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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 26 March 2026 has been entered.
The Examiner acknowledges the amendments to claims 1, 12, and 19, as well as the addition of new claims 21-22. Claims 1, 9-10, 12-13, 15, and 28-22 are pending.
Claim Objections
Claim(s) 15 is/are objected to because of the following informalities:
Claim 15 should read “claim 12, wherein” [line 2].
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, 18-20, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ivosevic (US-20190265134-A1, previously presented) in view of Sarstedt (US-5074312-A) 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 a center line of the stopper member is offset from a central axis of the point-of-care blood collection and dispensing device within the distal engagement portion.
Sarstedt discloses a blood collection device, comprising a stopper member [inner soft-elastic plug 21 of for example rubber (Sarstedt Figs. 2-3)] positioned within a distal engagement portion and configured to be pierced by a needle of a connection device [In accordance with FIG. 2 a cannula cone 14 extends from the front end of the closure cap 12 eccentrically to the axis 13 of the extraction tube 11 into an extension 15 which consists of an inner soft-elastic plug 21 of for example rubber (Sarstedt Col 5:38-42, Figs. 2-3); The front end of the passage 22 adjoins an elastic plate 18 which is arranged directly behind the needle passage opening 19 and consists of one piece with the material of the soft-elastic plug 21, the front plane end face 24 of said plate being flush with the front end face 23 of the plug 21. The thickness of the elastic plate 18 is so chosen that after withdrawal of the rear portion 16a of the cannula 16 from the piercing position shown in FIG. 3 the pierced opening automatically closes again due to the resilient properties and the clamping of the elastic plate 18 (Sarstedt Col 6:16-26)], wherein a center line of the stopper member is offset from a central axis of the blood collection device within the distal engagement portion [Sarstedt Col 5:38-42, Figs. 2-3].
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 wherein a center line of the stopper member is offset from a central axis of the point-of-care blood collection and dispensing device within the distal engagement portion, as this modification is considered to amount to mere simple substitution of one known element [stopper member as configured in Ivosevic] for another [offset configuration of the stopper member of Sarstedt] with similar expected results [allow for the stopper member to be pierced by a needle to define a flow path] [MPEP § 2143(I)(B)].
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 Sarstedt 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 one-way valve is configured to transition from a closed configuration to an open configuration responsive to compression of the sidewall portion, and wherein the one-way valve dispenses a small volume of the blood sample held within the fluid chamber when in the open configuration.
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 one-way valve is configured to transition from a closed configuration to an open configuration responsive to external pressure applied to the device, and wherein the one-way valve dispenses a small volume of the sample held within a fluid chamber of the device when in the open configuration [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 Sarstedt to employ 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 one-way valve is configured to transition from a closed configuration to an open configuration responsive to compression of the sidewall portion, and wherein the one-way valve dispenses a small volume of the blood sample held within the fluid chamber when in the open configuration, 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 [allow for controlled dispensing of a fluid sample contained within the device] [MPEP § 2143(I)(B)].
Regarding claim 9, Ivosevic in view of Sarstedt 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 Sarstedt 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 a center line of the stopper member is offset from a central axis of the point-of-care blood collection and dispensing device within the distal engagement portion.
Sarstedt discloses a blood collection device, comprising a stopper member [inner soft-elastic plug 21 of for example rubber (Sarstedt Figs. 2-3)] positioned within a distal engagement portion and configured to be pierced by a needle of a connection device [In accordance with FIG. 2 a cannula cone 14 extends from the front end of the closure cap 12 eccentrically to the axis 13 of the extraction tube 11 into an extension 15 which consists of an inner soft-elastic plug 21 of for example rubber (Sarstedt Col 5:38-42, Figs. 2-3); The front end of the passage 22 adjoins an elastic plate 18 which is arranged directly behind the needle passage opening 19 and consists of one piece with the material of the soft-elastic plug 21, the front plane end face 24 of said plate being flush with the front end face 23 of the plug 21. The thickness of the elastic plate 18 is so chosen that after withdrawal of the rear portion 16a of the cannula 16 from the piercing position shown in FIG. 3 the pierced opening automatically closes again due to the resilient properties and the clamping of the elastic plate 18 (Sarstedt Col 6:16-26)], wherein a center line of the stopper member is offset from a central axis of the blood collection device within the distal engagement portion [Sarstedt Col 5:38-42, Figs. 2-3].
