DETAILED ACTION
This action is responsive to the Amendment filed 2 October 2025. The Examiner acknowledges the amendments to claims 1, 12, 15 and 19, as well as the cancellation of claims 2-8, 11, 14, 16, and 17. Claims 1, 9-10, 12-13, 15, and 18-20 are pending.
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(s) 1, 12, and 19 is/are objected to because of the following informalities:
Claims 1, 12, and 19 should read “point-of-care” [line 11 in claim 1, line 18 in claim 12, line 18 in claim 19; wherein the Examiner notes a missing “-“ between “of” and “care” to maintain consistency].
Appropriate correction is required.
Claim Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 9-10, 12-13, 15, and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ivosevic (US-20190265134-A1, previously presented) in view of Abramson (US-4166450-A, previously presented) and Haley (US-20050214927-A1, previously presented).
Regarding claim 1, Ivosevic teaches
A point-of-care blood collection and dispensing device for use with a luer lock access device, comprising:
a distal engagement portion, wherein at least a part of the distal engagement portion is configured to engage a needle of the luer lock access device [The closure 28 protectively covers the inlet port 32. The closure 28 allows for introduction of a blood sample 12 into the passageway 36 of the housing 20 and may include a pierceable self-sealing stopper 82 (FIG. 17) with an outer shield 84 such as a Hemogard™ cap commercially available from Becton, Dickinson and Company (Ivosevic ¶0061, Fig. 17)];
a sidewall portion, wherein at least part of the sidewall portion is formed of a flexible material capable of being compressed [the collection chamber 26 includes a first deformable portion 62, a second deformable portion 64 (Ivosevic ¶0054)];
a fluid chamber configured to hold a blood sample, the fluid chamber bound at least partially by the distal engagement portion, a closed proximal end, and the sidewall portion [wherein the collection chamber 26 is considered to be bound at least partially by the first deformable portion 62, second deformable portion 64, and the closure 28 (see Ivosevic Fig. 17), wherein the Examiner notes that the collection chamber 26 is also considered to be bound by the cap 30 and venting plug 80, which are considered to define a closed proximal end];
a stopper member positioned within the distal engagement portion and configured to be pierced by the needle of the luer lock access device [a needle cannula 100 (FIGS. 17 and 18) is inserted into the passageway 36 of the housing 20 of the collection module 14 through the inlet port 32, such as through the pierceable self-sealing stopper 82 of closure 28 (Ivosevic ¶0062, Fig. 17)].
However, Ivosevic fails to explicitly disclose wherein the stopper member is offset from a central axis of the point-of care blood collection and dispensing device within the distal engagement portion.
The Examiner notes that while no specific portion of the stopper member is recited as being offset from a central axis of the device, any portion of the stopper 82 that is not located directly along the central axis of the device 10 of Ivosevic may be considered to be “offset” from the central axis [see Ivosevic Fig. 17]. The Examiner further notes that Abramson depicts a luer lock access device comprising a needle that is configured to pierce a stopper member at a position of the stopper member that is offset from a central axis of a blood collection device that the stopper member is disposed on [It is one of the features of the present device that the axis 24 of the main chamber is laterally offset from the axis 34 of the mid-chamber, antechamber and the needles, the offset being indicated at "0" in FIG. 2 (Abramson Col 5:28-31, Fig. 2); the outer end 62 of the auxiliary needle will penetrate the diaphragm at a point which is certain to be offset from the central evacuation opening 77 (Abramson Col 5:35-38, 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 device of Ivosevic to employ a portion of the stopper member offset from a central axis of the point-of care blood collection and dispensing device within the distal engagement portion as being the particular stopper member, as this modification is considered to merely apply a known technique to a known device (method, or product) [any offset portion of stopper 82 relative to the central axis of the device may be configured to pierced by a needle, such that the stopper member may be considered offset] ready for improvement to yield predictable results [MPEP § 2143(I)(D)].
However, while Ivosevic discloses an opening sized and configured to dispense a small volume of the blood sample held within the fluid chamber when the sidewall portion is compressed [the cap 30 may then be removed from the collection module 14 (FIG. 21) exposing the outlet port 34 of the housing 20 of the collection module 14 (Ivosevic ¶0065); the first deformable portion 62 and the second deformable portion 64 are transitionable between an initial position (FIGS. 1A-4 and 21-23) in which the sample 12 is contained within the collection chamber 26 and a deformed position (FIGS. 5 and 24) in which a portion of the sample 12 is expelled from the collection chamber 26 and the outlet port 34 (Ivosevic ¶0066)], Ivosevic in view of Abramson fails to explicitly disclose a one-way valve positioned within the distal engagement portion and offset from the central axis, so as to be in a side-by-side arrangement with the stopper, with the one-way valve including an opening, wherein the opening is sized and configured to dispense a small volume of the blood sample held within the fluid chamber when the sidewall portion is compressed.
