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 .
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1, line 6: insert “remote” before “area”. 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.
Claims 1-20 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 enablement requirement. The claims contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
In order to determine compliance with the enablement requirement of 35 U.S.C. 112(a), the Federal Circuit developed a framework of factors in In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), referred to as the Wands factors to assess whether any necessary experimentation required by the specification is "reasonable" or is "undue." The Wands factors are addressed below.
(A) The breadth of the claims and (B) the nature of the invention: independent claims 1, 10 and 20 recite basic method steps of providing a feed supplement comprising a therapeutic agent and an amount of sodium, placing the supplement in a remote area, and leaving the supplement in the remote area for at least 3 days.
Claim 1 further recites the result of the method is: that a cervid is attracted to and consumes the supplement at the area due to the predetermined sodium content of the supplement attracting the cervid; wherein the cervid self-administers the therapeutic agent in a therapeutically effective amount due to the predetermined sodium content limiting the cervid’s consumption of the supplement.
Claim 10 further recites the result of the method is: that the cervid is attracted to and consumes the consumption-limiting oral health supplement; wherein the consumption of the consumption-limiting oral health supplement by the cervid is limited via a predetermined sodium content in the form of sodium chloride included in consumption-limiting oral health supplement, so that the cervid self regulates the consumption of consumption-limiting oral health supplement due to the sodium chloride, the sodium chloride causing the cervid to become disinterested in the consumption-limiting oral health supplement and moving on to limit consumption of the consumption-limiting oral health supplement during a single feeding of the consumption-limiting oral health supplement by the cervid, wherein the cervid is impaired from overeating the consumption-limiting oral health supplement as a result of consuming the sodium chloride in the consumption-limiting oral health supplement during the single feeding.
Claim 20 further recites the result of the method is: that the whitetail deer or the elk is attracted to and consumes the supplement at the remote location due to the sodium chloride attracting the whitetail deer or the elk; wherein the whitetail deer or the elk consumes the supplement adjacent a ground surface in the remote area, wherein the whitetail deer or the elk self-administers the tuberculosis vaccine by consuming the supplement adjacent a ground surface in the remote area in a therapeutically effective amount due to the predetermined sodium content limiting the whitetail deer’s or the elk’s consumption of the supplement, wherein the whitetail deer or the elk craves electrolytes due to a depletion of electrolytes in the whitetail deer or the elk during the period of the spring green-up, wherein the whitetail deer or the elk consumes the supplement due to the sodium chloride to replenish the electrolytes in the whitetail deer or the elk, which thereby causes the whitetail deer or the elk to also consume the tuberculosis vaccine in the supplement.
The independent claims encompass all quantities of sodium in the supplement (greater than 0 to less than 100%) and quantities of the claimed therapeutic agent (greater than 0 to less than 100%). The independent claims recite no dosing quantity of the therapeutic agent for the animal. The claims also do not recite the disease or symptoms the therapeutic agent is meant to address. Therefore the claims include all therapeutic agents for all diseases or conditions.
The invention further requires that the wild animals, in an uncontrolled environment, self-administer therapeutically effective amounts of the therapeutic agent. The claims indicate that the quantity of the therapeutic agent consumed will be controlled by the amount of salt in the supplement. The specification indicates that the dosages and administration of the therapeutic agent, however, is unmetered and uncontrolled by human intervention, that is, a human does not know how much of the therapeutic agent or how many doses a particular animal takes, and therefore cannot really control the administration to the animal other than by placing or removing the feed supplement from the remote site [0063]. The specification indicates a therapeutically effective amount means an amount that impairs, suppresses, stops or prevents symptoms and/or progression of infections, diseases and harmful conditions in an animal [0062].
Thus the breadth of the claims is very large, it encompasses all animals in the family Cervidae, sodium quantities in the supplement from greater than 0 to less than 100 wt% and therapeutic agent quantities in the supplement from greater than 0 to less than 100 wt% all while the dosage of the therapeutic agent is controlled by a wild animal consuming the supplement without human intervention.
Dependent claims 7 and 11 recite the therapeutic agent can be a vaccine for chronic wasting disease.
(C) The state of the prior art and the level of one of ordinary skill: It is known in the art to add medication to bait feed for deer (Pound et al. Systemic treatment of white-tailed deer with ivermectin-medicated bait to control free-living populations of lone star ticks (Acari:Ixodidae). J Med Entomol. 1996 May;33(3):385-94. doi: 10.1093/jmedent/33.3.385. PMID: 8667385.). It is also known in the art to create wildlife mineral supplements for cervids comprising high levels of sodium, from 30-50 wt% sodium chloride (Kassouni, US 2010/0189752 A1, paras 0005 and 0012). It is also known in the art to leave deer bait/mineral supplements out in remote areas in order to attract deer to the area to eat the bait/supplements and then later hunt the same deer in the same area.
As disclosed by the USDA (USDA, NWRC Spotlight: Accomplishments in Chronic Wasting Disease Research, July 30, 2025, https://www.aphis.usda.gov/news/stories/accomplishments-chronic-wasting-disease-research) there is no known cure or vaccine for chronic wasting disease (CWD) (p2, para. 2).
As disclosed in the specification, the dosages and administration of the therapeutic agent is unmetered and uncontrolled by human intervention, that is, a human does not know how much of the therapeutic agent or how many doses a particular animal takes, and therefore cannot really control the administration to the animal other than by placing or removing the feed supplement from the remote site [0063].
