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 .
Priority
The present Application, filed August 13, 2024, is a national stage entry under 35 U.S.C. § 371 of International Patent Application No. PCT/US2023/014031, filed February 28, 2023, which claims priority to Indian Patent Application Nos. IN202211060815, IN20221057476, and IN202211010716, filed October 15, 2022, October 7, 2022 and February 28, 2022, respectively.
Status of the Claims
In the amendment filed August 13, 2024 claims 3-18 are amended. Claims 1-18 are currently pending.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on August 13, 2024 and February 26, 2026 are acknowledged.
Claim Rejections - 35 USC § 112(b)
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 2-12 and 14-15 and 18 are indefinite:
Claims 2-12 and 14-18 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 2 is indefinite for reciting, “an X-ray powder diffraction pattern substantially as depicted in Figure 3,” and “a solid state 13C NMR spectrum substantially as depicted in any of Figures 7, 8 or 9.”. Incorporation by reference to a specific figure or table “is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience.” Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993). In the present case, there is no indication that it is impractical to recite the salient features of the recited figures, such as by naming the location of XRD or NMR peaks (as is done in claim sections (b) and (c), for example). As such, the reference to Figures is not permitted and the phrases making such reference are indefinite. Claims 3-11 are indefinite for depending directly or indirectly from claim 2 without curing this indefiniteness. Claims 3 and 7 are further indefinite for repeating the figure references of claim 2.
Claim 2 is further indefinite for reciting, “and combinations of these data” in the final line, because a person of ordinary skill in the art could not reasonably determine the metes and bounds of this limitation. In particular, it is not clear what “combinations of these data” means in this context. The second line of the claim already recites that the salt “is characterized by data selected from one or more of the following,” so presumably the “combinations of these data” refers to something other than a statement that the salt can be characterized by more than one of data types (a)-(e). If the combinations includes, for example, combinations of partial data components of data sets (a)-(e), then it would be impossible to determine what combinations are within the intended scope of the claim. If the combinations refer to something else, it is uncertain what that is. For these reasons, this recitation further renders the claim indefinite.
Claim 12 is indefinite for reciting, “[a] method for preparing other crystalline forms of Trilaciclib, salts of Trilaciclib or crystalline forms thereof using the crystalline Trilaciclib hemicitrate salt of Claim 1,” because a person of ordinary skill could not reasonably determine the metes and bounds of this limitation. In particular, claim 12 purports to recite a method for preparing a crystalline salt, but recites no method steps that define the method. A claim reciting a method or process without reciting any step in the method or process merely recites a use, and is indefinite. Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986).
Similarly, claim 14 is indefinite for reciting, “[a] process for preparation of a pharmaceutical composition or formulation using the crystalline Trilaciclib hemicitrate salt of Claim 1,” because a person of ordinary skill in the art could not reasonably determine the metes and bounds of this limitation. As above, claim 14 purports to recite a process for preparation of a composition, but recites no process steps, and is indefinite for the same reason. Ex parte Erlich.
Claim 18 is indefinite for reciting “administering a therapeutically effective amount of crystalline Trilaciclib dihydrochloride salt according to Claim 1” in lines 2-3. This recitation lacks antecedent basis, because claim 1 recites a Trilaciclib hemicitrate salt, not a Trilaciclib dihydrochloride salt.
Allowable Subject Matter
Claims 1, 13, and 16-17 are allowed. Other forms and salts of Trilaciclib were known in the art; see, for example International Patent Application Publication No. WO2021/257587 to Mazurek et al. however, the art does not teach the presently claimed Trilaciclib hemicitrate.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDER K SHOWALTER whose telephone number is (571)270-0610. The examiner can normally be reached M-F 9:00 am to 5:00 pm, eastern time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S Lundgren can be reached on (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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/ALEXANDER K. SHOWALTER/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
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