DETAILED ACTION
Notice of 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 .
Status of the Claims
The amendments filed 3/23/2026 have been entered.
Response to Arguments
Applicant’s arguments, filed 3/23/2026, have been fully considered.
Regarding the rejection of claims under 35 U.S.C. 112(b), Applicant argues that “the claims have been amended to address the Office’s concerns” (Applicant Arguments, Page 27).
Yet, as discussed in the previous Action, “while every attempt has been made to identify all deficiencies in the claims as drafted, the above indicated issues may not be exhaustive” (Paragraph 13). The claims continue to contain language which render the claims indefinite as discussed below. As such, the claims are MAINTAINED rejected.
Regarding the rejection of claims on the grounds of nonstatutory double patenting over 18/841,597, the rejection is MAINTAINED since Applicant’s filing of a terminal disclaimer over 18/841,597 was disapproved.
Regarding the rejection of claims on the grounds of nonstatutory double patenting over 18/845,625, the rejection is WITHDRAWN in view of Applicant’s filing of a terminal disclaimer over 18/845,625.
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.
Claims 1-3, 5, 16, 18 and 21-23 are MAINTAINED rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
As amended, claim 1 recites:
“A vitamin D derivative represented by the following formula (1)...
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in the formula, R represents...”
The language is grammatically cumbersome. At minimum, the claim should be amended to include “, wherein:” following structure (1).
Claim 1 further recites that “R1, R3, R8 and R10 each independently represent a C1 to C6 alkyl group optionally substituted with 1 to 3 halogen atoms, a C3 to C6 cycloalkyl group, a C1 to C6 alkoxy group optionally substituted with 1 to 3 halogen atoms, a halogen atom, or a hydrogen atom”
The recitation is ambiguous as it is unclear whether R1, R3, R8 and R10 can each represent:
a C1 to C6 alkyl group optionally substituted with 1 to 3 halogen atoms,
a C3 to C6 cycloalkyl group,
a C1 to C6 alkoxy group optionally substituted with 1 to 3 halogen atoms,
a halogen atom, or
a hydrogen atom.
Alternatively, the recitation could indicate that R1, R3, R8 and R10 can each represent:
a C1 to C6 alkyl group optionally substituted with:
(1) 1 to 3 halogen atoms,
(2) a C3 to C6 cycloalkyl group,
(3) a C1 to C6 alkoxy group optionally substituted with 1 to 3 halogen atoms,
(4) a halogen atom, or
(5) a hydrogen atom.
The definition of R2, R4, R9 and R11 is similarly confusing.
Additionally, claim 1 at times recites, for example, “R2, R4, R9 and R11 each independently represent...” (wherein R9 is not separated from “and” by comma, and a comma does not follow R11) while simultaneously reciting “R6, R7, R12, R13, R14, R15, R16, R17, R18, R19, R20, R21, R22, and R23, each independently represent...” (wherein R22 is separated from “and” by comma, and a comma does follow R23).
The language should be consistent throughout the claims.
Claims 2-3 contain similarly indefinite language.
Allowable Subject Matter
Applicant’s elected compound species,
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, which reads on claims 1-3, 5, 16, 18 and 21-23, has been searched and is deemed to be free of the prior art and non-obvious.
As such, the search was further expanded to the extent possible given the indefiniteness of the claims as discussed above.
The closest prior art is considered to be Nagasawa et al (US 7,524,980), which teach functionally related vitamin D derivatives having the following generic structure:
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(Abstract), which differs from Applicant’s elected compound species (as well as the instantly claimed compounds of Formula (1) more broadly) in the instantly claimed R group as indicated by arrow. Specifically, the instantly claimed compounds can comprise the following R group
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which differs from that of Nagasawa et al in the location of the nitrogen atom on the pyrrolidine ring as well as lacking an oxo group substitution. Considering that “[c]ompounds 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” (see MPEP 2144.09(II), citing In re Wilder, 563 F.2d 457 (CCPA 1977)), it would have been prima facie obvious to modify the location of the nitrogen atom on the pyrrolidine ring of the compound of Nagasawa et al in an effort to make a claimed compound based thereon, in the expectation that compounds similar in structure will have similar properties. However, it would not have been obvious to further remove the oxo substitution to arrive at the instantly claimed compounds.
Despite the foregoing, in view of in the indefiniteness of the claims, it cannot be determined whether the full scope of Formula (1) is free of the prior art and non-obvious. However, at minimum, Applicant’s elected compound species is considered to be free of the prior art and non-obvious.
