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 .
DETAILED ACTION
Claim Status
Claims 1-31 are pending and under consideration.
Election/Restrictions
Applicant's election with traverse of Group II, claims 16-31, directed to the multi-supplement complex, in the reply filed on 12/22/2025 is acknowledged. Applicants also elected, without traverse, that the water soluble polysaccharide is chitosan, the water soluble nutritional supplement is vitamin B6, the oil soluble nutritional supplement is vitamin E and the second polysaccharide is maltodextrin in response to the species election requirement. The traversal is on the ground(s) that the groups are interdependent and interrelated aspects of a single invention. The applicant notes that the examiner referred to the groups as related as a product and a process of making and that this is sufficient to not require a restriction. This is not found persuasive because the acknowledgement of some level of relation between the inventions is not an acknowledgment that the invention are not distinct. As described in MPEP 806.05(f), a process of making and a product made by the process can be shown to be distinct inventions if either or both of the following can be shown: (A) that the process as claimed is not an obvious process of making the product and the process as claimed can be used to make another materially different product; or (B) that the product as claimed can be made by another materially different process. As described in the restriction requirement, the process of combining aqueous and oil solutions can be used to make a different emulsion product such as one with liposomes or other surfactant.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-15 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claims 16-31 are under consideration to the extent of the elected species, i.e., that the water soluble polysaccharide is chitosan, the water soluble nutritional supplement is vitamin B6, the oil soluble nutritional supplement is vitamin E and the second polysaccharide is maltodextrin.
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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 19, 21, 23 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 19 recites “solid (spray-dried) particulate form.” The use of the parenthesis renders the claim indefinite as it is unclear whether the limitation “spray-dried” is intended to be required per the claim or if it is merely exemplary of a solid particulate form.
Claim 21 recites the limitation "the water-soluble nutritional supplement". There is insufficient antecedent basis for this limitation in the claim. Base claim 16 recites “at least one water-soluble nutritional supplement”, which encompasses multiple water-soluble nutritional supplements, and it is unclear whether “the water-soluble nutritional supplement” includes just one or more than one water-soluble nutritional supplement. Amending claim 21 to recite “the at least one water-soluble nutritional supplement” would overcome this rejection.
Claim 23 recites the limitation "the oil-soluble nutritional supplement". There is insufficient antecedent basis for this limitation in the claim. Base claim 16 recites “at least one oil-soluble nutritional supplement”, which encompasses multiple oil-soluble nutritional supplements, and it is unclear whether “the oil-soluble nutritional supplement” includes just one or more than one oil-soluble nutritional supplement. Amending claim 23 to recite “the at least one oil-soluble nutritional supplement” would overcome this rejection.
Claim 28 recites “a tea bag comprising the nutritional multi-supplement complex according to claim 16 contained within a tea bag enclosure.” Referring to the tea bag enclosure at the end of the claim as “a” tea bag enclosure renders the claim indefinite as it is unclear what tea bag is intended. For example, it is not clear from the wording if the complex of claim 16 is intended to be in an additional tea bag separate from the tea bag recited at the beginning of the claim or if the tea bag enclosure containing the complex is the same as the initial tea bag recited.
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.
Claims 16-25 are rejected under 35 U.S.C. 103 as being unpatentable over Singh et al. (Carbohydrate Polymers 251, 117110, 19 Sep 2020) in view of Estevinho et al. (Powder Technology 289 (2016) 71–78), Lauriane et al. (WO 2016/124522, published 11 Aug 2016) and NIH (Vitamin B6, Fact Sheet for Consumers, 31 Jul 2014).
