DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after November 07, 2025, is being examined under the first inventor to file provisions of the AIA .
STATUS OF THE APPLICATION
Receipt of the response to the non-final office action, the amendments to the claims and applicant arguments/remarks, filed 11/07/2025 is acknowledged.
Claims 1, 4, 8-10, 16, 26, 28, 31, 33, 40, 57, and 64-69, are pending in this action. Claims 1, 4, 8-10, 16, 26, 28, 31, 33, 40, 57, and 64-69 are amended, claims 35 and 63 are cancelled. No new matter was added. All claims are currently under consideration.
Any rejection or objection not reiterated in this action is withdrawn. Applicant’s amendments necessitated new ground(s) of rejection or objection presented in this office action.
The present application, filed on or after November 07, 2025, is being examined under the first inventor to file provisions of the AIA . 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 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.
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 4 and 28 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 4 is indefinite because there is nothing specified to measure any improvement; the phrase “improved penetration” renders the claim indefinite.
Claim 28 contains the trademark/trade name Pluronic. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name.
Claim Rejections - 35 USC § 102
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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) or 35 U.S.C. 102(a)(2) as being anticipated by Magdassi et al., (WO 2020/035850).
Magdassi et al. teach an initial fine-tuned nanoemulsion that is designed to contain lipophilic nanodroplets of a specific size is the basis for the inventor’s solid-based delivery method. When the nanoemulsion is transformed into a powder, the integrity, composition, and size of the nanodroplets are preserved. Re-dispersion of the solid-based delivery method in water or contact with water further preserves their size, content, and integrity (See Description, pg. 4). Magdassi et al. teach a water-dispersible powder comprising lipophilic microspheres having a size of 50-900 nm that comprise surfactant, cannabinoid oil, sucrose and carboxymethyl cellulose (See claim 1). Cannabinoid oil is known for use in cosmetics as evidenced by the Jones reference. An example of the formulation is found on page 31: the powder comprises a cannabinoid material, sucrose, surfactant and carbohydrate (polysaccharide). With regard to claim 63, a significant quantity of the lipophilic/oil fraction may be added to the solid formulations up to as much as 75% (See Description, pages 3-4).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 4, 8-10, 16, 26, 28, 31, 33, 35, 40, 57, and 64-69 are rejected under 35 U.S.C. 103 as being unpatentable over Magdassi et al., (WO 2020/035850) in view of Brockmeyer et al., (WO2007/110383), and Shefer et al. US2003/0152629)
The teachings of Magdassi et al. are outlined above. Each dependent claim is discussed in detail below, with citations to where those limitations are taught by Magdassi et al. or Brockmeyer et al.
Brockmeyer et al. teach microcapsules for use in dermo cosmetics. Their compositions include many of the same ingredients as those of Magdassi et al.
It would have been obvious to one of ordinary skill in the in the instant invention to combine the teachings of Magdassi et al., with Brockmeyer et al., with at least one solid surfactant has been adsorbed onto the nanospheres. In certain embodiments, the procedure entails preparing an initial emulsion by changing its phase from oil to water. A surfactant and at least one carbohydrate are optional.
Regarding claim 4, Magdassi et al. teach that the inclusion of permeation enhancers to boost bioavailability and controlled release agents in the form of a matrix or coating utilizing state of the art techniques can ultimately further improve the hitherto mentioned formulations and dosage forms (See Description, pg. 5). under the same settings as in example 1, the same experiments were carried out using Pluronic F-127 and Pluronic F-68 (polyoxethylene-polyoxyproplene block copolymer) as appropriate surfactants: permeation enhancers in example 4 (See pg. 25, example 4, and Example 1, table 2 and 3).
Regarding claims 8, 10, and 65, Magdassi et al., teach that in numerous other embodiments, the invention’s compositions can include antioxidants, nutrients, a polysaccharide, peppermint oil, oregano oil, eucalyptus oil, plant sweeteners, natural antioxidants, vitamins, antioxidants such as vitamin E and C, and complete of fractionated extracts of cannabis plants in various proportions and combinations thereof (See pg. 15 last paragraph and pg. 16 1st paragraph).
