DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 26, 2026 has been entered.
Claim Amendment
3. The amendment filed March 31, 2026 has been entered. Claims 1-20, 22, 28 and 30 are cancelled. Claims 21, 23-24, 34, 37 and 39 were amended. Claims 21, 23-27, 29 and 31-40 are under consideration in this Office Action.
Priority
4. Applicant’s claim for domestic priority under 35 U.S.C. 119(e) is acknowledged. However, the provisional application upon which priority is claimed fails to provide adequate support under 35 U.S.C. 112 for claims 21, 23-27, 29 and 31-40 of this application. 09/518,165 is drawn to a method of detecting the presence of a carbohydrate antigen characteristic of at least one species or serogroup of both gram negative and gram-positive bacteria. However, neither of the provisional parent applications, for which priority is claimed 62/128761 or 62091445 an emulsion with a plurality of droplets comprising the claimed said cannabinoid and terpenoid, wherein the plurality of droplets has a polydispersity index of less than about 10. There is no teaching of an polydispersity index in either of the provisional applications. Thus priority cannot be granted to 62/128761 or 62091445 since what is now claimed, has not been previously recited in those applications. Therefore the priority date is December 4, 2015 for the filing date application 15/452,530.
Withdrawal of Rejections
5. The rejection of claim 30 under 35 U.S.C. 102(a)(2)as being anticipated by Finley et al., is withdrawn in view of Applicants amendment cancelling claim 30.
6. The rejection of claim 30 under 35 U.S.C. 102(a)(1) and/or 102(a)(2) as being anticipated by Tamarkin et al., is withdrawn in view of Applicants amendment cancelling claim 30.
New Grounds of Rejection
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.
7. Claim 29 is 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 29 recites the limitation "said plurality of microcapsules" in the claim. However claim 21 only recites a plurality of droplets, not microcapsules. There is insufficient antecedent basis for this limitation in the claim. Appropriate clarification is required to overcome the rejection.
Maintained Grounds of Rejection
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.
8. Claims 37-40 are rejected under 35 U.S.C. 102(a)(2)as being anticipated by
Carlson et al., (WO2017095932 published 2017-06-08; priority to Nov 30, 2015).
The claims are drawn to a personal care product comprising a container comprising a toothpaste, mouthwash or throat spray comprising at least one terpenoid and at least one cannabinoid compound selected from the group consisting of cannabidiol-class, cannabinol-class, cannabidiol and a surfactant, wherein the product comprises a plurality of droplets in an emulsion wherein each droplet in said plurality of droplets is neither a liposome nor micelle and said plurality of droplets comprises said cannabinoid and said terpenoid, said personal care product has a shelf half-life of at least 30 days, and said plurality of droplets has a polydispersity index of less than about 10.
Carlson et al., describe compositions including a plurality of steviol glycosides and uses of such sweetener compositions to prepare sweetened compositions including food, beverages, dental products, pharmaceuticals, nutraceuticals, and the like [abstract]. The sweetener composition can also contain one or more functional ingredients, which provide a real or perceived heath benefit to the composition. Functional ingredients include, but are not limited to saponins and antioxidants [para 103]. Saponins are glycosidic plant products comprising an aglycone ring structure and one or more sugar moieties. The combination of the nonpolar aglycone and the water soluble sugar moiety gives saponins surfactant properties, which allow them to form a foam when shaken in an aqueous solution [para 104]. "Antioxidant" refers to any substance which inhibits, suppresses, or reduces oxidative damage to cells and biomolecules. Without being bound by theory, it is believed that antioxidants inhibit, suppress, or reduce oxidative damage to cells or biomolecules by stabilizing free radicals before they can cause harmful reactions. As such, antioxidants may prevent or postpone the onset of some degenerative diseases [para 105]. Examples of suitable antioxidants of this disclosure include, but are not limited to saponins, limonoids, carotenoids, carotenoid terpenoids, and/or non- carotenoid terpenoids [para 106].
"Pharmaceutically active substance" means any drug, drug formulation, medication, prophylactic agent, therapeutic agent, or other substance having biological activity [para 127]. Examples of suitable pharmaceutically active substances for embodiments of the present disclosure include cannabinoids [para 129].
The composition or compound that provides for sensory modification may be referred to as a sensory modifier. A sensory modifier changes the sensory characteristics of a sweetened consumable, e.g., a sweetener composition, a beverage, a food product, and the like. Non-limiting examples of sensory characteristics that a sensory modifier can include flavor notes such as licorice flavor notes [para 11]. General sugar confections such as chewing gum can include licorice [para 140].
