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
Amended Claims 1, 3-6, 8-17 and 20-24 (dated 11/07/2024) are pending and now under consideration.
Priority
Applicants’ claim for the benefit of priority under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. This application is a 371 of PCT/US2023/066629 filed on 05/05/2023, which claims benefit of Provisional application 63/364,375 filed on 05/09/2022.
Information disclosure statement
The information disclosure statements (IDS) submitted on 11/07/2024 and 05/12/2025 are compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS statements are considered and initialed by the examiner.
Objections-Abstract/Specification
The Abstract of the disclosure is objected to because, Abstract should be on a separate sheet of paper. The abstract of the disclosure is objected to because the abstract is presented as part of the first page of a WO publication. The abstract should be presented as a single sheet apart from all other bibliographic material including the information included on the first page of a WO publication. If EFS is used to submit a replacement abstract, the appropriate abstract (ABST) document code should be used for the one-page document. Correction is required. See MPEP § 608.01 (b).
Claims Objections
I. Claim 5 is objected to, as said claim does not end with a period (“.”) and makes the claim indefinite and incomplete.
II. Claim 14 is objected to, due to the following informality: Claim 14 recites subject-matter in parentheses; i.e., “(SEQ ID NO: 86… and SEQ ID NO: 139)”; and it is not clear whether the subject-matter recited in parentheses is a limitation of claim 14 or merely exemplary?; examiner urges the applicants’ to make a direct reference and not recite the limitation in parentheses. Appropriate correction is required.
Claim Rejections: 35 USC § 112(b)
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.
I. Claim 11 and claims 13-14 depending therefrom 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 applicant regards as the invention.
Claim 11 lacks antecedent basis for the limitations “the ER1 locus”, “the ER3 locus”, “the PDC1 locus”, “the pyrF locus”, “the TRP3 locus”, “the gpdIIA locus”, and “the gpdIIB locus” as these genes are not present in each and every yeast species. For example, ER1 and ER3, which encode erythrose reductases, are only present in erythritol-producing yeasts (Rzechonek et al, Crit. Rev. Biotechnol., 2018, Vol. 38: 620-633; see page 624, left column, ¶1). Clarification and correction is required.
II. Claim 14 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 applicant regards as the invention.
It is unclear in claim 14 are the sequences in parenthesis are a required part of the claim or if they are merely optional/exemplary?. Clarification and correction is required.
III. Claim 17 and claims 20-24 depending therefrom 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 applicant regards as the invention.
In claim 17 it is unclear if “wherein fermentation of the substrate by the engineered yeast produces xylitol” is a method step or if it is merely stating what would happen if fermentation were to occur. Similarly, it is unclear if the fermentation conditions in dependent claims 20-24 are conditions applied to a method step or if they merely state conditions of a hypothetical fermentation. The rejections over claims 17 and 20-24 can be overcome by reciting fermentation as an active method step in claim 17 or by amending to make clear that fermentation is hypothetical. Clarification and correction is required.
Claim Rejections: 35 USC § 112(a)
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.
Written Description
Claims 1, 3-6, 8-17 and 20-24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112, first paragraph, as containing subject matter which was not disclosed in the specification in such a way as to reasonably convey to one of skilled in the relevant art that the invention(s), at the time the application was filed, had possession of the claimed invention.
Claims 1, 3-6, 8-17 and 20-24 as interpreted are directed to a genus of engineered yeast/cellular context (as in claims 1, 3-6, 9-17 and 20-24) comprising a genera of polypeptides having at least 80%-90% sequence identity to SEQ ID NOs: 12-15, 28-31 and 33 and having xylitol-phosphate dehydrogenase activity (XPDH: as in as in claims 1, 3-6, 8-17 and 20-24; examiner also notes that a search for enzyme name “xylitol-phosphate dehydrogenase” in Expasy/Enzyme site returned no hits/no results i.e., “No ENZYME entry was found with name containing xylitol-phosphate dehydrogenase) and a method for production of xylitol utilizing said genus of engineered yeast/cellular context (as in claims 17 and 20-24; also see claims objections and 35 U.S.C. 112(b) rejection above for claim interpretation).
