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 .
Specification
The disclosure is objected to because of the following informalities: alternative font color used for references listed on page 1 lines 15 – 19, lines 25 – 28, and page 2 lines 8 – 14. Since the reference font is in an alternative font color the text quality is limited. Moreover there is the potential for legibility issues if/when the application goes to print. Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities: duplication of the phrase “or a pharmaceutically acceptable salt thereof;” in lines 1 – 5 of the claim. The phrase “or a pharmaceutically acceptable salt thereof;” is stated twice in the claim once before the structure of Formula (I-A) is recited then immediately after the structure is recited. The duplication of this phrase is unnecessary and causes the claim to become difficult to read. Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 – 3, 10, 17, 24, 31, 50, 74, 90, 94, 135, 141, 147, 153, 226 – 229, and 234 – 239, are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US Patent Application Publication US 2022/0194926 A1 to Pennington et. al. (Pennington’926; cited on the IDS dated May 21st, 2026).
The applied reference has a common applicant and joint inventors with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Regarding claims 1 – 3, 10, 17, 24, 31, 50, 74, 90, 94, 135, 141, 147, 153, 226 – 229, and 234 – 239, Pennington’926 teach substituted piperidino compounds having orexin-2 receptor agonist activity. See page 1 paragraph 0007. Pennington’926 teach a compound represented by Formula I-A or a pharmaceutically acceptable salt thereof:
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206
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. See page 1 paragraph 0008. Moreover, Pennington’926 teach an embodiment for compounds of Formula I-A having the structure of Formula I or a pharmaceutically acceptable salt thereof:
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. See page 2 paragraph 0026. See claim 2 limitation for the compound according to claim 1 where the compound is a compound of Formula (I)
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. Furthermore, Pennington’926 teach pharmaceutical compositions comprising compounds of Formula I-A and/or Formula I and a pharmaceutically acceptable carrier. See page 2 paragraph 0044. See claims 227, 234, and 237 limitations for pharmaceutical compositions. Additionally, Pennington’926 teach the use of compounds of Formula I-A and/or Formula I in methods to treat narcolepsy and/ or cataplexy. See page 2 paragraph 0047. See claims 228 – 229, 235 – 236, and 238 – 239 limitation for methods of treating narcolepsy and/ or cataplexy comprising administering a compound according to claim 1, 2, or 226.
Specifically, Pennington’926 teach compound number 22 of structure
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228
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where examined ring A = phenyl; examined X = CH; examined Y = S(=O)2; examined R2 = R3 = R4 = R5 = R6 = R7 = R8 = H and examined m = 1; examined p = 0; examined E = Me or CH3; and examined R1 = pyridazinyl. See page 15 Table 1 column 1 row 4. See claim 1 limitation for a compound of Formula (I-A) where ring A = phenyl ring; X = CH; Y = S(=O)2; R2 = R3 = R4 = R5 = R6 = R7 = R8 = H and m = 1; R9 = absent when p = 0; E = C1 alkyl; and R1 = (CRcRd)n-(6-membered heteroaryl) where n = 0. See claim 2 limitation for the compound according to claim 1 where the compound is a compound of Formula (I). See claim 3 limitation for the compound according to claim 1 where ring A = phenyl. See claim 50 limitation for the compound according to claim 1 where p = 0. See claim 74 limitation for the compound according to claim 1 where E = C1 alkyl. See claim 90 limitation for the compound according to claim 1 where Y = S(=O)2. See claim 94 limitation for the compound according to claim 1 where X = CH. See claims 135, 141, 147, and 153 limitation for the compound according to claim 1 where R1 = (CRcRd)n-(6-membered heteroaryl) where n = 0. See claim 226 limitation for a selected compound that is
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.
