DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/02/2025 has been entered.
Status of claim rejections
The objection of record is withdrawn in view of Applicant’s arguments/amendments in the response filed 05/02/2025.
The rejection under 35 USC 112(b) is withdrawn in view of Applicant’s arguments/amendments in the response filed 05/02/2025.
The rejection under 35 USC 103 is modified in view of Applicant’s arguments/amendments in the response filed 05/02/2025.
Claim Objections
Claim 56 objected to because of the following informalities: the claim recites, inter alia, “in which D-lactic acid or a salt thereof constitutes less than 1% (w/w) of the lactic acid (D- and L-) or salts thereof at the end of the fermentation”. It is suggested to Applicant to reword the portion of the claim that recites “(D- and L-)”, such as removing the parentheses from the claim language for easier comprehension.
Appropriate correction is required.
Modified Claim Rejections - 35 USC § 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 56, 58 and 67-70 are rejected under 35 U.S.C. 103 as being unpatentable over Tsai et al (US 5464760A; published 11/07/1995; hereinafter “Tsai”) in view of Sheng et al (Appl Environ Microbiol. 2015 Jun 15;81(12):4098-110; hereinafter “Sheng”; prior art of record).
Tsai teaches bioconversion of industrial food waste containing starch to lactic acid using lactic acid bacteria by the use of both enzymes and microbiological action to produce highly stereospecific L-lactic acid (as in claim 1; see claim 1 and 8; col 1, lines 1-20; see col 4, lines 25-31). Tsai teaches providing organic food waste (such as potato waste; see Fig. 1A and B; see Example 1-3), adding lactic acid producing microorganism (as in claim 1; see Example 1-2) to produce highly pure stereospecific L-lactic acid at 98% (see Example 2). Tsai does not explicitly teach that D-lactic acid constitutes less that 1% (w/w) of the lactic acid at the end of fermentation, however, 98% L-lactic acid purity is close to 99%+ L-lactic acid. “A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985)” (see MPEP 2144.05).
The difference between Tsai and the instant claims is that Tsai does not explicitly teach processing/digesting the organic waste using a D-lactate oxidase to eliminate D-lactic acid originating from the organic waste.
However, Sheng teaches that the utilization of D-lactate as an energy source supports the growth of Gluconobacter oxydans (title). Sheng specifically teaches the characterization of GOX2071 from Gluconobacter oxydans, a soluble D-lactate oxidase with broad substrate specificity toward d-2-hydroxy acids (abstract). Sheng also teaches that GOX2071 can use O2 as a direct electron acceptor to oxidize D-lactate and teaches that the enzyme catalyzed the oxidation of D-lactate to pyruvate and H2O2 and that the generated H2O2 oxidized pyruvate to acetate (pg. 4104, col 2; pg. 4105, col 1; Fig. 5B; Table 6).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to modify the method of producing L-lactic acid using L-lactic acid producing organisms by including the D-lactate oxidase as taught by Sheng to arrive at the claimed invention. As Tsai teaches efficient production of pure L-lactic acid from food waste using bacteria and enzymes in combination and Sheng teaches the characterization of D-lactate oxidase that is capable of oxidizing D-lactate, one of ordinary skill would have been motivated to modify the method of Tsai with the oxidase of Sheng with a reasonable expectation of success. One of ordinary skill would have been motivated to make the modification because Sheng teaches that the D-lactate oxidase is capable of advantageously using O2 as a direct electron acceptor to catalyze the oxidation of D-lactate to pyruvate and lead to further removal of D-lactate in the process of Shapira.
It also would have been prima facie obvious to one of ordinary skill at the time of filing to utilize the D-lactate oxidase of Sheng in the method of Shapira either before, after or simultaneously with fermenting (as in claim 56, 68, and 70) the food waste of Tsai. Selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results (see MPEP 2144.04(IV)(C)). Both Tsai and Sheng teach, in combination, the method of producing L-lactic acid via fermentation of food waste and the addition of D-lactate oxidase. The teachings of these references satisfy the limitation of claim 56, as the order of processing the waste with D-lactate oxidase and fermentation steps would have been obvious to try to one of ordinary skill in the art, as there are a finite number of identified predictable solutions with a reasonable expectation of success. One of ordinary skill would have been motivated to alter the order of the process steps used, as it is routine in the art to optimize procedures by altering the steps of the protocol, so long as the rearrangement of steps does not modify the function and result of the protocol. As such, the idea of using any order of the process steps as claimed cannot be considered patentably distinct over the prior art.
