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
This Final Office Action is in response to the Amendment and Remarks filed 05/28/2026. Claim 1 is amended. Claim 21 is cancelled. Claims 1-20 are currently pending and considered herein.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-9, 16-17 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2021/0043316 A1 to Case et al., hereinafter “Case,” in view of U.S. 2003/0004751 A1 to Ng et al., hereinafter “Ng” and further in view of U.S. 2018/0304002 A1 to Holmes et al., hereinafter “Holmes.”
Regarding claim 1, Case discloses A method comprising: receiving, with a scanner of an apheresis system, data associated with a donor (See Case at least at Abstract; Paras. [0014]-[0021] (apheresis procedure and device), [0135]-[0136] (“The parameters received by the controller from the remote computer may comprise a donor identifier, wherein the system further comprises a scanner configured to scan a code associated with a donor.”), [0145]-[0146]; Claims 3-4; Figs. 2-5; determining, based on the data associated with the donor, an identification of the donor (See id. at least at Abstract; Paras. [0014]-[0021], [0135]-[0136], [0145] (donor identification), [0146]; receiving, with the scanner of the apheresis system, data associated with a blood component collection set (See id. at least at Abstract; Paras. [0004]-[0005] (blood component collection and apheresis), [0018], [0021], [0025], [0054], [0082]-[0084], [0145] (“[R]un parameters (e.g., target plasma product and/or target raw plasma to collect, components of blood to collect, etc.) may be transmitted to the apheresis device at the same time as donor identification data is transmitted to handheld device 1602, and the operator can start the procedure on blood processing device 1604 as soon as the donor identification is confirmed, and the donor identification may be linked to the device parameters.”), [0146] (“blood processing device 1604 comprises a scanning device”); Figs. 2-5); and performing, with the apheresis system, a plasma donation process based on the identification of the donor, the data associated with the blood component collection set, and the data associated with the plasma collection bottle (See id. at least at Abstract (“A system and method for collecting plasma includes drawing whole blood from a donor, combining anticoagulant with the whole blood from the donor, separating the whole blood into a plasma product and a second blood component and sending the plasma product to a collection container.”); Paras. [0004]-[0005] (collection container), [0014]-[0021], [0135]-[0136], [0145]-[0146]); and one or more settings of the plasma donation process are adjusted based on the data associated with the blood component collection set (See id. at least at Paras. [0016]-[0020] (adjusting based on calculations for draw phase)).
Case may not specifically describe but Ng teaches receiving, with the scanner of the apheresis system, data associated with a plasma collection bottle (See Ng at least at Paras. [0092]-[0093], [0098] (plasma volume determined by apheresis device and is stored), [0382]-[0400] (“[S]cans a blood collection kit's (i.e. a disposable kits/solutions/transfer pack) identification code, usually a bar code, and enters the relevant information to begin the apheresis procedure […] A bar code scanner is, thus, either attached directly to the apheresis instrument or the PDA is used to collect and transmit the information.” Scanning bleed number and information, scanning with apheresis device, scanning donor ID and bleed number to match expected values, blood collection barcode), [0406]-[0415]; Figs. 1-4, 49-55, 73, 77, 78, 106); receiving, with the scanner of the apheresis system, data associated with a plasma collection bottle (See id. at least at Paras. [0098] (apheresis instrument provides data after identification/blood donation, bleed number, donor number, storing plasma product volume, number of bags used), [0406]-[0415] (“Blood and blood component inventory can be tracked by the system. When the apheresis collection is completed, a bar code label identifying the product and volume is printed and affixed to the product. The blood product then moves to a post-processing area such as pathogen inactivation. A different bar code label can be printed and affixed to identify it as having been post-processed. The blood product then moves into the freezer storage area, where each incoming unit is scanned and the corresponding product inventory database is updated.”); Figs. 1-4, 49-55, 73, 77, 78, 106) and wherein the blood component collection set and the plasma collection bottle are associated with the donor in response to receiving the data associated with the blood component collection set and the data associated with the plasma collection bottle with the scanner (See id. at least at Paras. [0085]-[0088], [0092]-[0093] (bleed number and donor ID), [0240] (donor reports); [0098] (apheresis instrument provides data after identification/blood donation, bleed number, donor number, storing plasma product volume, number of bags used), [0406]-[0415] (“Blood and blood component inventory can be tracked by the system. When the apheresis collection is completed, a bar code label identifying the product and volume is printed and affixed to the product. The blood product then moves to a post-processing area such as pathogen inactivation. A different bar code label can be printed and affixed to identify it as having been post-processed. The blood product then moves into the freezer storage area, where each incoming unit is scanned and the corresponding product inventory database is updated. The instrument prints a bar code label containing necessary information identifying the product. The instrument includes a function to print bar code labels on an attached printer. The apheresis instrument prints a bar code label identifying the product as being processed.”); Figs. 1-4, 49-55, 73, 77, 78, 106).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure of Case to incorporate the teachings of Ng and provide scanning and associating blood and plasma collection sets. Ng is directed to an apheresis system and method for scanning, tracking and managing blood collection procedures and blood collection components and kits. Incorporating the blood collection scanning and identification of donors and related information as in Ng with the plasma collection programming and blood component collection into a container of Case would thereby improve the functionality and applicability of apheresis control.
