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 .
Election/Restrictions
Applicant’s election without traverse of Group III (Claims 4-11; drawn to an extraction method of a Hermetia illucens AMP) in the reply filed on October 13, 2025, is acknowledged.
Claims 1-3 and 12-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention (Groups I-II and IV-V), there being no allowable generic or linking claim.
DETAILED ACTION
The claims filed on July 11, 2023, have been acknowledged. In light of the Applicant’s elected invention, claims 1-3 and 12-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 4-11 are pending and examined on the merits.
Priority
Acknowledgment is made of Applicant’s claim for foreign priority under 35 U.S.C. 119(a)-(d).The applicant claims foreign priority from CN202211531619.6 filed on December 1, 2022. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55, received August 28, 2023. While a certified copy of the foreign patent application CN202211531619.6 is provided with the instant application, a certified English translation of said foreign patent application has not been provided.
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.
Claims 4-11 are 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.
Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “bred” in claim 4 is used by the claim to mean “reared,” and the term “breeding” in claim 5 while the accepted meaning is “producing offspring through sexual reproduction” is used by the claim to mean “rearing”. The terms are indefinite because the specification does not clearly redefine the term. Claim 2 specifically refers to breeding day 3 larva. However, larva cannot sexually reproduce. As such, the terms bred and breeding are best understood to mean rearing the larva.
Claims 5-11 are rejected because of their dependency on claim 4.
Claims 7, 9, and 11 are also rejected because of their dependency on claim 5.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries 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 4-7 and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (Insects 11: 1-11. 2020) and further in view of Sandrock et al. (Insects 13: 1-31. 2022. Published April 2022), Larouche (Masters Thesis: Processing methods for the black soldier fly (Hermetia illucens) larvae: From feed withdrawal periods to killing methods. 2019. Published February 2020), and Ho et al. (Scientific Reports 11: 1-11. 2021).
As an initial matter, regarding the collecting a Hermetia illucens larva bred by the method according to claim 2 limitation, this is considered a product-by-process limitation because the breeding is not an active step in the method of claim 4, only collecting the larva through sieving is an active step. As such, only the positively recited structures of the larva are considered germane to the patentability of the limitation.
The recited structures of the larva are considered:
At least 3 day old larva
There is no timeframe identified in claim 2 for breeding the larva in the medium according to claim 1 and the medium of claim 1 is so broad as to encompass miniscule amounts of wheat bran contamination in the media. Therefore, the process of claim 2 is considered so broad as to encompasses dipping the larva in the media with miniscule amounts of wheat bran with 65%-70% moisture content before placing it in a separate container for rearing or sieving for immediate use in the method of claim 4. As such, this quick dip encompassed by the product-by-process is not considered to change the structure of the larva.
The recitation of a process limitation in claim 4 is not viewed as positively limiting the claimed product absent a showing that the process of making recited in claims -12 and 4 imparts a novel or unexpected property to the claimed product, as it is assumed that equivalent products are obtainable by multiple routes. The burden is placed upon the applicants to establish a patentable distinction between the claimed and referenced products. The method in which the larva are bred is immaterial to their patentability.
"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 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 re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985). See also MPEP §2113.
Lee teaches a method of extracting antimicrobial peptides (AMPs) from Hermetia illucens larva (HIL) comprising:
Maintaining HIL, inoculating fifth instar HIL (older than 3 day old larva) with one of five species of Lactobacillus (an antimicrobial liquid) using a fine needle (diameter 0.35 mm, length 40 mm) comprising 101 to 109 cfu/mL of Lactobacillus species by abdominal puncture and then the larva were held at room temperature for 24 hours with starvation. Then, the hemolymph was isolated and assessed for antimicrobial activity and AMP mRNA expressions (page 2, paragraph 2-page 3, paragraph 4).
Lee does not teach wherein the larva are sieved prior to inoculating the larva with an antimicrobial liquid.
However, Sandrock teaches a method of sieving larva for experimental use. Neonates of each strain that hatched within a synchronised 12 h age cohort went through five days of nursery before they were separated from residues by sieving (1 mm mesh size), which also ensured larvae of homogenous size (page 5, paragraph 3).