Haley discloses systems and methods for collection and dispensing of a sample, wherein Haley discloses an inlet offset from a central axis of a sample collection and dispensing device with a distal end of the device [Sample is drawn into first passage 14 through first opening 18, drawn along first passage 14, and then withdrawn from first passage 14 through second opening 20 and valve 36. The exiting sample typically enters a reservoir of the vacuum source (e.g., a barrel 52 of syringe 50) (Haley ¶0019, Fig. 1)]; and a one-way valve positioned within the distal end of the device and offset from the central axis, in a side-by-side arrangement to the inlet, with the one-way valve including an opening, wherein the opening is sized and configured to dispense a small volume of the sample held within a fluid chamber of the device when external pressure is applied to the device [Second opening 24 of second passage 16 includes a valve 38 configured to allow fluid to exit second passage 16 via second opening 24 and to limit or prevent entry of fluid and particles to second passage 16 by second opening 24 (Haley ¶0018), wherein the valve 38 being configured to allow for fluid to exit but not enter the second passage 16 by second opening 24 is considered to define a one-way valve; The plunger of syringe 50 is then depressed to apply pressure to sample within barrel 52. Valve 36 closes to prevent material from reentering first passage 14. Sample is pushed into second passage 16 through first opening 22, pushed along second passage 16, and pushed from second opening 24 through valve 38 to exit device 10 (Haley ¶0020, Fig. 1)].
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 device of Ivosevic in view of Abramson to employ a one-way valve positioned within the distal engagement portion and offset from the central axis, with the one-way valve including an opening, wherein the opening is sized and configured to dispense a small volume of the blood sample held within the fluid chamber when the sidewall portion is compressed, as this modification would amount to mere simple substitution of one known element [opening for dispensing the collected sample as positioned by Ivosevic (see Ivosevic Figs. 3-5)] for another [opening for dispensing the collected sample as positioned by Haley] with similar expected results of allowing for controlled dispensing of a fluid sample contained within the device [MPEP § 2143(I)(B)].
Regarding claim 9, Ivosevic in view of Abramson and Haley teaches
The point-of-care blood collection and dispensing device of claim 1, wherein the sidewall portion comprises an indented portion configured to allow compression of the sidewall portion [see Ivosevic Fig. 17].
Regarding claim 10, Ivosevic in view of Abramson and Haley teaches
The point-of-care blood collection and dispensing device of claim 1, wherein at least part of the sidewall portion is formed of an elastomeric material [the first deformable portion 62 and the second deformable portion 64 may be made of natural or synthetic rubber, and other suitable elastomeric materials (Ivosevic ¶0058)].
Regarding claim 12, Ivosevic teaches
A small sample blood collection system for use with point-of-care diagnostic testing devices, comprising:
a luer lock access device comprising:
a luer lock access hub configured to couple the luer lock access device to an intermediate device for venous access to a patient [Advantageously, a biological fluid collection device of the present disclosure provides a consistent blood sample management tool for point-of-care and near patient testing applications, automatic blood draw, passive mixing technology, and controlled small sample dispensing capability to point-of-care cartridge and standard luer interfaces with near patient testing receiving ports (Ivosevic ¶0040), wherein Ivosevic Figs. 16-18 are considered to depict a hub (based on ¶0040 considered to use luer lock structures, see Annotated Figure 1) configured to couple the a device (based on ¶0040 considered to use luer lock structures) to an intermediate device for venous access],
a needle fluidly coupled to the luer lock access hub [needle cannula 100 (Ivosevic Fig. 17)], and
a holder at least partially surrounding the needle and configured to hold a blood collection device [As shown in FIGS. 16-18, the biological fluid collection device 10 including the combined collection module 14 and the outer housing 16 may be inserted into a conventional tube holder 102 having a cannula 100 through which biological fluid, such as a blood sample 12, is passed (Ivosevic ¶0062, Figs. 16-17)]; and
a point-of-care blood collection and dispensing device comprising:
