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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-5, 8, 18-21, and 24-25) in the reply filed on 05/22/2026 is acknowledged.
Claims 9-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 1-5, 8, 18-21, and 24-25 are directed to the elected invention and have been examined on their merits.
Priority
The present application is a § 371 National Stage Entry of PCT/JP2022/045039 (filed on 12/07/2022) and claims priority to Japanese application JP2021-199634 (filed on 12/08/2021).
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/22/2026 is in compliance with the provisions of 37 C.F.R. 1.97. All references cited in this IDS have been fully considered.
Claim Objections
Claim 3 is objected to because the taxonomic name “Caenorhabditis elegans” should be italicized.
Claim 24 is objected to because the verb “comprising” should be changed to “comprises” and the redundant article “and” should be removed before “a salt of the cation” as it is not the end of the list.
Appropriate correction is required.
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.
Claim 1-5, 8, 18-21, and 24-25 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention.
Claim 1 is considered to be indefinite because it is not clear what is meant by “a main component”. The specification does not provide guidance as to what is meant by this phrase and it is not clear what standard applicant has applied to distinguish whether a given component is a “main component”. For example, does the water-soluble polymer have to provide a particular effect (such as by acting as an active ingredient) to be a considered a “main component” or is the “main component” determined by another standard (such as concentration or weight)?
Because the metes and bounds of this subjective term are not clearly defined, the claim is indefinite.
In the interest of compact prosecution, this claim has been examined for any nematode-encapsulating composition which comprises a water-soluble polymer because, for the reasons discussed above, it is possible to ascertain what is meant by the phrase “main component”.
Claims 2-5, 8, 18-21, and 24-25 are indefinite because they depend from claim 1 (or reference the structure of claim 1) but do not remedy the above identified indefiniteness.
Claim 3 is also considered to be indefinite because it is not clear what species are encompassed by the phrase “related species thereof”. For example, it is unclear if “related species” includes all species within the Caenorhabditis genus, a subset of species within the Caenorhabditis genus, or includes species of other genera which are considered to be “related” to Caenorhabditis. Applicant’s specification teaches that “Examples” of “related species” include C. brenneri, C. briggase, C. japonica, C. remanei, and C. inopinata ([0031]) but it is not clear if these are the only species encompassed by the phrase. Because the metes and bounds are not distinctly defined, the claim is indefinite.
In the interest of compact prosecution, this term has been examined for prior art purposes as if it limits the nematode to the genus Caenorhabditis.
Claim Rejections - 35 USC § 102
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 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.
Claims 1-2, 4-5, and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim et al. (Journal of Pest Science, 2021, Vol. 94, pages 1196-1208; cited in IDS filed on 09/06/2024).
Kim et al. teaches compositions comprising entomopathogenic nematodes (EPNs) as biological control agents (abstract). Kim teaches that EPNs have been shown to be highly effective biological control agents with unique advantages that chemical and other biological pesticides do not have (p. 1197, right col., par. 2). Kim teaches that EPN application in large-scale farming is still rare because of some critical obstacles such as higher production cost compared to synthetic chemical pesticides and the vulnerability of EPN to environmental factors (p. 1198, left col., par. 1). Kim teaches that viability and infectivity of infectious juveniles (IJs) decreased over time and limits the shelf-life to maximally a few months even when properly stored (p. 1198, left col., par. 2). Additionally, IJs are susceptible to UV radiation, heat and desiccation, and require proper agitation in storage tanks to prevent EPN settling (Id.). To address these problems, Kim present an improved version of an alginate-based EPN formulation (p. 1198, right col., par. 3).
Regarding claim 1, Kim teaches the production of glycerol-containing Ca2+-alginate capsules and beads by combining alginate-glycerol (i.e., a water-soluble polymer that gelatinizes by reacting with a cation; this interpretation is supported by [0044] of applicant’s specification) and IJs of Heterorhabditis bacteriophora (i.e., an encapsulation composition containing a nematode)(p. 1199, right col., par. 4 through p. 1200, right col., par. 1). The EPN-alginate-glycerol solution was dripped into a container with CaCl2-glycerol and 10 minutes later Ca2+-alginate beads (i.e., at least one layer made of a membrane with which the encapsulation composition is encapsulated) were collected (Id.). Kim reports that Glycerol-free EPN beads were produced under the same conditions (Id.).
Thus, Kim teaches a nematode-encapsulated capsule comprising:
an encapsulation composition containing a nematode; and
at least one layer made of membrane with which the encapsulation composition is encapsulated, the membrane containing, as a main component, a water-soluble polymer that gelatinized by reacting with a cation.
Regarding claim 2, as discussed above, Kim teaches the composition of claim 1. Figure 1 of Kim shows the Ca2+ on a 60 mm diameter petri dish. Because none of the capsules (or beads) are larger than the 60 mm (6 cm) diameter petri dish, it is apparent that Kim’s capsules have an outer diameter of not more than 10 cm.
