DETAILED ACTION
Status of Claims
This action is in reply to the amendment filed on 01/12/2026.
Claims 1, 10 and 17 has been amended.
Claims 8, 12 and 19 has been cancelled.
Claims 1-7, 9-11, 13-18 and 20 are currently pending and have been examined.
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 .
Claim Rejections - 35 USC § 103
The present application is being examined under the pre-AIA first to invent provisions.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 1-7, 9-11, 14-18 and 20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Benjamin (US 2010/0049542 A1) in view of Fletcher-Haynes (US 7,430,478 B2).
Claim 1:
Benjamin discloses a system for collecting whole blood from blood donors and monitoring donation information on a handheld computing device (See Fig. 1 Operator 26 uses a mobile phone, see operations dashboard 400 in Fig. 4.), comprising:
first whole blood collection devices disposed at a first blood donation center and configured to collect whole blood from donors (See Fig. 1, Fig. 4, P0033 donor processing units 14 for donors at a Plasma center. See selected procedure as collected whole blood in P0084-P0085.), wherein the first blood donor center is a mobile collection site (See mobile collection site in P0044.);
second whole blood collection devices at a second blood donation center which is different than the first blood donation center (See Fig. 1, Fig. 4, P0033 donor processing units 14 for more than one donor at a Plasma center.);
a handheld computing device comprising a handheld housing, a touch screen display coupled to the housing, a memory to store an executable application, a network interface circuit configured to communicate wirelessly, and a processing circuit coupled to the display, the network interface circuit and the memory (See touch panel display used by an operator in P0055, wireless data interface in P0033, mobile data transmission devices, PDA’s, mobile computer and other handheld devices (P0029) and network 40 in communication with donor processing units 14 shown in Fig. 1, Fig. 4.);
a remote server computer in wireless communication with the first and second whole blood collection devices and the handheld computing device (See Fig. 1, Fig. 4 gateway server 42 in communication with donor processing units 14 mentioned in P0033.);
wherein the first and second whole blood collection devices are each configured to transfer donation procedure information to the remote server using at least one communication protocol, wherein the remote server computer is configured to facilitate retrieval of the donation procedure information at the handheld computing device (See Fig. 1, P0041 where an Administrator 46 includes Center Manager and Center Quality Assurance members are involved in reporting, data analysis or quality assurance processing (P0031, P0033) serve as protocol. Also, see Fig. 7 Donor Queue.);
wherein the donation procedure information comprises data based on product volume collected (See Fig. 4-6, [P0061] Each virtual bed 440-445 identifies the following characteristics: 1) a donation bed 450; 2) a donor presence 451; 3) a collection volume for the donor 452. Also, see P0044, P0061 real-time tracking include volume of collections.); and
wherein the donation procedure information comprises data indicating performance of operators of the whole blood collection devices (See utilizing performance data in P0045 via exemplary Fenwall Service operator or from Corporate Operations via computing device 64 shown in Fig. 3 mentioned in P0034, P0050.).
Although Benjamin discloses a system and method for collecting whole blood from blood donors and monitoring donation information on a handheld computing device, Benjamin does not explicitly teach displaying a number of whole blood units collected and displaying current goal status for a whole blood collection goal. Fletcher-Haynes teaches wherein the handheld computing device is configured to display a number of whole blood units collected (See product volume information in milliliters shown in Fig. 2C, Fig. 4, Fig. 5A, Fig. 5B and column 15, line 62 to column 16, line 16.), the number of whole blood units representing a number of whole blood donations (With units as bags, see bags of whole blood in column 3, lines 61-67, column 11, lines 19-24 and Fig. 3C item 334 where volume in milliliter units would allow a pint or 450-500 mL units whole blood to be donated.),
wherein the handheld computing device is configured to display current goal status for a whole blood collection goal, wherein the number of whole blood units collected further comprises a current number of whole blood units collected by each of the first and second blood donation centers (See Fig. 3A-3D show exemplary screens when preparing procedures for donors mentioned in column 15, lines 19-37, Fig. 4, column 1, lines 42-52, column 5, line 49 to column 6, line 18 a donor assigned to donor or screening rooms where lab data is collected for selecting proper collection procedure and donation number of units which serves as a goal. Also, see column 12, lines 27-52.).
Therefore, it would have been obvious to one of ordinary skill in the art of blood donor processing before the effective filing date of the claimed invention to modify the system and method of Benjamin to include displaying a number of whole blood units collected and displaying current goal status for a whole blood collection goal as taught by Fletcher-Haynes to better manage donor eligibility and avoid any blood loss wasted mentioned in Fletcher-Haynes’ column 2, lines 18-40.