a distal engagement portion, wherein at least a part of the distal engagement portion is configured to engage the needle of the luer lock access device [The closure 28 protectively covers the inlet port 32. The closure 28 allows for introduction of a blood sample 12 into the passageway 36 of the housing 20 and may include a pierceable self-sealing stopper 82 (FIG. 17) with an outer shield 84 such as a Hemogard™ cap commercially available from Becton, Dickinson and Company (Ivosevic ¶0061, Fig. 17)],
a sidewall portion, wherein at least part of the sidewall portion is formed of a flexible material capable of being compressed [the collection chamber 26 includes a first deformable portion 62, a second deformable portion 64 (Ivosevic ¶0054)],
a fluid chamber configured to hold a blood sample, the fluid chamber bound at least partially by the distal engagement portion, a closed proximal end, and the sidewall portion [wherein the collection chamber 26 is considered to be bound at least partially by the first deformable portion 62, second deformable portion 64, and the closure 28 (see Ivosevic Fig. 17), wherein the Examiner notes that the collection chamber 26 is also considered to be bound by the cap 30 and venting plug 80, which are considered to define a closed proximal end];
a stopper member positioned within the distal engagement portion and configured to be pierced by the needle of the luer lock access device [a needle cannula 100 (FIGS. 17 and 18) is inserted into the passageway 36 of the housing 20 of the collection module 14 through the inlet port 32, such as through the pierceable self-sealing stopper 82 of closure 28 (Ivosevic ¶0062, Fig. 17)].
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Annotated Figure 1. The Examiner has annotated Fig. 17 of Ivosevic to identify the portion of the system of Ivosevic that is considered to read on the claimed luer lock access hub.
However, Ivosevic fails to explicitly disclose wherein the stopper member is offset from a central axis of the point-of care blood collection and dispensing device within the distal engagement portion.
The Examiner notes that while no specific portion of the stopper member is recited as being offset from a central axis of the device, any portion of the stopper 82 that is not located directly along the central axis of the device 10 of Ivosevic may be considered to be “offset” from the central axis [see Ivosevic Fig. 17]. The Examiner further notes that Abramson depicts a luer lock access device comprising a needle that is configured to pierce a stopper member at a position of the stopper member that is offset from a central axis of a blood collection device that the stopper member is disposed on [It is one of the features of the present device that the axis 24 of the main chamber is laterally offset from the axis 34 of the mid-chamber, antechamber and the needles, the offset being indicated at "0" in FIG. 2 (Abramson Col 5:28-31, Fig. 2); the outer end 62 of the auxiliary needle will penetrate the diaphragm at a point which is certain to be offset from the central evacuation opening 77 (Abramson Col 5:35-38, 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 system of Ivosevic to employ a portion of the stopper member offset from a central axis of the point-of care blood collection and dispensing device within the distal engagement portion as being the particular stopper member, as this modification is considered to merely apply a known technique to a known device (method, or product) [any offset portion of stopper 82 relative to the central axis of the device may be configured to pierced by a needle, such that the stopper member may be considered offset] ready for improvement to yield predictable results [MPEP § 2143(I)(D)].
However, while Ivosevic discloses an opening sized and configured to dispense a small volume of the blood sample held within the fluid chamber when the sidewall portion is compressed [the cap 30 may then be removed from the collection module 14 (FIG. 21) exposing the outlet port 34 of the housing 20 of the collection module 14 (Ivosevic ¶0065); the first deformable portion 62 and the second deformable portion 64 are transitionable between an initial position (FIGS. 1A-4 and 21-23) in which the sample 12 is contained within the collection chamber 26 and a deformed position (FIGS. 5 and 24) in which a portion of the sample 12 is expelled from the collection chamber 26 and the outlet port 34 (Ivosevic ¶0066)], Ivosevic in view of Abramson fails to explicitly disclose a one-way valve positioned within the distal engagement portion and offset from the central axis, so as to be in a side-by-side arrangement with the stopper, with the one-way valve including an opening, wherein the opening is sized and configured to dispense a small volume of the blood sample held within the fluid chamber when the sidewall portion is compressed.
