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
Claims 1-10 are pending and is now under consideration for examination.
Priority
Acknowledgment is made of applicants’ claim for foreign priority under 35 U.S.C. 119(a)-(d). This application is a CON of PCT/JP2022/025134 filed on 06/23/2022 and claims the priority date of Japan application 2021-104343 filed on 06/23/2021; however, no English translation of said foreign priority application has been provided. Therefore, the priority date for instant claims under consideration is deemed to be the filing date of CON of PCT/JP2022/025134 filed on 06/23/2022.
Specification/Claims-Objection/Sequence Compliance
Applicants’ are advised that the application is not in compliance with 37 CFR §§ 1.821-1.825. This application contains sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR § 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR §§ 1.821-1.825. Specifically, applicants’ are required to comply with the sequence rules by inserting the sequence identification numbers of all sequences within the claims and/or specification. It is particularly noted that Fig. 10 of Drawings recite many sequences of fusion proteins; and additionally claim 4 recites linker sequence, but applicants’ fail to provide the SEQ ID NO: (sequence identifiers) to all the sequences recited in the Drawings and claims; i.e., nucleotides 10 (ten) or more and amino acids 4 (four) or more. Sequences must be referred to by their sequence identifiers, see particularly 37 CFR 1.821(d). If the sequences appearing in the specification do not have SEQ ID NO: assigned to them, then an amendment to the sequence listing will be required as well. There must not be any new matter submitted, therefore it is important to be careful to include only the sequences that are already disclosed in the current specification. Failure to correct the deficiency will be held a non-responsive to this Office action. Correction and clarification required.
Sequence Rules: The amino acid sequences presented requires having a sequence identifier. In order to comply with the sequence rules Applicants must identify the sequence by providing SEQ ID NO:, and where required provide a new version of the sequence listing and disk. Applicant must submit a CRF copy and paper copy of the Sequence Listing, a statement that the content of the paper and computer readable copies are the same and where applicable include no new matter as required by 37 C.F.R. j 1.821(e) or 1.821(9 or 1.821(g) or 1 .825(d), as well as an amendment directing its entry into the specification. Note: If the amino acid sequences are already part of the sequence listing and the CRF, Applicants may amend the specification by providing the appropriate SEQ ID NO: or provide the SEQ ID NO, to the legend of the figure(s). Applicant's cooperation is requested in correcting other unidentified sequences of which applicant may become aware of in the specification.
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).
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 1-10 are provisionally rejected on the ground of nonstatutory double patenting over: (i) claims 1-17 (dated 11/20/2022) of co-pending Application No. 18/084,957 (US 2023/0119996 A1); (ii) claims 1-11 (dated 01/07/2025) of co-pending Application No. 19/011,744 (US 2025/0145972 A1); and (iii) claims 1-11 (dated 01/07/2025) of co-pending Application No. 19/011,750 (US 2025/0146042 A1). 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 applications and would be covered by any patent granted on that co-pending applications i.e., (i) claims 1-17 (dated 11/20/2022) of co-pending Application No. 18/084,957 (US 2023/0119996 A1); (ii) claims 1-11 (dated 01/07/2025) of co-pending Application No. 19/011,744 (US 2025/0145972 A1); and (iii) claims 1-11 (dated 01/07/2025) of co-pending Application No. 19/011,750 (US 2025/0146042 A1), since the referenced co-pending applications and the instant application are claiming common subject matter, as follows: “A fusion protein obtained by fusing a ferredoxin-thioredoxin reductase and thioredoxin via a linker peptide…an electrode on comprising said fusion protein… and methods of use said fusion protein” as claimed in claims 1-10 of the instant application and falls entirely within the scope of: (i) claims 1-17 (dated 11/20/2022) of co-pending Application No. 18/084,957 (US 2023/0119996 A1); (ii) claims 1-11 (dated 01/07/2025) of co-pending Application No. 19/011,744 (US 2025/0145972 A1); and (iii) claims 1-11 (dated 01/07/2025) of co-pending Application No. 19/011,750 (US 2025/0146042 A1). This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
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 1-10 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 1-10 as interpreted are directed to a composition comprising a genera of fusion proteins having the associated activities i.e., a fusion protein obtained by fusing any ferredoxin-thioredoxin reductase and any thioredoxin via any linker peptide of undefined, unlimited structures including variants, mutants and homologs…an electrode comprising said genera of fusion proteins… and methods of use said genera of fusion proteins.
