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 .
Status of the Application
Receipt of the Response and Amendment after Non-Final Office Action filed March 12, 2026 is acknowledged.
The status of the claims upon entry of the present amendments stands as follows:
Pending claims:
1-15, 20-21
Withdrawn claims:
None
Previously canceled claims:
16-19
Newly canceled claims:
None
Amended claims:
None
New claims:
21
Claims currently under consideration:
1-15, 20-21
Currently rejected claims:
1-15, 20-21
Allowed claims:
None
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 21 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.
Claim 21 recites the limitation “wherein the electromagnetic radiation of the at least one light source having a radiation level of 120 micro watts per squared centimeters”. This recitation renders the claim indefinite because it is unclear whether the radiation level is the electromagnetic radiation or a different property of the at least one light source. For the purposes of examination, it is presumed that the claim recites “wherein the at least one light source has an electromagnetic radiation level at 120 microwatts per square centimeter”.
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 20-21 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).
Regarding claim 21, Oonincx teaches exposing yellow mealworms (i.e., coleoptera) to lamps with a UVB irradiance (i.e., radiation level) of 70.1 μW/cm2 (p. 3, Table 4, col. 7).
Oonincx does not teach wherein the light source has a radiation level of 120 μW/cm2.
In the same field of endeavor, Baur teaches exposing oils to UVB treatment with an irradiance of 650 μW/cm2 (p. 2, col. 1, ¶ 3).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to choose a light source with an electromagnetic radiation level that falls in between 70.1 μW/cm2 and 650 μW/cm2 as disclosed by Oonincx and Baur. MPEP §2144.05(I) states “A range can be disclosed in multiple prior art references instead of in a single prior art reference depending on the specific facts of the case. Iron Grip Barbell Co., Inc. v. USA Sports, Inc., 392 F.3d 1317, 1322, 73 USPQ2d 1225, 1228 (Fed. Cir. 2004).” Thus, the range of irradiance disclosed by Oonincx in view of Baur encompasses the claimed value of “120 microwatts per square centimeter”.
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.
Response to Arguments
Claim Rejections – 35 U.S.C. §103 of claims 1-15 and 20 over Oonincx, Baur, and Alles: Applicant’s arguments filed March 12, 2026 have been fully considered but they are not persuasive.
Applicant argued that the cited references do not teach exposing coleoptera oil to UV light (Remarks, p. 5, ¶ 4- p. 6, ¶ 1).
This argument has been considered. However, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Examiner maintains that the combination of Oonincx, Baur, and Alles is adequate for all that is relied on in the present claim rejections, and the combination of references is adequate to deem the present claims obvious. 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 argued that the present embodiments show unexpected results, and that the references cited by the examiner do not disclose the unexpected results of an enriched coleoptera oil with at least 300 micrograms of vitamin D3 per 100 grams of oil. Applicant further argued that there is no claimed range in which the embodiments rely on to product the unexpected results, and that 716.02(d) does not apply to the claims at issue (Remarks, p. 6, ¶ 2- p. 8, ¶ 4).
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).”
Regarding Applicant’s argument that MPEP §716.02(d) does not apply in the present case, MPEP §716.02(d) is not directed to only claims that recite ranges, but to all claims. The data provided for the assertion of unexpected results of the claimed invention is not commensurate in scope with the claimed invention. The data in the specification discusses variables that are required during the treatment, such as the distance between the light source and the coleoptera, the radiation power of the light source, the length of treatment time, and the temperature for the treatment (p. 6, l. 29- p. 7, l. 14). Because claim 1 does not recite any of these limitations, the data is not commensurate in scope with the claimed invention, and a showing of unexpected results has not been made.
Claim Rejections – New Claim 21: Applicant’s arguments filed March 12, 2026 have been fully considered but they are not persuasive.
Applicant argued that claim 21 is not taught or suggested by any of the presently asserted references (p. 8, ¶ 8).
This argument has been considered. However, as described the in the 35 USC 103 rejection of claim 21 above, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to choose a light source with an electromagnetic radiation level that falls in between 70.1 μW/cm2 and 650 μW/cm2 as disclosed by Oonincx and Baur. MPEP §2144.05(I) states “A range can be disclosed in multiple prior art references instead of in a single prior art reference depending on the specific facts of the case. Iron Grip Barbell Co., Inc. v. USA Sports, Inc., 392 F.3d 1317, 1322, 73 USPQ2d 1225, 1228 (Fed. Cir. 2004).” Thus, the range of irradiance disclosed by Oonincx in view of Baur encompasses the claimed value of “120 microwatts per square centimeter”.
The rejections of claims 1-15, 20-21 have been maintained herein.
Conclusion
THIS ACTION IS MADE FINAL. 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 Amanda S Hawkins whose telephone number is (703)756-1530. The examiner can normally be reached Generally available M-Th 8:00a-5:00p, F 8:00-2:00.
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/A.S.H./Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793
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