DETAILED ACTION
Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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.
Claims 16-35 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.
In claims 16, 17, and 18, the limitation “a second elongate flexible medical instrument (4)” is used, with reference to the “an elongate flexible medical instrument 4” of the specification, however “a first elongate flexible medical instrument (4)” is also defined within the same claim and linked to the same “an elongate flexible medical instrument 4” of the specification. The scope of these claims is thus rendered indefinite, since it is unclear whether the “a second elongate flexible medical instrument” and the ”a first elongate flexible medical instrument” refer to the same “an elongate flexible medical instrument 4” of the specification, or whether the claim intends to define two different elongate flexible medical instruments (inconsistent with the configuration depicted within the drawings and described within the detailed description section of the present specification, which discusses only one elongate flexible medical instrument). Appropriate clarification/correction is required. Claims 19-35 are also rendered indefinite by virtue of their dependence upon one of claims 16, 17, and 18.
Claim 19 recites the limitation "the Y connector" in lines 7 and 9. There is insufficient antecedent basis for this limitation in the claim. No Y connector structure is introduced within this claim nor claim 17, upon which this claim depends. It is therefore unclear whether the claimed Y connector refers to the same Y connector introduced in claim 18, or whether it may refer to some other structure. Appropriate clarification is required. Because of this uncertainty, no reasonable interpretation of the claim can be presently made for examination purposes, thus no rejection over the prior art is presented for this claim, however, this should not be taken as an indication of allowability of the claimed subject matter.
Claim 20 recites the limitation "the Y connector" in lines 7 and 8. There is insufficient antecedent basis for this limitation in the claim. No Y connector structure is introduced within this claim nor claim 17, upon which this claim depends. It is therefore unclear whether the claimed Y connector refers to the same Y connector introduced in claim 18, or whether it may refer to some other structure. Appropriate clarification is required. Because of this uncertainty, no reasonable interpretation of the claim can be presently made for examination purposes, thus no rejection over the prior art is presented for this claim, however, this should not be taken as an indication of allowability of the claimed subject matter.
Claim 21 recites the limitation "said manipulation area" in lines 3-4 and 6. There is insufficient antecedent basis for this limitation in the claim. No manipulation area structure is introduced within this claim nor claim 18, upon which this claim depends. It is therefore unclear whether the claimed manipulation area refers to the same manipulation area introduced in claim 17, or whether it may refer to some other structure. Appropriate clarification is required. Because of this uncertainty, no reasonable interpretation of the claim can be presently made for examination purposes, thus no rejection over the prior art is presented for this claim, however, this should not be taken as an indication of allowability of the claimed subject matter.
Claim 22 recites the limitation "said manipulation area" in lines 3 and 5-6. There is insufficient antecedent basis for this limitation in the claim. No manipulation area structure is introduced within this claim nor claim 18, upon which this claim depends. It is therefore unclear whether the claimed manipulation area refers to the same manipulation area introduced in claim 17, or whether it may refer to some other structure. Appropriate clarification is required. Because of this uncertainty, no reasonable interpretation of the claim can be presently made for examination purposes, thus no rejection over the prior art is presented for this claim, however, this should not be taken as an indication of allowability of the claimed subject matter.
Claim 23 recites the limitation "the Y connector" in line 6. There is insufficient antecedent basis for this limitation in the claim. No Y connector structure is introduced within this claim nor claim 17, upon which this claim depends. It is therefore unclear whether the claimed Y connector refers to the same Y connector introduced in claim 18, or whether it may refer to some other structure. Appropriate clarification is required. Because of this uncertainty, no reasonable interpretation of the claim can be presently made for examination purposes, thus no rejection over the prior art is presented for this claim, however, this should not be taken as an indication of allowability of the claimed subject matter.
