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 and the newly added claim 32 are pending.
Claims 1 – 27 is rejected.
Claims 28, 30 and 32 are withdrawn.
Election/Restriction
Applicant’s election without traverse of Group I, claims 1 – 27, in the reply filed on January 13, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Applicant specifically elected compound #1097:
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The compound reads on the structure of Formula (I) (claim 1):
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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.
The compound reads on the structure of Formula in claim 27:
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, wherein:
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Examination: Applicant’s elected compound #1097 reads on claims 1 - 27. The elected species is not allowable over the prior art. Examination of the Markush-type claim has not been extended. Pursuant to Federal Register, Vol. 76, No. 27, dated February 9, 2011, page 7166 (middle column):
“Under principles of compact prosecution, the examiner should also require the applicant to elect a species or group of indistinct species for search and examination (i.e., an election of species). If the examiner does not find the species or group of indistinct species in the prior art, then the examiner should extend the search to those additional species that fall within the scope of a permissible Markush claim. In other words, the examiner should extend the search to the species that share a single structural similarity and a common use. The improper Markush claim should be examined for patentability over the prior art with respect to the elected species or group of indistinct species…within the scope of a proper Markush claim.”
Subject matter not embraced by the elected embodiment or the scope searched is therefore withdrawn from further consideration. Claims 28, 30 and 32 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Priority
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Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on December 8, 2023, October 29, 2024, April 30, 2025 and July 31, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Specification
The specification amendment filed on July 27, 2023 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. Specifically, the following new phrase is not supported by the application (as filed on July 27, 2023): “the content of each of which is hereby incorporated by reference in its entirety”. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. See MPEP 211.02 and MPEP 201.06(c)(IV). PCT Rule 20.6, Rule 20.7 and Rule 4.18 are directed specifically to 371 applications. When a benefit claim 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. In order to overcome the objection, Applicant may amend by deleting the phrase “the content of each of which is hereby incorporated by reference in its entirety”.
Claim Objections
Claims 1 and 27 are objected to because of the following informalities:
Claim 1, page 2, lines 5-6: The limitation “and N-oxides, veterinary acceptable acid addition salts, salt derivatives, solvates, ester derivatives, crystal polymorphs, isotopes, stereoisomers and tautomers” is grammatically incorrect because it is directed to a compound of Formula (I) but not recited in proper singular form. In order to overcome the objection, Applicant may amend the limitation as follows: “or a N-oxide[[s]], veterinary acceptable acid addition salt[[s]], salt derivative[[s]], solvate[[s]], ester derivative[[s]], crystal polymorph[[s]], isotope[[s]], stereoisomer[[s]] and or a tautomer[[s]] thereof”.
Claim 27, page 10, lines 5-6 of the claim: The limitation “and N-oxides, veterinary acceptable acid addition salts, salt derivatives, solvates, ester derivatives, crystal polymorphs, isotopes, stereoisomers and tautomers” is grammatically incorrect because it is directed to a compound of Formula (I) but not recited in proper singular form. In order to overcome the objection, Applicant may amend the limitation as follows: “or a N-oxide[[s]], veterinary acceptable acid addition salt[[s]], salt derivative[[s]], solvate[[s]], ester derivative[[s]], crystal polymorph[[s]], isotope[[s]], stereoisomer[[s]] and or a tautomer[[s]] thereof”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1 – 27 are rejected under 35 U.S.C. 112(a) because the specification, while being enabling for the compounds of Formula (I), and N-oxides, veterinary acceptable acid addition salts, solvates, isotopes, stereoisomers and tautomers, does not reasonably provide enablement for the ester derivatives and crystal polymorphs of the compounds. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
MPEP 2164.01(a) states:
“There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is "undue." These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure”
The Breath of the Claims and Nature of the Invention
Claim 1 is directed to a method to control parasite infestations in fish comprising administering to a fish a compound of Formula (I)
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, and N-oxides, veterinary acceptable acid addition salts, salt derivatives, solvates, ester derivatives, crystal polymorphs, isotopes, stereoisomers and tautomers. Claim 27 is directed to a method to control parasite infestations in fish according to claim 1, wherein the compound is a compound of Formula
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, and N-oxides, veterinary acceptable acid addition salts, salt derivatives, solvates, ester derivatives, crystal polymorphs, isotopes, stereoisomers and tautomers. Thus, the nature of the invention includes the scope of all ester derivatives and crystal polymorphs of the compounds of Formula (I) encompassed by the instant claims.
The State of the Prior Art and the Predictability or Lack thereof in the Art
The state of the prior art is that N-oxides, veterinary acceptable acid addition salts, salt derivatives, solvates, ester derivatives, crystal polymorphs, isotopes, stereoisomers and tautomers are known in the pharmaceutical industry. The art pertaining to the preparation and use of N-oxides, veterinary acceptable acid addition salts, salt derivatives, solvates, ester derivatives, crystal polymorphs, isotopes, stereoisomers and tautomers are compound specific and not all prodrugs have the ability to regenerate in vivo. (See “Wolff, M.E., “Burger’s Medicinal Chemistry”, pp. 975-977, and Banker et al., “Modern Pharmaceuticals”, p. 596). Ester derivatives and crystal polymorphs in related compounds are not modified. The state of the art does not teach that preparing and using the ester derivatives and crystal polymorphs of compounds as claimed.