Regarding claim 4, as discussed above, Kim teaches a capsule comprising alginate. Thus, Kim teaches the capsule wherein the water-soluble polymer is a polysaccharide.
Regarding claim 5, as discussed above, Kim teaches the composition of claim 1 including a glycerol-alginate solution. Kim teaches that they “used glycerol to induce EPN quiescence” and “[i]f they are not in a state of quiescence, EPN will continuously try to wiggle out of the capsule” (p. 1205, right col., par. 2). Thus, because Kim used glycerol to induce quiescence in the EPNs, it involves a nematode having been treated with a hatching inhibitor.
Regarding claim 8, as discussed above, the encapsulation composition contains a hatching inhibitor (glycerol).
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 1-2, 4-5, 8, 20-21 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (Journal of Pest Science, 2021, Vol. 94, pages 1196-1208; cited in IDS filed on 09/06/2024).
The teachings of Kim are set forth above and applied herein. Kim is found to render obvious claims 1-2, 4-5, and 8.
Regarding claim 20, as discussed above, Kim teaches a nematode encapsulation composition made from a nematode (H. bacteriophora), water-soluble polymer (alginate), and a salt of a cation (CaCl2).
Kim differs because it does not explicitly state that these components can be in a production kit for producing the nematode-encapsulated capsule.
Nonetheless, it would have been prima facie obvious to have formulated each of the components in Kim’s method of manufacturing a nematode-encapsulated capsule in a generic “production kit” in order to, for example, improve the ease of use of Kim’s methods such as by providing each of the components in a ready-to-use form. Kim teaches that the cation is necessary to gelatinize the polymer around the nematode and it therefore would have been particularly advantageous to have provided each component separately. For example, Kim teaches procuring sodium alginate, CaCl2, and the nematodes separately (p. 1199, left col., par. 3 and right col., par. 3). There would have been a reasonable expectation of success because the modification merely requires packaging Kim’s components into a “kit”. This obviousness is based upon the “Some Teaching, Suggestion, or Motivation in the Prior Art That Would Have Led One of Ordinary Skill To Modify the Prior Art Reference or To Combine Prior Art Reference Teachings To Arrive at the Claimed Invention” rationale set forth in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007). See MPEP 2143(I)(G).
Regarding claim 21, as discussed above, Kim teaches a nematode encapsulation composition made from a nematode (H. bacteriophora), water-soluble polymer (alginate), and a salt of a cation (CaCl2). As discussed above, Kim teaches the composition of claim 1 including a glycerol-alginate solution. Kim teaches that they “used glycerol to induce EPN quiescence” and “[i]f they are not in a state of quiescence, EPN will continuously try to wiggle out of the capsule” (p. 1205, right col., par. 2). Thus, because Kim used glycerol to induce quiescence in the EPNs, it involves a nematode having been treated with a hatching inhibitor.
Kim differs because it does not explicitly state that these components can be in a production kit for producing the nematode-encapsulated capsule.
Nonetheless, it would have been prima facie obvious to have formulated each of the components in Kim’s method of manufacturing a nematode-encapsulated capsule in a generic “production kit” in order to, for example, improve the ease of use of Kim’s methods such as by providing each of the components in a ready-to-use form. Kim teaches that the cation is necessary to gelatinize the polymer around the nematode and it therefore would have been particularly advantageous to have provided each component separately. For example, Kim teaches procuring sodium alginate, CaCl2, and the nematodes separately (p. 1199, left col., par. 3 and right col., par. 3). There would have been a reasonable expectation of success because the modification merely requires packaging Kim’s components into a “kit”. This obviousness is based upon the “Some Teaching, Suggestion, or Motivation in the Prior Art That Would Have Led One of Ordinary Skill To Modify the Prior Art Reference or To Combine Prior Art Reference Teachings To Arrive at the Claimed Invention” rationale set forth in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007). See MPEP 2143(I)(G).
Regarding claim 24, as discussed above, Kim teaches the use of glycerol as a “hatching inhibitor”. For the reasons discussed above, it would have been obvious to have arrived at a generic “production kit” comprising a nematode, the water-soluble polymer, and a salt of the cation. For the same reasons, it would have been obvious to have further included the hatching inhibitor in such kit.
Claims 1-5, 8, 20-21 and 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (Journal of Pest Science, 2021, Vol. 94, pages 1196-1208; cited in IDS filed on 09/06/2024) in view of Hirotsu et al. (US 2020/0208192 A1).
The teachings of Kim are set forth above and applied herein. Kim is found to render obvious claims 1-2, 4-5, 8, 20-21, and 24.
Regarding claims 3 and 25, as discussed above, Kim teaches the production of the nematode-encapsulated capsule of claim 1.
Kim differs from the instant claims because it uses Heterorhabditis bacteriophora rather than Caenorhabditis elegans or a related species thereof (claim 3) or a nonparasitic nematode (claim 25).
