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 .
Election/Restrictions
Applicant's election with traverse of the following species:
N-(2,3-Dihydro-4H-benzo[b][1,4]oxazin-4-yl)-6-fluoro-3-(2-hydroxypropan-2-yl)-7-(2,3,5-trifluorophenyl)thieno[3,2-b]pyridine-2-carboxamide having the structure of:
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(compound 6.1 recites in paragraph [0592] of the specification)
is maintained.
Amended claim 18, and newly submitted claim 19 directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: the invention originally claimed is drawn to a product (i.e., “[a] compound of formula (I)”) whereas the newly added claims are drawn to a process (i.e., “[a] method of control, treatment and/or prevention of a disease”). If the newly submitted claims were earlier presented, the groups of inventions would subject to election/restriction requirement shown below:
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 1-17, drawn to a compound of formula (I)
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; and a pharmaceutical composition comprising a compound of formula (I) and/or a salt thereof, and at least one acceptable carrier.
Group II, claims 18 and 19, drawn to a method of control, treatment and/or prevention of a disease, comprising administering the compound of formula (I) of claim 1 and/or a salt thereof, wherein the disease is an infection caused by endoparasites, optionally a helminthic infection, optionally a heartworm infection.
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:
Group I-II lack unity of invention because even though the inventions of these groups require the technical feature of the compound of formula (I), this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Koolman et al. (WO 2021/242581 A1), which is addressed in the 35 U.S.C. 102 rejection set forth in the Non-Final Office Action mailed on December 29, 2025; and also does not make contribution over the prior art(s) set forth in the 103 rejection below.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 18-19 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Expansion of Election of Species Requirement
A reasonable and comprehensive search of the elected compound species of formula (I) conducted by the Examiner determined that the prior art at the time of the present invention was such that it did not anticipate or render obvious the elected species:
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. In light of this discovery, the search is expanded to the subject matter of the subgenus of the elected species, i.e., the compound of the formula (I), wherein the compound has the structure of:
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,
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,
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or
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.
Status of the Claims
Acknowledgement is made of the receipt and entry of the amendment to the claims filed on April 28, 2026, wherein claims 1-9, 16 and 18 are amended; claims 10-15 and 17 are unchanged; and claim 19 is amended.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-19 are pending.
Claims 18-19 are withdrawn.
Claims 1-17 under examination in accordance with the elected species along with the expanded compound species sets forth in the Expansion of Election of Species Requirement section above.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/18/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Priority
The instant application 18/253,061 filed on March 16, 2023 is a 371 of PCT/EP2021/081991 filed
on November 17, 2021, which claims priority to, and the benefits of U.S. Provisional Application No.
63/123,268 filed on December 9, 2020, U.S. Provisional Application No. 63/121,501 filed on December 4, 2020, and U.S. Provisional Application No. 63/115,478 filed on November 18, 2020.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications, U.S. Provisional Application No. 63/123,268, U.S. Provisional Application No. 63/121,501, and U.S. Provisional Application No. 63/115,478, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Each of these prior-filed applications failed to disclose the elected compound species of formula (I) having the structure of:
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. In addition, each of these prior-filed application also failed to disclose the expanded compound species sets forth in the Expansion of Election of Species Requirement section above; Therefore, to the extent that the claims are drawn to the elected compound species or the expanded compound species, the claims not entitled to the benefit of the prior-filed applications and will receive an effective filling date of November 17, 2021, which is the filling date of 371 of PCT/EP2021/081991.
Response to Arguments
Applicant's arguments filed on April 28, 2026 with respect to the disclosure of prior-filed applications have been fully considered but they are not persuasive.
In Summary, Applicant argues the prior-filed application discloses the genus of compound of formula (I), wherein the structures of:
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;
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; and
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are disclosed; and that provides sufficient support for a skilled person to arrive at the elected species and the expanded compound species.
In response, applicant’s argument is not found persuasive. The disclosure of a broad genus in a prior-filed applications do not support a later filed claim to a previously unnamed single species. The mere fact that the species falls within the boundaries of a broadly described genus does not mean the disclosure adequately describe each and every species falls within the scope of the broad genus in the original filing. Therefore, applicant’s arguments with respect to the priority section above is not found persuasive.
Action Summary
Acknowledgement is made of the receipt and entry of the amendment to the specification filed on April 28, 2026. Applicant’s amendment to the specification overcome each and every objection previously sets forth in the Non-Final Office Action mailed on December 29, 2025.
Acknowledgement is made of the receipt and entry of the amendment to the claims filed on April 28, 2026; However, Applicant’s amendment to the claims does not overcome each and every objection previously sets forth in the Non-Final Office Action mailed on December 29, 2025. Specifically, no amendment was made for the phrase “; and”, which is recited twice in between the two chemical structures (see objection shown below).
Claim 18 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for controlling or treating helminthic infection caused by Nippostrongylus brasiliensis, Dirofilaria immitis, C. elegans, Haemonchus contortus or Trichostrongylus colubriformis to the extent that the term “controlling” and “treating” does not includes preventing, does not reasonably provide enablement for controlling, treating and/or preventing each and every disease is withdrawn in light of the claim amendments that changes the invention. Specifically, applicant amends the claim from a product with intended use(s) to a process with active steps; and therefore, amended claim 18 is now drawn to an invention non-elected.
Claims 1-18 rejected on the judicially-created basis that it contains an improper Markush grouping of alternatives are maintained, but revisited and modified in light of the claim amendments.
