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 .
Claims Pending
Claims 1-14 are currently pending.
Election/Restrictions
Applicant’s without traverse of Invention I, Species A1, Claims 1-3 and 5-8, in the reply filed on 05/29/2026 is acknowledged.
Claims 4 and 9-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected Inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/29/2026.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Claims 1-3 and 5-8 are hereby under examination.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “first extension tube” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
The drawings are objected to because there is a lack of consistency in the manner in which the extension tubes are referred to in Fig. 2, 3, 4, and 5.
(Examiner's Note: In Fig. 2, extension tube 28 extends from side port 44 directly to adapter 40)
(Examiner's Note: In Fig. 3, second extension tube 54 extends from side port 44 directly to distal adapter 60, and extension tube 28 extends from distal adapter 60 to proximal adapter – 62)
(Examiner's Note: In Fig. 4, second extension tube 54 extends from side port 44 directly to distal adapter 64, and extension tube 28 extends from distal adapter 64 to proximal adapter – 66)
(Examiner's Note: In Fig. 5, extension tube 28 extends from side port 44 to distal adapter 68, and second extension tube 54 extends from distal adapter 68 to proximal adapter – 70)
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 claims are generally directed towards an arterial catheter system with a catheter assembly and needle assembly. The catheter assembly comprises a catheter hub and an arterial catheter extending from the distal end of the catheter hub. The needle assembly further comprises a needle hub and introducer needle. The system further comprises an extension tube coupled to the catheter assembly and a fluid pathway extending through the catheter, catheter hub, and extension tube. A fluidic resistance within the extension tube is greater than a second fluidic resistance in a fluid pathway located distally or proximally.
Claim(s) 1, 3, 5, and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ma (US Pub. No. 20210186394) hereinafter Ma, and further in view of Ma (US Pub. No. 20220110562) hereinafter Ciciliano.
Regarding claim 1, Ma discloses An arterial catheter system (Fig. 1C (device of Fig. 1C)), comprising:
a catheter assembly (Par. 73-74, Fig. 1C, catheter assembly – 37), comprising:
a catheter hub (Par. 73-74, Fig. 1C, catheter adapter -39), comprising a distal end and a proximal end (Par. 73, Fig. 1C, catheter adapter -39, “the catheter adapter 39 may include a distal end 42, a proximal end 44”);
an arterial catheter extending from the distal end of the catheter hub (Par. 73, Fig. 1C, catheter -40, “, the catheter 40 may be secured within the catheter adapter 39 and may extend distally from the catheter adapter 39…” “…the catheter adapter 39 may include a distal end 42, a proximal end 44”) (Fig. 1C (observable that catheter 40 extends from the distal end of catheter adapter -39));
a needle assembly (Par. 73, Fig. 1C, needle -45), comprising:
an introducer needle (Par. 73, Fig. 1C, needle -45);
an extension tube coupled to the catheter assembly and having a distal end and a proximal end (Par. 74, “the extension set 10 may be coupled to the catheter assembly 37 in any number of suitable ways”) (Fig. 1C, extension set -10) (Fig. 1C, Par. 71, “the extension set 10 may include an extension tube 32, which may extend between the distal end 12 of the extension set 10 and the proximal end 16 of the extension set 10”); and
a fluid pathway extending through the arterial catheter, catheter hub, and the extension tube (Par. 76, “the fluid pathway of the catheter system may include one or more of the following: the catheter 40, the catheter adapter 39, the other extension tube 46, the fourth luer adapter 50, the first luer adapter 14, the extension tube 32, the third luer adapter 34, the second luer adapter 24, and the blood collection device 18. In some embodiments, the extension set 10 may lower a flow rate of blood within the fluid pathway of the catheter system” (extension tube -32 is part of the extension set 10, and is in the fluid pathway with catheter adapter 39 and catheter 40)).
Ma highly suggests but fails to explicitly disclose a needle assembly, comprising: a needle hub; an introducer needle. (Examiner's Note: As indicated above, Ma discloses an introducer needle, and an unlabeled structure that appears that it could be a needle hub as seen in Fig. 1C of Ma, but fails to explicitly state that the indicated structure is a needle hub and does not state that the needle is secured by the structure).
