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 .
Claim Interpretation
The following claim elements were considered under 35 U.S.C. 112(f) interpretation. However, the elements do not recite corresponding functions or that the claim provide adequate structural meaning for the claim elements:
Interfacial connector in line 5 of claim 1 and line 7 of claim 9.
First adapter in line 2 of claim 2 line 2 of claim 14.
Spacing device in line 2 of claim 6 and line 2 of claim 10.
Pressure transducing assembly and Second adapter in line 2 of claim 8.
Second adapter in and line 5 of claim 14.
Pressure sensing transducing assembly in line 3 of claim 15.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 3-4, 7-9, and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over McEwen, et al., US 20070032819 A1 in view of Wachtenberg, E., US 20060217617 A1 (disclosed in the IDS filed 11/20/2024).
Regarding claims 1 and 9 teaches McEwen teaches a pressure sensing assembly (see cuff 10 in reproduced fig. 3 below and [0020]) and a method of manufacturing a pressure sensing assembly for a non-invasive blood pressure cuff ( [0023]), comprising:
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a semi-rigid sheet (transparent flexible sheath 20 [0020]) comprising an inflatable bladder 58 of figs. 4-5C and [0050].
an interfacial connector (cuff connector 24 of fig. 5B and 5C and [0021]) disposed within an aperture (pneumatic passageway 66 of [0062] and figs. 4-5C) of the second cavity of the semi-rigid sheet (fig. 5C shows the pneumatic passageway in connection with the inflatable bladder 58. Also see [0062]);
a tube assembly (instrument tubing 26 and cable 28 in figs. 5B and 5C) connected to the interfacial connector at a second surface of the semi-rigid sheet (see figs. 5B and 5C and [0021]); and
an impermeable film (bladder seal 60 of figs. 3 and 4 and [0050]) attached to at least a portion of the first surface of the semi-rigid sheet, wherein the impermeable film forms a fluid-tight seal over at least the second cavity (inflatable bladder 58 of [0053]) of the semi-rigid sheet ([0053]-[0054]).
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While McEwen discloses that the transparent flexible sheath 20 comprises an inflatable bladder 58 of figs. 4-5C and [0050] and a bladder seal 60, it does not explicitly teach that these chambers form a first cavity, a second cavity and a channel connecting the first cavity and second cavity, each of the first cavity, the second cavity and the channel being formed on a first surface of the semi-rigid sheet.
However, within the same field of endeavor, Wachtenberg teaches an automatic blood pressure monitor for measuring the arterial blood pressure at a location on a patient (abstract). Wachtenberg teaches a strap 2 of figs. 1A-1C and [0093] having a first cavity, a second cavity and a channel connecting the first cavity and second cavity ([0093] states that “In FIG. 1C it can be seen that two interconnected chambers are created within strap 2”), each of the first cavity, the second cavity and the channel being formed on a first surface of the semi-rigid sheet (fig. 1C and [0093]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure McEwen, so that the sheath comprises a first cavity, a second cavity and a channel connecting the first cavity and second cavity, each of the first cavity, the second cavity and the channel being formed on a first surface of the semi-rigid sheet, as taught by Wachtenberg, to provide an automatic monitoring device for blood pressure measurement that is small ([0008]), and easy to operate [0012], with a reasonable expectation of success as McEwen also strives to reduce component interferences during measurements in a clinical setting ([0008]).
Regarding claim 3, McEwen in view of Wachtenberg teaches all the limitations of claim 1 above.
McEwen wherein the pressure sensing assembly forms a continuous leak-free fluid path ([0049], [0050], and [0053] disclose sealing the film tubing and the bladder 58).
McEwen does not teach the sealing is for components comprising the first cavity, the channel, the second cavity, and the tube assembly.
However, Wachtenberg further teaches the first cavity, the channel, and the second cavity ([0093] states that “In FIG. 1C it can be seen that two interconnected chambers are created within strap 2”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure McEwen, wherein the pressure sensing assembly forms a continuous leak-free fluid path between the first cavity, the channel, the second cavity, and the tube assembly, as taught by Wachtenberg, to provide an automatic monitoring device for blood pressure measurement that is small ([0008]), and easy to operate [0012], with a reasonable expectation of success as McEwen also strives to reduce component interferences during measurements in a clinical setting ([0008]).
Regarding claim 4, McEwen in view of Wachtenberg teaches all the limitations of claim 3 above.
McEwen fails to teach a first fluid contained within the continuous leak-free fluid path.
However, Wachtenberg further teaches a first fluid contained within the continuous leak-free fluid path ([0093] discloses liquid in the chamber).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure McEwen, with a first fluid contained within the continuous leak-free fluid path, as taught by Wachtenberg, to provide an automatic monitoring device for blood pressure measurement that is small ([0008]), and easy to operate [0012], with a reasonable expectation of success as McEwen also strives to reduce component interferences during measurements in a clinical setting ([0008]).
Regarding claim 7, McEwen in view of Wachtenberg teaches all the limitations of claim 1 above.
McEwen further teaches a non-invasive blood pressure cuff (cuff 10 of figs. 1-3) comprising a pressure sensing assembly according to any one of claim 1 ([0061]).