Claims 1-6, 8-14 and 17-18 rejected under 35 U.S.C. 102(a)(2) as being anticipated by Koolman et al. (WO 2021/242581 A1; cited in the IDS filed on May 16, 2023) are withdrawn in light of the claim amendments.
Claims 1-15 and 17-18 rejected under 35 U.S.C. 103 as being unpatentable over Long et al. (WO 2020/191091 A1; cited in the IDS filed on May 16, 2023) in view of Koolman et al. (WO 2021/242581 A1; cited in the IDS filed on May 16, 2023) are maintained, but revisited and modified in light of the claim amendments.
Claims 1-18 rejected under 35 U.S.C. 103 as being unpatentable over Long et al. (WO 2020/191091 A1) in view of Koolman et al. (WO 2021/242581 A1) as applied to claims 1-15 and 17-18 above, and further in view of Long et al. (WO 2020/191091 A1; cited in the IDS filed on May 16, 2023) are maintained, but revisited and modified in light of the claim amendments.
Claims 1-15 and 17-18 rejected under 35 U.S.C. 103 as being unpatentable over Ducray et al. (US 2020/0385398 A1; cited in the IDS filed on May 16, 2023) are maintained, but revisited and modified in light of the claim amendments.
Claims 1-15 and 17-18 rejected under 35 U.S.C. 103 as being unpatentable over Pautrat et al. (US 2024/0360116 A1) are maintained, but revisited and modified in light of the claim amendments.
Claims 1-15 and 17-18 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 19-21 of copending Application No. 18/255,134 (reference application) are maintained, but revisited and modified in light of the claim amendments.
Claims 1-15 and 17-18 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 21, 23 and 25-27 of U.S. Patent No. 12,448,391 B2 (referred to herein as the reference patent) are maintained, but revisited and modified in light of the claim amendments.
Claim Objections
Claim 9 remain objected to because of the following informalities:
Regarding claim 9, the phrase “; and” is recited twice in the same sentence shown below (see shaded):
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, and this appears to be a typographical error.
Appropriate correction is required.
Claim Rejections - 35 USC § 112 – Improper Markush Grouping
Claims 1-17 remain rejected on the judicially-created basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). The improper Markush grouping includes species of the claimed invention that do not share both a substantial structural feature and a common use that flows from the substantial structural feature.
A Markush claim contains an “improper Markush grouping” if: (1) The species of the Markush group do not share a single structural similarity,” or (2) the species do not share a common use. Members of a Markush group share a "single structural similarity” when they belong to the same recognized physical or chemical class or to the same recognized physical or chemical class or to the same art-recognized class. Members of a Markush group share a common use when they are disclosed in the specification or known in the art to be functionally equivalent (see Federal Register, Vol. 76, No. 27, Wednesday, February 9, 2011, p. 7166, left and middle columns, bridging paragraph).
The members of the improper Markush grouping do not share a substantial feature for the following reasons:
In the present case, the claims recite a compound of formula (I)
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. The Markush grouping of these compound species alternatives of formula (I) is improper, because the alternatives defined by the Markush grouping do not share a substantial structural feature and a common use of treating infections caused by endoparasites, helminthic, and/or heartworms that flows from the substantial structural feature. It is noted that the following moiety:
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is the only portion of the formula (I) that each compound species shares in common, and that is not a substantial structure feature that constituted to the common use of treating infections caused by endoparasites, helminthic, and/or heartworms.
For instance, the moiety of
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of formula (I) includes ring alternatives having the structure of:
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and
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. According to Yamazaki et al. (US 5,440,036A), compound 14 having the structure of:
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is an exemplary compound of formula (I) with potassium channel activating effects that are useful as preventives or therapeutics for circulatory diseases, led by ischemic heart diseases such as angina pectoris and myocardial infarction and including hypertension and arrhythmia (see e.g., Col. 13, Table 4, Compd No. 14; Col. 2, line 16-24). According to Goto et al. (US 5,668,087), compound 198 having the structure of:
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, wherein R1 is
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; and
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is
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, is an exemplary compound of formula (I) with strong herbicidal activity useful as selective herbicides (see e.g., Col. 2, line 30-31; Col. 41, Table 1, Compound No. 198). In Summary, even though the compound species taught by each of these cited references contain the same moiety of
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, said compounds are taught to have a different use rather than treating infections caused by endoparasites, helminthic, and/or heartworms. Therefore, it is not apparent that the moiety of
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of formula (I) alone is the substantial structure feature that contribute to the desired properties instantly claimed as the compounds taught by the cited references do not share a common use.
In addition, the J moiety of formula (I) includes ring alternatives having the structure of:
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, and
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. According to Ochs et al. (US 2012/0130078 A1), 1H-benzotriazole-5-carbozamide having the structure of:
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is an exemplary compound of formula (II) useful for the treatment of diabetes (see e.g., [0002];[0058]). According to Wishka et al. (WO 03/022856 A1), compound of Example 16 having the structure of:
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is an exemplary compound of Formula I useful in treating disease or condition in which [Symbol font/0x61]7 nicotinic acetylcholine receptors are known to be involved, such as schizophrenia (see e.g., p. 127, Example 16; abstract; claim 73). Each of these cited reference further demonstrates that the compounds containing the alternatives of the J moiety do not share a common use of treating infections caused by endoparasites, helminthic, and/or heartworms.
