DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. The Preliminary Amendment filed on January 22, 2026, has been received and entered.
3. Applicant’s election with traverse of Group I (claims 1-29) on January 22, 2026, is acknowledged. The traversal is on the grounds that applicant does not want the method restricted from the product and request that the Office provide another method to produce the product. The Restriction Requirement established that the enzyme product could be utilized in another method such as a bioassay, the Office does not have a laboratory to demonstrate such a process. Applicant’s arguments is not deemed persuasive the Restriction is made to separate two inventions that are independent and distinct and can operate separately and have acquired a separate status in the art, therefore also burdensome. The method of performing an enzymatic reaction or enzymatic pathway can be utilized with any enzyme. Applicant is reminded that upon determination of an allowable product, applicant can pursue the rejoinder of the method claims that are similar in scope and maintained during prosecution (In re Ochai). Thus, the Restriction Requirement of record is deemed proper and made final.
Claim Disposition
4. Claims 1-30 are pending. Claims 1-29 are under examination. Claim 30 is withdrawn from consideration as directed to a non-elected invention.
Information Disclosure Statement
5. The Information Disclosure Statements filed on January 22, 2026, has been received and entered. The references cited on the PTO-1449 Form have been considered by the examiner and a copy is attached to the instant Office action.
Abstract Objection
6. The Abstract is objected to for the following informalities:
“The present invention relates to enzymatic reactor cells and related methods of use, [[e.g.]] for example, to produce formic acid and/or formate by using an enzymatic reactor cell, wherein the enzymatic reactor cell includes a surface, a linker, and one or more enzymes”.
Specification Objection
7. The specification is objected to for the following informalities:
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. The following is suggested: "An enzymatic reactor cell for bioelectric production of formate and formic acid".
The specification is objected to because the sequence notation is not proper, see paragraph [00218] for “SEQ ID No.25” which should be “SEQ ID NO: 25”.
Appropriate correction is required.
Claim objection
8. Claims 1-29 are objected to for the following informalities:
For clarity and precision of claim language it is suggested that claim 1 is amended to recite the specific surface and linker. The dependent claims hereto are also included.
For clarity it is suggested claims 1 and 18 are amended to add the transitional phrase “and” between the two wherein clause (i.e. “….. wherein the surface is….., and wherein the enzymatic reactor cell…”).
Claim 4 is objected to for the recitation of for the recitation of non-elected subject matter, see also claims 5, 8-13, 20, 22, 25-26 and 29 with similar situation.
For clarity is suggested that claim 4 is amended to recite, “SEQ ID NOs: 110-113”.
For clarity the typographical error of “stating” which should be “starting” should be amended in claim 5. For clarity and precision of claim language it is suggested that claim 5 is amended to read, “…..selected from [[one or more of]] the group [[s]] consisting of: gaseous CO2….. and[[/or]] water”.
For clarity it is suggested that claims 8-9, 17-18 and 20-21 are amended to spell out the acronym.
For clarity it is suggested that claims 22-23 and 29are amended to recite the proper sequence notation of “SEQ ID NO:” (see for example SEQ ID Nos.124-171 and SEQ ID NO.25).
For clarity and precision of claim language it is suggested that claim 25 is amended to delete ‘chemical means such as”. See also claim 26 with similar language.
For clarity it is suggested that claim 26 is amended to recite “comprising” in lieu of “included’.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
9. Claims 1-29 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claimed invention is an enzymatic reactor cell comprising a surface (any), a linker (any) and one or more enzymes (any), wherein the surface is directly linked to the linker and the linker is further directly linked to the enzyme, and wherein the enzymatic reactor cell produces formic acid and/or formate and/or a salt thereof. The claimed invention encompasses a broad variable genus of enzymes, peptides, surfaces and salt thereof, that are not adequately described. Note for example that dependent claims 6-7 recite that the surface is an electrode and said electrode is a cathode, however, independent claim 1 is not limited to that, thus the claimed invention is overly broad and not commensurate in scope with the disclosure in the specification or art as it is limitless. The invention as claimed in claim 3 encompasses the formate dehydrogenase enzyme being a mutant form, however, there are no indicia in the claim as to what is mutated or the structure that is mutated or a statement of retention of activity. Thus no correlation is made between structure and function for the enzyme utilized in the reactor cell.
