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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on October 9, 2025 has been entered.
Claim Rejections - 35 USC § 103
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 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, 3-4, 7-8, and 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Sinai et al. (US PGPUB 2013/0338440 – “Sinai”) in view Rust (US PGPUB 2009/0125094 – “Rust”).
With regard to Claim 1, Sinai discloses:
A robot (Sinai FIG. 9A, probe apparatus 900) for endoscopy (Sinai paragraph [0015], “Probe apparatus is optionally adapted to accommodate at least one medical instrument, for example an endoscope”) comprising:
a leading balloon (Sinai FIG. 9A, front balloon 904) and a trailing balloon (Sinai FIG. 9A, rear balloon 906), each balloon being configured for selective inflation to anchor a portion of the robot within a pipe (Sinai FIG.9E, showing front balloon 904 selectively inflated to anchor to the interior of lumen 902; Sinai FIG.9F, showing rear balloon 906 selectively inflated to anchor to the interior of lumen 902);
a soft fluidic actuator (Sinai FIG. 9C, advancement balloon 908, as described in a same exemplary embodiment as advancement balloon 108 depicted in Sinai FIG. 1E), comprising a cylindrical soft body (Sinai FIG. 9A and FIG. 9C, showing advancement balloon 908 in deflated and inflated states, thus disclosing the soft/malleable property of advancement balloon 908) , located between the leading balloon and the trailing balloon and which is operable to extend or contract the robot in a longitudinal direction (Sinai FIGs.9B-9E, showing probe apparatus 900 advancing through lumen 902); and
a cavity (Sinai FIG. 1G, instrument channel 124 in probe apparatus 100) extending through the trailing balloon, soft-fluidic actuator and leading balloon, wherein the cavity is configured for provision of at least one of cabling or instruments (Sinai paragraph [0103], “instrument channel 124, shown in FIG. 1G, which traverses the length of probe apparatus 100”).
Sinai does not explicitly disclose:
wherein the cylindrical soft body comprises internal walls defining a plurality of longitudinal fluid chambers that are integrated within the cylindrical soft body of the soft-fluidic actuator, the soft-fluidic actuator being arranged such that movement of the leading balloon in a plurality of directions in a 360 degree circumference around the longitudinal direction can be effected by fluidic control of fluid within the plurality of longitudinal fluid chambers,
wherein each of the plurality of longitudinal fluid chambers has a length along the longitudinal direction between the leading balloon and the trailing balloon and a width, the length being greater than the width,
wherein each of the plurality of longitudinal fluid chambers is arranged such that fluidic control of fluid within the plurality of chambers can selectively extend or contract the robot in the longitudinal direction and bend the robot to effect movement of the leading balloon in a plurality of directions in a 360 degree circumference around the longitudinal direction; and
wherein the plurality of longitudinal fluid chambers are constrained in a lateral direction such that said fluidic control effects expansion or contraction of each chamber in a longitudinal direction.
Rust teaches:
wherein the cylindrical soft body (Rust FIG. 2A, expansion structure 204) comprises internal walls defining a plurality of longitudinal fluid chambers (Rust FIG. 2A, balloons 206a-f) that are integrated within the cylindrical soft body, being arranged such that movement of the leading balloon in a plurality of directions in a 360 degree circumference around the longitudinal direction can be effected by fluidic control of fluid within the plurality of longitudinal fluid chambers (Rust paragraph [0039], “individual balloons 206 when expanded”; Examiner interprets Rust as teaching the individual control of balloons 206 as teaching angular movement of the expansion structure 204),
wherein each of the plurality of longitudinal fluid chambers has a length along the longitudinal direction between the leading balloon and the trailing balloon and a width, the length being greater than the width (Rust paragraph [0035], “balloons 206 may have a length that is longer than a length of the stent 207”; see also balloons 402 in Rust FIG. 4),
wherein each of the plurality of longitudinal fluid chambers is arranged such that fluidic control of fluid within the plurality of chambers (Rust FIG. 2B, lumen 208) can selectively extend or contract the robot in the longitudinal direction and bend the robot to effect movement of the leading balloon in a plurality of directions in a 360 degree circumference around the longitudinal direction (Rust paragraph [0040], “fluid can be provided via one or more lumens 208 of the flexible elongated member 202 to inflate the balloons 206”; thus teaching selective inflation of the balloons 206); and
wherein the plurality of longitudinal fluid chambers are constrained in a lateral direction such that said fluidic control effects expansion or contraction of each chamber in a longitudinal direction (Rust FIG. 2D, sheath 214; Rust paragraph [0041], “sheath 214 may limit a radial expansion of one or more portions of the balloons 206”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Rust’s individually controlled inflatable linear balloons with the robot disclosed by Sinai. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a robot with a balloon cannula/lumen that can negotiate turns without excessive bending of the balloons (see Rust paragraph [0010]). Rust is interpreted by Examiner as art that is analogous to Sinai since 1) they are in the same relevant field of endeavor of providing supportive structure to a lumen, and 2) Rust is reasonably pertinent to the problem solved by Sinai of controlling a shape and/or movement of a lumen. MPEP 2141.01(a).
