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 Claims
Claims 1-3, 5-7, 9, 15-18, 20-22 and 24 are pending and under exam. Claims 30-33, and 35 are withdrawn. Claims 4, 8, 10-14, 23, 25-29, 34, and 36-41 are cancelled.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08/26/2026 has been entered.
WITHDRAWN REJECTIONS
Claim Rejections - 35 USC § 102
Claims 1-2 and 15-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sun et al (Pediatr Res; 2015; See PTO-892 of 10/31/2025; hereinafter "Sun").
The rejection is withdrawn following claim amendments.
Claim Rejections - 35 USC § 103
Claims 3, 5-7, 9, 18, 20-22, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Sun et al (Pediatr Res; 2015; See PTO-892; hereinafter "Sun") in view of Ruggeri et al (Am Soc Hematol Educ Program. 2019 Dec 6; See IDS filed 4/12/2023; hereinafter "Ruggeri").
The rejection is withdrawn following claim amendments. New rejections are set forth below.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Sun et al (Pediatr Res; 2015; See PTO-892; hereinafter "Sun") in view of Onishi et al (Biol Blood Marrow Transplant. 2017 Dec; See PTO-892; hereinafter "Onishi") and as evidenced by Mayo clinic Aplastic anemia, PTO-892.
The rejection is withdrawn following claim amendments. New rejections are set forth below.
NEW REJECTIONS NECESSITATED BY CLAIM AMENDMENTS
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 1-2, and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Kaminski et al (WO2005097190A2; hereinafter “Kaminski;” Published Oct 20, 2005; See PTO-892) in view of Ichim et al (WO2008036374A2; hereinafter “Ichim;” Published Mar 27, 2008; See PTO-892).
Regarding claims 1, 15 and 17: Kaminski was directed to methods and systems for maintaining a stem cell registry comprising information about a plurality of stem cell units. Kaminski indicated that “[o]ne embodiment of the present invention is directed toward methods of collecting multiple stem cells transplant units from a given donor. An advantage of such collection schemes is that a portion of the stem cells from the given donor can be provided to a patient while retaining portions of the original stem cell donation from the given donor.” Kaminski taught that “Umbilical cord blood ("cord blood") is a viable alternative source to other hematopoietic progenitor sources (e.g., bone marrow and mobilized peripheral blood) for related and unrelated allogenic hematopoietic stem cell (HSC) / progenitor cell (HPC) transplantation.” (See Kaminski p. 3; 2nd para). As such, Kaminski indicated that population of stem cells (including hematopoietic stem cells) from a single donor and that a stem cell transplant unit may comprise a portion of the stem cell unit, and that a single donor collection may contain multiple stem cell transplant units and expressly recognized that a portion of the stem cells from a given donor may be provided to a patient while additional portions are retained. Kaminski further noted retaining sufficient additional stem cells from the same donor as an advantage for a patient who may require a second transplant. Therefore this reads on the claimed “administering a first portion of an umbilical cord blood preparation obtained from a single donor to said mammal at a first time point,” and “administering a second portion of said umbilical cord blood preparation to said mammal at a second time point, wherein said second time point is two weeks to eight months after said first time point.” It is noted that Kaminski did not teach the said second time point is two weeks to eight months after first time point. Ichim supplied this teaching. Ichim described allogenic stem cell therapy using umbilical cord blood stem cells. In Example 5 of Ichim, treatment of patients using allogenic cord blood stem cells is supplied. The Example taught that treatment of allogenic cord-blood stem cells and stated that the cells are administered twice a month. Thus, Ichim taught repeated administration of the allogenic umbilical cord blood cells at approximately two-week intervals.
One of ordinary skill in the art would have been motivated to use the multiple transplant portions obtained from the single-donor umbilical cord blood preparation of the Kaminski for successive hematopoietic stem cell transplantation, while employing the repeated approximately twice monthly administration schedule taught by Ichim for allogenic stem cell therapy. The resulting method would comprise administering a first portion of a single donor umbilical cord blood and administering a second portion of that same preparation at a subsequent time point approximately two week to eight month range. The combination consequently teaches or suggests each limitation of claim 1, including the use of hematopoietic stem cells transplantation to a mammal, a single donor umbilical cord preparation divided into multiple portions, administration of the portions at different time points, the claimed temporal interval and allogenic transplantation.
