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 .
Election/Restrictions
Applicant’s election of Group I, drawn to a compound of general formula (I), or a pharmaceutically acceptable salt thereof, and a pharmaceutical composition; and the following species:
a compound of Example 45 having the structure of:
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as the elected species of compound of general formula (I)
in the reply filed on August 17, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Please note the elected compound of Example 45, when reasonably construed in view of Example 45 of the specification (see e.g., p. 235), has a chemical name of N-[(1'S,14R)-19-fluorospiro[8,12-dioxa-21-azatetracyclo[14.3.1.110,13.02,7]henicosa-1(19),2,4,6,10,13(21),16(20),17-octaene-14,3'-cyclopentane]-1'-yl]methanesuifonamide.
Claims 19-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on August 17, 2026.
Status of Claims
Claims 1-14 and 17-22 are pending.
Claims 19-22 are withdrawn.
Claims 1-14 and 17-18 are under examination in accordance with the elected species.
Priority
The instant application 18/679,695 filed on May 31, 2024 claims priority to, and the benefits of Foreign Application No. EP23176747.6 filed on June 1, 2023, and Foreign Application No. EP24174838.3 filed on May 8, 2024.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/16/2024 and 8/17/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Please note that foreign references without an English translation but have an English translation of the abstract will only have the abstract considered by the Examiner.
Claim Rejections - 35 USC § 112
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 1-13 and 17-18 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.
The instant claims encompassed a genus of compounds of general formula (I)
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or pharmaceutically acceptable salts thereof. Although the specification expressly set forth general formula (I) and provides definition for the variables thereof, the disclosure does not reasonably convey to one of ordinary skill in the art that the inventor had possession, as of the filling date, of the full structural genus presently encompassed by the claims.
The rejection is not based merely upon the numerical size of the genus, nor upon a requirement that Applicant expressly exemplify every species encompassed by general formula (I). Indeed, the specification provides 119 synthesized compounds and those examples are evidenced that Applicant possessed the specifically disclosed compounds and structural families represented thereby. Rather, the deficiency is that the claimed genus encompassed substantial qualitative structural variation resulting from the independent selection and combination of, inter alia, Q, X, R1, R2, Ar1, Ar2, L, T, Y and Z, whereas the disclosed species do not reasonably represent the structural diversity encompassed by those alternatives and their combinations.
Q, X and R1
Claim 1 defines Q to be (C1-C2)alkylene; X to be -(CRaRb)-, -O- or a bond, wherein Ra and Rb each independently are selected from the group consisting of hydrogen and (C1-C4)alkyl; and R1 is hydrogen, or R1 and Ra or Rb may form a 3-cycloalkyl together with the carbon atoms to which they are attached.
Thus, general formula (I) does not merely encompass closely related homologous substitutions. The claim permits independent selection of Q, X and R1 to include chemically and structurally different classes of rings, including cycloalkyl and heterocycloaikyl, optionally fused to a cyclopropane. The disclosed compound species clustered around cyclopentane; thus, the specification demonstrates possession of particular combination of Q, X, and R1. However, the specification does not provide representative species spanning the full structural variation of Q, X and R1 in combination with the independent variables Y, Z, Ar1, Ar2, L, T and R2 groups.
R2
Claim 1 defines R2 to be, inter alia, (C1-C4)alkyl, (C3-C6)heterocyclalkyl, and -NRcRd. Accordingly, the claim permits independent selection of chemically and structurally different classes of functional groups, including heterocycloaikyl and amine. While the specification’s synthetic disclosure demonstrates possession of particular R2, it does not provide representative species spanning the full structural variation results from R2 alternatives in combination with the remaining independently variables Q, X, R1, Ar1, Ar2, L, T, Y, Z group.
Y, Z, Ar1, Ar2, L and T
Claim 1 defines Y to be bond or -O-; Z to be selected from phenyl, pyridyl, (C4-C6)cycloalkyl and (C2-C4)alkylene; Ar1 to be selected from phenyl, pyridyl, pyrazolyl, pyrimidinyl and thiazolyl; Ar2 to be selected from oxazolyl, oxadiazolyl, thiazolyl, pyrimidinyl, oxodihydropyrimidinyl and thiadiazolyl; L to be (C1-C3)alkylene; and T to be selected from -O-, -NH- and -NRe-, wherein Re represents (C1-C4)alkyl.
