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 December 30, 2022. The earliest effective filing date of the application is December 30, 2021.
Status of Application
The status of the claims stands as follows:
Pending claims: 1 – 20
Withdrawn claims: None
Amended claims: 1 – 20
Claims currently under consideration: 1 – 20
The status of the objections and rejections regarding the disclosure upon entry of the present amendment stands as follows:
Objections: The previous objections to claims 9 and 19 are withdrawn in light of applicant’s amendments. A new objection to claims 1 is presented below in light of applicant’s amendments.
Withdrawn Rejections: The previous rejections under 35 U.S.C. § 102(a)(1) of claims 12 and 16 – 18 over Sencha Tea Bar are withdrawn in light of applicant’s amendments. The previous rejections under 35 U.S.C. § 102(a)(1) of claims 12 – 15 over KDC are withdrawn in light of applicant’s amendments. The previous rejections under 35 U.S.C. § 102(a)(1) of claims 1, 2, 4, 6 – 8, 12, 14, and 16 – 18 over Mayberry are withdrawn in light of applicant’s amendments. The previous rejections under 35 U.S.C. § 103 of claims 3, 5, 9 – 11, 13, 15, 19, and 20 over Mayberry are withdrawn in light of applicant’s amendments.
35 U.S.C. § 112 Rejections: New rejections under 35 U.S.C. § 112(b) of claims 2 – 20 have been presented below in light of applicant’s amendments.
35 U.S.C. § 101 Rejections: The previous rejections under 35 U.S.C. § 101 of claims 1 – 20 have been adjusted and maintained in light of applicant’s amendments.
35 U.S.C. § 102 Rejections: The previous rejection under 35 U.S.C. § 102(a)(1) of claim 1 over the kava root is adjusted and maintained in light of applicant’s amendments. The previous rejections under 35 U.S.C. § 102(a)(1) of claims 1, 2, and 6 – 8 over Sencha Tea Bar are adjusted and maintained in light of applicant’s amendments. The previous rejections under 35 U.S.C. § 102(a)(1) of claims 1 – 5 over KDC are adjusted and maintained in light of applicant’s amendments. New rejections under 35 U.S.C. § 102(a)(1) of claims 1, 2, 4, 12, and 14 over Mayberry, as necessitated by applicant’s amendments, are presented below.
35 U.S.C. § 103 Rejections: New rejections under 35 U.S.C. § 103 of claims 3, 5 – 11, 13, and 15 – 20 over Mayberry, as necessitated by applicant’s amendments, are presented below.
Claim Interpretation
Claims 1 – 20 recite in the preamble “An animal nutritional supplement”. MPEP § 2111.02.II teaches, “[i]f the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.” In the instant case, the noted preamble merely states the purpose or intended use of the claimed composition. Therefore, the preamble does not further limit the claim.
Claims 1 – 20 recite “relaxant”. Because there is no definition provided for “relaxant” in the instant application, for the purpose of examination, any component with a relaxing effect when ingested is considered a “relaxant”.
Claim 1 – 20 recite “palatability enhancer”. Because there is no definition provided for “palatability enhancer” in the instant application, for the purpose of examination, anything in an edible composition that is not a relaxant is considered a palatability enhancer.
Claims 1, 3 – 8, 10, 11, 13 – 18, and 20 recite “… in the form of an extract”. Given there is no definition provided in the specification for what is or is not an “extract”, the broadest reasonable interpretation is applied as expounded upon below:
Claims 1, 10, and 20 recite “a relaxant in the form of an extract” which is interpreted broadly to encompass any compound that may be considered a relaxant, regardless of source.
Claim 1 and 11 recite “one or more palatability enhancers in the form of an extract” which is interpreted broadly to encompass any compound that may be considered a palatability enhancer, regardless of source.
Claims 3, 5, 13, and 15 recite “kavalactones in the form of an extract” which is interpreted broadly to encompass any compound that may be considered a kavalactone, regardless of source.
Claims 4, 5, 14, and 15 recite “ashwagandha in the form of an extract” which is interpreted broadly to encompass any compound that may be considered ashwagandha, regardless of source.
Claims 6, 8, 16, and 18 recite “dextrose in the form of an extract” which is interpreted broadly to encompass any compound that may be considered dextrose, regardless of source.
Claims 7, 8, 17, and 18 recite “fructose in the form of an extract” which is interpreted broadly to encompass any compound that may be considered fructose, regardless of source.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 recites “An animal nutritional supplement comprising: an animal nutritional supplement comprising:” which should be “An animal nutritional supplement comprising:”.
