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 .
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 27, 34-38, and 41-43 are rejected under 35 U.S.C. 103 as being unpatentable over Arsiwalla et al. US 2015/0374005 in view of Yoon et al. WO 2008/091137 and Dossey US 2015/0132433 as further evidenced by Hageman US 2008/0031814.
Regarding Claims 27 and 38, Arsiwalla et al. discloses a food comprising insect pulp derived from insect larvae (‘005, Paragraphs [0017] and [0019]) wherein the insect pulp is derived from black soldier fly (‘005, Paragraphs [0018] and [0043]).
Arsiwalla et al. is silent regarding the insect pulp having a free fatty acid content of less than 1.0%.
Yoon et al. discloses a method of preparing a feedstuff additive comprising drying housefly larvae to remove water and dissolving the dried larvae in an organic solvent to remove fats and obtain residues and mixing the residues with ethanol to obtain an ethanol extract (‘137, Page 5, lines 4-9) wherein the larvae of the housefly is dried to remove water at 80-150°C using a drying oven (‘137, Page 5, lines 10-12).
Arsiwalla et al. discloses a method of converting insects into multiple nutrient streams such as a fat containing stream and a protein containing stream (‘005, Paragraph [0007]) wherein the fat fraction is separated from the mixture (‘005, Paragraph [0022]) such that the dried protein material contains limited amounts of fat (‘005, Paragraph [0037]) and the fat fraction is isolated for further use (‘005, Paragraph [0038]). The resulting protein material can be used as animal feed (‘005, Paragraph [0041]). Arsiwalla et al. incorporates Yoon et al. by reference (‘005, Paragraph [0005]). Yoon et al. discloses a method of preparing a feedstuff additive comprising drying housefly larvae to remove water and dissolving the dried larvae in an organic solvent to remove fats and obtain residues and mixing the residues with ethanol to obtain an ethanol extract (‘137, Page 5, lines 4-9) wherein the larvae of the housefly is dried to remove water at 80-150°C using a drying oven (‘137, Page 5, lines 10-12).
Although Arsiwalla et al. does not explicitly state that the free fatty acid content of the heated insect pulp is 1.0% or less, Arsiwalla et al. discloses isolating the fat fraction from the protein fraction that contains limited amounts of fat (‘005, Paragraph [0037]). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the free fatty acid content of the insect pulp of Arsiwalla et al. to be 1.0% of less as claimed since differences in the free fatty acid content will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such free fatty acid content is critical. 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 view of In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP § 2144.05.II.A.). Arsiwalla et al. discloses separating out the protein fraction from the fat fraction wherein the protein fraction contains limited amounts of fat.
Further regarding Claims 27 and 38, the limitations “which has been subjected to a heat treatment wherein the heat treatment is for 50-100 seconds at a temperature of 60°C-95°C,” “obtained by providing insect larvae and preparing an insect pulp thereof, heating the insect pulp for 50-100 seconds at a temperature of 60°C-95°C and providing the heated insect pulp of step b) in the food, the feed, the food ingredient, or the feed ingredient” are product by process limitations. Even 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 view of In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (MPEP § 2113.I.). Nevertheless, Arsiwalla et al. discloses the steps of providing insect larvae (larvae of black soldier fly) and preparing a pulp thereof (‘005, Paragraph [0043]) and heating the insect pulp to a temperature of 60-100°C (‘005, Paragraph [0020]), which encompasses the claimed heating temperature of 60°-95°C. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the food and obtain the insect pulp by heating at the claimed temperature range as taught by Arsiwalla et al. since where the claimed heating temperature ranges overlaps heating temperature ranges disclosed by the prior art, a prima facie case of obviousness exists in view of 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) (MPEP § 2144.05.I.). Although Arsiwalla et al. does not explicitly disclose heating the insect pulp for 50-100 seconds, Arsiwalla et al. discloses a skilled person will be able to determine the suitable heating time (‘005, Paragraph [0020]). Furthermore, Dossey discloses insect products which may be used as substitutes or supplements for human food or animal feed (‘433, Paragraph [0002]) made using preservation methods including high temperature short time pasteurizing, sterilization, cooking, heat treating, to protect key nutrients of the insect product while killing and/or reducing pathogens, microbes, or other living organisms present inside or on the insects to improve the functionality and/or digestibility of the product for desired food product applications (‘433, Paragraph [0052]) wherein the insect slurry is heated to temperatures in the range of about 54-93°C for various time intervals depending on the type of equipment utilized (‘433, Paragraph [0053]) wherein the insect is black soldier fly (‘433, Paragraph [0017]). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the time of the process by which the food derived from insect pulp is heated to fall within the claimed time durations since differences in heating time will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such heating time is critical. 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 view of In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP § 2144.05.II.A.). Additionally, Dossey discloses heating the insect slurry at temperature than overlap the claimed heating temperatures for various time intervals depending on the type of equipment utilized in the heating step (‘433, Paragraph [0053]). Given that Claims 27 and 38 recite a generic heating step and does not specify the particular equipment used or the type of heating used in the product by process limitations, one of ordinary skill in the art would adjust the heating time in which black soldier fly is heated of the process of Arsiwalla et al. based upon the type of equipment and heating process used for preservation purposes as taught by Dossey.