Regarding claim 67, Tsai teaches use of lactic acid producing microorganisms such as L. delbrueckii, which is a thermophilic microorganism (see col 1, lines 30-45; col 7, Example 1) and temperatures of about 50-70 degrees Celsius (see col 5, lines 40-45). ). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Furthermore, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Further regarding claim 68, Tsai teaches maintaining the pH of the waste (see claim 1).
Regarding claim 69, Tsai teaches adding polysaccharide degrading enzymes such as glucoamylase and a-amylase (see claim 1; see also col 5, lines 53-58) and simultaneous saccharification and fermentation to produce the lactic acid (see abstract; col 1, lines 50-60).
Response to Arguments
Applicant’s arguments with respect to the Shapira reference, see pg. 9-12 and portions of pg. 13-14 (paragraphs 3-5), have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant's arguments filed 05/02/2025, regarding the Sheng reference, have been fully considered but they are not persuasive. Please note that though the majority of the arguments are moot as it relates to the combination of Shapira with Sheng, the examiner will respond to the rest of the arguments as it relates to the unexpected results (see pg. 12-13).
On pg. 12-13 of the remarks, Applicant argues that the successful use of externally added D-lactate dehydrogenase to organic waste is associated with unexpected effects resulting in advantageous L-lactic acid production process. Applicant argues that the result is surprising in view of what is known about the enzyme from Sheng. Applicant argues that Sheng uses the enzyme in very limited and controlled range of conditions (buffer and pH of 7.4 at 30 degrees Celsius). Applicant urges that the present invention surprisingly shows that D-lactate oxidase retains its activity when applied directly to food waste or pretreated food waste because “the food waste is a viscous, highly complex substrate, the exact composition of which is unknown, containing possible inhibitors and other factors that could negatively affect the enzyme”. Applicant argues that the surprising findings enable applying D-lactate oxidase directly to food waste prior to fermentation processes carried out at high temperatures to avoid contamination and achieve effective fermentation, enable using enzyme simultaneously with polysaccharide degrading enzymes at acidic pH, and applying the enzyme after fermentation, and provides flexibility in designing industrial processes.
In response, the examiner disagrees. First, newly cited Tsai teaches fermentation processes using lactic acid producing bacteria in combination with enzymes to produce highly pure L-lactic acid from food waste at low pH and higher temperatures as instantly argued (see rejection above, see also claim 1 and 8). As set forth above, Tsai teaches the method as claimed as it relates to the production of 98% pure L-lactic acid in a fermentation process using thermophilic bacteria, and Sheng explicitly teaches D-lactate oxidase is capable of advantageously using O2 as a direct electron acceptor to catalyze the oxidation of D-lactate to pyruvate, thus leading to its elimination. As such, one of ordinary skill would have been motivated to utilize the enzyme of Sheng specifically because of its ability to catalyze oxidation/removal of D-lactate.
Second, regarding Applicant’s arguments about “the food waste is a viscous, highly complex substrate, the exact composition of which is unknown, containing possible inhibitors and other factors that could negatively affect the enzyme”: [a]n argument by the applicant is not evidence unless it is an admission, in which case, an examiner may use the admission in making a rejection. Arguments presented by applicant cannot take the place of evidence in the record. See In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984); In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997) (see MPEP2145(I)). Applicant must provide empirical evidence that the food waste utilized by Tsai would contain such “possible inhibitors and other factors that could negatively affect the enzyme” that would render the combination of the D-lactate oxidase of Sheng with the process of Tsai unusable, such that the result would be unexpected. As such, the rejections are maintained as set forth above.
Conclusion
NO CLAIMS ALLOWED.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Adhikari et al (US20150197777A1)
Ohara et al (EP0770684A2)
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/G.C.R./Examiner, Art Unit 1651
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672