DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claims 1-55 have been cancelled. Claims 56-59 have been newly introduced.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 56-59 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 56-59 are not original claims. They were added by amendment on 8/16/2024. Basis was stated to be in paragraphs [0024, 088, 0107, and 0135]; however, this is not understood as the specification filed 5/1/2024 had no paragraph numbers. These paragraph numbers do not appear to be referencing PGPUB 2021/0400667.
Claim 56 is directed to a method of treating non-small cell lung cancer (NSCLC) in a subject in need thereof, comprising administering a therapeutically effective amount of a neutralizing antibody that specifically binds leukemia inhibitory factor (LIF), wherein the antibody inhibits proliferation of tumor stem cells.
Claim 57 is directed to a method of treating a pancreatic cancer in a subject in need thereof, comprising administering a therapeutically effective amount of a neutralizing antibody that specifically binds leukemia inhibitory factor (LIF), wherein the antibody inhibits proliferation of tumor stem cells.
Claims 58-59 specify that the antibody is a monoclonal antibody for claims 56-57.
At least for example, neutralizing antibodies against LIF are only disclosed in the context of glioblastoma multiforme (GBM) neurospheres and glioma initiating cells (GICs) in Examples 4-5 and Figures 5-6. Neutralizing antibodies are not disclosed in the context of claims 56-59 for treating non-small cell lung cancer (NSCLC) or pancreatic cancer. No basis is seen for these claims.
The claims constitute new matter.
Claims 56-59 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The instant specification discloses non-small cell lung cancer only once on page 36, lines 7-8, in a paragraph defining cancers and tumors.
The instant specification discloses pancreatic cancer on page 34, line 34, in a paragraph defining cancers and tumors. Figure 12 discloses LIF mRNA levels in pancreatic cancer cells (#39). Note that there are no circles for this example which are disclosed as reflecting aberrantly high levels of LIF. See page 8, lines 22-25. Use of pancreatic cancer cells is disclosed on page 44, lines 19.
That is, the specification does not disclose a relationship between LIF levels and administering neutralizing anti-LIF antibody inhibiting the proliferation of tumor stem cells for non-small cell lung cancer or pancreatic cancer. All of the examples concern glioblastoma cells. There is no experimental information with respect to non-small cell lung cancer or pancreatic cancer. These results cannot be extrapolated to predict results for the current methods of treatment. The neurospheres of the examples are not disclosed as being an art accepted model for non-small cell lung cancer or pancreatic cancer.
It is noted that Vescovi et al. (U.S. Patent Application Publication 2010/0167999, filed 19 July 2006) teaches away from the claimed methods. Claim 26 discloses administering LIF itself (not a neutralizing antibody against LIF) to decrease the number of tumor stem cells and/or tumor progenitor cells in a tumor. Paragraph [0098] discloses that the tumor can be pancreatic cancer or non-small cell lung cancer.
There is no evidence of record demonstrating that the claimed methods would have been operable at the time of the invention.
The claimed methods are not enabled.
The prior art of record does not disclose treating non-small cell lung cancer or pancreatic cancer by administering a therapeutically effective amount of a neutralizing antibody that specifically binds leukemia inhibitory factor (LIF) to a subject in need thereof, wherein the antibody inhibits proliferation of tumor stem cells.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIANNE P ALLEN whose telephone number is (571)272-0712. The examiner can normally be reached 7:00-3:30 EST Monday-Friday.
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/Marianne P Allen/Primary Examiner, Art Unit 1647
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