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 .
This office action is in response to the application filed on March 21, 2024. The earliest effective filing date of the application is September 21, 2021.
Priority
The present application is a 371 National Stage Application of PCT/US2022/044195 which has a filing date of September 21, 2022.
Election/Restrictions
Applicant has amended the claims of Group II, claims 13 – 17, to read on the elected Group I. Election was made without traverse in the reply filed on February 10, 2026.
Applicant’s election without traverse of Group I, claims 1 and 4 – 17, in the reply filed on February 10, 2026 is acknowledged.
Status of Application
The amendment filed on February 10, 2026 with the Response to Restriction Requirement has been entered. The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 1 and 4 – 17
Withdrawn claims: None
Amended claims: 13 – 17
Previously cancelled claims: 2 and 3
Claims currently under examination: 1 and 4 – 17
Claim Rejections - 35 USC § 112
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 7 – 9 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 7 recites “reduced cortisol as compared to a control” which renders the claim indefinite. The term “a control” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what for which parameters the control is standardized, and to what degree it is standardized. For the purpose of examination, an animal having any level of cortisol is considered to have “reduced cortisol as compared to a control”.
Claim 8 recites “reduced PGE2 as compared to a control” which renders the claim indefinite. The term “a control” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what for which parameters the control is standardized, and to what degree it is standardized. For the purpose of examination, an animal having any level of PGE2 is considered to have “reduced PGE2 as compared to a control”.
Claim 9 recites “increased resting time as compared to a control” which renders the claim indefinite. The term “a control” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what for which parameters the control is standardized, and to what degree it is standardized. For the purpose of examination, an animal having any resting time is considered to have “increased resting time as compared to a control”.
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, 4, 6 – 15, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Roettger (US 20130280343 A1 – IDS Filed on September 10, 2025).
Regarding claim 1, Roettger teaches a process for improving livestock characteristics, comprising: administering cannabinoid receptor agonists to livestock; the cannabinoid receptor agonists producing one or more significant pharmacological effects with positive efficacy in the livestock; and deriving one or more food products from the livestock (Claim 1). With respect to the recitation “administering an effective amount of cannabinoids to an animal before, during, and/or after exposure to a stressful event”, any time of administration could be considered “before, during, or after a stressful event”. Therefore, Roettger teaches administering cannabinoids to an animal before, during and/or after exposure to a stressful event.
Roettger further teaches after consuming Cannabis (i.e., cannabinoid receptor agonists) for several days, Taijma beef cattle experience physiological and behavioral effects as a result of the cannabinoids present in the ingested plants ([0024]). Roettger teaches some of these potential effects may be desirable to cattle farmers, such as the pacification of aggressive cattle (i.e., improved performance and/or behavior), an increase in beef quality, and an increase in carcass yield due to appetite stimulation and weight gain (i.e., improved carcass characteristics – [0024]). Because Roettger teaches the administration method produces cattle (i.e., animals) with pacified aggression (i.e., improved performance) and weight gain (i.e., improved carcass characteristics), the method of Roettger teaches the administration of an effective amount of cannabinoids to an animal to improve performance, behavior, and/or carcass characteristics.
While Roettger does not teach administering the cannabinoid receptor agonist for a total time period of from 5 – 14 days, Roettger teaches it is easy to experiment and determine the appropriate dosage level for obtaining a particular pharmacological effect using a given cannabinoid, method of administration, and species of animal ([0014]). One of ordinary skill in the art would have adjusted the dosage period, including to within 5 – 14 days, during routine optimization to obtain the desired pharmacological effect using a given cannabinoid MPEP §2144.05(II) states where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The claimed administration period for the cannabinoid receptor agonist, 5 – 14 days, would thus be obvious.
Regarding claim 4, Roettger teaches the cannabinoids administered include cannabidiol (CBD) ([0008]).
Regarding claim 6, the broadest reasonable interpretation of “improved performance after the stressful event”, encompasses any performance given the absence of an objective reference against which to compare a given animal’s performance. Therefore, the administration method taught by Roettger is encompassed by claim 6.
Regarding claim 7, for the purpose of examination, an animal having any level of cortisol is considered to have “reduced cortisol as compared to a control”. Therefore, the cortisol level of the Taijma beef cattle of the method of Roettger is encompassed by claim 7.
Regarding claim 8, for the purpose of examination, an animal having any level of PGE2 is considered to have “reduced PGE2 as compared to a control”. Therefore, the PGE2 level of the Taijma beef cattle of the method of Roettger is encompassed by claim 8.
Regarding claim 9, for the purpose of examination, an animal having any resting time is considered to have “increased resting time as compared to a control”. Therefore, the resting time of the Taijma beef cattle of the method of Roettger is encompassed by claim 9.
Regarding claim 10, while Roettger does not teach administering the cannabinoid receptor agonist for a total time period of from 5 – 7 days, Roettger teaches it is easy to experiment and determine the appropriate dosage level for obtaining a particular pharmacological effect using a given cannabinoid, method of administration, and species of animal ([0014]). One of ordinary skill in the art would have adjusted the dosage period, including to within 5 – 7 days, during routine optimization to obtain the desired pharmacological effect using a given cannabinoid MPEP §2144.05(II) states where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The claimed administration period for the cannabinoid receptor agonist, 5 – 7 days, would thus be obvious.
Regarding claim 11, Taijma beef cattle are ruminants.
