DETAILED ACTION
This office action is in response to applicant’s filing dated July 31, 2024.
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 .
Status of claims
Claims 1 - 10 are pending in the instant application. Acknowledgment is made of Applicant’s amendments filed July 31, 2024.
Priority
The present application is a 371 of PCT/US2023/061357, filed January 26, 2023, and claims the benefits of priority to European patent Application No. 22155054.4,
filed February 3, 2022.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on July 31, 2024 and August 4, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Interpretation
The limitation of claim 7, reciting “sunflower oleosome concentrate has a protein to lipid ratio in a range of from 0.09 to 0.20” was interpreted as protein to lipid ratio by weight from 0.09 to 0.20, according to units discussed in claim 6, from which claim 7 depends.
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.
Claim 9 is 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.
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 9 recites the broad recitation: “°h in a range of from 85 to 95, and C* of from 8.0 to 14.0”, and the claim also recites: “°h in a range of from 87 to 93, and C* of from 8.4 to 13.6” which is the narrower statement of the range/limitation. The claim also recites multiple open ended numerical ranges: "°h above 95, above 96, or above 97, and C* below 10.0, below 9.8, or below 9.6”, which is a confusion over the intended scope of the claim. 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 claims.
In the interest of compact prosecution, for the purposes of applying art, the broadest numerical ranges recited by claim 9 have been considered.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 – 5 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Cargill, Inc. (EP 3 494 796 A1, cited in IDS, filed 08/04/2025, hereinafter Cargill, Inc.).
Instant claims are drawn to a process of preparing a sunflower oleosome concentrate from high oleic and/or mid oleic sunflower seeds comprising of steps:
a) Grinding sunflower seeds in the presence of an aqueous solution and obtaining a sunflower seed slurry having a pH of from 7.0 to 7.2, and
b) Isolating from the sunflower seed slurry a sunflower oleosome fraction, and
c) Washing the sunflower oleosome fraction at a pH 6.6 - 7.0 and isolating the sunflower oleosome concentrate. Instant claims are further drawn to a soaking and/or washing of the sunflower seeds, prior to the grinding, and a step of subjecting the sunflower oleosome concentrate obtained in step (c) to a heat treatment step or dehydration step. Said process does not comprise an addition of reducing agents or acidulants.
Cargill, Inc., teaches a process for preparing the oleosomes from high oleic sunflower seeds comprising the following steps:
- High oleic sunflower seeds were soaked or preconditioned overnight in demineralized water at 4 °C. The soaked seeds were blended with deionized water, and the resulting slurry was filtered. The suspension was brought to a pH of 6.5-8.
- the resulting oleosomes were centrifuged. After centrifugation, the floating cream layer (oleosomes, oil bodies) was collected with a small metal spoon.
- the obtained cream was washed at least two times with water or sodium
phosphate buffer and centrifuged for obtaining the oleosomes (pages 4 - 5, [0032] and example 1). Cargill, Inc., further teaches that the obtained oleosomes are heated, preferably pasteurized at a temperature of from 80 to 90°C, for a few seconds (page 4, [0031]).
Regarding pH ranges, prior art teaches a range of pH from 6.5-8, which substantially overlaps the claimed range of pH from 7.0 to 7.2. The specific example describes blending seeds with deionized water (pH is ~7), and then bringing pH to 7.5. The example in Cargill, Inc. at pH 7 to 7.5 supports the fact that the disclosure of pH from 6.5-8 does teach one of ordinary skill in the art how to make and use the process at pH from 7.0 to 7.2. Cargill, Inc. thus teaches each and every element of claim 1 (see also MPEP 2131.03).
Regarding claim 5 limitation, which recites the process where no reducing agents or acidulants were added, Cargill, Inc. teaches the process, where sunflower seeds and following oleosome concentrate had been treated with deionized water or sodium phosphate buffer, without any additional agents.
Thus, teachings of Cargill, Inc. anticipate the method of claims 1 – 5.
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.
Claims 6 – 10 are rejected under 35 U.S.C. 103 as being unpatentable over Cassen et al (Biomolecules 2022, 12, 149, hereinafter Cassen).
Regarding claims 6 – 8, drawn to a sunflower oleosome concentrate comprising, expressed on dry weight of the oleosome concentrate:
- a protein content of from 8.0 to 17.0 wt.%, and
- a lipid content of from 83.0 to 92.0 wt.%, of which at least 70% is present as oleosomes;
- a fiber content up to 0.5 wt.%. Said sunflower oleosome concentrate has a protein to lipid ratio in a range of from 0.09 to 0.20 by weight.
Cassen teaches a concentrated cream phase, obtained from sunflower seeds using an aqueous integrated process, where the dry matter (dm) consists mainly of ~ 71 - 80 (w/w dm) lipids in the form of an oil body (oleosomes) dispersion (droplet size d(0.5): 2.0 μm), proteins (~ 11 – 15 % w/w dm) and extraneous matter, consisting of polysaccharides, fibers and other minor components (~ 8 – 13 % w/w dm) (page 1, abstract, page 4, Table 1). Thus, according to teachings of Cassen, sunflower oleosome concentrate has a protein to lipid ratio in a range of ~ 0.14 to 0.20, which falls within the claimed range. The “extraneous matter” fraction of oil bodies concentrate might contain fibers, which indicates that none to some amount of fiber is present in concentrate. The claim 8 limitation “up to” includes zero as a lower limit (see MPEP 2173.05(c)).
