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 Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4 and 8-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Burkholz et al. (US 20230001158 A1 – Cited by Applicant), hereinafter Burkholz.
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.
Claims 1-4 and 7-14, 18 are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz (US 20230001158 A1 – Cited by Applicant) in view of Stevens et al. (US 20040176705 A1 – Cited by Applicant), hereinafter Stevens.
Regarding claim 1, Burkholz discloses an arterial access system [see in Fig. 2A] comprising:
a catheter assembly [catheter assembly 56, see in Fig. 2A] comprising a catheter [catheter 62, see in Fig. 2A] and an access port [needleless connector 68, Fig. 2A];
a blood draw device [instrument delivery device 10, see in Fig. 2A; see also ¶ 0040] coupled to the access port and in fluid communication with the arterial catheter via the catheter assembly [see in Fig. 2A], the blood draw device comprising:
a catheter tube [tubing 12, see in Figs. 1B and 2A; see also ¶ 0040]; a housing [housing 14, see in Fig. 2A] having a proximal end portion [proximal end 16, see in Fig. 2A] and a distal end portion [distal end 18, see in Fig. 1B], the distal end portion coupleable to the access port [see in Fig. 2A], the housing defining an inner volume configured to movably receive the catheter tube [inner volume of housing 14, see in Fig. 1B; see also ¶ 0049 and ¶ 0053]; and
an advancement member [advancement element 22, see in Fig. 1B] configured to move relative to the housing to move the catheter tube between a first position, in which the catheter tube is disposed within the housing [see in Figs. 1A-1B; see also in ¶ 0043], and a second position in which a distal end of the catheter tube is disposed beyond the distal end portion of the housing and past a distal tip of the arterial catheter [see in ¶ 0061, as tubing 12 may extend through the catheter 62 when advancement element 22 is in the fully advanced position; see also Fig. 2A]; and
a collection device positioned proximal to the housing and in fluid communication with the catheter tube [see in Fig. 2A; see also ¶ 0060, as connector 70 may be coupled to or monolithically formed with a blood collection device]; wherein, with the catheter tube in the second position, the collection device is configured to directly collect a sample of blood through the catheter tube [see in ¶ 0040 and ¶ 0050; see also Fig. 2A].
Burkholz fails to disclose that the catheter is an arterial catheter and that the collection device is configured to directly collect a sample of arterial blood through the catheter tube.
However, Stevens discloses an arterial catheter and sampling of arterial blood through a catheter tube [see in ¶ 0026 and ¶ 0028, blood is a sample substance/fluid sample and venous and arterial catheters are interchangeable].
Burkholz and Stevens are both analogous to the claimed invention because they are in the same field of catheters and sampling devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to modify the method of Burkholz to further include that the catheter is an arterial catheter and that the collection device is configured to directly collect a sample of arterial blood through the catheter tube, as taught by Stevens, the motivation being to conveniently adapt for either intravenous or arterial blood sampling collection.
Regarding claim 2, Burkholz, as modified, discloses the discloses the arterial access system of claim 1, wherein the blood draw device comprises a secondary catheter coupled to the advancement member and extending out proximally therefrom and out the proximal end portion of the housing [extension tube 34, see in Fig. 2A], the secondary catheter fluidly connecting the catheter tube and the collection device [see in ¶ 0050 and ¶ 0060; see also Figs. 1B and 2A].
Regarding claim 3, Burkholz, as modified, discloses the arterial access system of claim 2, wherein the blood draw device comprises a coupler connected to a proximal end of the secondary catheter [connector 70, see in Fig. 2A; see also ¶ 0060], and wherein the collection device is connected to the secondary catheter via the coupler [see in ¶ 0060].
Regarding claim 4, Burkholz, as modified, discloses the arterial access system of claim 3, wherein the collection device comprises a vacuum-assisted collection device [see in ¶ 0060].
Regarding claim 7, Burkholz, as modified, discloses the arterial access system of claim 1, wherein the collection device is coupled directly to the housing [see in Fig. 2A; see also ¶ 0060].
