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 .
Status of Claims
The amendments and arguments filed on 01/22/2026 are acknowledged and have been fully considered. Claims 1 ,16-17, and 21have been amended. Claims 23,32-33,40,52, and 56 have been withdrawn. Claims 2-15,18,24-25,28-30,34-39,41-51,53-55, and 57-77 have been canceled; claim 78 is new. Applicants’ amendments are supported by the originally filed disclosure.
No new matter has been added.
Thus, claims 1,16-17,19-22, 26-27,31, and 78 will be examined on the merits herein.
Withdrawn Rejections
Rejection under 35 USC § 112
Applicants’ amendment to claims 1 and 21 are persuasive in overcoming the previously raised indefiniteness rejection. Said rejection is withdrawn.
Rejections under 35 USC 102/103 and 103
Applicants’ amendment to claims 1 is persuasive in overcoming the previously raised prior art rejections based on 35 USC § 102 and 35 USC § 103 over Magdassi et al (US 20210059975 A1; also available as IL261132A and WO2020035850A1) alone and Magdassi et al (US 20210059975 A1; also available as IL261132A and WO2020035850A1) further in view of Shefer et al (US 20030152629 A1). Said rejections are withdrawn.
New Grounds of Rejection — Necessitated by Amendment
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.
Claim(s) 1,16-17,19-22,26-27,31, and 78 are rejected under 35 U.S.C. 103 as being unpatentable over Magdassi et al (US 20210059975 A1; also available as IL261132A and WO2020035850A1) and HELLER (WO 2018204326 A1).
Magdassi discloses a nanoemulsion, and upon dispersion in water said formulation produces nanoparticles (droplets of a submicron size) with an average size of up to about 500 nm for treating disorders and broader application for a range of medical conditions (abstract). Magdassi teaches 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 (see entire document, for instance, [0018]). When the nanoemulsion is transformed into a powder, the integrity, composition, and size of the nanodroplets are preserved (see entire document, for instance, [0018]). Re-dispersion of the solid-based delivery method in water or contact with water further preserves their size, content, and integrity (see entire document, for instance, [0018]). Magdassi discloses a water-dispersible powder comprising lipophilic microspheres having a size of 50-900 nm that comprise surfactant such as ammonium glycyrrhizinate, pluronic F-127, F68, cannabinoid oil, sucrose, trehalose, or mannitol and maltodextrin and carboxymethyl cellulose (CMC) (see entire document, for instance, claim 1). Magdassi teaches a significant quantity of the lipophilic/oil fraction may be added to the solid formulations up to as much as 75% (see entire document, for instance, [0021]). Magdassi discloses certain solid oils can be added to facilitate controlled release, such as mono-, di- and triglyceride oils ([0122]).
Magdassi teaches 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 (see entire document, for instance, [0040]). Magdassi discloses when the nanoemulsion is transformed into a solid-based delivery system, such as powder, the size, composition, and integrity of the nanodroplets are preserved (see entire document, for instance, [0018]). Re-dispersion of the solid-based delivery method in water or contact with water further preserves their size, content, and integrity (see entire document, for instance, ([0018]) Magdassi discloses matrix modifying/controlled release materials, which include, fatty acids ([0123]). Magdassi discloses hemp oil and cannabis oils ([0025]).
However, it a does not expressly disclose including micrometric particles have an average size between about 10 μm and to about 300 μm. HELLER remedy this deficiency. HELLER discloses a composition of a powdered cannabinoid (see entire document, for instance, abstract). HELLER discloses a cannabinoid formulation that comprises encapsulated cannabinoids entrapped in a polymer matrix ([0009]). The cannabinoid embedded polymer matrix can be in a gel or colloidal solution (e.g., “sol”) state or can be dehydrated to make a millable free flowing powder ([0009]). The polymer matrix can be readily dissolvable in aqueous environments upon which the encapsulated cannabinoids can be released into the aqueous medium creating a substantially homogenous and substantially perpetual stable emulsion ([0009]). HELLER discloses in an effort to reduce the time required for absorption in the body, medium chain triglycerides (MCTs) can be chosen as the primary carrier oils ([0047]). MCTs are substantially, and optionally completely miscible with cannabinoids ([0047]). In MCTs demonstrate an ability to create emulsions of sufficiently small particle size that are stable for at least a plurality of months at a time ([0047]). HELLER teaches illustrative examples of MCT oils include coconut oil ([0047]). HELLER discloses emulsions made without carrier oil may not exhibit the same particle size and stability compared to when embodiments utilizing a carrier oil ([0066]). HELLER discloses maltodextrin ([0069], [00240] - [00248]). HELLER teaches cannabinoids (Terpenes, Essential Oils) are susceptible to oxidation and hydrolysis ([0071]). Dissolving the active ingredients in a carrier oil and encapsulating them in an emulsifier/surfactant can significantly improve the stability of the cannabinoids ([0071]). HELLER discloses chelating agents can prevent or at least mitigate the degradation of cannabinoids from metal ions in solution ([0075]). Chelating agents include, but are not limited to: polysaccharides, citric acid and any combination thereof ([0075]). HELLER teaches the density of the oil phase can be reduced by diluting the cannabis oil/carrier oil with an oil of lower density such as essential oils, aromatics or alcohols (ethanol, sugar alcohols) ([0081]). HELLER discloses oil-in-water emulsions are capable of drastically increasing the bioavailability of lipophilic drugs compared to aqueous suspensions of the drugs or when the drugs are administered in carrier oils neat ([0088]). Emulsions made using emulsifiers and/or surfactants offer a method of encapsulation for active drug components that protects them from environmental stresses that may cause unwanted degradation ([0088]). Depending on the ingredients and processing conditions, emulsions can be created with specific particle sizes ranging from several microns down to nanometers with both high and low polydispersity ([0088]). HELLER teaches encapsulation efficiency at least 99% ([00101]). HELLER discloses particle size: 50 nm - 20 microns, or optionally 100-800 nm ([0003], [0099]). HELLER teaches sucrose ([00361]). HELLER discloses anti-inflammatory agents ([00363]). HELLER teaches edible dosage forms can be made with the encapsulated cannabinoid powder ([00387]). The encapsulation of the cannabinoids prevents the influence of cannabinoids/off flavors in the taste of the edibles ([00387]). The powdered form easily mixes and evenly disperses into solid particulates, molten ingredients and liquids ([00387]). HELLER discloses particle size can also be used to control the drug release profile, drug particles with smaller cores have to travel shorter distances to cross the interfacial layer and therefore are released quicker ([00357]). HELLER discloses omega-3 fatty acids ([00362]).
It would have been obvious to utilize particle sizes as taught in HELLER in the composition of Magdassi. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to modify Magdassi to include the particle sizes instantly claimed as particle sizes affect the desired properties and the particle size or size range can be selected for a desired indication or a desired site of action. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976)). Thus, the determination of the optimum or workable amounts given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan (MPEP 2144.05).
Regarding instant claim 22, Magdassi teaches surfactant however, they do not expressly disclose including surfactant selected from a natural emulsifier, a monoglyceride, a diglycerine, a glycolipid, a lecithin or a fatty alcohol. HELLER remedy this deficiency. HELLER discloses polymer based emulsifiers can be utilized to create encapsulated cannabinoid emulsions ([00142]). HELLER discloses fatty acid esters of sorbitan and their ethoxylated derivatives such as polysorbates (Tween 20, 60, 80), Span (20, 60, 80, 83, 85, 120 00142]). It would have been obvious to utilize surfactant as taught in HELLER in the composition of Magdassi. One would have been motivated to do so HELLER teaches that type of surfactant is particularly useful for imparting has an impact on the particle size, the release profile and the encapsulation efficiency.
Magdassi discloses the invention’s compositions can include antioxidants, nutrients, a polysaccharide, peppermint oil (liquid at room temperature), oregano oil (liquid at room temperature), eucalyptus oil (liquid at room temperature), 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 ([0111]).
Regarding instant claim 19, Magdassi discloses 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 entire document, for instance, [0019], claim 1).
Regarding instant claim 26-27,29, Magdassi discloses lipophilic nanospheres containing a cannabinoid material (see entire document, for instance, [0144]). Magdassi teaches anorexia, emesis, pain, inflammation, multiple sclerosis, neurodegenerative disorders (such as Parkinson's disease, Huntington's disease, Tourette's syndrome, Alzheimer's disease), epilepsy, spasticity, autism, tuberculosis, inflammatory bowel diseases, including ulcerative colitis and Crohn's disease, irritable bowel syndrome, glaucoma, osteoporosis, schizophrenia, cardiovascular disorders, cancer, obesity, and metabolic syndrome-related disorders, fibromyalgia, graft versus host disease, constitute only a partial list of clinical conditions that are treatable by cannabinoid/cannabinoid agonists ([0076]). Magdassi teaches application to a wide range of human conditions, including inflammatory, neurological, psychiatric disorders, malignancies and further immune, metabolic disorders, nutritional deficiencies, infectious diseases, and types of gastrointestinal disorders, cardiovascular disorders, and various types of pain, including chronic and neuropathic pain ([0130]). Magdassi discloses lipo-nanospheres of a particular particle (droplets) size, have a potential to limitations in terms of increased dissolution or dispersion of actives, increased bioavailability and protection of actives from P-gp metabolism ([0026]). Magdassi teaches the potential of an increased bioavailability, especially for oral dosage forms ([0026]).
