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
Applicants’ election without traverse of Group I (claims 1-7, 27-31, 46, 48, 51, and 61); and Applicants’ election without traverse of species corresponding to a CaNCR13 peptide of SEQ ID NO: 1, in the reply filed on September 3, 2026, is acknowledged.
The traversal is on the ground(s) that the sequences of the rejection are linked by non-conservative substitutions in a specific portion of the peptide. This is not found persuasive because the claims are not limited to those substitutions, and unity was found lacking for other reasons. SEQ ID NO: 3 or CaNCR13 of WO 2020146360 (Shah et. al., published July 16, 2020) has identical sequence identity to the amino acid sequence set forth in SEQ ID NO: 1 in the instant claim; and Yampolsky et. al. (“The Exchangeability of Amino Acids in Proteins”; Lev Y. Yampolsky and Arlin Stoltzfus; Genetics 170: 1459–1472, published August 2005) teaches exchangeability of amino acids is a measure of effects focused mainly on protein activity and stability as measured with biochemical or growth assays in the laboratory.
Additionally, the traversal is on the ground(s) that Group I and Group III claim is not materially different in scope and that the method of Group III expressly requires use of the Group I product. This is not found persuasive because the test for distinct inventions is whether the product, method of using the product as claimed, can be used in a materially different process. The method of preventing or treating requires different search strategies than the product composition comprising peptide variant. In the instant case, the product could be used as antimicrobial agent in various bacterial, fungal, or viral infections and/or prevention of diseases, which is different than the composition/method of making the product of Group I.
The requirement is still deemed proper and is therefore made FINAL.
The species of group I, therefore, claims 1-7, 27-31, 46, 48, 51, and 61 which read on the elected species has been considered.
Claims 1-7, 27-31, 46, 48, 51, and 61 are hereby examined on the merits.
Claims 5, 27, and 30 are amended.
Claims 32-35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on September 3, 2026.
Priority
The present application is 371 of PCT/US2022/076386 filed September 14, 2022. This application claims the benefit of US Patent Application Serial No. 63/374,436, filed September 2, 2022, and US Patent Application Serial No. 63/261,223, filed September 15, 2021.
Status of Claims
Claims 1-7, 27-35, 46, 48, 51, and 61 are pending.
Claims 5, 27, and 30 are amended. Claims 32-35 are withdrawn.
Claims 1-7, 27-31, 46, 48, 51, and 61 are hereby examined on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on November 25, 2024, was reviewed by the Examiner.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
The use of the terms GenScript, Sigma, ÄKTA pure, TECAN Infinite, which are trade names or a marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , ® or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
Claim Interpretation
Claims 1-7, 27-31, 46, 48, 51, and 61 are drawn to the elected species SEQ ID NO:1.
BRI of claim 1 recite “a CaNCR peptide variant comprising: one or more amino acid substitutions in a CaNCR peptide, wherein said CaNCR peptide comprises a CaNCR13 peptide of SEQ ID NO: 1, …. wherein the amino acid substitutions in the CaNCR peptide correspond to a D7I substitution, a D7S substitution, a D9I substitution, a D9P substitution, a K12W substitution, a K29F substitution, or any combination of said substitutions in a full length reference peptide of SEQ ID NO: 1 when the CaNCR peptide is aligned with SEQ ID NO: 1 at all cysteine residues, and wherein the CaNCR peptide variant has at least 50% sequence identity to SEQ ID NO: 1….”
The use of “comprising” implies the scope of the elected species having an amino acid sequence is being interpreted as open-ended requiring 100% identity to the amino acid sequence. The election of species of SEQ ID NO:1 read on claims 2-7.
BRI of claim 27 recite “wherein said peptide can inhibit microbial growth at a concentration of about 3 μM”. The specification states a wide range of peptide concentrations of CaNCR13 peptide (SEQ ID NO: 1) exhibiting antifungal activity at micromolar concentrations against the pathogens (see instant specification Example 1, Table 1). Therefore, for the sake of compact prosecution, the claims have been interpreted broadly, i.e., “ concentration of about 3 μM” is interpreted as concentrations above and below the 3 μM peptide concentration.
