DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Election/Restriction
Applicant’s election without traverse of Group I, claims 1-10, and the species zinc, L-aspartic acid, inulin, alginate, vitamins A, C, and D, iron, L-glycine, fructooligosaccharide, zinc-L-glycine and magnesium-L-glycine, and inulin, stearic acid, and shellac in the reply filed on 31 December 2025, is acknowledged.
Status of Claims
Claims 1-20 are pending in the instant Office Action.
Claims 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 31 December 2025.
Claims 6 and 9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 31 December 2025.
Claims 1-5, 7-8, and 10 are under consideration in the instant Office Action.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 11 July 2024, and 30 December 2024, were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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 1-5, 7-8, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Rabovsky et al. (U.S. Patent No. 11,207,388 B2, published on 28 December 2021, cited by Applicant in the IDS filed on 11 July 2024, hereafter referred to as Rabovsky).
Rabovsky teaches dietary supplement compositions useful for human or animal consumption (Abstract). The dietary supplement may comprise one or more mineral-amino acid compound/polysaccharide complexes, in which the mineral-amino acid compounds are conjugated to one or more polysaccharides (claim 1 and col. 2, lines 21-23). In some embodiments, the mineral may be iron or zinc (col. 27, lines 45-53), the amino acid may be L-aspartic acid L-glycine (col. 27, lines 60-66), the polysaccharide may be inulin or oligofructose, which is interpreted as being equivalent to the elected fructooligosaccharide (col. 28, lines 7-10 and Table that spans col. 34-35). Rabovsky further teaches that the dietary supplement may contain additional ingredients, including vitamin A, vitamin C, and vitamin D (col. 29, lines 21-25). Finally, Rabovsky teaches that their composition may have a coating “designed to prevent moisture adsorption and minimize the water activity of the final blend” and “to deliver the contents [of the composition] to the intestines of a mammal following oral administration”, which is interpreted as being equivalent to a “slow release” coating (col. 6, lines 5-9 and col. 9, lines 39-43). In some embodiments the coating is sodium alginate (col. 6, line 14).
Although “picking, choosing, and combining various disclosures not directly related to each other by the teachings of the cited reference...has no place in...a 102, anticipation rejection,” picking and choosing may be entirely proper in an obviousness rejection. In re Arkley, 455 F.2d 586, 587 (CCPA 1972). Addressing the issue of obviousness, the Supreme Court noted that analysis under 35 U.S.C. 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ” (KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007)). The Court further emphasized that “[a] person of ordinary skill is…a person of ordinary creativity, not an automaton” (Id. at 1742).
The only difference between Rabovsky and the instant claims is that Rabovsky does not teach the specific combination of components as claimed in a single embodiment (e.g., the compositions of Supplement Formulation F [Tables 11-16] do not comprise all of the elected species in one embodiment), or with sufficient specificity to be anticipatory. The specific combination of features claimed is disclosed within the teaching of Rabovsky, but such “picking and choosing” within several variables does not necessarily give rise to anticipation. Where, as here, the reference does not provide any explicit motivation to select this specific combination of variables, anticipation cannot be found. However, it must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” See MPEP § 2141.I. Consistent with this reasoning, it would have been prima facie obvious to a person having ordinary skill in the art, prior to the effective filing date of the instant application, to have selected various combinations of the various disclosed ingredients from within the teachings of Rabovsky, to arrive at an invention such as the one being sought.
Claims 1-5, 7-8, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Rabovsky et al. (U.S. Patent No. 8,273,393 B2, published on 25 September 2012, cited by Applicant in the IDS filed on 11 July 2024, hereafter referred to as Rabovsky II) in view of Kruger et al. (Exp. Biol. Med. 2003, 228, 683., provided by Applicant in the IDS filed on 11 July 2024, hereafter referred to as Kruger) and Parreidt et al. (Foods 2018, 7, 170., hereafter referred to as Parreidt).
Rabovsky II teaches a complex of one or more mineral-amino acid compounds conjugated to one or more polysaccharides as dietary supplements (claim 1 and Abstract). The mineral may be zinc or iron (claims 7, 10, and 12-17, col. 1, line 61-col. 2, line 4, and col. 5, lines 10-11), the amino acid may be L-aspartic acid or L-glycine (col. 5, lines 11-17), and the polysaccharide may be inulin or a polyfructose (col. 5, lines 17-21). Finally, Rabovsky II teaches their complex to comprise additional ingredients including vitamin A, C, and D (claims 9-10 and 12-17 and col. 2, lines 4-5).
Rabovsky II does not teach the polysaccharide to be fructooligosaccharides nor the complex to have a coating. These deficiencies are offset by the teachings of Kruger and Parreidt.
