Prosecution Insights
Last updated: October 04, 2026
Application No. 18/553,946

VARIANT BACTERIAL STRAINS AND PROCESSES FOR PROTEIN OR BIOMASS PRODUCTION

Final Rejection §112
Filed
Oct 04, 2023
Priority
Apr 28, 2021 — FI 20215494 +1 more
Examiner
GRASER, JENNIFER E
Art Unit
1645
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Solar Foods Oyj
OA Round
2 (Final)
77%
Grant Probability
Favorable
3-4
OA Rounds
0m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 77% — above average
77%
Career Allowance Rate
801 granted / 1045 resolved
+16.7% vs TC avg
Strong +23% interview lift
Without
With
+23.4%
Interview Lift
resolved cases with interview
Typical timeline
2y 5m
Avg Prosecution
53 currently pending
Career history
1090
Total Applications
across all art units

Statute-Specific Performance

§101
6.0%
-34.0% vs TC avg
§103
26.4%
-13.6% vs TC avg
§102
16.3%
-23.7% vs TC avg
§112
39.5%
-0.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1045 resolved cases

Office Action

§112
DETAILED ACTION Acknowledgment and entry of the Amendment submitted on 5/13/26 is made. Claims 1, 2, 4-8, 10-33 are currently pending. Claims 11-33 remain withdrawn for being drawn to a non-elected invention. Claims 1, 2, 4-8 and 10 are currently under examination. Applicants’ arguments/response has obviated the former 101 rejection, 103 rejection and satisfied the Deposit Requirements. The amendment to the claims necessitated or did not overcome the rejections set forth below. Claim Rejections - 35 USC § 112-2nd paragraph 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, 2, 4-6, 8 and 10 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. Claim 1 is vague and indefinite because the claim recites “comprising a gene modification of one or more genes with highest sequence identity to phaC1 (SEQ ID NO: 63).” It is unclear what percent identity is being referenced so the claim is indefinite. Does this only encompass genes with 100% identity, 95%, 90%, 75%, etc.? The metes and bounds of the invention are not clearly understood. Appropriate clarification and/or correction is required. Claim 1 is also vague and indefinite “reduces the bacterial production of PHA as compared to strain VTT-E-193585” because strain VTT-E-193585 is not provided or know. The claim should provide any the deposited variant strain number, which would allow for one to identify the strain without ambiguity. The mere recitation of a name, variant of bacterial strain VTT-E-193585 comprising a genetic modification of one or more genes encoding PHA, does not adequately define the claimed bacterial strain. Claim 2 is vague and indefinite because it is unclear what the bacterial PHA synthase activity of strain VTT-E-193685 is since the strain is not adequately defined as described above. It is unclear how one would be able to make a comparison. Appropriate clarification and/or correction is required. Claim 6 recites the variant comprises “gene disruptions of both phaC1 (SEQ ID NO: 62) and phaC2 (SEQ ID NO: 63)” and is vague and indefinite because it is unclear what is encompassed by the language “gene disruptions”. Are these deletion mutants? How are the genes disrupted? While the specification can be used to provide definitive support, the claims are not read in a vacuum. Rather, the claim must be definite and complete in and of itself. Limitations from the specification will not be read into the claims. The claims as they stand are incomplete and fail to provide adequate structural properties to allow for one to identify what is being claimed. Appropriate clarification and/or correction is required. The amendment to the claims necessitated the modification of the 112, first paragraph rejections below. Applicants’ arguments are addressed in the new rejections. Claim Rejections - 35 USC § 112-Written description 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. Claims 1, 2, 4-6, 8 and 10 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The instant claims are drawn, for example, to: A variant of bacterial strain VTT-E-193585 comprising a genetic modification of one or more genes with highest sequence identity to phaC1 (SEQ ID NO: 62) encoding a PHA synthase that reduces the bacterial production of polyhydroxyalkanoic acid (PHA) as compared to strain VTT-E-193585. The variant above, wherein the genetic modification reduces bacterial PHA synthase activity as compared to strain VTT-E-193585, preferably wherein PHA synthase activity has been reduced to less than 10%, such as less than 5%, for example less than 2%. The variant above, wherein the variant comprises a genetic modification reducing the expression level of phaCl and/or the activity of the phaCl enzyme. The variant according to claim 1, wherein the variant comprises a genetic modification reducing the expression level of phaC2 and/or the activity of the phaC2 enzyme. wherein the variant has retained the ability to grow using hydrogen gas as energy source and carbon dioxide as the only carbon source. The instant specification at the paragraph bridging pages 3-4 recites that strain VTT-E-193585 has been isolated from the seashore of the Baltic Sea in Naantali, Finland. This organism is able to grow in suitable bioreactor conditions with minimal mineral medium with hydrogen as the energy source and carbon dioxide as the carbon source at limited oxygen conditions. 