Larouche teaches that it is common to harvest larva for further experimentation by sieving the larva to separate the larva from their feeding substrate. Larouche teaches that sieving is the most commonly used method in industry and consists of sieving the substrate while keeping the larvae into the sieve (page 9, paragraph 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the method of extracting AMPs from HILs hemolymphs of Lee with the rearing and sieving larva for further experimentation of Sandrock to arrive at the instantly claimed invention. One of ordinary skill in the art would have a reason to combine with a reasonable expectation of success because Lee teaches a general method of maintaining HIL before performing their experiments while Sandrock successfully reduces to practice that neonates can be reared for 5 days before they were separated from residues by sieving, Furthermore, Larouche teaches that sieving is the most commonly used method for collecting larva for further experimentation as it allows separation of larva from the feeding substrate during rearing. Therefore, it would have been obvious to one of ordinary skill that the rearing and collection method of Sandrock could be combined with the method of extracting AMPs from HIL of Lee as this was a commonly used method in the field for collecting larva for experimentation. Because the prior art teaches all of the elements of the claimed invention, there is a reasonable expectation of success.
Although Lee teaches that they inoculated fifth instar HIL (older than 3 day old larva) with one of five species of Lactobacillus (an antimicrobial liquid) using a fine needle (diameter 0.35 mm, length 40 mm) comprising 101 to 109 cfu/mL of Lactobacillus species by abdominal puncture, Lee does not identify that they injected the antimicrobial liquid into the larva.
However, Ho teaches that they collected and inoculated 20 10 day old larva for immunization studies by injecting the larva with either E. coli, S. aureus or combined bacterial strains (1 ×103 CFU/g, 10 μl) using insulin needles and that E. coli and S. aureus are commonly used to generate AMPs in HIL (page 6, paragraph 2-page 7, paragraph 5).
Therefore, it would have been obvious that one could inject the Lactobacillus species of Lee into the HIL to produce AMPs as Ho successfully reduces to practice that insulin needles comprising 10 μL of bacteria (E. coli and/or S. aureus) can be used to inoculate HIL.
Regarding claim 5, as an initial matter, it is reiterated that the “breeding” (considered rearing as identified by the 112b rejection above) is considered a part of the product-by-process limitation identified above and is not considered part of the active method of claim 4. As stated supra, there is no timeframe identified in claim 2 for breeding the larva in the medium according to claim 1 and the medium of claim 1 is so broad as to encompass miniscule amounts of wheat bran contamination in the media. Therefore, the process of claim 2 is considered so broad as to encompasses dipping the larva in the media with miniscule amounts of wheat bran with 65%-70% moisture content before placing it in a separate container for rearing or sieving for immediate use in the method of claim 4. As such, this quick dip encompassed by the product-by-process is not considered to change the structure of the larva.
Regarding claims 6-7, Lee is silent as to the age of the larva outside of stating that they are fifth instar larva.
However, Sandrock teaches that larva can be collected at age 5 days old through sieving (page 5, paragraph 3), Larouche teaches that larva can be collected at 4 days old and 10 days old through sieving (page 54, paragraph 4-page 55, paragraph 1), and Ho teaches that 10 day old larva can be collected (page 7, paragraph 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of extracting AMPs from HIL of the combined method of Lee, Sandrock, Larouche, and Ho by collecting 8 day old larva prior to injecting a microbial liquid to arrive at the instantly claimed invention. One of ordinary skill in the art would have a reason to modify with a reasonable expectation of success because Sandrock teaches that larva can be collected at age 5 days old through sieving, Larouche teaches that larva can be collected at 4 days old and 10 days old through sieving, and Ho teaches that 10 day old larva can be collected. As such, the combined teachings of Sandrock, Larouche, and Ho identify that larva can be collected at any point between ages 4-10 days old through sieving for further experimentation. It is also worth noting that the claims broadly encompass sieving days before the antimicrobial liquid is delivered as there is no timeframe identified between the collecting and injecting. Furthermore, Larouche specifically identifies that larva can be collected at multiple stages before experimentation. As 8 day old larva lie within the range of possible collecting ages identified by Sandrock, Larouche, and Ho, it would have been obvious that the larva could be collected at 8 days old before injecting them with a microbial liquid. Additionally, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. 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). It is routine procedure to optimize component amounts to arrive at an optimal product that is superior for its intended use, since it has been held where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are close enough that one skilled in the art would have expected them to have the same properties. See M.P.E.P. §2144.05(I). Because the prior art teaches all of the elements of the claimed invention, there is a reasonable expectation of success.
