DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 27 January 2026 has been entered.
Status of Claims
Claim(s) 1-2, 6, 8, 12 and 20 is/are currently amended. Claim(s) 1-20 is/are pending.
Objections and/or Rejections Withdrawn
Objections to the claims and/or rejections under 35 U.S.C. 112(b) (pre-AIA 35 U.S.C. 112, second paragraph) not reproduced has/have been withdrawn in view of Applicant's amendments to the claims and/or submitted remarks.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of pre-AIA 35 U.S.C. 112, first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 8 and claims dependent thereon is/are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 8 and claims dependent thereon, Applicant discloses, "The hollow needle may be connected to an intravenous (IV) supply tube filled with pressurized IV fluid or other fluid and further connected to a pressure transducer containing a media-isolated or similar pressure sensor. When a patient's heart beats, a blood pressure wave is generated and propagated through the patient's artery, through the cannula, and through the IV fluid to the pressure sensor of the pressure transducer. The pressure transducer may continuously monitor the change in pressure and output a pressure waveform associated with the patient's real-time blood pressure measurements" (¶ [0036]). Applicant does not disclose the IV fluid supply bag being substantially filled results in a blood pressure wave is transmitted from a bodily fluid of the patient to the intravenous fluid in the intravenous supply tube to interact with the flexible membrane as recited in amended claim 8. Claim 8 will be further discussed with the understanding that the IV fluid substantially fills the IV supply tube whose one end is in fluid communication with the pressure sensor and other end is in fluid communication with a cannula, such that a blood pressure wave is transmitted from a bodily fluid of the patient to the intravenous fluid in the intravenous supply tube to interact with the flexible membrane, consistent with Applicant's originally-filed disclosure (e.g., ¶ [0036] noted above).
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:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
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) 1-3, 5-6 8-13, 15 and 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0343408 A1 (previously cited, Handler) in view of US 4,690,675 A (Katz), US 2005/0197585 A1 (previously cited, Brockway) and US 2013/0131610 A1 (previously cited, Dewaele); or alternatively, over Handler in view of US 4,779,625 A (previously cited, Cole), Katz, Brockway and Dewaele.
Regarding claims 1-3, 8-9, 12-13, 17-18 and 20, Handler discloses and/or suggests a hemodynamic monitoring system comprising:
a pressure sensor (PIVA device 130, 630) comprising a pressure sensing element (pressure sensor 112, 612), wherein the pressure sensing element is isolated from intravenous (IV) fluid by a flexible membrane that deforms in response to a pressure force such that the pressure force is transmitted to the pressure sensing element (e.g., ¶ [0100] pressure sensor 612 may be coupled to the IV tube 604 via a flexible membrane that provides a sterile barrier between fluids and pressure sensor 612);
an IV fluid supply bag containing an IV fluid (fluid source 110, 610, e.g., ¶ [0003]), wherein the IV fluid supply bag is in fluid communication with the pressure sensor by a first IV supply tube (e.g., Figs. 1 and 6, tube/tubing illustrated between fluid source 110, 610 and PIVA device 130, 630, or transducer 112, 612 thereof);
a second IV supply tube (IV tube 104, 604) whose one end is in fluid communication with the pressure sensor (¶¶ [0039]-[0040], ¶¶ [0098]-[0100], etc., at some point along IV tube 104, 604, pressure sensor 112, 612 may be disposed in fluid connection with the interior of the IV tube 104, 604) and other end in fluid communication with a cannula (venous access device 106, 606) (¶¶ [0039]-[0040], ¶¶ [0098]-[0100], etc., a fluid connection is established between the IV tube 104, 604, and venous access device 106, 606, which may include a cannula; see, e.g., Figs. 1 and 6, tube/tubing 104, 604 illustrated between transducer 112, 812 and venous access device 106, 606), wherein the cannula is inserted in a blood vessel of a patient (¶ [0039], ¶ [0098], etc. venous access device 106, 606 is inserted into a peripheral vein of the patient),
wherein the pressure sensing element/flexible membrane is positioned proximate to an interface between the cannula and the second IV supply tube (e.g., ¶ [0101] pressure sensor 612 may be positioned at a location proximate to the connecting end of the venous access device),
wherein the IV fluid substantially fills the second IV supply tube, such that a blood pressure wave is transmitted from a bodily fluid of the patient to the IV fluid in the second IV supply tube to interact with the pressure sensing element (e.g., ¶ [0003] where existing IV lines may be utilized, which one of ordinary skill in the art would readily appreciate are substantially filled with IV fluid),
wherein the pressure sensor determines a blood pressure of the patient based at least in part of the pressure force while an IV fluid simultaneously flows from the IV fluid supply bag, through each of the IV supply tubes, and into the blood vessel of the patient (¶ [0040], ¶ [0100], etc., pressure sensor is enabled to measure pressure changes in the peripheral venous system of the patient based upon changes in the fluid pressure within the IV tube).
