DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicants’ Amendment
1) Acknowledgment is made of Applicants’ amendment filed 06/10/2026 in response to the non-final Office Action mailed 02/10/26. Said claim amendment is non-compliant under 37 C.F.R 1.121 in that claims drawn to previously non-elected species have an incorrect status identifier. For example, see claims 10-12, 15 and 20. Appropriate correction is needed.
Status of Claims
2) Claims 1, 6, 7, 9-12, 14 and 16 have been amended via the amendment filed 06/10/2026.
Claims 2-5, 17, 18 and 22 have been canceled via the preliminary amendment filed 06/10/2026.
Claims 1, 6-16 and 19-21 are pending.
Claim 16 is amended to replace the previously elected ClyA species with several ClyA mutant species. Accordingly, the examination is now extended to the ClyA E204K mutant species.
Claims 1, 3, 4, 6-9, 13, 14, 16, 19 and 21 are under examination.
Substitute Specification
3) Applicants’ substitute specification filed 06/10/26 is acknowledged.
Replacement Drawing(s)
4) Applicants’ replacement drawing(s) filed 06/11/26 is acknowledged.
Prior Citation of Title 35 Sections
5) The text of those sections of Title 35 U.S. Code not included in this action can be found in a prior Office Action.
Prior Citation of References
6) The references cited or used as prior art in support of one or more rejections in the instant Office Action and not included on an attached form PTO-892 or form PTO-1449 have been previously cited and made of record.
Objection(s) Moot
7) The objection to claim 2 set forth in paragraph 13 Office Action mailed 02/10/26 is moot
in light of Applicants’ cancellation of the claim.
Objection(s) Withdrawn
8) The objection to the specification and drawings set forth in paragraph 8(a) Office Action mailed 02/10/26 is withdrawn in light of Applicants’ amendments.
9) The objection to the specification and drawings set forth in paragraph 8(b) Office Action mailed 02/10/26 is withdrawn in light of Applicants’ amendments.
Rejection(s) Moot
10) The rejection of claims 2-4 and 22 set forth in paragraph 10 Office Action mailed 02/10/26 under 35 U.S.C § 112(a) or 112 (pre-AIA ), first paragraph, with regard to the written description issue is moot in light of Applicants’ cancellation of the claims.
11) The rejection of claims 2-4 and 22 set forth in paragraph 12 Office Action mailed 02/10/26 under 35 U.S.C § 112(b) or 35 U.S.C § 112 (pre-AIA ), second paragraph, as being indefinite is moot in light of Applicants’ cancellation of the claims.
Rejection(s) Withdrawn
12) The rejection of claims 1, 6-9, 13, 14, 16, 19 and 21 set forth in paragraph 10 Office Action mailed 02/10/26 under 35 U.S.C § 112(a) or 112 (pre-AIA ), first paragraph, with regard to the written description issue is withdrawn in light of Applicants’ claim amendments. Applicants’ arguments are moot in light of the withdrawal of the rejection. A new rejection is set forth in this Office Action to address the claims as amended.
13) The rejection of claim 1 set forth in paragraph 12(a) Office Action mailed 02/10/26 under 35 U.S.C § 112(b) or 35 U.S.C § 112 (pre-AIA ), second paragraph, as being indefinite is withdrawn in light of Applicants’ claim amendments.
14) The rejection of claim 21 set forth in paragraph 12(b) Office Action mailed 02/10/26 under 35 U.S.C § 112(b) or 35 U.S.C § 112 (pre-AIA ), second paragraph, as being indefinite is withdrawn in light of Applicants’ amendments to claim 1.
15) The rejection of claims 8 and 9 set forth in paragraph 12(c) Office Action mailed 02/10/26 under 35 U.S.C § 112(b) or 35 U.S.C § 112 (pre-AIA ), second paragraph, as being indefinite is withdrawn.
With regard to the limitations “guaBA” and “htrA”, Applicants contend that the structure of these ‘genes’ is known in S. Typhi and it is not necessary to refer to the genes and specify a particular SEQ ID number.