It is also noted that Ichim in claim 4 taught that the disease is inflammatory, neurological, gastrointestinal, dermatological, urological, respiratory, and cardiac diseases, which are nonmalignant diseases. It is also noted that claim 7 indicates diabetes, which is an inborn errors of metabolism disorder.
Regarding claim 2 and 16: As indicated above, Kaminski taught administering a portion of the stem cells from the given donor can be provided to a patient while retaining portions of the original stem cell donation from the given donor. It is submitted that the patient encompasses a human.
Claims 3, 5-7, 9, 18, 20-22, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Kaminski et al (WO2005097190A2; hereinafter “Kaminski;” Published Oct 20, 2005; See PTO-892 of 10/31/2025) in view of Ichim et al (WO2008036374A2; hereinafter “Ichim;” Published Mar 27, 2008; See PTO-892) and Sun et al (Pediatr Res; 2015; See PTO-892; hereinafter "Sun").
Regarding claim 3, 5-7, 9, 18, 20-22, and 24: The teachings of Kaminski in view of Ichim are set forth above. It is noted that none of the cited references taught first portion comprises from about 80 to about 95 percent of cord blood preparation. Sun taught that splitting autologous umbilical cord blood preparations into 80/20 system - “CBU was stored in a bag with an 80/20 configuration, the 20% compartment was generally used for the first infusion. If the 80% compartment contained an TNCC of >5 × 107/kg at the time of the second infusion, then only a portion of the cells in the 80% compartment were used and the remaining thawed cells were refrozen in an 80/20 bag for future dosing.” (See Sun, p. 713, col. 2, last para). Sun already demonstrated safe and viable multiple infusions. Thus, Sun taught a sequence in which a cord blood preparation was thawed for an initial administration, a remaining portion was separated and refrozen. Although Sun does not expressly teach allogeneic hematopoietic stem cell transplantation, Sun remains highly relevant to the claimed method because it teaches the same fundamental cord blood transplantation approach of administering portions of a single umbilical cord blood preparation to the same recipient at different time points. In particular, Sun teaches dividing a cord blood unit into portions, administering a first portion, and subsequently administering another portion of the same cord blood unit, including after the remaining portion has been refrozen. Thus, Sun provides the relevant teachings concerning repeated administration, timing between administrations, and portioning of a single cord blood preparation. The allogeneic nature of the transplantation is supplied by Ichim, which teaches allogeneic cord blood stem cell transplantation. Absent any unexpected results of administration of 80-95% cord blood in the initial infusion and 5-20% in the second infusion, it is considered routine in the art to optimize the specific doses with a reasonable expectation of success. It has been held that "a person with ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense." See KSR International Co. v Teleflex, Inc. 82 USPQ2d 1385 at 1390.
It is also noted that Sun taught first administering a cord blood preparation that was thawed and obtained from a frozen state only once as required by claim 5 and refreezing the remaining portion after removal of the portion for administration as required by claim 6. Although not explicitly stated, Sun also taught that the refrozen cells are thawed for subsequent infusions. In fact, Sun taught “19 infusions were performed using cells that had been previously thawed and refrozen.” (See Sun p. 713, col. 2, last para), which inherently requires freeze thawing as many times the infusion was carried out. As such thawing umbilical cord blood preparation twice from a frozen state is obvious and predictable variation in view of Sun.
Conclusion
No claim is free of art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAGAMYA VIJAYARAGHAVAN whose telephone number is (703)756-5934. The examiner can normally be reached 9:00a-5:00p.
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/JAGAMYA NMN VIJAYARAGHAVAN/Examiner, Art Unit 1633
/EVELYN Y PYLA/Primary Examiner, Art Unit 1633
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