DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. 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.
Current Status of 18/759,283
3. This Office Action is responsive to the amended claims of 16 October 2024.
4. Claims 1-15 are original. Claim 17 is currently amended. Claims 22-26 are new. Claims 16, 18-21 are canceled. Claims 1-15, 17, 22-26 have been examined on the merits.
Priority
5. The effective filing date 30 June 2023.
Information Disclosure Statement
6. No IDS is on file as of 06/18/2026.
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.
7. Claims 1, 3, 5, 7, 10, 13 and 15, 17, 22-26 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.
In claim 1, it cites “A crystalline form of Compound I”… ,“(Compound I Form I), wherein Compound I Form I is characterized by…”. It is mildly unclear (technically) on whether that is defining the compound since it is a parenthetical expression and following definition refers to Compound I Form I. The real subject matter should be crystalline form I of Compound I, not the compound itself.
Similar issues with claims 3, 5, 7, 10 and 13.
To overcome this rejection, here is a suggestion on rewriting the claim like “A crystalline form of Compound I, where the crystalline form is Form X, and Form X is a monohydrate characterized by…”.
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.
8. Claims 2, 4, 6, 8-9, 11-12 and 14-15 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 2, 4, 6, 8-9, 11-12 and 14-15 are not further limiting, because the independent claims 1, 3, 5, 7, 10 and 13 are to specific crystal polymorphs and those polymorphs would have all of the TGA, DSC, etc, from the respective dependent claims and it adds no further limitations. A recitation of what is in (for example) claim 10- compound 1 Form VI, fully defines what the crystalline form is and all characterizations for it are found in the spec, effectively a definition of the crystal form. You can’t have the polymorph and not have those DSC/TGA, etc, which are the inherent properties of the polymorph.
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
9. No claims are presently allowable as written.
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/BIN TAO/
Examiner, Art Unit 1625
/Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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