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 .
DETAILED ACTION
1. Applicant's amendment and arguments filed 8/11/26 have been fully considered but they are not deemed to be persuasive. The reasons are discussed following the rejection(s).
Claims 1-7, 9-11 & 13-20 are currently present and are under consideration.
2. Any objection or rejection of record which is not expressly repeated in this Office Action has been overcome by Applicant’s response and withdrawn.
3. The terminal disclaimer filed on 8/11/26 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of co-pending Application No.18/626102 has been reviewed and is accepted. The terminal disclaimer has been recorded.
4. 35 U.S.C. § 112, first paragraph (Written Description)
Claims 1-7, 9-11 & 13-20 are 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claimed invention is directed to the following genus claims.
1. A method for the production of muconate from an oxidized stream of acylated reductive catalytic fractionation oils of lignin wherein the method comprises reacting a Mn/Zr-based catalytic autoxidation system with the oxidized stream of reductive catalytic fractionation (RCF) oils of lignin.
2. The method of claim 1 wherein the Mn/Zr-based catalytic autoxidation system comprises Mn(OAc)2-4H20 and Zr(acetylacetonate)4.
3. The method of claim 2 wherein the Mn/Zr-based catalytic autoxidation system is reacted with the oxidized stream of reductive catalytic fractionation oils of lignin wherein the Mn/Zr-based catalytic autoxidation system comprises a molar ratio of eight percent Mn(OAc)2-4H20 and six percent Zr(acetylacetonate)4 relative to the moles of acetylated reductive catalytic fractionation oils of lignin oligomers.
4. The method of claim 1 wherein the reaction of the acetylated reductive catalytic fractionation oils of lignin with the Mn/Zr-based catalytic autoxidation system is at about 150 degrees Celsius.
5. The method of claim 1 wherein the reaction of the acetylated reductive catalytic fractionation oils of lignin with the Mn/Zr-based catalytic autoxidation system is under about 6 bar of oxygen pressure.
6. The method of claim 1 wherein the reaction of the acetylated reductive catalytic fractionation oils of lignin with the Mn/Zr-based catalytic autoxidation system reacts for up to 1.5 hours.
7. The method of claim 1 wherein the acetylated reductive catalytic fractionation oils of lignin comprise vanillate, isovanillate, veratric acid and veratraldehyde.
8. cancelled.
9. The method of claim 1 wherein the Mn/Zr-based catalytic autoxidation system comprises acetic acid.
10. The method of claim 1 wherein the Mn/Zr-based catalytic autoxidation system comprises a polar solvent.
11. The method of claim 1 wherein the Mn/Zr-based catalytic autoxidation system comprises a non-polar solvent.
12. Cancelled.
13. The method of claim 1 wherein the acylated reductive catalytic fractionation oils of lignin are derived from pine lignin reductive catalytic fractionation oils.
14. The method of claim 1 wherein the acylated reductive catalytic fractionation oils of lignin are derived from poplar lignin reductive catalytic fractionation oils.
15. The method of claim 1, wherein the method is performed in a genetically engineered bacterium.
16. The method of claim 15 wherein the genetically engineered bacterium is a Pseudomonas sp.
17. The method of claim 16 wherein the genetically engineered bacterium is ACB263.
18. The method of claim 16 wherein the method produces muconic acid.
19. The method of claim 16 wherein the method produces cis, cis-muconic acid.
20. The method of claim 17 wherein the genetically engineered bacterium is capable of metabolizing p-methoxylated aromatics.
The method claims are broadly drawn to: A method for the production of muconate from an oxidized stream of acylated reductive catalytic fractionation oils of lignin wherein the method comprises reacting a Mn/Zr-based catalytic autoxidation system with the oxidized stream of reductive catalytic fractionation (RCF) oils of lignin.
The claimed invention encompasses a genus of method steps not adequately described, for example, the specific substrates used, the product produced and the organism where the method is occurring.
