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 .
This Office Action is in response to the amendments dated September 9, 2026.
Claims 1-20 are pending.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 3, and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Tsuji (US 5,402,769) in view of Banik et al. (US 2006/0069306).
Regarding Claim 1, Tsuji discloses:
A scope device, comprising:
a handle (proximal end of endoscope 92); and
a shaft (elongated body of scope 92) extending from the handle to a distal tip of the shaft (distal tip of 92) and being configured to be inserted through a bodily lumen to a target site (the shaft can be inserted through a lumen), wherein the distal tip includes:
a camera (SID 17);
a light source (light fibers extend to the distal end as shown in Fig. 12); and
one or more sensors (94) comprising a pressure sensor (Col 10 Lines 63-64) that includes an active portion configured to measure pressure at the target site (strain gage has active portion to measure pressure), the active portion being adjacent to a port of the shaft configured to permit a fluid to exert pressure on the active portion, wherein the port includes only one opening (Col 11 Lines 38-42; the “port” can be one of the disclosed pores; see discussion below as to why this is also obvious in view of the reference), and wherein the active portion is radially inward of the port and proximate an outer surface of the shaft (Col 11 Lines 37-43; the pressure sensor may be located adjacent the pore and is not completely exposed on the surface).
Tsuji does not explicitly disclose the shaft comprising a working channel extending therethrough from the handle to the distal tip. The Examiner notes that working channels are common in the art. Banik is one example of an endoscope with a working channel (252) for tool insertion to the target site. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Tsuji’s device to include Banik’s working channel. Such a modification incorporates an old and well-known feature for guiding tools to the target site.
The Examiner also notes that Tsuji is considered, broadly, to disclose a handle. Banik also teaches using a handle as is known in the art for holding the proximal end of the device (Paragraph 0023). Handles are old and well-known (and often not shown in detail for this reason) for providing a means for grasping the device and as a place for various controls. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to include a handle in Tsuji.
As to the claim limitation “wherein the port includes only one opening”, the Examiner notes that if there are five pores, for example, the “port” can be considered to be one of those five pores. There is nothing in the claim that prevents additional ports. In the event this reasoning is rejected by a higher power, the feature is still obvious. The number of openings for fluid to enter the active portion is not critical for either the Applicant or the prior art. Applicant’s own disclosure shows window or port 154, but this is not even shown relative to the shaft. A person having ordinary skill in the art will appreciate that adjusting the number of openings does not change the function of the device. The function of the port or pores or openings or whatever name given to the feature is to allow fluid to reach the sensor. Having fewer openings may allow for more flow, but it may have the drawback of being a larger opening that can catch on the patient’s anatomy during insertion. More pores may reduce the likelihood of injuring a patient, but the flow to the sensor could be reduced. Maybe there are manufacturing considerations for the various configurations. The point is that nothing claimed amounts to a patentable distinction over the prior art. Therefore, if Tsuji is considered to not already disclose the feature, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Tjsuji’s device to have only opening. Such a modification is a change in the number of an already disclosed feature without changing its function, and Applicant’s disclose places no criticality on the feature.
Regarding Claim 3, Tsuji as modified further discloses wherein the one or more sensors is configured to transfer data to a processor (signals from 94 go through signal lines 18, 23 to circuit 24). To the extent this circuit is not considered a processor, the Examiner notes that Banik teaches having environmental sensors (including a pressure sensor) have signals transmitted back to the processor (see Paragraph 0029). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to include a processor in Tsuji’s device. Such a modification provides a means for processing the sensor signals.
Regarding Claim 6, Tsuji as modified further discloses wherein the one or more sensors includes a thermocouple configured to measure temperature (Banik discloses using more than one sensor including a temperature sensor, see Paragraph 0029; Tsuji discloses a temperature sensor including a thermocouple, see Col 6 Lines 52-55). Therefore, it would have been obvious to a person having ordinary skill in the art for Tsuji to have more than one environmental sensor in the distal tip to measure more than one parameter wherein one sensor is a temperature sensor with a thermocouple. Such a modification provides a means to monitor temperature and pressure using the same device.
Claims 2, 4-5, 12-13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Tsuji (US 5,402,769) and Banik et al. (US 2006/0069306), as applied to claim 1 above, and further in view of Hodgson et al. (US 2014/0167190).
Tsuji and Banik disclose the invention substantially as claimed as stated above.
