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 .
Applicant's cancellation of claims 2, 4, 6, 8, 10, 13, 15, 17, 19 and 21, amendment of claims 1-5, 7-10, 12-15, 17 and 18, in the paper of 5/5/2026, is acknowledged. Claims 1-18 are still at issue and are present for examination.
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-3, to a genetically engineered microorganism, in the paper of 4/8/2021, is acknowledged. Applicants elect with traverse on the basis that applicants submit that the examiner has not established there would be a serious burden on the examiner if restriction was not required between groups I and II.
Applicants traversal is acknowledged and has been carefully considered, however, is not found persuasive for the reasons previously made of record. As previously stated in the restriction requirement of 11/5/2025, “Because these inventions are distinct for the reasons given above, have acquired a separate status in the art as shown by their different classification, and/or the literature and sequence searches required for each of the Groups are not required for another of the Groups, restriction for examination purposes as indicated is proper”. Further “The examiner has required restriction between product and process claims. Where applicant elects claims directed to the product, and the product claims are subsequently found allowable, withdrawn process claims that depend from or otherwise require all the limitations of the allowable product claim will be considered for rejoinder. All claims directed to a nonelected process invention must require all the limitations of an allowable product claim for that process invention to be rejoined”.
Applicant’s election of the following species:
Group 1: 2) converts propionate to propionyl-CoA
Group 2: an overexpressed thiolase enzyme that catalyzes a condensation of an acetyl-CoA primer with a propionyl-CoA extender to generate 2-methyl-3-ketobutyryl-CoA
.
Group 3: Pseudomonas putida fadAx..
Group 4: an overexpressed 3-hydroxvacyl-CoA dehydrogenase enzyme that catalyzes a reduction of 2-methyl-3- ketobutyrvl-CoA to 2-methyl-3-hydroxybutyrvl-CoA
Group 5: Pseudomonas putida fad2Bx.
Group 6: Pseudomonas putida fadB1x.
Group 7: Escherichia coli fabl, but noting that this election of species is moot in view of the claim amendment.
Group 8: Escherichia coli vdiI.
Group 9: Each of the products listed in claim 4 and claim 8.
Group 10: propionic acid.
Group 11: 2-methyl-crotonoate.
in the paper of 5/5/2026, is acknowledged.
Applicants have requested clarification the species requirement because species groups 1-8 are recited in claims that are a part of Group I and species groups 9-11 are recited in claims which are part of Group II. The reasons for the species requirement is that both groups I and II comprise independent and distinct species within each group. Applicants are responsible for how their claims are drafted. Hence the requirement is necessary for examination.
Claim 3-18 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609 A(1) states, "the list may not be incorporated into the specification but must be submitted in a separate paper."
The information disclosure statements filed on 5/5/2026 is acknowledged and has been considered.
Claim Objections
Claims 1 and 2 are objected to because of the following informalities:
Newly amended claim 1 has an “indent before the recited e) a termination enzyme” which is inconsistent with the formatting used for parts a) -d). It is suggested applicants maintain consistency throughout the claims with regard to formatting.
Claims 1 and 2 refer to various enzymes as encoded by various “genes”. Sometimes applicants recite “gene” such as “said overexpressed acyl-CoA transferase enzyme is encoded by a Megasphaera elsdenii pct gene” (claim 1) and sometimes applicants do not recite “gene” such as “said overexpressed thiolase enzyme is encoded by Pseudomonas putida fadAx”(claim 1). Claim 2 refers similarly to “genes” such as “a Pseudomonas putida fadB1x encoding an enoyl-CoA hydratase” (claim 2) and “an Escherichia coli fabI gene encoding a trans-enoyl-CoA reductase”. It is suggested that applicants maintain consistency throughout the claims in referencing encoding “genes”.
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.
Claim 1 is 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 pre-AIA the applicant regards as the invention.
