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
Claims 20, 22, 24, 27 and 28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 3/20/2026.
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 1, 3-7, 10-16, 18, 19 and 30 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. The invention is drawn to an enzyme, nucleic acid coding for said enzyme, as well as vectors, constructs and cells that include either the enzyme or the nucleic acid sequence. Specifically, the invention is drawn to SEQ ID NO 3, and variants that possess 80% homology and must contain a phenylalanine at position 109; other embodiments further define what amino acids can and cannot be present at specific positions, but they continue to provide for at least 80% homology to SEQ ID NO 3, or a related sequence. Additionally, the sequence must possess “cytochrome P450 activity.”
Prior to analyzing the claims, it should be noted that cytochrome P450 defines a “superfamily” of enzymes with highly disparate functionalities. See the review by Denisov, et al (Chemical Reviews, 105, 2253-2277, 2005), who discusses that the cytochrome family is highly diverse class of enzymes. Cytochrome P450 is not one enzyme with one functionality, but rather, a class of related enzymes with overlapping oxygenase functionalities, wherein they catalyze the reactions of different substrates. Bearing this in mind, given the broadest reasonable interpretation of the claimed invention, the independent claim indicates that SEQ ID NO 3 can be mutated by adding, deleting, or changing, up to 85 amino acids from the original sequence (SEQ ID NO 3 is 424 amino acids). This amounts to an astronomically high number of possible sequences, wherein as many as 1-in-5 amino acids can be replaced with a different amino acid. Based upon this assessment, the claim requires the skilled artisan to test innumerable variants, in order to determine the presence of any P450 activity.
The instant specification provides for the wild-type sequence, defined as SeuC10 in the specification (SEQ ID NO 2). The specification also provides for some applied data, wherein Tables 2-4 provide for testing with mutants of the wild-type. When considering these mutants, it is noted that almost all examples have a single point mutation, and three applied examples with two points of mutation. There are no examples of mutations that exceed two amino acid changes, wherein two amino acids account for a less than 1% difference in homology. There are no examples of mutations greater than two, and no descriptions to the skilled artisan as to how to mutate these sequences in a manner that allows for the enzyme to retain P450 functionality. As such, there is nothing in the instant specification that would show evidence that the Applicant was in possession of a functional P450 enzyme that had more than 0.5% difference. Therefore, the claims require the skilled artisan to test innumerable possible embodiments in order to determine which embodiments provide for P450 functionality.
The most recent guidance, regarding 35 USC 112(a) Written Description rejections, can be found on the Office website. In this guidance, the Applicant can find examples of compliant, and non-compliant claim language regarding sequences and functional limitations. Specifically, by coupling a low level of homology to a specific enzyme functionality requires the skilled artisan to recreate the Applicant’s claim; this becomes problematic when the specification does not give clear guidance to the skilled artisan to create the sequence in the context of the claim. For example, there is nothing in the specification to suggest what regions must be retained and what regions can be mutated, or which amino acids provide for conservative substitutions, forcing the skilled artisan to test every possible iteration. Since the level of claimed homology and number of viable amino acids provides for an incomprehensible number of embodiments, the Applicant has placed an enormous burden on the skilled artisan, as they require the skilled artisan to make the claimed invention with no guidance. By only providing evidence and data for single and double amino acid mutations, the Applicant does not appear to be in possession of a reasonable number of different embodiments to show possession of the whole genus.
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 3, and 6 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 3 and 6 recite the broad recitation 80% identity, and the claim also recites 95% identity which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Allowable Subject Matter
The claimed sequences SEQ ID NO 3, 126, 128, and 130 are free of the prior art; by specifically claiming phenylalanine at position 109, the Applicant has eliminated Steele, et al (US Pat. 12,410,411) as viable prior art, since Steele does not provide for phenylalanine at position 109, nor is there any motivation to specifically choose to mutate this residue with this particular amino acid. As such, these specific sequences (and perhaps some variants) are free of the prior art, and should not be considered non-statutory double patenting with the cited patent (overlapping inventors and assignee). Since the sequences, per se, are free of the prior art, once the 35 USC 112(a) and 112(b) issues are eliminated, the claims will likely be allowable.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID W BERKE-SCHLESSEL whose telephone number is (571)270-3643. The examiner can normally be reached M-F 8AM-5:30PM.
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/DAVID W BERKE-SCHLESSEL/ Primary Examiner, Art Unit 1651
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