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 .
Claims 1-9 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.
Claims 1-9 are 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.
Claims 1-9 are rejected because the metes-and-bounds of the claims are unclear due to it being unclear how, or if, text in parenthesis of claims 1 reciting “blood cancer” limits the claims.
Claim 6 recites “…bound to CD1d receptor on the surface.” There is insufficient antecedent basis for “the surface” in the claim.
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.
Claims 1-8 are rejected under 35 U.S.C. 103(a) as being unpatentable over Chen et al (Eur. J. Immunol., 2006, 36: 1598-1607) in view of Gehrmann et al (Cancer Research, 2013, 73(13): 3865-3876; 12/4/23 IDS).
Chen et al teaches a method of therapeutically treating B cell lymphoma (BCL) in subjects comprising administering exosomes obtained from BCL cells (derived from a patient suffering from BCL) to the subjects, wherein the administered cancer cell derived exosomes resulted in decreases in tumor volume and increases in survival as compared to corresponding controls (Figure 5A, in particular). Chen et al further teaches improved antitumor efficacy of tumor-derived exosomes may be due to HSP and tumor antigens transferred by exosomes (right column on page 1604, in particular).
Chen et al does not specifically teach the administered exosomes have an NK T cell ligand, such as alpha-galactosyl ceramide bound to the surface of the exosomes. However, these deficiencies are made up in the teachings of Gehrmann et al.
Gehrmann et al teaches exosomes loaded with a-galactosylceramide (aGC) activate invariant NKT (iNKT) immune cells in vitro and in vivo and exosomes loaded with aGC plus a tumor antigen induce potent NK and gd T-cell innate immune responses and synergistically amplify T- and B-cell responses that are tumor antigen-specific, resulting in longer cancer patient survival and decreased tumor volume (Figure 7, in particular). Gehrmann et al further teaches the exosomes are capable of carrying aGC on the surface of both CD1d-/- and CD1d+/+ exosomes, though a greater immune response was detected with the CD1d+/+ exosomes (paragraph spanning pages 3871-3872, in particular).
One of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to perform a combined method of treating a subject with B cell lymphoma (BCL) comprising performing the therapeutic method of Chen et al of administering exosomes derived from BCL cells to the subject, wherein the administered cancer cell derived exosomes are both loaded with aGC and comprise tumor antigens found on BCL cells of the subject because Gehrmann et al teaches exosomes loaded with aGC plus a tumor antigen induce potent NK and gd T-cell innate immune responses and synergistically amplify T- and B-cell responses that are tumor antigen-specific, resulting in longer cancer patient survival and decreased tumor volume (Figure 7, in particular).
Further, one of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to perform said combined method wherein the administered exosomes are exosomes obtained from BCL cells of a subject (autologous) prior to administering the exosomes in order to tailor antigen-targeting of the combined method to antigens specifically found on BCL cells of the specific subject because Chen et al teaches improved antitumor efficacy of tumor-derived exosomes may be due to HSP and tumor antigens transferred by exosomes (right column on page 1604, in particular) and exosomes of the BCL cells from an autologously-treated subject predictably has such tumor antigens that would specifically enable antigen-specific targeting of the subject’s tumors.
This is an example of both combining prior art elements according to known methods to yield predictable results and some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention. See MPEP 2143. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, absent unexpected results.
Claim Rejections - 35 USC § 103
Claim(s) 1-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al (Eur. J. Immunol., 2006, 36: 1598-1607) in view of Gehrmann et al (Cancer Research, 2013, 73(13): 3865-3876; 12/4/23 IDS) as applied to claims 1-8 above, and further in view of Xu-Monette et al (Blood, 2018, 131(1): 68-83).
Teachings of Chen et al and Gehrmann et al are discussed above.
Chen et al and Gehrmann et al do not specifically teach an immune checkpoint inhibitor in combination with the exosomes to the subject with BCL. However, these deficiencies are made up in the teachings of Xu-Monette et al.
Xu-Monette et al teaches subjects with BCL therapeutically benefit from being administered PD-1/PD-L1 checkpoint inhibitors (page 74, in particular). Xu-Monette et al further teaches anti-PD-1 checkpoint inhibitors therapeutically function by promoting T-cell function by preventing PD-L1/PD-L2 from interacting with PD-1 (Figure 3, in particular).
One of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to perform the combined method of Chen et al and Gehrmann et al of treating a subject with BCL comprising further administering the subject a checkpoint inhibitor, such as an anti-PD-1 checkpoint inhibitor of Xu-Monette et al because (i) the combined method of Chen et al and Gehrmann et al treats BCL by inducing potent NK and gd T-cell innate immune responses and synergistically amplifies T- and B-cell responses that are tumor antigen-specific and Xu-Monette et al teaches the anti-PD-1 checkpoint inhibitor function by promoting T-cell function by preventing PD-L1/PD-L2 from interacting with PD-1 (Figure 3, in particular) and (ii) both the administered reagent of the combined method and the method of Xu-Monette et al therapeutically treat subjects with BCL. This is an example of both combining prior art elements according to known methods to yield predictable results and some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention. See MPEP 2143. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, absent unexpected results.
Conclusion
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/SEAN E AEDER/Primary Examiner, Art Unit 1642
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