Additionally, Pennington’926 teach compound number 9 of structure
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where examined ring A = pyrazinyl ring; examined X = CH; examined Y = S(=O)2; examined R2 = R3 = R4 = R5 = R6 = R7 = R8 = H and examined m = 1; examined p = 0; examined E = Me or CH3; and examined R1 = pyridazinyl. See page 13 Table 1 column 2 row 3. See claim 1 limitation for a compound of Formula (I-A) where ring A = pyrazinyl ring; X = CH; Y = S(=O)2; R2 = R3 = R4 = R5 = R6 = R7 = R8 = H and m = 1; R9 = absent when p = 0; E = C1 alkyl; and R1 = (CRcRd)n-(6-membered heteroaryl) where n = 0. See claim 31 limitation for the compound according to claim 1 where ring A = pyrazinyl ring.
Moreover, Pennington’926 teach compound number 4 of structure
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234
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where examined ring A = pyridinyl ring; examined X = CH; examined Y = S(=O)2; examined R2 = R3 = R4 = R5 = R6 = R7 = R8 = H and examined m = 1; examined p = 0; examined E = Me or CH3; and examined R1 = pyridazinyl. See page 13 Table 1 column 1 row 2. See claim 1 limitation for a compound of Formula (I-A) where ring A = pyridinyl ring; X = CH; Y = S(=O)2; R2 = R3 = R4 = R5 = R6 = R7 = R8 = H and m = 1; R9 = absent when p = 0; E = C1 alkyl; and R1 = (CRcRd)n-(6-membered heteroaryl) where n = 0. See claim 10 limitation for the compound according to claim 1 where ring A = pyridinyl ring.
Furthermore, Pennington’926 teach compound number 13 of structure
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226
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where examined ring A = pyridazinyl ring; examined X = CH; examined Y = S(=O)2; examined R2 = R3 = R4 = R5 = R6 = R7 = R8 = H and examined m = 1; examined p = 0; examined E = Me or CH3; and examined R1 = pyridazinyl. See page 14 Table 1 column 1 row 3. See claim 1 limitation for a compound of Formula (I-A) where ring A = pyridazinyl ring; X = CH; Y = S(=O)2; R2 = R3 = R4 = R5 = R6 = R7 = R8 = H and m = 1; R9 = absent when p = 0; E = C1 alkyl; and R1 = (CRcRd)n-(6-membered heteroaryl) where n = 0. See claim 17 limitation for the compound according to claim 1 where ring A = pyridazinyl ring.
Pennington’926 teach compound number 12 of structure
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where examined ring A = pyrimidinyl ring; examined X = CH; examined Y = S(=O)2; examined R2 = R3 = R4 = R5 = R6 = R7 = R8 = H and examined m = 1; examined p = 0; examined E = Me or CH3; and examined R1 = pyridazinyl. See page 14 Table 1 column 1 row 2. See claim 1 limitation for a compound of Formula (I-A) where ring A = pyrimidinyl ring; X = CH; Y = S(=O)2; R2 = R3 = R4 = R5 = R6 = R7 = R8 = H and m = 1; R9 = absent when p = 0; E = C1 alkyl; and R1 = (CRcRd)n-(6-membered heteroaryl) where n = 0. See claim 24 limitation for the compound according to claim 1 where ring A = pyrimidinyl ring.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1 – 3, 10, 17, 24, 31, 50, 52, 74, 90, 94-95, 226 – 229, and 234 – 239 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication Number US 2017/0226137 A1 to Fujimoto et. al. (Fujimoto’137).
Regarding claims 1 – 3, 10, 17, 24, 31, 50, 52, 74, 90, 94-95, 226 – 229, and 234 – 239, Fujimoto’137 teach substituted piperidine compound having an orexin type 2 receptor agonist activity. See page 2 paragraph 0038. Fujimoto’137 teach compounds represented by the formula:
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and
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. See page 2 paragraphs 0040 and 0043. Additionally, Fujimoto’137 teach compounds represented by the formula
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use in the prophylaxis or treatment of narcolepsy. See page 4 paragraph 0053. See claims 228, 235, and 238 limitation for methods of treating narcolepsy comprising administering a compound according to claim 1, 2, or 226. Furthermore, Fujimoto’137 teach compounds represented by the formula
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use in the treatment of cataplexy. See page 18 paragraph 0248. See claims 229, 236, and 239 limitation for methods of treating cataplexy comprising administering a compound according to claim 1, 2, or 226. Moreover, Fujimoto’137 teach that compounds of the disclosure can be administered orally, parenterally (e.g., intramuscular, intraperitoneal, intravenous, intraarterial, intraventricular, intracisternal injection or infusion; subcutaneous injection; or implant), and by topical route such as inhalation spray, intratracheal, nasal, vaginal, rectal, sublingual, subdermal, transdermal and ocular instillation administration, in a suitable unit dosage form containing a pharmaceutically acceptable conventional nontoxic carrier, adjuvant and vehicle suitable for each administration route. See page 21 paragraph 0268. See claims 227, 234, and 237 limitations for pharmaceutical compositions.
