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.
Claim 11 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. The use of the word “prolapse” to describe a shape renders this claim indefinite due to a “prolapse” shape being undefined by the applicant’s specification. Merriam Webster defines prolapse as “the falling down or slipping of a body part from its usual position or relations”. Therefore, the examiner interprets this term to mean an unintended shape, as seems to be the common definition of other terms used in conjunction with this term within the specification (paragraph 43 of applicant’s specification “evaluate the shape (e.g., buckling, prolapse, or an unexpected shape)” and “the presence of a prolapse shape, buckling, or other characteristic shapes”). The examiner requests that this claim be amended to definitively claim the subject matter.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5, 10-11, 19-20, 22, and 27-28 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Lopez et al (U.S. Patent Application Publication 2025/0160620, hereinafter “Lopez”). Regarding claim 1, Lopez teaches a system comprising:
a flexible elongated device (seen in figures 1, 2A, and 2B) including a flexible elongated body and a hydrophilic lubricious layer on the flexible elongated body (paragraph 112 a lubricating fluid such as oil or glycerin)
a sensor system configured to detect a hydration indicator for the hydrophilic lubricious layer (paragraph 36 details measuring the pressure within the pressure chamber containing the hydrophilic lubricious fluid, with higher pressure meaning more fluid is present within the chamber (pressure = hydration indicator))
and a control system configured to evaluate the hydration indicator to determine a hydration condition of the hydrophilic lubricious layer (paragraph 36 details the pressure measured being equated to the amount of fluid supplied to the chamber, so pressure (indicator) is used to determine how much fluid is to be supplied (hydration condition))
Regarding claim 2, Lopez teaches a system wherein the control system is further configured to initiate a responsive action if the hydration condition is determined to be below a threshold hydrated condition (paragraph 36 details the automatic adjustment to increase the pressure of the rigidizing device in response to the measured pressure within the chamber being too low (for example during withdrawal of the elongate device)).
Regarding claim 3, Lopez teaches a system wherein the responsive action is an issuance of an alert (paragraph 272 details an alert that causes the device to “increase the pressure and therefore the rigidity of the system”).
Regarding claim 4, Lopez teaches a system wherein the responsive action is a delivery of hydration to the flexible elongated device (paragraph 272 details an alert that causes the device to “increase the pressure and therefore the rigidity of the system” and pressure comes in the form of introducing more hydrophilic lubricious fluid to the pressure chamber).
Regarding claim 5, Lopez teaches a system wherein the responsive action is an initiation of a change of motion of the flexible elongated device (paragraph 140 teaches responsive action comprising “the blocking of certain motions or functions”).
Regarding claim 10, Lopez teaches a system wherein the sensor system includes a shape sensor disposed in the flexible elongated device and configured to detect a shape of the flexible elongated device, and wherein the hydration indicator includes the detected shape (paragraph 152 “a sensor, such as a fiber optic sensor, may be used to sense the shape of the steerable distal end section of the inner rigidizing device” where the shape of the distal end represents a hydration indicator (a lower pressure condition creates a displaced position)).
Regarding claim 11, Lopez teaches a system wherein evaluating the hydration indicator includes detecting a prolapse shape in the detected shape, wherein the prolapse shape is associated with the hydration condition. See 112B rejection set forth earlier in this document, Lopez teaches a shape sensor that detects an unintended displacement in the shape of the rigidizing member, which is in relation to the hydration condition (pressure supplied to the member).
Regarding claim 19, Lopez teaches a system wherein the sensor system includes an imaging system configured to capture an image of the hydration indicator (paragraph 153 details optical sensors, listing a camera as an example, which is attached to the distal tip of the rigidizing device). This camera captures an image of the interior of the patient’s body, and a hydration condition (shine/reflections in the displayed image) can be ascertained from the displayed image.
Regarding claim 20, Lopez teaches a system wherein the hydration indicator is a visual characteristic of an anatomic passageway in which the flexible elongated device is extended (shine/reflections in the displayed image received from the distal camera comprise the hydration indicator of the anatomic passageway).
Regarding claim 22, Lopez teaches a system wherein the sensor system includes a light sensor configured to detect a light property of the flexible elongated device associated with the hydration indicator (paragraph 152 details camera sensor (type of light sensor) that is located on the distal type and would detect a light property of the distal region).
Regarding claim 27, Lopez teaches a method comprising:
detecting, with a sensor system, a hydration indicator for a hydrophilic lubricious layer (paragraph 112 a lubricating fluid such as oil or glycerin) on a flexible elongated body of a flexible elongated device (paragraph 36 details measuring the pressure within the pressure chamber containing the hydrophilic lubricious fluid, with higher pressure meaning more fluid is present within the chamber (pressure = hydration indicator))
evaluating, with a control system, the hydration indicator to determine a hydration condition for the hydrophilic lubricious layer (paragraph 36 details the pressure measured being equated to the amount of fluid supplied to the chamber, so pressure (indicator) is used to determine how much fluid is to be supplied (hydration condition))
Regarding claim 28, Lopez teaches a method further comprising initiating a responsive action if the hydration condition is determined to be below a threshold hydrated condition(paragraph 36 details the automatic adjustment to increase the pressure of the rigidizing device in response to the measured pressure within the chamber being too low (for example during withdrawal of the elongate device)).
