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 .
Applicant’s arguments, filed 07/17/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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, 5-7, and 9-16 are pending.
Claims 9-13 and 16 are withdrawn.
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, 5-7, 14, and 15, stand 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.
Claims 5-7, 14, and 15, are also rejected for the same reasons for depending upon, or containing all limitations of, rejected claim 1.
Response to Arguments
Applicants assert the present specification expressly describes “an omega-3 lysine salt (omega-3-lys)” composition and further discloses that this composition contains around 32 wt% L-lysine and around 65 wt% polyunsaturated fatty acids, with EPA and DHA together accounting for about 58 wt% of the composition. Applicants assert the skilled artisan would have clearly understood from these disclosures that lysine is present in an approximately equimolar amount relative to the carboxylic acid content of the omega-3 fatty acids, and in an amount sufficient to neutralize essentially all of the disclosed omega-3 fatty acids. Thus, Applicants assert the specification reasonably conveys possession of an embodiment in which at least 90 wt% of the omega-3 fatty acids are present as lysine salts, and the claimed numerical threshold merely makes explicit what was already inherent in the disclosed omega-3-lys composition.
Respectfully, this argument is not persuasive. Although the specification discloses an omega-3 lysine salt containing 32 wt% L-lysine and 58 wt% EPA/DHA, these amounts do not indicate what portion of the omega-3 fatty acids are actually in salt form. The instant specification does not disclose any particular percentage of the lysine that is associated with the omega-3 fatty acid as a salt, nor does it exclude the presence of free acids. The disclosed 65 wt% polyunsaturated fatty acids includes fatty acids other than EPA/DHA (65 wt% vs 58 wt%), each having different molecular weights depending on chain length, etc., and without the identities and ratios of the additional polyunsaturated fatty acids, it is impossible to accurately calculate the molar amounts of the total polyunsaturated fatty acids to determine if the L-lysine is present in an equimolar amount relative to the total molar amount polyunsaturated fatty acids, much less that at least 90 wt% are present as lysine salts. Purely arguendo, even if somehow they were at equimolar amounts, molar equivalency does not appear to establish that at least 90 wt% of the omega-3 fatty acids are actually present as lysine salts. Equimolar quantities merely indicate that the components are present in amounts that could theoretically provide salt formation, but does not establish the extent that that fatty acids have actually been converted to the lysine salts, as some may remain unassociated depending on reaction conditions, pH, solvent content, etc. Accordingly, while the presence of omega-3 fatty acid lysine salts are disclosed, the present disclosure does not appear to expressly, implicitly, or inherently support the specifically claimed range of at least 90 wt% of the omega-3 fatty acids are present in the preparation as lysine salts.
Status of the Art
As previously recited and repeated here for convenience, 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
THIS ACTION IS MADE FINAL. 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 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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