Specifically, Fujimoto’137 teach example number 5 of structure
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23
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where examined ring A = phenyl; examined X = CH; examined Y = S(=O)2; examined R2 = R5 = R6 = R7 = R8 = H and examined m = 1; examined p = 0; examined E = Me or CH3; and examined R1 =
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. See page 38 Table 1 – 1 row 1. See claim 1 limitation for a compound of Formula (I-A) where ring A = phenyl ring; X = CH; Y = S(=O)2; R2 = R5 = R6 = R7 = R8 = H and m = 1; R9 = absent when p = 0; E = C1 alkyl; and R1 = (C(=O)-C1 alkoxyl. See claim 3 limitation for the compound according to claim 1 where ring A = phenyl. See claim 50 limitation for the compound according to claim 1 where p = 0. See claim 74 limitation for the compound according to claim 1 where E = C1 alkyl. See claim 90 limitation for the compound according to claim 1 where Y = S(=O)2. See claim 94 limitation for the compound according to claim 1 where X = CH. See claim 95 limitation for the compound according to claim 1 where R1 = C(=O)-C1 alkoxyl.
Moreover, Fujimoto’137 teach example number 251 of structure
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248
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where examined ring A = pyridinyl ring; examined X = CH; examined Y = S(=O)2; examined R2 = R5 = R6 = R7 = R8 = H and examined m = 1; examined p = 0; examined E = Me or CH3; and examined R1 = acetyl. See page 103 Table 1-42 row 1. See claim 1 limitation for a compound of Formula (I-A) where ring A = pyridinyl ring; X = CH; Y = S(=O)2; R2 = R5 = R6 = R7 = R8 = H and m = 1; R9 = absent when p = 0; E = C1 alkyl; and R1 = (C(=O)-C1 alkyl. See claim 10 limitation for the compound according to claim 1 where ring A = pyridinyl ring.
Fujimoto’137 teach example number 29 of structure
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12
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where examined ring A = pyrimidinyl ring; examined X = N; examined Y = S(=O)2; examined R2 = R5 = R6 = R7 = R8 = H and examined m = 1; examined p = 0; examined E = N(CH3)2; and examined R1 =
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. See page 44 Table 1-5 row 2. See claim 1 limitation for a compound of Formula (I-A) where ring A = pyrimidinyl ring; X = N; Y = S(=O)2; R2 = R5 = R6 = R7 = R8 = H and m = 1; R9 = absent when p = 0; E = NRaRb where Ra = Rb = C1 alkyl ; and R1 = C(=O)-C3 alkoxyl. See claim 24 limitation for the compound according to claim 1 where ring A = pyrimidinyl ring. See claim 52 limitation for the compound according to claim 1 where E = NRaRb.
However, Fujimoto’137 fails to teach a compound of
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. See claim 1 limitation. Additionally, Fujimoto’137 fails to teach the compound of claim 1 where the compound is a compound of Formula (I)
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or the compound is
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. See claims 2 and 229 limitation respectively. Moreover, Fujimoto’137 fails to teach the compound of claim 1 where ring A is either a pyridazinyl ring or a pyrazinyl ring. See claims 17 and 31 limitations respectively. Furthermore, Fujimoto’137 fails to teach the compound of claim 1 where E = C1 alkylene-NRaRb. See claim 53 limitation.