In one embodiment, a dental composition comprises a sweetener composition comprising steviol glycosides. Dental compositions generally comprise an active dental substance and a base material. The dental composition may be in the form of any oral composition used in the oral cavity such as mouth freshening agents, gargling agents, mouth rinsing agents, toothpaste, tooth polish, dentifrices, mouth sprays, teeth-whitening agent, dental floss, compositions to treat one or more oral indications (e.g., gingivitis), and the like, for example [para 135]. Thus teaching claims 38-40. Sweetenable compositions, mean substances which are contacted with the mouth of man or animal, including substances which are taken into but subsequently ejected from the mouth (such as a mouthwash rinse) [para 75]. The composition may be in the form of an emulsion [para 125]. It is noted that toothpaste has a standard shelf life of about 2 years; while mouthwash typically has a shelf life of 2 to 3 years. Therefore a standard formulation exceeds the instantly claimed shelf half-life.
With regard to the polydispersity index; since the Patent Office does not have the facilities for examining and comparing applicants’ claimed PDI of less than about 10 with the emulsified and/or encapsulated particle size of Carlson et al., the burden is upon the applicants to show an unobvious distinction between the material structural and functional characteristics of the claimed particle size variations or spread in the sizes within the composition of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594.
Thus, Carlson et al., anticipate the rejected claims.
Response to Arguments
9. Applicant's arguments filed March 13, 2026 have been fully considered but they are not persuasive.
Applicants point out that the Patent Office does not have the facilities for examining and comparing applicants' claimed PDI of less than about 10 with the emulsified and/or encapsulated particle size, whereby the burden is upon the applicants to show an unobvious distinction between the material structural and functional characteristics of the claimed particle size variation or spread in sizes within the composition of the prior art." Applicant disagrees and traverses. However Applicants failed to provide any scientific evidence regarding the unobvious distinction between the material structural and functional characteristics of the claimed particle size variation or spread in sizes within Carlson’s dental emulsion composition. Therefore, Applicants mere disagreement without any further evidence is not persuasive.
Applicants argue that Carlson et al., never actually disclosed the composition because the rejection points to clear and specific recitation of the claimed limitations within different paragraphs of the reference; therefore the Examiner is clearly picking and choosing from various disclosures in each rejection. However the Office is not combining unrelated disclosures. Applicants pointed to the relevant teachings within Carlson. In this case, the Carlson references discloses the instantly rejected limitations within its four corners and combines the elements in the same way. Carlson et al., disclose a dental emulsion composition, such as a mouthwash, toothpaste or spray comprising steviol glycosides, saponins as the surfactant, terpenoids as the antioxidant, and cannabinoid as the pharmaceutically active substance. Therefore, Carlson describes each ingredient formulated as an emulsion and not a micelle or liposome. Applicants have provided no evidence to the contrary regarding the ingredients.
With regard to Applicants argument about picking and choosing Applicants attention is directed to MPEP section 2123 teaches that patents are relevant as prior art for all they contain, “The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.” In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)). A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). See also Celeritas Technologies Ltd. v. Rockwell International Corp., 150 F.3d 1354, 1361, 47 USPQ2d 1516, 1522-23 (Fed. Cir.1998) (The court held that the prior art anticipated the claims even though it taught away from the claimed invention. “The fact that a modem with a single carrier data signal is shown to be less than optimal does not vitiate the fact that it is disclosed.”). Therefore applicant’s argument is not persuasive especially when considering Carlson et al., described dental emulsion composition, such as a mouthwash, toothpaste or spray comprising steviol glycosides, saponins as the surfactant, terpenoids as the antioxidant, and cannabinoid as the pharmaceutically active substance. It is well known that mouthwash, toothpaste and the like have shelf lives of more than 2 years, which is substantially longer than the instantly claimed 30 days.
Applicants argue that the Office is relying upon inherency to make the Carlson anticipation rejection. Applicants attention is directed to MPEP 2112. Where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the examiner may make a rejection under 35 U.S.C. 102. The Carlson et al., reference discloses each and every ingredient within the dental emulsion composition; thus there is no inherent argument with respect to the claimed ingredients. With respect to the polydispersity, the Office previously invited Applicants provide scientific evidence to the contrary. Applicants provided no evidence. Therefore, Applicant is reminded that something which is old does not become patentable upon the discovery of a new property, like the property of polydispersity. "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004), the court held that the claimed promoter sequence obtained by sequencing a prior art plasmid that was not previously sequenced was anticipated by the prior art plasmid which necessarily possessed the same DNA sequence as the claimed oligonucleotides. The court stated that "just as the discovery of properties of a known material does not make it novel, the identification and characterization of a prior art material also does not make it novel." Id. See also MPEP § 2112.01 with regard to inherency and product-by-process claims and MPEP § 2141.02 with regard to inherency and rejections under 35 U.S.C. 103. Therefore, Applicants argument is not persuasive since Applicants failed to provide any scientific evidence that a composition having identical components would have a polydispersity outside of the instantly claimed range.