Regarding claim 16, Magdassi et al. teach that because the powders of the invention retain their physical and chemical properties at room temperature for at least 12 months or more, i.e., the powders of the invention remain stable for at least about 6 months, 9 months, 12 months, or more at room temperature (this includes two years), they are easily convertible into pharmaceutical preparations of a variety of forms, suitable for a variety of administration modes and use in a variety of medicinal applications (See pg. 14, paragraph 6).
Regarding claim 26, Magdassi et al. teach that certain solid oils, such as trilaurin, tricaprin, tripalmitin, trimyristin, glyceryl, hydrogenated, palm oil distearate, hydrogenated castor oil, and hydrogenated vegetable oil, can be added to facilitate controlled release (See pg. 18, 2nd paragraph).
Regarding claims 28 and 66, Magdassi et al. teach along with ammonium glycyrrhizinate and maltodextrin, the powder contains sucrose, trehalose, or mannitol. In certain embodiments, the powder contains Pluronic F-127 or F68 together with maltodextrin and sucrose. In certain forms, the powder contains carboxymethyl cellulose (CMC), maltodextrin, and sucrose (See pg. 21, paragraph 5).
Regarding claim 33 and 40, Magdassi et al. teach the powder formulations can be further modified with appropriate pharmaceutical excipients for additional modes of administration, including inhalation techniques and devices. For instance, in reconstituted forms, the invention’s formulations can be further modified to function as depositories or as creams and aqueous dispersions for topical and transdermal administrations (See pg. 5, paragraph 3).
Regarding claim 35, as stated in claim 1, the powder can be administered enterally, parenterally, sublingually, topically, or transdermally (See claim 38).
Regarding claim 57, Magdassi et al. teach with the use of appropriate pharmaceutical excipients, the powder formulations can be further modified for use with inhalation devices and other administration techniques. For instance, the invention’s formulations can be further modified in reconstituted forms to become creams and dispersions for topical and transdermal applications. It should be mentioned that the invention’s formulations can be modified for any kind of administration, as is well recognized in the veterinary and medicinal fields. For topical administration, powders and reconstituted formulations can be chosen, modified, engineered, or customized. (See pg. 5, paragraph 4, pg.16, paragraph 5). Magdassi et al. teach as stated in claim 1, the powder can be applied topically or transdermally (See claim 38 and 55).
Regarding claim 64, Magdassi et al. teach a water-dispersible powder made up of lipophilic nanospheres with an average size of 50-900 nm, that have an adsorbed layer of at least one solid surfactant, and that significantly retain their size and structure when dissolved in an environment that contains water. A solid-based delivery system that can be derived from an initial fine-tuned nanoemulsion that is customized to contain lipophilic nanodroplets of a specific size has been devised by the inventors. When the nanoemulsion is transformed into a solid-based delivery system, such as powder, the size, composition, and integrity of the nanodroplets are preserved. Re-dispersion of the solid-based delivery method in water or contact with water further preserves their size, content, and integrity (See pages 3 and 4, paragraph’s 2-4, and pg. 3, paragraph 1).
Regarding claim 67, Magdassi et al. teach in other embodiments, matrix modifying/controlled release components, such as starch, polysaccharides, and others, may be included in oral dosage forms of the invention. The invention’s compositions may also include fructose, xanthan gum, sodium alginate, PG alginate, pectins, and carrageenans in other, more varied forms (See pg. 18, paragraph 3, and pg.16, paragraph 2 and 3).
Regarding claim 68, Magdassi et al. teach a water-dispersible powder that contains lipophilic nanospheres with a cannabis substance and at least one surfactant chosen from Pluronic F-127, Pluronic F-68, and ammonium glycyrrhizinate (See pg. 21, paragraph 3).
Regarding claim 69, Magdassi et al. teach the investigations were carried out under the same conditions as in Example 1 but using Pluronic F-127 and F-68 (polyoxyethylene-polyoxypropylene block copolymer) as surfactants rather than ammonium glycyrrhizinate (See pg. 25, Example 4).
