DETAILED ACTION
Claims 9-10 and 23-25 are cancelled by applicant.
Claims 1, and 6 are amended.
Claims 1-8, and 11-22 are pending.
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 .
Continued Examination
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07/07/2020 has been entered.
Priority
Applicants claim to foreign priority FI 20195716, filed on 08/30/2019 is presently acknowledged. A certified copy of the foreign priority application has been received.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 05/07/2024 and 02/24/2022 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities:
MPEP 2422.03(I) provides the following:
The Office strongly suggests filing the sequence listing required by 37 CFR 1.821(c) as a text file via EFS-Web. If a new application is filed via EFS-Web with an ASCII text file sequence listing that complies with the requirements of 37 CFR 1.824(a)(2) -(6) and (b), and applicant has not filed a sequence listing in a PDF file, the text file will serve as both the paper copy required by 37 CFR 1.821(c) and the computer readable form (CRF) required by 37 CFR 1.821(e). Note that the specification must contain a statement in a separate paragraph that incorporates by reference the material in the ASCII text file identifying the name of the ASCII text file, the date of creation, and the size of the ASCII text file in bytes. See MPEP § 2422.03(a) for additional information pertaining to EFS-Web submission of sequence listings.
The electronic file wrapper contains a Sequence Listing filed as a text file; however, the required statement indicated above cannot be found in the specification.
Appropriate correction is required.
Claim Objections
Claims 1, 11-12, and 15 are objected to because of the following informalities: Claims 1, 11-12, and 15 recite the term “alfa-galactosidase”. The correct spelling for this term is “alpha-galactosidase”. Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
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.
Claim 22 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
An “analysis of whether a particular claim is supported by the disclosure in an application requires a determination of whether that disclosure, when filed, contained sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention.” MPEP 2164.01. “A conclusion of lack of enablement means that . . . the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention [i.e. commensurate scope] without undue experimentation.” In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); MPEP 2164.01.
In In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir. 1988), several factors implicated in determination of whether a disclosure satisfies the enablement requirement and whether any necessary experimentation is “undue” are identified. These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). No single factor is independently determinative of enablement; rather “[i]t is improper to conclude that a disclosure is not enabling based on an analysis of only one of the above factors while ignoring one or more of the others.” MPEP 2164.01. Likewise, all factors may not be relevant to the enablement analysis of any individual claim. “According to In re Bowen, 492 F.2d 859, 862-63, 181 USPQ 48, 51 (CCPA 1974), the minimal requirement is for the examiner to give reasons explaining the uncertainty of the enablement. This standard is applicable even when there is no evidence in the record of operability without undue experimentation beyond the disclosed embodiments.” See also In re Brana, 51 F.3d 1560, 1566, 34 USPQ2d 1436, 1441 (Fed. Cir. 1995); MPEP 2164.04.
Breadth of the claim: Claim 22 recites “The method of claim 1, wherein the fungus has been deposited to the VTT Collection under the accession number VTT C-191026 or the accession number VTT C-201040”.
Nature of the invention: As shown above, the nature of claim 22 is predicated on one of ordinary skill in the arts ability to obtain and use the fungi deposited to the VTT Collection under accession numbers VTT C-191026 or the accession number VTT C-201040.
The claim recites a specifically deposited strain. Since the strain is essential to the claimed invention, the strain must be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public. While the strain of claim 22 is described in the specification to be formed using standard recombinant methods, the precise structure of the claimed strain is not obtainable with the limited experimental description described in the specification. Further, repetition of the same procedures can result in strains with slight structural variation. Additionally, the enablement requirements of 35 U.S.C. 112 may be satisfied by a deposit of the claimed strain. Accordingly, it is deemed that a deposit of the deposited strain should have been made in accordance with 37 CFR 1.801-1.809.
It is noted that applicants have deposited the organisms but there is no indication in the specification as to public availability. If the deposit was made under the terms of the Budapest Treaty, then an affidavit or declaration by applicants, or a statement by an attorney of record over his or her signature and registration number, stating that the specific strain has been deposited under the Budapest Treaty and that the strain will be available to the public under the conditions specified in 37 CFR 1.808, would satisfy the deposit requirement made herein.
If the deposit has not been made under the Budapest treaty, then in order to certify that the deposit meets the criteria set forth in 37 CFR 1.801-1.809, applicants may provide assurance or compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number, showing that:
1. during the pendency of this application , access to the invention will be afforded to the Commissioner upon request.