Additionally, Arsiwalla et al. explicitly discloses subjecting the heated pulp to a physical separation step thereby obtaining a fat fraction, an aqueous protein fraction, and a solid containing fraction (‘005, Paragraph [0021]).
Further regarding Claims 27 and 38, the limitations “wherein intestinal SN-1,3-lipase has been inactivated by the heat treatment” are limitations with respect to the properties of the food, feed, food ingredient, or feed ingredient when black soldier fly larvae pulp is subjected to a heat temperature at a temperature of 60°C-95°C. Where the claimed and prior art products are identical or substantially identical in structure or composition, a prima facie case of obviousness has been established in view of In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977) (MPEP § 2112.01.I.). One of ordinary skill in the art would expect the food derived from insect pulp of Arsiwalla et al. to also have the same properties as claimed, e.g. intestinal SN-1,3-lipase is inactivated, since Arsiwalla et al. also teaches the claimed food comprising black soldier larvae pulp that is heated to the claimed temperature range. Additionally, Hageman provides evidence that it was known in the food art (‘814, Paragraph [0002]) that lipases are denature at heating temperatures above 80°C (‘814, Paragraph [0064]). Since Arsiwalla et al. also teaches heating temperatures above 80°C that also overlap the claimed heating temperatures, one of ordinary skill in the art would expect these heating temperatures to inactivate/denature lipases such as intestinal SN-1,3-lipase as evidenced by Hageman.
Regarding Claim 34, Arsiwalla et al. does not explicitly state that the black soldier fly larvae are between 12 and 30 days of age. However, Arsiwalla et al. discloses the insects being in any developmental stage (‘005, Paragraph [0018]). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the days of age of the insects used in Arsiwalla et al. since differences in the days of age of the insects will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such heating time is critical. 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 view of In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP § 2144.05.II.A.).
Regarding Claim 35, Arsiwalla et al. discloses the black soldier fly larvae being prepared by mincing (cutting and/or milling) the black solider fly larvae (‘005, Paragraphs [0018]-[0019]).
Regarding Claim 36, Arsiwalla et al. discloses the average particle size of the remains of the black soldier fly larvae in the pulp being at least 10 microns (‘005, Paragraphs [0018]-[0019]), which overlaps the claimed the average particle size range of between 10 and 500 microns. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the average particle size of the remains of the black soldier fly larvae in the pulp since differences in average particle size of the remains of the black soldier fly larvae in the pulp will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such heating time is critical. 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 view of In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP § 2144.05.II.A.).
Regarding Claim 37, Arsiwalla et al. discloses the food being pet food (‘005, Paragraph [0017]).
Regarding Claims 41-42, the limitations “wherein the heat treatment is at a temperature of 75°C-95°C” and “wherein the heat treatment is at a temperature of 90°C” are product by process limitations and as such are rejected for the same reasons regarding product by process limitations enumerated in the rejections of Claim 27 provided above. Nevertheless, Arsiwalla et al. discloses the steps of providing insect larvae (larvae of black soldier fly) and preparing a pulp thereof (‘005, Paragraph [0043]) and heating the insect pulp to a temperature of 60-100°C (‘005, Paragraph [0020]), which encompasses the claimed heating temperature of 75°-95°C and 90°C. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the food and obtain the insect pulp by heating at the claimed temperature range as taught by Arsiwalla et al. since where the claimed heating temperature ranges overlaps heating temperature ranges disclosed by the prior art, a prima facie case of obviousness exists in view of 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) (MPEP § 2144.05.I.).