Nevertheless, Fujimoto’137 does teach a compound formulas (I)
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and (II)
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which differs from the examined applications formula (I-A) of structure
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by 1) the position of examined N-R1 and 2) the arrangement of the -CH2-O- bond. Moreover, as taught above, Fujimoto’137 teach that the compounds of the prior art disclosure are also orexin type 2 receptor agonist activity useful in treating narcolepsy and cataplexy. Hence the compounds of Fujimoto’137 and the compounds of the examined application are positional isomers of each other. Consequently, compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).
With regard to claims 2 and 226 limitation for the compound of claim 1 where the compound is a compound of Formula (I)
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and/or the compound is
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;Fujimoto’137 teach compounds represented by the formula:
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and
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. See page 2 paragraphs 0040 and 0043. Thus Fujimoto’137 such that compounds of the disclosure encompasses compound species with specific stereocenters as well as racemic mixtures. Moreover, Fujimoto’137 specifically, teach example number 5 of structure
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where examined ring A = phenyl; examined X = CH; examined Y = S(=O)2; examined R2 = R5 = R6 = R7 = R8 = H and examined m = 1; examined p = 0; examined E = Me or CH3; and examined R1 =
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. See page 38 Table 1 – 1 row 1. Now while Fujimoto’137 teaches a compound wherein the O-CH2- and -NH-Y bonds are the recited stereochemistry; Fujimoto’137 fails to teach a compound where the piperidinyl ring and ring A both have a dashed bond. Given that there are only two confirmations, dashed or wedged, it would have been obvious to one of ordinary skill in the art to make and purify out the compound of structure
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.
Moreover, in regard to claims 17 and 31 limitations for the compound of claim 1 where ring A is either a pyridazinyl ring
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or a pyrazinyl ring
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; Fujimoto’137 teach example number 29 of structure
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where examined ring A = pyrimidinyl ring; examined X = N; examined Y = S(=O)2; examined R2 = R5 = R6 = R7 = R8 = H and examined m = 1; examined p = 0; examined E = N(CH3)2; and examined R1 =
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. See page 44 Table 1-5 row 2. Thus Fujimoto’137 teach a compound which differs from the examined applications formula (I-A) of structure
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by the position of the 2 N atoms in the heteroaromatic ring, that is whether the N atoms are directly adjacent or separated by 1 – 2 methylene units. Moreover, as taught above, Fujimoto’137 the compounds of the prior art, which include example number 29, are orexin type 2 receptor agonist activity useful in treating narcolepsy and cataplexy. Hence prior art example number 29 of Fujimoto’137 and compounds species of the examined application as recited in claims 17 and 31 are positional isomers of each other. Consequently, compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).
Furthermore, with regard to claim 53 limitation for the compound of claim 1 where E = C1 alkylene-NRaRb; Fujimoto’137 teach example number 29 of structure
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where examined ring A = pyrimidinyl ring; examined X = N; examined Y = S(=O)2; examined R2 = R5 = R6 = R7 = R8 = H and examined m = 1; examined p = 0; examined E = N(CH3)2; and examined R1 =
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. See page 44 Table 1-5 row 2. Thus Fujimoto’137 teach a compound which differs from the examined applications formula (I-A) of structure
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by the addition of a -CH2- unit between the S(=O)2 group and the N(CH3)2 group. Moreover, as taught above, Fujimoto’137 the compounds of the prior art, which include prior art example 29, are orexin type 2 receptor agonist activity useful in treating narcolepsy and cataplexy. Hence prior art example number 29 of Fujimoto’137 and compounds species of the examined application claim 53 are homologs of each other. Consequently, compounds which are homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).
Claims 38 and 91 are rejected under 35 U.S.C. 103 as being unpatentable over International Publication Number WO 2017/135306 A1 to Fujimoto et. al. (Fujimoto’306; cited on the IDS dated May 21st, 2026), as applied to claims 1 – 3, 10, 17, 24, 31, 50, 52, 74, 90, 94-95, 226 – 229, and 234 – 239 above, and further in view of Ali et. al. ((2014) Input of Isosteric and Bioisosteric Approach in Drug Design, J. Chem. Soc. Pak., 36, page 150-169).