Haley discloses systems and methods for collection and dispensing of a sample, wherein Haley discloses an inlet offset from a central axis of a sample collection and dispensing device with a distal end of the device [Sample is drawn into first passage 14 through first opening 18, drawn along first passage 14, and then withdrawn from first passage 14 through second opening 20 and valve 36. The exiting sample typically enters a reservoir of the vacuum source (e.g., a barrel 52 of syringe 50) (Haley ¶0019, Fig. 1)]; and a one-way valve positioned within the distal end of the device and offset from the central axis, in a side-by-side arrangement to the inlet, with the one-way valve including an opening, wherein the opening is sized and configured to dispense a small volume of the sample held within a fluid chamber of the device when external pressure is applied to the device [Second opening 24 of second passage 16 includes a valve 38 configured to allow fluid to exit second passage 16 via second opening 24 and to limit or prevent entry of fluid and particles to second passage 16 by second opening 24 (Haley ¶0018), wherein the valve 38 being configured to allow for fluid to exit but not enter the second passage 16 by second opening 24 is considered to define a one-way valve; The plunger of syringe 50 is then depressed to apply pressure to sample within barrel 52. Valve 36 closes to prevent material from reentering first passage 14. Sample is pushed into second passage 16 through first opening 22, pushed along second passage 16, and pushed from second opening 24 through valve 38 to exit device 10 (Haley ¶0020, Fig. 1)].
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 system of Ivosevic in view of Abramson to employ a one-way valve positioned within the distal engagement portion and offset from the central axis, with the one-way valve including an opening, wherein the opening is sized and configured to dispense a small volume of the blood sample held within the fluid chamber when the sidewall portion is compressed, as this modification would amount to mere simple substitution of one known element [opening for dispensing the collected sample as positioned by Ivosevic (see Ivosevic Figs. 3-5)] for another [opening for dispensing the collected sample as positioned by Haley] with similar expected results of allowing for controlled dispensing of a fluid sample contained within the device [MPEP § 2143(I)(B)].
Regarding claim 13, Ivosevic in view of Abramson and Haley teaches
The small sample blood collection system of claim 12, wherein the luer lock access device further comprises a sheath at least partially surrounding the needle [wherein Ivosevic Fig. 17 is considered to depict a sheath at least partially surrounding needle cannula 100].
Regarding claim 15, Ivosevic in view of Abramson and Haley teaches
The small sample blood collection system of claim 12.
However, Ivosevic in view of Abramson and Haley as presently modified fails to explicitly disclose wherein the needle of the luer lock access device is correspondingly offset from a central axis of the luer lock access device.
Abramson discloses a luer lock access device comprising a needle that is offset from a central axis of the luer lock access device [It is one of the features of the present device that the axis 24 of the main chamber is laterally offset from the axis 34 of the mid-chamber, antechamber and the needles, the offset being indicated at "0" in FIG. 2 (Abramson Col 5:28-31, Fig. 2); the outer end 62 of the auxiliary needle will penetrate the diaphragm at a point which is certain to be offset from the central evacuation opening 77 (Abramson Col 5:35-38, 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 system of Ivosevic in view of Abramson and Haley to employ wherein the needle of the luer lock access device is correspondingly offset from a central axis of the luer lock access device, as this modification would amount to mere simple substitution of one known element for another [configuration of a needle of a luer lock access device configured to pierce a stopper member of a blood collection device] with similar expected results [MPEP § 2143(I)(B)].
Regarding claim 18, Ivosevic in view of Abramson and Haley teaches
The small sample blood collection system of claim 12, wherein at least part of the sidewall portion of the point-of-care blood collection and dispensing device is formed of an elastomeric material [Ivosevic ¶0058].