Kruger teaches the effect of fructooligosaccharides on calcium bioavailability in growing rats (Title and Abstract). Maximizing bone mass during adolescence is taught to be vital to preventing osteoporosis later in life and is strongly correlated with the bioavailability of calcium (pg. 683, right column, para. 1). Kruger assessed the retention of calcium in rats fed with diets containing inulin and fructooligosaccharides (FOS) and its impact on bones and collagen (pg. 633, right column, para. 3 - pg. 684, left column, para. 3). The results of the study demonstrated that inulin “increased calcium absorption significantly compared with [the] control” and that FOS significantly decreased Type I collagen cross-link excretion, which is indicative of bone resorption, and increased bone density (pg. 687, right column, para. 1).
Parreidt teaches the utility of edible alginate films and coatings, including improving/maintaining quality and extending the shelf-life of edible products by “reducing dehydration (as a sacrificial moisture agent), controlling respiration, enhancing product appearance, improving mechanical properties, etc.” (Abstract). Alginates are taught to be naturally occurring, indigestible polysaccharides which are classified as generally regarded as safe (GRAS) by the U.S. Food and Drug Administration, and are frequently used in food, beverage, and pharmaceutical industries (pg. 3-4, Alginate). The properties of alginates allow incorporation of natural and/or chemical additives when used as films and/or coatings, including plasticizers, surfactants, antimicrobials, antioxidants, flavors, and nutritional improvements (pg. 6-13, Additives). In addition to providing a moisture barrier (pg. 24) and gaseous barrier (pg. 25), Parreidt teaches that edible alginate coatings can be used to slowly release active compounds over an extended period of time, which has been utilized to slowly release molecules such as glucose, insulin, potassium sorbate, and lemongrass oil, among other species (pg. 26, Active Compound Release Applications). Parreidt concludes that edible alginate coatings can be used to efficiently decrease evaporation of water, loss of desirable odor and flavor, and prevent microorganism growth (pg. 27, Conclusions).
It would have been prima facie obvious to a person of ordinary skill in the art, prior to the filing of the instant application, to combine the teachings of Kruger and Parreidt with the invention of Rabovsky II to arrive at the claimed invention because combining prior art elements according to known methods to impart known benefits yields predictable results. Rabovsky II taught dietary supplements containing mineral-amino acid compounds conjugated to one or more polysaccharides, which may be zinc or iron, L-aspartic acid or L-glycine, and inulin, respectively, as well as the additional components vitamins A, C, and D. In view of the teachings of Kruger, one of ordinary skill would be motivated to select an FOS as the polysaccharide because Kruger teaches the oligosaccharides to improve bone density and calcium retention in subjects that ingest the molecule, which the ordinary artisan would recognize as beneficial in a dietary supplement. Further, a person of ordinary skill would be motivated to coat the invention of Rabovsky II with an edible alginate coating in view of the teachings of Parreidt because Parreidt teaches the coatings to be safe, allow the incorporation of beneficial molecules such as glucose, insulin, and potassium sorbate, allow the modification of active component release rates, and to protect the coated material from degradation, which the ordinary artisan would also recognize as beneficial in a dietary supplement. As a result, there is a reasonable expectation of success in arriving at the invention of claims 1-5, 7-8, and 10 in view of the teachings of Rabovsky II, Kruger, and Parreidt.
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 1-5, 7-8, and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7-10, 12-20, 22-27, and 30 of U.S. Patent No. 8,273,393 B2 in view of Kruger (Exp. Biol. Med. 2003, 228, 683.) and Parreidt (Foods 2018, 7, 170.).
U.S. Patent No. 8,273,393 B2 recites a composition comprising a complex of one or more mineral-amino acid compounds conjugated to one or more polysaccharides (claims 1, 7-10, 12-20, 22-27, and 30). The minerals may be zinc and iron (claims 8, 10, 12-17, and 22-23), the amino acid may be L-glycine and L-aspartic acid (claims 25-26), and the polysaccharide may be inulin (claims 27 and 30). Finally, Patent ‘393 recites the composition to comprise the additional ingredients vitamins A, C, and D (claims 9-10 and 12-20).
U.S. Patent No. 8,273,393 B2 does not recite the polysaccharide to be fructooligosaccharide nor the composition to be coated with alginate. These deficiencies are offset by the teachings of Kruger and Parreidt.
Kruger and Parreidt have been described above.