Claim 1 is indefinite in that it is drawn to genetically engineered bacteria comprising a number of enzymes including an overexpressed acyl-CoA transferase enzyme is encoded by a Megasphaera elsdenii pct gene (part a) of claim 1) and a termination enzyme selected from a thioesterase encoded by Escherichia coli ydiI, an acyl-CoA transferase encoded byMegacheiran elsdenii pct; or a phosphotransacylase encoded by Clostridium acetobutylicum ptb and a carboxylate kinase encoded by Clostridium acetobutylicum buK (part e) of claim 1). Thus the inclusion of an acyl-CoA transferase encoded by Megasphaera elsdenii pct as an optional termination enzyme (part e) of claim 1), wherein it is already a limitation of the claimed genetically engineered bacteria (part a) of claim 1) is indefinite in that it is confusing and unclear.
Appropriate amendment and/or comment is required.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1 and 2 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2 and 3 of US Patent No. 11,697,830. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 2 and 3 of US Patent No. 11,697,830 drawn to composition comprising a genetically engineered bacteria in a media containing propionic acid or glycolic acid, and said bacteria comprising a Megasphaera elsdenii pct gene; Pseudomonas putida fadAx, fadB2x, fadB1x genes; and E. coli YdiI gene and a composition comprising a genetically engineered bacteria in a media containing propionic acid or glycolic acid, and said bacteria comprising a Megasphaera elsdenii pct gene; Pseudomonas putida fadAx, fadB2x, fadB1x genes and E. coli FabI gene anticipate/make obvious instant claims 1 and 2 drawn to a genetically engineered bacteria, said bacteria comprising: a) an overexpressed acyl-CoA transferase enzyme that converts propionate to propionyl-CoA and wherein said overexpressed acyl-CoA transferase enzyme is encoded by a Megasphaera elsdenii pct gene; b) an overexpressed thiolase enzyme that catalyzes a condensation of an acetyl-CoA primer with a propionyl-CoA extender to generate 2-methyl-3-ketobutyryl-CoA wherein said overexpressed thiolase enzyme is encoded by Pseudomonas putida fadAx; c) an overexpressed 3-hydroxyacyl-CoA dehydrogenase enzyme that catalyzes a reduction of 2-methyl-3-ketobutyryl-CoA to 2-methyl-3-hydroxybutyryl-CoA, wherein said overexpressed 3-hydroxyacyl-CoA dehydrogenase enzyme is encoded by Pseudomonas putida fadB2x, d) an enoyl-CoA hydratase or a 3-hydroxyacyl-CoA dehydratase enzyme that catalyzes a dehydration of 2-methyl-3-hydroxybutyryl-CoA to 2-methyl-crotonoyl-CoA wherein said overexpressed enoyl-CoA hydratase or 3-hydroxyacyl-CoA dehydratase enzyme is encoded by a Pseudomonas putida fadB1xe) a termination enzyme(s) able to use a substrate selected from any CoA thioester intermediate produced by enzymes [[b-e]] b-d to makeEscherichia coli ydiI, ii) an acyl-CoA transferase encoded byMegasphaera elsdenii pct; or iii) a phosphotransacylase encoded by Clostridium acetobutylicum ptb and a carboxylate kinase encoded by Clostridium acetobutylicum buK and a genetically engineered bacteria, said bacteria comprising: a Megasphaera elsdenii pct gene encoding acyl-CoA transferase enzyme that converts propionate to propionyl-CoA; b. a Pseudomonas putida fadAx gene encoding a thiolase that catalyzes the condensation of an acetyl-CoA primer or a propionyl-CoA primer with a propionyl-CoA extender to generate 2-methyl-3-ketobutyryl-CoA or 2-methyl-3-ketopentanoyl-CoA; c. a Pseudomonas putida fadB2x encoding a 