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 .
Preliminary Amendment
1) Acknowledgment is made of Applicants’ preliminary amendment filed 09/29/2025.
Election
2) Acknowledgment is made of Applicants’ elections filed 02/12/2026 and 09/29/25 in response to the restriction and the species election requirement mailed 08/19/2025. Applicants have elected invention I without traverse and the healthy subject species via the election filed 09/29/2025. Via the election filed 02/12/26 in response to the Notice of not-fully responsive Reply mailed 12/17/25, Applicants have elected the PorA-ProB-RmpM- serogroup B Neisseria meningitidis outer membrane microvesicles without traverse.
Status of Claims
3) Claims 12-22 have been canceled via the amendment filed 09/29/25.
New claims 23-25 have been added via the amendment filed 09/29/25.
Claims 1-11 and 23-25 are pending and are examined on the merits.
Information Disclosure Statement
4) Acknowledgment is made of Applicants’ information disclosure statement filed 09/01/22. The information referred to therein has been considered and a signed copy is attached to this Office Action.
Sequence Listing
5) Acknowledgment is made of Applicants’ sequence listing, which has been entered on 09/02/2022.
Drawings
6) Acknowledgment is made of Applicants’ replacement drawings filed 09/02/22.
The Figure 2C drawing is objected to for using the trademark recitation ‘Coomassie’. All trademark recitations should be CAPITALIZED wherever they appear, or where appropriate, should include a proper symbol indicating use in commerce such as TM, SM, or ® following the term. See M.P.E.P 608.01(v) and Appendix l. Although the use of trademarks is permissible in patent applications, the propriety nature of the marks should be respected and every effort made to prevent their use in any manner, which might adversely affect their validity as trademarks. It is suggested that Applicants examine the whole specification and all the drawings to make similar corrections to trademark recitations, wherever such recitations appear.
Priority
7) The instant AIA application, filed 09/02/2022, is a continuation of U.S. application 16632278 filed 01/17/2020, now US patent 11464845, which is the national stage application filed under 35 U.S.C § 371, of the international application PCT/US2018/043054 filed 07/20/2018, which claims the benefit of the US provisional application 62/535,627 filed 07/21/2017.
The US provisional priority application is not supportive of at least the following parts or aspects of the instant application:
Example 9 - Results in animal Demonstrating Immune Response to Neisseria meningitidis.
Example 10 and Example 11,
Several Figures and their descriptions including Figures 8, 9A, 9B and 10; and Figures 5A-5C,
Figures 5A-5C, 8, 9A, 9B and 10 drawings,
PorA-PorB-RmpM- N. meningitidis,
Instant method claims.
The US provisional priority application further lacks support for the following claim limitations:
(a) Microvesicles,
(b) Outer membrane microvesicles,
(c) PorA-PorB-RmpM- N. meningitidis,
(d) PorA-PorB- N. meningitidis,
(e) Protective immune response and
(f) Therapeutic immune response.
Objection(s) to Specification
8) Instant specification is objected to for the following reason(s):
(a) First paragraph does not reflect the issued status of the prior application, 16632278, which is now issued as US patent 11464845.
(b) The listing of references in the specification is not a proper way of information disclosure. 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.
(c) 35 U.S.C § 132 states that no amendment shall introduce new matter into the disclosure of the invention. 37 CFR 1.75(d)(1) provides, in part, that ‘the terms and phrases used in the claims must find clear support or antecedent basis in the description so that the meaning of the terms in the claims may be ascertainable by reference to the description.’ Furthermore, 35 U.S.C § 132 states that no amendment shall introduce new matter into the disclosure of the invention.
New claim 25, set forth below, includes limitations indicated below in bold, which limitations lack descriptive support in the as-filed specification:
25. (New) The method of claim 5, wherein administration of the immunogenic composition induces clearance of a subsequent Neisseria meningitidis.
Applicants refer to pages 17-22 and Example 9 as well as claim 4 for support. However, these parts of the specification fail to provide antecedent basis and descriptive support for this new claim.
Rejection(s) under 35 U.S.C § 112(a) or (Pre-AIA ), First Paragraph
9) 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.
10) Claim 25 is 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 claims contain 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 the (pre-AIA ), the Applicant. This is a new matter rejection.
New claim 25, set forth below, includes limitations indicated below in bold, which limitations lack descriptive support in the as-filed specification:
25. (New) The method of claim 5, wherein administration of the immunogenic composition induces clearance of a subsequent Neisseria meningitidis.
