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 .
Application Status
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/10/2026 has been entered.
In response to FINAL-Office Action mailed on 06/10/2026, applicants’ response dated 09/10/2026 is acknowledged; in said response applicants’ have amended claim 1, cancelled claims 12-32. Amended claims 1-3, 6-8, 10-12 and 33-40 are present in the instant application and are now under consideration for examination. Rejections and/or objections not reiterated from previous office action are hereby withdrawn.
Withdrawn-Claim Rejections: 35 USC § 112(a)
Previous rejection of claims 1-3, 6-8, 10-12 and 33-40 rejected under 35 U.S.C. 112(a), for written-description and enablement, is being withdrawn due to claim amendments.
Withdrawn-Claim Rejections: 35 USC § 103
Previous rejection of claims 1-3, 6-8, 10-12 and 33-40 rejected under 35 U.S.C. 103(a) as being unpatentable over North et al., (US 2024/0060037 A1; priority 03/25/2021) and further in view of Larsson et al., (IET Proc.: Syst. Biol. 2011, Vol. 5: 245-251), Berry et al., (WO 2009/111513 A1), Voight et al., (US 9,040,266 B2) and Wood et al., (US 2020/0337314 A1), is being withdrawn due to claim amendments.
Objection to Claims
Necessitated by claim amendments
Clam 33 is objected to for the following informality; regarding claim 33, said claim appears in the same line as cancelled claim 32; examiner suggests separating the claim 33 form cancelled claim 32.
New-Matter/Objection to Specification
Necessitated by claim amendments
Upon further review of claims amendment; amended new claim 1 and claims 2-3, 6-8, 10-12 and 33-40 depending therefrom are objected to under 35 U.S.C. 132(a), because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: Amended new claim 1 (dated 09/10/2026) recites “Saccharomyces cerevisiae strain ATCC 9651” and as claimed was not contemplated in the specification as originally filed dated 05/30/2023 or in the original claim set dated 05/30/2023. The specification (¶ [0068], Example 1, page 18) and prior art has support for the following strain Saccharomyces cerevisiae strain ATCC 96581; neither the specification nor the prior art discloses “Saccharomyces cerevisiae strain ATCC 9651”.
New Matter-Claim Rejections: 35 USC § 112 (a)
Necessitated by clam amendments
Amended new claim 1 and claims 2-3, 6-8, 10-12 and 33-40 depending therefrom are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA )/new-matter, 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(s), at the time the application was filed, had possession of the claimed invention Amended new claim 1 and claims 2-3, 6-8, 10-12 and 33-40 depending therefrom is rejected because, claim 1 (dated 09/10/2026), recites the following subject matter “Saccharomyces cerevisiae strain ATCC 9651” as claimed was not contemplated in the specification as originally filed dated 05/30/2023 or in the original claim set dated 05/30/2023; see Purdue Pharma L.P. v. Faulding Inc., 230 F .3d 1320, 1326, 56 USPQ2d 1481, 1486 (Fed. Cir. 2000).
New-Claim Rejections: 35 USC § 112(a)
Necessitated by claim amendments
The following is a quotation 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.
Enablement
Claims 1-3, 6-8, 10-12 and 33-40 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 enablement requirement. The claims contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. Claims 1-3, 6-8, 10-12 and 33-40 recite specific strain “Saccharomyces cerevisiae strain ATCC 9651” comprising specific gene/encoding polynucleotides i.e., an oleate hydratase encoded by SEQ ID NO: 1 and a linalool dehydratase encoded by SEQ ID NO: 2. It is apparent that specific strain “Saccharomyces cerevisiae strain ATCC 9651” comprising specific gene/encoding polynucleotides i.e., an oleate hydratase encoded by SEQ ID NO: 1 and a linalool dehydratase encoded by SEQ ID NO: 2” is required to practice the claimed invention. As such the biological material must be readily available or obtainable by a repeatable method set forth in the specification, or otherwise readily available to the public. If it is not so obtainable or available, the requirements of 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, may be satisfied by a deposit of specific strain “Saccharomyces cerevisiae strain ATCC 9651” comprising specific gene/encoding polynucleotides i.e., an oleate hydratase encoded by SEQ ID NO: 1 and a linalool dehydratase encoded by SEQ ID NO: 2, and there is no indication in the specification as to the public availability. If the deposit was made under the terms of Budapest Treaty, then a statement, affidavit or declaration by applicants’, or a statement by an attorney of record over his/her signature and registration number, or someone empowered to make such a statement, stating that the invention will be irrevocably and without restriction released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein. In order to certify that the deposit meets the criteria set forth in 37 CFR 1.801-1.809 and MPEP 2402-2411.05, applicants’ may provide assurance of compliance by statement, affidavit or declaration, or by someone empowered to make same, or by a statement by an attorney of record over his/her signature and registration number showing that:
(a) during the pendency of the application, access to the invention will be afforded to the Commissioner upon request;
(b) all restrictions upon availability to the public will be irrevocably removed upon granting the patent;
(c) the deposit will be maintained in public depository for a period of 30 years, or 5 years after the last request or for the enforceable life of the patent, whichever is longer;
(d) a test of the viability of the biological material at the time of deposit (see 37 CFR 1.807); and the deposit will be replaced if it should ever become inviable.
