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 .
Applicant’s arguments, filed 14 July 2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Horcajada et al. (EP 2981253 B1, 01/06/2021, IDS reference 03/03/2026) (hereinafter Horcajada).
Regarding claims 1-6, 9, 11 and 15, Horcajada discloses a nutritional composition comprising bioactive substance such as vitamins A and C ([0043]; [0057]), a blend of different fibers including xanthan gum and guar gum in hydrolyzed or non-hydrolyzed form ([0056]), lecithin ([0060]), and may additionally include glucooligosaccharides, xylooligosaccharides ([0054]), and amylose starch ([0059]). The composition may be formulated in the form of tablets ([0068]). Effective amounts of a composition will vary with the particular composition, route of administration, and/or age and condition of recipient ([0037]).
Together these would provide compositions as instantly claimed. The prior art is not anticipatory insofar as this combination must be selected from various lists/locations in the reference. It would have been obvious, however, to make the combination since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. See MPEP § 2143 (I)(A). See also MPEP § 2144.06(I), supporting combining known ingredients for their known functions is generally obvious.
Although Horcajada does not explicitly recite the ranges of the components, the selection of appropriate weight percentages would appear to require no more than routine testing on the part of the skilled artisan, and so it would have been obvious to determine workable ranges to arrive at the claimed amounts in weight percentages. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See MPEP § 2144.05(II)(A).
Regarding claim 7, although Horcajada does not explicitly disclose a mannose/galactose ratio, as noted by Para. [0054] of the instant specification: the mannose/galactose (M/G) ratio of fenugreek, guar, tara, and locust bean gums are 1.0-1.1/1.0, 1.6-1.8/1.0, 3.0/1.0, and 3.9-4.0/1.0, respectively. Accordingly, since the prior art discloses substantially the same substance, one of ordinary skill in the art would reasonably conclude the guar gum of Horcajada to reasonably possess substantially the same properties as the claimed invention, such as a M/G ratio of 1.6-1.8/1.0, meeting the limitation as instantly claimed.
Regarding claims 8 and 10, although Horcajada does not explicitly recite the weight ratios of the components, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed weight ratios of the components through routine experimentation based on the desired amounts suitable for the intended population as taught by Horcajada. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See MPEP § 2144.05(II)(A).
Regarding claims 12-14, reciting properties of a powder, it is not necessary for Horcajada to disclose the recited particle size of said powder since claim 11, from which it depends, as currently recited, does not require the nutraceutical composition in the form of a powder. Claim 11 recites wherein the nutraceutical formulation may be in the form of a powder, granules, syrup, tablets, capsules, or spherical beads, which Horcajada discloses by disclosing wherein the composition may be formulated as tablets. Moreover, in any case, the selection of appropriate powder particle sizes would appear to require no more than routine testing on the part of the skilled artisan, and so alternatively it would have been obvious to determine workable ranges to arrive at the claimed particle sizes in mesh or nm. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See MPEP § 2144.05(II)(A).
Response to Arguments
Applicant mainly asserts on pp. 7-8 of the Remarks that the independent claim 1 employs a deliberately structured compositional framework integrating hydrolyzed galactomannans, unhydrolyzed galactomannans, and emulsifying agents to function cooperatively as integrated system, enhancing dispersion, stability, and delivery characteristics (e.g., pharmacokinetics with improvements in parameters such as bioavailability, absorption, elimination half-life, residence time, and maximum available plasma concentration, etc. once the formulation is ingested) across a broad spectrum of bioactive substances. Specifically, the hydrolyzed galactomannans enhance aqueous dispersion of hydrophilic bioactive compounds, while the unhydrolyzed galactomannans help incorporation of hydrophilic compounds and provide sustained release and increase oil/fat miscibility; and the emulsifying agent ensures homogeneous incorporation of lipophilic bioactive substances. Collectively, these components enable the formulation to accommodate bioactive compounds with substantially divergent physicochemical properties within a single, stable composition. Applicant also asserts that the relative percentage of hydrolyzed to unhydrolyzed galactomannans in a formulation is decided by the hydrophobicity or hydrophilicity of the bioactive substance and its weight percentages in a formulation. At optimized ratio, hydrolyzed/unhydrolyzed galactomannan matrix impart structural integrity, viscosity modulation, and stabilization of the delivery matrix. Applicant asserts the functional advantages are realized only when the respective components are incorporated within the claimed concentration ranges and compositional ratios, that these limitations directly influence the stability, dispersion behavior, and delivery performance of the composition.
