DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11, 2025, has been entered.
Claims 15-18 and 20 are examined on the merits.
Claim Objections
Claims 15-18 and 20 objected to because of the following informalities:
The word “and” in line 3 in claim 15 should be deleted since it does not precede the second-to-last item in the list.
Appropriate correction is required.
Notice Re: Prior Art Available Under Both Pre-AIA and AIA
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.
Claim Rejections - 35 USC § 102/103
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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 15-18 and 20 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Arsiwalla (WO 2013/191548. Listed on IDS filed 1/4/24).
Arsiwalla discloses a method of converting insects into nutrient streams, including an aqueous proteinaceous-containing fraction (abstract; page 3, lines 8-9; page 6, last paragraph). The most preferred insects that are converted into nutrient streams include mealworm (Tenebrio molitor) (page 3, lines 8-16). For the method, the insects are first squashed to obtain a pulp (page 3, line 24). Subsequently, the pulp is subjected to enzymatic hydrolysis (page 4, line 7). The hydrolyzed mixture is then subjected to a physical separation step to obtain the nutrient streams, one of which is the aqueous fraction containing proteinaceous matter (page 4, lines 26-29). The aqueous proteinaceous fraction can further be dried to obtain dried proteinaceous material (page 6, lines 25-27). Since the dried proteinaceous material was obtained from the enzymatic hydrolysis of the pulp of insects which can be Tenebrio molitor, then it is directed to a ‘Hydrolysate prepared from insects…wherein the insects are Tenebrio molitor’ as instantly claimed.
Additionally, Arsiwalla discloses that the dried proteinaceous material contains at least 45 wt.% protein-derived matter, based on dry weight (page 7, lines 4). The lower limit of 45 wt.% based on dry weight is above the lower limit of 40 wt.% of the range for proteins of instant claim 15, and the range of protein content of Arsiwalla is fully within the claimed range. Therefore, every embodiment of dried proteinaceous material of Arsiwalla, including the embodiment in which the dried proteinaceous material is obtained from Tenebrio molitor, has a protein content that meets the claimed limitation of a hydrolysate comprising at least 40% by weight proteins based on the total weight of dry weight.
Arsiwalla does not disclose that their dried proteinaceous material obtained from Tenebrio molitor comprises at maximum 10% by weight ash based on the total weight of dry matter, a content of water-soluble proteins larger than 12,400 g/mol of less than 50% by weight based on the total weight of water-soluble proteins, and a pepsin digestibility greater than 95%, as recited in instant claim 15 for the hydrolysate. Though Arsiwalla does not recognize that their dried proteinaceous material from Tenebrio molitor possesses these properties, said dried proteinaceous material of Arsiwalla inherently possesses these properties. As indicated in MPEP 2112(I), “‘[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.’” Since the dried proteinaceous material obtained from Tenebrio molitor of Arsiwalla is directed to a hydrolysate prepared from Tenebrio molitor comprising proteins at a weight percentage that meets the claimed limitation (at least 40% by weight proteins based on the total weight of dry matter), then the dried proteinaceous material inherently possesses the claimed properties regarding ash content of instant claims 15 (ash content is at a maximum 10% by weight based on the total weight of dry matter) and 18 (ash content is less than 4% by weight), content of water-soluble proteins larger than 12,400 g/mol of instant claim 15, and pepsin digestibility of instant claim 15. Moreover, the teachings in Arsiwalla support the expectation that the dried proteinaceous material obtained from Tenebrio molitor of Arsiwalla inherently possesses the claimed pepsin digestibility. Regarding pepsin digestibility, Arsiwalla teaches that the insect protein-derived matter in the composition preferably has a pepsin digestibility of at least 50% (page 7, lines 9-13). In a preferred embodiment, the proteinaceous material contains at least 50 wt.% insect protein-derived matter and has a protein digestibility of at least 85%, preferably 90-95% (page 7, lines 13-16). The pepsin digestibility ranges of at least 50% and at least 85% overlap with the claimed range of ‘greater than 95%.’ This supports the expectation of a pepsin digestibility that falls within the claimed range of ‘greater than 95%.’
Therefore, Arsiwalla anticipates instant claims 15 and 18.
Regarding instant claim 16, since the insects were squashed to obtain the pulp that is enzymatically hydrolyzed in the invention of Arsiwalla (page 3, line 24; page 4, line 7; and page 9, lines 10-13), then the dried proteinaceous material is prepared from insect cuticles. Thus instant claim 16 is anticipated.
