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 .
Election/Restrictions
Applicant’s election of Group I, claims 1-6, 9, 11, 12, and 15-17, in the reply filed on 07 October 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
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, 15, and 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.
Regarding claim 12, the claim recites that “the one or more image sensors are located at one of: in proximity to a distal end of said catheter”, and that “the one or more images sensors are located at one of: in proximity to a distal end of the catheter and inside said catheter at a distance from said distal end”. It is unclear what is meant by “located at in proximity”. The limitation in claim 12 is being interpreted as “located one of: in proximity… at an inner surface… in proximity…”. Furthermore, the limitation “in proximity to a distal end of the catheter and inside said catheter at a distance from said distal end” comprises both a narrow (in proximity) and broad (at a distance from) range, rendering the claim indefinite. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Finally, the phrase “in proximity” is a relative term that renders the claim indefinite. The phrase “in proximity” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Regarding claim 15, the phrase “said image sensors” lacks proper antecedent basis as claim 11 recites “one or more image sensors”. When one image sensor is present, the phrase “said image sensors” lacks proper antecedent basis. The phrase in claim 15 is being interpreted as “said one or more image sensors”.
Regarding claim 16, the phrase “said controller” lacks proper antecedent basis. For this examination, the phrase is being interpreted as “said control unit”. Further regarding claim 16, it is unclear what it means for the optical reflectors to “deploy upon command from said controller”. The specification provides no guidance as to what the optical reflectors are or how they would be “deployed upon command from said controller”. Assuming that the optical reflectors are generic reflectors (e.g., a mirror, a reflective lens), how would those elements be “deployed upon command from said controller”? Clarification is requested.
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 1-5, 9, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Broens’044 (US Pub No. 2012/0265044 – cited by Applicant) in view of O’dea et al.’328 (US Pub No. 2010/0094328).
Regarding claim 1, Figure 6 of Broens’044 discloses a device comprising: a catheter 54; an inflatable balloon 63 located in a distal portion of the catheter, wherein the inflatable balloon is at least partially insertable into a body cavity (sections [0030], [0036]); one or more pressure sensors located inside the inflatable balloon (pressure sensor 62, section [0050]); an inflating unit in fluid connection with the inflatable balloon (section [0046]); and a control unit (Figure 1, control unit 1; section [0025]) attached to the catheter and configured to receive pressure measurements from the one or more pressure sensors (section [0050]).
Broens’044 discloses all of the elements of the current invention, as discussed above, except for the control unit controlling the inflating unit to control the pressure inside the inflatable balloon based on the received measurements. O’dea et al.’328 teaches controlling the inflation of an inflatable balloon based on pressure measurements received by a control unit in order to determine when the inflatable balloon is abutting an inner wall defining a lumen of a body cavity (sections [0057], [0080]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Broens’044 such that its control unit controls the inflating unit to control the pressure inside the inflatable balloon based on the received measurements, as it would merely be combining prior art elements according to known methods to yield predictable results. The modification to Broens’044 would allow the device to determine when the inflatable balloon is abutting the inner wall of the body cavity.
Regarding claim 2, Broens’044 discloses that pressure sensor 62 is attached to an outer surface of said inflatable balloon (section [0050]). While Broens’044 fails to disclose that the pressure sensor is attached to an inside surface of the inflatable balloon, it is noted that the position of the pressure sensor is merely an obvious matter of design choice because shifting the position of the pressure sensor would not have modified the operation of the device of Broens’044 (see MPEP 2144.04 VI. C.).
Regarding claim 3, Broens’044 discloses that at least one of said one or more pressure sensors is located inside the balloon to measure the pressure in the balloon (section [0050]). As evidenced by Rao et al.’984 (USPN 5,924,984 – cited by Applicant), it is known to attach a pressure sensor to a catheter inside a balloon in order to measure the pressure in the balloon (see Figure 2, pressure sensor 74; col. 3, lines 1-9).
Regarding claim 4, Broens’044 discloses that the catheter is an anorectal catheter (sections [0030], [0036]).
Regarding claim 5, Official notice is being taken that the pressure sensor types recited in the claim are well-known pressure sensor types. As such, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have used any of a polyvinylidene fluoride membrane, a piezoresistive strain gauge, a capacitive sensor, an electromagnetic sensor, a piezoelectric sensor, or an optical sensor as the pressure sensor of Broens’044 in view of O’dea et al.’328.
Regarding claim 9, Figure 6 of Broens’044 discloses that the device further comprises one or more additional pressure sensors 58a, 58b, 58c, 59a, 59b, 59c attached to a portion of the catheter that is external to the balloon (section [0050]).
Regarding claim 17, Broens’044 discloses that the device comprises one or more stimulating electrodes 55a, 55b, 56a, 56b, 57a, 57b configured to deliver electrical signals to rectal muscles (sections [0049], [0051-0052]). While Broens’044 fails to disclose that the stimulating electrodes are attached to an outer surface of the inflatable balloon, it is noted that the position of the stimulating electrodes is merely an obvious matter of design choice because shifting the position of the stimulating electrodes would not have modified the operation of the device of Broens’044 (see MPEP 2144.04 VI. C.).
Claims 11, 12, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Broens’044 in view of O’dea et al.’328, as applied to claim 1, further in view of Raleigh’680 (US Pub No. 2014/0243680 – cited by Applicant).