Accordingly, the claim encompasses compounds having materially different connectivity between each independently selected Y, Z, Ar1, Ar2, L and T, for example, Z and T group can be attached to the same atom of Ar1 or attached to the adjacent atoms within Ar1. The independently selected Y, Z, Ar1, Ar2, L and T groups produces a wide variety of combinations across chemically and structurally different classes, for example, selecting phenyl for Ar1 and oxazolyl for Ar2 produces (a combination composed of carbocyclic aromatic ring and heterocyclic aromatic ring) is materially different than selecting thiazolyl for Ar1 and oxodihydropyrimidinyl for Ar2 (a combination composed of heterocyclic aromatic ring and non-aromatic heterocycles). The permitted selections alter the identity, atom composition, and connectivity of substantial portions of the spiro-macrocyclic framework, for example, selecting an alkylene group for Z and a bond for Y produces a materially different ring path from selecting an aromatic group of Z and oxygen for Y; and selecting -CH2- for L and O for T also produces a materially different ring path from selecting -CH2CH(CH3)- for L and N-methyl for T. The specification provides definition and examples of the meanings of “alkyl”, “cycloalkyl”, “alkylene”, but such generic definitions identify the universe encompassed by the claimed terminology, they do not themselves demonstrate possession of compounds represented by general formula (I) spanning the full range of independently selectable Q, X, R1, R2, Ar1, Ar2, L, T, Y, Z combinations.
The disclosed 119 compounds
The Examiner acknowledges that the specification provides detailed synthetic preparations and structural identification for compounds 1-119. Those species demonstrate possession of those compounds and of structural subject matter reasonably represented thereby. However, the mere number of disclosed species does not resolve the written-description inquiry where the claimed genus contains substantial qualitative structural variation not adequately represented by these species. Here, the disclosed compounds occupy particular structural families involving selected Q/X/R1 ring, selected spiro-macrocyclic framework composed of Ar1/Ar2/L/T/Y/Z. The specification does not identify a structural principle demonstrating that the disclosed species are representative of the full genus generated by independently selecting the substantial broader Q, X, R1, Ar1, Ar2, L, T, Y and Z and terminal functional group R2.
Claims 2 narrows the stereochemistry of the compound of general formula (I); However, said claim still encompasses the full genus generated by independently selecting the substantial broader Q, X, R1, Ar1, Ar2, L, T, Y and Z; thus, it does not cure the above deficiency.
Claims 3-11 narrow selected variables but do not restrict the remaining general formula (I) variables sufficiently to cure the above deficiency.
Claim 12 restricts the compound to general formula (I-d), and that restricts Q, X, R1, Ar2, L, T, Y, R6 and R7 alternatives. Nevertheless, formula (I-d) still encompass substantial structural variation in the remaining independently variable groups, permitting different connectivity between Z and Ar1 and -O-, and encompassing variables that belong to chemically and structurally different classes. Accordingly, the disclosed examples do not provide representative species reasonably commensurate with the full breadth remaining in these claims.
Claim 13 narrowed selected variables of general formula (I-d); However, the claim still permits substantial structural variation in the remaining independently variable groups, different connectivity between Z and Ar1 and -O-, and encompassing variables that belong to chemically and structurally different classes; thus, the claim do not restrict the remaining general formula (I) variables sufficiently to cure the above deficiency.
Claims 17-18 incorporates the compounds and pharmaceutically acceptable salt thereof of claim 1 directly or through dependency, and their additional pharmaceutically acceptable excipients/carriers and other therapeutically active amounts limitation do not cure the lack of written description for the underlying structural genus.
Claims 1-14 and 17-18 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of claim 1 is improper because the alternatives encompassed by general formula (I) do not constitute a recognized physical or chemical class and do not share a substantial structure feature that has been shown to be essential to their asserted common utility. Although the specification generally attributes Orexin 2 receptor agonists utility to the claimed compounds, the existence of an asserted common utility alone is insufficient where the members do not share a substantial structural feature essential to that utility.
Although the claimed compounds may contain the recited sulfonamides moiety circled as follows:
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, the specification does not establish that this moiety constitutes a substantial structural feature responsible for the asserted common Orexin 2 receptor agonists utility throughout the claimed genus. Rather, the instant general formula (I) permits substantial and independent structural variation at Q, X, R1, R2, R6, R7, Ar1, Ar2, L, T, Y, and Z, including materially different cycloalkyl, heterocycloalkyl, fused ring systems, and functional moieties.
Moreover, the biological data drawn to Orexin 2 receptor agonist activity is limited to selected compounds, and does not establish that the structurally diverse alternatives encompassed by general formula (I) possess the asserted common utility by virtue of a shared substantial structural feature. Accordingly, the members encompassed by the Markush grouping have not been to share the requisite structural relationship necessary to support their inclusion in a single Markush group.
Likewise, claim 14 is additionally included in this rejection. Although claim 14 limits the claimed subject matter to the specifically enumerated compounds, the limitation to expressly disclosed species does not, by itself, establish proper Markush grouping. The enumerated compounds encompass substantially different molecular architecture, including materially different ring systems, substitution patterns, functional moieties, and connectivity of substantial portions of the spiro-macrocyclic framework; However, the biological data are limited to particular combination of Q, X, R1, R2, R6, R7, Ar1, Ar2, L, T, Y, and Z group, and does not establish that these structurally diverse species possess the asserted common utility by virtue of the shared sulfonamides moiety.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Claim Rejections - 35 USC § 101 and Statutory Double Patenting
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.
