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 .
Priority
Examiner acknowledges that, according to the Filing receipt received 07/31/2025, that the instant application 18/953,864 filed 11/20/2024 is a continuation of 17/837,619 (U.S. Patent no. 12,171,75) filed 06/10/2022, and claims benefit of U.S. provisional application 63/202,423 filed 06/10/2021. As such, all of the instant claims have been awarded the effective filing date of 06/10/2021.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because the abstract recites phrases which can be implied, such as "the present disclosure provides". Correction is required. See MPEP § 608.01(b)IC.
The disclosure is objected to because of the following informalities:
Paragraphs [008], [0081], [00260]: “or” before “or urea” should be deleted.
Appropriate correction is required.
Claim Objections
Claims 1 and 57 are objected to because of the following informalities: “;” should read “,” after Formula IV-b. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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, 6-7, 47, 57, 63-64, and 88 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 recites a Markush grouping of compounds with the Formulae I-V. However, the listed compounds are absent any alternative phrase, such as “or”, preceding the final member of the list. The lack of alternative form renders claim 1 and dependent claims 6-7, 47, and 64 are indefinite because it cannot be determined if Formulae I-V can be alternatively combined in the co-crystalline form with a coformer, if all of Formulae I-V are meant to be present in the co-crystalline form with a coformer, or if the coformer is part of the Markush group as an alternative.
Claim 57 recites a Markush grouping of compounds with the Formulae I-V. However, the listed compounds are absent any alternative phrase, such as “or”, preceding the final member of the list. The lack of alternative form renders claim 57 and dependent claim 63 indefinite because it cannot be determined if Formulae I-V can be alternatively combined in the co-crystalline form with a coformer or if all of Formulae I-V are meant to be present in the co-crystalline form with a coformer, or if the coformer is part of the Markush group as an alternative.
Claim 57 recites “wherein n is 0-6”. However, the compounds of Formulae II-V also contain variable nodes “m” and “p”, which are not defined in claim 57 or in any proceeding dependent claims. Therefore, as the metes and bounds of “m” and “p” cannot be ascertained, claims 57 and 63 are indefinite.
Claim 57 recites “a co-crystalline form of the compound”. The limitation “the compound” lacks antecedent basis. Examiner recommends amending “of the compound having a formula of” to read “of a compound having a formula of”.
Claims 47 and 88 are directed toward a pharmaceutical composition comprising a co-crystalline form of claim 1, and a pharmaceutical composition comprising a crystalline form of claim 68, respectively. However, the specification discloses that compositions include liquid preparations such as solutions (pars. [00452] and [00454]) and that with co-crystalline forms can be combined in compositions with carriers such as diluents and solubilizers (par. [00434]). In solution one would not expect the crystalline form of the claimed co-crystals to be maintained. It is unclear how a pharmaceutical composition can require a co-crystalline form when the co-crystal is dissolved in solution.
Claim Rejections - 35 USC § 112(a)
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, 6-7, 10, 16, 22, 27, 33, 38, 43, 47, 57, 63-64, 68-69, 86, 88, and 97 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.
Claims 1, 6-7, 10, 16, 22, 27, 33, 38, 43, 47, 57, 63-64, 68-69, 86, 88, and 97 are directed toward co-crystalline and crystalline forms of compounds of Formula I through V. However, no requisite peaks are listed for the claimed co-crystalline and crystalline forms. While claim 86 provides peaks presumably associated with disparate crystalline forms, only one peak is required by the scope of the claim. A claimed crystalline polymorph is generally considered adequately described when characterized by at least three to five XRPD peaks. See Brittain (2009), page 334.
Vas-Cath Inc. V. Mahurkar, 19 USPQ2d 1111, states that Applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention, for purposes of the written description inquiry, is whatever is now claimed (see page 1117). A review of the language of the claims indicates that these claims are drawn to a generic formula.
To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof.
Applicant has therefore only provided adequate written description for co-crystalline forms I (Formula I and urea), II (Formula I and trimesic acid), III (Formula I and 3,5-dihydroxybenzoic acid), IV (Formula I and 3,5-dihydroxybenzoic acid), V (Formula I and ellagic acid), VI (Formula I and MgCl2), and VII (Formula I and CaCl2); a co-crystal of Formula IV-I and trifluorotriiodobenzene, 4-aminobenzoic acid, L-aspartic acid, paracetamol, ellagic acid, 2-aminobenzoic acid, or urea as in Figs. 28-34; a co-crystal of Formula IV-Ia and catechin, urea, or triiodotrifluorobenzene as in Figs. 35-37; and a crystalline form VIII of Formula IV-I, provided that they are clearly claimed in association with the above requisite number of peaks. No other co-crystalline or crystalline forms within the scope of the claimed invention could be ascertained by one of ordinary skill in the art in view of the instant disclosure. One of ordinary skill in the art would not be apprised that Applicant was in possession of the full scope of the claimed invention at the time of filing. Correction is required.
