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 .
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 4, 5 and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jacki Kornbluth (US20200163993A1).
Regarding claim 1, Kornbluth describes a method of treating a subject with cancer comprising administering to said subject an NK cell exosome preparationt (see claim 11) and describes the cancer as leukemia (see claim 14).
Regarding claim 4, Kornbluth describes using allogeneic cells from peripheral blood (see 0050).
Regarding claim 5, Kornbluth describes using NK cell exosomes from a healthy donor (see claim 20).
Regarding claim 6, Kornbluth describes using fresh or frozen (preserved) NK-derived exosomes (see 0014 and Fig. 4).
Claims 1, 3, 5, 7-8, 10-11, 13-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Robert Seeger et. al. (JP2016535009A).
Regarding claims 1, Seeger teaches methods of treating cancer patients by administering an effective amount of a composition comprising exosomes comprising Fc receptors (see abstract) and teaches the exosomes to be from NK cells (see page 5, para. 5) and the cancer to be leukemia (see page 5, para. 7).
Regarding claims 3, 5 and 10, Seeger teaches “in one aspect, the composition further comprises an effective amount of autologous NK cells grown in vitro” (see page 6, para. 4) and teaches the cell to be from a healthy donor (see page 7, 1st para.).
Regarding claims 7-8, Seeger teaches wherein the leukemia can be ALL, AML, CLL, or CML (see page 6, last para.) and teaches the therapy is meant to induce remission specifically for leukemia remission (see page 6, para. 3 and 5).
Regarding claim 11, Seeger teaches “the inventors have found that highly cytotoxic NK cells derived from patients can be expanded in vitro, and that aNK cells release large amounts of exosomes when grown in vitro” and with the broadest reasonable interpretation this cell line that is expanded in vivo would be an NK-cell line when so broadly claimed.
Regarding claim 13-14, Seeger teaches “in some embodiments, the composition further comprises a therapeutic agent, including but not limited to chemotherapeutic agents, immunomodulators, or combinations thereof” (see page 5, last two para.).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 5, 7-14 are rejected under 35 U.S.C. 103 as being unpatentable over Robert Seeger et. al. (JP2016535009A).
Regarding claims 1, Seeger teaches methods of treating cancer patients by administering an effective amount of a composition comprising exosomes comprising Fc receptors (see abstract) and teaches the exosomes to be from NK cells (see page 5, para. 5) and the cancer to be leukemia (see page 5, para. 7).
Regarding claim 2, Seeger teaches that exosomes derived from activated NK cells express CD64 according to various aspects of the invention. Western blot analysis: (1) isolated exosomes, or (2) 10 μg protein from NK cell lysate” (see page 10, 3rd para.).
Regarding claims 3, 5 and 10, Seeger teaches “in one aspect, the composition further comprises an effective amount of autologous NK cells grown in vitro” (see page 6, para. 4) and teaches the cell to be from a healthy donor (see page 7, 1st para.).
Regarding claims 7-8, Seeger teaches wherein the leukemia can be ALL, AML, CLL, or CML (see page 6, last para.) and teaches the therapy is meant to induce remission specifically for leukemia remission (see page 6, para. 3 and 5).
Regarding claim 11, Seeger teaches “the inventors have found that highly cytotoxic NK cells derived from patients can be expanded in vitro, and that aNK cells release large amounts of exosomes when grown in vitro” and with the broadest reasonable interpretation this cell line that is expanded in vivo would be an NK-cell line when so broadly claimed.
Regarding claim 13-14, Seeger teaches “in some embodiments, the composition further comprises a therapeutic agent, including but not limited to chemotherapeutic agents, immunomodulators, or combinations thereof” (see page 5, last two para.).
Seeger does not specifically teach the amount of exosome derived protein as being from 1 to 3 or 1 to 4 ug per treatment course however given the prior art this optimization is well within the purview of any skilled artisan.
Therefore it would have been obvious to persons having ordinary skill in the art to optimize the effective amount of NK-derived exosomal protein at 1 to 3 or 1 to 4 ug per treatment as claimed. The NK-derived exosomes are the active components for treating leukemia and Seeger tests those components and determines at least 10 ug of protein to be within those components. Optimizing the amount would have been something that could have been done without any undue experimentation, especially as those are known as the effective variables which can alter whether the treatment is effective or not.
Conclusion
Currently no claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACOB ANDREW BOECKELMAN whose telephone number is (571)272-0043. The examiner can normally be reached Monday-Friday 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached at 571-272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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JACOB A BOECKELMANExaminer, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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