Burkholz fails to explicitly disclose that the collection device comprises a diagnostic test cartridge, and wherein the diagnostic test cartridge directly collects a micro-sample of arterial blood through the catheter tube.
However, Stevens discloses a collection device [cartridge collection system 100, see in Fig. 1] that comprises a diagnostic test cartridge [cartridge 102, see in Fig. 1; see also ¶ 0024], and wherein the diagnostic test cartridge directly collects a micro-sample of arterial blood through the catheter tube [see in ¶ 0024 and ¶ 0028].
Burkholz and Stevens are both analogous to the claimed invention because they are in the same field of catheters and sampling devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to modify the arterial access system of Burkholz to further include that the collection device comprises a diagnostic test cartridge, and wherein the diagnostic test cartridge directly collects a micro-sample of arterial blood, as taught by Stevens, the motivation being that Stevens discloses that the apparatus of the present invention works just as well with other collection mechanism assemblies, and Burkholz notes the use of another suitable blood collection device [see in Stevens ¶ 0023; see in Burkholz ¶ 0060].
Regarding claim 8, Burkholz, as modified, discloses the arterial access system of claim 1, wherein the catheter assembly comprises:
a catheter adapter coupled to a proximal end of the arterial catheter [catheter adapter 58, see in Fig. 2A], the catheter adapter comprising an adapter port [side port 60, see in Fig. 2A]; and
a connector [T-connector 66, see in Fig. 2A] connected to the adapter port via an extension tube [extension tube 64, see in Fig. 2A], wherein the access port is provided at a proximal end of the connector [see in Fig. 2A].
Regarding claim 9, Burkholz, as modified, discloses the arterial access system of claim 8, wherein the connector comprises a side port positioned distally from the access port [side port extending from T-connector 66, see in Fig. 2A], and wherein the arterial access system further comprises an extension set connected to the side port [extension set extending from the side of T-connector 66, see in Fig. 2A] and that is in fluid connection with the arterial catheter [see in Fig. 2A; see also ¶ 0060, as blood is configured to flow through T-connector 66], the extension set providing arterial blood from the arterial catheter to a hemodynamic monitoring system connected thereto [see in ¶ 0046, as guidewire 13 can be replaced with a suitable probe or instrument may include one or more sensors for patient or device monitoring and may include sensors measuring pressure, temperature, pH, blood chemistry, oxygen saturation, flow rate, or another physiological property; see also Fig. 2A, as guidewire 13 is coupled to the extension extending from the side of T-connector 66, by virtue of the components of instrument delivery device 10 being connected].
Regarding claim 10, Burkholz, as modified, discloses the arterial access system of claim 1, wherein the distal end portion of the housing comprises a lock configured to couple the housing to the access port [see in ¶ 0045; see also Figures 1B and 2A].
Regarding claim 11, Burkholz, as modified, discloses a method for direct arterial blood sampling via an indwelling arterial catheter of a catheter assembly [see in ¶ 0040-¶ 0041], the method comprising:
coupling a blood draw device [instrument delivery device 10, see in Fig. 2A; see also ¶ 0040] to an access port [needleless connector 68, see in Fig. 2A] of the catheter assembly [catheter assembly 56, see in Fig. 2A], the blood draw device comprising:
a catheter tube [tubing 12, see in Figs. 1B and 2A; see also in ¶ 0040];
a housing [housing 14, see in Fig. 2A] having a proximal end portion [proximal end 16, see in Fig. 2A] and a distal end portion [distal end 18, Fig. 1B], the distal end portion coupleable to the access port [see in Fig. 2A], the housing defining an inner volume configured to movably receive the catheter tube [inner volume of housing 14, Fig. 1B; see also ¶ 0049 and ¶ 0053]; and
an advancement member [advancement element 22, see in Fig. 1B] configured to move relative to the housing to move the catheter tube between a first position, in which the catheter tube is disposed within the housing [see in Figs. 1A-1B; see also ¶ 0043], and a second position, in which a distal end of the catheter tube is disposed beyond the distal end portion of the housing and past a distal tip of the indwelling arterial catheter [see in ¶ 0061, as tubing 12 may extend through the catheter 62 when advancement element 22 is in the fully advanced position; see also Fig. 2A];
connecting a collection device at the proximal end portion of the housing [see in Fig. 2A; see also ¶ 0060, as connector 70 may be coupled to or monolithically formed with a blood collection device];
moving the advancement member along the housing to advance the catheter tube to the second position [see in ¶ 0061]; and
directly collecting a sample of blood in the collection device with the catheter tube in the second position [see in ¶ 0040, ¶ 0050, and ¶ 0060; see also Fig. 2A].
