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 response filed on 05/26/2026 (along with a preliminary amendment filed on 05/28/2026) is duly acknowledged.
Claims 1-12 were previously presented (amended claim set dated 05/22/2024).
Claims 13-19 have been newly presented for examination.
Claims 1-19, as currently amended/presented, are now pending in this application.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-5, and new claims 13-19; directed to “A genetically modified malate-producing yeast strain…”) in the reply filed on 05/26/2026 (see REM, p. 21, last paragraph) is acknowledged.
Accordingly, claims 6-12 (non-elected inventions of Groups II and III) have been withdrawn from further considerations.
Claims 1-5 and 13-19 (taken under elected invention of Group I, without traverse; directed to “A genetically modified malate-producing yeast strain…”), as currently amended/presented, have been examined on their merits in this action hereinafter.
Priority
This application is a 371 of PCT/CN2022/133964 (filed on 11/24/2022), which claims foreign priority from a Chinese application CN 202111406618.4 (filed on 11/24/2021).
Claims
Instant claim 1 has been interpreted as a modified yeast strain that comprises exogenous malate transport protein and NADPH-dependent malate dehydrogenase enzyme in light of instant disclosure of record, and therefore, though all yeast cells produce malic acid in TCA cycle, a 101 rejection under natural product judicial exception, has not been made. Applicants are suggested to clarify the invention by reciting “exogenous” malate transport protein and NADPH-dependent malate dehydrogenase, or other genetic modification(s) in claim 1 that distinguishes the claimed yeast strain from naturally existing yeast cells.
Claim and Specification Objections
1. Claim 2 (as currently amended) is objected to because of the following informalities: claim 2 recites limitations “(phosphoenolpyruvate carboxykinase” (line 4), which starts with a sign of parenthesis, and should be amended to remove the start of parenthesis. Appropriate correction is required.
2. Claim 5 (as currently amended) is objected to because of the following informalities: claim 5 recites limitation “Rhodotroula” in line 3, which should be corrected to recite “Rhodotorula” instead (taken as a typographical error).
It is noted that instant specification also incorrectly recites the name of this genus of yeast (see for instances, SPEC, p. 4, 3rd paragraph; p. 34, last line), and should also be amended to correctly recite the genus as “Rhodotorula”.
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.
1. Claims 13, 14 and 16 (as 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.
Claims 13, 14 and 16 each recite the term “derived from” at multiple places (see claim 13, lines 5 and 8; claim 14, line 5; claim 16, line 6). It is unclear as to what exactly is being encompassed by such limitation in the claims, as the components recited as “derived from” could encompass just a fragment, variant, mutant, etc., for which the structure-function nexus has not been provided in the claims. Applicants are suggested to amend claims to recite “obtained from” instead.
2. Claims 15 and 16 (as presented) recite limitations “or a degenerate sequence thereof” (see claim 15, sections (i)-(vi); claim 16, 4th and 5th paragraphs) for the nucleic acid sequences encoding several enzymes (such as having SEQ ID NOs: 1-5, 7 and 8), which renders the claimed product ambiguous as it is not clear as to what exact sequence of the corresponding SEQ ID NOs: 1-5, 7 and 8 are being required that would still have the specific corresponding enzyme activity as currently required by the claims 15 and 16, as presented. Since, the nucleic acid sequences as recited would variously depend on the degree and type of degeneracy of the codons for each individual amino acids (pertaining to nearly all 20 naturally occurring amino acids in a given protein), even in light of the disclosure of particular nucleic acid sequence(s) as recited, it would not be clear to a person of ordinary skill in the art, as to what exactly is encompassed by the claims, as currently presented. Thus, the metes and bounds of the claimed product does not appear to be properly defined.
Appropriate correction and/or explanation is required.
Claim Rejections - 35 USC § 112 – WD requirement
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 1-5 and 13-18 (as currently 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 invention as claimed.
Claim 1 is directed to “A genetically modified malate-producing yeast strain, having activity or enhanced activity of malate transport protein and having activity or enhanced activity of NADPH-dependent malate dehydrogenase.” (it is noted that instant claim does not require any particular yeast strain as well as having exogenous malate transport protein and NADPH-dependent malate dehydrogenase activities per se).
