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 with traverse of Group I, corresponding to claims 1-15, in the reply filed on 03/24/2026 is acknowledged. The traversal is on the ground(s) that no additional search or examination burden exists. This is not found persuasive for the reasons set forth in the Restriction Requirement mailed 01/26/2026.
The requirement is still deemed proper and is therefore made FINAL.
Claims 16-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 03/24/2026.
Claim Objections
Claim 1 is objected to because of the following informalities: the first recitation of MSC should be preceded by the full term, e.g., “mesenchymal stem cells (MSC).” Appropriate correction is required.
Claim Rejections - 35 USC §§ 102/103
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 1-11 are 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 Shi et al. (US 2015/0313946, hereinafter, “Shi”).
Regarding claim 1, Shi discloses a method of treating liver disease comprising administration of mesenchymal stem cells (MSCs) to a patient in need thereof (Abstract; ¶¶ 0041-0045; Example 12, ¶¶ 0168-0169).
Regarding claims 2-5, Shi discloses the MSCs were activated with IL-17, TNF-α, and IFNγ (¶¶ 0041-0045; Example 12, ¶¶ 0168-0169).
Regarding claims 6-7, Shi discloses that the patient is a mammal, e.g., a mouse, preferably a human (¶ 0044; Example 12, ¶¶ 0168-0169).
Regarding claim 8, Shi discloses administration via intravenous injection or intravenous infusion (¶ 0040, 0070; Example 12, ¶¶ 0168-0169).
Regarding claims 9-10, Shi discloses that the MSCs are autologous or allogenic (¶ 0067).
Regarding claim 11, Shi discloses a dose 5 x 105 cells (Example 12, ¶¶ 0168-0169).
In a specific embodiment, Shi discloses intravenous administration of a dose of 5 x 105 MSCs, activated with IFNγ, TNFα, and IL-17, to mice with concanavalin A (ConA) induced liver injury (a model of autoimmune or viral fulminant hepatitis) (¶ 0085; Example 12, ¶¶ 0168-0169).
As such, Shi teaches each and every element of the claimed method. In the alternative, all the claimed limitations are found in one reference and are taught to be optional variations to a ‘base’ method they exemplify. As such, the claimed method is within the scope of Shi, and thus Shi renders the claimed method prima facie obvious. The rationale to support this conclusion of obviousness is that Shi provides a teaching, suggestion, and motivation to substitute different variables disclosed within the reference. Furthermore, there is no evidence on the record that indicates that the claimed method exhibits any unexpected results compared to the prior art.
Accordingly, Shi anticipates the claimed method or, in the alternative, renders the claimed method prima facie obvious.
Claims 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Shi.
The rejection of claims 1-11 as anticipated by or, in alternative, rendered prima facie obvious over Shi is set forth above.
Regarding claims 12-15, Shi further teaches that “treatment can be composed of a single dose or a plurality of doses over a period of time,” which would reasonably encompass at least two, three, four or five doses (¶ 0070). At a minimum, it would have been a matter of routine experimentation using standard laboratory techniques available at the time of filing to determine the optimal number of the plurality of doses taught by Shi to maximize the therapeutic effect of the activated MSCs taught by Shi with a reasonable expectation of success.
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art at the time of filing especially in the absence of evidence to the contrary.
Conclusion
NO CLAIMS ARE ALLOWED
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Shi et al., Cell Death Diff., 21:1758-1768 (2014), IL-17 dramatically enhanced
the immunosuppressive effect of MSCs induced by IFNγ and TNFα, revealing a novel role of IL-17 in immunosuppression.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS J VISONE whose telephone number is (571)270-0684. The examiner can normally be reached Monday-Thursday, 8:30 AM to 6:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Patricia Mallari can be reached at 571-272-4729. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THOMAS J. VISONE/ Supervisory Patent Examiner, Art Unit 1672
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