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/Restriction
The response filed on 6/30/26 to the restriction requirement of 4/30/26 has been received. Applicant has elected a polypeptide comprising the disclosed CDRs of the “Genovac2-C1” antibody (see Tables 7-8), namely: SEQ ID NOs: 223-225, 299, 300, and 160. Because Applicant did not distinctly and specifically point out any errors in the restriction requirement, the election has been treated as an election without traverse (MPEP 818.03(a)).
Claims 66, 68-77, 79-81, and 86-113 are pending and currently under consideration.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 80 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 80 recites “The method of treating or preventing a disease in a subject in need thereof, comprising administering to the subject the….” There is insufficient antecedent basis for “The method of treating or preventing a disease in a subject” in the claim.
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 79-81 and 92-113 are 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 methods of depleting CXCR6-positive leukocytes in a subject comprising administering to the subject a polypeptide that specifically binds CXCR6 wherein the polypeptide comprises CDRs comprising 223-225, 299, 300, and 160, does not reasonably provide enablement for methods of “treating” and/or “preventing” just any disease in a subject comprising administering a polypeptide that specifically binds CXCR6 wherein the polypeptide comprises CDRs comprising 223-225, 299, 300, and 160. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to perform the invention commensurate in scope with these claims.
Factors to be considered in determining whether undue experimentation is required are summarized in Ex parte Forman, 230 USPQ 546 (BPAI 1986). They include the nature of the invention, the state of the prior art, the relative skill of those in the art, the amount of direction or guidance disclosed in the specification, the presence or absence of working examples, the predictability or unpredictability of the art, the breadth of the claims, and the quantity of experimentation which would be required in order to practice the invention as claimed.
The instant claims are drawn to methods of “treating” and/or “preventing” just any disease in a subject comprising administering a polypeptide that specifically binds CXCR6 wherein the polypeptide comprises CDRs comprising 223-225, 299, 300, and 160. This instant specification discloses “treating” includes improving, ameliorating, stabilizing (i.e., not worsening), preventing, or curing a disease (see [0150] spanning pages 33-34, in particular). The instant specification demonstrates “Genovac2-C1” antibody, a CXCR6-binding antibody comprising CDRs comprising 223-225, 299, 300, and 160, kills CXCR6-positive leukocytes through ADCC (Figure 17, in particular). The specification does not demonstrate any polypeptide that specifically binds CXCR6 wherein the polypeptide comprises CDRs comprising 223-225, 299, 300, and 160 is capable of improving, ameliorating, stabilizing (i.e., not worsening), preventing, or curing any disease when administered to any subject. Further, undue experimentation would be required to determine whether polypeptides encompassed by the claims improve, ameliorate, stabilize, prevent, or cure each disease broadly encompassed by the claims in order to perform the claimed methods with any predictability of success.
This invention is in a class of invention which the CAFC has characterized as "the unpredictable arts such as chemistry and biology". Mycogen Plant Sci., Inc. v. Monsanto Co., 243 F.3d 1316, 1330 (Fed. Cir. 2001).
Reasonable guidance with respect to preventing disease, such as any cancer, relies on quantitative analysis from defined populations which have been successfully pre-screened and are predisposed to particular types of the disease. This type of data might be derived from widespread genetic analysis, disease/cancer clusters, or family histories. The essential element towards the validation of a preventive therapeutic is the ability to test the drug on subjects monitored in advance of clinical disease and link those results with subsequent histological confirmation of the presence or absence of disease. This irrefutable link between antecedent drug and subsequent knowledge of the prevention of the disease is the essence of a valid preventive agent.
One cannot extrapolate the teachings of the specification to the scope of the claims because the claims are broadly drawn to methods of “treating” and/or “preventing” just any disease in a subject comprising administering a polypeptide that specifically binds CXCR6 wherein the polypeptide comprises CDRs comprising 223-225, 299, 300, and 160, and Applicant has not enabled said method because it has not been shown that polypeptides that specifically bind CXCR6 and comprise CDRs comprising 223-225, 299, 300, and 160 treat and prevent just any disease. Further, undue experimentation would be required to determine whether polypeptides encompassed by the claims improve, ameliorate, stabilize, prevent, or cure each disease broadly encompassed by the claims in order to perform the claimed methods with any predictability of success.
In view of the teachings above and the lack of guidance, workable examples and or exemplification in the specification, it would require undue experimentation by one of skill in the art to determine with any predictability, that the method would function as claimed.
Allowable Subject Matter
Claims 66, 68-77, and 86-91 are allowed.
Conclusion
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/SEAN E AEDER/ Primary Examiner, Art Unit 1642
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