Prosecution Insights
Last updated: April 19, 2026
Application No. 18/560,059

MACHINE AND ACCESSORIES FOR PERFORMING DOUBLE VOLUME EXCHANGE TRANSFUSION IN NEONATES

Non-Final OA §102§103
Filed
Nov 09, 2023
Examiner
STRANSKY, KATRINA MARIE
Art Unit
3700
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
COUNCIL OF SCIENTIFIC AND INDUSTRIAL RESEARCH
OA Round
1 (Non-Final)
74%
Grant Probability
Favorable
1-2
OA Rounds
3y 4m
To Grant
99%
With Interview

Examiner Intelligence

Grants 74% — above average
74%
Career Allow Rate
441 granted / 596 resolved
+4.0% vs TC avg
Strong +25% interview lift
Without
With
+24.6%
Interview Lift
resolved cases with interview
Typical timeline
3y 4m
Avg Prosecution
10 currently pending
Career history
606
Total Applications
across all art units

Statute-Specific Performance

§101
0.9%
-39.1% vs TC avg
§103
41.2%
+1.2% vs TC avg
§102
31.6%
-8.4% vs TC avg
§112
18.1%
-21.9% vs TC avg
Black line = Tech Center average estimate • Based on career data from 596 resolved cases

Office Action

§102 §103
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 Objections Claim 8 is objected to because of the following informalities: In line 2, before “controller”, the word “the” is missing, and in line 3, in the phrase “to detect on of bubbles” should read “to detect one of bubbles” . Appropriate correction is required. Claim Rejections - 35 USC § 102 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale , or otherwise available to the public before the effective filing date of the claimed invention. Claim 10 is rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Chattopadhyay et al, US 7,083,587 . Regarding claim 10 , Chattopadhyay discloses a method for blood transfusion in a specimen ( Abstract, col. 2, lines 20-65, Fig. 2 ), the method comprising: receiving, from a user by a controller (manual or stepper motor , col. 2, lines 55-60 ) , an instruction of closing a first valve( 14 ) and opening a second valve(11), wherein the first valve (1 4 ) is in fluid communication with a first syringe (1 3 ), a source of fresh blood, and the specimen, and the second valve (11) is in fluid communication with a second syringe (10), the specimen, and a waste bin ( col. 2, lines 20-65 , col. 3, lines 1-40, see Fig. 2) ; actuating, by the controller, a first plunger ( slider of syringe, para [0044] ) inside the first syringe(1 3 ) and a second plunger ( slider of syringe, para [0044] ) in the second syringe (10) to execute a backward stroke, wherein the blood from the source of fresh blood is drawn into the first syringe (1 3 ) and blood from the specimen into the second syringe (10 , col. 2, lines 20-65, col. 3, lines 1-40 ); actuating, by the controller, the first valve (1 4 ) in open state and the second valve (11) in closed state ( col. 2, lines 20-65, col. 3, lines 1-40 ) ; actuating, by the controller, the first plunger and the second plunger execute a forward stroke, wherein the blood from the first syringe ( 13 ) is pumped into the specimen and blood from the second syringe (10) is pumped into the waste bin ( col. 2, lines 20-65, col. 3, lines 1-40 ). 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. Claim s 1- 4, 7- 9 are rejected under 35 U.S.C. 103 as being unpatentable over Chattopadhyay et al, US 7,083,587 in view of Bonetti, EP 1 634 613 . Regarding claim 1 , Chattopadhyay discloses a Double Volume Exchange Transfusion (DVET) unit ( Fig. 2, col. 2, lines 20-60 ) comprising: a first syringe ( 13 ) and a second syringe ( 10 ) having a first plunger ( syringe 13 inherently has plunger, Fig. 2 ) and a second plunger ( syringe 10 inherently has plunger, Fig. 2 ), respectively, wherein each of the first plunger and the second plunger is adapted to execute a backward stroke and a forward stroke in the respective syringe (Stroke 1, Stroke 2, Fig. 2) ; a first valve ( 14 ) in fluid communication with the first syringe, a fresh blood source, and a specimen ( Fig. 2, col. 2, lines 20-40 ); and a second valve (11) in fluid communication with the second syringe, the specimen, and a waste bin ( Fig. 2, col. 2, lines 20-40 ), wherein the first valve ( 14 ) is adapted to be closed and the second valve (11) is adapted to be open to draw blood from the fresh blood source and the specimen into the first syringe and the second syringe , respectively, during the backward stroke (col. 2, line 55 to col. 3, line 15) , and the first valve( 14 ) is adapted to be open and the second valve( 11 ) is adapted to be closed to pump the blood, drawn during the backward stroke, from the first syringe and the second syringe into the specimen and the waste bin, respectively, during the forward stroke (col. 2, line 55 to col. 3, line 15) . Chattopadhyay is silent as to the first and second valves disposed in a housing. However, Bonetti , in the same field of art, namely, transfusion /infusion devices, teaches a transfusion unit (100, Figs. 1-3, para [0019]) having first and second syringes (3, 3a, Fig. 3) with first and second plungers respectively (4, 4a, Fig. 3) , and a first valve (7) disposed in a housing (101) and in fluid communication with the first syringe (3) , and a second valve (7a) disposed in the housing (101) and in fluid communication with the second syringe ( 3a, paras [0030]-[0031] ). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to p lace the valves of Chattopadhyay in a housing as taught by Bonetti in order to provide the benefit of protect ing the pumping group /valve system from debris/contamination, and since it is known in the art to use a closed casing to provide support and protection to the valves, hoses and syringes during a medical procedure . Regarding claim 2 , Chattopadhyay as modified discloses t he DVET unit as claimed in claim 1, comprising: a first Y-connector ( 7, Fig. 2 , col. 3, lines 45-55 ) adapted to fluidically couple the specimen to inlet ports of each of the first valve ( 14 ) and the second valve ( 11 ); a second Y-connector ( 16 , col. 3, lines 45-55 ) adapted to fluidically couple the first syringe ( 13 ) with an outlet port of the first valve ( 14 ) and the fresh blood source ( Fig. 2 ); and a third Y-connector ( 16 , col. 3, lines 45-55 ) adapted to fluidically couple the second syringe ( 10 ) with an outlet port of the second valve ( 11 ) and the waste bin ( Fig. 2 ). Regarding claim 3 , Chattopadhyay as modified discloses t he DVET unit as claimed in claim 1, comprising: a first one-way valve ( 15 ) adapted to prevent backflow from the first syringe ( 13 ) to the fresh blood source ( Fig. 2 ); and a second one-way valve ( 12 ) adapted to prevent backflow from the waste bin ( Fig. 2 ) to the second syringe ( 10 ). Regarding claim 4 , Chattopadhyay as modified discloses t he DVET unit as claimed in claim 1, comprising an actuation unit ( driving mechanism, col. 3, lines 10-35 ) coupled to the first plunger ( 13 ) and the second plunger ( 10 ) to execute the backward stroke and the forward stroke. Regarding claim 7 , Chattopadhyay as modified discloses t he DVET as claimed in claim 1, comprising a controller ( col. 4, lines 55-67, automatic system with switches and display ) adapted to: actuate the first valve ( 14 ) to close and the second valve ( 11 ) to open during the backward stroke; and actuate the first valve ( 14 ) to open and the second valve ( 11 ) to close during the forward stroke. Regarding claim 8 , Chattopadhyay as modified discloses t he DVET unit as claimed in claim 7, comprising a sensor coupled to controller ( col. 4, lines 55-67, automatic system with alarms would inherently include a sensor to trigger alarm ) and attached to a hose connecting the specimen ( patient ) and the first Y-connector ( 7 ), and adapted to detect on of bubbles and clots in the blood passing through the hose ( col. 4, lines 55-67 ) , wherein the controller is capable of paus ing one of the backward stroke and forward stroke in presence of one of sensed bubble and clot in the blood (col. 4, lines 55-67) . Regarding claim 9 , Chattopadhyay as modified discloses t he DVET unit as claimed in claim 8, comprising a pressure sensor ( col. 4, lines 55-67, automatic system with alarms would inherently include a pressure sensor to trigger alarm based on high pressure ) adapted to detect pressure gradient in the hose, wherein the pressure gradient is based on one of a resistance and ease in the backward stroke and the forward stroke by the actuation ( col. 4, lines 55-67 ). Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Chattopadhyay and Bonetti, and further in view of Wight et al, US 2017/0281857 A 1. Regarding claim 5, Chattopadhyay discloses the DVET as claimed in claim 4, wherein the actuation unit (driving mechanism, col. 3, lines 10-35) comprising: a stepper motor (col. 4, lines 20-25). Chattopadhyay is silent as to a screw coupled to the stepper motor and adapted to rotate clockwise and anticlockwise by the stepper motor; a carriage mounted on the screw and coupled to ends of the first plunger and the second plunger, wherein the carriage moves along a length of the screw in response to the rotation of the screw. However, Wight, in the same field of art, teaches a syringe infusion pump ( Figs. 1-6, para [0043] ) , having a syringe with a plunger ( 100, 102, para [0041] ) coupled to an actuation unit ( pump 10, paras [0043]-[0044] ), where the actuation unit is a stepper motor including a screw ( lead screw, para [0043] ) coupled to the stepper motor and adapted to rotate clockwise and anticlockwise by the stepper motor ( para [0043] ); a carriage ( 30 ) mounted on the screw ( Fig. 1 ) and coupled to end of the plunger ( para [0043] ), wherein the carriage ( 30 ) moves along a length of the screw in response to the rotation of the screw ( para [0043] ). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the stepper motor/screw and carriage arrangement as taught by Wight in the stepper motor of Chattopadhyay in order to provide the stated advantages of automatically stopping and/or withdrawing the drive head in order to provide safety action to prevent high pressure (para [0005]), and since the motor of Wight would be known to one of ordinary skill in the art as an alternative and/or substitute to the motor of Chattopadhyay which would result in more efficient pumping and lead to a reasonable expectation of success . Regarding claim 6, Chattopadhyay as modified discloses the DVET unit as claimed in claim 5, and Wight further teaches comprising a push button ( switch 24 ) adapted to indicate the mounting of syringe ( 100 ) on the carriage ( 30 ) (para [0046]) . It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the push button/switch arrangement as taught by Wight in the stepper motor of Chattopadhyay in order to provide the stated advantages of indicating that the syringe is in proper position to prevent inadvertent pumping (Wight, para [0046]). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT KATRINA M STRANSKY whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-3843 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday-Friday 8:30 am-5:00 pm EST . 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, Thomas Barrett can be reached at (571)272-4 7 4 6 . 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. /KATRINA M STRANSKY/ Primary Examiner, Art Unit 3700
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Prosecution Timeline

Nov 09, 2023
Application Filed
Mar 11, 2026
Non-Final Rejection — §102, §103 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
74%
Grant Probability
99%
With Interview (+24.6%)
3y 4m
Median Time to Grant
Low
PTA Risk
Based on 596 resolved cases by this examiner. Grant probability derived from career allow rate.

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