2. upon granting of the patent the strain will be available to the public under the conditions specified in 37 CFR 1.808;
3. the deposit will be maintained in a public repository for a period of 30 years or 5 years after the last request or for the effective life of the patent, whichever is longer; and
4. the deposit will be replaced if it should ever become inviable.
See below 37 CFR § 1.801-1.809:
For the reasons above, claim 22 fails to comply with the enablement requirement as it pertains to biological deposits. The above requirements stated in 37 CFR § 1.801-1.809 are required for one of ordinary skill in the art to obtain/make and use the invention. Accordingly, claim 22 is rejected.
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.
Claims 1-4, 6-8, 11-18, and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Rajgarhia US 20030190630 A1 (cited in IDS filed 02/24/2022) in view of Jarrell US 20100093037 A1 (see form PTO-892 Notice of References Cited), and Montelongo (cited in IDS filed 02/24/2022).
Regarding claims 1, and 20-21, Rajgarhia teaches a Candida sonorensis yeast genetically modified to overexpress lactate dehydrogenase and alpha-galactosidase, that can produce lactic acid and/or lactate when cultured (Rajgarhia, claim 9; claim 12; claim 16; [38]). Rajgarhia teaches a method of producing lactic acid by culturing the above cell (Rajgarhia, claim 25).
Regarding claim 2, Rajgarhia also teaches recovering the lactic acid from the culture medium (Rajgarhia, [188]).
Regarding claims 3-4, Rajgarhia teaches that the lactic acid produced is optically pure L-lactic acid isomer which was purified, and isolated using high-performance liquid chromatography (Rajgarhia, [172-173]).
Regarding claims 11-12, and 15-16 Rajgarhia teaches that the heterologous alpha-galactosidase gene is MEL5 from S. cerevisiae (Rajgarhia, claim 10; [20]).
Regarding claims 13-15, Rajgarhia teaches that the heterologous lactate dehydrogenase gene is from Rhizopus oryzae (Rajgarhia, claim 4).
Regarding claims 17-18, Rajgarhia also teaches that the genetically modified fungus has been modified to decrease ethanol production by deleting pdc1 (Rajgarhia, claim 21).
Rajgarhia does not teach culturing the fungus on a medium comprising a carbon substrate comprising galacto-oligosaccharides, wherein the carbon substrate comprises soy molasses.
Regarding claim 1, Jarrell teaches growing a Candida fungus in a soy molasses medium (Jarrell, [10]). Jarrell teaches that the medium may comprise soy molasses as the only carbon source (Jarrell, claim 4). This is interpreted to mean that the carbon substrate of the medium comprises up to 100 wt% of soy molasses.
Regarding claim 7, Jarrell teaches that soy molasses comprises stachyose and raffinose as major constituents (Jarrell, [46]).
Regarding claim 8, Jarrell teaches that soy molasses also comprises sucrose, fructose, and glucose (Jarrell, [46]).
Regarding claims 1, 6, and 7, Montelongo teaches a soy molasses composition containing a total carbohydrate composition of 32% by dry weight, 11% stachyose and 2% raffinose by dry weight (Montelongo, pg. 864, right column, [1]). Stachyose and raffinose are galacto-oligosaccharides, as shown in instant claim 7. Additionally, because the total carbohydrate composition of soy molasses is 32% by weight, and 11% stachyose and 2% raffinose by weight, this meets the limitations of instant claim 6. Using simple arithmetic, the galacto-oligosaccharides percent by weight of total carbohydrates is roughly 40% (i.e., 13/32 x 100 = 40.6%).
It would have been obvious at the time of filing to one of ordinary skill in the art to combine the teachings of Rajgarhia, Jarrell, and Montelongo. Specifically, it would have been obvious to substitute the medium used in the method taught by Rajgarhia with the soy molasses medium taught by Montelongo. The teachings of Rajgarhia differ from the instant claim 1 in that Rajgarhia does not teach the use of a soy molasses culture medium. Rajgarhia utilizes a different culture medium in order to produce lactic acid using the genetically modified Candida sonorensis described above. Jarrell teaches the use of a soy molasses culture medium to produce lactic acid with fungi, such as a Candida species (Jarrell, [10]). Additionally, one of ordinary skill in the art would be motivated to use a soy molasses culture medium because Jarrell teaches that soy molasses is a less expensive, alternative carbon source as compared to other cell culture media (Jarrell, [3-4]). Montelongo similarly teaches that “an alternative use to increase the economic value of soy molasses may be to convert such carbohydrate portions of soy molasses to lactic acid” (Montelongo, pg. 863, left column, [5]). Furthermore, one of ordinary skill in the art would have a reasonable expectation of success in substituting the culture media taught by Rajgarhia for the soy molasses medium taught by Jarrell. Jarrell teaches that certain fungi have alpha-galactosidase
which allows them to metabolize stachyose and raffinose present in soy molasses (Jarrell, [10]). Jarrell further specifies that Candida fungal species have alpha-galactosidase (Jarrell, [10]). Additionally, the Candida sonorensis species taught by Rajgarhia has been modified to overexpress alpha-galactosidase (Rajgarhia, claim 12; claim 16; [38]). Accordingly, claims 1-4, 6-9, 11-18, and 20-21 are rejected.
