DETAILED ACTION
Status of Application
Receipt of the response to the non-final office action, the amendments to the specification, drawings, and claims as well as applicant arguments/remarks, filed 03/24/2026, is acknowledged. Amendments to the specification and drawings have been entered.
Claims 1-21 are pending in this action. Claims 1-3, 6, 11, 16, 21 have been amended. Claims 1-21 are currently under consideration.
Any rejection or objection not reiterated in this action is withdrawn. Applicant's amendments necessitated new ground(s) of rejection presented in this office action.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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 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.
Priority
This application is a 371 of PCT/US2021/015107, filed January 26, 2021.
Specification
The lengthy specification (55 pages, exclusive of claims) has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification. MPEP 608.01. The specification is further objected to because of the following informalities:
As stated previously, the use of the trademarks/trade names/product names has been noted in this application, e.g., Lactobacillus acidophilus NCFM, Lactiplantibacillus plantarum WCFS1 (Page 2); Polyscreen, Tween-20, Biomax MR (Page 41); VSL#3, Jarrow, etc. (e.g., Page 49). Although the use of trademarks/trade names/product names is permissible in patent applications, the proprietary nature of the trademarks/trade names/product names should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as trademarks. The use of language such as “the product X (a descriptive name) commonly known as Y (trademark)” is not permissible since such language does not bring out the fact that the latter is a trademark. Language such as “the product X (a descriptive name) sold under the trademark Y” is permissible. MPEP §608.01(v). Further, it is noted that the trademarks/trade names/product names are used to identify a source of goods, and not the goods themselves. The formula or characteristics of the product may change from time to time and yet it may continue to be sold under the same trademark/trade name. Thus, a trademark/trade name/product names do not identify or describe the goods associated with the trademark/trade name/product name. Appropriate correction is required.
Information Disclosure Statement
The information disclosure statement, filed 01/08/2026, is acknowledged and has been considered. Please see the attached initialed PTO-1449.
The information disclosure statement fails to comply with 37 CFR 1.98(b)(5), which requires that each publication listed in an information disclosure statement must be identified by publisher, author (if any), title, relevant pages of the publication, date, and place of publication. MPEP 609.05(a). In the present case, examiner has considered all references filed by the applicant to expedite the prosecution. However, the applicant is informed that the references filed in an improper format (lined through) should be resubmitted in a proper format to be printed in the patent. MPEP 1302.12. Regarding electronic document(s) retrieved from an online source, it is noted that the format for the citation of an electronic document should be similar to the format used for paper documents of the same type, with the addition of the information in the locations (internet, database, etc.) indicated. MPEP 707.05(e).
The information disclosure statement does not include Certificate Statement and Privacy Act Statement (MPEP 609), and/or does not have a signature of the applicant or representative that is required in accordance with CFR 1.33.
Claim Rejections - 35 USC § 112(b)
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 1-21 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 pre-AIA the applicant regards as the invention.
Claim 1 recites the limitations “capsule is configured to be destroyed”, “capsules are configured such that… remain viable after 3 hours”, “is configured … to release at least about 50%” that are unclear and indefinite. As stated previously, “Claiming a result without reciting what materials produce that result is the epitome of an indefinite claim. Such a claim fails to delineate with any reasonable certainty the requirements of the formulation.” Forest Labs., Inc. v. Teva Pharms. USA, Inc. 2017 U.S. App. LEXIS 24877. Further, it is noted that “[i]f a claim is amenable to two or more plausible constructions, applicant is required to amend the claim to more precisely define the metes and bounds of the claimed invention or the claim is indefinite under §112, ¶ 2. Ex parte Miyazaki, 89 USPQ2d 1207 (BPAI 2008) (expanded panel).” Furthermore, “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). Similar is applied to claims 7, 8 regarding the limitation “compound that can be converted … into bioactive metabolite”, to claims 9, 10 regarding the limitation “derived or extracted from”, to claims 12, 14 regarding the limitation “capable of being metabolized”. Clarification is required.
As stated previously, claim 8 recites the limitation “compound … comprises at least one punicalagin” that is not reasonably clear. Does this limitation disclose a compound as a mixture of compounds (i.e., comprises)? Clarification is required.
Claims 2-6, 11, 13, 15-21 are rejected as being dependent on rejected independent claim 1 and failing to cure the defect.
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.
Claims 1-21 are rejected under 35 U.S.C. 103 as being unpatentable over Kabadi et al., US 9,907,755 B2 (cited in IDS; herein after referred to as Kabadi), in view of Penalver Mellado et. al., US 2012/0269790 (hereinafter referred to as Penalver Mellado), and Bathaei, US 2017/0020999 (cited in IDS).
Kabadi teaches targeted gastrointestinal tract delivery systems for the oral delivery of one or more species of microencapsulated live probiotic organisms, wherein said systems can be in a form of capsules, and wherein the formulation comprises one or more species of bacteria that are normally present in the intestine of a subject (Title; Abstract; Col. 3, Lns. 7-14 as applied to claim 1). To this point, Kabadi teaches:
(i) the delivery systems can be symbiotic, i.e., may include probiotics and prebiotics, wherein the prebiotic compounds selectively favor the probiotic microorganisms (Col. 5, Lns. 35-40; Col. 13, 29-32 as applied to claim 1);
(ii) the delivery systems can be in a capsule-in-capsule form, wherein probiotic is in an inner core/capsule and the outer capsule comprises additional agent, e.g., prebiotic (Col. 8, Lns 59-62, Col. 9, Lns. 29-49; Table 1 as applied to claim 1);
(iii) the compounds in use can be formulated in a pharmaceutical composition including pharmaceutically acceptable carriers (Col. 14, Lns. 1-7 as applied to claims 4, 5);
(iv) the compositions may be substantially free of water/solvent (Col. 24, Ln. 54 as applied to claim 6);
(v) the probiotic component may include a consortium of microbial strains and encapsulated live probiotics may include species of the genus Lactobacillus and/or Bifidobacterium (Claim 8; Col. 4, Lns. 11-25, Col. 9, Lns. 38-49 as applied to claims 1, 16-19).