Regarding claim 19, Ivosevic teaches
A method of small sample blood collection and dispensing, comprising:
providing a luer lock access device comprising:
a luer lock access hub configured to couple the luer lock access device to an intermediate device for venous access to a patient [Advantageously, a biological fluid collection device of the present disclosure provides a consistent blood sample management tool for point-of-care and near patient testing applications, automatic blood draw, passive mixing technology, and controlled small sample dispensing capability to point-of-care cartridge and standard luer interfaces with near patient testing receiving ports (Ivosevic ¶0040), wherein Ivosevic Fig. 16 is considered to depict a hub (based on ¶0040 considered to use luer lock structures) configured to couple the a device (based on ¶0040 considered to use luer lock structures) to an intermediate device for venous access],
a needle fluidly coupled to the luer lock access hub [needle cannula 100 (Ivosevic Fig. 17)], and
a holder at least partially surrounding the needle and configured to hold a blood collection device [As shown in FIGS. 16-18, the biological fluid collection device 10 including the combined collection module 14 and the outer housing 16 may be inserted into a conventional tube holder 102 having a cannula 100 through which biological fluid, such as a blood sample 12, is passed (Ivosevic ¶0062, Figs. 16-17)];
providing a point-of-care blood collection and dispensing device comprising:
a distal engagement portion, wherein at least a part of the distal engagement portion is configured to engage the needle of the luer lock access device [The closure 28 protectively covers the inlet port 32. The closure 28 allows for introduction of a blood sample 12 into the passageway 36 of the housing 20 and may include a pierceable self-sealing stopper 82 (FIG. 17) with an outer shield 84 such as a Hemogard™ cap commercially available from Becton, Dickinson and Company (Ivosevic ¶0061, Fig. 17)],
a sidewall portion, wherein at least part of the sidewall portion is formed of a flexible material capable of being compressed [the collection chamber 26 includes a first deformable portion 62, a second deformable portion 64 (Ivosevic ¶0054)],
a fluid chamber configured to hold a blood sample, the fluid chamber bound at least partially by the distal engagement portion, a closed proximal end, and the sidewall portion [wherein the collection chamber 26 is considered to be bound at least partially by the first deformable portion 62, second deformable portion 64, and the closure 28 (see Ivosevic Fig. 17), wherein the Examiner notes that the collection chamber 26 is also considered to be bound by the cap 30 and venting plug 80, which are considered to define a closed proximal end];
a stopper member positioned within the distal engagement portion and configured to be pierced by the needle of the luer lock access device [a needle cannula 100 (FIGS. 17 and 18) is inserted into the passageway 36 of the housing 20 of the collection module 14 through the inlet port 32, such as through the pierceable self-sealing stopper 82 of closure 28 (Ivosevic ¶0062, Fig. 17)];
distally directing the point-of-care blood collection and dispensing device toward the luer lock access device such that the needle of the luer lock access device punctures the stopper of the point-of-care blood collection and dispensing device [a needle cannula 100 (FIGS. 17 and 18) is inserted into the passageway 36 of the housing 20 of the collection module 14 through the inlet port 32, such as through the pierceable self-sealing stopper 82 of closure 28 (Ivosevic ¶0062, Fig. 17)]; and
collecting a blood sample within the fluid chamber of the point-of-care blood collection and dispensing device [the biological fluid collection device 10 including the combined collection module 14 and the outer housing 16 may be inserted into a conventional tube holder 102 having a cannula 100 through which biological fluid, such as a blood sample 12, is passed (Ivosevic ¶0062)].
However, Ivosevic fails to explicitly disclose wherein the stopper member is offset from a central axis of the point-of care blood collection and dispensing device within the distal engagement portion.
The Examiner notes that while no specific portion of the stopper member is recited as being offset from a central axis of the device, any portion of the stopper 82 that is not located directly along the central axis of the device 10 of Ivosevic may be considered to be “offset” from the central axis [see Ivosevic Fig. 17]. The Examiner further notes that Abramson depicts a luer lock access device comprising a needle that is configured to pierce a stopper member at a position of the stopper member that is offset from a central axis of a blood collection device that the stopper member is disposed on [It is one of the features of the present device that the axis 24 of the main chamber is laterally offset from the axis 34 of the mid-chamber, antechamber and the needles, the offset being indicated at "0" in FIG. 2 (Abramson Col 5:28-31, Fig. 2); the outer end 62 of the auxiliary needle will penetrate the diaphragm at a point which is certain to be offset from the central evacuation opening 77 (Abramson Col 5:35-38, 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 point-of-care blood collection and dispensing device used in the method of Ivosevic to employ a portion of the stopper member offset from a central axis of the point-of care blood collection and dispensing device within the distal engagement portion as being the particular stopper member, as this modification is considered to merely apply a known technique to a known device (method, or product) [any offset portion of stopper 82 relative to the central axis of the device may be configured to pierced by a needle, such that the stopper member may be considered offset] ready for improvement to yield predictable results [MPEP § 2143(I)(D)].