Regarding Claim 2, they do not explicitly disclose wherein the active portion is water-tight. Hodgson teaches sealing a pressure sensor in a similar device to prevent fluid ingress (see Paragraph 0048). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Tsuji and Banik’s device to include Hodgson’s fluid-impermeable coating. Such a modification prevents the sensor from being exposed to bodily fluid while still allowing it to obtain pressure measurements.
Regarding Claims 4 and 5, Tsuji and Banik do not explicitly disclose wherein the pressure sensor is within a housing and wherein the pressure sensor includes a chip operatively coupled to a lead extending proximally from the chip to the handle. Hodgson teaches using a chip (MEMS pressure sensor 160) within a housing (120) with leads extending proximally to the handle (110 and 142) for power and data transfer. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Tsuji and Banik’s device to include Hodgson’s chip, housing, and leads. Such a modification substitutes one known sensor with another to yield predictable results. The components are used to obtain pressure readings and transmit the data to the processor as is known in the art.
Regarding Claim 12, Tsuji discloses:
A scope device, comprising:
a handle (proximal end of endoscope 92); and
a shaft (elongated body of scope 92) extending from the handle to a distal tip of the shaft (distal tip of 92) and being configured to be inserted through a bodily lumen to a target site (the shaft can be inserted through a lumen), wherein the distal tip includes:
two or more sensors including a pressure sensor (94; Col 10 Lines 63-64) radially inward of a port of the shaft configured to permit a fluid to exert pressure on the sensor wherein the port includes only one opening (Col 11 Lines 38-42; the “port” can be one of the disclosed pores; see discussion below as to why this is also obvious in view of the reference; the pressure sensor may be located adjacent pores and is not completely exposed on the surface).
Tsuji does not explicitly disclose the shaft comprising a working channel extending therethrough from the handle to the distal tip, a temperature sensor, wherein the pressure sensor includes a chip within a housing; and wherein the temperature sensor includes a thermocouple, a thermistor, or fiber optics.
The Examiner notes that working channels are common in the art. Banik is one example of an endoscope with a working channel (252) for tool insertion to the target site. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Tsuji’s device to include Banik’s working channel. Such a modification incorporates an old and well-known feature for guiding tools to the target site.
The Examiner also notes that Tsuji is considered, broadly, to disclose a handle. Banik also teaches using a handle as is known in the art for holding the proximal end of the device (Paragraph 0023). Handles are old and well-known (and often not shown in detail for this reason) for providing a means for grasping the device and as a place for various controls. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to include a handle in Tsuji.
Banik teaches using more than one sensor including a temperature sensor (see Paragraph 0029). Tsuji discloses a temperature sensor including a thermocouple (see Col 6 Lines 52-55). Therefore, it would have been obvious to a person having ordinary skill in the art for Tsuji to have more than one environmental sensor in the distal tip to measure more than one parameter wherein one sensor is a temperature sensor with a thermocouple. Such a modification provides a means to monitor temperature and pressure using the same device.
Hodgson teaches using a chip (MEMS pressure sensor 160) within a housing (120) with leads extending proximally to the handle (110 and 142) for power and data transfer. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Tsuji and Banik’s device to include Hodgson’s chip, housing, and leads. Such a modification substitutes one known sensor with another to yield predictable results. The components are used to obtain pressure readings and transmit the data to the processor as is known in the art.
As to the claim limitation “wherein the port includes only one opening”, the Examiner notes that if there are five pores, for example, the “port” can be considered to be one of those five pores. There is nothing in the claim that prevents additional ports. In the event this reasoning is rejected by a higher power, the feature is still obvious. The number of openings for fluid to enter the active portion is not critical for either the Applicant or the prior art. Applicant’s own disclosure shows window or port 154, but this is not even shown relative to the shaft. A person having ordinary skill in the art will appreciate that adjusting the number of openings does not change the function of the device. The function of the port or pores or openings or whatever name given to the feature is to allow fluid to reach the sensor. Having fewer openings may allow for more flow, but it may have the drawback of being a larger opening that can catch on the patient’s anatomy during insertion. More pores may reduce the likelihood of injuring a patient, but the flow to the sensor could be reduced. Maybe there are manufacturing considerations for the various configurations. The point is that nothing claimed amounts to a patentable distinction over the prior art. Therefore, if Tsuji is considered to not already disclose the feature, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Tjsuji’s device to have only opening. Such a modification is a change in the number of an already disclosed feature without changing its function, and Applicant’s disclose places no criticality on the feature.
