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
Claims 1-4 and 6-18 are currently pending and an amendment to the claims filed on 12/17/2025 is acknowledged. Claims 14-18 have been withdrawn and thus, claims 1-4 and 6-13 are being examined at this time.
Withdrawn rejections:
Applicant's amendments and arguments filed 12/17/2025 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below are herein withdrawn.
The following rejection and/or objection are either reiterated or newly applied. They constitute the complete set of rejection and/or objection presently being applied to the instant application.
New Grounds of Rejection --- as necessitated by amendment
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.
Claims 1-4 and 6-13 are rejected under 35 U.S.C. 103 as being unpatentable over Mastaloudic et al. (US2019/0255134A1) in view of Fang et al. (US2012/0263826A1).
Applicant claims the below claim 1 filed on 12/17/2025:
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Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a medical/pharmaceutical/nutraceutical prebiotic/probiotic research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from medicine, pharmacy, physiology and chemistry— without being told to do so.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art (MPEP 2141.01); Ascertainment of the difference between the prior art and the claims (MPEP 2141.02) and Finding of prima facie obviousness Rational and Motivation (MPEP 2142-2143)
Mastaloudic discloses intestinal health promoting compositions comprising plant extracts such as a bilberry extract comprising anthocyanins of cyanidins and delphinidins (e.g., abstract, [0079] and [0082]) that reads on the claimed plant secondary metabolites polyphenol (instant claims 1 and 8) and an inulin extract from banana, chicory, onion, etc. ([0106]) that reads on the claimed plant secondary metabolite polysaccharide (instant claims 1 and 8) wherein the bilberry is derived from vaccinium myrtillus ([0100]) and is used in an amount of about 2 to about 20% of the composition and the bilberry contains anthocyanin content ranging from about 1 to about 40% ([0057] and [0101]) which overlaps the instant range of each plant secondary metabolites being less than about 50%, and wherein the inulin is used in an amount of about 15 to about 25% ([0057] and [0106]-[0107]) that overlaps the instant range of each plant secondary metabolites being less than about 50% or at least 10%. Note that [0057] discloses the extracts can be dried powder or other solid form. Please see MPEP 2144.05: “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); and the composition containing anthocyanin e.g., cyanidins and delphinidins and inulin extracted from plants can further include coatings ([0113]) and can be provided in the oral dosage form of capsule (claim 73 of prior art), which means said metabolites would be encapsulated by coatings (instant claim 1 (in part), claims 2, 6 and 9-12); the composition further includes excipients, diluents, and other ingredients ([0063])(instant claim 4); since each anthocyanin and inulin components are extracted from different plants of bilberry, and e.g., chicory ([0106] and [0116]), they would be enriched or purified (instant claims 1 and 7-8: different extract source); the oral dosage form can further include the prebiotic or prebiotic blend that can include inulin, fuctooligosaccharides or a combination thereof ([0123]); and the composition contains vitamins ([0113]) and the composition further can comprise tea extract from camellia sinesis ([0052]), flavonoids such as peels of citrus ([0047]). This prior art further teaches methods of treating a condition or disorder related to gastrointestinal health in a subject ([0130]), the method can include optimizing a balance of gut microbiota in the gastrointestinal tract and for one example, optimizing the balance of gut microbiota can include increasing commensal bacteria levels in the gastrointestinal tract when compared to levels of commensal bacteria in the gastrointestinal tract prior to administering the method. In another example, the commensal bacteria can belong to bifidobacteria genus. In one example, the commensal bacteria can belong to bacteroidetes phylum. In another example, the commensal bacteria can be bacterdies caccae, bacteriodes uniformis, or a combination thereof ([0148]) and thus prebiotic/probiotic good diet is used (Fig. 4).
However, Mastaloudic does not expressly teach acidic-resistant coating of instant claims 1 and 3; and micro-capsulation or nano-capsulation of instant claim 13. The deficiencies are cured by Fang.
Fang discloses encapsulation system for protection of probiotics during processing (title) and the encapsulation coating is made to protect acidic resistant of stomach fluid (abstract and [0066]) and the encapsulation technique includes microencapsulation which is to prevent damage during processing and storage and from degradation by gastric acid, proteolytic enzymes and bile salts ([0007]), and the materials to be encapsulated include botanical extracts (e.g., [0092] and [0102]) and polysaccharide such as pectin ([0106] and [0117]), and encapsuled capsules containing active ingredient are stable at pH 4.1 (Figs. 13) due to encapsulation which reads on the acid resistant coating and suggests coating dissolves at above pH of 4.0 (instant claims 1, 3 and 13 – microencapsulation).