In view of the foregoing, not all members recited in the Markush grouping share a substantial structural feature and a common use that flows from the substantial structural feature. Accordingly, claims 2-18 are rejected based on their dependency on a rejected base claim that contains an improper Markush grouping of alternatives.
In response to this rejection, Applicant should either amend the claim(s) to recite only individual species or grouping of species that share a substantial structural feature as well as a common use that flows from the substantial structural feature, or present a sufficient showing that the species recited in the alternative of the claims(s) in fact share a substantial structural feature as well as a common use that flows from the substantial structural feature. This is a rejection on the merits and may be appealed to the Board of Patent Appeals and Interferences in accordance with 35 U.S.C. §134 and 37 CFR 41.31(a)(1) (emphasis provided).
Response to Arguments
Applicant's arguments filed on April 28, 2026 have been fully considered.
Applicant's arguments filed on April 28, 2026 with respect to the rejection of claims 1-17 on the judicially-created basis that it contains an improper Markush grouping of alternatives have been fully considered but they are not persuasive.
Applicant amends claim 18 from the recitation of “[t]he compound of formula (I) and/or salt according to claim 1” to the recitation of “[a] method of control, treatment and/or prevention of a disease, comprising administering the compound of formula (I) of claim 1 and/or a salt thereof”, and that changes the claim to an invention non-elected. Applicant further amends claim 16 from the recitation of “[t]he compound of claim 1” to the recitation of “[a] compound”, and that changes the dependency of the claim. Each of these findings demonstrate the amendment changes the scope of the claims, thus, the rejection of record has been revisited and modified in light of the claim amendments.
In Summary, applicant argues the Markush grouping of compound of formula (I) is proper, because the common structural feature does not necessarily need to be novel itself; and that common structure element is considered significant because it is essential for the shared anthelmintic property, which is not taught by the cited reference.
In response, applicant’s argument is not found persuasive. Applicant appears to mischaracterize the rejection of record, because the cited references are applied to support that the structure feature shared by all alternative members of group does not constitute a substantial structural feature essential for the common utility, rather than establishing the common structure feature is not novel. As noted in the rejection above, the moiety having the structure of:
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is the only structure feature that each compound species of formula (I) shares in common, and several references have established that simply having said moiety in common does not exhibit the same activity as claimed (treating or preventing an infection caused by endoparasites), e.g., compound 14 of Yamazaki et al. has potassium channel activating effects rather than treating or preventing an infection caused by endoparasites. In other words, applicant’s assertion that said moiety shared among all compound species of formula (I) is a significant structure feature essential for the common use appears to be mere argument without objective evidence, because said moiety does not represent a significant portion of the molecule as a whole, and it is not apparent that this structure feature alone (
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) constitute the common utility for treating or preventing an infection caused by endoparasites.
There is also insufficient disclosure to provide adequate bases for concluding that the unexemplified compound species of formula (I) instantly claimed can successfully treat or prevent the full scope of infection caused by endoparasites. For example, the disclosure fails to exemplify compound species of formula (I) with
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,
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, or
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at
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;
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at
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; and
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or
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at J has the same desired properties (treating or preventing an infection caused by endoparasites); therefore, the compound species embraced by formula (I) are so varied such that each species of the Markush grouping do not share a structural similarities that is substantial for the compound as a whole.
Therefore, applicant’s argument is not found persuasive.
Claim Rejections - 35 USC § 103
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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-15 and 17 remain rejected under 35 U.S.C. 103 as being unpatentable over Long et al. (WO 2020/191091 A1; cited in the IDS filed on May 16, 2023) in view of Koolman et al. (WO 2021/242581 A1; cited in the IDS filed on May 16, 2023).
Long et al. teaches a compound 204-0 having the structure of:
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(referred to herein as “Compound 204”) is an exemplary compound of Formula (I) useful for the treatment, control or prevention of a parasitic infestation or infection in an animal in need thereof (see e.g., p. 173, compound labeled “204-0”; p. 211, cmpd 204). Long et al. further teaches a veterinary acceptable composition comprising a compound of Formula (I) and a veterinary acceptable carrier useful for controlling parasites, including helminths (see e.g., p.4, line 12-15).
Long et al. does not teach the expanded compound species sets forth in the Expansion of Election of Species Requirement section above (
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).
Koolman et al. teaches a compound 614 having the structure of:
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(see e.g., p. 200, Scheme 24, Compound 614) and a compound 306 having the structure of:
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(see e.g., p. 149, Scheme 12, Compound 306) are exemplary compounds of Formula (I) useful for the treatment, control or prevention of a parasitic infestation or infection in an animal in need thereof (see e.g., claim 33; abstract). Koolman et al. further teaches the compound of Formula (I):
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, wherein the group
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represents the following groups, inter alia,
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Ring System A and
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Ring System AAA (see e.g., claim 33).
In the instant case, the difference between the compound 204 of Long et al. and the claimed compound lies on the benzopyran ring of the compound 204 shown below (see shaded):
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.
It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to select the compound 204 of Long et al. and then modify said compound by substituting the benzopyran ring
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with a benzomorpholine ring
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, as taught by Koolman et al. One would have been motivated to do so, because Koolman et al. clearly teaches that when interchanging the benzopyran ring
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(Ring System A) with a benzomorpholine ring
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(Ring System AAA) would successfully arrive at a compound useful for the treatment, control or prevention of a parasitic infestation or infection in an animal in need thereof; and specifically exemplify the compound 614 and the compound 306 in the working examples. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that by substituting the benzopyran ring of the compound 204 of Long et al. with a benzomorpholine ring having the structure of:
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would have successfully treat, control or prevent a parasitic infestation or infection.