Appropriate correction is required.
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 2 – 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 2 recites “wherein the supplement is suspended in water” which renders the claim indefinite. The entire composition of claim 2 is “the supplement” therefore, the water within the supplement is also a part of it. It is unclear what portion of “the supplement” is suspended in water. For the purpose of examination, any component of the composition of claim 2 that is not water may be suspended in water.
Claim 12 recites “wherein the supplement is suspended within the adhesive” which renders the claim indefinite. The entire composition of claim 12 is “the supplement” therefore, the adhesive within the supplement is also a part of it. It is unclear what portion of “the supplement” is suspended in the adhesive. For the purpose of examination, any component of the composition of claim 12 that is not the adhesive may be suspended within the adhesive.
Claims 3 – 11 and 13 – 20 are rejected as dependent on a rejected base claim.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1 – 20 are rejected under 35 U.S.C. 101 as evidenced by Ohmenhaeuser et al. (Qualitative and Quantitative Control of Honeys Using NMRSpectroscopy and Chemometrics. Hindawi Publishing Corporation, ISRN Analytical Chemistry. (2013)), National Honey Board (Honey: A Versatile and Functional Ingredient. National Honey Board. (March 6, 2017) Retrieved from: https://honey.com/newsroom/press-release/honey-a-versatile-and-functional-ingredient), and Local Hive (What Makes Honey Sticky? Local Hive Honey. (n.d.) Retrieved from: https://localhivehoney.com/blogs/blog/what-makes-honey-sticky-local-hive).
MPEP § 2106 sets forth the Subject Matter Eligibility Test to determine if a claim is directed to patent eligible subject matter. The following analysis is presented within the framework enumerated in MPEP § 2106.
Subject Matter Eligibility Test
Step 1: Applicant’s claims are directed to a product.
Step 2A, Prong 1:
Claim 1 recites a composition comprising the naturally occurring phenomena: a relaxant, and one or more palatability enhancers. As stated in the instant specification, a relaxant may be comprised of but is not limited to Withania somnifera ("ashwagandha") and/or kavalactones similar to those found in the kava plant of either the tudei and/or noble varieties ([1900]). Absent evidence to the contrary, a palatability enhancer may be a natural product, as many natural products have pleasant flavor, sweetness, and/or mouthfeel. Furthermore, because there is not definition provided for “palatability enhancer” in the instant application, for the purpose of examination, anything in an edible composition that is not a relaxant is considered a palatability enhancer, meaning honey, lettuce, or lavender, for example, can be considered naturally occurring palatability enhancers.
Claims 2 and 9 – 11 recite a composition comprising the naturally occurring phenomena: a relaxant, one or more palatability enhancers, an emulsifier, and water. As stated in the instant specification, a relaxant may be comprised of but is not limited to Withania somnifera ("ashwagandha") and/or kavalactones similar to those found in the kava plant of either the tudei and/or noble varieties ([1900]). Absent evidence to the contrary, a palatability enhancer may be a natural product, as many natural products have pleasant flavor, sweetness, and/or mouthfeel. Furthermore, given the current interpretation of “palatability enhancer” anything in an edible composition that is not a relaxant is considered a palatability enhancer, meaning honey, lettuce, or lavender, for example, can be considered naturally occurring palatability enhancers. Absent evidence to the contrary, an emulsifier may be a natural product such as honey or egg.
Claims 3 – 5 recite a composition comprising the naturally occurring phenomena: a relaxant comprising ashwagandha and/or kavalactones, one or more palatability enhancers, an emulsifier, and water. Ashwagandha is a naturally occurring root. Kavalactones naturally occur in the kava root. Absent evidence to the contrary, a palatability enhancer may be a natural product, as many natural products have pleasant flavor, sweetness, and/or mouthfeel. Furthermore, given the current interpretation of “palatability enhancer” anything in an edible composition that is not a relaxant is considered a palatability enhancer, meaning honey, lettuce, or lavender, for example, can be considered naturally occurring palatability enhancers. Absent evidence to the contrary, an emulsifier may be a natural product such as honey or egg.