However, Ciciliano teaches a needle assembly (Fig. 3, Par. 37, needle assembly – 54), comprising: a needle hub (Fig. 3, Par. 37, needle hub – 56); an introducer needle (Fig. 3, Par. 37, introducer needle – 58) (Par. 37, “a needle assembly 54 may be coupled to the catheter assembly 46. In some embodiments, the needle assembly 54 may include a needle hub 56 and an introducer needle 58 secured within the needle hub 56”).
Ma and Ciciliano are considered to be analogous art to the claimed invention as they are involved with catheters.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the system of Ma with that of Ciciliano to include a needle assembly, comprising: a needle hub; an introducer needle through the combination of references as it would have yielded the predictable result of providing the exact structure needed to secure the introducer needle (Ciciliano (Par. 37)).
Modified Ma fails to explicitly disclose wherein a first fluidic resistance within a portion of the fluid pathway within the extension tube is greater than a second fluidic resistance within the fluid pathway distal to or proximal to the portion of the fluid pathway.
However, Ma does teach in embodiments wherein a first fluidic resistance within a portion of the fluid pathway within the extension tube is greater than a second fluidic resistance within the fluid pathway distal to or proximal to the portion of the fluid pathway (Par. 73, “the extension set 10 may act as a flow resistor in a fluid pathway of a catheter system”) (Par. 76, “the extension set 10 may lower a flow rate of blood within the fluid pathway of the catheter system, which may in turn lower a shear rate for hemolysis management”).
Ma further teaches varying fluid resistance (Par. 81, “extension tube may include or correspond to the extension tube 32. Since μ is the viscosity of the fluid and not part of the extension tube geometry, a geometric factor G.sub.f is defined such that R.sub.f (the fluid resistance)”) (Par. 82, “the extension tube 32 may have multiple sections with lengths (L1, L2, L3) and inner diameters of (D1, D2, D3), the geometric factor is then…”)(Par. 82, “the extension tube 32 may have an inner diameter that changes over the length of the extension tube, the geometric factor is then…”) (Par. 28, “It should also be understood that the embodiments may be combined”).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the system of Ma and Ciciliano with the embodiment of Ma to explicitly include wherein a first fluidic resistance within a portion of the fluid pathway within the extension tube is greater than a second fluidic resistance within the fluid pathway distal to or proximal to the portion of the fluid pathway through the combination of embodiments as differing tube modifications are known (Ma (Par. 81-82)) and it would have yielded the predictable result of managing hemolysis (Ma (Par. 76)).
Regarding clam 3, modified Ma further discloses wherein the extension tube comprises no more than one lumen extending therethrough (Ma (Par. 76, “the fluid pathway of the catheter system may include one or more of the following: the catheter 40, the catheter adapter 39, the other extension tube 46, the fourth luer adapter 50, the first luer adapter 14, the extension tube 32, the third luer adapter 34, the second luer adapter 24, and the blood collection device 18” (single fluid pathway)).