Regarding instant claim 17, though Arsiwalla does not recognize that the dried proteinaceous material obtained from Tenebrio molitor has a protein content greater than or equal to 70% by weight, it inherently possesses that claimed property. Again, see MPEP 2112(I). Moreover, Arsiwalla supports the expectation of the claimed protein content because Arsiwalla discloses that the dried proteinaceous material contains at least 45 wt.% protein-derived matter, more preferably 55-85 wt.%, based on dry weight (page 7, lines 1-3). These protein weight percentage ranges overlap with the protein content range of ‘greater than or equal to 70% by weight’ of instant claim 17. Thus instant claim 17 is anticipated
Regarding instant claim 20, though Arsiwalla does not recognize that the dried proteinaceous material obtained from Tenebrio molitor has a lipid content less than 14% by weight, it inherently possesses that claimed property. Again, see MPEP 2112(I). Moreover, Arsiwalla supports the expectation of the claimed lipid content because Arsiwalla discloses that the dried proteinaceous material contains at most 25 wt.%, fat, and preferably 3-20 wt.% fat (page 7, lines 1-4). These fat weight percentage ranges overlap with the lipid content range of ‘less than 14% by weight’ of instant claim 20.
However, even if Arsiwalla were not considered anticipatory of the instant claims, it would have been obvious that the dried proteinaceous material obtained from Tenebrio molitor necessarily possesses the claimed properties regarding ash content, content of water-soluble proteins larger than 12,400 g/mol of instant claim 15, and pepsin digestibility, based on the fact that the dried proteinaceous material is a hydrolysate prepared from Tenebrio molitor that has a protein content meeting the claimed limitation of ‘at least 40% by weight proteins based on the total weight of dry matter.’ As indicated in MPEP 2112(I), “‘[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.’” Therefore, the dried proteinaceous material obtained from Tenebrio molitor necessarily possesses at a maximum 10% by weight ash based on the total weight of dry matter, more specifically an ash content less than 4% by weight; a content of water-soluble proteins larger than 12,400 g/mol of less than 50% by weight based on the total weight of water-soluble proteins; and a pepsin digestibility greater than 95%. Moreover, the teachings in Arsiwalla support the expectation that the dried proteinaceous material obtained from Tenebrio molitor of Arsiwalla necessarily possesses the claimed pepsin digestibility. Regarding pepsin digestibility, Arsiwalla teaches that the insect protein-derived matter in the composition preferably has a pepsin digestibility of at least 50% (page 7, lines 9-13). In a preferred embodiment, the proteinaceous material contains at least 50 wt.% insect protein-derived matter and has a protein digestibility of at least 85%, preferably 90-95% (page 7, lines 13-16). The pepsin digestibility ranges of at least 50% and at least 85% overlap with the claimed range of ‘greater than 95%.’ Moreover, the preferred protein digestibility of 90-95% renders obvious the claimed range of ‘greater than 95%’ since 95% is close to the lower limit of the claimed range (e.g. 95.1%). As pointed out in MPEP 2144.05(I), “…a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close.” Therefore, these teachings in Arsiwalla support the expectation of a pepsin digestibility that falls within the claimed range of ‘greater than 95%.’ As such, Arsiwalla renders obvious instant claims 15 and 18.
Regarding instant claim 16, since the insects were squashed to obtain the pulp that is enzymatically hydrolyzed in the invention of Arsiwalla (page 3, line 24; page 4, line 7; and page 9, lines 10-13), then the dried proteinaceous material is prepared from insect cuticles. Thus instant claim 16 is rendered obvious.
Regarding instant claim 17, Arsiwalla does not recognize that the dried proteinaceous material obtained from Tenebrio molitor has a protein content greater than or equal to 70% by weight. However, Arsiwalla discloses that the dried proteinaceous material contains at least 45 wt.% protein-derived matter, more preferably 55-85 wt.%, based on dry weight (page 7, lines 1-3). These protein weight percentage ranges overlap with the protein content range of ‘greater than or equal to 70% by weight’ of instant claim 17. In view of the more preferred protein content disclosed in Arsiwalla, it would have been obvious that the embodiment of Arsiwalla of a dried proteinaceous material obtained from T. molitor has a protein content of 55-85 wt% which renders obvious instant claim 17 due to the overlap in the ranges. Thus instant claim 17 is rendered obvious.
Regarding instant claim 20, Arsiwalla does not recognize that the dried proteinaceous material obtained from Tenebrio molitor has a lipid content less than 14% by weight. However, Arsiwalla discloses that the dried proteinaceous material contains at most 25 wt.%, fat, and preferably 3-20 wt.% fat (page 7, lines 1-4). These fat weight percentage ranges overlap with the lipid content range of ‘less than 14% by weight’ of instant claim 20. It would have been obvious that the embodiment of Arsiwalla of a dried proteinaceous material obtained from T. molitor has the preferred fat content of 3-20 wt.% which renders obvious instant claim 20 due to the overlap in the fat content range with the claimed lipid content range. Thus instant claim 20 is rendered obvious.