Claims 6 – 8 recite a composition comprising the naturally occurring phenomena: a relaxant, one or more palatability enhancers wherein one palatability enhancer comprises dextrose and/or fructose, an emulsifier, and water. As stated in the instant specification, a relaxant may include but is no limited to Withania somnifera ("ashwagandha") and/or kavalactones similar to those found in the kava plant of either the tudei and/or noble varieties ([1900]). Absent evidence to the contrary, a palatability enhancer may be a natural product, as many natural products have pleasant flavor, sweetness provided by dextrose and/or fructose, and/or mouthfeel. Furthermore, given the current interpretation of “palatability enhancer” anything in an edible composition that is not a relaxant is considered a palatability enhancer, meaning honey, sweet potato, or mango, for example, can be considered naturally occurring palatability enhancers comprising dextrose and/or fructose. Absent evidence to the contrary, an emulsifier may be a natural product such as honey or egg.
Claims 12, 19, and 20 recite compositions comprising the naturally occurring phenomena: a relaxant, one or more palatability enhancers, and an adhesive. As stated in the instant specification, a relaxant may include but is no limited to may be comprised of but is not limited to Withania somnifera ("ashwagandha") and/or kavalactones similar to those found in the kava plant of either the tudei and/or noble varieties ([1900]). Absent evidence to the contrary, a palatability enhancer may be a natural product, as many natural products have pleasant flavor, sweetness, and/or mouthfeel. Furthermore, given the current interpretation of “palatability enhancer” anything in an edible composition that is not a relaxant is considered a palatability enhancer, meaning honey, lettuce, or lavender, for example, can be considered naturally occurring palatability enhancers. Absent evidence to the contrary, an adhesive may be a natural product such as honey or egg.
Claims 13 – 15 recite a composition comprising the naturally occurring phenomena: a relaxant comprising ashwagandha and/or kavalactones, one or more palatability enhancers, and an adhesive. Ashwagandha is a naturally occurring root. Kavalactones naturally occur in the kava root. Absent evidence to the contrary, a palatability enhancer may be a natural product, as many natural products have pleasant flavor, sweetness, and/or mouthfeel. Furthermore, given the current interpretation of “palatability enhancer” anything in an edible composition that is not a relaxant is considered a palatability enhancer, meaning honey, lettuce, or lavender, for example, can be considered naturally occurring palatability enhancers. Absent evidence to the contrary, an adhesive may be a natural product such as honey or egg.
Claims 16 – 18 recite a composition comprising the naturally occurring phenomena: a relaxant, one or more palatability enhancers wherein one palatability enhancer comprises dextrose and/or fructose, and an adhesive. As stated in the instant specification, a relaxant may include but is no limited to may be comprised of but is not limited to Withania somnifera ("ashwagandha") and/or kavalactones similar to those found in the kava plant of either the tudei and/or noble varieties ([1900]). Absent evidence to the contrary, a palatability enhancer may be a natural product, as many natural products have pleasant flavor, sweetness provided by dextrose and/or fructose, and/or mouthfeel. Furthermore, given the current interpretation of “palatability enhancer” anything in an edible composition that is not a relaxant is considered a palatability enhancer, meaning honey, sweet potato, or mango, for example, can be considered naturally occurring palatability enhancers comprising dextrose and/or fructose. Absent evidence to the contrary, an adhesive may be a natural product such as honey or egg.
Claims 1 – 20 recite nature-based product limitations – they must be evaluated by the markedly different characteristics analysis. See MPEP § 2106.04 (b) - (c).
Markedly different characteristics analysis
If the nature-based product limitation is not naturally occurring, for example due to some human intervention, then the markedly different characteristics analysis must be performed to determine whether the claimed product limitation is a product of nature exception. See MPEP § 2106.04(c)(I). The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties. See MPEP § 2106.04(c)(II).
In this case, there is no modification of the ingredients within the claimed composition.
Regarding claim 1, relaxants such as chamomile, ashwagandha, or kava are naturally occurring. Palatability enhancers such as honey, maple syrup, or mint are naturally occurring. While the relaxant and palatability enhancers are combined to comprise the claimed composition, there is no process claimed that alters the relaxant or palatability enhancers in a way that modifies its natural composition. The limitations of claim 1 encompass, for example, chamomile and honey, without significantly more.
Regarding claims 2 and 9 – 11, relaxants such as chamomile, ashwagandha, or kava are naturally occurring. Palatability enhancers such as honey, maple syrup, or mint are naturally occurring. Honey is also a naturally occurring emulsifier as evidenced by National Honey Board (p. 1, paragraph 2). While the relaxant, palatability enhancers, and emulsifier are combined to comprise the claimed composition, there is no process claimed that alters the relaxant, palatability enhancers, or emulsifier in a way that modifies its natural composition. The limitations of claims 2 and 9 – 11 encompass, for example, chamomile, honey, and water, without significantly more.