Claim 23 also recites the limitation "said manipulation body (42)" in line 10. There is insufficient antecedent basis for this limitation in the claim. While a manipulation area (41) is introduced in claim 17, upon which claim 23 depends, and a body (42) of the first elongate flexible medical instrument (4) is also defined therein, no “manipulation body” feature is introduced, nor is the body (42) defined as being a site of manipulation. Rather, the body and manipulation area are mutually exclusively defined within claim 17, wherein the body (42) is the portion of the first elongate flexible medical instrument (4) intended to enter the body of the patient, and the manipulation area (41) is the portion of the first elongate flexible medical instrument (4) intended to remain outside of the body of the patient (see claim 17, lines 5-8). It thus appears that the applicant(s) have conflated these two mutually exclusive features when referring to the “manipulation body (42)” claimed, thereby introducing a contradiction within the claim that renders the claim indefinite. Appropriate correction is required. Because of this contradiction, no reasonable interpretation of the claim can be presently made for examination purposes, thus no rejection over the prior art is presented for this claim, however, this should not be taken as an indication of allowability of the claimed subject matter.
Claim 24 recites the limitation "said manipulation area" in line 1. There is insufficient antecedent basis for this limitation in the claim. No manipulation area structure is introduced within this claim nor claim 16, upon which this claim depends. It is therefore unclear whether the claimed manipulation area refers to the same manipulation area introduced in claim 17, or whether it may refer to some other structure. Appropriate clarification is required. Because of this uncertainty, no reasonable interpretation of the claim can be presently made for examination purposes, thus no rejection over the prior art is presented for this claim, however, this should not be taken as an indication of allowability of the claimed subject matter.
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.
Claim(s) 16, 25-28, 30, and 32-33 are rejected under 35 U.S.C. 103 as being unpatentable over Yu (U.S. Pat. Pub. No. 2014/0277334 A1) in view of Trost (NPL, “Needles, Guidewires, Catheters, and Stents”) and Callan (NPL, “Care and Management of Patients with Urinary Catheters: A Clinical Resource Guide”).
Regarding claim 16, Yu discloses a catherization robot (robotic catheter assembly 18, comprising instrument driver 34) comprising: a base (housing 68 of instrument driver 34), a first drive module (active catheter feeder 80) for [interpreted “configured for”] driving a first elongate flexible medical instrument (leader catheter 38) in translation along a longitudinal first direction (see Fig. 3-4 and [0108-0111]) configurable in the manner of a first embodiment (active catheter feeder 100, the embodiment of Fig. 6-26 and [0113-0170]) and a second embodiment (active catheter feeder 300, the embodiment of Fig. 27-50 and [0171-197]), said first drive module: being fixed relative to the base (see [0109], [0113], and [0173]).
In the first embodiment of Fig. 6-26, the first drive module comprises at least one pair of two drive surfaces (pairs of jaw assemblies 120/130, each jaw assembly comprising a pair of gripping pads/drive surfaces 140/142) which are located face to face (see Fig. 12-14 and [0117]) and which: move closer to each other in translation along a transverse second direction, in a first directional orientation, firstly so as to grip the first elongate flexible medical instrument (see Fig. 12-14 and [0116-0120]) in order to then be able to drive it in translation along the longitudinal first direction (see Fig. 7-14 and [0121-0127]), and move away from each other in translation along the transverse second direction, in a second directional orientation that is opposite to the first directional orientation, in order to release the first elongate flexible medical instrument so it is then free for extraction from the catherization robot (see Fig. 12-14 and [0117-0120]).
In the second embodiment of Fig. 27-50, the first drive module comprises at least one pair of two drive surfaces (outer surfaces of gripping pads 314) which are located face to face (see Fig. 27-40 and [0174-0177]) and which: move closer to each other in translation along a transverse second direction, in a first directional orientation, firstly so as to grip the first elongate flexible medical instrument in order to then be able to drive it in translation along the longitudinal first direction (see Fig. 27-40, [0175-0181], [0183], and [0190]), and move away from each other in translation along the transverse second direction, in a second directional orientation that is opposite to the first directional orientation, in order to release the first elongate flexible medical instrument so it is then free for extraction from the catherization robot (see Fig. 27-40, [0175], [0183], and [0190]).