Accordingly, none of Applicants arguments are found to be persuasive and the rejection of record is maintained.
Claim Rejections - 35 USC § 102
10. Claims 21, 23-27, 29, 31-32 and 37-38 are rejected under 35 U.S.C. 102(a)(2)as being anticipated by Finley et al., (WO 2016123475 published 2016-08-04; priority to Jan. 31, 2015).
The claims are drawn to a personal care product comprising a container comprising a lotion, moisturizer or sunscreen comprising at least one terpenoid and at least one cannabinoid compound and a surfactant, wherein the product comprises a plurality of droplets in an emulsion which is not a micelle or liposome and said plurality of droplets comprises said cannabinoid and said terpenoid, has a shelf half-life of at least 30 days and said plurality of droplets has a polydispersity index of less than about 10.
Finley et al., describe cannabis oil extracts and compositions thereof [abstract]. he medicinal use of oils and extracts derived from cannabis plant material has been growing in popularity. Pharmacologically active compounds in cannabis plant material including, but not limited to, delta-9-tetrahydrocannabinol (or THC) and cannabidiol (CBD) have been shown to reduce the effects of nausea and vomiting caused by certain chemotherapy treatments. Research has also shown the ability of cannabinoids and other compounds found in cannabis to stimulate bone growth, relieve pain, aid sleep, inhibit bacterial cell growth, inhibit cancer cell growth, and alleviate or otherwise reduce the symptoms of multiple diseases and inflammation [para 3]. The term "cannabis oil" refers to a mixture of compounds obtained from the extraction of cannabis plants. Such compounds include, but are not limited to, cannabinoids, terpenes, terpenoids, and other compounds found in the cannabis plant [para 0028]. The term "cannabinoid" refers to a chemical compound that shows direct or indirect activity at a cannabinoid receptor. Examples of cannabinoids include, but are not limited to, tetrahydrocannabinol (THC), cannabidiol (CBD), cannabinol (CBN), cannabigerol (CBG), cannabichromene (CBC), cannabicyclol (CBL), cannabivarin (CBV), tetrahydrocannabivarin (THCV), cannabidivarin (CBDV), cannabichromevarin (CBCV), cannabigerovarin (CBGV), and cannabigerol monom ethyl ether (CBGM) [para 29]. Thus teaching the cannabinoid and terpenoid of claims 21 and 37.
Homeopathic remedies can also be included in cannabis oil compositions prepared according to the invention. Examples of suitable homeopathic remedies and indications that can be treated with homeopathic remedies include Quillaja Saponaria [para 152]. One or more essential oils are added to the extracted cannabis oil to provide properties such as improved palatability. Essential oils can also provide antioxidant and preservative properties in the cannabis oil compositions [para 143]. Thus teaching claim 24.
An oral pharmaceutical composition or a medicament can take the form of, e.g., a tablet or a capsule prepared by conventional means with a pharmaceutically acceptable excipient. Thus teaching claim 26. Preferred are tablets and gelatin capsules comprising the active ingredient(s), together with (a) diluents or fillers, (b) lubricants, (c) binders, (d) disintegrants such as alginic acid or its sodium or potassium salt, or effervescent mixtures; (e) wetting agents, and/or (f) absorbents, colorants, flavors and sweeteners [para 163]. Thus teaching claim 27. Preparations for oral administration can take the form of, for example, solutions, syrups, suspensions, and toothpastes [para 164]. Thus teaching claims 37-38. Typical formulations for topical administration include creams, ointments, sprays, lotions, hydrocolloid dressings, and patches [para 165]. Thus teaching claims 21, 25, and 31-32. Formulations for injection can be presented in unit dosage form, for example, in ampoules or in multi-dose containers. Injectable compositions are preferably aqueous isotonic solutions or suspensions, and suppositories are preferably prepared from fatty emulsions or suspensions. The compositions may be sterilized and/or contain adjuvants, such as preserving, stabilizing, wetting or emulsifying agents, solution promoters, salts for regulating the osmotic pressure, buffers, and/or other ingredients [para 166]. Thus teaching claim 29-30. In some embodiments, the cannabis oil extract includes one or more added essential oils including Rosemary Antioxidant, clary sage, and cinnamon [para 147]. The compositions of the invention can also include one or more herbal extracts of clove, fennel, oregano, coriander, Chinese licorice, Licorice, Licorice Mint, Licorice Root, sweet licorice, wood licorice [para 150]. It is noted that clove, fennel, oregano, and coriander, all of which are known to have antioxidant properties; while licorice contains natural surfactants called saponins. Thus teaching claims 23 and 26.