Claims 1-5, 6-9, 11-18, and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Rajgarhia, Jarrell, and Montelongo as applied to claims 1-4, 6-9, 11-18, and 20-21 above, and further in view of Ohara, US 5508378 A (published 1996, hereby referred to as Ohara).
The teachings of Rajgarhia, Jarrell, and Montelongo, as they apply to claim 1 are stated above.
Rajgarhia, Jarrell, and Montelongo do not teach a method of preparing polylactic acid from the obtained lactic acid.
Ohara teaches a method of producing polylactic acid from lactic acid using polymerization methods (Ohara, [6]).
One of ordinary skill in the art would be motivated to combine the teachings of Rajgarhia, Jarrell, Montelongo, and Ohara to utilize the obtained lactic acid in order to produce polylactic acid, which is a biologically safe and degradable polymer that can be used for medical purposes (Ohara, [5]). Additionally, one would have a reasonable expectation of success in combining the teachings of Rajgarhia, Jarrell and Montelongo for the production of lactic acid, with the teachings of Ohara in order to produce polylactic acid. Ohara teaches that the lactic acid used to produce polylactic acid may a D-isomer, L-isomer, DL-isomer, or a combination of D and L-isomers. As applied to claim 1 above, the genetically modified fungus taught by Rajgarhia is capable of producing L-lactic acid, and Rajgarhia teaches methods for obtaining and purifying the lactic acid (Rajgarhia, [172-173]; [188]). Therefore, it would have been obvious to one of ordinary skill in the art to combine the teachings of Rajgarhia, Jarrell, and Montelongo, with the method of producing polylactic acid taught by Ohara. Accordingly, claims 1-5, 6-9, 11-18, and 20-21 are rejected.
Claims 1-4, 6-9, 11-18, and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Rajgarhia, Jarrell, and Montelongo as applied to claims 1-4, 6-9, 11-18, and 20-21 above, and further in view of Kim, US 9453246 B2 (published 2016, hereby referred to as Kim).
The teachings of Rajgarhia, Jarrell and Montelongo as applied to claim 1 are stated above.
Rajgarhia, Jarrell, and Montelongo do not teach that the genetically modified fungus comprises a genetic modification to one or more of the genes CYB2, GPD1, GPD2, GPP1, GPP2, or a combination thereof.
Kim teaches a genetically modified yeast, capable of producing lactate and/or lactic acid, wherein the genetically modified yeast comprises genetic modifications that reduce or eliminate the activity of CYB2, and GPD1 (Kim, claim 9; claim 14).
A person having ordinary skill in the art would have been motivated to combine the teachings of Rajgarhia, Jarrell, and Montelongo with the teachings of Kim to further genetically modify the yeast cell taught by Rajgarhia because the genetic modifications taught by Kim may result in increased lactate production. Kim teaches inactivating the CYB2 and GPD1 genes because they are involved in pathways that compete with the production of lactate (Kim, Fig. 7). CYB2 expression is responsible for the conversion of lactate to pyruvate (Kim, [37]). GPD1 expression is responsible for the conversion of DHAP to glycerol-3-phosphate (Kim, [38]). Both of the above conversions may result in a reduction in lactate production; therefore, it would be advantageous to reduce or eliminate the activity of the CYB2 and GPD1 genes. Additionally, a person having ordinary skill in the art would have a reasonable expectation of success in further modifying the fungus taught by Rajgarhia with the CYB2 and GPD1 modifications taught by Kim. The genetically modified fungus taught by Rajgarhia is Candida sonorensis (Rajgarhia, claim 12, claim 16, claim 27). The genetically modified fungus taught by Kim also belongs to the genus Candida (Kim, claim 15), and in specific embodiments may be Candida sonorensis (Kim, [25]). Additionally, both of the genetically modified cells taught by Rajgarhia and Kim are intended to be used for the production of lactate and/or lactic acid (Kim, [12]; claim 18). Therefore, it would have been obvious to one of ordinary skill in the art to combine the teachings of Rajgarhia, Jarrell, Montelongo, and Kim to arrive at the invention of instant claims 1 and 19. Accordingly, claims 1-4, 6-9, 11-18, and 19-21 are rejected.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-8, and 11-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-6, 8-14, 16, and 19-26 of copending Application No. 17/922,695 in view of Rajgarhia, Jarrell, Montelongo, Ohara, and Kim, as applied to claims 1-8, and 11-21.