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 wherein a center line of the stopper member is offset from a central axis of the point-of-care blood collection and dispensing device within the distal engagement portion, as this modification is considered to amount to mere simple substitution of one known element [stopper member as configured in Ivosevic] for another [offset configuration of the stopper member of Sarstedt] with similar expected results [allow for the stopper member to be pierced by a needle to define a flow path] [MPEP § 2143(I)(B)].
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 Sarstedt 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 one-way valve is configured to transition from a closed configuration to an open configuration responsive to compression of the sidewall portion, and wherein the one-way valve dispenses a small volume of the blood sample held within the fluid chamber when in the open configuration.
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 one-way valve is configured to transition from a closed configuration to an open configuration responsive to external pressure applied to the device, and wherein the one-way valve dispenses a small volume of the sample held within a fluid chamber of the device when in the open configuration [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 Sarstedt to employ 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 one-way valve is configured to transition from a closed configuration to an open configuration responsive to compression of the sidewall portion, and wherein the one-way valve dispenses a small volume of the blood sample held within the fluid chamber when in the open configuration, 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 [allow for controlled dispensing of a fluid sample contained within the device] [MPEP § 2143(I)(B)].
Regarding claim 13, Ivosevic in view of Sarstedt 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 18, Ivosevic in view of Sarstedt 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 a center line of the stopper member is offset from a central axis of the point-of-care blood collection and dispensing device within the distal engagement portion.
Sarstedt discloses a blood collection device, comprising a stopper member [inner soft-elastic plug 21 of for example rubber (Sarstedt Figs. 2-3)] positioned within a distal engagement portion and configured to be pierced by a needle of a connection device [In accordance with FIG. 2 a cannula cone 14 extends from the front end of the closure cap 12 eccentrically to the axis 13 of the extraction tube 11 into an extension 15 which consists of an inner soft-elastic plug 21 of for example rubber (Sarstedt Col 5:38-42, Figs. 2-3); The front end of the passage 22 adjoins an elastic plate 18 which is arranged directly behind the needle passage opening 19 and consists of one piece with the material of the soft-elastic plug 21, the front plane end face 24 of said plate being flush with the front end face 23 of the plug 21. The thickness of the elastic plate 18 is so chosen that after withdrawal of the rear portion 16a of the cannula 16 from the piercing position shown in FIG. 3 the pierced opening automatically closes again due to the resilient properties and the clamping of the elastic plate 18 (Sarstedt Col 6:16-26)], wherein a center line of the stopper member is offset from a central axis of the blood collection device within the distal engagement portion [Sarstedt Col 5:38-42, Figs. 2-3].
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 method of Ivosevic to employ wherein a center line of the stopper member is offset from a central axis of the point-of-care blood collection and dispensing device within the distal engagement portion, as this modification is considered to amount to mere simple substitution of one known element [stopper member as configured in Ivosevic] for another [offset configuration of the stopper member of Sarstedt] with similar expected results [allow for the stopper member to be pierced by a needle to define a flow path] [MPEP § 2143(I)(B)].
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 Sarstedt 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 one-way valve is configured to transition from a closed configuration to an open configuration responsive to compression of the sidewall portion, and wherein the one-way valve dispenses a small volume of the blood sample held within the fluid chamber when in the open configuration.