Regarding claim 5, modified Ma further discloses wherein the extension tube is a first extension tube (Ma (Par. 74, “the extension set 10 may be coupled to the catheter assembly 37 in any number of suitable ways”) (Fig. 1C, extension set -10) (Fig. 1C, Par. 71, “the extension set 10 may include an extension tube 32, which may extend between the distal end 12 of the extension set 10 and the proximal end 16 of the extension set 10”)),
wherein the arterial catheter system further comprises a second extension tube having a distal end and a proximal end (Ma (Par. 74, Fig. 1C, extension tube – 46 (the distal end is the end connected to the side port, where the proximal end is with adapter -50)),
wherein the arterial catheter system further comprises a distal adapter (Ma (Par. 74, Fig. 1C (adapter – 50))) and a proximal adapter (Ma (Par. 74, Fig. 1C, (adapter - 34)) (Par. 74, “one or more of the first luer adapter 14, the second luer adapter 24, the third luer adapter 34, and the fourth luer adapter 50 may include a slip or thread or clip male luer adapter, a slip or thread female luer adapter, a needleless connector, a blunt cannula, or another suitable access device.”)),
wherein the catheter hub further comprises a side port disposed between the distal end of the catheter hub and the proximal end of the catheter hub (Ma (Par. 74, “another extension tube 46 may extend from a side port 48 the catheter adapter 39.”)(Fig. 1C (observable that side port -48 is between the distal end 42 and proximal end 44 of catheter adapter – 39))),
wherein the distal end of the second extension tube is integrated with the side port (Ma (Par. 74, “another extension tube 46 may extend from a side port 48 the catheter adapter 39.”)(Fig. 1C, (end of extension tube -46 connected with the side port -48))(Par. 119, “In some embodiments, the first extension tube 58 and/or the second extension tube 60 (see, for example, FIGS. 4-9) may be integrated into the side port 48. In some embodiments, the other extension tube 46 may be similar or identical to the first extension tube 58 in terms of one or more included features and/or operation..”)),
wherein the proximal end of the second extension tube is integrated into the distal adapter (Ma (Par. 74, “a proximal end of the other extension tube 46 may include a fourth luer adapter 50, which may be coupled to the first luer adapter 14”) (Par. 74, “one or more of the first luer adapter 14, the second luer adapter 24, the third luer adapter 34, and the fourth luer adapter 50 may include a slip or thread or clip male luer adapter, a slip or thread female luer adapter, a needleless connector, a blunt cannula, or another suitable access device.”)),
wherein the distal end of the first extension tube is coupled to the distal adapter (Ma (Fig. 1c, (the end of extension set 10 with adapter -14))(Par. 74, “a proximal end of the other extension tube 46 may include a fourth luer adapter 50, which may be coupled to the first luer adapter 14”) (Par. 72, “the distal end 36 may be coupled to or integrated with the first luer adapter 14”) (Par. 74, “one or more of the first luer adapter 14, the second luer adapter 24, the third luer adapter 34, and the fourth luer adapter 50 may include a slip or thread or clip male luer adapter, a slip or thread female luer adapter, a needleless connector, a blunt cannula, or another suitable access device.”)),
wherein the proximal end of the first extension tube is coupled to the proximal adapter (Ma (Par. 72, “the proximal end of the extension tube 32 may be coupled to or integrated with the third luer adapter 34.”)(Fig. 1c, (the end of extension set 10 with adapter -19)) (Par. 74, “one or more of the first luer adapter 14, the second luer adapter 24, the third luer adapter 34, and the fourth luer adapter 50 may include a slip or thread or clip male luer adapter, a slip or thread female luer adapter, a needleless connector, a blunt cannula, or another suitable access device.”)).
Regarding clam 7, modified Ma further discloses wherein the first extension tube comprises no more than one lumen extending therethrough (Ma (Par. 76, “the fluid pathway of the catheter system may include one or more of the following: the catheter 40, the catheter adapter 39, the other extension tube 46, the fourth luer adapter 50, the first luer adapter 14, the extension tube 32, the third luer adapter 34, the second luer adapter 24, and the blood collection device 18” (single fluid pathway)), wherein the second extension tube comprises no more than one lumen extending therethrough (Ma (Par. 76, “the fluid pathway of the catheter system may include one or more of the following: the catheter 40, the catheter adapter 39, the other extension tube 46, the fourth luer adapter 50, the first luer adapter 14, the extension tube 32, the third luer adapter 34, the second luer adapter 24, and the blood collection device 18” (single fluid pathway)).
Claim(s) 2 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ma in view of Ciciliano as applied to claim 1 above, and further in view of Ma (US Pub. No. 20210228125) hereinafter Burkholz.
Ma and Ciciliano teach the system of claim 1 above.
