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 .
DETAILED ACTION
1. Claims 1, 110, 111, 112, 113, 120, 123, 124, 126, 131, 135, 128 are amended. Claims 118-119, 140 are canceled. New claims 151, 152 are added. Claims 1, 101-117, 120-139, 141-152 are under consideration.
Information Disclosure Statement
2. The information disclosure statements (IDS) were submitted on 5/14/2026; 6/30/2026; 7/21/2026; 8/11/2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
3. (previous objection, withdrawn) Claims 124, 140 were objected to because of informalities.
Applicant contends: the claim has been canceled.
The objection is moot.
Claim Rejections - 35 USC § 112
4. (previous rejection, withdrawn) Claims 1, 101-109, 114-125, 131, 135 were rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to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.
Applicant contends: the claims have been amended.
In view of applicant’s amendments, the rejection is withdrawn.
5. (previous rejection, withdrawn) Claims 1, 101-117, 121-138, 148-150 were rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being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 treating multiple sclerosis and administering cladribine with vaccination for VZV, does not reasonably provide enablement for treating any autoimmune disease and administering cladribine with vaccination for any infection.
Applicant contends: the claims have been amended.
In view of applicant’s amendments, the rejection is withdrawn.
6 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.
6. (new, necessitated by amendment) Claim 151 is 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.
See claim 151 as submitted 630/2026.
As to claim 151, the claim recites “said first vaccination, said first dose and/or said first shot” and “said second vaccination, said second dose and/or said second shot”. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102/103
7. (previous rejection, withdrawn) Claims 1, 117-119 were rejected under 35 U.S.C. 102(a)(1)/(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Sotelo-Morales et al. (previously cited).
Applicant contends: claim 1 was amended.
In view of applicant’s amendments, the rejection is withdrawn.
Claim Rejections - 35 USC § 103
8. (previous rejection, withdrawn) Claim 109 was rejected under 35 U.S.C. 103 as being unpatentable over Sotelo-Morales et al. (US20060121052)(cited above) as applied to claims 1, 117-119 above.
In view of the withdrawal of the rejection over Sotelo-Morales et al. on which the instant rejection depends, the instant rejection is also withdrawn.
9. (previous rejection, withdrawn) Claim 120 was rejected under 35 U.S.C. 103 as being unpatentable over Sotelo-Morales et al. as applied to claims 1, 117-119 above and further in view of Steinman ("Immunology of relapse and remission in multiple sclerosis," Annu Rev Immunol, 32: 257-281 (2014); previously cited).
In view of the withdrawal of the rejection over Sotelo-Morales et al. on which the instant rejection depends, the instant rejection is also withdrawn.
10. (previous rejection, withdrawn) Claims 1, 101-103, 109, 115-126, 129, 130, 131, 135, 138 were rejected under 35 U.S.C. 103 as being unpatentable over Dangond et al. (WO-2019101960-A1)(cited in applicant's IDS submitted 3/8/2024) in view of Sotelo- Morales et al. (US20060121052)(cited in applicant's IDS submitted 3/8/2024).
Applicant contends: claim 1 was amended.
In view of applicant’s amendments, the rejection is withdrawn.
Double Patenting
11. (previous rejection, withdrawn) Claims 1, 101-106, 109-121, 126-142, 144-150 were rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 12533408.
Applicant contends: a terminal disclaimer has been submitted.
In view of the submission of the terminal disclaimer indicated to be accepted, the rejection is withdrawn.
12. (previous rejection, withdrawn) Claims 1, 101-106, 109-122, 126-150 were rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 12539329.
Applicant contends: a terminal disclaimer has been submitted.
In view of the submission of the terminal disclaimer indicated to be accepted, the rejection is withdrawn.
13. (previous rejection, withdrawn) Claims 1, 101-106, 108-121, 125-150 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of copending Application No. 19/384362.
Applicant contends: a terminal disclaimer has been submitted.
In view of the submission of the terminal disclaimer indicated to be accepted, the rejection is withdrawn.
14. (previous rejection, withdrawn) Claims 1, 101-106, 108-122, 124-150 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of copending Application No. 19/430755.
Applicant contends: a terminal disclaimer has been submitted.
In view of the submission of the terminal disclaimer indicated to be accepted, the rejection is withdrawn.
Conclusion
15. Claims 1, 101-117, 120-139, 141-150, 152 are allowed.
16. 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 M FRANCO G SALVOZA whose telephone number is (571)272-4468. The examiner can normally be reached M-F 8:00 to 5:00.
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, Thomas Visone can be reached at 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672
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