Additionally, the invention is directed to any peptide, etc. (see claim13) for the linker. It is noted that the surface binding moiety (undefined) binds to or is immobilized to the surface of a portion of the linker (undefined) is recited as being covalently or non-covalently bonded. Further, the surface binding moiety that is undefined, can comprise a material binding peptide. An ordinary skilled worker will not have a glimpse of the claimed invention because it is not adequately described.
The claimed invention is not adequately described because it encompasses a large variable genus of structures and not limited to a specific embodiment. The vast amounts of products or compounds claimed in the large genus are not demonstrated by applicant as being in their possession. In addition, there is no nexus between the modified structures and production of the product claimed (see claim 3).
The claimed invention is not commensurate in scope with the disclosure in the specification and over reaches. The claimed invention requires products that are not adequately described because there is no structure-function correlation provided for the broad variable genus encompassed in the claims. Although some dependent claims recite the missing information from claim 1, claim 1 needs to stand on its own. An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. See Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir.1997). Thus, applicant has not demonstrated possession of the invention as claimed. Furthermore, the 'written description' requirement.., serves both to satisfy the inventor's obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee was in possession of the invention that is claimed ....The descriptive text needed to meet these requirements varies with the nature and scope of the invention at issue, and with the scientific and technologic knowledge already in existence." Capon v. Eshhar, 418 F.3d 1349, 1357 (Fed. Cir. 2005). The purpose of the written description requirement "is to ensure that the scope of the right to exclude ... does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification." Reiffin v. Microsoft Corp., 214 F.3d 1342, 1345-46 (Fed. Cir. 2000). The goal of the written description requirement is "to clearly convey the information that an applicant has invented the subject matter which is claimed." In re Barker, 559 F.2d 588, 592 n.4 (CCPA 1977) "A disclosure in an application, to be complete, must contain such description and details as to enable any person skilled in the art or science to which the invention pertains to make and use the invention as of its filing date." In re Glass, 492 F.2d 1228, 1232 (CCPA 1974).
Additionally, Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir.1991), states that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed" (See page 1117). The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed" (See Vas-Cath at page 1116). The skilled artisan cannot envision the detailed chemical structure of the encompassed genus of structures, and therefore, conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993).
Accordingly, the claimed invention is determined as lacking adequate written description because applicant has not demonstrated possession of the entire genus encompassed in the claims which is vast with respect to the fusion protein that encompasses mutants and fragments with no asserted activity.
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.
10. Claims 1-29 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 and the dependent claims hereto are indefinite for the recitation of “an enzymatic reactor cell that comprises any surface, any linker and any enzymes and the undefined surface is directly linked to the undefined linker that is further directly linked to the undefined enzymes, wherein the enzymatic reactor cell produces formic acid and/or formate and/or a salt thereof” and there is no linkage between the two ‘wherein clause’ therefore not clear that the components of the reactor cell contributes to the production of the formic acid, or formate or salt thereof singly or in combination. There are also so many undefined components thus, its not clear that said reactor cell achieves direct linkage and produces the claimed products and can a single surface and linker work with multiple enzymes simultaneously. Furthermore, is the surface interior or exterior? The dependent claims hereto are also included.
Claim 4 is indefinite for the recitation of “the formate dehydrogenase is from a list of organisms or from one or more amino acid sequences selected from a group”, because the enzyme would be obtained from the organism but would contain a certain amino acid sequence that was encoded from a gene, thus the language is confusing and may be best to recite, “….and wherein the formate dehydrogenase comprises one or more amino acid sequence selected from the group consisting of….”.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). Note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), as to where broad language is followed by "such as" and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Note also, for example, the decisions of Ex parte Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949). In the present instance, claim 25 recites the broad recitation nanowire, and the claim also recites chemical nanowire which is the narrower statement of the range/limitation.
Claim 25 is indefinite for the recitation of the phrase “such as” because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims 15-20 are indefinite in the recitation “portion” in the context of linker or enzyme, wherein the phrase “portion” is a relative term, which renders the claim indefinite. The term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. See MPEP 2173.05(b), part (I). Thus, clarification is required.
Claim 18 is indefinite for the recitation if “protein expression” because the claim lacks clear antecedent basis for said expression and there are no indicia in the claims as to for example, expression in vitro or recombinant expression in cellular systems.
Claim Rejections - 35 USC § 112(f), Sixth Paragraph
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The limitation of “chemical means” comprises a means for the enzymatic reactor cell to achieve something in claims 25-26 which is being treated in accordance with pre-AIA 35 U.S.C. 112(f), sixth paragraph because the limitation uses the word “means” rendering the aforementioned claims as indefinite.
