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 Priority This Application is a n onprovisional application filed under 35 U.S.C. § 111(a) filed on November 9, 2023 with an effective filing date of 11/09/2023 that is hereby acknowledged by the Examiner. Status of the Claims The amendment dated 11/0 9/2023 is acknowledged . Claims 1-29 and 32 are pending and under examination. Information Disclosure Statement The information disclosure statement (IDS) submitted on 06/10/2024 and 03/28/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) is/are being considered by the E xaminer. Drawings The drawing filed on 11/09/2023 are acknowledged and accepted by the Examiner. Specification The disclosure is objected to because of the following informalities: MPEP 608.01(a) Arrangement of Application (e) INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A COMPACT DISC : The specification is required to include an incorporation-by-reference of electronic documents that are to become part of the permanent United States Patent and Trademark Office records in the file of a patent application. See 37 CFR 1.52(e) and MPEP § 608.05. Computer program listings (37 CFR 1.96 (c)), "Sequence Listings" (37 CFR 1.821 (c)), and tables having more than 50 pages of text were permitted as electronic documents on compact discs beginning on September 8, 2000. Claim Objections Claims 16 and 17 are objected to for the following informalities: Claims 16 and 17 are recited as a “product-by-process claim. According to the MPEP (2113), PRODUCT-BY-PROCESS CLAIMS ARE NOT LIMITED TO THE MANIPULATIONS OF THE RECITED STEPS, ONLY THE STRUCTURE IMPLIED BY THE STEPS "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) Claim Rejections - 35 USC § 112 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. Claims 2, 4-5, 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. MPEP 2163.11.A.2.(a).i) states, "Whether the specification shows that applicant was in possession of the claimed invention is not a single, simple determination, but rather is a factual determination reached by considering a number of factors. Factors to be considered in determining whether there is sufficient evidence of possession include the level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention". For claims drawn to a genus, MPEP § 2163 states 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 the applicant was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. 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. Thus, when a claim covers a genus of inventions, the specification must provide written description support for the entire scope of the genus. Support for a genus is generally found where the applicant has provided a number of examples sufficient so that one in the art would recognize from the specification the scope of what is being claimed. The claims are directed t he recombinant KalbTGase substrate of claim 1, wherein A n is selected from the group consisting of SEQ ID NO: 4, SEQ ID NO: 5, and SEQ ID NO: 6, or a functional variant thereof with a sequence identity of 85% or higher (instant claim 2); and t he recombinant KalbTGase substrate of claim 1, wherein each A n is selected from the group consisting of SEQ ID NO: 4, SEQ ID NO: 5, and SEQ ID NO: 6, or a functional variant thereof with a sequence identity of 85% or higher (instant claim 4); and t he recombinant KalbTGase substrate of claim 1, wherein all A n is selected from the group consisting of SEQ ID NO: 4, SEQ ID NO: 5, and SEQ ID NO: 6, and the A n amino acid sequences are at least 90% identical (instant claim 5) . To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. The grounds for the written description rejection are as follows: Claims 2 and 4 recite “ a functional variant thereof with a sequence identity of 85% ” without guidance on what encompasses “a functional variant thereof” ; (2) Claim s 2, 4 and 5 recites “the A n amino acid sequences are at least 85% and 90% identical. The claims are rejected because the specification does not satisfy the written description requirement for the genus of the claimed proteins. The “functional variant thereof ” can have any type of mutation (e.g., deletion, insertion, substitution), anywhere along th e peptide bond sequence. The specification only sets forth the functional variant refers to a polypeptide with a similar function as the non-varied reference polypeptide. In an embodiment a functional variant of a FKBP chaperone amino acid sequence preserves chaperone function. There is some general teaching in the art that some amino acid variations are tolerated without losing a protein' s tertiary structure, but conservation of structure is not necessarily a surrogate for conservation of function. While one of skill in the art could, with the aid of a computer as suggested, could identify all the protein and nucleic acid sequences, this