The specification discloses and is limited to a single yeast species i.e., Moniliella pollinis comprising the polypeptide sequences of SEQ ID NOs: 12-15, 28-31 and 33 and having the claimed xylitol-phosphate dehydrogenase activity for producing xylitol (see Example 1-11, pages 18-39 of specification), which is insufficient to put one of skill in the art in possession of the attributes and features of all species within the claimed genus i.e., a genus of engineered yeast/cellular context (as in claims 1, 3-6, 9-17 and 20-24) comprising a genera of polypeptides having at least 80%-90% sequence identity to SEQ ID NOs: 12-15, 28-31 and 33 and having xylitol-phosphate dehydrogenase activity (XPDH: as in as in claims 1, 3-6, 8-17 and 20-24; examiner also notes that a search for enzyme name “xylitol-phosphate dehydrogenase” in Expasy/Enzyme site returned no hits/no results i.e., “No ENZYME entry was found with name containing xylitol-phosphate dehydrogenase) and a method for production of xylitol utilizing said genus of engineered yeast/cellular context (as in claims 17 and 20-24; also see claims objections and 35 U.S.C. 112(b) rejection above for claim interpretation).
A sufficient written description of a genus of may be achieved by a recitation of structural features common to members of genus, which features constitute a substantial portion of the genus. There is no recited structural feature of the genus in the specification, i.e., a genus of engineered yeast/cellular context (as in claims 1, 3-6, 9-17 and 20-24) comprising a genera of polypeptides having at least 80%-90% sequence identity to SEQ ID NOs: 12-15, 28-31 and 33 and having xylitol-phosphate dehydrogenase activity (XPDH: as in as in claims 1, 3-6, 8-17 and 20-24; examiner also notes that a search for enzyme name “xylitol-phosphate dehydrogenase” in Expasy/Enzyme site returned no hits/no results i.e., “No ENZYME entry was found with name containing xylitol-phosphate dehydrogenase) and a method for production of xylitol utilizing said genus of engineered yeast/cellular context (as in claims 17 and 20-24; also see claims objections and 35 U.S.C. 112(b) rejection above for claim interpretation). Therefore, one skilled in the art cannot reasonably conclude that the applicant had possession of the claimed invention at the time the instant application was filed.
In University of California v. Eli Lilly & Co., 43 USPQ2d 1938, the Court of Appeals for the Federal Circuit has held that “A written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as by structure, formula, [or] chemical name,’ of the claimed subject matter sufficient to distinguish it from other materials”. As indicated in MPEP § 2163, the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show that Applicant was in possession of the claimed genus. In addition, MPEP § 2163 states that a representative number of species means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
The Federal Circuit in Lilly, Fiers, Rochester and many other cases has determined that the written description issue applies to situations where the definition of the subject matter of the claims fails to provide description commensurate with the genus. Case law directly supports this rejection. As the District Court in University of Rochester v. G.D. Searle & Co., Inc. (2003 WL 759719 W.D.N.Y., 2003. March 5, 2003) noted “In effect, then, the '850 patent claims a method that cannot be practiced until one discovers a compound that was not in the possession of, or known to, the inventors themselves. Putting the claimed method into practice awaited someone actually discovering a necessary component of the invention.”
This is similar to the current situation, since the breadth of the current claims comprises a genus of engineered yeast/cellular context (as in claims 1, 3-6, 9-17 and 20-24) comprising a genera of polypeptides having at least 80%-90% sequence identity to SEQ ID NOs: 12-15, 28-31 and 33 and having xylitol-phosphate dehydrogenase activity (XPDH: as in as in claims 1, 3-6, 8-17 and 20-24; examiner also notes that a search for enzyme name “xylitol-phosphate dehydrogenase” in Expasy/Enzyme site returned no hits/no results i.e., “No ENZYME entry was found with name containing xylitol-phosphate dehydrogenase) and a method for production of xylitol utilizing said genus of engineered yeast/cellular context (as in claims 17 and 20-24; also see claims objections and 35 U.S.C. 112(b) rejection above for claim interpretation) which the present inventors were not in the possession of, or which were not known to the inventors.