With respect to the shelf half life of lotions, Lotion doesn't have a rigid chemical "half-life". Instead, it has a shelf life—usually 2 to 3 years unopened and 6 to 12 months after opening. The relevant oral products have the same 2-3 year shelf life. Therefore, all time periods exceed the instantly claimed time period of at least 30 days.
With regard to the polydispersity index; since the Patent Office does not have the facilities for examining and comparing applicants’ claimed PDI of less than about 10 with the emulsified and/or encapsulated particle size of Finley et al., the burden is upon the applicants to show an unobvious distinction between the material structural and functional characteristics of the claimed particle size variations or spread in the sizes within the composition of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594.
Thus, Finley et al., anticipate the rejected claims.
Response to Arguments
11. Applicant's arguments filed March 13, 2026 have been fully considered but they are not persuasive.
Applicants point out that the Patent Office does not have the facilities for examining and comparing applicants' claimed PDI of less than about 10 with the emulsified and/or encapsulated particle size, whereby the burden is upon the applicants to show an unobvious distinction between the material structural and functional characteristics of the claimed particle size variation or spread in sizes within the composition of the prior art." Applicant disagrees and traverses. However Applicants failed to provide any scientific evidence regarding the unobvious distinction between the material structural and functional characteristics of the claimed particle size variation or spread in sizes within Finley et al’s emulsion composition. Therefore, Applicants mere disagreement without any further evidence is not persuasive.
Applicants argue that Finley et al., never actually disclose the composition because the rejections points to clear and specific recitation of the claimed limitations within different paragraphs of the reference; therefore the Examiner is clearly picking and choosing from various disclosures in each rejection. However the Office is not combining unrelated disclosures. Applicants pointed to the relevant teachings within Finley et al. In this case, the Finley et al., reference discloses the instantly rejected limitations within its four corners and combines the elements in the same way. Finley et al., disclose a topical and oral emulsion composition, such as a lotions and toothpaste comprising cannabinoid, terpenoid, saponin as the Quillaja Saponaria extract, antioxidants, alginate salts as the excipients, stabilizers, not formulated as a micelle or liposome. Therefore, Finley et al., describes each ingredient formulated as an emulsion and not a micelle or liposome. Applicants have provided no evidence to the contrary regarding the ingredients.
With regard to Applicants argument about picking and choosing Applicants attention is directed to MPEP section 2123 teaches that patents are relevant as prior art for all they contain, The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain. A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art. Therefore applicant’s argument is not persuasive especially when considering Finley et al., described emulsion composition, antioxidants, excipients, quillaja extract, saponins, stabilizers, alginate salts, cannabinoid and terpenoid. It is well known that lotion, mouthwash, toothpaste and the like have shelf lives of more than 2 years, which is substantially longer than the instantly claimed 30 days.
Applicants argue that the Office is relying upon inherency to make the Finley et al., anticipation rejection. Therefore, Applicants attention is again directed to MPEP 2112. Where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the examiner may make a rejection under 35 U.S.C. 102. Finley et al., disclose each and every ingredient within the lotion emulsion or toothpaste emulsion composition; thus there is no inherent argument with respect to the claimed ingredients. With respect to the polydispersity, the Office invited Applicants to provide scientific evidence to the contrary. Applicants failed to provide evidence to the contrary.
Therefore, Applicant is reminded that something which is old does not become patentable upon the discovery of a new property, like polydispersity. The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004). The court stated that "just as the discovery of properties of a known material does not make it novel, the identification and characterization of a prior art material also does not make it novel." Id. Therefore, Applicants argument is not persuasive since Applicants failed to provide any scientific evidence that a composition having identical components would have a polydispersity outside of the instantly claimed range.
Accordingly, Applicants arguments are not found persuasive and the rejection of record is maintained.
Claim Rejections - 35 USC § 102
12. Claims 21, 23, 25-27, 29 and 31-33 are rejected under 35 U.S.C. 102(a)(1) and/or 102(a)(2) as being anticipated by Tamarkin et al., (US20070292461 published 2007-12-20; priority to Aug 2003).