Regarding Claim 43, Arsiwalla et al. discloses the heated insect pulp comprising fat, protein, and solids (‘005, Paragraph [0043]).
Claims 28 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Arsiwalla et al. US 2015/0374005 in view of Yoon et al. WO 2008/091137 and Dossey US 2015/0132433 as further evidenced by Hageman US 2008/0031814 as applied to claim 27 above as further evidenced by Firmansyah et al. “Production of protein hydrolysate containing antioxidant activity from Hermetia illucens” (published June 21, 2019) (cited on Information Disclosure Statement filed March 15, 2022).
Regarding Claim 28, Dossey discloses an insect product including a composition derived from at least one whole insect (‘433, Paragraph [0010]) having a peroxide value of about 1 meq/kg of fat or less (‘433, Paragraph [0019]), which falls within the claimed feed having a level less than 1.3 meq/kg fat.
Both modified Arsiwalla et al. and Dossey are directed towards the same field of endeavor of methods of making insect based foods. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the food of modified Arsiwalla et al. and adjust the peroxide value to the claimed range of less than 1.3 meq/kg fat as taught by Dossey since where the claimed meq/kg levels overlaps meq/kg levels disclosed by the prior art, a prima facie case of obviousness exists in view of 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) (MPEP § 2144.05.I.). Furthermore, differences in meq/kg levels will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such meq/kg levels is critical. 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 view of In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP § 2144.05.II.A.).
Further regarding Claim 28, the limitations “wherein the food, feed, food ingredient, or feed ingredient comprises the heat treated black soldier fly larvae pulp which has antioxidant properties” are limitations with respect to the properties of the claimed food comprising the insect pulp. Where the claimed and prior art products are identical or substantially identical in structure or composition, a prima facie case of obviousness has been established in view of In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977) (MPEP § 2112.01.I.). One of ordinary skill in the art would expect the food derived from insect pulp of Arsiwalla et al. to also have the same properties as claimed, e.g. have antioxidant properties, since Arsiwalla et al. also teaches the claimed food comprising insect pulp. Additionally, Firmansyah et al. provides evidence that food derived from insects (BSFL, i.e. black soldier fly larvae) has antioxidant properties (Right Column, Page 3). Arsiwalla et al. teaches the black soldier fly being heated (‘005, Paragraphs [0012] and [0018]).
Regarding Claim 39, the limitations “wherein the food, feed, food ingredient, or feed ingredient has antioxidant properties” are limitations with respect to the properties of the claimed food comprising the insect pulp. Where the claimed and prior art products are identical or substantially identical in structure or composition, a prima facie case of obviousness has been established in view of In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977) (MPEP § 2112.01.I.). One of ordinary skill in the art would expect the food derived from insect pulp of Arsiwalla et al. to also have the same properties as claimed, e.g. have antioxidant properties, since Arsiwalla et al. also teaches the claimed food comprising insect pulp. Additionally, Firmansyah et al. provides evidence that food derived from insects (BSFL, i.e. black soldier fly larvae) has antioxidant properties (Right Column, Page 3).
Response to Arguments
Applicant's arguments filed December 12, 2025 with respect to the previous obviousness rejections under 35 USC 103(a) have been fully considered but they are not persuasive.
Examiner notes that applicant amended Claims 27 and 38 to require the subject matter of now canceled Claim 40 that the intestinal SN-1,3-lipase has been inactivated by the heat treatment. Claim 40 was previously rejected over Arsiwalla in view of Yoon et al. and Dossey as further evidenced by Hageman. Claim 27 is currently rejected over Arsiwalla in view of Yoon et al. and Dossey as further evidenced by Hageman in view of applicant’s amendments.
Applicant argues on Page 6 of the Remarks that Paragraphs [0037]-[0038] of Arsiwalla discloses the fat is isolated for further use and the dried protein material is used as animal feed, which is in line with the overall teaching of Paragraph [0013] of Arsiwalla of subjecting the heated pulp to a physical separation step thereby obtaining a fat fraction, an aqueous protein fraction, and a solid containing fraction. Applicant continues that Claim 27 maintains the insect pulp as a whole product while also using a method which provides microbial safety and enzyme inactivation without fractionation and that a person of ordinary skill in the art would not be motivated to modify the fractionation focused process of Arsiwalla towards a process that preserves the pulp integrity for storage and direct use. Applicant also argues that dependent Claim 43 specifies that the pulp includes fat, protein, and solids. Applicant continues on Pages 6-7 of the Remarks that Paragraph [0037] of Arsiwalla discloses that isolating the fat fraction from the protein fraction that contains limited amounts of fat would motivate a person of skill in the art to modify the free fatty acid content of the insect pulp to be 1.0% of less as claimed and that this would be fractionating the streams to achieve the low free fatty acid content and would not meet the claim requirement to product black soldifer fly larvae pulp as a whole and not the requirements of Claim 43 requiring that the pulp includes protein, fat, and solids.