would not tell one the structure of the polypeptides having the recited functional activity of catalyzing the formation of an isopeptide bond between a donor acyl group, particularly of a glutamine side chain and an alkyl amine donor group . Applicant has not provided a structure-function nexus for claiming “a functional variant thereof ”. (2) The instant claims encompass a genus of peptides having alterations of any portion (i.e. part thereof) of the substrate only requiring 85% sequence identity or 90% sequence identity . For example, SEQ ID NO: 4 , contains 1 64 amino acids (AA) long, so a peptide can vary up to 24 AA along the sequence (85% sequence identity) , so, for substitutions alone ( i.e ., each position could be any one of the 20 canonical amino acids) would encompass 20 24 = 16.777 x 10 30 peptide species, which also need to have the ability to catalyze the formation of an isopeptide bond between a donor acyl group, particularly of a glutamine side chain and an alkyl amine donor group as disclosed by Applicant . Accordingly, it does not appear applicants were in possession of the claimed sequences having “a functional equivalent” or “part thereof” at the time of filing. Given that there is no identification of any particular portion of the structure that must be conserved, and in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus. While it is possible to make the polypeptides, the specification must provide an adequate description of the genus. The provision of a partial structure and a function without a nexus between the two does not put one in possession of the large genus of variants encompassed by the claims. Vas-Cath Inc. V. Mahurkar, 19 USPQ2d 1111, clearly 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). Thus, the Applicant has not shown, otherwise, which mutations would retain the functional limitation. The Applicant has not provided adequate written description to support the claimed genus of the construct limited by the function of “catalyzing the formation of an isopeptide bond between a donor acyl group, particularly of a glutamine side chain and an alkyl amine donor group” (specification para [0052]) . Therefore, the written description is not commensurate in scope with the claims drawn to “ a functional variant thereof ”; with a sequence identity of 85% or higher , or 90% or higher sequence identity . Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics of the claimed genus, the claims are rejected as lacking adequate descriptive support for the claimed invention. 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. (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. Claims 1- 7 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Schraeml et al. “Schraeml” (WO2017/102759, IDS of record dated 06/10/2024). The claims are directed to a recombinant KalbTGase substrate comprising a fusion polypeptide of Formula I, Rm is a flexible or rigid linker amino acid sequences comprising 5 to 500 amino acids, and in case of m > 1, each Rm is an independently selected flexible or rigid linker amino acid sequences comprising 5 to 500 amino acids; Qtagm is an amino acid sequence motif containing an acyl donor glutamine residue for KalbTGase transglutaminase activity, and in case of m > 1, each Qtagm is an independently selected amino acid sequence motif containing an acyl donor glutamine residue for KalbTGase transglutaminase activity; with the proviso that SEQ ID NO: 18 and SEQ ID NO: 19 are excluded from Formula I. Regarding claim s 1 -7 , Schraeml discloses the general structure of the substrate: (F*-L)y-X (I) , wherein F* is selected from an amino acid sequence of the FKBP domain of an FKBP polypeptide, wherein the "insert-in-flap" (IF) domain thereof is, at least in part, replaced by an amino acid sequence ("Q-tag") of 5 to 20 amino acids, the Q-tag comprising a subsequence of 5 contiguous amino acids having at least 80% sequence identity to the YRYRQ portion of the peptide sequence Xr YRYRQ-X2 (SEQ ID NO. 1 ), wherein X1 and X2 are absent or constitute linker amino acids; L is absent or is selected from a linker amino acid sequence; and X is a protein of interest; y is an integer of between 1 and 100, and wherein said TG substrate is a substrate for the TG function of the Kutzneria albida TG according to SEQ ID No. 23. Shcraeml further discloses figure 3; SEQ ID NO:60 , a recombinant KalbTGase substrate comprising a fusion protein SlyD-Qtag(YRYRQ; with rhutenium label)SlyD- Xa-gp21-8H (SlyD is a FKBP family member; see also figures 5, 6; claims therein). The recombinant transglutaminase (TG) substrate comprises an amino acid sequence of the FKBP domain of an FKBP polypeptide, wherein the "insert-inflap" (IF) domain thereof is, at least in part, replaced by an amino acid sequence ("Q-tag"). SEQ ID NO:27 (165 aa; E. coli sylD protein FKBP domain) comprises ; SEQ ID NO:4 (164aa) of present application ; SEQ ID NO:57 (149 aa; E. coli SlpA protein) comprises SEQ ID NO:6 (148 aa) of present application ; SEQ ID NO: 60 shows the amino acid sequence of the recombinant fusion protein tSlyQD- Xa-gp21-8H\ ; SEQ ID NO: 61 shows the amino acid sequence of the recombinant fusion protein 'TtSlyD-Xa-gp21-8H' ; and SEQ ID NO: 62 shows the amino acid sequence of the recombinant fusion protein 'TtSlyKQD-SlpA-Xa-gp21 -8H'. Schraeml discloses that “ It was surprisingly found that the two parts of the FKBP domain upstream and downstream insertion of the IF domain function as structurally rather rigid and precise scaffold or "collar" for the sequence that is inserted into and/or replaces the IF domain part ("head", "Q-tag"). Because of this, the presentation and orientation of the insertion/replacement reliably does not substantially interfere with any other function of the other components of the substrate, in particular the function(s) of the protein of interest (X). Furthermore, the presentation of the – in this case - TG substrate binding site (Q-tag) leads to a highly controlled stoichiometric binding of the label, and hence labelling of the protein of interest". The protein of interest can be an antigen (claim 6 of Schraeml ). Therefore, the cited prior art anticipates the claimed invention. 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). Claims 8 is rejected under 35 U.S.C. 103(a) as being unpatentable over Schraeml et al. “Schraeml” (WO2017/102759, IDS of record dated 06/10/2024) as applied to claims 1 and 7 above, in view of Faatz et al. “Faatz” (WO2018/197406, IDS of record dated 06/10/2024) . The teachings of Schraeml are outlined above and incorporated herein. Regarding claim 8, Schraeml discloses the recombinant KalbTGase substrate wherein B is an antigen amino acid sequence but does not disclose the amino acid sequence of SEQ ID NO: 76 or SEQ ID NO: 77. Faatz, however, discloses (SEQ ID NO:7) Dengue virus 1 NS1 wing domain (residues 30-180), which comprises SEQ ID NO:76 of present application . Said sequence is identical with SEQ ID NO:77 of present application with the exception of position 150 ("X" in SEQ ID NO:7). Accordingly, in view of namely the provision of a further KalbTGase with a target polypeptide (=antigen) being Dengue virus 1 NS1 wing domain , i n view of the disclosure in the prior art, it would be obvious to one of ordinary skill in the art having the option to insert alternative antigens, such as dengue antigen. One of ordinary skill in the art would be motivated to do so with a reasonable expectation of success given the fact that Schraeml discloses KalbTGase substrate comprising an antigen and given the knowledge that Faatz discloses dengue virus 1 NS1 wing domain that has 100% sequence identity to SEQ ID NO: 76 of the present application for the benefit of detecting target antibodies in a sample. Therefore, the claimed invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention. Double Patenting Claims 1-18 of this application are patentably indistinct from claims 1-18 of Application No. 15/664,807. Pursuant to 37 CFR 1.78(f), when two or more applications filed by the same applicant or assignee contain patentably indistinct claims, elimination of such claims from all but one application may be required in the absence of good and sufficient reason for their retention during pendency in more than one application. Applicant is required to either cancel the patentably indistinct claims from all but one application or maintain a clear line of demarcation between the applications. See MPEP § 822. Claims 1-29 and 32 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1- 29 and 32 of co-pending Application no. 1 8/506.022 . This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented . A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co. , 151 U.S. 186 (1894); In re Vogel , 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert , 245 F.2d 467, 114 USPQ 330 (CCPA 1957). A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101. Claims 1-29 and 32 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1- 29 and 32 of co-pending Application no. 1 8/505,075 . This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented . A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co. , 151 U.S. 186 (1894); In re Vogel , 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert , 245 F.2d 467, 114 USPQ 330 (CCPA 1957). A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101. Conclusion No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Barry Chestnut whose telephone number is (571)270-3546 . The examiner can normally be reached on M-Th 8:00 to 4:00 . If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone can be reached on 571-270-0684 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /BARRY A CHESTNUT/ Primary Examiner, Art Unit 1672