Claims 1 and 14 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1 and 14 of copending Application No. 19/488,195 (reference application).
This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Non-Statutory 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 1-14 and 17-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,590,106 B2 in view of Patani et al. (Chem. Rev., 1996. Vol. 96, 8: 3147-3176).
The claims of the reference patent are drawn to a compound selected from the group consisting of, inter alia, N-[(1'S,14R)-6,19-difluorospiro[8,12-dioxa-21-azatetracyclo[14.3.1.110,13.02,7]henicosa-1(19),2,4,6,10,13(21),16(20),17-octaene-14,3'-cyclopentane]-1'-yl]methanesulfonamide
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(referred to herein as Compound 1); and a pharmaceutical composition comprising said compound or pharmaceutically acceptable salt thereof, and one or more pharmaceutically acceptable excipients or carriers; and together with one or more other therapeutically active compounds.
The claims of the reference patent do not teach the elected compound species.
Patani et al. teaches bioisosterism represents one approach used by the medicinal chemist for the rational modification of lead compounds into safer and more clinically effective agents (see e.g., “introduction” section on p. 3147). Patani et al. further teaches a group of bioisosteres elicit similar biological activity, and have been classified as either classical or nonclassical, wherein the classical bioisosteres are a series of replacements defined by Grimm’s Hydride Displacement Law and Erlenmeyer’s definition of isosteres (see e.g., p. 3148-3149). Patani et al. further teaches the substitution of hydrogen by fluorine is one of the more commonly employed monovalent isosteric replacements because the steric parameters for hydrogen and fluorine are similar; and exemplified said monovalent substitution using the naphthyl-fused diazepines shown below:
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(see e.g., p. 3149, left column, “1. Fluorine vs Hydrogen Replacements”; Figure 2 and Table 4).
The difference between the compound of the reference patent and the claimed elected compound is shown below (see shaded):
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.
It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to arrive at the claimed invention by selecting the compound 1 of the reference patent, and then modifying said compound by replacing fluorine with hydrogen to arrive at applicant’s claimed elected compound. One would have been motivated to modify the compound 1 of the reference patent by selecting the hydrogen in place of the fluorine of said compound, because Patani et al. teaches the replacement of fluorine with hydrogen constitutes a classical monovalent bioisosteric replacement and that such biososteric substitution are employed in medicinal chemistry for the rational modification of lead compounds to obtained structurally related compounds having similar biological activity. Accordingly, one of ordinary skill in the art would have reasonably expected that by selecting the fluorine atom of the compound 1 and replace it with hydrogen as the monovalent isosteres taught by Patani et al. would provide the corresponding analogs while retaining the biological activity that is the same or substantially similar to the compound 1 of the reference patent with a reasonable expectation of success.
Claims 1-14 and 17-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 19-27 of copending Application No. 19/552,858 in view of Patani et al. (Chem. Rev., 1996. Vol. 96, 8: 3147-3176).
The claims of reference application are drawn to compounds that fall within the scope of general formula (I) instantly claimed. For instance, the claims of reference application are drawn to a compound having the chemical name of N-[(1'S,14R)-6,19-difluorospiro[8,12-dioxa-21-azatetracyclo[14.3.1.110,13.02,7]henicosa-1(19),2,4,6,10,13(21),16(20),17-octaene-14,3'-cyclopentane]-1'-yl]methanesulfonamide (referred to herein as Compound 1) or a pharmaceutically acceptable salt thereof. Please note said compound 1 has the chemical structure of:
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according to the specification. The claims of the reference application is also drawn to a pharmaceutical composition comprising the compound or pharmaceutically acceptable salt thereof, and one or more pharmaceutically acceptable excipients or carriers; and together with one or more other therapeutically active compounds.
The reference application does not teach the elected compound species.
Patani et al. teaches bioisosterism represents one approach used by the medicinal chemist for the rational modification of lead compounds into safer and more clinically effective agents (see e.g., “introduction” section on p. 3147). Patani et al. further teaches a group of bioisosteres elicit similar biological activity, and have been classified as either classical or nonclassical, wherein the classical bioisosteres are a series of replacements defined by Grimm’s Hydride Displacement Law and Erlenmeyer’s definition of isosteres (see e.g., p. 3148-3149). Patani et al. further teaches the substitution of hydrogen by fluorine is one of the more commonly employed monovalent isosteric replacements because the steric parameters for hydrogen and fluorine are similar; and exemplified said monovalent substitution using the naphthyl-fused diazepines shown below:
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(see e.g., p. 3149, left column, “1. Fluorine vs Hydrogen Replacements”; Figure 2 and Table 4).