Yu further discloses a second drive module (catheter carriage 76) for [interpreted “configured for”] driving the first elongate flexible medical instrument (or alternatively it is capable of driving a second elongate flexible medical instrument) in translation along the longitudinal first direction (see Fig. 3-5 and [0106-0108]), said second drive module being movable in translation along the longitudinal first direction relative to the first drive module (see Fig. 3-4 and [0108-0111]), one end of the first elongate flexible medical instrument being fixed to the second drive module (see Fig. 3-5 and [0106], wherein an end of the lead catheter 38 is fixed to the catheter carriage 76 via adapter 56, which receives the end of the lead catheter 38 and which is removably affixed to the catheter carriage 76).
While Yu fails to explicitly teach that the maximum value of the separation distance between the two drive surfaces of the first drive module, which is reached when the two drive surfaces are moving away from each other, is greater than 20mm, or greater than 25mm, or greater than 30mm, or greater than 35mm, it is clear from Fig. 14 in the first embodiment and Fig. 30-32 in the second embodiment of Yu that the maximum value may be significantly larger than the transverse width of the elongate flexible medical instrument at the location of the drive surfaces, such as more than twice the width of the elongate flexible medical instrument at the location of the drive surfaces, as depicted in Fig. 14 and Fig. 30-32. Yu teaches that the separation may be configured in order to allow the catherization robot to accommodate elongate flexible medical instruments (catheters) of varying width ([0110], ln 4-17 and [0147], ln 18-23), and in the first embodiment, to allow the drive surfaces to translate freely relative to the elongate flexible medical instrument during the process of catherization (see Fig. 25a-26d and [0156-0170]), and in the second embodiment, to allow the elongate flexible medical instrument (leader catheter 38) to be top loaded into the first drive module ([0177]), thereby facilitating fast and easy use of the device. Further, it is well known within the art that large-diameter catheters of certain types may commonly be as big as 30 French (having an inner diameter of 10 mm, and an outer diameter greater than 10 mm – see Trost, ln 10-18, which describes that the outer diameter of a catheter is significantly larger than the inner diameter given by the French number, and Callan, pg. 6, ln 6-14, wherein catheters of up to 30 Fr, or 10 mm, inner diameter are considered as conventional for applications such as urinary catheters). As such, in order to allow the catherization robot of Yu to accommodate large diameter catheters in the same manner as is depicted in Fig. 14, 25e-25f, and 30-32, such as may be necessary in some circumstances in which an inner diameter of up to 30 French (10 mm) may be required, it would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to try selecting a maximum separation distance of greater than 20 mm, thereby ensuring that large elongate flexible medical instruments may be accommodated and that, at least in the first embodiment, the drive surfaces may translate freely relative to the elongate flexible medical instrument as intended by Yu in order to thereby enable catherization, and that at least in the second embodiment, the elongate flexible medical instrument may be top loaded into the first drive module, thereby facilitating fast and easy use of the device.
Regarding claim 25, Yu further discloses, according to the second embodiment (active catheter feeder 300, the embodiment of Fig. 27-50 and [0171-197]) that said two drive surfaces may be respectively carried by two rollers (rotatable gripping pads 314) which rotate about two parallel axes (those of vertical shafts 312) but in directions opposite to each other and which are part of the first drive module (see Fig. 27-40, [0174-0177], and [0190]).
Regarding claim 26, Yu further discloses, in the first embodiment, that said two drive surfaces are respectively carried by two endplates (gripping flanges 136/138) which are movable in translation (see Fig. 12-14 and [0117-0127]).
Regarding claim 27, Yu further discloses, in the second embodiment, that said two drive surfaces are respectively carried by two platforms (upper arms 308a, 308b): which are movable in transverse translation along the transverse second direction (see Fig. 27-40, [0174-0175], [0183], and [0192-0197]), and which are part of the first drive module which also comprises an actuator (gripping force adjustment mechanism 368) for driving said two platforms in translation along the transverse second direction (see Fig. 44-49 and [0192-0197]).
