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 .
Specification
The disclosure is objected to because of the following informalities: The first paragraph of the specification should reflect that the parent application was granted to USPN 12,150,465.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
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 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 1-4, 6, 9, 11, 19, 20, 22-27, 32 are rejected under 35 U.S.C. 103 as being unpatentable over Melvik (USPA 2006/0159823) in view of Gaserod (USPA 2005/0137272) and Sexton et al. (USPA 2014/0037830), all made of record by Applicant.
Regarding amended Claims 1-4, 6, 9, 11, 19, 20, 22-27, and new Claim 32, Melvik teaches an alginate hydrogel, said hydrogel consisting of 0.1-5% alginate, as Melvik teaches a gels from soluble and insoluble alginate at a concentration level ranging from 0.5-10% by weight (Paragraph 39), therefore teaching and rendering obvious the claimed amount and ranges of alginate as recited in Claim 1 and dependent claims indicated. Melvik teaches that the alginate is present in a solvent and is gelled by a gelling ion which can be calcium, where the gelling ion solution can be combined with sodium alginate solution (Paragraphs 45-51), and where the solvent can be water, sugar solution or nucleic acid solution, among others (Paragraph 57). Melvik teaches the % of the gelling ions present affect gel strength and the degree of bioavailability of the gel and teach an example where the calcium is at 50% saturation (Example 20). Melvik is seen to teach the hydrogel consisting of alginate within the claimed range, calcium ions and teaches where the solvent can include sugar solution, therefore teaching an aqueous solution comprising active ingredients which can be sugars. Melvik teaches cross-linking to form the alginate gels (Paragraphs 4, 5). Melvik teaches the insoluble alginate is present in the solution of soluble alginate and forms a slurry which can be poured, injected or can otherwise self-gel within a mold or cavity to form the shape of such a mold or cavity and where the gel can also be used in pharmaceutical and food applications (Paragraphs 53, 57 and 61). However, Melvik does not specifically teach motivation to change the calcium saturation in the alginate gel to be in the claimed ranges, or where the gel is a nutritional supplement.
Gaserod teaches a nutritional supplement including an alginate hydrogel, said hydrogel comprising: a) alginate in an amount of 0.5 wt% to about 10 wt% alginate in an aqueous dispersion (Paragraphs 32-40). Gaserod teaches the gelling agent comprises a polyvalent cation, preferably calcium (Paragraph 35), where the invention is a dried gelled foam comprising a gel-forming polymer crosslinked with polyvalent cation and a water soluble plasticizer (Paragraph 20), and teaches the gel saturation is dependent on the application on the dried gelled foam, and that for applications where it is desired for the dried gelled foam to disintegrate and/or dissolve in water or aqueous media, such as in certain food and pharmaceutical applications, the gel would be calcium saturated at a level of about 10% to 60% (Paragraph 40), where the disclosed range encompasses the % of calcium saturated recited in Claims 2-4, and 6. Therefore, at least Gaserod is seen to teach the limitation of the alginate is cross-linked with sub-saturating amounts of calcium in light of the claimed calcium saturation taught. Gaserod teaches higher saturation such as from 60-200% is suitable for other applications (Paragraph 40). Therefore, considering that Melvik teaches 50% calcium saturation which is within the wider suitable range taught by Gaserod for use in food and pharmaceutical applications where the gel is desired to disintegrate or dissolve in water or aqueous medium such as in certain food and pharmaceutical applications, it would have been obvious to one of ordinary skill in the art to have used the alginate gel of Melvik for applications other than food and pharmaceutical, namely, for a nutritional supplement, and to have adjusted the calcium saturation of the alginate gel, within the parameters of the prior art, depending on the particular application of the gel.
Melvik in view of Gaserod do not specifically teach the aqueous solution comprising from 1-75% active ingredients or the amounts of the recited sugars. Melvik in view of Gaserod also do not teach the claimed method comprising consuming the nutritional supplement of Claim 1 before, during or after exercise.
