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)
in the reply filed on November 20, 2025 is acknowledged. The traversal is on the ground(s) that the common structural element of the claimed compounds of formula (I) in the form of
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is a special technical in view of the prior art, including Aldous et al., because the alternatives of the Markush grouping are of similar nature.
This is found persuasive; however, technical feature shared among the group of species still lack unity of invention in view of the prior art rejections set forth below.
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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,
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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 November 11, 2025, wherein claims 1-16 are amended; and claims 17-18 are unchanged.
Claims 1-18 are pending and 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 statements (IDS) submitted on 5/16/2023, 6/14/2023, 7/29/2025 and 11/14/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are 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.
Specification
The disclosure is objected to because of the following informalities:
Page 1, line 14-15: a line break recites after the phrase of “and then migrate through the” appears to be a typographical error shown below:
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Page 173, line 25: the recitation of “Haemonchus contortus I Trichostrongylus colubriformis in gerbil” contains a letter “I” in between “Haemonchus contortus” and “Trichostrongylus colubriformis”; and that appears to be a typographical error as it should be a symbol slash (/).
Appropriate correction is required.
Claim Interpretation
The limitation of “adapted for control, treatment and/or prevention of a disease, wherein the disease is optionally an infection caused by endoparasites, optionally a helminthic infection, optionally a heartworm infection” in claim 18 is reasonably construed to be an intended use of the product positively recited; and the limitations followed after the term “optionally” is reasonably construed to be optional diseases that are not required. Therefore, if the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2111.02.
Claim Objections
Claim 9 is 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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. In addition, the phrase “M is O” is also recited twice in the claim shown below (see shaded):
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. Each of these appears to be a typographical error.
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claim 18 is 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. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Attention is directed to In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors: (1) the nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and, (8) the quantity of experimentation necessary. All of the Wands factors have been considered and discussed below:
(1, 5) The breadth of the claims and the Nature of the Invention: As stated in MPEP 2164.05(a), “[t]he initial inquiry” for determining whether the Specification is enabling “is into the nature of the invention, i.e., the subject matter to which the claimed invention pertains.”
In the present case, claim 18 recites “[t]he compound of formula (I) and/or salt according to claim 1 or a pharmaceutically composition thereof adapted for control, treatment and/or preventing of a disease, wherein the disease is optionally an infection caused by endoparasites, optionally a helminthic infection, optionally a heartworm infection”.
The term “treatment”, when construed in light of the special definition provides on page 167, line 18-22 of the instant specification, is taken to include restraining, slowing, reducing, ameliorating, reversing the progression of severity of an existing symptom, or preventing a disease.
The term “control”, when construed in light of the special definition provides on page 167, line 23-30 of the instant specification, is taken to include decreasing, reducing, or ameliorating the risk of a symptom, disorder, condition, or disease, and protecting an animal from a symptom, disorder, condition, or disease; and said control includes therapeutic, prophylactic, and preventative administration.
The term “disease” is given its broadest reasonable interpretation to include any disease known to those skilled in the art, such as cancer.
Thus, the breadth of the claim covers control, treatment and/or prevention of each and every disease.
(2, 3, 4) The state of the prior art, the level of skill in the art, and the predictability or lack
thereof in the art: As stated in MPEP 2164.05(a), “[t]he state of the prior art is what one skilled in the
art would have known, at the time the application was filed, about the subject matter to which the
claimed invention pertains” and, as stated in MPEP 2164.05(b), “[t]he relative skill of those in the art
refers to the skill of those in the art in relation to the subject matter to which the claimed invention
pertains at the time the application was filed.”
As discussed above, the claimed invention pertains to the compound of formula (I) and/or salt or a pharmaceutical composition thereof adapted for control, treatment, and/or prevention of each and every disease.
At the time the application was filed, one skilled in the art would have known that the control of Schistosomiasis, a water borne disease caused by Schistosoma spp., relies almost exclusively on praziquantel, but this drug does not kill juvenile worms during the early stages of infection or prevent post-treatment reinfection, according to Hines-Kay et al. (Mol Biochem Parasitol, 2012. Vol. 186 (2): 87-94). In other words, the state of the art with respect to controlling, treating, or preventing the entire scope of disease, including Schistosomiasis, with a single anthelminthic agent is still underdeveloped given that some anthelminthic agent (e.g., praziquantel) is stage-specific and cannot be use to prevent reinfection.