The specification discloses and is limited to few species of the claimed fusion protein, comprising specific encoding structure/polynucleotides (SEQ ID NO: 1 and SEQ ID NO: 6) encoding ferredoxin-thioredoxin reductase polypeptide; polynucleotide (SEQ ID NO: 2) encoding thioredoxin polypeptide and said fusion protein comprising few species of linker sequences (SEQ ID NOs: 3-5; see ¶ [0045] 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.
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, comprising a genera of fusion proteins having the associated activities i.e., a fusion protein obtained by fusing any ferredoxin-thioredoxin reductase and any thioredoxin via any linker peptide of undefined, unlimited structures including variants, mutants and homologs…an electrode comprising said genera of fusion proteins… and methods of use said genera of fusion proteins. 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 composition comprising a genera of fusion proteins having the associated activities i.e., a fusion protein obtained by fusing any ferredoxin-thioredoxin reductase and any thioredoxin via any linker peptide of undefined, unlimited structures including variants, mutants and homologs…an electrode comprising said genera of fusion proteins… and methods of use said genera of fusion proteins which the present inventors were not in the possession of, or which were not known to the inventors.
Examiner finds support for his position in the following references:
Dai et al., (Photosynth. Res., 2004, Vol. 79: 233-248) disclose point mutations ferredoxin-thioredoxin reductase affect the activity and conclude no common activation mechanism can be put forward for ferredoxin-thioredoxin reductase and thioredoxins and thus it is important to provide a specific structure with the associated activity, and structural data is very important to fully understand the intramolecular modifications linked to activation (see Abstract; col. 1, page 236 to col. 2, page 241; Conclusion; and entire document);
Juniar et al., (Prot. Sci., 2020, Vol. 29: 2538-2545) disclose there are many different isoforms of thioredoxins obtained from a specific source with differing enzyme kinetics and interactions with ferredoxin-thioredoxin reductase (Abstract; Fig. 1-2, pages 2540-2541; and entire document); and
Walters et al., (Biochem., 2009, Vol. 48: 1016-1024) disclose point mutations in ferredoxin-thioredoxin reductases affect the activity and results differences in biochemical properties (Abstract; Fig. 2-7, Table 1, pages 1019-1022; and entire document).
Hence, claims are reading on significant numbers of inoperative embodiments in the claimed process that 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).
Applicant is 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, first paragraph, published in the Official Gazette and also available at <http://www.uspto.gov>.
Enablement
II. Claims 1-10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification is enabling for the characterization of few species and is limited to few species of the claimed fusion protein, comprising specific encoding structure/polynucleotides (SEQ ID NO: 1 and SEQ ID NO: 6) encoding ferredoxin-thioredoxin reductase polypeptide; polynucleotide (SEQ ID NO: 2) encoding thioredoxin polypeptide and said fusion protein comprising few species of linker sequences (SEQ ID NOs: 3-5; see ¶ [0045] of specification). However, specification does not reasonably provide enablement for a composition comprising a genera of fusion proteins having the associated activities i.e., a fusion protein obtained by fusing any ferredoxin-thioredoxin reductase and any thioredoxin via any linker peptide of undefined, unlimited structures including variants, mutants and homologs…an electrode comprising said genera of fusion proteins… and methods of use said genera of fusion proteins. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Factors to be considered in determining whether undue experimentation is required are summarized in In re Wands (858 F.2d 731, 8 USPQ 2nd 1400 (Fed. Cir. 1988)) as follows: (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claim(s).