Sexton teaches a nutritional supplement composition comprising carbohydrates, amino acids, vitamins and electrolytes (Paragraph 10), which comprises a hydrogel (Paragraph 13), where the composition may be delivered in a sustained and extended matter for peak athletic performance and recovery, where the composition may release the nutritional supplements so that absorption and oxidation rates of exogenous carbohydrates are increased during exercise (Paragraph 9), and teaches methods of improving athletic performance comprising administering to an individual a composition comprising nutritional supplements to increase exercise duration and cumulative power (Paragraph 27). Sexton teaches the hydrogels are prepared from alginate (Paragraph 16) and that the compositions can be formulated as a beverage, for example (Paragraph 27). Sexton teaches of various additives that can be added to the composition, including carbohydrates, preferably a combination of glucose and fructose in a preferable range of about 1:1 to about 100:1, and where preferably the composition comprises a range of about 15 to about 85%, or about 30-70% by weight carbohydrates/sugar content (Paragraphs 74-75). Sexton teaches that fructose and glucose are absorbed by different intestinal transport systems in the body and that generally, the ingestion of a mixture of carbohydrates that have different transport mechanisms for absorption into the blood stream, simultaneously increases carbohydrate and water absorption (Paragraph 70). Therefore, since Melvik teaches a calcium alginate hydrogel that can have a sugar solution solvent, where the gel can be molded for use in food and beverage applications, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have used the aqueous alginate gel composition of Melvik in view of Gaserod in a method of providing nutrition to an individual during exercise, and to have used the guidelines taught in Sexton in order to modify the amounts of sugars to be maximized for optimal athletic performance that can be released from a gel composition. Therefore, where the total sugar content of the composition is about 60%, and the ratio of glucose to fructose is 1:1, this would provide about 30% each of glucose and fructose as the carbohydrates, therefore rendering obvious the claimed amounts of carbohydrates as an effective means of providing carbohydrates in a nutritional composition.
Regarding Claims 24-27, Melvik in view of Gaserod and Sexton are taken as cited above. Sexton teaches various carbohydrates that can be added also include more complex edible carbohydrates such as maltodextrins (Paragraph 75), and teaches where preferably the composition comprises a range of about 15 to about 85%, or about 30-70% by weight carbohydrates/sugar content (Paragraphs 74-75). Sexton also teaches electrolytes can also be included, particularly sodium, potassium, magnesium, chloride, etc. (Paragraphs 10 and 28). Therefore, adding the claimed ranges of complex carbohydrates and electrolytes to the gel composition of Melvik in view of Gaserod would have been obvious to one of ordinary skill in the art before the effective filing date of the invention, in light of the teachings of Sexton and the desire to prepare effective nutritional supplements for athletes that can be released from alginate-gel compositions.
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.
Claims 1-4, 6, 9, 11, 19, 20, 22-27, 32 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-30 of U.S. Patent No. 12,150,465. Although the claims at issue are not identical, they are not patentably distinct from each other because Applicant’s instant claims recite a nutritional supplement consisting of an alginate hydrogel, said hydrogel comprising the same amount of alginate and aqueous solution comprising the same active ingredients as recited in the claims of the prior granted patent. Additionally, while instant Claim 1 does not specifically recite that the alginate is 20-80% calcium saturated as is recited in the claims of the prior granted patent, Applicant’s instant claims 2-4 recite limitations of calcium saturated that render the above limitation obvious to one of ordinary skill in the art. The balance of Applicant’s instant dependent claims are the same as recited in the prior granted patent. Therefore, Applicant’s instant claims would have been obvious to one of ordinary skill in the art over Claims 1-30 of the prior granted patent for the reasons set forth above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNA A WATTS whose telephone number is (571)270-7368. The examiner can normally be reached Monday-Friday. 9am-4:30pm.
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JENNA A. WATTS
Primary Examiner
Art Unit 1791
/JENNA A WATTS/Primary Examiner, Art Unit 1791 10/7/2026
