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 .
Claims 1 is at issue and are present for examination.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosu53 and 54re 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 1/2/2025 is acknowledged. Those references considered have been indicated as such.
Claim Rejections - 35 USC § 112
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 is rejected under 35 U.S.C. 112, first paragraph, as containing 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(s), at the time the application was filed, had possession of the claimed invention.
Claims 1 is directed to all possible viable recombinant bacterium comprising a heterologous dual 3-hydroxy-acyl-ACP dehydratase/isomerase, wherein the viable recombinant bacterium produces a non-native monounsaturated fatty acid derivative when cultured, and wherein the non-native monounsaturated fatty acid derivative has a double bond in a position characteristic of the heterologous dual 3-hydroxy-acyl-ACP dehydratase/isomerase.
There is no disclosure of any particular structure to function/activity relationship in the disclosed species. There is insufficient disclosure of the genus of viable recombinant bacterium and heterologous 3-hydroxy-acyl-ACP dehydratase/isomerases. The application has demonstrated E. coli expressing Marinobacter dual 3-hydroxy-acyl-ACP dehydratase/isomerase is viable and produces non-native [Symbol font/0x77]-9 monounsaturated fatty acids (examples 2-5). No further combinations of recombinant bacterium/heterologous dual 3-hydroxy-acyl-ACP dehydratase/isomerase have been disclosed to be viable, especially no further combinations of recombinant bacterium of taxonomic classification: class Gammaproteobacteria/ heterologous dual 3-hydroxy-acyl-ACP dehydratase/isomerase derived from a bacterium of taxonomic classification Gammaproteobacteria. Thus, the specification fails to describe sufficient representative species of these recombinant bacterium/heterologous dual 3-hydroxy-acyl-ACP dehydratase/isomerase, for which no predictability of structure with correlated function is apparent.
Regarding the level of skill and knowledge in the art of amino acid mutation, the reference of Singh et al. (Curr. Protein Pept. Sci. 18:1-11, 2017; cited on the attached Form PTO-892) reviews various protein engineering methods and discloses that despite the availability of an ever-growing database of protein structures and highly sophisticated computational algorithms, protein engineering is still limited by the incomplete understanding of protein functions, folding, flexibility, and conformational changes (see p. 7, column 1, top). Also, the unpredictability associated with amino acid mutations is exemplified by the reference of Zhang et al. (Structure 26:1474-1485, 2018; cited on the attached Form PTO-892), which discloses that even a mutation of a surface residue that was predicted to be benign caused significant structural changes and unexpected effects on the function of a polypeptide (p. 1475, column 1).
Given this lack of additional representative species as encompassed by the claims, Applicants have failed to sufficiently describe the claimed invention, in such full, clear, concise, and exact terms that a skilled artisan would recognize Applicants were in possession of the claimed invention.
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 § 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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Valle et al. (US 9,447,436).
Valle et al. teach the production of saturated fatty alcohols and fatty acids from engineered microorganisms (see abstract).
Valle et al. disclose methods of producing fatty alcohols and fatty alcohol derivative compounds in an engineered host cell (see abstract and supporting text). Valle et al. disclose engineered microorganisms (e.g., bacteria) exhibiting improved properties including the production of fatty alcohols and specifically including the production of saturated fatty alcohols and compositions comprising at least one saturated fatty alcohol (e.g., a composition comprising at least C12, C14, C16 and/or C18 saturated fatty alcohols). Valle et al. further teach engineered microorganisms which include at least one heterologous gene encoding a fatty acyl-ACP reductase enzyme (FAR) and an over-expressed endogenous fatty acid biosynthetic (fab) gene and the engineered microorganism is E. coli.