Examiner argues Claims 27 and 38 recite the limitations “a heat treated black solider fly larvae pulp which has been subjected to a heat treatment” and “providing insect larvae and preparing an insect pulp thereof,” respectively. Arsiwalla teaches providing insect larvae and preparing an insect pulp thereof (‘005, Paragraph [0043]). Claims 27 and 38 does not recite maintaining the insect pulp as a whole product and also does not utilize the term “whole.” The disclosure at the time of filing also never discloses maintaining the insect pulp as a whole product. Applicant argues limitations that are not commensurate in scope with the claimed invention. With respect to applicant’s comments regarding Claim 43 specifying that the pulp includes fat, protein, and solids, Arsiwalla et al. explicitly discloses the pulp including a combined protein fraction and a fat fraction with a solid residue (‘005, Paragraph [0043]), which indicates that the pulp includes fat, protein, and solids. Furthermore, Arsiwalla discloses the method converting insects into nutrient streams of a fat containing stream and a protein containing stream which can be further separated into an aqueous protein stream and a solids containing stream (‘005, Paragraph [0007]). The phrase “can be” are preferred embodiments that are not required by the disclosure of Arsiwalla. Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments in view of In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971) (MPEP § 2123.II.). Furthermore, Arsiwalla discloses the protein material containing limited amounts of fat (‘005, Paragraph [0037]), i.e. the protein material contains some amount of fats. Paragraph [0037] does not state that the protein material contains no fats. Paragraph [0037] of Arsiwalla broadly teaches the heated insect pulp comprising fats. Therefore, these arguments are not found persuasive.
Applicant argues on Page 7 of the Remarks that the cited prior art references do not teach the specific time temperature combination recited by Claim 27 and fails to disclose the critical limitation that the heat treatment inactivates intestinal SN 1,3-lipase. Applicant points to Paragraph [0020] of Arsiwalla as disclosing the pulp is heated during 0.1-4 hours, for example 5-10 minutes which encompasses a broader time range that the specific 50-100 seconds recited by Claim 27. Applicant continues that Paragraph [0053] of Dossey discloses HTST pasteurization is utilized with a temperature in the range of 172-195°F and an exposure time in the range of 3 to 15 seconds. Applicant contends that these both teach a different time temperature combination than the claimed 50-100 seconds at 60°C-95°C. Applicant continues on Pages 7-8 of the Remarks that the specification demonstrates that the pasteurization time and temperature combination is significant for inactivation of intestinal SN-1,3-lipase and establishes that if not inactivated this enzyme could hydrolyze triglycerides into free fatty acids and that insect puree heated at 90°C for 40 seconds has relatively high amounts of free fatty acids of approximately 70% with heating for just 40 seconds being ineffective in the deactivation of lipase whereas low amounts of free fatty acids are observed when puree is heated for 80 seconds indicating the sufficient time for enzyme inactivation at 90°C and that the specification concludes that heating minced insect larvae at 90°F for 80 seconds is critical for enzyme inactivation and prevents free fatty acid formation.
