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 1-15 have been canceled.
Claims 16-29 are under examination on the merits.
Claim Objections
Claims 16-29 are objected to because of the following informalities: claims 16-29 appear to be word for word translation of a foreign language into English and at times do not make sense. Applicant is advised to rewrite said claims in concise English in response to this rejection. Appropriate correction is required.
Specification
The amendments to the specification of 5/14/24 (see 2-page document) is partially objected to because it is unclear why the paragraph regarding “Ono et al” should be entered. If said paragraph is not part of the English translation of the PCT/Ep2021/083372, then it is unclear on what grounds applicant decided to have that paragraph entered into the specification. Applicant is advised to avoid entering new mater into the specification. Appropriate clarification 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 16-29 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 16 (and its dependent claims 17-29) are unclear. This is because applicant has not utilized active steps in claim 16 and refer to steps taken in passive language, such as “is carried out” etc.
Applicant may consider rewriting the claim as following (or something equivalent):
“16. A process for producing L-cysteic acid comprising:
contacting (reacting) O-acetyl-L-serine (OAS) with at least one enzyme from EC 4.2.99.8, having OAS sulfhydrylase activity in the presence of a salt of sulfurous acid, wherein the OAS sulfhydrylase is CysM and wherein the reaction is pH controlled and the concentration of OAS in the reaction is at least 10 g/L”.
Further, in claim 16, lines 1-2, the term “comprising:” is followed by “wherein”, which is grammatically incorrect.
Furthermore, the phrase “the biotransformation” and “the batch” lack antecedent basis. In addition, it is unclear what applicant means by “biotransformation”. The examiner searched for the meaning of said term in the dictionary but did not find any specific definition for said term.
Claims 17-29 are rejected for depending from claim 16.
Claims 19, 22 and 25 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. The phrase “stems from” in claims 19, 22 and 25 is confusing. Applicant may consider substituting said phrase by “produced by” or something equivalent.
Claims 20-21, 23 and 24 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. In claims 20-21 and 23-24, the phrase “produced fermentatively with the aid of” is confusing as it is unknown if the strains utilized were actually necessary to ferment and produce the OAS sulfhydrylase or if they just helped with production of said acid but were not critical for the enzyme production. Applicant may consider rewriting said phrase as “is produced by fermentation of microorganism ….”.
Claim 25 is 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 25, repeats the same concept namely “utilizing reactants such as OAS and OAS sulfhydrylase which are prepared non-recombinantly” several times, thereby confusing the claim. Further, claim 25 recites “i.e.”, which is improper. In addition, it is unknown what applicant means by the phrase “not produced chemically”. Chemicals are involved in all recombinant and non-recombinant production processes. Applicant needs to rewrite said claim in concise English and avoid redundancy.
Claim 29 is 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. In claim 29, The phrase “is enriched from” is confusing. Firstly, the phrase “enriched from” is ambiguous because it reads on a “concentrated but not purified product” (such as precipitate), an “isolated product”, “concentrated and purified product” etc. Applicant needs to substitute said phrase with some more specific term or phrase. Secondly, the phrase “the reaction batch” itself in claim dependent claim 29 lacks antecedent basis because said claim depends from a base claim (see claim 16) which lacks antecedent basis.
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 21 and 24 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. It is noted that applicant has deposited the strains recited in claims 21 and 24 but there is no indication in the specification as to the public availability. Since the deposit was made under the terms of the Budapest Treaty, then an affidavit or declaration by applicants, or a statement by an attorney of record over his or her signature and registration number, stating that the specific strain has been deposited under the Budapest Treaty and that the strain will be irrevocably and without restriction or condition released to the public upon the issuance of the patent, would satisfy the deposit requirement made herein.
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) 16-19, 22, 26-29 are rejected under 35 U.S.C. 103 as obvious over Ono et al., “Ono” (Free Radical Biology and Medicine, 106, 69-79, 2017, cited in the IDS).
Ono discloses a preparation method of cysteine derivatives from OAS substrate using CysM (which is from a bacterial source) in the presence of hydrogen sulfide (see Materials and Methods section, Fig 2C and page 78, under discussion). In page 70, reference is made to other salts for use in Ono’s method, such as sodium hydrogen sulfide (NaHS), sodium sulfite (Na2SO3), and sodium thiosulfate (Na2S2O3), wherein Na2SO3 is a salt of sulfurous acid of this invention (see [0016] of this case patent publication).
In page 70, section 2.4, Ono discloses that CysM reaction pH was 7.6 which is almost the same as pH 7.5 of this invention (see claim 28), within experimental error.
Therefore, given the teachings of Ono, one of ordinary skill in the art, before the effective filing of this application, is readily motivated that whenever he/she wants to prepare a L-cysteine derivative(s) including L-cysteic acid of this invention, to start with the OAS of Ono and react it with OAS sulfhydrylase of Ono (such as CysM, CysK etc.) in the presence of salts of Ono under pH’s very close to 7.6 and then isolate said derivative(s) including L-cysteic acid, from the reaction solution.
Finally, one of ordinary skill in the art has a reasonable expectation of success in preparing L-cysteic acid by reacting OAS with CysM of Ono in the presence of the salt(s) of Ono because Ono has worked out all necessary parameters and variables for such reaction(s) to successfully prepare L-cysteine derivatives, before the effective filing of this application, rendering this invention obvious.
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.
Claims 16-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-21 of copending Application No. 18/712,705. Although the claims at issue are not identical, they are not patentably distinct from each other because: a method of taurine production of the copending application recite a method of L-cysteic acid production in its base claim 11 step (i) and hence, the scope of instant claims (being generic) embraces the scope of claims in said copending application (species).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARYAM MONSHIPOURI whose telephone number is (571)272-0932. The examiner can normally be reached full-flex.
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/MARYAM MONSHIPOURI/Primary Examiner, Art Unit 1651