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 .
DETAILED ACTION
Status of 17/920,001
Claims 1-2, 4, 6, 8, 10, 117-118, 123, 127, 135-137, 141-142, 144, 151, 155-157, and 170-173 are currently pending.
Priority
Instant application 17/920,001, filed 10/19/2022, claims priority as follows:
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Receipt of the certified, translated foreign priority application is acknowledged and thus, the instant claims are granted the effective filing date of 4/20/2020.
Information Disclosure Statement
All references from the IDS’s submitted on 1/5/2023, 10/30/2023, 4/1/2024, and 8/8/2025 have been considered unless marked with a strikethrough. The Examiner notes there is an additional form classified as an IDS submitted on 1/5/2023; however, it is not the PTO-1449 form and therefore will not be formally considered.
Response to Applicant Arguments/Amendments
The amendment filed 1/28/2026 has been entered. Claims 6, 8, 10, 142, 151, and 156-157 have been amended. Claims 170-173 have been added, but are not considered new matter.
In the Non-Final dated 10/29/2025, the drawings were objected to for containing pixelated and illegible images. In response, Applicant has submitted a new drawing set, but has not overcome the objection as the figures still contain pixelated and illegible text. Thus, the objection is maintained.
Claims 2, 4, 6, 8, and 10 were objected to in the Non-Final dated 10/29/2025 for being substantial duplicates of claim 1. In response, Applicant argues that according to MPEP § 608.01(n), a dependent claim must reference a previous claim and specify a further limitation, and that reciting additional XRPD peaks is a further limitation. Further, Applicant gives the example that a substance that matches the five XRPD peaks recited in claim 1 but not the additional XRPD peaks recited in claim 2 would infringe claim 1, but not claim 2. Applicants arguments have been considered but are not persuasive because current USPTO guidance on examination of polymorphs indicates that the recitation of a specific crystal form of a compound, in this case “form VI”, in a claim encompasses all of the characteristics and data points of form VI disclosed in the instant specification as well. Stated differently, because form VI of claim 1 is currently being interpreted as having all of the characteristics and data points of the instant disclosure, claims 2, 4, 6, 8, and 10 do not further limit claim 1. Thus, the objection is not overcome and maintained. Alternatively, if Applicants would like a different interpretation of the claims, Applicants would need to review the “Form” language in the claims. If Applicants remove the “Form” language, the claims will no longer convey all of the limitations of the form of the instant disclosure and Applicants can claim specific aspects of the form.
Claims 2, 4, 6, 8, and 10 were rejected under 35 U.S.C. 112(d) in the Non-Final dated 10/29/2025. Applicant has concisely presented the same arguments as above, and the Examiner has considered the arguments, but they are not found persuasive. The rejection is not overcome and is maintained.
In the Non-Final dated 10/29/2025, claims 6, 8, 10, 142, 151, and 156-157 were rejected under 35 U.S.C. 112(b). In response, Applicant has amended claims 6, 8, 10, 142, 151, and 156-157 to omit the indefinite and unclear limitations, which overcomes the rejections. The rejections are withdrawn.
In the interest of compact prosecution, the Examiner notes that claims 142 and 151 are dependent on claim 141, which was previously indicated as containing allowable subject matter, and upon the withdrawal of the 112(b) rejections above, claims 142 and 151 are now considered to contain allowable subject matter. Claims 156 and 157 are dependent on claim 155, which was also previously indicated as containing allowable subject matter. Upon the withdrawal of the 112(b) rejections of 156 and 157, the claims are now considered to contain allowable subject matter.
Additionally, new claims 170, 171, 172, and 173 are dependent on claims 141, 155, 155, and 151, respectively. Claims 141, 151, and 155 are considered to contain allowable subject matter, and thus claims 170-173 are also now considered to contain allowable subject matter.
Election/Restriction
Applicant’s election of Group I, claims 1-2, 4, 6, 8, 10, 141-142, 144, 151, and 155-157, drawn to crystal form VI of the compound of formula A and pharmaceutical compositions comprising the compound of Formula A, with traverse in the reply filed 8/20/2025 is acknowledged. Applicant’s election of the single disclosed species of pharmaceutical composition is as follows:
About 40 mg of the crystal form VI of compound A,
About 112 mg of lactose monohydrate and about 220 mg of microcrystalline cellulose,
About 12 mg of croscarmellose sodium,
About 12 mg of colloidal silica, and
About 4 mg of magnesium stearate.
In the reply filed 8/20/2025, is also acknowledged. The traversal is on the grounds that Groups I and II are related as crystal forms and preparation methods of the same. Accordingly, there is a single general inventive concept and involves a special technical feature. The Examiner agrees; there is a special technical feature, the compound of formula (A), which is known in the art. Unity of invention is broken in the Requirement for Restriction/Election dated 6/20/2025. With respect to the argument that there would be no serious burden if the groups were searched and examined together, the Examiner notes that search burden is not a requirement for restriction/election of applications filed under 35 U.S.C. 371, and consequently this argument is considered unpersuasive. The requirement is still deemed proper and is therefore made FINAL.
Examination will begin with the elected species. In accordance with MPEP § 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non- elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be examined again. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during further examination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
The elected species was searched and no prior art was identified. The scope of the search was expanded to encompass the claims of Group I and no prior art was identified. However, additional rejections were identified. Claims 1-2, 4, 6, 8, 10, 141-142, 144, 151, 155-157, and 170-173 comprise Group I and are the subject of this office action. Claims 117-118, 123, 127, and 135-137 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species and/or group, there being no allowable generic or linking claim. The withdrawn claims may be rejoined if the Group I claims are found allowable.
