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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/28/2026 has been entered.
Applicants' arguments, filed 04/28/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 Status
Claims 1, 4-7, and 9-17 are pending.
Claims 9-13 and 16 are withdrawn.
Claim Objections
Claim 1 is objected to because of the following informalities: the commas following lines 8, 10, 12, and 13, should be replaced by a semicolon.
Additionally, at the end of line 12, “and” should be removed for proper sentence structure, as an additional “and” was added in newly amended line 12.
Finally, line 13 should be preceded by “wherein,” in order to be consistent with the wording throughout the claim.
Appropriate correction is required.
Applicant is advised that should claim 4 be found allowable, claim 17 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). In the present instance, claims 4 and 17 depend from claim 1 and limit the EPA and DHA (i.e., the omega-3 fatty acids) to be in the form of fatty acid lysine salts, and therefore appear to be substantial duplicates.
Claim 7 is objected to because of the following informalities: “omega-3 fatty acid” should read “omega-3 fatty acids” in order to be consistent with the terminology used in claim 1. Additionally, “a total weight of the preparation” should read “the total weight of the preparation”. Appropriate correction is required.
Claim 17 is objected to because of the following informalities: “omega-3 fatty acids lysine salts” should read “omega-3 fatty acid lysine salts” for purposes of proper syntax. Appropriate correction is required.
Claim Rejections - 35 USC § 112(a) or pre-AIA 1st ¶ - New Matter
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 4-7, 14, 15, and 17, are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “wherein at least 90 wt.% of the omega-3 fatty acids are present in the preparation as lysine salts,” and the limitation does not appear to have support in the original disclosure. While omega-3 fatty acids and mixtures thereof are disclosed, there appears to be no recitation of a wt.% of the omega-3 fatty acids that are in the form of lysine salts. Accordingly, the limitation appears to be new matter.
Claim 1 recites “at an equivalent total L-rhamnose content” regarding the newly added claim limitation comparing the claimed embodiment to the pectin containing embodiment, and the limitation appears to be new matter. While the instant specification does appear to disclose embodiments comprising pectin and EPA/DHA-Lys, the amount of L-rhamnose used in those disclosed embodiments comprise significantly less L-rhamnose than the amount instantly claimed, and the comparative embodiments from table 3. Therefore, there does not appear to be support in the original disclosure for pectin embodiments comprising an equivalent total L-rhamnose content as those claimed, and appears to be new matter.
Claim 1 recites “a content of L-rhamnose,” and it is unclear if “a content” is referring to the total content, or just part of the total amount of L-rhamnose. For purposes of examination, the claim is being interpreted as “wherein the L-rhamnose is present in an amount of at least 20 wt% relative to the total weight of the preparation”.
Claims 4-7, 14, 15, and 17, are also rejected for the same reasons for depending upon, or containing all limitations of, rejected claim 1.
Claim Rejections - 35 USC § 112(b) or pre-AIA 2nd ¶
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, 4-7, 14, 15, and 17, 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.
Claim 1 recites the limitation “wherein the preparation increases a propionate-acetate ratio after 72 hours as measured in an in vitro experiment,” and it is unclear what the in vitro experiment is, and if it is the same in vitro experiment from the newly amended “in vitro human colonic fermentation model.”
Claims 4-7, 14, 15, and 17, are also rejected for the same reasons for depending upon rejected claim 1.
Claim 6 recites the preparation further comprises pectin and rhamnogalacturonan (L-rhamnose containing polymers, see ¶ 13 of the instant specification), and it is unclear how these L-rhamnose containing polymers can be further included when claim 1, as newly amended, recites the preparation is free of pectin and other L-rhamnose containing polymers.
Status of the Art
Bartz et al (DE 10214005 A1, cited on IDS dated 11/22/2021), while teaching a composition comprising pectin (an L-rhamnose containing polymer), EPA, and DHA, the reference appears to include pectin as a critical component of the composition in order to bind gut cholesterol, as well as to act as a ballast and swelling agent. While monomeric L-rhamnose was known from Vogt et al (Am J Clin Nutr, 2004, 80:98-94, cited on IDS dated 11/22/2021) to increase propionate and decrease acetate levels in the gut, it does not appear that the skilled artisan would have motivation to modify Bartz et al by specifically substituting monomeric L-rhamnose for the critical pectin component, as doing so would appear to alter the purpose of the formulations of Bartz et al. Further, Bartz et al appears to make no mention of L-rhamnose specifically as being critical to the formulations, nor any mention propionate/acetate ratios.
Applicants assert that the combination of EPA/DHA-Lys with monomeric L-rhamnose, was able to beneficially increase propionate, decrease acetate, and increase the propionate/acetate ratio compared to either used alone, as shown in Table 3 of the instant specification. The status of the prior art with regards to whether or not these results would have been expected are as follows.
Regarding L-rhamnose, Vogt et al is discussed above and teaches monomeric L-rhamnose was known to increase propionate and decrease acetate levels, therefore increasing the propionate/acetate ratio. However, it is noted the Vogt et al do not teach EPA and DHA, nor their lysine salts.
Regarding EPA/DHA, it was known from Constantini et al (Int J Mol Sci, 2017, 18, 2645, pp. 1-18, cited on IDS dated 11/22/2021) that omega-3 polyunsaturated fatty acids, namely eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), increase short-chain fatty acid production (acetate, propionate, butyrate) in gut lumen, but appears to suggest that all of acetate, propionate, and butyrate production increases. Likewise, Ramos-Romero et al (Food Res Int, 97, 2017, pp. 364-371) teach omega-3 PUFAs, including EPA and DHA, where generally known to increase acetate levels in gut microbiota, rather than decrease them. The examiner notes that neither Constantini et al nor Ramos-Romero et al teach EPA/DHA in the form of lysine salts, as required by the instant claims.
Regarding EPA/DHA-lysine salts, the lysine salts of EPA/DHA were known from Bruzzese et al (US 5750572, hereinafter “Bruzzese”), however, Bruzzese teaches that the lysine salt form of EPA/DHA are used to increase solubility and enhance the detoxifying action exerted by lysine and DHA. The reference does not appear to teach or suggest what effect lysine salts would have on the propionate/acetate ratio of EPA/DHA in the gut microbiome, nor their interaction with L-rhamnose.
From the teachings of the prior art, it does not appear the combination as instantly claimed, comprising EPA/DHA-Lysine salts in combination with monomeric L-rhamnose, would have been reasonably expected to increase propionate, decrease acetate, and increase the propionate/acetate ratio, compared to either component used alone, as shown in instant Table 3. Accordingly, it appears that the claimed combination is non-obvious over the prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA A ATKINSON whose telephone number is (571)270-0877. The examiner can normally be reached M-F: 9:00 AM - 5:00 PM + Flex.
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/JOSHUA A ATKINSON/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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