New-Claim Rejections: 35 USC § 103
Necessitated by claim amendments
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-3, 6-8, 10-12 and 33-40 are rejected under 35 U.S.C. 103(a) as being unpatentable over Lopes et al., (US 11,286,490 B2; priority 07/12/2016) and further in view of ATCC, Saccharomyces cerevisiae 96581 (5 pages down-loaded on 09/21/2026), Xian et al., (CN104031872-A, 09/10/2014; see English version, Machine Translation), Culler et al., (US 10,941,454 B2; priority 05/26/2016), Larsson et al., (IET Proc.: Syst. Biol. 2011, Vol. 5: 245-251), Voight et al., (US 9,040,266 B2) and Wood et al., (US 2020/0337314 A1).
Claims 1-3, 5-9, 12, 33-34, 36-37 and 39-40 as interpreted are directed to microorganism engineered to express one or more enzymes which enhances the microorganism's ability to produce C2-4 alkene from C2-4 alkanol, wherein the microorganism is selected from Saccharomyces cerevisiae strain ATCC 9651, comprises an oleate hydratase encoded by SEQ ID NO: 1 and a linalool dehydratase encoded by SEQ ID NO: 2 (see 35 USC 112(a) rejection above for New-matter; the specification (¶ [0068], Example 1, page 18) and prior art has support for the following strain Saccharomyces cerevisiae strain ATCC 96581; neither the specification nor the prior art discloses “Saccharomyces cerevisiae strain ATCC 9651 (as in claims 1, 6-8, 10-12 and 33-40) and comprising and any non-native enzyme of undefined and unlimited structures catalysing the conversion of C2-4 alkanol (as in claims 2-3); and said microorganism wherein C2-4 alkene is ethylene (as in claim 40).
Regarding claims 1-3, 6-8, 10-12 and 33-39, the disclosure of Lopes et al., (US 11,286,490 B2; priority 07/12/2016) teaches microorganisms engineered to express one or more enzymes which enhances the microorganism's ability to produce C2-4 alkene from C2-4 alkanol, wherein the recombinant microorganism is selected from Saccharomyces cerevisiae strain and comprising an oleate hydratase and linalool dehydratase, utilization of acyclic substrate and method of producing one or more primary alkenes (see Abstract; col. 1, lines 28-40; said reference also discloses many non-native heterologous genes/expression of enzymes in said recombinant microorganism, col. 3, lines 12-67 to col. 9, lines 1-21; col. 23, lines 40-65; col. 25, lines 60-67; col. 26, lines 25-40; col. 89, lines 32-41; col. 90, lines 15-52; and entire document). Certain relevant sections from of Lopes et al., (US 11,286,490 B2; priority 07/12/2016) is reproduced below:
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Lopes et al., (US 11,286,490 B2; priority 07/12/2016) as applied to claims 1-3, 5-9, 12, 33-34, 36-37 and 39-40 is described above. However, Lopes et al., are silent regarding wherein the microorganism is selected from Saccharomyces cerevisiae strain ATCC 9651, comprises an oleate hydratase encoded by SEQ ID NO: 1 and a linalool dehydratase encoded by SEQ ID NO: 2 (see 35 USC 112(a) rejection above for New-matter; the specification (¶ [0068], Example 1, page 18) and prior art has support for the following strain Saccharomyces cerevisiae strain ATCC 96581; neither the specification nor the prior art discloses “Saccharomyces cerevisiae strain ATCC 9651 (as in claims 1, 6-8, 10-12 and 33-40), comprising an oleate hydratase encoded by SEQ ID NO: 1 and a linalool dehydratase encoded by SEQ ID NO: 2 and further comprising and any non-native enzyme of undefined and unlimited structures catalysing the conversion of C2-4 alkanol (as in claims 2-3); and said microorganism wherein C2-4 alkene is ethylene (as in claim 40).
Regarding claim 1, ATCC, Saccharomyces cerevisiae 96581 (5 pages down-loaded on 09/21/2026) advantageously teach the availability of Saccharomyces cerevisiae 96581 and its use in many industrial and research settings.
