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 .
DETAILED ACTION
Applicant’s response filed on 06/16/2026 is duly acknowledged.
Claims 13 and 18 have been canceled by applicant’s current claim amendments.
Claim 19 has been newly presented for examination.
Claims 1-12, 14-17 and 19 as currently amended/presented are pending in this application.
Claims 6-12, 14 and 15 (non-elected Groups II-III) remain withdrawn.
Claims 1-5, 16, 17 and 19 (elected Group I with traverse; directed to “A microorganism oil composition…”) as currently amended/presented have been examined on their merits in this action hereinafter.
Priority
This application is a 371 of PCT/EP2022/051011 (filed on 01/18/2022), which claims foreign priority from an application filed in FRANCE 2100486 on 01/19/2021.
Claim Objections- Withdrawn
In view of current amendments to claims 3-5, the claim objection as previously made by the examiner, has been withdrawn.
Claim Rejections - 35 USC § 112 - Withdrawn
In view of the current amendments to claims 1, 4 and cancellation of claim 13, the 112(b) rejection as previously made by the examiner, has been withdrawn.
Claim Rejections - 35 USC § 102 -Withdrawn
In view of current amendments to claims, the rejections of claims 1-4, 13, 16 and 17 under 35 USC 102, as previously made by the examiner, has now been withdrawn.
Applicant’s current claim amendments have necessitated new grounds of objection/rejection as discussed below:
NOTE: 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.
Claim Rejections - 35 USC § 103 – Made/Maintained
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.
1. Claims 1-5, 16, 17 and 19 (as currently amended/presented) are/remain rejected under 35 U.S.C. 103 as being unpatentable over Miranda et al (2013; NPL cited in IDS dated 11/22/2023, citation #3) taken with Kralovec et al (2017; WO 2017/062523 A2; FOR previously cited on record).
Claim 1 (as currently amended) is directed to “A microorganism oil composition enriched with polyunsaturated fatty acids, wherein the microorganism oil composition comprises:
-an eicosapentaenoic acid and/or docosahexaenoic acid content greater than or equal to 500 mg/g of the microorganism oil composition,
and, with respect to a total quantity of glycerides of the microorganism oil composition:
- a quantity of diglycerides greater than 45%,
- a quantity of monoglycerides and diglycerides greater than 60% , and wherein the oil composition is further characterized by at least one of the following fatty acid profiles: (i) the presence of docosapentaenoic acid (DPA) n-6; or (ii) the substantial absence of eicosenoic acid (C20:1) and docosenoic acid (C22:1).”
(see also independent claims 16 and 17, as presented)
Claim 5 (as currently amended) is directed to “The eicosapentaenoic acid content greater than or equal to 600 mg/g of composition.”
Claim 19 (as newly presented) is directed to “The microorganism oil composition according to claim 1, wherein the microorganism oil composition comprises a docosahexaenoic acid content greater than 700 mg/g of composition.”
See also limitations of dependent claims 2-4, as currently amended/presented.
Miranda et al (2013), while teaching optimization of structured diacylglycerols production containing omega-3 fatty acids (via an enzyme-catalyzed glycerolysis of fish oil; see Abstract on page 435), disclose (regarding the product composition of instant claim 1) a polyunsaturated fatty acid (PUFA)-enriched fish oil composition comprising 47% diglycerides (DGs; i.e. “a quantity of diglycerides greater than 45%”), 17% monoglycerides (MGs; i.e. “a quantity of monoglycerides and diglycerides greater than 60%”) and 24% triglycerides (TGs), with a docosahexaenoic acid (DHA) content of 69.7% (i.e. 697 mg/g of the oil composition; see Miranda et al, page 437, Table 1, Experiments 7-8; and page 438, Table 3, for instance).