Claims 1, 6-7, 10, 16, 22, 27, 33, 38, 43, 47, 57, 63-64, 68, 88, and 97 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 co-crystalline forms I (Formula I and urea), II (Formula I and trimesic acid), III (Formula I and 3,5-dihydroxybenzoic acid), IV (Formula I and 3,5-dihydroxybenzoic acid), V (Formula I and ellagic acid), VI (Formula I and MgCl2), and VII (Formula I and CaCl2); a co-crystal of Formula IV-I and trifluorotriiodobenzene, 4-aminobenzoic acid, L-aspartic acid, paracetamol, ellagic acid, 2-aminobenzoic acid, or urea as in Figs. 28-34; a co-crystal of Formula IV-Ia and catechin, urea, or triiodotrifluorobenzene as in Figs. 35-37; and a crystalline form VIII of Formula IV-I, does not reasonably provide enablement for a co-crystalline form of a compound of Formula I-V and a co-former generally, or a crystalline form of Formula IV-I generally. 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 test of enablement is whether one skilled in the art could make and use the claimed invention from the disclosures in the application coupled with information known in the art without undue experimentation. (United States v. Teletronics Inc., 8 USPQ2d 1217 (Fed. Cir. 1988)). Whether undue experimentation is needed is not based on a single factor, but rather a conclusion reached by weighing many factors (See Ex parte Forman 230 USPQ 546 (Bd. Pat. App. & Inter. 1986) and In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988).
In In re Wands, 8 USPQ2d 1400 (1988), factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first paragraph, have been described. They are:
1. the nature of the invention,
2. the state of the prior art,
3. the predictability or lack thereof in the art,
4. the amount of direction or guidance present,
5. the presence or absence of working examples,
6. the breadth of the claims,
7. the quantity of experimentation needed, and
8. the level of the skill in the art.
In the instant case, the Wands factors are relevant for the following reasons:
1) Amount of guidance provided by applicant. The instant specification only provides particular species of the claimed co-crystals and crystalline forms. Namely, only compounds of Formula I, IV-I, and IV-Ia are successfully disclosed as being crystallized with particular species of coformers (see pages 90-106 of specification). The terms “co-crystalline”, “coformer”, and “crystalline” are incredibly broad. Additionally, the compounds themselves are variable in structure, such as ring size and alkylene length.
As was stated in Morton International Inc. v. Cardinal Chemical Co., 28 USPQ2d 1190 “The specification purports to teach, with over fifty examples, the preparation of the claimed compounds with the required connectivity. However...there is no evidence that such compounds exist...the examples of the '881 patent do not produce the postulated compounds...there is...no evidence that such compounds even exist.” The same circumstance appears to be true here. Hence, Applicants must show that solvates, hydrates, or prodrugs of these compounds can be made, or limit the claims accordingly.
2) The nature of the invention and predictability in the art. The invention is directed ALDH2 inhibitors co-crystallized with a coformer. Regarding predictability in the art, chemistry is generally regarded as unpredictable, particularly the formation of crystals. Additionally see In Re Marzocchi and Horton, 169 USPQ at 367 paragraph 3:
“Most non-chemists would probably be horrified if they were to learn how
many attempted syntheses fail, and how inefficient research chemists are.
The ratio of successful to unsuccessful chemical experiments in a normal
research laboratory is far below unity, and synthetic research chemists, in
the same way as most scientists, spend most of their time working out
what went wrong, and why. Despite the many pitfalls lurking in organic
synthesis, most organic chemistry textbooks and research articles do give
the impression that organic reactions just proceed smoothly and that the
total synthesis of complex natural products, for instance, is maybe a labor-
intensive but otherwise undemanding task. In fact, most syntheses of
structurally complex natural products are the result of several years of
hard work by a team of chemists, with almost every step requiring careful
optimization. The final synthesis usually looks quite different from that
originally planned, because of unexpected difficulties encountered in the initially chosen synthetic sequence. Only the seasoned practitioner who
has experienced for himself the many failures and frustrations which the
development (sometimes even the repetition) of a synthesis usually
implies will be able to appraise such work ......Chemists tend not to publish
negative results, because these are, as opposed to positive results, never
definite (and far too copious)...” Dorwald F. A. Side Reactions in Organic
Synthesis, 2005, Wiley: VCH, Weinheim pg. IX of Preface.