Regarding the limitation of “[a] pharmaceutical composition comprising a compound of formula (I) according to claim 1, and/or a salt thereof, and at least one acceptable carrier” in claim 17, it would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to combine the modified compound 204 of Long et al. and Koolman et al. sets forth above with a veterinary acceptable carrier, as taught by Long et al. One would have been motivated to do so, because Long et al. clearly teaches the compound of Formula (I) can be combined with a veterinary acceptable carrier to arrive at a veterinary composition useful for controlling parasites. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that by combining the modified compound 204 of Long et al. and Koolman et al. sets forth above with a veterinary acceptable carrier, which is an acceptable carrier, would have successfully arrive at a veterinary composition that is a pharmaceutical composition useful for controlling parasites; and that meets the structural limitation of a pharmaceutical composition instantly claimed.
Therefore, the claimed invention is prima facie obvious to one of ordinary skill in the art at the time the application was filed, absent factual evidence to the contrary.
Claims 1-17 remain rejected under 35 U.S.C. 103 as being unpatentable over Long et al. (WO 2020/191091 A1) in view of Koolman et al. (WO 2021/242581 A1) as applied to claims 1-15 and 17 above, and further in view of Long et al. (WO 2020/191091 A1; cited in the IDS filed on May 16, 2023).
The teachings of Long et al. and Koolman et al. are set forth above and applied as before.
The teachings of Long et al. and Koolman et al. does not teach the expanded compound species recites in claim 16 (
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).
In addition to the teachings set forth above, Long et al. further teaches in some embodiments, the compound of Formula (I) is the compound of formula (Ic):
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(see e.g., p. 32, line 1-6), R3 is phenyl substituted by 1,2, 3 or 4 substituents which are independently, inter alia, halo (see e.g., p. 24, line 5-6). Long et al. further teaches in some embodiments, R3 is trihalophenyl, e.g., trifluoro (see e.g., p. 25, line 8-9).
In the instant case, the difference between the modified compound 204 of Long et al. and Koolman et al. sets forth above and the expanded compound species instantly claimed is that the prior art compound has two fluoro substituted on the phenyl ring rather than 3 fluoro (see shaded):
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.
It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to further modify the modified compound 204 of Long et al. and Koolman et al. sets forth above and then modify said compound by adding a fluoro atom to give a trifluorophenyl ring at the R3 position of the formula (I) taught by Long et al. One would have been motivated to do so, because Long et al. teaches a list of alternated R3, including phenyl substituted by 2 or 3 halo such as trifluorophenyl, to arrive at the compound useful for the treatment, control or prevention of a parasitic infestation or infection in an animal in need thereof. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that by adding a fluoro atom to the difluorophenyl ring of the modified compound 204 of Long et al. and Koolman et al. would have successfully treat, control or prevent a parasitic infestation or infection.
Therefore, the claimed invention is prima facie obvious to one of ordinary skill in the art at the time the application was filed, absent factual evidence to the contrary.
Claims 1-15 and 17 remain rejected under 35 U.S.C. 103 as being unpatentable over Ducray et al. (US 2020/0385398 A1; cited in the IDS filed on May 16, 2023).
Ducray et al. teaches a compound of Example 3.4, N-(2,3-dihydro-1,4-benzoxazin-4-yl)-4-morpholino-8-(2,3,5 trifluorophenyl)-1,5-naphthyridine-3-carboxamide, having the structure of:
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is an exemplary compound of formula (I) useful for the treatment and/or control, in particular helminths, in which the endoparasitic nematodes and trematodes may be the cause of serious diseases of mammals and poultry (see e.g., p. 23, [0161], example 3.4; [0006], [0214]). Ducray et al. further teaches a composition comprising the compound of formula (I) or a salt thereof and an acceptable excipient; and some examples of acceptable excipients are found in Remington's Pharmaceutical Sciences and the Handbook of Pharmaceutical Excipients and include, inter alia, carriers (see e.g., [0045]; [0222]).
The difference between the compound of Example 3.4 of Ducray et al. and the claimed compound is that the prior art compound contains the naphthyridine ring
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rather than a pyrrolo[3,2-b]pyridine ring (
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or
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) shown below (see shaded):
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. In the absence of showing unobvious results, it would have been prima facie obvious to one of ordinary skill in the art at the time of the application was filed when faced with the compound of Example 3.4 of Ducray et al. to make the instantly claimed derivatives of a known product. The instantly claimed compound and prior art compound are common derivatives known as homologs. According to MPEP 2144.09 with regard to close structural similarity between chemical compounds (homologs, analogues, isomers), “[c]ompounds which are…homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977)…[p]rior art structures do not have to be true homologs or isomers to render structurally similar compounds prima facie obvious. In re Payne, 606 F.2d 303, 203 USPQ 245 (CCPA 1979)”. In the instant case, the naphthyridine ring of the compound of Example 3.4 of Ducray et al. shares a similar chemical structure with the claimed compound. The primary difference between these compounds is the number of non-hydrogen atoms in the ring structure. Specifically, the naphthyridine ring of the prior art compound consists of two fused six-membered pyridine whereas the claimed compound contains a pyrrolo[3,2-b]pyridine ring that is a five-membered pyrrole ring fused to a six-membered pyridine ring.
