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 .
Election/Restrictions
Applicant’s election without traverse of the following species: i) claim 2, ii) claim 10, and iii) SEQ ID NO: 48 of claim 13 in the reply filed on 7/29/2026 is acknowledged.
Status of the Claims
Claims 3 and 6-8 have been withdrawn as being directed to a non-elected species. Claims 1-2, 4-5, and 9-20 are under examination at this time.
Specification
The use of trademarks has been noted in this application. A trademark should be capitalized wherever it appears and be accompanied by the generic terminology.
Although the use of trademarks is permissible in patent applications, the proprietary 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.
Claim Objections
Claim 18 is objected to because of the following informalities: Claim 18 should recite “wherein the commensal microbe antigen and the HIV antigen enhance[[s]] an immune response”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1-2, 4-5, and 9-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method for enhancing an immune response against HIV Env by administering or priming with EF-Tu from Limosilactobacilius reuteri (L. reuteri) or Bacteroides thetaiotaomicron (B. thetaiotaomicron), does not reasonably provide enablement for a method for enhancing an immune response against an HIV antigen other than Env by administering or priming with a commensal microbe antigen other than EF-Tu from L. reuteri or B. thetaiotaomicron. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make/use the invention commensurate in scope with these claims.
The claims are directed to a method of preventing an infection from a human immunodeficiency virus (HIV), the method comprising administering to a subject an effective amount of a first composition comprising a commensal microbe antigen and an effective amount of a second composition comprising an HIV antigen.
There is one example demonstrating that animals primed with full length EF-Tu from L. reuteri or B. thetaiotaomicron elicited a greater/stronger antibody response to HIV-1 antigen RSC3, which mimics the CD4bs on the Env protein.
However, there is no evidence that antigens other than EF-Tu from L. reuteri or B. thetaiotaomicron or antigens from commensal microbes other than from L. reuteri or B. thetaiotaomicron are capable of enhancing the HIV Env immune response. Additionally, there is no evidence that EF-Tu from L. reuteri or B. thetaiotaomicron can enhance the immune response against HIV antigens other than HIV Env. Further, there is no evidence that fragments of EF-Tu from L. reuteri or B. thetaiotaomicron can enhance the immune response against HIV Env.
Given the breadth of the claims, the lack of guidance in the specification, and the lack of working examples demonstrating the prevention or inhibition of HIV infections, it would require undue experimentation for one skilled in the art to practice the claimed method.
Claims 1-2, 4-5, and 9-19 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The claims are directed to a method of preventing an infection from a human immunodeficiency virus (HIV), the method comprising administering to a subject an effective amount of a first composition comprising a commensal microbe antigen and an effective amount of a second composition comprising an HIV antigen.
There is one example demonstrating that animals primed with EF-Tu elicited a greater/stronger antibody response to HIV-1 antigen RSC3, which mimics the CD4bs on the Env protein. However, there is no evidence that the greater/stronger antibody response can prevent or inhibit an HIV infection or even treat HIV.
Given the breadth of the claims, the lack of guidance in the specification, and the lack of working examples demonstrating the prevention or inhibition of HIV infections, it would require undue experimentation for one skilled in the art to practice the claimed method.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nicole Kinsey White whose telephone number is (571)272-9943. The examiner can normally be reached M to Th 6:30 am to 6:00 pm.
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/NICOLE KINSEY WHITE/Primary Examiner, Art Unit 1672
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