Regarding Claim 13, Tsuji as modified further discloses wherein the chip is part of an active portion of the pressure sensor that is water-tight (see Hodgson – Paragraph 0048 discussing sealing the pressure sensor to prevent fluid ingress).
Regarding Claim 15, Tsuji as modified further discloses wherein the two or more sensors are configured to transfer data to a processor in real-time (Tsuji, Banik, and Hodgson all include leads or wires for transferring the data in real-time; there is nothing in any of the references suggesting a delay).
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Tsuji (US 5,402,769) and Banik et al. (US 2006/0069306), as applied to claim 1 above, and further in view of Salour (US 8,201,997).
Tsuji and Banik disclose the invention substantially as claimed as stated above.
Regarding Claims 7-9, they do not explicitly disclose wherein the one or more sensors includes fiber optics; wherein the one or more sensors that includes fiber optics is configured to measure temperature, pressure, or pH; and wherein the one or more sensors that includes fiber optics extends through a lumen adjacent to the working channel. Salour teaches using a fiber optic temperature sensor (Fig. 3; see also, Col 2 Line 31) that runs separately from an imaging fiber (see Fig. 3 and fiber 290). Because this is a fiber optic extending from the distal end to the proximal end, including a lumen provides a dedicated space for the fiber. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Tsuji and Banik’s device to include Salour’s fiber optic sensor. This is the simple substitution of one type of temperature sensor for another to yield predictable results of measuring temperature. The Examiner also notes that Applicant’s disclosure takes for granted that such sensors are known in that there is no explanation as to how a fiber optic element can measure temperature, pressure, or pH. Therefore, the Examiner asserts that the use of fiber optic sensors in the art is known and would have been obvious to a person having ordinary skill in the art.
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Tsuji (US 5,402,769) and Banik et al. (US 2006/0069306), as applied to claim 1 above, and further in view of Hotto et al. (US 2011/0301414).
Tsuji and Banik disclose the invention substantially as claimed as stated above and a processor and wherein the one or more sensors is configured to transfer data to the processor (Tsuji includes circuitry and Banik includes processor 108 with which the sensor communicates as shown in Fig. 2).
Regarding Claim 10, they do not explicitly disclose a display, and wherein the display is configured to show the pressure measured by the pressure sensor in real-time. Hotto teaches displaying pressure data on a display (see Fig. 5A and Paragraph 0079). The Examiner also notes that displaying the data from the sensor is obvious in that this would provide the user with the data being collected. While there may be several reasons for measuring pressure or temperature, one of which would be to provide the user or surgeon with the measurements. Displaying the numerical values on a monitor is a well-known means for communicating the information to the user. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Tsuji and Banik’s device to include Hotto’s display. Such a modification provides a well-known means for communicating the measured data with the user.
Regarding Claim 11, Tsuji as modified further discloses wherein the display is also configured to show a live video feed of the target site (see Hotto Fig. 5A showing the data with the images from the endoscope; both Tsuji and Banik disclose video imaging, Tsuji includes circuit 4 and see Banik Paragraph 0021). The Examiner also notes that this is obvious. Tsuji includes a camera to take images of a patient. Showing those images to the user is the reason for the camera. Placing the data from the sensors on the same display allows the user to view the patient’s anatomy at the same time as receiving the information related to the sensors. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the live feed and the sensor data on the same monitor. Such a modification provides the acquired information to the user on a single screen to make it easier to view and to reduce the number of displays required, saving money and space.
Claims 14 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Tsuji (US 5,402,769), Banik et al. (US 2006/0069306), and Hodgson et al. (US 2014/0167190), as applied to claim 12 above, and further in view of Salour (US 8,201,997).
Tsuji, Banik, and Hodgson disclose the invention substantially as claimed as stated above.
Regarding Claims 14 and 16, they do not explicitly disclose wherein the two or more sensors include fiber optics; wherein the temperature sensor extends through a lumen extending through a length of the shaft. Salour teaches using a fiber optic temperature sensor (Fig. 3; see also, Col 2 Line 31) that runs separately from an imaging fiber (see Fig. 3 and fiber 290). Because this is a fiber optic extending from the distal end to the proximal end, including a lumen provides a dedicated space for the fiber. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Tsuji and Banik’s device to include Salour’s fiber optic sensor. This is the simple substitution of one type of temperature sensor for another to yield predictable results of measuring temperature. The Examiner also notes that Applicant’s disclosure takes for granted that such sensors are known in that there is no explanation as to how a fiber optic element can measure temperature, pressure, or pH. Therefore, the Examiner asserts that the use of fiber optic sensors in the art is known and would have been obvious to a person having ordinary skill in the art.
