CTNF 18/550,807 CTNF 101563 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Election/Restriction 18-18 REQUIREMENT FOR UNITY OF INVENTION As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art. The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e). When Claims Are Directed to Multiple Categories of Inventions: As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories: (1) A product and a process specially adapted for the manufacture of said product; or (2) A product and a process of use of said product; or (3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or (4) A process and an apparatus or means specifically designed for carrying out the said process; or (5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process. Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c). 18-19 AIA Restriction is required under 35 U.S.C. 121 and 372. This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1. In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted. 18-06 AIA Group I , claim(s) 1-5, 7-10, and 17 , drawn to an isolated, recombinant or synthetic protein comprising an amino acid sequence, at least 70% sequence identity to SEQ ID NOs: 1-20, or a biologically active fragment or variant thereof . Group II , claim(s) 11-12 and 14-15 , drawn to a recombinant protein encoded by a nucleotide sequence, having at least 70% sequence identity to SEQ ID NOs: 21-53, or a biologically active fragment or variant thereof . Group III , claim(s) 18-20 , drawn to a method of treating or preventing an inflammatory or autoimmune condition . 18-06 AIA Group IV , claim(s) 25 and 27 , drawn to an isolated nucleic acid, vector or expression comprising a nucleotide sequence . Group V , claim(s) 28 , drawn to a method of producing a protein or biologically active fragment. Species Election This application contains claims directed to more than one species of the generic invention. These species are deemed to lack unity of invention because they are not so linked as to form a single general inventive concept under PCT Rule 13.1. The species are as follows: Multiple amino acid sequence comprised in the protein or biologically active fragment or variant thereof (See claims 1 and 11). Regardless of inventive group chosen , Applicants are required to elect a single and specific embodiment of the following species: A single and specific amino acid sequence comprised in the protein or biologically active fragment or variant thereof (See claims 1 and 11). The election must include the complete and full amino acid sequence of the elected peptide and the corresponding SEQ ID NO:. An example of a complete election would be: Applicants elect Group II , wherein the isolated, recombinant or synthetic protein is SEQ ID NO: 13. Applicant is required, in reply to this action, to elect a single species to which the claims shall be restricted if no generic claim is finally held to be allowable. The reply must also identify the claims readable on the elected species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered non-responsive unless accompanied by an election. Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which are written in dependent form or otherwise require all the limitations of an allowed generic claim. Currently, the following claim(s) are generic: claims 1 and 11. The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons: Groups I and II lack unity of invention because the groups do not share the same or corresponding technical feature. Group I is drawn to an isolated, recombinant or synthetic protein comprising an amino acid sequence having at least about 70% sequence identity to any one of SEQ ID NOs: 1-20, or a biologically active fragment or variant thereof. Group II is drawn to a recombinant protein encoded by a nucleotide sequence having at least about 70% sequence identity with any one of SEQ ID NOs: 21-53, or a biologically active fragment or variant thereof . 18-07-02 AIA Groups I, III, IV and V lack unity of invention because even though the inventions of these groups require the technical feature of the protein of claim 1, or a biologically active fragment or variant thereof , this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Makedonka Mitreva (Draft genome of the parasitic nematode Ancylostoma duodenale). Mitreva discloses a sequence from Ancylostoma duodenale that has 321 amino acid residues and shares 98.9% sequence similarity to SEQ ID NO: 4 of the instant application. See residues 1-321 of the calcium/phospholipid binding ligand of Ancylostoma duodenale . During a telephone conversation with Lisa Hillman on 17 March 2026, a provisional election was made without traverse to prosecute the invention of Group III, claims 18-20. Affirmation of this election must be made by applicant in replying to this Office action. Claims 1-5, 7-10, 17, 11-12, 14-15, 25 and 27-28 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention. Applicants elected SEQ ID NO: 11 as the species to be searched . 