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 .
This action is responsive to papers filed 03/17/2026.
Claims 55, 57, 61, and 53 have been amended. Claims 1, 3, 5-8, 50-54 have been newly canceled and no claims have been newly added.
Claims 55, 57-63 are currently pending and have been examined on their merits.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn due to amendment. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) and 35 U.S.C. 365(c), is acknowledged.
The claims have been examined with the effective filing date of the provisional 62/694849 which is 07/06/2018.
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.
Claim(s) 55, 57, 61 and 62 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Airau et al (HemaSphere, published June 5, 2018).
Regarding claims 55, 61, and 62, Airau disclose a method for providing a human patient (human recipient) with an erythrocyte cell population (a graft made up of blood cells) that has been loaded in vitro with dasatinib (contacting the cell graft with a composition comprising dasatinib and then providing to a human recipient) (abstract, pages 2-3, page 9).
Regarding claim 57, Airau disclose wherein the donor cells are from informed healthy donors (only human donors are informed) (page 9 column 2).
Therefore, the teaching of Airau et al anticipates Applicant’s invention.
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.
Claim(s) 55, 57, 61-62 are rejected under 35 U.S.C. 103 as being unpatentable over Airau et al (HemaSphere, published June 5, 2018).
Regarding claims 55, 57, 61-62, Airau disclose a method for providing a human patient (human recipient) with an erythrocyte cell population (a graft made up of blood cells) that has been loaded in vitro with dasatinib (contacting the cell graft with a composition comprising dasatinib and then providing to a human recipient) (abstract, pages 2-3, page 9). Airau disclose wherein the donor cells are from informed healthy donors (only human donors are informed) (page 9 column 2).
While it appears that Airau anticipates the claimed method as described above, even if this were not the case and anticipation is not present, the fact that Airau discloses all the steps and elements of the claimed method as desirable for providing a red blood cell graft that has been contacted with dasatinib and then provided to a recipient renders the claimed method obvious with a reasonable expectation of success due to the extensive testing performed by Airau (Figures 1-7).
Therefore, the teaching of Airau et al at least renders obvious Applicant’s invention as claimed.
Claim(s) 55, and 57-63 are rejected under 35 U.S.C. 103 as being unpatentable over June (US 6632789-from IDS filed 07/28/2021) in view of Schade et al (Blood, 2008).
Regarding claims 55 and 57-63, June teaches and suggests wherein an agent, such as quercetin, is used to down modulate the immune response in a transplant recipient of an organ or bone marrow graft (includes tissue, bone marrow, organ grafts) by contacting the graft with an agent that inhibits phosphatidylinositol 3-kinase, such as quercetin (column 3 lines 10-29, column 5 lines 54-65, column 8 lines 1-20). June also teaches an embodiment wherein the T cells (blood cell graft) are contacted with both an inhibitor of phosphatidylinositol 3-kinase and an inhibitor of a protein tyrosine kinase inhibitor (column 2 lines 51-57). A preferred protein tyrosine kinase inhibitor is one which inhibits src protein tyrosine kinases (column 6 lines 1-14). June teaches wherein the bone marrow is contacted with the agent and also includes residual T cells (blood cell population) (column 8 lines 10-17).
June teaches that the subjects of their method include mammals, such as humans (column 6 lines 59-61) and that the transplants are allogeneic (column 7 line 57-column 8 line 16). Allogeneic transplants involve the transplantation of cells from one individual to another individual of the same species and thus an allogeneic transplant to a human subject includes a human donor.
One of ordinary skill in the art would have been motivated with a reasonable expectation of success to include human donors and human recipients in their method because they suggest both as suitable and desirable for use in their method.
June do not include an embodiment wherein the donor graft is treated with a composition containing an agent, such as dasatinib.
Schade disclose that dasatinib is a small-molecule protein tyrosine inhibitor that inhibits T-cell activation and proliferation and is useful in therapeutic opportunities to address autoimmune diseases, graft versus host disease (GVHD) and transplant allograft rejection with SFK inhibitors (Title, abstract, page 1366). Dasatinib inhibits src protein tyrosine kinases (abstract, page 1366).
One of ordinary skill in the art would have been motivated to administer both quercetin and dasatinib to the donor cell graft prior to providing the graft to the recipient because June suggest an embodiment wherein the graft is contacted with both an inhibitor of phosphatidylinositol 3-kinase and an inhibitor of a protein tyrosine kinase inhibitor and Schade teach that dasatinib is a protein tyrosine kinase inhibitor that is beneficial and useful in the therapeutic methods addressing autoimmune diseases, GVHD and transplant allograft rejection. One of ordinary skill in the art would have had a reasonable expectation of success because June indicate that an embodiment of their method will include an agent, such as quercetin, and a protein tyrosine kinase inhibitor, preferably of the SRC family (column 2 lines 55-60, column 6 lines 1-14) and dasatinib is a protein tyrosine kinase inhibitor of the SRC family tyrosine kinases as per Schade (page 1366).
Therefore, the combined teachings of June and Schade et al render obvious Applicant’s invention as claimed.
Response to Arguments
Applicant’s arguments with respect to claim(s) 55 and 57-63 have been considered but are moot because the new grounds of rejection do not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Lichter et al., “Controlled-Release Apoptosis Modulating Compositions and Methods for the Treatment of Otic Disorders”, US 2010/0016218 A1.
(Includes the addition of dasatinib and quercetin to a stem cell transplant graft prior to administration to the recipient, see page 4 para 22, page 14 para 168, page 22 para 268, para 276, page 23 para 278, page 49 para 492-494, 496).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA J SCHUBERG whose telephone number is (571)272-3347. The examiner can normally be reached 8:30-5:00 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James (Doug) Schultz can be reached on 571-272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
LAURA J. SCHUBERG
Primary Examiner
Art Unit 1631
/LAURA SCHUBERG/Primary Examiner, Art Unit 1631
Prosecution Insights