It would have been prima facie obvious to a person of ordinary skill in the art, prior to the filing of the instant application, to combine the teachings of Kruger and Parreidt with the invention of commonly assigned U.S. Patent ‘393 to arrive at the claimed invention because combining prior art elements according to known methods to impart known benefits yields predictable results. Patent ‘393 recited dietary supplements containing mineral-amino acid compounds conjugated to one or more polysaccharides, which may be zinc or iron, L-aspartic acid or L-glycine, and inulin, respectively, as well as the additional components vitamins A, C, and D. In view of the teachings of Kruger, one of ordinary skill would be motivated to select an FOS as the polysaccharide because Kruger teaches the oligosaccharides to improve bone density and calcium retention in subjects that ingest the molecule, which the ordinary artisan would recognize as beneficial in a dietary supplement. Further, a person of ordinary skill would be motivated to coat the invention of Patent ‘393 with an edible alginate coating in view of the teachings of Parreidt because Parreidt teaches the coatings to be safe, allow the incorporation of beneficial molecules such as glucose, insulin, and potassium sorbate, allow the modification of active component release rates, and to protect the coated material from degradation, which the ordinary artisan would also recognize as beneficial in a dietary supplement. As a result, there is a reasonable expectation of success in arriving at the invention of claims 1-5, 7-8, and 10 in view of the invention recited in claims 1, 7-10, 12-20, 22-27, and 30 of U.S. Patent No. 8,273,393 B2 and in view of the teachings of Kruger and Parreidt.
Claims 1-5, 7-8, and 10 are directed to an invention not patentably distinct from claim claims 1, 7-10, 12-20, 22-27, and 30 of commonly assigned U.S. Patent No. 8,273,393 B2. Specifically, see above.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned U.S. Patent No. 8,273,393 B2, discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Claims 1-5, 7-8, and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 19-20, and 22-23 of U.S. Patent No. 11,207,388 B2 in view of Rabovsky II (U.S. Patent No. 8,273,393 B2, published on 25 September 2012, cited by Applicant in the IDS filed on 11 July 2024), Kruger (Exp. Biol. Med. 2003, 228, 683.), and Parreidt (Foods 2018, 7, 170.).
Commonly assigned U.S. Patent No. 11,207,388 recites a dietary supplement comprising one or more mineral-amino acid compounds conjugated to one or more polysaccharides (claim 1). The minerals may be iron or zinc and the polysaccharide may be oligofructose, which is equivalent to the elected fructooligosaccharide (claims 19-20 and 22-23). Finaly, Patent ‘388 recites the composition to comprise the additional components vitamins A, C, and D (claims 6 and 19-20).
U.S. Patent No. ‘388 does not recite the specific amino acid, the polysaccharide to be inulin, nor the composition to be coated with alginate. These deficiencies are offset by the teachings of Rabovsky II, Kruger, and Parreidt.
Rabovsky II, Kruger, and Parreidt have been described above.
It would have been prima facie obvious to a person of ordinary skill in the art, prior to the filing of the instant application, to combine the teachings of Rabovsky II and Parreidt with the invention recited in claims 1, 6, 19-20, and 22-23 of U.S. Patent No. 11,207,388 B2 to arrive at the invention of instant claims 1-5, 7-8, and 10 because combining prior art elements according to known methods to impart known benefits yields predictable results. Patent ‘388 recited dietary supplements containing mineral-amino acid compounds conjugated to one or more polysaccharides, that the minerals may be zinc or iron and the polysaccharide FOS, as well as comprising the additional components vitamins A, C, and D. In view of the teachings of Rabovsky II, one of ordinary skill would be motivated to try using L-glycine or L-aspartic acid as the amino acid in the composition of Patent ‘388 because Rabovsky II teaches the amino acids to be suitable for use in a complex with a mineral that is subsequently conjugated to a polysaccharide and provides missing information the ordinary artisan would need to complete the invention of Patent ‘388.
In view of the teachings of Kruger, a person of ordinary skill would be motivated to use inulin alongside or in place of FOS as the polysaccharide because Kruger teaches both oligosaccharides to improve bone density and calcium retention in subjects that ingest the molecule, which the ordinary artisan would recognize as beneficial in a dietary supplement. Finally, one of ordinary skill would be motivated to coat the invention of Patent ‘388 with an edible alginate coating in view of the teachings of Parreidt because Parreidt teaches the coatings to be safe, allow the incorporation of beneficial molecules such as glucose, insulin, and potassium sorbate, allow the modification of active component release rates, and to protect the coated material from degradation, which the ordinary artisan would also recognize as beneficial in a dietary supplement. As a result, there is a reasonable expectation of success in arriving at the invention of claims 1-5, 7-8, and 10 in view of the invention recited in claims 1, 6, 19-20, and 22-23 of U.S. Patent No. 11,207,388 B2 and in view of the teachings of Rabovsky II, Kruger, and Parreidt.
Claims 1-5, 7-8, and 10 are directed to an invention not patentably distinct from claim 1, 6, 19-20, and 22-23 of commonly assigned U.S. Patent No. 11,207,388 B2. Specifically, see above.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned U.S. Patent No. 11,207,388 B2, discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Conclusion
No claims are allowed.
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/S.J.S./
Examiner, Art Unit 1619
/TIGABU KASSA/Primary Examiner, Art Unit 1619