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 1-17 are pending in the application.
Claim Objections
Claim 15 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 14. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112
4. 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.
Claims 1-10 and 12-16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. There is no written description for preparing metabolites of instant compounds of formula (I). There is not even a single example present for preparing any metabolite of instant compounds of formula (I).
Claims 1-10 and 12 -16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for preparing compounds and salts, does not reasonably provide enablement for preparing solvates and prodrugs of instant compounds. 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 the invention commensurate in scope with these claims. The following eight different factors (see Ex parte Foreman, 230 USPQ at 547; Wands, In re, 858.F. 2d 731, 8 USPQ 2d 1400, Fed. Cir. 1988) must be considered in order for the specification to be enabling for what is being claimed:
Quantity of experimentation necessary, the amount of direction or guidance provided, presence or absence of working examples, the nature of the invention, the state of the prior art, the relative skill of those in the art, the predictability or unpredictability and the breadth of claims. In the instant case, the specification is not enabling based on atleast four of the above mentioned eight different factors such as quantity of experimentation necessary, the amount of direction or guidance provided, presence of working examples, state of the prior art, unpredictability and the breadth of claims.
In regard to lack of enablement issue of instant claims 1 and 12 for solvates or prodrug forms of instant compounds of formula (I), there is no teaching or guidance present in the specification for preparing any specific solvates or prodrugs. Preparation of specific solvates of any compound is a very specialized field and involves their characterization using different techniques such as infrared spectrum, XRD powder diffraction etc. There is no teaching or guidance present in the specification regarding any specific solvents used for preparing specific solvate and their characterization using any techniques such as XRD powder diffraction or infrared spectrum etc. There is not even a single example present for preparing any specific solvate of instant compounds of formula (I). Healy (Adv. Drug Deliv. Rev.) teaches that differences in solid forms (hydrates, solvates or polymorphic forms) often leads to differences in thermodynamic parameters and physiochemical properties such as solubility, dissolution rate, stability and mechanical properties (see abstract and table 1 on page 28). Therefore, in absence of such teachings, guidance, presence of working examples and unpredictability, it would require undue experimentation to select specific solvates of instant compounds with enhanced stability properties.
In regard to prodrugs, there is no teaching or guidance present in the specification for preparing specific types of prodrug such carboxylic acid esters, amino acid or amide esters, phosphate esters, phosphono esters, sulfate esters etc. There is not even a single working example present in the specification for preparing any type of specific prodrug of instant compounds of formula (I). Kumar (J. of Drug Deliv. Sci. & Technol.) teaches that various pharmacokinetic reasons are considered to be responsible for developing the prodrugs such as improving drug solubility, reducing pre-systemic metabolism and increasing bioavailability, penetration to blood brain barrier, site specific drug delivery, improving time of onset action, masking taste and odor, reducing pain at injection site, enhancing the chemical stability and reduction of toxicity (see pages 2-9). Therefore, in absence of such teachings, guidance, presence of working examples and unpredictability, it would require undue experimentation to select specific types of prodrugs of instant compounds of formula (I) which will be effective following in vivo administration.
8. 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 9, 10, 13 and 17 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.
In claims 9 and 10, the term - - comprising - - - compound is vague and indefinite since it is not clear whether compound is represented by formula 1(a) in claim 9 and formula 1(b) in claim 10 or some other large compounds of unknown structures having formulae 1(a) and 1(b) embedded somewhere.
In claims 9 and 10, the values of variables R3-R8 are defined twice (see last line) which are different from previously defined values.
In claims 9 and 10, values of variables R9 and R10 are not defined.
In claim 13, SSTR4 receptor-related diseases are not defined and furthermore, it is not clear whether these diseases are related to either hyperactivity or hypoactivity of SSTR4 receptors.
Claim 17 is directed to preparing compounds of formula (I). However, it is not clear what is being reacted and prepared since the structures of formula (I), first compound, second compound, first intermediate compound and second intermediate compound are missing in the claim.
Claim Rejections - 35 USC § 102
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4 and 6-16 are rejected under 35 U.S.C. 102(a) (1) as being anticipated by Guanpeng (WO 2021/233428 A1, cited on applicant’s form 1449).
Guanpeng discloses compounds as SST4 receptor agonists for treating pain. The compound disclosed in example 5 (see paragraph 0586 of english translation) as well as compounds disclosed in claims 1, 15-25, 49-63 (where variable Q represents 3rd structure, L4 is CH2, L1 is a single bond, L2 is NH and M represents either single bond or alkyl group) anticipate the instant claims when variables m and n represent 1 in the instant compounds of formula (I).
Claims 1, 2, 6, 7, 12, 13 and 17 are rejected under 35 U.S.C. 102(a) (1) as being anticipated by Li (CN 112778274 A, cited on applicant’s form 1449).
Li discloses compounds for treating inflammatory diseases. The compounds 1D, 1E, 1, 1-a and 1-banjd a process for preparing them (see page 29) disclosed by Li anticipate the instant claims when variables m and n represent 1 and variable R3 represents either H or oxygen containing alkyl group in the instant compounds of formula (I).
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, 6-8 and 12-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 8-12 of copending Application No. 19/265,559 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the compounds of the cited application anticipate the instant compounds when variable R3 represents oxygen containing alkyl group in the instant compounds of formula (I).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claim 5 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARANJIT AULAKH whose telephone number is (571)272-0678. The examiner can normally be reached Monday-Friday 7:00-3:30.
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/CHARANJIT AULAKH/ Primary Examiner, Art Unit 1621