Claims 1-10 are so broad as to encompass: a composition comprising a genera of fusion proteins having the associated activities i.e., a fusion protein obtained by fusing any ferredoxin-thioredoxin reductase and any thioredoxin via any linker peptide of undefined, unlimited structures including variants, mutants and homologs…an electrode comprising said genera of fusion proteins… and methods of use said genera of fusion proteins. The scope of the claim is not commensurate with the enablement provided by the disclosure with regard to the extremely large number of polynucleotides/genes and encoded polypeptides broadly encompassed by the claims. Since the amino acid sequence of a protein encoded by a polynucleotide determines its structural and functional properties, predictability of which changes can be tolerated in a protein's amino acid sequence and obtain the desired activity requires a knowledge of and guidance with regard to which amino acids in the protein's sequence and the respective codons in its polynucleotide, if any, are tolerant of modification and which are conserved (i.e., expectedly intolerant to modification), and detailed knowledge of the ways in which the encoded proteins' structure relates to its function. However, in this case the disclosure is limited to characterization of few species and is limited to few species of the claimed fusion protein, comprising specific encoding structure/polynucleotides (SEQ ID NO: 1 and SEQ ID NO: 6) encoding ferredoxin-thioredoxin reductase polypeptide; polynucleotide (SEQ ID NO: 2) encoding thioredoxin polypeptide and said fusion protein comprising few species of linker sequences (SEQ ID NOs: 3-5; see ¶ [0045] of specification). It would require undue experimentation of the skilled artisan to make and use the claimed polynucleotides/genes and encoded polypeptides, a composition comprising a genera of fusion proteins having the associated activities i.e., a fusion protein obtained by fusing any ferredoxin-thioredoxin reductase and any thioredoxin via any linker peptide of undefined, unlimited structures including variants, mutants and homologs…an electrode comprising said genera of fusion proteins… and methods of use said genera of fusion proteins. The specification but provides no guidance with regard to the making of variants and mutants or with regard to other uses. In view of the great breadth of the claims, amount of experimentation required to make and use the claimed polypeptides, the lack of guidance, working examples, and unpredictability of the art in predicting function from a polypeptide primary structure, the claimed invention would require undue experimentation. As such, the specification fails to teach one of ordinary skill how to make and use the full scope of the polypeptides encompassed by the claims. However, claims reading on significant numbers of inoperative embodiments would render claims non-enabled when the specification does not clearly identify the operative embodiments 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). Here, the claims read on a significant number of inoperative embodiments.
While enzyme isolation techniques, recombinant and mutagenesis techniques are known, and it is not routine in the art to screen for multiple substitutions or multiple modifications as encompassed by the instant claims, the specific amino acid positions within a protein's sequence where amino acid modifications can be made with a reasonable expectation of success in obtaining the desired activity/utility are limited in any protein and the result of such modifications is unpredictable. In addition, one skilled in the art would expect any tolerance to modification for a given protein to diminish with each further and additional modification, e.g. multiple substitutions.
The specification does not support the broad scope of the claims which encompass: a composition comprising a genera of fusion proteins having the associated activities i.e., a fusion protein obtained by fusing any ferredoxin-thioredoxin reductase and any thioredoxin via any linker peptide of undefined, unlimited structures including variants, mutants and homologs…an electrode comprising said genera of fusion proteins… and methods of use said genera of fusion proteins, because the specification does not establish: (A) a rational and predictable scheme for modifying specific nucleotides or amino acid residues in any ferredoxin-thioredoxin reductase and any thioredoxin having no specific structural elements of any kind and an expectation of obtaining the desired biological/biochemical function; (B) a rational and predictable scheme for modifying any amino acid residue with an expectation of obtaining the desired biological/biochemical function; (C) defined core regions/motifs involved in the desired catalytic activity of encoded polypeptide; (D) the tertiary structure of the molecule and folding patterns that are essential for the desired activity and tolerance to modifications; and (E) the specification provides insufficient guidance as to which of the essentially infinite possible choices is likely to be successful.
While as discussed above, the specification provides guidance with regard to the characterization of few species and is limited to few species of the claimed fusion protein, comprising specific encoding structure/polynucleotides (SEQ ID NO: 1 and SEQ ID NO: 6) encoding ferredoxin-thioredoxin reductase polypeptide; polynucleotide (SEQ ID NO: 2) encoding thioredoxin polypeptide and said fusion protein comprising few species of linker sequences (SEQ ID NOs: 3-5; see ¶ [0045] of specification), however, the scope of claims 1-10 is so broad and the lack of guidance either in the specification or in the prior art, the claims remains not commensurate in scope with the enabled invention and therefore for the rejected claims, this would clearly constitute undue experimentation. While enablement is not precluded by the necessity for routine screening, if a large amount of screening is required, the specification must provide a reasonable amount of guidance with respect to the direction in which the experimentation should proceed (guided mutants). Such guidance has not been provided in the instant specification or in the prior art. The art also teaches the following regarding complexity of the structure/function relationship: The reference of Chica et al., (Curr. Opin. Biotechnol., 2005, Vol. 16: 378-384) teaches that the complexity of the structure/function relationship in enzymes has proven to be the factor limiting the general application of rational enzyme modification and design, where rational enzyme modification and design requires in-depth understanding of structure/function relationships. The reference of Sen et al., (Appl. Biochem. Biotechnol., 2007, Vol.143: 212-223), teaches in vitro recombination techniques such as DNA shuffling, staggered extension process (STEP), random chimera genesis on transient templates (RACHITT), iterative truncation for the creation of hybrid enzymes (ITCHY), recombined extension on truncated templates (RETT), and so on have been developed to mimic and accelerate nature's recombination strategy. However, such rational design and directed evolution techniques only provide guidance for searching and screening for the claimed polypeptide which is not guidance for making and/or using the claimed polypeptide. Additionally, knowledge is not extant in the art to assay all possible enzymatic activities, how to express all possible enzymes or how predictably assay for such activities. For example, the reference of Banerjee et al., (Bioenerg. Res. 2010, Vol. 3: 82-92), on page 84, right column, second paragraph, describe that “enzymes have critical properties besides specific activity and thermal tolerance that must be considered but which can be difficult to assay in vitro. For example, besides catalyzing a particular chemical reaction, enzymes must be efficiently translated and secreted, able to resist proteases, act cooperatively with other enzymes, and have low product and feedback inhibition. One can easily imagine that an “improved” enzyme, based on assay in isolation on a model substrate, might perform poorly in a real-world situation”.
