DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1-2, 6, 9-11, 13-15, and 17-27 are pending (claim set as filed on 05/24/2023).
Election/Restrictions
Applicant’s election of Group I, composition claims, in the reply filed on 12/17/2025 is acknowledged. Because Applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP 818.01(a)).
Method claims 11, 13-15, and 17-27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Therefore, only composition claims 1-2, 6, and 9-10 are presented for examination.
Priority
This application is a 371 of PCT/IL2021/051400 filed on 11/24/2021, which has a provisional application no.: 63/117,652 filed on 11/24/2020.
Information Disclosure Statement
The Information Disclosure Statement (IDS) submitted on 05/24/2024 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the Examiner.
Drawings
The drawings filed on 05/24/2023 have been accepted.
Abstract Objection
The abstract of the disclosure is objected to because it does not comply with the proper language and format (see MPEP 608.01(b)). Appropriate correction is required.
Applicant is reminded of the proper language and format for an abstract of the disclosure. The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words. It is important that the abstract not exceed 150 words in length since the space provided for the abstract on the computer tape used by the printer is limited. The form and legal phraseology often used in patent claims, such as “means” and “said” should be avoided. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details. The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns”, “The disclosure defined by this invention”, or “The disclosure describes”, etc.
Claim Rejections - 35 USC §101, Subject Matter Eligibility
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-2, 6, and 9-10 are rejected under 35 U.S.C. 101 because they are drawn to ineligible subject matter (based on the 2019 Revised Patent Subject Matter Eligibility Guidance).
STEP 1: Is the claim directed to a process, machine, manufacture, or a composition of matter?
YES, the claims are directed to a composition of matter.
STEP 2A: PRONG ONE: Does the claim recite an abstract idea, law of nature, or natural phenomenon?
YES, the claims are considered to be “product of nature” exceptions (i.e., a nature-based product(s)). The courts have held that “products of nature” fall under the laws of nature and/or natural phenomena exceptions.
PRONG TWO: Does the claim recite additional elements that integrate the judicial exception into a practical application?
NO, the additional elements or a combination of elements in the claims does not impose a meaningful limit on the judicial exception. Note that the markedly different characteristics analysis is used to determine if a nature-based product is a “product of nature” exception. Thus, the markedly different characteristics analysis is part of Step 2A, i.e., it helps answer the question of whether a claim is directed to an exception as further explained below.
STEP 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
NO, the claimed invention is directed to a law of nature and/or natural phenomena (i.e., a product of nature) without significantly more.
Claim interpretation: note that the claims must be interpreted under the broadest reasonable interpretation (BRI) standard when evaluating for a marked difference:
the claims’ preamble(s) recite the term “synthetic” which suggests that the composition is engineered, artificially produced, or man-made influenced thereby implying that the claimed composition “are not found in nature” (as disclosed by the pre-grant specification at ¶ [0055]). However, the analysis is not based on whether or not it is found in nature but rather if the claimed composition is patentably different enough from what is found in nature (i.e., markedly different from its naturally occurring counterpart) (MPEP 2106.04(c) “a comparison of the claimed [cloned] sheep to naturally occurring sheep when determining that the claimed sheep was a product of nature because it "does not possess ‘markedly different characteristics from any [farm animals] found in nature”).
regarding base claim 1’s mixture comprising “eggs, juveniles, dauers, and adults” belonging to genus Allodiplogaster, these are developmental stages of the naturally occurring free-living nematode. Bar-Eyal (reference cited below in the prior art section) teaches “isolated a species of diplogastrid predatory nematode from tomato roots infected with the root-knot nematode M. javanica and this has been described as Koerneria sudhausi” (see Bar-Eyal at page 634, left col. cited below & the pre-grant specification at ¶ [0176] which discloses Allodiplogaster (=Koerneria)sudhausi).
regarding claims 1, 6, and 9, under BRI, naturally occurring water reads on the claimed phrases of “an acceptable carrier” and “a liquid carrier”. Moreover, the recitation of “optionally”, the MPEP 2111.04 states that “a claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure”. Thus, the limitations following the term “optionally” are not required.
regarding claims 2 and 10, the amount of dauer and “mixture of predatory nematode and said carrier … weight per weight (w/w) ratio ranging from 1:40 to 1:100” describes how much dauer or water is present but this does not make it markedly different from its counterpart.