Regarding claim 28, Yu further discloses that the actuator is formed by a worm screw system (see Fig. 44-49 and [0192-0197], wherein the gripping force adjustment mechanism comprises a worm screw assembly of lead screw 420 and lead nut 422).
Regarding claim 30, Yu further discloses, in the first embodiment, that the first drive module comprises at least two of said pairs of two drive surfaces (up to three jaw assemblies 120/130 are exhibited), which are located one after the other along the longitudinal first direction (see Fig. 7, 9-11, 22-24, and 26a-26d, and [0116-0127], [0139], and [0164-0170]).
Regarding claim 32, Yu further discloses, in the first embodiment, that the catherization robot is adapted to implement a method for moving an elongate flexible medical instrument (lead catheter 38) in the catherization robot, successively comprising: a first step in which a body of the first elongate flexible medical instrument is driven in translation along the longitudinal first direction by at least one pair of drive surfaces (see Fig. 26a-26d, [0121-0127], [0139-0140], and [0164-0170]), a second step in which the body of the first elongate flexible medical instrument is driven in translation along the longitudinal first direction by a translational movement of the second drive module relative to the first drive module along the longitudinal first direction (see [0108], wherein the body of the lead catheter 38 is advanced by the a translational movement of the catheter carriage 76 simultaneously to the driving performed by the drive surfaces of the active catheter feeder 80).
Regarding claim 33, Yu further discloses, in the first embodiment, that the first step comprises: a first sub-step in which the body of the first elongate flexible medical instrument is driven in translation along the longitudinal first direction by at least two of said pairs of drive surfaces (see Fig. 26b, [0139-0140], and [0164-0167], wherein throughout the cycle of jaw assembly 120a-120c strokes, the lead catheter is often gripped and translated by two of jaw assemblies 120a-120c, as is depicted in Fig. 26b), a second sub-step in which the body of the elongate flexible medical instrument is driven in translation along the longitudinal first direction by only one of said pairs of drive surfaces (see Fig. 26a, [0139-0140], and [0164-0166], wherein for at least momentary points throughout the cycle of jaw assembly 120a-120c strokes, the lead catheter is only gripped and translated by a single one of jaw assemblies 120a-120c, as is depicted in Fig. 26a).
Claim(s) 17-18, 31, and 34-35 are rejected under 35 U.S.C. 103 as being unpatentable over Yu in view of Klem (WO2021/011533 A1).
Regarding claim 17, Yu discloses a catherization robot (robotic catheter assembly 18, comprising instrument driver 34) comprising: a base (housing 68 of instrument driver 34), a first elongate flexible medical instrument (leader catheter 38), a first drive module (active catheter feeder 80) for [interpreted “configured for”] driving in translation, along a longitudinal first direction, the first elongate flexible medical instrument (leader catheter 38) (see Fig. 3-4 and [0108-0111]).
Yu further discloses that the first drive module is configurable in the manner of a first embodiment (active catheter feeder 100, the embodiment of Fig. 6-26 and [0113-0170]) and a second embodiment (active catheter feeder 300, the embodiment of Fig. 27-50 and [0171-197]), said first drive module: being fixed relative to the base (see [0109], [0113], and [0173]).
In the first embodiment of Fig. 6-26, the first drive module comprises at least one pair of two drive surfaces (pairs of jaw assemblies 120/130, each jaw assembly comprising a pair of gripping pads/drive surfaces 140/142) which are located face to face (see Fig. 12-14 and [0117]) and which: move closer to each other in translation along a transverse second direction, in a first directional orientation, firstly so as to grip the first elongate flexible medical instrument (see Fig. 12-14 and [0116-0120]) in order to then be able to drive it in translation along the longitudinal first direction (see Fig. 7-14 and [0121-0127]), and move away from each other in translation along the transverse second direction, in a second directional orientation that is opposite to the first directional orientation, in order to release the first elongate flexible medical instrument so it is then free for extraction from the catherization robot (see Fig. 12-14 and [0117-0120]).