It would have been obvious to modify the teachings of Mastaloudic with microencapsulation of Fang in order to prevent damage of plant extracts during processing and storage and from degradation by gastric acid, proteolytic enzymes and bile salts as taught by Fang.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the combined references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant’s arguments have been fully considered, but are not persuasive.
Applicant argues that the applied art in combination does not teach or suggest the encapsulation of at least two plant secondary metabolites from different extract source by an acid resistant coating within a single composition, let alone at balanced ratios of less than about 50% as claimed, which is capable of synergistic microbiome-modulating effects; in particular, each secondary metabolites is maintained at less than about 50% which provides unexpected results as demonstrated in instant Table A; the composition comprises at least two secondary metabolites from different plant extract source as demonstrated in Figs. 1-4; the at least two secondary metabolites are encapsulated within an acid-resistant coating and its results are demonstrated in Fig. 5, and however, Mastaloudic does not disclose a single co-encapsulated extract, and each is added independently to nutritional formulations and is not controlled for balanced proportions below 50%, and to the contrary, the composition of amended claim 1 specifies that at least two plant secondary metabolites from different source are encapsulated and constitute less than about 50% by dry weight of an extract; Fang fails to remedy the deficient teachings of Mastaloudic, and importantly, the encapsulation system taught by Fang are intended for protecting probiotics, e.g., to enhance viability while maintaining taste profiles in acidic foods (e.g., [0007] and [0066]), and there is nothing in Fang that would suggest that the teachings related to probiotic survival would apply to the claimed combinations of plant secondary metabolites.
The Examiner responds that as noted in the body of action, Mastaloudic discloses overlapping dry weight of less than 50% ([0057], [0101] and [0106]-[0107]), and each secondary metabolites are derived from different plant extract source ([0106], [0116], [0123]); both applied references relate to intestinal delivery of biologically active plant extract compounds, e.g., Mastaloudic also discloses decreasing harmful gut bacteria ([0151]-[0152]) and treating a condition or disorder related to gastrointestinal health in a subject ([0130]) with optimizing a balance of gut microbiota in the gastrointestinal tract and for one example, optimizing the balance of gut microbiota can include increasing commensal bacteria levels in the gastrointestinal tract when compared to levels of commensal bacteria in the gastrointestinal tract prior to administering the method; and Fang teaches acid-resistant/enteric coatings to protect sensitive active ingredients from acidic environments, and that is, protection of active ingredients against gastric or acidic conditions is a general problem in oral formulation, not limited to probiotics or food matrices, and Fang teaches encapsulation for any acid-sensitive compounds including dietary, botanical or other bio-actives, and ordinary artisans recognize that acid-sensitive botanical compounds (like plant secondary metabolites) are conceptually similar to probiotics in terms of acid degradation, and thus, there is motivation to combine the references to protect acid-sensitive actives for oral delivery, and the combination is obvious to improve stability and intestinal delivery of plant secondary metabolites. That is, Mastaloudic teaches/suggests a composition comprising two or more plant secondary metabolites derived from two different source with overlapping amounts for intended intestinal delivery, and botanical extracts are highly susceptible to degradation in the stomach due to the acidic environment, and notes that the subject may have a balanced gut microbiota prior to administration, indicating the importance of deliver to the intestine (see [0002], [0064] and [0076], etc); and Fang discloses acid-resistant encapsulated of orally administered acid-sensitive compounds such as probiotics, to protect them from gastric degradation. It would have been obvious to a person of ordinary skill in the art to apply the encapsulation system of Fang to the secondary metabolites composition of Mastaloudic to ensure delivery of the acid-sensitive plant secondary metabolites to the intestine, as both references address the common technical problem of protecting acid-sensitive oral actives.
In light of the foregoing, applicant’s arguments are not persuasive.
Conclusion
All examined claims are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 KYUNG S CHANG whose telephone number is (571)270-1392. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Yong (Brian-Yong) S Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYUNG S CHANG/Primary Examiner, Art Unit 1613