DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. The amendment filed June 23, 2026 has been received and entered. The text of those sections of Title 35, U.S. Code, not included in this action can be found in a prior Office action. Any rejection set forth in a previous Office action that is not specifically set forth below is withdrawn.
3. The declaration of Paola Petrini, filed June 23, 2026 has been received and considered.
4. Claims 1-10 and 12-19 are pending.
Election/Restrictions
5. In the reply filed on December 22, 2025, applicant elected Group I, claims 1-5, 9, 10, 12-19, butyrate (butyric acid) for species A and CaCO3 for species B with traverse.
6. Claims 4, 6-8, 9, 10, 12-15, and 17-29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention and species, there being no allowable generic or linking claim.
7. Claims 1, 2, 3, 5, and 16 are examined on the merits in regards to the elected species.
Specification
8. The disclosure is objected to because of the following informalities: the specification recites the bacteria “L. casei, L. plantarum, L. acidophilus, L. delbrueckii, B. longum, B. breve, B. infantis, A. muciniphila and S. boulardii.” However, the full names of these bacteria are not recited. The genus and species for each bacteria needs to be stated at their first recitation for the abbreviations to have proper basis.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
9. Claim(s) 1 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kochetkova (RU 2185816 C1 – English translation) in view of McAnalley (US 4,851,224) and Wallerstein (US 1,997,615).
Kochetkova teaches a topical gelled composition comprising aloe and 0.5 to 3% pectin. The composition also contains calcium ions as a crosslinking (gelling) agent for the pectin. The reference teaches that the composition is useful for healing the skin (see pages 2 and 3 of the translation). The reference does not teach that the aloe ingredient is an aloe vera juice which is a transparent juice from the inner part of the leaves and does not contain latex.
However, McAnalley teaches a clear aloe juice mucilage ingredient which does not contain latex. The ingredient is extracted from the inner portion of the aloe leaf. The reference teaches that this aloe product is superior to other aloe products due to its improved effectiveness in healing the skin and increased stability during storage (see column 2, lines 13-28; column 7; column 9, line 60-column 10, line 34; column 11, lines 50-52; column 29, lines 22-33; and Example 5).
Thus, given the benefits of the aloe juice mucilage taught by McAnalley, an artisan of ordinary skill would reasonably expect that the use of this aloe juice mucilage as the aloe ingredient in the composition taught by Kochetkova would improve the composition of Kochetkova. The artisan would expect this product to show improved wound healing and stability. This reasonable expectation of success would have motivated the artisan to modify Kochetkova to include the aloe juice mucilage ingredient taught by McAnalley.
Kochetkova teaches using calcium ions as a gelling agent for the pectin; however, the reference does not specifically teach using calcium carbonate (CaCO3). However, Wallerstein teaches using calcium carbonate as a gelling agent for pectin. The reference teaches that the use of calcium carbonate produces gelled compositions with improved characteristics in terms of strength, consistency and color (see column 1). Thus, an artisan of ordinary skill would reasonably expect that using calcium carbonate as the calcium source in the gelled composition of Kochetkova and McAnalley would produce a gelled composition with improved characteristics as taught by Wallerstein. This reasonable expectation of success would have motivated the artisan to modify Kochetkova and McAnalley to include the use of calcium carbonate in the composition.
10. Claim(s) 2, 3, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kochetkova (RU 2185816 C1 – English translation) in view of McAnalley (US 4,851,224) and Wallerstein (US 1,997,615) as applied to claims 1 and 5 above, and further in view of Yatcilla (WO 2018/009328).
The teachings of Kochetkova, McAnalley, and Wallerstein are discussed above. The references do not teach including butyrate in the composition. However, Yatcilla teaches including butyric acid salts (butyrate) as acidity modifiers in compositions that contain aloe (see paragraph 93). Thus, an artisan of ordinary skill would reasonably expect that this ingredient could be used to modify the acidic characteristics of the composition taught by Kochetkova, McAnalley, and Wallerstein. This reasonable expectation of success would have motived the artisan to modify Kochetkova, McAnalley, and Wallerstein to include the addition of butyrate to the gel.
The references do not specifically teach adding the butyrate in the amounts claimed by applicant. However, as discussed in MPEP section 2144.05(II)(A), “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[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.’ In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” Yatcilla teaches using the butyric acid ingredient in a variety of concentrations (see paragraph 93). Varying the concentration of this ingredient within the parameters taught by reference is not considered to be inventive unless the concentration is demonstrated as critical. In this particular case, there is no evidence that the claimed concentration of the ingredient produces an unexpected result. Thus, absent some demonstration of unexpected results from the claimed parameter, this optimization of ingredient concentration would have been obvious before the effective filing date of applicant’s claimed invention.
Response to Arguments
11. Applicant's arguments filed June 23, 2026 have been fully considered but they are not persuasive. Applicant argues that the Petrini declaration, filed June 23, 2026, demonstrates that the claimed composition is patentable over the prior art based on unexpected results shown in the declaration. The declaration and the arguments state that the combination of aloe with 0.1 to 3% added pectin behaves in a superior manner in comparison to aloe alone and that the aloe does not function as a passive carrier for pectin. The results compare aloe, pectin, a combination of aloe and pectin, and a combination of pectin, aloe, and CaCO3. However, the results shown in the declaration are not in comparison with the closest prior art. MPEP section 716.02(e) states “An affidavit or declaration under 37 CFR 1.132 must compare the claimed subject matter with the closest prior art to be effective to rebut a prima facie case of obviousness…”. The closest prior art is Kochetkova which teaches a gelled composition comprising aloe, 0.5 to 3% added pectin, and calcium ions in the form of calcium chloride as a crosslinking (gelling) agent for the composition. Applicant does not demonstrate that the differences between the claimed invention, i.e. the use of a latex free aloe ingredient and CaCO3 as the calcium source, and the closest prior art result in an unexpected difference. Thus, the results shown in the declaration are not considered to be a persuasive showing of unexpected results because there is no evidence to show that the specific usage of CaCO3 in place of the calcium chloride produces a composition with unexpected characteristics or that the specific usage of the latex free aloe in comparison with latex containing aloe produces a composition with unexpected characteristics.
In addition, the results shown in the declaration are also not commensurate in scope with the claimed invention (see MPEP section 716.02). The declaration states and demonstrates that the concentration of the aloe and CaCO3 is important in creating a gelled composition with the desired characteristics (see pages 4, 5 and 7-9). The claims do not require a specific concentration of aloe and CaCO3. Thus, the claims are not commensurate in scope with the results shown in the declaration.
12. No claims are allowed.
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 Susan Hoffman whose telephone number is (571)272-0963. The examiner can normally be reached M-Th 8:30am - 5:00pm.
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/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655
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