DETAILED CORRESPONDENCE
Note: This office action is in response to communication filed on 03/10/2026.
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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/10/2026 has been entered.
Status of Claims
Claims 1-14 and 18-20 are pending in the application.
Claim(s) 1-13 and 19 is/are allowed.
Claim(s) 14, 18, and 20 are examined on the merits.
Information Disclosure Statement
The new information disclosure statements (IDS) submitted on 03/10/2026 in compliance with the provisions of 37 CFR 1.97. Accordingly, the new information disclosure statement has been considered by the examiner.
Response to Arguments
Applicant’s arguments filed on 03/10/2026 have been fully considered but are moot because the independent claim(s) has/have been amended and the new ground of rejection does not rely on the same combination references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Claim 18 is 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.
Claim 18 recites the limitation “combining said solution with said target cell population in a volume selected to arrive at said predetermined hematocrit” which is indefinite. There is not sufficient antecedent basis for “solution” in the claim. In addition, it is unclear if the “solution with said target cell population in a volume selected to arrive at said predetermined hematocrit” same or different from the “volume of saline” that is combined with “the target cell population to arrive at a treatment-ready product including a predetermined hematocrit”. The limitation has been examined below as if it read -- combing said [[volume of saline with said target cell population [[
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 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.
Claim(s) 14, 18, and 20 is/are rejected under 35 U.S.C 103 as being unpatentable over Radwanski (US PGPUB 20150196706) in view of Koudelka (US PGPUB 20150219558), Min (US PGPUB 20050137516) and Grimm (US PGPUB 20030175150).
Regarding claim 14, Radwanski discloses a method for maintaining fluid balance in a patient undergoing a therapeutic cellular treatment (Abstract; ¶0007; and Fig. 5) comprising:
having a fluid flow path of a disposable fluid circuit mounted on a unit (¶0026-0027: disposable processing set 200 mounted on a separation device 10);
collecting a target cell population from a patient in fluid communication with said fluid circuit (Steps 30 and 32 in Fig. 5; ¶0032);
combining a volume of saline with said target cell population to arrive at a treatment-ready product including a predetermined hematocrit (Step 33 in Fig. 5; ¶0033);
treating the treatment-ready product to arrive at a treated cellular product (Steps 34-44 in Fig. 5; ¶0033 and 0036-0037);
administering the treated cellular product to said patient (Step 46 in Fig. 5).
Radwanski further discloses the disposable processing set is remotely controlled by a separate controller such as a computer (¶0035), but does not disclose a reusable hardware unit.
In the same field of endeavor, apparatus for collecting and processing blood, Koudelka discloses a blood separation system provided for controlling the interface between separated blood components (Abstract). Koudelka further discloses the blood separation system is mounted on a reusable hardware unit (¶0004) for the benefit(s) of optimizing centrifugation process and controlling flow through the fluid circuit (¶0004).
Since Radwanski suggests the disposable processing set can be controlled by a computer, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the system of Radwanski in view of Koudelka by incorporating a reusable hardware unit, in order to optimize centrifugation process and control flow through the fluid circuit, as suggested in ¶0004 of Koudelka.
Radwanski does not disclose priming the fluid flow path of the disposable fluid circuit mounted on the reusable hardware unit with a predetermined volume of anticoagulated whole blood and administering said anticoagulated whole blood used for priming to said patient.
In the same field of endeavor, apparatus for collecting and processing blood, Min discloses an apparatus for collecting and separating whole blood into one or more components (Abstract). Min further teaches to use anticoagulated whole blood as a priming solution (0031) for the benefit of preventing unnecessary step to have a separate container/bag of saline as part of fluid circuit assembly (¶0031).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the system of Radwanski/ Koudelka in view of Min by selecting anticoagulated whole blood as priming fluid, in order to prevent unnecessary step to have a separate container/bag of saline as part of fluid circuit assembly, as suggested in ¶0031 of Min. Thus, Radwanski/Koudelka/Min discloses a method step of priming the fluid flow path of the disposable fluid circuit mounted on the reusable hardware unit with a predetermined volume of anticoagulated whole blood.
Radwanski/Koudelka/Min does not disclose administering said anticoagulated whole blood used for priming to said patient.
In the same field of endeavor, systems for separating one or more components from blood, Grimm discloses an apheresis system comprising a disposable fluid circuit 12 (¶0024 and Fig. 1). Grimm further discloses adding/mixing anticoagulant with whole blood and then returning to a donor/patient (¶0007) for the benefit of preventing donor/patient’s blood from clotting as it is processed through the fluid circuit (¶0005).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the method of Radwanski/Koudelka/Min in view of Grimm by administering anticoagulated whole blood to patient, in order to prevent patient’s blood from clotting as it is processed through the fluid circuit, as suggested in ¶0005 of Grimm.
Regarding claim 18, Radwanski/Koudelka/Min in view of Grimm further discloses combining said volume of saline with said target cell population to arrive at said predetermined hematocrit (see rejection of claim 14 above).
Regarding claim 20, Radwanski/Koudelka/Min in view of Grimm discloses administering said anticoagulated whole blood used for priming to said patient (see rejection of claim 14 above), but does not disclose administering said anticoagulated whole blood used for priming to said patient prior to collecting said target cell population.
Grimm discloses anticoagulant is used to prevent the donor/patient's blood from clotting as it is processed through the fluid circuit of the apheresis system (¶0005). From the teaching of Grimm, a person having ordinary skill in the art would have recognized/deduced that administering said anticoagulated whole blood used for priming to said patient prior to collecting said target cell population yields the predictable result of preventing donor/patient’s blood from clotting as it is processed through the fluid circuit.
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the method of Radwanski/Koudelka/Min in view of Grimm in view of Grimm by administering anticoagulated whole blood to patient prior to collecting said target cell population, in order to prevent patient’s blood from clotting as it is processed through the fluid circuit, as suggested in ¶0005 of Grimm.
Allowable Subject Matter
Claim(s) 1-13 and 19 is/are allowed.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 1, Gara does not disclose diverting at least a portion of said predetermined volume of said priming solution from the flow path of the fluid circuit to a container and then combining said at least a portion of said predetermined volume of said priming solution with said target cell population to arrive at a treatment-ready product. Examiner did not find any teachings/motivations to modify the method for collecting and treating blood component of Gara to comprise method steps of diverting at least a portion of said predetermined volume of said priming solution from the flow path of the fluid circuit to a container and combining said at least a portion of said predetermined volume of said priming solution with said target cell population to arrive at a treatment-ready product. In addition, Applicant’s arguments, on pages 10-11 of the remarks dated 07/03/2025, explaining why the combination of these limitations make the claimed invention novel and non-obvious over the prior art of record are found persuasive.
Therefore, claim 1 and its dependent claims 2-13 and 19 are deemed novel and non-obvious over the prior art of record.
No other prior art was located that fairly suggested the claimed invention in whole or in part, along with the requisite motivation for combining to render the claimed invention obvious.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NHU Q TRAN whose telephone number is (571)272-2032. The examiner can normally be reached Monday-Thursday 8:00-5:00 (PST).
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/NHU Q. TRAN/Examiner, Art Unit 3781 /JESSICA ARBLE/Primary Examiner, Art Unit 3781