See also limitations of dependent claims 2-5 and 13-18 as presented.
The BRI of the claimed product in the form of a yeast strain would encompass any species of yeast (including any species and/or strains from various yeast genera Candida, Saccharomyces, Pichia, Rhodotorula, Yarrowia, etc.; see also instant specification, page 4, 3rd paragraph). In addition, the claimed product also encompasses any “malate transport protein” and any “NADPH-dependent malate dehydrogenase” (MDH) from any source (be it any species of fungi, bacteria, plants, or other sources). The dependent claims may further comprise activity (or overexpression) of at least one of the enzymes such as pyruvate carboxylase, phosphoenolpyruvate carboxykinase, phosphoenolpyruvate carboxylase, biotin transport protein; and/or reduced (or inactivated) activity of pyruvate decarboxylase, NAD-dependent glycerol-3-phosphate dehydrogenase, orotidine 5' -phosphate decarboxylase, monocarboxylate permease, dicarboxylate transport protein, malic enzyme, bifunctional enzyme of oxaloacetate decarboxylase and 3-hydroxy-3-methylglutarate aldolase (see instant claim 2-5); wherein the nucleic acid sequences (see instant claims 15-16) encoding said MDH, malate transport protein, biotin transport protein, pyruvate carboxylase, and phosphoenolpyruvate carboxykinase (recited as requiring “at least 75%” sequence identity to SEQ ID NOs: 1-8, or “a degenerate sequence thereof”, and having corresponding activities) have been recited as to encompass sequences that have 25% variation (and/or degeneracy in sequences) and still possess the corresponding enzyme activity.
However, instant disclosure of record pertains to a specific, genetically modified, malate-producing yeast strain of Pichia kudriavzevii CY902 (deposited by applicants under the deposit number of CGMCC No. 20885; see instant SPEC, p. 2, 2nd paragraph; p. 16, 1st paragraph; p. 28, 3rd paragraph, for instances) that has the enhanced activity of NADPH-dependent malate dehydrogenase encoded from nucleic acid obtained from plant Sorghum bicolor (SbMDH) with the specific sequence of SEQ ID NO: 1, and a malate transport protein from Schizosaccharomyces pombe (SpMAE1 from S. pombe; with nucleic acid sequence of SEQ ID NO: 2) detailed per specification Example 1 (see Examples starting on SPEC, p. 38). It is noted that that only the enzymes/polypeptides encoded by the nucleotide sequence with SEQ ID NOs: 1 and 2 (corresponding to SbMDH and SpMAE1, respectively) are mainly supported by the instant disclosure, and no other type of MDH and malate transport proteins have been disclosed per se.
Since, “at least 75% sequence identity to SEQ ID NOs: 1-8 as currently required for the nucleic acid sequences for enzymes would entail about 25% sequence variations of any kind and/or anywhere in the nucleotide sequence, and since no disclosure or guidance has been provided by applicants regarding the nexus for such variation in structure and nexus with the enzymatic function (i.e. malate production and secretion/transport) said sequences pertain to and are currently required in the claims, the disclosure appears to be lacking in relevant guidance for appropriate number of species that would be required for the scope of variants in any yeast strain, as currently claimed. Since, minor changes and/or alterations in structure may affect the functional aspects of the proteins/enzymes, and since the specification does not adequately provide information correlating the nexus between the structure-function of such variants as claimed (in any yeast strain with any heterologous MDH and malate transport proteins), applicants do not appear to be in possession of the entire scope of the invention as currently claimed.
Appropriate correction is required.
Claim Rejections - 35 USC § 112 – Biological Deposit Requirement
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 19 (as newly presented) is 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 claim(s) contains 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. Claim 19 is reproduced below:
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The invention appears to employ a biological material, in the form of a malate-producing yeast strain Pichia kudriavzevii (deposited in China General Microbiological Culture Collection Center (CGMCC) under the deposit number of CGMCC No. 20885). Since the biological materials are essential to the claimed invention they must be obtainable by a repeatable method set forth in the specification or otherwise readily available to the public. If the biological material is not so obtainable or available, the requirements of 35 U.S.C. §112 may be satisfied by a deposit of the biological material. The specification does not disclose a repeatable process to obtain the biological material and it is not apparent if the biological material is readily available to the public.
