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 .
Response to Amendment
The amendment filed on 11/25/2025 is acknowledged and has been entered.
Claims 16-17, 19-32 and 34-35 are currently pending and under consideration.
Applicants elected species has the following formula:
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. The elected species has been found to be free of the prior art for a method of treating an ectoparasitic invention. As noted in the previous rejection, the species election was expanded to include additional species as noted within the prior art cited previously and below.
Information Disclosure Statement
The information disclosure statements filed on 1/31/2025, 2/24/2025, 7/31/2025 and 9/11/2025 have been considered except where lined through.
Claim Interpretation
The claims encompass a compound of Formula I having the generic structure
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and further defines what variables X and Y are if the bond attached to X or Y is a double bond vs. a single bond. The claims do not indicate what the “4th” bond to the carbon linked to R3, R4, R5 and A if the bond is a single bond. In view of the specification and the specific examples, the Examiner is interpreting the 4th bond is to a hydrogen if the bond is a single bond.
Rejections Withdrawn
The rejection of Claim 33 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in view of the cancelation of claim 33.
The rejection of claims 18 and 33 under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter. Based upon an analysis with respect to the claim as a whole, claim(s) 18 and 33 do not recite something significantly different than a judicial exception is withdrawn in view of the cancellation of the claims.
The rejections of Claim(s) 18 and 33 under 35 U.S.C. 102a(1) as being anticipated by Sumitoma Pharma (WO9848801A1, 1998-11-05, IDS, google translation provided herewith), claim(s) 18 under 35 U.S.C. 102a(1) as being anticipated by E.I. Dupont (WO1995003306A1, 1995-02-02, IDS), Claim(s) 18 under 35 U.S.C. 102a(1) as being anticipated by “Pyridine, 3-(2-piperidinylmethoxy)” Registry, Cas Reg. No. 933759-31-0, 2007, Claim(s) 18 under 35 U.S.C. 102a(1) as being anticipated by “(-)-Anatabine” Registry, Cas Reg. No. 581-49-7, 1984, and Claim(s) 18 under 35 U.S.C. 102a(1) as being anticipated by “(-)-Anabasine” Registry, Cas Reg. No. 494-52-0, 1984 are withdrawn in view of the cancellation of the claims.
The provisional rejection of Claims 18 and 33 on the ground of nonstatutory double patenting as being unpatentable over claims 13-25 of copending Application No. 18/260,293 (reference application) is withdrawn in view of cancellation of the claims.
Rejection Maintained
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 17, 19-32 and 34-35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16-24, 27, 29-34 and 36-37 of copending Application No. 17/622,001(reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application claims a method of reducing an infestation of ectoparasites comprising applying a compound of formula I which falls within the scope of the instantly claimed compound of formula 1.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
In response to this rejection, Applicants request that the provisional double patenting rejection be held in abeyance.
Rejection Maintained, but amended for clarity
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.
Claim(s) 17, 20-21, 23-25, 27-32 and 34-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over E.I. Dupont (WO1995003306A1, 1995-02-02, IDS.
E.I. Dupont teach anthropodicidal compounds encompassed by formula I having the structures
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which read on the instantly claimed compound of formula I (page 23, Table 5). Moreover, EI Dupont teach athropodicidal compositions and method of use in both agronomic and agronomic environments, wherein the athropodicidal compounds are those of the formula:
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(page 3). For example, the WO document teaches compounds having the specific structures
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(page 46). The WO document further teaches that the compounds of the invention exhibit activity against a wide spectrum of arthropods including, but not limited to, mites which are pests of household and public and animal health , wherein the compounds can be applied as a formulation comprising one or more of the compounds with suitable carriers or diluents (page 43, lines 1-6 and page 45, lines 12-15). Regarding the application, the WO document teaches that the compound is applied to the environment of the pests, including the infestation, the area to be protected or directly to the pests to be controlled, wherein the preferred method of application is by spraying (page 45, lines 3-6).
The WO documents does not specifically teach formulation the compound of formula I into a formulation and a method of treating pests.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the formulation and method of use taught by the WO document to include the compounds of formula I. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-The WO document describes the compounds of formula I as anthropodicidal compounds
Regarding the limitation that the pests are mosquitos or ticks, the claimed limitation does not appear to result in a different in the prior arts application since the claims do not specifically require a subject in need thereof. As such, application of the compounds of formula 1 would appear to necessarily reduce mosquitos and/or ticks.