The scope of any co-crystalline or crystalline forms wherein the variables were not those mentioned above are not adequately enabled or defined. Applicants provide no guidance as to how these compounds are made.
3) Number of working examples. The disclosure is not sufficient to allow extrapolation of the limited examples to enable the scope of the co-crystalline and crystalline forms instantly claimed. Applicant has provided no working examples of any co-crystals or crystals comprising compounds of Formula I-a through III-b, VI, IV-b, or V, nor has Applicant demonstrated that a broad scope of coformers can be used to form co-crystals. The only co-crystalline and crystalline forms successfully made are of Form I (Formula I and urea), II (Formula I and trimesic acid), III (Formula I and 3,5-dihydroxybenzoic acid), IV (Formula I and 3,5-dihydroxybenzoic acid), V (Formula I and ellagic acid), VI (Formula I and MgCl2), and VII (Formula I and CaCl2); a co-crystal of Formula IV-I and trifluorotriiodobenzene, 4-aminobenzoic acid, L-aspartic acid, paracetamol, ellagic acid, 2-aminobenzoic acid, or urea as in Figs. 28-34; a co-crystal of Formula IV-Ia and catechin, urea, or triiodotrifluorobenzene as in Figs. 35-37; and a crystalline form VIII of Formula IV-I. Crystalline forms are not considered predictable, nor can they simply be willed into existence. There is no evidence that any of the other claimed compounds have been successfully co-crystallized with any of the tested coformers.
Within the specification, “specific operative embodiments or examples of the invention must be set forth, Examples and description should be of sufficient scope as to justify the scope of the claims, Markush claims must be provided with support in the disclosure for each member of the Markush group. Where the constitution and formula of a chemical compound is stated only as a probability or speculation, the disclosure is not sufficient to support claims identifying the compound by such composition or formula.” See MPEP 608.01(p).
4) Scope of the claims. The scope of the claims is all of co-crystalline forms of Formulas I-V, wherein every listed compound is co-crystallized with a coformer, as well as crystalline forms of Formula IV-I. Therefore, the claims are incredibly broad.
5) Level of skill in the art. The artisan using Applicant’s invention would be an individual with an M.D. or chemist with a Ph.D. degree and having several years of bench experience.
6) Undue experimentation. MPEP §2164.01 (a) states, "A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)."
The conclusion is clearly justified here that Applicant is not enabled for making these co-crystalline and crystalline forms.
Claims 57, 63, and 92 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 a process of preparing a co-crystalline form comprising dry grinding the compound and the co-former or slurrying the compound and the coformer in an organic solvent to form the co-crystalline form therefrom (claims 57 and 63); or a process of preparing a crystalline form of Formula VI-I comprising dissolving the compound of Formula IV-I in an organic solvent and crystallizing the compound to form Form VIII, does not reasonably provide enablement for a process of preparing a co-crystalline form comprising co-crystallizing the compound and the coformer; or a process of preparing a crystalline form of Formula IV-I comprising crystallizing Formula IV-I to form Form VIII generally. 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 or use the invention commensurate in scope with these claims.
As stated in the MPEP 2164.01 (a), “There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue.”
In In re Wands, 8 USPQ2d 1400 (1988), factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first paragraph, have been described. They are:
1. the nature of the invention,
2. the state of the prior art,
3. the predictability or lack thereof in the art,
4. the amount of direction or guidance present,
5. the presence or absence of working examples,
6. the breadth of the claims,
7. the quantity of experimentation needed, and
8. the level of the skill in the art.
In the instant case, the Wands factors are relevant for the following reasons:
The nature of the invention, state and predictability of the art, and relative skill level.
The nature of the invention claims methods of preparing co-crystalline forms of compounds of Formula I-V, and methods of preparing crystalline forms of Formula IV-I. The preparation of crystalline forms and co-crystals is generally considered unpredictable in the art despite a high level of skill, such as a bench chemist with a PhD. MPEP 2164.03, “The amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).”