The references may not specifically describe but Holmes teaches the blood component collection set including a soft cassette assembly to be used during a plasma donation process (See Holmes at least at Abstract; Paras. [0004], [0032]-[0034] (soft cassette assembly), [0036], [0120] (plasma donation), [0138]; Figs. 3-5) and the data associated with the blood component collection set including at least one of a date of manufacture of the blood component collection set or an identity of a manufacturer of the blood component collection set (See Holmes at least at Paras. [0121]-[0122] (Identity of manufacturer of collection kit and system); See also Ng at least at Abstract; Paras. [0105]-[0107] (“For each instrument, the manufacturer identity, the model name/number, the serial number, and the enabled/disabled flag are stored […] the manufacturer’s product number.”)); and the one or more [adjusted] settings include a flow rate of the apheresis system (See id. at least at Abstract; Paras. [0136] (“The plasma flow control valve 286 and/or the saline flow control valve 288 may be a solenoid valve, linear actuator, pinch valve, clamp valve, tubing valve, and/or other actuatable valve configured to selectively alter, e.g., occlude, a fluid passage associated with a particular portion of tubing 112, 116, 120.”), [0221]-[0224]; Figs. 2-5),
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure of Case and Ng to incorporate the teachings of Holmes and provide a soft cassette assembly and controlling a flow rate. Holmes is directed to fluid control and bypass features for an apheresis system. Incorporating the soft cassette for blood component collection and fluid control as in Holmes with the blood collection scanning and identification of donors and related information as in Ng and the plasma collection programming and blood component collection into a container of Case would improve the collection and control of blood components during the donation process.
Regarding claim 2, Case as modified by Ng and Holmes discloses the limitations of claim 1 and Case further discloses wherein receiving the data associated with the donor comprises scanning, with the scanner, an image (See Case at least at Paras. [0135]-[0136] (“the system further comprises a scanner configured to scan a code associated with a donor. The scanner may be a barcode scanner, camera, or other scanning device.”)).
Regarding claim 3, Case as modified by Ng and Holmes discloses the limitations of claim 1 and Ng further teaches wherein the scanner is disposed on the apheresis system (See Ng at least at Paras. [0098] (apheresis instrument provides data after identification/blood donation, bleed number, donor number, storing plasma product volume, number of bags used), [0406]-[0415] (“Blood and blood component inventory can be tracked by the system. When the apheresis collection is completed, a bar code label identifying the product and volume is printed and affixed to the product. The blood product then moves to a post-processing area such as pathogen inactivation. A different bar code label can be printed and affixed to identify it as having been post-processed. The blood product then moves into the freezer storage area, where each incoming unit is scanned and the corresponding product inventory database is updated.”); Figs. 1-4, 49-55, 73, 77, 78, 106).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure of Case and Holmes to incorporate the teachings of Ng and provide the scanner on the apheresis system. Ng is directed to an apheresis system and method for scanning, tracking and managing blood collection procedures and blood collection components and kits. Incorporating the blood collection scanning and identification of donors and related information as in Ng with the soft cassette for blood component collection and fluid control as in Holmes and the plasma collection programming and blood component collection into a container of Case would improve the classification of systems and components during apheresis procedures.
Regarding claim 4, Case as modified by Ng and Holmes discloses the limitations of claim 2 and Case further discloses wherein the image comprises one of a one-dimensional barcode or a two-dimensional barcode (See id. at Paras. [0135]-[0136]).
Regarding claim 5, Case as modified by Ng and Holmes discloses the limitations of claim 2 and Case further discloses wherein the data associated with the donor is displayed on a user device (See id. at least at Paras. [0028], [0051], [0119], [0133]-[0136]).