The nature of the art is that it involves screening to determine which structural compounds exhibit the desired in vivo pharmaceutical activity. There is no absolute predictability even in view of the seemingly high level of skill in the art. Thus, the art is unpredictable since it requires each embodiment to be individually assessed for the sequestering activity. The more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute. In re Fisher, 427 F.2d 833, 166 USPQ 18 (CCPA 1970).
The Amount of Direction Provided and Existence of Working Examples
The disclosure teaches the preparation of salts, acid addition salts, solvates, and N-oxides of said compounds (see, e.g., paragraphs [0340]-[0346]):
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The specification also teaches that the compounds may exist in various isomeric forms. See, e.g., paragraphs [0347]-[0354]. Thus, the specification teaches subsequent compounds of Formula (I), and N-oxides, veterinary acceptable acid addition salts, solvates, isotopes, stereoisomers and tautomers. However, there are no data or guidance that is sufficiently described in the specification or known to a person having ordinary skill in the art to support that all of the ester derivatives and crystal polymorphs of the compounds encompassed by the instant claims can also be prepared or used. It is not the norm that one can predict with any accuracy whether a particular ester form of an active compound will be more soluble, more easily handled in formulations or more bioavailable without art recognized data to support same. The specification provides no guidance as to what type(s) of ester derivatives and crystal polymorphs are suitable for the instant compounds. Generally, ester derivatives and crystal polymorphs themselves are not considered to be therapeutically active but only to provide the active compound in vivo.
The Quantity of Experimentation Needed
Identifying ester derivatives and crystal polymorphs would require knowledge of in vivo regeneration pathways of instant compounds and short of extensive experimentation, the skilled artisan would need much more data to determine the ester derivatives and crystal polymorphs of the instant compounds and compositions. The quantity of experimentation needed is undue. Applicant has not postulated a metabolic pathway or mechanism, which facilitate conversion of the ester derivatives and crystal polymorphs into an active agent. A person having ordinary skill in the art, without direction, would be unable to regenerate the instant compounds in vivo as claimed by one or more biological processes.
As a result of the broad and unpredictable nature of the invention and the lack of specific guidance from the specification, it is respectfully submitted that the quantity of experimentation needed to make and use the invention would be great. Note that there must be sufficient disclosure, either through illustrative examples or terminology, to teach those of ordinary skill how to make and use the invention as broadly as it is claimed. In re Vaeck, 947 F.2d 488, 496 & n.23, 20 USPQ2d 1438, 1445 * n.23 (Fed. Cir. 19991). Also, note that the amount of guidance or direction needed to enable the invention is inversely related to the degree of predictability in the art. In re Fisher, 839, 166 USPQ 24. Thus, although a single embodiment may provide broad enablement in cases involving predictable factors, such as mechanical or electrical elements, in cases involving unpredictable factors, more teaching or guidance is required. In re Fisher, 427 F.2d 839, 166 USPQ 24; Ex Parte Hitzeman, 9 USPQ 2d 1823.
The specification fails to provide sufficient support for preparing and using the ester derivatives and crystal polymorphs of the compounds. The prior art also does not provide sufficient guidance. As a result, a person skilled in the art would recognize that the instantly claimed invention is unpredictable and would require an unreasonable amount of experimentation to assess the entire scope of the claimed invention and test whether the ester derivatives and crystal polymorphs of the compounds, encompassed in the present claims, can be prepared or used, with no reasonable expectation of success.
In order to overcome the rejection, Applicant can amend claims 1 and 27 to delete the limitations “ester derivatives” and “crystal polymorphs” from the scope of compound of Formula (I).
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.
Claims 1 – 27 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention.
Claims 1 and 27 recite the limitations “salt derivatives” and “ester derivatives”, which implies more than what is being positively recited. The term "derivative" can include any or all organic compounds derived from the core structure, and thus, the metes and bounds are not properly defined.
In order to overcome the rejection, Applicant may amend to delete the limitations “salt derivatives” and “ester derivatives” in claims 1 (see, page 2, lines 5-6) and 27 (see, page 10, lines 5-6 of the claim).
Claim 23 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention.
Claim 23 recites the limitation “… by topical administration such as by bath treatment or by intraperitoneal or intramuscular injection”. See, lines 3-4 of the claim. 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).
In order to overcome the rejection, Applicant may amend the rejection to delete the phrase “such as”.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 – 23 and 26 – 27 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Heemstra et al. US 9,781,935 B2 (publ. October 10, 2017; effect. filed April 17, 2015).
Heemstra et al. compound of general Formula One. See, e.g., column 23, lines 45-55. The compound of general Formula One is presented below:
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Heemstra et al. teach the compounds have pesticidal utility and the process of using the composition comprising said compounds against pests. See, e.g., Abstract, and column 1, lines 18-23. Heemstra also teaches that the compounds of Formula One can be used for controlling endoparasites and ectoparasites. See, e.g., column 524, lines 54-56. Specifically Heemstra teaches compound F309 (see, e.g., column 263, lines 36-40; and columns 627-628, last compound):
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The prior art anticipates the instant claims as presented below:
With respect to 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 teachings of Heemstra et al., compound F309 is capable of controlling parasite infestations in fish. Compound F309 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.
With respect to 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).
With respect to claim 27, the compound reads on the structure of Formula:
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, wherein:
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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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Claim 22 in US ‘211 specifically claims the method, wherein the compound is compound 453:
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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 teachings of Heemstra et al., compound F309 is capable of controlling parasite infestations in fish. Compound F309 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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Conclusion
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
/KAMAL A SAEED/Primary Examiner, Art Unit 1626