16) The rejection of claims 16 and 19 set forth in paragraph 12(d) Office Action mailed 02/10/26 under 35 U.S.C § 112(b) or 35 U.S.C § 112 (pre-AIA ), second paragraph, as being indefinite is withdrawn in light of Applicants’ amendments to claim 16.
17) The rejections of claim 1 set forth in paragraphs 12(e), 12(f) and 12(g) Office Action mailed 02/10/26 under 35 U.S.C § 112(b) or 35 U.S.C § 112 (pre-AIA ), second paragraph, as being indefinite are withdrawn in light of Applicants’ claim amendments.
18) The rejection of claims 6, 7 and 9 set forth in paragraph 12(h) Office Action mailed 02/10/26 under 35 U.S.C § 112(b) or 35 U.S.C § 112 (pre-AIA ), second paragraph, as being indefinite is withdrawn in light of Applicants’ claim amendments.
19) The rejection of claim 6 set forth in paragraph 12(i) Office Action mailed 02/10/26 under 35 U.S.C § 112(b) or 35 U.S.C § 112 (pre-AIA ), second paragraph, as being indefinite is withdrawn in light of Applicants’ claim amendment.
20) The rejection of claim 9 set forth in paragraph 12(j) Office Action mailed 02/10/26 under 35 U.S.C § 112(b) or 35 U.S.C § 112 (pre-AIA ), second paragraph, as being indefinite is withdrawn in light of Applicants’ claim amendment.
21) The rejection of claim 14 set forth in paragraph 12(k) Office Action mailed 02/10/26 under 35 U.S.C § 112(b) or 35 U.S.C § 112 (pre-AIA ), second paragraph, as being indefinite is withdrawn in light of Applicants’ claim amendment.
22) The rejection of claim 16 set forth in paragraph 12(l) Office Action mailed 02/10/26 under 35 U.S.C § 112(b) or 35 U.S.C § 112 (pre-AIA ), second paragraph, as being indefinite is withdrawn in light of Applicants’ claim amendment.
23) The rejection of claims 6-9, 13, 14, 16, 19 and 21 set forth in paragraph 12(n) Office Action mailed 02/10/26 under 35 U.S.C § 112(b) or 35 U.S.C § 112 (pre-AIA ), second paragraph, as being indefinite is withdrawn in light of Applicants’ amendments the base claim.
Rejection(s) under 35 U.S.C § 112(b) or (Pre-AIA ), First Paragraph
24) The following is a quotation of 35 U.S.C § 112(a):
(a) IN GENERAL - The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 35 U.S.C. § 112 (pre-AIA ), first paragraph:
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 the invention.
25) Claims 1, 6-9, 13, 14, 16, 19 and 21 are rejected under 35 U.S.C § 112(a) or 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 purpose of the written description requirement is “to ensure that the inventor had possession, as of the filing date of the application relied on, of the specific subject matter later claimed by him.” In re Edwards, 568 F.2d 1349, 1351-52, 196 USPQ 465, 467 (CCPA 1978). The analysis of whether the as-filed specification complies with the written description requirements calls for the Office to compare the scope of the claims with the scope of the description to determine whether Applicants have demonstrated possession of the full scope of the claimed invention at the time of the invention. In the instant application, an analysis of the scope of the claims and of the variant genus encompassed therein indicates the following.
