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 .
DETAILED ACTION
This office action is in response to applicant’s reply filed on June 4, 2026.
Status of Claims
Amendment of claims 1, 17 and 20-23, cancellation of claims 2-16, 18 and 32; and addition of claims 33-39 is acknowledged.
Claims 1, 17, 19-30 and 33-39 are currently pending and are the subject of this office action.
Claims 17 and 23-30 were withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on December 9, 2025.
Claims 1, 19-22 and 33-39 are presently under examination.
Priority
The present application is a 371 of PCT/EP2022/051674 filed on 01/26/2022 and claims priority to provisional application No. 63,292,561 filed on 12/22/2021
Rejections and/or Objections and Response to Arguments
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated (Maintained Rejections and/or Objections) or newly applied (New Rejections and/or Objections, Necessitated by Amendment or New Rejections and/or Objections not Necessitated by Amendment). They constitute the complete set presently being applied to the instant application.
Responses to Applicant’s arguments have been addressed immediately after the corresponding rejections, or in the section: Withdrawn Rejections and/or Objections, if the rejection was withdrawn.
Claim Rejections - 35 USC § 102 (Modified Rejection Necessitated by Amendment).
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.
Claim(s) 1, 19-20, 22 and 33-34 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Heemstra et. al. (US 2016/0304522).
For claims 1, 19-20 and 22, Heemstra teaches a method of treatment of parasitic infestation of an animal (see [2940], [2941] and [2942]) comprising administering to the animal compounds of formula I:
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(See abstract),
wherein the specific compound can be F309 (see page 142, paragraphs [1322]-[1323]):
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(identical to the elected species, see instant claim 22, compound 453),
wherein the parasite is a tick, and the animal is cattle (see [2941]).
The prior art is silent regarding the statement of claim 1: “wherein the method has at least 90% efficacy against the parasitic infestation for a period of at least one month””.
However, the above statements do not require additional steps to be performed and simply expresses the intended result of carrying the process anticipated by the prior art: “a method of treatment or control of parasitic infestation in an animal in need thereof comprising administering to the cattle a composition comprising the compound like F309 (see above), wherein the parasite is a tick and wherein the animal is cattle ".
MPEP 2114.04 states: “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “ adapted to ” or “adapted for ” clauses;
(B) “ wherein ” clauses; and
(C) “ whereby ” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby’ clause states a condition that is material to patentability; it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat ’l Ass ’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” (Emphasis added).
In the instant case “wherein the method has at least 90% efficacy against the parasitic infestation for a period of at least one month” appears to be the result of the process anticipated by the prior art: “a method of treatment or control of parasitic infestation in an animal in need thereof comprising administering to the cattle a composition comprising the compound like F309 (see above), wherein the parasite is a tick and wherein the animal is cattle ", e. g. the intended result of a process step positively recited. As such, this limitation in the instantly claimed method has not been given any weight.
Further, Heemstra teaches that the methods achieve more than 90% efficacy and preferably more than 99% efficacy (see [0113]), although it does not specify the time.
The office does not have the facilities and resources to provide the factual evidence needed in order to establish that the method anticipated by the prior art does not possess the same material, structural and functional characteristics of the compound claimed in the instant application. In the absence of evidence to the contrary, the burden is on the applicant to prove that efficacy of the claimed method is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
For claims 33-34, Heemstra teaches that the tick can be a Rhipicephalus (see [0105]).
Response to Applicant’s arguments related to the above rejection
Applicant's arguments have been fully considered but are not persuasive.
Since a new rejection necessitated by amendment was issued (see above), it is the Examiner’s belief that most of the arguments presented by Applicant have been considered/answered in the rejection itself.
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) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heemstra et. al. (US 2016/0304522).
Heemstra teaches all the limitations of claim 21 (see above 102(a)(1) above, except for the specific dose regimen. However, Heemstra teaches that the dosages and formulations that are suitable depend on the species being treated see [2941]).
Before the effective filing date of the claimed invention, it would have been prima facie obvious for a person of ordinary skill in the art to further modify the dose regimen since the prior art teaches that dose regimen optimization is a routine practice in the pharmaceutical/veterinarian art, with the motivation of determining the optimal amount of compounds of formula I required for optimal therapy for a particular animal, thus resulting in the practice of claim 21 with a reasonable expectation of success.
Claim Rejections - 35 USC § 102 (New Rejection Necessitated by Amendment).
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.
Claim(s) 35-38 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Heemstra et. al. (US 2016/0304522).
For claims 35-38, Heemstra teaches a method of treatment of parasitic infestation of an animal (see [2940], [2941] and [2942]) comprising administering to the animal compounds of formula I:
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148
246
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(See abstract),
wherein the specific compound can be F309 (see page 142, paragraphs [1322]-[1323]):
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112
252
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(identical to the elected species, see instant claim 36, compound 453),
wherein the parasite is a tick, and the animal isa dog or a cat (see [2941]).
The prior art is silent regarding the statement of claim 35: “wherein the method has at least 90% efficacy against the parasitic infestation for a period of at least one month””.
However, the above statements do not require additional steps to be performed and simply expresses the intended result of carrying the process anticipated by the prior art: “a method of treatment or control of parasitic infestation in an animal in need thereof comprising administering to the cattle a composition comprising the compound like F309 (see above), wherein the parasite is a tick and wherein the animal is a cat or a dog ".
MPEP 2114.04 states: “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “ adapted to ” or “adapted for ” clauses;
(B) “ wherein ” clauses; and
(C) “ whereby ” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby’ clause states a condition that is material to patentability; it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat ’l Ass ’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” (Emphasis added).
In the instant case “wherein the method has at least 90% efficacy against the parasitic infestation for a period of at least one month” appears to be the result of the process anticipated by the prior art: “a method of treatment or control of parasitic infestation in an animal in need thereof comprising administering to the cattle a composition comprising the compound like F309 (see above), wherein the parasite is a tick and wherein the animal is a cat or a dog ", e. g. the intended result of a process step positively recited. As such, this limitation in the instantly claimed method has not been given any weight.
Further, Heemstra teaches that the methods achieve more than 90% efficacy and preferably more than 99% efficacy (see [0113]), although it does not specify the time.
The office does not have the facilities and resources to provide the factual evidence needed in order to establish that the method anticipated by the prior art does not possess the same material, structural and functional characteristics of the compound claimed in the instant application. In the absence of evidence to the contrary, the burden is on the applicant to prove that efficacy of the claimed method is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
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) 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heemstra et. al. (US 2016/0304522).
Heemstra teaches all the limitations of claim 39 (see above 102(a)(1) above, except for the specific dose regimen. However, Heemstra teaches that the dosages and formulations that are suitable depend on the species being treated see [2941]).
Before the effective filing date of the claimed invention, it would have been prima facie obvious for a person of ordinary skill in the art to further modify the dose regimen since the prior art teaches that dose regimen optimization is a routine practice in the pharmaceutical/veterinarian art, with the motivation of determining the optimal amount of compounds of formula I required for optimal therapy for a particular animal, thus resulting in the practice of claim 39 with a reasonable expectation of success.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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 date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCOS L SZNAIDMAN whose telephone number is (571)270-3498. The examiner can normally be reached Flexing M-F 7 AM-7 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached on 571 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARCOS L SZNAIDMAN/
Primary Examiner, Art Unit 1628
June 15, 2026.
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