DETAILED ACTION
Claims 26-28 and 30 are pending.
Claim Rejections - 35 USC § 112
Claim 30 is 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 a subject suffering from cancer, does not reasonably provide enablement for all diseases. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Factors to be considered in determining whether a disclosure enables one skilled in the
art to make and use the claimed invention in its full scope without resorting to undue
experimentation include: (1) the quantity of experimentation necessary; (2) the amount of
direction or guidance presented; (3) the presence or absence of working examples; (4) the
nature or complexity of the invention; (5) the state of the prior art; (6) the relative skill of those in
the art; (7) the predictability or unpredictability of the art; and (8) the breadth of the claims. See
In re Wands, 8 USPQ2d. 1400 (Fed. Cir. 1988).
Breadth of the claims
Regarding claim 30, the claim recites a method of treating a subject suffering from a disease, the method comprising administering to said subject a pharmaceutical composition of claim 26 and immunotherapy, thereby treating said subject. The breadth of the claims is drawn to a method of treating a subject suffering from any disease.
Nature or complexity of invention and the level of ordinary skill
The nature of this invention is complex and unpredictable, involving the effects of a pharmaceutical agent and an immunotherapy treating a subject of a disease, and it would require undue experimentation for the full scope of the invention. Based on the complexity and unpredictability with disease treatments, the level of a person having ordinary skill in the art is not high enough to determine which diseases the pharmaceutical composition works with and which diseases it does not work with. One of ordinary skill in the art would require undue experimentation in order to determine which diseases can be treated with the pharmaceutical agent and immunotherapy. In order to practice the full scope of the invention claimed, undue experimentation would be required to determine which diseases can be treated with the pharmaceutical agent and immunotherapy.
Presence or absence of working examples
The specification teaches that the pharmaceutical agent and immunotherapy can be used to treat cancers (see [003], see [056], see [0146] - [0147], see [0150]). While the specification contains a laundry list of cancers (see [056]), the specification specifically points out treating lung cancer, breast cancer, colon cancer, renal cancer, and melanoma (see [014], see figure 8, see [0144]). The specification teaches that neutrophils that highly express lymphocyte antigen 6E (Ly6E) in subjects suggesting from cancer is predictive of the subject being a responder to immunotherapy (see [053]), therefore the claims are not enabled for treating all diseases, only those who have cancer where the neutrophils highly express Ly6E.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most connected, to use the invention commensurate in scope with these claims. The specification offers insufficient guidance and does not appear to enable the treatment of all diseases.
Absent specific guidance, one skilled in the art before the effective filing date of the claimed invention would not know how to practice the claimed invention and would require undue experimentation to practice over the full scope of the invention claimed.
State of the Prior Art
The state of the prior art for treating a subject suffering from any disease by administering a pharmaceutical agent and an immunotherapy is low. The instant specification teaches that the disease is cancer (see [003]). The state of the prior art for treating a subject who has cancer by administering a pharmaceutical agent and an immunotherapy is complex and unpredictable.
Du et al., Cancer systems biology: embracing complexity to develop better anticancer therapeutic strategies. Oncogene. 2015 Jun;34(25):3215-25. doi: 10.1038/onc.2014.291. Epub 2014 Sep 15. PMID: 25220419 teaches that at a protein level, the frequent involvement of complex signaling networks makes it difficult to anticipate the influences of oncogenic perturbations to predict how to effectively reverse those influences with pharmacological agents see page 3215). Du teaches that cancer treatments are complex and unpredictable (see page 3215). Furthermore, in re Vaeck, 947 F.2d 488,495, 20 USPQ2d 1438, 1444 (Fed. Cir. 1991), the Court ruled that a rejection under 35 U.S.C. 112, first paragraph for lack of enablement was appropriate given the relatively incomplete understanding in the biotechnological field involved, and the lack of a reasonable correlation between the narrow disclosure in the specification and the broad scope of protection sought in the claims.
Due to the large quantity of experimentation necessary to determine which diseases can be treated with the pharmaceutical composition of claim 26 and immunotherapy, the lack of direction/guidance presented in the specification, the absence of working examples, the complex nature of the invention, and the breath of the claims, undue experimentation would be required of the skilled artisan to make and/or use the claimed invention in its full scope.
Allowable Subject Matter
Claims 26-28 are allowed.
Conclusion
Claims 26-28 are allowed. Claim 30 is not allowed.
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/MCKENZIE A DUNN/ Examiner, Art Unit 1678
/GREGORY S EMCH/ Supervisory Patent Examiner, Art Unit 1678
