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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 25 April 2026 has been entered.
Response to Amendment
The Applicants’ arguments filed 25 April 2026 are acknowledged. For clarity, in this action, said arguments will be referred to as “Remarks”.
The declaration under 37 CFR 1.130(b) filed 24 April 2026 is acknowledged and disqualifies Kumaresan et al. (2021, Front. Immunol.) as prior art under 35 U.S.C. 102(b)(1)(A). Kumaresan et al. was cited as prior art not relied upon for any rejections in the Final Office Action mailed 29 October 2025; thus, no rejection(s) are withdrawn as a result of this declaration.
Objection(s) and Rejection(s) Withdrawn
The objection to claim 3 is withdrawn in view of the amendments to the claim.
The rejection of claims 3 and 5-6 under 35 U.S.C. 112(a) is withdrawn in view of the amendments to claim 3.
New Rejection(s)
Claim Rejections - 35 USC § 103
Claims 3 and 5-6 are newly rejected under 35 U.S.C. 103 as being unpatentable over Williams et al. (1986, J. Clin. Microbiol.; herein “Williams”) in view of Yamaguchi et al. (AU 2005253864 B2; herein “Yamaguchi”).
Regarding claim 3, Williams teaches a method comprising administering live Nine Mile phase II C. burnetii cells and a pharmaceutical carrier (implied by obtaining viable microorganisms “purified from infected yolk sacs of embryonated chicken eggs”) to guinea pigs (i.e., a mammal) intraperitoneally (pg. 936, left col.). After homologous challenge with live Nine Mile phase II C. burnetii (CB9MIIC4), guinea pigs immunized and challenged with CB9MIIC4 produced antibody responses to phase I and phase II C. burnetii, i.e., an immunoprotective response to a phase I form of virulent C. burnetii (Abstract, pg. 937, left col., para. 5, and pg. 938, left col., para. 3).
However, Williams does not teach a method of immunizing a mammal against Q fever wherein the live phase II C. burnetii and pharmaceutical carrier is administered intranasally, as in claim 3, or wherein the live phase II C. burnetii and pharmaceutical carrier further comprises an adjuvant, as in claim 5, including an aluminum adjuvant, Freund’s adjuvant, or N-acetylmuramyl-L-alanyl-D-glutamine adjuvant, as in claim 6.
Regarding claim 3, Yamaguchi teaches a Q fever vaccine comprising inactivated Nine Mile C. burnetii having a phase II phenotype (pg. 6, lines 30-36). Yamaguchi also teaches that the vaccine may be administered by intranasal administration and that “intranasal inoculation [is] more preferable, because the respiratory tract and digestive tract mucous membranes are important sites at early stages of infection.” (pg. 12, lines 25-27)
Regarding claims 5-6, Yamaguchi teaches that the vaccine may contain adjuvants, including aluminum adjuvants (pg. 12, lines 7-10).
Therefore, it would have been prima facie obvious, before the effective filing date of the claimed invention, to a person of ordinary skill in the art, to modify the method of administering live phase II C. burnetii taught by Williams by administering the phase II C. burnetii intranasally and combining the composition with the adjuvants taught by Yamaguchi, thereby arriving at the claimed invention. The person of ordinary skill in the art would have been motivated to make the modification because intranasal administration involves the mucous membranes of the respiratory and digestive tracts, which are important sites in the early stages of Q fever infection, as taught by Yamaguchi. Additionally, one would be motivated to use an adjuvant, such as an aluminum adjuvant, because it is known in the art that adjuvants boost the immune response. Therefore, the combination is also desirable (see MPEP 2144(II)). The person of ordinary skill in the art would have had a reasonable expectation of successfully immunizing a mammal against Q fever because Yamaguchi teaches that Nine Mile phase II C. burnetii (i.e., the same strain used by Williams) can be used as a Q fever vaccine, and formulating a composition for and performing intranasal and adding adjuvants to a composition are known in the art. One of ordinary skill in the art would have had a reasonable expectation of the intranasal administration of live phase II C. burnetii successfully inducing an immunoprotective response to a phase I form of virulent C. burnetii because the same composition induced an antibody response against phase I C. burnetii when administered intraperitoneally, and one would expect that administering intranasally alone or in combination with an adjuvant would produce an immune response at least as strong as that induced when the composition is administered intraperitoneally. Therefore, the combination leads to expected results because each element performs the same function as is does individually.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that combining prior art elements according to known methods to yield predictable results, 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 that the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results. In the instant case, all elements (i.e., administration of live phase II C. burnetii, intranasal administration, and adjuvants) were known in the art. In addition, combining these elements yields a method/composition wherein each element merely performs the same function as it does separately; thus, the results of the combination would be recognized as predictable to one of ordinary skill in the art. Therefore, 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 claim is allowed.
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
/SAMIRA J JEAN-LOUIS/Supervisory Patent Examiner, Art Unit 1642
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