18-22 AIA Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species or invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention. The election of an invention or species may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected invention or species. Should applicant traverse on the ground that the inventions have unity of invention (37 CFR 1.475(a)), applicant must provide reasons in support thereof. Applicant may submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. Where such evidence or admission is provided by applicant, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention. 08-23-02 AIA Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i). 08-21-04 AIA The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined. In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01. 12-151 AIA 26-51 12-51 Status of Claims The claim listing filed 21 March 2024 is pending. In response to the restriction requirement called in on 17 March 2026, Applicant elected, without traverse, Group III, claims 18-20. Claims 1-5, 7-10, 17, 11-12, 14-15, 25 and 27-28 are withdrawn from further consideration for the reasons set forth above, 37 CFR 1.142(b). Claims 18-20, drawn to SEQ ID NO: 11, are being examined on the merits in this office action. Priority The present application claims status as a 371 (National Stage) of PCT/AU2022/050234 filed 17 March 2022, and claims priority under 119(a)-(d) to European Patent Application Nos. AU2021900769 (filed 17 March 2021) and AU2022900508 (filed 3 March 2022). Information Disclosure Statement The Information Disclosure Statements (IDSs) submitted on 15 September 2023, 21 November 2025 and 02 March 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the Information Disclosure Statements are being considered by the examiner. Note: The Examiner has corrected the accession nos. listed on the IDS filed 15 September 2023 to match those of the submitted UniProt accession numbers. Drawings 06-22-07 AIA The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: Figures 2A, 2B and 2C are labeled in the drawings, but are not specified in the disclosure . Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. Specification 07-29-04 The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. See pages 67-69, paragraphs [0204], [0206], [0207], [0208], and [0210]. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. Appropriate correction is required. Claim Objections 07-29-01 AIA Claim 19 is objected to because of the following informalities: Claim 19 recites “The method according to claim 18, comprising the step identifying a subject having an inflammatory or autoimmune condition; and thereby treating or preventing an inflammatory or autoimmune condition in the subject.”. For improved clarity, please amend the claim to say “The method according to claim 18, comprising the step of identifying a subject having an inflammatory or autoimmune condition and treating or preventing an inflammatory or autoimmune condition in the subject.” . Appropriate correction is required. Claim Rejections - 35 USC § 112 07-30-02 AIA 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. 07-34-01 Claim 19 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 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 19 recites the limitation, “The method according to claim 18, comprising the step identifying a subject having an inflammatory or autoimmune condition”, after depending from claim 18, which states “A method for treating or preventing an inflammatory or autoimmune condition comprising administering to a subject in need thereof…”. The claim is indefinite because the patient population as described in claim 18 is already identified (a subject in need of treating or preventing an inflammatory or autoimmune condition). The limitation of claim 19 is not further limiting or changing the scope of the invention. Claim Rejections - 35 USC § 103 07-20-aia AIA The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. Claims 18-20 are rejected under 35 U.S.C. 103 as being obvious over Ruyssers et al., hereafter “Ruyssers” (“Therapeutic Potential of Helminth Soluble Proteins in TNBS-induced Colitis in Mice”, Inflammatory Bowel Diseases , Volume 15, Issue 4, 1 April 2009, Pages 491–500, https://doi.org/10.1002/ibd.20787), in view of Basavaraju et al., hereafter “Basavaraju” (“Ac-FAR-1, a 20 kDa fatty acid- and retinol-binding protein secreted by adult Ancylostoma caninum hookworms: gene transcription pattern, ligand binding properties and structural characterisation.” Mol Biochem Parasitol. 2003 Jan;126(1):63-71. doi: 10.1016/s0166-6851(02)00253-0. Erratum in: Mol Biochem Parasitol. 