Regarding claim 6, Case as modified by Ng and Holmes discloses the limitations of claim 1 and Case further discloses wherein receiving the data associated with the donor comprises scanning an RFID (See id. at least at Para. [0126]).
Regarding claim 7, Case as modified by Ng and Holmes discloses the limitations of claim 1 and Case further discloses after receiving the data associated with the donor, confirming receipt of the data associated with the donor through a feedback system (See id. at least at Abstract (“receives a user input to confirm the parameter and/or procedure, determines a target volume for plasma product and/or raw plasma based on the parameters and, in response to confirming the donor, controls the system to collect the plasma using draw and return phases.”); Paras. [0013], [0122]-[0124], [0130]-[0138]).
Regarding claim 8 Case as modified by Ng and Holmes discloses the limitations of claim 7 and Case further discloses wherein the feedback system comprises one or more of a speaker and a graphical user interface (See id. at least at Paras. [0050]-[0051], [0119]-[0130], [0133] (microphone with a diaphragm as a speaker)).
Regarding claim 9, Case as modified by Ng and Holmes discloses the limitations of claim 1 and Ng further teaches determining, based on the data associated with the donor, the donor is a new donor (See Ng at least at Paras. [0007], [0324]-[0325]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure of Case and Holmes to incorporate the teachings of Ng and provide a determination of a new donor. Ng is directed to a method for tracking blood collection in a blood collection facility. Incorporating the blood donation tracking system as in Ng with the soft cassette for blood component collection and fluid control as in Holmes and the plasma collection programming and blood component collection into a container of Case would improve the classification of donors and components during apheresis procedures.
Regarding claim 16, Case as modified by Ng and Holmes discloses the limitations of claim 1 and Case further discloses after receiving the data associated with the blood component collection set, confirming receipt of the data associated with the blood component collection set through a feedback system (See id. at least at Abstract (“receives a user input to confirm the parameter and/or procedure, determines a target volume for plasma product and/or raw plasma based on the parameters and, in response to confirming the donor, controls the system to collect the plasma using draw and return phases.”); Paras. [0013], [0122]-[0124], [0130]-[0138]).
Regarding claim 17, Case as modified by Ng and Holmes discloses the limitations of claim 16 and Case further discloses wherein the feedback system comprises one or more of a speaker and a graphical user interface (See id. at least at Paras. [0050]-[0051], [0119]-[0130], [0133] (microphone with a diaphragm as a speaker)).
Regarding claim 19, Case as modified by Ng and Holmes discloses the limitations of claim 1 and Case further discloses after receiving the data associated with the plasma collection bottle, confirming receipt of the data associated with the plasma collection bottle through a feedback system (See id. at least at Abstract (“receives a user input to confirm the parameter and/or procedure, determines a target volume for plasma product and/or raw plasma based on the parameters and, in response to confirming the donor, controls the system to collect the plasma using draw and return phases.”); Paras. [0013], [0122]-[0124], [0130]-[0138]).
Regarding claim 20, Case as modified by Ng and Holmes discloses the limitations of claim 19 and Case further discloses wherein the feedback system comprises one or more of a speaker and a graphical user interface (See id. at least at Paras. [0050]-[0051], [0119]-[0130], [0133] (microphone with a diaphragm as a speaker)).
Claims 10-15 and 18 are rejected under 35 U.S.C. 103 by Case, in view of Ng, in view of Holmes and further in view of U.S. 2016/0328521 A1 to Mickles et al., hereinafter “Mickles.”
Regarding claim 10, Case as modified by Ng and Holmes discloses the limitations of claim 1. The references may not specifically describe but Mickles teaches wherein the data associated with the donor comprises biological information and donor history (See id. at least at Paras. [0031], [0045]-[0049], [0060], [0074], [0078]; Figs. 7, 7A).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure of Case, Ng and Holmes to incorporate the teachings of Mickles and provide donor history. Mickles is directed to a blood donation tracking system. Incorporating the tracking system of Mickles with the blood collection scanning and identification of donors and related information as in Ng, the soft cassette for blood component collection and fluid control as in Holmes and the plasma and blood component collection as in Case would improve the classification of donors and components during apheresis procedures.
Regarding claim 11, Case as modified by Ng, Holmes and Mickles discloses the limitations of claim 10 and Case further discloses wherein the biological information comprises one or more of an age, a weight, and a height of the donor (See Case at least at Paras. [0010], [0024], [0051], [0074]-[0082]).
