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 of group I and species in the reply filed on November 6, 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 42-54 are pending. Claims 1-41 are canceled. Claims 43-44, 48-54 are withdrawn. Claims 42, 45-47 are examined.
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.
Claim(s) 42, 45-47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhu et al., (US 2020/0031920) in view of Petkov et al., (US 2020/0113921).
Claims are broadly drawn to administering an “agent” capable of inhibiting IL-11-mediated signaling to a subject that has a smooth muscle cell (SMC) disorder. Claims also encompass administering agent where the agent is anti-IL11 antibody.
Zhu et al. teach methods of treating a smooth muscle cell-mediated disease wherein the disease is a “bladder disease” [bladder cancer, 0124] comprising administering an agent capable of binding to and inhibiting IL-11 [0133] wherein the agent can be an anti-IL11 monoclonal antibody or an oligonucleotide [0163] or an anti-IL11R (receptor) monoclonal antibody [0019]. Absent evidence to the contrary, and due to the systemic delivery of the agent(s) for treatment purposes [0149], the agents would inherently inhibit the activity of smooth muscle cells including those that are secretory or vascular. Zhu et al. does not teach the other SMC-mediated disease in the Markush listing.
Petkov et al. teach (page 19) several agents (formulas I, II, III, or IV) that suppress or inhibit the expression of several cytokines including IL-11 (page 23, 2nd column, Claim 15 and 18, [0142-0143]) for the treatment of an inflammatory disease including such SMC-disorders as irritable bowel syndrome, ulcerative colitis, inflammatory bowel disease and aortic valve stenosis [0133-0134].
It would have been obvious to one of ordinary skill in the art at the time of the filing to treat the other IL-11 related disease of Petkov using the method of Zhu treatment of administering monoclonal antibody to IL-11 to inhibit IL-11 for the smooth muscle related disease. One of ordinary skill in the art would be motivated to combine the treat additional disease because the diseases of Zhu and Petkov are treated successfully by inhibition of IL-11. Absent evidence to the contrary, and due to the systemic delivery of the agent(s) for treatment purposes [0125], the agents would inherently inhibit the activity of smooth muscle cells including those that are secretory or vascular.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL D PAK whose telephone number is (571)272-0879. The examiner can normally be reached on flexible.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford can be reached on 571-272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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.
/MICHAEL D PAK/Primary Examiner, Art Unit 1674