Applicants refer to pages 17-22 and Example 9 as well as claim 4 for support. Claim 4 is set forth below:
4. (Original). The method of claim 3, wherein the subject has a Neisseria meningitidis infection, and the administration of the immunogenic induces clearance of the Neisseria meningitidis.
However, these parts of the specification fail to provide descriptive support for this new claim. Therefore, the above-identified limitations in the claim and the current scope of the claim constitute new matter. See M.P.E.P 608.04 to 608.04(c).
Applicants are invited to point to the descriptive support in specific pages and lines of the disclosure, as originally filed, for the limitation identified above, or alternatively, remove the new matter from the claim(s). Applicants should specifically point out the support for any amendments made to the disclosure. See MPEP 714.02 and 2163.06.
11) Claims 3, 4, 8, 9 and 1 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 claims contain 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 the (pre-AIA ), the Applicant. 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 indicates the following.
Claim 1 is representative of the claimed method. Claim 3 depends from claim 1 and it is drawn to a method of inducing an immune response to Neisseria meningitidis in a mammalian subject comprising administering to the mammalian subject an immunogenic composition comprising an effective amount of isolated PorA-ProB-RmpM- serogroup B Neisseria meningitidis outer membrane microvesicles, wherein the mammalian subject has a N. meningitidis infection and wherein the immune response is a therapeutic response. Claim 4 depends from claim 3, wherein the mammalian subject has a N. meningitidis infection and the administration of the immunogenic composition induces clearance of the Neisseria meningitidis. In the method of the dependent claim 8, the N. meningitidis infection is of the same serogroup as of the outer membrane microvesicles, whereas in the method of the dependent claim 9, the N. meningitidis infection is of a different serogroup as of the outer membrane microvesicles, However, at the time of the invention, Applicants were not in possession of such a method wherein the immune response induced by the isolated outer membrane microvesicles of a PorA-ProB-RmpM- mutant of serogroup B Neisseria meningitidis is a therapeutic immune response that clears the N. meningitidis in a mammalian subject including a human having a N. meningitidis infection as claimed.
MPEP § 2163.02 states: ‘[a]n 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’. In the instant application, the limitation ‘a N. meningitidis infection’ encompasses serious, life-threatening and fatal systemic infections including meningitis and meningococcemia, i.e., meningococcal blood infection, often resulting in severe neurologic sequelae. The limitation ‘a mammalian subject’ encompasses within its scope infants, children, adolescents, elderly, individuals with compromised immune systems etc. The individuals deficient in components of the alternate and terminal complement pathways are known to be highly predisposed to invasive, often recurrent meningococcal infections. The limitation ‘administering’ encompasses administration via all routes including oral, intraperitoneal, intrathecal, intradermal, topical, vaginal, sublingual, subcutaneous, intravenous, intramuscular, intranasal, mucosal, rectal etc. Accordingly, the claimed method is required to elicit “a therapeutic immune response” and induce “clearance of the N. meningitidis” in these subjects. However, while Applicants were in possession of a method of immunizing or inducing an immune response in a healthy mammalian subject against a homologous or heterologous N. meningitidis serogroup B strains comprising intramuscular injection of an effective amount of purified outer membrane microvesicles of PorA-ProB-RmpM- mutant of serogroup B Neisseria meningitidis along with an adjuvant, Applicants were not possession of the claimed method of inducing a therapeutic immune response in a mammalian subject including a human subject such as an infant, child, adolescent, or complement deficient individual already having a N. meningitidis infection such as meningococcemia or meningitis at the time of the invention. This is important because at the time of the invention there was no predictability that administration by any route of the recited outer membrane microvesicles would induce an immune response that is therapeutic and that clears homologous or heterologous N. meningitidis.
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.
Evidence required to demonstrate possession 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 courts have decided that the purpose of the ‘written description’ requirement is broader than to merely explain how to ‘make and use’; the 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 Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Federal Circuit, 1991). Applicants should note that written description provision of 35 U.S.C § 112(a) is severable from its enablement provision, and that 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. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (written description requirement is not satisfied by merely providing "a result that one might achieve if one made that invention"); In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming a rejection for lack of written description because the specification does "little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate"). A mere idea or unsubstantiated function in an unpredictable art and a mere proposal, a mere plan, and a wish with a hope of achieving the goal are insufficient for written description. The specific description or guidance, not general description or guidance is needed.