In response to this rejection, Applicants contend that while some ectoparasites may fall under the definition of an “arthropod” as set out in E.I. Dupont, there is nothing in this document which demonstrates that the compounds may actually be effective against ectoparasites. Applicants contend that this is further demonstrated by the examples of E.I. Duport which relate to infestation of crops, and not ectoparasites that specifically infest skins of human beings and other animals. Accordingly, Applicants submit that the method recited in claim 17 demonstrates a technical effect which is not obvious from the description of E.I. Dupont.
These arguments have been carefully considered, but are not found persuasive.
In the instant case, Examiner does not dispute Applicants assertion that the examples provided by E.I. Dupont relate to infestation of crops. However, the examiner recognizes that the neither the specification or claims limit an ectoparasite to be one that specifically infects skins of human beings and other animals. Accordingly, a two spotted spider mite which is a plant feeding mite (see example D of E.I. Dupont) would encompass an ectoparasite. Additionally, it is important to note, as noted above and in the previous office action, that the instant claims do not require that a human or animal having an infestation be exposed to the compound. In contrast, the claims are pretty broad and encompass “exposing” pretty generally. Accordingly, applying the compound to the environment of the pests, including the infestation, the area to be protected or directly to the pests to be controlled, wherein the preferred method of application is by spraying as taught by E.I.Dupont would broadly reduce a variety of ectoparasites.
New Rejections upon further consideration
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.
Claims 17, 19-32 and 34-35 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The instant claims are drawn to a method of reducing or treating an infestation with one or more ectoparasites, the method comprising exposing the one or more ectoparasites to a compound of formula (I) having the generic structure:
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wherein
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. Accordingly, the claims encompass an enormous amount of compounds since, for example, each
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, R1, R4, R3 and R5 can be as singularly defined or R1 and R4, or R3 and R5 are taken together to form group Z, which ranges from one to three atoms in length, e.g. a bridged ring system. Note: A search of STN REGISTRY database for the generic compound of formula I provided over 5 million compounds which is to large to bring over into CAPLUS and as such a search of the full scope of compounds encompassed by the claims is not feasible in combination with the required use.
The specification teaches approximately 29 specific compounds having ectoparasitic activity, some of which R3 and R5 are taken together to form a Z group, as well as, a number of compounds when the
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attached to the X is a double bond or single bond and a number of compounds when the
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attached to Y is a double bond or a single bond. The state of the art at the time the invention was made teaches compounds encompassed by the generic formula I wherein R3 and R5 are taken together to form a Z group (see prior art of record). However, neither the specification or prior art teaches the full scope of compounds encompassed by Formula I having ectoparasitic activity.
The Applicant is reminded on the written description guidelines set out by the USPTO in MPEP 2163:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A), above), reduction to drawings (see i)(B), above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
While the genus is described by a generic formula, the generic formula is not sufficiently detailed to show that the Applicant was in possession of the gull scope of the claimed invention at the time of filing. Namely, that the definition described above, while not being indefinite, are not sufficiently detailed in order to stand on their own as being adequately described. Therefore, the “representative number of species” standard is used to determine whether the claims are adequately described. MPEP 2163 goes on to describe what a “representative number of species” is:
What constitutes a "representative number" is an inverse function of the skill and knowledge in the art. Satisfactory disclosure of a "representative number" depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features of the elements possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly. Description of a representative number of species does not require the description to be of such specificity that it would provide individual support for each species that the genus embraces. For example, in the molecular biology arts, if an applicant disclosed an amino acid sequence, it would be unnecessary to provide an explicit disclosure of nucleic acid sequences that encoded the amino acid sequence. Since the genetic code is widely known, a disclosure of an amino acid sequence would provide sufficient information such that one would accept that an applicant was in possession of the full genus of nucleic acids encoding a given amino acid sequence, but not necessarily any particular species. Cf. In re Bell, 991 F.2d 781, 785, 26 USPQ2d 1529, 1532 (Fed. Cir. 1993) and In re Baird, 16 F.3d 380, 382, 29 USPQ2d 1550, 1552 (Fed. Cir. 1994). If a representative number of adequately described species are not disclosed for agenus, the claim to that genus must be rejected as lacking adequate written description under 35 U.S.C. 112, para. 1.
The species described in the specification does not cover the entire genus such that it is a representative sample of the genus as the species are close together in structure and only describe an extremely small portion of the claimed genus. Therefore, the claims lack written description for the full scope of that being claimed.
Conclusion
Claim 16 is free of the prior art and allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON J FETTEROLF whose telephone number is (571)272-2919. The examiner can normally be reached M-F 6AM-4PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S Lundgren can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRANDON J FETTEROLF/Primary Examiner, Art Unit 1626