Regarding claims 3 – 5, relaxants such as ashwagandha, or kava are naturally occurring. As stated in the instant specification, kavalactones naturally occur in the kava plant ([0019]). Palatability enhancers such as honey, maple syrup, or mint are naturally occurring. Honey is also a naturally occurring emulsifier as evidenced by National Honey Board (p. 1, paragraph 2). While the relaxant, palatability enhancers, and emulsifier are combined to comprise the claimed composition, there is no process claimed that alters the relaxant, palatability enhancers, or emulsifier in a way that modifies its natural composition. The limitations of claims 3 – 5 encompass, for example, ashwagandha, kava, honey, and water, without significantly more.
Regarding claims 6 – 8, relaxants such as chamomile, ashwagandha, or kava are naturally occurring. Palatability enhancers such as honey, maple syrup, or mint are naturally occurring. As evidenced by Ohmenhaeuser, honey naturally comprises 28 – 40% fructose and 20 – 35% glucose (i.e., dextrose – p. 7, Table 3, Glucose, Fructose). Honey is also a naturally occurring emulsifier as evidenced by National Honey Board (p. 1, paragraph 2). While the relaxant, palatability enhancers, and emulsifier are combined to comprise the claimed composition, there is no process claimed that alters the relaxant, palatability enhancers, or emulsifier in a way that modifies its natural composition. The limitations of claims 6 – 8 encompass, for example, chamomile, honey, and water, without significantly more.
Regarding claims 12, 19, and 20, relaxants such as chamomile, ashwagandha, or kava are naturally occurring. Palatability enhancers such as honey, maple syrup, or mint are naturally occurring. Honey is also a naturally occurring adhesive as evidenced by Local Hive (p. 2, paragraph 4). While the relaxant, palatability enhancers, and adhesive are combined to comprise the claimed composition, there is no process claimed that alters the relaxant, palatability enhancers, or adhesive in a way that modifies its natural composition. The limitations of claims 2 and 9 – 11 encompass, for example, chamomile and honey, without significantly more.
Regarding claims 13 – 15, relaxants such as ashwagandha, or kava are naturally occurring. As stated in the instant specification, kavalactones naturally occur in the kava plant ([0019]). Palatability enhancers such as honey, maple syrup, or mint are naturally occurring. Honey is also a naturally occurring adhesive as evidenced by Local Hive (p. 2, paragraph 4). While the relaxant, palatability enhancers, and adhesive are combined to comprise the claimed composition, there is no process claimed that alters the relaxant, palatability enhancers, or adhesive in a way that modifies its natural composition. The limitations of claims 3 – 5 encompass, for example, ashwagandha, kava, and honey, without significantly more.
Regarding claims 16 – 18, relaxants such as chamomile, ashwagandha, or kava are naturally occurring. Palatability enhancers such as honey, maple syrup, or mint are naturally occurring. As evidenced by Ohmenhaeuser, honey naturally comprises 28 – 40% fructose and 20 – 35% glucose (i.e., dextrose – p. 7, Table 3, Glucose, Fructose). Honey is also a naturally occurring adhesive as evidenced by Local Hive (p. 2, paragraph 4). While the relaxant, palatability enhancers, and adhesive are combined to comprise the claimed composition, there is no process claimed that alters the relaxant, palatability enhancers, or adhesive in a way that modifies its natural composition. The limitations of claims 6 – 8 encompass, for example, chamomile and honey, without significantly more.
In the instant application, each naturally occurring claim element has the same effect it always had. The claimed naturally occurring products perform in their natural way. Their use in combination does not improve in any way their natural functioning. They serve the ends nature originally provided and act quite independently of any effort of the patentee. As such, the characteristics of the claimed invention are not markedly different from their naturally occurring counterparts. Therefore, the claims are drawn to mixtures of naturally occurring products. Thus, the claims are directed to a judicial exception.
Step 2A, Prong 2: Nothing is done with these naturally occurring products therefore there is no practical application.
Step 2B: Evaluating additional elements to determine whether they amount to an inventive concept requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself. See MPEP § 2106.05. In this case, there are no additional elements.
Therefore, claims 1 – 20 are not directed to patent eligible subject matter.
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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by the kava root as evidenced by Bilia et al. (Kava-kava and anxiety: Growing knowledge about the efficacy and safety. Life Sciences. Vol. 70. Pp. 2581 – 2597. (2002)).