Thus, applicants’ have not provided sufficient guidance to enable one of ordinary skill in the art to make and use the claimed invention in a manner reasonably correlated with the scope of the claims broadly including polynucleotides and encoded polypeptides with an enormous number of modifications. The scope of the claim must bear a reasonable correlation with the scope of enablement (In re Fisher, 166 USPQ 19 24 (CCPA 1975)). Without sufficient guidance, determination of polypeptides/enzymes having the desired biological characteristics is unpredictable and the experimentation left to those skilled in the art is unnecessarily, and improperly, extensive and undue. See In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988).
Although the claims are examined in the light of the specification, specification cannot be read into the claims, i.e., the limitations of the specification cannot be read into the claims (see MPEP 2111 R-5).
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 1-2 and 4-5 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by I. Briggs et al., (US 2003/0211511, in IDS); and II. Wang et al., (CN101899460_MT in IDS) when given the broadest reasonable interpretation.
Claims 1-2 and 4-5 as interpreted are directed to a composition comprising a genera of fusion proteins having the associated activities i.e., a fusion protein obtained by fusing any ferredoxin-thioredoxin reductase and any thioredoxin via any linker peptide of undefined, unlimited structures including variants, mutants and homologs… and methods of use said genera of fusion proteins.
I. Briggs et al., (US 2003/0211511, in IDS) disclose a fusion protein comprising a thioredoxin and a thioredoxin reductase and said fusion protein having the biochemical property of reducing allergenicity of foods (see Abstract; ¶ [0005-0006], [0225-0026]; and entire document); said fusion protein comprising a linker sequence of glycine-serine polymers (GGGGS)n; (¶ [0256]).
II. Wang et al., (CN101899460_MT in IDS) also disclose a fusion protein comprising a thioredoxin and a thioredoxin reductase and said fusion proteins having the biochemical property of reducing allergenicity of foods (Claims 1-5; ¶ [0011-0015]; and entire document); said fusion protein comprising a linker sequence of glycine-serine polymers (GGGGS)3; (Claim 5; ¶ [0016]).
Therefore, the references of I. Briggs et al., (US 2003/0211511, in IDS) and II. Wang et al., (CN101899460_MT in IDS) is deemed to anticipate claims 1-2 and 4-5 as written and when given the broadest reasonable interpretation and is rejected under rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2).
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 1-10 are rejected under 35 U.S.C. 103(a) as being unpatentable over I. Briggs et al., (US 2003/0211511, in IDS) and II. Wang et al., (CN101899460_MT in IDS) as applied to claims 1-2 and 4-5 (see 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) rejection above) and further in view of Brightbill et al., (PhD., Thesis, Georgia Inst. Technol., May 2021), Nomoto et al. JP 2009/002689 A_MT, in IDS) and Kubo et al., (US 7,816,025 B2).
The disclosures of I. Briggs et al., (US 2003/0211511, in IDS) and II. Wang et al., (CN101899460_MT in IDS) as applied to claims 1-2 and 4-5 is described above. However, Briggs et al., or Wang et al., are silent regarding fusion protein, wherein the linker peptide further includes at least one of (i) H2N-CHR-COOH where R is either an alkyl group having 1 to 4 carbon atoms or a hydrogen group or (ii) H2N-CHR-COOH where R is an alkyl group that has 1 or 2 carbon atoms and in which at least one hydrogen group has been substituted with a hydroxyl group (as in claim 3); and electrode on which said fusion protein is immobilized (as in claims 6-10).