Tamarkin et al., describe stable pharmaceutical or cosmetic foam compositions containing certain active agents, having unique therapeutic properties and methods of treatment using such compositions [abstract]. Embodiments of the oleaginous composition forms an emulsion [para 58]. The composition of the present invention comprises at least one active agent that provides therapeutic or cosmetic activity wherein the one “active agent”, provides the following benefits: favorable spreadability and absorption, compared to conventional ointment, cream, lotion and the like; improved treatment convenience, leading to better compliance; and enhanced delivery, leading to elevated bioavailability of the cosmetic active agent into the target thereby improving treatment efficacy [para 170-173]. Thus teaching claim 21. The compositions of the present invention comprise at least one solvent selected from a hydrophobic solvent, a co-solvent, an emollient and mixtures thereof, which provides a refatting and skin soothing effect. The selected solvents allow the inclusion of oil-soluble active agents in the formulation. In one or more embodiments, the solvents provide synergistic benefits in combination with the active agent. The compositions may comprise at least one oil soluble active agent [para 88]. The “co-solvent” is an organic solvent, other than a short chain alcohol, typically soluble in both water and oil. Examples of co-solvents, include: terpenes, di-terpenes, tri-terpenes, terpen-ols, limonene, terpene-ol, 1-menthol [para 125]. In one or more embodiments, the surface-active agent is a non-ionic surfactant and can be, for example, a phospholipid. The surface-active agent can be a mixture of at least one non-ionic surfactant and at least one ionic surfactant [para 63]. Thus describing the inclusion of a surfactant.
Essential oils which contain terpenoids and perfumes which contain terpenoids. Non-limiting examples of essential oils which have high content of terpene-ols and esters include bergamot (62% terpenoids); sage (>50% terpenoids); styrax (>50% terpenoids); peppermint (>50% terpenoids); and pine Siberian (75% terpenoids %) [para 420]. Thus teaching the instantly claimed terpenoids. Non-limiting examples of active agents include cannabinoids and/or tetrahydrocannabinol [para 177-178]. In one or more embodiments, the NSAID is a cannabinoid. Cannabinoids are known to affect inflammation through suppression of runaway inflammation and other untoward effects of immune system activation, as well as pain [para 360]. In certain embodiments, the cannabinoid agent is cannabidiol [para 361]. Thus disclosing the instantly claimed cannabinoids.
In the context of the present invention, an antibiotic agent is a substance, that has the capacity to inhibit the growth of or to destroy bacteria and other microorganisms [para 207]. In one or more embodiments, the antibiotic peptide is a naturally-occurring peptide that possesses an antibacterial and/or an antifungal activity [para 218]. In embodiments, the antibiotic agent is a naturally occurring antibiotic compound. As used herein, the term “naturally-occurring antibiotic agent” includes all antibiotic that are obtained, derived or extracted from plant or vertebrate sources. Non-limiting examples of families of naturally-occurring antibiotic agents include antibiotic saponin fractions [para 240]. Thus describing the instantly claimed saponins.
The steroid possesses immunomodulating and/or anti-inflammatory properties. Without being bound to a specific theory, immunomodulating and/or anti-inflammatory steroids act, among other mechanisms, through inhibition of the activity of phospholipase A2. They also may have anti-proliferative effects on keratinocytes and other cell types. They can suppress collagen synthesis by fibroblasts and have anti-inflammatory application [para 293]. In one or more embodiments, the steroid is a phytosteroid or a phytosterol. As used herein, the term “phytosteroid” or “phytosterol” includes all steroids that are obtained, derived or extracted from plant sources. Non-limiting examples of families of phytosteroids and phytosterols include steroid saponins [para 305]. Thus describing the instantly claimed saponins.
In one or more embodiments, the surface-active agent is a non-ionic surfactant and can be, for example, a phospholipid. The surface-active agent can be a mixture of at least one non-ionic surfactant and at least one ionic surfactant [para 63]. Thus disclosing the instantly claimed surfactant. In one embodiment the active agent is a cosmetic agent a skin protective agent, and/or a massaging oil [para 429]. The foam composition comprises a combination of a skin-whitening agent and an inorganic sunscreen agent. When inorganic sunscreen agents, are rubbed onto the skin [para 458-459]. Thus describing the instantly claimed sunscreen agent.
Exemplary gelling agents that can be used include naturally-occurring polymeric materials such as sodium alginate and carrageenin gum sodium alginate [para 157]. Thus describing the salt of alginate. The pharmaceutical or cosmetic composition may further comprise a variety of therapeutic or cosmetic ingredients, which are added in order to fine-tune the consistency of the formulation, protect the formulation components from degradation and oxidation and bestow their cosmetic acceptability. Such excipients may be selected, for example are stabilizing agents, antioxidants, and other formulation components, used in the art of pharmaceutical and cosmetic formulary [168]. Thus teaching the stabilizers and antioxidants. It is well known that lotion has a shelf life of more than 2 years, which is substantially longer than the instantly claimed 30 days.