Claim Rejections - 35 USC § 101
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 1-7, 27-31, 46, 48, 51, and 61 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a natural product) without significantly more.
Claims 1 and 30 are drawn to CaNCR13 peptide of SEQ ID NO: 1.
The claims above recite the peptide SEQ ID NO: 1, which read on the following natural product:
is a plant derived product (See NCR13 - Nodule cysteine-rich protein 13 - Cicer arietinum (Chickpea) | UniProtKB, record date March 16, 2016, accessed September 15, 2026).
PNG
media_image1.png
293
646
media_image1.png
Greyscale
PNG
media_image2.png
410
574
media_image2.png
Greyscale
PNG
media_image3.png
154
522
media_image3.png
Greyscale
Claims 2-7, 27-29, 31, 46, 48, 51, and 61 are directed to compositions that comprise the claimed composition as recited in instant claims 1. Thus, the claimed invention is directed to a product or composition of matter, which is one of the statutory categories of invention.
Thus, claims 2-7, 27-29, 31, 46, 48, 51, and 61 encompass a naturally occurring product and a peptide which is not markedly different from its naturally occurring counterpart because it conveys the same genetic information. Therefore, the claimed invention is directed to a judicial exception.
These judicial exceptions are not integrated into a practical application because claims 1-7, 28, 29 and 31 fail to recite a practical application of the peptide variant composition comprising Nodule cysteine-rich protein 15 from source Cicer arietinum (Chickpea) (Garbanzo).
Regarding the recitation of “variant”, the term does not imply any structure to peptide of claims 2-7 beyond the requirement that the variant comprise, for example, “one or more amino acid substitutions in the peptide sequence,” relative to SEQ ID NO: 1. However, a protein that differs from SEQ ID NO: 1 by the presence a single amino acid will read on a product of nature, as set forth above.
Claim 27 is drawn to a peptide can inhibit microbial growth at a concentration of about 3uM, comprising administering an antimicrobial effective amount of the antimicrobial peptide of claim 1 to the locus of the microbe or yeast or to a plant or animal susceptible to an attack by the microbe or yeast. As explained above, the antimicrobial peptide of claim 1 encompasses a natural product, CaNCR13, isolated from Cicer arietinum. It is further noted that during the natural process of nodule formation, Cicer arietinum expresses said peptide in nodule tissue, where it contacts a microbe (nitrogen fixing bacterium) and inhibits the microbe by imposing irreversible terminal differentiation and a loss of cell-division capacity (see page 210, Abstract; column 2, paragraph 1, Montiel et. al. [cited in IDS filed November 25, 2024]). Thus, claim 27 encompasses the natural process of nodule formation in Cicer arietinum and is not directed to significantly more than a natural process.
Claim 30 is drawn to a composition comprising the antimicrobial peptide of claim 1. As explained above, the antimicrobial peptide of claim 1 encompasses a natural product, CaNCR13, isolated from Cicer arietinum. Claim 30 recited the additional element of an acceptable carrier, dilutant, or excipient. A person having skill in the art would recognize that water constitutes such a carrier, dilutant or excipient. During the natural process of nodule formation of Cicer arietinum, the peptide of claim 1 would naturally be diluted in the aqueous intracellular environment after expression and secretion. Thus, claim 30 is not directed to significantly more than a product of nature. Thus, the intended use of the judicial exception does not add a meaningful limitation to the claimed invention, as it is at such high level of generality that it fails to integrate the natural product into a practical application. Thereby, claims 1-7, and 27-31 are nothing more than an attempt to generally link the product of nature to a particular technological environment.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the structure of the claimed oligo-alpha-glucan and the tetrapeptide and compositions comprising the claimed the oligo-alpha-glucan and tetrapeptide, do not require a modification that is significantly more than the naturally occurring products in order to result in markedly different peptide and markedly different compositions.