Guided by the teaching of Ducray et al., one skilled in the art would be able to make similar compounds by making homologs of the known compound, in this case, the homologs of the compound of Example 3.4 of Ducray et al. The motivation would be to prepare similar compounds that are pharmacologically active compounds useful for treatment and/or control, in particular helminths, in which the endoparasitic nematodes and trematodes. The instant obviousness rejection is based on the close structural similarity of the prior art compound and the claimed compounds, and the common utility shared among the compounds. There is an expectation among those of ordinary skill in the art that similar structural compounds will have similar properties and that modification of a known structure is mere experimentation within the means of a skilled artisan.
Regarding the limitation of “[a] pharmaceutical composition comprising a compound of formula (I) according to claim 1, and/or a salt thereof, and at least one acceptable carrier” in claim 17, it would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to combine the homologs of the compound of Example 3.4 of Ducray et al. sets forth above with a acceptable carrier taught by Ducray et al. One would have been motivated to do so, because Ducray et al. clearly teaches the compound of Formula (I) can be combined with a carrier as an acceptable excipient to arrive at a composition useful for the treatment and/or control of helminths. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that by combining the homologs of the compound of Example 3.4 of Ducray et al. sets forth above with an acceptable carrier would have successfully arrive at a composition that is a pharmaceutical composition useful for the treatment and/or control of helminths; and that meets the structural limitation of a pharmaceutical composition instantly claimed.
Therefore, the claimed invention is prima facie obvious to one of ordinary skill in the art at the time the application was filed, absent factual evidence to the contrary.
Claims 1-15 and 17 remain rejected under 35 U.S.C. 103 as being unpatentable over Pautrat et al. (US 2024/0360116 A1).
Pautrat et al. teaches a compound of Example 3.4, N-(2,3-dihydro-1,4-benzoxazin-4-yl)-4-morpholino-8-(2,3,5 trifluorophenyl)-1,5-naphthyridine-3-carboxamide, having the structure of:
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is an exemplary compound of formula (I’) useful for controlling endoparasitic infections in human and/or animals (see e.g., [0349]; [0661], Ex. 3.4; [0471]; claim 21). Pautrat et al. further teaches a composition comprising the compound of formula (I) or a salt thereof and an acceptable carrier (see e.g., [0721]; claim 20).
The difference between the compound of Example 3.4 of Pautrat et al. and the claimed compound is that the prior art compound contains the naphthyridine ring
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rather than a pyrrolo[3,2-b]pyridine ring (
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or
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) shown below (see shaded):
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. In the absence of showing unobvious results, it would have been prima facie obvious to one of ordinary skill in the art at the time of the application was filed when faced with the compound of Example 3.4 of Pautrat et al. to make the instantly claimed derivatives of a known product. The instantly claimed compound and prior art compound are common derivatives known as homologs. According to MPEP 2144.09 with regard to close structural similarity between chemical compounds (homologs, analogues, isomers), “[c]ompounds which are…homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977) …[p]rior art structures do not have to be true homologs or isomers to render structurally similar compounds prima facie obvious. In re Payne, 606 F.2d 303, 203 USPQ 245 (CCPA 1979)”. In the instant case, the naphthyridine ring of the compound of Example 3.4 of Pautrat et al. shares a similar chemical structure with the claimed compound. The primary difference between these compounds is the number of non-hydrogen atoms in the ring structure. Specifically, the naphthyridine ring of the prior art compound consists of two fused six-membered pyridine whereas the claimed compound contains a pyrrolo[3,2-b] pyridine ring that is a five-membered pyrrole ring fused to a six-membered pyridine ring.
Guided by the teaching of Pautrat et al., one skilled in the art would be able to make similar compounds by making homologs of the known compound, in this case, the homologs of the compound of Example 3.4 of Pautrat et al. One would have been motivated to do so in order to prepare similar compounds that are pharmacologically active compounds useful for controlling endoparasitic infections. The instant obviousness rejection is based on the close structural similarity of the prior art compound and the claimed compounds, and the common utility shared among the compounds. There is an expectation among those of ordinary skill in the art that similar structural compounds will have similar properties and that modification of a known structure is mere experimentation within the means of a skilled artisan.
Regarding the limitation of “[a] pharmaceutical composition comprising a compound of formula (I) according to claim 1, and/or a salt thereof, and at least one acceptable carrier” in claim 17, it would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to combine the homologs of the compound of Example 3.4 of Pautrat et al. sets forth above with an acceptable carrier. One would have been motivated to do so, because Pautrat et al. clearly teaches the compound of Formula (I’) can be combined with an acceptable carrier to arrive at a pharmaceutical composition useful for controlling endoparasitic infections. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that by combining the homologs of the compound of Example 3.4 of Pautrat et al. sets forth above with an acceptable carrier would have successfully arrive at a pharmaceutical composition useful for controlling infection caused by endoparasites; and that meets the structural limitation of a pharmaceutical composition instantly claimed.
Therefore, the claimed invention is prima facie obvious to one of ordinary skill in the art at the time the application was filed, absent factual evidence to the contrary.
Response to Arguments
Applicant's arguments filed on April 28, 2026 with respect to the rejection of claims 1-15 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Long et al. (WO 2020/191091 A1) in view of Koolman et al. (WO 2021/242581 A1) have been fully considered but they are not persuasive for the reasons set forth below.