However, Magdassi et al. fails to teach wherein the at least one cosmetic lipophilic active ingredient is selected from a UV protection agent, a moisturizing agent, a whitening agent, a tanning agent, an anti-wrinkling agent, an elasticity promoting agent, an antiaging agent, a skin exfoliation agent, or a combination thereof.
Regarding claim 9, Brockmeyer et al., teach that the lipophilic active ingredient is chosen from the class of lipophilic UV protection agents. Skin moisturizing or moisturizing substances are examples of appropriate cosmetically and/or dermocosmetically active agents. Artificial skin tanning agents that can be used to tan skin without exposure to UV light, either naturally or artificially. According to the innovation, skin care products include, among other things, skin creams and anti-wrinkle creams. When the inventions preparations are applied to the prevention and treatment of both intrinsic and extrinsic skin aging symptoms (See claim 14, Detailed description of the invention).
Regarding claim 31, Brockmeyer et al. teach monoglycerides are especially preferred surfactants. Lecithins and fatty acid triglycerides are the groups of ingredients chosen for the oil and/or fat phase of the compositions in accordance with the invention. Mineral and synthetic oils, such as fatty acid esters, fatty acids, and fatty alcohols, are preferred oil and fat components of skin cosmetic and dermocosmetic agents. Sucrose distearate, and sucrose stearate. Among the components are sucrose stearate and sucrose distearate or a mixture thereof (See Description).
It would have been obvious to one of ordinary skill in the art before the effective filing date to select a lipophilic cosmetic active ingredient from the classes taught by Brockmeyer et al. for incorporation into the delivery systems of Magdassi et al. because Brockmeyer et al. teach that such lipophilic cosmetic actives are well known and routinely used in cosmetic compositions for the precise purposes described in the art. Substituting one known lipophilic cosmetic active ingredient for another, or selecting a specific species of a known genus of lipophilic cosmetic actives, represents nothing more than the predictable use of prior-art elements according to their established functions, consistent with KSR and MPEP 2144 (routine optimization and substitution of one known equivalent for another).
In view of the combined teachings of the references, it would have been obvious to include in the compositions of Magdassi et al. a lipophilic active ingredient selected from UV protection agents, moisturizing agents, whitening agents, tanning agents, anti-wrinkling agents, elasticity promoting agents, anti-aging agents, skin exfoliation agents, or combinations thereof, as taught by Brockmeyer et al. to obtain cosmetic benefits that each reference independently recognizes as desirable. The modification merely applies known cosmetic lipophilic actives with predictable results and does not require undue experimentation. Therefore, the limitation “wherein the at least one cosmetic lipophilic active ingredient is rendered obvious by the combined teachings of Magdassi et al. and Brockmeyer et al.
Regarding claim 1, the term “sugar” refers to a general term for soluble carbohydrates that taste sweet, such as glucose, fructose, sucrose, galactose and lactose.
Shefer et al. discloses an aqueous mixture of edible substances that is spray-dried into a powdered form (See paragraph 0058-0059).
Although Shefer et al. do not specifically state that the composition is water-dispersible, it would be reasonable to assume (i.e., obvious) that the composition is water-dispersible given that it was dispersed in water prior to turning into a powder.
Additionally, Shefer et al. disclose that the powdered compositions are hydratable to form soups or sauces (See paragraph 0083), which implies that the compositions are edible and water-dispersible as stated.
Shefer et al. reveal that the composition is made up of microspheres with an average size of between 20 to 100 µm (See paragraph 0047). As a result, the teaching includes the assertion that the compositions are made up of particles with an average size in the range of 10 to 900 µm.
Shefer et al. disclose that the composition comprises at least one sugar (See paragraph 0083), at least one polysaccharide (See paragraph 0100), and at least one surfactant (See paragraphs 0093-0097).
Shefer et al. disclose that the composition must contain at least one edible lipophilic substance (See paragraph 0091) as matric material for the nanospheres (See section 1 title), which imparts a portion of the at least one lipophilic substance inside a plurality of lipophilic nanospheres.
Shefer et al. disclose the use of oil-soluble compounds (See paragraphs 0006, 0050, 0080, 0081, and 0091-0092) and at least one edible oil (See paragraphs 0091-0092).
