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 of Group V, claims 23, 24, and 26, and species SEQ ID NO: 40 in the reply filed on 09/02/2025 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)).
SEQ ID NO: 40 corresponds to a banana PPO1 amino acid sequence. Applicant requests that SEQ ID NOs: 5, 151, and Banana Genome Hub Acc. No. Ma06_31080, which are nucleotide sequences encoding SEQ ID NO: 40, also be examined (response, paragraph bridging p. 10-11).
Claims 23, 24, and new claims 36-48 are pending. Claims 23, 24, 36-40, 42-44, 46-48, SEQ ID NOs: 5, 40, 151 and Banana Genome Hub Acc. No. Ma06_31080 are examined herein. Claims 41 and 45 are withdrawn from consideration as being drawn to non-elected inventions or species.
Information Disclosure Statement
The entry for JP-2004049022-A in the information disclosure statement of 09/20/2024 is lined through as not considered. It is acknowledged that the IDS indicates that the English counterpart for this JP document is EP 15412016 (which is also listed in the IDS and considered). However, the copy of the JP document itself is missing most of its text.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code, on 1) p 30, line 20, 2) p. 37, line 26, 3) p. 92, line 13, 4) p. 93, line 23, and 5) p. 98, line 6. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
The specification in Table 8 recites nucleotide sequences which are not referred to by their sequence identifiers, and Figs. 3, 6, and 7 recite amino acid or nucleotide sequences that are not referred to by their sequence identifiers, as required by 37 CFR 1.821(d). It is suggested that Table 8 be amended, and either the figures or their brief descriptions, be amended by inserting the respective sequence identifiers. Each of the aforementioned amino acid or nucleotide sequences are at least 4 amino acids or 10 nucleotides long. These sequences must be contained in the sequence listing, if they are not already within it, in accordance with 37 CFR 1.821(c).
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 23, 24, 40, 42, and 43 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.
Claim 23 is found indefinite because of the term “characterised” in the recitation, “(D) comprising a sequence characterized by (a) Banana Genome Hub accession number Ma06_31080 (PPO1)”. It is unclear what is meant by the term “characterized” in the context of the claim. The specification indicates that the protein PPO1 is set forth in SEQ ID NO: 40 and is in the Banana Genome Hub accession number Ma06_31080 (p. 95, Table 1; p. 12, lines 29-30). The specification also indicates that SEQ ID NOs: 5 and 151 are both the PPO1 gene coding sequences from banana, also in Accession number Ma06_31080 (p. 11, lines 1-2; p. 16, lines 26-27). However, it is not apparent that “characterized by” is only referring to the nucleotide sequence encoding PPO1 within Acc. No. Ma06_31080 (which is set forth in SEQ ID NOs: 5 and 151), especially given that part (A) of the claim recites, “comprising a coding sequence selected from…SEQ ID NO: 5”, part (B) recites, “encoding a polyphenol oxidase selected from…SEQ ID NO: 40”, and part (C) recites, “comprising a polynucleotide sequence selected from…SEQ ID NO: 151”. If “characterised by” is intended to only refer to the nucleotide sequence of the banana PPO1 gene, it is suggested that part (D) of the claim be deleted, given the sequence is provided in SEQ ID NOs: 5 and 151.
Claims 24, 40, 42, and 43 are included in this rejection, as they depend from claim 23 and do not obviate the issue.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 23, 24, 36-40, 42-44, 46-48 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.
Example 2 in the specification teaches how the banana polyphenol oxidase (PPO) genes were identified. Nine banana (Musa acuminata) PPO homologs were identified. The amino acid sequence of the PPO1 protein is set forth in SEQ ID NO: 40. As discussed above, SEQ ID NOs: 5 and 151 are both disclosed in the specification as setting forth nucleotide sequences that encode the sequence in SEQ ID NO: 40, and all three sequences are disclosed as being with Banana Genome Hub Acc. No. Ma06_31080.
The claims broadly encompass a banana plant or part thereof comprising in its genome a modification in an endogenous PPO1 gene, wherein said modification results in a reduction in, or loss of function of, the PPO1 polyphenol oxidase encoded by said modified endogenous PPO1 gene, wherein said modification is located in an endogenous PPO1 gene comprising a coding sequence of SEQ ID NO: 5 or a polynucleotide with at least 75% sequence identity to SEQ ID NO: 5, or an endogenous PPO1 gene encoding a PPO of SEQ ID NO: 40 or a polypeptide with at least 75% sequence identity to SEQ ID NO: 40, or an endogenous PPO1 gene comprising a polynucleotide sequence of SEQ ID NO: 151 or a polynucleotide sequence with at least 75% sequence identity to SEQ ID NO: 151, or an endogenous PPO1 gene comprising a sequence characterized by Banana Genome Hub Acc. No. Ma06_31080.
The specification does not disclose any endogenous banana PPO1 coding sequence other than the nucleotide sequences set forth in SEQ ID NOs: 5 and 151. While the claims encompasses endogenous PPO1 genes with coding sequences that differ from SEQ ID NOs: 5 and 151 by as much as 25%, no other banana endogenous PPO1 genes are described in the specification or the prior art. The specification also does not describe polyphenol oxidases, and their endogenous coding sequences, having amino acid sequences that differ from SEQ ID NO: 40 by as much as 25%. SEQ ID NOs: 5, 40, and 151 are the only endogenous banana PPO1 amino acid or coding sequences that are described. These are the only endogenous banana sequences that are correlated with PPO1 activity. No other endogenous banana PPO1 sequences were identified (Example 2).
Further, in regards to part (D) of claim 23: any other sequences that may be in Acc. No. Ma06_31080 besides SEQ ID NOs: 5, 40, and 151 are not described in the specification. The specification contains a statement that all publications mentioned therein are incorporated by reference (p. 111, last paragraph). However, essential subject matter cannot be incorporated by reference to a non-U.S. patent or U.S. patent application publication (37 CFR 1.57(d)).
Given the breadth of the claims, it is submitted that the specification fails to provide adequate written description of the broad genus of banana plants or parts encompassed by the claims.
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 23, 24, 36-40, 42-44, 46-48 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 19/422,730 (reference application; there is at least one inventor in common). Although the claims at issue are not identical, they are not patentably distinct from each other because they are both drawn to a banana plant comprising a mutation in an endogenous PPO1 gene, wherein the modification results in a reduction in, or loss of function of, the endogenous PPO1 gene.
‘730 is a plant patent application that claims a new and distinct variety of banana plant. The specification of ‘730 indicates that the new banana (Musa acuminata) variety is named ‘Pomona’, which was generated by using gene-editing techniques to induce mutations in three polyphenol oxidase (PPO1) genes in the parent variety Cavendish Grande Naine. Pomona has reduced browning of fruit flesh after damage or exposure to air ([0002]-[0004]). The mutations result in premature stop codons, resulting in truncated PPO1 proteins ([0014]). The banana plant claimed in ‘730 is the same specie as that of the instant claims, therefore the endogenous PPO1 gene sequence in the plant claimed in ‘730 before modification is that encompassed by the instant claims before modification as well. The plant claimed in ‘730 anticipates instant claims 23, 24, 36-40, 42, 44, 46, and 47. It would have been obvious for one of ordinary skill in the art to have peeled the banana of the plant claimed in ‘730 to obtain the fruit for consumption (reading on instant claims 43 and 48).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHWIN D MEHTA whose telephone number is (571)272-0803. The examiner can normally be reached M-F 9am-5pm.
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/ASHWIN D MEHTA/ Primary Examiner, Art Unit 6211
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