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 .
Claim Status
The amendment of 03/12/2026 has been entered. Claims 1-16 are pending in this US patent application. Claims 4-8 and 15-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 09/02/2025.
Claims 1-3 and 9-14 are currently under examination and were examined on their merits.
Withdrawn Rejections
The rejection of the claims under 35 U.S.C. 112(b) as being indefinite as set forth in the previous Office action is withdrawn in light of the amendment of 03/12/2026, which removed the word “preferably” from the claims.
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 and 9-14 remain 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.
Claim 1, which is incorporated into all other claims under examination in the instant application, is drawn to a polypeptide sequence having “at least about 70% identity to SEQ ID NO.: 1” that also “catalyzes the conversion of a fatty acid that is at least one of: stearic acid, oleic acid, linoleic acid, linolenic acid, or mixtures thereof.” While Applicant has provided support for particular embodiments of engineered fatty acid alpha-dioxygenases that meet the requirements of claim 1, Applicant has not provided sufficient support for the entire recited genus of polypeptides, which can vary up to 30% from the native structure while still maintaining the recited functions. Applicant has provided no information regarding structural elements of the recited polypeptides that would link the claimed structural variants with the recited enzymatic activities. As such, the instant claims are rejected under 35 U.S.C. 112(a) as failing to comply with the description requirement.
Election/Restrictions
Applicant’s elected species of the polypeptide of SEQ ID NO.: 21 is free of the prior art. The closest prior art to SEQ ID NO.: 21 is found in Bettiol (see below). However, this reference does not teach the replacement of S72 and G74 with proline or that such variation would result in the 10-fold improvement in enzymatic activity shown in Table 2 of the instant specification. Additionally, the amendment of 03/12/2026 has removed the Examiner’s previously selected species from the scope of claim 1. As such, the Examiner has selected another species within the scope of instant claim 1 for examination with respect to the prior art. The Examiner’s selected species is the sequence of SEQ ID NO.: 1 with a K248R mutation. In light of this selection, claims 2-3 are withdrawn from examination at this time.
Claims 1 and 9-14 are currently under examination with respect to the prior art and were examined on their merits.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 and 9-14 remain rejected under 35 U.S.C. 103 as being unpatentable over US patent application 2019/0144790 filed by Bettiol et al., published 05/16/2019.
Please note that this rejection has been slightly augmented to incorporate discussion of the newly added limitations in the claims of 03/12/2026. However, because the basis of the rejection is unchanged, the rejection has been maintained.
Bettiol teaches compositions comprising 0.0001 wt% to 1 wt% of alpha-dioxygenase enzymes, which may be the Oryza sativa alpha-dioxygenase (see entire document, including paragraph [0038]; cf. claims 1, 9, and 11; the Examiner notes that instant SEQ ID NO.: 1 is Oryza sativa alpha-dioxygenase). The invention also includes variants of enzymes, including conservative substitutions, such as arginine for lysine (paragraphs [0039]-[0042]; cf. claims 1 and 9). The composition may further comprise other enzymes (paragraph [0049]; cf. claim 10; the list of enzymes in paragraph [0049] substantially overlaps with the instantly recited list). The composition may further comprise 1% to 60% by weight of a surfactant, which may be an anionic surfactant (paragraphs [0052]-[0053]; cf. claims 12-14).
However, Bettiol does not specifically teach the substitution of K248 with R.
While Bettiol does not specifically teach the substitution of K248 with R, it would have been obvious to one of ordinary skill in the art to do so because Bettiol teaches that lysines in the alpha-dioxygenase enzymes may be conservatively substituted with arginine. One of ordinary skill in the art would have a reasonable expectation that substituting any lysine in Oryza sativa alpha-dioxygenase, including K248, with arginine would successfully result in the production of an Oryza sativa alpha-dioxygenase enzyme that is capable of acting on fatty acids.
Therefore, claims 1 and 9-14 are rendered obvious by Bettiol and are rejected under 35 U.S.C. 103.
The Supreme Court has acknowledged:
When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation…103 likely bars its patentability…if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill. A court must ask whether the improvement is more than the predictable use of prior-art elements according to their established functions……the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results (see KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 U.S. 2007) (emphasis added).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant has traversed the above rejection of the claims under 35 U.S.C. 112(a). Applicant states that, with removal of the limitation “and its functional fragments thereof,” the claim satisfies the written description requirement (remarks, page 1). This argument has been fully considered but has not been found persuasive because the scope of amended claim 1 still allows for a large amount of variation in the structure of the enzyme, up to 30%, and there is still no information regarding the structural characteristics that are required to produce the instantly recited function.
Applicant has traversed the rejection of the claims under 35 U.S.C. 103 as being unpatentable over Bettiol. Applicant states that Bettiol fails to teach or provide a reason to modify to arrive at each element of the current claims (remarks, page 2). This argument has been fully considered but has not been found persuasive because the Examiner does not agree with Applicant’s assertion regarding the teachings of Bettiol. See full discussion above under Claim Rejections – 35 USC 103.
Therefore, the Examiner has maintained the rejections presented above.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Erin M. Bowers, whose telephone number is (571)272-2897. The examiner can normally be reached Monday-Friday, 7:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau, can be reached at (571)272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Erin M. Bowers/Primary Examiner, Art Unit 1653 04/02/2026