Regarding claim 2, Benjamin discloses the system of Claim 1, wherein the data indicating performance of operators of the whole blood collection devices comprises a real time scoreboard or scorecard (Taught as operations dashboard 400 in Fig. 4 mentioned in P0057.).
Regarding claim 3, Benjamin discloses the system of Claim 2, wherein the handheld computing device is configured to generate feedback relating to the performance of the operators (See Fig. 1, P0041 where an Administrator 46 includes Center Manager and Center Quality Assurance members are involved in reporting, data analysis or quality assurance processing (P0031, P0033). Also, see Fig. 7 Donor Queue.).
Regarding claim 4, Benjamin discloses the system of Claim 1, wherein the handheld computing device is configured to receive user selection of one or more donation locations and to display donation records comprising quantity of blood donations at the one or more donation locations (See Fig. 4-6, [P0061] Each virtual bed 440-445 identifies the following characteristics: 1) a donation bed 450; 2) a donor presence 451; 3) a collection volume for the donor 452; 4) presence of an installed soft good set 453; 5) progress of the donation 454; and/or 6) a status of the donation 455, including any alarms or alerts.).
Regarding claim 5, Benjamin discloses the system of Claim 1, wherein the handheld computing device keeps track of progress of donations (See [P0061] progress of the donation 454; and/or 6) a status of the donation 455, including any alarms or alerts.).
Regarding claim 6, Benjamin discloses the system of Claim 1, wherein the first and second whole blood collection devices are configured to generate electronic donation records, wherein the donation procedure information comprises the electronic donation records (See [P0069-P0070] The information system can be used to determine eligibility of a donor to donate various blood components based on donor history and donation guidelines for a particular donor and/or procedure.).
Regarding claim 7, although Benjamin teaches the system of Claim 1 mentioned above, Benjamin does not explicitly teach donation statistics. Fletcher-Haynes teaches wherein the donation procedure information comprises donation statistics (Besides Fig. 2E Blood Loss History 291 and Procedure History 299 in column 8, lines 28-34, see prediction algorithm in column 2, line 66 to column 3, line 11 and calculations in column 13, lines 39 – 65.).
Therefore, it would have been obvious to one of ordinary skill in the art of blood donor processing before the effective filing date of the claimed invention to modify the system and method of Benjamin to include donation statistics as taught by Fletcher-Haynes to better manage donor eligibility and avoid any blood loss wasted mentioned in Fletcher-Haynes’ column 2, lines 18-40.
Regarding claim 9, Benjamin discloses the system of Claim 1, wherein the donation procedure information comprises facility information (See Fig. 1 where inventory and distribution dock information serve as facility information.).
Regarding claim 10, Benjamin discloses the system of Claim 9, wherein the handheld computing device is configured to retrieve a location at which a donation is happening at the first blood donation center (See Fig. 7, P0062 where donation location includes Bay and Bed.).
Regarding claim 11, Benjamin discloses the system of Claim 9, wherein the handheld computing device is configured to retrieve from the first and second whole blood collection devices for display facility information for the first and second blood donation centers (Inventory and distribution dock information (Fig. 1), as facility information can be retrieved from a plurality of collection facilities/Plasma Centers (Fig. 2, P0034). Also, audit trail (P0047) would allow a user to retrieve whole blood collection information.).
