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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/28/2026 has been entered.
Status of Claims
Receipt of Remarks/Amendments filed on 01/28/2026 is acknowledged. Claims 1, 4, and 9-12 have been amended. Claims 15-16 are cancelled. Claims 17-19 are new. Claims 1-14 and 17-19 are presented for examination on the merits for patentability.
Rejection(s) not reiterated from the previous Office Action are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set of rejections presently being applied to the instant application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/12/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
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 1-2, 9-10, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Helgason et al. (US 2014/0023712 A1; Of record), hereinafter Helgason, in view of Shafizadeh, F. (New York Urologic. Food Sources for Lycopene. Obtained from URL: https://www.newyorkurologic.com/wp-content/uploads/2018/04/Lycopene.pdf obtained on 04/16/2026), and as evidenced by San-Ei Gen F.F.I. (Color Emulsion: Lycopene | Our Products | San-Ei Gen F.F.I., Inc. Obtained from Wayback Machine on 04/16/2026 from URL: https://web.archive.org/web/20200729204636/https://www.saneigen.com/lycopene.html July 29, 2020), hereinafter San-Ei Gen.
Helgason teaches aqueous transparent oil-in-water emulsion comprising carotenoid, recognizing the low solubility of carotenoids in oil and their very low water solubility (Abstract; [0008]). Helgason discloses forming microemulsions and formation of small emulsions by dispersion of liquid oil in water with an emulsifier followed by homogenization at high pressure to overcome the problem [0005]-[0007].
Helgason teaches O/W emulsion with carotenoid at 0.025-20-00 ppm, which is equivalent to 0.0000025%-0.2%, encompassing the claimed ranges for both β-carotene and lycopene in Claims 1 and 9-10 (Claim 1). Helgason teaches the claimed carotenoids lycopene and beta-carotene (Claims 1-2; [0019]-[0020].
Regarding Claim 1, Helgason teaches a) a) manufacturing a solution comprising modified starch and/or at least one surface active protein, at least one carbohydrate, and water; b) manufacturing a solution by mixing at least one carotenoid in triacylglycerol oil, and mixing b) with a); pre-emulsification is performed using a rotator/stator mixer; performing at least one step of high-pressure homogenization; spray-drying the emulsion to obtain a powder; and preparing an emulsion by introducing the powder in water ([0068]-[0075]; Example 1). Helgason teaches an embodiment wherein the triacylglycerol is 1-50%, which overlaps with the amount of oil claimed [0100].
Helgason does not expressly recite that the β-carotene is contained in the oil and/or fat and the lycopene is contained in the aqueous phase. However, because the composition and method of Helgason is the same as instantly claimed, one skilled in the art would expect the same result as instantly claimed, i.e. with the β-carotene is contained in the oil and/or fat and an amount of lycopene is contained in the aqueous phase, which is the continuous phase.
Helgason teaches “at least one carotenoid” in its composition, but does not necessarily provide a reason to use lycopene and beta-carotene together. However, Shafizadeh provides the motivation to use both because it teaches that while lycopene is closely related to beta-carotene, it decreases the risk of various cancers (p. 1, paragraphs 1-3). Shafizadeh also teaches that the bioavailability of lycopene is significantly higher when lycopene is ingested along with ß-carotene than when ingested alone (p. 2).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to combine the teachings of Shafizadeh with Helgason and prepare compositions comprising both lycopene and beta-carotene carotenoids because Shafizadeh teaches that lycopene decreases cancer risks and ß-carotene increases the bioavailability of lycopene.
Helgason teaches its product to be used in food including in sauces, salad dressing, and soups [0105]-[0106]. With regards to the intended use of “seasoning”, nothing precludes the use of the composition of the prior art Helgason as instantly claimed (see MPEP 2112.02(II), nor does the recitation impart any structural characteristic that would distinguish it from the prior art composition. "It is not invention to perceive that the product which others had discovered had qualities they failed to detect". See 67 USPQ 155, 326 US 242, 249 (1945).
Regarding Claim 2, Helgason teaches the modified starch is present in a concentration of 0.7-70%, which encompasses the claimed range (Claims 12-13).
Regarding Claim 13, Helgason teaches an embodiment wherein the emulsion comprises modified starch and/or at least one surface active protein and/or natural polymers such as lignin sulfonate, pectin, fenugreek gum and gum arabic, which reads on the gummy matter or emulsifier [0052].
Claims 4, 6, 11-12, 14 and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Helgason in view of Shafizadeh, as applied to Claims 1-2, 9-10, and 13 above, and in further view of Rocha-Selmi et al. (Journal of Chemistry, Volume 2013, Article ID 982603, 7 pages), hereinafter Rocha-Selmi.
The teachings of Helgason have been set forth supra.
Regarding Claims 4 and 14, Helgason does not expressly teach the method step of dispersing the lycopene in an aqueous phase.
Rocha-Selmi comprehends the usefulness of lycopene as a carotenoid in foods, conferring both color and functional characteristics, and understand the problem of lycopene isomerization and oxidation (Introduction, 1st paragraph). Rocha-Selmi teaches complex coacervation, producing microcapsules to encapsulate lycopene using for example gum arabic and maltodextrin as encapsulation agents, as a solution to the problem (Introduction, paragraphs 2-3 and 6-7).