Examiner argues Arsiwalla et al. discloses the pulp being heated to a temperature in the range of from 60 to 100°C and that a skilled person will be able to determine suitable heating times (‘005, Paragraphs [0020]). Arsiwalla et al. teaches that a suitable heating time can be determined by a skilled person. Additionally, Dossey discloses heating the insect slurry at temperature than overlap the claimed heating temperatures for various time intervals depending on the type of equipment utilized in the heating step (‘433, Paragraph [0053]). Given that Claim 27 recites a generic heating step and does not specify the particular equipment used or the type of heating used in the product by process limitations, one of ordinary skill in the art would adjust the heating time in which black soldier fly is heated of the process of Arsiwalla et al. based upon the type of equipment and heating process used for preservation purposes as taught by Dossey. In response to applicant's arguments against the references individually, 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). With respect to applicant’s comments that the specification demonstrates that the pasteurization time and temperature combination is significant for inactivation of intestinal SN-1,3-lipase and establishes that if not inactivated this enzyme could hydrolyze triglycerides into free fatty acids and that insect puree heated at 90°C for 40 seconds has relatively high amounts of free fatty acids of approximately 70% with heating for just 40 seconds being ineffective in the deactivation of lipase whereas low amounts of free fatty acids are observed when puree is heated for 80 seconds indicating the sufficient time for enzyme inactivation at 90°C and that the specification concludes that heating minced insect larvae at 90°F for 80 seconds is critical for enzyme inactivation and prevents free fatty acid formation, these statements are not supported with any objective evidence proving these allegations. Arguments presented by the applicant cannot take the place of evidence in the record in view of In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965) and In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984) (MPEP § 716.01(c).II.). Conclusory statements that results were “unexpected,” unsupported by objective factual evidence are considered but not found to be of substantial evidentiary value in view of Ex parte George, 21 USPQ2d 1058 (Bd. Pat. App. & Inter. 1991) (MPEP § 716.01(c).III.). Therefore, these arguments are not found persuasive.
Applicant argues on Page 8 of the Remarks that Example 4, Table 8 and Paragraphs [0173] and [0175] of applicant’s disclosure shows that short heating times in the range of 50-100 seconds are critical to allow for beneficial low free fatty acid content under 1% and heating the minced insect larvae at 90°C for 80 seconds is sufficient for preventing free fatty acid formation. Applicant contends that heating for shorter or longer periods results in higher free fatty acid content outside the claimed range and that the short heating time is critical for obtaining the low free fatty acid content of the pulp.
Examiner argues the data for Table 8 only shows data for heating at a temperature of 90°C. Claim 27 recites a broad range of 60°C-95°C. It is unknown if the data for Table 8 would also be applicable to lower temperatures at or around 60°C for the claimed time duration of 50-100 seconds. Additionally, Table 8 shows data for pasteurization times below the claimed heating time range of 50-100 seconds of 0 seconds heating time having a free fatty acid content below 1% and 40 seconds heating time having a free fatty acid content of about 70%. Applicant shows data for two heating times that both fall below the claimed heating times of 50-100 seconds wherein one of the heating times (at 0 seconds) shows applicant’s alleged benefit of low free fatty acid content of the pulp and another of the heating times (at 40 seconds) show’s applicant’s alleged disadvantage of about 70% free fatty acid content. Applicant has not shown any data in Table 8 that is critical to applicant’s claimed assertion that heating for shorting periods always results in higher free fatty acid content outside the claimed range, i.e. 0 second heating time results in free fatty acid content within the claimed range. Therefore, applicant’s assertion that Table 8 shows unexpected results that are critical are not found persuasive. Although Arsiwalla et al. does not explicitly state that the free fatty acid content of the heated insect pulp is 1.0% or less, Arsiwalla et al. discloses isolating the fat fraction from the protein fraction that contains limited amounts of fat (‘005, Paragraph [0037]). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the free fatty acid content of the insect pulp of Arsiwalla et al. to be 1.0% of less as claimed since differences in the free fatty acid content will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such free fatty acid content is critical. 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 view of In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP § 2144.05.II.A.). Arsiwalla et al. discloses separating out the protein fraction from the fat fraction wherein the protein fraction contains limited amounts of fat. Additionally, the data shown in Table 8 is not the closest prior art of record. While a change in the proportions of a combination shown to be old may be inventive, such changes must be critical as compared with the proportions used in the prior art processes producing a difference in kind rather than degree in view of In re Wells, 56 F.2d 674, 675, 12 USPQ 430 (CCPA 1932) (MPEP § 2144.05.III.A.). Dossey discloses an insect slurry heated to 54.4-93.3°C and an example wherein an exposure time is in the range of 3 to 15 seconds and that temperatures applied for various time intervals depend on the type of equipment utilized (‘433, Paragraph [0053]). Applicant has not shown data in Table 8 that specifies different types of equipment and heating methods that arrive at the same conclusions that short heating times for all types of heating equipment and process is critical for obtaining low free fatty acid content of the pulp. Additionally, Cadesky US 2018/0310591 discloses a method of making edible protein produces derived from at least one insect (‘591, Paragraph [0002]) wherein insect milk is heated to about 40°C to about 60°C and proteins are hydrolyzed for about 2 minutes to about 60 minutes (‘591, Paragraph [0195]) or the insect milk is heated to a temperature of about 90°C for about at least 2 minutes to destroy microorganisms and inactivate endogenous insect enzymes that lead to discoloration and undesirable flavor and texture in the final product (‘591, Paragraph [0205]) wherein pasteurization is carried out at a variety of time-temperature combinations either continuously as in a high temperature short time process or in batch as in a vat pasteurization process wherein the high hydrostatic pressure treated insect milk is pasteurized at about 72°C for about 15 seconds (‘591, Paragraph [0211]). Applicant has not provided data that compares the claimed invention to the closest prior art.