2010 Oct;173(2):175. PMID: 12554085), in the IDS filed 21 November 2025. In the provisional species election, on 17 March 2026, Applicants elected SEQ ID NO: 11 as the SEQ ID NO: to be searched. Regarding claim 18, Ruyssers teaches that the excretory/secretory proteins (ESP) of the dog hookworm ( Ancylostoma caninum ) (AcESP), resulted in significantly less macroscopic colonic damage was observed in the mice with trinitrobenzene sulfonic acid (TNBS) -induced colitis (pg. 495,“AcESP ameliorated clinical disease symptoms in mice with colitis, reaching a statistically significant decrease after treatment with 25 μ g proteins ( Fig. 2 A). When treated with 25 μ g or 50 μ g of AcESP, significantly less macroscopic colonic damage was observed in TNBS-treated animals (Fig. 2B). In accordance with the macroscopic inflammation score, the extent of colonic damage was significantly attenuated after treatment with 25 μ g or 50 μ g AcESP (Fig. 2C).”). Ruyssers does not teach the protein of claim 1 (elected species SEQ ID NO: 11) as being the protein being used to treat or prevent inflammatory or autoimmune conditions. Basavaraju discloses the sequence as described in the instant SEQ ID NO: 11. See the peptide represented by residues 17-181 of the fatty-acid and retinol-binding protein of Ancylostoma caninum as an excretory/secretory (ES) product (pg. 64, “Here we report the molecular characterization of a fatty acid-retinol binding protein (Ac-FAR-1), the encoding DNA for which was isolated from a cDNA expression library using serum from rabbits immunized with A. caninum ES products.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ruyssers’ teachings with Basavaraju's teachings because Ruyssers teaches that administering A. caninum secretory proteins reduces the damage seen in mice with TNBS-induced colitis and Basavaraju teaches a protein secreted by A. caninum . One of ordinary skill in the art would be motivated to the substitute the protein of Ruyssers with the protein of Basavaraju would result in a similar method of treating or preventing an inflammatory or autoimmune condition. Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention. Regarding claim 19, Ruyssers teaches that the mice, before and after sacrifice were assigned clinical disease scores and macroscopic inflammation scores (pg. 493, “Prior to sacrifice mice were given a clinical disease score between 0 and 8 based on the following characteristic parameters: weight loss, piloerection, immobility, and conjunctivitis (adapted from De Winter et al). Each parameter was graded from 0 to 2 according to severity of disease (0 = absent, 1 = moderate, 2 = severe).”; pg. 493, “After sacrifice, the colon was removed and carefully opened to score colonic damage macroscopically. Four parameters were taken into account: presence of adhesions, degree of colonic ulcerations, wall thickness, and degree of mucosal edema. Each parameter was given a score from 0 (normal) to 3 (severe) as previously described in the literature. The total score ranged from a minimum of 0 to a maximum of 12. The extent of inflammation (expressed in cm) in the colon was also measured.”). Regarding claim 20, Ruyssers teaches that the administration of helminth proteins, such as the ones seen in A. caninum , decreases the expression of IL-17, which is known to be that cause of inflammation in many diseases, including but not limited to rheumatoid arthritis, asthma, and IBD (pg. 499, “Injection of helminth proteins, on the other hand, decreased expression of IL-17 in both colon and MLN T cells, indicating that helminth extracts are able to influence the recently discovered proinflammatory Th17 pathway. It has been shown that IL-17 is critical for the development of inflammation in many inflammatory conditions, e.g., rheumatoid arthritis, asthma, and IBD .”). It would have been obvious to one of ordinary skill in the art to administer the elected peptide to a patient population with rheumatoid arthritis, asthma, and/or IBD due to Ruyssers teaching that the inflammation in these conditions is caused by the expression of IL-17. Ruyssers shows that helminth proteins decrease the expression of IL-17 in colon cells, as shown by the decrease in inflammation in the mouse models after administration. The elected peptide is a known helminth ES protein. It would be obvious to one of ordinary skill in the art to the administer a peptide that decreases inflammation caused by IL-17 expression to multiple patient populations that have conditions that also have inflammation symptoms caused by IL-17 expression. Summary Claim 19 is objected to. Claim 19 is rejected under rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph. Claims 18-20 are rejected under 35 U.S.C. 103. No claims are allowed. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to Daliyah M. Brown whose telephone number is (571)272-0136. The examiner can normally be reached Monday-Thursday 9:00 am - 4:30 pm. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko Garyu can be reached at (571) 270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /Daliyah M. Brown/Examiner, Art Unit 1654 /LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654 Application/Control Number: 18/550,807 Page 2 Art Unit: 1654 Application/Control Number: 18/550,807 Page 3 Art Unit: 1654 Application/Control Number: 18/550,807 Page 4 Art Unit: 1654 Application/Control Number: 18/550,807 Page 5 Art Unit: 1654 Application/Control Number: 18/550,807 Page 6 Art Unit: 1654 Application/Control Number: 18/550,807 Page 7 Art Unit: 1654 Application/Control Number: 18/550,807 Page 8 Art Unit: 1654 Application/Control Number: 18/550,807 Page 9 Art Unit: 1654 Application/Control Number: 18/550,807 Page 10 Art Unit: 1654 Application/Control Number: 18/550,807 Page 11 Art Unit: 1654 Application/Control Number: 18/550,807 Page 12 Art Unit: 1654 Application/Control Number: 18/550,807 Page 13 Art Unit: 1654 Application/Control Number: 18/550,807 Page 14 Art Unit: 1654