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 .
Missing paragraphs for election without traverse.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 3/27/2026 is acknowledged.
Claims 19 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3/27/2026.
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 (i.e., changing from AIA to pre-AIA ) 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.
Claims 1-10 and 12-18 are rejected under 35 U.S.C. 103 as being unpatentable over Rule et al. (US Pub No. 20110313318 A1, herein, Rule) in view of Kern et al. (US Pub No. 20130123969 A1, herein, Kern).
Regarding claim 1, Rule discloses an automated blood sampling and infusion system comprising:
a sampling pump (522 – Fig.5) in communication with a blood sample collection apparatus (360 – Fig.3A, [Para [0059]-[0060], [0092]);
an infusion pump (518 – Fig.5) configured to perform infusion; and
a controller (405 – Fig.4) configured to:
control the infusion pump to perform the infusion on a patient during an infusion event (Para [0090]);
control the sampling pump to draw blood from the patient into the blood sample collection apparatus during a sample collection event following the infusion event (Para [0103], “The function of the valves, pumps… described below is controlled by one or more controllers (e.g., the fluid system controller)” – Para [0089], Para [0113]); and
automatically store in a memory unit (“a memory” – Para [0084]) a timestamped data of the infusion event (“dosing history button to determine the time when the patient last received an insulin dose, the last dosage amount, and/or the time and amount of the next dosage” – para [0246], Para [0265], Para [0274]).
However, Rule does not expressly disclose automatically storing in a memory unit a timestamped data of the sample collection event.
Kern teaches a blood sampling system automatically storing in a memory unit (110 – Fig.1) a timestamped data of the sample collection event (“automatically determine a timestamp for a bio-fluid sample” – Para [0025]).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention, to modify the controller’s memory unit disclosed by Rule to automatically store a timestamped data of the sample collection event as taught by Kern since the timestamp is indicative of a time at which the bio-fluid sample is received since it improves sample traceability, reduces record keeping errors, and managing time-sensitive blood samples.
Regarding claim 2, Rule discloses the system as set forth above, but Rule is silent to wherein the timestamped data includes (a) a start time of the sample collection event or the infusion event and (b) an end time of the sample collection event or the infusion event. Although Rule is silent to the specifics of the timestamped data, it would be obvious to one skilled in the art that a dosing history would include information identifying when a dose was administered, such as a start time and an end time to accurately track dosing events and their duration (“dosing history button to determine the time when the patient last received an insulin dose, the last dosage amount, and/or the time and amount of the next dosage” – para [0246], Para [0265], Para [0274]).
Regarding claim 3, Rule discloses the system as set forth above, further comprising a user interface (2400 – Fig.24) to input information regarding the sample collection event and the infusion event (“for inputting commands and/or information” – Para [0238]).
Regarding claim 4, Rule discloses the system as set forth above, wherein the blood sample collection apparatus (360 – Fig.3A) includes a plurality of sample containers (350 – Fig.3A), each being configured to receive one sample of the blood drawn from the patient during the sample collection event (“receive a fluid sample from one or more test tubes” – Para [0058]).
However, Rule does not expressly disclose each of the plurality of sample containers being linked to the timestamped data assigned to the sample collection event.
Kern teaches a plurality of sample containers (125 – Fig.2) being linked to a timestamped data assigned to a sample collection event (Para [0024]).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention, to modify the sample containers of Rule to be linked to the timestamped data assigned to the sample collection event as taught by Kern, since the timestamp is indicative of a time at which the blood sample is received since it improves sample traceability, reducing record keeping errors, and managing time-sensitive blood samples.
Regarding claim 5, Rule discloses the system as set forth above, wherein an amount of blood drawn for the sample ranges from 1.0 cc to 10.0 cc (“between approximately 1.0 ml and approximately 10.0 ml” – Para [0068]) but fails to explicitly disclose an amount of blood drawn for the sample ranges from 0.01 cc to 10 cc.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the sample ranges of Rule to have sample ranges from 0.01 cc to 10 cc since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the system of Rule would not operate differently with the claimed range considering Rule discloses a sample within the applicant’s range wherein the amount of sample withdrawn can be small and can be outside the range given (Rule, Para [0068]). Further, applicant places no criticality on the range claimed, indicating simply that “In some examples, the amount of blood drawn for the sample ranges from 0.01 cc to 10 cc” – Para [0013]).
