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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-7) in the reply filed on Feb. 4, 2026 is acknowledged.
Claims 25-38 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1-7 are pending and examined below.
Priority
The present application is a DIV of a 35 U.S.C. 371 national stage filing of the International Application No. PCT/IL2018/050537, filed May 16, 2018. Applicant’s claim for the benefit of a prior-filed parent provisional application 62/506,699 filed on May 16, 2017 under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Thus, the earliest possible priority for the instant application is May 16, 2017.
Information Disclosure Statement
The information disclosure statements filed Jan. 17, 2914 (2); and Oct. 29 2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDSs have been considered by the examiner.
Claim Objections
Claim 1 is objected to because of the following informalities: it recites “CD/133-“ instead of “CD133-“. Appropriate correction is required.
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 1 and 2 are 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 claims are directed to methods for selecting a thawed umbilical cord blood unit for ex-vivo expansion and transplantation that includes determining percent viability of the thawed cells and selecting unit having about 40% to about 85% viability prior to separation of cord blood into CD133+/CD34+ and CD133-/CD34- fractions. The claims are indefinite because it is unclear what, exact, steps would need to be performed to practice the method of claims 1 and 2. Is running any test that determines viability of thawed umbilical cord blood cells (such 7-AAD or Trypan Blue) acceptable? Once units that have viability between 40% to 85% (70% for claim 2) have been determined, then what must happen? What exactly is entailed in the “selecting” step, as this appears to be a mental step. Therefore, it appears that testing a cell sample, such that a determination that a thawed umbilical cord blood cells had cell viability between 40% and 85% (or 70%) would be enough to meet the limitations of the claims that require actual, physical steps. It is unclear how this step would then provide a method for selecting a thawed umbilical cord blood unit for ex-vivo expansion and transplantation. For example, the claims recite that this step is undertaken prior to separation based on CD34 and CD133 status. Does that mean that the blood unit must then undergo such separation? Or only that the blood being assessed for viability has not previously undergone such testing? And if undergoing the further separation based on CD34 and CD133 status, does the claim really provide a method for selecting a thawed umbilical cord blood unit for ex-vivo expansion and transplantation, as separation based on CD34 and CD133 status is standard prior to transplantation. For at least these reasons, claim 1 and 2 are indefinite.
Conclusion
Claims 3-7 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TERESA E KNIGHT whose telephone number is (571)272-2840. The examiner can normally be reached Monday-Friday 9-4.
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/TERESA E KNIGHT/Primary Examiner, Art Unit 1634
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