Thus, Cassen teaches sunflower oleosome concentrate of identical or similar composition, where the composition ranges of all components overlap with or close to the instantly claimed ranges. MPEP 2144.05 states: In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985).
Regarding claim 9, drawn to a color values, wherein sunflower oleosome concentrate has a color, expressed in color values according to CIELAB of: "°h in a range of from 85 to 95, and C* of from 8.0 to 14.0; or "°h above 95, above 96, or above 97, and C* below 10.0, below 9.8, or below 9.6; measured on sunflower oleosome concentrate standardized to a dry substance in a range of 30 to 35 % and a pH in a range of 6.9 to 7.1, using an illuminant D65, an observation angle of 100 and an aperture size of 30 mm.
Cassen does not explicitly teach the color of sunflower oleosome concentrate, however since Cassen teaches sunflower oleosome concentrate of the same as or similar composition and texture (creamy) to instantly claimed, the color is expected to be similar, since "products of identical chemical composition cannot have mutually exclusive properties”. MPEP 2112.01 states: Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, claimed properties or functions are presumed to be inherent.
Regarding claim 10, drawn to a process for preparing food and feed products, pharmaceutical products, personal care products, nutritional compositions and industrial products, and the process is comprising the step of blending the sunflower oleosome concentrate with at least one ingredient other than oleosomes. Cassen teaches oil bodies applications in food formulations, such as soymilk and mayonnaise (page 13, “conclusion”), which indicates that obtained oleosome concentrate is mixed with other ingredients, required by e.g. mayonnaise preparation recipe.
Thus, since Cassen teaches an identical or similar composition (sunflower oleosome concentrate), where the composition ranges of all components overlap with or close to the instantly claimed ranges, where said composition is prepared by a similar process and is applicable for the same purposes (food formulations), it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the composition taught by prior art by optimizing the workable ranges to arrive at instant composition. The one of ordinary skills would be motivated to do so through routine experimentation to find an optimum combination of percentages to improve desirable properties of known composition with the reasonable expectation of success. MPEP 2144.05 states: 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).
Therefore, taking all together, taught by prior art, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was made,
as evidenced by the references, especially in the absence of evidence to the contrary.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 6 – 10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9 – 11 and 13 -14 of copending Application No. 18/834,672 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because instant claims are directed to a sunflower oleosome concentrate comprising, expressed on dry weight of the oleosome concentrate:
- a protein content of from 8.0 to 17.0 wt.%, and
- a lipid content of from 83.0 to 92.0 wt.%, of which at least 70% is present as oleosomes;
- a fiber content up to 0.5 wt.%. Said sunflower oleosome concentrate has a protein to lipid ratio in a range of from 0.09 to 0.20 by weight, and wherein sunflower oleosome concentrate has a color, expressed in color values according to CIELAB of: "°h in a range of from 85 to 95, and C* of from 8.0 to 14.0; or "°h above 95, above 96, or above 97, and C* below 10.0, below 9.8, or below 9.6; measured on sunflower oleosome concentrate standardized to a dry substance in a range of 30 to 35 % and a pH in a range of 6.9 to 7.1, using an illuminant D65, an observation angle of 100 and an aperture size of 30 mm. Instant claims are further directed to a process for preparing food and feed products, pharmaceutical products, personal care products, nutritional compositions and industrial products, and the process is comprising the step of blending the sunflower oleosome concentrate with at least one ingredient other than oleosomes.
Claims of copending application are directed to a sunflower oleosome concentrate comprising, expressed on dry weight of the oleosome concentrate:
- a protein content of from 13.0 to 17.0 wt.%, and
- a lipid content of from 83.0 to less than 87.0 wt.%, of which at least 70% is present as oleosomes;
- a fiber content in a range of at most 0.5 wt.%. Said sunflower oleosome concentrate has a protein to lipid ratio in a range of from 0.09 to 0.20 by weight, and wherein sunflower oleosome concentrate has a color, expressed in color values according to CIELAB of: "°h in a range of from 85 to 95, and C* of from 8.0 to 14.0; or "°h above 95, above 96, or above 97, and C* below 10.0, below 9.8, or below 9.6; measured on sunflower oleosome concentrate standardized to a dry substance in a range of 30 to 35 % and a pH in a range of 6.9 to 7.1, using an illuminant D65, an observation angle of 100 and an aperture size of 30 mm. Copending claims are further directed to a process for preparing food and feed products, pharmaceutical products, personal care products, nutritional compositions and industrial products, and the process is comprising the step of blending the sunflower oleosome concentrate with at least one ingredient other than oleosomes. Thus, claims of copending application teach an identical or similar composition, where the composition ranges of all components are the same or similar to instantly claimed ranges, and where said composition is applicable for the same purposes (food formulations).
Thus, claims of copending application would anticipate instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1 – 10 are rejected. No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELENA V VISHNYAKOVA whose telephone number is (571)272-3781. The examiner can normally be reached 7:30am - 5pm ET.
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/E.V.V./Examiner, Art Unit 1691
/SAVITHA M RAO/Primary Examiner, Art Unit 1691
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