Burkholz fails to explicitly disclose that the sample of blood directly collected in the collection device is arterial blood.
However, Stevens discloses collecting a sample of arterial blood [blood listed as a sample substance, arterial and venous catheters can be interchangeable in the arrangement, see in ¶ 0026 and ¶ 0028].
Burkholz and Stevens are both analogous to the claimed invention because they are in the same field of catheters and sampling devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to modify the method of Burkholz to further include that the sample of blood directly collected in the collection device is arterial blood, as taught by Stevens, the motivation being that Burkholz discloses obtaining a blood sample by use of a catheter inserted into a patient's vasculature, and Stevens notes that fluid samples can be collected using venous catheters or arterial catheters [see in Burkholz ¶ 0040 – ¶ 0041; see in Stevens ¶ 0028].
Regarding claim 12, Burkholz, as modified, discloses the method of claim 11, wherein connecting the collection device comprises connecting the collection device to a proximal end of a secondary catheter [extension tube 34, Fig. 2A] that fluidly connects the collection device to the catheter tube, the secondary catheter extending out from the proximal end portion of the housing [see in ¶ 0050 and ¶ 0060; see also Figures 1B and 2A].
Regarding claim 13, Burkholz, as modified, discloses the method of claim 12, wherein connecting the collection device comprises connecting the collection device to a coupler attached to the proximal end of a secondary catheter [connector 70, see in Fig. 2A; see also ¶ 0060].
Regarding claim 14, Burkholz, as modified, discloses the method of claim 13, wherein connecting the collection device comprises connecting a vacuum-assisted collection device to the proximal end of the secondary catheter [see in ¶ 0060].
Regarding claim 18, Burkholz, as modified, discloses the method of claim 11, wherein connecting the collection device is directly connected to the housing [see in Fig. 2A; see also ¶ 0060], and wherein directly collecting the sample of arterial blood comprises directly collecting a micro-sample of arterial blood in the collection device, through the catheter tube [see in ¶ 0050 and ¶ 0060].
Burkholz fails to explicitly disclose that the collection device comprises a blood diagnostic test cartridge, and wherein directly collecting the sample of arterial blood comprises directly collecting a micro-sample of arterial blood in the blood diagnostic test cartridge.
However, Stevens discloses a collection device [cartridge collection system 100, see in Fig. 1] that comprises a blood diagnostic test cartridge [cartridge 102, see in Fig. 1; see also ¶ 0024], and wherein the blood diagnostic test cartridge directly collects a micro-sample of arterial blood [see in ¶ 0024 and ¶ 0028].
Burkholz and Stevens are both analogous to the claimed invention because they are in the same field of catheters and sampling devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to modify the method of Burkholz to further include that the collection device comprises a blood diagnostic test cartridge, and wherein the blood diagnostic test cartridge directly collects a micro-sample of arterial blood, as taught by Stevens, the motivation being to conveniently adapt for either intravenous or arterial blood sampling collection and directly collect information from the sensors regarding the contained sample [see in Stevens ¶ 0024, ¶ 0028, and ¶ 0008].