Regarding claim 1, the kava root contains eighteen α-pyrones known as kavalactones, as evidenced by Bilia (p. 2583, Active principles). As evidenced by Bilia, kavalactones have been shown to have anxiolytic, sedative, analgesic, anticonvulsant and local anesthetic effects (i.e., kavalactones are relaxants – p. 2593, Conclusions, paragraph 1). As evidenced by Bilia, the kava root also comprises essential oils (i.e., palatability enhancer – p. 2583, Active principles). Because the kavalactones and essential oil in the kava root are different chemical species, the relaxant in the kava root is a different substance from the one or more palatability enhancers. Therefore, claim 1 is anticipated by the kava root.
Claims 1, 2, and 6 – 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sencha Tea Bar (How to Make Chamomile Tea: 5 Recipes From Simple Tea to a Hot Toddy. Sencha Tea Bar. (2018). Retrieved from: https://senchateabar.com/blogs/blog/how-to-make-chamomile-tea) as evidenced by Ohmenhaeuser et al. (Qualitative and Quantitative Control of Honeys Using NMRSpectroscopy and Chemometrics. Hindawi Publishing Corporation, ISRN Analytical Chemistry. (2013)), National Honey Board (Honey: A Versatile and Functional Ingredient. National Honey Board. (March 6, 2017) Retrieved from: https://honey.com/newsroom/press-release/honey-a-versatile-and-functional-ingredient), and Local Hive (What Makes Honey Sticky? Local Hive Honey. (n.d.) Retrieved from: https://localhivehoney.com/blogs/blog/what-makes-honey-sticky-local-hive).
Regarding claim 1, Sencha Tea Bar teaches a tea comprising chamomile (i.e., relaxant), lavender (i.e., palatability enhancer), mint (i.e., palatability enhancer), lemon juice (i.e., palatability enhancer), and honey (i.e., palatability enhancer – p. 4, 2. Lavender and Chamomile tea).
Regarding claim 2, Sencha Tea Bar teaches a tea comprising chamomile (i.e., relaxant), lavender (i.e., palatability enhancer), mint (i.e., palatability enhancer), lemon juice (i.e., palatability enhancer), honey (i.e., palatability enhancer), and water (p. 4, 2. Lavender and Chamomile tea). Honey is an emulsifier as evidenced by National Honey Board (p. 1, paragraph 2). Absent evidence to the contrary, there is no disclosure in the instant application that prevents the palatability enhancer from also being an emulsifier within the composition. In this case, honey is both a palatability enhancer and an emulsifier. Given the chamomile tea is a liquid which comprises water, the ingredients within the tea are considered to be suspended in water.
Regarding claims 6 – 8, Sencha Tea Bar teaches a tea comprising chamomile (i.e., relaxant), lavender (i.e., palatability enhancer), mint (i.e., palatability enhancer), lemon juice (i.e., palatability enhancer), and honey (i.e., palatability enhancer and emulsifier – p. 4, 2. Lavender and Chamomile tea). As evidenced by Ohmenhaeuser, honey naturally comprises 28 – 40% fructose and 20 – 35% glucose (i.e., dextrose – p. 7, Table 3, Glucose, Fructose).
Claims 1 – 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by KDC (Kava Ashwagandha Tincture Blend. Kava Dot Com. (2018). Retrieved from: https://kava.com/shop/kava-ashwagandha-tincture-blend/?srsltid=AfmBOooSJjf7pPAbp3BRgJrKk12E5FE8MlEXPRCAORii10CGG7ulpxj0).
Regarding claim 1, KDC teaches a kava and ashwagandha tincture (i.e., animal nutritional supplement) comprising kava extract (i.e., relaxant), ashwagandha extract (i.e., relaxant), grain alcohol (i.e., palatability enhancer), and glycerin (i.e., palatability enhancer) and water (i.e., palatability enhancer – p. 1, Supplement Facts). KDC teaches the kava extract is 6% kavalactones (p. 1, Supplement Facts).
Regarding claim 2, KDC teaches the kava and ashwagandha tincture (i.e., animal nutritional supplement) comprises glycerin, which is a known emulsifier. Absent evidence to the contrary, there is no disclosure in the instant application that prevents the palatability enhancer from also being an emulsifier within the composition. In this case, glycerin is both a palatability enhancer and an emulsifier. Given the kava and ashwagandha tincture a liquid which comprises water, the ingredients within the tincture are considered to be suspended in water.
Regarding claims 3 – 5, KDC teaches the kava and ashwagandha tincture (i.e., animal nutritional supplement) comprises 145 mg kavalactones (i.e., relaxant) and 1000 mg ashwagandha extract (i.e., relaxant – p. 1 Supplement Facts).
