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 .
Response to Amendment
Applicant’s amendments filed on 01/14/2026 has been fully considered. Claims 65-67, 69, 71-73, 75-101, and 103-105 are pending in this application. Claims 1-64, 68, 70, 74, and 102 are cancelled. Claims 91-101 are withdrawn. Claims 103-105 are newly added. Claims 65, 69, and 88-89 are amended.
Response to Arguments
Applicant’s arguments with respect to claim(s) 65 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.
Though some of the same prior art reference is re-used herein, amended independent claim 65 and newly added dependent claims 103-105 required a change in the grounds of rejection relying on additional prior art as detailed below in the prior art rejection. More specifically, the amended claim 65 with the claim limitations “a measurement substructure extending laterally from the flow path” and “a data processing unit disposed within the housing; at least one sensor element in electrical communication with the data processing unit and configured to determine at least one fluid parameter in the flow path of the conduit, wherein the at least one sensor element is in fluid communication with the measurement substructure when the housing is coupled to the intermittent urinary catheter; and an engagement mechanism configured to removably couple the signal processing device to the intermittent urinary catheter…” further narrows the scope of the claimed invention.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 90 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 90 recites the limitation "the measuring device" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim. In an effort to compact prosecution, the limitation is interpreted as –the at least one sensor element--.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 65-73 and 103-105 are rejected under 35 U.S.C. 103 as being unpatentable over Hickmott et al. (Publication No. US 2018/0169377 A1) in view of Recinella et al. (Publication No. US 2010/0114063 A1).
Regarding claim 65, Hickmott teaches an intermittent urinary catheterisation assembly for self- catheterisation (assembly 1; Abstract; Paragraph 0069; Figure 1) comprising:
an intermittent urinary catheter (urinary catheter 2; Paragraph 0069; Figure 1) comprising:
a catheter tube (urinary catheter 2 has a tubular length; Figure 1; Paragraph 0069) comprising an insertable portion insertable into a user's urethra (proximal end 3 is insertable into the urethra; Paragraph 0050 and 0069; Figure 1), a non-insertable portion not intended for insertion into the user's urethra (distal end 5 is not insertable into the urethra; Figure 1; Paragraph 0069), and a connecting portion being integral with or mounted to the non-insertable portion (connector 9 is mounted on the distal end 5; Figure 1; Paragraph 0069);
a conduit extending longitudinally within the catheter tube and defining a flow path from a distal insertion end of the insertable portion to a proximal outlet end of the connecting portion (catheter 2 has a conduit/lumen that extends longitudinally to form a flow path for urine to flow through; Figure 1; Paragraph 0061-0064 and 0069); and
wherein the catheter tube has a single-lumen that is a sole passage for the flow path between the distal insertion end and the proximal outlet end of the intermittent urinary catheter (catheter 2 has a single lumen that is the sole passage for urine between the proximal insertion end 3 to the flange 10; Paragraph 0069; Figure 1).
Hickmott does not teach a measurement substructure extending laterally from the flow path and
a signal processing device, comprising:
a housing,
a data processing unit disposed within the housing;
at least one sensor element in electrical communication with the data processing unit and configured to determine at least one fluid parameter in the flow path of the conduit, wherein the at least one sensor element is in fluid communication with the measurement substructure when the housing is coupled to the intermittent urinary catheter; and
an engagement mechanism configured to removably couple the signal processing device to the intermittent urinary catheter.
However, Recinella teaches a measurement substructure extending laterally from the flow path (channel 41 extends laterally from lumen 56; Paragraph 0065; Figure 10 and 14), and
a signal processing device (monitoring gauge 15; Figure 8, and 14; Paragraph 0049 and 0060), comprising:
a housing (monitoring gauge 15 has housing that holds electronic components in it; Paragraph 0049-0050 and 0060; Figure 8 and 14),
a data processing unit disposed within the housing (microprocessor 51; Figure 8; Paragraph 0053, 0056-0057, and 0060);
at least one sensor element in electrical communication with the data processing unit and configured to determine at least one fluid parameter in the flow path of the conduit (sensor 17 in electrical communication with microprocessor 51 through wire 31 and to measure pressure of fluid flow through the lumen 56; Figure 8; Paragraph 0060-0062), wherein the at least one sensor element is in fluid communication with the measurement substructure when the housing is coupled to the intermittent urinary catheter (sensor 17 is in fluid communication with channel 41 when housing of monitoring gauge 15 is coupled to catheter; Figure 8); and
an engagement mechanism configured to removably couple the signal processing device to the intermittent urinary catheter (monitoring gauge 15 can be snap-fitted to the catheter; Paragraph 0066; Figures 16A-16B).
