DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Claims included in prosecution are claims 1-20.
Previous Rejections
Applicants' arguments, filed Oct. 31, 2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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.
1. Claim(s) 1-7, 12, and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Riepma et al. (WO 2019/221598, Nov. 21, 2019) (hereinafter Riepma).
Riepma teaches a composition for oral administration to a subject, comprising dehydrated liposomal vesicles, wherein the dehydrated liposomal vesicles comprise a nutritional supplement selected from the group consisting of vitamins, minerals, enzymes, proteins, peptides, and/or herbal extracts and to a method for preparing the composition (Abstract). The liposomal vesicles preferably comprise a bilayer of lecithin extracts, which comprise at least 25 wt% phosphatidylcholine (pg. 2, line 6-8). The vitamins, minerals, enzymes, proteins, peptides, and/or herbal extracts deposited in the vesicles may be fat-soluble, water-soluble, and/or both (satisfies claim 2 & 6) (pg. 2, line 9-10). The resulting composition is a dry (i.e. dehydrated) powder and may be used as a food supplement or a medicament (satisfies claim 3) (pg. 3, line 1-2). More preferably, the nutritional supplement is vitamin B12, methyl-cobalamin (satisfies claim 12) (pg. 3, line 35). Preferably, the composition further comprises a pharmaceutically acceptable carrier (pg. 5, line 4). Preferably, the pharmaceutically acceptable carrier is chosen from a group including cellulose (satisfies claim 14) (pg. 5, line 18-19). The manufacturing of the liposomes includes a step of diluting materials with a physiological salt solution (comprises water) comprising any water-soluble active ingredient, such as vitamin C and/or B12 (satisfies claim 7). The compositions are ultimately dried in the presence of a carrier such as maltodextrin and cellulose (pg. 8, lines 1-30). A liposomal vitamin B12 powder was mixed with a glass a water and administered to a volunteer (satisfies claim 5) (pg. 9, lines 32-36).
In regards to claim 4, the compositions of the Riepma are substantially the same as the compositions of the instant claims comprising a dehydrated liposome comprising vitamins, minerals and proteins, and may be administered to a subject as a powder. Therefore, the liposomes of Riepma would rehydrate in a gastrointestinal tract of a user because the composition of Riepma and the composition of the instant claims are substantially the same.
In regards to claim 1 reciting at least a first supplement and at least a second supplement, as discussed above, Riepma discloses wherein the vesicles comprise a nutritional supplement selected from the group consisting of vitamins, minerals, enzymes, proteins, peptides, and/or herbal extracts. This would satisfy at least a first and second supplement as instantly claimed.
The prior art anticipates the indicated claims because it discloses compositions comprising liposomes with a lipid bilayer loaded with vitamins, minerals, enzymes, proteins, peptides, and/or herbal extracts which may be dehydrated.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
1. Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Riepma et al. (WO 2019/221598, Nov. 21, 2019) (hereinafter Riepma).
The teachings of Riepma are discussed above.
As discussed above, Riepma discloses that the composition is a dry (i.e. dehydrated) powder and may be used as a food supplement or a medicament (pg. 3, line 1-2). Riepma further discloses that the nutritional supplement used in the vesicles is preferably chosen from vitamin C (pg. 3, line 6). Preferably, the composition comprises between 1 - 50 wt% of nutritional supplement (pg. 6, line 3).
Regarding the amounts recited in instant claim 17 (i.e., 15-95 wt%), in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). As discussed above, Riepma’s liposome may comprise vitamin C in an amount ranging from 1 - 50 wt%. Accordingly, because the amount recited in the instant claim overlaps with the amount disclosed by Riepma, the amount disclosed by Riepma meets the instantly recited limitations.
Therefore, the teachings of Riepma render obvious claim 17.
2. Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Riepma et al. (WO 2019/221598, Nov. 21, 2019) (hereinafter Riepma) in view of Kaufman (US 2016/0263047, Sep. 15, 2016) (hereinafter Kaufman).
The teachings of Riepma are discussed above.
Riepma differs from the instantly recited claim insofar as not disclosing wherein the composition comprises a combination of iron, hyaluronic acid, and ashwagandha extract.