Hence, claims are reading on significant numbers of inoperative embodiments would render claims non-enabled/lack of written-description, when the specification does not clearly identify the operative embodiments or evidence of possession and undue experimentation is involved in determining those that are operative.” Atlas Powder Co. v. E.I. duPont de Nemours & Co., 750 F.2d 1569, 1577, 224 USPQ 409, 414 (Fed. Cir. 1984); In re Cook, 439 F.2d 730, 735, 169 USPQ 298, 302 (CCPA 1971); MPEP 2164.08(b).
Therefore, claims 1, 3-6, 8-17 and 20-24 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. Applicants are referred to the revised guidelines concerning compliance with the written description requirement of 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, published in the Official Gazette and also available at www.uspto.gov.
Claim Rejections: 35 USC § 102 (AIA )
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.
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 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.
Claims 1, 3, 5, 9-10, 12-13, 15-17 and 21-24 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Miasnikov et al., (US 7,226,761 B2) when given the broadest reasonable interpretation.
Regarding claims 1, 3, 9-10, 12-13, 15-17 and 21-24, Miasnikov et al., (US 7,226,761 B2) disclose “a host is constructed that expresses or over-expresses XPDH gene, using recombinant XPDH gene sequences; such sequences have been identified by the inventors in L. rhamnosus and R. halodurans; similar sequences from C. difficile (SEQ ID NO:51, 52 and 53) would also be useful in this regard; such hosts are especially useful for the production of xylitol in a pathway in which xylulose-5-P is converted to xylitol-1-P by XPDH, and then the xylitol-1-P is converted to xylitol with a phosphatase” (see Abstract; col. 1, lines 30-40; col. 3, lines 15-17; col. 16, lines 30-43; and entire document); said reference polypeptides sequences have 100% sequence identities to SEQ ID NOs: 12-15 of the instant invention (see provided sequence alignments); said reference discloses the host cells are yeasts Candida (in the art Candida is recognized as osmotolerant yeast cell) and Pichia (see col. 16, lines 68-67); said reference discloses 40-175 fold increase in xylitol production without the production of erythritol (see Tables 7-21); said reference host cells comprise genes of interest under the control of constitutive promoters (col. 17, lines 47-67 to col. 18, lines 1-17); said reference discloses as carbon sources/substrates glucose, sucrose and fructose (col. 16, lines 11-30); said reference also suggests “Further improvement of this system can be achieved by a more accurate control of the fermentation conditions particularly, the dissolved oxygen concentration, glucose concentration and feed rate in a fed-batch fermentation etc.)” (see col. 37, lines 5-10).
Therefore, the reference of Miasnikov et al., (US 7,226,761 B2) is deemed to anticipate claims 1, 3, 5, 9-10, 12-13, 15-17 and 21-24 as written and when given the broadest reasonable interpretation and rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2).
Since the Office does not have the facilities for examining and comparing applicants’ engineered yeast and method with the engineered yeast and method of the prior art, the burden is on the applicant to show a novel or unobvious difference between the claimed engineered yeast and method and the engineered yeast and method of the prior art (i.e., that the engineered yeast and method of the prior art does not possess the same material structural and functional characteristics of the engineered yeast and method of the instant invention). See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594.