The examiner notes Handler does not expressly state the IV fluid substantially fills the second IV supply tube and/or blood pressure is determined while an IV fluid simultaneously flows from the IV fluid supply bag into the blood vessel of the patient. However, Handler discloses existing or conventional IV lines may be utilized in the disclosed invention (e.g., ¶ [0003]). One of ordinary skill would readily appreciate that existing/conventional IV lines are substantially filled by IV fluid from an IV source (e.g., IV fluid supply bag), such that a blood pressure wave is transmitted from a bodily fluid of the patient to the IV fluid in the IV line. Accordingly, one of ordinary skill would at once envisage the above-noted features based on the disclosure of Handler.
Alternatively/Additionally, Cole more expressly discloses it is well known in the art that an IV fluid flowing from an IV fluid supply, through an IV supply tube(s), and into a blood vessel of a patient substantially fills said IV supply tube(s), such that a blood pressure wave is transmitted from a bodily fluid of the patient to the IV fluid in the IV supply tube(s) to interact with a pressure sensing element (col. 1, lines 10-18). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system/apparatus of Handler with the IV fluid flowing from the IV fluid supply bag, through and substantially filling the first IV supply tube and the second IV supply tube, and into the blood vessel of the patient, such that a blood pressure wave is transmitted from a bodily fluid of the patient to the IV fluid filling the second IV supply tube to interact with a pressure sensing element as taught/suggested by Cole in order to provide a liquid or incompressible fluid connection between the blood stream of the patient and the pressure sensing element that provides excellent pressure transmission characteristics thereto (Cole, col. 3, line 66 – col. 4, lines 24).
Handler does not disclose the cannula comprises a cannula housing and a hollow needle inserted in a blood vessel of a patient, wherein the hollow needle is attached to the cannula housing.
Katz discloses/suggests a cannula, or venous access device, comprising a cannula housing and a hollow needle configured to be inserted in a blood vessel of a patient (hollow needle 10; Figs. 2-3; etc.), wherein the hollow needle is attached to the cannula housing (Fig. 1, central body 13, cylindrical member 12 thereof, etc.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system/apparatus of Handler with the cannula comprising a hollow needle configured to be inserted in a blood vessel of a patient and attached to a cannula housing as taught/suggested by Katz as a simple substitution of one suitable cannula/venous access device for another to yield no more than predictable results. See MPEP 2143(I)(B).
Handler as modified discloses/suggests the system, or an apparatus thereof, may comprise a flexible membrane configured to deform in response to a pressure force and isolate the pressure sensing element from the IV fluid, and the pressure sensing element/flexible membrane may be positioned proximate to an interface of the cannula housing and the second IV supply tube, as noted above. However, Handler as modified does not expressly disclose the system/apparatus comprises a tube filled with an incompressible fluid and disposed within the second IV supply tube, the fluid-filled tube comprising a first end coupled to the pressure sensing element; and a second end terminating in the flexible membrane, such that pressure force is transmitted through the incompressible fluid to the pressure sensing element.
Brockway discloses/suggests a tube (tubular shaft 112) filled with an incompressible fluid (pressure transmitting fluid 114), the tube comprising: a first end coupled to a pressure sensing element (e.g., Fig. 2, end of shaft 112 coupled to pressure transducer 132); and a second end terminating in a flexible membrane (e.g., Fig. 2, end of shaft 112 having pressure responsive barrier 116, which may comprise a flexible membrane, e.g., ¶ [0029]), wherein the flexible membrane deforms in response to a pressure force such that the pressure force is transmitted through the in-compressible fluid that creates a continuous medium through which a blood pressure wave propagates to the pressure sensing element, and the pressure sensor/sensing element determines a blood pressure based at least in part on the pressure force (e.g., ¶ [0031] transdermal catheter portion 110 refers pressure from an intravascular lumen to the pressure transducer 132 via a pressure transmitting fluid 114 and a pressure responsive barrier 116). Additionally, Dewaele discloses a pressure-measuring tube comparable to the tube disclosed by Brockway (capillary tube or lumen, which may be filled with an incompressible fluid (¶ [0246]) may be disposed within a fluid-carrying lumen (Abstract) and arranged proximal to the distal tip of the fluid-carrying lumen (e.g., ¶ [0148]). Dewaele further discloses/suggests said arrangement enables measuring pressure at the distal end of said capillary tube to the exclusion of a hydrodynamic/hydrostatic measurement at the proximal end of the fluid-carrying lumen (e.g., ¶¶ [0123]-[0124]; etc.).