Rocha-Selmi teaches gelatin and gum arabic solutions were dissolved in water at 50˚C, and oil dispersed lycopene were mixed in a shaker to obtain an emulsion. The emulsion was then mixed with the gum arabic solution by mechanical stirring, the pH adjusted, and then cooled in an ice bath to precipitate the particles, i.e. the coacervated microcapsules of lycopene, which were ultimately freeze-dried (Section 2.2.1). Rocha-Selmi further teaches rehydrating the microcapsules by adding water to the freeze dried samples, and the dispersion stirred for 5 minutes (Section 2.2.2). Rocha-Selmi teaches application of the microcapsules to food systems making it compatible with Helgason (Section 2.2.4). The retention of lycopene was found to be greater in the microcapsules as compared to the free material, indicating the potential of microencapsulation to provide greater protection against degradation of the carotenoid, favoring its application in food formulations (Conclusion). The Examiner notes that the lycopene used by Applicant are Lycopene base No. 34824 and 35153 manufactured by San-Ei Gen. San-Ei Gen’s lycopene product series are similarly prepared using a propriety emulsification technology.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to incorporate the coacervation step of Rocha-Selmi in the method of Helgason prior to mixing and emulsification with the β-carotene in oil, and encapsulate lycopene in gum arabic or maltodextrin with reasonable expectation of success that the lycopene will be better protected against degradation. Applying a known technique to a known method ready for improvement to yield predictable results is the rationale supporting obviousness. See MPEP § 2143 and KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385, 1395-97 (2007). As such, Claims 17-19 are also rendered obvious.
Regarding Claims 6, and 11-12, the features of these claims have been rendered obvious above.
Claims 3, 5, and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Helgason and in view of Shafizadeh and Rocha-Selmi, as applied to Claims 1-2, 4, 6, 9-14 and 17-19 above, and in view of Runge et al. (US 6,509,029 B2; Of record), hereinafter Runge, as evidenced by Akhtar (Critical Reviews in Food Science and Nutrition 54.12 (2014): 1562-1575; Of record).
Runge also teaches the production of an emulsion of β-carotene/lycopene/lutein (Example 4; Claim 1). Runge teaches an aqueous solution of distilled water, sodium hydroxide and ascorbyl palmitate is prepared and then mixed with glycerol, β-carotene, lycopene, etc. are added to coconut oil, and the oil and aqueous phase were mixed (Example 4).
Regarding Claims 3, 5, and 7-8, Runge teaches inclusion of polyunsaturated fatty acids, e.g. linoleic acid, linolenic acid, arachidonic acid, eicosapentaenoic acid, docosahexaenoic acid Col. (2, lines 65-67). Especially in the case of a suspension or an emulsion, Runge teaches that it is advantageous to use in sesame oil, corn oil, peanut oil, fish oils etc. Helgason also teaches an embodiment wherein the triacylglycerol oil is selected from a group which includes peanut oil [0031], which Runge also teaches.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to choose an oil comprising unsaturated fatty acids, such as for example peanut oil, which comprises 52% monounsaturated fat (MUFA) and 32% polyunsaturated fat (PUFA), as evidenced by Akhtar. As such, the unsaturated fatty acid content is 70%, which is greater than 65%, and reads on the features of Claims 3, 5, and 7, and is near Claim 8. A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See MPEP 2144.05. Given that Applicant did not point out the criticality of the unsaturated fatty acid content being not less than 75%, based on instant Claim 7, it is concluded that the normal desire of scientists or artisans to improve upon what is already generally known would provide the motivation to determine where in a disclosed set of ranges is the optimum amounts. NOTE: MPEP 2144.05.
Response to Arguments:
Applicant traversed the rejection over Runge in view of Helgason, stating that the prior art does not teach that the β-carotene is contained in the oil and/or fat and the lycopene is contained in a continuous phase, which is achieved by first dispersing lycopene in an aqueous solution to prepare a continuous phase comprising lycopene.
The Examiner has considered the argument, but is not persuaded. The modified rejection supra now relies on Helgason in view of Shafizadeh in teaching a composition comprising β-carotene and lycopene, rendering Claim 1 obvious. Contrary to what is implied in the Remarks, Claim 1, as written, does not need to be made by the method of Claim 4. Because of the presence of the emulsifier, one skilled in the art would expect that all, if not a portion of the lycopene would be present in the aqueous phase. The burden shifts to the Applicant to show that the prior art composition is not identical composition claimed, and explain where this difference arise from, e.g. by comparing to closest art, claim the difference/absence of specific emulsifier/s.
Furthermore, regarding the method Claim 4, the known technique of coacervation is taught by Rocha-Selmi for encapsulating lycopene using gum arabic and maltodextrin as encapsulation agents to protect the lycopene. Applying a known technique to a known method ready for improvement to yield predictable results is the rationale supporting obviousness. See MPEP § 2143 and KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385, 1395-97 (2007).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANICE Y SILVERMAN whose telephone number is (571)272-2038. The examiner can normally be reached M-F, 10-6 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Erik Kashnikow can be reached on (571) 270-3475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/J.Y.S./Examiner, Art Unit 1792
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792
Prosecution Insights