The difference between the compound of the reference patent and the claimed elected compound is shown below (see shaded):
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It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to arrive at the claimed invention by selecting the compound 1 of the reference application, and then modifying said compound by replacing fluorine with hydrogen to arrive at applicant’s claimed elected compound. One would have been motivated to modify the compound 1 of the reference application by selecting the hydrogen in place of the fluorine of said compound, because Patani et al. teaches the replacement of fluorine with hydrogen constitutes a classical monovalent bioisosteric replacement and that such biososteric substitution are employed in medicinal chemistry for the rational modification of lead compounds to obtained structurally related compounds having similar biological activity. Accordingly, one of ordinary skill in the art would have reasonably expected that by selecting the fluorine atom of the compound 1 and replace it with hydrogen as the monovalent isosteres taught by Patani et al. would provide the corresponding analogs while retaining the biological activity that is the same or substantially similar to the compound 1 of the reference application with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection.
Claims 1-14 and 17-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 19-27 of copending Application No. 19/643,140 (reference application), in view of Patani et al. (Chem. Rev., 1996. Vol. 96, 8: 3147-3176).
The claims of reference application are drawn to compounds that fall within the scope of general formula (I) instantly claimed. For instance, the claims of reference application are drawn to a
Compound having the chemical name of N-[(1'S,14R)-6,17,19-trifluorospiro[8,12-dioxa-21-azatetracyclo[14.3.1.110,13.02,7]henicosa-1(19),2,4,6,10,13(21),16(20),17-octaene-14,3'cyclopentane]-1'-yl]methanesulfonamide (referred to herein as Compound 1) or a pharmaceutically acceptable salt thereof. Please note said compound 1 has the chemical structure of:
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according to the specification. The claims of the reference application are also drawn to a pharmaceutical composition comprising said compound or pharmaceutically acceptable salt thereof, and one or more pharmaceutically acceptable excipients or carriers; and together with one or more other therapeutically active compounds.
The reference application does not teach the elected compound species.
Patani et al. teaches bioisosterism represents one approach used by the medicinal chemist for the rational modification of lead compounds into safer and more clinically effective agents (see e.g., “introduction” section on p. 3147). Patani et al. further teaches a group of bioisosteres elicit similar biological activity, and have been classified as either classical or nonclassical, wherein the classical bioisosteres are a series of replacements defined by Grimm’s Hydride Displacement Law and Erlenmeyer’s definition of isosteres (see e.g., p. 3148-3149). Patani et al. further teaches the substitution of hydrogen by fluorine is one of the more commonly employed monovalent isosteric replacements because the steric parameters for hydrogen and fluorine are similar; and exemplified said monovalent substitution using the naphthyl-fused diazepines shown below:
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(see e.g., p. 3149, left column, “1. Fluorine vs Hydrogen Replacements”; Figure 2 and Table 4).
The difference between the compound of the reference patent and the claimed elected compound is shown below (see shaded):
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.
It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to arrive at the claimed invention by selecting the compound 1 of the reference application, and then modifying said compound by replacing fluorines with hydrogens to arrive at applicant’s claimed elected compound. One would have been motivated to modify the compound 1 of the reference application by selecting the hydrogen in place of the fluorine of said compound, because Patani et al. teaches the replacement of fluorine with hydrogen constitutes a classical monovalent bioisosteric replacement and that such biososteric substitution are employed in medicinal chemistry for the rational modification of lead compounds to obtained structurally related compounds having similar biological activity. Accordingly, one of ordinary skill in the art would have reasonably expected that by selecting the fluorine atoms of the compound 1 and replace them with hydrogens as the monovalent isosteres taught by Patani et al. would provide the corresponding analogs while retaining the biological activity that is the same or substantially similar to the compound 1 of the reference application with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection.
Claims 1-14 and 17-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of copending Application No. 19/488,195 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of reference application are drawn to compounds of general formula (I), including N-[(1'S,14R)-19-fluorospiro[8,12-dioxa-21-azatetracyclo[14.3.1.110,13.02,7]henicosa-1(19),2,4,6,10,13(21),16(20),17-octaene-14,3'-cyclopentane]-1'-yl]methanesuifonamide or a pharmaceutically acceptable salt thereof; and a pharmaceutical composition comprising the compound together with one or more pharmaceutically acceptable excipients or carriers; and together with one or more other therapeutically active compounds.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Chihyi Lee whose telephone number is (571)270-0663. The examiner can normally be reached Monday - Friday 8:30 am - 5:00 pm EST.
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/CHIHYI LEE/Examiner, Art Unit 1628 /JEAN P CORNET/Primary Examiner, Art Unit 1628