MAINTAINED OBJECTIONS AND REJECTIONS
Issue of Note
Claims 4, 8, and 10 recite references to figures in the claim, found in the drawings of the application. According to MPEP § 2173.05(s), claims should be complete and should not incorporate figures or tables by reference unless absolutely necessary. In the instant case, because the figures would be a large amount of information to bring into the claims, the Examiner considers it a burden to bring the figures into the claims. Therefore, the instant case is a rare occurrence where it is necessary to refer to the figures, and said figures do not need to be introduced into the claim itself.
Objection to Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because Figures 1-55 are not able to be interpreted as they are pixelated and illegible, an example being the labels of the X and Y axes. It is unclear what the figures are depicting. Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
Claim Objections
Claims 2, 4, 6, 8, and 10 are objected to under 37 CFR 1.75 as being a substantial duplicate of claim 1. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. Claim 1 recites “the crystal as claimed in claim 1, wherein the crystal is in crystal form A of the compound of formula (1)”. Please note that the term “crystal form VI” is being interpreted in light of the Specification as referring to a crystal form of formula (A) which necessarily comprises all of the characteristics disclosed for crystal Form VI in the specification, including, but not limited to: the XRPD data of Table 4.6-1 (starting on page 79), the PLM analysis, the NMR analysis, the MS analysis, the UV analysis, the DSC and TGA thermal analysis, the DVS analysis, the IR analysis, and the corresponding data in figures 8-23. See also the rejection under 112(d) further below and MPEP § 608.01(m).
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, 4, 6, 8, and 10 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 2 fails to further limit the subject matter of claim 1 upon which it depends. Claim 1 recites “the crystal form VI of a compound of formula (A)”. Please note that the term “crystal form VI” is being interpreted in light of the Specification as referring to a crystal form of the compound of formula (A) which necessarily comprises all of the characteristics disclosed for crystal Form VI in the specification, including, but not limited to: the XRPD data of Table 4.6-1 (starting on page 79), the PLM analysis, the NMR analysis, the MS analysis, the UV analysis, the DSC and TGA thermal analysis, the DVS analysis, the IR analysis, and the corresponding data in figures 8-23. Therefore, while claim 1 recites only five characteristic XRPD peaks, “form VI” recited by claim 1 is considered to necessarily comprise the additional characteristic features recited in claim 2. Consequently, claim 2 does not further limit claim 1.
Claim 4 fails to further limit the subject matter of claim 2 upon which it depends. For the same reasons identified above in claim 1, claim 4 fails to limit claim 2 due to the reference to XRPD peaks, which is already encompassed by the previous claims.
Claim 6 fails to further limit the subject matter of claim 1 from which it depends. For the same reasons identified above, claims 6 fails to limit claim 1 due to the reference to a melting endothermic peak and a thermogravimetric analysis, which is already encompassed by claim 1.
Claim 8 fails to further limit the subject matter of claim 1 upon which it depends. For the same reasons identified above, claim 8 fails to limit claim 1 due to the reference to the infrared absorption spectrum.
Claim 10 fails to further limit the subject matter of claim 1 from which it depends. For the same reasons identified above, claims 10 fails to limit claim 1 due to the reference to the absorption peaks in the UV spectrum.
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.
Close Prior Art Not Cited Under 35 U.S.C. 102 or 103
Close prior art identified is Shenzhen TargetRX, Inc. (WO 2018/133827 A1, cited in the IDS of 1/5/2023, herein after “Shenzhen”), which discloses heteroarylamide compounds as kinase inhibitors and, with respect to claims 1-2, 4, 6, 8, and 10, specifically teaches the compound of formula (A) as compound 17 (machine translation, page 26):
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Regarding claims 141-142, 144, 151, and 155-157, the reference Shenzhen teaches that compounds of the disclosure can be generated in solid forms for oral administration and may include the following components, or a compound having similar properties, and explicitly teaches an excipient such as lactose (page 23, line 42), a binder such as microcrystalline cellulose (page 23, line 42), cellulose-based materials (page 22, lines 19-20) of which croscarmellose sodium is, a glidant such as colloidal silica (page 23, line 43), and a lubricant such as magnesium stearate (page 23, line 43). For clarification, Shenzhen teaches that lactose is an excipient, whereas the instant disclosure defines lactose as a diluent. Further, Shenzhen teaches cellulose-based materials as a pharmaceutically acceptable carrier, adjuvant, or vehicle, whereas the instant disclosure defines croscarmellose sodium as a disintegrant.
However, Shenzhen fails to disclose a crystal structure of compound 17 or crystallization methods/techniques with explicit solvents disclosed in the instant specification, an example being the dissolution-precipitation crystallization conditions of Table 3.4 (page 67). There is no teaching, suggestion, or motivation in Shenzhen, or in combination with the prior art, to generate the crystal form VI of the compound of formula (A) and a pharmaceutical composition thereof.
Allowable Subject Matter
Claims 1, 141-142, 144, 151, 155-157, and 170-173 are allowed.
Conclusion
Claims 1, 141-142, 144, 151, 155-157, and 170-173 are allowed. Claims 2, 4, 6, 8, and 10 are objected to. Claims 2, 4, 6, 8, and 10 are rejected. Claims 117-118, 123, 127, and 135-137 are withdrawn.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Kendall Heitmeier whose telephone number is (703)756-1555. The examiner can normally be reached Monday-Friday 8:30AM-5:00PM ET.
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/K.N.H./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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