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 .
Status of the Claims
Claims 1 – 28, 30, 32 and newly added claim 33 are pending.
Claims 1 – 23 and 26 – 27 are rejected.
Claims 24 – 25 and 33 are objected.
Claims 28, 30 and 32 are withdrawn.
Response to Applicant’s Remarks
Applicant’s amendments/remarks filed on May 20, 2026 have been fully considered.
The objection to the specification is withdrawn in view of amendment to delete the limitation “the content of each of which is hereby incorporated by reference in its entirety”.
The objections to claims 1 and 27 are withdrawn in view of amendments to recite proper singular form in the claims.
The rejection under 35 U.S.C. §112(a) of claims 1 – 27 is withdrawn in view of amendments to delete the terms “ester derivatives and crystal polymorphs”.
The rejection under 35 U.S.C. §112(b) of claims 1 – 27 is withdrawn in view of amendments to delete the terms “salt derivatives” and “ester derivatives”.
The rejection under 35 U.S.C. §112(b) of claim 23 is withdrawn in view of amendments to delete the phrase “such as”.
Regarding the rejection under 35 U.S.C. §102(a)(1)/102(a)(2) of claims 1 – 23 and 26 – 27, Applicant’s remarks are addressed below:
On page 16, 2nd paragraph, Applicant states that the limitations “administering to a fish a compound of Formula (I)” is not part of the preamble. Applicant notes that Heemstra does not disclose a method to control parasite infestations in fish comprising administering to a fish a compound of Formula (I). Heemstra does not teach the control of parasites in an aquatic environment, and there is not teaching or suggestion that the claimed compounds of Formula (I) could be used in an effective method of controlling parasitic infestations in fish. Applicant’s remarks are persuasive. The limitation “administering to a fish a compound of Formula (I)” is an active step that requires fish as the primary subject of administration. Therefore, the rejection is withdrawn.
Regarding the provisional nonstatutory double patenting rejection of claims 1 – 23 and 26 – 27 as being unpatentable over claims 1 – 10, 17, 19 and 22 of copending Application No. 18/263,111, it is noted that the copending Application ‘211 has the same effective filing date as the instant application. MPEP 804(I)(B)(1)((b)(iii) states:
“If both the application under examination and the reference application have the same patent term filing date, the provisional nonstatutory double patenting rejection made in each application should be maintained until it is overcome. Provisional nonstatutory double patenting rejections are subject to the requirements of 37 CFR 1.111(b). Thus, applicant can overcome a provisional nonstatutory double patenting rejection by filing a reply that either shows that the claims subject to the rejection are patentably distinct from the claims of the reference application, or includes a compliant terminal disclaimer under 37 CFR 1.321 that obviates the rejection. If the reply is sufficient, the examiner will withdraw the nonstatutory double patenting rejection in the application in which it was submitted”.
Applicant states that the amended claims in the instant application and the potential amendments in Application No. 18/263,211 do not contain overlapping subject matter. Applicant’s remarks are not persuasive and the rejection is maintained.
Examination: Applicant’s amendments necessitate extending the search. The search has been extended to include the complete scope of claims 1 – 27 and 33.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on May 20, 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claims 24 – 25 and 33 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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 – 23 and 26 – 27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 10, 17, 19 and 22 of copending Application No. 18/263,211 (US ‘211) (reference application US 20240315993 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 1 in US ‘211 claims a method of treatment or control of a parasitic infestation of an animal comprising administering to an animal a Compound of Formula (I):
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340
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.
Claim 22 in US ‘211 specifically claims the method, wherein the compound is compound 453:
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.
MPEP §804(II)(B)(1)(3rd paragraph) states:
“The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim”.
MPEP §804(II)(B)(1)(5th paragraph) also states:
“In construing the claims of the reference patent or application, a determination is made as to whether a portion of the specification, including the drawings and claims, is directed to subject matter that is within the scope of a reference claim… [b]ecause that portion of the disclosure of the reference patent is an embodiment of the reference patent claim, it may be helpful in determining the full scope and obvious variations of the reference patent claim”.
In the instant case, a portion of the disclosure was analyzed to properly construe the scope of the claims in US ‘211. The disclosure of US ‘211 defines that the compound can be administered to a fish. See, e.g., paragraphs [0081] and [0098].. Because the above portion of the disclosure is an embodiment of the claims of US ‘211, the claims in US ‘211 render the instant claims unpatentable for anticipatory-type double patenting as presented below:
Regarding claims 1 – 18, the limitation “to control parasite infestations in fish” is an intended use limitation as governed by MPEP §2111.02(II). Intended use limitations are interpreted based on the structural limitations they impart to the invention. In this case, the intended use only requires that the compound of Formula (I) to control parasite infestations in fish, but does not impart any specific limitations to the structure. Based on the definition in the disclosure of US ‘211, compound 453 is administered to a fish in a method of treatment or control of parasite infestations in fish. Compound 453 reads on the structure of instant Formula (I):
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, wherein:
R1, R3, R5 – R6 and R9 – R12 are each H,
R2, R4 and R7 – R8 are each Cl,
Q1 and Q2 are each O,
X1 is CR13, wherein R13 is Cl,
X2 is CR14, wherein R14 is H, and
X3 is N(R15)(heterocyclyl), wherein R15 is H, and the heterocyclyl is pyridyl ring substituted with two F.
Regarding claims 19 – 23 and 26, the claims recite further limitations directed to the intended use limitation. As governed by MPEP §2111.02(II), the intended use does not impart any specific limitations to the structure. Based on the teachings of Heemstra et al., compound F309 is capable of controlling parasite infestations in fish as claimed, wherein:
The parasite infestation is a sea lice infestation (claim 19),
The parasite is at least one of Lepeophtheirus salmonis, Caligus celmensi, Caligus curtus, Caligus dussumieri, Caligus elongates, Caligus longicaudatus, Caligus rogercresseyi or Caligus stromii (claim 20),
The parasite infestation is with copepodites, pre-adult, or adult sea lice or a mixed infestation with various stages (claim 21),
The rate of infestation of the fish is between 0.5 and 3 parasites on average per fish in a fish facility (claim 22),
The method comprises administering to fish the compound of Formula(I) as defined in claim 1 by oral administration, or by topical administration such as by bath treatment or by intraperitoneal or intramuscular injection (claim 23), and
The fish is a salmonide (claim 26).
Regarding claim 27, the compound reads on the structure of Formula:
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, wherein:
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827
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.
Conclusion
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 Sagar Patel whose telephone number is (571)272-1317. The examiner can normally be reached Monday - Friday: 9am to 5pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant 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, Amy L. Clark can be reached at (571) 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Sagar Patel/Examiner, Art Unit 1626
/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626
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