(E) The level of predictability in the art: as disclosed by applicant in the specification, the dosages and administration of the therapeutic agent is unmetered and uncontrolled by human intervention, that is, a human does not know how much of the therapeutic agent or how many doses a particular animal takes, and therefore cannot really control the administration to the animal other than by placing or removing the feed supplement from the remote site [0063]. Therefore, the amount of a therapeutic agent self-administered by wild cervids with a variety of body masses, a variety of tolerances or needs for salt intake, in an uncontrolled environment is highly unpredictable.
(F) The amount of direction provided by the inventor: the specification indicates the sodium can be included in the supplement from 5-50 wt% [0055]. The amount of sodium is deemed to be an effective amount when it functions in its intended role to cause a wild animal to cease eating or intaking the feed supplement after the animal has eaten a certain amount of the feed supplement. The effective amount may vary depending on the animal, and its size [0029].
The specification does not recite the quantity of the therapeutic agent in the supplement. No reproducible nexus is identified between the amount of salt, the amount of therapeutic agent and the amount of consumption of the supplement by the wild cervid.
(G) The existence of working examples; there are no working examples commensurate in scope with the instant claims. The specification at [0047] and [0049] discloses experiments with the composition of Table 1 (p19), however the composition of Table 1 does not include any therapeutic agent (as required by claims 1-20) nor the tuberculosis vaccine (required by claim 20).
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure: applicant discloses a wide range of sodium in the supplement, 5-50 wt% [0055]. Applicant does not disclose the quantity of the therapeutic agent in the supplement. Applicant discloses and administration of the therapeutic agent is unmetered and uncontrolled by human intervention, that is, a human does not know how much of the therapeutic agent or how many doses a particular animal takes, and therefore cannot really control the administration to the animal other than by placing or removing the feed supplement from the remote site [0063], while the claims require the cervid self-administers the therapeutic agent in a therapeutically effective amount due to the predetermined sodium content limiting the cervid’s consumption of the supplement.
Applicant provides no working examples commensurate in scope with the claims.
The administration of a therapeutically effective amount indicates a safe range of ingestion of the therapeutic agent. The specification indicates a therapeutically effective amount means an amount that impairs, suppresses, stops or prevents symptoms and/or progression of infections, diseases and harmful conditions in an animal [0062]. Delivering a therapeutically effective amount would require the wild cervid to consume neither too much of the therapeutic agent nor too little of the therapeutic agent, both of which could have detrimental health effects on the animal. As disclosed by applicant one really cannot control the administration to the animal other than by placing or removing the feed supplement from the remote site.
Therefore in order for one of ordinary skill in the art to make or use the disclosed invention would require undue experimentation. One would have to test all inclusion rates of the therapeutic agents, with a wide variety of cervid animals of different ages and size, at the indicated wide range of sodium inclusion rates, and for all therapeutic agents known for treating diseases or harmful conditions in cervids. Additionally the one of ordinary skill in the art would have to determine a way to measure whether or not a cervid has ingested a therapeutically effective amount. How is this accomplished since the dose of the supplement cannot be measured or controlled? Is it required to capture and assess the animal in some way, whether that is assessing the animal for symptoms of diseases and harmful conditions or assessing the level of the therapeutic agent in the animals themselves?
Due to the unpredictable nature of the invention, as established by Applicant, where wild animals self-regulate and self-administer a dose of a therapeutic agent in an uncontrolled environment, and the vast quantity of possible combinations of sodium content, different therapeutic agents, quantities of those therapeutic agents and the range of “effective amounts” of said therapeutic agents consumed by the cervids, the lack of working examples provided by applicant and the lack of the existence of a vaccine for chronic wasting disease, a great quantity of experimentation would be required in order to make or use the invention of the instant claims.
In light of the above factors, it is seen that undue experimentation would be necessary to perform and use the invention of claims 1-20.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-9 and 20 are rejected 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.
Claim 1, lines 8-9, recite “wherein the cervid self-administers the therapeutic agent in a therapeutically effective amount.” It is unclear how one of ordinary skill in the art would have to determine a way to measure whether or not a cervid has ingested a therapeutically effective amount. How is this accomplished since the dose of the supplement cannot be measured or controlled, since it is self-administered by a wild animal in an uncontrolled environment? Is it required to capture and assess the animal in some way, whether that is assessing the animal for symptoms of diseases and harmful conditions or assessing the level of the therapeutic agent in the animals themselves?
Claim 20, line 3, requires a therapeutic agent in the consumption-limiting oral health supplement of line 2. Line 5 requires the tuberculosis vaccine included in the supplement. It is unclear if the tuberculosis vaccine is considered to meet the claim limitation of a therapeutic agent, or if another therapeutic agent is required in addition to the tuberculosis vaccine.
Claim 20, lines 13-15, recite “wherein the whitetail deer or the elk consumes the supplement adjacent a ground surface in the remote area, wherein the whitetail deer or the elk self-administers the tuberculosis vaccine by consuming the supplement adjacent a ground surface in the remote area in a therapeutically effective amount due to the predetermined sodium content limiting the whitetail deer’s or the elk’s consumption of the supplement.” It is unclear how one of ordinary skill in the art would have to determine a way to measure whether or not a deer or elk has ingested a therapeutically effective amount. How is this accomplished since the dose of the supplement cannot be measured or controlled, since it is self-administered by a wild animal in an uncontrolled environment? Is it required to capture and assess the animal in some way, whether that is assessing the animal for symptoms of diseases and harmful conditions or assessing the level of the therapeutic agent in the animals themselves?
Claims 2-9 are rejected here because they depend from claim 1.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The prior art made of record in the IDS dated 05/03/2024 is considered pertinent to the disclosure.
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/Michele L Jacobson/Primary Examiner, Art Unit 1793
/C.L.G./Examiner, Art Unit 1793
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