Claim 1 is representative of the instant invention. It is now drawn to a live Salmonella Typhi vector that has been engineered to express: a) one or more antigens from a pathogen, the OmpA of Acinetobacter baumanni being the elected species; b) an outer membrane folding protein BamA comprising SEQ ID NO: 18 or a variant thereof wherein the variant is at least 90% identical to SEQ ID NO: 18; and c) a lipid A deacylase PagL comprising SEQ ID NO: 2 or SEQ ID NO: 4 or a variant thereof wherein the variant is at least 90% identical to SEQ ID NO: 2 or SEQ ID NO: 4, wherein the Salmonella Typhi vector is capable of delivering the antigen to a mucosal tissue via an outer membrane vesicle when administered to a subject. The OmpA antigen recited in claim 13, which is dependent from a canceled claim, i.e., claim 4, is required to comprise one or more generic mutations, whereas the OmpA antigen recited in claim 14, dependent directly from claim 13 and indirectly from the canceled claim 4, is required to comprise the elected D271A substitution mutation species. Thus, each of the a), b) and c) elements represent a huge genus encompassing a large number and variety of species of vast scope and variable structure. The guaBA and htrA recited in claims 8 and 9 comprised in the claimed vector are required to have “a” deletion therein, yet the specific location of “a” deletion is not identified in the claims. The vector claimed in claims 16 and 19 is required to overexpress cytolysin A (ClyA) that is mutated at specific amino acid positions of ‘Cly A’ such as E204K, wherein the Cly A comprises SEQ ID NO: 16. The genus of at least 90% identical variants of the BamA and the PagL as claimed in claim 1 encompass structurally divergent variant species that are up to 10% non-identical to each of SEQ ID NOs: 18, 2 and 4, which species are permitted to comprise multiple random amino acid substitutions, additions, deletions, mutations, insertions, truncations, point mutations and any combinations thereof anywhere along the length of SEQ ID NOs: 18, 2 and 4. The claimed engineered Salmonella Typhi vector is required to have the capacity to deliver the antigen species to a mucosal tissue via an outer membrane vesicle in vivo in a generic subject upon its administration by any generic route to the subject with the overexpressed mutated ClyA having the capacity to reduce hemolytic activity of ClyA. Also, the as-filed specification intends ‘vaccine’ applications for the claimed engineered genus of Salmonella Typhi vector. However, at the time of the invention, Applicants were not in possession of each of the variant genus and the full scope of the claims as claimed.
“[T]he purpose of the written description requirement is to ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor’s contribution to the field of art as described in the patent specification.’” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1353-54 (Fed. Cir. 2010) (en banc) (quoting Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920 (Fed. Cir. 2004)). To satisfy the written description requirement, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562-63, 19 USPQ2d 1111 (Fed. Cir. 1991). See also MPEP 2163.04. “[A] sufficient description of a genus .... requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Ariad, 598 F.3d at 1350 (quoting Eli Lilly, 119 F.3d at 1568-69). A “representative number of species” means that those species that are adequately described are representative of the entire genus. AbbVie Deutschland GMBH v. Janssen Biotech, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (“The ’128 and ’485 patents, however, only describe species of structurally similar antibodies that were derived from Joe-9. Although the number of the described species appears high quantitatively, the described species are all of the similar type and do not qualitatively represent other types of antibodies encompassed by the genus.”). Thus, when there is substantial variation within the genus, as in the instant case, one must describe a sufficient variety of species to reflect the variation within the genus to provide a "representative number” of species. The “structural features common to the members of the genus” needed for one of skill in the art to ‘visualize or recognize’ the members of the genus takes into account the state of the art at the time of the invention. “An adequate written description must contain enough information about the actual makeup of the claimed products - “a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials,” which may be present in “functional” terminology “when the art has established a correlation between structure and function.” Ariad, 598 F.3d at 1350.
The written description requirement can be met by describing the claimed subject matter to a person skilled in the art using sufficiently detailed, relevant identifying characteristics such as functional characteristics, and correlating those functional characteristics with a disclosed structure. See Enzo Biochem v. Gen-Probe, 323 F.3d 956, 964, 967, 968 (Fed. Cir. 2002). The mere recitation of names of the elements to describe the invention is not sufficient to satisfy the Statute's requirement. A mere statement that the invention includes a Salmonella Typhi vector expressing the variant elements as claimed is insufficient to meet the written description requirement of the claimed invention. To satisfy the written description provision of 35 U.S.C § 112(a) or 35 U.S.C § 112 (pre-AIA ), first paragraph, a convincing structure-function relationship must exist between the structure of a representative number and variety of the various element species and their intended or requisite functions. Note that Vas-Cath Inc. V. Mathukar, 19 USPQ2d 1111 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.
