DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
The amendment filed November 7, 2025 in response to the Office Action of August 8, 2025 has been acknowledged and entered.
Claim Rejections - 35 USC § 103
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.
Claim 1-14, 16-19, 21-25, 27, 29, and 31-34 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Desch (US 6050957) (cited by Applicant) in view of Dillon (WO 0024313).
Regarding claim 1, Desch teaches a multiple-draw, variable suction syringe device, (Fig. 1) comprising: a housing (10) that defines an inlet port (22) for receiving blood (30); a chamber (20) connected with the inlet port, the chamber configured to collect a first portion of the blood responsive to a suction source (Col. 4, lines 7-9, plunger 42, piston 14); and a flow controller (Col. 4, lines 20-22 check valve 54) configured to prevent blood flow into the sampling channel (conduit 50) until the first portion of the blood is in the chamber. (Col. 2, lines 33-35).
However, Desch does not teach “a sampling channel connected with the inlet port and configured to convey a subsequent portion of the blood from the inlet port responsive to the suction source”.
Dillon, in a related field of endeavor, teaches a blood collection device, (Figs. 1-2a) comprising: a sampling channel (curved channel 134) connected with the inlet port (106a) and configured to convey a subsequent portion of the blood from the inlet port (106a) responsive to the suction source (Fig. 1; Page 6, lines 15-16, sampling syringe 126).
Although Dillon teaches that during collection, the use of sample port/syringe 126 is used to take samples from pouch 116, shifting the position of the syringe to sample line 118a instead would not have modified the operation of the device. As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Desch to teach “a sampling channel connected with the inlet port and configured to convey a subsequent portion of the blood from the inlet port responsive to the suction source” as taught by Dillon. Doing so enables blood collection of a subsequent portion to be isolated directly in a syringe without an intermediate sample pouch.
Regarding claim 2, Desch illustrates (Fig. 1) wherein the housing (10) defines at least a portion of the chamber (20) and at least a portion of the sampling channel (50).
Regarding claim 3, Desch illustrates (Fig. 2) wherein the first portion of the blood (30) is an initial portion of the blood from a patient after venipuncture. (Col. 3, lines 51-55, first chamber 20 adjacent to fluid inlet 22 which receives flow of initial fluid 30 when syringe is in use).
Regarding claim 4, Desch teaches wherein the suction source (plunger 42, piston 14) is a dual seal suction source. (Col. 2, lines 17-19, piston and plunger are sealably engaging and slidable along an interior wall of the cylindrical body).
Regarding claim 5, Desch teaches wherein the chamber (20) is configured to collect the first portion of the blood (30) when the suction source applies a suction in the chamber (Col. 4, lines 7-9, plunger 42, piston 18), and the sampling channel (50) is configured to convey the subsequent portion of the blood when the suction source applies the suction in the sampling channel. (Col. 4, lines 14-19).
Regarding claim 6, Desch teaches wherein the flow controller (54) is configured, in a first position, to initially close off the sampling channel, (Fig. 2, check valve 54 in a closed position) and is further configured, in a second position, to facilitate a flow of the subsequent portion of the blood (30) through the sampling channel. (Fig. 3, check valve 54 in an open position).
Regarding claim 7, Desch teaches wherein the chamber (20) is configured to collect and sequester the first portion of the blood (30), the sampling channel (50) is configured to convey the subsequent portion of the blood past the chamber and the first portion of the blood sequestered therein. (See Figs. 2-3).
Regarding claim 8, Desch teaches a device, (Fig. 1) comprising: a housing (10) that defines an inlet port (22) for receiving blood (30); a chamber (20) connected with the inlet port and configured to collect an amount of blood when suction is applied via a suction source in the chamber (Col. 4, lines 7-9, plunger 42, piston 14); and a flow controller (Col. 4, lines 20-22 check valve 54), configured, in a first position, (Fig. 2) to prevent blood flow from flowing into the sampling channel (conduit 50), and further configured, in a second position, (Fig. 3), such that the subsequent amount of the blood flows past the chamber and through the sampling channel. (Col. 2, lines 33-35).
However, Desch does not teach “a sampling channel connected with the inlet port and configured to convey a subsequent amount of the blood from the inlet port when suction is applied, via the suction source, in the sampling channel.”
Dillon teaches (Figs. 1-2) a sampling channel (curved channel 134) connected with the inlet port (106a) and configured to convey a subsequent portion of the blood from the inlet port (106a) when suction is applied, via the suction source, in the sampling channel. (Fig. 1; Page 6, lines 15-16, sampling syringe 126).
Although Dillon teaches that during collection, the use of sample port/syringe 126 is used to take samples from pouch 116, shifting the position of the syringe to sample line 118a instead would not have modified the operation of the device. As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Desch to teach “a sampling channel connected with the inlet port and configured to convey a subsequent amount of the blood from the inlet port when suction is applied, via the suction source, in the sampling channel” as taught by Dillon. Doing so enables blood collection of a subsequent portion to be isolated directly in a syringe without an intermediate sample pouch.