To overcome the rejection of claims under 35 U.S.C. 112(b), the following claim 1 is proposed and Applicant is encouraged to amend all claims depending from claim 1 (including withdrawn claims) consistent therewith. Applicant is, however, advised that – despite the indication in the instant Action that the following propose claim would be ALLOWABLE – this is not an indication that the any such claim(s) will be entered after final.
Claim 1: “A vitamin D derivative of formula (1):
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,
or a pharmaceutically acceptable salt or solvate thereof, wherein:
R is selected from the group consisting of
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,
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,
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,
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and
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, wherein:
R1, R3, R8, and R10 each independently represent a hydrogen atom, a halogen atom, a C1 to C6 alkyl group optionally substituted with 1 to 3 halogen atoms, a C1 to C6 alkoxy group optionally substituted with 1 to 3 halogen atoms, or a C3 to C6 cycloalkyl group;
R2, R4, R9, and R11 each independently represent a hydrogen atom, a hydroxy atom, or a C1 to C6 alkyl group optionally substituted with 1 to 3 halogen atoms;
provided that, when R1, R3, R8, and R10 each independently represent a halogen atom or a C1 to C6 alkoxy group optionally substituted with 1 to 3 halogen atoms, then each of R2, R4, R9, and R11 substituting the same carbon atom together with said R1, R3, R8, and R10 is not a hydroxy group;
R5 represents a hydrogen atom, a C1 to C6 alkyl group optionally substituted with -OR501 or a C3 to C6 cycloalkyl group optionally substituted with -OR501, wherein R501 represents a hydrogen atom or a C1 to C6 alkyl group;
R6, R7, R12, R13, R14, R15, R16, R17, R18, R19, R20, R21, R22, and R23 each independently represent a hydrogen atom, a C1 to C6 alkyl group optionally substituted with 1 to 3 halogen atoms, or a C3 to C6 cycloalkyl group;
or each pair of R1 and R2, R3 and R4, R6 and R7, R10 and R11, R12 and R13, R14 and R15, R16 and R17, R18 and R19, R20 and R21, and R22 and R23 can be bonded together with each other to form a 3- to 5- membered ring; and
R24 represents a hydrogen atom, C1 to C3 alkyl group, or C1 to C3 alkylsulfonyl group;
X1 and X2 each independently represent a hydrogen atom or a C1 to C3 alkyl group, or X1 and X2 together form a methylidene group;
X3 represents a CH2 group or a C=CH2 group, provided that, when X1 and X2 together form a methylidene group, then X3 is not a C=CH2 group; and
n represents and integer from 1 to 3;
wherein:
the stereochemistry of the hydroxyl group at C-1 represents either the (R) configuration or the (S) configuration; and
the stereochemistry of the methyl group at C-20 represents either the (R) configuration or the (S) configuration.”
1) or a pharmaceutically acceptable salt or solvate thereof:
Amend claims 2-17 consistent therewith.
Claim 18 should be amended to recite
“A vitamin D derivative selected from the group consisting of:
(1) (1R,3S,Z)-5-(2-((1R,3aS,7aR,E)-7a-methyl-1-((S)-1-((S)-3-methylpyrrolidin-1-yl)propan-2-yl)octahydro-4H-inden-4-ylidene)ethylidene)-4-methylenecyclohexane-1,3-diol (Compound B001);
...
(234) (1R,3R,Z)-5-(2-(1R,3aS,7aR,E)-7a-methyl-1-((S)-1-(R)-3- methylmorpholino)propan-2-yl)octahydro-4H-inden-4-ylidene)ethylidene)-4- methylenecyclohexane-1,3-diol (Compound 1005); and
(235) (1R,3R,Z)-5-(2-(1R,3aS,7aR,E)-1-((S)-1-(3,3- dimethylmorpholino)propan-2eyl)-7a-methyloctahydro-4H-inden-4-ylidene)ethylidene)-4- methylenecyclohexane-1,3-diol (Compound 1006);
or a pharmaceutically acceptable salt or solvate thereof.”
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-3, 5, 16, 18 and 21-23 are MAINTAINED provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims of copending Application No. 18/841,597.
Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘597 claims are similarly drawn to compounds of formula (1) wherein R can be, for example,
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which reads on the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No new ground(s) of rejection are presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CRAIG D RICCI whose telephone number is (571) 270-5864. The examiner can normally be reached on Monday through Thursday, and every other Friday, 7:30 am - 5:00 pm ET.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached on (571) 272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CRAIG D RICCI/Primary Examiner, Art Unit 1611
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