Claims 1, 2, 4, 12, and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mayberry et al. (WO 2021216640 A1).
Regarding claim 1, Mayberry teaches a composition for treating sleeplessness, anxiety, pain or inflammation in a mammal (i.e., an animal nutritional supplements) comprising:
(i) one or more pharmacologically active, non-psychoactive cannabinoids (i.e., relaxant); and
(ii) a pharmacologically active, non-prescription, non-cannabinoid active agent (i.e., relaxant); and
an optional carrier or matrix in which the active ingredients are dissolved or dispersed (i.e., palatability enhancer – [0007]).
Regarding claims 2 and 4, Mayberry teaches the optional carrier or matrix may comprise ingredients that provide the composition in a useful form (i.e., chews, tablets, tinctures, etc.) configured for easy administration to a mammal of an appropriate pharmacological dosage of the active ingredients ([0008]; [0040]; [0103]). As an example, Mayberry teaches an ingestible gravy topper comprising GABA, L-theanine, and ashwagandha (i.e., relaxants), flavorings (i.e., palatability enhancers), vegetable glycerin and lecithin (i.e., emulsifiers), and water, among other ingredients ([0118]). Given the gravy topper is a semi-liquid form which comprises water, the ingredients within the gravy are considered to be suspended in water.
Regarding claims 12 and 14, while the instant specification does not provide a definition for “adhesive”, it states "Adhesive 210 of nutritional supplement 200 may include relaxant 105 in a liquid (e.g., tincture or in a liquid solution of relaxant 105 which may include emulsifier 110) and/or liquid palatability enhancers 115 (e.g., molasses, oils, dextrose, fructose, saccharin, sucralose, glucose, maltose, lactose, fruit extracts, liquid vitamins, etc.)” which appears to indicate that tincture ingredients, emulsifiers, and liquid palatability enhancers may be considered adhesives, and that adhesives are necessarily liquids (Figure 2; [2200]). For the purpose of examination, any liquid that aids in binding a composition together, including non-relaxant tincture ingredients, emulsifiers, and liquid palatability enhancers is considered an adhesive.
Mayberry teaches the optional carrier or matrix may comprise ingredients that provide the composition in a useful form (i.e., chews, tablets, tinctures, etc.) configured for easy administration to a mammal of an appropriate pharmacological dosage of the active ingredients ([0008]; [0040]; [0103]). As an example, Mayberry teaches an ingestible gravy topper comprising GABA, L-theanine, and ashwagandha (i.e., relaxants), flavorings (i.e., palatability enhancers), vegetable glycerin and lecithin (i.e., adhesives), and water, among other ingredients ([0118]). Given the gravy topper is a semi-liquid form (i.e., a paste) which comprises adhesives, the ingredients within the gravy are considered to be suspended in the adhesives.
Because vegetable glycerin and lecithin are liquid emulsifiers, they are also considered adhesives. Absent evidence to the contrary, there is no disclosure in the instant application that prevents the palatability enhancer from also being an emulsifier and/or an adhesive within the composition. In this case, glycerin and lecithin are palatability enhancers, emulsifiers, and adhesives.
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 9 – 11, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Mayberry et al. (WO 2021216640 A1).
Regarding claim 9, Mayberry does not teach the ratio of emulsifier to relaxant is between 1:1 and 1:4.
Mayberry teaches the optional carrier or matrix may comprise ingredients that provide the composition in a useful form (i.e., chews, tablets, tinctures, etc.) configured for easy administration to a mammal of an appropriate pharmacological dosage of the active ingredients ([0008]; [0040]; [0103]). Mayberry teaches the ingestible form factor is preferably selected to meet the preferences of the mammal taking the ingestible composition ([0103]).
While Mayberry does not teach the ratio of emulsifier to relaxant is between 1:1 and 1:4., one of ordinary skill in the art would have adjusted the ratio of emulsifier to relaxant in the ingestible gravy topper (i.e., animal nutritional supplement) during routine optimization to find the ingestible form factor with the best palatability for the intended subject. 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 ratio of emulsifier to relaxant, between 1:1 and 1:4, would thus be obvious.
Regarding claim 10 and 20, Mayberry teaches the ingestible gravy topper comprises 12 parts of a blend of active agents (160 parts GABA, 130 parts L-theanine and 10 parts ashwagandha – relaxants), combined with 0.7 parts broad spectrum hemp oil, and 85 parts of typical gravy ingredients ([0118]).
According to the formulation as described by Mayberry, the ingestible gravy topper (i.e., animal nutritional supplement) comprises 13.0 wt% relaxant.