Hickmott and Recinella are both considered to be analogous to the claimed invention because they are in the same field of pressure measuring catheter assemblies. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hickmott to incorporate the teachings of Recinella and have the measuring substructure, sensor, and signal processing device of Recinella connected onto the non-insertable portion of the catheter tube of Hickmott, using the engagement mechanism of Recinella. This would allow for the measurement of the fluid flow through the flow path (Recinella; Paragraph 0048 and 0060-0062).
Regarding claim 66, Hickmott in view of Recinella teaches the assembly of claim 65. Hickmott further teaches wherein the intermittent urinary catheter is configured to rest in the user's urethra for a period of time not exceeding 15 minutes (intermittent catheter is used for about 5 to 10 minutes; Paragraph 0019).
Regarding claim 67, Hickmott in view of Recinella teaches the assembly of claim 65. Hickmott further teaches wherein at least an outer surface of the insertable portion of the catheter tube comprises a hydrophilic surface coating (outer surface of insertable portion with hydrophilic surface coating; Paragraph 0019-0020 and 0030-0032).
Regarding claim 69, Hickmott in view of Recinella teaches the assembly of claim 65. The combination of Hickmott in view of Recinella further teaches wherein the measurement substructure is embedded in or integral with the catheter tube (Recinella; channel 41 is embedded with lumen 56; Figure 8 and 14; Paragraph 0052 and 0065).
Regarding claim 71, Hickmott in view of Recinella teaches the assembly of claim 65. The combination of Hickmott in view of Recinella further teaches wherein the measurement substructure comprises a barrier embedded in the catheter tube (Recinella; diaphragm 69 is embedded in tube 56 at entrance of channel 41; Paragraph 0065; Figure 14), the barrier being configured to prevent liquid in the flow path from contacting the at least one sensor element (Recinella; diaphragm 69 prevents fluid from contacting sensor 17 in monitoring gauge 15; Figure 14; Paragraph 0065).
Regarding claim 72, Hickmott in view of Recinella teaches the assembly of claim 71. The combination of Hickmott in view of Recinella further teaches wherein the barrier comprises a liquid impermeable flexible membrane (Recinella; Paragraph 0065).
Regarding claim 73, Hickmott in view of Recinella teaches the assembly of claim 71. The combination of Hickmott in view of Recinella further teaches wherein the barrier comprises a gas conduit configured to establish a gaseous buffer between the flow path and the signal processing device (Recinella; obvious that channel 41 behind diaphragm 69 between flow path of lumen 56 and the monitoring gauge 15; Paragraph 0065; Figure 14).
Regarding claim 103, Hickmott in view of Recinella teaches the assembly of claim 65. The combination of Hickmott in view of Recinella further teaches wherein the signal processing device further comprises a power source (Recinella; battery 49 is in monitoring gauge 15; Figure 8; Paragraph 0060).
Regarding claim 104, Hickmott in view of Recinella teaches the assembly of claim 65. The combination of Hickmott in view of Recinella further teaches wherein the intermittent urinary catheter further comprises another sensor element (Recinella; two sensors 17 can be used; Paragraph 0049).
Regarding claim 105, Hickmott in view of Recinella teaches the assembly of claim 104. The combination of Hickmott in view of Recinella further teaches wherein the engagement mechanism comprises a set of electrical contacts arranged to contact a set of corresponding contacts electrically coupled to the another sensor element (contacts/wires 31 connect transducers 17 to the processor 51; thus connecting the wires 31 of both sensors 17 to each other; Paragraph 0049, and 0053-0054; Figure 2).
Claim(s) 75, 77-88, and 90 are rejected under 35 U.S.C. 103 as being unpatentable over Hickmott et al. (Publication No. US 2018/0169377 A1) in view of Recinella et al. (Publication No. US 2010/0114063 A1), as applied to claim 65 above, and further in view of Richardson et al. (Publication No. US 2005/0256447 A1).
