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 .
The amendment filed 04/21/2026 has been entered. Claims 38 and 40-41 have been canceled. Claims 32, 37 and 39 have been amended.
The amendment to the specification is acknowledged.
Claim Rejection Withdrawn
The rejection of claims 38 and 40-41under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph is withdrawn in view of the amendment to the claims
Claim Rejection Maintained
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 37 and 39 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 treating Candida infection, the method comprising administering to the subject an antibody comprising the CDRS of 2B10C1, the CDRS of 1D4H5, the CDRS of 2D5F7, the CDRS of 10E7E2, the CDRS of 7C6E8-1, the CDRS of 7C6E8-2, the CDRS of 6H1G8 AND the CDRS of 7H6A2 as set forth in claim 23, does not reasonably provide enablement for a method for preventing Candida infection. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims
Applicant’s Response
Specifically, the Examiner alleges that the specification "does not reasonably provide enablement for a method for treating or preventing any other microbial infection including other fungal infections, bacterial infections, viral infections and protozoal infections." See, the Office Action at page 6. Applicant notes that the Examiner acknowledges that the specification is enabling for a method for treating Candida infection. Without conceding to the correctness of the Examiner's position, and solely in an effort to expedite prosecution, Applicant respectfully submits herewith amendments to the claims. Specifically, claim 37 has been amended to recite "a method of treating or preventing a Candida spp. infection, the method comprising administering to the subject the antibody or fragment according to claim 23."
Response to Applicant
Applicants response has been carefully considered but is not found persuasive. The rejection stated that the specification is enabling for a method for treating Candida infection. The most pertinent Wands factors were discussed in the rejection especially guidance in the specification and the existence of working examples. The specification discloses monoclonal antibodies raised against Candida antigen peptides. See paragraph 283 table 5. The protective effect of each monoclonal antibody (mAb) was examined by passive transfer experiments. Mice were administered the monoclonal antibody and then challenged with a lethal dose of Candida cells. See paragraph 284.
The specification teaches that mAbs 6H1G8 and 9F2G5 provided best protection, evidenced by highest survival and lowest fungal burdens in targeted organs. mAbs 10E7E2 and 3H7E3 also provided some protection with 25% survival, and lower fungal loads in targeted organs. 6HG8 and 9F2G5 were able to almost clear fungal burden and See paragraph 415 and figure 15. Figure 15 shows that none of the antibodies prevented infection but were able to reduce the burden of infection after challenge with Candida auris. After passively immunizing the mice, challenging the mice with C. auris means that the mice become infected with C. auris providing an opportunity for the antibodies to combat the infection. The antibodies did not prevent the challenge infection. Overtime (post challenge), the passive immunization was able to reduce fungal burden. See figure 15. Therefore, the specification is only enabling for treating a Candida spp infection but not preventing Candida spp infection.
New Claim Objection/Rejections
Claim 23 is objected to because of the following informalities:
Please insert the appropriate punctuation mark to separate the name of the antibody from the CDR sequences listed in claim 23 a-h. For instance claim 23 “2B10C1” should be separated from “a VH CDR1”. Appropriate correction is required.
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.
Claims 23-37 and 39 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 the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The terms “2B10C1”, “1D4H5”, “2D5F7”, “10E7E2”, “7C6E8”, “9F2G5”, “6HIG8”, or “7H6A2” in claim 23, 29 and 30 are laboratory designations that are not defined in the specification and represent positions on a microtiter plate. These terms do not imply the structure of the antibody. Therefore, the metes and bounds of these terms is vague and indefinite.
Status of Claims
Claims 23-37 and 39 are rejected are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLUWATOSIN A OGUNBIYI whose telephone number is (571)272-9939. The examiner can normally be reached IFP.
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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Allen can be reached at 5712703497. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/OLUWATOSIN A OGUNBIYI/ Primary Examiner, Art Unit 1645
Prosecution Insights