DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
The amended claim set filed on 31 July 2025 is acknowledged. Claims 3 and 5-6 are currently pending. Of those, claims 3 and 5 are amended. There are no new claims and no claims are withdrawn. Claims 1-2 and 4 are cancelled. Claims 3 and 5-6 will be examined on the merits herein.
Response to Amendment
The Applicants’ arguments filed 31 July 2025 are acknowledged. For clarity, in this action, said arguments will be referred to as “Remarks” and the Non-Final Office Action mailed 2 April 2025 will be referred to as “NFOA”.
Rejection(s) Withdrawn
The rejections of claim 4 under 35 U.S.C. 112(b) and 103 are moot because the claim has been cancelled.
The rejections of claims 3 and 5-6 under 35 U.S.C. 112(b) are withdrawn in view of the amendments to the claims.
The rejection of claim 3 under 35 U.S.C. 102(a)(1) is withdrawn in view of the amendments to the claim.
The rejection of claims 3 and 5-6 under 35 U.S.C. 103 is withdrawn in view of the amendments to the clams. Applicants arguments are not persuasive and contain several inaccuracies. At Remarks pg. 4, Applicant quotes from Williams Results para. 1, but this quote does not appear anywhere in the Williams reference. Remarks pg. 6 refers to Figure 6D in the instant specification and Remarks pg. 7 refers to Figure 10D, but these figures does not exist. Remarks pg. 7 states that “intranasal NMII immunization provides superior protection (Figure 5D, paragraph [0057]) and safety, with no nodule-like inflammation unlike PIV (paragraph [0039]),” but this is directly contradicted by the location cited to in the specification which states that “there was no significant difference in splenomegaly and bacterial burden in the spleens between viable NMII-immunized and PIV-immunized mice” [0057] (i.e. not superior protection). The remarks have not been completely checked to identify every possible inaccuracy.
New Objection(s) and Rejection(s)
Claim Objections
Claim 3 is newly objected to because of the following informalities: the claim was amended to recite more than one method step, but does not separate each step by line indentation, as set forth in para. 10 of the NFOA: “MPEP 608.01(m) states: Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation, 37 CFR 1.75(i)”. Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
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.
Claims 3 and 5-6 are newly 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
Claim 3 is drawn to a method of immunizing a mammal against Q fever comprising intranasally administering a live avirulent C. burnetii stain having a phase II LPS phenotype and a pharmaceutical carrier. The claim is amended to recite, “producing an active step of inducing an immunoprotective response to a phase I form of virulent C. burnetii.” However, there does not appear to be a written description of the claim limitation “producing an active step of inducing an immunoprotective response” in the application as filed, where the “active step” is a separate step performed by the user of the method other than the separately-claimed “intranasal administration” step.
Applicant has pointed to the claims as originally filed and paragraphs [0008] and [0036] of the specification (Remarks pg. 3) as support for the amendments to the claims. However, neither the claims as originally filed, nor para. [0008] of the specification teach inducing an immunoprotective response against a phase I C. burnetii. Para. [0036] of the specification teaches “mice immunized with viable NMII elicited significant protection against NMI infection” and “[v]iable NMII also induced significant protection against challenge with virulent Priscilla and Scurry strains”, but does not teach “an active step of inducing” said immune response. The examples taught in the instant specification teach methods comprising steps of intraperitoneally administering viable NMII bacteria to three groups of mice and challenging the mice with NMI bacteria 7, 14, or 28 days after immunization with NMII (para. 52). The example also teaches measuring splenomegaly and bacterial burden in the spleen 14 days after NMI challenge (para. 52). Other methods teach practicing the above steps with varying doses of NMII bacteria (para. 53) and further comprising collecting immune sera from the mice and measuring antibody titers by ELISA (para. 54), and practicing the above steps by administering the NMII bacteria via different administration routes (para. 55).
There is no teaching in the specification that “inducing an immunoprotective response” is a separate action performed by the person doing the other steps, as the phrase “an active step of inducing…” would suggest; the teachings of the specification indicate that the immunoprotective response against a phase I form of C. burnetii is the result of the step of administering the NMII bacteria to the mice. Additionally, one of ordinary skill in the art would not have identified a separate step of inducing an immunoprotective response by some means as described anywhere else in the specification as filed. Therefore, claims 3 and 5-6 are rejected because the specification fails to demonstrate possession of the claimed method.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kumaresan et al. (published 20 Oct. 2021, Front. Immunol.) teaches immunization of mice with viable NMII (i.e., a live avirulent C. burnetii strain) via intranasal route (pg. 3, left col., para. 5 and right col., para. 3), which results in protective immunity against challenge from NMI bacteria (pg. 6, right col.). Kumaresan does not teach an additional active step to induce an immunoprotective response.
Elliott et al. (2013, Infect. Immun.; cited in IDS) teaches intranasally administering NMII bacteria to BALB/c and SCID mice by aerosolizing the bacteria “ensur[ing] a uniform dose of bacteria to the lower airways through a nose-only aerosol exposure.” (pg. 4605, left col., “Animals” section and pg. 4606, left col., “Aerosol infection” section). Elliott does not teach an additional active step to induce an immunoprotective response.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 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 nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BAILEY M MORGAN whose telephone number is (703)756-5388. The examiner can normally be reached M-F 9-5 ET.
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/BAILEY M MORGAN/Examiner, Art Unit 1645
/GARY B NICKOL/Supervisory Patent Examiner, Art Unit 1645
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