The Examiner appreciates Applicant’s detailed explanation, but does not find the assertion to be persuasive. It is noted that the features upon which Applicant relies, including: an increase in bioavailability, increase in stability, improvement in dispersion behavior, a collective of optimized ratios of hydrolyzed to unhydrolyzed galactomannan to emulsifying agent to at least one bioactive substance relative to each other) are not recited in the rejected claims in a manner that is supported and consistent with the Examples. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Moreover, as noted by the Applicant, the relative percentage amounts and ratios of unhydrolyzed and hydrolyzed galactomannan varies depending on the bioactive substance and its weight percentages and ratios in relation to each other, and the emulsifying agent amount would also change depending on the other three components. It is noted that such feature (i.e., a combination of specific ratio of the bioactive substance to hydrolyzed galactomannan to unhydrolyzed galactomannan to emulsifying agent) is not recited in the instant claims. As such, Applicant’s assertion is unpersuasive.
Applicant mainly asserts on p.9 of Remarks that Horcajada lacks directions for arriving at the specific species and amounts of the bioactive substance or emulsifying agent, that the nutritional composition of Horcajada contains other ingredients, and that Horcajada discloses vitamins A and C only as optional further vitamins and antioxidants with no weight percentages assigned, and lecithin only as a source of fat and only emulsifying agent. Therefore, Horcajada does not teach or suggest a bioactive substance present at 5-50 wt.% of the composition, or an emulsifying agent at 5-35 wt.% functioning to incorporate lipophilic bioactive substances as recited in claim 1. Applicant also asserts on pp. 10-11 of Remarks that Horcajada does not teach the simultaneous incorporation of hydrolyzed and unhydrolyzed galactomannans as mandatory constituents of a delivery system.
The Examiner does not find the assertion to be persuasive. Horcajada demonstrates that various nutritional ingredients can be combined to form a nutritional composition. Generally, it is obvious to combine known compositions each of which is taught by the prior art to be useful for the same purpose (in this instant case as a nutritional substance), in order to form a third composition to be used for the very same purpose. See MPEP § 2144.06. The fact that Horcajada discloses alternative bioactive substances in addition to vitamin A and C or alternative sources of fat in addition to lecithin does not render vitamins A and C less obvious s as a choice of bioactive substance or lecithins less obvious as a choice of fat source. Therefore, it would have been obvious to one of ordinary skill in the art to have included such bioactive substance and such fat source in the composition since Horcajada does not disclose wherein vitamins A and C or lecithins cannot be used as a bioactive substance or source of fat, respectively. See also MPEP § 2131.02(II), where the Board held that the comprehensiveness of the listing did not negate the fact that a claimed compound was specifically taught. The Board compared the facts to the situation in which a compound was found in the Merck Index, saying that "the tenth edition of the Merck Index lists ten thousand compounds. In our view, each and every one of those compounds is ‘described’ as that term is used in that publication."
Moreover, the instant claims employ the open-ended transitional term “comprising,” which would not exclude other nutritional substances.
Finally, regarding the amounts, routine experimentation is permitted, and the determination of appropriate percentages of known components for their known function would seem to reasonably constitute no more than routine experimentation. In this regard, note that the heading for MPEP § 2144.05 IIA reads: “Optimization within Prior Art Conditions Or Through Routine Experimentation”. The latter does not require identification of a “result effective variable”, which is reinforced by the statement later in the section explaining that courts have cautioned that “a mere carrying forward of an original patented conception involving only a change in form, proportion or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes in kind may produce better results than prior inventions.” As such, Applicant’s assertion is unpersuasive.
