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
Applicant's election with traverse of the species of sesame oleosin, SEQ ID NO 1, and Thermotoga maritima in the reply filed on 3/11/26 is acknowledged. The traversal is on the ground(s) that the species are biological alternatives and not a serious burden to examine. This is not found persuasive because a serious burden exists, see the restriction requirement mailed on 1/13/26 (e.g., individual species would require separate searches and would require different prior art references).
The requirement is still deemed proper and is therefore made FINAL.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The IDS filed on 10/7/23, 10/23/25, and 3/6/26 have been fully considered except where references have been lined through.
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 1-14 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.
Regarding claim 1, the claim requires “an artificial oil body immobilized enzyme” (singular) followed by a list of 5 enzymes (plural) that are all required by the claim. Therefore, it is unclear if the end product is an oil body comprising a single enzyme or the 5 enzymes appearing in the claim.
Regarding claim 2, it is unclear if the what the phrase “a gene for each enzyme” is supposed to encompass. This could encompass a vector with two oleosin genes, or a vector comprising just one oleosin gene, or any combination thereof, or an oleosin with some other unnamed enzyme. Claim 1 only recites oleosin genes. Therefore, the metes and bounds of this claim are unclear.
Regarding claim 10, the claim requires “a power of 20-30% and 8000-12,000 rpm/min”. These power and RPM requirements provide different results depending on the power source/model of the ultrasonicator and the RPM results in different g forces depending on the radius of the rotor of the machine. Therefore, as these parameters vary depending on the particular machine used the metes and bounds of the claim are unclear. For examination purposes, as all the claimed parameters are relative, any step of sonicating and centrifuging will be regarded as meeting the claimed limitations.
Regarding claim 11, MPEP 2175.05(q) states that “Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112, second paragraph. For example, a claim which read: “A process for using monoclonal antibodies of claim 4 to isolate and purify human fibroblast interferon.” was held to be indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986).”
Claim 12-14 recites the limitation "… the artificial oil body-immobilized multi-enzymes" in reference to claim 1. There is insufficient antecedent basis for this limitation in the claim.
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.
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 1-3, 5-7, 10-14 are rejected under 35 U.S.C. 103 as being unpatentable over Wichelecki (US20190017083A1) and Tseng ("Immobilization of Clostridium cellulolyticum D-psicose 3-epimerase on artificial oil bodies." Journal of agricultural and food chemistry 62.28 (2014): 6771-6776).
Regarding claims 1 and 10-11, Wichelecki teaches enzymatic production of tagatose (abstract). Wichelecki teaches that that a series of enzymes can be used to create the tagatose (fig 2 and [0018]). Wichelecki teaches that alpha-glucan phosphorylase, phosphoglucomutase, phosphoglucoisomerase, fructose 6-phosphate epimerase and tagatose 6-phosphate phosphatase are used (fig 2 and [0018]). While Wichelecki uses the nomenclature of fructose 6-phosphate epimerase rather than the claimed tagatose 6-phosphate 4-empimerase, instant specification [0016] indicates that any enzyme capable of catalyzing the reaction of fructose-6-phosphate into tagatose-6-phosphate is a tagatose 6-phosphate 4-empimerase. As Wichelecki teaches that fructose 6-phosphate epimerase catalyzing the reaction of fructose-6-phosphate into tagatose-6-phosphate is a tagatose 6-phosphate 4-empimerase, one of ordinary skill in the arts understands that the enzyme of Wichelecki is the same as the claimed enzyme.
Wichelecki does not explicitly teach the enzymes immobilized in an oil body.