Claim Rejections: 35 USC § 103
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, 8-17 and 20-24 are rejected under 35 U.S.C. 103(a) as being unpatentable Miasnikov et al., (US 7,226,761 B2) as applied to claims 1, 3, 5, 9-10, 12-13, 15-17 and 21-24 (see 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) rejection above) and further in view of Maeda et al., (US 11,505,812 B2; priority 06/26/2018), Jauert et al., (US 10,738,332), Goh et al., (UniProtKB/TrEMBL#A0A0C2S6H5, disclosing polypeptides annotated as alcohol dehydrogenase and having 90.2% sequence identity to SEQ ID NO: 28 and disclosing a polypeptides annotated as alcohol dehydrogenase and having 100% sequence identity to SEQ ID NO: 29 of the instant invention), Berendsen et al., (UniProtKB/TrEMBL#A0A150KKV0 disclosing polypeptides annotated as Galactitol-1-phosphate 5-dehydrogenase and having 100% sequence identities to SEQ ID NO: 30 and SEQ ID NO: 33 of the instant invention) and Ueki et al., (UniProtKB/TrEMBL#A0A6V8SFC6 disclosing a polypeptide annotated as Galactitol-1-phosphate 5-dehydrogenase and having 100% sequence identity to SEQ ID NO: 31 of the instant invention).
The disclosure of Miasnikov et al., (US 7,226,761 B2) as applied to claims 1, 3, 5, 9-10, 12-13, 15-17 and 21-24 is described above (see 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2). However, Miasnikov et al., are silent regarding wherein the yeast cell is a cell of the subphylum Ustilaginomycotina… Moniliella pollinis cell (as in claims 4, 6 and 8); wherein the exogenous polynucleotide sequence is integrated into the genome of the yeast cell at a loci selected from… PDCl locus (as in claim 11); wherein the constitutive heterologous or artificial promoter is selected from the group consisting of pyruvate kinase 1 promoter… 3- phosphoglycerate kinase promoter… and RPL16B (as in claim 14); and wherein the fermentation temperature is at or between 25 °C to 45 °C, 30 °C to 40 *C, or 32 °C to 37 °C and the volumetric oxygen uptake rate (OUR) is between 0.5 to 40 (as in claim 20).
Regarding claims 4, 6 and 8, Maeda et al., (US 11,505,812 B2; priority 06/26/2018) provide teaching, suggestion and motivation for the choice of yeast cell is a cell of the subphylum Ustilaginomycotina… Moniliella pollinis cell, as said host cell is able to produce xylitol and culture conditions; “in the present invention, the microbe belonging to the genus Moniliella…; further, the microbe belonging to the genus Moniliella is preferably at least one selected from the group consisting of Moniliella pollinis CBS461.67” (see col. 3, lines 26-45); “in the present invention, Step (1) can comprise a step of further allowing the microbe belonging to the genus Moniliella to produce at least one selected from the group consisting of sugar alcohols, alcohols, and organic acids. In the present invention, the sugar alcohol is not limited and examples include erythritol, xylitol” (see col. 5, lines 43-48); and culture temperature “the culture temperature is not particularly limited but typically 25° C. or more, and preferably 27° C. or more, and typically 37° C. or less, and preferably 35° C. or less… specifically, the culture can be carried out for 24 hours to 8 days” (see col. 5, lines 22-31).
Regarding claims 11, 14 and 20, Jauert et al., (US 10,738,332), disclose genetically engineered yeast capable of manufacturing a fermentation product using sucrose as a fermentation substrate, and fermentation processes using such yeasts and provide teaching, suggestion and motivation for the following “the host yeast cell can be any suitable yeast strain, as would be understood by a person skilled in the art; to genetically modify the yeast cell, a suitable locus is selected for gene integration; one of ordinary skill in the art would know how to select suitable loci in a yeast genome for gene integration” (see col. 8, lines 29-36); “the yeast further comprises an exogenous or artificial promoter for the functional invertase gene; in some embodiments, the promoter is selected from the group consisting of Pyruvate decarboxylase, Glyceraldehyde-3-phosphate dehydrogenase, Translational elongation factor, Transaldolase, RPL16B, 3-phosphoglycerate kinase, and Enolase” (see col. 2, lines 10-16); and further disclose the significance of “oxygen uptake rate” (“OUR”) refers to the volumetric rate at which oxygen is consumed during a fermentation; inlet and outlet oxygen concentrations can be measured with exhaust gas analysis, for instance by mass spectrometers; OUR can be calculated by one of ordinary skill in the relevant arts” (see col. 5, lines 3-13); and suggest “fermentation process can be run within certain oxygen uptake rate (OUR) ranges; in some embodiments, the volumetric OUR of the fermentation process can be in the range of 0.5 to 40, 1 to 30, 3 to 20, or 5 to 16 mmol O2/(L.h); in some embodiments, the specific OUR can be in the range of 0.2 to 13, 0.3 to 10, 1 to 7, or 2 to 6 mmol O2/(g cell dry weight.h)” (see col. 11, lines 14-20).