Regarding claim 19, Burkholz, as modified, discloses the method of claim 11, wherein coupling the blood draw device to the access port comprises coupling the blood draw device to a connector of the catheter assembly [T-connector 66, see in Fig. 2A], the connector comprising: a proximal end including the access port [see in Fig. 2A]; a distal end connected to a catheter adapter of the catheter assembly [catheter adapter 58, Fig. 2A] via an extension tube [extension tube 64, see in Fig. 2A], the catheter adapter receiving the indwelling arterial catheter [see in Fig. 2A]; and a side port positioned between the proximal end and the distal end of the connector [side port extending from T-connector 66, see in Fig. 2A].
Regarding claim 20, Burkholz, as modified, discloses the method of claim 19, further comprising:
connecting an extension set to the side port [extension set extending from the side of T-connector 66, Fig. 2A] that is in fluid connection with the indwelling arterial catheter [Fig. 2A; see also ¶ 0060, as blood is configured to flow through T-connector 66];
connecting a hemodynamic monitoring system to the extension set [see in ¶ 0046, as guidewire 13 can be replaced with a suitable probe or instrument may include one or more sensors for patient or device monitoring and may include sensors measuring pressure, temperature, pH, blood chemistry, oxygen saturation, flow rate, or another physiological property];
providing a flow of arterial blood to the hemodynamic monitoring system via the indwelling arterial catheter and the extension set [see in ¶ 0050 and ¶ 0060; see also Fig. 2A];
wherein the flow of arterial blood is provided to the hemodynamic monitoring system simultaneous with the collecting of the sample of arterial blood in the collection device [see in ¶ 0040, ¶ 0050, and ¶ 0060].
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz (US 20230001158 A1 – Cited by Applicant) in view of Stevens (US 20040176705 A1 – Cited by Applicant), further in view of Burkholz et al. (US 20200046948 A1 – Cited by Applicant), hereinafter ‘948.
Regarding claim 5, Burkholz, as modified, discloses the arterial access system of claim 3.
Burkholz fails to disclose that the collection device comprises a non-vacuum-assisted collection device.
However, ‘948 discloses a collection device that comprises a non-vacuum-assisted collection device [see in ¶ 0051, as collection device 51 may include a reservoir or test tube].
Burkholz and ‘948 are both analogous to the claimed invention because they are in the same field of catheter systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to modify the arterial access system of Burkholz to further include that the collection device comprises a nonvacuum-assisted collection device, as taught by '948, the motivation being that Burkholz discloses that the collection device can include another suitable blood collection device, and '948 lists such devices among suitable blood collection devices [see in Burkholz ¶ 0060; see in '948, ¶ 0051].
Regarding claim 6, Burkholz, as modified, discloses the arterial access system of claim 5.
Burkholz fails to explicitly disclose that the coupler comprises a venting feature configured to vent the vacuum or non-vacuum-assisted collection device.
However, ‘948 discloses a coupler [Y-adapter 24, see in Figs. 1C- 1E] that comprises a venting feature configured to vent a vacuum or non-vacuum-assisted collection device [vent cap 44, see in Fig. 1D; see also ¶ 0048 – ¶ 0051].
Burkholz and ‘948 are both analogous to the claimed invention because they are in the same field of catheter systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to modify the arterial access system of Burkholz to further include that that the coupler comprises a venting feature configured to vent the vacuum or non-vacuum-assisted collection device, as taught by '948, the motivation being that such a configuration allows air to escape the catheter system as blood enters the catheter system, as well as may relieve residual pressure and allow a user to insert the catheter into the vein of a patient and visualize blood flashback without waiting the approximately 30 seconds or more for the dripping of a priming solution to slow or stop [see in '948, see in ¶ 0010 and 0046].
Claims 17 is rejected under 35 U.S.C. 103 as being unpatentable over Burkholz (US 20230001158 A1 – Cited by Applicant) in view of Stevens (US 20040176705 A1 – Cited by Applicant), further in view of Gelfand et al. (US 20210137434 A1 – Cited by Applicant), hereinafter Gelfand.
Regarding claim 17, Burkholz, as modified, discloses the method of claim 11.