Regarding claim 75, Hickmott in view of Recinella teaches the assembly of claim 65. The combination of Hickmott in view of Recinella further teaches wherein the at least one fluid parameter comprises a pressure (Recinella; pressure is measured by sensor 17; Paragraph 0060-0062; Figure 8); and wherein the at least one sensor element comprises at least one pressure gauge in fluid communication with the flow path via the measurement substructure (Recinella; sensor 17 in electrical communication with microprocessor 51 through wire 31 and to measure pressure of fluid flow through the lumen 56 through passage 41; Figure 8; Paragraph 0060-0062).
The combination of Hickmott in view of Recinella does not teach wherein: the assembly comprises a flow restrictor in the flow path or adapted for fluid communication with the flow path and forming a through-going passage configured to restrict the flow therethrough.
However, Richardson teaches wherein: the assembly comprises a flow restrictor in the flow path or adapted for fluid communication with the flow path and forming a through-going passage configured to restrict the flow therethrough (venturi flow meter 32 is a flow restrictor in the flow path from catheter 18 inlet and to the drainage container 20 with reduced cross-section in middle of venturi tube 32/through-going passage; Figure 5-6; Paragraph 0040 and 0086).
Richardson and Hickmott in view of Recinella are considered to be analogous to the claimed invention because they are in the same field of pressure measurement catheters. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hickmott in view of Recinella to incorporate the teachings of Richardson and have flow restrictor of Richardson in the flow path of Hickmott in view of Recinella. This allows for the assembly to measure the flow rate of the fluid, travelling through the flow path of the assembly (Richardson; Paragraph 0086).
Regarding claim 77, Hickmott in view of Recinella and Richardson teaches the assembly of claim 75. The combination of Hickmott in view of Recinella and Richardson further teaches wherein: the conduit defines an internal lumen having a first maximum cross-sectional area (Richardson; conduit of tube 1 has a first maximum cross-section; Figure 6); and wherein the through-going passage has a second minimum cross-sectional area (Richardson; through-going passage has a smaller, second cross-section; Figure 6).
Regarding claim 78, Hickmott in view of Recinella and Richardson teaches the assembly of claim 77. The combination of Hickmott in view of Recinella and Richardson does not expressly teach wherein the second minimum cross-sectional area of the through-going passage of the flow restrictor is sized to be in the range of 17-95% of the size of the first maximum cross- sectional area of the internal lumen of the intermittent urinary catheter.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the second minimum cross-sectional area to be sized in the range of 17-95% of the size of the first maximum cross-sectional area since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984)(MPEP 2144.04(IV)(A)). In the instant case, the assembly of Hickmott in view of Recinella and Richardson would not operate differently with the claimed first and second cross-sectional areas since it has the same function of displacing fluid through the venturi through the change in cross-sectional areas which inhibits the change in fluid pressure through the tubing. Further, applicant places no criticality on the range claimed, indicating simply that the second minimum cross-sectional area to be within the claimed ranges (specification; page 24, lines 29-33).
Regarding claim 79, Hickmott in view of Recinella and Richardson teaches the assembly of claim 77. The combination of Hickmott in view of Recinella and Richardson further teaches wherein the flow restrictor comprises an orifice plate or orifice tube (Richardson; venturi flow meter 32 is a flow restrictor wherein through-going passage is an orifice tube – elongated tube that extends parallel to flow direction through the orifice; Paragraph 0040 and 0086; Figure 6).
Regarding claim 80, Hickmott in view of Recinella and Richardson teaches the assembly of claim 79. The combination of Hickmott in view of Recinella and Richardson does not expressly teach wherein the second minimum cross-sectional area of the through-going passage of the orifice plate or tube is sized to be in the range of 30-95% of the size of the first maximum cross-sectional area of the internal lumen of the intermittent urinary catheter.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the second minimum cross-sectional area to be sized in the range of 30-95% of the size of the first maximum cross-sectional area since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984)(MPEP 2144.04(IV)(A)). In the instant case, the assembly of Hickmott in view of Recinella and Richardson would not operate differently with the claimed first and second cross-sectional areas since it has the same function of displacing fluid through the venturi through the change in cross-sectional areas which inhibits the change in fluid pressure through the tubing. Further, applicant places no criticality on the range claimed, indicating simply that the second minimum cross-sectional area to be within the claimed ranges (specification; page 25, lines 8-15).
