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 .
Claims 62-83 are examined.
Election/Restrictions
Applicant's election with traverse of species SEQ ID NO: 37 in the reply filed on 12/16/2025 is acknowledged. The traversal is on the ground(s) that the sequences belong to the same group of stable microbial peptides. This is not found persuasive because each sequence represents a structurally distinct
chemical composition having an independent and distinct biological function. As such, each sequence would require a unique and individually customized search strategy to find relevant prior art. Moreover, a search on sequence identity alone may not reveal art regarding the methods of use and expression of the sequences. Therefore, to search all the species of the invention together would cause undue search burden. The requirement is still deemed proper and is therefore made FINAL.
Nucleotide and/or Amino Acid Sequence Disclosures
This application contains sequence disclosures in accordance with the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.831(a) and 1.831(b). However, this application fails to comply with the requirements of 37 CFR 1.831-1.834. The examiner has noted that claims 62, 69 and 75 comprise sequences which do not have identifiers and are not in the sequence listing. Claim 62 has a 63 residue-long amino acid sequence without an identifier, more than 4 non-variable residues, and several “X” residues. The most similar sequence in the application’s sequence listing is SEQ ID NO: 27, disclosed in SEQ.XML.SUPP (6/11/2024), which is also 63 residues-long but SEQ ID NO: 27 specifies the variable residues more narrowly than the unidentified sequence of claim 62, i.e., SEQ ID NO: 27 is not the same as the unidentified sequence of claim 62. The unidentified sequences in claims 69 and 75 are similarly deficient. Applicant must provide:
• A replacement “Sequence Listing XML” part of the disclosure, as described above in item 1. or 2.
• A statement that identifies the location of all additions, deletions, or replacements of sequence information in the “Sequence Listing XML” as required by 1.835(b)(3);
• A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.835(b)(4);
• A statement that the “Sequence Listing XML” includes no new matter in accordance with 1.835(b)(5); and
• A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required incorporation by reference paragraph as required by 37 CFR 1.835(b)(2), consisting of:
o A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
o A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
While Applicant has provided a response to the Office’s request for updated sequence listing mailed 4/12/2024, it is noted that the response still lacks a marked-up Specification and a sequence identifier for each sequence claimed as detailed above.
Claim Objections
Claims 74 and 75 are objected to because of the following informalities: both claims recite, “the SAMP sequence is a SAMP sequence from a different species of the plant” (claim 75) or a similar recitation (claim 74). It appears that Applicant may direct the claims to the same intended limitation by reciting, “the SAMP sequence is not endogenous to the plant”
Appropriate correction is required.
Improper Markush Grouping
Claims 62-83 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of sequences encompassed by the unidentified sequence of claims 62 and 75 are improper because the alternatives do not share both a single structural similarity and a common use for the following reasons: the members of the improper Markush grouping of claim 85 do not share a substantial feature and a common use that flows from the substantial structural feature for the following reasons: they include a multitude of unique protein sequences encompassed by the unidentified sequence comprising variable residues; the composition of which are structurally divergent.
Dependent claims 63-74 and 76-83 fail to cure the improper Markush groups of claims 62 and 75 and therefore these claims are also rejected for including improper Markush groups.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Claim Rejections - 35 USC § 112
Indefiniteness
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 62-83 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.
Claims 62 and 75 recite, “increased disease resistance or disease tolerance…”. Applicant has not provided a particular definition for either “disease resistance” or “disease tolerance”. The terms are overlapping or synonymous in scope as used by Applicant; however, Applicant’s claims are drawn to these terms in the alternative, indicating that the claimed products can only be one or the other. One of ordinary skill in the art would not be informed of how to differentiate which plant has increased resistance and which has increased tolerance.
Dependent claims 63-74 and 76-83 fail to cure the deficiency and therefore are also indefinite.
Claim 70 recites, “[t]he plant of claim 62, wherein the modified SAMP comprises at least one amino acid substitution corresponding to… any one of positions X1 to X25 of SEQ ID NO: 27. This makes the metes and bounds of the claim unclear because X1 to X25 of SEQ ID NO: 27 are variable residues. It is not clear how a substitution would be characterized relative to a residue which is already variable.
Improper Dependency
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 74 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 74 recites, “[t]he plant of clam 62, wherein the modified SAMP comprises the SAMP sequence of a different species of the plant.” This fails to encompass all limitations of the claim on which it depends because claim 62 requires that the modification is to an endogenous SAMP.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Written Description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 62-83 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Applicant claims a plant comprising a modification to an endogenous SAMP gene an isolated stable antimicrobial peptide (SAMP) comprising any variation of sequence encompassed by: X1GX2X3VSX4ENX5X6QGFX7HX8FEX9TFX10SX11EGX12AEYX13X14HPX15HVEX16ANX17X18LX19X20LEKX21LX22X23DYKPX24TX25RV, wherein the X residues are variable and wherein the plant has increased disease resistance to any disease (claim 62) Applicant claims a plant modified to express a SAMP of the same limitations (claim 75).