Regarding claim 8, McEwen in view of Wachtenberg teaches all the limitations of claim 7 above.
McEwen further teaches a pressure transducing assembly (transducer 64 of [0061]) having a second adapter(cuff connector 24 of fig. 5A and 5B) connected to a pressure transducer (see [0044]), wherein the first adapter (cuff connector 22 of fig. 5B) of the tube assembly (instrument connector 22 of fig. 5A and 5B) is connected to the second adapter (cuff connector 24 of fig. 5A and 5B) of the pressure transducing assembly ([0021] states that within sheath 20, tourniquet instrument connector 22 mates with cuff connector 24 (shown in detail in FIGS. 3, 4, 5A, 5B, and 5C) on cuff 10 to form a releasable pneumatic connection to the inflatable portion of cuff 10).
Regarding claim 12, McEwen in view of Wachtenberg teaches all the limitations of claim 9 above.
McEwen further teaches wherein one or more of the first cavity, the second cavity, and the channel are formed using injection molding and/or thermoforming ([0050], [0054]).
Regarding claim 13, McEwen in view of Wachtenberg teaches all the limitations of claim 9 above.
McEwen further teaches wherein connecting the tube assembly to the interfacial connector (cuff connector 24 of fig. 5B and 5C and [0021]) forms a fluid path (passageway 66 of figs. 5A-5C) between the tube assembly, the second cavity, the channel, and the first cavity (see figs. 5A-5C).
Claims 2, and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over McEwen, et al., US 20070032819 A1 in view of Wachtenberg, E., US 20060217617 A1 (disclosed in the IDS filed 11/20/2024), as applied to claims 1 and 9, respectively above, and further in view of Eide, US 5396894 A.
Regarding claim 2, McEwen in view of Wachtenberg teaches all the limitations of claim 1 above.
McEwen further teaches wherein the tube assembly comprises a tube (instrument tubing 26 of reproduced fig. 5B below and [0021]).
McEwan in view of Wachtenberg fails to teach a first adapter, the interfacial connector being connected at a first end of the tube and the first adapter being connected to a second end of the tube.
However, within the same field of endeavor, Eide teaches a disposable blood pressure cuff for use in a conventional blood pressure measuring and/or monitoring system comprises an elongate, flexible, inflatable plastic sleeve sized to wrap around an individual's upper arm above the elbow, a flexible tube connected to the sleeve to enable the internal pressurization thereof, and an attached flexible plastic strip for releasably attaching the sleeve around an individual's arm (see abstract). The cuff comprises a first adapter (36 of reproduced fig. 2 below), the interfacial connector (34 of fig. 2 and col. 4, lines 31-38) being connected at a first end (126) of the tube (122) and the first adapter (124) being connected to a second end (128) of the tube (122) (see fig. 2 below).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure McEwen, as modified by Wachtenberg, with a first adapter, the interfacial connector being connected at a first end of the tube and the first adapter being connected to a second end of the tube, as taught by Eide, to provide an inexpensive, but effective, blood pressure cuff that can be disposable after a single use, and the risk of contaminating one individual by the blood of a previous patient, by using a contaminated blood pressure cuff, can thereby be eliminated (col. 2, lines 61-68).
Regarding claim 14, McEwen in view of Wachtenberg teaches all the limitations of claim 9 above.
McEwen further teaches wherein the tube assembly (118) comprises a tube (instrument tubing 26 of reproduced fig. 5B below and [0021]) and a first adapter, wherein the method further comprises: connecting the first adapter (cuff connector 22 of fig. 5B) of the tube assembly (instrument connector 22 of fig. 5A and 5B) to a second adapter (cuff connector 24 of fig. 5A and 5B) of a pressure transducing assembly ([0021] states that within sheath 20, tourniquet instrument connector 22 mates with cuff connector 24 (shown in detail in FIGS. 3, 4, 5A, 5B, and 5C) on cuff 10 to form a releasable pneumatic connection to the inflatable portion of cuff 10); wherein the pressure transducing assembly comprises the second adapter and a pressure transducer filled with a second fluid (see figs. 5A-5C), the first and second adapters forming a leak-free boundary between the first fluid of the tube assembly and the second fluid of the pressure transducing assembly ([0049], [0050], and [0053] disclose sealing the film tubing and the bladder 58).
McEwan in view of Wachtenberg fails to teach a first adapter, the interfacial connector being connected at a first end of the tube and the first adapter being connected to a second end of the tube.
However, within the same field of endeavor, Eide teaches a disposable blood pressure cuff for use in a conventional blood pressure measuring and/or monitoring system comprises an elongate, flexible, inflatable plastic sleeve sized to wrap around an individual's upper arm above the elbow, a flexible tube connected to the sleeve to enable the internal pressurization thereof, and an attached flexible plastic strip for releasably attaching the sleeve around an individual's arm (see abstract). The cuff comprises a first adapter (36 of reproduced fig. 2 below), the interfacial connector (34 of fig. 2 and col. 4, lines 31-38) being connected at a first end of the tube and the first adapter being connected to a second end of the tube (see fig. 2 below).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure McEwen, as modified by Wachtenberg, with a first adapter, the interfacial connector being connected at a first end of the tube and the first adapter being connected to a second end of the tube, as taught by Eide, to provide an inexpensive, but effective, blood pressure cuff that can be disposable after a single use, and the risk of contaminating one individual by the blood of a previous patient, by using a contaminated blood pressure cuff, can thereby be eliminated (col. 2, lines 61-68).
