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 10/30/2025 is duly acknowledged.
Claims 1-18 as presented on 07/11/2023 are pending in this application.
Election/Restrictions
Applicant's election with traverse of Group I (claims 1-5, 13 and 16-18; directed to “A microorganism oil composition…”) in the reply filed on 10/30/2025 (see REM, page 1) is acknowledged. The traversal is on the ground(s) stated by applicants as follows:
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This is not found persuasive because: First, it is to be noted that there are no figures in this application per se. Second, for 371 national stage applications, the search burden on the office is not the only criteria for restriction between independent or distinct groups of inventions. As noted in the election/restriction requirement by the examiner (see paper dated 09/16/2025, page 4), since the product of claim 1 (i.e. the common special technical feature) has been disclosed in the cited prior art of Miranda et al, 2013, the inventions of Groups I-III are deemed to lack unity, a posteriori. Moreover, the search and examination burden for the examiner lies not only in the search of US Patents, but in the search for non-patent literature (NPL) and foreign patents, and examination of the claim language vis-a-vis specification for compliance with the statutes concerning bio-sequences, added new matter, eligibility under 101 guidelines, distinctness of the inventions, written description and scope of enablement, and various application-related double patenting issues.
Therefore, the requirement is still deemed proper and is therefore made FINAL.
Claims 6-12, 14 and 15 (non-elected Groups II-III) have been withdrawn from further considerations.
Claims 1-5, 13 and 16-18 (elected Group I with traverse; directed to “A microorganism oil composition…”) as 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.
Claims
Instant claims 16-18 as currently presented have been taken as Product-by-process claims, which have been interpreted herein as per the following guidelines:
"[E]ven though product-by-process claims are limited by and defined by the process,
determination of patentability is based on the product itself. The patentability of a product
does not depend on its method of production. If the product in the product-by-process
claim is the same as or obvious from a product of the prior art, the claim is unpatentable
even though the prior product was made by a different process." In re Thorpe, 777
F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Claim Objections
1. Claims 3-5 (as amended) are objected to because of the following informalities: claims 3-5, each recites the limitations “The the microorganism oil composition…” in line 1, which should be corrected to recite “The microorganism oil composition…”. 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.
1. Claims 1, 4 and 13 (as amended/presented) 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 "the total quantity of glycerides" in line 6. There is insufficient antecedent basis for this limitation in the claim as currently presented. Claim 1 does not provide reasonable basis for a “total quantity of glycerides” or for an amount of “glycerides” per se. Additionally, claim 1 in line 5 recites “equal to 500 mg/g of composition”, which does not refer to “the microorganism oil composition” per se, rendering recitation of the claimed product unclear and ambiguous, as it is not clear if the limitations refer to the same oil composition, or some other “composition”. Appropriate correction is required.
Claim 4 recites the limitations “more preferentially greater than 700 mg/g of composition” in line 4 of the claim, which is ambiguous and confusing. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 4 recites the broad recitation of “greater than or equal to 600 mg/g of composition”, and the claim also recites “more preferentially greater than 700 mg/g of composition”, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claim. Thus, the metes and bounds of the claimed product has not been properly defined. Appropriate correction is required.
Claim 13 as currently amended recites the limitations “An oil composition that comprises a mixture of an oil composition as defined in claim 1”, which is ambiguous and confusing because it is unclear as to what exactly is being encompassed by an additional limitation of “a mixture of an oil composition” because instant claim 1 already defines an oil composition with components defined as part of the claimed product, which is presumably “enriched with polyunsaturated fatty acids”. Additionally, claim 13, as recited appears to fail to further limit the product of claim 1 in the absence of any other component (i.e. a different oil or components therefrom, for instance) recited in the claim in order to form the “mixture”, if that is what is intended by applicants. Appropriate correction and/or explanation is required.
Instant claim 13 has been treated solely as per the recitations of instant claim 1 (from which it directly depends from) for the prior art purposes hereinafter.
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 § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
1. Claims 1-4, 13, 16 and 17 (as currently amended/presented) are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Miranda et al (2013; NPL cited in IDS dated 11/22/2023, citation #3).
Claim 1 (as currently amended) is directed to “A microorganism wherein the microorganism oil composition comprises:
-an eicosapentaenoic acid and/or docosahexaenoic acid content greater than or equal to 500 mg/g of composition,
and, with respect to the total quantity of glycerides:
- a quantity of diglycerides greater than 45%,
- a quantity of monoglycerides and diglycerides greater than 60%.”
See also limitations of dependent claims 2-4, 13, 16 and 17, as 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). It is noted that the preamble recitation for “A microorganism oil composition” does not structurally limit or change the oil composition per se, particularly with respect to the specific structural components of the claimed oil composition as currently recited in instant claim 1. No distinguishing feature(s) and/or structural component(s) is required in the instant claim 1 as presented, the absence or presence of which can set the product apart from the PUFA-enriched oil composition disclosed by the cited prior art reference of Miranda et al. Therefore, all the limitations of the product composition as claimed are deemed to be met by the cited prior art, as discussed above.
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”); and wherein (regarding instant claim 13) the disclosed oil composition is taken as a mixture of an “oil composition as defined in claim 1” in the absence of recitation of any addition structural component/feature for the composition per se.
Regarding instant claims 16-17 (taken as product-by-process claims), since all the structural components of the oil composition has been fully disclosed by Miranda et al (see discussion above), and 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, as recited in instant claims 16-17; see Miranda et al, page 435, right column, 1st paragraph, in particular), the limitations of claims 16 and 17 are deemed to be met by the cited prior art of Miranda et al, as discussed above.
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).
Claim Rejections - 35 USC § 103
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, 13 and 16-18 (as currently amended/presented) are 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 cited as ref. [N] on PTO 892 form).
Claim 5 (as currently amended) is directed to “The the microorganism oil composition claim 1, wherein he microorganism oil composition
Claim 18 (as newly presented) is directed to “An oil composition that comprises a mixture of an oil composition obtained by a method according to claim 6, and of at least one other oil” (taken as product-by-process claim).
The detailed teachings and/or suggestions from Miranda et al (2013) for an oil composition as they pertain to instant claims 1-4, 13, 16 and 17 have been discussed above, and are further relies upon hereinafter in the same manner.
However, an oil composition comprising a “microorganism oil” (it is to be noted that the term “microorganism oil” has not been specifically defined by the 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 mixture of “at least one other oil” (see instant claim 18), have not been specifically disclosed and/or exemplified by the disclosure from Miranda et al, as discussed above.
Kralovec et al (2017), while teaching oil compositions that are enriched in 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/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); and wherein the oil composition can comprise a marine oil such as a fish oil, or any combinations thereof (see Kralovec et al, [0017], [0060]-[0061], for instance).
Thus, given the detailed disclosure for purification and concentration of various microbial and marine oil composition 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 mixture of other oils such as fish oil, or combinations thereof (see Kralovec et al, teachings above), 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 in order to achieve desired concentrations of components EPA 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 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). Thus, the product 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 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.
Conclusion
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