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 with traverse of group II (claims 21-25 and 27-30) in the reply filed on 23 February 2026 is acknowledged. Applicant's election with traverse of SEQ ID NO:103 representing a BSα and SEQ ID No:104 representing a BSβ in the reply filed on 23 February 2026 is acknowledged. The traversal is on the ground(s) that Boatright teaches enzymes present in petunia tissues which are not products of nature. This is not found persuasive, because Boatright also teaches extracts from the petunia plant (Section titled, “Enzyme Assays,” p. 2010).
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-20 and 32-48 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 23 February 2026. Note that in Applicant’s response to a species election requirement, it is unclear if they intended to traverse the species election requirement. If a traversal was intended, it is assumed that it would be on the same grounds as the traversal of the restriction requirement. If this is the case, the traversal in unpersuasive for the reason indicated above.
Claim Status
Claims 1-25, 27-30, and 32-48 are pending.
Claims 1-20 and 32-48 are withdrawn from consideration.
Claims 21-25 and 27-30 are examined on the merits.
Claim Interpretation
The claims are drawn to active heterodimeric enzymes “isolated from the biosynthesis platform,” without the specification providing guidance as to the meaning of “isolated.” It is interpreted that any separation from the place of production is considered “isolated.” This means that crude extracts from plants naturally expressing these constructs is within the scope of the claim. Note that claims 22 and 25 make clear that broad claims are intended to encompass embodiments wherein the BSα and BSβ subunits are from the same species. Further, if these embodiments occur naturally then they are not patent eligible as products of nature whether “isolated” or not. See rejection under 35 USC 101 below. Additionally, note that Lycopersicon esculentum, Solanum lycopersicum, and Solanum esculentum are synonyms.
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.
Claims 22-24 and 29-30 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 pre-AIA the applicant regards as the invention.
Claim 22 recites, “independently selected.” It is unclear how this recitation is intended to limit the claims. The step of “independently selecting” something seems to be a step that is only mental. This means that infringement could only be determined by a mind reader. Claims 23-24 are rejected for depending from an indefinite claim and failing to recite additional limitations that would render the claims definite.
Claim 24: The groupings of in items (i)-(iii) are not similar in nature to the point that the structure of the claim borders on confusing. Item (i) specifies that the first nucleic acid is from Arabidopsis thaliana and the second nucleic acid is selected from the species Prunus dulcis, Petunia hybrida, and Solanum lycopersicum. Item (ii) specifies that the first nucleic acid is from Arabidopsis thaliana and the second nucleic acid is from the species Prunus dulcis. Item (iii) specifies that the first nucleic acid is from Arabidopsis thaliana and the second nucleic acid is from the species Petunia hybrida. This results in item (i) being very asymmetrical to items (ii) and (iii) even though all three items use the same level of itemization in the outline scheme. It is unclear why the item (i) does not specify that the first nucleic acid is from Arabidopsis thaliana and the second nucleic acid is from the species Solanum lycopersicum. This would result in all three combinations listed in item (i) being claimed in items (i)-(iii) in a much clearer manner.
Claims 29-30 recite, “wherein the BSα/β subunit is or comprises SEQ ID NO…” The recited SEQ ID NOs all represent nucleotide sequences, so it unclear how the nucleotide molecules can be a BSα/β subunit. As such, the metes and bounds of claims cannot be determined.
Lack of Written Description
The following is a quotation 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 21 and 27-28 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 21 broadly drawn to any heterodimeric benzaldehyde synthase that comprises both BSα and BSβ subunits regardless of their structure. Claim 27 requires that the BSα is encoded by a polynucleotide at least 50% identical to SEQ ID NO:3 and the BSβ is encoded by a polynucleotide at least 50% identical to SEQ ID NO:4. Polynucleotides with 50% identity to SEQ ID NO:3 can have up to 426 substitutions. The polypeptide encoded by SEQ ID NO:3 is only 283 amino acids in length. Polynucleotides with 50% identity to SEQ ID NO:4 can have up to 400 substitutions. The polypeptide encoded by SEQ ID NO:3 is only 266 amino acids in length. If the substitutions are non-synonymous the resultant polypeptides would not share any identity with the polypeptides SEQ ID NO:3 and SEQ ID NO:4. Thus, claims 27-28 also do not have any structural limitations on the BSα and BSβ subunits encompassed in the claims.
The instant disclosure describes working examples from BSα and BSβ subunits from four different species (Arabidopsis thaliana, Prunus dulcis, Petunia hybrida, and Solanum lycopersicum). The only BSα and BSβ subunits combination that did not yield active was the Arabidopsis thaliana BSβ combined with Petunia hybrida or Solanum lycopersicum BSα subunits (Example 7). While this suggests that many combinations will form an active heterodimer, there is some indication that this may need to be determined empirically. It is of note that tomato and petunia are from the same family and the subunits likely share substantial identity to one another and thus would be more likely to form an active heterodimer.
These descriptions are insufficient, because they fail represent the broad scope of unlimited structures of BSα and BSβ subunits that could form an active heterodimer.
Given the broad scope of the claimed genus, the lack of working examples and the failure to describe the structures required to confer the claimed function, one of skill in the art would not have recognized that Applicant was in possession of the claimed genus at the time of filing.
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 21, 25, and 27-30 are rejected under 35 U.S.C. 101, because the claimed invention is directed to a product of nature without significantly more. The claim(s) recite(s) isolated active heterodimeric enzymes that include naturally-occurring embodiments. This judicial exception is not integrated into a practical application, because a naturally occurring product is not patent-eligible merely because it has been isolated (Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013)).
Claim Rejections - 35 USC § 102
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.
Claim(s) 21 and 27-28 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Boatright 2004 (Plant Physiology 135: p. 1993-2011).
Boatright discloses extracts from the petunia plant which necessarily comprise the benzaldehyde synthase enzyme naturally occurring in petunia (Section titled, “Enzyme Assays,” p. 2010). SEQ ID NOs:3 and 4 naturally occur in petunia. Accordingly, claims 21 and 27-28.
Claim(s) 21-23, 25, and 27-30 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bravo et al (EP0262666A1).
Bravo et al disclose somatic hybrid plants regenerated made from protoplast fusions of L. esculentum (Solanum lycopersicum) and L. peruvianum (Solanum peruvianum). In Example 3, they indicate that they made cytoplasmic extracts. These comprised both BSα and BSβ subunits from both species, some of which would form heterodimers from both species and from a single species as well as in instant claim 25. Additionally, it is noted that SEQ ID NO:105 and 106 inherently are present in the extracts and SEQ ID NOs:105 and 106 are greater than 50% identical to SEQ ID NOs: 3 and 4, respectively. Accordingly, claims 21-23, 25, and 27-30.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW R KEOGH whose telephone number is (571)272-2960. The examiner can normally be reached M-Th 7-4:30, half day on Fridays.
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/MATTHEW R KEOGH/Primary Examiner, Art Unit 1663