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
The present FINAL Office Action is in response to December 4, 2025 Information Disclosure Statement, November 5, 2025 Amendment/Request for Reconsideration After Non-Final Amendment, Rule 132 Affidavit and corresponding documents.
Claims 7, 9-13 and 15 are pending amended and claims 1-6, 8, 14 and 16-19 are cancelled in the above-identified application.
Priority
U.S. Pat. Appln. Ser. No.: 17/995,388. Filed: October 03, 2022 is a 371 Nat.’ l Stage Entry of WO2021209477A1 (i.e., PCT/EP2021/059604, Intern.’ l Filing Date: April 14, 2021, Intern.’ l Pub. Date: October 21, 2021), which claims foreign priority to CN 20170197.6, Filed: April 17, 2020.
Information Disclosure Statement
A December 4, 2025 Information Disclosure Statement was filed in the instant application, which has been considered by the Examiner accordingly.
Inadvertent Typographical Errors In November 5, 2025 Non-Final Rejection
For clarification, the original header of the following rejection did not recite all the claim numbers recited in the body of the rejection itself and should have stated in the July 16, 2025 Non-Final Rejection:
Claims 1-13, 15 and 17-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd 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(s)), regards as the invention.
Now outstanding issues will be addressed in this action accordingly.
WITHDRAWN REJECTIONS/OBJECTIONS
Applicants are notified that any outstanding rejection(s) or objection(s), respectively, not expressly maintained in this office action now are withdrawn or rendered moot in view of Applicants amendments and/or remarks of record.
Based on Applicants November 5, 2025 Amendment and Reconsideration After Non-Final Rejection and corresponding claim amendments, the following information is acknowledged, objections and/or rejections are withdrawn or rendered moot:
Rejection of claims 1-9, 10-13, 15 and 17-18 (i.e., claims 1-6, 8, 17-18 are cancelled) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd para., is WITHDRAWN as being indefinite for failing to particularly: point out and distinctly claim the subject matter (i.e., 9[C] and 13[F] non kit maintained) Note rejection of claim 15 withdrawn in favor new rejection as necessitated by Applicant’s amendment to claim 15;
Rejection of claims 9 and 11 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th para., is WITHDRAWN for 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.
Rejection of claim 1 on the ground of non-statutory obviousness-type double patenting is WITHDRAWN as being unpatentable over claims 1-13 of U.S. Pat. No. 11,491,162, Issued: November 8, 2022 (i.e., corresp. to U.S Appln. Ser. No. 15/733,732, Filed: April 9, 2019 (“U.S. ‘162 Pat.”))
Provisional Rejection of claim 1 on the ground of non-statutory obviousness-type double patenting is WITHDRAWN as being unpatentable over claims 1-16 of U.S. Appln. Ser. No. 18/001,775; 371, Filed: December 14, 2022 (“U.S. ‘371 Appln.”; corresp. to U.S. Pat. Pub 2023/0301981 A1, Pub. Date: Sept. 28, 2023).
Rejection of claims 1-19 under 35 U.S.C. 103 is WITHDRAWN as being unpatentable over Zheng et al., “Synthesis of 7351, a new antimalarial drug”, Yaoxue Xuebao (1979), 14(12), 736-7 (see STIC SEARCH HCAPLUS STN ACCESSION NUMBER:1980:532397, DOC. No.: 93:132397, ORIG. REF. NO.:93:21109a,21112a “Zheng”), alone, in view of or in combination with WO 2019/197367 A1 to Merck Patent GMBH (i.e., Intern.’l Filing Date: April 9, 2019, Intern.l Pub Date: October 17, 2019), Fu et al.: “In vitro activity of chloroquine, the two enantiomers of chloroquine, desethyl-chloroquine and pyronaridine against Plasmodium falciparum”, Br J Clin Pharmacol. 1986, 22: 93-96.]; and
Cited teaching or informational references: i.e., inc. Material Data Sheets from Cayman Chemical, Sigma Aldrich and Ardanuy et al., “Pyronaridine Tetraphosphate Is An Efficacious Antiviral And Anti-Inflammatory Active Against Multiple Highly Pathogenic Coronaviruses”, mBio 2023 Aug 15;14(5):e01587-23. doi: 10.1128/mbio.01587-23).; and
Rejection of claim 1 under 35 U.S.C. 103 is WITHDRAWN as being unpatentable over: CN112209926A, Filed: July 12, 2019 (Google English Version; See STIC Search HCAPLUS: ACCESSION NO: 2021:106835 DOCUMENT NUMBER:174:379715) alone, in view of or in combination with Berge et al., J. Phar,. Sci., Jan 1977, Vol. 66, No. 1, pp. 1-19 and Kumar et al. Pharmaceutical Technology (March 2, 2008) Vol. 32, Issue 3.