Applicant also asserts on pp. 10-11 of the Remarks that Horcajada fails to teach or suggest the structural relationships, and any modification to arrive at the instant invention is driven purely by impermissible hindsight analysis. Applicant submits that the working examples in the specification corroborate that a composition containing both hydrolyzed and unhydrolyzed galactomannans and an emulsifier within the claimed ranges produces substantial, statistically significant bioavailability enhancements for both hydrophilic and lipophilic substances. Applicant points to calcium ascorbate (claim 3, hydrophilic), providing an AUC approximately 7 folds higher than the unformulated tablet, in Example 16, Table 4; trans-resveratrol (claim 4, lipophilic), providing an AUC 10.48 fold greater than the unformulated capsule, in Example 11, Table 1; and fisetin (claim 5, lipophilic), providing an AUC 26.9 fold greater than the unformulated substance, in Example 18, Table 5. Moreover, the specification itself characterizes the weight ratio of hydrolyzed to unhydrolyzed galactomannans as critical for the controlled release of bioactive substances from the formulation, recognizing it as a result-effective variable that Horcajada’s catalog of optional ingredients neither discloses nor renders predictable.
The Examiner appreciates Applicant’s detailed explanation, but unfortunately does not find the assertion to be persuasive as the features claimed (i.e. increase bioavailability, controlled release of bioactive substances, ratio of hydrolyzed to unhydrolyzed galactomannans, as well as specific species of lipophilic and hydrophilic bioactive substances) are not recited in the independent claim. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Moreover, although Horcajada does not discloses the galactomannans for the same reasons as the Applicant’s, rationale different from Applicant’s is permissible. It is not necessary for the prior art to suggest the combination to achieve the same advantage or result discovered by Applicant. See MPEP 2144(IV).
Finally, regard potential evidence of unexpected results, Applicant has the burden of explaining the data in any declaration they proffer as evidence of non-obviousness. MPEP § 716.02(b)(II). Note that factually uncorroborated assertions (such as those referenced in the specification) cannot take the place of evidence in the record. See MPEP § 716.01 (c)(Il). Moreover, any differences between the claimed invention and the prior art may be expected to result in some difference in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. The burden is on applicant to establish that the results are in fact really unexpected and of statistical and practical significance. Ex parte Gelles, 22 USPQ2d 1318 (Bd. Pat. App. & Inter. 1992). See also MPEP § 716.02. Applicant does not appear to have discussed same (at least in specific detail) with respect to the putative probative value of the objective data in the working examples. Although Applicant has briefly discussed calcium ascorbate, trans-resveratrol, and fisetin, it is noted that Examples 1-7 contain specific structural relationships (e.g., formulation of a powder, particle size range, specific bioactive species in specific amount percentages) in addition to the critical ratio alleged by the Applicant. For example, based on p. 14, lines 12-22 of the instant Specification, the hydrolyzed galactomannan forms a coating on the bioactive substances to stabilize the bioactive substance, and provide longer circulation half-life resulting in an improvement to its pharmacokinetics profile. Such features are not recited in the instant claims.
Finally, assuming purely arguendo that the unexpectedness of the results has been established, the probative value of the evidence as compared to the invention as claimed must then be determined, i.e., the claims must be “commensurate in scope” with the showing. MPEP § 716.02(d). See also MPEP § 2145. Applicant must explain the “manner in which the specific compositions illustrated are considered to be commensurate in scope with the claimed invention”; see Ex parte Gelles, 22 USPQ2d 1318 (Bd. Pat. App. & Inter. 1992); see also MPEP 716.02, citing same. Examples 1-7 of the instant specification employ specific components in specific percentages, and even if Applicant were to show unexpected results, they would have been obtained, for example, not with the broad class of “bioactive substance” or “emulsifying agent” generally, but instead with specific species of same. Note, for example, Examples 1-7 of the instant Specification uses resveratrol, calcium ascorbate, and fisetin as the “at least one bioactive substance” and lecithin, polysorbate, and glycyrrhizin as the “emulsifying agent,” respectively. Applicant would need to explain how these specific species are “reasonably representative” of the more broadly claimed subject matter of the claims, even were the results persuasively demonstrated to be “in fact really unexpected and of statistical and practical significance”.
Lastly, Applicant asserts on p. 12 of Remarks that the Examiner is relying on para. [0054] of the instant Specification to teach the claimed galactose-to-mannose ratio of claim 7, and that claims 12-14 are not rendered obvious because Horcajada does not disclose the recited particle sizes nor provides any basis to arrive at them through routine experimentation.