Application 17/922,695 recites the following claims:
1. (Currently amended) A method of producing an organic acid or a salt thereof, wherein said method comprises combining a carbon substrate composition comprising legume molasses and an aqueous suspension comprising calcium hydroxide to obtain a mixture, wherein said mixture has a calcium hydroxide content of at least 4 g (dry weight)/100 g (dry weight) of legume molasses, and culturing a microorganism in a medium comprising said mixture to obtain an organic acid or a Salt thereof, and optionally isolating and/or purifying the organic acid or salt thereof.
2. The method of claim 1, wherein a temperature of the carbon substrate composition is about 80°C or less, 70°C or less, 60°C or less, or 50°C or less when it is combined with the aqueous suspension comprising calcium hydroxide, 15 and/or wherein the mixture has a temperature about 80°C or less, 70°C or less, 60°C or less, 50°C or less, or 40°C or less when said mixture is added to the medium for culturing the microorganism.
3. (Currently Amended)The method of claim 1, wherein pH of the medium is controlled by adding 20 the mixture or the aqueous suspension to the medium.
5. (Currently amended) The method of claim 1 further comprising preparing a polymer, polyester or polylactic acid from the obtained organic acid or salt thereof.
6. A mixture comprising legume molasses and calcium hydroxide or obtained by combining a carbon substrate composition comprising legume molasses and an 30 aqueous suspension comprising calcium hydroxide, for producing an organic acid or a salt thereof by a microorganism, wherein the mixture has a calcium hydroxide content of at least 4 g/ 100 g (dry matter) of legume molasses.
8. (Currently amended) The method of claim 1, wherein the mixture has a calcium hydroxide content of at least 5 g/ 100 g (dry matter) of legume molasses, or at least 6 g/ 100 g (dry matter) of legume molasses, and/or pH at least 1110. The method or mixture of any of the previous claims, wherein the legume molasses, carbon substrate or carbon substrate composition comprises galacto-oligosaccharides at least about 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, or 90% by weight of the total carbohydrates in said legume molasses or carbon substrate.
9. (Currently amended) The method of claim 6, wherein the mixture is a homogeneous suspension.
10. (Currently amended) The method of claim 1, wherein the legume molasses, carbon substrate or carbon substrate composition comprises galacto- oligosaccharides at least about 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, or 90% by weight of the total carbohydrates in said legume molasses or carbon substrate.
11. (Currently amended) The method of claim 1 or mixture of any of the previous claims, wherein the legume molasses, carbon substrate or carbon substrate composition comprises galacto-oligosaccharides selected from the group consisting of melibiose, manninotriose, manninotetraose, raffinose, stachyose, verbascose, ajucose, galactinol, digalactosyl myo-inositol, galactopinitol A, galactopinitol B, ciceritol, fagopyritol B1, fagopyritol B2 and any combination thereof.
12. (Currently amended) The method of claim 1, wherein the legume molasses, carbon substrate or carbon substrate composition comprises glucose, fructose, galactose, sucrose, lactose, maltose, starch, cellulose and/or any combination thereof.
13. (Currently amended) The method of claim 11, wherein the legume molasses or galacto-oligosaccharides are from soya, fava bean, broad bean, peas, chickpeas, or any combination thereof; or the legume molasses comprises molasses of soya, fava bean, broad bean, peas and/or chickpeas.
14. (Currently amended) The method of claim 1, wherein the organic acid or salt thereof is selected from the group consisting of a lactic acid, preferably optically pure lactic acid isomer, typically L-lactic acid isomer; acetic acid[[,]]: formic acid[[,]]:; pyruvic acid[[,]]; butyric acid[[,]]; citric acid[[,]]; oxalic acid[[,]]: glycolic acid[[,]]: gluconic acid[[,]]; aad furan-dicarboxylic acid (FDCA)[[,]]; and e-any combination thereof.
