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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 November 17, 2025 has been entered.
Claim Status
The status of the claims upon entry of the present amendments stands as follows:
Pending claims:
1-15, 20
Withdrawn claims:
None
Previously canceled claims:
16-19
Newly canceled claims:
None
Amended claims:
1, 10, 12
New claims:
None
Claims currently under consideration:
1-15, 20
Currently rejected claims:
1-15, 20
Allowed claims:
None
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-15 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Oonincx (Oonincx, D G A B, et al. “Evidence of vitamin D synthesis in insects exposed to UVb light”. Scientific Reports, 8:10807, published July 17, 2018 [accessed online January 27, 2025]) in view of Baur (Baur, Anja C, et al. “Plant Oils as Potential Sources of Vitamin D”. Frontiers in Nutrition, Vol. 3, Article 39, published August 12, 2016 [accessed online January 27, 2025]) and Alles (Alles, Martina Comiotto, et al. “Bio-refinery of insects with Pulsed electric field pre-treatment”. Innovative Food Science and Emerging Technologies, Vol. 64, published May 29, 2020 [accessed online February 3, 2025]).
Regarding claim 1, Oonincx teaches exposing insects to low irradiance UV light to increase vitamin D3 in house crickets (Abstract) including Coleoptera (p. 6, ¶ 6). Oonincx also teaches that 7DHC is the precursor which forms vitamin D3 in vertebrates (p.1, ¶ 2).
Oonincx does not teach extracting the coleoptera oil having an oil fraction and a sub-oil fraction, extracted from the oil fraction, exposing the oil of coleoptera to UV light, or enriching to coleoptera oil with at least 300 micrograms of vitamin D3 per 100 grams of oil.
Regarding extracting the coleoptera oil having an oil fraction and a sub-oil fraction, extracted from the oil fraction, Alles teaches of a technique for the pre-treatment for defatting insect biomass and that the pre-treatment before oil pressing improved the oil extraction yield and reduced extractions time, and that pre-treatment is performed before subsequent fractionation (p. 1, right-hand column, ¶ 2 – p. 2, left-hand col., ¶ 1). Because the process is for extracting oil from a biomass, it logically follows that the result of the extraction results in at least an oil fraction and a separate solids fraction.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the process of increasing vitamin D in coleoptera using UV light of Oonincx with the use of an initial extraction step as taught by Alles. One would be motivated to make this modification because the use of an extraction step prior to light treatment would allow for the UV treatment of only the coleoptera oil, rather than the insect itself. This would make the process of UV treatment easier because the oil would take up less volume than the insects would themselves.
Regarding exposing the coleoptera oil to UV light, Baur teaches exposing plant oils with vitamin D precursors including 7DHC to UV light to stimulate the synthesis of vitamin D (Abstract).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the process of Oonincx by exposing the oil of coleoptera to UV light. One would be motivated to make this modification because the use of the known technique of exposing plant oil to UV light to increase vitamin D to improve the vitamin D content of coleoptera oil, a similar oil, is obvious. MPEP §2143(I)(C) states the rationale to support a conclusion that the claim would have been obvious is that a method of enhancing a particular class of devices (methods, or products) has been made part of the ordinary capabilities of one skilled in the art based upon the teaching of such improvement in other situations. One of ordinary skill in the art would have been capable of applying this known method of enhancement to a "base" device (method, or product) in the prior art and the results would have been predictable to one of ordinary skill in the art.
Regarding enriching to coleoptera oil with at least 300 micrograms of vitamin D3 per 100 grams of oil, this limitation is a necessary result of performing the method as claimed. Evidence to support that the coleoptera oil is enriched with at least 300 micrograms of vitamin D3 per 100 grams of oil is provided by the instant specification. P. 4, lines 24-26 state that coleoptera oil obtained by performing the claimed method results in an oil comprising at least 300 micrograms of vitamin D3 per 100 grams of oil.
Regarding claim 2, Oonincx modified by Baur and Alles teaches all elements of claim 1 as described above.
Although the cited prior art does not teach subjecting the oil fraction and/or sub-oil fraction to the light treatment, MPEP 2144.04(IV)(C) states “selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results”, In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946). Therefore, it would have been obvious to expose to coleoptera oil to UV light after fractionation absent evidence of unexpected results.
Regarding claim 3, Oonincx modified by Baur and Alles teaches all elements of claim 1 as described above.
