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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The IDS filed on 1/12/24 has been fully considered except where references have been lined through.
Specification
The use of the term Diversify PCR Random Mutagenesis Kit and Takara, (PGPUB [0116]), which is a trade name or a mark used in commerce, has been noted in this application. The above list may not be exhaustive. The term should be accompanied by the generic terminology; furthermore the term 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.
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 1-2 and 5-14 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 instant claims require any amino acid substitution at positions 43, 58, and 74 and does not recite any required amino acids or protein structure correlated with the enzyme activity of a beta-carotene 15,15’-oxygenase. As evidenced by Xue, there are over 800 naturally occurring amino acids and 1000s of unnatural amino acids (introduction). Therefore, there could be in excess of 8,400 variants (800 natural amino acids and 2000 unnatural amino acids at each position). Applicants have only reduced to practice a single variant with the substitutions, A43V, L58Q, and I74V, which is insufficient to represent the entire genus of beta-carotene 15,15’-oxygenase variants containing any mutation at positions 43, 58, and 74. Further, there is no suggestion to use unnatural amino acids in the specification. Further, one of ordinary skill in the arts understands that some of these variants could result in non-functional enzymes. Applicant has not provided any information on what domains are essential for the function of the claimed beta-carotene 15,15’ oxygenase variant and therefore no structure-function relationship has been disclosed by applicant. Therefore, the specification only discloses 4 SEQ IDs. The claims are drawn to a broad genus of enzymes with a particular enzymatic function, but the specification does not sufficiently disclose structure-function relationship for this genus of enzymes such that Applicants are in possession of the entirety of the claimed 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 1-14 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 1 only recites negative limitation, wherein the amino acids at positions 43, 58 and 74 from the N-terminus of an amino acid sequence of SEQ ID NO:1, are not alanine, leucine and isoleucine. It is uncertain whether the claimed beta-carotene 15,15’ oxygenase variant is required to be identical to any portion of SEQ ID NO:1. It is further uncertain whether positions 43, 58 and 74 of SEQ ID NO:1 correspond to the same positions in the amino acid sequence of the instantly claimed beta-carotene 15,15’ oxygenase variant. Another alternative interpretation is that the claimed beta-carotene 15,15’ oxygenase variant has the same sequence as SEQ ID NO: 1 except for different residues substituted for A43, L58 and I74.
Regarding claims 5-14, the claims require “the variant” as opposed to “the beta-carotene 15,15’-oxygenase variant” terminology that is used in claims 1-3. Therefore, it is unclear if the language of “the variant” is in reference to “the beta-carotene 15,15’-oxygenase variant” or a different variant.
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 2 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.
Regarding claim 2, the claim requires “…with an amino acid other than alanine…” “with an amino acid other than leucine…” and “…with an amino acid other than isoleucine…”. Instant claim 1 already requires A43, L58, and I74 to be substituted with a different amino acid. Therefore, claim 2 does not further limit claim 1 as claim 1 already requires the substitution of the amino acids A43, L58, and I74.
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.
Pertinent Prior Art
The closest prior art is Song on 27 January 2020 under Accession No. NCF46772.1, A beta-carotene 15,15'-dioxygenase, Brp/Blh family [Alphaproteobacteria bacterium] has the A43V substitution but has L58 and I74 (see appendix). There is no prior art further suggesting mutations at L58 and I74.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TREVOR L KANE whose telephone number is (571)272-0265. The examiner can normally be reached M-F 7:00 am-4:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Louise Humphrey can be reached at 571-272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/TREVOR KANE/Examiner, Art Unit 1657
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