16S sequencing and Illumina metagenomics sequencing have shown that the strain most likely is a member of the genus, member of the genus Xanthobacter, but species is not known. The inventors have constructed genetically-modified variants of VTT-E-193585 comprising disruptions of the phaC1 and/or phaC2 loci. The variant comprising a gene disruption of phaC1 has been deposited on April 19th, 2021 in the VTT Culture Collection at the VTT Technical Research Centre of Finland, P.O. Box 1000, FI-02044 VTT, Finland, an International Depositary Authority under the Budapest Treaty. The accession number is VTT E-213595. In a first main aspect, the invention relates to a variant of bacterial strain VTT-E-193585 comprising a genetic modification that reduces the bacterial production of polyhydroxyalkanoic acid (PHA) as compared to strain VTT-E-193585. Thus, the invention relates to a genetically-modified variant of bacterial strain VTT-E-193585. In other words, strain VTT-E-193585 further characterized in that it comprises a genetic modification. Page 5 of the specification recites that the variant is the bacterial strain deposited under number VTT-E-213595, in which the phaC1 gene has been disrupted. In a preferred embodiment, the variant has retained the ability to grow using hydrogen gas as energy source and carbon dioxide as the only carbon source. In one embodiment, if the strain is a variant of strain VTT-E-193585, the variant comprises the 16S ribosomal RNA set forth in SEQ ID NO:1 or a 16S ribosomal RNA having up to 20 nucleotide differences with SEQ ID NO:1, e.g. 1 to 10, such as 1 to 5, e.g. one, two or three nucleotide differences with SEQ ID NO:1. Page 52 of the instant specification recites that the sequencing of the bacterial genome of strain VTT-E-193585 described in Example 1 identified genes phaC1 (SEQ ID NO:60, encoding the protein set forth in SEQ ID NO:62) and phaC2 (SEQ ID NO:61, encoding the protein set forth in SEQ ID NO:63). Two plasmids were constructed to target deletion of phaC1 and phaC2 genes in the genome of SoF1 (Table 7). Accordingly, the instant specification does not provide written description for the full breadth of the claims. To fulfill the written description requirements set forth under 35 USC § 112, first paragraph, the specification must describe at least a substantial number of the members of the claimed genus, or alternatively describe a representative member of the claimed genus, which shares a particularly defining feature common to at least a substantial number of the members of the claimed genus, which would enable the skilled artisan to immediately recognize and distinguish its members from others, so as to reasonably convey to the skilled artisan that Applicant has possession the claimed invention. Applicants have not described the genus of claimed fructanases such that the specification might reasonably convey to the skilled artisan that Applicants had possession of the claimed invention at the time the application was filed. The description in the claims allows for many different bacterial strains found in from many different sources with PHA genes not disclosed in the instant specification and/or well-known in the prior art. With the written description of a genus, however, merely drawing a fence around a perceived genus is not a description of the genus. One needs to show that one has truly invented the genus, i.e., that one has conceived and described sufficient representative species encompassing the breadth of the genus. Otherwise, one has only a research plan, leaving it to others to explore the unknown contours of the claimed genus. See Ariad, 598 F.3d at 1353 (The written description requirement guards against claims that "merely recite a description of the problem to be solved while claiming all solutions to it and . . . cover any compound later actually invented and determined to fall within the claim's functional boundaries."). Abbvie Deutschland GmbH & Co. v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 U.S.P.Q.2d 1780, 1790, 2014 BL 183329, 12 (Fed. Cir. 2014). To fulfill the written description requirements set forth under 35 USC § 112, first paragraph, the specification must describe at least a substantial number of the members of the claimed genus, or alternatively describe a representative member of the claimed genus, which shares a particularly defining feature common to at least a substantial number of the members of the claimed genus, which would enable the skilled artisan to immediately recognize and distinguish its members from others, so as to reasonably convey to the skilled artisan that Applicant has possession the claimed invention. Applicants have not described the genus of variants of VTT-E-193585 with one or more genetic modifications in one of more genes encoding a PHA synthase such that the specification might reasonably convey to the skilled artisan that Applicants had possession of the claimed invention at the time the application was filed. The purpose of the "written description" requirement is broader than tomerely explain how to "make and use"; the applicant must convey with reasonableclarity to those skilled in the art that, as of the filing date sought, he or she was inpossession of the invention. The invention is, for purposes of the "writtendescription" inquiry, whatever is now claimed. See Vas-Cath, Inc. v. Mahurkar,935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Federal Circuit, 1991).Furthermore, the written description provision of 35 USC § 112 is severable fromits enablement provision; and adequate written description requires more than amere statement that it is part of the invention and reference to a potential methodfor isolating it. The nucleic acid [product] itself is required. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing the invention was 'ready for patenting' such as by disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention" (Id. at 1104). Moreover, because the claims encompass a genus of variant species, an adequate written description of the claimed invention must include sufficient description of at least a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics sufficient to show that Applicant was in possession of the claimed genus. An objective standard for determining compliance with the written description requirement is, "does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed." In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989). To satisfy the written description requirement, an 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, and that the invention, in that context, is whatever is now claimed. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991) and MPEP 2163.02. However, factual evidence of an actual reduction to practice has not been disclosed by Applicant in the specification with the exception of the deposited variant VTT-E-21395; and with a VTT-E-193585 strain with a mutation in phaC1 comprising SEQ ID NO: 60 and/or phaC2 comprising SEQ ID NO: 61 wherein the mutation reduces the strains production of PHA as compared to wild-type VTT-E-192585. Applicant has not shown the invention was "ready for patenting" by disclosure of drawings or structural chemical formulas that show that the invention was complete; nor has Applicant described distinguishing identifying characteristics sufficient to show that Applicant were in possession of the claimed invention at the time the application was filed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus'" (Id. at 1106); accordingly, it follows that an adequate written description of a genus cannot be achieved in the absence of a disclosure of at least one species within the genus. The scope of the claim includes numerous structural variants, and the genus is highly variant because a significant number of structural differences between genus members is permitted. One of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus, and thus, that the applicant was not in possession of the claimed genus. The claimed subject matter is not supported by an adequate written description because a representative number of species has not been described. Because the art is unpredictable, in accordance with the Written Description Guidelines and the scope of the claim includes numerous structural variants and the genus is highly variant because a significant number of structural differences between genus members is permitted. The specification does not describe any members of the claimed genus by complete structure. One of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus, and thus, that the applicant was not in possession of the claimed genus. The claimed subject matter is not supported by an adequate written description because a representative number of species has not been described. There are no drawings or structural formulas disclosed of any of theseother bacteria and other PHA sequences with the recited functional requirements. Based on the lack of knowledge and predictability in the art, those of ordinaryskill in the art would not conclude that the applicant was in possession of theclaimed genus of bacterial variant strains. Applicant is referred to the revised guidelines concerning compliance with the written description requirement of U.S.C. 112, first paragraph, published in the Official Gazette and also available at www.uspto.gov Claim Rejections - 35 USC § 112-Scope of Enablement 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. Claims 1, 2, 4-6, 8 and 10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for: The bacterial strain deposited under VTT-E-213595 which comprises a genetic modification in the phaC1 gene comprising SEQ ID NO: 60 which reduces the bacterial production of polyhydroxyalkanoic acid (PHA); and/or a genetically-modified variant of deposited strain VTT-E-193585 comprising a disruption of the phaC1 gene (SEQ ID NO: 62) and/or phaC2 gene (SEQ ID NO: 63) that reduces the expression level of polyhydroxyalkanoic acid (PHA)” does not reasonably provide enablement for: A variant of bacterial strain VTT-E-193585 comprising a genetic modification of one or more genes with highest sequence identity to PhaC1 (SEQ ID NO: 62) encoding a PHA synthase that reduces the bacterial production of polyhydroxyalkanoic acid (PHA) as compared to strain VTT-E-193585. The variant above, wherein the genetic modification reduces bacterial PHA synthase activity as compared to strain VTT-E-193585, preferably wherein PHA synthase activity has been reduced to less than 10%, such as less than 5%, for example less than 2%. wherein the variant has retained the ability to grow using hydrogen gas as energy source and carbon dioxide as the only carbon source. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims. The specification states that substitutions, additions, or deletions, may be made to the defined sequences; however, the specification provides no guidance as which amino acids may be changed without causing a detrimental effect to the enzyme and with the added enzymatic function requirement. It is unpredictable as to which amino acids could be removed and which could be added. While it is known that many amino acid substitutions are possible in any given protein, the position within the protein’s sequence where amino acid substitutions can be made with a reasonable expectation of success are limited. Other positions are critical to the protein’s structure/function relationship, e.g., such as various positions or regions directly involved in binding, catalysis in providing the correct three-dimensional spatial orientation of binding and catalytic sites. These regions can tolerate only very little or no substitutions. Selective point mutation to one key residue could eliminate the function of the polypeptide. It could eliminate its functional properties. If the range of decreased binding ability after single point mutation of a protein antigen varies, one could expect point mutations in the protein antigen to cause varying degrees of loss of protection/function, depending on the relative importance to the binding interaction of the altered residue. Alternatively, the combined effects of multiple changes, as instantly claimed, in an antigenic determinant could again result in loss of function. A protein having multiple point mutations, or accumulated point mutations at key residues could create a new antigen that is precipitously or progressively unrecognizable. As stated above, Applicants have not shown the particular substitution and the result it produces. Applicants have provided no guidance to enable one of ordinary skill in the art how to determine, without undue experimentation, the effects of different amino substitutions and the nature and extent of the changes that can be made. It is expensive and time consuming to make amino acid substitutions at more than one position, in a particular region of the protein, in view of the many fold possibilities for change in structure and the uncertainty as to what utility will be possessed. See Mikayama et al. (Nov.1993. Proc.Natl.Acad.Sci. USA, vol. 90 : 10056-10060) which teaches that the three-dimensional structure of molecules is important for their biological function and even a single amino acid difference may account for markedly different biological activities. Amino acids owe their ‘significance’ to their inclusion in a pattern which is directly involved in recognition by, and binding to, the receptor and the significance of the particular amino acids and sequences for different amino acids cannot be predicted a priori, but must be determined from case to case by painstaking experimental study. The instant claims allow for substitutions with amino acids of vastly different properties and they do not recite the specific changes in the claims. Applicants have recited that in the instant specification at the paragraph bridging pages 3-4 recites that strain VTT-E-193585 has been isolated from the seashore of the Baltic Sea in Naantali, Finland. This organism is able to grow in suitable bioreactor conditions with minimal mineral medium with hydrogen as the energy source and carbon dioxide as the carbon source at limited oxygen conditions. 16S sequencing and Illumina metagenomics sequencing have shown that the strain most likely is a member of the genus, member of the genus Xanthobacter, but species is not known. The inventors have constructed genetically-modified variants of VTT-E-193585 comprising disruptions of the phaC1 and/or phaC2 loci. The variant comprising a gene disruption of phaC1 has been deposited on April 19th, 2021 in the VTT Culture Collection at the VTT Technical Research Centre of Finland, P.O. Box 1000, FI-02044 VTT, Finland, an International Depositary Authority under the Budapest Treaty. The accession number is VTT E-213595. In a first main aspect, the invention relates to a variant of bacterial strain VTT-E-193585 comprising a genetic modification that reduces the bacterial production of polyhydroxyalkanoic acid (PHA) as compared to strain VTT-E-193585. Thus, the invention relates to a genetically-modified variant of bacterial strain VTT-E-193585. In other words, strain VTT-E-193585 further characterized in that it comprises a genetic modification. Page 5 of the specification recites that the variant is the bacterial strain deposited under number VTT-E-213595, in which the phaC1 gene has been disrupted. In a preferred embodiment, the variant has retained the ability to grow using hydrogen gas as energy source and carbon dioxide as the only carbon source. In one embodiment, if the strain is a variant of strain VTT-E-193585, the variant comprises the 16S ribosomal RNA set forth in SEQ ID NO:1 or a 16S ribosomal RNA having up to 20 nucleotide differences with SEQ ID NO:1, e.g. 1 to 10, such as 1 to 5, e.g. one, two or three nucleotide differences with SEQ ID NO:1. Page 52 of the instant specification recites that the sequencing of the bacterial genome of strain