Since Handler discloses/suggests pressure may be measured within the second IV supply tube proximate to the interface of the cannula, as noted above, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system/apparatus of Handler with a tube filled with an incompressible fluid and disposed within the second IV supply tube, the tube comprising a first end coupled to the pressure sensing element, and a second end terminating in a flexible membrane positioned proximate to an interface of the cannula housing, wherein the flexible membrane deforms in response to a pressure force such that said force is transmitted through the incompressible fluid to the pressure sensing element, and wherein the pressure sensor determines a blood pressure based at least in part on the pressure force, as taught/suggested by Brockway and Dewaele, such that the pressure sensing element is isolated from the IV fluid and the a blood pressure wave is transmitted from a bodily fluid of the patient to the IV fluid in the second IV supply tube to interact with the flexible membrane, in order to measure blood pressure in a manner than provides a sterile barrier between administered fluids and the pressure sensing element (Handler, ¶ [0100]; Dewaele, ¶ [0118]; etc.); to enable measuring pressure proximate the interface of the cannula to the exclusion of hydrostatic pressure acting on the proximal end of the second IV tubing (Dewaele, ¶¶ [0123]-[0124]); and/or as a simple substitution of one suitable means/configuration for providing the pressure sensing element in fluid communication with the peripheral vein of a patient through the second IV supply tube for another to yield no more than predictable results. See MPEP 2143(I)(B).
Regarding claims 5-6 and 15, Handler as modified discloses/suggests the tube terminates prior to entering a blood vessel of a patient, such that the flexible membrane is isolated from contact with bodily fluids of the patient (e.g., ¶¶ [0040]-[0041] where the pressure sensor is positioned in fluid communication with the interior of IV tube 104, e.g., proximate the connecting end of the venous access device, which, as noted above, is filled with IV fluid, not bodily fluids).
Regarding claims 10 and 19, Handler as modified discloses/suggests the incompressible fluid comprises a viscous incompressible silicone material (Brockway, ¶ [0031] fluorinated silicone oil, wherein one of ordinary skill in the art would readily appreciate an "oil" as a viscous material). Alternatively/Additionally, at the time the invention was effectively filed, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the system and/or apparatus of Handler with the incompressible silicone material being viscous because Applicant has not disclosed that viscosity of the material provides an advantage, is used for a particular purpose, or solves a stated problem. As no evidence has been provided to the contrary, one of ordinary skill in the art would have expected Applicant's invention to perform equally well with the incompressible silicone material disclosed by Brockway (or Handler as modified thereby) because either configuration permits transmitting a pressure wave(s) from the flexible membrane to the pressure-sensing element.
Regarding claim 11, Handler as modified discloses/suggests the limitations of claim 1, as discussed above, but does not expressly teach the tube comprises an inner diameter between 0.4 and 0.6 millimeters and an outer diameter between 0.9 and 1.1 millimeters. However, Dewaele discloses a pressure-measuring capillary tube disposed within the fluid-carrying lumen may have an outer diameter of, e.g., 0.9 mm (e.g., ¶ [0150]) and may have a wall thickness between, e.g., 0.3 and 0.5 mm (e.g., ¶ [0152]), thereby resulting in an inner diameter between 0.4 and 0.6 mm, such that it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Handler with the tube comprising an inner diameter between 0.4 and 0.6 millimeters and an outer diameter between 0.9 and 1.1 millimeters as taught/suggested by Handler in order to facilitate obtaining pressure measurements while not hindering the flow of fluid through the second IV tube (Dewaele, ¶ [0150]).