Response to Arguments
Applicant’s arguments, filed November 11, 2025, with respect to the rejection under 35 U.S.C. 112(b) of claim 22, the rejection under 35 U.S.C. 102(a)(1) and 102(a)(2) of claims 15, 16, 20, and 22 as being anticipated by Arsiwalla, and the rejection under 35 U.S.C. 103 of claims 17-19 and 21 as being unpatentable over Arsiwalla, have been fully considered and are persuasive. In particular, the rejection under 35 U.S.C. 112(b) has been rendered moot by the canceling of claim 22. The rejection under 35 U.S.C. 102(a)(1) and 102(a)(2) has been overcome by the amendment to claim 15 since the rejection did not address the claimed limitations regarding pepsin digestibility and Tenebrio molitor as the insects. The rejection under 35 U.S.C. 103 has been overcome by the amendment to claim 15 since the rejection did not address the claimed pepsin digestibility for a hydrolysate prepared from Tenebrio molitor. Therefore, these rejections have been withdrawn.
However, upon further consideration, a new ground(s) of rejection is made in view of the previously cited reference Arsiwalla, as necessitated by the amendments to the claims. Applicant’s arguments are not persuasive with respect to the new grounds of rejection. Applicant argues that the process employed in Applicants’ claimed invention, which allows achieving the claimed features of the hydrolysate, is quite specific such that the enzymatic hydrolysis is carried out on a raw material having a low lipid content, which Applicant argues is not the case with the process disclosed in Arsiwalla for obtaining their products. In particular, Applicant cites pages 16 and 17 of the specification for disclosing a processing comprising the steps of grinding the cuticles of insects, pressing the cuticles of insects so that the press cake obtained has a low lipid content, then performing enzymatic hydrolysis of the cuticles of insects with a proteolytic enzyme. However, Arsiwalla discloses that in a step (a), the insects are squashed to obtain a pulp, and preferably the insects are thereby reduced in size (page 3, lines 24-25). Moreover, the squashing and reducing size can conveniently be done in a micro-cutter mill (page 3, lines 26-27). Such squashing and reduction in size is directed to grinding as in the process disclosed in the instant specification.
Further still, Applicant points out that in Arsiwalla, the enzymatic hydrolysis is performed on the pulp (i.e., the squashed insects or worms) without any prior lipid extraction. The support for this appears to be page 4, line 7 of the reference. Therefore, Applicant asserts that the enzymatic hydrolysis is performed on a raw material having a high lipid content. Applicant then cites page 26 of the specification for indicating that when the initial lipid content is high the enzyme responsible for hydrolysis hydrolyses, by catalytic promiscuity, lipids in addition to proteins. Therefore, Applicant asserts that this reduces protein hydrolysis and consequently results in peptides having higher molecular weights and reduced digestibility. However, the specification, including the cited page 26, does not indicate that the catalytic promiscuity (due to ‘high’ initial lipid content) reduces protein hydrolysis and results in peptides having higher molecular weights and reduced digestibility. Applicant has not provided any evidence for showing that performing enzymatic hydrolysis on a press cake is critical for obtaining the claimed content of water-soluble proteins larger than 12,4000 g/mol and the claimed pepsin digestibility.
Additionally, page 26 of the specification states “…when the initial lipid content is high, greater than 12%, the enzyme responsible for hydrolysis is caused to hydrolyse not only the proteins, but also the lipids by catalytic promiscuity” (last paragraph on page 26). According to Ravzanaadii (Int. J. Indust. Entol. 2012. 25(1): 93-98), adult Tenebrio molitor is 7.59% crude fat, based on dry basis (Table 1 on page 95). Therefore, when squashed according to the method disclosed in Arsiwalla, then the pulp that is enzymatically hydrolyzed has a lipid content of at most 7.59%, most likely lower given that water would have been an additional component. As such, the argued catalytic promiscuity would not have been an issue with respect to the method by which the dried proteinaceous material of Arsiwalla is obtained. Therefore, the Examiner does not find that there is sufficient evidence to demonstrate that the hydrolysate of Arsiwalla cannot have the claimed content of water-soluble proteins and pepsin digestibility.
Furthermore, Applicant asserts that one of ordinary skill in the art knows that pepsin digestibility is negatively affected by the chitin content and by the ADF content, citing Ozimek of the concurrently filed IDS. Poshina of the concurrently filed IDS is also cited by Applicant as evidence of the diffusion of pepsin to hydrolysis sites being restricted due to chitin’s structural relationship with proteins. Applicant also cites Marono for teaching that T. molitor exhibits higher chitin ADF than H. illucens. Applicant thus argues that one of ordinary skill in the art would not have selected T. molitor, at least because it has higher chitin and ADF contents. However, Arsiwalla specifically discloses T. molitor as a preferred insect for their invention (page 3, lines 14-16). Therefore, this argument is unpersuasive.
Conclusion
No claims are allowed.
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/SUSAN E. FERNANDEZ/Examiner, Art Unit 1651