Whether or not one of skill in the art would recognize that Applicants were in possession of the claimed invention as a whole at the time of invention is to be determined upon considering the actual reduction to practice, sufficient relevant identifying characteristics, disclosure of drawings or structural chemical formulas, method of making the claimed invention, level of skill and knowledge in the art, and predictability in the art. The written description inquiry is case and context-specific. It “depend[s] on the nature of the claimed invention and the knowledge of one skilled in the art at the time an invention is made and a patent application is filed.” Ariad, 560 at 1372. A number of factors guide the inquiry, including “the existing knowledge in the particular field, the extent and content of the prior art, the maturity of the science or technology, and the predictability of the aspect at issue.” Ariad, 560 at 1372. [Emphasis added]. According to MPEP 2163 [Emphasis added]:
The description needed to satisfy the requirements of (pre-AIA ) 35 U.S.C § 112 “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 at 1357, 76 USPQ2d at 1084. Patents and printed publications in the art should be relied upon to determine whether an art is mature and what the level of knowledge and skill is in the art.
The evidence required to demonstrate possession of the invention at the time of the invention is fact-specific and varies inversely with the maturity and predictability of the technology area. Inventions in “unpredictable” arts are subject to greater scrutiny under the written description requirement, and require a greater showing of possession than more predictable arts. The various species encompassed within the claimed genus are structurally different. The capacity of a Salmonella Typhi engineered to express the various variant species that retain the functions of the unmodified native species was neither predictable, nor was it established within the instant application at the time of the invention. This is important because the art reflects unpredictability as to which amino acids in a specific protein or a polypeptide sequence can be varied or mutated without adversely affecting the functional properties of that specific protein or polypeptide sequence. While it is known in the art that variation, mutation and/or deletion of one or more amino acids is possible in a given protein or sequence, the exact position within its amino acid sequence where replacements, mutations or variations can be made, with a reasonable expectation of success of retaining the sequence’s functional competence, is not certain or predictable. A random replacement affecting the epitopic amino acid positions that are critical, for example, to the three-dimensional conformational structure and specific functional property of the protein or polypeptide, would result in a protein or polypeptide that may be non-functional, or not optimally functional, because such positions tolerate no or little modifications. For instance, Mikayama et al. (Proc.NatI.Acad.Sci. USA, 90: 10056-10060, 1993, of record) taught that the three-dimensional structure of molecules is important for their biological function and even a single amino acid difference may account for markedly different biological activities. In the instant case, this is important because the purpose of the instantly claimed vector expressing the structurally variable species encompassed within the huge genus is to use the claimed vector in the above-identified bio-applications. With regard to this issue, Skolnick et al. (Trends in Biotechnology, 18: 34-39, 2000, of record) taught that the skilled artisan is well aware that assigning functional activities for any particular protein or protein family based on sequence homology is inaccurate, in part because of the multifunctional nature of proteins. See abstract and ‘Sequence-based approaches to function prediction’ on page 34. Skolnick et al. teach that even in situations where there is some confidence of a similar overall structure between two proteins, only experimental research can confirm the artisan's best guess as to function of the structurally related protein. See in particular abstract and Box 2. With regard to the structure-function relationship of an amino acid sequence in general, Rudinger J. (In: Peptide Hormones. (Ed) JA Parsons, University Park Press, pages 1-7, 1976, of record) taught that ‘the significance of particular amino acid sequences for different aspects of biological activity cannot be predicted a priori but must be determined from case to case by painstaking experimental study’. See page 6 of Rudinger J. Rudinger J. further taught that ‘it is impossible to attach a unique significance to any residue in a sequence’ and that a ‘given amino acid will not by any means have the same significance in different peptide sequences, or even in different positions of the same sequence. See page 3 of Rudinger J. The art further recognizes that even the existence of as high as at least 95%, or even 98% sequence identity between two enzymatic bacterial polypeptides is not necessarily predictive of identical or near identical functional activity. For example, the state of the art documents that two enzymatic bacterial polypeptides which are 98% identical to each other can be functionally different. See title; abstract; and the last sentence of paragraph bridging pages 2405 and 2406 of Seffernick et al. (J. Bacteriol. 