Regarding claim 81, Hickmott in view of Recinella and Richardson teaches the assembly of claim 79. The combination of Hickmott in view of Recinella and Richardson does not expressly teach wherein the second minimum cross-sectional area of the through-going passage of the orifice plate or tube is sized to be in the range of 60-90% of the size of the first maximum cross-sectional area of the internal lumen of the intermittent urinary catheter.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the second minimum cross-sectional area to be sized in the range of 60-90% of the size of the first maximum cross-sectional area since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984)(MPEP 2144.04(IV)(A)). In the instant case, the assembly of Hickmott in view of Recinella and Richardson would not operate differently with the claimed first and second cross-sectional areas since it has the same function of displacing fluid through the venturi through the change in cross-sectional areas which inhibits the change in fluid pressure through the tubing. Further, applicant places no criticality on the range claimed, indicating simply that the second minimum cross-sectional area to be within the claimed ranges (specification; page 25, lines 16-21).
Regarding claim 82, Hickmott in view of Recinella and Richardson teaches the assembly of claim 77. The combination of Hickmott in view of Recinella and Richardson further teaches wherein the flow restrictor comprises a venturi (Richardson; venturi flow meter 32 is a flow restrictor wherein through-going passage is an orifice; Paragraph 0040 and 0086; Figure 6).
Regarding claim 83, Hickmott in view of Recinella and Richardson teaches the assembly of claim 82. The combination of Hickmott in view of Recinella and Richardson does not expressly teach wherein the second minimum cross-sectional area of the through-going passage of the venturi is sized to be in the range of 17-80% of the size of the first maximum cross-sectional area of the internal lumen of the intermittent urinary catheter.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the second minimum cross-sectional area to be sized in the range of 17-80% of the size of the first maximum cross-sectional area since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984)(MPEP 2144.04(IV)(A)). In the instant case, the assembly of Hickmott in view of Recinella and Richardson would not operate differently with the claimed first and second cross-sectional areas since it has the same function of displacing fluid through the venturi through the change in cross-sectional areas which inhibits the change in fluid pressure through the tubing. Further, applicant places no criticality on the range claimed, indicating simply that the second minimum cross-sectional area to be within the claimed ranges (specification; page 25, line 33 to page 26, line 3).
Regarding claim 84, Hickmott in view of Recinella and Richardson teaches the assembly of claim 82. The combination of Hickmott in view of Recinella and Richardson does not expressly teach wherein the second minimum cross-sectional area of the through-going passage of the venturi is sized to be in the range of 30-60% of the size of the first maximum cross-sectional area of the internal lumen of the intermittent urinary catheter.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the second minimum cross-sectional area to be sized in the range of 30-60% of the size of the first maximum cross-sectional area since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984)(MPEP 2144.04(IV)(A)). In the instant case, the assembly of Hickmott in view of Recinella and Richardson would not operate differently with the claimed first and second cross-sectional areas since it has the same function of displacing fluid through the venturi through the change in cross-sectional areas which inhibits the change in fluid pressure through the tubing. Further, applicant places no criticality on the range claimed, indicating simply that the second minimum cross-sectional area to be within the claimed ranges (specification; page 26, lines 5-9).
Regarding claim 86, Hickmott in view of Recinella and Richardson teaches the assembly of claim 75. The combination of Hickmott in view of Recinella and Richardson further teaches wherein the measurement substructure is a first measurement substructure (Recinella; channel 41 extends laterally from lumen 56; Paragraph 0065; Figure 10 and 14) and the at least one pressure gauge (Recinella; sensor 17; Figure 8; Paragraph 0060-0062) comprises:
a first pressure gauge adapted for fluid communication with the flow path via the first measurement substructure upstream of the flow restrictor (Recinella; sensor 17 to measure pressure of fluid flow through the lumen 56 through passageway 41; Figure 8; Paragraph 0060-0062; Richardson; flow restrictor 32; Figure 6; Paragraph 0086). The combination of Hickmott in view of Recinella and Richardson does not teach a third pressure gauge adapted for fluid communication via a second measurement substructure extending laterally from the through-going passage, and wherein the signal processing device is configured to determine a fluid flow rate on the basis of a difference between a first pressure determined by the first pressure gauge and a third pressure determined by the third pressure gauge.