In sum, the disclosure and Examples in the instant application are not commensurate in scope with the claimed method inducing a therapeutic immune response that clears N. meningitidis in a mammalian subject already infected with N. meningitidis of any serogroup. Applicants’ specification does not contain a written description sufficient to show that they had possession of the full scope of the claimed invention at the time the application was filed. 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. Instant claims do not meet the written description provision of 35 U.S.C § 112(a) or (pre-AIA ), first paragraph.
Rejection(s) under 35 U.S.C § 112(b) or Pre-AIA , Second Paragraph
12) 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.
13) Claims 1-11 and 23-25 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 regards as the invention.
(a) Claim 1 is ambiguous and indefinite in the parenthetic limitation “(N.)” in line 1 within the phrase “Neisseria (N.) meningitidis”, because it is not clear whether or not the feature therein is optional. MPEP § 2173.05(d). For the purpose of distinctly claiming the subject matter, it is suggested that Applicants delete the limitation ‘(N.)’ as it is unnecessary given the correct and routinely used format “N. meningitidis” as recited in claim 3.
(b) The dependent claim 24 is indefinite for having insufficient antecedence in the limitations “isolated PorA-ProB-RmpM- serogroup B Neisseria meningitidis outer membrane microvesicles”. See line 2. For proper antecedence and for the purpose of distinctly claiming the subject matter, it is suggested that Applicants replace said limitations with the limitations --the isolated PorA-ProB-RmpM- serogroup B Neisseria meningitidis outer membrane microvesicles--.
(c) The dependent claim 25 is indefinite for lacking sufficient antecedence in the limitation ‘administration’. See line 1. For proper antecedence and for the purpose of distinctly claiming the subject matter, it is suggested that Applicants replace the above-identified limitation with the limitation --the administration--.
(d) The dependent claim 4 is indefinite for lacking sufficient antecedence in the limitation ‘a Neisseria meningitidis infection’. See line 1. For proper antecedence and for the purpose of distinctly claiming the subject matter, it is suggested that Applicants replace the above-identified limitation with the limitation --the Neisseria meningitidis infection--.
(e) New claim 25 is vague, ambiguous and indefinite in the limitation “a subsequent Neisseria meningitidis” because it is unclear what or which Neisseria meningitidis qualifies as a “subsequent” Neisseria meningitidis. Is this a Neisseria meningitidis of serogroup X? One of ordinary skill in the art cannot understand in an unambiguous way the metes and bounds of the claim.
(f) Claims 2-11 and 23-25, which depend directly or indirectly from claim 1, are also rejected as being indefinite due to the indefiniteness identified above in the base claim(s).
Rejection(s) under 35 U.S.C § 103
14) 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 of this title, 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 claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 148 USPQ 459, that are applied for establishing a background for determining obviousness under 35 U.S.C § 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or unobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were effectively filed absent any evidence to the contrary. Applicants are advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned at the time a later invention was effectively filed in order for the examiner to consider the applicability of 35 U.S.C § 102(b)(2)(C) for any potential 35 U.S.C § 102(a)(2) prior art against the later invention.
15) Claims 1, 2, 5, 7, 10, 11 and 23-24 are rejected under 35 U.S.C § 103 as being unpatentable over Marzoa et al. (Vaccine 30: 2387-2395, 2012) (Marzoa et al., 2012) as evidenced by Aase et al. (Vaccine 21: 2042-2051, 2003) in view of Matthias et al. (In: Abstracts of the 115th General Meeting of American Society for Microbiology, New Orleans, Louisiana, pages 1-2, May 30 - June 02, 2015 - Applicants’ IDS) (Matthias et al., 2015).
Marzoa et al. (2012) taught a method of immunizing mice comprising administering to said mice, i.e., healthy mammalian subjects, a composition comprising an adjuvant and effective amount of OMVs from a serogroup B meningococcal PorA- mutant lacking PorA, a serogroup B meningococcal PorB- mutant lacking PorA, or a serogroup B meningococcal RmpM- mutant lacking RmpM. The anti-OMV sera obtained from the mice immunized with the mutants in the prior art method showed opsonophagocytosis of a homologous wild-type strain and all heterologous meningococcal strains tested. The prior art method elicited anti-OMV bactericidal antibodies against the homologous meningococcal strains. See 3rd full sentence of ABSTRACT; 3rd full paragraph of page 2388, particularly the last three lines therein; Tables 2 and 1; sections 2.6, 2.2, 3.3, and 3.4.4; and Figure 3A. That the anti-OMV opsonophagocytic and/or bactericidal antibodies against meningococci in the prior art method are protective is inherent from the teachings of Marzoa et al. (2012) in light of what was well known in the art at the time of the invention. For instance, Aase et al. identified both serum bactericidal antibodies (SBA) and opsonophagocytic activity against meningococci as important effector functions regarding protection. See 1st sentence in the 1st full paragraph in right column of page 2043.