In the second embodiment of Fig. 27-50, the first drive module comprises at least one pair of two drive surfaces (outer surfaces of gripping pads 314) which are located face to face (see Fig. 27-40 and [0174-0177]) and which: move closer to each other in translation along a transverse second direction, in a first directional orientation, firstly so as to grip the first elongate flexible medical instrument in order to then be able to drive it in translation along the longitudinal first direction (see Fig. 27-40, [0175-0181], [0183], and [0190]), and move away from each other in translation along the transverse second direction, in a second directional orientation that is opposite to the first directional orientation, in order to release the first elongate flexible medical instrument so it is then free for extraction from the catherization robot (see Fig. 27-40, [0175], [0183], and [0190]).
Yu further discloses a second drive module (catheter carriage 76) for [interpreted “configured for”] driving the first elongate flexible medical instrument (or alternatively it is capable of driving a second elongate flexible medical instrument) in translation along the longitudinal first direction (see Fig. 3-5 and [0106-0108]), said second drive module being movable in translation along the longitudinal first direction relative to the first drive module (see Fig. 3-4 and [0108-0111]), one end of the first elongate flexible medical instrument being fixed to the second drive module (see Fig. 3-5 and [0106], wherein an end of the lead catheter 38 is fixed to the catheter carriage 76 via adapter 56, which receives the end of the lead catheter 38 and which is removably affixed to the catheter carriage 76).
Yu further discloses that the first elongate flexible medical instrument comprises a body (body 50) which is intended to enter the body of a patient and a proximal end of the first elongate flexible medical instrument (proximal end 52) which is intended to remain outside the body of the patient (being fixed to the adapter 48 – see Fig. 4 and [0102]). Yu does not explicitly disclose that the first elongate flexible medical instrument comprises a manipulation area which is intended to remain outside the body of the patient and which allows gripping this first elongate flexible medical instrument, said manipulation area having a maximum transverse dimension that is greater than the maximum transverse dimension of the body of the first elongate flexible medical instrument, the respective transverse dimensions of the manipulation area and of the body of the first medical instrument being oriented in a transverse second direction which is orthogonal to the longitudinal first direction, such features are common of flexible medical instruments/catheters within the art. For example, Klem exhibits an elongate flexible medical instrument/catheter (catheter 512) which comprises a body portion (shaft 516) that is intended to enter the body of a patient and a manipulation area (hub 514) which is intended to remain outside the body of the patient and which allows gripping this first elongate flexible medical instrument (see Fig. 8B, [0249-0250], [0254], and [0258]), said manipulation area having a maximum transverse dimension that is greater than the maximum transverse dimension of the body (shaft 516) of the first elongate flexible medical instrument (see Fig. 8B), the respective transverse dimensions of the manipulation area and of the body of the first medical instrument being oriented in a transverse second direction which is orthogonal to the longitudinal first direction (see Fig. 8B). Klem further teaches that such a flexible medical instrument/catheter may be used with a catheterization robot (catheter procedure system 10) of the type disclosed by Yu (see Fig. 1-4H, [0151-0153], [0202-0215], [0220], [0227], [0232-0235], and [0261-0263]). As such, it would have been obvious for one of ordinary skill in the art to try to use the catheterization robot of Yu on a catheter of the type exhibited by Klem, comprising the claimed features, since such features are commonly included on catheters within the art, and since, based upon the example of Klem, one of ordinary skill in the art would have reasonable expectation of success in driving such a catheter within a catheterization robot of the type disclosed by Yu.
Klem further exhibits that the maximum transverse dimension of the manipulation need not be much greater than the maximum transverse dimension of the body of the first elongate flexible medical instrument (see Fig. 8B). It is clear from Fig. 14 in the first embodiment and Fig. 30-32 in the second embodiment of Yu that the maximum value of the separation distance between the two drive surfaces may be significantly larger than the transverse width of the elongate flexible medical instrument at the location of the drive surfaces, such as more than twice the width of the elongate flexible medical instrument at the location of the drive surfaces, as depicted in Fig. 14 and Fig. 30-32. As such, it is clear that for a flexible medical instrument/catheter of the type taught by Klem (and incorporated to be used within the catheterization robot of Yu in the above modification), wherein the maximum transverse dimension of the manipulation is not much greater than the maximum transverse dimension of the body and the transverse width of the catheter is of small to medium size, such as 6 Fr (see [0110], ln 15-19), the separation distance between the two drive surfaces of Yu would reach a maximum value which is greater than said transverse dimension of said body of the first elongate flexible medical instrument, and the maximum value of the separation distance between the two drive surfaces of the first drive module is greater than said maximum transverse dimension of said manipulation area of the first elongate flexible medical instrument.