However, Richardson teaches a third pressure gauge adapted for fluid communication (Richardson; pressure sensor 36 is at through-going passage of venturi 32; Figure 6; Paragraph 0086), and wherein the signal processing device is configured to determine a fluid flow rate on the basis of a difference between a first pressure determined by the first pressure gauge and a third pressure determined by the third pressure gauge (Richardson; Paragraph 0086, 0088, and 0091; Figure 6).
Richardson and Hickmott in view of Recinella and Richardson are considered to be analogous to the claimed invention because they are in the same field of pressure measurement catheters. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hickmott in view of Recinella and Richardson to incorporate the teachings of Richardson and duplicate the pressure gauge with the measurement substructure of Hickmott in view of Recinella to be placed as the third pressure gauge, as taught by Richardson, where the first and third pressure sensors are positioned on the flow restrictor, as taught by Richardson. This allows for the assembly to measure the flow rate of the fluid, travelling through the flow path of the assembly (Richardson; Paragraph 0086). The combination of Hickmott in view of Recinella and Richardson further teaches a third pressure gauge adapted for fluid communication via a second measurement substructure extending laterally from the through-going passage (see combination above).
Regarding claim 87, Hickmott in view of Recinella and Richardson teaches the assembly of claim 75. The combination of Hickmott in view of Recinella and Richardson further teaches wherein the measurement substructure is a first measurement substructure (Recinella; channel 41 extends laterally from lumen 56; Paragraph 0065; Figure 10 and 14) and the at least one pressure gauge (Recinella; sensor 17; Figure 8; Paragraph 0060-0062) comprises:
a first pressure gauge adapted for fluid communication with the flow path via the first measurement substructure upstream of the flow restrictor (Recinella; sensor 17 to measure pressure of fluid flow through the lumen 56 through passageway 41; Figure 8; Paragraph 0060-0062; Richardson; flow restrictor 32; Figure 6; Paragraph 0086). The combination Hickmott in view of Recinella and Richardson does not teach a second pressure gauge adapted for fluid communication with the flow path via a second measurement substructure downstream of the flow restrictor,
and wherein the signal processing device is configured to determine a fluid flow rate on the basis of a difference between a first pressure determined by the first pressure gauge and a second pressure determined by the second pressure gauge.
Since the applicant has not disclosed that placing a pressure gauge downstream of the flow restrictor does anything more than produce predictable results (i.e. measures pressure through the flow path at the desired location), the mere duplication of the pressure gauge is not considered to have patentable significance. Therefore it would have been obvious to one having ordinary skill in the art at the time the invention was made, to modify Hickmott in view of Recinella and Richardson to include a second pressure gauge downstream of the flow restrictor with the signal processing device calculating a second flow rate, in order to predictably measure an additional flow rate/pressure measurement downstream of the flow restrictor. The mere duplication of parts has no patentable significance unless a new and unexpected result is produced. See In re Harza, 124 USPQ 378 (CCPA 1960) (MPEP 2144.04(VI)(B)).
The combination of Hickmott in view of Recinella and Richardson further teaches a second pressure gauge adapted for fluid communication via a second measurement substructure downstream of the flow restrictor (see combination above), and wherein the signal processing device is configured to determine a fluid flow rate on the basis of a difference between a first pressure determined by the first pressure gauge and a second pressure determined by the second pressure gauge (Richardson; Paragraph 0086, 0088, and 0091; Figure 6; see combination above).
Regarding claim 88, Hickmott in view of Recinella teaches the assembly of claim 65. The combination of Hickmott in view of Recinella does not teach wherein the signal processing device is configured to continuously determine a loss of pressure in the fluid flow along a predetermined length of the conduit and to determine a fluid flow rate on the basis of the loss of pressure.
However, Richardson teaches wherein the signal processing device is configured to continuously determine a loss of pressure in the fluid flow along a predetermined length of the conduit and to determine a fluid flow rate on the basis of the loss of pressure (sensors 34, 36 in measuring system measures loss of pressure of fluid flow across venturi flow meter 32; Figure 6; Paragraph 0040, 0086, 0088, and 0091).