Regarding instant claim 2, Miranda et al disclose oil composition comprising 24% TGs (i.e. “a quantity of triglycerides of less than 30%”), 47% diglycerides (i.e. “a quantity of diglycerides of between 45 and 75%”), and 17% monoglycerides (i.e. “a quantity of monoglycerides of between 10 and 30%”); wherein (regarding instant claim 3) the enzyme-catalyzed glycerolysis process is able to produce an oil composition comprising theoretical maximum of 50% diglycerides (see Miranda et al, page 439, section “Conclusions”); wherein (regarding instant claim 4) the oil composition comprises DHA content of 69.7%, i.e. 697 mg/g of composition (i.e. “a docosahexaenoic acid content greater than or equal to 600 mg/g of composition”). It is also noted that oil composition disclosed by Miranda et al is deemed suitable for pharmaceutical and/or nutraceutical purposes of intended use (i.e. for use as food supplementation and/or for treatment of obesity; see Miranda et al, page 435, right column, 1st paragraph, in particular).
However, an oil composition comprising a “microorganism oil” (it is to be noted that the term “microorganism oil” has not been specifically defined by applicants in the disclosure of record; see instant specification, page 3, lines 16-23 and Example 1, for instance) comprising- (1) an eicosapentaenoic acid (EPA) content “greater than or equal to 600 mg/g of composition” (instant claim 5), and (2) wherein the “microorganism oil” composition comprises a docosahexaenoic acid (DHA) content greater than 700 mg/g of composition” (see newly presented claim 19); and (3) wherein the oil composition is “further characterized by at least one of the following fatty acid profiles: (i) the presence of docosapentaenoic acid (DPA) n-6; or (ii) the substantial absence of eicosenoic acid (C20:1) and docosenoic acid (C22:1)” (see instant claim 1, as currently amended), have not been specifically disclosed and/or exemplified by the disclosure from Miranda et al, as discussed above.
Regarding the characterization of the “microorganism oil” as claimed, the disclosure of record states the following (see page 3, lines 24-33):
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However, instant claim 1 does not required any particular “microorganism” per se, as specific source of the oil in the PUFA-enriched composition as currently claimed (see currently amended claim 1).
Kralovec et al (2017), while teaching oil compositions that are enriched in polyunsaturated fatty acids (PUFAs) including DHA and EPA, and methods of making and using said oil compositions, wherein the oil is preferably a microbial or marine oil, wherein the microbial oil is produced from microorganisms such as microalgae, bacteria, fungi and protists (see Title, Abstract, p. 1, [0002], [0014]-[0015], [0055]-[0059]; and p. 39, claims 20-27, for instance); wherein in one embodiment, the oil comprises at least about 50% to about 99% EPA, the preferred embodiment comprises EPA in ester form (see Kralovec et al, [0034]); wherein the oil compositions can be formulated in the form of food supplements, or pharmaceutical and/or nutraceutical products (see [0016], [0074]-[0075], claims 75-78, for instance); wherein the method of concentrating oil compositions employs short-path distillation steps (see Kralovec et al, Example 1, disclosing transesterification, purification and concentration of crude oil from fermentation of Schizochytrium sp., using short path distillation apparatus and vacuum, for instance) in order to obtain desired concentrations of DHA and EPA (see Kralovec et al, p. 20-22, Tables 3-4, for instance, wherein as per Table 3 results, the amount of EPA and DHA obtained is 126 mg/g and 715 mg/g, respectively); wherein the oil composition can comprise microbial oil such as from microalgae, or a marine oil such as from fish oil, or any combinations thereof (see Kralovec et al, [0056]-[0061]; and claims 20-27, for instance); and wherein the oil composition comprising ester fraction can include docosapentaenoic acid n-3 (DPA n-3) and docosapentaenoic acid n-6 (DPA n-6), wherein “in some embodiments, from about 2% to about 8% by weight of the fatty acids in the ester fraction is DPA n-6” (see [0007], [0026], and claims 38, 40, for instance).
