DETAILED ACTION
Notice of AIA Status
The instant application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the Leahy-Smith America Invents Act (AIA ).
Status of the Claims
The listing of claims filed via Preliminary Amendment on 18 September 2024 has been examined.
Claims 1–18, 20, and 29 are pending.
Claims 19, 21–28, and 30–38 are canceled.
Benefit of Earlier Filing Date
The instant application was filed 18 September 2024; is a national stage application of PCT/CA2022/051266, filed 22 August 2022, and claims the benefit of an earlier filing date of U.S. Prov. Pat. App. Nos. 63/321,440, filed 18 March 2022, and 63/347,835, filed 1 June 2022. Applicant’s claim is acknowledged.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 18 June 2025; 27 June 2025; 31 July 2025; 30 December 2025; 31 December 2025; 9 March 2026; 8 May 2026; and 29 June 2026 are acknowledged and have been considered.
Objections to the Specification
The abstract of the disclosure is objected to because it recites language referring to the purported merits of the invention (“novel”) and phrases that can be implied (“Disclosed are”).
Appropriate correction is required.
Examiner recommends: “
For guidelines for the preparation of patent abstracts, see MPEP § 608.01(b) (Explaining: The abstract should be in narrative form and avoid legal phraseology (e.g., means, said), terms referring to purported merits of the invention (e.g., new, novel), and phrases that can be implied (e.g., The disclosure concerns, The disclosure defined by this invention). The language should be clear and concise, and not repeat information given in the title. It should not compare the invention with the prior art. The abstract is generally limited to a single paragraph within the range of 50 to 150 words in length.).
Claim Rejections - 35 U.S.C. § 112
The following is a quotation 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.
Claims 1–18, 20, and 29 are rejected under 35 U.S.C. § 112(a) as failing to comply with the written description requirement. The claims contain subject matter (i.e., carbonothioate moiety or derivative thereof) that was not described in the Specification in such a way as to reasonably convey to one of ordinary skill in the art that Applicant, at the time the application was filed, had possession of the claimed invention.
In Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc), the Federal Circuit stated “the hallmark of written description is disclosure.” A specification adequately describes an invention when it “reasonably conveys to those skilled in the art the inventor had possession of the claimed subject matter as of the filing date.” (Id.). “A ‘mere wish or plan’ for obtaining the claimed invention is not adequate written description.” Centocor Ortho Biotech, Inc. v. Abbott Labs., 636 F.3d 1341, 1348 (Fed. Cir. 2011).
What is required to meet the written description requirement “varies with the nature and scope of the invention at issue, and with the scientific and technologic knowledge already in existence.” Capon v. Eshhar, 418 F.3d 1349, 1357 (Fed. Cir. 2005). In Ariad, the Federal Circuit explained what is required to meet the written description requirement:
This inquiry, as we have long held, is a question of fact. Ralston Purina, 772 F.2d at 575. Thus, we have recognized that determining whether a patent complies with the written description requirement will necessarily vary depending on the context. Capon v. Eshhar, 418 F.3d 1349, 1357–58 (Fed. Cir. 2005). Specifically, the level of detail required to satisfy the written description requirement varies depending on the nature and scope of the claims and on the complexity and predictability of the relevant technology. Id. For generic claims, we have set forth a number of factors for evaluating the adequacy of the disclosure, including “the existing knowledge in the particular field, the extent and content of the prior art, the maturity of the science or technology, [and] the predictability of the aspect at issue.” Id. at 1359.
(Ariad, at 1351).
The written description of a genus, such as a chemical genus, “requires a precise structure, formula, [or] chemical name” of the claimed subject matter sufficient to distinguish it from other materials. Regents of the Univ. of Cal. v. Eli Lilly & Co., 199 F.3d 1559, 1568 (Fed. Cir. 1997). The Federal Circuit commented on that case in the Ariad decision:
We held that a sufficient description of a genus instead requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can “visualize or recognize” the members of the genus. Id. at 1568-69. We explained that an adequate written description requires a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials. Id. at 1568 (quoting Fiers v. Revel, 984 F.2d 1164, 1171 (Fed. Cir. 1993)). We have also held that functional claim language can meet the written description requirement when the art has established a correlation between structure and function. See Enzo, 323 F.3d at 964 (quoting 66 Fed. Reg. 1099 (Jan. 5, 2001)). But merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species.
(Ariad, at 1350).
The factors outlined in the above Federal Circuit cases are analyzed in turn below with respect to the claimed invention.
(A) The nature and scope of the claimed invention in view of the specification: relates generally to the chemical art and more specifically to the pharmaceutical art; and even more specifically to a compound of formula (I) (shown below); a pharmaceutical composition comprising the compound; and methods of administering the compound to a patient to treat a brain neurological disorder.