Furthermore, one skilled in the art would have also known that there is no way to prevent eye cancer, according to Cleveland Clinic (“Eye Cancer” [Online]) (see e.g., “How can I prevent eye cancer?” section). Therefore, to the extent that the scope of disease includes cancer, the cited reference demonstrate that the state of the art with respect to controlling, treating, or preventing the entire scope of disease, such as eye cancer, is still underdeveloped.
According to Nixon et al. (International Journal for Parasitology: Drugs and Drug Resistance, 2020. Vol. 14: 8-16), there is no single screening approach for anthelmintics that suits all parasites or all discovery purposes, for example, the glutamate-gated chloride channel is the target of macrocyclic lactones (ML) in nematode; However, in filarial larvae, ML-responsive channels appear to only be expressed in muscles surrounding the excretory-secretory pore and unlikely to play the same role in locomotion and motility for filarial worms as it does for other nematodes (see e.g., p. 10, right column, 1st paragraph). The cited reference further demonstrates that a single anthelminthic agent useful for treating a specific helminthic infection does not necessarily treat other helminthic infection caused by other nematodes.
While applicant’s claimed compound of formula (I) or a salt thereof or a pharmaceutical composition may play a role in controlling or treating helminthic infection caused by Nippostrongylus brasiliensis, Dirofilaria immitis, C. elegans, Haemonchus contortus or Trichostrongylus colubriformis as disclosed in the instant specification, it is uncertain whether each and every compound species of formula (I) and/or a salt thereof or a pharmaceutical composition thereof can be used to treat, control and/or prevent the entire scope of disease.
(6, 7, 8) The amount of guidance given, the presence of working example and the quantitation
of experimentation required:
In view of all of the foregoing, at the time the invention was made, it would have required undue experimentation to practice the entire scope of the claimed invention. Although the instant specification tested the biological activities of the compound of formula (I) against the CHO cell lines expressing C.elegans Slo-1a or D. immitis Slo-1, Dirofilaria immitis microfilariae purified from blood, Dirofilaria immitis isolated from vector, Nippostrongylus brasiliensis, and Haemonchus contortus or Trichostrongylus colubriformis in gerbil (see e.g., in vitro assay 1-5; and Animal parasitic nematodes in vivo). It is noted that the biological activities of the compound of formula (I) against other diseases have not been disclosed; and there is no disclosure specifically demonstrate the preventative effect of the compound of formula (I) against a disease. Therefore, the quantity of experimentation necessary to carry out the claimed invention is high, because one of the relative skill in the art could not reasonably predict which disease encompassed by the claim would successfully be adapted for treating, controlling and/or preventing by each and every compound species of formula (I) based on the limited disclosure provided. It would require undue experimentation as it is highly unpredictable that each and every compound species of formula (I) would, in fact, be usable across the entire scope of disease.
Accordingly, the intended use of the claimed compound of formula (I) and/or salt or a pharmaceutical composition thereof that covers controlling, treating and/or preventing the entire scope of disease is not enabled by the instant specification. To overcome this rejection, applicant should narrow the scope of the claims such that they bear a reasonable correlation with the disclosure.
Claim Rejections - 35 USC § 112 – Improper Markush Grouping
Claims 1-18 are 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).
Claim Rejections - 35 USC § 102
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 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 1-6, 8-14 and 17-18 are 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).
Koolman et al. teaches a compound 204 having the structure of:
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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. 200, Scheme 24, Compound 614; claim 33; abstract). Koolman et al. further teaches a veterinary composition comprising the compound of Formula (I) or a pharmaceutically or a veterinary acceptable salt thereof and a veterinary acceptable carrier (see e.g., claim 34; p. 70, line 13 to p. 71, line 1).