Regarding claim 1, Xian et al., (CN104031872-A, 09/10/2014; see English version, Machine Translation), disclose an oleate hydratase having 100% sequence identity to SEQ ID NO: 1 of the instant invention, said reference also discloses the use of said reference oleate hydratase in recombinant microorganism for the production isoprene/alkene (see provided sequence alignment; claims; ¶ [0001-0002], [0006-0008], [0010], [0021], [0042]; and entire document).
Regarding claim 1, Culler et al., (US 10,941,454 B2; priority 05/26/2016), disclose a linalool dehydratase having 100% sequence identity to SEQ ID NO: 2 of the instant invention, said reference also discloses the use of said reference linalool dehydratase in recombinant microorganism/Saccharomyces cerevisiae for the production isoprene/alkene (see provided sequence alignment; Abstract; col. 6, lines, 20-30; Examples 1-2, col. 73 to col. 78; and entire document).
Regarding claim 2-3 and 40, and comprising and any non-native enzyme of undefined and unlimited structures catalysing the conversion of C2-4 alkanol (as in claims 2-3); and said microorganism wherein C2-4 alkene is ethylene (as in claim 40), the following references provides teaching, suggestion and motivation:
Larsson et al., (IET Proc.: Syst. Biol. 2011, Vol. 5: 245-251), provide teaching, suggestion and motivation for engineering Saccharomyces cerevisiae comprising SAM pathway enzymes for the production of ethylene (see Abstract; col. 2, page 245 second ¶; Fig. 1, page 246; Table 1, page 248; Table 2, page 249; and entire document).
Voight et al., (US 9,040,266 B2) discloses a recombinant organism, such as a yeast/Saccharomyces cerevisiae, expressing a heterologous S-adenosylmethionine (SAM)-dependent pathway enzyme and a carbon source in a cultivation medium under conditions to increase flux through a S-adenosyl-methionine (SAM) biosynthetic pathway (Abstract; Summary of invention, col. 1, lines 55-67 to col. 7, lines 1-6; Claims; and entire document) and suggest said genetically engineered yeast/Saccharomyces cerevisiae for the production of ethylene (col. 18, lines 29-45); cultivation/fermentation medium/culturing conditions and co-culturing/consortium of microorganisms comprising yeast and other genetically modified microorganisms (col. 22, lines 10-67 to col. 28, lines 1-7).
Regarding claims 35 and 38, the following reference Wood et al., (US 2020/0337314 A1) teaches microbial based compositions including yeast/Saccharomyces cerevisiae in a consortium with other microorganisms; cocultured in consortium in culture medium and wherein microorganisms of interest are in an amount of at least about 1 x 105 CFU/g depending on the experimental need (see Abstract; ¶ [0003-0006], [0010], CFU/g [0020-0023]; and entire document).
As such, disclosure of strategy and methods for recombinant organisms, such as Saccharomyces cerevisiae, expressing heterologous an oleate hydratase having 100% sequence identity to SEQ ID NO: 1 of the instant invention and a linalool dehydratase having 100% sequence identity to SEQ ID NO: 2 of the instant invention, said references also discloses the use of said reference oleate hydratase and linalool dehydratase in recombinant microorganism/Saccharomyces cerevisiae for the production isoprene/alkene and further comprising heterologous S-adenosylmethionine (SAM)-dependent pathway enzymes and ethylene biosynthetic production pathway genes including dehydratase and a carbon source in a cultivation medium under conditions to increase flux through a S-adenosyl-methionine (SAM) biosynthetic pathway and suggest said genetically engineered Saccharomyces cerevisiae, for the production of ethylene; and compositions including yeast/Saccharomyces cerevisiae in a consortium with other microorganisms; as in claims 1-3, 6-8, 10-12 and 33-40, such as that of references of Xian et al., Culler et al., Larsson et al., Voight et al., and Wood et al., teaching the advantages of said modifications, clearly suggests to a skilled artisan to modify the teachings of Lopes et al., and incorporate the structural and functional elements of Xian et al., Culler et al., Larsson et al., Voight et al., and Wood et al., in the claimed engineered host cell/choice of cellular context and method of use for the production of ethylene from ethanol as claimed in the instant invention. One of ordinary skill in the art would have a reasonable expectation of success, since engineered host cell/choice of cellular context, method of use for the production of ethylene are well known in the art.
Therefore, claims 1-3, 6-8, 10-12 and 33-40 are rejected under 35 U.S.C. 103(a) as being unpatentable over Lopes et al., (US 11,286,490 B2; priority 07/12/2016) and further in view of ATCC, Saccharomyces cerevisiae 96581 (5 pages down-loaded on 09/21/2016), Xian et al., (CN104031872-A, 09/10/2014; see English version, Machine Translation), Culler et al., (US 10,941,454 B2; priority 05/26/2016), Larsson et al., (IET Proc.: Syst. Biol. 2011, Vol. 5: 245-251), Voight et al., (US 9,040,266 B2) and Wood et al., (US 2020/0337314 A1).