Regarding claim 18, Yu discloses a catherization robot (robotic catheter assembly 18, comprising instrument driver 34) comprising: a base (housing 68 of instrument driver 34), a first drive module (active catheter feeder 80) for [interpreted “configured for”] driving a first elongate flexible medical instrument (leader catheter 38) in translation along a longitudinal first direction (see Fig. 3-4 and [0108-0111]) configurable in the manner of a first embodiment (active catheter feeder 100, the embodiment of Fig. 6-26 and [0113-0170]) and a second embodiment (active catheter feeder 300, the embodiment of Fig. 27-50 and [0171-197]), said first drive module: being fixed relative to the base (see [0109], [0113], and [0173]).
In the first embodiment of Fig. 6-26, the first drive module comprises at least one pair of two drive surfaces (pairs of jaw assemblies 120/130, each jaw assembly comprising a pair of gripping pads/drive surfaces 140/142) which are located face to face (see Fig. 12-14 and [0117]) and which: move closer to each other in translation along a transverse second direction, in a first directional orientation, firstly so as to grip the first elongate flexible medical instrument (see Fig. 12-14 and [0116-0120]) in order to then be able to drive it in translation along the longitudinal first direction (see Fig. 7-14 and [0121-0127]), and move away from each other in translation along the transverse second direction, in a second directional orientation that is opposite to the first directional orientation, in order to release the first elongate flexible medical instrument so it is then free for extraction from the catherization robot (see Fig. 12-14 and [0117-0120]).
In the second embodiment of Fig. 27-50, the first drive module comprises at least one pair of two drive surfaces (outer surfaces of gripping pads 314) which are located face to face (see Fig. 27-40 and [0174-0177]) and which: move closer to each other in translation along a transverse second direction, in a first directional orientation, firstly so as to grip the first elongate flexible medical instrument in order to then be able to drive it in translation along the longitudinal first direction (see Fig. 27-40, [0175-0181], [0183], and [0190]), and move away from each other in translation along the transverse second direction, in a second directional orientation that is opposite to the first directional orientation, in order to release the first elongate flexible medical instrument so it is then free for extraction from the catherization robot (see Fig. 27-40, [0175], [0183], and [0190]).
Yu further discloses a second drive module (catheter carriage 76) for [interpreted “configured for”] driving the first elongate flexible medical instrument (or alternatively it is capable of driving a second elongate flexible medical instrument) in translation along the longitudinal first direction (see Fig. 3-5 and [0106-0108]), said second drive module being movable in translation along the longitudinal first direction relative to the first drive module (see Fig. 3-4 and [0108-0111]), one end of the first elongate flexible medical instrument being fixed to the second drive module (see Fig. 3-5 and [0106], wherein an end of the lead catheter 38 is fixed to the catheter carriage 76 via adapter 56, which receives the end of the lead catheter 38 and which is removably affixed to the catheter carriage 76).