With regard to Claim 3, Sinai in view of Rust teach the features of Claim 1, as described above.
Sinai further discloses wherein the actuator is a positive differential pressure (PDP) actuator (Sinai FIG. 9C; Sinai paragraph [0125], “as advancement balloon 908 inflates (1506), front balloon 904 moves forward into lumen 902 and away from rear balloon 906”; Examiner interprets this as teaching that the positive pressure / inflation of balloon 908 causes balloon 908 to perform as a PDP actuator).
With regard to Claim 4, Sinai in view of Rust teach the features of Claim 1, as described above.
Rust further teaches wherein the actuator comprises three or four chambers (Rust Fig. 2C, showing five balloons 206a-f).
With regard to Claim 7, Sinai in view of Rust teach the features of Claim 1, as described above.
Sinai further discloses wherein the robot is configured as a disposable device (Sinai paragraph [0106], “at least one component of probe apparatus 100 is disposable, for example at least one supply line 128, 130 and/or at least one balloon 110, 104, 120, and/or at least one medical instrument such that probe apparatus 100 is reusable and/or at least partially disposable.”).
With regard to Claim 8, Sinai in view of Rust teach the features of Claim 1, as described above.
Sinai further discloses wherein at least one of the leading balloon or the trailing balloon comprise a soft silicon rubber (Sinai paragraph [0097], “at least one of balloons 104, 110, 118 is constructed from a flexible and/or elastic material, for example silicone”).
With regard to Claim 13, Sinai in view of Rust teach the features of Claim 1, as described above.
Sinai in view of Rust do not explicitly teach wherein the actuator has an external diameter in a range of 12mm to 20mm.
However, it appears that applicant places no criticality on the range claimed, indicating simply that the diameter “may” be within the claimed ranges (see paragraph [0035] of the present specification).That is, there is nothing in Applicant’s disclosure that indicates that it is critical to the present invention for the external diameter of actuator be between 12mm and 20mm. As such, it would have been further obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Sinai in view of Rust to have an actuator has an external diameter in a range of 12mm to 20mm, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). Rather, the diameter of the actuator need only be of a dimension that provides adequate support for the balloons while retaining the requisite flexibility of the device taught by Sinai in view of Rust. See also MPEP 2144.04(IV)(A).
With regard to Claim 14, Sinai in view of Rust teach the features of Claim 1, as described above.
Sinai in view of Rust do not explicitly teach wherein the plurality of chambers each have a length in a range of 12mm to 30mm.
However, it appears that applicant places no criticality on the range claimed, indicating simply that the chamber length “may” be within the claimed ranges (see paragraph [0040] of the present specification).That is, there is nothing in Applicant’s disclosure that indicates that it is critical to the present invention for the chambers to each have a length in a range of 12mm to 30mm. As such, it would have been further obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Sinai in view of Rust to have a chamber having a length in a range of 12mm to 30mm, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). Rather, the length of the chambers need only be long enough to encircle the insertion portion of the device taught by Sinai in view of Rust. See also MPEP 2144.04(IV)(A).
With regard to Claim 15, Sinai in view of Rust teach the features of Claim 1, as described above.
Sinai further discloses fluid control tubes (Sinai FIG. 1A, supply lines 128) fluidly connected to each of the leading balloon, the trailing balloon (Sinai paragraph [0105], “inflation material supply lines 128 are provided to at least one of front balloon 110, advancement balloon 104 and/or rear balloon 120 through which an inflation material is transported in and/or out for inflation and/or deflation, respectively, of at least one balloon 110, 104, 120”).
