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 .
Response to Amendment
The amendments received 11/25/2025 have been entered. Claims 1-14, 16, and 18 are pending. Any objection or rejection set forth in the Office Action mailed 07/31/2025 not maintained herein has been overcome and is withdrawn.
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 12-14 and 16 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 12-14 and 16 are directed toward a composition, formulation, or medicament comprising Crystalline Form M5, and a process for preparing a formulation thereof. However, the scope of these compositions would necessarily include liquids (see, for example, specification p. 16). A liquid composition would not maintain the Crystalline Form M5 therein. Rather, the ensartinib dihydrochloride: L-tartaric acid would be present in solution as its respective ions and L-tartaric acid. It is unclear how a liquid composition/formulation/medicament could contain Crystalline Form M5. Clarification is required.
Claim Rejections - 35 USC § 112(d)
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 2-5 and 7-11 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.
Claims 2-5 recite additional XRPD peaks, the FTIR spectrum, and the % amorphous composition associated with Crystalline Form M5. Claims 7-11 recite additional peaks, the salt/hydrate form, and the % amorphous composition associated with Crystalline Form T1. Claims 2-5 do not further limit claim 1. Claims 7-11 do not further claim 6. These claims recite details which are inherent to the scope of “Crystalline Form M5” and “Crystalline Form T1” as set forth in the instant specification and the limitations of claims 2-5 and 7-11 are already within the scope of claims 1 and 6, respectively.
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's arguments filed 11/25/2025 have been fully considered but they are not persuasive.
35 U.S.C. 112(b)
Regarding the rejection of claims 12-14 and 16 under 35 U.S.C. 112(b), Applicant argues that the specification extensively discloses solid pharmaceutical compositions wherein the crystalline form would be maintained, and that the claim requires that the crystalline form be present in the composition, therefore excluding dissolved formulations (Remarks, p. 8). This is not persuasive.
Applicant points to paragraph [00100] of the instant specification (Remarks, p. 8), which states, “In liquid compositions of the present invention, Ensartinib and any other solid excipients can be dissolved or suspended in a liquid carrier.” In construing the scope of the claimed compositions in light of the specification, one of ordinary skill in the art would ascertain that liquid compositions, including those wherein the ensartinib is dissolved, would be within the scope of the claimed invention. This contradicts with the instant claims, which imply that the crystalline form must be maintained. It is this contradiction that results in the claims being indefinite. Examiner suggests that the rejected claims be amended to exclude dissolved compositions/formulations/medicaments or to limit the claims to solids and suspensions.
The rejection is maintained.
35 U.S.C. 112(d)
Regarding the rejection of claims 2-5 and 7-11 under 35 U.S.C. 112(d), Applicant argues that the dependent claims need only specify a further limitation and need not claim a distinct invention (Remarks p. 8). This is not persuasive. This is not persuasive. The properties in claims 2-5 and 7-11 do not specify further limitations of claims 1 and 6, respectively, because they are inherent to the scope of claims 1 and 6, which is directed toward crystalline forms designated Form M5 and Form T1. For the claimed crystalline forms to be that of Form M5 and Form T1, all of the limitations recited in claims 2-5 and 7-11, respectively, must already be true. Therefore, while they may recite additional “details” pertaining to Form M5 and Form T1, they do not in fact further limit the claimed crystalline forms.
Applicant additionally argues that the dependent claims select a specific definition from the list of alternatives set forth in claims 1 and 6 and specify further structural or compositional limitations to narrow the scope of the invention (Remarks, p. 9). This is not persuasive for the same reasons as above, wherein the structural and compositional properties of the crystalline forms must necessarily exist (either inherently or explicitly) to be of Form M5 or Form T1.
The rejection is maintained.
Allowable Subject Matter
Claims 1, 6, and 18 are allowed.
Conclusion
Claims 1, 6, and 18 are allowed. Claims 2-5, 7-14, and 16 are rejected.
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 MADELINE E BRAUN whose telephone number is (703)756-4533. The examiner can normally be reached M-F 8:30am-5:00pm ET.
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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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/M.E.B./Examiner, Art Unit 1624 12/23/2025
/BRENDA L COLEMAN/Primary Examiner, Art Unit 1624
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