However, while Ivosevic discloses an opening sized and configured to dispense a small volume of the blood sample held within the fluid chamber when the sidewall portion is compressed [the cap 30 may then be removed from the collection module 14 (FIG. 21) exposing the outlet port 34 of the housing 20 of the collection module 14 (Ivosevic ¶0065); the first deformable portion 62 and the second deformable portion 64 are transitionable between an initial position (FIGS. 1A-4 and 21-23) in which the sample 12 is contained within the collection chamber 26 and a deformed position (FIGS. 5 and 24) in which a portion of the sample 12 is expelled from the collection chamber 26 and the outlet port 34 (Ivosevic ¶0066)], Ivosevic in view of Abramson fails to explicitly disclose a one-way valve positioned within the distal engagement portion and offset from the central axis, so as to be in a side-by-side arrangement with the stopper, with the one-way valve including an opening, wherein the opening is sized and configured to dispense a small volume of the blood sample held within the fluid chamber when the sidewall portion is compressed.
Haley discloses systems and methods for collection and dispensing of a sample, wherein Haley discloses an inlet offset from a central axis of a sample collection and dispensing device with a distal end of the device [Sample is drawn into first passage 14 through first opening 18, drawn along first passage 14, and then withdrawn from first passage 14 through second opening 20 and valve 36. The exiting sample typically enters a reservoir of the vacuum source (e.g., a barrel 52 of syringe 50) (Haley ¶0019, Fig. 1)]; and a one-way valve positioned within the distal end of the device and offset from the central axis, in a side-by-side arrangement to the inlet, with the one-way valve including an opening, wherein the opening is sized and configured to dispense a small volume of the sample held within a fluid chamber of the device when external pressure is applied to the device [Second opening 24 of second passage 16 includes a valve 38 configured to allow fluid to exit second passage 16 via second opening 24 and to limit or prevent entry of fluid and particles to second passage 16 by second opening 24 (Haley ¶0018), wherein the valve 38 being configured to allow for fluid to exit but not enter the second passage 16 by second opening 24 is considered to define a one-way valve; The plunger of syringe 50 is then depressed to apply pressure to sample within barrel 52. Valve 36 closes to prevent material from reentering first passage 14. Sample is pushed into second passage 16 through first opening 22, pushed along second passage 16, and pushed from second opening 24 through valve 38 to exit device 10 (Haley ¶0020, Fig. 1)].
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 point-of-care blood collection and dispensing device used in the method of Ivosevic in view of Abramson to employ a one-way valve positioned within the distal engagement portion and offset from the central axis, with the one-way valve including an opening, wherein the opening is sized and configured to dispense a small volume of the blood sample held within the fluid chamber when the sidewall portion is compressed, as this modification would amount to mere simple substitution of one known element [opening for dispensing the collected sample as positioned by Ivosevic (see Ivosevic Figs. 3-5)] for another [opening for dispensing the collected sample as positioned by Haley] with similar expected results of allowing for controlled dispensing of a fluid sample contained within the device [MPEP § 2143(I)(B)].
Regarding claim 20, Ivosevic in view of Abramson and Haley teaches
The method of claim 19, further comprising:
removing the point-of-care blood collection and dispensing device from engagement with the needle of the luer lock access device [In one embodiment, once sample collection is complete, the outer housing 16 including the collection module 14 is separated from the tube holder 102 (FIG. 18), and then the outer housing 16 is separated from the collection module 14 (FIG. 20) by removing the closure 28, which is still attached to the collection module 14, from the outer housing 16 (Ivosevic ¶0064, Fig. 22)];
positioning the point-of-care blood collection and dispensing device relative to a point-of-care diagnostic testing device [Ivosevic Fig. 23]; and
compressing at least a portion of the sidewall portion of the point-of-care blood collection and dispensing device so as to dispense a portion of the blood sample collected within the fluid chamber into or onto the point-of-care diagnostic testing device [The first deformable portion 62 and the second deformable portion 64 are simultaneously squeezed to transition from the initial position (FIGS. 1A-4 and 21-23) to the deformed position (FIGS. 5 and 24). In this manner, the blood sample 12 may be transferred to a device intended to analyze the sample, e.g., such as a point-of-care testing device 120 (FIGS. 23 and 24), a cartridge tester, or a near patient testing device, while minimizing the exposure of the medical practitioner to the blood sample (Ivosevic ¶0066); wherein based on the § 103 modification of claim 19 above, the sample is considered to be dispensed from the modified one-way valve].