Regarding claims 1 and 15-16, the following references provides teaching, suggestion and motivation to a skilled artisan regrading structural and functional elements of the instant invention:
Examiner reiterates that Miasnikov et al., (US 7,226,761 B2) disclose that sugar alcohol dehydrogenases can be tested for XPDH activity and utilized for the synthesis of xylitol (see Abstract; col. 1, lines 30-40; col. 3, lines 15-17; col. 16, lines 30-43; and entire document); Goh et al., (UniProtKB/TrEMBL#A0A0C2S6H5, disclosing polypeptides annotated as alcohol dehydrogenase and having 90.2% sequence identity to SEQ ID NO: 28 and disclosing a polypeptides annotated as alcohol dehydrogenase and having 100% sequence identity to SEQ ID NO: 29 of the instant invention), Berendsen et al., (UniProtKB/TrEMBL#A0A150KKV0 disclosing polypeptides annotated as Galactitol-1-phosphate 5-dehydrogenase and having 100% sequence identities to SEQ ID NO: 30 and SEQ ID NO: 33 of the instant invention) and Ueki et al., (UniProtKB/TrEMBL#A0A6V8SFC6 disclosing a polypeptide annotated as Galactitol-1-phosphate 5-dehydrogenase and having 100% sequence identity to SEQ ID NO: 31 of the instant invention)
As such, disclosure of strategy and methods for “a host is constructed that expresses or over-expresses XPDH gene, using recombinant XPDH gene sequences. would also be useful in this regard and such hosts are especially useful for the production of xylitol in a pathway in which xylulose-5-P is converted to xylitol-1-P by XPDH, and then the xylitol-1-P is converted to xylitol with a phosphatase”, as in claims 4, 6, 8, 11, 14 and 20 of the instant invention, such as that of references of Maeda et al., and Jauert et al., teaching the advantages of said modifications, clearly suggests to a skilled artisan to modify the teachings of Miasnikov et al., and incorporate the structural and functional elements of Goh et al., (UniProtKB/TrEMBL#A0A0C2S6H5, disclosing polypeptides annotated as alcohol dehydrogenase and having 90.2% sequence identity to SEQ ID NO: 28 and disclosing a polypeptides annotated as alcohol dehydrogenase and having 100% sequence identity to SEQ ID NO: 29 of the instant invention), Berendsen et al., (UniProtKB/TrEMBL#A0A150KKV0 disclosing polypeptides annotated as Galactitol-1-phosphate 5-dehydrogenase and having 100% sequence identities to SEQ ID NO: 30 and SEQ ID NO: 33 of the instant invention) and Ueki et al., (UniProtKB/TrEMBL#A0A6V8SFC6 disclosing a polypeptide annotated as Galactitol-1-phosphate 5-dehydrogenase and having 100% sequence identity to SEQ ID NO: 31 of the instant invention) in the claimed genetically engineered yeast and method of producing xylitol as claimed in the instant invention. One of ordinary skill in the art would have a reasonable expectation of success, since genetically engineered yeast and method of producing xylitol are well known in the art.