Singh teaches a spray-dried Pickering emulsion powder using chitosan as a Pickering emulsifier and alginate as a coating material as a delivery system for applications in the food industry (abstract). A schematic of the invention is presented in Figure 1 and shown below:
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From this schematic it can be seen that chitosan particles with a spheroidal shape surround corn oil droplets and that an alginate and maltodextrin mixture surrounds the chitosan-oil droplets. This teaching from Singh renders obvious an oil solution encapsulated by spheroidal polysaccharide stabilized complexes, where the polysaccharide complexes comprise a water-soluble polysaccharide of chitosan (the elected species), as in claims 16 and 20. The alginate-maltodextrin is prepared with water (section 2.3), rendering obvious an aqueous medium as in claim 16. The encapsulation with maltodextrin renders obvious encapsulation by a second polysaccharide of maltodextrin as in claim 17 and 18. The maltodextrin/chitosan encapsulating oil mixture was spray dried to form a powder (sections 2.6-2.7, Conclusion), rendering obvious a solid spray-dried particulate form as in claim 19. Singh teaches Pickering emulsions are known for their potential in controlling release of food actives (Introduction) and that the powder has great potential for food applications (Conclusion).
Singh does not teach the inclusion of vitamin E (elected species of oil-soluble nutritional supplement) in the oil solution, the inclusion of vitamin B6 (elected species of water-soluble nutritional supplement) or that the oil is vegetable oil (claim 25). These deficiencies are made up for in the teachings of Estevinho, Lauriane and NIH.
Estevinho teaches soluble vitamins microencapsulated with biopolymers by a spray drying process (title). Estevinho teaches that vitamins are important micronutritional compounds involved in many biochemical functions in the human body but are not synthesized by it and have to be supplied through diet (abstract). Estevinho teaches that vitamins are sensitive which provokes loss during food processes and storage but that microencapsulation can be used to minimize the loss of vitamins (abstract). Estevhinho teaches spray drying the highly complex vitamin B12 and vitamin C which has high applicability and is representative of water-soluble vitamins, where the vitamins are microencapsulated in biopolymers including chitosan and sodium alginate (page 72 left column). Estevinho teaches that the vitamins were successfully encapsulated in the biopolymers through spray drying (Conclusion) and that the release of the vitamins depended on the encapsulating agent with a slower release with chitosan and faster release with alginate (page 76 right column). Estevinho teaches that the microencapsulated vitamins can be used in drinks prepared from powder formulations (page 76 right column).
Lauriane teaches Pickering emulsions with at least one oil stabilized by silica nanoparticles (page 2 middle) where the nanoparticles are modified with a cationic polysaccharide such as chitosan (page 3 middle). Lauriane teaches that the oil may be of any origin (page 7) and teaches emulsions as suitable with vegetable oil (page 9). Lauriane teaches the emulsions are suitable for use in a variety of fields including food products (page 12 middle). Lauriane teaches that the emulsions may include nutraceuticals and oil soluble vitamins such as vitamin E (page 7 bottom).
NIH teaches that the body needs vitamin B6 for more than 100 enzyme reactions involved in metabolism and is involved in brain development during pregnancy and infancy as well as immune function (page 1 What is vitamin B6 and what does it do?). NIH teaches that vitamin B6 is available in dietary supplements (page 1 What kinds of vitamin B6 dietary supplements are available?)
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to have included vitamins E and B6 in the powder of Singh and to use vegetable oil as the oil. Specifically it would have been obvious to include vitamin E in the oil solution and vitamin B6 with the chitosan complex. Forming pickering oil emulsions stabilized with chitosan particles and maltodextrin/alginate and where the emulsions are spray dried, is known from the teachings of Singh. It is additionally known from Estevinho that vitamins are important nutritional compounds that have to be supplied through the diet and that vitamins, such as the water soluble vitamins B12 and C may be encapsulated in biopolymers such as chitosan and spray dried and used in drink formulations. It is additionally known from Lauriane that a variety of oils, including vegetable oil, may be used in Pickering emulsions and that they may be used to encapsulate oil soluble vitamins such as vitamin E. In addition to vitamins B12, C and E mention above, it is further known from NIH that vitamin B6 is involved in important roles of metabolism, brain development, and immune function and that it may be delivered as a supplement. Thus, it would have been obvious to include vitamins