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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Current Status of 18/287,170
This Office Action is responsive to the amended claims of 10 May 2024.
Claims 1-4, 7, 9-13, 17, 27, 35-37, 52, and 54-55 are subject to a Restriction Requirement.
Election/Restriction
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claims 1-4, 7, 9-13, 17, 27, and 54-55, drawn to methods of treating Kawasaki disease using a compound of general formula (I).
Group II, claims 35-37 and 52, drawn to methods of treating Kawasaki disease using a compound of general formula (II).
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I and II share the required technical feature of: treating Kawasaki disease through the use of a compound containing the substructure of chemical formula (I) of instant claim 1 shown below.
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Groups I and II lack unity of invention because this shared technical feature is not a special technical feature, as it does not make a contribution over the prior art in view of KOYANO (US 2007/0123493 A1; Publication Date 31 May 2007) and BRAHN (Brahn, E.; Lehman, T.J.; Peacock, D.J.; et al. “Suppression of Coronary Vasculitis in a Murine Model of Kawasaki Disease Using an Angiogenesis Inhibitor” Clinical Immunology Vol. 90, No. 1, January, pp. 147–151, 1999). KOYANO teaches compounds which “have high angiogenesis inhibiting activity” (abstract), and specifically teaches compound 1-3-50 in paragraph [0639] on page 47 therein (structure shown below). BRAHN teaches that compounds which act to inhibit angiogenesis are useful for the treatment of vasculitis and Kawasaki disease in a mouse model (title and abstract).
It would have been obvious to one of ordinary skill in the art, before the instant effective filing date to test the use compound 1-3-50 (taught by KOYANO to be an angiogenesis inhibitor) for the treatment of Kawasaki disease, as is taught by BRAHN to be a useful application of angiogenesis inhibitors. The artisan would have expected success in this use of compound 1-3-50, because this compound is taught to be an angiogenesis inhibitor, as is required by the method of BRAHN. Therefore, it would have been obvious to use a compound containing the chemical substructure shared by the instant independent claims to treat Kawasaki disease, and therefore, Groups I and II lack unity.
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During a telephone conversation with Peter Hecker on 22 December 2025 a provisional election was made without traverse to prosecute the invention of Group I, being claims 1-4, 7, 9-13, 17, 27, and 54-55. Affirmation of this election must be made by applicant in replying to this Office action. Claims 35-37 and 52 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Current Status of 18/287,170
This Office Action is responsive to the telephone election of 22 December 2025.
Claims 1-4, 7, 9-13, 17, 27, 35-37, 52, and 54-55 currently pending.
Election/Restrictions
Applicant’s election without traverse of Group I, being claims 1-4, 7, 9-13, 17, 27, and 54-55 via telephone on 22 December 2025 is acknowledged. Claims 35-37 and 52 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.
Priority
Applicant’s claim for the benefit of the prior-filed patent applications PCT/CN2022/087452 (18 April 2022) and PCT/CN2021/088107 (19 April 2021) under 35 U.S.C. 119(e), 120, 121, 365(c), or 386(c) is acknowledged.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
As of 23 December 2025, Applicants have not filed an Information Disclosure Statement.
Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application for the following reasons: Figures 3A-3C contain text that is too small and/or low resolution to be legible. Fig. 4 contains the text “CXCL-1” beneath the “Vehicle” bar. This text may confuse the reader as all bars should show the expression of CXCL-1 mRNA. Applicant may choose to delete the “CXCL-1” text.
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 1, 3, and 17 are objected to because of the following informalities: Wherever the word “each” is followed by a list of items, this should be then followed by the verb “is”. The word “are” is incorrectly used in multiple locations, for example, following the list in claim 1 that begins with “each R1A, R3A…”. Applicant should find and correct all locations where the verb “are” is incorrectly used. Appropriate correction is required.
Claims 1 and 2 are objected to because of the following informalities: All uses of the phrase “together with the atoms attached thereto” should be changed to “together with the atom attached thereto”, because there can be only 1 attached atom. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: The word “wherein” is missing before the phrase “R3 and R4”. Appropriate correction is required.