The breadth of the claims
The claims are very broad insofar as the instant claims are generic toward the co-crystalline forms, compounds, coformers, techniques used to form the co-crystals and crystals, as well as the conditions and/or solvents used. As such, the claims are extremely broad.
The amount of direction or guidance provided and the presence or absence of working examples
Applicant has provided no working examples of any co-crystals or crystals comprising compounds of Formula I-a through III-b, VI, IV-b, or V, nor has Applicant demonstrated that a broad scope of coformers can be used to form co-crystals. The only co-crystalline and crystalline forms successfully made are of Form I (Formula I and urea), II (Formula I and trimesic acid), III (Formula I and 3,5-dihydroxybenzoic acid), IV (Formula I and 3,5-dihydroxybenzoic acid), V (Formula I and ellagic acid), VI (Formula I and MgCl2), and VII (Formula I and CaCl2); a co-crystal of Formula IV-I and trifluorotriiodobenzene, 4-aminobenzoic acid, L-aspartic acid, paracetamol, ellagic acid, 2-aminobenzoic acid, or urea as in Figs. 28-34; a co-crystal of Formula IV-Ia and catechin, urea, or triiodotrifluorobenzene as in Figs. 35-37; and a crystalline form VIII of Formula IV-I. Crystalline forms are not considered predictable, nor can they simply be willed into existence. There is no evidence that any of the other claimed compounds have been successfully co-crystallized with any of the tested coformers. Moreover, the techniques used to form the co-crystalline forms are limiting to dry grinding and slurrying, while crystalline Form VIII is prepared by dissolving Formula IV-I in an organic solvent and crystallizing the compound from the solvent.
The quantity of experimentation necessary
Due to the known unpredictability in the art, and in the absence of experimental evidence, the amount of experimentation necessary to practice the full scope of the claims is expected to be undue.
MPEP 2164.01(a) states, "A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)." That conclusion is clearly justified here.
Claims 64 and 97 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 treating alcohol use disorder, alcohol abuse,, does not reasonably provide enablement for treating or preventing alcohol-related disorders generally. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
As stated in the MPEP 2164.01 (a), “There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue.”
In In re Wands, 8 USPQ2d 1400 (1988), factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first paragraph, have been described. They are:
1. the nature of the invention,
2. the state of the prior art,
3. the predictability or lack thereof in the art,
4. the amount of direction or guidance present,
5. the presence or absence of working examples,
6. the breadth of the claims,
7. the quantity of experimentation needed, and
8. the level of the skill in the art.
In the instant case, the Wands factors are relevant for the following reasons:
The nature of the invention, state and predictability of the art, and relative skill level.
The nature of the invention claims that the administration of a co-crystalline form of claim 1 can treat or prevent an alcohol-related disorder. Paragraph [002] discloses that the compounds of the co-crystals of claim 1 are ALDH2 inhibitors.
The state of the art does not provide that all alcohol-related disorders can be treated or prevented by ALDH2 inhibitors. There is little predictability in the art even in view of the seemingly high level of skill in the art.
The ability to treat all alcohol-related disorders with the claimed ALDH2 inhibitors is not predictable. One alcohol-related disorder of note is Wernicke-Korsakoff syndrome treatment, characterized by thiamine deficiency. Current treatments for Wernicke-Korsakoff syndrome include parenteral administration of thiamine to attenuate thiamine deficiency (Isenberg-Grzeda et al.; p. 511, col. 2, par. 2). There is little reason to conclude that an ALDH2 inhibitor would be capable of attenuating a thiamine deficiency. Furthermore, alcohol-induced disorders such as alcoholic-induced cardiac dysfunction can in fact be worsened by ALDH inhibitors. Cyanamide, an ALDH inhibitor, has been shown to potentiate alcohol intake-induced myocardial cell death (Zhang et al.; p. 89, col. 1, par. 2). Regarding alcohol intoxication, the current hypothesis in the art is that variation in alleles for aldehyde dehydrogenase, by reduced activity of ALDH2, causes an increase in concentration of aldehyde in the body (Cook et al., abstract). This increase in aldehyde concentration, in individuals who possess such genetic variations, increases the severity of symptoms related to alcohol intoxication such as vomiting (Cook et al., abstract). Finally, regarding alcohol withdrawal, current evidence in the art implicates that ALDH2 has little influence on alcohol withdrawal syndrome, and that acetaldehyde is unlikely to be involved in the development of withdrawal (Higuchi et al.; p. 476 par. 3). Therefore, it is unlikely that ALDH2 inhibitors would confer any degree of amelioration to an individual experiencing alcohol withdrawal.