While Mayberry does not teach the ingestible gravy topper (i.e., the animal nutritional supplement) comprises 40 to 72 percent of the relaxant, Mayberry teaches the optional carrier or matrix may comprise ingredients that provide the composition in a useful form (i.e., chews, tablets, tinctures, etc.) configured for easy administration to a mammal of an appropriate pharmacological dosage of the active ingredients ([0008]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to adjust the content of the active ingredients (i.e., relaxants) including within 40 to 72 percent of the weight of the ingestible gravy topper (i.e., the animal nutritional supplement). One of ordinary skill in the art would have been motivated to do so to provide a composition of the appropriate strength for each treatment population. One of ordinary skill in the art would have had a reasonable expectation of success for doing so because adjustment of active ingredients in compositions is routinely practiced in the art.
Regarding claim 11, Mayberry teaches the ingestible gravy topper comprises 12 parts of a blend of active agents (160 parts GABA, 130 parts L-theanine and 10 parts ashwagandha – relaxants), combined with 0.7 parts broad spectrum hemp oil (i.e., relaxant), and 85 parts of typical gravy ingredients (i.e., palatability enhancers – [0118]).
According to the formulation as described by Mayberry, the ingestible gravy topper (i.e., animal nutritional supplement) comprises 87 wt% palatability enhancers.
While Mayberry does not teach the ingestible gravy topper (i.e., the animal nutritional supplement) comprises 4 to 20 percent of the palatability enhancers, Mayberry teaches the optional carrier or matrix may comprise ingredients that provide the composition in a useful form (i.e., chews, tablets, tinctures, etc.) configured for easy administration to a mammal of an appropriate pharmacological dosage of the active ingredients ([0008]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to adjust the content of the active ingredients (i.e., relaxants) including within 40 to 72 percent of the weight of the ingestible gravy topper (i.e., the animal nutritional supplement). One of ordinary skill in the art would have been motivated to do so to provide a composition of the appropriate strength for each treatment population. One of ordinary skill in the art would have had a reasonable expectation of success for doing so because adjustment of active ingredients in compositions is routinely practiced in the art.
Regarding claim 19, Mayberry does not teach the ratio of adhesive to relaxant is between 1:1 and 1:4.
Mayberry teaches the optional carrier or matrix may comprise ingredients that provide the composition in a useful form (i.e., chews, tablets, tinctures, etc.) configured for easy administration to a mammal of an appropriate pharmacological dosage of the active ingredients ([0008]; [0040]; [0103]). Mayberry teaches the ingestible form factor is preferably selected to meet the preferences of the mammal taking the ingestible composition ([0103]).
While Mayberry does not teach the ratio of emulsifier to relaxant is between 1:1 and 1:4., one of ordinary skill in the art would have adjusted the ratio of adhesive to relaxant in the ingestible gravy topper (i.e., animal nutritional supplement) during routine optimization to find the ingestible form factor with the best palatability for the intended subject. 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 ratio of adhesive to relaxant, between 1:1 and 1:4, would thus be obvious.
Claims 3, 5, 13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Mayberry et al. (WO 2021216640 A1) as applied to claims 2 and 12 above, and further in view of Bilia et al. (Kava-kava and anxiety: Growing knowledge about the efficacy and safety. Life Sciences. Vol. 70. Pp. 2581 – 2597. (2002)).
Regarding claims 3, 5, 13, and 15, Mayberry does not teach the blend of active ingredients (i.e., relaxant) comprises kavalactones.
Bilia teaches the kava root contains eighteen α-pyrones known as kavalactones (p. 2853, Active principles). Bilia teaches the kavalactones present in the kava root have been shown to have anxiolytic, sedative, analgesic, anticonvulsant and local anesthetic effects (p. 2593, Conclusion, paragraph 1). Bilia teaches the pharmacological properties of kava-kava are comparable to those of benzodiazepines, however the effect on the brain is different from that of benzodiazepines or tricyclic antidepressants (p. 2593, Conclusion, paragraph 2). Bilia teaches kava extract modifies sleep such that the deep sleep phase was lengthened and the duration of REM sleep was not influenced (p. 2591, paragraph 2).
Mayberry and Bilia are combinable because they are concerned with the same field of endeavor, namely, natural anti-anxiety and sleep improvement supplements. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to include kava root as the ingredient of subclass (ii) in the blend of active ingredients (i.e., relaxant) in the ingestible gravy topper (i.e., the animal nutritional supplement) of Mayberry because the kava root comprises kavalactones, which have anxiolytic, sedative, analgesic, anticonvulsant and local anesthetic effects, as well as sleep-improving properties, as taught by Bilia.
