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
Applicant’s submission filed on 05/30/2024 is duly acknowledged.
Claims 1-116 (previously presented) have been canceled by the applicants.
Claims 117-130, as currently newly presented, are pending in this application, and have been examined on their merits in this action hereinafter.
Priority
This application is a DIV of 16/878,032 (filed on 05/19/2020; now a US PAT 11,913,049), which is a CON of 15/562,606 (filed on 09/28/2017; now abandoned), which is a 371 of PCT/US2016/025103 (filed on 03/31/2016), which claims domestic benefit from a US provisional application 62/140,628 filed on 03/31/2015.
Claim Objections
Claim 125 (as newly presented) is objected to because of the following informalities: Claim 125 recites the several biological name limitations (for instance, “Azoarcus sp. HxN1” in line 2), wherein the names of the microorganism should be italicized in order to conform to standard recitation of such biological entities.
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.
Claims 120, 123-125 and 128-130 (as newly presented) 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 120 recites the limitations in parentheses:
PNG
media_image1.png
53
691
media_image1.png
Greyscale
It is unclear if the limitations presented in parentheses are to be taken as an example, or has to be treated as the specific “glycolytic enzymes” for the microorganism as currently being claimed. Therefore the metes and bounds of the claimed product as presented does not appear to be properly defined. Applicant is advised to present the components enzymes without parenthesis in order to avoid such ambiguity. Appropriate correction is required.
Claim 123 in component “a” recites limitation “keto-acid (pyruvate) to malate” in line 3, which renders the claim indefinite and uncertain whether claim 123 requires pyruvate.
Claim 125 recites in parentheses, Azoarcus sp. HxN1 masBCDEG (A9J4K0, A9J4K2, A9J4K4, A9J4K6, A9J4J6), which apparently refer to various genes and/or accession numbers for genes, and is not clear if they are mere exemplifications and not required, or they are actually being required. Appropriate correction is required.
Claims 125, 129 and 130 each recite various limitations for genes without sequence identifiers in the form of accession numbers in parentheses, which renders the claimed product indefinite. Since entries in GenBank can maintained with modifications in the sequence submitted, i.e. the sequence incorporated by reference of an accession number may vary with time, and therefore may not identify and/or truly represent a proper gene sequence in the claim.
Claims 123 and 124 each recite the limitation "said pathway" in line 1 of each claims. There is insufficient antecedent basis for this limitation in the claims. Each of claims 123 and 124 directly depend from independent claim 117, which as currently presented recites “a sequence of reactions”, but does not reasonably provide basis for “a pathway” per se. Appropriate correction is required.
Claim 128 (as newly presented) recites the limitation "said termination pathway" in line 1 of the claim. There is insufficient antecedent basis for this limitation in the claims. Claim 128 directly depends from independent claim 117, which does not provide a reasonable basis for “a termination pathway” per se. Appropriate correction is required.
Claim Rejections - 35 USC § 112 – WD Rejection
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.
Claim 117-130 (as newly presented) 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 entire scope of the claimed invention.
The independent claim 117 is reproduced as follows:
PNG
media_image2.png
339
704
media_image2.png
Greyscale
The BRI of the instant product in the form of an “genetically engineered microorganism” as claimed encompasses- 1) any genetically engineered microorganism (the term has not been specifically defined and is not limited to a recombinant bacteria per se; see instant disclosure [0021], [0029], for instance); and 2) wherein said genetically engineered microorganism comprises enzymes (i.e. encompasses native, chromosomally expressed endogenous enzymes), as such not limited to “overexpressed” enzymes via plasmid-encoded vectors (see instant specification, term “Overexpression” or “overexpressed” as defied in paragraph [0040]), for instance.
It is noted that the disclosure of record mainly pertains to bacterial (such as Escherichia coli) plasmid-based overexpression of cloned, native enzymes (from bacterial sources) involved in the oxygen-independent activation (under anaerobic conditions; see instant disclosure [0005], [0069]-[0070], for instance) of short-chain C1-C5 alkanes via fumarate addition (using alkyl succinate synthase enzyme) to form an acyl-CoA and subsequent conversion to intermediate acetyl-CoA for producing desired products (see schematic in Fig. 2-4, for instance). The disclosure provides specific plasmid vectors overexpressing alkyl succinate synthase enzyme (cloned from different bacterial sources as specifically recited in instant claims 125, 129 and 130) in Escherichia coli host cells (see Fig. 6-11, and disclosure in paragraphs [0058]-[0063], and [0088], in particular) that can be used to produce desired products. Although, the generic disclosure states that “a gene or cDNA may be "optimized" for expression in E coli, yeast, algae or other species using the codon bias for the species in which the gene will be expressed” (see instant specification, p.11, [0026]-[0028], for instance), other than E. coli based vectors and plasmid overexpression system, no other host expression system (or specific plasmids therefor) has been demonstrated for the overexpression of relevant oxygen-independent enzymes for the production of desired products from the intermediate acetyl-CoA, such as carboxylic acids, alcohols, etc. (see applicant’s instant disclosure, p.1, [0003], for instance). In addition, it is also noted that no disclosure for the endogenous chromosomal expression of such oxygen-independent enzymes including alkyl succinate synthase that has been shown to be effective in the activation and conversion reactions for generating acyl-CoA, intermediate acetyl-CoA or keto acid, and final desired product(s), has been provided on record.
It is noted that anaerobic oxidation of short-chain hydrocarbons by certain marine bacterial species (such as sulphate-reducing bacteria Desulfosarcina or Desulfococcus sp., including BuS5 strains; see disclosure form Kniemeyer et al, 2007; NPL cited as ref. [U] on PTO 892 form; see page 898, Abstract and Fig. 3, in particular) using addition of fumarate to activate short-chain alkanes (such as propane and butane; see Kniemeyer et al, page 899, right column) yielding methyl-alkyl-succinates, for instance, have been disclosed. However, the prior art in general does not appear to disclose a “genetically engineered” microorganism using short-chain C1-C5 alkane as a substrate and alkyl succinate synthase-based activation (in an oxygen-independent manner) of said alkane via fumarate addition by enzymes overexpressed in the recombinant or genetically engineered microbial host in order to produce desired products from an acetyl-CoA intermediate, as specifically recited in the components a) to d) of instant claim 117.
Thus, in the absence of such guidance and specific disclosure provided on record, at least for a few species of the claimed “genetically engineered microorganism” by applicants for the points as discussed above, applicants do not appear to be in possession of the entire scope of the product invention as currently claimed. Appropriate correction is required.
Conclusion
NO claims are currently allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SATYENDRA K. SINGH whose telephone number is (571)272-8790. The examiner can normally be reached M-F 8:00- 5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LOUISE W 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
SATYENDRA K. SINGH
Primary Examiner
Art Unit 1657
/SATYENDRA K SINGH/Primary Examiner, Art Unit 1657