Regarding claim 12, while Roettger does not teach administering an effective amount of 0.5 mg/kg bodyweight to about 30 mg/kg of bodyweight of the cattle, Roettger teaches it is easy to experiment and determine the appropriate dosage level for obtaining a particular pharmacological effect using a given cannabinoid, method of administration, and species of animal ([0014]). One of ordinary skill in the art would have adjusted the dosage amount, including to within 0.5 mg/kg bodyweight to about 30 mg/kg of bodyweight of the cattle, during routine optimization to obtain the desired pharmacological effect using a given cannabinoid MPEP §2144.05(II) states where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The claimed administration amount, 0.5 mg/kg bodyweight to about 30 mg/kg of bodyweight of the cattle, would thus be obvious.
Regarding claim 13, Roettger teaches Tajima beef cattle are finished on a diet consisting of 80% temper rolled barley, 10% haylage, and 10% dried Cannabis sativa plant matter of various cultivars (i.e., administering an animal feed comprising an effective amount of cannabinoids – [0024]). Roettger teaches after consuming Cannabis (i.e., cannabinoid receptor agonists) for several days, Taijma beef cattle experience physiological and behavioral effects as a result of the cannabinoids present in the ingested plants ([0024]). Therefore, the amount of cannabinoids in the diet are considered to be effective.
Regarding claim 14, Roettger teaches the diet comprises barley and haylage, which are considered to be taste enhancers ([0024]).
Regarding claim 15, Roettger teaches another embodiment wherein finishing hogs are supplied water which has been fortified with an alcohol extract comprising THC, CBN, and many other phytocannabinoids ([0028]). According to the broadest reasonable interpretation of “top dressing”, the alcohol extract of comprising THC, CBN, and many other phytocannabinoids is considered to be a top dressing.
MPEP § 2131.02 states, a reference disclosure can anticipate a claim when the reference describes the limitations but "'d[oes] not expressly spell out' the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination." According to the teachings of Roettger described above, one of ordinary skill in the art would have at once envisaged including the alcohol extract comprising THC, CBN, and many other phytocannabinoids (i.e., a top dressing) in the diet of administration method for Taijma beef cattle.
Regarding claim 17, Roettger teaches another embodiment wherein finishing hogs are supplied water which has been fortified with an alcohol extract comprising THC, CBN, and many other phytocannabinoids (i.e., isolated and/or concentrated cannabinoids – [0028]).
MPEP § 2131.02 states, a reference disclosure can anticipate a claim when the reference describes the limitations but "'d[oes] not expressly spell out' the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination." According to the teachings of Roettger described above, one of ordinary skill in the art would have at once envisaged including the alcohol extract comprising THC, CBN, and many other phytocannabinoids (i.e., isolated and/or concentrated cannabinoids) in the diet of administration method for Taijma beef cattle.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Roettger (US 20130280343 A1 – IDS Filed on September 10, 2025), as applied to claim 1 above, and further in view of APHIS (U.S. Feedlot Processing Practices for Arriving Cattle. APHIS. (2012)).
Regarding claim 5, Roettger teaches Tajima beef cattle are finished on a diet consisting of barley, haylage, and Cannabis ([0024]).
Roettger does not teach administering the diet as an on arrival therapeutic for an animal transported to a feedlot.
APHIS teaches cattle finishing is typically conduced on a feedlot (p. 1, paragraph 1).
Roettger and APHIS are combinable because they are concerned with the same field of endeavor, namely, finishing cattle. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have administered the diet of Roettger to Taijma cattle in a feedlot (i.e., as an on arrival therapeutic for an animal transported to a feedlot), as taught by APHIS, because APHIS provides that it was known for cattle to be finished on feedlots before the time of filing, which means it was within the general skill of a worker in the art to finish the Taijma cattle on feedlots, and thus administer the diet of Roettger to the cattle upon arrival to the feedlot, because it would be obvious to one of skill in the art to do such a thing on the basis of its suitability for a similar intended use. See MPEP § 2144.07.
Given the therapeutic benefits of the diet administered by Roettger to the Taijma cattle (the pacification of aggressive cattle), the administration of the diet to the cattle upon arrival to the feedlot would satisfy the intended use recited in claims 5 that the diet is administered “as a therapeutic”.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Roettger (US 20130280343 A1 – IDS Filed on September 10, 2025), as applied to claim 13 above, and further in view of Gibb et al. (Effect of full-fat hemp seed on performance and tissue fatty acids of feedlot cattle. Canadian Journal of Animal Science. Pp. 223 – 230. (2005)).
Roettger does not teach the diet in the administration method comprises industrial hemp.
The instant specification defines “industrial hemp” as Cannabis sativa with <0.3% tetrahydrocannabinol (THC – p. 3, lines 6 – 7). Gibb concurs that industrial hemp contains less than 0.3% THC (p. 224, paragraph 1). Gibb teaches the administration of industrial hemp seed to cattle favorably alters cattle carcass fat by increasing levels of conjugated linoleic acids (CLA) and n-fatty acids without negatively affecting cattle performance (p. 228, paragraph 6).
Roettger and Gibb are combinable because they are concerned with the same field of endeavor, namely, methods of administering diets comprising Cannabis sp. to cattle. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have included industrial hemp seed in the diet of the administration method of Roettger, as taught by Gibb, because the administration of industrial hemp seed to cattle favorably alters cattle carcass fat by increasing levels of CLA and n-fatty acids without negatively affecting cattle performance.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LARK JULIA MORENO whose telephone number is (571)272-2337. The examiner can normally be reached 6:30 - 4:30 M - F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Emily Le can be reached at (571) 272-0903. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.J.M./Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793
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