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 .
Applicant’s cancellation of claims 6-9, in the paper of 4/8/2025, is acknowledged. Claims 1-12 are still at issue and are present for examination.
Election/Restrictions
Applicant's election with traverse of the invention of Group 1, claims 1-9 and 11, to a process for synthesizing a functionalized mercaptan, in the paper of 9/3/2025, is acknowledged. Applicant's election with traverse of the species of O-acetyl-L-homoserine, in the paper of 9/3/2025, is acknowledged.
Applicants traverse the restriction requirement on the basis that applicants submit that White does not disclose sulfydrylases of the class EW.C. 2.5.1 for the production of compounds of formula (I). Applicants complete traversal is acknowledged and has been carefully considered, with regard to applicants newly amended claims and White. In light of applicants amendment, it is noted that Bradshaw (US 10,544,436 and WO 2016/179545) teaches the method of claim 1, as discussed below, and thus unity of invention is lacking.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure 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."
Applicants filing of information disclosure statements on 1/12/2023, 2/1/2023, 9/17/2024 and 9/3/2025 are acknowledged and have been considered.
Specification
The disclosure is objected to because of the following informalities:
The use of the terms: Triton (page 18, line 19), BLAST (paragraph [0087]) which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
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 1-8 and 11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Claims 1-8 and 11 are directed a process for synthesizing at least one functionalized mercaptan of the following general formula (I): R2-X-C*H(NR1R7)-(CH2)n-SH (I) in which, - R1 and R7, which are identical or different, are a hydrogen atom or an aromatic or nonaromatic, linear, branched or cyclic, saturated or unsaturated, hydrocarbon chain of 1 to 20 carbon atoms which may comprise one or more heteroatoms; - X is chosen from -C(=O)-, -CH2- or -CN; - R2 is: (i) either absent when X represents -CN, (ii) or a hydrogen atom, (iii) or -OR3, R3 being a hydrogen atom or an aromatic or nonaromatic, linear, branched or cyclic, saturated or unsaturated, hydrocarbon chain of 1 to 20 carbon atoms which may comprise one or more heteroatoms, (iv) or -NR4R5, R4 and R5, which are identical or different, being a hydrogen atom or an aromatic or nonaromatic, linear, branched or cyclic, saturated or unsaturated, hydrocarbon chain of 1 to 20 carbon atoms which may comprise one or more heteroatoms; n is equal to 1 or 2; and * represents an asymmetric carbon; said process comprising the steps of: a) provision of at least one compound of the following general formula (II): R2-X-C*H(NR1R7)-(CH2)-G (II) in which *, R1, R2, R7, X and n are as defined for formula (I) and G represents either (i) R6-C(O)-O-, or (ii) (R70)(R80)-P(O)-0-, or (iii) R90-SO2-0-; with R6 being a hydrogen atom or a linear, branched or cyclic, saturated or unsaturated hydrocarbon chain of 1 to 20 carbon atoms which may comprise one or more aromatic groups and may be substituted by one or more groups chosen from -OR10, (=0), - C(O)OR11, -NR12R13; R10, R11, R12 and R13 being independently chosen from: H or a linear, branched or cyclic, saturated or unsaturated hydrocarbon chain of 1 to 20 carbon atoms; R7 and R8, which are identical or different, being a proton, an alkali metal, an alkaline earth metal or an ammonium; R9 being chosen from a proton, an alkali metal, an alkaline earth metal or an ammonium; b) provision of at least one hydrosulfide salt and/or sulfide salt or H2S; c) reaction between said at least one compound of formula (II) and said at least one hydrosulfide and/or sulfide salt or H2S in the presence of at least one enzyme chosen from sulfhydrylases of the class EC 2.5.1.XX, and preferably a sulfhydrylase associated with said compound of formula (II); said reaction being performed essentially in the absence of oxygen, preferably in the absence of oxygen; that is not patent-eligible pursuant to the Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics, Inc., 106 USPQ2d 1972 (June 13, 2013). Hsiao and Wei (Biotechnology and Bioengineering, Vol 30, pp 875-881, 1987) discloses that Salmonella typhimurium comprises a O-acetylserine sulfhydrase that catalyzes the conversion of O-acetylhomoserine and H2S to homocysteine, thus evidencing that the claimed method is a naturally occurring method and is thus not patent eligible.
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 1-8 and 11 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 (claims 2-8 and 11 dependent from) is indefinite in the description of “R2” as it recites “(ii) or…”, “(iii) or…” and “(iv) or…”. It is believed that applicants intent is to describe “R2” in the alternative with regard to “(i)”, “(ii)”, “(iii)” and “(iv)” and this is how the claim is interpreted.