Regarding claim 12, Case as modified by Ng, Holmes and Mickles discloses the limitations of claim 10 and Case further discloses determining, based on the data associated with the donor, a body mass of the donor (See Case at least at Abstract; Paras. [0004], [0074]-[0082], [0140]; Figs. 1, 7-11).
Regarding claim 13, Case as modified by Ng, Holmes and Mickles discloses the limitations of claim 10 and Case further discloses wherein a volume of plasma collected during the plasma donation process is controlled based on one or more of the body mass of the donor and a weight of the donor (See Case at least at Abstract; Paras. [0004], [0074]-[0082], [0140]; Figs. 1, 7-11).
Regarding claim 14, Case as modified by Ng and Holmes discloses the limitations of claim 1 and Ng further teaches wherein receiving the data associated with the blood component collection set comprises scanning, with a scanner (See Ng at least at Paras. [0098] (apheresis instrument provides data after identification/blood donation, bleed number, donor number, storing plasma product volume, number of bags used), [0406]-[0415] (“Blood and blood component inventory can be tracked by the system. When the apheresis collection is completed, a bar code label identifying the product and volume is printed and affixed to the product. The blood product then moves to a post-processing area such as pathogen inactivation. A different bar code label can be printed and affixed to identify it as having been post-processed. The blood product then moves into the freezer storage area, where each incoming unit is scanned and the corresponding product inventory database is updated.”); Figs. 1-4, 49-55, 73, 77, 78, 106). However, the references do not specifically describe but Mickles teaches one or more of an image RFID attached to the blood component collection set (See Mickles at least at Paras. [0023], [0040]-[0042], [0071]; Figs. 1, 2, 5-10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure of Case, Ng and Holmes to incorporate the teachings of Mickles and provide scanning an RFID attached to blood component collection set. Mickles is directed to a blood donation tracking system. Incorporating the tracking system of Mickles with the blood collection scanning and identification of donors and related information as in Ng, the soft cassette for blood component collection and fluid control as in Holmes and the plasma and blood component collection as in Case would thereby improve the functionality and applicability of code scanning and apheresis data control.
Regarding claim 15, Case as modified by Ng, Holmes and Mickles discloses the limitations of claim 14 and Case further discloses wherein the image comprises one of a one-dimensional barcode or a two-dimensional barcode (See Case at Paras. [0135]-[0136]).
Regarding claim 18, Case as modified by Ng and Holmes discloses the limitations of claim 1 and Case further discloses wherein receiving the data associated with the blood component collection set comprises scanning, with a scanner, one or more of an image (See id. at least at Paras. [0082]-[0084], [0132]-[0140], [0145]-[0146]). The references may not specifically describe but Mickles teaches scanning RFID attached to the blood component collection set (See Mickles at least at Paras. [0023], [0040]-[0042], [0071]; Figs. 1, 2, 5-10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure of Case and Ng to incorporate the teachings of Mickles and provide scanning an RFID attached to blood component collection set. Mickles is directed to a blood donation tracking system. Incorporating the tracking system of Mickles with the blood collection scanning and identification of donors and related information as in Ng, the soft cassette for blood component collection and fluid control as in Holmes and the plasma and blood component collection as in Case would thereby improve the functionality and applicability of code scanning and apheresis data control.
Response to Arguments
Applicant’s remarks filed May 28, 2026 have been fully considered and are not persuasive. The following explains why:
Applicant’s arguments pertaining to prior art rejections are not persuasive. The claims have been addressed with regard to the 35 U.S.C. §103 rejection discussed above. The arguments pertaining to prior art references of the Applicant’s Remarks at Pages 6-7 are not persuasive. The arguments at pages 6-7 are moot in light of at least new reference Holmes. The Examiner asserts the recited art reads on the broadest reasonable interpretation of the current claims. As such, it is submitted that the cited prior art, including those identified by Applicant, in the same field of endeavor, i.e., medical diagnostics and blood plasma collection techniques teaches and/or suggests all of the limitations of the pending claims under a broad and reasonable interpretation thereof.
Conclusion
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 WILLIAM T. MONTICELLO whose telephone number is (313)446-4871. The examiner can normally be reached M-Th; 08:30-18:30 EST.
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/WILLIAM T. MONTICELLO/ Examiner, Art Unit 3682
/FONYA M LONG/ Supervisory Patent Examiner, Art Unit 3682
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