Oonincx teaches the presence of 7-dehydrocholesterol as a precursor for vitamin D in vertebrates (p. 1, ¶ 1). Therefore, it logically follows that an oil fraction would inherently comprise 7-dehydrocholesterol, which constitutes a lipid from the sterol class as claimed.
Regarding claim 4, Oonincx modified by Baur and Alles teaches all elements of claim 2 and claim 3 as described above.
Oonincx does not teach wherein the oil fraction or sub-oil fraction comprises lipids extracted from fresh live larvae, fresh frozen larvae, larvae which have been subjected to boiling, or dehydrated or powder reduced coleoptera larvae.
However, Alles teaches using live larvae as the raw material for the oil extraction (p. 2, left-hand column, ¶ 4).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to use live larvae as taught by Alles in the in the process of increasing vitamin D in coleoptera taught by Oonincx. One would be motivated to make this modification because the use of insect that have been dead could lead to concerns regarding decomposition.
Regarding claim 5, Oonincx modified by Baur and Alles teaches all elements of claim 1 as described above.
Oonincx does not teach wherein the extraction phase comprises hot or cold mechanical pressing of the larvae.
However, Alles teaches hot pressing to extract higher amounts of oil yield from the insects (p. 6, left-hand column, ¶ 2).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the process of Oonincx with the use of hot pressing as taught by Alles. One would be motivated to make this modification because, as taught by Alles, hot pressing leads to higher amounts of oil yield (p. 6, left-hand column, ¶ 2).
Regarding claim 6, Oonincx modified by Baur and Alles teaches all elements of claim 1 as described above.
Oonincx does not teach wherein the extraction phase comprises at least one centrifugation step.
However, Alles teaches that fractionation methods including centrifugation are well known in the art (p. 1, left-hand column, ¶ 1).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the process taught by Oonincx with the use of an extraction step comprising centrifugation as taught by Alles. The claim would have been obvious because all claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective function, and the combination yielded nothing more than predictable results to one of ordinary skill in the art, see MPEP §2143(A).
Regarding claims 7 and 8, Oonincx modified by Baur and Alles teaches all elements of claim 1 as described above.
Oonincx does not teach adding a solvent to promote extraction during the extraction phase.
However, Alles teaches adding water (a known solvent) to the pre-treatment chamber (p. 2, left-hand column, ¶ 5).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the process taught by Oonincx with the use of water during the extract phase. The claim would have been obvious because all claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective function, and the combination yielded nothing more than predictable results to one of ordinary skill in the art, see MPEP §2143(A).
Regarding claim 9, Oonincx modified by Baur and Alles teaches all elements of claim 1 as described above. Oonincx also teaches that the light source used had a power of 23 Watts (p. 7, ¶ 6), which falls within the claimed range of “between 20 and 50 Watts”.
Regarding claim 10, Oonincx modified by Baur and Alles teaches all elements of claim 1 as described above. Although the cited prior art does not teach increasing the distance between the at least one light source and the coleoptera oil to decrease ultraviolet radiation emitting on the coleoptera oil, Baur teaches that the UV lamp used emits 650 µW/cm2 at a distance of 15 cm. Therefore, one of ordinary skill in the art would have adjusted the distance from the UV lamp during routine optimization to find the distance that resulted in the desired UV radiation exposure. MPEP §2144.05(II) states where 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). The claimed range would thus be obvious.
Regarding claim 11, Oonincx modified by Baur and Alles teaches all elements of claim 1 as described above. Oonincx also teaches exposure to high irradiance lamps for 0 – 3840 minutes (p. 7, ¶ 9), which overlaps with the claimed range of between 10 minutes and 90 minutes.
With respect to the overlapping ranges, MPEP §2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
Regarding claim 12, Oonincx modified by Baur and Alles teaches all elements of claim 1 as described above.
Oonincx does not teach that the treatment step occurs in a receptacle that has a depth between 1 and 50 mm.
However, Baur teaches using glass vessels with an oil layer thickness of 1.6 or 3.2 mm (p. 2, right-hand column, ¶ 1). Although Baur does not teach the depth of the glass vessel, MPEP §2144.04(IV)(A/B) states “Claims directed to a lumber package ‘of appreciable size and weight requiring handling by a lift truck’ were held unpatentable over prior art lumber packages which could be lifted by hand because limitations relating to the size of the package were not sufficient to patentably distinguish over the prior art”, In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955). In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. Additionally, “The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant” In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). Because the claimed receptacle does not require any functional differences from the glass vessel taught by Baur, the claimed receptacle would have been obvious to one of ordinary skill in the art.