With regard to the polydispersity index; since the Patent Office does not have the facilities for examining and comparing applicants’ claimed PDI of less than about 10 with the emulsified and/or encapsulated particle size of Tamarkin et al., the burden is upon the applicants to show an unobvious distinction between the material structural and functional characteristics of the claimed particle size variations or spread in the sizes within the composition of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594.
Thus, Tamarkin et al., anticipate the rejected claims.
Response to Arguments
13. Applicant's arguments filed March 13, 2026 have been fully considered but they are not persuasive.
Applicants point out that the Patent Office does not have the facilities for examining and comparing applicants' claimed PDI of less than about 10 with the emulsified and/or encapsulated particle size, whereby the burden is upon the applicants to show an unobvious distinction between the material structural and functional characteristics of the claimed particle size variation or spread in sizes within the composition of the prior art." Applicant disagreed and traversed. Applicants failed to provide any scientific evidence regarding the unobvious distinction between the material structural and functional characteristics of the claimed particle size variation or spread in sizes within Tamarkin et al’s emulsion composition. Therefore, Applicants mere disagreement without any further evidence is not persuasive.
Applicants argue that Tamarkin et al., never actually disclose the emulsion composition because the rejections points to clear and specific recitation of the claimed limitations within different paragraphs of the reference; therefore the Examiner is clearly picking and choosing from various disclosures in each rejection. However the Office is not combining unrelated disclosures. Applicants pointed to the relevant teachings within Tamarkin et al., describing each and every instantly rejected component within the emulsion composition. Tamarkin et al., disclose an emulsion composition, such as a lotions comprising cannabinoid, terpenoid, surfactants, saponin, antioxidants, alginate salts, stabilizers, not formulated as a micelle or liposome.
With regard to Applicants argument about picking and choosing, Applicants are reminded that patents are relevant as prior art for all they contain. A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art. Therefore applicant’s argument is not persuasive especially when considering Tamarkin et al., described the instantly claimed emulsion composition. It is well known that lotion have shelf lives of more than 2 years, which is substantially longer than the instantly claimed 30 days.
Therefore, Applicant is reminded about MPEP 2112. Something which is old and clearly described by the art, does not become patentable upon the discovery of a new property. Tamarkin et al., disclose each and every ingredient within the lotion emulsion composition; thus there is no inherent argument with respect to the claimed ingredients. With respect to the polydispersity, the Office previously invited Applicants to provide scientific evidence to the contrary. Applicants did not any evidence showing that composition having identical ingredients formulated as an emulsion, just as instantly claimed would have a polydispersity index different from that which is instantly claimed.
Accordingly, Applicants arguments are not found persuasive and the rejection over Tamarkin et al., is maintained.
Claim Rejections - 35 USC § 102
14. Claims 34-36 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Bromley (US Pat Pub 20160081927 published 2016-03-24; priority to Sept. 18, 2014).
The claims are drawn to a personal care product.
Bromley disclose compositions and methods for producing water-soluble powders that contain additives such as essential fatty acids, including omega-3 fatty acids, omega-6 fatty acids, conjugated fatty acids, and other fatty acids; phytochemicals, including phytosterols; other oils; and coenzymes, including coenzyme Q10, and other oil-based additives [abstract]. The water-soluble powder provided herein, include non-polar ingredients and/or non-polar compound or contains a mixture of non-polar compounds. For example, the non-polar ingredient contains a non-polar compound that is a polyunsaturated fatty acids (PUFAs), medium chain triglycerides, phospholipids, coenzyme Q compounds, flavonoids, carotenoids, micronutrients, alkaloids, antioxidants, or mixtures thereof. Among the water-soluble powders provided herein is a powder that contains an emulsion stabilizer that is one or more of a blend of xanthan gum, guar gum or sodium alginate; and a co-emulsifier that is saponin [para 22]. Any of such powders can further contain saponin [para 27]. For saponins, the saponin is from quillaja bark which is commercially available formulations as emulsions [para 380]. Examples of antioxidants include, but are not limited to hormones, carotenoids, carotenoid terpenoids, non-carotenoid terpenoids [para 310]. The non-polar compounds further include cannabinoids {para 265]. Cannabinoids and cannabinoid-containing compounds are exemplary of non-polar ingredients suitable for use in the pre-emulsion concentrates provided herein. Cannabinoids include phytocannabinoids (found in the Cannabis sativa plant and some other plants) [para 304]. Exemplary phytocannabinoids derived from the Cannabis sativa plant include cannabidiol (CBD), cannabigerol (CBG), cannabichromene (CBC), cannabinol (CBN), cannabicyclo (CBL), cannabivarin (CBV), tetrahydrocannabivarin (THCV), cannabidivarin (CBDV), cannabielsoin (CBE), cannabicitran (CBT), cannabinodiol (CBDL), cannabichromevarin (CBCV), cannabigerovarin (CBGV), cannabigerol monoethyl ether (CBGM), and mixtures and derivatives thereof [para 305].