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Claim 1 states, “R4 is a carbonothioate moiety or a derivative thereof.”
Claim 2 states, “the carbonothioate moiety or a derivative thereof has the chemical formula (III):
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wherein R4b is an alkyl group, a cyclo-alkyl group, or an aryl group, each of which are optionally substituted.”
Claim 3 states, “the carbonothioate moiety or a derivative thereof has the chemical formula (IV):
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wherein R4c is an alkyl group, a cyclo-alkyl group, or an aryl group, each of which are optionally substituted.”
The specification states:
The term “carbonothioate moiety or derivative thereof”, as used herein, refers to a derivative including a group having chemical formula (XII)a or (XII)b;
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Wherein R4′ is a hydrocarbon group, for example, an alkyl group, cyclo-alkyl group, or an aryl group. It is noted that the partially bonded oxygen atom of the group having formula (XII)a and (XII)b can be bonded to another entity, including, for example, to the C4 atom of tryptamine. It is further noted that R4′ can herein additionally include numerical subscripts, such as 4a, 4b, 4c, 4d etc., and be represented, for example, as R4a, R4b, R4c or R4d, respectively. Where such numerical values are included, they reference a chemical entity extending from the carboxyl group extending in turn from the thus numbered C atom of the prototype indole structure. Thus, for example, R4c is a chemical entity extending from a carbonothioate group attached to the C4 atom of the indole ring structure.
(Spec., ¶69) (emphasis added).
The definition above is non-limiting—it states the claim term includes a group having the formulae (XII)a or (XII)b (which correspond to the chemical formulae (III) and (IV) in the claims). The definition allows for other, unrecited chemical formulae because includes is considered an open-ended term.
Furthermore, the definition does not explain what the term derivative thereof includes or does not include. A derivative may include, for example, substituting one atom for another on the carbonothioate moiety (e.g., replacing a sulfur atom with an oxygen atom) and/or modifying an R group attached to the carbonothioate moiety (e.g., converting an alkyl to an alkyl-acid group). Additionally, the R group attached to the carbonothioate moiety can be substituted, which multiplies the number of possible embodiments encompassed by the claim term.
Other than the chemical formulae (III), (IV), (XII)a or (XII)b, the specification does not provide any guidance or examples for the claimed carbonothioate moiety or derivative thereof. Such guidance may include, for example, the identification of which atoms on the structure would be targeted for modification (i.e., derivatization), what the structure of the resulting derivative would be, and how the derivative would be prepared.
In view of the above, the scope of the claims is broad because it encompasses various possible derivatizations of the carbonothioate moiety. The scope of claims encompasses thousands or millions of compounds. In contrast, the specification only discloses two chemical formulae of the carbonothioate moiety and a limited number of species (e.g., see claim 17).
(B) The extent and content of the prior art: the compounds of formula (I) appear to be novel. As such, derivatives of the carbonothioate moiety in the compounds of formula (I) are unlikely to be known in the prior art. Considered as a whole, the prior art does not inform one of ordinary skill in the art how the carbonothioate moiety should be derivatized or how to make and use the derivative compounds. Accordingly, Applicant’s disclosure is critical to show possession.
(C) The maturity of the science or technology: the compounds of formula (I) appear to be novel. As such, the undisclosed and undescribed derivatives of the carbonothioate moiety in the compounds of formula (I), other than the chemical formulae (III), (IV), (XII)a or (XII)b, are in an infant stage of development.
(D) The predictability of the aspect at issue: the chemical and pharmaceutical arts are generally recognized as unpredictable. In re Fisher, 427 F.2d 833, 839 (CCPA 1970). The art requires, for example, each potential drug candidate to be assessed for physiological activity. (Id.). Applications in unpredictable arts require more specific disclosures to satisfy the statutory requirement. In this case, there is no evidence suggesting the claimed invention is more predictable than the chemical and pharmaceutical arts are generally.
The question of written description
After considering the above factors and the evidence discussed therein, Examiner finds the specification does not adequately describe a representative number of species for the claimed carbonothioate moiety and derivatives thereof with respect to the compounds of formula (I). Nor does the specification provide adequate guidance for particularly understanding the scope of the term or for making and using such derivatives. As such, the specification does not reasonably convey to those skilled in the art that applicant had possession of a representative number of species of the claimed subject matter as of the filing date.
Examiner recommends amending claim 1 to incorporate the subject matter of claims 2 and 3 (i.e., the structures of chemical formulae (III) and (IV) and definitions for Rb and Rc), and further, deleting all instances of the term “or a derivative thereof.”
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 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046 (Fed. Cir. 1993); In re Longi, 759 F.2d 887 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937 (CCPA 1982); In re Vogel, 422 F.2d 438 (CCPA 1970); In re Thorington, 418 F.2d 528 (CCPA 1969).
