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
Claims 1-11 are pending.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-4, and the species of SEQ ID NO: 6, SEQ ID NO: 7, and HBA in the reply filed on 4/8/2026 is acknowledged.
Claims 5-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/8/2026.
Claims 1-4 are examined herein.
In addition to Applicant’s elected species of SEQ ID NO: 6, SEQ ID NO: 1-5 of Genus (A) were also searched.
Claim Objections
Claims 1-4 are objected to because of the following informalities:
Claims 1 and 4 recite hyphenated bullet points, which are conventionally separators between alphanumeric characters. Applicant should consider replacing the hyphens with Roman numerals (i), (ii), (iii).
In claim 1, Applicant may consider amending “A genetically modified strain of Pseudomonas putida, wherein it comprises a gene coding for:” to “A genetically modified strain of Pseudomonas putida comprising a gene coding for:,” for a more formal tone.
Similarly, in claim 2, Applicant may consider amending “The genetically modified strain as claimed in claim 1, wherein it is capable of producing…” to “The genetically modified strain of claim 1, wherein the strain is capable of producing…”
Also in claim 2, the numbers should be in subscripts: R1, R2, R3, R4 and OCH3 to match the designations in formula (I) and the scientific convention for naming compounds.
In claim 3, Applicant may consider amending “The genetically modified strain as claimed in claim 2, wherein it is capable of producing” to “The genetically modified strain of claim 2, wherein the strain is capable of producing…”
In claim 3, Applicant may consider amending “The genetically modified strain as claimed in claim 1, wherein it also comprises on or more additional recombinant genes“ to The genetically modified strain of claim 1, further comprising one or more additional recombinant genes:”
Appropriate correction is required.
Drawings
The drawings are objected to because Figures 1-2 are illegible because of its low resolution. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. See [0012] and [0042].
Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
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.
Claims 1-4 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 indefinite for the limitation “having an amino acid sequence defined by the sequence” in each of the hyphenated bullet points of a). The claim language is indefinite because it is unclear what constitutes “an amino acid sequence defined by the sequence.” Applicant may consider amending to “having the amino acid sequence” prior to each of the recited sequence identifiers.
Claim 1 is further indefinite for “one of the sequences chosen from SEQ ID NO: 1 to 6” In b). The claim can reasonably be interpreted as either requiring selection from SEQ ID NO: 1 to 6 or from a smaller, undefined subset of the sequences (“the sequences chosen from SEQ ID NO: 1 to 6”). Applicant may consider amending to “the amino acid sequence chosen from SEQ ID NO: 1 to 6.”
Claim 2 recites the genetically modified strain as claimed in claim 1, wherein it is capable of producing a compound of formula (I): [1]. Claim 2 is indefinite because it is unclear whether (I) is the same as [1], referring to the same chemical formula.
Claim 2 is further indefinite for “wherein R1, R2, and R3 are chosen independent of each other from hydrogen, or an OH, or OCH3 group,” which does not present a closed group of alternatives for R1, R2, or R3. Applicant may consider amending to “wherein R1, R2, and R3 are each independently selected from hydrogen, OH, and OCH3.”
Claim 3 recites the genetically modified strain as claimed in claim 2, wherein it is capable of producing frambinone or zingerone, preferably frambinone. Claim 3 is indefinite because it is unclear whether the claim scope is limited to frambinone (narrower limitation) or frambinone or zingerone (broader limitation with two alternatives). Per MPEP 2173.05(d), “Description of examples or preferences is properly set forth in the specification rather than the claims.”
Claim 4 is indefinite for the limitations following “in particular” because it is unclear whether the claim requires the broad limitation of recombinant genes encoding polypeptides with TAL activity, 4-CL activity, and/or BAS activity, or requires the narrow limitation of genes encoding SEQ ID NO: 7-9.
Claim 4 is indefinite for the combination of “one or more additional recombinant genes chosen from: … … and/or,” which does not present a single closed group of alternatives. Applicant may consider amending the claim to replace “and/or” with “and.”