NEW REJECTIONS NECESSITATED BY AMENDMENT
Claim Rejections - 35 USC § 112
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 7, 9-13 and 15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd 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.
Claim 7 is rejected under 35 U.S.C. 112(b) for being indefinite, vague and ambiguous because:
while it states that:
the compound 4-[(7-chloro-2-methoxybenzo[b][1,5]n aphthyridin-10-yl)amino]-2,6-bis(pyrrolidin-1-ylmethyl)phenol exist as two different and specific anhydrous solid state crystalline free base forms (VI) and (VII), resp. (shown below):
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; and
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;
the fact that:
the claim indicates that one [and/or], two peaks characteristic X-ray powder diffraction (XRPD) peaks is insufficient to definitively identify or differentiate between two specific polymorphic forms of a compound as typically 3 to 10 peaks (i.e. a minimum is required) are conventionally understood in to sufficiently characterize and distinguish a polymorphic form others.; i.e.,
One or two characteristic XRPD peaks cannot differentiate or characterize different polymorphic forms.
In the instant case, Applicants are required to either:
delete the terms “one, two” from the phrase “ . . .a powder X-ray diffraction pattern having OR
delete Forms (VI) and (VII) and just identify it as a polymorph:
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;
Claims 9-13 and 15 are rejected as being dependent from the rejected base claim.
Claim 9 is rejected under 35 U.S.C. 112(b) for being vague, ambiguous and/or indefinite.
claim 9 is directed to a medicament, which is not written in characteristic US Patent law format, i.e., e.g., typically written as a of composition of matter (where such a product is defined by physical or chemical characteristics, ingredients, proportions, not primarily by its intended use alone, unless use inherently defines the product (which is not the case here, as a "medicament" can be many things)) or a method of treatment to provide clear structural or process boundaries.
In the instant case, the phrase 'effective for treating a parasitic infection' recited in claim 9
is an intended use that does not result in a structural difference between the claimed medicament and the crystalline form in claim 7.
As such, it fails to particularly point out and distinctly claim the subject matter".
Claim 15 is indefinite because the recited process steps do not provide the specific parameters regarding essential process conditions necessary to carry out the claimed invention without undue experimentation. For example, the claim recites terms such as:
"eluting the column with water followed by methanol,"
"treating the column with methanolic ammonia," and
"concentrating resulting eluents"
are functional recitations that lack clear boundaries or conditions.
While Examples 8 and 9 in the specification detail preparation processes with specific process conditions (i.e., e.g., essential conditions, such as specific flow rates, bed volumes, elution temperatures, and concentration parameters), as claimed, the metes and bounds of the claimed process are not clear, making it difficult for a person of ordinary skill in the art to determine whether their process would infringe the claim without undue experimentation. Instead, the broad, unqualified language in the instant claims embraces potentially infinite variations, many of which may not result in the claimed crystalline form or may not be operable as claimed.
A person of ordinary skill in the art would not be able to determine, with reasonable certainty, the specific amounts of solvent, flow rates, temperatures, or final concentrations required to reliably obtain the claimed "crystalline compound form" according to the metes and bounds of the claim. The lack of these specific conditions renders the claim scope ambiguous.
Claim 15 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd 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(s)), regards as the invention.
Appropriate correction is required accordingly.
35 USC § Claim Rejections 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.
In the instant case, claim 9 is directed to a medicament, which comprises only the actual compound itself without any additional carriers, adjuvants or carriers; such that it fails to further limit the claim from which it is dependent.
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In the instant case, the phrase 'effective for treating a parasitic infection' recited in claim 9
is an intended use that does not result in a structural difference between the claimed medicament and the crystalline form in claim 7.
As such, it fails to particularly point out and distinctly claim the subject matter".
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
Applicants amendment necessitated the new ground(s) of rejection presented in this Office action. There will be no rejoinder and examination of withdrawn claims in the instant matter. 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 GRACE C HSU whose telephone number is (571) 270-1689. The Examiner can normally be reached Monday-Friday 7:30 am - 6 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicants 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, Jeffrey Murray can be reached on 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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/G.C.H./
Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624