DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 11, 2025 has been entered.
Claim 1 has been amended. Claims 4, 5, 9, 11-15, 24, and 50 remain withdrawn. Claims 1, 3, 6-8, 10, 16-23, and 49 are currently pending and under examination.
This application claims benefit priority of priority to U.S. Provisional Application No. 62/798629, filed January 23, 2019, U.S. Provisional Application No. 62/837765, filed April 24, 2019, and U.S. Provisional Application No. 62/965032, filed January 23, 2020.
Withdrawal of Rejections:
The rejection of claims 1, 3, 6-8, 10, 16-23, and 49 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite, is withdrawn.
The rejection of claims 1, 3, 6, 8, 10, 16-23, and 49 under 35 U.S.C. 103 as being unpatentable over Tedder et al., as evidenced by Sandi et al, and further in view of Chavez et al., is withdrawn.
The rejection of claims 1, 6, and 7 under 35 U.S.C. 103 as being unpatentable over Tedder et al. in view of Chavez et al., and further in view of Fang et al., is withdrawn.
New Rejections:
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 3, 6, 10, 16-23, and 49 are rejected under 35 U.S.C. 103 as being unpatentable over Fillatreau et al. (WO 2011/147622; Published 2011).
With regard to claim 1, Fillatreau et al. teach the treatment of an autoimmune disease or disorder in a subject by administering isolated modified B cells to the subject in an amount including about 1,000 to about 1x109 B cells (p. 1, para. 1; p. 9, para. 2; p. 15, last para. to p. 16, para. 1), which is a therapeutically effective amount. The autoimmune disease to be treated includes amyotrophic lateral sclerosis (ALS) (p. 12, last para.; p. 14, line 8). As Fillatreau et al. expressly teach that ALS is an autoimmune disease treatable by the administration of the B cells of the invention, it would have been obvious to one of ordinary skill in the art to administer the B cells to treat a subject having ALS.
With regard to claim 3, Fillatreau et al. teach that the B cells are human B cells and are administered to humans (p. 11, para. 4-5). As such the B cells are allogeneic B cells.
With regard to claim 6, Fillatreau et al. teach that the B cells are administered with additional components including antimicrobials (p. 16, para. 2), which is a second therapeutic composition.
With regard to claim 10, Fillatreau et al. teach that the isolated B cells are re-programmed (p. 2, last para.), which is stimulating B cells ex vivo.
With regard to claims 16-18, Fillatreau et al. teach that the B cells can be administered intravenously, subcutaneously, or intramuscularly, which is systemic administration, or administered directly into or onto the affected individual, which is local administration (p. 16, para. 1).
With regard to claim 19, Fillatreau et al. teach that the B cells are administered for a range of times, including once daily, or in doses over multiple days (p. 16, para. 2).
With regard to claims 20-23, Fillatreau et al. teach administering about 1,000 to about 1x109 B cells (p. 15, last para. to p. 16, para. 1), wherein about 1,000 to about 1x109 B cells encompasses at least 0.5x107, 1x108, 2x108, and 1x109 B cells, and wherein it would have been obvious to an ordinary artisan to administer an amount of B cells within the expressly taught range.
With regard to claim 49, Fillatreau et al. teach the subject is a human patient (p. 11, para. 4).
Claims 1 and 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Fillatreau et al., as applied to claims 1 and 6 above, and further in view of Fang et al. (Stage at which riluzole treatment prolongs survival in patients with amyotrophic lateral sclerosis: a retrospective analysis of data from a dose-ranging study, The Lancet, Vol. 17, (2018), pp. 416-422 – Previously Presented).
The teachings of Fillatreau et al. as applied to claims 1 and 6 have been set forth above.
With regard to claims 7 and 8, while Fillatreau et al. teach that the administered B cells themselves can be engineered to express immunomodulatory molecules (p. 1, para. 2), it is not specifically taught that a second immunomodulatory composition, or Edaravone or Riluzole, is administered as a secondary therapy.
Fang et al. teach that administration of the drug riluzole prolongs survival for subjects with ALS (Abs.).
It would have been obvious to one of ordinary skill in the art to combine the teachings of Fillatreau et al. with Fang et al., because both teach the treatment of the neurodegenerative disease ALS. The treatment of ALS by administering riluzole is known in the art as taught by Fang et al. The addition of riluzole as taught by Fang et al. as a second therapeutic/ immunomodulatory treatment for ALS would have been expected to predictably and successfully improve the method of Fillatreau et al., by providing an additional agent known to prolong survival of subjects having ALS.
Response to Arguments
In view of Applicant’s amendments, all previous rejections have been withdrawn. Therefore, Applicant’s arguments are moot. However, new rejections have been set forth above.
Conclusion
No claims are allowable.
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/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653