Regarding claim 2, modified Ma further discloses wherein the extension tube is a first extension tube (Ma (Par. 74, “the extension set 10 may be coupled to the catheter assembly 37 in any number of suitable ways”) (Fig. 1C, extension set -10) (Fig. 1C, Par. 71, “the extension set 10 may include an extension tube 32, which may extend between the distal end 12 of the extension set 10 and the proximal end 16 of the extension set 10”)), wherein the arterial catheter system comprises a second extension tube (Ma (Fig. 1C, other extension tube - 46)) in fluid communication with the fluid pathway (Ma (Par. 76, “the fluid pathway of the catheter system may include one or more of the following: the catheter 40, the catheter adapter 39, the other extension tube 46, the fourth luer adapter 50, the first luer adapter 14, the extension tube 32, the third luer adapter 34, the second luer adapter 24, and the blood collection device 18. In some embodiments, the extension set 10 may lower a flow rate of blood within the fluid pathway of the catheter system” (extension tube -32 is part of the extension set 10, and is in the fluid pathway with catheter adapter 39 and catheter 40, and extension tube - 46))), wherein the first extension tube is proximal to the second extension tube (Ma (Fig. 1C, other extension tube - 46)) (Ma (Par. 74, “the extension set 10 may be coupled to the catheter assembly 37 in any number of suitable ways”) (Fig. 1C, extension set -10) (Fig. 1C, Par. 71, “the extension set 10 may include an extension tube 32, which may extend between the distal end 12 of the extension set 10 and the proximal end 16 of the extension set 10”) (Fig. 1C (extension tube – 32 is observably proximal to extension tube 46))) and a blood collection port is disposed at a proximal end of the first extension tube (Ma (Fig. 1A-C, (blood collection device – 18 at adapter – 34)) (Par. 69, “holder 22, which may be generally cylindrical and may be configured to hold the blood collection container.”) (Par. 72, “the proximal end of the extension tube 32 may be coupled to or integrated with the third luer adapter 34.”)(Par. 70, “the blood collection device 18 may include the second luer adapter 24”) (Par. 74, “one or more of the first luer adapter 14, the second luer adapter 24, the third luer adapter 34, and the fourth luer adapter 50 may include a slip or thread or clip male luer adapter, a slip or thread female luer adapter, a needleless connector, a blunt cannula, or another suitable access device.”)).
Ma fails to explicitly disclose wherein a geometric factor Gf of the portion of the fluid pathway within the first extension tube is different than a geometric factor Gf of another portion of the fluid pathway within the second extension tub.
Ma does disclose differing extension set configurations (Ma (Par. 121, “In some embodiments, the extension set 126 may be similar or identical to one or more of the following in terms of one or more included features and/or operation: the extension set 10 of FIGS. 1A-1C, the extension set 52 of FIGS. 2A-2C, the extension set 56 of FIGS. 3A-3C, the extension set 70 of FIGS. 4A-4C, the extension set 72 of FIGS. 6A-6C, the extension set 82 of FIGS. 7A-7C, and the extension set 90 of FIG. 8. In some embodiments, the extension set 126 may be similar or identical to one or more of the following in terms of one or more included features and/or operation: the extension sets of FIGS. 9-13.”)).
Burkholz teaches wherein a geometric factor Gf of the portion of the fluid pathway within the first extension tube (Fig. 3, Par. 37, second extension tube – 350b) is different than a geometric factor Gf of another portion of the fluid pathway within the second extension tub (Fig. 3, Par. 37, first extension tube – 350a) (Par. 37, “a flow resistance of first extension tube 350a is less than a flow resistance of catheter 330, and less than a flow resistance of second extension tube 350b.”).
Ma, Ciciliano, and Burkholz are considered to be analogous art to the claimed invention as they are involved with catheters.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the system of Ma and Ciciliano with that of Burkholz to include wherein the first extension tube is proximal to the second extension tube and a blood collection port is disposed at a proximal end of the first extension tube through the substitution of the extension tube flow resistance of Ma with that of Burkholz as it would have yielded the predictable result of optimizing the flow resistance at the blood collection port for managing hemolysis (Ma (Par. 76)) (Burkholz (Par. 36-37)).