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 3-4, 7, 9-13, 17, 27, and 55 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 3 and 17 each recite “or one or more of R10.1, R10.2, R10.3, and R10.4 are optionally joined to each other or to atoms of the piperazinyl ring to form a substituted or unsubstituted heterocycloalkyl”. This portion of the claim is unclear because the use of the word “or” to start the quoted phrase above indicates that the previously provided definition for R10.1 and the others does not apply here. Therefore, it is not clear what the identity of these groups is when they are joined together. This renders claims 3, 7, 9-13, 17, and 27 indefinite. Additionally, even if the word “or” above were changed to “and” the same section would still render these claims indefinite, because it is not clear how these groups would be attached to each other. Applicant may choose to delete the quoted section of claims 3 and 17.
Claim 4 recites definitions for L1 and R9, and this claim currently depends upon claim 2. These moieties are not shown within either of the parent claims of claim 4. Therefore, L1 and R9 lack antecedent basis within claim 4, rendering claim 4 indefinite. Applicant may choose to amend claim 4 to depend upon instant claim 3.
Claim 55 recites “a subject diagnosed with Periodic Fever, Aphthous Stomatitis, Pharyngitis, and Adenitis’ (“PFAPA”)”. It is unclear to the reader whether this claim indicates that the patient is suffering from PFAPA in addition to Kawasaki disease, or instead of Kawasaki disease. This renders claim 55 indefinite. The Applicant may choose to amend the claim to make clear that the patient is suffering from PFAPA in addition to Kawasaki disease. If the patient is suffering from PFAPA instead of Kawasaki disease, an amendment to clarify this would likely require a rejection under 35 USC 112(d).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3, 7, 9-13, and 54-55 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over:
Claims 1-3, 6, 8, 70-71, and 78 of copending Application No. 18/246,565 (referred to below as the ‘565 application)
in view of:
DIAKOLIOS (Diakolios, K; Bourazani, E; Adramerina, A.; et al. “KAWASAKI DISEASE IN A PFAPA PATIENT: SHOULD BE AWARE OF THIS COMBINATION” Paediatrics Today 2015;11(2):176-178).
The ‘565 application teaches the compound copied below as one of the last few compounds of claim 8 therein. The compound of the ‘565 application can be shown to fall within the scope of instant claim 1, because defining the variables of instant claim 1 as follows yields the compound of the ‘565 application: R1 is an unsubstituted C2 alkyl group (alkynyl may be synonymous with alkyl according to the definition in the instant specification), R2 is hydrogen, R3 and R4 are Cl, R6 and R7 are H, R5 is -NR5BR5C, and R5B and R5C are joined to form an unsubstituted 6-membered heterocycloalkyl group.
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Claims 70 and 78 of the ‘565 application together teach the treatment of a disease characterized by inappropriate ALPK1-dependent proinflammatory signaling in a subject, using a compound therein, wherein the subject also carries a mutation in ALPK1. Claim 71 of the ‘565 application specifically teaches the treatment of a patient suffering from periodic fever, aphthous stomatitis, pharyngitis and cervical adenitis syndrome (PFAPA).
The ‘565 application does not specifically claim the treatment of Kawasaki disease in a patient.
DIAKOLIOS teaches that PFAPA was associated with the development of Kawasaki disease in multiple pediatric patients (abstract and title).
It would have been obvious to one of ordinary skill in the art, before the instant filing date, to apply the method of treating a patient suffering from PFAPA using the compound of the ‘565 application shown above (as taught by the ‘565 application) to a patient suffering from both PFAPA and Kawasaki disease (as taught by DIAKOLIOS), for the purpose of treating the PFAPA condition of the subject. The artisan would have expected success in this application of the method of the ‘565 application, because this is the exact use defined in the method therein. Because the action of the compound of the ‘565 application is based upon its structure, and the compound of the ‘565 application and the instant claims are identical, the compound of the ‘565 application would treat both PFAPA and Kawasaki disease in the subject having both conditions, as instantly claimed.
Conclusion
No claims are currently allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN D MCANANY whose telephone number is (571)270-0850. The examiner can normally be reached 8:30 AM - 5:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ANDREW D KOSAR can be reached at (571)272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JDMc/Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625