Burkholz fails to explicitly disclose dispensing at least a portion of the sample of arterial blood to a point-of-care (POC) testing device, the POC testing device comprising a blood diagnostic test cartridge or a blood analyzer test instrument.
However, Gelfand discloses dispensing at least a portion of the sample of arterial blood to a point-of-care (POC) testing device, the POC testing device comprising a blood diagnostic test cartridge or a blood analyzer test instrument [see in ¶ 0003 and ¶ 0004].
Burkholz and Gelfand are both analogous to the claimed invention because they are in the same field of blood sampling transfer devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to modify the method of Burkholz to further include dispensing at least a portion of the sample of arterial blood to a point-of-care (POC) testing device, the POC testing device comprising a blood diagnostic test cartridge or a blood analyzer test instrument, as taught by Gelfand, the motivation being that Burkholz notes such sampling and testing as common healthcare procedures to determine the physiological and biochemical states of a patient [see Gelfand ¶ 0003 and ¶ 0004].
Claims 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz (US 20230001158 A1 – Cited by Applicant) in view of Stevens (US 20040176705 A1 – Cited by Applicant), further in view of ‘948 (US 20200046948 A1 – Cited by Applicant).
Regarding claim 15, Burkholz, as modified, discloses the method of claim 13.
Burkholz fails to explicitly disclose that connecting the collection device comprises connecting a non-vacuum-assisted collection device to the proximal end of the secondary catheter.
However, ‘948 discloses a collection device that comprises a non-vacuum-assisted collection device [see in ¶ 0051, as collection device 51 may include a reservoir or test tube].
Burkholz and ‘948 are both analogous to the claimed invention because they are in the same field of catheter systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to modify the method of Burkholz to further include that connecting the collection device comprises connecting a non-vacuum-assisted collection device to the proximal end of the secondary catheter, as taught by '948, the motivation being that Burkholz discloses that the collection device can include another suitable blood collection device, and '948 lists such devices among suitable blood collection devices [see Burkholz ¶ 0060; see '948, ¶ 0051].
Regarding claim 16, Burkholz, as modified, discloses the method of claim 15.
Burkholz fails to explicitly disclose venting the vacuum or non-vacuum-assisted collection device via a vent included adjacent the proximal end of the secondary catheter or on the coupler, so as to facilitate collection of the sample of arterial blood, with an arterial blood pressure causing a flow of arterial blood into the vented non-vacuum-assisted collection device.
Burkholz fails to explicitly disclose venting the vacuum or non-vacuum-assisted collection device via a vent included adjacent the proximal end of the secondary catheter or on the coupler, so as to facilitate collection of the sample of arterial blood, with an arterial blood pressure causing a flow of arterial blood into the vented non-vacuum-assisted collection device.
However, ‘948 discloses venting a vacuum or non-vacuum-assisted collection device via a vent included adjacent a proximal end of a secondary catheter or on a coupler, so as to facilitate collection of the sample of blood, with a blood pressure causing a flow of blood into the vented non-vacuum-assisted collection device [vent cap 44 on Y-adapter 24, see in Figs. 1C-1E; see also ¶ 0048- ¶ 0051].
Burkholz and ‘948 are both analogous to the claimed invention because they are in the same field of catheter systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to modify the method of Burkholz to further include venting the vacuum or non-vacuum-assisted collection device via a vent included adjacent the proximal end of the secondary catheter or on the coupler, so as to facilitate collection of the sample of arterial blood, with an arterial blood pressure causing a flow of arterial blood into the vented non-vacuum-assisted collection device, as taught by '948, the motivation
being that such a configuration allows air to escape the catheter system as blood enters the catheter system, as well as may relieve residual pressure and allow a user to insert the catheter into the vasculature of a patient and visualize blood flashback without waiting the approximately 30 seconds or more for the dripping of a priming solution to slow or stop [see '948, ¶ 0010 and ¶ 0046].
Conclusion
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/HY KHANH DOAN/Examiner, Art Unit 3791 /TSE W CHEN/Supervisory Patent Examiner, Art Unit 3791