The Examiner does not find the assertions to be persuasive. A more detailed explanation to further clarify the rationale of obviousness for claim 7 has been provided. The Examiner does not rely on para. [0054] of the instant Specification to teach the galactose : mannose ratio. Rather, the Examiner explains that since Horcajada discloses substantially the same guar gum as noted in the instant Specification, one of ordinary skill in the art would reasonably expect the guar gum to possess substantially the same properties as the claimed invention, such as a galactose to mannose ratio of 1.0 : 1.6-1.8. As such, it appears the guar gum of Horcajada would meet the limitation as instantly claimed. Regarding claims 12-14, which depend from claim 11, it is noted that claim 11 does not require a form of powder; rather, the Examiner is relying on the embodiment of tablets, which is a recited alternative in claim 11. As such, Applicant’s assertions are unpersuasive.
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 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 8,785,380; claims 1-7 of U.S. Patent No. 9,855,308; claims 1-10 of U.S. Patent No. 10,624,942; and claims 1-11 of U.S. Patent No. 11,241,462 in view of Horcajada et al. (EP 2981253 B1, 01/06/2021, IDS reference 03/03/2026) (hereinafter Horcajada).
The pending claims differ from the patented claims insofar as reciting a hydrolyzed galactomannan and further ingredients of instant claim 15.
However, these features are known. As noted in the current rejections, the teachings of Horcajada render obvious claims 1-15.
Therefore, as claims 1-12 of U.S. Patent No. 8,785,380, claims 1-7 of U.S. Patent No. 9,855,308, claims 1-10 of U.S. Patent No. 10,624,942, claims 1-11 of U.S. Patent No. 11,241,462, and Horcajada all disclose nutritional compositions comprising bioactive substances, galactomannans, and emulsifying agents, it would have been prima facie obvious to one of ordinary skill in the art to have modified the patented applications and to include the teachings of Horcajada as discussed in the rejections above, because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as instantly claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]idea of combining them flows logically from their having been individually taught in the prior art." See MPEP 2144.06(I).
Response to Arguments
Applicant mainly asserts on pp. 13-14 that the ‘308 and ‘942 patents do not disclose hydrolyzed and unhydrolyzed galactomannans and their complementary roles in stabilizing hydrophilic and lipophilic bioactive substances; the ‘462 patent does not require or suggest the multi-fiber matrix containing hydrolyzed and unhydrolyzed galactomannan together with lecithin in the exact weight percentages. Applicant assert Examples 4, 5, and 16 are directed to hydrophilic bioactive substance exhibiting drastically reduced molecular weights, lower solution viscosities, and highly specialized physical kinetics that are structurally and functionally distinct from the native polymers claimed in the prior patents.
The Examiner appreciates Applicant’s explanation but does not find the assertions to be persuasive for reasons similar to the responses above. The instant claims do not require a particular molecular weight range for the hydrolyzed galactomannans, or a multi-fiber matrix containing hydrolyzed and unhydrolyzed galactomannan together with specifically lecithin, in particular weight percentages and ratios. Similarly, instant claim 1 does not require a hydrophobic or hydrophilic bioactive substance. As such, Applicant’s assertions are unpersuasive in view of the instant claims as currently amended.
Citation of the State of the Art and Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Matsuda et al. (US 2006/0188633 A1, 08/24/2006), directed to a water soluble dietary fiber-containing composition comprising a thickening polysaccharide.
Spence et al. (US 2011/0027412 A1, 02/03/2011), directed to a composition for promoting gastrointestinal and/or cardiovascular health comprising dietary fibers..
Paliyath et al. (US 2022/0018038 A1, 01/20/2022) and (US 2022/0008349 A1, 01/13/2022), directed to plant tissue-derived nanoparticles and food powder.
Urakabe (WO 2018/181380 A1, 10/04/2018), directed to health food containing an edible composition for intestinal bacteria.
Conclusion
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 LUCY TIEN whose telephone number is (571)272-8267. The examiner can normally be reached Monday - Thursday 8:30 AM - 6:30 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, SAHANA 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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/LUCY M TIEN/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