183: 2405-2410, 2001, of record). Even with conservative amino acid substitutions within a protein, the state of the art documents functional unpredictability. For example, Lazar et al. (Mol. Cellular Biol. 8: 1247-1252, 1988, of record) demonstrated that a substitution of the Leu residue with a conservative amino acid residue such as, Ile or His, in the transforming growth factor (TGF) alpha led to a mutant protein with dramatically altered biological activities. Lazar et al. stated that they ‘did not expect that a mutation of Leu to Ile (which have similar sizes and polarities) would cause such a strong effect’. See paragraph bridging left and right columns on page 1251; and third full paragraph on page 1251. In the instant case, the capacity of the claimed S. Typhi vector, with or without comprising ‘a’ deletion in guaBA and htrA, engineered to express the recited BamA and PagL variant genus and the ClyA mutant to retain the vaccine functions and the capacity to deliver the A. baumannii OmpA antigen in vivo to a mucosal tissue via an outer membrane vesicle when administered, by any generic route, to a generic subject, was neither predictable at the time of the invention, nor has it been shown within the as-filed specification. Even if one engineered a Salmonella Typhi vector expressing said variants and mutant of the various elements falling within the scope of the instant claims, there is no predictability that such structurally variable variant species expressed by the vector would exert the requisite and intended biologic functions in vivo absent a concrete structure-function correlation. In the instant case, a skilled artisan cannot immediately envision or recognize at least a substantial number of members of each of the claimed variant genus such that the claimed engineered vector has or retains the intended vaccine functions and the requisite capacity to deliver the variable antigen species to a mucosal tissue via an outer membrane vesicle in vivo in a generic subject upon its administration to the subject by any route. Clearly, a convincing structure-function correlation for the entire genus is lacking.
MPEP § 2163.02 states: ‘an objective standard for determining compliance with the written description requirement is, does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed’. It must be noted that "[t]he invention, is for purposes of the ‘written description’ inquiry, whatever is now claimed.” See page 1117 of Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64 (Fed.Cir.1991). Vas-Cath further makes clear that the written description provision of 35 U.S.C § 112(a) is severable from its enablement provision. See page 1115. The written description requires more than a mere statement that something is part of the invention and a reference to a potential method for isolating it. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. The specific description or guidance, not general description or guidance is needed. A mere idea or unsubstantiated function is insufficient for written description; characterization of a representative number of species as claimed with their precise structure correlated with the requisite or intended in vivo functions is required.
The essence of the written description requirement is that a patent Applicant, as part of the bargain with the public, must describe his or her invention so that the public will know what it is and that he or she has truly made the claimed invention. See Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722, 736 (2002) (“The requirements must be satisfied before issuance of the patent, for exclusive patent rights are given in exchange for disclosing the invention to the public. What is claimed by the patent application must be the same as what is disclosed in the specification .....” (internal citations omitted)); O’Reilly v. Morse, 56 U.S. 62, 120–21 (1853) (“The evil is the same if he claims more than he has invented, although no other person has invented it before him. He prevents others from attempting to improve upon the manner and process which he has described in his specification and may deter the public from using it.”). We have explained that “requiring a written description of the invention plays a vital role in curtailing claims .... that have not been invented, and thus cannot be described.” Ariad, 598 F.3d at 1352. One particular question regarding the written description requirement has been raised when a genus is claimed but the specification only describes a part of that genus that is insufficient to constitute a description of the genus. In Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997) “For generic claims, we have set forth a number of factors for evaluating the adequacy of the disclosure, including ‘the existing knowledge in the particular field, the extent and content of the prior art, the maturity of the science or technology, [and] the predictability of the aspect at issue.’” Id. (quoting Capon v. Eshhar, 418 F.3d 1349, 1359 (Fed. Cir. 2005)). ‘When a patent claims a genus using functional language to define a desired result, the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus’. Capon v. Eshhar, 418 F.3d 1349 (Fed. Cir. 2005) (Emphasis added). The written description for the claimed genus may be satisfied through sufficient description not of every species, but a representative number of species. Species must be adequately described and must fairly represent the variation within the entire genus. In the instant application, adequate written description of a genus cannot be achieved in the absence of disclosure of a representative number and variety of the various species within each variant genus that includes up to 10% non-identical variant species of specific structure within the structurally variable broad genus such that the claimed vector has the requisite capacity to deliver the antigen to a mucosal tissue via an outer membrane vesicle in vivo in a generic subject upon its administration to the subject by any route and the intended ‘vaccine’ functions and the overexpressed mutated ClyA reduced hemolytic activity of ClyA, or Cly A comprising SEQ ID NO: 16. The structure of a representative number and variety of such species within the recited huge genus has not been correlated with the above-identified requisite in vivo functions in any subject species. Clearly, the specification does not describe the claimed embodiments in sufficient detail to convey to a person skilled in the art that Applicants were in possession of the broadly claimed variant genus and the full scope of the claimed invention at the time of filing. Applicants did not have possession of, or did not reduce to practice, the engineered vector as claimed at the time of the invention. Instant claims do not meet the written description provision of 35 U.S.C § 112(a).