Alternatively/Additionally, Dewaele discloses/suggests the outer diameter provides a quality that can be optimized, e.g., flow of fluids though a main tube lumen (¶ [0150]), and further discloses a skilled person would understand how to determine an optimum thickness of the tube (and therefore, the resulting inner diameter) (¶ [0152]), disclosing, for optimal transduction of a pressure change, rigid tubing material is preferred (¶ [0140]), wherein stiffness and/or rigidity of a tube is a function of wall thickness (e.g., ¶ [0138]). Accordingly, Dewaele discloses each of the outer diameter and the inner diameter (a function of outer diameter and wall thickness) of the tube are result effective variables. Accordingly, the claimed inner and outer tube diameter ranges would have been obvious because it has been held that the discovery of optimum or workable ranges by routine experimentation is not inventive. See MPEP 2144.05(II).
Claim(s) 4, 7, 14 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Handler in view of Katz, Brockway and Dewaele (or Handler in view of Cole, Katz, Brockway and Dewaele) as applied to claim(s) 1 and 12 above, and further in view of US 5,573,007 A (previously cited, Bobo).
Regarding claims 4 and 14, Handler as modified discloses/suggests the limitations of claims 1 and 12, as discussed above, and further discloses/suggests the second end of the tube is positioned to contact a fluid within the IV supply tube (e.g., ¶¶ [0040]-[0041] where the pressure sensor is positioned in fluid communication with the interior of the IV tube, e.g., at a location proximate to the connecting end of the venous access device). Handler as modified does not disclose the flexible membrane protrudes from the second end of the tube forming a rounded surface positioned to contact a fluid within the said IV supply tube.
Bobo discloses/suggests a comparable fluid-filled tube for measuring pressure of a fluid, wherein the tube comprises a flexible membrane that protrudes from the second end of tube forming a rounded surface positioned to contact said fluid (e.g., Fig. 3a, bulbous pressure sensing membrane 24 mounted on the distal end of catheter body 20; col. 7, lines 43-46; etc.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system/apparatus of Handler with the flexible membrane protruding from the second end of the tube forming a rounded surface positioned to contact a fluid within the second IV supply tube as taught and/or suggested by Bobo as a simple substitution of one suitable flexible membrane shape/configuration that enables sensing pressure of a surrounding fluid for another to yield no more than predictable results. See MPEP 2143(I)(B).
Regarding claims 7 and 16, Handler as modified discloses/suggests the limitations of claims 1 and 12, as discussed above, but does not disclose the flexible membrane comprises a membrane made of biocompatible polyvinyl chloride material.
Bobo discloses/suggests a comparable fluid-filled tube comprising a flexible membrane at the distal end thereof (membrane 24 mounted on the distal end of catheter body 20), wherein the flexible membrane comprises a thin membrane of biocompatible polyvinyl chloride material (col. 8, lines 8-18, membrane-walled chamber is formed of one or more polymeric materials, such as PVC, in a thin film form; Abstract, catheter is insertable into the mammalian body, suggesting biocompatible materials are used; etc.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system/apparatus of Handler with the flexible membrane comprising a membrane made of biocompatible polyvinyl chloride material as taught/suggested by Bobo in order to provide the flexible membrane with a desired pliability, with minimal gas or liquid permeability, etc. (Bobo, col. 8, lines 8-18) and/or as a simple substitution of one suitable flexible membrane material that enables sensing the pressure of a surrounding fluid for another to yield no more than predictable results. See MPEP 2143(I)(B).
Response to Arguments
Applicant's arguments with respect to the prior art failing to disclose or suggest a cannula comprising a cannula housing and a hollow needle attached to the cannula housing 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.
Applicant's remaining arguments have been fully considered but they are not persuasive.
Applicant discloses each of Handler, Cole, Brockway and Dewaele individually, noting various features that are not disclosed by said references.
With respect to Handler, Applicant contends Handler does not disclose a tube is disposed within the second intravenous supply tube (Remarks, pg. 9). This is acknowledged in the rejection of record. The examiner has made no contention that Handler alone discloses said feature. Applicant further contends, "Handler merely teaches that the pressure sensor is disposed at the terminating end of an IV tube inserted specifically for the purpose of measuring pressure within the peripheral vein" (Remarks, pg. 10). The examiner agrees that Handler does disclose that the pressure sensor may be disposed at the terminating end of an IV tube; however, this is only one location for the pressure sensor disclosed by Handler. As noted in the rejection of record above, Handler discloses the pressure sensor may be positioned proximate to an interface of the venous access device (e.g., cannula) (e.g., ¶ [0041]).