Regarding claim 3, linker peptide includes at least one glycine and at least one serine; and further includes at least one of (i) H2N-CHR-COOH where R is either an alkyl group having 1 to 4 carbon atoms or a hydrogen group, the following reference Brightbill et al., (PhD., Thesis, Georgia Inst. Technol., May 2021) provide teaching, suggestion and motivation including the biochemical strategy and methods for the choice of linker sequences comprising H2N-CHR-COOH in the production of biosensors/electrodes; said reference provides suggestion to a skilled artisan the following: “protein adsorption behavior, it is important to understand basic protein structure; a protein is a complex copolymer composed of amino acids (AmA), which are attached end-to-end through covalent peptide bonds, forming a polypeptide chain; all AmAs have the general structure H2N-CHR-COOH, in which the R group identifies one of 20 different AmAs; the identity of the R-group further gives the residue specific functional characteristics, such as hydrophilicity, polarity, charge, and hydrogen bonding capability”; design of fusion proteins comprising amino acids having the general structure H2N-CHR-COOH, proper folding of protein of interest to maintain the catalytic activity, adsorption behavior of proteins of intertest and coupling to biosensors/electrodes (see Abstract; pages 18-40; Fig 1-12-Fig. 1.13; and entire document).
Regarding claims 6-10, electrode on which said fusion protein comprising a thioredoxin and a thioredoxin reductase protein is immobilized, the following references teach electrodes comprising fusion protein comprising a thioredoxin and a thioredoxin reductase protein:
(i) Nomoto et al. JP 2009/002689 A_MT, in IDS) disclose an electrode comprising a thioredoxin and a thioredoxin reductase protein (see Claims; ¶ [0003], [0010-0011], [0032], Fig. 1-9; and entire document); and
(ii) Kubo et al., (US 7,816,025 B2) also disclose an electrode comprising fusion proteins, said fusion protein comprising a thioredoxin reductase protein, methods and strategies for immobilization of said reference fusion proteins (see Abstract; Fig. 1-6; col. 3, lines 35-40; and entire document).
As such, disclosure of biochemical strategy and methods for the choice of linker sequences comprising H2N-CHR-COOH in the production of biosensors/electrodes, and an electrode comprising fusion proteins, said fusion protein comprising a thioredoxin reductase protein, methods and strategies for immobilization of said reference fusion proteins, such as that of Brightbill et al., Nomoto et al. and Kubo et al., clearly suggests to a skilled artisan to modify the teachings of Briggs et al., or Wang et al., and incorporate the structural and functional elements of Brightbill et al., Nomoto et al. and Kubo et al., in the claimed electrode and method of use i. e., a genera of fusion proteins having the associated activities i.e., a fusion protein obtained by fusing any ferredoxin-thioredoxin reductase and any thioredoxin via any linker peptide of undefined, unlimited structures including variants, mutants and homologs; wherein the linker peptide includes at least one glycine and at least one serine; and further includes at least one of (i) H2N-CHR-COOH where R is either an alkyl group having 1 to 4 carbon atoms or a hydrogen group or (ii) H2N-CHR-COOH where R is an alkyl group that has 1 or 2 carbon atoms and in which at least one hydrogen group has been substituted with a hydroxyl group; and electrode on which said fusion protein is immobilized… and methods of use said genera of fusion proteins as claimed in the instant invention. One of ordinary skill in the art would have a reasonable expectation of success, since of fusion proteins having the associated activities and an electrode comprising said fusion proteins are well known in the art.
Therefore, claims 1-10 are rejected under 35 U.S.C. 103(a) as being unpatentable over I. Briggs et al., (US 2003/0211511, in IDS) and II. Wang et al., (CN101899460_MT in IDS) as applied to claims 1-2 and 4-5 (see 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) rejection above) and further in view of Brightbill et al., (PhD., Thesis, Georgia Inst. Technol., May 2021), Nomoto et al. JP 2009/002689 A_MT, in IDS) and Kubo et al., (US 7,816,025 B2).
Allowable Subject Matter/Conclusion
None of the claims are allowable.
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/GANAPATHIRAMA RAGHU/ Primary Examiner, Art Unit 1652