Richardson and Hickmott in view of Recinella are considered to be analogous to the claimed invention because they are in the same field of pressure measurement catheters. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hickmott in view of Recinella to incorporate the teachings of Richardson and have flow restrictor and the sensors of Richardson in the flow path of Hickmott in view of Recinella, where the signal processing device of Recinella determines the fluid flow rate, as taught by Richardson. This allows for the assembly to measure the flow rate of the fluid, travelling through the flow path of the assembly (Richardson; Paragraph 0086).
Regarding claim 90, Hickmott in view of Recinella teaches the assembly of claim 65. The combination of Hickmott in view of Recinella further teaches wherein the at least one fluid parameter comprises a pressure (Recinella; pressure is measured by sensor 17; Paragraph 0060-0062; Figure 8), and the at least one sensor element comprises at least one pressure gauge in fluid communication with the flow path Recinella; sensor 17 in electrical communication with microprocessor 51 through wire 31 and to measure pressure of fluid flow through the lumen 56 through passage 41; Figure 8; Paragraph 0060-0062). The combination of Hickmott in view of Recinella does not teach wherein at least the conduit of the intermittent urinary catheter has a pre-defined characteristic pressure drop, and wherein the signal processing device is configured to determine a fluid flow rate on the basis of at least the pre-defined characteristic pressure drop and a pressure determined by the at least one pressure gauge.
However, Richardson teaches wherein at least the flow restrictor of the intermittent urinary catheter has a pre-defined characteristic pressure drop (flow restrictor; Figure 6; Paragraph 0086), and wherein the signal processing device is configured to determine a fluid flow rate on the basis of at least the pre-defined characteristic pressure drop and a pressure determined by the at least one pressure gauge (sensors 34, 36 in measuring system measures loss of pressure of fluid flow across venturi flow meter 32; Figure 6; Paragraph 0040, 0086, 0088, and 0091).
Richardson and Hickmott in view of Recinella are considered to be analogous to the claimed invention because they are in the same field of pressure measurement catheters. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hickmott in view of Recinella to incorporate the teachings of Richardson and have flow restrictor and the sensors of Richardson in the flow path of Hickmott in view of Recinella. This allows for the assembly to measure the flow rate of the fluid, travelling through the flow path of the assembly (Richardson; Paragraph 0086).
The combination of Hickmott in view of Recinella and Richardson does not teach wherein at least the conduit of the intermittent urinary catheter has a pre-defined characteristic pressure drop.
However, since the specification of the instant application is silent to unexpected results, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to make the pressure tubing 56 of Recinella of the measurement substructure of Hickmott in view of Recinella and Richardson to be integral with the catheter tube with the flow restrictor of Hickmott in view of Recinella and Richardson where the two lumens are to be integrated into a single catheter tubing, with the same functionality of removing urine away from the user for disposal. Making elements integral is generally recognized as being within the level of ordinary skill in the art. In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965) (MPEP 2143(I)(B)).
Claim(s) 76 and 85 are rejected under 35 U.S.C. 103 as being unpatentable over Hickmott et al. (Publication No. US 2018/0169377 A1) in view of Recinella et al. (Publication No. US 2010/0114063 A1) and Richardson et al. (Publication No. US 2005/0256447 A1), as applied to claim 75 above, and further in view of Holochwost et al. (Publication No. US 2016/0135829 A1).
Regarding claim 76, Hickmott in view of Recinella and Richardson teaches the assembly of claim 75. The combination of Hickmott in view of Recinella and Richardson does not teach wherein: the through-going passage defines an inner surface having at least a third liquid coefficient of friction; at least part of a perimeter of the flow path upstream of the flow restrictor has a fourth liquid coefficient of friction; and wherein the third liquid coefficient of friction is larger than at least the fourth liquid coefficient of friction.
However, Holochwost teaches a section of tubing defines an inner surface having at least a third liquid coefficient of friction (cannula 10 made of second materials 30b with a third liquid coefficient of friction; annotated Figure 6 below; Paragraph 0007, 0031, and 0037); at least part of a perimeter of the flow path upstream of the section of tubing has a fourth liquid coefficient of friction (cannula 10 made of first materials 30a upstream of second materials 30b with a fourth liquid coefficient of friction; annotated Figure 6 below; Paragraph 0007, 0031, and 0037); and wherein the third liquid coefficient of friction is larger than at least the fourth liquid coefficient of friction (second material with third liquid coefficient of friction is larger than first material with fourth liquid coefficient of friction; annotated Figure 6 below; Paragraph 0007, 0031, and 0037).