Kabadi also teaches the use of capsule-in-capsules, wherein the outer capsule is configured to be dissolved under specific pH conditions (Col 72, Lns. 11-34), and/or wherein the inner capsule is configured upon entry into the colon of a human subject to release at least 90% of the desirable probiotic (Col. 9, Lns. 11-21 as applied to claim 1).
Kabadi does not teach the use of prebiotic components as disclosed in claims 7-15).
Penalver Mellado teaches the use of a pomegranate extract rich in punicalagins together with a probiotic bacterium or a mixture of probiotic bacteria, e.g., strains of Lactobacillus and/or Bifidobacterium, for providing a beneficial effect on health, e.g., for enhancing the production of urolithins, e.g., urolithin A, in the lumen of the colon in humans (Claims 1, 4, 11-12; Abstract; Para. 0040-0045, 0055; Examples). Penalver Mellado specifically teaches the use of such species of Bifidobacterium as Bifidobacterium lactis, Bifidobacterium breve and Bifidobacterium longum (Para. 0041).
Bathaei teaches pharmaceutical or nutraceutical compositions for preventing or treating of chronic inflammation and concomitant biofilms in the gastrointestinal tract (Abstract), wherein said compositions may be in the form of a capsule and/or different ingredients can be spread over different capsules (Para. 0037, 0110, 0113), and wherein said compositions may include Punica granatum extract that is rich in punicalagin (Para. 0066, 0089).
Therefore, the examiner maintains the positions that it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use/include/try a pomegranate extract rich in punicalagins as taught by Penalver Mellado and Bathaei as a prebiotic component into the compositions as taught by Kabadi. One would do so with expectation of beneficial results, because the cited prior art teaches that said constituent can be used for providing a beneficial effect on health, e.g., for enhancing the production of urolithins, e.g., urolithin A, in the lumen of the colon in humans, and/or for preventing or treating of chronic inflammation and concomitant biofilms in the gastrointestinal tract. With regard to the concentrations instantly claimed (claim 2), it is noted that differences in experimental parameters such as concentration of compounds in a solution/formulation will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such parameter is critical. The prior art teaches formulations comprising the same components. The determination of suitable or effective concentration/composition can be determined by one of ordinary skill in the art through the use of routine or manipulative experimentation to obtain optimal results, as these are variable parameters attainable within the art. Where 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. Claims 3, 16-21 are rejected as being dependent on rejected claim 1.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 2024/0216449 A1 (priority date 01/11/2021) - teaches compositions/capsules suitable for oral administering to be used in medical treatments, wherein said composition comprise specific strains of probiotic bacteria, e.g., Lactobacillus crispatus LCR01, Limosilactobacillus fermentum, Lactiplantibacillus plantarum, Limosilactobacillus reuteri, Bifidobacterium breve BR03, Bifidobacterium infantis, Bifidobacterium lactis, Bifidobacterium longum, and a prebiotic (Para. 0019-0032, 0053-0068, 0074-0083, 0172).
Response to Arguments
Applicant's arguments, filed 03/24/2026, have been fully considered, but they were not found to be persuasive for the reasons set forth above. New arguments and/or rejections have been added to the record to clarify the position of the examiner and/or to address newly introduced amendments. Additional examiner comments are set forth next.
In response to the applicant’s argument that Kabadi provides examples of capsule-in-capsule, wherein the outer capsule of said capsule-in-capsule formulation "remained intact with no disintegration" after 3 hours under the acidic conditions of the stomach and upper small intestine, it is noted that “A reference is not limited to working examples.” In re Fracalossi 215 USPQ 569 (CCPA 1982). “A reference is good not only for what it teaches by direct anticipation, but also for what one of ordinary skill might reasonably infer from the teachings.” In re Opprecht 12 USPQ 2d 1235, 1236 (Fed. Cir. 1989); In re Bode 193 USPQ 12 (CCPA 1976); In re Lamberti 192 USPQ 278 (CCPA 1976); In re Bozek 163 USPQ 545, 549 (CCPA 1969); In re Preda 159 USPQ 342 (CCPA 1968); In re Van Mater 144 USPQ 421 (CCPA 1965); In re Jacoby 135 USPQ 317 (CCPA 1962); In re LeGrice 133 USPQ 365 (CCPA 1962). Further, it is noted that it is well known in the field that that properties of multicomponent systems (i.e., compositions, capsules, shells, coatings, etc.) depend on compounds included as well as on concentrations and distribution of said compounds that define the network of intermolecular interactions, and thereby physical and chemical properties of the system/composition. Therefore, it is expected that different compositions might have different properties. The determination of suitable or effective compositions/concentrations (for providing/controlling properties of compositions) can be and usually is determined by one of ordinary skill in the art through the use of routine or manipulative experimentation to obtain optimal/desired results, as these are variable parameters attainable within the art. Therefore, the applicant’s argument is not persuasive. Applicant is advised to clarify the claim language, the structure of the claimed product and clearly point out the patentable novelty, which the applicant thinks the claims present in view of the state of the art disclosed by the references cited, to place the application in condition
Conclusion
No claim is allowed at this time.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA V. TCHERKASSKAYA whose telephone number is (571)270-3672. The examiner can normally be reached 9 am - 6 pm, Monday - Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax can be reached at (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/SHIRLEY V GEMBEH/Primary Examiner, Art Unit 1615
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