Regarding claim 8, modified Ma further discloses wherein the extension tube is a first extension tube (Ma (Par. 74, “the extension set 10 may be coupled to the catheter assembly 37 in any number of suitable ways”) (Fig. 1C, extension set -10) (Fig. 1C, Par. 71, “the extension set 10 may include an extension tube 32, which may extend between the distal end 12 of the extension set 10 and the proximal end 16 of the extension set 10”)),
wherein the arterial catheter system comprises a second extension tube having a distal end and a proximal end (Ma (Par. 74, Fig. 1C, extension tube – 46 (the distal end is the end connected to the side port, where the proximal end is with adapter -50)),
wherein the catheter hub further comprises a side port disposed between the distal end of the catheter hub and the proximal end of the catheter hub (Ma (Par. 74, “another extension tube 46 may extend from a side port 48 the catheter adapter 39.”)(Fig. 1C (observable that side port -48 is between the distal end 42 and proximal end 44 of catheter adapter – 39))),
wherein the distal end of the second extension tube is integrated with the side port (Ma (Par. 74, “another extension tube 46 may extend from a side port 48 the catheter adapter 39.”)(Fig. 1C, (end of extension tube -46 connected with the side port -48))(Par. 119, “In some embodiments, the first extension tube 58 and/or the second extension tube 60 (see, for example, FIGS. 4-9) may be integrated into the side port 48. In some embodiments, the other extension tube 46 may be similar or identical to the first extension tube 58 in terms of one or more included features and/or operation..”)),
wherein the arterial catheter system further comprises a distal adapter (Par. 74, Fig. 1C (adapter – 50))) integrated with the proximal end of the second extension tube (Ma (Par. 74, “a proximal end of the other extension tube 46 may include a fourth luer adapter 50, which may be coupled to the first luer adapter 14”)(Par. 74, “one or more of the first luer adapter 14, the second luer adapter 24, the third luer adapter 34, and the fourth luer adapter 50 may include a slip or thread or clip male luer adapter, a slip or thread female luer adapter, a needleless connector, a blunt cannula, or another suitable access device.”)) and a distal end of the first extension tube (Ma (Fig. 1c, (the end of extension set 10 with adapter -14))(Par. 74, “a proximal end of the other extension tube 46 may include a fourth luer adapter 50, which may be coupled to the first luer adapter 14”) (Par. 72, “the distal end 36 may be coupled to or integrated with the first luer adapter 14”) (Par. 74, “one or more of the first luer adapter 14, the second luer adapter 24, the third luer adapter 34, and the fourth luer adapter 50 may include a slip or thread or clip male luer adapter, a slip or thread female luer adapter, a needleless connector, a blunt cannula, or another suitable access device.”)),
wherein the arterial catheter system further comprises a proximal adapter integrated with the proximal end of the first extension tube (Ma (Par. 74, Fig. 1C, (adapter - 34)) (Par. 72, “the proximal end of the extension tube 32 may be coupled to or integrated with the third luer adapter 34.”) (Fig. 1c, (the end of extension set 10 with adapter -19))) (Par. 74, “one or more of the first luer adapter 14, the second luer adapter 24, the third luer adapter 34, and the fourth luer adapter 50 may include a slip or thread or clip male luer adapter, a slip or thread female luer adapter, a needleless connector, a blunt cannula, or another suitable access device”)), wherein the proximal adapter comprises a blood collection port (Ma (Fig. 1A-C, (blood collection device – 18 at adapter – 34)) (Par. 69, “holder 22, which may be generally cylindrical and may be configured to hold the blood collection container.”) (Par. 72, “the proximal end of the extension tube 32 may be coupled to or integrated with the third luer adapter 34.”)(Par. 70, “the blood collection device 18 may include the second luer adapter 24”) (Par. 74, “one or more of the first luer adapter 14, the second luer adapter 24, the third luer adapter 34, and the fourth luer adapter 50 may include a slip or thread or clip male luer adapter, a slip or thread female luer adapter, a needleless connector, a blunt cannula, or another suitable access device.”)).
Ma fails to explicitly disclose wherein the first extension tube comprises a spiral shape.