With respect to Cole, Applicant contends Cole does not disclose particular limitations of the pending claims. However, the examiner has made no assertion that Cole discloses or suggests the cited features. With respect to Brockway and Dewaele. Applicant contends the Office Action relies on said references "as allegedly disclosing the feature 'a tube filled with an incompressible fluid and disposed within an IV supply tube, the fluid-filled tube comprising a first end coupled to the pressure sensing element; and a second end comprised of a flexible membrane, wherein the flexible membrane deforms in response to a pressure force such that the force is transmitted through the incompressible fluid to the pressure sensing element, and the pressure sensor'" (Remarks, pg. 12). Applicant again points to features of the claimed invention that are lacking in either individual reference that the examiner has made no contention that either reference alone discloses (Remarks, pgs. 12-14).
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 has not asserted that either Brockway or Dewaele expressly discloses the "tube filled with an incompressible fluid…" limitation(s). The test for obviousness is not that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
In the instant case, as noted in the rejections of record above, the primary reference to Handler discloses/suggests measuring blood pressure while an IV fluid simultaneously flows into the blood vessel of a patient via a venous access device (e.g., cannula) by disposing a pressure sensing element, or a flexible membrane that isolates the pressure sensing element from IV fluid and transmits a pressure force thereto, in an IV tube. Handler discloses the pressure sensing element/flexible membrane may be disposed at various distances relative to said venous access device, including at a location proximate to the connecting end of the venous access device.
Brockway discloses/suggests a tube filled with an incompressible fluid, said tube having a first end coupled to a pressure sensing element, and a second end terminating in a flexible membrane, wherein the flexible membrane deforms in response to a pressure force such that the pressure force is transmitted through the incompressible fluid that creates a continuous medium through which a blood pressure wave propagates to the pressure sensing element, and the pressure sensor/sensing element determines a blood pressure based at least in part on the pressure force. Accordingly, Brockway discloses/suggests a fluid-filled tube structure as a suitable means/method for isolating a pressure sensing element from the fluid in which pressure is being measured.
Dewaele discloses a pressure-measuring tube comparable to the tube disclosed by Brockway (capillary tube or lumen, which may be filled with an incompressible fluid (¶ [0246])), which may be disposed within a fluid-carrying lumen (Abstract), wherein the distal end of said tube is arranged proximal to the distal tip of the fluid-carrying lumen (e.g., ¶ [0148]). Dewaele further discloses/suggests said arrangement enables measuring pressure at the distal end of said capillary tube to the exclusion of a hydrodynamic/hydrostatic measurement at the proximal end of the fluid-carrying lumen (e.g., ¶¶ [0123]-[0124]; etc.). Accordingly, Dewaele discloses/suggests a fluid-filled tube structure, comparable to that disclosed by Brockway, may be disposed within a fluid-carrying lumen and proximate to the distal interface thereof, and utilized to accurately measure pressure at the distal end of said tube, even if/when a pressure-sensing element (e.g., transducer) is located at the proximal end of the tube and fluid-carrying lumen.
In view of the above, the cited prior art in combination at least suggests modifying the system/apparatus of Handler with a tube filled with an incompressible fluid and disposed within the second IV supply tube, the tube comprising a first end coupled to the pressure sensing element, and a second end terminating in a flexible membrane positioned proximate to an interface of the cannula housing, wherein the flexible membrane deforms in response to a pressure force such that said force is transmitted through the incompressible fluid to the pressure sensing element, and wherein the pressure sensor determines a blood pressure based at least in part on the pressure force would have been obvious in order to measure blood pressure in a manner than provides a sterile barrier between administered fluids and the pressure sensing element (Handler, ¶ [0100]; Dewaele, ¶ [0118]; etc.); to enable measuring pressure proximate the interface of the cannula to the exclusion of hydrostatic pressure acting on the proximal end of the second IV tubing (Dewaele, ¶¶ [0123]-[0124]); and/or as a simple substitution of one suitable means/configuration for providing the pressure sensing element in fluid communication with the peripheral vein of a patient through the second IV supply tube for another to yield no more than predictable results. See MPEP 2143(I)(B).
Conclusion
The prior art made of record and not relied upon is considered pertinent to Applicant's disclosure: see attached PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Meredith Weare whose telephone number is 571-270-3957. The examiner can normally be reached Monday - Friday, 9 AM - 5 PM.
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/Meredith Weare/Primary Examiner, Art Unit 3791