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 .
Status of the Claims
Claims 1-13, 15-17, 19, and 22-27 are pending.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-13, 15, 17, and 22-25, drawn to crystalline forms TM2 and TM5 of Telatinib mono mesylate, in the reply filed on April 13th, 2026 is acknowledged.
Applicant’s election without traverse of the species form TM2 in the reply filed on April 13th, 2026 is acknowledged.
Crystalline form TM2 has been found free of the prior art. Thus, examination has been expanded to encompass the full scope of Group I, both form TM2 and form TM5.
Claims 16, 19, and 26-27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on April 13th, 2026.
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 and claims foreign priority to IN202111030504, filed July 7th, 2021; IN202111032580, filed July 20th, 2021; IN202111040848, filed September 9th, 2021; and IN202211020232, filed April 4th, 2022.
Claim Rejections - 35 USC § 112(b)
Indefinite
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 1-13, 15, 17, and 22-25 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.
Claims 1-3, and 5-9 recite the abbreviation XRPD. It is improper to use abbreviations in a claim unless said abbreviation is used in combination with the unabbreviated version in the first
instance in which it appears. Upon a review of the specification, it is noted that the specification teaches XRPD stands for X-ray powder diffraction.
Claims 4, 10-13, 15, and 17, which depend from claim 1, do not clarify the ambiguity of claim 1. Therefore, the rejection also applies to claims 4, 10-13, 15, and 17.
Claim Rejections - 35 USC § 112
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 and 8-9 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.
Conclusion
Claims 1-13, 15, 17, and 22-25 are rejected.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLIVER D. HEES whose telephone number is (571)272-9840. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm.
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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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/O.D.H./Examiner, Art Unit 1628
/Rayna Rodriguez/Primary Examiner, Art Unit 1628
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