However, Burkholz teaches wherein the first extension tube comprises a spiral shape (Par. 38, “For example, in some embodiments a second extension tube 450b of catheter assembly 400 may include a non-linear portion such as a spiral, a coil shape, an S-shape, or another suitable non-linear shape. The non-linear portion may facilitate increased flow resistance within the catheter assembly to distribute the pressure differential and thereby reduce shear stress experienced by red blood cells. In some embodiments, no fluid flowing through non-linear portion 451 may flow in a straight or linear pattern. In some embodiments, non-linear portion 451 may increase a length of the fluid pathway of second extension tube 450b and thereby may increase flow resistance and decrease blood flow within catheter assembly. Accordingly, these embodiments may further reduce a risk of hemolysis during blood collection.”)(Fig. 4, second extension tube – 450b (observable spiral shape)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the system of Ma and Ciciliano with that of Burkholz to include wherein the first extension tube comprises a spiral shape through the substitution of the extension tubes of Ma with that of Burkholz as differing non-linear shapes are known (Burkholz (Par. 38)) and it would have yielded the predictable result of reducing the risk of hemolysis during blood collection (Burkholz (Par. 38)).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ma in view of Ciciliano as applied to claim 5 above, and further in view of Burkholz (US Pub. No. 20190021640) hereinafter Burkholz 2.
Ma and Ciciliano teach the system of claim 5 above.
Regarding claim 6, modified Ma further discloses wherein the proximal adapter (Ma (Par. 72, “the proximal end of the extension tube 32 may be coupled to or integrated with the third luer adapter 34.”)) comprises a blood collection port (Ma (Fig. 1A-C, (blood collection device – 18 at adapter – 34)) (Par. 69, “holder 22, which may be generally cylindrical and may be configured to hold the blood collection container.”) (Par. 72, “the proximal end of the extension tube 32 may be coupled to or integrated with the third luer adapter 34.”)(Par. 70, “the blood collection device 18 may include the second luer adapter 24”) (Par. 74, “one or more of the first luer adapter 14, the second luer adapter 24, the third luer adapter 34, and the fourth luer adapter 50 may include a slip or thread or clip male luer adapter, a slip or thread female luer adapter, a needleless connector, a blunt cannula, or another suitable access device.”)).
Ma fails to explicitly disclose wherein the distal adapter comprises a blood pressure monitoring port.
However, Burkholz 2 teaches wherein the distal adapter (Par. 49, “catheter assembly 14 may include an adapter or coupler element 32, which may be coupled to the corresponding coupling mechanism 30 of the extension 10. In some embodiments, the extension tube 22 may provide compliance and/or flexibility in the system, which may allow a length of the extension 10 to be shortened and/or prevent use of another extension tube, as will be explained later in further detail. In some embodiments, the coupler element 32 may include a y-adapter, a single port, or dual ports. In some embodiments, the coupler element 32 may include a luer fitting and/or a blood control valve. In some embodiments, the blood control valve may facilitate maintenance of the closed system and prevent blood leakage.”) comprises a blood pressure monitoring port (Par. 42, “In some embodiments, the sensors may measure one or more parameters and/or detect one or more elements related to, for example, diagnostic information, blood chemistry, pressure, flow rate, drug identification, microbes, placement of an implantable stent, in-vein catheter tip stabilization feature, or other device, etc”)(Par. 42, “instrument 12 may include a probe, which may be at least partially disposed within the extension 10. In some embodiments, the probe may include one or more openings and/or one or more sensors”) (Par. 51, “the instrument 12 may be at least partially disposed or housed within the housing 28”) (Par. 48, “the distal end of the housing 28 may include a coupling mechanism 30”)(Par. 49, “a proximal end of the extension tube 22 of the catheter assembly 14 may include an adapter or coupler element 32, which may be coupled to the corresponding coupling mechanism 30 of the extension 10”) (Fig. 1A, (instrument 12 is observably in housing 28, which is connected to coupling mechanism 30, which is connected to adapter 32)).
Ma, Ciciliano, and Burkholz 2 are considered to be analogous art to the claimed invention as they are involved with catheters.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the system of Ma and Ciciliano with that of Burkholz 2 to include wherein the distal adapter comprises a blood pressure monitoring port through the substitution of adapters as differing adapters are known (Burkholz 2 (Par. 49)) (Ma (Par. 118)) and it would have yielded the predictable result of providing pressure information (Burkholz 2 (Par. 42)).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARI SINGH KANE PADDA whose telephone number is (571)272-7228. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm.
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/ARI S PADDA/Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791
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