Regarding claim 6, Rule discloses the system as set forth above, further comprising a user interface (2400 – Fig.24) but Rule is silent to a user interface to facilitate inputting the amount of blood to be drawn for the sample. Although Rule is silent to the specifics of the user interface inputs, it would be obvious to one skilled in the art that since Rule discloses a blood collection system that performs blood sampling operations, Rule’s user interface would be configured to facilitate inputting the amount of blood to be withdrawn, as blood collection procedures routinely require specification of a target sample volume to ensure a sufficient sample is obtained (Rule, Para [0068], Para [0093]).
Regarding claim 7, Rule discloses the system as set forth above, further comprising at least one additional electronic device (414 – Fig.4) operatively coupled with the controller via a wired or wireless network connection (Fig.4), the at least one additional electronic device configured to provide information regarding the sample collection event and the infusion event and to receive the timestamped data of every sample collection event and infusion event facilitated by the controller (“a display system and an algorithm processor that assist in fluid sample analysis and presentation of data” – Para [0063], “the operating status is "Running," which indicates that the system is fluidly connected to the patient ("Jill Doe") and performing normal system functions such as infusing fluid and/or drawing blood” – Para [0240], Para [0242]).
Regarding claim 8, Rule discloses the system as set forth above, further comprising a multi-lumen catheter comprising at least a first lumen (514 – Fig.5) and a second lumen (582 – Fig.5), wherein the first lumen is in fluid communication with an infusion solution storage (548 – Fig.5) and the second lumen is in fluid communication with a sample collection storage (528 – Fig.5, Para [0109]).
Regarding claim 9, Rule discloses the system as set forth above, wherein the memory unit stores therein a drug library comprising instructions on the sample collection event and the infusion event (Para [0317]) associated with each of a plurality of drugs that may be administered during the infusion event (2745, 2755 – Fig.27, Para [0274]-[0275]). Although Rule does not expressly disclose the memory storing instructions on the sample collection event and the infusion event, Rule’s disclosure of automatically performing such events would have conveyed to one skilled in the art that the device necessarily includes stored instructions in the memory for carrying out these operations.
Regarding claim 10, Rule discloses the system as set forth above, wherein the controller is configured to control the sampling pump to perform a plurality of sample collection events associated with a plurality of timestamped data (Para [0095]), and wherein the blood sample collection apparatus (360 – Fig.3A) includes a cassette (362 – Fig.3A) removably installed therein and containing a plurality of sample containers (“one or more test tubes” – Para [0058]), and each of the sample containers contains one sample of the blood drawn from the patient during one of the sample collection events (“receive a fluid sample from one or more test tubes” – Para [0058]).
Regarding claim 12, Rule discloses the system as set forth above, wherein an amount of blood drawn for the sample ranges from 1.0 cc to 10.0 cc (“between approximately 1.0 ml and approximately 10.0 ml” – Para [0068]) but fails to explicitly disclose an amount of blood drawn for the sample ranges from 0.01 cc to 10 cc.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the sample ranges of Rule to have sample ranges from 0.01 cc to 10 cc since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the system of Rule would not operate differently with the claimed range considering Rule discloses a sample within the applicant’s range wherein the amount of sample withdrawn can be small and can be outside the range given (Rule, Para [0068]). Further, applicant places no criticality on the range claimed, indicating simply that “In some examples, the amount of blood drawn for the sample ranges from 0.01 cc to 10 cc” – Para [0013]).
Regarding claim 13, Rule discloses the system as set forth above, further comprising a user interface to facilitate inputting an amount of blood to be drawn for the sample and a time interval between the sample collection events (Para [0068], Para [0093], “the sample can be withdrawn at discrete time intervals” – Para [0066]).
Regarding claim 14, Rule discloses a method of automating fluid sampling and infusion, comprising:
controlling, by a controller (405 – Fig.4), an infusion pump (518 – Fig.5) to perform infusion on a patient during an infusion event (“The function of the valves, pumps… described below is controlled by one or more controllers (e.g., the fluid system controller)” – Para [0089]);
controlling, by the controller, a sampling pump (522 – Fig.5) to draw blood from the patient into a blood sample collection apparatus (360 – Fig.3A), during a sample collection event ([Para [0059]-[0060], [0092], “The function of the valves, pumps… described below is controlled by one or more controllers (e.g., the fluid system controller)” – Para [0089]) following the infusion event (Para [0113]).