The teachings of Fujimoto’306 as they relate to claim 1 from claims 38 and 91 depend, are given previously in this office action and are fully incorporated here.
However, Fujimoto’306 fail to teach the compound of claim 1 where ring A is a triazinyl ring. See claim 38 limitation. Moreover, Fujimoto’306 fail to teach the compound of claim 1 where Y = C(=O). See claim 91 limitation.
Nevertheless, Ali et. al. teach isosterism or bioisosterism is one of the approaches most frequently used in the design of new molecules. See page 150 column 1 paragraph 1. Furthermore, Ali et. al. teach that bioisosterism is a well-established technique in modern drug design, extensively studied for modification of drug target selectivity, bioactivity, efficacy, potency, membrane permeability, biotransformation pathways and toxicity profile. See page 150 column 1 paragraph 1. Moreover, Ali et. al. teach that the isosteric replacement approach is a practical and, possibly, better substitutes to recent lead optimization techniques. See page 150 column 1 paragraph 1. Specifically, Ali et. al. teach that the sulfonyl group, that is where S(=O)2 is a bioisostere for a carbonyl group, that is where C=O. See page 157 Table 7 row 1. Moreover, Ali et. al. teach that in general and in a ring system the substitution of -CH= with -N= is well established in the art as a classical substitution. See page 155 Figure 3. Thus Ali et. al. suggest the ability to either substitute a carbonyl group for a sulfonyl and/or substitute a -CH= in a ring for a -N= with a reasonable expectation that compounds with either modification would have similar biological properties.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify compound example number 29 of Fujimoto’137 in view of Ali et. al., that is to either substitute one of the pyrimidinyl -CH= with a -N= or substitute the sulfonyl group with a carbonyl group so that Y is C=O. One of ordinary skill in the art would have been motivated to make this modification to modify a drug target selectivity, bioactivity, efficacy, potency, membrane permeability, biotransformation pathways and toxicity profile. One or ordinary skill in the art would have had a reason expectation of success because the ability to either substitute a carbonyl group for a sulfonyl and/or substitute a -CH= in a ring for a -N= with a reasonable expectation that compounds with either modification would have similar biological properties.
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 – 3, 10, 17, 24, 31, 38, 50, 52, 74, 90 – 91, 94-95, 226 – 229, and 234 – 239 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 3, 10, 17, 24, 31, 38, 50, 52 – 53, 74, 90 – 91, 94 – 95, 135, 141, 147, 153, 159, 226, 227 – 229, and 234 – 239 of copending Application No. 18/983706 to Hande et.al. (reference application; Hande’706).
Hande’706 recite a compound of Formula (I-A) or a pharmaceutical pharmaceutically acceptable salt thereof:
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. See reference claim 1. Futhermore, Hande’706 recite sturctural features as defined in reference claims 2 – 3, 10, 17, 24, 31, 38, 50, 52 – 53, 74, 90 – 91, 94 – 95, 135, 141, 147, 153, 159, 226, 227 – 229, and 234 – 239. Additionally, Hande’706 recites a pharmactuical composition comprising a compound of (refrence) claims 1, 2, and 226 or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier. See reference claims 227, 234, and 237. See examined claims 227, 234, and 237. Moreover, Hande’706 recite methods of treating narcolepsy and/ or cataplexy comprising administereing to the subjected a compound of (reference) claims 1, 2, or 226 or a composition thereof. See reference claims 228 – 229, 235 – 236, and 238 – 239. See examined claims 228 – 229, 235 – 236, and 238 – 239.
However, Hande’706 fails to recite a compound of
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. See claim 1 limitation.