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.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Lopez in view of Goldstein et al (U.S. Patent Application Publication 2015/0216471, hereinafter “Goldstein”). While Lopez teaches the limitations of claim 1, it fails to teach a system wherein the sensor system includes a timer configured to detect an elapsed time that the flexible elongated device has been in an exposed environment and wherein the hydration indicator includes the elapsed time. Goldstein teaches a system wherein the sensor system includes a timer configured to detect an elapsed time that the flexible elongated device has been in an exposed environment and wherein the hydration indicator includes the elapsed time (paragraph 55 details the use of a timer to time a hydration state sampling period). It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the sensor system of Lopez with the timer of Goldstein in order to model a dehydration rate rather than only an instantaneous hydration state. This provides data that would allow an operator to measure the dehydration rate of the elongate device and provide an exact compensatory level of hydration to counter dehydration and keep hydration at a level that reduces potential damage to the patient during an operation.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Lopez and Goldstein in view of Mulligan et al (U.S. Patent Application Publication 2020/0205747, hereinafter “Mulligan”). While Lopez and Goldstein combined teach the limitations of claims 1 and 6, they fail to teach a system wherein evaluating the hydration indicator includes evaluating the elapsed time with reference to a time-based dehydration model. Mulligan teaches a system wherein evaluating the hydration indicator includes evaluating the elapsed time with reference to a time-based dehydration model (paragraph 100 details use of a dehydration model, and paragraph 118 details the use of time intervals in the dehydration model). In the analagous art of using a device to determine hydration level in complex fluid dynamics systems (wearable physiological monitoring systems in the case of Mulligan, and inserted tools in the case of Lopez and Goldstein), it would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the systems of Lopez and Goldstein with the dehydration model of Mulligan to create a more accurate determination of a dehydration state, and therefore allowing for a more accurate responsive action to be undertaken as a result. The use of an analytical model like that of Mulligan provides for “individual-specific estimations” as stated in paragraph 124, allowing for the system to adapt to the individual environment it resides it rather than making a non-specific blanket environmental hydration state determination like that of Lopez or Goldstein.
Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Lopez in view of Stulen et al (U.S. Patent Application Publication 2017/0000516, hereinafter “Stulen”). Regarding claim 8, while Lopez teaches the limitations of claim 1, it fails to teach a system wherein the sensor system includes a force sensor configured to detect friction force data for the flexible elongated device and wherein hydration indicator includes the friction force data. Stulen teaches a system wherein the sensor system includes a force sensor configured to detect friction force data for the flexible elongated device and wherein hydration indicator includes the friction force data (paragraph 223 “a force measurement is taken using any of the methods described herein to calculate the tissue coefficient of friction μ to determine the hydration level of the tissue”). It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the system of Lopez with the force sensor of Stulen in order to both monitor the hydration state of the system but also to monitor friction levels against a threshold at which damage to the patient could occur. It is well known in the art that lubricating fluids can be used about devices inserted into a patient to reduce stick-slip behavior or friction damage within a patient, and the addition of a force sensor to monitor friction would be obvious to reduce the likelihood of this type of damage occurring during an operation.
Regarding claim 9, Lopez and Stulen combined teach the limitations of claims 1 and 8, and Stulen futher teaches a system wherein evaluating the hydration indicator includes recognizing a friction force pattern in the friction force data, wherein the friction force pattern is associated with the hydration condition (paragraph 223 “a force measurement is taken using any of the methods described herein to calculate the tissue coefficient of friction μ to determine the hydration level of the tissue”). It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the system of Lopez with the force sensor of Stulen in order to both monitor the hydration state of the system but also to monitor friction levels against a threshold at which damage to the patient could occur. It is well known in the art that lubricating fluids can be used about devices inserted into a patient to reduce stick slip behavior or friction damage within a patient, and the addition of a force sensor to monitor friction would be obvious to reduce the likelihood of this type of damage occurring during an operation.
Claims 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Lopez in view of Williams et al (U.S. Patent Application Publication 2024/0247869, hereinafter “Williams”). Regarding claim 12, while Lopez teaches the limitations of claim 1, it fails to teach a system wherein the sensor system includes a sensor configured to detect a hydrochromic pigment on the flexible elongated device and wherein the hydration indicator includes a color property of the hydrochromic pigment associated with hydration. Williams teaches a system wherein the sensor system includes a sensor configured to detect a hydrochromic pigment on the flexible elongated device and wherein the hydration indicator includes a color property of the hydrochromic pigment associated with hydration (paragraph 26 details use of a hydrochromic pigment that changes color when contacted with moisture, and paragraph 62 details machine/computer implementation of the methods of the disclosure). It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the system of Lopez with the hydrochromic pigment of Williams in order to specifically locate the hydration indicator, allowing for an operator to determine if just part of the system is at the correct hydration level and not the whole system. If the operator sees that just a portion of the system shows a color change of the hydrochromic pigment, they can determine that the rest of the system is not at the required hydration level and take adjustive action to increase lubricity and limit damage to the patient during insertion.