It is noted that applicant has deposited the biological material (instant specification, p. 2, “Summary of the Invention”, first paragraph, for instance), but there is no indication in the specification as to public availability. If the deposit is made under the Budapest Treaty, then an affidavit or declaration by applicant, or a statement by an attorney of record over his or her signature and registration number, stating that the specific biological material (in the instant case, malate-producing yeast strain Pichia kudriavzevii deposited as CGMCC No. 20885) has been deposited under the Budapest Treaty and that the biological material will be irrevocably and without restriction or condition released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein. If the deposit has not been made under the Budapest Treaty, then in order to certify that the deposit meets the criteria set forth in 37 C.F.R. §1.801-1.809, applicant may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number, showing that:
(a) during the pendency of this 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 of the patent;
(c) the deposit will be maintained in a public depository for a period of 30 years or 5 years after the last request or for the effective life of the patent, whichever is longer;
(d) a test of the viability of the biological material at the time of deposit will be made (see 37 C.F.R. §1.807); and
(e) the deposit will be replaced if it should ever become inviable.
Applicant’s attention is directed to M.P.E.P. § 2400 in general, and specifically to § 2411.05, as well as to 37 C.F.R. §1.809(d), wherein it is set forth that “the specification shall contain the accession number for the deposit, the date of the deposit, the name and address of the depository, and a description of the deposited material sufficient to specifically identify it and to permit examination”. The specification should be amended to include this information, however, applicant is cautioned to avoid the entry of new matter into the specification by adding any other information.
Appropriate correction is required.
NOTE: 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.
Claim Rejections - 35 USC § 102
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.
1. Claims 1-5 and 13-17 (as currently presented) are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Winkler et al (US 2011/045559 A1; cited as ref. [B] on PTO 892 form; also published as WO 2008/144626 A1 and cited by IPER, submitted by applicants on record).
Claim 1 is directed to “A genetically modified malate-producing yeast strain, having activity or enhanced activity of malate transport protein and having activity or enhanced activity of NADPH-dependent malate dehydrogenase.”
See also limitations of dependent claims 2-5 and 13-17, as currently presented.
Winkler et al-2011, while teaching malic acid production using recombinant yeast strains (including Saccharomyces sp. and Pichia sp.; see Title, Abstract, Summary of the Disclosure starting on page 2, [007], [014], [0113], [0161]-[0173], Example 1 and 13, [0239], Figure 6, and Claims 263, 268, 274, 279-280, for instance), disclose malic acid production in recombinant yeast cells which were modified to contain a malate dehydrogenase and a malic acid transporter to facilitate export of malate (see paragraph [0168]-[0172] as reproduced below):
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The paragraph [0174] of Example 2 partially discloses the following:
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Winkler et al-2011 disclose the yeast strain that has reduced pyruvate decarboxylase enzyme (PDC) activity (i.e., is PDC-reduced or PDC-negative; see also paragraph [015] taken as PDC gene deletion or knockout strain) and is functionally transformed to increase the activity of either a pyruvate carboxylase (PYC) polypeptide, a phosphoenolpyruvate carboxylase (PPC) polypeptide, a malate dehydrogenase (MDH) polypeptide, and/or an organic acid transport (MAE) polypeptide (see also [091], for instance); and wherein the phosphoenolpyruvate carboxylase (PPC) or a variant thereof can be obtained from E. coli (see [0113], and amino acid and nucleotide sequences disclosed as SEQ ID NOs: 7 and 8, respectively), and the pyruvate carboxylase (PYC) can be obtained from Aspergillus sp. (see Example 13, [0239], for instance).