Claim 14:
Benjamin discloses a system for collecting whole blood from blood donors and monitoring donation information on a handheld computing device (See Fig. 1 Operator 26 uses a mobile phone, see operations dashboard 400 in Fig. 4.), comprising:
whole blood collection devices disposed at a blood donation center and configured to collect whole blood from donors (See Fig. 1, Fig. 4, P0033 donor processing units 14 for donors at a Plasma center. See selected procedure as collected whole blood in P0084-P0085.);
a handheld computing device comprising a handheld housing, a touch screen display coupled to the housing, a memory to store an executable application, a network interface circuit configured to communicate wirelessly, and a processing circuit coupled to the display, the network interface circuit and the memory (See Fig. 11 processor 1112 and memory 1124, 1125. See touch panel display used by an operator in P0055, wireless data interface in P0033, mobile data transmission devices, PDA’s, mobile computer and other handheld devices (P0029) and network 40 in communication with donor processing units 14 shown in Fig. 1, Fig. 4.);
a remote server computer in communication with the whole blood collection devices and the handheld computing device (See Fig. 1, Fig. 4 gateway server 42 in communication with donor processing units 14 mentioned in P0033.),
wherein the whole blood collection devices are each configured to transfer donation procedure information to the remote server, wherein the remote server computer is configured to facilitate retrieval of the donation procedure information at the handheld computing device (See Fig. 1, P0041 where an Administrator 46 includes Center Manager and Center Quality Assurance members are involved in reporting, data analysis or quality assurance processing (P0031, P0033). Also, see Fig. 7 Donor Queue.);
wherein the procedure information comprises data based on product volume collected (See Fig. 4-6, [P0061] Each virtual bed 440-445 identifies the following characteristics: 1) a donation bed 450; 2) a donor presence 451; 3) a collection volume for the donor 452. Also, see P0044, P0061 real-time tracking include volume of collections.);
wherein the donation procedure information comprises data indicating performance of operators of the whole blood collection devices (See Fig. 1, P0041 where an Administrator 46 includes Center Manager and Center Quality Assurance members are involved in reporting, data analysis or quality assurance processing (P0031, P0033). Also, see Fig. 7 Donor Queue.); and
wherein the data indicating performance of operators of the whole blood collection devices comprises a real time scoreboard or scorecard (Taught as operations dashboard 400 in Fig. 4 mentioned in P0057.).
Although Benjamin discloses a system and method for collecting whole blood from blood donors and monitoring donation information on a handheld computing device, Benjamin does not explicitly teach displaying a number of whole blood units collected. Fletcher-Haynes teaches wherein the handheld computing device is configured to display a number of whole blood units collected (See product volume information in milliliters shown in Fig. 2C, Fig. 4, Fig. 5A, Fig. 5B and column 15, line 62 to column 16, line 16.) the number of whole blood units representing a number of whole blood donations (With units as bags, see bags of whole blood in column 3, lines 61-67, column 11, lines 19-24 and Fig. 3C item 334 where volume in milliliter units would allow a pint or 450-500 mL units whole blood to be donated.).
Therefore, it would have been obvious to one of ordinary skill in the art of blood donor processing before the effective filing date of the claimed invention to modify the system and method of Benjamin to include displaying a number of whole blood units collected as taught by Fletcher-Haynes to better manage donor eligibility and avoid any blood loss wasted mentioned in Fletcher-Haynes’ column 2, lines 18-40.
Regarding claim 15, Benjamin discloses the system of Claim 14, wherein the handheld computing device is configured to generate feedback relating to the performance of the operators (See Fig. 1, P0041 where an Administrator 46 includes Center Manager and Center Quality Assurance members are involved in reporting, data analysis or quality assurance processing as performance of operations (P0031, P0033). Also, see Fig. 7 Donor Queue.).
Regarding claim 16, Benjamin discloses the system of Claim 14, wherein the first blood donation center is a mobile collection site, wherein the handheld computing device is configured to retrieve a location at which a donation is happening at the first blood donation center (See Fig. 7, P0062 where donation location includes Bay and Bed.).
Claim 17:
Benjamin discloses method of collecting whole blood from blood donors, comprising:
collecting whole blood from donors using first whole blood collection devices at a first blood donation center (See Fig. 1, Fig. 4, P0033 donor processing units 14 for donors at a Plasma center. See selected procedure as collected whole blood in P0084-P0085.);
collecting whole blood from donors using second whole blood collection devices at a second blood donation center which is different than the first blood donation center (See Fig. 1, Fig. 4, P0033 donor processing units 14 for more than one donor at a Plasma center.);
providing a handheld computing device comprising a handheld housing (wireless data interface in P0033, mobile data transmission devices, PDA’s, mobile computer and other handheld devices (P0029) and network 40 in communication with donor processing units 14 shown in Fig. 1, Fig. 4);
providing a remote server computer in wireless communication with the first and second whole blood collection devices and the handheld computing device (See Fig. 1, Fig. 4 gateway server 42 in communication with donor processing units 14 mentioned in P0033.),
transferring donation procedure information from the first and second whole blood collection devices relating to the collections of whole blood to the remote server computer using at least one communication protocol (See Fig. 1, P0041 where an Administrator 46 includes Center Manager and Center Quality Assurance members are involved in reporting, data analysis or quality assurance processing (P0031, P0033) serve as protocol. Also, see Fig. 7 Donor Queue.);
facilitating retrieval of the donation procedure information by the handheld computing device from the remote server computer, wherein the retrieved donation procedure information comprises data based on product volume collected and data indicating performance of operators of the first and second whole blood collection devices (Inventory and distribution dock information (Fig. 1), as facility information can be retrieved from a plurality of collection facilities/Plasma Centers (Fig. 2, P0034). Also, audit trail (P0047) would allow a user to retrieve whole blood collection information.); and
receiving user selection of one of the first blood donation center and the second blood donation center and displaying donation records comprising quantity of blood donations at the selected blood donation center (See Fig. 4-6, [P0061] Each virtual bed 440-445 identifies the following characteristics: 1) a donation bed 450; 2) a donor presence 451; 3) a collection volume for the donor 452; 4) presence of an installed soft good set 453; 5) progress of the donation 454; and/or 6) a status of the donation 455, including any alarms or alerts.);
generating feedback relating to the performance of the operators on the handheld computing device, whereby blood collection can be improved (See Fig. 1, P0041 where an Administrator 46 includes Center Manager and Center Quality Assurance members are involved in reporting, data analysis or quality assurance processing as performance of operations (P0031, P0033). Also, see Fig. 7 Donor Queue.).
