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 .
DETAILED ACTION
Response to Amendment
The amendment filed 3/10/2026 has been entered. Newly amended Claims 6-12, 15-20, and 22-29 are pending in the application. Claims 15-16 and 18-20 are withdrawn. Claims 6-12, 17, and 22-29 are examined on the merits herein.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied and constitute the complete set presently being applied to the instant application.
Response to Applicant’s Arguments
Regarding the extant rejection over 35 USC 112(d), applicant argues “Claims 8-12 and 22-24 are the further limitations of Claim 7” (Remarks: Page 2). For example “‘comprises any 2, 3, 4 or 5 of the diffraction peak at 2Theta angle ...’ is the subordinate concept of ‘comprises at least one diffraction peak at 2Theta angle...’ in Claim 7.” While examiner understands and agrees that requiring two or more peaks is a narrower limitation than requiring a single peak, the scopes of the claims as written are not commensurate with applicant’s argument. The independent claims are written naming Forms I-V. These named forms are distinct polymorphs identified and characterized throughout applicant’s disclosure, all of which are necessarily limited by all the XRPD peaks, spectra, DSC, and TGA data as disclosed. Merely claiming the term “Form I” requires that every peak inherently present in the XRPD spectrum—whether specifically identified within the claim or not—is included as an implicit, inherent limitation in the claim reciting “Form I”.
Applicant may overcome the rejection reissued below by (1) deleting the non-limiting claims and optionally incorporating the data into the independent claim explicitly or (2) removing the language naming particular forms which necessarily carry all those limitations described in dependent claims. Applicant is advised, however, that the latter amendment option would require further search and examination because removing the specific forms from the respective claims broadens the scope to any crystal form which exhibits or would be expected to exhibit the claimed properties or renders obvious said properties.
Claim Objections
Applicant is advised that should Claim 6 be found allowable, Claim 7 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof, or vice versa. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Both independent Claims recite crystal Forms I-V of the same compound. Despite narrower or broader descriptions accompanying each form in each claim, the respective forms necessarily require all of the limitations and properties inherent to them. Therefore, Claims 6 and 7 are identical in scope.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(d)
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 8-12, 22-25, and 27-29 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.
Claims 7 and 26 describe crystal forms I-V of 6-(((R)-2-hydroxy…, which are described in the specification as being distinct polymorphs with corresponding XRPD spectra, peaks, and other properties shown in figures 1-15. The cited claims describing specific peaks do not serve to further limit the independent claims because said claims describe forms I-V which all inherently possess the properties belonging to each polymorph. Explicitly describing properties which are implicitly, inherently present does not further limit the independent claims.
Further, applicant is cautioned against using the language “optionally, further comprising” which does not limit the claim because optional limitations are not necessarily incorporated when recited in a properly dependent claim.
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
No claim is allowable.
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 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 mailing date of this final action.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Richard G. Peckham whose telephone number is (703)756-4621. The examiner can normally be reached 7:30am - 4:30pm.
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, Kortney Klinkel can be reached on (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RICHARD GRANT PECKHAM/Examiner, Art Unit 1627
/Kortney L. Klinkel/Supervisory Patent Examiner, Art Unit 1627
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