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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 04/12/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group 1 drawn to drawn to a method for providing a mammal with a hematopoietic stem cell transplantation, and a method for treating a mammal having a non-malignant disorder with a hematopoietic stem cell transplantation in the reply filed on 10/14/2025 is acknowledged.
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 Claims 30-33, and 35 are withdrawn.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.
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 1-2 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; hereinafter "Sun").
Regarding claims 1-2, and 15-16: Sun sought “to establish the safety and feasibility of repeated intravenous infusions of autologous CB in young babies with congenital hydrocephalus.” (See Sun Abstract). Sun taught a 1st infusion at 2 months and a second infusion at 9 months. (See Sun Figure 1). As such Sun disclosed a period between 2 weeks to 8 months as required by the claim. Furthermore, Sun disclosed that the Cord blood was autologous, which means there were from the same cord blood preparation. It is also noted that Sun describes human infants as required by claims 2 and 16. Further it is known that cord blood comprises hematopoietic stem cells (See specification page 2, lines 23-25). It is also noted that congenital hydrocephalus is a non-malignant disease as required by claim 15.
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 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").
Regarding claim 3, 5-7, 9, 18, 20-22, and 24: It is noted that Sun taught that splitting the 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). Ruggeri taught that “When selecting the UCB unit, TNC is the main requirement applied by CBB, in association with the CD34+ cell dose, which is not clearly standardized across the different cell therapy laboratories.” A skilled artisan in view of the teachings of Sun in view of Ruggeri would have been motivated to optimize the dose of cord blood cells that are administered for the initial infusion versus the second or any subsequent infusion. Sun already demonstrated safe and viable multiple infusions. 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.
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.
Regarding claims 17: Sun sought “to establish the safety and feasibility of repeated intravenous infusions of autologous CB in young babies with congenital hydrocephalus.” (See Sun Abstract). Sun taught a 1st infusion at 2 months and a second infusion at 9 months. (See Sun Figure 1). Sun did not specifically teach hematopoietic stem cell transplantation for the bone marrow failure. However, Onishi taught that “umbilical cord blood could be an effective and promising option for stem cell source for urgent second transplantation in patients with aplastic anemia who develop GF [graft failure] after the first HSCT [hematopoietic stem cell transplantation].” (See Onishi Abstract). It is noted that aplastic anemia is a bone marrow failure syndrome. (See evidence in Mayo clinic Aplastic anemia, PTO-892). A person of ordinary skill in the art would have, based on the teachings of Sun, realized that the cord blood cells can be safely stored for later infusion. It would have been obvious in view of Onishi to use the same umbilical cord blood preparation for improvement of graft in case of failure or suboptimal transplantation, with the second transplantation. It is noted that both Sun and Onishi taught second infusion within the claimed 2 weeks to 8 months.
Accordingly, the claimed method would have been obvious to a person of ordinary skill in the art at the time of invention, as it merely combines known techniques. At the time of the invention, it was well understood that cord blood contains viable HSCs capable of engraftment and that the cells survive cryopreservation (See Sun Abstract). Further Onishi taught that additional infusions support engraftments. Therefore, a skilled artisan would have had a reasonable expectation of success administering a second portion of cord blood from the same donor within 2 weeks to 8 months would successfully contribute to hematopoietic reconstitution.
Conclusion
No claim is free of art.
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/JAGAMYA NMN VIJAYARAGHAVAN/Examiner, Art Unit 1633
/EVELYN Y PYLA/Primary Examiner, Art Unit 1633