Applicant's arguments filed on April 28, 2026 with respect to the rejection of claims 1-18 under 35 U.S.C. 103 as being unpatentable over Long et al. (WO 2020/191091 A1) in view of Koolman et al. (WO 2021/242581 A1) as applied to claims 1-15 and 17-18 above, and further in view of Long et al. (WO 2020/191091 A1; cited in the IDS filed on May 16, 2023) have been fully considered but they are not persuasive for the reasons set forth below.
Applicant's arguments filed on April 28, 2026 with respect to the rejection of claims 1-15 and 17-18 under 35 U.S.C. 103 as being unpatentable over Ducray et al. (US 2020/0385398 A1; cited in the IDS filed on May 16, 2023) have been fully considered but they are not persuasive for the reasons set forth below.
Applicant's arguments filed on April 28, 2026 with respect to the rejection of claims 1-15 and 17-18 under 35 U.S.C. 103 as being unpatentable over Pautrat et al. (US 2024/0360116 A1) have been fully considered but they are not persuasive for the reasons set forth below.
Applicant amends claim 18 from the recitation of “[t]he compound of formula (I) and/or salt according to claim 1” to the recitation of “[a] method of control, treatment and/or prevention of a disease, comprising administering the compound of formula (I) of claim 1 and/or a salt thereof”, and that changes the claim to an invention non-elected. Applicant further amends claim 16 from the recitation of “[t]he compound of claim 1” to the recitation of “[a] compound”, and that changes the dependency of the claim. Each of these findings demonstrate the amendment changes the scope of the claims, thus, the rejection of record has been revisited and modified in light of the claim amendments.
In Summary, Applicant argues the claimed compound differ from the compounds of Long, Ducray and Pautrat at least in the presence of the N-atom at the linking position in the bicyclic ring system; and further argues that an N-C (nitrogen-carbon) bond and an N-N (nitrogen-nitrogen) bond cannot be considered bioisosteric replacement for one another as they are fundamentally distinct in their chemical and physical properties. Applicant argues N-N bond is more polarizable, introduce lone pair-lone pair repulsion, and cannot act as hydrogen bond receptors; therefore, these influence the metabolic stability, biological activity, solubility, membrane permeability and binding affinity of compounds. Applicant argues none of the cited references teach or suggest replacing the N-C bond by an N-N bind at this location, and said N-C bond is part of the invariant core structure; therefore, one would understand said N-C bond is crucial for the function of the disclosed compounds. Applicant further argues the obviousness-type rejection(s) based upon improper hindsight reasoning because Long, Ducray and Pautrat teaches several variables/substituents, and does not expressly teach this particular N-C bond should be varied; therefore, the rejection of record involves picking and choosing variables with hindsight reasoning. Applicant further argues one would not have any motivation to combine Long, Ducray and Pautrat with Koolman to arrive at the claimed invention, because Koolman teaches a completely different invariant core structure attached to the linking moiety L which contains the substituents R1, R2, and R3; therefore, the rejection of record is based upon improper hindsight reasoning involves in dissecting distinct molecular scaffolds from different references and reassembling them without any teaching or suggestion to do so.
In response, applicant’s argument is not found persuasive because of the reasons set forth below:
First, applicant appears to mischaracterize the rejection(s) of record. For example, applicant argues Long, Ducray and Pautrat fails to teach the presence of the N-N (nitrogen-nitrogen) bond; However, the compound of Example 3.4 of Ducray et al. and the compound of Example 3.4 of Pautrat et al. both do not require the modification of an N-C (nitrogen-carbon) bond, because each of these compounds already contain the N-N (nitrogen-nitrogen) bond, and does not require said modification. In addition, the rejection(s) of record does not combine the teachings of Long et al., Ducray et al., Pautrat et al., and Koolman et al. altogether. It is respectfully noted that the rejection is form using the combination of Long et al. and Koolman et al.; and Ducray et al. and Pautrat et al. are applied individually to form a separate obviousness-type rejection.
Second, in response to applicant’s argument that Long et al. fails to teach the presence of the N-N (nitrogen-nitrogen) bond, it is noted that the rejection of record does not rely on Long et al. alone but relies on the combination of prior arts, i.e., Long et al. and Koolman et al., to teach the substitution of N-C bond with the N-N bond. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In this case, the rejection of record is form on the basis that Long et al. teaches a compound 204-0 having the structure of:
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(referred to herein as “Compound 204”) is useful for controlling parasitic infestation or infection; and Koolman et al. teaches a compound 614 having the structure of:
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(see e.g., p. 200, Scheme 24, Compound 614) and a compound 306 having the structure of:
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(see e.g., p. 149, Scheme 12, Compound 306) are exemplary compounds of Formula (I) useful for the treatment, control or prevention of a parasitic infestation or infection in an animal in need thereof (see e.g., claim 33; abstract). In other words, Koolman et al. teaches the replacement of benzopyran ring
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with benzomorpholine ring
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to arrive at a compound with the same activity (controling parasitic infestation or infection). According to MPEP 2144.09 “[a] prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. ‘An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties.’ In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). See In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963)”. Applying same logic to instant claim(s), the compound 204 of Long et al. has very close structural similarity, and the difference between the compound 204 of Long et al. and the claimed compound is that the prior art compound contains the N-C rather than the N-N bond shown below (see shaded):
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. In view of the teachings noted above, a person of ordinary skill in the art would have reasonably expected that the replacement of
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of compound 204 of Long et al. with
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would have successfully arrive at a compound useful for controlling parasitic infestation or infection.