Please note the following information regarding terminal disclaimers:
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(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.
(i) Claims 1–18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1–13 of US Pat. No. 11,707,447 (reference claims).
18/848,351
11,707,447
A compound having the formula:
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R4b = alkyl, cycloalkyl, or aryl
A compound having the formula:
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R4b = alkyl
As shown above, the compounds of formula (I) of the reference claims are a subgenus of the compounds of formula (I) of the instant claims; i.e., the compounds of the reference claims overlap with the compounds in the instant claims when R4 = formula (III) and R4b = alkyl. Thus, it would have been prima facie obvious for one of ordinary skill in the art to arrive at the claimed invention in view of the reference claims due to the substantial overlapping subject matter. And while instant claim 18 does not recite the ability of the compounds to function as a prodrug as recited reference claim 13, one of ordinary skill in the art would appreciate the claimed compounds are capable of that function because they have the same functional group (carbonothioate) required for in vivo hydrolysis. Although the conflicting claims at issue are not identical, they are not patentably distinct from each other because they cover the same compounds and compositions thereof. As such, an infringer of the reference application would also be an infringer of the instant claims and vice versa for the overlapping subgenus.
(ii) Claims 20 and 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1–20 of US Pat. No. 11,945,778 (reference claims).
18/848,351
11,945,778
A method of treating a brain neurological disease comprising administering a compound of formula (I):
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R4b = alkyl, cycloalkyl, or aryl
A method of treating a brain neurological disease comprising administering a compound of formula (I):
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R4b = alkyl
As shown above, the conflicting claims are directed to a method of treating a brain neurological disease comprising administering a compound of formula (I). The compounds of formula (I) in the reference claims are a subgenus of the compounds of formula (I) in the instant claims; i.e., the compounds of the reference claims overlap with the compounds in the instant claims when R4 = formula (III) and R4b = alkyl. Thus, it would have been prima facie obvious for one of ordinary skill in the art to arrive at the claimed invention in view of the reference claims due to the substantial overlapping subject matter. Although the claims at issue are not identical, they are not patentably distinct from each other because they cover the same compounds and compositions thereof. As such, an infringer of the reference application would also be an infringer of the instant claims and vice versa for the overlapping compounds.
(iii) Claims 1–17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of US Pat. App. Serial No. 18/848,277 (reference claim).
18/848,351
18/848,277
A compound having the formula:
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R4b = carbonothioate moiety or derivative thereof
A compound having the formula:
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R4 = carbonothioate moiety or derivative thereof, etc. [5 other options]
As shown above, the compounds of formula (I) in the instant claims are a subgenus of the compounds of formula (I) in the reference claims; i.e., the compounds of the conflicting claims overlap with one another when R4 = carbonothioate moiety or derivative thereof. The reference claims define substituent R4 as six different functional groups, including a carbonothioate moiety or derivative thereof, which is the subject matter of the instant claims. Thus, it would have been prima facie obvious for one of ordinary skill in the art to select any of the six options for substituent R4 because they represent a finite number of limited subgenera; i.e., the claimed formula (I) would have been prima facie obvious in view of the reference claims. Although the claims at issue are not identical, they are not patentably distinct from each other because they cover the same compounds and compositions thereof. As such, an infringer of the reference application would also be an infringer of the instant claims and vice versa for the overlapping subgenus.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
(iv) Claims 1–18, 20, and 29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1–6, 37, 38, 46, 52–54, 59, and 68 of US Pat. App. Serial No. 18/848,367 (reference claims) in view of Berge et al., J. Pharm. Sci. (1977), 66(1), 1–19 (“Berge”).
18/848,351
18/848,367
A compound having the formula:
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R4b = alkyl, cycloalkyl, or aryl
A salt compound having the formula:
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But for the compounds of the reference claims being in salt form, the conflicting claims cover the same compounds according to formula (I) when R4 = carbonothioate moiety or derivative thereof.
Berge explains the properties of medicinal compounds can be manipulated and optimized by conversion of the compound to a salt form. (Berge, p.1). Berge discloses the 53 most common salts used in pharmaceutical formulations (“Tables I and II list all salts that were commercially marketed through 1974.”). (Id., p.2).
It would have been prima facie obvious for one of ordinary skill in the art to convert the compounds of the instant claims to a salt form in view of Berge because doing so may optimize the properties of the compounds. Because Berge discloses a limited and finite number of commercially marketed salts, it would have been obvious to try any of those disclosed and have a reasonable expectation of success in arriving at the compounds of the reference claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jason Nolan at (571) 272-2480. The examiner can normally be reached Monday through Friday between 9:00–5:00.
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/JASON M. NOLAN/Patent Examiner, Art Unit 1623 /GEORGE W KOSTURKO/ Primary Examiner, Art Unit 1621
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