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 .
Status of Claims
Claims 1, 3-7, 10, 12, 31-34, and 39-46 are pending in the instant application.
Claims 2, 8-9, 11, 13-30, and 35-38 are pending in the instant application.
Election/Restrictions
This action is in response to an election from a restriction requirement filed on November 20th, 2025. There are 20 claims pending and 18 claims under consideration. Claims 33-34 have been withdrawn as claims drawn to a non-elected invention. This is the first action on the merits. The present invention relates to a compound in a crystalline form having the formula as recited at instant Claim 1.
Applicant’s election without traverse of Group I, drawn to Claims 1, 3-7, 20, 12, 31-32, and 39-46 in the reply filed January 20th, 2026 is acknowledged. Therefore this restriction is considered porper and thus made FINAL.
Priority
Acknowledgement is made of Applicant’s claim for foreign priority based on the CN202210700943.X application filed in the People’s Republic of China on June 20th, 2022.
Information Disclosure Statement
The Information Disclosure Statements filed on July 29th, 2025 and January 20th, 2026 have been fully considered by the examiner, except where marked with a strikethrough.
Specification
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any of the errors of which Applicant may become aware of in the specification.
Drawings
Acknowledgement is made of the drawings received October 10th, 2023. These drawings are acceptable.
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 3-7, 10, 12, 39-40, 43, and 45 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.
Claim 3 is rendered indefinite due to the recitations of Form I and the requirement of only one or more XRPD peaks selected from the recited list. A single peak is insufficient to define a specific polymorphic form of a compound, in this case Form I. For example, a single peak recited is 7.5o 2 theta, ± 0.2o. Within the margin of error, this could include peaks ranging from 7.3o to 7.7o. Form II, as recited at Claim 4, for example, includes an XRPD peak at 7.7o. Therefore, a single peak at 7.7o is insufficient to differentiate between Forms I and II. Further, the recitation of the phrase “e.g.” renders Claim 3 indefinite, as it is unclear whether the limitations that follow are intended to be limiting.
Claim 4 is rendered indefinite due to the recitations of Form II and the requirement of only one or more XRPD peaks selected from the recited list. A single peak is insufficient to define a specific polymorphic form of a compound, in this case Form II. For example, a single peak recited is 7.7o 2 theta, ± 0.2o. Within the margin of error, this could include peaks ranging from 7.5o to 7.9o. Form I, as recited at Claim 3, for example, includes an XRPD peak at 7.5o. Therefore, a single peak at 7.5o is insufficient to differentiate between Forms I and II. Further, the recitation of the phrase “e.g.” renders Claim 4 indefinite, as it is unclear whether the limitations that follow are intended to be limiting.
Claim 5 is rendered indefinite due to the recitations of Form III and the requirement of only one or more XRPD peaks selected from the recited list. A single peak is insufficient to define a specific polymorphic form of a compound, in this case Form III. For example, a single peak recited is 7.0o 2 theta, ± 0.2o. Within the margin of error, this could include peaks ranging from 6.8o to 7.2o. Form II, as recited at Claim 3, for example, includes an XRPD peak at 7.1o. Therefore, a single peak at 7.1o is insufficient to differentiate between Forms II and III. Further, the recitation of the phrase “e.g.” renders Claim 5 indefinite, as it is unclear whether the limitations that follow are intended to be limiting.
Claim 6 is rendered indefinite due to the recitations of Form IV and the requirement of only one or more XRPD peaks selected from the recited list. A single peak is insufficient to define a specific polymorphic form of a compound, in this case Form IV. For example, a single peak recited is 21.0o 2 theta, ± 0.2o. Within the margin of error, this could include peaks ranging from 20.8o and 21.2o. Form V, as recited at Claim 7, for example, includes an XRPD peak at 20.8o. Therefore, a single peak at 20.8p is insufficient to differentiate between Forms IV and V. Further, the recitation of the phrase “e.g.” renders Claim 6 indefinite, as it is unclear whether the limitations that follow are intended to be limiting.
Claim 7 is rendered indefinite due to the recitations of Form V and the requirement of only one or more XRPD peaks selected from the recited list. A single peak is insufficient to define a specific polymorphic form of a compound, in this case Form V. For example, a single peak recited is 20.8o 2 theta, ± 0.2o. Form VIII, recited at Claim 10, for example, includes an XRPD peak at 20.8o. Therefore, a single peak at 20.8o is insufficient to differentiate between Forms V and VIII. Further, the recitation of the phrase “e.g.” renders Claim 7 indefinite, as it is unclear whether the limitations that follow are intended to be limiting.
Claim 10 is rendered indefinite due to the recitations of Form VIII and the requirement of only one or more XRPD peaks selected from the recited list. A single peak is insufficient to define a specific polymorphic form of a compound, in this case Form VIII. For example, a single peak recited is 20.8o 2 theta, ± 0.2o. Form V, recited at Claim 7, for example, includes an XRPD peak at 20.8o. Therefore, a single peak at 20.8o is insufficient to differentiate between Forms VIII and V. Further, the recitation of the phrase “e.g.” renders Claim 10 indefinite, as it is unclear whether the limitations that follow are intended to be limiting.
Claim 12 is rendered indefinite due to the recitations of Form X and the requirement of only one or more XRPD peaks selected from the recited list. A single peak is insufficient to define a specific polymorphic form of a compound, in this case Form X. For example, a single peak recited is 23.6o 2 theta, ± 0.2o. Form VIII, recited at Claim 10, for example, includes an XRPD peak at 23.6o. Therefore, a single peak at 23.6o is insufficient to differentiate between Forms X and VIII. Further, the recitation of the phrase “e.g.” renders Claim 12 indefinite, as it is unclear whether the limitations that follow are intended to be limiting.
Claim 39 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements are: Reagents required for the deprotection of Compound 1-4.
Claim 40 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements are: oxidizing agents suitable for use in the oxidation of Compound 1-3.
Regarding claim 43, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 45, the phrases "preferably" and “more preferably” render the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Allowable Subject Matter
Claim 1 is allowed.
Claims 31-32, 41-42, 44 and 46 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.
Conclusion
Claims 3-7, 10, 12, 39-40, 43, and 45 are rejected.
Claims 31-32, 41-42, 44, and 46 are objected to.
Claim 1 is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL JOHN BURKETT whose telephone number is (703)756-5390. The examiner can normally be reached Monday - Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D.J.B./ Examiner, Art Unit 1624
/JEFFREY H MURRAY/ Supervisory Patent Examiner, Art Unit 1624