In response to applicant’s arguments that the replacement of N-C (nitrogen-carbon) bond with an N-N (nitrogen-nitrogen) bond would change the metabolic stability, biological activity, solubility, membrane permeability and binding affinity of the compounds, this appears to be mere arguments without objective evidence. If applicant contends the replacement of N-C bond with N-C bond changes the activities of compound 204 of Long et al., said evidence is respectfully requested. According to MPEP 716.01(c), I, “[o]bjective evidence which must be factually supported by an appropriate affidavit or declaration to be of probative value includes evidence of unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the inventor or at least one joint inventor. See, for example, In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984)”.
Furthermore, it may well be true that Ducray et al. and Pautrat et al. both teaches a compound of Example 3.4, which contains the naphthyridine ring having the structure of:
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as the core, and that is not the J structure instantly claimed. However, the only difference between the compound of Example 3.4 of Ducray et al. and Pautrat et al., respectively, and the claimed compound is that the prior art compound contains a pyridine ring fused with another pyridine whereas the claimed compound contains a pyrrole ring fused with another pyridine as shown below (see shaded):
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.
It is respectfully noted that pyridine and pyrrole are both nitrogen-containing aromatic rings except pyridine is a six-membered ring rather than a five-membered ring. These two chemical structures have very close structural similarity that differs by the successive addition of a single carbon ring member. According to MPEP 2144.09, “[c]ompounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978)”; and “[p]rior art structures do not have to be true homologs or isomers to render structurally similar compounds prima facie obvious. In re Payne, 606 F.2d 303, 203 USPQ 245 (CCPA 1979)”. Therefore, applying the same logic to instant claims, one would have reasonable expectation of success to arrive at a derivative of a compound of Example 3.4 of Ducray et al. and Pautrat et al., respectively, by replacing the pyridine with pyrrole to form the fused ring; and would reasonably expect said derivative to exert the same or substantially similar effect as the compound of example 3.4 for controlling endoparasitic infections.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In this case, the mere fact that the prior arts teaches other variables or substituents (e.g., variable Q of Formula (I) of Koolman et al.) to arrive at the compound useful for controlling parasitic infestation or infection does not constitute a teaching away from replacing the benzopyran ring
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(Ring System A) with benzomorpholine ring
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(see rejection above), because such disclosure does not criticize, discredit, or otherwise discourage the incorporation of any of these variables to arrive at a compound with the same activity. Please note that according to MPEP 2141.02, “the prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed…." In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004)”.
In view of the foregoing, the arguments are not found persuasive and the rejection of record has been maintained for the reasons set forth herein.
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 1-15 and 17 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 19-21 of copending Application No. 18/255,134 (reference application).
The claims of the reference application is drawn to a compound of Example 3.4, N-(2,3-dihydro-1,4-benzoxazin-4-yl)-4-morpholino-8-(2,3,5-trifluorophenyl)-1,5-naphthyridine-3-carboxamide (see claim 19). Please note the compound of Example 3.4 is a compound having the structure of:
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. The claims of the reference patent is further drawn to a composition comprising the compound of formula (I’) or a salt thereof, and at least one acceptable carrier (see claim 20); and a compound of formula (I’) and/or a pharmaceutical composition for use in the control, treatment and/or prevention of a disease, wherein optionally the disease is an infection caused by endoparasites, optionally a helminthic infection, optionally a heartworm infection (see claim 21).
The difference between the compound of Example 3.4 of the reference application and the claimed compound is that the reference compound contains the naphthyridine ring
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rather than a pyrrolo[3,2-b]pyridine ring (
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or
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) shown below (see shaded):
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. In the absence of showing unobvious results, it would have been prima facie obvious to one of ordinary skill in the art at the time of the application was filed when faced with the compound of Example 3.4 of the reference application to make the instantly claimed derivatives of a known product. The instantly claimed compound and reference compound are common derivatives known as homologs. According to MPEP 2144.09 with regard to close structural similarity between chemical compounds (homologs, analogues, isomers), “[c]ompounds which are…homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977)…[p]rior art structures do not have to be true homologs or isomers to render structurally similar compounds prima facie obvious. In re Payne, 606 F.2d 303, 203 USPQ 245 (CCPA 1979)”. In the instant case, the naphthyridine ring of the compound of Example 3.4 of reference application shares a similar chemical structure with the claimed compound. The primary difference between these compounds is the number of non-hydrogen atoms in the ring structure. Specifically, the naphthyridine ring of the reference compound consists of two fused six-membered pyridine whereas the claimed compound contains a pyrrolo[3,2-b]pyridine ring that is a five-membered pyrrole ring fused to a six-membered pyridine ring.
Guided by the reference application, one skilled in the art would be able to make similar compounds by making homologs of the known compound, in this case, the homologs of the compound of Example 3.4 of the reference application. One would have been motivated to do so in order to prepare similar compounds that are pharmacologically active compounds useful for controlling endoparasitic infections. The instant obviousness rejection is based on the close structural similarity of the reference compound and the claimed compounds, and the common utility shared among the compounds. There is an expectation among those of ordinary skill in the art that similar structural compounds will have similar properties and that modification of a known structure is mere experimentation within the means of a skilled artisan.