Rust further teaches fluid control tubes fluidly connected to the plurality of chambers (Rust paragraph [0040], “fluid can be provided via one or more lumens 208 of the flexible elongated member 202 to inflate the balloons 206”;.
With regard to Claim 16, Sinai in view of Rust teach the features of Claim 1, as described above.
Sinai further discloses wherein the robot comprises a camera (Sinai FIG. 1H, medical instrument 132; Sinai paragraph [0103], “medical instrument 132 includes a camera”).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Sinai et al. (US PGPUB 2013/0338440 – “Sinai”) in view of Rust (US PGPUB 2009/0125094 – “Rust”) and Francois et al. (US PGPUB 2003/0149338 – “Francois”).
With regard to Claim 5, Sinai in view of Rust teach the features of Claim 1, as described above.
Although Rust teaches wherein each one of the plurality of chambers is arranged for expansion in substantially the longitudinal direction, Sinai in view of Rust do not explicitly teach wherein each one of the plurality of chambers is arranged for expansion in the longitudinal direction to push a common face plate to direct the robot.
Francois teaches wherein each one of the plurality of chambers is arranged for expansion in the longitudinal direction to push a common face plate to direct the robot (Francois FIG. 2, showing bellows 10 pushing against endpiece 6a).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Francois’ bellows and endpiece with the robot taught by Sinai in view of Rust. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result an endplate that is directly controlled by bellows, in order to provide precise control of a distal tip of an insertion portion of the endoscope.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Sinai et al. (US PGPUB 2013/0338440 – “Sinai”) in view of Rust (US PGPUB 2009/0125094 – “Rust”) and Yoshida et al. (US Patent 7,935,047 – “Yoshida”).
With regard to Claim 6, Sinai in view of Rust teach discloses the features of Claim 1, as described above.
Sinai in view of Rust do not explicitly disclose a closed-loop control system arranged to monitor at least one of fluid volume or pressure in at least one of the leading balloon or the trailing balloon to determine when to stop inflation.
Yoshida teaches a closed-loop control system arranged to monitor at least one of fluid volume or pressure in at least one of the leading balloon or the trailing balloon to determine when to stop inflation (Yoshida FIG. 2, control units 130a and 130b; Yoshida col.4, lines 58-60, “The control units 130a and 130b measures the air pressures in the balloons 118 and 122 for fixing the endoscope and the overtube to control the pressures in the balloons, respectively.”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Yoshida’s pressure regulators with the robot disclosed by Sinai in view of Rust. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a robot that is able to control the inflation/deflation of balloons thereon (Yoshida FIG. 2, pump 128a, pump 128b, control boards 134a and 134b, selector valves 126a and 126b; Yoshida col.4 line 64 – col. 5, line 11, “The pressure sensor 132a is disposed at a midpoint in a path between the pump 128a and the air supply tube 120. The pressure sensor 132b is disposed at a midpoint in a path between the pump 128b and the air supply tube 124. The pressure sensors 132a and 132b measure the pressures in the respective paths, so that the sensors can detect the air pressures in the balloons 118 and 122, respectively. The pressure sensors 132a and 132b are connected to the control boards 134a and 134b, respectively. The pressure sensors 132a and 132b transmit the measurement results to the control boards 134a and 134b, respectively. The pumps 128a and 128b and the selector valves 126a and 126b are connected to the control boards 134a and 134b, respectively. The control boards 134a and 134b control the ON/OFF operations of the pumps 128a and 128b”).
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Sinai et al. (US PGPUB 2013/0338440 – “Sinai”) in view of Rust (US PGPUB 2009/0125094 – “Rust”) and Khachi (US PGPUB 2008/0009673 – “Khachi”).
With regard to Claim 9, Sinai in view of Rust teach the features of Claim 1, as described above.
Sinai in view of Rust do not explicitly teach wherein at least one of the leading balloon or the trailing balloon has a deflated external diameter in a range of 12mm to 20mm.