Claim 4 is also indefinite because SEQ ID NO: 8 encodes a feruloyl-CoA synthase from P. putida, not a 4-coumarate-CoA ligase. Thus, it is unclear whether the 4-coumarate-CoA ligase or the feruloyl-CoA synthase is required.
Claim 4 recites the limitation " the TAL_RG_OPT polypeptide" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 4 is further indefinite for “a TAL polypeptide having at least 80% identity with the amino acid sequence SEQ ID NO: 7 of the TAL_RG_OPT polypeptide,” The phrase “of the TAL_RG_OPT polypeptide” renders the claim scope indefinite, since it is unclear whether SEQ ID NO: 7 is a synonym for “the TAL_RG_OPT polypeptide” or whether SEQ ID NO: 7 is a fragment of the “the TAL_RG_OPT polypeptide.”
Claims 2-4 are rejected for depending from a rejected base claim and not rectifying the source of indefiniteness discussed above.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2-3 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 2 recites “wherein the genetically modified strain is capable of producing a compound of formula (I). Claim 3 recites wherein the genetically modified strain is capable of producing frambinone or zingerone. Claims 2-3 fail to further limit the subject matter of the claim upon which they depend because claim 1 already recites all of the structural elements of the genetically modified strain. Applicant may consider incorporating the subject matter of claims 2-3 as wherein clauses into independent claim 1.
Applicant may cancel the claims, amend the claims to place the claims in proper dependent form, rewrite the claims in independent form, or present a sufficient showing that the dependent claims comply with the statutory requirements.
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 1-4 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.
Claim 1 recites a genus of functional variants of benzalacetone reductase having an amino acid sequence bearing at least 80% identity with the amino acid sequence selected from SEQ ID NO: 1 to 6. Claim 4 recites a genus of tyrosine ammonia lyase variants, 4-coumarate-CoA ligase variants, and benzalacetone synthase variants having at least 80% identity to SEQ ID NO: 7-9, respectively.
The person of ordinary skill in the art would not have recognized, at the time the application was filed, that the inventors had possession of the claimed genera of functional benzalacetone reductase variants or variants of SEQ ID NO: 7-9.
The specification does not disclose any variants of benzalacetone reductase or variants of SEQ ID NO: 7-9. Rather, the specification discloses in silico screening of candidate benzalacetone reductases followed by the cloning and expression of the genes encoding SEQ ID NO: 1-6 in P. putida (specification [0086], [0088], [0090], Fig. 1). No variants of SEQ ID NO: 1-9 are generated.
Regarding the genus of benzalacetone reductase variants, the prior art of Milke et al. (Microbial Cell Factories 19.1 (2020): 92) teaches that curcumin reductase (CurA) from E. coli is a benzalacetone reductase (Abstract Results). Milke teaches a codon-optimized variant of the curA gene (page 4, left column, middle of paragraph). Milke does not generate any variants of the CurA protein. CurA from E. coli is only 70.25% identical to the CurA from P. putida (SEQ ID NO: 3): see [0087] of the instant specification. Milke teaches that both E. coli and S. cerevisiae both possess unidentified endogenous reductases with benzalacetone reductase activity (page 2, left column, paragraph 2).
Wang et al. (Applied Microbiology and Biotechnology 103.9 (2019): 3715-3725) teaches that 4-hydroxybenzylidene acetone is reduced to raspberry ketone by benzalacetone reductase, which is an NADPH-dependent reductase (page 3716, left column, paragraph 2). Wang teaches that RiRZA1 (from raspberry plant or Rheum ideus) is an NADPH-dependent benzalacetone reductase (page 3716, left column, paragraph 2).
Milke et al. (Microbial Cell Factories 19.1 (2020): 92) teaches that the amino acid substitution G191D in RiRZA1 confers relaxed substrate specificity, allowing the enzyme to accept NADH as a cofactor (page 4, left column, paragraph 1).
Thus, the state of the art with respect to benzalacetone reductases was highly unpredictable just before the effective filing date of the claimed invention, with a limited number of species of benzalacetone reductase identified by the prior art. Neither the prior art nor the specification teaches the structure-function correlation between benzalacetone reductase and its activity (i.e. the specific residues required for catalytic function).