Regarding claims 10-11, although Lee teaches that they inoculated their larva with different Lactobacillus strains at a concentration of 109 cfu/mL (equal to 106 cfu/μL), Lee does not teach inoculating the larva with S. aureus to produce AMPs.
However, Ho teaches that they collected and inoculated 20 10 day old larva for immunization studies by injecting the larva with either E. coli, S. aureus or combined bacterial strains (1 ×103 CFU/g, 10 μl) using insulin needles and that E. coli and S. aureus are commonly used to generate AMPs in HIL (page 6, paragraph 2-page 7, paragraph 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the combined method of Lee, Sandrock, Larouche, and Ho of extracting AMPs from HILs hemolymphs after injecting them with different Lactobacillus strains by injecting the HILs with S. aureus instead to produce different AMPs, as identified by Ho, to arrive at the instantly claimed invention. One of ordinary skill in the art would have a reason to inject them with S. aureus instead to produce AMPs with a reasonable expectation of success because Lee and Ho teach similar methods for inoculating HIL with different bacteria to produce AMPs and Ho teaches that S. aureus is commonly used to generate AMPs in HIL and successfully reduces to practice that HIL can be inoculated with S. aureus to produce AMPs. Therefore, it would have been obvious to one of ordinary skill in the art that they could have injected S. aureus to produce AMPs instead of different strains of Lactobacillus. Because the prior art teaches all of the elements of the claimed invention, there is a reasonable expectation of success.
As stated supra, Lee teaches that larva can be with bacteria at a concentration of 109 cfu/mL (equal to 106 cfu/μL) and Ho, as stated supra, teaches that 10 μL can be used to inject bacteria into the HIL.
As these concentrations and liquid amounts have been previously used to inoculate HIL, it would have been obvious that they could be used as part of this method of inoculating HIL with S. aureus. Because the prior art teaches all of the elements of the claimed invention, there is a reasonable expectation of success.
Claims 4-5 and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (Insects 11: 1-11. 2020) and further in view of Sandrock et al. (Insects 13: 1-31. 2022. Published April 2022), Larouche (Masters Thesis: Processing methods for the black soldier fly (Hermetia illucens) larvae: From feed withdrawal periods to killing methods. 2019. Published February 2020), and Ho et al. (Scientific Reports 11: 1-11. 2021) as applied to claims 4-5 above and further in view of Deng et al. (Science of the Total Environment 845: 1-20. 2022. Published July 2022).
The teachings of Lee, Sandrock, Larouche, and Ho are as discussed above.
The combined teachings of Lee, Sandrock, Larouche, and Ho do not teach using an 8-mesh sieve to separate the larva from the medium.
However, Deng teaches that they separated black soldier fly larva (BSFL; Hermetia illucens larva) from waste residues using an 8-mesh sieve before storing them for one day without feeding. Then the BSFL were processed for chemical analysis (abstract and page 2, column 2, paragraphs 1-4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the 1 mm sieve identified by Sandrock in the combined method of Lee, Sandrock, Larouche, and Ho of extracting AMPs from HILs hemolymphs by using an 8-mesh strainer instead, as identified by Deng, to arrive at the instantly claimed invention. One of ordinary skill in the art would have a reason to substitute the sieves with a reasonable expectation of success because Deng successfully reduces to practice that an 8-mesh sieve can be used to collect larva prior to starving them (as was done by Lee) for separating the larva from residues and substrates. Therefore, it would have been obvious to one of ordinary skill in the art that 8-mesh sieve can be used to collect larva and separate them from the substrate for later experimentation as it has been used for this exact purpose by Deng. Because the prior art teaches all of the elements of the claimed invention, there is a reasonable expectation of success.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEENAN A BATES whose telephone number is (571)270-0727. The examiner can normally be reached M-F 7:30-5:00.
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/KEENAN A BATES/Examiner, Art Unit 1631