VTT-E-193585 described in Example 1 identified genes phaC1 (SEQ ID NO:60, encoding the protein set forth in SEQ ID NO:62) and phaC2 (SEQ ID NO:61, encoding the protein set forth in SEQ ID NO:63). Two plasmids were constructed to target deletion of phaC1 and phaC2 genes in the genome of SoF1 (Table 7). The scope of the claim includes numerous structural variants, and the genus is highly variant because a significant number of structural differences between genus members is permitted. The specification fails to teach other variants of bacterial strain VTT-E-193585 in such the term “variant” allows for bacterial of many different Genus and species and the claim fails to teach other bacteria that are of the same Genus species of VTT-E-193585, and the working examples only show the variant is the bacterial strain deposited under number VTT-E-213595, in which the phaC1 gene has been disrupted. in Example 1 identified genes phaC1 (SEQ ID NO:60, encoding the protein set forth in SEQ ID NO:62) and phaC2 (SEQ ID NO:61, encoding the protein set forth in SEQ ID NO:63) only. Genentech Inc. v. Novo Nordisk A/S (CAFC) 42 USPQ2d 1001 clearly states: “Patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable. See Brenner v. Manson, 383 U.S. 519, 536, 148 USPQ 689, 696 (1966) (stating, in context of the utility requirement, that "a patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.") Tossing out the mere germ of an idea does not constitute enabling disclosure. While every aspect of a generic claim certainly need not have been carried out by an inventor, or exemplified in the specification, reasonable detail must be provided in order to enable members of the public to understand and carry out the invention.” The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims. Allowable Subject Matter Claim 7 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Additionally, “[a] genetically-modified variant of deposited strain VTT-E-193585 comprising a disruption of the phaC1 gene (SEQ ID NO: 62) and/or phaC2 gene (SEQ ID NO: 63) that reduces the expression level of polyhydroxyalkanoic acid (PHA)” is allowable. 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. Prior art, not presently relied upon: TITLE: Studies on polyhydroxyalkanoate (PHA) accumulation in a PHA synthase I-negative mutant of Burkholderia cepacia generated by homogenotization AUTHOR(S): de Andrade Rodrigues, M. F.; Vicente, E. J.; Steinbuchel, A. CORPORATE SOURCE: Instituto de Pesquisas Technologicas do Estado de Sao Paulo, Sao Paulo, Brazil SOURCE: FEMS Microbiology Letters (2000), 193(1), 179-185 CODEN: FMLED7; ISSN: 0378-1097 DIGITAL OBJECT ID: 10.1016/S0378-1097(00)00483-3 PUBLISHER: Elsevier Science B.V. DOCUMENT TYPE: Journal LANGUAGE: English ED Entered STN: 29 Nov 2000 AB In the genome of Burkholderia cepacia strain IPT64, which accumulates a blend of the two homopolyesters poly(3-hydroxybutyrate) [poly(3HB)] and poly(3-hydroxy-4-pentenoic acid) [poly(3H4PE)] from sucrose or gluconate as single carbon source, the polyhydroxyalkanoate (PHA) synthase structural gene was disrupted by the insertion of a chloramphenicol-resistant gene cassette (phaC1::Cm). The suicide vector pSUP202 harboring phaC1::Cm was transferred to B. cepacia by conjugation. The inactivated gene was integrated into the chromosome of B. cepacia by homologous recombination. This mutant and also 15 N-methyl-N'-nitrosoguanidine (NMG)-induced mutants still accumulated low amts. of PHAs and expressed low PHA synthase activity. The anal. of the mutant phaC1::Cm showed that it accumulated about 1% of PHA consisting of 68.2 mol% 3HB and 31.8 mol% 3H4PE from gluconate. The wild-type, in contrast, accumulated 49.3% of PHA consisting of 96.5 mol% 3HB and 3.5 mol% 3H4PE. Our results indicated that the genome of B. cepacia possesses at least two PHA synthase genes, which probably have different substrate specificities. Correspondence regarding this application should be directed to Group Art Unit 1645. Papers related to this application may be submitted to Group 1600 by facsimile transmission. Papers should be faxed to Group 1600 via the PTO Fax Center located in Remsen. The faxing of such papers must conform with the notice published in the Official Gazette, 1096 OG 30 (November 15,1989). The Group 1645 Fax number is 571-273-8300 which is able to receive transmissions 24 hours/day, 7 days/week. 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). Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jennifer E. Graser whose telephone number is (571) 272-0858. The examiner can normally be reached on Monday-Friday from 8:00 AM-4 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Thomas Visone, can be reached at (571) 270-0684. Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist whose telephone number is (571) 272-0500. /JENNIFER E GRASER/Primary Examiner, Art Unit 1645 7/23/26
Read full office action

Prosecution Timeline

Oct 04, 2023
Application Filed
Feb 24, 2026
Non-Final Rejection mailed — §112
May 13, 2026
Response Filed
Jul 27, 2026
Final Rejection mailed — §112 (current)

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Prosecution Projections

3-4
Expected OA Rounds
77%
Grant Probability
99%
With Interview (+23.4%)
2y 5m (~0m remaining)
Median Time to Grant
Moderate
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