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 .
Current Status
This action is responsive to the amended claims of 12 November 2025. Claims 1-2, 4-5, 7-8, 10-11, 13, 15, 17-18, 21-24, 26-27, and 31-32 are pending. Claim 32 is new. Claims 1-2, 4-5, 7-8, 10-11, 13, 15, 17-18, 21-24, 26-27, and 31-32 have been examined on the merits.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
The effective filing date is 01/15/2020.
Response to Arguments
Examiner acknowledges receipt of and has reviewed the amendments and remarks of 11/12/2025 and 11/17/2025; no new matter is found.
Applicant has provided a certified English translation of the foreign priority document CN 202010043882.5, filed 01/15/2020, accompanied by a signed letter from the translator. Support for the instant claims is found in the foreign priority document. Thus, the effective filing date is now 01/15/2020.
The objection to the drawings is withdrawn since Applicant provided higher resolution drawings filed 11/17/2025.
All of the objections to the claims are withdrawn. Applicant has fixed the typos in claims 2, 4, 8, 10, and 17 which were pointed out in the previous action.
Note, in view of the amendments to claim 1, the claim interpretation of ¶13-14 of the previous action (mailed 07/09/2025) no longer applies. Independent claim 1 is now understood as drawn to at least one of the specified 7 crystal forms – (1), (2), (3), (i), (ii), (iii), or (iv) – in the alternative as indicated by the use of “or” throughout the claim.
The 112(b) rejection of claim 31 is withdrawn in view of amendments. Applicant has amended so claim 31 properly introduces a composition of the crystalline form of parent claim 1.
The 112(d) rejection of claim 31 is similarly withdrawn for the same reason stated above, ¶10.
The 102 rejection of claims 1, 5, 7, 20-22, and 31 over YANG is withdrawn. YANG was applied as a 102(a)(2) reference based on an earlier effectively filed date of 01/15/2020. In view of the perfection of foreign priority, YANG is no longer earlier effectively filed. The instant EFD (01/15/2020) and the effectively filed date of YANG (01/15/2020) are the same, thus, YANG cannot be considered prior art.
The 103 rejection of claims 1, 20-22, and 31 over LUO, BERGE, and ELDER is withdrawn in view of Applicant’s amendments. The 103 rejection of 07/09/2025 was made in view of the broad interpretation of claim 1 as including any crystal forms (e.g., salts); however, Applicant has amended claim 1 to be drawn to crystal forms characterized by specific diffraction peaks. LUO, BERGE, and ELDER do not, individually or together, teach any of the instantly claimed crystal forms. Thus, the amendments overcome the prior art rejection. Further, Applicant states LUO is commonly owned and, thus, is exempt under 102(b)(2)(C).
The non-statutory obviousness-type double patenting rejection of claims 1, 20, 22, and 31 over US Patent No. 11,993,596 in view of BERGE and ELDER is withdrawn due to amendments. The amendments to claim 1 have limited the scope to very specific crystal forms of the instant compound. These crystal forms are not taught by the Patent reference nor the prior art references, individually or together. Thus, the rejection is overcome by the amendment.
The non-statutory anticipatory double patenting rejections of claims 1, 5, 7, 20-22, and 31 over copending Application No. 17/792,282 (reference claims) is not overcome by the amendments. Further, Applicant's arguments have been fully considered but they are not persuasive. Applicant argues since the reference claims are directed to a pharmaceutical composition further comprising a specific surfactant, the use of a surfactant cannot be expected from the disclosures of the instant application. Examiner understands Applicant’s argument to state that the reference claims cannot be anticipated by the instant claims; however, the instant rejection is made over the instant claims being anticipated by the reference claims. The rejection of 07/09/2025 stated that reference claim 14 is drawn to the crystal form defined by the same diffraction peaks as those recited in instant claim 5 (now in amended instant claim 1).
Since the reference claim 14 is drawn to a species of the instant claims (specifically crystal form (2) of instant claim 1) and since instant claim 1 is drafted in the alternative (i.e., crystal form (1), or (2), or (3), or (i), or (ii), or (iii), or (iv)), the reference claim merely needs to teach one of the instant crystal forms to anticipate the instant claims drawn to that crystal form. The inclusion of a further component in the reference claims does not take away from the reference teaching the same crystal form and a pharmaceutical composition thereof. In order to make the pharmaceutical composition of the reference claims, the practitioner would have to be in possession of the instant crystal form.
Note, the rejection is modified below to account for the amendments to the claims and the addition of new claim 32 which depends from claim 1 via claim 31.
Response to Amendment
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, 5, 7, 21-22, and 31-32 are provisionally rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claims 1, 14, 16, 19, and 21 of copending Application No. 17/792,282 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claims 1, 5, and 22, reference claim 1 is drawn to a pharmaceutical composition comprising the instant compound
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or a pharmaceutically acceptable salt thereof and a surfactant. Reference claim 19 is drawn to a method administering a therapeutically effective amount of the pharmaceutical composition of reference claim 1. Reference claim 14 recites the pharmaceutical composition of reference claim 1, comprising the crystal form recited in instant claims 1 and 5:
Instant claim 1 crystal form (2):
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which is further recited in instant claim 5; and
Reference claim 14 crystal form:
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. Thus, the reference claims teach the instant crystal form (i.e., instant claims 1 & 5) and a pharmaceutical composition thereof (i.e., instant claim 22). Note, in order to make the pharmaceutical composition of the reference claims the practitioner would need to be in possession of the instant crystal form.