Regarding claim 15, McEwen in view of Wachtenberg and Eide teaches all the limitations of claim 14 above.
McEwen further teaches wherein the pressure transducing assembly (206) is disposable ([0044] states that cuff 10 is constructed of materials that are appropriate for a single use disposable cuff manufactured for use inside a sterile surgical field for a single surgical procedure) and the first adapter (cuff connector 22 of fig. 5B) of the tube assembly (instrument connector 22 of fig. 5A and 5B) is connected to the second adapter (cuff connector 24 of fig. 5A and 5B) of the pressure transducing assembly ([0021] states that within sheath 20, tourniquet instrument connector 22 mates with cuff connector 24 (shown in detail in FIGS. 3, 4, 5A, 5B, and 5C) on cuff 10 to form a releasable pneumatic connection to the inflatable portion of cuff 10).
Claims 5-6, and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over McEwen, et al., US 20070032819 A1 in view of Wachtenberg, E., US 20060217617 A1 (disclosed in the IDS filed 11/20/2024), as applied to claims 1 and 9, respectively above, and further in view of Sawanoi, et al., US 20190090761 A1.
Regarding claim 5, McEwen in view of Wachtenberg teaches all the limitations of claim 4 above.
McEwen in view of Wachtenberg fail to teach wherein the first fluid is a silicone oil.
However, within the same field of endeavor, Sawanoi teaches a blood pressure measuring cuff according to the present invention includes a pressing cuff which is belt-shaped, is wrapped around a part to be measured, and receives supply of a pressurizing fluid to press the part to be measured (see abstract). Sawanoi teaches wherein the first fluid is a silicone oil ([0060]-[0061]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure McEwen, as modified by Wachtenberg, wherein the first fluid is a silicone oil, as taught by Sawanoi, to provide a blood pressure measuring cuff which can accurately measure blood pressure even when a cuff width dimension is set small ([0007]).
Regarding claim 6, McEwen in view of Wachtenberg teaches all the limitations of claim 1 above.
McEwen in view of Wachtenberg fails to teach at least one of a plurality of projections and/or a spacing device disposed within the first cavity of the semi-rigid sheet.
However, Sawanoi further teaches at least one of a plurality of projections (cylindrical nipples 75 and76 of [0051] and fig. 3A) and/or a spacing device (fluid bags 21A, 21B, and 21C of [0051] and figs. 3A-3C) disposed within the first cavity of the semi-rigid sheet (figs. 3A-3C).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure McEwen, as modified by Wachtenberg, at least one of a plurality of projections and/or a spacing device disposed within the first cavity of the semi-rigid sheet, as taught by Sawanoi, to provide a blood pressure measuring cuff which can accurately measure blood pressure even when a cuff width dimension is set small ([0007]).
Regarding claim 10, McEwen in view of Wachtenberg teaches all the limitations of claim 9 above.
McEwen in view of Wachtenberg fails to teach installing a spacing device within at least the first cavity of the semi-rigid sheet prior to attaching the impermeable film to the first surface of the semi-rigid sheet.
However, Sawanoi further teaches teach installing a spacing device within at least the first cavity of the semi- rigid sheet prior to attaching the impermeable film to the first surface of the semi-rigid sheet (fluid bags 21A, 21B, and 21C of [0051] and figs. 3A-3C).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure McEwen, as modified by Wachtenberg, installing a spacing device within at least the first cavity of the semi- rigid sheet prior to attaching the impermeable film to the first surface of the semi-rigid sheet, as taught by Sawanoi, to provide a blood pressure measuring cuff which can accurately measure blood pressure even when a cuff width dimension is set small ([0007]).
Regarding claim 11, McEwen in view of Wachtenberg teaches all the limitations of claim 9 above.
McEwen in view of Wachtenberg fails to teach forming a plurality of projections within at least the first cavity of the semi-rigid sheet prior to attaching the impermeable film to the first surface of the semi-rigid sheet.
However, Sawanoi further teaches forming a plurality of projections within at least the first cavity of the semi-rigid sheet prior to attaching the impermeable film to the first surface of the semi-rigid sheet (cylindrical nipples 75 and76 of [0051] and fig. 3A).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure McEwen, as modified by Wachtenberg, forming a plurality of projections within at least the first cavity of the semi-rigid sheet prior to attaching the impermeable film to the first surface of the semi-rigid sheet, as taught by Sawanoi, to provide a blood pressure measuring cuff which can accurately measure blood pressure even when a cuff width dimension is set small ([0007]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Farouk A Bruce whose telephone number is (408)918-7603. The examiner can normally be reached Mon-Fri 8-5pm PST.
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/FAROUK A BRUCE/ Examiner, Art Unit 3797
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