However, Rule does not expressly disclose automatically storing by the controller in a memory unit, a timestamped data of the infusion event and the sample collection event.
Kern teaches a blood sampling system automatically storing by the controller (105 – Fig.1) in a memory unit (110 – Fig.1), a timestamped data of the infusion event and the sample collection event (“automatically determine a timestamp for a bio-fluid sample” – Para [0025]).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention, to modify the controller’s memory unit disclosed by Rule to automatically store a timestamped data of the sample collection event as taught by Kern since the timestamp is indicative of a time at which the bio-fluid sample is received since it improves sample traceability, reduces record keeping errors, and manages time-sensitive blood samples.
Regarding claim 15, Rule discloses the method as set forth above, but Rule is silent to wherein the timestamped data includes (a) a start time of the sample collection event or the infusion event and (b) an end time of the sample collection event or the infusion event. Although Rule is silent to the specifics of the timestamped data, it would be obvious to one skilled in the art that a dosing history would include information identifying when a dose was administered, such as a start time and an end time to accurately track dosing events and their duration (“dosing history button to determine the time when the patient last received an insulin dose, the last dosage amount, and/or the time and amount of the next dosage” – para [0246], Para [0265], Para [0274]).
Regarding claim 16, Rule discloses the method as set forth above, further comprising:
receiving, by the controller via a user interface (2400 – Fig.24), information regarding the sample collection event and the infusion event (Para [0240]).
Regarding claim 17, Rule discloses the method as set forth above, wherein the blood sample collection apparatus (360 – Fig.3A) includes a plurality of sample containers (350 – Fig.3A), the method further comprising:
configuring, by the controller, each of the plurality of sample containers to receive one sample of the fluid drawn from the patient during the sample collection event (“receive a fluid sample from one or more test tubes” – Para [0058]).
However, Rule does not expressly disclose linking, by the controller, each of the plurality of sample containers to the timestamped data assigned to the sample collection event.
Kern teaches linking, by a controller (105 – Fig.1), each of a plurality of sample containers (125 – Fig.2) to the timestamped data assigned to the sample collection event (Para [0022], [0024]).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention, to modify the sample containers of Rule to be linked, by the controller, to the timestamped data assigned to the sample collection event as taught by Kern, since the timestamp is indicative of a time at which the bio-fluid sample is received since it improves sample traceability, reducing record keeping errors, and managing time-sensitive blood samples.
Regarding claim 18, further comprising:
receiving, by the controller from at least one additional electronic device (414 – Fig.4) operatively coupled with the controller via a wired or wireless network connection (Fig.4), information regarding the sample collection event and the infusion event; and
transmitting, by the controller to the at least one additional electronic device, the timestamped data of every sample collection event and infusion event facilitated by the controller (“a display system and an algorithm processor that assist in fluid sample analysis and presentation of data” – Para [0063], “the operating status is "Running," which indicates that the system is fluidly connected to the patient ("Jill Doe") and performing normal system functions such as infusing fluid and/or drawing blood” – Para [0240], Para [0242]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Rule in view of Kern as applied to claim 1 above, and further in view of Levine (US Pub No. 20210379268 A1).
Regarding claim 11, Rule discloses the system as set forth above, but is silent to wherein the blood sample collection apparatus is operable to refrigerate the sample containers during the sample collection events.
Levine teaches a blood sample collection apparatus (100 – Fig.1) that is operable to refrigerate the sample containers during the sample collection events (“include refrigeration or cryogenic units that manage blood storage” – Para [0042]).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention, to modify the blood sample collection apparatus of Rule to be operable to refrigerate the sample containers during the sample collection events as taught by Levine since Levine teaches that storing blood in a refrigerator is a well know type of storage for blood samples which maintains blood sample integrity while preventing growth of bacteria.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Marissa Taylor whose telephone number is (571)272-3542. The examiner can normally be reached Monday-Thursday 6:30am-3:30pm EST.
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/MARISSA TAYLOR/Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
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