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 .
Election/Restrictions
Applicant’s election of Group (I) in the reply filed on 05/27/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 6-8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Priority
This application is a U.S. National Stage Application of International Application No. PCT/IN2022/050772, filed August 30, 2022; which claims the benefit of priority to Indian Chinese Patent Application No. IN202141039393, filed in August 31, 2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/15/2024 has been considered by the examiner.
Drawings
The drawings are objected to because Figures 1-4 are not of sufficient quality for reproduction Specifically, the figures appear blurred and/or faded, and the labels, numerical values, and axes are not clearly legible. Therefore, the drawings are not suitable for reproduction. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The abstract of the disclosure is objected to because it characterizes the invention as “novel,” thereby implying patentability. Whether the claimed subject matter is novel is a legal determination and is not a proper characterization of the abstract. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. Specifically, the title contains the term “novel.”. The title should be limited to a brief and technically descriptive identification of the invention and should imply patentability.
The disclosure is objected to because the term “novel” is repeatedly used to characterize the invention and implies patentability. Specifically, the phrase “such as “novel stable crystalline polymorph, Form-N of lurbinectedin,” “novel crystalline form of Lurbinectedin,” and similar recitations appearing throughout the specification are improper because whether the claimed subject matter is novel is a legal determination based upon prior art. Appropriate correction is required.
Claim Objections
Claim 1 is objected to because the claim lacks a proper introductory article and uses the designation “Form-N” without first identifying the subject matter to which the designation applies. Appropriate correction is required. For example, claim 1 may be amended to recite “A crystalline Form-N of lurbinectedin.”
Claims 2-5 are objected to because the introductory phrase “The form as claimed in claim 1”, which is imprecise and inconsistent with the terminology used in claim 1. Claim 1 is directed to the specific crystalline polymorph, Form-N of lurbinectedin. Applicant is requested to amend the claims to recite “The crystalline form-N lurbinectedin of claim 1” if Applicant choose to adopts the earlier suggestion for the objection claim 1 or equivalent language for consistency with accepted claim drafting practice.
Claim 2 is further objected to because the phrase “substantially the same as of the X-ray powder diffraction patterns shown in Figure 1” is grammatically incorrect. Applicant is required to amend the phrase to read, for example, “substantially the same as the X-ray powder diffraction pattern shown in Figure 1.” Additionally, claim 2 inconsistently refers to a single X-ray powder diffraction “pattern” while subsequently referring to “patterns” shown in Figure 1. Figure 1 depicts a single X-ray powder diffraction pattern. Accordingly, Applicant is requested to amend the claim to consistently recite “the X-ray powder diffraction pattern shown in Figure 1.”
Claim 3 is also objected because the phrase “exhibits DSC as shown in Figure -2” should be revisited to identify the analytical result rather than the analytical technique. Applicant is requested to amend the claim to recite, for example, “exhibits a differential scanning calorimetry (DSC) thermogram as shown in Figure 2” or equivalent language.
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 2 and 3 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.
With respect to claim 2, the claim recites that the form of claim 1 “exhibits and X-ray powder diffraction pattern substantially the same as the X-ray powder diffraction patterns shown in Figure 1.” The metes and bounds of the claim are unclear because it is not apparent what degree of similarity to the X-ray powder diffraction pattern shown in Figure 1 is required by the phrase “substantially the same.” Moreover, the phrase “substantially the same as of the X-ray powder diffraction patterns shown in Figure 1” is grammatically unclear and renders scope of the claim uncertain. Thus, one of ordinary skill in the art would not be reasonably apprised of the scope of the claimed subject matter.
With respect to claim 3. The claim recites that the Form of claim 1 “exhibits DSC as shown in Figure-2.” The metes and bounds of the claim are unclear because differential scanning calorimetry (DSC) is an analytical technique and the claim fails to identify what feature or characteristic of the DSC thermogram shown in Figure-2 defines the claimed form. It is unclear whether the claim is intended to encompass a particular melting point, onset temperature, endothermic peak, enthalpy, or the entire thermogram. Therefore, one of ordinary skill in the art would not reasonably apprise of the scope of the claimed subject matter.
No Prior Art Rejection
Claims 1-5 have been considered with respect to the prior art of record. The closest prior art known to the Examiner is Zarzuelo et al. (WO2021/099635 A1 cited in the IDS), which teaches crystalline forms of lurbinectedin characterized by different PXRD patterns and thermal properties. However, Zarzuelo does not disclose or suggest the presently claimed PXRD peaks recited in claim 1. Accordingly, no rejection under 35 U.S.C 102 or 103 is made in the present Office Action. Nevertheless, claims 1-5 are not in condition for allowance because they are subjected to the objections and rejections set forth in this Office action, including the rejection under 35 U.S.C. 112(b). Therefore, claims 1-5 are not allowable.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEAN P CORNET whose telephone number is (571)270-7669. The examiner can normally be reached Monday-Thursday from 7.00am-5.30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L Clark can be reached at 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JEAN P CORNET/Primary Examiner, Art Unit 1628
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