Tseng teaches the immobilization of epimerases in an artificial oil body for the production of a rare sugar (abstract). Tseng teaches that this method saves time, money, and is easy and effective (introduction). Tseng teaches that recombinant enzymes are coupled to an oleosin gene, expressed, and inserted into the oil body (materials and methods, fig 1). Tseng teaches the protein is combined with buffer, olive oil (oil body), and phospholipids, then ultrasonicated, centrifuged, and collected (materials and methods). While Tseng does not explicitly specify collecting the upper layer, as the components are the same as the claimed invention and the layering is simply a result of the properties of the composition, one of ordinary skill in the arts would understand that the oil body would form on the top layer and it would have been obvious to collect such layer.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the immobilize the enzymes of Wichelecki in as oil body as taught by Tseng. One of ordinary skill in the art would be motivated to do so because Tseng teaches that this method saves time, money, and is easy and effective. Further, one of ordinary skill in the art would be motivated to do so because these artificial oil bodies have been successfully used to immobilize enzymes to make rare sugars, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. There would be a reasonable expectation of success as both Wichelecki and Tseng are in the same field of endeavor of enzymes.
Regarding claim 2, Wichelecki teaches bacteria expressing the enzymes (expression vectors) can be transformed, expressed and isolated ([0070-0075]).
Regarding claim 3, Tseng teaches that the oleosin can be from sesame (introduction).
Regarding claim 5, Wichelecki teaches the enzymes are thermostable ([0074]).
Regarding claim 6, Wichelecki teaches the enzymes can be derived from Thermotoga maritima ([0076]).
Regarding claim 7, Wichelecki teaches that the enzymes can be present in any desired ratio to maximize the product yield ([0032]). Therefore, the mass ratios of the enzymes is a result effective variable and one of ordinary skill in the arts would be motivated to experiment with the mass ratios of the enzymes to arrive at the claimed concentration. See MPEP 2144.05 II. B.
Regarding claim 12, Wichelecki teaches that starch can be used as a raw material (fig 2).
Regarding claim 13, Wichelecki teaches the process is carried out at 40-70oc ([0014]). Wichelecki teaches the phosphate (inorganic phosphate) can be in the range of 0-150mM ([0035]). This overlaps the claimed range and therefore the claimed range is prima facia obvious. Wichelecki teaches the starch can be degraded (debranched) using enzymes ([0038-0042]). Wichelecki teaches the debranching enzymes can be used at 5 U/mL (example 5) Wichelecki teaches HEPES buffer in the range of 5-8 pH can be used ([0062]). Wichelecki teaches that 100 mM HEPES can be used (example 5). Wichelecki teaches that 5 mM MgCl2 and 0.5 mM ZnCl2 can be used (example 5). Wichelecki teaches that starch or its derivative including maltodextrin can be used ([0009]). Wichelecki teaches that maltodextrin can be used at a concentration of 50 g/L (example 13).
Regarding claim 14, Tseng teaches that the artificial oil body comprising enzymes can be recycled (Reusability of the AOB-lmmobilized CC-DPEase).
Claims 8 -9 are rejected under 35 U.S.C. 103 as being unpatentable over Wichelecki (US20190017083A1) and Tseng ("Immobilization of Clostridium cellulolyticum D-psicose 3-epimerase on artificial oil bodies." Journal of agricultural and food chemistry 62.28 (2014): 6771-6776) as applied to claims 1-3, 5-7 and9-14 above, and further in view of Wijesundera (US20140024714A1).
Regarding claim 8, Tseng teaches olive oil can be used (vegetable oil containing triglyceride) (material and methods).
Wichelecki and Tseng do not explicitly teach where the phospholipid is lecithin.
Wijesundera teaches artificial oil bodies (abstract). Wijesundera teaches lecithin can be used as a phospholipid for creation of the oil bodies ([120-121]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use lecithin in the invention of Tseng and Wichelecki above. One of ordinary skill in the art would be motivated to do so because these phospholipids have been successfully used to create artificial oil bodies, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. There would be a reasonable expectation of success as both Tseng and Wijesundera are in the same field of endeavor of oil bodies.
Regarding claim 9, the claim is a product by process claim and as such is only limited by the product and not the process steps needed to make the product. In instant case, the mass ratios are construed as the process, and the product only needs to comprise the enzyme oil body with triglyceride and lecithin which is met by the combination of references in claim 8. There are no clear mass ratio limitations regarding the final product.
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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/TREVOR KANE/ Examiner, Art Unit 1657
/ROBERT J YAMASAKI/ Primary Examiner, Art Unit 1657
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