Response to Arguments
Applicant’s arguments, see Applicant’s Remarks p. 8, filed 2 October 2025, with respect to the previously presented drawing objection(s) have been fully considered and are persuasive. The drawing objection(s) have been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 8, with respect to the previously presented claim objections have been fully considered and are persuasive. The claim objections of claims 12 and 19 have been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 8-12, with respect to the rejection(s) of claim(s) 1-3, 9-14, and 18-20 under § 102 and claims 5-8 and 16-17 under § 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Ivosevic (US-20190265134-A1, previously presented) in view of Abramson (US-4166450-A, previously presented) and Haley (US-20050214927-A1, previously presented) with respect to claims 1, 12, 19, and those dependent therefrom.
The Applicant asserts that Ivosevic does not teach or suggest the amended limitations of “a stopper member positioned within the distal engagement portion and configured to be pierced by the needle of the luer lock access device, wherein the stopper member is offset from a central axis of the point-of care blood collection and dispensing device within the distal engagement portion” and/or “a one-way valve positioned within the distal engagement portion and offset from the central axis, so as to be in a side-by-side arrangement with the stopper, with the one-way valve including an opening, wherein the opening is sized and configured to dispense a small volume of the blood sample held within the fluid chamber when the sidewall portion is compressed”, wherein the Applicant specifically notes that the self-sealing stopper 82 of Ivosevic is not taught as being offset from a central axis, as well as a general lack of disclosure regarding a one-way valve positioned within closure 28 [considered to be equivalent to the claimed distal engagement portion] as presently claimed. However, the Examiner notes that Applicant’s arguments with respect to claim(s) 1, 12, and 19 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Ivosevic is presently modified by Abramson and Haley to teach the amended limitations, wherein the Examiner notes that regarding the amendment of “a stopper member positioned within the distal engagement portion and configured to be pierced by the needle of the luer lock access device, wherein the stopper member is offset from a central axis of the point-of care blood collection and dispensing device within the distal engagement portion”, no specific portion of the stopper member is recited as being offset from a central axis of the device, such that any portion of the stopper 82 that is not located directly along the central axis of the device 10 of Ivosevic may be considered to be “offset” from the central axis [see Ivosevic Fig. 17], and that Abramson is considered to disclose a luer lock access device comprising a needle that is configured to pierce a stopper member at a position of the stopper member that is offset from a central axis of a blood collection device that the stopper member is disposed on [It is one of the features of the present device that the axis 24 of the main chamber is laterally offset from the axis 34 of the mid-chamber, antechamber and the needles, the offset being indicated at "0" in FIG. 2 (Abramson Col 5:28-31, Fig. 2); the outer end 62 of the auxiliary needle will penetrate the diaphragm at a point which is certain to be offset from the central evacuation opening 77 (Abramson Col 5:35-38, Figs. 2-5)]. The Examiner further notes that Haley is considered to render obvious the amendment “a one-way valve positioned within the distal engagement portion and offset from the central axis, so as to be in a side-by-side arrangement with the stopper, with the one-way valve including an opening, wherein the opening is sized and configured to dispense a small volume of the blood sample held within the fluid chamber when the sidewall portion is compressed”, as Haley discloses an inlet offset from a central axis of a sample collection and dispensing device with a distal end of the device [Haley ¶0019, Fig. 1] and a one-way valve positioned within the distal end of the device and offset from the central axis, in a side-by-side arrangement to the inlet, with the one-way valve including an opening, wherein the opening is sized and configured to dispense a small volume of the sample held within a fluid chamber of the device when external pressure is applied to the device [Haley ¶¶0018, 0020, Fig. 1)].
The Applicant also asserts that Sarrine fails to teach or suggest “a one-way valve positioned within the distal engagement portion and offset from the central axis, so as to be in a side-by-side arrangement with the stopper, with the one-way valve including an opening, wherein the opening is sized and configured to dispense a small volume of blood sample held within the fluid chamber when the sidewall portion is compressed”, as the Applicant notes that there is no “one-way valve” disclosed in Sarrine, which further renders the claimed arrangement relative to the stopper as not being disclosed in Sarrine. However, the Examiner notes that Applicant’s arguments with respect to claim(s) 1, 12, and 19 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument [see Examiner’s response above].
The Applicant further asserts that there is nothing taught or suggested in Abramson or Haley that would be combined with what is disclosed in Ivosevic and Sarrine that would render obvious the amended limitations of claims 1, 12, and 19. However, the Examiner notes that Applicant’s arguments with respect to claim(s) 1, 12, and 19 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument [see Examiner’s response above].
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.
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/CHARLES A MARMOR II/Supervisory Patent Examiner
Art Unit 3791
/S.P.L./Examiner, Art Unit 3791