However, Kaufman teaches compositions for the delivery of nutraceutical factors (¶ [0001]). The term "nutraceutical factor" may refer to any composition of one or more nutritional supplements (¶ [0029]). Suitable nutraceutical factors include ashwagandha extract (¶ [0238]); iron (¶ [0245]); and hyaluronic acid (¶ [0250]).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. As discussed above, Riepma discloses wherein the dehydrated liposomal vesicles comprise a nutritional supplement. Accordingly, it would have been prima facie obvious for one of ordinary skill in the art to have formulated the composition of Riepma to comprise iron, hyaluronic acid, and ashwagandha extract, since they are known nutritional supplements as taught by Kaufman.
Regarding claims 8 reciting optimizing the payload for improving women’s health, as well as improving healthy blood cell formation, skin and joint lubrication, and vagal nerve and adrenal function, this is merely a recitation of the intended use of the claimed composition. The composition of Riepma in view of Kaufman contain substantially the same compounds as the instantly claimed composition and as such, and one would reasonably conclude that the composition would be useable for the same purpose as the composition of the instant claims.
Therefore, the combined teachings of Riepma and Kaufman render obvious claim 8.
3. Claim(s) 9-11, 16, and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Riepma et al. (WO 2019/221598, Nov. 21, 2019) (hereinafter Riepma) in view of Moodley et al. (US 2008/0113031, May 15, 2008) (hereinafter Moodley).
The teachings of Riepma are discussed above.
Riepma differs from the instantly recited claims insofar as not disclosing wherein the composition comprises the compounds claimed.
However, Moodley teaches minicapsules having a core containing an active entity and an encapsulating body wherein the active entity may be in the form of a liposome (Abstract). Suitable actives for use include: phospholipids such as choline (satisfies choline of claim 11 & 20) (¶ [0474]); herbal oils such as pumpkin seed oil and cranberry seed oil (satisfies extracts of claim 9-10) (¶ [0476]); other oils such as Coenzyme Q10 (satisfies CQ10 of claim 11 & 20) (¶ [0478]); vitamins such as Vitamin C, B Vitamins such as Biotin; Folic Acid; Inositol; PABA (Para Aminobenzoic Acid) (i.e., B10); Vitamin B6; Riboflavin (Vitamin B2); and Thiamine (Vitamin B1), Vitamin A, Vitamin D, Vitamin E, Vitamin K (¶ [0479]), niacin (vitamin B3), and folate cyanocobalamin (vitamin B12) (satisfies vitamins of claim 10-11 & 20) (¶ [0529]); minerals such as chromium, iodine, iron, magnesium, manganese, molybdenum, selenium, and zinc (satisfies minerals of claim 11 & 20) (¶ [0482]); and proteins/amino acids such as L-Glycine, L-Isoleucine, L-Leucine, L-Lysine, and L-Valine (satisfies BCAA of claim 9 and glycine of claim 11 & 20) (¶ [0484]).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. As discussed above, Riepma discloses wherein the dehydrated liposomal vesicles comprise a nutritional supplement selected from the group consisting of vitamins, minerals, enzymes, proteins, peptides, and/or herbal extracts. Accordingly, it would have been prima facie obvious for one of ordinary skill in the art to have formulated the composition of Riepma to comprise the compounds taught by Moodley, since they are known vitamins, minerals, enzymes, proteins, peptides, and/or herbal extracts for use in medicaments containing liposomes as taught by Moodley.
Regarding claims 9-11 reciting optimizing the payload for improving men’s/women’s health, as well as improving muscle growth and prostate function, supporting a healthy urinary tract and healthy bone formation, and improving whole body wellness, this is merely a recitation of the intended use of the claimed composition. The composition of Riepma in view of Moodley contain substantially the same compounds as the instantly claimed composition and as such, one would reasonably conclude that the composition of Riepma in view of Moodley would be useable for the same purpose as the composition of the instant claims.
Regarding the amounts recited in instant claims 16 and 18-19, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). As discussed above, the composition of Riepma in view of Moodley contain Vitamins A and E as well as thiamine and riboflavin and Riepma’s liposome may comprise the nutritional supplement in an amount ranging from 1 - 50 wt%. Accordingly, because the amounts recited in the instant claims overlaps with the amount disclosed by Riepma, the amount disclosed by Riepma meets the instantly recited limitations.
Therefore, the combined teachings of Riepma and Moodley render obvious claims 9-11, 16, and 18-20.
4. Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Riepma et al. (WO 2019/221598, Nov. 21, 2019) (hereinafter Riepma) in view of Mortensen et al. (EFSA Journal 2017; 15(4) : 4742) (hereinafter Mortensen).
The teachings of Riepma are discussed above.
As discussed above, Riepma discloses that the liposomal bilayer is preferably formed from lecithin extracts, which comprise at least 25 wt% phosphatidylcholine (pg. 2, line 6-8) Riepma further discloses that utilizing lecithins with lower percentages of phosphatidylcholine results in liposomal vesicles that are not adequately formed (pg. 5, line 31-32).
Riepma differs from the instantly recited claim insofar as not specifying wherein the lecithin used in the liposomal bilayer are sunflower lecithin.
However, Mortensen discloses that deoiled sunflower lecithin contains 24.97–27.57% phosphatidylcholine (Table 2). Mortensen further discloses that lecithin is an ingredient used in dietary supplements and pharmaceutical products (Sec. 3.4.3).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. As discussed above, Riepma discloses wherein the liposomal bilayer is preferably formed from lecithin extracts, which comprise at least 25 wt% phosphatidylcholine. Accordingly, it would have been prima facie obvious for one of ordinary skill in the art to have formulated the composition of Riepma to comprise sunflower lecithin containing 24.97–27.57%, since it is a known lecithin for use in dietary supplements and pharmaceutical products, and comprises at least 25% phosphatidylcholine as taught by Mortensen.
Therefore, the combined teachings of Riepma and Mortensen render obvious claim 15.
Response to Arguments
Regarding Applicant’s argument that while Riepma does disclose the inclusion of a fat-soluble nutritional supplement and/or a water-soluble nutritional supplement at step a) and/or at step c), Applicant alleges that Riepma discloses that the vesicles are formed after step c) and in step d). The Examiner respectfully disagrees. The Examiner specifically draws Applicant’s attention to Pg. 2, ln. 18-19 of the Riepma disclosure where Riepma explicitly recites that step c) comprises “creating vesicles”. As such, since the supplement which may contain vitamins, minerals, enzymes, proteins, peptides, and/or herbal extracts may be added to step c), the step at which the vesicles are created, it would be reasonable for one of ordinary skill in the art to conclude that the vesicles created would contain said supplements. Furthermore, assuming purely arguendo that the vesicles were indeed created in step d) this would still lead one of ordinary skill in the art to reasonably conclude that the resulting vesicles would contain vitamins, minerals, enzymes, proteins, peptides, and/or herbal extracts since the intended use of Riepma’s product is to deliver to a subject a composition comprising said supplements.
Regarding Applicant’s argument that Riepma discloses checking for the chosen nutritional supplement, the Examiner submits that this doesn’t teach away from the recited limitations. Riepma discloses that the nutritional supplement comprises vitamins, minerals, enzymes, proteins, peptides, and/or herbal extracts. As such, after processing it would logically follow that one of ordinary skill in the art would check the chosen nutritional supplement components they chose out of the possible combinations mentioned above. In other words, referring to the nutritional supplement as “chosen” does not automatically narrow down its composition to one component, especially in light of the fact that Riepma explicitly discloses that said nutritional supplement comprises vitamins, minerals, enzymes, proteins, peptides, and/or herbal extracts.
Regarding Applicant’s argument that Riepma's process only discloses each single liposomal vesicle with a payload comprising a single nutrient, at Pg. 8, ln. 6-10 of the Riepma disclosure, which Applicant refers to, Riepma explicitly discloses wherein suitable examples of water soluble active ingredients are “ vitamin C and/or B12”. Accordingly, one of ordinary skill in the art would reasonably conclude that the composition of Riepma does indeed satisfy the claimed concept of "wherein the payload comprises at least a first supplement nutrient and a second supplement nutrient" since the vesicle may contain vitamin C and vitamin B12 as taught by Riepma.
In light of the foregoing, the Examiner does not find Applicant’s arguments to be persuasive and the rejection is maintained.
Conclusion
Claims 1-20 are rejected.
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 Abdulrahman Abbas whose telephone number is (571)270-0878. The examiner can normally be reached M-F: 8:30 - 5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana S. Kaup can be reached at 571-272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.A./Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612