Shefer et al. teach a portion of the lipophilic material being outside the nanospheres, Shefer et al. state that a range of active ingredients are incorporated in either the microsphere matrix, the nanosphere matrix, or both (See paragraph 0046). These active ingredients include essential fatty acids like omega-3 fatty acids and mid-chain triglycerides (See paragraph 0080) and oil soluble vitamins like A, D, E, and K.
Thus, the presence of active components in the microsphere matrix, such as the aforementioned oil-soluble types, ensures that a portion of the lipophilic material is outside the nanosphere as claimed.
Shefer et al. disclose the average size of the nanoparticles/spheres is between 0.01 and 10 µm (See paragraph 0078). This includes the nanospheres, which have an average size between 50 and 900 nm, (0.05 and 0.9 µm).
Regarding the nanospheres substantially maintained upon dispersion of the powder composition in water, it is noted in the pending specification that this is due to the composition and structure of the lipophilic nanospheres (pending pub. 0112). Therefore, since the teaching above provides a similar composition comprising similar amounts of similar ingredients, including similar nanospheres, which reflects the breadth of the claimed composition, it would be reasonable to expect that said nanospheres are substantially maintained upon dispersion of the powder composition, absent a demonstration of criticality.
Characteristics of the composition: regarding encapsulation capacity, it should be noted that the term “encapsulation capacity” refers to the quantity or percentage of edible lipophilic substances that are trapped inside the powder composition as a whole or the particulate matter (See paragraph 0118). According to Shefer et al. the nanospheres have a high loading capacity (See paragraph 0089), containing between 1 and 80 weight percent of the active components (See paragraph 0117). Additionally, Shefer et al. reports that the microsphere contains between 1 and 50 weight percent of the active substances and between 1 and 80 weight percent of the nanospheres (See paragraph 0132). This indicates that the composition contains between 1 and 80 weight percent of active ingredient in 1 to 80 weight percent of nanospheres and between 1 and 50 weight percent of active ingredients in 20 to 99 weight percent of microspheres.
As a result, the composition as a whole contains between 21 and 100 weight percent of an active ingredient, where the active ingredient (i.e., at least one edible lipophilic substance) is for use in both the micro and nano spheres (the powdered composition as a whole), as previously discussed. This includes: where the composition has an encapsulation capacity of 70 to 98% (w/w) relative to the total weight of the at least one edible lipophilic substance in the composition.
Furthermore, absent a demonstration of criticality, it would be reasonable to assume that the composition has an encapsulation capacity of 70 to 98% (w/w) relative to the total weight of the at least one edible lipophilic substance in the composition, as claimed, since Shefer et al. provides a similar composition with similar amounts of similar ingredients, reflecting the breadth of the claimed composition. This is because teaching a similar composition suggests or expects that the composition taught will have the same or a similar utility.
Regarding the composition that improves the delivery of at least one edible lipophilic substance, it is observed that the specific structural characteristics of the compositions of the invention are responsible for the improved delivery of the compositions in light of the pending specification (See paragraph 0162). According to Shefer et al. the active ingredients have improved bioavailability (See paragraph 0044). Since the active ingredients contain at least one edible lipophilic substance, as was previously discussed, this indicates that the compositions made provide improved delivery of the at least one edible lipophilic substance as claimed.
Furthermore, in the absence of a demonstration of criticality, it would be reasonable to anticipate that the composition offers improved delivery of at least one edible lipophilic substance, as claimed, since Shefer et al. provides a similar composition with similar amounts of similar ingredients and a similar structure that reflects the breadth of the claimed composition. This is because teaching a similar composition suggests that the composition taught will have the same or a similar utility.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference
claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321 (d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AlA. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection |.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1, is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, of copending Application No. 17/779,036 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims disclose at least one sugar, one polysaccharide, one surfactant, and at least one edible oil which is liquid at room temperature or at least one edible lipophilic substance comprised or dissolved in such oil, which form a composite matter of micrometric particles with an encapsulated core comprising the at least one liquid edible oil in the form of a plurality of lipophilic nanospheres with an average size in the range of about 50 nm to about 900 nm .
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not been patented.
Conclusion
No claim is allowed.
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/KIMBERLY BARBER/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615