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 .
Claim Objections
Claim 1 is objected to because of the following informalities: spelling errors. In lines 7 and 9 of claim 1, the words “heterocycyl” should be replaced with “heterocyclyl. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: missing punctuation. A semicolon is missing between the phrase“-C1-3alkylene,” and “n is 0, 1, or 2,”. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: missing conjunction. A conjunction is missing between the phrase “m is 0, 1, or 2,” and “provided that the compound,”. Appropriate correction is required.
Claim 37 is objected to because of the following informalities: missing conjunction. A conjunction is missing between the phrase “one to three R5b,” and “R5a is C1-3alkyl,”. Appropriate correction is required.
Claim 39 is objected to because of the following informalities: missing conjunction. A conjunction is missing between the last two structures for option (iii) R3. Appropriate correction is required.
Claims 43 and 45 are objected to because of the following informalities: status identifiers. Both claims 43 and 45 are missing the status identifiers describing the claims as being amended. Appropriate correction is required.
Claim 89 is objected to because of the following informalities: duplicate chemical name. The chemical name, “(1S,4S)-5-((R)-8-((4-(difluoromethoxy)phenyl)sulfonyl)-8-azaspiro[4.5]decan-2-yl)-2-oxa-5-azabicyclo[2.2.1]heptane,” appears twice in the claim. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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, 3, 5, 9, 19, 22, 29, 31, 37, 39, 43, 45, 47, 49 – 50, 68, 70 – 71, 74 – 75, 77, 82, 84, and 89 – 91 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.
Regarding claim 1, which recites the limitation, “provided that the compound is not any one of the compounds shown in Table I;” without stating the chemical name or chemical structure. Applicant is reminded that, where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted). See MPEP 2173.05(s). Additionally, claims 3, 5, 9, 19, 22, 29, 31, 37, 39, 43, 45, 47, 49 – 50, 68, 70 – 71, 74 – 75, 77, 82, 84, and 90 – 91 are included in the rejection for failing to correct the issue.
Regarding claim 89, which recites the limitation for a compound, or a pharmaceutically acceptable salt thereof, wherein the compound is selected from: “1-(8-((2-methoxy-6-methyl-2H-l12-pyridin-5-yl)sulfonyl)-8-azaspiro[4.5]decan-2-yl)azetidin-3-ol; 8-((2-methoxy-6-methyl-2H-I12-pyridin-5-yl)sulfonyl)-N-(2-methoxyethyl)-N-methyl-8-azaspiro[4.5]decan-2-amine;” is ambiguous because one or ordinary skill in the art would not know the chemical structure for either “1-(8-((2-methoxy-6-methyl-2H-l12-pyridin-5-yl)sulfonyl)-8-azaspiro[4.5]decan-2-yl)azetidin-3-ol” or “8-((2-methoxy-6-methyl-2H-I12-pyridin-5-yl)sulfonyl)-N-(2-methoxyethyl)-N-methyl-8-azaspiro[4.5]decan-2-amine.” In particular, both chemical names includes the typo “2H-l12-pyridin-5-yl,” which does not correspond to a known chemical structure. Is the typo suppose to read “2H-1,1,2-pyridin-5-yl,”“2H-1’-2-pyridin-5-yl,” or “2H-1,2-pyridin-5-yl?” Therefore, given the uncertainty around the chemical names in claim 89; claim 89 is rejected under 35 U.S.C. 112(b).
Discussion of the Prior Art
The closet prior art of International Publication Number WO 2017/214002 A1 to Tran et. al. (Tran’002; cited on the ISR and IDS form) teach certain 1-oxa-8-azaspiro[4.5]decan-3-yl-aminopropanyl-ether derivatives of Formula Ia
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134
414
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. See page 2 line 12. Particularly, Tran’002 teach compounds of Formula (Ie) of structure
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130
380
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where reference R1 is an aryl or heteroaryl. See page 37 lines 19 and 21.
However, Tran’002 fails to teach a compound wherein instant either R1 or R2 are each independently selected from H, C1-6alkyl, C3-8cycloalkyl, C3-8cycloalkenyl, 6 to 10-membered bicyclic heterocyclyl, and 4 to 6-membered monocyclic heterocyclyl, provided at least one of R1 or R2 is not H; or instant R1 and R2 together with the N atom from which they are attached form a 4 to 7-membered monocyclic heterocycle or 6 to 10-membered bicyclic heterocycle. See claim 1. Additionally, Tran’002 fails to teach any of the compound species recited in examined claim 89. See claim 89. Moreover, the prior art fails to teach a motivation for modifying the prior art compound species to obtain a compound where at least one of R1 or R2 is C1-6alkyl, C3-8cycloalkyl, C3-8cycloalkenyl, 6 to 10-membered bicyclic heterocyclyl, and 4 to 6-membered monocyclic heterocyclyl. Therefore, since the closet prior art of Tran’002 fails to anticipate or render obvious examined claims 1, 3, 5, 9, 19, 22, 29, 31, 37, 39, 43, 45, 47, 49 – 50, 68, 70 – 71, 74 – 75, 77, 82, 84, and 89 – 90; examined claims 1, 3, 5, 9, 19, 22, 29, 31, 37, 39, 43, 45, 47, 49 – 50, 68, 70 – 71, 74 – 75, 77, 82, 84, and 89 – 90 are free of the prior art. Moreover, examine claim 91 directed to a method is also free of the prior art since examined claim 91 administers a compound of examined claim 1 which was found to be free of the prior art.
Conclusion
Claims 1, 3, 5, 9, 19, 22, 29, 31, 37, 39, 43, 45, 47, 49 – 50, 68, 70 – 71, 74 – 75, 77, 82, 84, and 89 – 91 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAWANNA S WHITE whose telephone number is (703)756-4687. The examiner can normally be reached 7:00 am - 5:00 pm [EST] M - Th.
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/DAWANNA SHAR-DAY WHITE/Examiner, Art Unit 1627
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