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 .
Status of the claims
Claims 8, 11 and 12 are pending and are examined.
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 12 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.
The claim is drawn to a method of treating a viral infection associated with the bone marrow in a subject comprising contacting NK cells with one or more of PM21 particles and FC21 feeder cells and adoptively transferring the NK cells to the subject.
It is not clear how, in claim 12, the contact of the PM21 particles and/or FC21
feeder cells with the NK cells occurs following transfer of the NK cells to a patient. Are the NK cells transferred with PM21 particles and feeder cells?
As such, the metes and bounds of the claim could not be determined.
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 8 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Oyer et al. (In Vivo expansion of NK cells stimulated with PM21 particles under ultralow
IL-2. Biol Blood Marrow Transplant 21, p. 632-639, 2015- cited by Applicant).
The claim is drawn to a method of treating a viral infection associated with the bone marrow in a subject comprising contacting NK cells with one or more of PM21 particles and FC21 feeder cells and adoptively transferring the NK cells to the subject.
Oyer et al. disclose a particle-based method to specifically expand cytotoxic NK
cells from unselected PBMCs. The particle-based NK cell expansion technology uses plasma membrane particles (PM-particles) derived from K562-mbIL15-41BBL FCs. These PM-particles induce selective expansion of NK cells from unsorted PBMCs, with NK cells increasing 250-fold typically after 17 days. The rate and efficiency of NK cell expansions with PM-particles and live FCs are comparable and far better than stimulation with soluble 41BBL, IL-15, and IL-2. Furthermore, NK cells expand
selectively with PM-particles to 86% of total cells after 14 days. The extent of NK cell expansion and cell content was PM-particle concentration dependent; these NK cells were highly cytotoxic (abstract).
NK cells were disclosed by the reference as being cytotoxic against cells infected by viruses (fact already known in the art : see for instance:
Scheper et al. (Hunting for clinical translation with innate-like immune cells and their receptors. Leukemia 28, 1181–1190, 2014-abstract).
Law et al. (U.S. Pub No. 20150225697).
Hariri et al. (U.S. Pat. No. 8,926, 964).
Bendelac et al. (WO 2006029010).)
It would have been obvious for a person of ordinary skill in the art at the time that the invention was filed to have used the highly cytotoxic activated NK cells of Oyer et al and treat viral infections with a reasonable expectation of success. This is because Oyer et al. obtained a superior product that is expected, as per the knowledge in the art, to function in treating viral infections.
Conclusion
No claims are allowed.
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ELLY-GERALD STOICA
Primary Examiner
Art Unit 1647
/Elly-Gerald Stoica/ Primary Examiner, Art Unit 1647