Soap does not have a strict "half-life" in the scientific sense, but most commercial and natural bar soaps have a practical shelf life of 2 to 3 years. After this point, they lose moisture, scent, and lathering ability, though they remain safe to use.
As used herein, “emulsion” refers to a colloidal dispersion of two immiscible liquids, for example, an oil and water (or other aqueous liquid, e.g., a polar solvent), one of which is part of a continuous phase and the other of which is part of a dispersed phase. Emulsions typically are stabilized by one or more surfactants and/or co-surfactants and/or emulsion stabilizers. Surfactants form an interfacial film between the oil and water phase of the emulsion, providing stability [para 89]. One or more, typically two or more, vessels, can be used in the methods to contain the ingredients of the provided compositions and powders, for example, during mixing and/or heating or cooling. The vessels can be tanks, for example, water-jacketed tanks; pots; and/or beakers, for example, Pyrex® beakers [para 417]. Typically, the vessels are cleaned, for example, rinsed, soaped and/or sanitized, according to known procedures prior to use and between uses, such as with the cleaning procedures [para 148].
With regard to the polydispersity index; since the Patent Office does not have the facilities for examining and comparing applicants’ claimed PDI of less than about 10 with the emulsified and/or encapsulated particle size of Bromley et al., the burden is upon the applicants to show an unobvious distinction between the material structural and functional characteristics of the claimed particle size variations or spread in the sizes within the composition of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594.
Thus, Bromley et al., anticipate the rejected claims.
Response to Arguments
15. Applicant's arguments filed March 13, 2026 have been fully considered but they are not persuasive. The rejection of claims 34-36 under 35 U.S.C. 102(a)(2) as being anticipated by Bromley is maintained for reasons of record.
Applicants argues the Patent Office does not have the facilities for examining and comparing applicants' claimed PDI of less than about 10 with the emulsified and/or encapsulated particle size, whereby the burden is upon the applicants to show an unobvious distinction between the material structural and functional characteristics of the claimed particle size variation or spread in sizes within the composition of the prior art." Applicant disagreed and traversed. However Applicants failed to provide any scientific evidence regarding the unobvious distinction between the material structural and functional characteristics of the claimed particle size variation or spread in sizes within Bromley soap or sanitizer emulsion composition. Therefore, Applicants mere disagreement without any further evidence is not persuasive.
Applicants argue that Bromley never actually disclose soap or sanitizer emulsion composition because the rejection points to clear and specific recitation of the claimed limitations within different paragraphs of the reference; therefore the Examiner is clearly picking and choosing from various disclosures in each rejection. However the Office is not combining unrelated disclosures. Applicants pointed to the relevant teachings within Bromley reference. In this case, the Bromley discloses the instantly rejected limitations within its four corners and combines the elements in the same way. Bromley disclose a soap or hand sanitizer emulsion composition, comprising cannabinoid, terpenoid, stabilizer, Quillaja extract, saponin, sodium alginate, antioxidants, and excipients, not formulated as a micelle or liposome. Therefore, Bromley describes each ingredient formulated as an emulsion and not a micelle or liposome. Applicants have provided no evidence to the contrary regarding the ingredients.
With regard to Applicants argument about picking and choosing Applicants is reminded about MPEP section 2123 teaching that patents are relevant as prior art for all they contain. A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art. Therefore applicant’s argument is not persuasive especially when considering Bromley described soap and sanitizer emulsion composition. It is well known that soap and sanitizers have shelf lives of 2-3 years, which is substantially longer than the instantly claimed 30 days.
Applicants argue that the Office is relying upon inherency to make the Finley et al., anticipation rejection. Therefore, Applicants attention is again directed to MPEP 2112. Where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the examiner may make a rejection under 35 U.S.C. 102. Bromley disclose each and every ingredient within the soap emulsion composition; thus there is no inherent argument with respect to the claimed ingredients. With respect to the polydispersity, the Office previously invited Applicants to provide scientific evidence to the contrary and Applicants failed to provide evidence to the contrary.