Regarding the limitation of “[a] pharmaceutical composition comprising a compound of formula (I) according to claim 1, and/or a salt thereof, and at least one acceptable carrier” in claim 17, it would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to combine the homologs of the compound of Example 3.4 of the reference application sets forth above with an acceptable carrier. One would have been motivated to do so, because the claims of the reference application clearly teaches the compound of Formula (I’) can be combined with an acceptable carrier to arrive at a pharmaceutical composition useful for controlling endoparasitic infections. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that by combining the homologs of the compound of Example 3.4 of the reference application sets forth above with an acceptable carrier would have successfully arrive at a pharmaceutical composition useful for controlling infection caused by endoparasites; and that meets the structural limitation of a pharmaceutical composition instantly claimed.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-15 and 17 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 21, 23 and 25-27 of U.S. Patent No. 12,448,391 B2 (referred to herein as the reference patent).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the reference patent is drawn to a compound 3.4, N-(2,3-dihydro-1,4-benzoxazin-4-yl)-4-morpholino-8-(2,3,5-trifluorophenyl)-1,5-naphthyridine-3-carboxamide (see claim 21). Please note the compound 3.4 has the structure of:
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. The claims of the reference patent is further drawn to a composition comprising the compound or a salt thereof, and at least one acceptable carrier (see claim 23); and a product comprising the compound or salt thereof for manufacture of a medicament for treating endoparasites; for treating heartworm; and for controlling heartworm (see claims 25-27).
The difference between the compound 3.4 of the reference patent and the claimed compound is that the reference compound contains the naphthyridine ring
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rather than a pyrrolo[3,2-b]pyridine ring (
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or
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) shown below (see shaded):
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. In the absence of showing unobvious results, it would have been prima facie obvious to one of ordinary skill in the art at the time of the application was filed when faced with the compound 3.4 of the reference patent to make the instantly claimed derivatives of a known product. The instantly claimed compound and prior art compound are common derivatives known as homologs. According to MPEP 2144.09 with regard to close structural similarity between chemical compounds (homologs, analogues, isomers), “[c]ompounds which are…homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977)…[p]rior art structures do not have to be true homologs or isomers to render structurally similar compounds prima facie obvious. In re Payne, 606 F.2d 303, 203 USPQ 245 (CCPA 1979)”. In the instant case, the naphthyridine ring of the compound 3.4 of the reference patent shares a similar chemical structure with the claimed compound. The primary difference between these compounds is the number of non-hydrogen atoms in the ring structure. Specifically, the naphthyridine ring of the reference compound consists of two fused six-membered pyridine whereas the claimed compound contains a pyrrolo[3,2-b]pyridine ring that is a five-membered pyrrole ring fused to a six-membered pyridine ring.
Guided by the reference patent, one skilled in the art would be able to make similar compounds by making homologs of the known compound, in this case, the homologs of the compound 3.4 of the reference patent. The motivation would be to prepare similar compounds that are pharmacologically active compounds useful for treating endoparasites or heartworm, or controlling heartworm. The instant obviousness rejection is based on the close structural similarity of the reference compound and the claimed compounds, and the common utility shared among the compounds. There is an expectation among those of ordinary skill in the art that similar structural compounds will have similar properties and that modification of a known structure is mere experimentation within the means of a skilled artisan.
Regarding the limitation of “[a] pharmaceutical composition comprising a compound of formula (I) according to claim 1, and/or a salt thereof, and at least one acceptable carrier” in claim 17, it would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to combine the homologs of the compound 3.4 of the reference patent sets forth above with an acceptable carrier. One would have been motivated to do so, because the reference patent teaches the compound of Formula (I) can be combined with an acceptable carrier. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that by combining the homologs of the compound 3.4 of the reference patent sets forth above with an acceptable carrier would have successfully arrive at a composition that is a pharmaceutical composition useful for treating endoparasites or heartworm, or controlling heartworm; and that meets the structural limitation of a pharmaceutical composition instantly claimed.
Therefore, the nonstatutory double patenting rejection applies.
Response to Arguments
Applicant's arguments filed on April 28, 2026 with respect to the provisional rejection of claims 1-15 and 17-18 on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 19-21 of copending Application No. 18/255,134 (reference application) have been fully considered but they are not persuasive.
Applicant's arguments filed on April 28, 2026 with respect to the provisional rejection of claims 1-15 and 17-18 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 21, 23 and 25-27 of U.S. Patent No. 12,448,391 B2 (referred to herein as the reference patent) have been fully considered but they are not persuasive.
Applicant amends claim 18 from the recitation of “[t]he compound of formula (I) and/or salt according to claim 1” to the recitation of “[a] method of control, treatment and/or prevention of a disease, comprising administering the compound of formula (I) of claim 1 and/or a salt thereof”, and that changes the claim to an invention non-elected. Applicant further amends claim 16 from the recitation of “[t]he compound of claim 1” to the recitation of “[a] compound”, and that changes the dependency of the claim. Each of these findings demonstrate the amendment changes the scope of the claims, thus, the rejection of record has been revisited and modified in light of the claim amendments.
In Summary, applicant did not put forth any arguments against the nonstatutory double patenting rejections noted above; and states that terminal disclaimer(s) will be considered upon an indication of allowable subject matter.
In response, given that applicant did not put forth any arguments, the rejection has been maintained, but revisited and modified in light of the claim amendments for the same reasons of record and for the reasons set forth herein.
Conclusion
No claims are allowed.
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.
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/CHIHYI LEE/Examiner, Art Unit 1628 /JEAN P CORNET/Primary Examiner, Art Unit 1628
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