DETAILED ACTION
This office action is in response to applicant’s filing dated August 17, 2026.
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 .
Notice of Change of Examiner
Please note that the Examiner prosecuting this application has been changed to Examiner Rayna B. Rodriguez of Art Unit 1628. Please address all future correspondences to Examiner Rodriguez.
Status of the Claims
Claims 1-13, 15-17, 19, and 22-27 are pending. Acknowledgement is made of Applicant's remarks and amendments filed August 17, 2026. Acknowledgement is made of Applicant's amendment of claims 1-13, 15, 16, 19, and 22-27. Claims 14, 18, 20, and 21 were previously canceled.
Applicants elected without traverse Group I, drawn to crystalline forms TM2 and TM5 of Telatinib mono mesylate as the elected invention and Form (TM2) as the elected species in the reply filed on April 13, 2026. The requirement is still deemed proper. Claims 16, 19, 26, and 27 remain withdrawn.
The elected species Form (TM2) was found free of the prior art in the office action mailed May 15, 2026. Thus, examination was expanded to encompass the full scope of Group I, both form TM2 and form TM5.
Claims 1-13, 15, 17, and 22-25 are under examination as they relate to the elected invention Group I and elected species of crystalline form TM2.
Priority
This application is a 371 of PCT/US2022/035413, which claims benefit of foreign priority to IN202111030504 filed on July 7, 2021; IN202111032580 filed on July 20, 2021; IN202111040848 filed on September 9, 2021; and IN202211020232 filed on April 4, 2022.
Objections and/or Rejections and Response to Arguments
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated (Maintained Objections and/or Rejections) or newly applied (New Objections and/or Rejections, Necessitated by Amendment or New Objections and/or Rejections, NOT Necessitated by Amendment). They constitute the complete set presently being applied to the instant application.
Drawings
Acknowledgement is made of the drawings received on December 6, 2023. These drawings are accepted.
Withdrawn Objections and/or Rejections
Claim Rejections - 35 USC § 112(b)
Indefinite
The rejection of claims 1-13, 15, 17, and 22-25under 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 has been rendered moot in view of the amendment of claims 1-9. Thus, the rejection has been withdrawn.
Maintained Objections and/or Rejections
Claim Rejections - 35 USC § 112(d)
Failure to Further Limit
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 2-6, 8, and 9 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.
Claim 1 is directed to a crystalline form of Telatinib mono mesylate, designated as Form TM2, that exhibits an X-ray powder diffraction pattern having characteristic peaks expressed in degrees 2-theta at approximately 16.0, 16.5, 18.0, 22.6 and 24.9. Claims 2-6 describe X-ray powder diffraction pattern peaks of the identical compound cited in claim 1. Therefore, claims 2-6 are directed to inherent properties of the identical compound cited in claim 1. Thus, claims 2-6 do not further limit the limitations of claim 1.
Claim 7 is directed to a crystalline form of Telatinib mono mesylate, designated as Form TM2, that exhibits an X-ray powder diffraction pattern having characteristic peaks expressed in degrees 2-theta at approximately 18.3, 18.6, 20.1, 27.8 and 30.0 degrees. Claims 8-9 describe X-ray powder diffraction pattern peaks of the identical compound cited in claim 7. Therefore, claims 8-9 are directed to inherent properties of the identical compound cited in claim 1. Thus, claims 8-9 do not further limit the limitations of claim 7.
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.
Response to Arguments
Applicant argues:
The premise of the rejection has been removed by amendment. Independent claims 1 and 7 have been amended to delete the recitations "designated as Form TM2" and "designated as Form TM5," respectively. As amended, claim 1 recites "[a] crystalline form of Telatinib mono mesylate, which is characterized by an X-ray powder diffraction pattern having peaks at 16.0, 16.5, 18.0, 22.6 and 24.9 degrees 2-theta 1 0.2 degrees 2-theta," and is not limited to any single, designated crystalline form. The rejection rests on the proposition that the dependent claims recite properties of "the identical compound" already fixed by the parent claim; because neither amended claim 1 nor amended claim 7 is now directed to a single designated form, that proposition no longer applies.
Examiner's response:
The above argument has been carefully considered and has not been found persuasive.
Crystalline forms are defined by their unique three-dimensional arrangement often
described utilizing x-ray powder diffraction. X-ray diffraction pattern is an inherent property of
the crystalline form of which it describes. As set forth above, claims 2-6 describe X-ray powder diffraction pattern peaks of the identical compound cited in claim 1 and claims 8-9 describe X-ray powder diffraction pattern peaks of the identical compound cited in claim 7. Thus, claims 2-6, 8 and 9 simply express additional inherent properties of the identical compound and thus do not further limit the limitations of the claims from which they depend.
Conclusion
Claims 2-6, 8, and 9 are rejected.
Claims 1, 7, 10-13, 15, 17, and 22-27 are allowable.
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAYNA B RODRIGUEZ whose telephone number is (571)272-7088. The examiner can normally be reached 8am-5:00pm, Monday - Thursday.
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, 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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/Rayna Rodriguez/Primary Examiner, Art Unit 1628