Nonetheless, Hirotsu teaches a method for highly sensitively and highly specifically detecting a kidney cancer by diluting a urine sample and determining whether or not nematodes exhibit attraction behavior toward the diluted urine sample (abstract). Specifically, Hirotsu teaches a diagnostic kit for a kidney cancer, containing nematodes, the kit being for use in a method for detecting a kidney cancer ([0087]). Hirotsu defines nematode to mean Caenorhabditis elegans ([0043])(i.e., a nonparasitic nematode as required by claim 25).
Because Hirotsu teaches compositions comprising C. elegans (i.e., a nonparasitic nematode) and because Kim teaches encapsulated nematodes as addressing the problem of nematode stability, shelf-life, and efficient application, it would have been obvious to have simply substituted Kim’s H. bacteriophora with another nematode such as C. elegans. Both nematodes were previously known in the art and the substitution would have predictably resulted in a more stable C. elegans formulation for Hirotsu’s methods. The modified nematode composition would have been predictably operable because Kim teaches that the “EPN can readily escape when quiescence is broken by adding water” (Kim, p. 1205, right col., par. 2) and Hirotsu’s urine samples (a) comprise water naturally and (b) are diluted in water, distilled water, or sterile water ([0071]). Thus, a person having ordinary skill in the art would have had a reasonable expectation of success when making this substitution. This obviousness is based upon the “Simple Substitution of One Known Element for Another to Obtain Predictable Results” rationale set forth in in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
Thus, claims 3 and 25 are obvious over Kim in view of Hirotsu.
Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Hirotsu et al. (US 2020/0208192 A1) in view of Kim et al. (Journal of Pest Science, 2021, Vol. 94, pages 1196-1208; cited in IDS filed on 09/06/2024).
The teachings of Kim and Hirotsu are set forth above and applied herein.
Regarding claim 18, as discussed above, Hirotsu teaches a method for highly sensitively and highly specifically detecting a kidney cancer by diluting a urine sample and determining whether or not nematodes exhibit attraction behavior toward the diluted urine sample (abstract). Hirotsu teaches a diagnostic kit for a kidney cancer, containing nematodes, the kit being for use in a method for detecting a kidney cancer ([0087]).
Accordingly, Hirotsu teaches a nematode response evaluation kit comprising a nematode.
Hirotsu differs from the instant claim because it does not teach that the nematode is formulated as a nematode-encapsulated capsule according to claim 1.
As discussed above, Kim teaches the encapsulated nematode composition of claim 1.
Specifically, Kim teaches the production of Glycerol-containing Ca2+-alginate capsules and beads by combining alginate-glycerol (i.e., a water-soluble polymer that gelatinizes by reacting with a cation; this position is supported by [0044] of applicant’s specification) and IJs of Heterorhabditis bacteriophora (i.e., an encapsulation composition containing a nematode)(p. 1199, right col., par. 4 through p. 1200, right col., par. 1). The EPN-alginate-glycerol solution was dripped into a container with CaCl2-glycerol and 10 minutes later Ca2+-alginate beads (i.e., at least one layer made of a membrane with which the encapsulation composition is encapsulated) were collected (Id.). Kim reports that Glycerol-free EPN beads were produced under the same conditions (Id.).
Thus, Kim teaches a nematode-encapsulated capsule comprising:
an encapsulation composition containing a nematode; and
at least one layer made of membrane with which the encapsulation composition is encapsulated, the membrane containing, as a main component, a water-soluble polymer that gelatinized by reacting with a cation.
Because Hirotsu teaches a nematode response evaluation kit comprising a nematode and because Kim teaches that encapsulated nematodes such as the nematode capsules and beads can provide benefits such as improving nematode viability and shelf life (Kim, p. 1204, right col., par. 4-5), it would have been obvious to have modified Hirotsu’s kit such that the nematode is a nematode-encapsulated capsule described by Kim. There would have been a reasonable expectation of success because the modification does not change the active component (the nematode) in the kit but merely provides it in a form which was previously known to be superior to the nematode per se. And although Kim’s nematode capsules are largely directed to agricultural purposes, their applicability to Hirotsu’s methods would have been readily recognized because the “EPN can readily escape when quiescence is broken by adding water” (Kim, p. 1205, right col., par. 2) and Hirotsu’s urine samples (a) comprise water naturally and (b) are diluted in water, distilled water, or sterile water ([0071]). This obviousness is based upon the “Some Teaching, Suggestion, or Motivation in the Prior Art That Would Have Led One of Ordinary Skill To Modify the Prior Art Reference or To Combine Prior Art Reference Teachings To Arrive at the Claimed Invention” rationale set forth in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007). See MPEP 2143(I)(G).
Thus, claim 18 is obvious over Hirotsu in view of Kim.
Regarding claim 19, although the particular purpose of the kit is an intended use and does not impart any structural limitations on the kit (i.e., although claim 19 is obvious for the same reasons set forth above), it is noted that Hirotsu’s kit is for a cancer test.
Conclusion
No claim is allowed.
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/GRANT C CURRENS/Examiner, Art Unit 1651
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