Regarding claim 9, Desch illustrates (Fig. 1) wherein the housing (10) defines at least a portion of the chamber (20) and at least a portion of the sampling channel (50).
Regarding claim 10, Desch illustrates (Fig. 2) wherein the amount of the blood (30) is an initial amount of the blood after venipuncture. (Col. 3, lines 51-55, first chamber 20 adjacent to fluid inlet 22 which receives flow of initial fluid 30 when syringe is in use).
Regarding claim 11, Desch teaches wherein the suction source (plunger 42, piston 14) is a dual seal suction source. (Col. 2, lines 17-19, piston and plunger are sealably engaging and slidable along an interior wall of the cylindrical body).
Regarding claim 12, Desch teaches wherein a flow path (fluid flow through fluid outlet 24) is defined between the inlet port (22) and the chamber (20) when the flow controller (54) is in the first position. (Fig. 2).
Regarding claim 13, Desch teaches wherein the flow controller (54) is configured to occlude at least a portion of the sampling channel (50) before the amount of the blood is collected in the chamber. (See Fig. 2).
Regarding claim 14, Desch teaches (Fig. 3), wherein the flow controller (54) is configured to be moved after the amount of the blood is in the chamber. (Figs. 2-3, Col. 4, lines 40-47 check valve 54 comprises a ball 80 that is shiftable from a position in engagement with the conduit conical sidewall 76 whereby to close the conduit inlet, and a position supported by the stems 78 in spaced relationship from the conduit outlet 74 whereby to permit flow of fluid through the conduit chamber 70, out of the conduit outlet and into the enclosed fluid collection receptacle 52.)
Regarding claim 16, Desch teaches a device, (Fig. 1) comprising: a housing (10) that defines an inlet port (22) for receiving blood (30); a chamber (20) connected with the inlet port and configured to collect an amount of blood when suction source applies suction within the housing (Col. 4, lines 7-9, plunger 42, piston 14); and a flow controller (Col. 4, lines 20-22 check valve 54), configured, in a first position, (Fig. 2) to prevent blood flow from flowing into the sampling channel (50), and further configured, in a second position, (Fig. 3), such that the subsequent amount of the blood flows past the chamber (20) and through the sampling channel (50). (Col. 2, lines 33-35).
However, Desch does not teach “a sampling channel connected with the inlet port and configured to convey a subsequent amount of the blood from the inlet port under continued suction within the housing.”
Dillon teaches (Figs. 1-2) a sampling channel (curved channel 134) connected with the inlet port (106a) and configured to convey a subsequent portion of the blood from the inlet port (106a) under continued suction within the housing. (Fig. 1; Page 6, lines 15-16, sampling syringe 126).
Although Dillon teaches that during collection, the use of sample port/syringe 126 is used to take samples from pouch 116, shifting the position of the syringe to sample line 118a instead would not have modified the operation of the device. As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Desch to teach “a sampling channel connected with the inlet port and configured to convey a subsequent amount of the blood from the inlet port under continued suction within the housing” as taught by Dillon. Doing so enables blood collection of a subsequent portion to be isolated directly in a syringe without an intermediate sample pouch.
Regarding claim 17, Desch illustrates (Fig. 1) wherein the housing (10) defines at least a portion of the chamber (20) and at least a portion of the sampling channel (50).
Regarding claim 18, Desch illustrates (Fig. 2) wherein the amount of the blood (30) is an initial amount of the blood after venipuncture. (Col. 3, lines 51-55, first chamber 20 adjacent to fluid inlet 22 which receives flow of initial fluid 30 when syringe is in use).
Regarding claim 19, Desch teaches wherein the flow controller (54) is configured, in a first position, to initially close off the sampling channel, (Fig. 2, check valve 54 in a closed position) and is further configured, in a second position, to facilitate a flow of the subsequent portion of the blood (30) through the sampling channel. (Fig. 3, check valve 54 in an open position).
Regarding claim 21, Desch teaches wherein the chamber (20) is configured to collect and sequester the amount of the blood (30), the sampling channel (50) is configured to convey the subsequent portion of the blood past the chamber and the first portion of the blood sequestered therein. (See Figs. 2-3).
Regarding claim 22, Desch teaches a device, (Fig. 1) comprising: a housing (10) that defines an inlet port (22) for receiving blood (30); a chamber (20) connected with the inlet port; a sampling channel (conduit 50) connected with the inlet port; and a flow controller (Col. 4, lines 20-22 check valve 54), configured, in a first position, (Fig. 2), to close off the sampling channel such that a suction source (Col. 4, lines 7-9, plunger 42, piston 14) draws a first portion of the blood into the chamber (20),
However, Desch does not teach “the flow controller further configured, in a second position, to open the sampling channel such that a sample of the blood is drawn, via the suction source, from the inlet port through the sampling channel.”
