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. Applicant’s response of 9/23/2025 is acknowledged. Status of Claims 3. Claims 1-3, 5, 8, 10-17, 20, 22, 27, 29, 31-32 and 39 are pending. Claims 4, 6-7, 9,18-19, 21, 23-26, 28, 30, 33-38, 40 have been canceled by previous amendment. Drawings 4. The drawings submitted by the applicant dated 10/12/2022 have been accepted by the examiner. Information Disclosure Statement 5. Applicants’ information disclosure statement filed 2 / 17 /202 3 has been considered. Initialed copy of 1449 is enclosed. The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered. Election /Restrictions 6. Applicants’ election of 9/23/2025 is acknowledged. Applicants elected group I (claims 1, 2, 3, 5, 8) an antibody or any antigen-binding fragment thereof with traverse . The traversal is on the ground(s) Applicants argue: The election is made with traverse as it will be shown during the course of prosecution that the elected claims do, indeed, define over the prior art. At that point the unity of invention election must be readdressed and all of the claims found to be based on a common special technical feature that defines over the prior art, and thus the requirement must be withdrawn. This is not persuasive because: The inventions listed as Groups I-VI do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they fail to define a technical feature that is "special" within the meaning of PCT Rule 13.2 for the following reasons, because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons: Claims of group I are drawn to antibodies, groups II and III are drawn to a method of treatment, group IV to a kit, group V to a diagnostic method and group VI to a method of modulating immune response, each group constitute different entities and as such do not share the same technical feature. The requirement is still deemed proper and is therefore made FINAL. Claims 1, 2, 3, 5 and 8 are under consideration. Claims 10-17, 20, 22, 27, 29, 31-32 and 39 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to non-elected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 9/23/2025 . Claim Rejections - 35 USC § 101 7. 35 U.S.C. 101 reads as follows: Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. 8. Claims 1, 2, 3, 5 and 8 are rejected under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter. Based upon an analysis with respect to the claim as a whole, claim 1 does not recite something significantly different than a judicial exception. T he claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claims do not recite something significantly more. The claims are drawn to: Claim 1. An antibody or any antigen-binding fragment thereof, wherein said antibody comprises at least one heavy chain complementarity determining region (CDRH) 1 comprising the amino acid sequence GFTFSHYA, as denoted by SEQ ID NO: 6, CDRH2 comprising the amino acid sequence INSNGDST, as denoted by SEQ ID NO: 10, CDRH3 comprising the amino acid sequence ARDRRAGYFDYW, as denoted by SEQ ID NO: 14, and at least one light chain complementarity determining region (CDRL) 1 comprising the amino acid sequence RDNIGKNY as denoted by SEQ ID NO: 22, CDRL2 comprising the amino acid sequence RNN as denoted by SEQ ID NO: 26, and CDRL3 comprising the amino acid sequence SAWDTSLNA as denoted by SEQ ID NO: 30, or any derivative, variant and biosimilar thereof. Claim 2. The antibody according to claim 1, wherein said antibody specifically recognizes and binds at least one component of the Type III Secretion System (T3SS) of at least one bacterium. Based on this, claims would appear to be simply a combination of judicial exceptions and does not require any higher order non-naturally occurring structure into which these components are included. Claims are directed to antibodies. The instant product claim recites something that appears to be a natural product that is not markedly different in structure and function from naturally occurring products. There is no structural difference because each of the components of the claimed invention is not markedly different. The mere recitation of sequences does not change the components from what exists in nature. Using the December 16, 2014 Eligibility Guidelines and broadest reasonable interpretation of the instant claims as outlined above, the answer to question 1 is YES, the claimed invention is directed to a composition of matter. With regard to Step2A, the answer to Step 2A is YES, the claimed invention is directed to a judicially recognized exception. When the nature-based product is produced by combining multiple components, the markedly different characteristics analysis should be applied to the resultant nature-based combination, rather than its component parts. The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. (To show a marked difference, a characteristic must be changed as compared to nature, and cannot be an inherent or innate characteristic of the naturally occurring counterpart.) And will be evaluated based on what is recited in the claim on a case-by-case basis. As seen by the examples that are being released in conjunction with this Interim Eligibility Guidance, even a small change can result in markedly different characteristics from the products naturally. As stated above, the claims do not recite any markedly different characteristics or properties. The structural and functional characteristics are the same. With regard to Step 2B, the answer to the question--Does the claim as a whole amount to significantly more than the judicial exception, is NO. To determine whether any element, or combination of elements, in the claim is sufficient to ensure that the claim amounts to significantly more than the judicial exception, examiners will: - Consider the additional elements claimed with the exception, both individually and as an ordered combination, to ensure that the claim as a whole describes a product or process that applies the exception in a meaningful way. It is noted that claims do not recite any additional elements that can be applied with the exception in a meaningful way. Simply appending well-understood, routine and conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception is not enough to qualify as "significantly more" when recited in a claim. In view of the foregoing eligibility analysis, claims 1, 2, 3, 5 and 8 are not eligible subject matter. Claim Rejections - 35 USC § 112 (a) 9. 