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 .
DETAIL ACTION
This office action is a response to a 371 application filed ----- which is a national stage application of PCT/EP2022/0555521 filed 3/4/2022, which claims foreign priority to EP21161489.6 filed 3/9/2021.
As filed, claims 1 and 4-14 are pending, wherein claims 13 and 14 are new; and claims 2 and 3 are cancelled. Claims 1 and 12-14 are independent claims.
Election/Restrictions
Applicant's election with traverse of Group I – Claims 1 and 4-7 in the reply filed on 2/5/2026 is acknowledged. Regarding the newly added claims 13 and 14, these claims are drawn to the elected invention of Group I and thus, these claims will be exmined herein.
Claims 8-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 2/5/2026.
Regarding the restriction requirement, the Examiner interprets the traversal, in summary, is on the ground(s) that the compound (IIc) of Egger is an acetone solvate, and the Applicant has provided evidences (e.g. different DSC curves, different X-ray powder diffractogram, etc.) that the the crystalline modification I or II of the compound of instant formula (I) is patentably distinct from the abovementioned acetone solvate of Egger.
This is found persuasive because the Examiner confirms that the DSC curves and X-ray diffractogram of compounds (IIa), (IIb), and (IIc) of Egger are different when compared to the DSC curves and X-ray diffractogram of the crystalline modification I or II of the compound of instant formula (I). In addition, the method for making the compounds (IIa), (IIb), and (IIc) of Egger are different than the method of making the crystalline modification I or II of the compound of instant formula (I). For these reasons, the crystalline form I or II of the compound of instant formula (I) that is common between Groups I and II is a special technical feature that defines a contribution over Egger and thus, the lack of unity requirement between Group I and II are hereby withdrawn. Accordingly, claims 8-12 will be rejoined and examined herein.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2/13/2024; 2/23/2024; and 10/30/2025 has been considered by the Examiner.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Specification
The disclosure is objected to because of the following informalities:
The amendment filed 9/6/2023 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: “each of which is incorporated by reference herein in its entirety”.
MPEP 211.02 and MPEP 201.06(c)(IV) state the following in regard to “Incorporation by Reference” and PCT Rule 20.6, Rule 20.7 and Rule 4.18 are directed specifically to International applications:
MPEP 211.02, in-part
For applications filed on or after September 21, 2004, a claim under 35 U.S.C. 119(e) or 120 and 37 CFR 1.78 for benefit of a prior-filed provisional application, nonprovisional application, international application designating the United States, or international design application designating the United States that was present on the filing date of the continuation or divisional application, or the nonprovisional application claiming benefit of a prior-filed provisional application, is considered an incorporation by reference of the prior-filed application as to inadvertently omitted material, subject to the conditions and requirements of 37 CFR 1.57(b). The purpose of 37 CFR 1.57(b) is to provide a safeguard for applicants when all or a portion of the specification and/or drawing(s) is (are) inadvertently omitted from an application. See MPEP § 201.06 and 217. However, applicants are encouraged to provide in the specification an explicit incorporation by reference statement to the prior-filed application(s) for which benefit is claimed under 35 U.S.C. 119(e) or 120 if applicants do not wish the incorporation by reference to be limited to inadvertently omitted material pursuant to 37 CFR 1.57(b). See 37 CFR 1.57(c). See also MPEP §§ 217 and MPEP § 608.01(p).
MPEP 201.06(c)(IV), in-part
201.06(c) 37 CFR 1.53(b) and 37 CFR 1.63(d) Divisional-Continuation Procedure [R-07.2015]
IV. INCORPORATION BY REFERENCE
An applicant may incorporate by reference the prior application by including, in the continuing application-as-filed, an explicit statement that such specifically enumerated prior application or applications are “hereby incorporated by reference.” The statement must appear in the specification. See 37 CFR 1.57(c) and MPEP § 608.01(p). The inclusion of this incorporation by reference statement will permit an applicant to amend the continuing application to include subject matter from the prior application(s), without the need for a petition provided the continuing application is entitled to a filing date notwithstanding the incorporation by reference. For applications filed prior to September 21, 2004, the incorporation by reference statement may appear in the transmittal letter or in the specification. Note that for applications filed prior to September 21, 2004, if applicants used a former version of the transmittal letter form provided by the USPTO, the incorporation by reference statement could only be relied upon to add inadvertently omitted material to the continuation or divisional application.