Therefore, Applicant is reminded that something which is old does not become patentable upon the discovery of a new property, like polydispersity. The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer. Therefore, Applicants argument is not persuasive since Applicants failed to provide any scientific evidence that a composition having identical components would have a polydispersity outside of the instantly claimed range.
Accordingly, Applicants arguments are not found persuasive and the rejection of record is maintained.
Pertinent Art
16. The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure.
Toothpaste has a standard shelf life of about two years from its manufacturing date. Rather than a scientific half-life, the fluoride slowly degrades. While safe to use afterward, it gradually loses its enamel-protecting efficacy and may change in color, texture, or flavor. Because the U.S. Food and Drug Administration (FDA) and American Dental Association (ADA) classify fluoride-containing toothpastes as over-the-counter drugs, manufacturers are legally required to print an expiration date on the tube.
https://www.colgate.com/en-ph/oral-health/nutrition-and-oral-health/does-toothpaste-expire
Unopened mouthwash typically has a shelf life of 2 to 3 years from the manufacturing date, after which active ingredients degrade and effectiveness drops. Once opened, use it within 1 to 6 months (or up to 12 months for specific therapeutic gargles). Mouthwash does not have a "half-life" in the same radioactive or medical sense, but it does slowly break down over time.
Lotion doesn't have a rigid chemical "half-life". Instead, it has a shelf life—usually 2 to 3 years unopened and 6 to 12 months after opening. However, its active ingredients and preservatives degrade over time, causing it to lose effectiveness or grow bacteria. https://www.google.com/url?sa=t&source=web&rct=j&url=https%3A%2F%2Fskintypesolutions.com%2Fblogs%2Fskincare%2Fdoes-lotion-expire&ved=0CAEQ1fkOahcKEwiIqcPEwO6UAxUAAAAAHQAAAAAQCA&opi=89978449
Elzinga et al., (US20150080265 published 2015-03-19; priority to Sep 18, 2013).
Elzinga et al., describe terpene based compositions which are fragrant and contain at least a member set culled from a library of compositions, each being comprised of sub-combinations of selected terpenes [abstract]. The fragrant components of the oils are largely terpenes. Terpenes are also known as terpenoids [para 4]. The terpene formulations may comprise one or more selected from a list comprising menthol, limonene and/or linalool [para 16]. These are known as terpenoids. The composition comprises a modifier. The modifier may comprise a cannabinoid [para 24]. Cannabinoids are another class of modifiers contemplated by the invention. Cannabinoids are a class of diverse chemical compounds that act on cannabinoid receptors in the brain. Many are produced naturally in the human body. Some commonly known compounds include tetrahydrocannabinol (THC) and cannabidiol (CBD) [para 98]. In device embodiments, what is provided is a device comprising one of the compositions. In other device embodiments, what is provided is the above device that is a container or wrapper that comprises a soap, a container that comprises a perfume, a container that comprises a cosmetic crème, an edible substance, a tincture, or a container holding a pressurized composition that is configured for aerosol dispersal [para 36].
WO2012006445 teach a buccal delivery dosage form for administration of an active ingredient, including pharmaceutically, pharmacologically, or biologically active ingredients, in the mouth of a subject comprising cannabinoids, saponin and terpenoid such as I-menthol.
Examples of saponin-based surfactants
Quillaja saponin: Extracted from the soap bark tree, this is a well-known and highly active surfactant used in food and beverage industries, especially for its emulsifying properties.
Tea saponin: Saponins extracted from tea plants (like the tea seed cake) are natural, non-ionic surfactants used in detergents and for soil remediation.
Mojave yucca saponin: Extracted from the Mojave yucca plant, these saponins are used for their surfactant and emulsifying properties.
Licorice saponin: Found in licorice root, this is a notable saponin with both surfactant properties and various pharmacological effects.
Soybean and other legume saponins: Saponins from soybeans, beans, and peas are rich sources used in various applications due to their surfactant properties.
These natural saponins are used for their emulsifying and cleaning properties in various applications, such as beverages, detergents, and pharmaceuticals.
Essential oils with high antioxidant properties include clove, myrrh, citronella, coriander, fennel, and clary sage. Other oils with significant antioxidant activity include cinnamon, thyme, and oregano, which are rich in compounds like eugenol and thymol.
Licorice contains natural surfactants called saponins, primarily glycyrrhizic acid, which are used in various applications for their foaming, emulsifying, and wetting properties.
Conclusion
17. No allowed claims.
18. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JA-NA A HINES whose telephone number is (571)272-0859. The examiner can normally be reached Monday thru Thursday.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor Peter Paras, can be reached on 571-272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JANA A HINES/Primary Examiner, Art Unit 1645
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