Claims 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Tsuji (US 5,402,769) in view of Banik et al. (US 2006/0069306), and further in view of Finkman et al. (US 2011/0144429).
Tsuji and Banik disclose the invention substantially as claimed as stated above.
Regarding Claim 17, Tsuji discloses:
A scope device, comprising:
a handle (proximal end of endoscope 92); and
a shaft (elongated body of scope 92) extending from the handle to a distal tip of the shaft (distal tip of 92) and being configured to be inserted through a bodily lumen to a target site (the shaft can be inserted through a lumen), wherein the distal tip includes:
a camera (SID 17);
a light source (light fibers extend to the distal end as shown in Fig. 12); and
one or more sensors including a pressure sensor (94; Col 10 Lines 63-64);
wherein the one or more sensors is configured to transfer data to a processor in real-time (signals go through signal cable 95 to a processor without anything to delay the signal transfer).
Tsuji does not explicitly disclose the shaft comprising a working channel extending therethrough from the handle to the distal tip; wherein the pressure sensor is within a housing, wherein the pressure sensor includes fiber optics.
The Examiner notes that working channels are common in the art. Banik is one example of an endoscope with a working channel (252) for tool insertion to the target site. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Tsuji’s device to include Banik’s working channel. Such a modification incorporates an old and well-known feature for guiding tools to the target site.
The Examiner also notes that Tsuji is considered, broadly, to disclose a handle. Banik also teaches using a handle as is known in the art for holding the proximal end of the device (Paragraph 0023). Handles are old and well-known (and often not shown in detail for this reason) for providing a means for grasping the device and as a place for various controls. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to include a handle in Tsuji.
Finkman teaches using an optical fiber in a housing for measuring pressure (42 in Fig. 1). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Tsuji and Banik’s device to include Finkman’s fiberoptic pressure sensor. Such a modification substitutes one known sensor with another to yield predictable results. The components are used to obtain pressure readings and transmit the data to the processor as is known in the art. The Examiner also notes that this feature does not seem critical to Applicant’s invention as the fiberoptic pressure sensor in a housing is not even shown.
Regarding Claim 18, Tsuji as modified further discloses wherein the one or more sensors includes a thermocouple configured to measure temperature (Banik discloses using more than one sensor including a temperature sensor, see Paragraph 0029; Tsuji discloses a temperature sensor including a thermocouple, see Col 6 Lines 52-55). Therefore, it would have been obvious to a person having ordinary skill in the art for Tsuji to have more than one environmental sensor in the distal tip to measure more than one parameter wherein one sensor is a temperature sensor with a thermocouple. Such a modification provides a means to monitor temperature and pressure using the same device.
Regarding Claim 19, Tsuji as modified further discloses:
A system comprising the scope device of claim 17 (see rejection of claim 17 above) and the processor (Tsuji includes circuitry and Banik includes processor 108 with which the sensor communicates as shown in Fig. 2).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Tsuji (US 5,402,769), Banik et al. (US 2006/0069306), and Finkman et al. (US 2011/0144429), as applied to claim 17 above, and further in view of Hotto et al. (US 2011/0301414).
Tsuji, Banik, and Finkman disclose the invention substantially as claimed as stated above.
Regarding Claim 20, Tsuji as modified does not explicitly disclose a display configured to show the pressure measured by the pressure sensor and a live video feed of the target site. Hotto teaches displaying pressure data on a display (see Fig. 5A and Paragraph 0079). The Examiner also notes that displaying the data from the sensor is obvious in that this would provide the user with the data being collected. While there may be several reasons for measuring pressure or temperature, at least one is to provide the user or surgeon with the measurements. Displaying the numerical values on a monitor is a well-known means for communicating the information to the user. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Tsuji and Banik’s device to include Hotto’s display. Such a modification provides a well-known means for communicating the measured data with the user.
Response to Arguments
Applicant's arguments filed September 9, 2026, have been fully considered but they are not persuasive.
Applicant argues that the references fail to read on the claims as amended. The Examiner disagrees. A more detailed discussion can be found above, but going from the plural to the singular in this case does not result in a patentable distinction. Also, fiberoptic pressure sensors are known in the art such that the feature is obvious.
The application is not in condition for allowance at this time.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY JAY NEAL whose telephone number is (313)446-4878. The examiner can normally be reached Mon-Fri 7:30-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at (571)272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIMOTHY J NEAL/ Primary Examiner, Art Unit 3795