An incorporation by reference statement added after an application’s filing date is not effective because no new matter can be added to an application after its filing date (see 35 U.S.C. 132(a) ). If an incorporation by reference statement is included in an amendment to the specification to add a benefit claim under 35 U.S.C. 120 after the filing date of the application, the amendment would not be proper. When a benefit claim under 35 U.S.C. 120 is submitted after the filing of an application, the reference to the prior application cannot include an incorporation by reference statement of the prior application. See Dart Indus. v. Banner, 636 F.2d 684, 207 USPQ 273 (C.A.D.C. 1980).
20.6 Confirmation of Incorporation by Reference of Elements and Parts
(a) The applicant may submit to the receiving Office, within the applicable time limit under Rule 20.7, a written notice confirming that an element or part is incorporated by reference in the international application under Rule 4.18, accompanied by:
(i) a sheet or sheets embodying the entire element as contained in the earlier application or embodying the part concerned;
(ii) where the applicant has not already complied with Rule 17.1(a), (b) or (b-bis) in relation to the priority document, a copy of the earlier application as filed;
(iii) where the earlier application is not in the language in which the international application is filed, a translation of the earlier application into that language or, where a translation of the international application is required under Rule 12.3(a) or 12.4(a), a translation of the earlier application into both the language in which the international application is filed and the language of that translation; and
(iv) in the case of a part of the description, claims or drawings, an indication as to where that part is contained in the earlier application and, where applicable, in any translation referred to in item (iii).
(b) Where the receiving Office finds that the requirements of Rule 4.18 and paragraph (a) have been complied with and that the element or part referred to in paragraph (a) is completely contained in the earlier application concerned, that element or part shall be considered to have been contained in the purported international application on the date on which one or more elements referred to in Article 11(1)(iii) were first received by the receiving Office.
(c) Where the receiving Office finds that a requirement under Rule 4.18 or paragraph (a) has not been complied with or that the element or part referred to in paragraph (a) is not completely contained in the earlier application concerned, the receiving Office shall proceed as provided for in Rule 20.3(b)(i), 20.5(b) or 20.5(c), as the case may be.
20.7 Time Limit
(a) The applicable time limit referred to in Rules 20.3(a) and (b), 20.4, 20.5(a), (b) and (c), and 20.6(a) shall be:
(i) where an invitation under Rule 20.3(a) or 20.5(a), as applicable, was sent to the applicant, two months from the date of the invitation;
(ii) where no such invitation was sent to the applicant, two months from the date on which one or more elements referred to in Article 11(1)(iii) were first received by the receiving Office.
(b) Where neither a correction under Article 11(2) nor a notice under Rule 20.6(a) confirming the incorporation by reference of an element referred to in Article 11(1)(iii)(d) or (e) is received by the receiving Office prior to the expiration of the applicable time limit under paragraph (a), any such correction or notice received by that Office after the expiration of that time limit but before it sends a notification to the applicant under Rule 20.4(i) shall be considered to have been received within that time limit.
4.18 Statement of Incorporation by Reference
Where the international application, on the date on which one or more elements referred to in Article 11(1)(iii) were first received by the receiving Office, claims the priority of an earlier application, the request may contain a statement that, where an element of the international application referred to in Article 11(1)(iii)(d) or (e) or a part of the description, claims or drawings referred to in Rule 20.5(a) is not otherwise contained in the international application but is completely contained in the earlier application, that element or part is, subject to confirmation under Rule 20.6, incorporated by reference in the international application for the purposes of Rule 20.6. Such a statement, if not contained in the request on that date, may be added to the request if, and only if, it was otherwise contained in, or submitted with, the international application on that date.
The instant application is a 371 application which has an International filing date of 3/4/2022. See a partial capture of the BIB sheet of the instant application below.