Regarding claim 11, Broens’044 in view of O’dea et al.’328 discloses all of the elements of the current invention, as discussed in paragraph 6 above, except for the device further comprising one or more image sensors located inside the balloon. Raleigh’680 teaches a device wherein one or more image sensors are located inside an inflatable balloon attached to a catheter (sections [0013], [0019], [0039]), wherein the one or more image sensors are used to generate an image of a body cavity (see ABSTRACT, sections [0054-0056]) and aid in diagnostic procedures (section [0059]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Broens’044 in view of O’dea et al.’328 to further comprise one or more image sensors located inside the balloon, as taught by Raleigh’680, as it would allow the device of Broens’044 in view of O’dea et al.’328 to image the body cavity into which the device is placed. The modification to Broens’044 in view of O’dea et al.’328 would aid diagnostic procedures.
Regarding claim 12, Raleigh’680 discloses that the one or more image sensors are located in proximity to a distal end of the catheter (sections [0027-0028], [0039]).
Regarding claim 15, Raleigh’680 discloses that the one or more image sensors is configured to capture images of the internal shape of the inflatable balloon (section [0017]).
Claims 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over O’dea et al.’328.
Regarding claim 1, Figure 7 of O’dea et al.’328 discloses a device comprising: a catheter 8; multiple inflatable balloons 61 located in a distal portion of the catheter, wherein the inflatable balloons are at least partially insertable into a body cavity (sections [0002-0005] [0095]); one or more pressure sensors (section [0080]); an inflating unit 34 in fluid connection with the inflatable balloons (sections [0080], [0095); and a control unit 35 (seen in Figure 1) attached to the catheter and configured to receive pressure measurements from the one or more pressure sensors, and to control the inflating unit to control the pressure inside the inflatable balloons based on the received measurements (sections [0057], [0080], [0095]).
O’dea et al.’328 discloses all of the elements of the current invention, as discussed above, except for the one or more pressure sensors being located inside the inflatable balloons. While O’dea et al.’328 fails to disclose that the pressure sensors are located inside the inflatable balloons, it is noted that the positions of the pressure sensors are merely an obvious matter of design choice because shifting the positions of the pressure sensors would not have modified the operation of the device of O’dea et al.’328 (see MPEP 2144.04 VI. C.).
Regarding claim 2, O’dea et al.’328 discloses all of the elements of the current invention, as discussed above, except for the one or more pressure sensors being attached to an inside surface of the inflatable balloons. While O’dea et al.’328 fails to disclose that the pressure sensors are attached to an inside surface of the inflatable balloons, it is noted that the positions of the pressure sensors are merely an obvious matter of design choice because shifting the positions of the pressure sensors would not have modified the operation of the device of O’dea et al.’328 (see MPEP 2144.04 VI. C.).
Regarding claim 3, O’dea et al.’328 discloses all of the elements of the current invention, as discussed above, except for the one or more pressure sensors being directly attached to the catheter. While O’dea et al.’328 fails to disclose that the pressure sensors are directly attached to the catheter, it is noted that the positions of the pressure sensors are merely an obvious matter of design choice because shifting the positions of the pressure sensors would not have modified the operation of the device of O’dea et al.’328 (see MPEP 2144.04 VI. C.).
Regarding claim 4, the device of O’dea et al.’328 is capable of being used as an anorectal catheter (sections [0002-0005]).
Regarding claim 5, Official notice is being taken that the pressure sensor types recited in the claim are well-known pressure sensor types. As such, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have used any of a polyvinylidene fluoride membrane, a piezoresistive strain gauge, a capacitive sensor, an electromagnetic sensor, a piezoelectric sensor, or an optical sensor as the pressure sensor of O’dea et al.’328.
Regarding claim 6, Figure 7 of O’dea et al.’328 discloses multiple inflatable balloons separately inflatable by a separate inlet (section [0095]: “Each balloon 61 is independently inflatable relative to the other balloons 61…”).
Examiner’s Note
The following is a statement of reasons for the lack of prior art rejections:
Regarding claim 16, none of the prior art discloses or suggests, either alone or in combination, a device comprising one or more optical reflectors located inside an inflatable balloon, the one or more optical reflectors being configured to deploy upon command from a controller, in combination with the other claimed elements.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
O’dea (US Pub No. 2012/0035642) teaches a control unit configured to inflate an inflatable balloon based on received pressure measurements (section [0169]). O’dea et al.’642 also discloses a device comprising: a catheter; an inflatable balloon located in a distal portion of the catheter, wherein the inflatable balloon is at least partially insertable into a body cavity; one or more pressure sensors; and an inflating unit in fluid connection with the inflatable balloon (Figure 1).
Aundal et al.’430 (US Pub No. 2005/0187430) teaches that pressure sensors can take a variety of forms, including as a strain gauge or as a piezoelectric transducer (section [0035]).
Wood et al.’702 (US Pub No. 2010/0319702) teaches that a piezoelectric pressure sensor is a suitable type of pressure sensor that may be integrated into or onto an exterior wall of a tube that is configured to be inserted into a body cavity (section [0023]).
Tearney et al.’178 (US Pub No. 2011/0137178) teaches that different types of pressure sensors may be incorporated into the wall of a tube, including piezoresistive and optical sensors (section [0095]).
Burnett et al.’262 (US Pub No. 2013/0030292) teaches using a piezoelectric pressure sensor or an optical pressure sensor as the pressure sensor of a pressure sensing catheter (section [0019]).
Hartholt et al.’543 (US Pub No. 2019/0254543) teaches that a pressure sensor may comprise any of various capacitive, resistive, or piezoelectric materials, or a polymer such as polyvinylidene fluoride (section [0020]).
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/ETSUB D BERHANU/Primary Examiner, Art Unit 3791
