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 .
Status of Claims
Claims 1-2, 4, 7, 9-10, 12, 14-18, 20-23, 25, 27-28 & 30 are pending, of which Claim 1 is amended and Claims 15-18, 20-23, 25, 27-28, 30 remain withdrawn. Claims 1-2, 4, 7, 9-10, 12 & 14 are examined on the merits.
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 103
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.
Claims 1-2, 12, 14 are rejected under 35 U.S.C. 103 as being unpatentable over Abedin et al. (US 2018/0214626) in view of Binninger et al. (US 2017/0262601) and Fletcher-Haynes et al. (US 2003/0154108).
Re Claim 1, Abedin discloses a system for processing and/or treating blood and blood components comprising:
a) a separator (10, Fig. 2, e.g., [0034]) for separating blood into its components;
b) a disposable fluid circuit (“disposable processing set or fluid circuit 200”, [0034], also shown in Fig. 4) associated with said separator (see Fig. 2); and
c) a controller (see e.g., Abstract, [0043]) configured to
(i) direct the collection and/or treatment of blood components (e.g., [0043] “microprocessor-based controller in cooperation with the valves, pumps, weight scales and sensors of device 10 and fluid circuit 200 may be configured to adjust the volume of blood processed in each cycle”),
(ii) store information including pre-determined default values or limits for certain components (e.g., [0010] “receiving input of a target hematocrit” and [0011] disclosing controller adjusting blood product volumes based on the target hematocrit, which means the target hematocrit was stored, so as to be able to make comparison and then make adjustments), and
(iii) establish and/or calculate recommended procedure settings based on one or more of said stored information and other input information (e.g., [0011] “microprocessor-based controller is configured to automatically adjust the first and/or second product volumes so that a volume ratio of a total volume of red blood cells within the mononuclear cell product to a total volume of mononuclear cell product equals the target hematocrit”).
Abedin does not expressly disclose d) a user interface associated with said separator and coupled to said controller for entering information and displaying said established and/or calculated procedure settings. Binninger discloses an apheresis system having a controller (controller 300) that controls the operation of the system ([0015]), and a user interface (input 302, [0044]) that is coupled to the controller for entering information and displaying procedure settings ([0044]). It would have been obvious to one skilled in the art at the time of filing to modify Abedin with Binninger’s teaching of a user interface such that instructions may be updated as needed ([0044]).
Abedin also does not disclose storing historical collection data of a donor/patient and storing selected blood component conditions. Fletcher-Haynes discloses a system for collecting blood components, wherein the system stores information including historical collection data of a patient (e.g., [0019], [0100], [0107]) and selected blood component conditions (e.g., [0015] “blood component loss over a period of time” reflects the condition, e.g., depleted). It would have been obvious to one skilled in the art at the time of filing to modify Abedin with the information management system taught by Fletcher-Haynes because this helps to improve patient safety and well as allowing better management of blood component inventory in the facility.
Re Claim 2, Abedin, Binninger and Fletcher-Haynes combine to disclose claim 1, and Abedin further discloses wherein said processing comprises the collection of stem cells or mononuclear cells (MNCs) and said treating comprises extracorporeal photopheresis of mononuclear cells (MNC) (see e.g., Abstract).
Re Claim 12, Abedin, Binninger and Fletcher-Haynes combine to disclose claim 1, and Abedin further discloses wherein said controller is configured to receive information of a target blood component yield and of a volume of blood to be processed (e.g., [0049] “operator may choose to shorten MNC collection procedure and/or decrease the volume of whole blood processed”, also see [0050] “the microprocessor-based controller may configure the RBC volume per cycle … to achieve the target hematocrit of the suspended MNC product”).
Re Claim 14, Abedin, Binninger and Fletcher-Haynes combine to disclose claim 1, and Abedin further discloses wherein the controller is configured to establish and/or calculate one or more of a targeted whole blood volume to process (e.g., [0049] “operator may choose to shorten MNC collection procedure and/or decrease the volume of whole blood processed”), a blood component targeted yield, a number of collection cycles, a volume per cycle, procedure time, flow rates and recommended offsets for mononuclear cell transfer.
Claims 4, 7, 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Abedin, Binninger and Fletcher-Haynes as applied to claim 1 above, and further in view of Nguyen et al. (US 2018/0256805).
Re Claim 4, Abedin, Binninger and Fletcher-Haynes combine to disclose claim 1 but neither discloses wherein said controller is configured to establish and/or calculate recommended procedure settings based at least in part on a determined collection efficiency for a selected component and a selected subject, wherein said collection efficiency is determined based on historical data from previous collections from the subject or based on a default collection efficiency. Nguyen discloses calculating ideal plasma flow rate and updating the pump to adjust the actual plasma flow rate so as to optimize collection efficiency of the system ([0090]-[0091]). It would have been obvious to one skilled in the art at the time of filing to glean from Nguyen’s teachings to optimize the system functions.
Re Claim 7, Abedin, Binninger and Fletcher-Haynes combine to disclose claim 1 but neither discloses wherein said controller is configured to establish and/or calculate recommended procedure settings based at least in part on pre-determined limits on product contamination for a selected blood component, wherein said pre-determined limits on product contamination include limits as to one or more of platelet contamination, red blood cell contamination and granulocyte contamination. Nguyen discloses a photopheresis system comprising a controller (interface controller 12) and contamination detection that includes monitoring plasma contamination by e.g., hemolysis ([0077]). Nguyen further discloses a control scheme performed by the controller that employs “corrective steps” as a result of detecting plasma contamination ([0078]-[0081] discloses that before fluid processing, turbidity/contamination in plasma, is measured, and subsequently, a “correction factor” is calculated based on detected turbidity and corrective steps are taken by the controller). It would have been obvious to one skilled in the art at the time of filing to modify further with Nguyen’s teaching since this would improve the safety of the entire system.
Re Claim 9, Abedin, Binninger, Fletcher-Haynes and Nguyen combine to disclose claim 7 but none discloses the controller is configured to prioritize selected product contamination based on a selected procedure. However, given that there are only a few components in blood, the options of “a selected procedure” is limited because an apheresis system can only yield a few types of separated blood components. One skilled in the art would reasons that depending on the blood component that needs UV treatment, that would be the blood product that should be prioritized.
Re Claim 10, Abedin, Binninger and Fletcher-Haynes combine to disclose claim 1 but neither expressly discloses wherein said controller is configured to establish and/or calculate recommended procedure settings based at least in part on selected blood conditions, wherein said selected blood conditions include HbS and concentration of lipids. Nguyen discloses a photopheresis system comprising a controller (interface controller 12) and contamination detection that includes monitoring lipid concentration, which can indicate lipemia ([0077]). Nguyen further discloses a control scheme performed by the controller that employs “corrective steps” as a result of detecting lipemia ([0078]-[0081] discloses that before fluid processing, turbidity in plasma, which reflects contamination by e.g., lipids or red blood cells, is measured, and subsequently, a “correction factor” is calculated based on detected turbidity and corrective steps are taken by the controller). It would have been obvious to one skilled in the art at the time of filing to modify further with Nguyen’s teaching since this would improve the safety of the system.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Benjamin et al. (US 2010/0049542) discloses a system for managing blood processing procedures in blood component collection facilities.
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 SUSAN S SU whose telephone number is (408)918-7575. The examiner can normally be reached M-F 9:00 - 5:00 Pacific.
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, Rebecca Eisenberg can be reached at 571-270-5879. 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.
/SUSAN S SU/ Primary Examiner, Art Unit 3781
16 April 2026
Prosecution Insights