Regarding claim 13, Oonincx modified by Baur and Alles teaches all elements of claim 1 as described above. Oonincx also teaches the treatment temperatures being between 26.3 – 35.6[Symbol font/0xB0]C (p. 3, Table 3) which lies close to the claimed range of “between 21 and 24[Symbol font/0xB0]C”.
With respect to the close range, MPEP §2144.05 states 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 14, Oonincx modified by Baur and Alles teaches all elements of claim 1 as described above. Oonincx also teaches that synthesis of vitamin D requires exposure to ultraviolet light with a wavelength between 280 and 320 nm (UVb) (p. 1, ¶ 2), which matches the claimed range of “between 280 and 320 nm”.
Regarding claim 15, Oonincx modified by Baur and Alles teaches all elements of claim 1 as described above. Oonincx also teaches that the minimum distance between the UV lamp and insect were 8.0 cm, 10.0 cm, and 11.0 cm for different insects (p. 7, ¶ 5), which all fall within the claimed range of “between 5 and 20 centimeters”.
Regarding claim 20, Oonincx modified by Baur and Alles teaches all elements of claim 1 as described above. Oonincx also teaches Tenebrio molitor (p. 3, Figure 2 description).
Response to Arguments
Drawing Objections: Applicant has overcome the objections to the drawings based on submission of corrected drawing sheets. Accordingly, the objections have been withdrawn.
Claim Objections: Applicant has overcome the objections to the claims based on amendments in the Claims. Accordingly, the objections have been withdrawn.
Claim Rejections - 35 U.S.C. §112(d): Applicant has overcome the 35 U.S.C. § 112(d) rejections of claim 12 based on amendments to the claims and/or cancelation. Accordingly, the 35 U.S.C. § 112(d) rejections have been withdrawn.
Claim Rejections – 35 U.S.C. §103 of claims 1-15 and 20 over Oonincx, Baur and Alles: Applicant’s arguments filed November 17, 2025 have been fully considered but they are not persuasive.
Applicant argued that Baur merely discloses exposing plant oils to UV light and that one of ordinary skill would readily appreciate that exposing plant oils with vitamin D precursors to UV light does not read on exposing coleoptera oil to UV light because the oils are chemically different (Remarks, p. 7, ¶ 8- p. 8, ¶ 1).
This argument has been considered. However, Oonincx teaches that vertebrates contain 7DHC, which is a precursor for vitamin D3 (p.1, ¶ 2). Because Baur teaches that exposing vitamin D precursors, such as 7DHC to UV light stimulates synthesis of Vitamin D3 (Abstract), one of ordinary skill would have found it obvious to expose coleoptera oil, which contains 7DHC, to UV light to synthesize vitamin D3.
Applicant further argued that there would have been no motivation to combine the cited art because there would have been no reasonable expectation of success (Remarks, p. 8, ¶ 2-4).
This argument has been considered. However, Oonincx teaches that vertebrates contain 7DHC, which is a precursor for vitamin D3 (p.1, ¶ 2). Because Baur teaches that exposing vitamin D precursors, such as 7DHC to UV light stimulates synthesis of Vitamin D3 (Abstract), one of ordinary skill would have reasonable expectation of success converting 7DHC in coleoptera oil to vitamin D3 by exposure to UV light as taught by Baur. The Examiner maintains that one of ordinary skill in the art would have been capable of applying the known method of exposing oil comprising 7DHC to UV light to coleoptera oil and the results would have been predictable, see MPEP §2143(I)(C).
Applicant also argued that the cited prior art would still fail to produce the unexpected result of 300 micrograms of vitamin D3 per 100 grams of oil because Oonincx discloses the plateau amount of vitamin D3 in insects of 6400 IU/kg, which corresponds to 40 µg/100 g of oil (Remarks, p. 8, ¶ 4- p. 9, ¶ 3).
This argument has been considered. However, the Examiner maintains that the amount of vitamin D3 in the coleoptera oil is a necessary result of performing the method as claimed. The instant specification states that coleoptera oil obtained by performing the claimed method results in an oil comprising at least 300 µg of vitamin D3 per 100 grams of oil (p. 4, line 24-26). Because the cited prior art teaches the method of the claimed invention, it would necessarily result in the claimed amount of vitamin D3, absent a showing of unexpected result. At present, there is insufficient evidence of unexpected results. MPEP §716.02(d) states that “Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980)” and “To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960).”
The rejections of claims 1-15 and 20 have been maintained herein.
Conclusion
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/A.S.H./Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793
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