Accordingly, it is the Examiner’s position that the claimed the oligo-alpha-glucan and tetrapeptide and compositions are directed to a “product of nature” exception without significantly more because it does not exhibit markedly different characteristics from the naturally occurring counterparts in the natural state.
Further, by virtue of their dependency, claims 46, 48, 51, and 61 are also rejected for this same reasoning.
Thus, claims 1-7, 27-31, 46, 48, 51, and 61 encompass patent ineligible subject matter.
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.
(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.
Claims 1-7, 27-31, 46, 48, 51, and 61 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by WO 2020146360 (published July 16, 2020).
WO’360 teaches antimicrobial nodule specific cysteine rich (NCR) peptides and proteins and recombinant or edited polynucleotides encoding the NCR peptides and proteins; the antimicrobial NCR peptides or proteins can be applied directly to a plant, human, or animal, applied to a plant in the form of microorganisms that produce the peptides, or the plants can be genetically transformed or edited to produce the peptides or proteins; and also relates to recombinant polynucleotides, edited polynucleotides, edited genomes, microorganisms and plants comprising those polynucleotides or genomes, and compositions useful in controlling pathogenic microbes (see [0003]).
For claims 1-7, 28: WO’360 discloses antimicrobial peptide comprising: …(ii) a variant of the amino acid sequence of SEQ ID NO: 3 (see claim 1); which is identical to the instantly claimed CaNCR13 peptide of SEQ ID NO: 1.
For claim 27: WO’360 exemplifies antimicrobial activity of the plant antimicrobial CaNCR13 peptide (see Example 1); the CaNCR13 peptide (SEQ ID NO: 3) exhibited antifungal activity at micromolar concentrations against the pathogens used in this study (see [00130], Table 2),
PNG
media_image4.png
142
676
media_image4.png
Greyscale
For claim 29: WO’360 teaches in certain embodiments, a third structural feature of NCR peptides is presence of one or more of the 6 conserved cysteine residues (see [0054]).
For claim 30: WO’360 discloses a composition comprising a first antimicrobial peptide comprising: … (ii) a variant of the amino acid sequence of SEQ ID NO: 3…and an agriculturally, pharmaceutically, or veterinarily acceptable carrier, diluent, or excipient (see claim 73).
For claim 31: WO’360 discloses the composition, wherein the first and/or the second antimicrobial peptide are provided at a concentration of about 0.1, 0.5, 1.0, or 5 ug/ml to about 1, 5, 20, 50, or 100 mg/ml for a liquid composition or at a concentration of about 0.1, 0.5, 1.0, or 5 ug/gram to about 1, 5, 20, 50, or 100 mg/gram for a powder or solid composition (see claim 83).
For claim 46: WO’360 teaches a recombinant polynucleotide comprising a first polynucleotide encoding a first antimicrobial peptide comprising: …(ii) a variant of the amino acid sequence of SEQ ID NO: 3 (see claim 1); a template polynucleotide comprising the polynucleotide encoding the antimicrobial peptide or a fragment thereof; and … a guide RNA (see [0014]); the encoding nucleotide sequence (e.g., gene, plasmid DNA, cDNA, or synthetic DNA) will thus have corresponding base substitutions, permitting it to encode biologically functional equivalent forms of the NCR peptides (see [0062]).
For claim 48: WO’360 teaches the recombinant polynucleotide, wherein the polynucleotide encoding the first antimicrobial peptide is inserted into a heterologous nuclear or plastid genome of a cell (see claim 8).
For claims 51 and 61: WO’360 teaches the recombinant polynucleotide, wherein the promoter provides for expression of the first antimicrobial peptide in a plant (see claim 7); the recombinant polynucleotide, wherein the heterologous nuclear or plastid genome is a monocot crop plant or a dicot crop plant nuclear or plastid genome (see claim 9.