Nevertheless, the only difference between compounds of the examined application and copending Hande’706 is the arrangement of the -CH2-O- bond. Hence the compounds of Hande’706and the compounds of the examined application are positional isomers of each other. Consequently, compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1 – 3, 10, 17, 24, 31, 38, 50, 52, 74, 90 – 91, 94-95, 226 – 229, and 234 – 239 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 47 of U.S. Patent No. US 12441710 B2 to Pennington et. al. (Pennington’710).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the invention of Pennington’710 and copending examined application direct to the genus of substituted pyrrolidinyl and piperidinyl orexin type 2 receptor agonist. The genus of compounds taught by the claims Pennington’710 in claim 1 is identical to that taught in examined claim 1. Pennington’710 recite a compound of Formula I-A
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where reference R1, and 7 -14, T, U, V, W, X and p are defined. See reference claims 1. See examined claims 1. Furthermore, Pennington’710 recite additional structural features of compounds species of (reference) claim 1 which anticipate the general formula (I) of examined claim 1. See reference claims 2 – 47. See examined claims 2– 3, 10, 17, 24, 31, 38, 50, 52, 74, 90 – 91, 94-95, 226. Additionally, Pennington’710 recites a pharmactuical composition comprising a compound of (refrence) claim 1 or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier. See reference claim 45. See examined claims 227, 234, and 237. Moreover, Pennington’710 recite methods of treating narcolepsy and/ or cataplexy comprising administereing to the subjected a compound of (reference) claim 1 or a composition thereof. See reference claims 46 – 47. See examined claims 228 – 229, 235 – 236, and 238 – 239.
Claims 1 – 3, 10, 17, 24, 31, 38, 50, 52, 74, 90 – 91, 94-95, and 226 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 121 of U.S. Patent No. US 11760747 B2 to Pennington et. al. (Pennington’747).
Pennington’747 recite a compound of Formula I
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where reference R1, and 7 -14, T, U, V, W, X and p are defined. See reference claims 1. See examined claims 1 – 2. Furthermore, Pennington’747 recite additional structural features of compounds species of (reference) claim 1 which renders obvious general formula (I) of examined claim 2. See reference claims 2 – 121. See examined claims 2– 3, 10, 17, 24, 31, 38, 50, 52, 74, 90 – 91, 94-95, 226.
However, Pennington’747 fails to recite a compound of
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. See claim 1 limitation.
Nevertheless, the only difference between compounds of the examined application and copending Pennington’747 is the arrangement of the -CH2-O- bond. Hence the compounds of Pennington’747 and the compounds of the examined application are positional isomers of each other. Consequently, compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).
Claims 1 – 3, 10, 17, 24, 31, 38, 50, 52, 74, 90 – 91, 94-95, 226 – 229, and 234 – 239 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2 – 6 of copending Application No. 19/335265 to Pennigton et. al. (reference application; Pennington’265).
Pennington’265 recite a method of treating cataplexy in a subject in need thereof comprising administering to the subject a compound of Formula I or a pharmaceutically acceptable salt thereof, or a composition thereof, wherein the compound of Formula I or a pharmaceutically acceptable salt thereof is selected from the group consisting of a list of compounds that includes
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.See reference claim 2. See examined claims 229, 236, and 239. Futhermore, Pennington’265 additional compound species which are obvious over compounds of examined formula I-A and I. See examined claims 1 – 2.
However, Pennington’265 fails to recite a compound of
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. See claim 1 limitation.
Nevertheless, the only difference between compounds of the examined application and copending Pennington’265 is the arrangement of the -CH2-O- bond. Hence the compounds of Pennington’265 and the compounds of the examined application are positional isomers of each other. Consequently, compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).
However, Pennington’265 fails to recites a pharmactuical composition comprising a compound of claim 1 or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier. See examined claims 227, 234, and 237.
Nevertheless, given that the skill level of one of ordinary skill in the art is relatively high it would have been within the purview of such artisan to formulate the composition of Pennington’265 with a pharmaceutical acceptable excipient to facilitate the administration of the compound according to the method of (reference) claim 1. Moreover, the formulation of pharmaceutical compositions with pharmaceutical acceptable excipients is well known in the pharmaceutical arts thus one of ordinary skill in the arts would have a reasonable expectation of accomplishing such formations.
Conclusion
Claims 1 – 3, 10, 17, 24, 31, 38, 50, 52, 74, 90 – 91, 94-95, 226 – 229, and 234 – 239 are rejected.
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/DAWANNA SHAR-DAY WHITE/Examiner, Art Unit 1627