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 one-way valve is configured to transition from a closed configuration to an open configuration responsive to external pressure applied to the device, and wherein the one-way valve dispenses a small volume of the sample held within a fluid chamber of the device when in the open configuration [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 method of Ivosevic in view of Sarstedt to employ 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 one-way valve is configured to transition from a closed configuration to an open configuration responsive to compression of the sidewall portion, and wherein the one-way valve dispenses a small volume of the blood sample held within the fluid chamber when in the open configuration, 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 [allow for controlled dispensing of a fluid sample contained within the device] [MPEP § 2143(I)(B)].
Regarding claim 20, Ivosevic in view of Sarstedt 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].
Regarding claim 22, Ivosevic in view of Sarstedt and Haley teaches
The point-of-care blood collection and dispensing device of claim 1, wherein the stopper member forms only a portion of the distal engagement portion, with the one-way valve forming a remainder of the distal engagement portion [see § 103 modification of claim 1 above; wherein in light of the modifications based on the subject matter of Sarstedt Figs. 2-3 depicting a stopper (plug 21) formed on only a portion of a “distal engagement portion”, and Haley Fig. 1 depicting a one-way valve (valve 38) formed only on a portion of a “distal engagement portion” alongside an inlet, the claim language is considered to be taught by the combination of Ivosevic in view of Sarstedt and Haley].
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ivosevic in view of Sarstedt and Haley, as applied to claim 12 above, in further view of Abramson (US-4166450-A, previously presented).
Regarding claim 15, Ivosevic in view of Sarstedt and Haley teaches
The small sample blood collection system of claim 12.
However, Ivosevic in view of Sarstedt and Haley fail 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.
Sarstedt discloses the use of a needle that is aligned with the stopper member that is offset from the central axis of the blood collection device [Sarstedt Col 6:16-26, Figs. 1-2].
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 Sarstedt 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 [piercing a corresponding stopper member to define a fluid flow path] [MPEP § 2143(I)(B)].
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ivosevic in view of Sarstedt and Haley, as applied to claim 1 above, in further view of Wilkinson (US-20170035336-A1).
Regarding claim 21, Ivosevic in view of Sarstedt and Haley teaches
The point-of-care blood collection and dispensing device of claim 1.
However, Ivosevic in view of Sarstedt and Haley fails to explicitly disclose wherein the sidewall portion is integrally formed with the closed proximal end as part of a singular collection tube.
Wilkinson discloses a blood collection and dispensing device [to transfer a portion of a blood sample 16 from the biological fluid collection device 10 to a point-of-care testing device 80, a user can squeeze the tube 12 to expel the blood sample 16 as shown in FIG. 11 (Wilkinson ¶0071, Fig. 11)], comprising: a sidewall portion and a fluid chamber configured to hold a blood sample, wherein the fluid chamber is bound at least partially by a closed proximal end and the sidewall portion [the sample collection portion 12 is adjacent the first end 20 and defines a cavity 40 therein adapted to receive a blood sample 16… Referring to FIG. 11, the tube 12 can be formed of a material that is resiliently deformable to facilitate expulsion of a sample as is described in more detail below (Wilkinson ¶0040, Fig. 2); The tube 12 may include a closed bottom end 42, an open top end 44, and a tube sidewall 46 extending therebetween (Wilkinson ¶0044, Fig. 2)]; wherein the sidewall portion is integrally formed with the closed proximal end as part of a singular collection tube [the tube 12 of the biological fluid collection device 10 may be a sample collection tube. For example, the tube 12 of the biological fluid collection device 10 may be a sample collection tube, such as a proteomics, molecular diagnostics, chemistry sample tube, blood or other bodily fluid collection tube, microtainer tube, coagulation sample tube, hematology sample tube, or a similar tube (Wilkinson ¶0041); the lancet device 98 and the tube 12 are integral components that form the biological fluid collection device 10. In one embodiment, the housing 100 of the lancet device 98 and the tube 12 are formed of the same material and form a sidewall 30 of the biological fluid collection device 10 that houses the cavity 40 of the tube 12 and the lancet device 98 (Wilkinson ¶0062), wherein as depicted in at least Wilkinson Fig. 5, the tube 12 is formed of a single material].