Although Benjamin discloses a system and method for collecting whole blood from blood donors and monitoring donation information on a handheld computing device, Benjamin does not explicitly teach displaying a number of whole blood units collected and representing a number of whole blood donations. Fletcher-Haynes teaches displaying on the handheld computing device a number of whole blood units collected (See product volume information in milliliters shown in Fig. 2C, Fig. 4, Fig. 5A, Fig. 5B and column 15, line 62 to column 16, line 16.) the number of whole blood units representing a number of whole blood donations (See interface screen as Fig. 3C, item 334 allows a user to indicate whether a pint or 450-500 mL bag unit of whole blood to be donated. Also, see bags of whole blood as units in column 3, lines 61-67 and column 11, lines 19-24.).
Therefore, it would have been obvious to one of ordinary skill in the art of blood donor processing before the effective filing date of the claimed invention to modify the system and method of Benjamin to include displaying a number of whole blood units collected and representing a number of whole blood donations as taught by Fletcher-Haynes to better manage donor eligibility and avoid any blood loss wasted mentioned in Fletcher-Haynes’ column 2, lines 18-40.
Regarding claim 18, Benjamin discloses the method of Claim 17, wherein the data indicating performance of operators of the whole blood collection devices comprises a real time scoreboard or scorecard (Taught as operations dashboard 400 in Fig. 4 mentioned in P0057.).
Claim 13 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Benjamin (US 2010/0049542 A1) in view of Fletcher-Haynes (US 7,430,478 B2) further in view of Ng (US 2003/0018289 A1).
Regarding claim 13, although Benjamin and Fletcher-Haynes teach the system of Claim 1 mentioned above, Benjamin and Fletcher-Haynes do not explicitly teach username and password access. Fletcher-Haynes teaches wherein the remote server is configured to provide username and password access to an administrator to log into an account on a website operated by the remote server (See operator’s security password and identification required for login in P0066, P0122.).
Therefore, it would have been obvious to one of ordinary skill in the art of blood collection facility before the effective filing date of the claimed invention to modify the system of Benjamin and Fletcher-Haynes to include username and password access as taught by Ng to better protect patient records and avoid a computer security breach.
Response to Arguments
Applicant's arguments filed 01/12/2026 have been fully considered but they are not persuasive. Applicant arguses that neither Benjamin nor Fletcher-Haynes teach “displaying at the handheld device data from multiple different collection facilities. Benjamins’ Fig. 7 Donor Queue, the Administrator 46 including Center Manager and Center Quality Assurance members are involved in reporting, data analysis or quality assurance processing (P0031, P0033 and P0041) would allow a user to access and display procedures and blood donor activities from multiple different collection facilities and mobile collection site (P0044).
Regarding the prior art rejections, Applicant’s amendments have been fully considered, but are now moot in view of the new grounds of rejection. The Examiner has entered a new rejection under 35 USC § 103 and applied art already of record.
Conclusion
THIS ACTION IS MADE FINAL. 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 TERESA S WILLIAMS whose telephone number is (571)270-5509. The examiner can normally be reached Mon-Fri, 8:30 am -6:30 pm.
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/T.S.W./Examiner, Art Unit 3687 05/07/2026
/ALAAELDIN M. ELSHAER/Primary Examiner, Art Unit 3687
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