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 .
Specification
The incorporation of essential material in the specification by reference to an unpublished U.S. application, foreign application or patent, or to a publication is improper. Applicant is required to amend the disclosure to include the material incorporated by reference, if the material is relied upon to overcome any objection, rejection, or other requirement imposed by the Office. The amendment must be accompanied by a statement executed by the applicant, or a practitioner representing the applicant, stating that the material being inserted is the material previously incorporated by reference and that the amendment contains no new matter. 37 CFR 1.57(g).
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. 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.
Information Disclosure Statement
The information disclosure statement filed 1/25/2024 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
Claim Objections
Claim 1 is objected to because of the following informalities: the genus name Yarrowia should be italicized. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: the binomial species name Lachancea marantina should be italicized. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: there is no need to provide exempli gratia in the claim, because the ordinary artisan fully understands what “at least 20%” means. Appropriate correction is required.
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 1 and 3-10 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.
Regarding claims 1, 4-8 and 10, the phrases "particularly" and “preferably” render the claims indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims 3, 5-7, 9 and 10 all include the term “about.” Since the range of “about” is not defined in the instant specification, it is unclear where the metes and bounds of “about” lie. For example, it is unclear if “about” could be interpreted as a margin of 1%, or 5%, or 10%; without defining the term, it is unclear how far from the claimed value can be considered within the scope of the invention.
Claim 9 is indefinite because it is unclear what homology the Applicant considers consistent with the claim limitations. The first limitation indicates that the sequence must provide for substitutions that have “at least about 20%” homology to the claimed sequence. If we exclude the “about” language, even though the scope is inconceivably high, there is no ambiguity with this limitation; however, the next limitation further limits the claim to indicate that these substitutions can only correspond to one or more of 34 explicitly claimed amino acid locations. If the only substitutions can be made at these 34 locations, and there are 559 amino acids in the claimed sequence, this homology should be “at least about 6%.” Since the narrowness of the second limitation entirely conflicts with the broadness of the first limitation, there is no way to wholly understand what the Applicant is trying to claim. For the sake of examining the claim on its merits, it will be assumed that the substitutions are limited to only the claimed amino acid locations.
Claim Rejections - 35 USC § 102/103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 10 are rejected under 35 U.S.C. 103 as being unpatentable over Balch, et al (US Pat. 11,578,344) and Il’chenko, et al (Applied Biochemistry and Microbiology, 41, 426-432, 2005). Balch teaches a method of producing retinyl acetate in a fungal host cell. See column 1, lines 45-65. Balch indicates that the fungal host cell can include Yarrowia. See column 2, line 13. Although Balch states that the retinol can be acetylated by encoding an alcohol acetyl transferase to the yeast cell, Balch does not teach the fermentation in the presence of ethanol. See column 18, line 35-37. Although not explicitly stated, this would tell the ordinary artisan that if acetate were present, this added gene would allow for the retinol to be esterified into retinyl acetate.
Il’chenko provides a review paper that discusses Yarrowia physiology, and how it metabolizes ethanol, when it is present in the medium. Il’chenko notes that Yarrowia will produce “considerable amounts of acetate” when ethanol is present in the medium. See page 426, right column, 2nd [full] paragraph.
Based upon Il’chenko, and Balch, it would be clear to the ordinary artisan that if ethanol was present in the method of Balch, the Yarrowia would naturally metabolize this to acetate. Since Balch explicitly suggests the inclusion of an enzyme that would allow for the esterification of the acetate to the retinol, resulting in retinyl acetate, and the presence of ethanol would naturally allow for the formation of acetate, while also providing a carbon/energy source for the Yarrowia, the instant method would be obvious. This would be obvious to the ordinary artisan because this method simultaneously provides for an energy for the Yarrowia, while also providing a excess of substrate to allow for the formation of retinyl acetate from retinol. If there is an excess of acetate present, there will be an expectation that the enzymatic kinetics would favor product formation.
With respect to claim 1, Balch teaches all of the limitations except for the inclusion of ethanol in the medium. Il’chenko, and the knowledge known by the ordinary artisan, provide reasonable motivation to further include ethanol in the reaction medium of Balch.
With respect to claim 2, Balch teaches fed-batch. See column 10, line 6.
With respect to claim 3, although the prior art does not appear to explicitly describe the claimed value, since the rejection relies on a combination of references, the claimed value appears as though is an optimizable value that would only require routine experimentation and ordinary skill in the art. See MPEP 2144.05.
With respect to claim 4, Balch does not explicitly state that there must be any triglycerides present in the fermentation. In some of the applied examples, Balch notes that either corn oil or glucose can be used as carbon sources; this would suggest that there is no need for any triglycerides to be present. This is further underscored by Il’chenko, who indicates that ethanol can be used as a carbon source. This would inform the ordinary artisan that Balch’s method could predictably be carried out with ethanol as the carbon source, wherein there are no triglycerides present.
With respect to claims 5-7 and 10, since the limitations of the instant claims can only occur in the combination of Balch and Il’chenko, neither reference would explicitly teach these limitations. However, if the ordinary artisan were informed by Balch and Il’chenko, in a manner as described in the rejections above, these limitations would be inherent to the method. See MPEP 2112.
With respect to claim 8, as discussed above, Balch suggests adding heterologous genes to the yeast cell.
With respect to claim 9, Balch teaches SEQ ID No 33, which possesses 100% homology to the claimed SEQ ID No 18.
Double Patenting
Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,578,344 in view of Il’chenko, et al (Applied Biochemistry and Microbiology, 41, 426-432, 2005). See the 35 USC 103 rejection above. The patent teaches methods of using identical yeasts to produce identical products, with the only difference being that the instant invention explicitly requires the inclusion of ethanol in the medium, whereas the patent claims “under suitable culture conditions.” Since Il’chenko notes that the inclusion of ethanol can be a “suitable culture condition,” the broadly claimed patent can read upon the more narrowly claimed instant claim-set.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie Gordon can be reached at 571-272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID W BERKE-SCHLESSEL/Primary Examiner, Art Unit 1651