Rejection(s) under 35 U.S.C § 112(b) or (Pre-AIA ), Second Paragraph
26) 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.
27) Claims 1, 6-9, 13, 14, 16, 19 and 21 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 inventor or a joint inventor, or for the pre-AIA the Applicant regards as the invention.
(a) Claim 1, as amended, is indefinite because of the antecedence issue with regard to the limitation “the antigen” in line 5. Note that the earlier recitation in line 3 of the claim is of the limitation “one or more antigens”. The limitation “the antigen” in line 5 is also inconsistent with the limitations with the correct antecedence --the one or more antigens-- in line 12 of the amended claim.
(b) Claim 13 and claim 14 that depends from claim 13 are indefinite for depending directly or indirectly from a canceled claim, i.e., claim 4.
(c) Claim 16, as amended, is ambiguous, inconsistent, confusing and indefinite with regard to the limitations: “a mutant cytolysin (ClyA)” in line 2, “ClyA” in lines 3 and 4, and “Cly A” with a space therein in line 5 of the claim. Given that the parenthetic abbreviation “(ClyA)” is recited to represent “a mutant cytolysin (ClyA)”, it is unclear what does the limitation “ClyA” at the beginning of line 4 of the claim and the limitation “Cly A” with a space therein in line 5 of the claim represent or encompass structure-wise or scope-wise. How the former “ClyA” differs from the latter “Cly A” recited in line 5 structure-wise or scope-wise is not clear. Note that the latter “Cly A” with a space therein comprises SEQ ID NO: 16, but the former “ClyA” of broader scope has no structure or SEQ ID NO. identified. Claim 16, as amended, is internally inconsistent.
(d) Claims 2-4, 6-9, 13, 14, 16, 19 and 21, which depend directly or indirectly from claim 1, are also rejected as being indefinite due to the indefiniteness identified supra in the base claim.
Conclusion
28) No claims are allowed.
29) Applicants’ amendment necessitated the new ground(s) of rejection presented in this Office action. THIS ACTION IS MADE FINAL. Applicants are reminded of the extension of time policy as set forth in 37 C.F.R 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 C.F.R 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence
30) Any inquiry concerning this communication or earlier communications from the Examiner should be directed to S. Devi, Ph.D., whose telephone number is (571) 272-0854. A message may be left on the Examiner’s voice mail system. The Examiner is on a flexible work schedule, however she can normally be reached Monday to Friday from 8.00 a.m. to 4.00 p.m. (EST). If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s Supervisor, Jeffrey Stucker, can be reached at (571) 272-0911. The fax phone number for the organization where this application or proceeding is assigned (571) 273-8300.
31) Information regarding the status of an application may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center or Private PAIR to authorized users only. Should you have questions about access to Patent Center or the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). 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.
/S. DEVI/
S. Devi, Ph.D.Primary Examiner
Art Unit 1645
August, 2026
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