Claims 6 – 8 and 16 – 18 are rejected under 35 U.S.C. 103 as being unpatentable over Mayberry et al. (WO 2021216640 A1) as applied to claims 2 and 12 above, and further in view of Diamond (Cats and Carbohydrates: Fueling your Feline. Diamond. (December 2, 2021). Retrieved from Wayback Machine Archive - https://web.archive.org/web/20211202224014/https://www.diamondpet.com/blog/health/weight-management/cats-and-carbohydrates/).
Regarding claims 6 – 8 and 16 – 18, Mayberry does not teach the ingestible gravy topper (i.e., the animal nutritional supplement) comprises fructose and dextrose.
Diamond teaches glucose (i.e., dextrose) is metabolically essential to cats (p. 2, paragraph 5). Diamond teaches that while cat’s digestive systems are different from more omnivorous species such as dogs, cats can efficiently digest, absorb and use dietary carbohydrates (p. 2, paragraph 9). Diamond teaches cats typically prefer to eat several small meals throughout the day, which is an eating pattern that favors a reduced, but regular, intake of carbohydrates and may complement their liver’s enzyme physiology (p. 2, paragraph 9). Diamond teaches glucose (i.e., dextrose) and fructose are examples of absorbable carbohydrates (p. 2, Contributions of dietary carbs to cat foods, Absorbable).
Mayberry and Diamond are combinable because they are concerned with the same field of endeavor, namely, mammal nutrition. 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 added glucose (i.e., dextrose) and/or fructose, as taught by Diamond to the ingestible gravy topper (i.e., the animal nutritional supplement) of Mayberry because glucose (i.e., dextrose) and fructose are examples of carbohydrates absorbable by cats, and dietary carbohydrates complement a cat’s enzyme physiology.
Response to Arguments
Applicant's arguments filed December 3, 2025 have been fully considered but they are not persuasive.
Applicant argues claims 17 – 20 were indicated as allowable but dependent on a rejected base claim (p. 7, paragraph 3).
Applicant’s argument has been carefully considered however the argument is not persuasive. The Office has not indicated claims 17 – 20 are allowable but dependent on a rejected base claims.
Applicant argues forming and combining two different extracts is not a naturally occurring phenomena, therefore the rejection under 35 U.S.C. § 101 of claims 1 – 20 should be withdrawn (p. 8, paragraph 1).
Applicant’s argument has been carefully considered however the argument is not persuasive. MPEP § 2106.04(c).I.A states “Where the claim is to a nature-based product produced by combining multiple components (e.g., a claim to "a probiotic composition comprising a mixture of Lactobacillus and milk"), the markedly different characteristics analysis should be applied to the resultant nature-based combination, rather than its component parts.” In this case, given the broadest reasonable interpretation of “extract”, and that the combination of the nature-based products recited in the claims does not result in an effect greater than the individual sum of its parts, therefore, while the combination of the nature based products does not necessarily occur in nature, their combination does not result in markedly different characteristics.
Applicant argues the kava root does not anticipate claim 1 as amended (p. 8, paragraph 2; p. 9 paragraph 1).
Applicant’s argument has been carefully considered however the argument is not persuasive. Given the broadest reasonable interpretation of “extract”, kava root anticipates claim 1 as amended.
Applicant argues Honey Board does not disclose an “animal nutritional supplement” (p. 9, paragraph 2).
Applicant’s argument has been carefully considered however the argument is not persuasive. The chamomile tea of Sencha Tea Bar anticipates claims 1, 2, and 6 – 8 because humans are animals, and the preamble of the present claim is not considered limiting.
Applicant argues KDC does not disclose an “animal nutritional supplement” (p. 10, paragraph 2).
Applicant’s argument has been carefully considered however the argument is not persuasive. The tincture of KDC anticipates claims 1 – 5 because humans are animals, and the preamble of the present claim is not considered limiting.
Applicant argues Mayberry does not disclose an “animal nutritional supplement” (p. 11, paragraph 2).
Applicant’s argument has been carefully considered however the argument is not persuasive. The compositions of Mayberry anticipate claims 1, 2, 4, 12, and 14 because humans are animals, and the preamble of the present claim is not considered limiting.
Applicant argues the hard or soft chew of Mayberry is not suspended in water (p. 12, paragraph 1).
Applicant’s argument has been fully considered and is persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Mayberry.
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 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.
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/L.J.M./Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793