Regarding claim 7, the disclosure of Application ‘282 is referred to in order to understand the properties of the claimed crystal form, in accordance with MPEP 804(II)(B)(1): “those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970).”. The reference claim 14 crystal form is further taught to have the exothermic peak of instant claim 7 in the disclosure of Application ‘282 at Pg. 8 2nd to last paragraph.
Further, since the crystal form of the reference and the crystal form of the instant claims share the same XRPD peaks, they are understood to be the same crystal form. The exothermic peak is, thus, understood to be an inherent property of the crystal form. MPEP 2112.01.II states: "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Since the reference claim teaches the crystal form of instant claims 1 & 5, it would be expected that the crystal form would have the same physical properties as the crystal form in the instant application, namely that the compound exhibits the exothermic peak of instant claim 7.
Regarding claim 21, Reference claim 16 is drawn to the pharmaceutical composition of reference claim 1 wherein the mass ratio of the compound of Formula (I)/salt thereof to the surfactant is 1:200 to 100:1. The disclosure of ‘282 states more preferably 1:1 to 15:1, for example, about 10:1 at Pg. 4 ¶5 (see MPEP 804(II)(B)(1)). Since the reference composition only requires two components, 50%-94% of the weight of the composition is the compound of Formula (I). In view of reference claim 14, the pharmaceutical composition is understood to be a crystalline composition comprising 50% or more of the crystal form. Thus, the reference claims anticipate the instant claim 21.
Regarding claims 31-32, reference claim 19 is drawn to a method for preventing or treating a condition associated with PDE3 and/or PDE4 in a mammal comprising administering a therapeutically effective amount of the pharmaceutical composition of reference claim 1. Reference claim 21 further defines wherein the treated PDE3/PDE4 condition is asthma, chronic obstructive pulmonary disease, anti-inflammatory action, or bronchodilation – these are species of instant claims 31-32. Considering the species of pharmaceutical composition taught in reference claim 14, which overlaps with the instant crystal form (2), the reference claims teach species of the instant claims.
Thus, the instant claims 1, 5, 7, 21-22, and 31-32 are anticipated by the reference claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. While this is the only pending rejection against the instant claims, the rejection may not be withdrawn since the instant and reference applications have the same filing date. See MPEP 1490(VI)(D)(2)(b): “If both the application under examination and the reference application have the same patent term filing date, the provisional nonstatutory double patenting rejection made in each application should be maintained until it is overcome. Provisional nonstatutory double patenting rejections are subject to the requirements of 37 CFR 1.111(b). Thus, applicant can overcome a provisional nonstatutory double patenting rejection by filing a reply that either shows that the claims subject to the rejection are patentably distinct from the claims of the reference application or includes a compliant terminal disclaimer in the application under 37 CFR 1.321 that obviates the rejection. If the reply is sufficient, the examiner will withdraw the nonstatutory double patenting rejection in the application in which it was submitted.”
Conclusion
Claims 1, 5, 7, 21-22, and 31-32 are rejected.
Claims 2, 4, 8, 10-11, 13, 15, and 17-18 are objected to due to their dependence on a rejected claim.
Claims 23-24 and 26-27 are allowable as drafted.
Note: a search for the compound of Formula (I) and method of making same only retrieved a small number of references (see SEARCH 6 of the attached search notes). The close art is represented by the commonly owned LUO (WO 2020/011254, published 01/16/2020, effectively filed 07/13/2018, cited in IDS of 07/14/2022). While LUO may teach the compound of Formula (I) and salts thereof (see the rejection ¶28 of the previous action mailed 07/09/2025), the reference does not teach the instantly claimed crystalline forms to which independent claim 1 has been narrowed by the amendments of 11/12/2025. Further, the close art document does not teach the methods 1 and 2 of making the compound of Formula (I) of claims 23-24 and 26-27 (wherein parent claim 23 is drafted as an independent claim).
The instantly claimed crystal forms are defined by very specific XRPD peaks in the instant claims which are not found in the references, neither do the references teach methods of making such crystal forms that would result in the instant XRPD patterns. Crystal growth is a fine art where the final product is hard to predict, thus the XRPD peaks of the claimed crystals must either be anticipated by or proven to be obvious in the prior art. The reference fails to meet either requirement for the instant claims.
Furthermore, while LUO teaches the compound BB-4 and 5-hydroxy-3-methyl-1,2,3-triazole-4-carboxylic acid are reacted to form the compound of Formula (I) (see, for example, Pg. 35 Table), LUO does not teach or suggest the first step of method 1 comprising compound 1-2a nor the compound 1-4b of method 2. Since neither of the compounds 1-2a and 1-4b are taught by the prior art references, it would not be obvious to the artisan to make these compounds to then utilize them in a reaction to synthesize the compound of Formula (I).
Moreover, while LUO is the only reference retrieved with a date that qualifies under either of the 102(a)(1) or (a)(2) date provisions, the document is commonly owned and therefore an exception.
Thus, the instant claims are free of the prior art.
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 SARA ELIZABETH BELL whose telephone number is (703)756-5372. The examiner can normally be reached Monday-Friday 9:00-5:30.
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/S.E.B./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625