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-5 and 13-18 (as currently presented) are rejected under 35 U.S.C. 103 as being unpatentable over Rush et al (WO 2014/018755 A1; FOR previously of record; also cited by IPER submitted by applicants on record) taken with Winkler et al (US 2008/090273 A1, cited as ref. [A] on PTO 892 form) and Winkler et al (US 2011/045559 A1; cited as ref. [B] on PTO 892 form; also published as WO 2008/144626 A1 and cited by IPER, submitted by applicants on record; hereinafter Winkler et al-2011)
Claim 1 is directed to “A genetically modified malate-producing yeast strain, having activity or enhanced activity of malate transport protein and having activity or enhanced activity of NADPH-dependent malate dehydrogenase.”
See also limitations of dependent claim 2-5 and 13-18 as currently presented.
Rush et al (2014), while teaching yeast cells having NADP(H)-dependent reductive TCA pathway from pyruvate to succinate (see Title, Abstract, p. 16-17, and Claims 1-3, 9, 10, for instances), disclose (regarding instant claim 1) modified, recombinant yeast cells, for instance species from genera Pichia, Candida, or Saccharomyces (see claims 83-87; it is noted that Pichia kudriavzevii is also known in the art as Issatchenkia orientalis, or I. orientalis); wherein said yeast cell contains at least one exogenous NADPH-dependent gene in the pathway from phosphoenolpyruvate or pyruvate to succinate, preferably overexpressing the NADPH-dependent malate dehydrogenase (MDH; see Abstract); wherein the MDH gene is obtained from plant Sorghum bicolor that is encoded by SEQ ID NO:29, which has 81.6% identity to SEQ ID NO:1 of the instant application; wherein they also disclose that the yeast cell can optionally express a NADPH-dependent fumarate reductase (see claims 9, 10); wherein they also disclose the use of the Schizosaccharomyces pombe malic enzyme (MAE), the gene designated as nucleotide sequence of SEQ ID NO:6, which is 87.4% identical to SEQ ID NO:2 of the instant application, wherein the specific integration fragment P4-4 (designated as nucleotide sequence of SEQ ID NO:8) is disclosed containing said S. pombe MAE gene (see p. 28, 2-4 paragraphs; Table 6, for instance); wherein (regarding instant claim 2) the modified yeast cells also comprise an exogenous pyruvate carboxylase and/or a fumarase (see claim 14), and/or a succinate exporter/transport protein (see p. 16, first full paragraph). In addition, the cells may comprise deletions/disruptions of the endogenous genes, including pyruvate decarboxylase, alcohol dehydrogenase, glycerol-3-phosphate dehydrogenase (see p. 17, first full paragraph, for instance).
However, a yeast strain comprising activity of, or overexpressed nucleic acid sequence for encoding the malate transport protein such as SpMAE1 protein having SEQ ID NO: 2 (instant claims 13, 15), and wherein the phosphoenolpyruvate carboxylase (PPC) is from Escherichia coli (instant claim 14), have not been specifically disclosed by Rush et al, as discussed above.
Winkler et al (2008) disclose recombinant yeast strains (which also includes strains from Pichia species; see Abstract, and paragraphs [0020]-[0021], [0032], Figure 6, and Claims 1, 4, 6 for instance) engineered to produce malate wherein the yeast is modified to express a malate dehydrogenase (MDH) and a malic acid transporter protein (MAE), in particular the one of Schizosaccharomyces pombe, SpMAE1 (designated as amino acid sequence of SEQ ID NO:3), and encoded by nucleic acid sequence, e.g. SEQ ID NO:6, which has 77.8% identity to SEQ ID NO:2 of the instant application (see paragraphs [0032], [0040], [0048], in particular); wherein they disclose that nucleic acid sequences can be optimized by an artisan in the art for both MDH as well as MAE proteins based on the redundancy of the genetic code, and utilized for making said recombinant yeast strain.