16. (Currently amended) The method of claim 1 or mixture of any of the previous claims, wherein the microorganism is a fungus, optionally a yeast or filamentous fungus.
19. (Currently amended) A method of producing one or more products selected from the group consisting of polymers, polyesters and polylactic acids, said method comprising culturing a microorganism in a medium comprising legume molasses and calcium hydroxide or the mixture of claim 6 to produce an organic acid or a salt thereof, and utilizing the produced organic acid or salt thereof in production of polymers, polyesters and/or polylactic acids.
20. (New) The mixture of claim 6, wherein the mixture has a calcium hydroxide content of at least 5 g/ 100 g (dry matter) of legume molasses, or at least 6 g/ 100 g (dry matter) of legume molasses, and/or pH at least 11.
21. (New) The mixture of claim 6, wherein the legume molasses, carbon substrate or carbon substrate composition comprises galacto-oligosaccharides at least about 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, or 90% by weight of the total carbohydrates in said legume molasses or carbon substrate.
22. (New) The mixture of claim 6, wherein the legume molasses, carbon substrate or carbon substrate composition comprises galacto-oligosaccharides selected from the group consisting of melibiose, manninotriose, manninotetraose, raffinose, stachyose, verbascose, ajucose, galactinol, digalactosyl myo-inositol, galactopinitol A, galactopinitol B, ciceritol, fagopyritol B1, fagopyritol B2 and any combination thereof.
23. (New) The mixture of claim 6, wherein the legume molasses, carbon substrate or carbon substrate composition comprises glucose, fructose, galactose, sucrose, lactose, maltose, starch, cellulose and/or any combination thereof.
24. (New) The mixture of claim 21, wherein the legume molasses or galacto-oligosaccharides are from soya, fava bean, broad bean, peas, chickpeas, or any combination thereof; or the legume molasses comprises molasses of soya, fava bean, broad bean, peas and/or chickpeas.
25. (New) The mixture of claim 6, wherein the organic acid or salt thereof is selected from the group consisting of a lactic acid, preferably optically pure lactic acid isomer, typically L-lactic acid isomer; acetic acid; formic acid; pyruvic acid; butyric acid; citric acid; oxalic acid; glycolic acid; gluconic acid; furan-dicarboxylic acid (FDCA); and any combination thereof.
26. (New) The mixture of claim 6, wherein the microorganism is a fungus, optionally a yeast or filamentous fungus.
For the same reasons shown above regarding the obviousness rejections of claims 1-8, and 11-21, one of ordinary skill in the art would practice an embodiment of the copending claims using the teachings of the instant application in combination with Rajgarhia, Jarrell, Montelongo, Ohara, and Kim. Particularly, it would have been obvious to use the Candida sonorensis taught by Rajgarhia, the soy molasses medium taught by Jarrell and Montelongo, the polylactic acid production method taught by Ohara, and the additional CYB2, and GPD1 modifications taught by Kim, with the claims of copending claims of application No. 17/922,695. Additionally, instant claim 1, from which all other instant claims depend, uses the term “comprising” which is open ended. Therefore, the scope of the instant claims read upon the copending claims of application No. 17/922,695.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicants Arguments regarding the previous 103 rejections made in the Final Rejection filed 04/04/2025: Applicants argue that Rajgarhia only teaches the production of lactic acid using simple hexose sugar mediums, and is silent regarding the use of complex carbohydrates. Applicant additionally notes that Montelongo does not provide evidence that the Candida sonorensis taught by Rajgarhia would be capable of metabolizing galacto-oligosaccharides into lactic acid. Applicant further argues that neither Rajgarhia and or Montelongo teach the use of a higher concentration of soy molasses in the culture medium with a certain percentage of galacto-oligosaccharides, as presently claimed (i.e., 10% by weight of total carbohydrates in said carbon substrate, and 5-100 wt% of soy molasses).
The new grounds of rejections in this official correspondence are due to applicants amendments to the claims. Previous rejections made in the Final Rejection filed 04/04/2025 are hereby withdrawn. In response to applicants arguments, the new 103 rejections of this official correspondence include the citation of Jarrell, which address applicants arguments above. Jarrell provides a clearer reasoning to combine the references, and provides one of ordinary skill in the art with a reasonable expectation of success in using the Candida sonorensis taught by Rajgarhia on a soy molasses medium to produce lactic acid.
Conclusion
No claims are allowed.
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/BENJAMIN HALL EASTON/Examiner, Art Unit 1652
/TODD M EPSTEIN/Primary Examiner, Art Unit 1652