Valle et al. teach an engineered bacteria microorganism according to the invention encompasses a polynucleotide sequence encoding a heterologous fatty acyl-ACP reductase enzyme FAR; one or more heterologous polynucleotide sequences encoding i) a FabZ enzyme, ii) a FabI enzyme, and/or iii) a FabA enzyme (column 7, line 25-32); and one or more inactivated genes such as a fabF or fadR. gene. Valle et al. an engineered bacterial microorganism according to the invention comprises (a) an heterologous FabZ and/or (b) an heterologous FabI and/or (c) an heterologous FabA (column 16, line 63- column 17, line 35). Valle et al. teach that the FabA enzyme can be introduced into an engineered cell (e.g., a bacterial cell). For example, the polynucleotide sequence encoding a FabA enzyme is set forth herein as SEQ ID NO:9, and the encoded amino acid sequence is set forth as SEQ ID NO:10. Valle et al. further teach that the FabA can be encoded by a nucleic acid sequence that can selectively hybridize to SEQ ID NO:9 under moderately stringent, stringent or highly stringent conditions, and that FabA sequences can be identified by any of a variety of methods known in the art. For example, a sequence alignment can be conducted against a database, for example against the NCBI database, and sequences with the lowest HMM E-value can be selected
Valle et al. further teach that the above microbial cells can be engineered to express a heterologous thioesterase (column 23, line 8- column 24, line 45).
Thus Valle et al. teaches a viable recombinant bacterium (E.coli) comprising a heterologous dual 3-hydroxy-acyl-ACP dehydratase/isomerase (FabA), wherein the viable recombinant bacterium produces a non-native monounsaturated fatty acid/alcohol derivative when cultured, and wherein the non- native monounsaturated fatty acid derivative has a double bond in a position characteristic of the heterologous dual 3-hydroxy-acyl-ACP dehydratase/isomerase.
One of skill in the art before the effective filing date would have been motivated to alter the engineered recombinant bacterium comprising a heterologous FabA enzyme taught by Valle et al. to express other additionally taught fatty acyl-ACP reductase enzymes (FAR) as taught by Valle et al. to alter the types of saturated fatty alcohols produced. The expectation of success is high based upon the high level of skill in the art of recombinant bacterial genetic engineering and the fact that Valle et al. teaches all the required to methods, and substrates to produce the obvious recombinant bacterium for producing altered fatty alcohol/acid derivatives.
Thus claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Valle et al. (US 9,447,436).
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.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,221,644. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-18 of U.S. Patent No. 12,221,644 drawn to a viable recombinant bacterium comprising a heterologous dual 3-hydroxy-acyl-ACP dehydratase/isomerase, wherein: the viable recombinant bacterium produces a non-native monounsaturated fatty acid derivative when cultured; the non-native monounsaturated fatty acid derivative has a double bond in a position characteristic of the heterologous dual 3-hydroxy-acyl-ACP dehydratase/isomerase; the viable recombinant bacterium is a bacterium of taxonomic classification: Class gamma-proteobacteria; the heterologous dual 3-hydroxy-acyl-ACP dehydratase/isomerase is derived from a bacterium of taxonomic classification: Class gamma-proteobacteria; the heterologous dual 3-hydroxy-acyl-ACP dehydratase/isomerase is a Fab A homolog or a FabA-type dual 3-hydroxy-acyl-ACP dehydratase/isomerase; and the heterologous dual 3-hydroxy-acyl-ACP dehydratase/isomerase replaces the native dual 3-hydroxy-acyl-ACP dehydratase/isomerase anticipate/make obvious instant claim 1 drawn to a viable recombinant bacterium comprising a heterologous dual 3-hydroxy-acyl-ACP dehydratase/isomerase, wherein the viable recombinant bacterium produces a non- native monounsaturated fatty acid derivative when cultured, and wherein the non- native monounsaturated fatty acid has a double bond in a position characteristic of the heterologous dual 3-hydroxy-acyl-ACP dehydratase/isomerase.
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.
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rgh
8/31/2026
/RICHARD G HUTSON/Primary Examiner, Art Unit 1652
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