DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Please note that the Patent Examiner of your application has changed. All communications should be directed to Mary Lyons, Art Unit 1645, whose telephone number is (571)272-2966.
Information Disclosure Statement
3. The information disclosure statement (IDS) submitted on 11/25/25 was filed and entered. The submission is in compliance with the provisions of 37 CFR 1.97 and has been considered by the Examiner.
Claim Status
4. The amendment, filed 11/25/25, has been entered. Claims 34-35 and 295-303 are pending and under examination. Claims 1-33 and 36-294 are cancelled. Claims 297-303 are newly added. Claims 34 and 35 are amended.
Withdrawal of Objections/Rejections
5. The following are withdrawn from the Office Action, filed 06/23/25:
The rejection of claims 34-35 and 292-296 on the basis that they contain an improper Markush grouping of alternatives, found on page 2 at paragraph 1, is withdrawn in light of Applicant’s amendments thereto; specifically amending to the treatment of allergies.
The rejection of claims 34-35 and 292-296 under 35 U.S.C. 102(a)(1) as being anticipated by Tsai et al. 2004 (US 2004/0052808), found on page 4 at paragraph 2, is withdrawn in light of Applicant’s amendments thereto; specifically requiring intradermal administration.
The rejection of claims 34-35 and 292-296 under 35 U.S.C. 102(a)(1) as being anticipated by Koya (US 2008/0119440), found on page 5 at paragraph 3, is withdrawn in light of Applicant’s amendments thereto; specifically requiring treatment of allergies and/or intradermal administration.
All nonstatutory double patenting rejections found on pages 7-9 are withdrawn in light of Applicant’s amendments thereto; specifically requiring treatment of allergies and/or intradermal administration.
New Rejections Necessitated by Applicant’s Amendments
New Rejection: Claim Rejections - 35 USC § 102
6. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
7. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
8. Claims 34-35 and 295-301 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sun et al. 2006 (US 2006/0115494).
Sun teaches therapeutic treatment methods comprising intradermal administration of compositions comprising BCG to human patients (e.g. [0071, 0077]; meeting limitations found in instant claims 34, 295, and 296). Sun teaches compositions of BCG with a pharmaceutically acceptable carrier (i.e. sole therapeutic agent; e.g. [0092]; meeting limitations found in instant claim 297) at preferable doses of 105 to 109 organisms (e.g. [0091]; meeting limitations found in instant claims 298, 299, and 300 with sufficient specificity; see MPEP 2131.03). Sun teaches the use of priming and booster doses (e.g. [0090]; meeting limitations found in instant claim 301).
With regards to the preamble of “A method of treating an allergy in a subject in need thereof…” in claim 34 and the types of allergies in claim 35; it is noted that MPEP 2112.02 states when the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated; emphasis added; see In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978) (Claims 1 and 6, directed to a method of effecting nonaddictive analgesia (pain reduction) in animals, were found to be anticipated by the applied prior art which disclosed the same compounds for effecting analgesia but which was silent as to addiction. The court upheld the rejection and stated that the applicants had merely found a new property of the compound and such a discovery did not constitute a new use. See also In re Tomlinson, 363 F.2d 928, 150 USPQ 623 (CCPA 1966) "While the references do not show a specific recognition of that result, its discovery by appellants is tantamount only to finding a property in the old composition." 363 F.2d at 934, 150 USPQ at 628 (emphasis in original)).
Therefore, Sun anticipates the invention as claimed.
New Rejection: Claim Rejections - 35 USC § 102
9. Claims 34-35 and 295-303 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bottomly et al. 2000 (WO 2000/61157).
Bottomly teaches methods of treating allergies comprising intradermal administration of therapeutically effective amounts of compositions comprising BCG to human patients (e.g. see pages 6, 8, 12, and 31; and Bottomly claims 1, 2, 7, 66, 104; meeting limitations found in instant claims 34, 295, and 296). Bottomly teaches the allergies include those to pollen, food, and/or drugs (e.g. see page 12; meeting limitations found in instant claim 35). Bottomly teaches therapy takes several rounds of vaccination over 3 to 5 years or more and includes booster immunizations (e.g. see pages 12 and 26; meeting limitations found in instant claims 301, 302 and 303 with sufficient specificity). Bottomly teaches their compositions may be utilized alone or in combination and with typical doses of 1 x 106 cells per injection (e.g. see page 26; meeting limitations found in instant claims 297, 298, 299, and 300 with sufficient specificity; see MPEP 2131.03).
Therefore, Bottomly anticipates the invention as claimed.
Conclusion
10. No claims are allowed.
11. 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).
12. 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.
13. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARY MAILLE LYONS whose telephone number is (571)272-2966. The examiner can normally be reached on Monday-Friday 8 am to 5 pm EST. 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, Dan Kolker can be reached on (571)-272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
14. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARY MAILLE LYONS/Examiner, Art Unit 1645
March 9, 2026