Applicants’ have traversed the above 35 U.S.C. 103(a) rejection following claim amendments and said arguments are relevant to the new rejection (see pages 7-8 of Applicants’ REMARKS dated 09/10/2026).
Applicants’ argue: “…Claim 1 has been amended herein to recite, "A microorganism engineered to express one or more enzymes which enhances the microorganism's ability to produce C2-4 alkene from C₂-4 alkanol, wherein the microorganism is Saccharomyces cerevisiae strain ATCC 9651, and wherein said strain comprises an oleate hydratase encoded by SEQ ID NO: 1 and a linalool dehydratase encoded by SEQ ID NO: 2." None of the cited prior art alone or in combination discloses all the features of presently amended claim 1. Specifically, none of the cited prior art teaches or suggests S. cerevisiae strain ATCC 9651 comprising an oleate hydratase encoded by SEQ ID NO: 1 and a linalool dehydratase encoded by SEQ ID NO: 2. As presently amended, claim 1 and its dependents, are not obvious over North, Larsson, Berry, Voight, and Wood. Applicant believes this rejection to be overcome and respectfully requests its withdrawal.”
Reply: Applicants’ arguments have been fully considered but are not deemed persuasive for the following reasons. Contrary to applicants’ arguments and assertions, examiner has provided new references Lopes et al., (US 11,286,490 B2; priority 07/12/2016) and further in view of ATCC, Saccharomyces cerevisiae 96581 (5 pages down-loaded on 09/21/2016), Xian et al., (CN104031872-A, 09/10/2014; see English version, Machine Translation) and Culler et al., (US 10,941,454 B2; priority 05/26/2016) (for details see the rejection above).
Therefore, examiner continues to take the position that each and every element of the instant invention is taught in the combination of cited references and that the combined teachings in the cited prior art provides a reasonable expectation of success and predictability for the claimed method herein and the claimed benefits are very much expected and predictable.
The Supreme Court has acknowledged: When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation...103 likely bars its patentability...if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person's skill. A court must ask whether the improvement is more than the predictable use of prior-art elements according to their established functions ...... the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results (see KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 U.S. 2007) (emphasis added).
Examiner continues to hold the position that the cited references render claims 1-3, 6-8, 10-12 and 33-40 prima facie obvious to one of ordinary skill in the art when one applies the Teaching, Suggestion and Motivation (TSM) test under the rationale for arriving at a conclusion of obviousness as suggested by the KSR ruling. The rationale applied for this rejection is as follows:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) “Obvious to try”–choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
The combined teachings in the cited prior art provides a reasonable expectation of success and predictability for the claimed invention. In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Summary of Pending Issues
The following is a summary of issues pending in the instant application.
Upon further review of claims amendment; amended new claim 1 and claims 2-3, 6-8, 10-12 and 33-40 depending therefrom are objected to under 35 U.S.C. 132(a), because it introduces new matter into the disclosure.
Amended new claim 1 and claims 2-3, 6-8, 10-12 and 33-40 depending therefrom are rejected under 35 U.S.C. 112(a) new-matter, as failing to comply with the written description requirement.
Claims 1-3, 6-8, 10-12 and 33-40 are rejected under 35 U.S.C. 112(a) as failing to comply with the enablement requirement/Biologic-deposit.
Claims 1-3, 6-8, 10-12 and 33-40 are rejected under 35 U.S.C. 103(a) as being unpatentable over Lopes et al., (US 11,286,490 B2; priority 07/12/2016) and further in view of ATCC, Saccharomyces cerevisiae 96581 (5 pages down-loaded on 09/21/2026), Xian et al., (CN104031872-A, 09/10/2014; see English version, Machine Translation), Culler et al., (US 10,941,454 B2; priority 05/26/2016), Larsson et al., (IET Proc.: Syst. Biol. 2011, Vol. 5: 245-251), Voight et al., (US 9,040,266 B2) and Wood et al., (US 2020/0337314 A1).
Conclusion
None of the claims are allowable. Claims 1-3, 6-8, 10-12 and 33-40 are objected/rejected for the reasons identified in the Rejections and Summary sections of this Office Action. Applicants’ must respond to the rejections in each of the sections in this Office Action to be fully responsive for prosecution.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GANAPATHIRAMA RAGHU whose telephone number is (571)272-4533. The examiner can normally be reached on M-F 8:30am-5pm EST.
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/GANAPATHIRAMA RAGHU/ Primary Examiner, Art Unit 1652
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