Applicant argues on Page 8 of the Remarks that Hageman is focused on creating hypoallergenic foods from highly purified synthetic ingredients which is different from insect processing and makes no mention of insects or insect derived ingredients, natural lipase inactivation in food processing or food safety through enzyme control. Applicant contends that Hageman does not render obvious the specific time temperature combination of 50-100 seconds at a temperature of 60°C-95°C that achieves both lipase inactivation and the unexpectedly low free fatty acid content of less than 1.0% in an insect derived product as recited in Claim 27.
Examiner argues Hageman is being relied upon as an evidentiary reference that it was known in the food art (‘814, Paragraph [0002]) that lipases are denature at heating temperatures above 80°C (‘814, Paragraph [0064]). Since Arsiwalla et al. also teaches heating temperatures above 80°C that also overlap the claimed heating temperatures, one of ordinary skill in the art would expect these heating temperatures to inactivate/denature lipases such as intestinal SN-1,3-lipase as evidenced by Hageman. Hageman is not being relied upon to render obvious the limitations of low free fatty acid content (which is already rendered obvious by Arsiwalla that teaches isolating the fat fraction from the protein fraction that contains limited amounts of fat (‘005, Paragraph [0037]). Therefore, this argument is not found persuasive.
Applicant argues on Page 9 of the Remarks that Claims 41-42 limits the heat treatment temperature to a narrower range of 75°C-95°C or 90°C that allegedly shows criticality for these claims in Example 4, Table 8.
Examiner argues Table 8 shows all five treatments at 90°C having free fatty acid content that overlaps within the claimed free fatty acid content of less than 1.0% for a pasteurization time of 0 seconds, 80 seconds, 300 seconds, and 1800 seconds. Table 8 shows free fatty acid content of less than 1.0% for heat treatment times less than 50-100 seconds claimed (at 0 seconds), within the claimed 50-100 seconds (at 80 seconds), and above the claimed 50-100 seconds (at 300 seconds and 1800 seconds). Table 8 shows results of free fatty acid content of less than 1.0% for heat treatment times below the claimed 50-100 second heat treatment, within the claimed 50-100 second heat treatment, and above the claimed 50-100 second heat treatment. Table 8 does not show any unexpected results pertaining to the particular heat treatment time range of 50-100 seconds with respect to unexpected free fatty acid content ranges. Table 8 does not show any unexpected results.
Applicant argues on Page 9 of the Remarks that it is legal error to recreate a hypothetical composition identical to what is claimed and then determine that a claimed property is inherent therein and that the same physical and chemical properties would exist in a composition identical to a claimed composition but a composition that is identical to the claimed compositions does not exist in the art.
Examiner maintains that the limitations “wherein the food, feed, food ingredient, or feed ingredient comprises the heat treated black soldier fly larvae pulp which has antioxidant properties” are limitations with respect to the properties of the claimed food comprising the insect pulp. Where the claimed and prior art products are identical or substantially identical in structure or composition, a prima facie case of obviousness has been established in view of In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977) (MPEP § 2112.01.I.). One of ordinary skill in the art would expect the food derived from insect pulp of Arsiwalla et al. to also have the same properties as claimed, e.g. have antioxidant properties, since Arsiwalla et al. also teaches the claimed food comprising insect pulp. Additionally, Firmansyah et al. provides evidence that food derived from insects (BSFL, i.e. black soldier fly larvae) has antioxidant properties (Right Column, Page 3). Arsiwalla et al. teaches the black soldier fly being heated (‘005, Paragraphs [0012] and [0018]). Therefore, this argument is not found persuasive.
Examiner notes that applicant’s comments on Page 10 of the Remarks does not specifically and distinctly point out the supposed errors of the Office Action.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 ERICSON M LACHICA whose telephone number is (571)270-0278. The examiner can normally be reached M-F, 8:30am-5pm, EST.
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/ERICSON M LACHICA/Examiner, Art Unit 1792