Dillon teaches (Figs. 1-2) the flow controller (110) further configured, in a second position, (Fig. 2a) to open the sampling channel (curved channel 134) such that a sample of the blood is drawn, via the suction source, (Fig. 1; Page 6, lines 15-16, sampling syringe 126), from the inlet port (106a) through the sampling channel (134).
Although Dillon teaches that during collection, the use of sample port/syringe 126 is used to take samples from pouch 116, shifting the position of the syringe to sample line 118a instead would not have modified the operation of the device. As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Desch to teach “the flow controller further configured, in a second position, to open the sampling channel such that a sample of the blood is drawn, via the suction source, from the inlet port through the sampling channel” as taught by Dillon. Doing so enables blood collection of a subsequent portion to be isolated directly in a syringe without an intermediate sample pouch.
Regarding claim 23, Desch illustrates (Fig. 1) wherein the housing (10) defines at least a portion of the chamber (20) and at least a portion of the sampling channel (50).
Regarding claim 24, Desch illustrates (Fig. 2) wherein the amount of the blood (30) is an initial amount of the blood after venipuncture. (Col. 3, lines 51-55, first chamber 20 adjacent to fluid inlet 22 which receives flow of initial fluid 30 when syringe is in use).
Regarding claim 25, Desch teaches wherein the flow controller (54) is configured to be moved to the second position (Fig. 3) after the first portion of the blood is in the chamber (Fig. 2).
Regarding claim 27, Desch teaches wherein the flow controller (54) is configured, in the second position, (Fig. 3), such that the sample of the blood flows past the chamber (20) and through the sampling channel (50).
Regarding claim 29, Desch contemplates a sealing member positioned in the housing and configured to facilitate the chamber collecting the first portion of the blood. (Col. 2, lines 17-19, piston and plunger are sealably engaging and slidable along an interior wall of the cylindrical body).
Regarding claims 31-34, Dillon teaches wherein the sampling channel (134) conveys the sample of the blood (via sample line 118a) to a sample volume separate from the chamber (Fig. 1, pouch 116). (See Figs. 1, 2a and 2b; Page 9, lines 17-27).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Desch to teach “wherein the sampling channel conveys the sample of the blood to a sample volume separate from the chamber” as taught by Dillon. Doing so enables blood to be sequestered into a container that may be removed from the sample line for later access. (Page 5, lines 24-27).
Claims 15, 20, 26, 28, and 30 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Desch in view Dillon, further in view of Phillips (US 20040124389) (previously cited).
Regarding claims 15, 20, 26, and 28, Desch does not teach “wherein the flow controller is a movable elastomeric seal configured to form a fluid tight seal with an inner surface of the housing.”
Phillips, in a related field of endeavor, teaches a blood collection device (Figs. 4-5) wherein the flow controller (valve plug 70) is a movable elastomeric seal configured to form a fluid tight seal with an inner surface of the housing (42). (Paragraph [0055] As such, the distal head 75 of the valve plug 70 is configured to seat against the shoulder so as to achieve a surface-to-surface seal when the valve plug is forced into contact with the shoulder by a biasing device such as elastomeric device 90; Paragraph [0057] elastomeric device 90 biases the valve plug distally so as to maintain a bias tending to maintain a seal between the valve plug head 75 and the flow passage distal shoulder 49).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Desch to teach “wherein the flow controller is a movable elastomeric seal configured to form a fluid tight seal with an inner surface of the housing”. Doing so minimizes risk of fluid escape. (Paragraph [0059]).
Regarding claim 30, Desch does not teach “wherein the sealing member is configured to transition from a first configuration to a second configuration as the first portion of blood is collected in the chamber.”
Phillips illustrates wherein the sealing member is configured to transition from a first configuration (Fig. 4) to a second configuration (Fig. 5) as the first portion of blood is collected in the chamber.
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Desch to teach “wherein the sealing member is configured to transition from a first configuration to a second configuration as the first portion of blood is collected in the chamber”. Doing so enables the ability to selectively seal the flow passage. (Paragraph [0065]).
Response to Arguments
Applicant’s arguments, see “Remarks”, filed 11/7/2025, with respect to the rejection of claims
1-2, 4-9, 11-17, 19-23 and 25-34 under 35 U.S.C. 103 have been fully considered. However, upon further consideration, a new ground of rejection was necessitated by the claim amendments made in view of Dillon.
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 Om A. Patel whose telephone number is (571)272-6331. The examiner can normally be reached Monday - Friday 8 a.m. - 5 p.m..
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/OM PATEL/Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791