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. 10. Claims 1, 2, 3, 5 and 8 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. This is a written description rejection. The Written Description Guidelines for examination of patent applications indicates, “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, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical characteristics and/or other 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 applicant was in possession of the claimed genus.” (See MPEP 2163). The claims are drawn to: Claim 1. An antibody or any antigen-binding fragment thereof , wherein said antibody comprises at least one heavy chain complementarity determining region (CDRH) 1 comprising the amino acid sequence GFTFSHYA, as denoted by SEQ ID NO: 6, CDRH2 comprising the amino acid sequence INSNGDST, as denoted by SEQ ID NO: 10, CDRH3 comprising the amino acid sequence ARDRRAGYFDYW, as denoted by SEQ ID NO: 14, and at least one light chain complementarity determining region (CDRL) 1 comprising the amino acid sequence RDNIGKNY as denoted by SEQ ID NO: 22, CDRL2 comprising the amino acid sequence RNN as denoted by SEQ ID NO: 26, and CDRL3 comprising the amino acid sequence SAWDTSLNA as denoted by SEQ ID NO: 30, or any derivative, variant and biosimilar thereof . The scope of the claims includes a genus of antibodies i.e., heavy and light chain and fragments thereof),( hereafter referred to antibody variants in the entire action) and the genus is highly variant, inclusive to numerous structural variants because a significant number of structural differences between genus members is permitted. The specification and the claims do not provide any guidance on the structure of the antibody and what changes can or cannot be made. For example, Lederman et al (Molecular Immunology 28:1171-1181, 1991) disclose that a single amino acid substitution in a common allele ablates binding of a monoclonal antibody (see entire document). Li et al (Proc. Natl. Acad. Sci. USA 77:3211-3214, 1980) disclose that dissociation of immunoreactivity from other activities when constructing analogs (see entire document). The amino acid sequences and conformations of each of the heavy and light chain CDRs are critical in maintaining the antigen binding specificity and affinity, which is characteristic of the immunoglobulin. It is expected that all of the heavy and light chain CDRs in their proper order and in the context of framework sequences which maintain their required conformation, are required in order to produce a protein having antigen-binding function and that proper association of heavy and light chain variable regions is required in order to form functional antigen binding sites ,Paul, Fundamental Immunology, 3 rd edition, 1993, pages 292-295 ( see page 293, first column, lines 3-8 and line 31 to column 2, line 9 and lines 27-30). Even minor changes in the amino acid sequences of the heavy and light variable regions, particularly in the CDRs, may dramatically affect antigen-binding function as evidenced by Rudikoff et al (Proc. Natl. Acad. Sci. USA, 79(6):1979-1983, March 1982). Rudikoff et al. teach that the alteration of a single amino acid in the CDR of a phosphocholine-binding myeloma protein resulted in the loss of antigen-binding function. “A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when … the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed.” In re Curtis , 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004). For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly . Further, it is not sufficient to define it solely by its principal biological property, because an alleged conception having no more specificity than that is simply a wish to know the identity of any material with that biological property. Per the Enzo court’s example, ( Enzo Biochem , Inc. v. Gen-Probe Inc ., 63 USPQ2d 1609 (CA FC 2002) at 1616) of a description of an anti-inflammatory steroid, i.e., a steroid (a generic structural term) couched “in terms of its function of lessening inflammation of tissues” which, the court stated, “fails to distinguish any steroid from others having the same activity or function” and the expression “an antibiotic penicillin” fails to distinguish a particular penicillin molecule from others possessing the same activity and which therefore, fails to satisfy the written description requirement. Similarly, binding to (T3SS) does not distinguish a particular antibody variant from others having the same activity and as such, fails to satisfy the written-description requirement. Applicant has not disclosed any relevant, identifying characteristics, such as structure or other physical and/or chemical properties, sufficient to show possession of the claimed genus. Mere idea or function is insufficient for written description; isolation and characterization at a minimum are required. A description of what a material does, rather than what it is, usually does not suffice. Eli Lilly , 119 F.3d at 1568, 43 USPQ2d at 1406. Structural features that could distinguish “antibody variants” in the genus from others in the protein class are missing from the disclosure and the claims. No common structural attributes identify the members of the genus. The general knowledge and level of skill in the art do not supplement the omitted description, because specific, not general guidance is needed. Since the disclosure does not describe the common attributes or structural characteristics that identify members of the genus, and because the genus is highly variant, the function of the binding of antibody alone is insufficient to describe the genus of “antibody variants ” of that function equivalently. One of skill in the art would reasonably conclude that the disclosure of antibody of (SEQ NO: 6, 10, 14, 22, 26 and 30) , does not provide a representative number of species of antibody to describe the claimed genus and as a consequence antibodies that bind such. As such, generic sequences that are unrelated via structure and function are highly variant and not conveyed by way of written description by the specification at the time of filing. As such the specification lacks written description for the highly variant genus of antibody and one skilled in the art would not recognize that applicants had possession of the genus of claimed antibody as instantly claimed. Therefore, only the antibodies (SEQ NO: 6, 10, 14, 22, 26 and 30), but not the full breadth of the claim meets the written description provision of 35 U.S.C. §112, first paragraph. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision (see page 1115). Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the genus of antibody variants as claimed. Claim Rejections - 35 USC § 112 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. Claims 1, 2, 3, 5 and 8 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 is vague and indefinite due to the phrase “ antigen binding fragments thereof”. A fragment reads on as few as one amino acid. Additionally, the “fragment or analogues thereof” are derived from polypeptide sequences that vary by as much as 30% from the known sequences. The current claim language allows from these sequences to be drawn from the portion of the sequences that is unknown. The metes and bounds of the claimed molecule cannot be understood. It is not clear what is encompassed by “ fragments thereof”. Claim 1 is vague and indefinite due to the phrase “any derivative, variant and biosimilar thereof ”. Claim 1 is vague and indefinite because claim language “…comprising the amino acid sequence GFTFSHYA, as denoted by SEQ ID NO: 6….” It appears CDRH1 comprises SEQ ID NO:6. The “as denoted by” language is unclear and the metes and bounds to determine what is comprised and what is denoted have not been defined. Therefore, it is suggested amend the claim language to clear recite CDRH1 comprises SEQ ID NO:6 for each of CDRH2, CDRH3, CDRL1, CDRL2 and CDRL3. Claims 2, 3, 5 and 8 are indefinite as being dependent from indefinite claim 1. Claim Rejections - 35 USC § 103 13. T he 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 1, 2, 3, 5 and 8 are obvious over W.H. Schmied , Structure and Function of the Type 3 Secretion System in Salmonella typhimurium March 1, 2010 in view of. D. E. Tabor et al., Pseudomonas aeruginosa PcrV and Psl , the Molecular Targets of Bispecific Antibody MEDI3902, Are Conserved Among Diverse Global Clinical Isolates, The Journal of lnfectious Diseases 2018;218: 1983 -94. (Art of record applicants search report). Note: The claim is not limited to just the SEQ ID NO sequences for the heavy and light chains. The claims include any derivative, variant and biosimilar thereof. Therefore, any antibody using any fragment is art. The claims are drawn to: Claim 1. An antibody or any antigen-binding fragment thereof, wherein said antibody comprises at least one heavy chain complementarity determining region (CDRH) 1 comprising the amino acid sequence GFTFSHYA, as denoted by SEQ ID NO: 6, CDRH2 comprising the amino acid sequence INSNGDST, as denoted by SEQ ID NO: 10, CDRH3 comprising the amino acid sequence ARDRRAGYFDYW, as denoted by SEQ ID NO: 14, and at least one light chain complementarity determining region (CDRL) 1 comprising the amino acid sequence RDNIGKNY as denoted by SEQ ID NO: 22, CDRL2 comprising the amino acid sequence RNN as denoted by SEQ ID NO: 26, and CDRL3 comprising the amino acid sequence SAWDTSLNA as denoted by SEQ ID NO: 30, or any derivative, variant and biosimilar thereof. Claim 2. The antibody according to claim 1, wherein said antibody specifically recognizes and binds at least one component of the Type III Secretion’ W.H. Schmied refer to antibody raised against Type 3 Secretion System of Salmonella typhimurium (See DI, figure 3A on page 17). D. E. Tabor et al refer to antibody raised against Type 3 Secretion System of (See title and abstract). However, current application refers to antibody raised against Type 3 Secretion System of Escherichia coli. The subject-matter of claims 1 and 2 consists in the selection of an antibody raised against type 3 secretion system (T3SS), which is known in the art as taught by Schmied , figure 3A on page 17 and D. E. Tabor et al , title and abstract). The claims also read on any antibody binding fragment, derivative, variant or biosimilar antibody . A biosimilar antibody would be that binds a T3SS expressing bacteria. Any antibody that binds any EPEC, EHEC, e coli, Salmonella. Therefore, the subject matter of claims is known in the art as taught by the above references. Therefore, it would have been prima facie obvious at the time of applicants’ invention to combine the composition and method of references to obtain the instant invention. It would have been obvious to one of ordinary skill in the art that to modify the CDRs in the light and heavy chains of an antibody raised against type 3 secretion system (T3SS), which is known in the art as taught by Schmied , figure 3A on page 17 and D. E. Tabor et al , title and abstract). Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses combining prior art elements according to known methods to yield predictable results, thus the combination is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses, "The combination of familiar element according to known methods is likely to be obvious when it does no more than yield predictable results". It is well known to combine known compositions, which function in a predictable manner to yield a reasonable expectation of success along with predictable results to one of ordinary skill in the art at the time of the invention. Thus, it would have been obvious to a person of ordinary skill in the art to combine prior art elements according to known compositions that is ready for improvement to yield predictable results. The claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary. Conclusion No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT KHATOL S SHAHNAN SHAH whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-0863 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Mon-Tue, Thurs-Fri 12pm-8pm 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, FILLIN "SPE Name?" \* MERGEFORMAT Vanessa Ford can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571) 272 -0857 . 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. /KHATOL S SHAHNAN SHAH/ Examiner, Art Unit 1645 December 17, 2025 /JANA A HINES/ Primary Examiner, Art Unit 1645