Regarding the genus of tyrosine ammonia lyase variants (variants of SEQ ID NO: 7), Zhou et al. (Applied microbiology and biotechnology 100.24 (2016): 10443-10452) teaches a small number of species of functional tyrosine ammonia lyase variants from Rhodotorula: S9N, A11T, and E518V (Abstract). S9N increases expression level, A11T improves catalytic efficiency, and E518V enhances affinity between TAL and L-tyrosine (Abstract). However, the presently claimed genus covers variants with far more than three amino acid point mutations. 80% identity to SEQ ID NO: 7, which is 693 amino acids, encompasses variants with as many as 139 amino acid substitutions.
Regarding the genus of variants of SEQ ID NO: 8 (which is actually a feruloyl-CoA synthase from P. putida, not a 4-coumarate-CoA ligase), the prior art does not teach any variants of feruloyl-CoA synthase from P. putida.
Regarding the genus of variants of SEQ ID NO: 9 (BAS from Rheum palmatum), a small number of species of variants are taught by the prior art. Morita et al. (Proceedings of the National Academy of Sciences 107.2 (2010): 669-673) teaches a chalcone-producing Rheum palmatum BAS variant comprising the amino acid substitutions I207L and L208F (Abstract). However, the presently claimed genus of BAS variants encompasses far more than two amino acid substitutions. SEQ ID NO: 9 is 384 amino acids long, so a variant with 80% identity to SEQ ID NO: 9 can have as many as 77 amino acid substitutions.
Given the limited number of species of variants taught by the prior art and disclosed by Applicant, and the lack of a structure-function correlation between the enzymes and their activities, the person of ordinary skill in the art would not have been able to reasonably predict and visualize the species of the claimed genera. Therefore, the person of ordinary skill in the art would not have recognized, at the time the application was filed, that the inventors had possession of the claimed genera of benzalacetone reductase variants and variants of SEQ ID NO: 7-9.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-4 are rejected under 35 U.S.C. 101 because the claimed invention is directed to the judicial exception of a product of nature without significantly more. The rationale for this determination is explained below.
A flowchart has been established to determine subject matter eligibility under 35 U.S.C. 101. See MPEP 2106 part (III) and 2106.04 part (II)(A). The flowchart comprises answering: Step 1) Is the claim to a process, machine, manufacture or composition of matter? Step 2A Prong One) Does the claim recite an abstract idea, law of nature or natural phenomenon? Step 2A Prong Two) Does the claim recite additional elements that integrate the judicial exception into a practical application? Step 2B) Does the claim recite additional elements that amount to significantly more than the judicial exception? The claims are analyzed for eligibility in accordance with their broadest reasonable interpretation.
Claim 1 recites a genetically modified strain of Pseudomonas putida comprising a gene coding for SEQ ID NO: 3. Claims 1-4 are drawn to a composition of matter, which is one of the four statutory categories of invention (Step 1: Yes). Claims 1-4 recite a strain of Pseudomonas putida bacteria, which is a product of nature judicial exception (Step 2A Prong One: Yes). Pseudomonas putida is a naturally occurring environmental bacteria (see Abstract of de Lorenzo et al., Journal of bacteriology 206.7 (2024): e00136-24). P. putida naturally contains the gene Q88K17_PSEPK, as evidenced by Q88K17_PSEPK (2003 website, see “Organism”), which is identical to the instant SEQ ID NO: 3 (OA Appendix A). Although the method preamble recites that the strain is “genetically modified,” no genetic modification is actually recited within the claim for the embodiment in which the strain comprises SEQ ID NO: 3. Thus, the claim recites the judicial exception of a product of nature (Step 2A Prong One: Yes).
Claims 1-3 are not integrated into a practical application because the claims are drawn to the strain itself (Step 2A Prong Two: No). The claims do not recite any additional elements besides the judicial exception of a product of nature (Step 2B: No).
Claim 4 is ineligible for the embodiment in which the additional gene is SEQ ID NO: 8 because SEQ ID NO: 8 is a naturally occurring gene of P. putida as evidenced by WP_409262622 (2024 website), which is 99% identical to the instant SEQ ID NO: 8 (OA Appendix B).
