 12-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-9 of copending Application No. 18/005,165 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘165 patent is directed to the same compound and its salts.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL J SCHMITT whose telephone number is (571)270-7047. The examiner can normally be reached M-F 8-6 MidDay Flex.
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/MICHAEL J SCHMITT/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
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