Applicant claims the plant is citrus (claim 63).
Applicant claims the disease is bacterial (claim 64).
Applicant claims the disease is a Liberibacter disease (claim 65) wherein the disease is HLB (claim 66).
Applicant claims the disease is an Agrobacterium or a Pseudomonas syringae disease (claim 67).
Applicant claims the modification is by CRISPR/Cas (claim 68).
Applicant specifies amino acids for the variable residues of the sequence of claim 62: X1 is R, K, or W; X2 is K or E; X3 is N or D; X4 is T or I; X5 is L, F, or R; X6 is H or Q; X7 is P or T; X8 is I, L, or V; X9 is S or F; X10 is E or D; X11 is T or L; X12 is V or I; X13 is V or I; X14 is S, A, or D; X15 is S, A, or V; X16 is Y or F; X17 is L or T; X18 is F, M, or L; X19 is A, P, or T; X20 is N or Q; X21 is V or F; X22 is V or I; X23 is V or I; X24 is T, E, or Q; and X25 is V, E, L (claim 69).
Applicant claims the plant of claim 62 has a modified SAMP with a substitution in the variable residues of SEQ ID NO: 27 (claim 70). This is interpreted as comprising the sequence of SEQ ID NO: 27, which comprises 25 variable residues.
Claims 70-74 are dependent on claim 62 and specify limitations of the modified SAMP.
Independent claim 75 is similar to claim 62 but requires the SAMP is not endogenous to the plant.
Claim 76 specifies that the modification of claim 75 is by infection with a citrus tristeza virus (CTV) vector comprising a nucleic acid sequence encoding the SAMP. Claim 77 specifies that the modification is by a CRISPR/Cas system. Claim 78 specifies that the nucleic acid encoding the SAMP is operably linked to a tissue-specific promoter. Claim 79 specifies that the promoter is a phloem-specific promoter. Claim 80 specifies that the promoter is constitutive. Claim 81 specifies that the SAMP comprises a polyadenylation region from a naturally occurring SAMP gene at the 3’ end of the coding region. Claims 82-83 specify sequence limitations of the SAMP protein sequence.
Applicant describes proteins SEQ ID NO: 1 and 2 being injected into the stems of Nicotiana benthamiana to treat infection of Candidatus Liberibacter solanacearum (Example 2, pages 46-47). Applicant describes an unidentified SAMP injected into the stems of HLB-positive citrus plants resulted in new shoots being non-symptomatic and reduced bacteria in the trees overall (Example 3, page 47). Applicant describes reducing infection of Candidatus Liberibacter solanacearum-infected potato and tomato, it appears this treatment was also applied by stem injection (Example 4, page 47). It is noted that elected SEQ ID NO: 37 shares 99% identity with SEQ ID NO: 1 from the working examples. However, while claim 73 requires the full-length of SEQ ID NO: 37, this claim is not limited by pathogens which it would increase disease resistance to.
Applicant does not describe the genus of sequences as broadly claimed. Applicant does not describe any sequences other than SEQ ID NO: 1 and 2. Applicant does not describe increasing disease resistance to any pathogen except for Candidatus Liberibacter solanacearum. SEQ ID NO: 1 and 2 share limited identity with the unidentified, variable sequence, which represents many embodiments, of claim 62 (see alignments below). Applicant does not describe the plant comprising the proteins other than by stem injection.
The described embodiments are not representative of the breadth of the claimed genus such that one of ordinary skill in the art would be able to envision which members of the claimed genus possess the claimed function. Applicant has not provided a structure-function relationship beyond SEQ ID NO: 1 and 2 reducing infection of Candidatus Liberibacter solanacearum.
Given the breadth of the genera encompassed by the claims, the described species are not sufficiently representative.
Alignment of unidentified sequence of claim 62 to SEQ ID NO: 1
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Alignment of unidentified sequence of claim 62 to SEQ ID NO: 2
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229
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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 62-83 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 11963533. Although the claims at issue are not identical, they are not patentably distinct from each other. The instant claims are drawn to a plant comprising a modified SAMP gene and protein encoded by the gene wherein the plant has increased disease resistance. Claims of the patent are directed to a composition that comprises a peptide that comprises the same peptide of the instant claims. The patented claims also recite an expression cassette introduced to a plant comprising a sequence encoding the SAMP. These claims make obvious a plant comprising the peptide. It is also noted that a plant comprising this peptide represents a species of an agricultural composition of claim 1 of the patent.
Conclusion
Claims 62-83 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID R BYRNES whose telephone number is (571)270-3935. The examiner can normally be reached 9:00 - 5:00 M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bratislav Stankovic can be reached at (571) 270-0305. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID R BYRNES/Examiner, Art Unit 1662
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