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 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.
Claims 12-16 are 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 12 requires “one or more sensors” and “a pressure sensor and a temperature sensor” where it is unclear how one sensor can be two sensors. Is this intended to be one sensor with two functions or two separate sensors? The Examiner assumes that the claim requires two or more sensors where one sensor is a pressure sensor and one is a temperature sensor. Appropriate correction is required.
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);
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 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 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. 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.
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, 15, 17-19 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:
one 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 (Col 11 Lines 37-43; 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.
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 one or more sensors is 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).
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 a chip 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.
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 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).
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 and 20 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.
Regarding Claim 20, Tsuji as modified further discloses a display configured to show the pressure measured by the pressure sensor and 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 one or more sensors includes 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.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 7-14, and 16-17 of U.S. Patent No. 12,226,079. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent anticipates the application’s claims.
For claims 1 and 17, the patent claims a scope with a handle, a shaft, a distal tip with a camera and light source, a working channel, and one or more sensors comprising a pressure sensor with the active portion adjacent a port configured to transmit the sensor data to a processor (claims 1, 7, 9, and 16).
Claim 2 - The patent also claims wherein the active portion is water-tight (claims 1 and 9).
Claim 3 - The patent also claims wherein the one or more sensors is configured to transfer data to a processor (claims 7 and 16)
Claim 4 - The patent also claims wherein the pressure sensor is within a housing (claims 1 and 9).
Claim 5 - The patent also claims wherein the pressure sensor includes a chip (claim 2) operatively coupled to a lead extending proximally from the chip to the handle (the Examiner considers it obvious to include a lead to transmit signals to and from the chip to processors and control devices in the proximal portion of the system as is known and standard in the art).
Claim 19 - The patent also claims a system comprising the scope device of claim 17 and the processor (claims 1, 7, 9, and 16).
The Examiner notes that claims 6-18 and 20, while not claimed are considered obvious. As set forth above in the art rejection, each of these features is known in the art such that modifying the patent claims to include them is considered obvious. A person having ordinary skill in the art would have the same reasons for modifying the patent as set forth above in relation to the art rejection in that all of the claim limitations are directed to standard uses of well-known elements like displays and sensors.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 7, 12, 14-15, and 17-18 of U.S. Patent No. 12,016,529. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent anticipates the application’s claims.
For claims 1 and 17, the patent claims a scope with a handle, a shaft, a distal tip with a camera and light source, a working channel, and one or more sensors comprising a pressure sensor with the active portion adjacent a port configured to transmit the sensor data to a processor (claims 1 and 14).
Claim 2 - The patent also claims wherein the active portion is water-tight (claims 1 and 14).
Claim 3 - The patent also claims wherein the one or more sensors is configured to transfer data to a processor (claims 1 and 14)
Claim 4 - The patent also claims wherein the pressure sensor is within a housing (claims 1 and 14).
Claim 10 - The patent also claims a processor, and a display, wherein the one or more sensors is configured to transfer data to the processor, and wherein the display is configured to show the pressure measured by the pressure sensor in real-time (claims 7 and 17).
Claim 19 - The patent also claims a system comprising the scope device of claim 17 and the processor (claims 1 and 14).
The Examiner notes that claims 5-9, 11-18 and 20, while not claimed are considered obvious. As set forth above in the art rejection, each of these features is known in the art such that modifying the patent claims to include them is considered obvious. A person having ordinary skill in the art would have the same reasons for modifying the patent as set forth above in relation to the art rejection in that all of the claim limitations are directed to standard uses of well-known elements like displays and sensors.
Conclusion
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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/TIMOTHY J NEAL/ Primary Examiner, Art Unit 3795
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