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The incorporation by reference statement is being added by way of a Preliminary Amendment filed 9/6/2023, which is after the instant application's International filing date of 3/4/2022. Therefore, the “incorporation by reference” statement being added to the instant specification by way of the Preliminary Amendment is deemed new matter.
Applicant is required to cancel the new matter in the reply to this Office Action.
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 8-11 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.
Regarding claim 8 the claim recites the phrase, “the amorphous form” wherein the word, “the”, requires antecedent basis, and it is unclear where applicant has defined “an” amorphous form. Without antecedent basis, the claim is rendered indefinite.
Regarding claim 8 the claim recites the phrase, “the crystalline modification A” wherein the word, “the”, requires antecedent basis, and it is unclear where applicant has defined “a” crystalline modification A. Without antecedent basis, the claim is rendered indefinite.
Regarding claim 9, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 10, the claim is dependent of claim 8 and it failed to correct the indefiniteness issue of claim 8, which rendered the claim indefinite.
Regarding claim 11, the term "preferable" is synonymous as the phrase, “such as”, which renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Objections
Claims 1, 4-9, 13, and 14 are objected to because of the following informalities:
Regarding claim 1, the claim recites the phrase, “which is the crystalline modification I”.
Such expression can be clarified by reciting -- which is
Regarding claim 1, the claim is not in proper form because it failed to recite the word, -- and --, before the recitation of the last reflection value.
Regarding claim 4, the claim recites the phrase, “The crystalline modification I of the compound of the formula (I) of claim 1 characterized by”.
Such expression can be clarified by reciting – The crystalline form of claim 1 is the crystalline modification I
Regarding claim 5, the claim recites the phrase, “The crystalline modification II of the compound of the formula (I) of claim 1 characterized by”.
Such expression can be clarified by reciting – The crystalline form of claim 1 is the crystalline modification II
Regarding claims 4 and 5, the claims are not in proper form because it failed to recite the word, -- and --, before the recitation of the last band maxima value.
Regarding claim 6, the claim recites the phrase, “The crystalline modification I of the compound of the formula (I) of claim 1 for use in the treatment”.
Such expression can be clarified by reciting -- The crystalline form of claim 1 is the crystalline modification I
Regarding claim 7, the claim recites the phrase, “The crystalline modification II of the compound of the formula (I) of claim 1 for use in the treatment”.
Such expression can be clarified by reciting -- The crystalline form of claim 1 is the crystalline modification II
Regarding claim 8, the claim recites the phrase, “Process for preparing the crystalline modification I”.
Such expression can be clarified by reciting -- A method
Regarding claim 9, the claim recites the phrase, “ethanol and methanol, and mixtures thereof as well as mixtures of the solvents with water”.
Such expression, can be clarified by reciting – ethanol, and mixtures of the solvents with water --.
Regarding claim 13, the claim recites the phrase, “which is the crystalline modification I”.
Such expression can be clarified by reciting -- which is
Regarding claim 14, the claim recites the phrase, “which is the crystalline modification II”.
Such expression can be clarified by reciting -- which is --.
Appropriate correction is required.
Allowable Subject Matter
Claim 12 is allowed.
Conclusion
Claims 8-11 are rejected.
Claim 12 is allowed.
Claims 1, 4-9, 13, and 14 are objected.
Claims 2 and 3 are cancelled.
The instant claims are drawn to a crystalline form of the compound of instant formula (I), a compound of instant formula (II), and a method of making the crystalline form thereof; and the XRPD and the DSC curves of the instant crystalline form, as well as the method of making the instant crystalline form do not appear to have been disclosed previously in the prior arts. For at least this reason, the instant claims are substantially differentiated from any prior art reference, such as WO2019/175043, hereinafter Egger (see IDS filed 2/13/2024). Furthermore, the prior art provide insufficient guidance or motivation that would have led a person having ordinary skill in the art to arrive at the instantly claimed process.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PO-CHIH CHEN whose telephone number is (571)270-7243. The examiner can normally be reached Monday - Friday 10:00 am to 6:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PO-CHIH CHEN/Primary Examiner, Art Unit 1621