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 Sarstedt and Haley to employ wherein the sidewall portion is integrally formed with the closed proximal end as part of a singular collection tube, as this modification would amount merely amount to a matter of obvious engineering choice [making elements integral (MPEP § 2144.04(V)(B)); In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965)].
Response to Arguments
Applicant’s arguments, see Applicant’s Remarks p. 7, filed 26 March 2026, with respect to the previously presented claimed objection(s) have been fully considered and are persuasive. The objections to claims 1, 12, and 19 have been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 7-12, with respect to the rejection(s) of claim(s) 1, 12, and 19 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 Sarstedt (US-5074312-A) and Haley (US-20050214927-A1, previously presented).
The Applicant asserts that neither Ivosevic or Abramson disclose a stopper member positioned within the distal engagement portion and configured to be pierced by the needle of the luer lock access device, wherein a center line of the stopper member is offset from a central axis of the point-of-care blood collection and dispensing device within the distal engagement portion, as Ivosevic only teaches a self-sealing stopper 82 positioned in/at a “distal engagement portion [closure 28], but there is no teaching of a center line of the stopper 82 as claimed; and as Abramson discloses a rubber diaphragm 75 at its open end being penetrated by needl60 at a point spaced from a central axis 24 of the carrier 10, but there is no teaching that a center line of the diaphragm 75 is offset from the center axis 24 of the carrier 10. However, the Examiner notes that Applicant’s arguments with respect to claim(s) 1/12/19 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 in view of Sarstedt (US-5074312-A), wherein Sarstedt discloses a blood collection device, comprising a stopper member [inner soft-elastic plug 21 of for example rubber (Sarstedt Figs. 2-3)] positioned within a distal engagement portion and configured to be pierced by a needle of a connection device, wherein a center line of the stopper member is offset from a central axis of the blood collection device within the distal engagement portion [Sarstedt Col 5:38-42, Col 6:16-26, Figs. 2-3)].
The Applicant further asserts that neither of Ivosevic nor Haley discloses a distal engagement portion that includes a stopper member and 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 one-way valve is configured to transition from a closed configuration to an open configuration responsive to compression of the sidewall portion, and wherein the one-way valve dispenses a small volume of the blood sample held within the fluid chamber when in the open configuration, as Ivosevic fails to teach a one-way valve positioned within the closure 28 and offset from the central axis; and as Hayley provides no teaching of either of valves 36, 38 being configured to transition from a closed configuration to an open configuration responsive to compression of the sidewall portion, and wherein the one-way valve dispenses a small volume of the blood sample held within the fluid chamber when in the open configuration, and instead discloses opening/closing of valves 36, 38 responsive to advancement of plunger 55. However, the Examiner disagrees with the Applicant’s argument, as the Examiner notes that in response to applicant’s arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The Examiner notes that Ivosevic was cited as teaching the claimed sidewall portion, wherein at least part of the sidewall portion is formed of a flexible material capable of being compressed [Ivosevic ¶0054], and further 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 [Ivosevic ¶¶0065-0066; see p. 5-6 of Final Rejection dated 29 December 2025]; whereas Haley is cited as teaching a an inlet offset from a central axis of a sample collection and dispensing device with a distal end of the device, 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 one-way valve is configured to transition from a closed configuration to an open configuration responsive to external pressure applied to the device, and wherein the one-way valve dispenses a small volume of the sample held within a fluid chamber of the device when in the open configuration [Haley ¶¶0018-0020, Fig. 1; see p. 6-7 of the Final Rejection dated 29 December 2025], such that in combination Ivosevic, as modified in of at least Haley, is considered to teach the argued subject matter of the one-way valve as amended.
Conclusion
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/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791
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