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 .
Final Action
Priority
Instant application 17/793,817 filed on 07/19/2022 claims benefit as follow:
CONTINUING DATA:
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Status of the Application
Claims 1, 3-5, 7-15, 17-19 and 21-32 are pending.
Response to Arguments/Amendments
The amendment filled on 10/21/2025 has been entered.
Applicant amended claim 1 and added new claims 29-32.
Applicant’s amendment overcome the rejections of record; therefore, all rejections of record are withdrawn.
However, it should be noted that none of the amended claims is directed to the elected composition comprising only cannabidiol and analgesics. The amended claims require at least one of a yeast wall source and hydrolyzed brewer’s yeast.
Applicant’s amendment necessitated new grounds of rejections presented in this office action. The withdrawn rejections are reapplied with an additional reference.
In addition, new rejections over US-20190078168-A1 are made.
Regarding Applicant’s arguments, Applicant submitted:
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Applicant's arguments have been fully considered but they are not persuasive. It should be noted that the instant specification describes comparative data of instant gel compositions and oil compositions. However, no comparative data of the instant composition and gel compositions disclosed in prior art has been presented.
In addition, even if the disclosed compositions show improvements over the gel compositions described in prior art, the improved results are not commensurate in scope with the instant claims because it is not clear what amount of yeast (and/or other ingredients) lead to improved bioavailability.
As evidenced by Pletcher (https://www.healthline.com/health/food-nutrition/is-yeast-extract-bad-for-me, updated on October 12, 2017) yeast are often used as food flavoring and/or as nutritional supplements:
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Regarding nutritional supplements, for example Macrogard Pet is sold as food supplement supporting immune system of dogs (https://www.biolabfarma.com.br/en/product-9/macrogard-pet-2/, printed 12/3/2025):
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Further, Immune Health Basis contains ingredients derived from “the call wall of a proprietary strain of yeast” (https://www.nhc.com/immune-health-basics-500-mg-by-immune-health-basics ):
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Therefore, a person of ordinary skill would have been motivated to add yeast cell wall source or/and hydrolyzed brewer’s yeast to the compositions disclosed in prior art. It is known that unflavored cannabidiol (CBD) has a strong taste that many people consider unpleasant (as evidenced by https://sorsetech.com/why-do-most-cannabis-products-taste-so-bad/).The skilled artisan would have been motivated to add yeast as nutritional supplement or/and to improve the taste of the composition.
Election/Restrictions
Claims 15, 17-19 and 21-28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 06/16/2025.
In response to species election requirement,
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Applicant elected composition of cannabidiol and analgesics for oral administration to mammalian.
Applicant also elected inflammation for the species of disease or disorder.
The instant claim 1 recite “a source of the at least one cannabinoid is a hemp oil extract”.
Since the elected composition comprises only cannabidiol and analgesics (additional ingredients have not been named/elected), it implies that the cannabidiol is derived from hemp oil extract (is not synthetic as required in instant claim 7).
Regarding instant claims 30-32, the elected composition comprises only cannabidiol and analgesics, thus, the newly added claims 30-32 do not read on the elected composition.
Claims 7, 8, 9, 13 and 30-32 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 06/16/2025.
Examination will begin with the elected species. In accordance with the MPEP 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. Id. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. Id. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final. Id.
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, 3-5, 10-12 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sayre (US2019/0078168 A1).
Sayre teaches and claims compositions comprising water soluble cannabinoids and yeast cells (see claim 1):
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Sayre teaches cannabidiol (CBD) from Cannabis (aka hemp):
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Sayre teaches a composition comprising CBD and yeast:
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Sayre teaches gel formulations for oral administration:
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Sayre teaches pharmaceutical formulations in unit dosage forms:
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Regarding claims 10-11, Sayre teaches the compositions are intended for mammals:
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Regarding claim 12, Sayre does not explicitly teach that the mammalian subject is a cat. However, MPEP states that 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." (See also MPEP 2131.02 III). Sayre teaches administrations to mammals (e.g., humans), thus, one of ordinary skill would ‘at once envisage’ common mammals, for example, cats.
Regarding claim 14, Sayre teaches the compositions further comprising nutritional supplements:
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Since the teachings of Sayre meet all the limitations of instant claims 1, 3-5, 10-12 and 14, those claims are anticipated.
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.
Claims 1, 3-5, 10-12, 14 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Ghalili (US-20200085739 -A1, Filed Aug, 29, 2019) in view of Auinger (Annegret Auinger et al., Eur J Nutr (2013) 52:1913–1918) evidenced by Regulations.gov (Yeast Extract Hydrolysate from Saccharomyces cerevisiae ; PC Code: 100053., September 24, 2018).
Ghalili teaches hydrogel compositions useful as analgesics comprising cannabinoids, menthol and anesthetic in a composition formulated to be administrable to a non-human animal rectally (abstract).
