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 .
Application Status
The amendment filed on 1/02/2026 in response to the Non-Final Office Action of 10/02/2025 is acknowledged and has been entered. Claims 1-3, 5-6, 8-9, 15-17, 19-21, 23-25, 27, 29-30 and 54 are currently pending and under consideration.
Rejections Withdrawn in view of Amendments:
The rejection of Claims 19, 21 and 23 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in view of Applicants arguments.
Rejections Maintained, amended in view of amendments
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1 remains rejected under 35 U.S.C. 102a(1) as being anticipated by Blueprint Medicines Corporation (WO2017/079140A1, 2017-11-05, IDS) referred to herein as Blueprint.
Blueprint teaches the synthesis of a compound referred to as compound 130, wherein two diastereomers were isolated from the mixture having the structures
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in 10% and 46% yield respectfully (page 52). With the synthesis of a compound 130, Blueprint teaches the following intermediates
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138
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wherein the chloro compound would read on an activated R group (page 51). While the prior art does not specifically teach the specific diastereomers of
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128
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, the claimed limitation would appear to be present in the generic teachings of the racemate since the compound is chiral and therefore, all enantiomers would necessarily exist in the racemate.
In response to the rejection, Applicants contend that while the ‘140 publication discloses on page 50, the following compound
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, the ‘140 publication does not disclose the isomers
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159
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. Moreover, Applicants contend that contrary to the PTO’s allegation in the office Action that “the claimed limitation would appear to be present in the generic teachings of the racemate since the compound is chiral and therefore, all enantiomers would necessarily exist in the racemate”, the Federal Circuit ruled that claims to a single enantiomer pharmaceutical compound were not anticipated. See Forest Labs., Inc. v. Ivax Pharmaceuticals, Inc., 501 F.3d 1263 (Fed. Cir. 2007).
These arguments have been carefully considered, but are not found persuasive.
In the instant case, the Examiner does not dispute that a single enantiomer pharmaceutical compound were not anticipated. However, the Examiner recognizes that this ruling was for pharmaceutical compounds wherein Forest presented evidence demonstrating the difficulty in separating the enantiomers and the unexpected properties of (+)-citalopram. In the instant case, no evidence has been submitted discussing the difficulties in separating these enantiomers and further, the instant compounds is an intermediate and no biological activity exists on record.
Thus, the rejection of claim 1 is maintained.
New Rejections Necessitated by the amendment
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 15-17 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 15, which depends from claim 1, recites “… wherein the compound is a compound of formula (V):
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”. However, compound V was amended out of claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Conclusion
Claims 2-3, 5-6 and 8-9 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 19-21, 23-25, 27, 29-30 and 54 appear to be in condition for allowance.
The closest prior art was discussed in the prior office action.
Applicant's amendment necessitated the new ground(s) of rejection 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON J FETTEROLF whose telephone number is (571)272-2919. The examiner can normally be reached M-F 6AM-4PM.
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 S Lundgren can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRANDON J FETTEROLF/Primary Examiner, Art Unit 1626