Regarding specific choice of integration locus, promoters, culturing conditions are also provided/suggested in the combination of references, and examiner also takes the position the following position; optimization of known variables, and the examiner finds support in: MPEP 2144.05 [R-5]: A. Optimization Within Prior Art Conditions or Through Routine Experimentation Generally, differences in choice of integration locus, promoters, culturing conditions will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such integration locus, promoters, culturing conditions is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation". As to optimization results, a patent will not be granted based upon the optimization of result effective variables when the optimization is obtained through routine experimentation unless there is a showing of unexpected results which properly rebuts the prima facie case of obviousness. See In re Boesch, 617 F.2d 272,276,205 USPQ 215,219 (CCPA 1980). See also In re Woodruff, 919 F.2d 1575, 1578, 16 USPQ2d 1934, 1936-37 (Fed. Cir. 1990), and In re Aller, 220 F2d 454,456,105 USPQ 233,235 (CCPA 1955). Furthermore, "it is prima facie obvious to combine two or more methods each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition or third method to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980)”. Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Therefore, claims 1, 3-6, 8-17 and 20-24 are rejected under 35 U.S.C. 103(a) as being unpatentable Miasnikov et al., (US 7,226,761 B2) as applied to claims 1, 3, 5, 9-10, 12-13, 15-17 and 21-24 (see 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) rejection above) and further in view of Maeda et al., (US 11,505,812 B2; priority 06/26/2018), Jauert et al., (US 10,738,332), Goh et al., (UniProtKB/TrEMBL#A0A0C2S6H5, disclosing polypeptides annotated as alcohol dehydrogenase and having 90.2% sequence identity to SEQ ID NO: 28 and disclosing a polypeptides annotated as alcohol dehydrogenase and having 100% sequence identity to SEQ ID NO: 29 of the instant invention), Berendsen et al., (UniProtKB/TrEMBL#A0A150KKV0 disclosing polypeptides annotated as Galactitol-1-phosphate 5-dehydrogenase and having 100% sequence identities to SEQ ID NO: 30 and SEQ ID NO: 33 of the instant invention) and Ueki et al., (UniProtKB/TrEMBL#A0A6V8SFC6 disclosing a polypeptide annotated as Galactitol-1-phosphate 5-dehydrogenase and having 100% sequence identity to SEQ ID NO: 31 of the instant invention).
Double Patenting rejection
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 §§ 706.02(l)(1) - 706.02(l)(3) 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).
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Amended Claims 1, 3-6, 8-17 and 20-24 (dated 11/07/2024) of the instant invention are provisionally rejected on the ground of nonstatutory double patenting over amended claims 1-5, 7 and 18-25 (dated 04/23/2026) of co-pending Application No. 19/581,086. This is a provisional double patenting rejection because the patentably indistinct claims have not in fact been patented.
The subject matter claimed in the instant application is fully disclosed in the referenced co-pending application and would be covered by any patent granted on that co-pending application, since the referenced co-pending application and the instant application are claiming common subject matter, the instant application claims and co-pending application claims recite “comprising” and is an open language and includes unrecited elements, and the claimed common subject-matter is as follows: The recited amended claims 1-5, 7 and 18-25 (dated 04/23/2026) of co-pending Application No. 19/581,086 encompass “genetically engineered yeast cell capable of producing xylitol, the engineered yeast cell comprising: an exogenous polynucleotide sequence encoding a xylitol-phosphate dehydrogenase (XPDH) enzyme comprising a sequence at least 80% identical to at least one of SEQ ID NOs: 5, 95-101, and 103”; said reference polypeptides having xylitol-phosphate dehydrogenase (XPDH) activity and have 100% sequence identity to SEQ ID NOs: 12-15, 28-31 and 33 of the instant application (see provided sequence alignments) and the subject-matter as claimed in amended claims 1, 3-6, 8-17 and 20-24 (dated 11/07/2024) of the instant application, falls entirely within the scope of co-pending claims in co-pending reference application.
Allowable Subject Matter/Conclusion
None of the claims are allowable.
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/GANAPATHIRAMA RAGHU/ Primary Examiner, Art Unit 1652
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