SEQ ID NO: 1-2, 4-7, and 9 are heterologous genes (not native to P. putida). Thus, the embodiments of claims 1-4 in which the strain comprises any of SEQ ID NO: 1-2, 4-7, and 9 are eligible under 35 U.S.C. 101.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Espinosa-Urgel et al. (Applied and Environmental Microbiology, Sept. 2004, p. 5190–5198) as evidenced by Q88K17_PSEPK (2003, website).
The specification defines a “genetically modified strain” in [0045] as a strain which comprises either (i) at least one recombinant nucleic acid, or transgene, stably integrated into its genome, and/or present on a vector, for example a plasmid vector, or (ii) one or more unnatural mutations by nucleotide insertion, substitution or deletion, said mutations being obtained via gene transformation techniques or via gene editing techniques known to those skilled in the art. Thus, the specification defines a genetically modified strain as either having a recombinant nucleic acid or transgene in its gene or having one or more unnatural mutations (mutations not present in the wild-type strain). The process by which the product is made, such as obtaining mutations by gene transformation techniques, is only given weight insofar as it limits the structure of the claimed product.
Espinosa-Urgel teaches P. putida KT2440R, which is a spontaneous rifampin-resistant derivative of KT2440 in which a point mutation (A to G) in nucleotide 1562 of the rpoB gene results in amino acid 521 changing from aspartic acid to glycine (page 5191, Materials and Methods, Strains, plasmids, and culture conditions, left column, paragraph 1). Thus, KT2440R is a genetically modified strain because it contains a spontaneous point mutation.
P. putida KT2440 naturally contains the gene Q88K17_PSEPK as evidenced by Q88K17_PSEPK (Organism), which is identical to the instant SEQ ID NO: 3 (OA Appendix A) as recited in line 9 of claim 1. Since KT2440R only contains the spontaneous mutation D521G, then KT2440R necessarily contains Q88K17_PSEPK.
Claims 2-3 do not further limit the structure of the claimed genetically modified P. putida, thus claims 2-3 are also rejected here based on the same grounds of rejection as above.
Claim 4 is rejected under 35 U.S.C. 102(a)(1) as anticipated by Espinosa-Urgel et al. (Applied and Environmental Microbiology, Sept. 2004, p. 5190–5198) as evidenced by Q88K17_PSEPK (2003, website), as applied to claims 1-3 above, further evidenced by WP_409262622 (2024, website).
See discussion of Espinosa-Urgel and Q88K17_PSEPK above, which is incorporated into this rejection as well.
Claim 4 is interpreted as requiring that the strain further comprises SEQ ID NO: 8, which is a feruloyl-CoA synthase.
Regarding claim 4, Pseudomonas putida also naturally contains the gene feruloyl-CoA synthase, as evidenced by WP_409262622 (Title) , which is 99% identical to the instant SEQ ID NO: 8 (OA Appendix B).
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.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10-11 of copending Application No. 18/962,309 (hereafter ‘309) as evidenced by Q88K17_PSEPK (2003, website). Although the claims at issue are not identical, they are not patentably distinct from each other because, claim 1 is anticipated by claims 10-11 of ‘309.
Claim 10 of ‘309 recites a genetically modified Pseudomonas putida strain comprising a gene encoding a tyrosine ammonia lyase; and/or a gene encoding a 4-coumarate-ligase, and/or a gene encoding a benzalacetone reductase.
Claim 11 of ‘309 recites the strain further comprises a gene encoding a feruloyl synthase.
Regarding claim 1, Pseudomonas putida contains an endogenous benzalacetone reductase as evidenced by Q88K17_PSEPK (see Organism on page 1), which is identical to the instant SEQ ID NO: 3 (OA Appendix A). Therefore, the genetically modified strains of claims 10-11 of ‘309 necessarily contain benzalacetone reductase because they are P. putida strains and no genetic modification is recited to knock out the endogenous benzalacetone reductase.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 2-3 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10-11 of copending Application No. 18/962,309 (hereafter ‘309) as evidenced by Q88K17_PSEPK (2003, website), as applied to claim 1 above, further evidenced by Milke et al. (Microbial Cell Factories 19.1 (2020): 92). Although the claims at issue are not identical, they are not patentably distinct from each other because, claims 2-3 are anticipated by claims 10-11 of ‘309.