Use of the word “means” (or “step for”) in a claim with functional language creates a rebuttable presumption that the claim element is to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is invoked is rebutted when the function is recited with sufficient structure, material, or acts within the claim itself to entirely perform the recited function.
Absence of the word “means” (or “step for”) in a claim creates a rebuttable presumption that the claim element is not to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is not invoked is rebutted when the claim element recites function but fails to recite sufficiently definite structure, material or acts to perform that function.
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.
11. Claim(s) 1-6, 8-9, 13-16 and 19 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Lim et al.(Membranes, December 27, 2021, of record in the application)
The primary reference discloses an enzymatic reactor cell, comprising a surface, a linker, and one or more enzymes, wherein the surface is directly linked to the linker and the linker is further directly linked to the enzyme, wherein the enzymatic reactor cell produces formic acid and/or formate and/or a salt thereof (i.e. multi-enzyme cascade using an enzyme-aided reactor systems), wherein formate dehydrogenase is from Candida boidinii and the reactor uses water as a starting agent. The reference also discloses that the surface can be an electrode and is carbon based. Further, the reference discloses methods of using the enzymatic reactor cell (see abstract and pages 1-2). The references also teach the use of CO2 (see abstract) and metal electrodes (see pages 1-2), and teach polymers (see page 10). Disclosed are bonds that can be non-covalent for surface binding moiety to attached to (see pates 11-14). The reference teaches cathodic compartments and covalent binding (see page 13).
Therefore, the limitations of the claims are met by the reference.
12. Claims 1-28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Weiss et al. (Methods and compositions for protein purification and enzyme reaction. US 2018/0252713 A1, publication 09/06/2018).
Weiss et al. teach an enzyme reactor comprising a first enzyme, a protein binding film (linker) and a solid support (surface), wherein enzyme is reacting with its substrate in the glass container as enzyme reactor, wherein the enzymes are esterase, alcohol dehydrogenase, laccase, fumarase (para 96, 224), wherein the solid support is coated with IMAC-resin (para 48), wherein said resin is a polymer, and IMAC is immobilized metal affinity chromatography component of resin for purification of desired proteins, or enzymes, wherein the metal is nickel, cobalt or copper (para 145-147), wherein said first enzyme is alcohol dehydrogenase, and second enzymes is laccase or fumarase (para 96, 224) is immobilized to said protein binding film (linker) in a first zone, and wherein said protein binding film is immobilized to said solid support (surface), wherein the solid support as surface is a glass container or a glass tube, in a cylindrical shape, as glass reactor, wherein the glass is made of silica, or silicon with a plane shape, or silicon dioxide, wherein said enzyme reactor comprises one or more additional enzymes, wherein said one or more additional enzymes are immobilized to said protein binding film as non-covalent binding in said first zone, wherein at least one of said one or more additional enzymes are immobilized to said protein binding film in one or more zones that are different from said first zone, wherein said enzyme reactor comprises one or more additional zones, wherein said protein binding film is covalently immobilized to said solid support, wherein said protein binding film is non-covalently immobilized to said solid support, wherein said first enzyme or said one or more additional enzymes are covalently bound to said protein binding film, wherein said first enzyme or said one or more additional enzymes are non-covalently bound to said protein binding film, wherein said first enzyme or said one or more additional enzymes comprise a binding moiety (see, para 92-93, claims 20-23), wherein said binding moiety is an expression tag, wherein said expression tag is a MBP, CBP, GST or 6XHis-tag (para 143, 147), wherein the protein or peptide tag can be biotinylated with enzyme catalyzed conjugation to isolate said protein with streptavidin as well as immobilizing the protein or enzyme can be done by using glutaraldehyde (see, Table 6, and para 145, 303), wherein said protein binding film comprises a binding partner of said binding moiety, wherein said binding partner is nickel, cobalt or copper (metal), wherein said protein binding film comprises an amine group, wherein said solid support is an inner surface of a reactor, wherein said reactor comprises a closed end and an open end, wherein said reactor is cylindrical, wherein said reactor is a glass reactor, wherein said first and said one or more additional zones are along the longitude axis of said solid support (see, abstract, para 4, 24, 40, 66-69, 72, 81, 91, 92-93, 145, and claims 12, 20-23, and 32-55). Therefore, the limitations of the claims are met by the reference.
Conclusion
13. No claims are presently allowable.
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/HOPE A ROBINSON/Primary Examiner, Art Unit 1652