There is no indication that the claimed composition has any markedly different characteristic (e.g., structure, function, phenotype, etc.) that is different than what is found in nature. Thus, it appears that Applicant is claiming a mixture of naturally occurring product(s) or at least substantially resembling thereof.
Therefore, the claims are interpreted under the BRI standard, wherein the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim does not recite any additional elements.
Therefore, the claims, as a whole, are considered as products of nature which are directed to judicially recognized exceptions without amounting to significantly more from what occurs in nature and thus, are not eligible subject matter under 35 U.S.C. §101.
Claim Rejections - 35 USC §102, Anticipation
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, 6, and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bar-Eyal (Laboratory studies on the biocontrol potential of the predatory nematode Koerneria sudhausi (Nematoda: Diplogastridae), 2008 - previously cited and in the IDS filed on 05/24/2024).
Bar-Eyal’s general disclosure relates to using predatory nematodes to control plant-parasitic nematodes (see page 633, left col. 1st sentence).
Bar-Eyal teaches “we have isolated a species of diplogastrid predatory nematode from tomato roots infected with the root-knot nematode M. javanica and this has been described as Koerneria sudhausi” (see page 634, left col. 1st sentence). Claim interpretation: the specie K. sudhausi belongs to the genus Allodiplogaster (see pre-grant specification at ¶ [0176] which discloses Allodiplogaster (=Koerneria)sudhausi). Bar-Eyal further teaches adult and juveniles of K. sudhausi were isolated and introduced to a nematode growth medium (see page 634, left col.). Eggs were collected from the nematode culture (see page 634, right col.). Bar-Eyal further teaches tomato assays wherein “One thousand K. sudhausi consisting of eggs, juveniles and adults in 10 ml of tap water were introduced to the soil by injecting the nematode suspension into five holes (7 cm depth) in the pot soil” (see page 635, left col.). Bar-Eyal teaches “Another advantage of K. sudhausi is the existence of dauer juveniles, which are tolerant to adverse environmental conditions” (see page 637, left col.).
Regarding claims 6 and 9 pertaining to the acceptable carrier, Bar-Eyal teaches the predatory nematodes were suspended in tap water (see page 634, left col.). Bar-Eyal further teaches tomato assays wherein “One thousand K. sudhausi consisting of eggs, juveniles and adults in 10 ml of tap water were introduced to the soil by injecting the nematode suspension into five holes (7 cm depth) in the pot soil” (see page 635, left col.).
Claim Rejections - 35 USC §103, Obviousness
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 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 non-obviousness.
Claims 2 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Bar-Eyal as applied to claims 1, 6, and 9 above.
Bar-Eyal’s teachings is discussed above as it pertains to a composition comprising a mixture of developmental stages of a predatory nematode belonging to the genus Allodiplogaster comprising eggs, juveniles, dauers, and adults, and an acceptable carrier.
However, Bar-Eyal does not teach: wherein at least 2% of said predatory nematodes in said mixture are dauers (claim 2); or wherein said mixture of predatory nematode and said carrier are present in said synthetic nematocidal composition in a weight per weight (w/w) ratio ranging from 1:40 to 1:100 (claim 10).
Furthermore, if not expressly taught by the references, based upon the overall objective provided by Bar-Eyal with respect maximizing efficiency of predation on plant-parasitic nematode by diplogastrid predators in soil environments and reduction of root galling index (see page 633, right col.), the adjustments of particular conventional working conditions (e.g., the amount of dauers or mixture weight ratio thereof) is deemed a matter of judicious selection and routine optimization which is within the purview of the skill artisan. The MPEP 2144.05(II)(A) states that “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature 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”. Bar-Eyal performs experimental assays with various amounts of eggs, juveniles, and adults (see Materials and Methods section) and teaches that “Another advantage of K. sudhausi is the existence of dauer juveniles, which are tolerant to adverse environmental conditions” (see page 637, left col.). This is motivation for someone of ordinary skill in the art to practice or test the parameter widely to find those that are functional or optimal which then would be inclusive or cover the steps as instantly claimed. Absent any teaching of criticality by the Applicant concerning the amount of dauers and/or weight ratio of the mixture, it would be prima facie obvious that one of ordinary skill in the art would recognize these limitations are result effective variable which can be met as a matter of routine optimization.
Conclusion
No claims were allowed.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NGHI V NGUYEN whose telephone number is (571)270-3055. The examiner can normally be reached Mon-Fri: 9 - 3 pm (ET).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached on (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NGHI V NGUYEN/Primary Examiner, Art Unit 1653