Marzoa et al. (2012) are silent on the administered OMVs being obtained from the serogroup B Neisseria meningitidis mutated to delete each of porA, porB and rmpM.
However, the outer membrane vesicles (OMVs) prepared from a strain of serogroup B Neisseria meningitidis that was mutated to delete all of porA, porB and rmpM, i.e., the ΔporAΔporBΔrmpM triple mutant was known in the art at the time of the invention. For instance, Matthias et al. (2015) disclosed outer membrane vesicles (OMVs) prepared from a strain of serogroup B Neisseria meningitidis that was mutated to delete all of porA, porB and rmpM, i.e., the MC58 ΔporAΔporBΔrmpM triple mutant, a.k.a. delta-ABR Neisseria meningitidis. See Abstract, particularly 7th and 8th sentences. These prior art OMVs (i.e., outer membrane microvesicles) are the same as the instantly recited outer membrane microvesicles and therefore, all the characteristics and the functional properties of the OMVs of this ΔporAΔporBΔrmpM triple mutant serogroup B Neisseria meningitidis as claimed including the immunogenicity and the capacity to induce a protective immune response to homologous or heterologous Neisseria meningitidis strains are the intrinsic properties and characteristics inseparable therefrom since two identical products cannot have mutually exclusive properties.
Given the teachings of Marzoa et al. (2012) of eliciting bactericidal and/or opsonophagocytic anti-OMV antibodies against N. meningitidis via administration to a mammalian subject of a composition comprising OMVs (microvesicles) of N. meningitidis PorA negative mutant lacking PorA, N. meningitidis PorB negative mutant lacking PorAB, or N. meningitidis RmpM negative mutant lacking RmpM, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the art-known OMVs from the serogroup B Neisseria meningitidis strain mutated to delete each porA, porB and rmpM, i.e., the ΔporAΔporBΔrmpM triple mutant, a.k.a. delta-ABR Neisseria meningitidis of Matthias et al. (2015) to produce the instant invention. One of ordinary skill in the art would have been motivated to produce the instant invention for the expected benefit of economically using one single immunogenic composition comprising a serogroup B meningococcal OMVs lacking all of porA, porB and rmpM as opposed to three separate OMV compositions each lacking porA, porB or rmpM, One of ordinary skill in the art would have been motivated to produce the instant invention because the resultant method of immunization would be expected to advantageously accomplish elicitation of anti-meningococcal bactericidal and/or opsonophagocytic protective antibodies in mammalian subjects by administration of a single economical OMV composition.
Claims 1, 2, 5, 7, 10, 11 and 23-24 are prima facie obvious over the prior art of record.
Double Patenting Rejection(s)
16) The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/patent/patents-forms/. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
17) Claims 1, 2, 5-7, 10, 11, 23 and 24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9, 8, 7, 12, 11, 14, 26, 4, 6 and 1 of the co-pending 19497929 application.
Although the claims at issue are not identical, they are not patentably distinct from each other. The claims of the co-pending ‘929 application, drawn to a method of inducing an immune response including a protective and a heterologous anti-meningococcal immune response for an N. meningitidis infection comprising administering to a mammalian subject such as a healthy human an immunogenic composition comprising an effective amount of outer membrane microvesicles isolated from a serogroup B N. meningitidis that comprises therein PorA- PorB-RmpM- mutations, read on and anticipate instant claims.
This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim(s) Objection - Suggestion
18) Claim 7 is objected to for the following reason:
Claim 7 is objected to for the non-italicized limitation “meningitidis” within the limitation “N. meningitidis”. To be consistent with the practice in the art of scientific nomenclature of bacteria and to be consistent with the correct format used, for example, in line 3 of claim 8, it is suggested Applicants delete the above-identified non-italicized limitation via strikethrough, i.e., meningitidis-- with underlining, i.e., meningitidis.
Conclusion
19) No claims are allowed.
Correspondence
20) 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, Supervisory Patent Examiner 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.
21) 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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