Ghalili teaches compositions used to relive pain and/or inflammation for oral administration:
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Ghalili teaches cannabidiol (CBD) and full spectrum hemp oil:
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Regarding instant claims 4 and 5, please note that the instant specification states that cannabis oil extract comprising CBD is extracted from hemp and any cannabis plants (see page 92):
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Ghalili teaches unit dose formulations (see para [0045]):
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Ghalili teaches the composition comprising analgetic, menthol (see para [0051]):
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Ghalili teaches the composition comprising analgetic, benzocaine:
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Ghalili teaches:
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Regarding claims 10-12, Ghalili teaches mammalian subjects, including cats:
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Ghalili is silent about yeast cell wall source and hydrolyzed brewer’s yeast.
Auinger teaches that yeast (1,3)-(1,6)-beta-glucan helps to maintain the body’s defense against pathogens (see title and Introduction):
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Applying KSR prong (A) - it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine cannabinoids and yest beta-glucans. A person of ordinary skill would have been motivated to add yeast cell wall source or/and hydrolyzed brewer’s yeast to the compositions disclosed by Ghalili as nutritional supplement. In addition, since it is known that unflavored cannabidiol (CBD) has a strong taste that many people consider unpleasant, the skilled artisan would have been motivated to add hydrolyzed brewer’s yeast to improve the taste of the composition. As evidenced by Regulations.gov, hydrolized brewer’s yeast is a safe flavor enhancer (see page 4, II Use and Usage):
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Claims 1, 3, 4, 5, 10-12, 14 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Hoag (US-20180344676-A1) in view of Auinger (Annegret Auinger et al., Eur J Nutr (2013) 52:1913–1918) evidenced by Regulations.gov (Yeast Extract Hydrolysate from Saccharomyces cerevisiae; PC Code: 100053., September 24, 2018).
Hoag teaches compositions comprising cannabidiol and one or more NSAIDs:
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Hoag teaches analgesics compositions that can be administered orally:
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Hoag teaches extract from Cannabis sativa (aka hemp):
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Hoag teaches gel formulations (para [00310]):
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Hoag teaches composition comprising CBD and THC:
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Regarding claims 10-12, Hoag teaches mammals:
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Regarding instant claim 12, a person of ordinary skill would at once envisioned mammals including domestic animals (cats and dogs). MPEP 2131.02 states that “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."
Further the person of ordinary skill would at once envisioned the formulations formulated in unit dosage because unit dosage packaging enhances safety and convenience.
However, Hoag is silent about yeast cell wall source and hydrolyzed brewer’s yeast.
Auinger teaches that yeast (1,3)-(1,6)-beta-glucan helps to maintain the body’s defense against pathogens (see title and Introduction):
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Applying KSR prong (A) - it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine cannabinoids and yest beta-glucans. A person of ordinary skill would have been motivated to add yeast cell wall source or/and hydrolyzed brewer’s yeast to the compositions disclosed by Hoag as nutritional supplement. In addition, since it is known that unflavored cannabidiol (CBD) has a strong taste that many people consider unpleasant, the skilled artisan would have been motivated to add hydrolyzed brewer’s yeast to improve the taste of the composition. As evidenced by Regulations.gov, hydrolized brewer’s yeast is a safe flavor enhancer (see page 4, II Use and Usage):
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Claims 1, 3-5, 10-12, 14 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Stinchcomb (US-20100273895-A1) in view of Nielsen (Nielsen et al., Neuropsychopharmacology (2017) 42, 1752–1765) evidenced by Atlas of Florida Plants (https://florida.plantatlas.usf.edu/plant/species/1838; printed 04/10/2025 and in view of Auinger (Annegret Auinger et al., Eur J Nutr (2013) 52:1913–1918) and evidenced by Regulations.gov (Yeast Extract Hydrolysate from Saccharomyces cerevisiae ; PC Code: 100053., September 24, 2018).
This rejection applies to the elected composition comprising analgesics.
Stinchcomb teaches compositions comprising pharmaceutically active cannabinoids (paragraph [0002]).
Further, Stinchcomb teaches that “cannabinoids have been shown to regulate various steps in the immune response and could show some therapeutic benefit in the treatment of certain inflammatory diseases such as psoriatic arthritis” (paragraph [0008]).
Furthermore, Stinchcomb teaches the cannabinoid, or mixture of cannabinoids, is obtained from the extract from of a natural source e.g., Cannabis sativa (aka hemp) or from synthetic chemical reactions:
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As evidenced by Atlas of Florida Plants (https://florida.plantatlas.usf.edu/plant/species/1838; printed 04/10/2025 –provided with the previous office action) “Hemp” refers to a plant, scientifically known as Cannabis sativa.