Regarding instant claim 31, Magdassi discloses parenteral administration (e.g., including all systemic administration routes, not involving administration via the gastrointestinal tract). Non-limiting administration routes effective for administration or powders or reconstituted formulations of the invention include oral, sublingual, mucosal, aerosol, inhalation, parenteral, subcutaneous, intravenous, intramuscular, interperitoneal, rectal and vaginal administrations ([0114]). Magdassi teaches oral dosage forms with a controlled release property ([0120]). The term “controlled release” refers to a property or a modification enabling to achieve time dependent release, sustained release, prolonged release and also pulse release, i.e., delayed release of the drug ([0120]). The term further relates to gastro-resistance, i.e., a property or a modification enabling to achieve pH-controlled drug release, gastrointestinal targeting, colon delivery, protection of acid-sensitive actives, protection of gastric mucosa from aggressive actives ([0120]). In this sense, gastro-resistance is also targeted drug release ([0120]). Gastro-resistant coatings and modifications are also known to improve storage stability ([0120]).
Regarding instant claim 78, Magdassi discloses hydrogenated palm oil distearate (oil that is solid or semi-solid at room temperature) ([0122]).
Response to Arguments
Applicant's arguments and declaration filed 01/22/2026 have been fully considered but they are not persuasive in view of the modified grounds of rejection as necessitated by amendment.
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 AIA . 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 I.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 1,9,19-22 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9, 14,16, 18, 20, 22, 24, 78-83 and 85 copending Application No. 17/779,036 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
The copending claims are directed to an edible water-dispersible powder comprising a plurality of micrometric particles comprising: a) at least one sugar, b) at least one polysaccharide c) at least one surfactant and d) at least one liquid edible oil or at least one edible lipophilic substance dissolved in said at least one edible oil, which are configured to form a plurality of lipophilic non-solid nanospheres with an average size in the range of about 50 nm to about 900 nm comprised in the micrometric particles,
wherein an encapsulation capacity of the at least one edible lipophilic substance and/or the at least one edible oil is of at least 85%to 98%, and wherein the size of the nanospheres is substantially maintained upon dispersion of the powder composition in water, thereby conferring the edible powder improved delivery of edible lipophilic substances and oils. The powder of claim 1 having a loading capacity of the at least one edible lipophilic substance up to about 50% (w/w). The micrometric particles have an average size between about 10 pm and to about 300 pm. The at least one edible polysaccharide is selected from maltodextrin and carboxymethyl cellulose (CMC). The at least one edible surfactant is selected from a monoglyceride, a diglycerine, a glycolipid, a lecithin, a fatty alcohol, a fatty acid, and a sucrose fatty acid ester (sugar ester), or a mixture thereof. An improved bio-accessibility of the at least one edible lipophilic substance into at least a part of the gastrointestinal (GI) tract or at least one tissue in the GI tract; (iii) an improved permeation of the at least one edible lipophilic substance into at least a part of the gastrointestinal (GI) tract or at least one tissue.
The copending claims, while teaching each of the instantly claimed elements, does not teach the elements with sufficient specificity to rise to the level of anticipation, however, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instantly claimed invention, to utilize the elements as taught by the copending claims, and thereby arrive at the instantly claimed invention. There would be a reasonable expectation of success since it would require no more than following the guidance of the claims in order to arrive at the instantly claimed invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1,9,11,19, and 22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,31, and 65-66 of copending Application No. 17/800,333 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
The copending claims are directed to a water-dispersible powder for cosmetic applications comprising at least one sugar, at least one polysaccharide, at least one surfactant and at least one cosmetic lipophilic active ingredient comprised or is dissolved in at least one liquid cosmetic oil, which are configured to form a plurality of micrometric particles each comprising a plurality of non-solid lipophilic nanospheres with an average size in the range of about 50 nm to about 900 nm, wherein the at least one cosmetic lipophilic substance is distributed inside and/or outside the lipophilic nanospheres wherein an encapsulation capacity of the at least one cosmetic lipophilic active ingredient and the at least one cosmetic oil is of at least 90- 98% , and wherein the size of the lipophilic nanospheres is substantially maintained upon dispersion of the powder in water and in high osmolarity solutions, thereby an improved topical and/or dermal delivery of the at least one cosmetic lipophilic active ingredient and/or at least one cosmetic oil. The at least one surfactant is selected from a monoglyceride, a diglycerine, a glycolipid, a lecithin, a fatty alcohol, a fatty acid, a sucrose fatty acid ester (sugar ester) or a mixture thereof. The micrometric particles have an average size between about 10 pm and to about 300 pm. The at least one sugar is selected from the groups of oligo-, di-, monosaccharides and polyols.
The copending claims, while teaching each of the instantly claimed elements, does not teach the elements with sufficient specificity to rise to the level of anticipation, however, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instantly claimed invention, to utilize the elements as taught by the copending claims, and thereby arrive at the instantly claimed invention. There would be a reasonable expectation of success since it would require no more than following the guidance of the claims in order to arrive at the instantly claimed invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
The Applicant "requests that these rejections be held in abeyance until such time as allowable subject matter is indicated.” As such the rejections are maintained for reasons of record until such a time as TDs are filed.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANET JOSEPH whose telephone number is (571)270-1372. The examiner can normally be reached Monday and Thursday 0730-1730 Eastern.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham, can be reached at (571)272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JANET JOSEPH/Patent Examiner, Art Unit 1611
/TREVOR LOVE/Primary Examiner, Art Unit 1611
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