Winkler et al-2011, while teaching malic acid production using recombinant yeast strains (including Saccharomyces sp. and Pichia sp.; see Title, Abstract, Summary of the Disclosure starting on page 2, [007], [014], [0113], [0161]-[0173], Example 1 and 13, [0239], Figure 6, and Claims 263, 268, 274, 279-280, for instance), disclose malic acid production in recombinant yeast cells which were modified to contain a malate dehydrogenase and a malic acid transporter to facilitate export of malate (see paragraph [0168]-[0172] as reproduced below):
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The paragraph [0174] of Example 2 partially discloses the following:
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Winkler et al-2011 disclose the yeast strain that has reduced pyruvate decarboxylase enzyme (PDC) activity (i.e., is PDC-reduced or PDC-negative; see also paragraph [015] taken as PDC gene deletion or knockout strain) and is functionally transformed to increase the activity of either a pyruvate carboxylase (PYC) polypeptide, a phosphoenolpyruvate carboxylase (PPC) polypeptide, a malate dehydrogenase (MDH) polypeptide, and/or an organic acid transport (MAE) polypeptide (see also [091], for instance); and wherein the phosphoenolpyruvate carboxylase (PPC) or a variant thereof can be obtained from E. coli (see [0113], and amino acid and nucleotide sequences disclosed as SEQ ID NOs: 7 and 8, respectively), and the pyruvate carboxylase (PYC) can be obtained from Aspergillus sp. (see Example 13, [0239], for instance).
Thus, given the detailed disclosure for modified yeast strains that produce malic acid (including from Pichia sp.) and that express malate transport protein such as SpMAE1 (as disclosed by Winkler et al discussed above) and for the various sources of enzymes such as PPC and PYC enzymes and/or variants derived from E. coli or Aspergillus sp. (as disclosed by Winkler et al-2011, above), it would have been obvious to an artisan of ordinary skill in the art to modify the yeast strain disclosed by Rush et al such that it incorporates a functional equivalent of malate transport protein derived from S. pombe such as SpMAE1 as specifically demonstrated by Winkler et al for the same purposes of producing and secreting enhanced amounts of malic acid out of modified yeast cells producing higher amounts of malic acid. The specific enzymes derived from various sources such as E, coli or Aspergillus sp. would have been obvious to an artisan in the art as Winkler et al-2011 already disclose such alternatives for PPC and PYC enzymes that efficiently work when incorporated in yeast strains including Pichia or Saccharomyces as shown by the cited prior art references above. Since, all the cited references are in the same field having the same purpose of producing higher amounts of dicarboxylic acids such as malic acid using yeast as a host, such modification would have been fully contemplated by an artisan of ordinary skill in the art, unless evidence/data provided on record to the contrary.
Thus, the claim as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention as claimed.
As per MPEP 2111.01, during examination, the claims must be interpreted as broadly as their terms reasonably allow. In re American Academy of Science Tech Center, F.3d, 2004 WL 1067528 (Fed. Cir. May 13, 2004)(The USPTO uses a different standard for construing claims than that used by district courts; during examination the USPTO must give claims their broadest reasonable interpretation.). This means that the words of the claim must be given their plain meaning unless applicant has provided a clear definition in the specification. In re Zletz, 893 F.2d 319, 321, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989).
NOTE: It is to be noted that SEQ ID NOs: 1 and 2 for 100% identity appear to be free of prior art issues.
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.
Claim 19 (as presented) is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over at least claims 1 and 5 of copending Application No. 18/712,509 (reference application; filed on the same day by common inventors and assignee). Although the claims at issue are not identical, they are not patentably distinct from each other because the claim 5 of the copending application ‘509 is also directed to essentially the same “yeast strain” that has been deposited by applicants as Pichia kudriavzevii that has been deposited in China General Microbiological Culture Collection Center (CGMCC) under the SAME deposit number of CGMCC No. 20885. The claim 1 (partially) and claim 5 of ‘509 have been reproduced hereinbelow:
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Since, both set of claims as currently presented are drawn to essentially the same yeast strain (as per the same deposit number recited and/or disclosed in both the applications; see instant disclosure, p. 2, 2nd paragraph, and copending application ‘509, p. 2, 2nd paragraph, for instance) of Pichia kudriavzevii, and since yeast strains naturally possess capability to produce malate and succinate (in TCA cycle, for instance), an ODP rejection over such co-extensive scope as claimed is deemed proper.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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.
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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.
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SATYENDRA K. SINGH
Primary Examiner
Art Unit 1657
/SATYENDRA K SINGH/Primary Examiner, Art Unit 1657
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