In the present case, the compound 614 taught by Koolman et al. is a compound of instant formula (I)
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, wherein n is 1; J is
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(which is
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, wherein A2 is CRA2 and RA2 is hydrogen; A3 is N; B1 is CRB1 and RB1 is
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[C4 alkyl]; B2 is N; B5 is CRB5 and RB5 is H; X2 is N); Q is
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(which is 6-membered aryl substituted with 2 chloro [halogen]); G is
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(which is
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, M is O; R7 is hydrogen);
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is
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(wherein n is 1; Y1 is CR8R9 and R8 is hydrogen and R9 is hydrogen; Y2 is O; Z1 is CR11 and R11 is hydrogen; Z2 is CR11 and R11 is hydrogen; Z3 is CR11 and R11 is hydrogen; Z4 is CR11 and R11 is hydrogen). Koolman et al. also further teaches a veterinary composition comprising said compound with a veterinary acceptable carrier, and that is a pharmaceutical composition instantly claimed.
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, in the present case, Koolman et al. clearly teaches a veterinary composition comprising the compound of Formula (I), including compound 614, with a veterinary acceptable carrier that is an acceptable carrier; therefore, the veterinary composition taught by Koolman et al. is a pharmaceutical composition instantly claimed.
Regarding the limitation of “adapted for control, treatment and/or prevention of a disease, wherein the disease is optionally an infection caused by endoparasites, optionally a helminthic infection, optionally a heartworm infection” in claim 18, the claimed limitation is drawn to an intended use of the compound of formula (I) instantly claimed; However, the intended use of the claimed compound does not patentably distinguish the compound, per se, since such undisclosed use is inherent in the reference compound. In the instant case, the intended use does not create a structural difference, thus, the intended use is not limiting. “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Therefore, the claimed invention is being anticipated by Koolman et al.
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 17-18 are 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.
Regarding the limitation of “adapted for control, treatment and/or prevention of a disease, wherein the disease is optionally an infection caused by endoparasites, optionally a helminthic infection, optionally a heartworm infection” in claim 18, the claimed limitation is drawn to an intended use of the compound of formula (I) instantly claimed. In the instant case, the modified compound 204 of Long et al. and Koolman et al. sets forth above meets the structural limitation of the claimed compound, and that renders obvious the limitation 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 1-18 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) 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).
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 17-18 are 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.
Regarding the limitation of “adapted for control, treatment and/or prevention of a disease, wherein the disease is optionally an infection caused by endoparasites, optionally a helminthic infection, optionally a heartworm infection” in claim 18, the claimed limitation is drawn to an intended use of the compound of formula (I) instantly claimed. In the instant case, the homologs of the compound of Example 3.4 of Ducray et al. sets forth above meets the structural limitation of the claimed compound, and that renders obvious the limitation 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 17-18 are 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.
Regarding the limitation of “adapted for control, treatment and/or prevention of a disease, wherein the disease is optionally an infection caused by endoparasites, optionally a helminthic infection, optionally a heartworm infection” in claim 18, the claimed limitation is drawn to an intended use of the compound of formula (I) instantly claimed. In the instant case, the homologs of the compound of Example 3.4 of Pautrat et al. sets forth above meets the structural limitation of the claimed compound, and that renders obvious the limitation 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.
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 17-18 are 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.
Regarding the limitation of “adapted for control, treatment and/or prevention of a disease, wherein the disease is optionally an infection caused by endoparasites, optionally a helminthic infection, optionally a heartworm infection” in claim 18, the claimed limitation is drawn to an intended use of the compound of formula (I) instantly claimed. In the instant case, the homologs of the compound of Example 3.4 of the reference application sets forth above meets the structural limitation of the claimed compound, and that renders obvious the limitation 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 17-18 are 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.
Regarding the limitation of “adapted for control, treatment and/or prevention of a disease, wherein the disease is optionally an infection caused by endoparasites, optionally a helminthic infection, optionally a heartworm infection” in claim 18, the claimed limitation is drawn to an intended use of the compound of formula (I) instantly claimed. In the instant case, the homologs of the compound 3.4 of the reference patent sets forth above meets the structural limitation of the claimed compound, and that renders obvious the limitation instantly claimed.
Therefore, the nonstatutory double patenting rejection applies.
Conclusion
No claims are allowed.
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/CHIHYI LEE/Examiner, Art Unit 1628
/JEAN P CORNET/Primary Examiner, Art Unit 1628