Regarding claim 2, the genetically modified Pseudomonas putida of claims 10-11 of ‘309 is necessarily capable of producing a compound of formula (I) because P. putida contains an endogenous benzalacetone reductase, which catalyzes the reaction of pHBA to the claimed compound of formula (I) in which R1 is hydrogen or OCH3, R2 is OH, R3 is hydrogen, and R4 is a methyl group, as evidenced by Milke (Fig. 1).
Regarding claim 3, the enzyme benzalacetone reductase is capable of producing raspberry ketone, as evidenced by Milke (Fig. 1), which is a synonym for frambinone.
This is a provisional nonstatutory double patenting rejection.
Claim 4 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10-11 of copending Application No. 18/962,309 (hereafter ‘309) as evidenced by Q88K17_PSEPK (2003, website), as applied to claim 1 above, further evidenced by WP_409262622 (2024, website). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 4 is anticipated by claims 10-11 of ‘309.
The claim 4 is interpreted as requiring the feruloyl-CoA synthase SEQ ID NO: 8.
Regarding claim 4, claims 10-11 of ‘309 do not recite the sequence of the feruloyl-CoA synthase.
However, Pseudomonas putida also naturally contains the gene feruloyl-CoA synthase, as evidenced by WP_409262622 (Title) , which is 99% identical to the instant SEQ ID NO: 8 (OA Appendix B).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6, 8-9 and 11-13 of copending Application No. 18/289,895 (hereafter ‘895) as evidenced by Q88K17_PSEPK (2003, website) and Milke et al. (Microbial Cell Factories 19.1 (2020): 92). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-4 are anticipated by claims 6, 8-9 and 11-13 of ‘895.
Claim 1 of ‘895 is drawn to a genetically modified strain of Pseudomonas putida comprising a mutated AroF-I gene encoding 3-deoxy-D-arabino-heptulosonate-7-phosphate (DAHP) synthase, the sequence of which has at least 90% identity to the sequence SEQ ID NO:1 and having at least one P160L mutation, a P160L/Q164A double mutation, or a P160L/S193A double mutation.
Claim 6 of ‘895 recites the strain further comprises one or more additional recombinant genes selected from TAL, 4-CL and BAS.
Claims 8-9 are drawn to a method of synthesizing a phenylpropanoid compound comprising growing the genetically modified strain of claim 6.
Claim 11 of ‘895 requires the TAL has at least 80% identity to SEQ ID NO: 7.
Claim 12 of ‘895 requires the 4-CL has at least 80% identity to SEQ ID NO: 8.
Claim 13 of ‘895 requires the BAS has at least 80% identity to SEQ ID NO: 9.
Regarding instant claim 1, P. putida contains an endogenous benzalacetone reductase as evidenced by Q88K17_PSEPK, which is identical to the instant SEQ ID NO: 3 (OA Appendix A), so the genetically modified strains of claims 6, 8-9, and 11-13 of ‘893 necessarily contain benzalacetone reductase because they are P. putida strains and no genetic modification is recited to knock out the endogenous benzalacetone reductase.
Regarding claims 2-3, phenylpropanoid is converted into phenylbutanones such as raspberry ketone (synonym for frambinone) through the enzymes 4-CL, BAS, and BAR, as evidenced by Milke (Fig. 1). Therefore, the genetically modified strains of claims 6, 8-9, and 11-13 of ‘895 are necessarily capable of producing frambinone, which is a compound of formula (I).
Regarding claim 4, the instant SEQ ID NO: 8 is identical to the SEQ ID NO: 8 of ‘895 (OA Appendix C).
This is a provisional nonstatutory double patenting rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CANDICE LEE SWIFT whose telephone number is (571)272-0177. The examiner can normally be reached M-F 8:00 AM-4:30 PM (Eastern).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Louise Humphrey can be reached at (571)272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/CANDICE LEE SWIFT/Examiner, Art Unit 1657
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