Regarding claim 13, Lopez and Williams combined teach the limitations of claims 1 and 12, and Williams further teaches a system wherein evaluating the hydration indicator includes determining the color property of the hydrochromic pigment is associated with the hydration condition (paragraph 26 details observing the change in color of the hydrochromic pigment to determine a hydration condition of the system. It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the system of Lopez with the hydrochromic pigment of Williams in order to specifically locate the hydration indicator, allowing for an operator to determine if just part of the system is at the correct hydration level and not the whole system. If the operator sees that just a portion of the system shows a color change of the hydrochromic pigment, they can determine that the rest of the system is not at the required hydration level and take adjustive action to increase lubricity and limit damage to the patient during insertion.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Lopez and Williams in view of Farrell (U.S. Patent Application Publication 2021/0316045). While Lopez and Williams combined teach the limitations of claims 1 and 12, they fail to teach a system wherein the hydrochromic pigment is incorporated into the hydrophilic lubricious layer. Farrell teaches a system wherein the hydrochromic pigment is incorporated into the hydrophilic lubricious layer (paragraphs 13 and 14 detail a hydrophilic lubricious coating incorporating hydrochromic pigment). It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the systems of Lopez and Williams with the hydrochromic lubricious layer of Farrell in order to specifically locate the hydration indicator along the flexible elongate device, allowing for an operator to determine if just part of the device is at the correct hydration level and not the whole device. If the operator sees that just a portion of the device shows a color change of the hydrochromic pigment, they can determine that the rest of the device is not at the required hydration level and take adjustive action to increase lubricity and limit damage to the patient during insertion.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Lopez in view of Nerandzic et al (U.S. Patent Application Publication 2022/0104916, hereinafter “Nerandzic”). While Lopez teaches the limitations of claim 1, it fails to teach a system wherein the sensor system includes a humidity sensor configured to detect a moisture level of the flexible elongated device and wherein the hydration indicator includes the moisture level. Nerandzic teaches a system wherein the sensor system includes a humidity sensor configured to detect a moisture level of the flexible elongated device and wherein the hydration indicator includes the moisture level (paragraph 8 details use of a humidity sensor to determine a hydration state of the system). It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the system of Lopez with the humidity sensor of Nerandzic in order to determine the humidity of the air within the patient’s body, allowing an operator to monitor for sudden changes in humidity that can be indicative of a leak from the flexible elongate body or a rupture into another cavity caused by the movement of the elongate body within the patient, alerting the operator to a dangerous situation and allowing for earlier corrective action.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Lopez in view of Farrell. While Lopez teaches the limitations of claim 1, it fails to teach a system where wherein the hydration indicator is a visual characteristic of the hydrophilic lubricious layer. Farrell teaches a system where wherein the hydration indicator is a visual characteristic of the hydrophilic lubricious layer (paragraphs 13 and 14 detail a hydrophilic lubricious coating incorporating hydrochromic pigment, with the visual characteristic being a change in color observed within the laer). It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the systems of Lopez and Williams with the hydrochromic lubricious layer of Farrell in order to specifically locate the hydration indicator along the flexible elongate device, allowing for an operator to determine if just part of the device is at the correct hydration level and not the whole device. If the operator sees that just a portion of the device shows a color change of the hydrochromic pigment, they can determine that the rest of the device is not at the required hydration level and take adjustive action to increase lubricity and limit damage to the patient during insertion.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Lopez in view of Shelton et al (U.S. Patent Application Publication 2025/0166786, hereinafter “Shelton”). While Lopez teaches the limitations of claim 1, it fails to teach a system wherein the sensor system includes a vibration sensor configured to detect a sound associated with the flexible elongated device, and wherein the hydration indicator includes the detected sound. Shelton teaches a system wherein the sensor system includes a vibration sensor configured to detect a sound associated with the flexible elongated device, and wherein the hydration indicator includes the detected sound (paragraph 100 details use of sensors to determine hydration state through detection of vibrations). It would have been obvious before the effective filing date of the claimed invention to modify the system of Lopez with the vibration sensor of Shelton in order to detect vibrations associated with frictional contact between the insertion device and the patient’s body, alerting the operator to potential damaging contact between an inserted device and the wall of the patient’s anatomic passageways and allowing for corrective action to be taken.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAYTON BARKER whose telephone number is (571)272-0912. The examiner can normally be reached between 9:00 and 5:00 PM EST Monday-Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Carey can be reached at 5712707235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAYTON HYUN JIN BARKER/Patent Examiner, Art Unit 3795
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
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