It is maintained by the Examiner that Applicant has not enabled the instant claims in view of the current state of the art, as applicant fails in the specification to demonstrate the ability of the ALDH2 inhibitors of claim 1, the pharmaceutical composition of claim 47, or the co-crystalline forms prepared according to claim 57, to treat or prevent any of the aforementioned diseases or any alcohol use disorder.
The breadth of the claims
The claims are very broad insofar as the instant claims recite the treatment or prevention of “an alcohol-related disorder”. While the treatment of some of the disorders may be possible with the co-crystals of claim 1, it is as a practical matter impossible to determine whether any and all alcohol-related disorders can be treated or prevented by the claimed products.
The amount of direction or guidance provided and the presence or absence of working examples
The specification provides prophetic methods by which alcohol-related disorders can be treated (Example 17, Example 18). However, the specification provides no other direction of guidance regarding the treatment of specific alcohol-related disorders, nor does the specification provide evidence of data or working examples in a subject. Furthermore, Applicant fails to provide evidence that any product of the invention can actually inhibit ALDH2. Given the breadth of the disorders to be treated by the claimed invention, it cannot be ascertained whether the exemplary methods of Example 17 and Example 18 would actually provide an effective treatment of an alcohol-related disorder generally.
The quantity of experimentation necessary
Due to the known unpredictability in the art, and in view of the limited experimental evidence, one skilled in the art would not accept the assertion that the instantly claimed products would be predictably used for the treatment of any and all alcohol-related disorder. Accordingly, instant claims 97, 99, 103-105, and 107 do not comply with the enablement requirement of §112, since to practice the claimed invention a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success.
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, 7, 10, 16, 22, 27, 33, 38, 47, 57, and 63-64 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 12171753 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Claim 1 of the ‘753 patent is directed toward a co-crystalline form comprising a compound of Formula I-V and a coformer, wherein the coformer is urea, 2,3-dihydroxybenzoic acid, trimesic acid, ellagic acid, MgCl2, or CaCl2, or any combination thereof. Claim 9 is directed toward a pharmaceutical composition comprising a co-crystalline form of claim 1. Claim 16 is directed toward a method of preparing a co-crystalline form comprising a compound of Formula I-V and a coformer, wherein the coformer is urea, 2,3-dihydroxybenzoic acid, trimesic acid, ellagic acid, MgCl2, or CaCl2, or any combination thereof.
The claims of the ‘753 patent are narrower than, and therefore anticipate, instant claims 1, 7, 47, and 57. Instant claims 10, 16, 22, 27, 33, 38, and 63 substantially overlap in scope with the claims of the ‘753 patent such that it would be prima facie obvious for one of ordinary skill in the art to arrive at the instant invention.
Regarding instant claim 64, when making obviousness-type double patenting decisions, the Federal Circuit has stated, “[O]bviousness-type double patenting encompasses any use for a compound that is disclosed in the specification of an earlier patent claiming the compound and is later claimed as a method of using that compound”. Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381 (Fed. Cir. 2010).
The reference patent discloses, in columns 7-8 (bridging paragraph) and column 8 lines 5-22, a method of treating and/or preventing an alcohol-related disorder comprising administering the disclosed co-crystalline forms. As such, it would be prima facie obvious for one of ordinary skill in the art to administer the co-crystals of claim 1 of the ‘753 patent for the treatment or prevention of an alcohol-related disorder as the ‘753 patent encompasses the instantly claimed use of the claimed co-crystals.
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claim 6 is/are rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 1 of prior U.S. Patent No. 12171753 B2. This is a statutory double patenting rejection.
Examiner’s Note
No claims are allowed. However, the instant claims are free of the prior art. The closest prior art is Gozzo et al. (US 3975180 A). Gozzo et al. teaches crystal adducts of carbamoyl sulfoxides and urea. However, Gozzo et al. does not teach any of the compounds of the instant invention co-crystallized with urea. Furthermore, Gozzo et al. is directed toward applications of herbicides and therefore does not suggest the co-crystals of the instant invention, which are ALDH2 modulators.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MADELINE E BRAUN whose telephone number is (703)756-4533. The examiner can normally be reached M-F 8:30am-5:00pm ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MADELINE E BRAUN/Examiner, Art Unit 1624 10/06/2026
Prosecution Insights