3-hydroxyacyl-CoA dehydrogenase enzyme that catalyzes a reduction of 2-methyl-3-ketobutyryl-CoA to 2-methyl-3- hydroxybutyryl-CoA or 2-methyl-3-ketopentanoyl-CoA to 2-methyl-3-hydroxypentanoyl-CoA; d. a Pseudomonas putida fadB1x encoding an enoyl-CoA hydratase or a 3- hydroxyacyl-CoA dehydratase enzyme that catalyzes a dehydration of 2-methyl-3- hydroxybutyryl-CoA to 2-methyl-crotonoyl-CoA or 2-methyl-3-hydroxypentanoyl-CoA to 2- methyl-pentenoyl-CoA; e. an Escherichia coli fabI gene encoding a trans-enoyl-CoA reductase or an enoyl- [acyl-carrier-protein] reductase enzyme that catalyzes a reduction of 2-methyl-crotonoyl-CoA to 2-methyl-butyryl-CoA or 2-methyl-pentenoyl-CoA to 2-methyl-pentanoyl-CoA; and f. an Escherichia coli ydiI gene encoding a thioesterase enzyme that catalyzes a conversion of 2-methyl-crotonoyl-CoA to 2-methyl-crotonoate or 2-methyl-butyryl-CoA to 2- methyl-butyrate or 2-methyl-pentenoyl-CoA to 2-methyl-pentenoate or 2-methyl-pentanoyl-CoA 2-methyl-pentanoate.
Closest Prior Art.
Ro et al. U.S. Patent No. 8,163,980. Ro et al. teach a yeast host cell comprising an inducible expression vector for expressing enzymes
Gonzalez et al. (WO 2012/109176). Gonzales et al. teach an E. coli engineered microorganism which expresses (even overexpresses) a number of the enzymes of the -oxidation cycle, including acyl-CoA transferase (atoD), thiolase enzyme (atoB), 3-hydroxyacyl-CoA dehydrogenase (fabG), enoyl-CoA hydratase (fadE), trans-enoyl-CoA reductase (fadE) and thioesterase (tesA). Thus Gonzales et al. teach an enginneered microorganism which comprises a means for expressing the enzymes of the b-oxidation cycle including acyl-CoA transferase, thiolase enzyme, 3-hydroxyacyl-CoA dehydrogenase, enoyl-CoA hydratase, trans-enoyl-CoA reductase and thioesterase. While the engineered E. coli cells taught by Gonzales et al. may or may not comprise the over expression of the above enzymes, the E. coli cells taught by Gonzales et al. clearly clomprise a means for expressing the -oxidation cycle enzymes, including acyl-CoA transferase, thiolase enzyme, 3-hydroxyacyl-CoA dehydrogenase, enoyl-CoA hydratase, trans-enoyl-CoA reductase and thioesterase. Further the microorganism taught by Gonzales et al. has a pathway beginning with said acyl-CoA thioester primer and said alpha-functionalized CoA thioester extender unit and running in a biosynthetic direction and resulting in the addition of 2 carbons to said Acyl-CoA backbone per cycle of said pathway. The specific alpha group of the functionalized alpha group of the acyl-CoA thioester and the products produced by the E. coli are inherent to the enzymes products produced by the taught E. coli has a means for expressing. The microorganisms taught by Gonzales et al. further are delta pta (or ackA or both), poxB, adhE, yqhD,eutE knockouts block/reduce the synthesis of acetate DELTA.pta or .DELTA.ackA and DELTA.poxB, DELTA.adhE, .DELTA.yqhD, DELTA.frdA, DELTA.ldhA and .DELTA.eutE). The microorganisms taught by Gonzales et al. further comprise fadR, atoC, DELTA arcA, DELTAcrp and crp*.
Remarks
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RICHARD G HUTSON whose telephone number is (571)272-0930. The examiner can normally be reached on 6-3 EST Mon-Fri.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert 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.
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rgh
6/16/2026
/Richard G Hutson/
Primary Examiner, Art Unit 1652a
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