The instant specification describes “A method for production of muconate from oxidation streams of methylated pine RCF (reductive catalytic fractionation) in P. putida strain ACB263, using a Mn/Zr-based catalytic autoxidation system wherein the method comprises reacting the acetylated lignin oligomers produced from reductive catalytic fractionation with a mixture of a manganese salt and a zirconium salt; and wherein Aldehyde dehydrogenase(s) (ALDH) catalyze the oxidation of veratraldehyde to veratrate, which then undergoes p-demethylation to vanillate and wherein VanAB O-demethylates vanillate to protocatechuate, which is decarboxylated to catechol and ring-cleaved to produce muconate; and cultivation of strain ACB263 in M9+2 mM veratraldehyde produces the equivalent molar yield of muconate.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him. The courts have stated:
"To fulfill the written description requirement, a patent specification must describe aninvention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) ("[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what isclaimed."). Thus, an applicant complies with the written description requirement "bydescribing the invention, with all its claimed limitations, not that which makes it obvious,"and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966."Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents" of the University of California v. Eli Lilly & Co. the court stated:
"A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials." Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus ...") Regents" of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is "not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence." MPEP § 2163. The MPEP does state that for a generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP § 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP § 2163. Although the MPEP does not define what constitutes a sufficient number of representative species, the courts have indicated what do not constitute a representative number of species to adequately describe a broad generic. In Gostelli, the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872, F.2d at 1012, 10 USPQ2d at 1618. The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include "level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient." MPEP § 2163. While all of the factors have been considered, a sufficient amount for a prima facie case is discussed below.
Further, to provide evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include: a) the scope of the invention; b) actual reduction to practice; c) disclosure of drawings or structural chemical formulas; d) relevant identifying characteristics including complete structure, partial structure, physical and/or chemical properties, and structure/function correlation; e) method of making the claimed compounds; f) level of skill and knowledge in the art; and g) predictability in the art.
Moreover, Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir.1991), states that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed" (See page 1117). The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed" (See Vas-Cath at page 1116). The skilled artisan cannot envision the detailed chemical structure of the encompassed genus of polypeptides, and therefore, conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993).
Therefore, for all these reasons the specification lacks adequate written description, and one of skill in the art cannot reasonably conclude that the applicant had possession of the claimed invention at the time the instant application was filed.
Applicants’ arguments: Applicants argue that in amending claims 1-7, 13-16, 18, and 19 - more specificity to the claims have been added per the discussion in the Office Action on page 4. Accordingly, Applicant respectfully requests removal of this rejection.
Response: Applicants’ arguments are considered but not found to be persuasive as explained in the rejections.
5. Claims 1-7, 9-11 & 13-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: “A method for production of muconate from oxidation streams of methylated pine reductive catalytic fractionation (RCF) in P. putida strain ACB263, using a Mn/Zr-based catalytic autoxidation system wherein the method comprises reacting the acetylated lignin oligomers produced from reductive catalytic fractionation with a mixture of a manganese salt and a zirconium salt; and wherein Aldehyde dehydrogenase(s) (ALDH) catalyze the oxidation of veratraldehyde to veratrate, which then undergoes p-demethylation to vanillate and wherein VanAB O-demethylates vanillate to protocatechuate, which is decarboxylated to catechol and ring-cleaved to produce muconate; and cultivation of strain ACB263 in M9+2 mM veratraldehyde produces the equivalent molar yield of muconate.
6. Double Patenting Rejection- Claims 1-20 previously provisionally rejected under the judicially created doctrine of double patenting over claims 1-20 of co-pending Application No.18/626102 is withdrawn as a terminal Disclaimer has been filed.
7. No claim is allowed.
8. Renders et al. Current Opinion in Biotechnology 2019, V56, pages 193-201, is the closest prior art presented for information, but not used is any rejection.
9. 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.
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to TEKCHAND SAIDHA whose telephone number is (571)272-0940. The examiner can normally be reached on M-F 8.00-5.30. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert B Mondesi can be reached on 408 918 7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TEKCHAND SAIDHA/
Primary Examiner, Art Unit 1652
Recombinant Enzymes, Hoteling
Telephone: (571) 272-0940
Fax: (571) 273-0940
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