Further, Stinchcomb teaches CBD gels formulations:
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Stinchcomb teaches pharmaceutical dosage forms (see paragraphs [0100] – [0109]) including “a single dosage unit of any formulation comprises a therapeutically effective amount or a therapeutically and/or prophylactically effective amount of cannabidiol” (paragraph [0110]).
Moreover, Stinchcomb teaches pharmaceutical compositions suitable for different methods of administration e.g., for oral administration:
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Stinchcomb teaches the pharmaceutical compositions comprise one or more pharmaceutically acceptable excipients, including oils (paragraph [0073]).
Regarding instant claims 10-12, Stinchcomb teaches mammalian subjects, including domestic animals (see para [0092]):
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However, Stinchcomb is silent about yeast cell wall source and hydrolyzed brewer’s yeast.
Further, regarding the elected composition, Stinchcomb does not teach the composition comprising additional analgesics.
Auinger teaches that yeast (1,3)-(1,6)-beta-glucan helps to maintain the body’s defense against pathogens (see title and Introduction):
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Regarding additional analgesics, Stinchcomb teaches cannabinoids, including cannabidiol, are effective in alleviating pain:
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In addition, Nielsen teaches combinations of medications can maximize analgetic response (see abstract and page 1752, right column):
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Applying KSR prong (A) - it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine cannabinoids, analgesics and yeast cell wall source and/or hydrolyzed brewer’s yeast with a reasonable expectation of success.
One of ordinary skill would have been motivated by the teachings of Nielson to maximize analgetic response of the composition. Further, one of ordinary skill in the art would have been motivated to formulate the compositions comprising CBD and analgetic in unit dosage because unit dosage packaging enhances safety and convenience.
In addition, a person of ordinary skill would have been motivated to add yeast cell wall source or/and hydrolized brewer’s yeast to the compositions disclosed by Stinchcomb as nutritional supplement because Auinger teaches immunostimulatory effect of a yeast (1,3)-(1,6)-beta-glucan preparation (see page 1917, left column, second paragraph and right column, first paragraph):
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[…]
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Since it is known that unflavored cannabidiol (CBD) has a strong taste that many people consider unpleasant, the skilled artisan would have been motivated to add hydrolyzed brewer’s yeast to improve the taste of the composition. As evidenced by Regulations.gov, hydrolized brewer’s yeast is a safe flavor enhancer (see page 4, II Use and Usage):
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Claims 1, 3-5, 10-12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Sayre (US2019/0078168 A1) in view of Nielsen (Nielsen et al., Neuropsychopharmacology (2017) 42, 1752–1765).
This rejection applies to the elected composition comprising analgesics.
The teachings of Sayre have been discussed above (see the 102 rejection above) and those teachings are incorporated herein by reference
Regarding analgesics Sayre teaches cannabinoids for treating pain (see paragraph [0254]):
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However, Sayre does not explicitly teach composition comprising additional analgesics.
Nielsen teaches combinations of medications can maximize analgetic response (see abstract and page 1752, right column):
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Applying KSR prong (A) - it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine cannabinoids, analgesics and yeast with a reasonable expectation of success. One of ordinary skill would have been motivated by the teachings of Nielson to maximize analgetic response of the composition.
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Sayre (US2019/0078168 A1) in view of Regulations.gov (Yeast Extract Hydrolysate from Saccharomyces cerevisiae ; PC Code: 100053., September 24, 2018) evidenced by Joseph (2014, Encyclopedia of Food Microbiology).
The teachings of Sayre have been discussed above (see the 102 rejections) and those teachings are incorporated herein by reference.
Sayre teaches compositions comprising autolyzed yest extract:
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However, regarding claim 29, Sayre does not teach hydrolyzed brewer’s yeast.
As evidenced by Joseph, the difference between autolyzed yeast and hydrolyzed yeast is the method of cell breakdown. In preparation of autolyzed yeast, the enzymes found in the yeast are used to break down the proteins. In hydrolyzed yeast, enzymes or other agents are added to the yeast:
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Regulations.gov, teaches hydrolyzed brewer’s yeast is a safe flavor enhancer (see page 4, II Use and Usage):
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Applying KSR prong (B) - Simple substitution of one known element for another to obtain predictable results - it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute autolyzed yeast disclosed by Sayre for hydrolyzed brewer’s yeast for the same purpose. For example, since it is known that unflavored cannabidiol (CBD) has a strong taste that many people consider unpleasant, the skilled artisan would have been motivated to add hydrolyzed brewer’s yeast to improve the taste of the composition. In addition, yeast extracts are often used as dietary supplements because yeast extracts are rich in B vitamins.
Conclusion
No claim is 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IZABELA SCHMIDT whose telephone number is (703)756-4787. The examiner can normally be reached Monday - Friday from 9 am to 5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton A Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/I.S./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621