such as vitamin B6 with the chitosan particles and vitamin E in the oil and that the oil may be vegetable oil in the maltodextrin/chitosan oil particles taught by Singh. The oil used by Singh was corn oil and a variety of oils including vegetable oil are known to be useful with Pickering emulsions, as taught by Lauriane, rendering it obvious that the oil may be substituted with alternative oils. One would have a reasonable expectation of success in incorporating the vitamins as Singh teaches the powder for food applications and Pickering emulsions are known from Lauriane to be suitable for encapsulating vitamin E and encapsulating water soluble vitamins in spray dried biopolymers such as chitosan is known from Estevinho. Thus the incorporation of vitamin E and B6 merely represents including known vitamin compounds with components known to be suitable for use with vitamins. It would be desirable to include vitamins as they are important nutrients that must be supplied from the diet, as taught by Estevinho. The incorporation of vitamin B6 would specifically be desirable for the role it plays in metabolism, brain development, and immune function and that it is already known for delivery in supplements, as taught by NIH. Regarding the limitation of claim 16 that water soluble polysaccharide and supplement are complexed by ionic interactions, the examiner notes that this feature would be a necessary result of including the vitamin B6 with the chitosan polymer. Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. It is obvious to encapsulate vitamin B6 with chitosan as required per the claim, for the reasons described above, and the interaction between the chitosan and vitamin b6 would necessarily result in ionic interactions.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
Claims 26-31 are rejected under 35 U.S.C. 103 as being unpatentable over Singh et al. (Carbohydrate Polymers 251, 117110, 19 Sep 2020) in view of Estevinho et al. (Powder Technology 289 (2016) 71–78), Lauriane et al. (WO 2016/124522, published 11 Aug 2016) and NIH (Vitamin B6, Fact Sheet for Consumers, 31 Jul 2014) as applied to claims 16-25 above, and further in view of Vora et al. (bmjnph 2021;4:e000209. doi:10.1136/bmjnph-2020-000209).
The teachings of Singh, Estevinho, Lauriane, and NIH are described supra.
Singh, Estevinho, Lauriane, and NIH do not teach dispersing in an aqueous medium or inclusion with tea components or a tea bag. These deficiencies are made up for in the teachings of Vora.
Vora teaches that the second most common beverage worldwide is tea and that it is an outstanding vehicle for fortification with folate and vitamin B12 (abstract). Vora teaches that teabags were spiked with therapeutic doses of the folate and vitamin B12 (abstract-Methods). Vora teaches the tea is brewed in water and the teabags are steeped in water (page 295 and 296 left columns) rendering obvious homogenous dispersion in an aqueous medium suitable for human consumption (claim 26).
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have incorporated the maltodextrin/chitosan oil powder particles containing vitamins E and B6 into a tea bag to be used in a beverage. It is obvious to form a powder containing vitamin supplements such as E and B6, as described above, and it is known from Vora that vitamin supplements may be spiked into tea bags to supplement a tea beverage with vitamins. Thus, it would have been obvious to one of ordinary skill to include the vitamin containing powder in a tea bag to serve as means of delivering vitamin supplements. The use of the powder with food application is known from Singh and tea is the second most popular drink, as taught by Vora, making it an obvious choice for beverages. One would have a reasonable expectation of success as vitamins are known from Vora to be suitable for including in tea bags and delivery of vitamins such as B6 as a supplement is known from NIH. Incorporating the vitamins into a bag containing tea components renders obvious including tea components (claim 27), a tea bag enclosure (claim 28) and the components of a botanical source and a tea plant (claims 29-30). Regarding the limitation of claim 31 that the tea bag has a pore size cut off sufficient to retain the complex in the tea bag, the examiner notes that the tea is formed when the bag is steeped in water, as taught by Vora, and the purpose of the tea bag is to retain the contents until it is placed in water. If the bag did not retain the contents such as the tea components and the vitamins spiked into it, then the tea beverage supplemented with vitamins could not form. Thus, one of ordinary skill would recognize that the pore size of the bag would have to be at a size sufficient to retain the contents so that the tea beverage could actually be formed.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EDWIN C MITCHELL whose telephone number is (571)272-7007. The examiner can normally be reached Mon-Fri 8:00-5:00.
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/E.C.M./Examiner, Art Unit 1619
/ANNA R FALKOWITZ/Primary Examiner, Art Unit 1600