Khachi teaches wherein at least one of the leading balloon or the trailing balloon has a deflated external diameter in a range of 12mm to 20mm (Khachi FIG. 1, combination of balloons 22a, 22b, 22c, 22d; Khachi page 3, Table I; outer diameter of 5-20mm for deflated balloon used in general/thoracic surgical procedures).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute balloons 22a-22d taught by Khachi for one or both of the balloons 904/906 in the robot disclosed by Sinai in view of Rust. A person having ordinary skill in the art would be motivated to make this simple substitution of one known element for another to obtain predictable result of a robot having dimensions suitable for a particular type of endoscopic surgery (Khachi paragraph [0032], “The balloon endoscope shaft 10 of the present invention can be sized to render it suitable for performing a number of different medical or surgical procedures”).
With regard to Claim 10, Sinai in view of Rust teach the features of Claim 1, as described above.
Sinai in view of Rust do not explicitly teach wherein at least one of the leading balloon or the trailing balloon has an inflated external diameter of up to at least 90mm.
Khachi teaches wherein at least one of the leading balloon or the trailing balloon has an inflated external diameter of up to at least 90mm (Khachi FIG. 1, combination of balloons 22a, 22b, 22c, 22d; Khachi page 3, Table I; outer diameter of 25-150mm for inflated balloon used in general/thoracic surgical procedures).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute balloons 22a-22d taught by Khachi for one or both of the balloons 904/906 in the robot disclosed by Sinai in view of Rust. A person having ordinary skill in the art would be motivated to make this simple substitution of one known element for another to obtain predictable result of a robot having dimensions suitable for a particular type of endoscopic surgery (Khachi paragraph [0032], “The balloon endoscope shaft 10 of the present invention can be sized to render it suitable for performing a number of different medical or surgical procedures”).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Sinai et al. (US PGPUB 2013/0338440 – “Sinai”) in view of Rust (US PGPUB 2009/0125094 – “Rust”),and Kokish et al. (US PGPUB 2010/0189876 – “Kokish”).
With regard to Claim 11, Sinai in view of Rust teach the features of Claim 1, as described above.
Sinai in view of Rust do not explicitly teach wherein at least one of the leading balloon or the trailing balloon has an activation pressure of 100kPa or below.
Kokish teaches wherein at least one of the leading balloon or the trailing balloon has an activation pressure of 100kPa or below (Kokish FIG. 1, balloon 24; Kokish paragraph [0048], “approximately 6.9 kPa-13.8 kPa (approximately 1-2 psi) of air flows from the inflation port (not shown), through the annular lumen 20, and into the inflatable balloon 24 causing the balloon 24 to partially inflate”.)
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to utilize Kokish’s inflation pressure with the balloons 904/906 in the robot disclosed by Sinai in view of Rust. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a robot whose balloons are not prone to rupturing their outer surfaces (see FIG. 3 and paragraph [0048] of Kokish, “the desired fluid pressure flowing through the balloon should be an amount that allows partial inflation of the balloon 24 while maintaining the structural integrity of the microporous coating 38”).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Sinai et al. (US PGPUB 2013/0338440 – “Sinai”) in view of Rust (US PGPUB 2009/0125094 – “Rust”),and Chuang et al. (US PGPUB 2012/0302922 – “Chuang”).
With regard to Claim 12, Sinai in view of Rust teach the features of Claim 1, as described above.
Sinai in view of Rust do not explicitly teach wherein the cavity has a diameter in a range of 1mm to 8mm.
Chuang teaches wherein the cavity has a diameter in a range of 1mm to 8mm (Chuang FIG. 6, instrument channel 61; Chuang paragraph [0032], “The diameter of the instrument channel 61 of a medical endoscope ranges from 1 to 6 millimeter.”)
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute Chuang’s cavity/instrument channel 61 for Sinai’s cavity/instrument channel 124 in the robot taught by Sinai in view of Rust. A person having ordinary skill in the art would be motivated to make this simple substitution of one known element for another to obtain the predictable results of a robot having a working/instrument channel large enough to accommodate medical instruments used in endoscopic surgery.
Response to Arguments
Applicant’s arguments with respect to the rejections of Claims 1-4, 7-8, and 13-16 under 35 U.S.C. 103 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIM BOICE whose telephone number is (571)272-6565. The examiner can normally be reached Monday-Friday 9:00am - 5:00pm Eastern.
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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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JIM BOICE
Examiner
Art Unit 3795
/JAMES EDWARD BOICE/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
10/18/25