Holochwost and Hickmott in view of Recinella and Richardson are considered to be analogous to the claimed invention because they are in the same field of tubing for catheters. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hickmott in view of Recinella and Richardson to incorporate the teachings of Holochwost and have the portion of tubing upstream of the through-going passage of Hickmott in view of Recinella and Richardson to be made of the first material to have fourth liquid coefficient of friction, as taught by Holochwost, and have the through-going passage of Hickmott in view of Recinella and Richardson to be made of the second material to have third liquid coefficient of friction, as taught by Holochwost. This would allow for an enhancement of flow through the tubing with the difference in fluid pressure between the different sections of friction (Holochwost; Paragraph 0037 and 0039).
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Annotated Figure 6
Regarding claim 85, Hickmott in view of Recinella and Richardson teaches the assembly of claim 82. The combination of Hickmott in view of Recinella and Richardson does not teach wherein the venturi has a second liquid coefficient of friction at least at the circumference of the second minimum cross-sectional area of the through going passage of the venturi, and wherein at least part of the internal lumen of the intermittent urinary catheter has a first liquid coefficient of friction, and wherein the second liquid coefficient of friction is smaller than the first liquid coefficient of friction.
However, Holochwost teaches a section of tubing has a second liquid coefficient of friction (cannula 10 made of first materials 30a upstream of second materials 30b with a second liquid coefficient of friction; annotated Figure 6 above; Paragraph 0007, 0031, and 0037); another section of tubing having a first liquid coefficient of friction (cannula 10 made of second materials 30b with a first liquid coefficient of friction; annotated Figure 6 above; Paragraph 0007, 0031, and 0037); and wherein the second liquid coefficient of friction is smaller than the first liquid coefficient of friction (first material 30a with second liquid coefficient of friction is smaller than second material 30b with first liquid coefficient of friction; annotated Figure 6 above; Paragraph 0007, 0031, and 0037).
Holochwost and Hickmott in view of Recinella and Richardson are considered to be analogous to the claimed invention because they are in the same field of tubing for catheters. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hickmott in view of Recinella and Richardson to incorporate the teachings of Holochwost and have the venturi at least at the circumference of the second minimum cross-sectional area of the through-going passage of the venturi of Hickmott in view of Recinella and Richardson to be made of the first material to have second liquid coefficient of friction, as taught by Holochwost, and have the internal lumen of the intermittent urinary catheter of Hickmott in view of Recinella and Richardson to be made of the second material to have first liquid coefficient of friction, as taught by Holochwost. This would allow for an enhancement of flow through the tubing with the difference in fluid pressure between the different sections of friction (Holochwost; Paragraph 0037 and 0039).
Claim(s) 89 is rejected under 35 U.S.C. 103 as being unpatentable over Hickmott et al. (Publication No. US 2018/0169377 A1) in view of Recinella et al. (Publication No. US 2010/0114063 A1), as applied to claim 65 above, and further in view of Greenwald et al. (Publication No. US 2011/0046514 A1).
Regarding claim 89, Hickmott in view of Recinella teaches the assembly of claim 65. The combination of Hickmott in view of Recinella does not teach wherein the measuring system is configured to continuously determine a fluid flow rate of fluid through the conduit and to integrate the flow rate over time to obtain a measure of a total volume of urine voided from the bladder.
However, Greenwald teaches wherein the measuring system is configured to continuously determine a fluid flow rate of fluid through the conduit and to integrate the flow rate over time to obtain a measure of a total volume of urine voided from the bladder (Paragraph 0071-0072 and 0077).
Greenwald and Hickmott in view of Recinella are considered to be analogous to the claimed invention because they are in the same field of urinary catheters. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hickmott in view of Recinella to incorporate the teachings of Greenwald and have the measuring system of Hickmott in view of Recinella to continually determine the flow rate to determine the total volume of fluid, as taught by Greenwald. This would allow for the assembly to automatically determine the total volume of urine in the assembly (Greenwald; Paragraph 0071-0072 and 0077).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/KATHERINE-PH MINH PHAM/Examiner, Art Unit 3781
/KAI H WENG/Primary Examiner, Art Unit 3781