Claim 1 is further indefinite in the recitation “provision” in the context of the claimed “method”, which is interpreted as “providing”.
Claim 1 is further indefinite in the recitation “reaction” in the context of the claimed “method”, which is interpreted as “reacting”.
Claim 1 recites the limitation "said at least one compound of formula (II)" for which there is not literal antecedent basis. While claim 1 recites “at least one compound of the following general formula (II)” this begs the question if applicants reference to “general formula (II)” is the indended to be the same a “formula(II)” or if there is a difference. It is suggested that applicants maintain consistency throughout the claims.
Claim 1 is further indefinite in the recitation “said reaction being performed essentially in the absence of oxygen, preferably in the absence of oxygen” in the that it is unclear and confusing as to the applicants intended meaning in the terms “essentially” and “preferably”. The use of these terms obscure the scope of the claims and thus they are not given patentable weight.
Claim 2 recites the limitation "the reaction mixture" in claim 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 recites the limitation "the gas phase" in claim 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 recites the limitation "Synthesis process according to Claim 1" for which there is not literal antecedent basis. It is suggested that this be amended to “ The process for synthesizing at least one functionalized mercaptan of the following general formula (I) according to claim 1”.
Claim 6 recites the limitation "the reaction medium" in claim 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "Process according to Claim 1" for which there is not literal antecedent basis. It is suggested that this be amended to “ The process for synthesizing at least one functionalized mercaptan of the following general formula (I) according to claim 1”. It is suggested that applicants maintain consistency throughout the claims.
Appropriate correction and/or comment is required.
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.
(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(s) 1, 2, 3, 4, 5, 6, 7, 8 and 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bradshaw (US 10,544,436 and WO 2016/179545).
Bradshaw teach compositions and methods for the biological production of methionine. Bradshaw teach a method of providing O-acetylhomoserine within a hydrogenotrophic microorganism which incorporates H2S into O-acetylhomoserine to produce homocysteine which is further converted to methionine. The methods taught by Bradshaw include providing O-acetylhomoserine, providing H2S, the catalyzation (reacting) of the reaction of O-acetylhomoserine and H2S by O-acetyl-L-homoserine sulfhydrylase (EC 2.5.1.49) (column 30, lines 52-67 and supporting text). Bradshaw further teach the above methods of providing O-acetylhomoserine, providing H2S, the catalyzation (reacting) of the reaction of O-acetylhomoserine and H2S by O-acetyl-L-homoserine sulfhydrylase (EC 2.5.1.49) in a bioreactor. Bradshaw further teach the above methods of producing methionine comprising culturing a methanogenic archaea in a bioreactor under anaerobic conditions (see claims 19-22 and supporting text).
Thus claim(s) 1, 2, 3, 4, 5, 6, 7, 8 and 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bradshaw (US 10,544,436 and WO 2016/179545).
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.
Claims 1-8 and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of copending Application No. 18/255,803 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-11 of copending Application No. 18/255,803 (reference application) drawn to process for synthesizing at least one functionalized mercaptan of the following general formula (I): R2-X-C*H(NRiR7)-(CH2)n-SH (I) in which, - R1 and R7, which are identical or different, are a hydrogen atom or an aromatic or nonaromatic, linear, branched or cyclic, saturated or unsaturated, hydrocarbon chain of 1 to 20 carbon atoms which may comprise one or more heteroatoms; - X is chosen from -C(=0)-, -CH2- or -CN; - R2 is:(i) either absent when X represents -CN, (ii) or a hydrogen atom, (iii) or -OR3, R3 being a hydrogen atom or an aromatic or nonaromatic, linear, branched or cyclic, saturated or unsaturated, hydrocarbon chain of 1 to 20 carbon atoms which may comprise one or more heteroatoms, (iv) or -NR4R5, R4 and R5, which are identical or different, being a hydrogen atom or an aromatic or nonaromatic, linear, branched or cyclic, saturated or unsaturated, hydrocarbon chain of 1 to 20 carbon atoms which may comprise one or more heteroatoms; n is equal to 1 or 2; and * represents an asymmetric carbon; said process comprising the stages of:a) provision of at least one compound of the following general formula (II):R2-X-C*H(NRiR7)-(CH2)n-G (II) in which *, Ri, R2, R7, X and n are as defined for formula (I) and G represents either (i) R6-C(O)-O-, or (ii) (R70)(R80)-P(O)-O-, or (iii) R90-SO2-0-;with R6 being a hydrogen atom or a linear, branched or cyclic, saturated or unsaturated hydrocarbon chain of 1 to 20 carbon atoms which may comprise one or more aromatic groups and may be substituted by one or more groups chosen from -ORio, (=0), -C(O)ORii, -NR12R13;Rio, Rii, R12 and R13 being independently chosen from: H or a linear, branched or cyclic, saturated or unsaturated hydrocarbon chain of 1 to 20 carbon atoms; R7 and R, which are identical or different, being a proton, an alkali metal, an alkaline earth metal or an ammonium; R9 being chosen from a proton, an alkali metal, an alkaline earth metal or an ammonium; b) provision of H2S; c) reaction between said at least one compound of formula (II) and H2S in the presence of at least one enzyme chosen from sulfhydrylases, preferably a sulfhydrylase associated with said compound of formula (II); said reaction being performed in a reactor with a partial pressure of H2S in the gas headspace of said reactor of between 0.01 and 4 bars, for example between 0.01 and 3 bars, preferably between 0.1 and 3 bars, for example between 0.1 and 2.5 bars, at the reaction temperature; d) obtaining of at least one functionalized mercaptan of formula (I); e) optional separation of said at least one functionalized mercaptan of formula (I) which is obtained in stage d); and f) optional additional functionalization and/or optional deprotection of the functionalized mercaptan of formula (I) which is obtained in stage d) or e); and wherein stages a) and b) are optionally performed simultaneously. anticipate/make obvious instant claims 1-8 and 11 drawn to Process for synthesizing at least one functionalized mercaptan of the following general formula (I):
R2-X-C*H(NR1R7)-(CH2)n-SH (I) in which,- R1 and R7, which are identical or different, are a hydrogen atom or an aromatic or nonaromatic, linear, branched or cyclic, saturated or unsaturated, hydrocarbon chain of 1 to 20 carbon atoms which may comprise one or more heteroatoms; - X is chosen from -C(=O)-, -CH2- or -CN; - R2 is:
(i) either absent when X represents -CN,(ii) or a hydrogen atom,(iii) or -OR3, R3 being a hydrogen atom or an aromatic or nonaromatic, linear, branched or cyclic, saturated or unsaturated, hydrocarbon chain of 1 to 20 carbon atoms which may comprise one or more heteroatoms,(iv) or -NR4R5, R4 and R5, which are identical or different, being a hydrogen atom or an aromatic or nonaromatic, linear, branched or cyclic, saturated or unsaturated, hydrocarbon chain of 1 to 20 carbon atoms which may comprise one or more heteroatoms; n is equal to 1 or 2; and * represents an asymmetric carbon; said process comprising the steps of: a) provision of at least one compound of the following general formula (II): R2-X-C*H(NR1R7)-(CH2)-G (II) in which *, R1, R2, R7, X and n are as defined for formula (I) and G represents either (i) R6-C(O)-O-, or (ii) (R70)(R80)-P(O)-0-, or (iii) R90-SO2-0-; with R6 being a hydrogen atom or a linear, branched or cyclic, saturated or unsaturated hydrocarbon chain of 1 to 20 carbon atoms which may comprise one or more aromatic groups and may be substituted by one or more groups chosen from -OR10, (=0), - C(O)OR11, -NR12R13; R10, R11, R12 and R13 being independently chosen from: H or a linear, branched or cyclic, saturated or unsaturated hydrocarbon chain of 1 to 20 carbon atoms; R7 and R8, which are identical or different, being a proton, an alkali metal, an alkaline earth metal or an ammonium;
R9 being chosen from a proton, an alkali metal, an alkaline earth metal or an ammonium; b) provision of at least one hydrosulfide salt and/or sulfide salt or H2S;
c) reaction between said at least one compound of formula (II) and said at least one hydrosulfide and/or sulfide salt or H2S in the presence of at least one enzyme chosen from sulfhydrylases of the class EC 2.5.1.XX, and preferably a sulfhydrylase associated with said compound of formula (II); said reaction being performed essentially in the absence of oxygen, preferably in the absence of oxygen; d) obtaining of at least one functionalized mercaptan of formula (I); e) optional separation of said at least one functionalized mercaptan of formula (I) which is obtained in step d); and f) optional additional functionalization and/or optional deprotection of the functionalized mercaptan of formula (I) which is obtained in step d) or e); and wherein steps a) and b) are optionally performed simultaneously.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 6-3 EST Mon-Fri.
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rgh
10/27/2025
/RICHARD G HUTSON/Primary Examiner, Art Unit 1652
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