Thus, given the detailed disclosure for purification and concentration of various microbial oil and marine oil compositions in order to obtain PUFAs-enriched oil compositions (intended for use as food supplement and/or pharmaceutical/nutraceutical applications thereof), wherein the oil composition can comprise EPA content from “at least about 50% to about 99% EPA”, and can comprise microbial oil, or a mixture of marine oils such as fish oil, or combinations thereof (see Kralovec et al, see detailed teachings above), including the presence of DPA n-6 up to 8% by weight of the fatty acid esters, it would have been obvious to an artisan of ordinary skill in the art to employ the same method for purification and/or concentration of oil compositions comprising suitable PUFAs, or mixture thereof (see Kralovec et al, [0021], for instance) in order to achieve desired concentrations of components EPA, DPA, and/or DHA in diglycerides, including up to about 50 to 90% EPA, as per need/requirement in the art. Since, Kralovec et al already disclose the compositions comprising microbial and marine oils that can be processed for desired concentrations and/or amounts of EPA, DPA, and/or DHA, such adjustments including making oil compositions mixed with another oil such as fish oil (as taught by Miranda et al, see detailed discussion above) would have been obvious and/or fully contemplated by an artisan of ordinary skill in the art, unless evidence and/or data provided on record to the contrary (which is currently lacking on record; see Examples 1-2), at least for the preparation of oil compositions that are suitable for use in food and/or pharmaceutical applications as already eluded by both cited references on record (see Miranda et al, Introduction, 1st paragraph; and Kralovec et al, [0074]-[0075], for instance). Thus, the product composition as currently claimed fails to distinguish itself over the combined teachings and/or suggestions from the cited prior art references (i.e. Miranda et al when taken with the disclosure from Kralovec et al), as discussed above.
Thus, the claim as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention as claimed.
As per MPEP 2111.01, during examination, the claims must be interpreted as broadly as their terms reasonably allow. In re American Academy of Science Tech Center, F.3d, 2004 WL 1067528 (Fed. Cir. May 13, 2004)(The USPTO uses a different standard for construing claims than that used by district courts; during examination the USPTO must give claims their broadest reasonable interpretation.). This means that the words of the claim must be given their plain meaning unless applicant has provided a clear definition in the specification. In re Zletz, 893 F.2d 319, 321, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989).
Examiner’s Response to Applicant’s Arguments
Applicant’s arguments filed on 06/16/2026 (see REM, p. 7-9) with respect to claim(s) of record as currently amended by applicants, have been considered but are moot because of the new ground of rejection made in this office action, as discussed above. However, applicant’s pertinent arguments regarding the 103(a) rejection have been responded to hereinafter.
Applicants mainly argue the following:
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Applicant’s argument that the references cannot be combined is duly noted. However, since both references are directed to oil compositions that are suitable for food and/or pharmaceutical/nutraceutical applications (see discussion in the rejection of record, above), and since Kralovec et al already disclose the oil compositions that are obtained from PUFA esters/components derived from microbial and/or marine sources, the argument is duly considered, but is not found to be persuasive. In addition, as noted in the new grounds of rejection above, since Kralovec et al disclose the presence of DPA n-6 in the oil compositions up to 8% by weight (see teachings discussed above), the argument that the two cited prior art references are not compatible with each other, is duly noted and considered, but is not found to be persuasive. Given the combined disclosure by Miranda et al when taken with Kralovec et al (and given the health benefits of such oil compositions already disclosed by both cited references), an artisan of ordinary skill in the art would have been able to modify the oil compositions (that may include suitable marine oil and/or microbial oil PUFA components; it is also noted that instantly claimed products do not explicitly eliminate components from marine or fish oil sources as the claims 1, 16 and 17 recite a “comprising” language) such that they comprise desired PUFAs and amounts as currently recited in the claims, unless evidence provided on record to the contrary.
Thus, the 103(a) rejection of record is properly made and/or maintained.
Applicants are advised to amend independent claims in order to recite critical parameters that distinguish the claimed oil composition from the products disclosed and/or suggested by the cited prior art of record, albeit without introducing new matter situations.
Conclusion
NO claims are currently 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 SATYENDRA K. SINGH whose telephone number is (571)272-8790. The examiner can normally be reached M-F 8:00- 5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LOUISE W HUMPHREY can be reached at 571-272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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SATYENDRA K. SINGH
Primary Examiner
Art Unit 1657
/SATYENDRA K SINGH/Primary Examiner, Art Unit 1657
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