Accordingly, the claims are anticipated.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-7, 27-31, 46, 48, 51, and 61 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,604,903 B2 (US‘903)( Date Published April 21, 2026). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claims 1-7, 28, 29: US’903 recites each antimicrobial peptide comprises the amino acid sequence of SEQ ID NO: 3 (see claim 4); wherein each antimicrobial peptide comprises an amino acid sequence that is at least 90% identical to the amino acid sequence set forth in SEQ ID NO: 3; wherein the amino acid sequence of each antimicrobial peptide monomer comprises, within the corresponding region of SEQ ID NO: 3, the six cysteine residues of SEQ ID NO: 3 in the same relative positions as in SEQ ID NO: 3 (see claim 1).
Amino acid sequence of SEQ ID NO: 3 of US’903 is identical to the instantly claimed CaNCR13 peptide of SEQ ID NO: 1
Regarding claim 27, US’903 specifies that compositions to inhibit growth of a susceptible microbial species; in certain embodiments, the susceptible microbial species is a Fusarium sp., Alternaria sp., Verticillium sp., Phytophthora sp., Colletotrichum sp., Botrytis cinerea, Cercospora sp., Phakopsora sp. Rhizoctonia sp., Sclerotinia sp., Pythium sp., or Puccinia sp. or is a human and animal microbial pathogen that is an Aspergillus sp., Fusarium sp., Candida sp., Histoplasma capsulatum, Paracoccidioides brasiliensis, Sporothrix shenkii, Blastomyces dermatitidis, Coccidioides sp., Geomyces destructans, Trichophyton sp. or Malassezia sp. Use of any of any of the aforementioned compositions in a method of treating, preventing, or inhibiting microbial or yeast infection in a subject in need thereof are provided. Use of any of the aforementioned first antimicrobial peptide or proteins in the manufacture of a medicament or composition for inhibiting microbial infection in a subject in need thereof (see col 4, line 34-52).
US’903 exemplifies antimicrobial activity of the plant antimicrobial CaNCR13 peptide (see Example 1); the CaNCR13 peptide (SEQ ID NO: 3) exhibited antifungal activity at micromolar concentrations against the pathogens used in this study (see Table 2).
PNG
media_image4.png
142
676
media_image4.png
Greyscale
Regarding claim 30: US’903 specifies a composition comprising a first antimicrobial peptide comprising: … (ii) a variant of the amino acid sequence of SEQ ID NO: 3…and an agriculturally, pharmaceutically, or veterinarily acceptable carrier, diluent, or excipient (see col 51, line 32-34).
Regarding claim 31: US’903 specifies the composition, wherein the first and/or the second antimicrobial peptide are provided at a concentration of about 0.1, 0.5, 1.0, or 5 ug/ml to about 1, 5, 20, 50, or 100 mg/ml for a liquid composition or at a concentration of about 0.1, 0.5, 1.0, or 5 ug/gram to about 1, 5, 20, 50, or 100 mg/gram for a powder or solid composition (see col 52, line 59-65).
For claim 46: US’903 specifies recombinant polynucleotides comprising a first polynucleotide encoding a first antimicrobial peptide comprising: .. a variant of the amino acid sequence of SEQ ID NO:3 (see col 2, line 43-47).
For claim 48, 51, and 61: US’903 specifies cells, plants, or plant parts comprising any of the aforementioned recombinant polynucleotides (see col 3, line 23-24).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KOYELI BANERJEE whose telephone number is (571)272-5751. The examiner can normally be reached Monday-Friday 8-4PM.
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, Melissa Fisher can be reached at (571) 270-7430. 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.
/KOYELI BANERJEE/ Examiner, Art Unit 1658
/Melissa L Fisher/ Supervisory Patent Examiner, Art Unit 1658
Prosecution Insights