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. Claims 1-20 are currently pending.
Election/Restrictions
3. Applicant's election with traverse of Group I, claims 1-5 and 9-20, butyrate for species A and CaCO3 for species B in the reply filed on December 22, 2025 is acknowledged. The traversal is on the ground(s) that the election of species is improper because the restriction requirement did not establish that there was a patentable distinction between the species as required by MPEP section 808.01(a). This is not found persuasive because the species lack unity because they are all drawn to chemically distinct ingredients that lack unity demonstrated the fact that the linking claim 1 lacks a special technical feature. Applicant also argues that the groups of invention do not lack unity because they require the same technical feature. However, the linking technical feature is not a special technical feature because it does not represent a contribution to the art as discussed in the restriction and as shown by the references cited below. Applicant also argues that it would not be burdensome to search all of the inventions together. However, it is not required to establish burden for a restriction in a 371 case. Restriction in a 371 application is based on lack of unity rather than burden.
The requirement is still deemed proper and is therefore made FINAL.
4. Claims 4, 6-10, 12-15, and 17-29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention and species, there being no allowable generic or linking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.
5. Claims 1, 2, 3, 5, 11, 16, and 20 are examined on the merits in regards to the elected species.
Claim Objections
6. Claims 2, 3, 5, 11, 16, and 20 are objected to because of the following informalities: these dependent claims should begin with “The composition” rather than “A composition”. Appropriate correction is required.
7. Claim 20 is objected to because of the following informalities: there appears to be a word missing between “further” and “CaCO3”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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, 2, 3, 5, 11, 16, and 20 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
8. Claim 1 is indefinite because it is unclear what components are considered to be “residual fibrous components.” Thus, the structural characteristics of the aloe ingredient are unclear.
9. Claims 2 and 3 are indefinite because it is unclear what chain lengths are encompassed by “short-chain”.
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.
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.
10. 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).
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 does not contain fibrous ingredients or latex.
However, McAnalley teaches an aloe juice mucilage ingredient which does not contain latex and has had the fiber ingredients removed. 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).
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.
11. Claim(s) 2, 3, 11 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) as applied to claims 1 and 5 above, and further in view of Yatcilla (WO 2018/009328).
The teachings of Kochetkova and McAnalley 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 and McAnalley. This reasonable expectation of success would have motived the artisan to modify Kochetkova and McAnalley 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.
12. Claim(s) 20 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) as applied to claims 1 and 5 above, and further in view of Wallerstein (US 1,997,615).
The teachings of Kochetkova and McAnalley are discussed above. As discussed above, 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.
13. No claims are allowed.
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