While Yu does disclose that the catherization robot comprises a Y connector (active valve 64), the Y connector of Yu is fixed to the first drive module (via proximal sheath adapter 48) and thus not carried by the second drive module. However, it is well known within the art for elongate flexible medical instruments/catheters of the type driven by the catherization robot of Yu to also comprise a Y connector fixed to the proximal, handling end of the elongate flexible medical instrument/catheter. Klem, for example, exhibits an elongate flexible medical instrument/catheter (catheter 512) which comprises a Y connector (see Fig. 8A and [0251]) fixed to the proximal, handling end of the elongate flexible medical instrument/catheter in order to provide fluid access to the lumen of the catheter, enabling, for example, balloon inflation ([0251]). Klem further teaches that such a flexible medical instrument/catheter may be used with a catheterization robot (catheter procedure system 10) of the type disclosed by Yu (see Fig. 1-4H, [0151-0153], [0202-0215], [0220], [0227], [0232-0235], and [0261-0263]). As such, it would have been obvious for one of ordinary skill in the art to modify the elongate flexible medical instrument/catheter of Yu to comprise a Y connector fixed to the proximal, handling end of the elongate flexible medical instrument/catheter, or else to use an elongate flexible medical instrument/catheter comprising such a feature with the catheterization robot of Yu, since such features are commonly included on catheters within the art, wherein, based upon the example of Klem, one of ordinary skill in the art would have reasonable expectation of success in driving such a catheter within a catheterization robot of the type disclosed by Yu, and since such a connector provides fluid access to the lumen of the catheter, enabling, for example, balloon inflation, as described by Klem ([0251]), therefore one of ordinary skill in the art would select an elongate flexible medical instrument/catheter comprising such a Y connector if balloon inflation were a necessary component of the treatment being performed (as is common in some catheterization procedures).
Upon providing a elongate flexible medical instrument/catheter of the type taught by Klem into the catherization robot of Yu, it then follows that the second drive module would carry the Y connector (it being fixed to the lead catheter) within which the elongate flexible medical instrument/catheter can move in translation along the longitudinal direction (the elongate flexible medical instrument/catheter being at least partially contained within the Y connector, and both features being driven in translation along the longitudinal direction by the second drive module).
Klem further exhibits that the maximum transverse dimension of the Y connector need not be much greater than the maximum transverse dimension of the body of the first elongate flexible medical instrument (see Fig. 8A). It is clear from Fig. 14 in the first embodiment and Fig. 30-32 in the second embodiment of Yu that the maximum value of the separation distance between the two drive surfaces may be significantly larger than the transverse width of the elongate flexible medical instrument at the location of the drive surfaces, such as more than twice the width of the elongate flexible medical instrument at the location of the drive surfaces, as depicted in Fig. 14 and Fig. 30-32. As such, it is clear that for a flexible medical instrument/catheter of the type taught by Klem (and incorporated to be used within the catheterization robot of Yu in the above modification), wherein the maximum transverse dimension of the Y connector is not much greater than the maximum transverse dimension of the body and the transverse width of the catheter is of small to medium size, such as 6 Fr (see [0110], ln 15-19), the separation distance between the two drive surfaces of Yu, which is reached when the two drive surfaces are moving away from each other (see Fig. 14 and 30-32), would reach a maximum value which is greater than the maximum transverse dimension of the Y connector along the transverse second direction.
Regarding claim 31, Yu further discloses, in the first embodiment, that the first drive module comprises at least two of said pairs of two drive surfaces (up to three jaw assemblies 120/130 are exhibited), which are located one after the other along the longitudinal first direction (see Fig. 7, 9-11, 22-24, and 26a-26d, and [0116-0127], [0139], and [0164-0170]).
Regarding claim 34, Yu further discloses, in the first embodiment, that the catherization robot is adapted to implement a method for moving an elongate flexible medical instrument (lead catheter 38) in the catherization robot, successively comprising: a first step in which a body of the first elongate flexible medical instrument is driven in translation along the longitudinal first direction by at least one pair of drive surfaces (see Fig. 26a-26d, [0121-0127], [0139-0140], and [0164-0170]), a second step in which the body of the first elongate flexible medical instrument is driven in translation along the longitudinal first direction by a translational movement of the second drive module relative to the first drive module along the longitudinal first direction (see [0108], wherein the body of the lead catheter 38 is advanced by the a translational movement of the catheter carriage 76 simultaneously to the driving performed by the drive surfaces of the active catheter feeder 80).
Regarding claim 35, Yu further discloses, in the first embodiment, that the first step comprises: a first sub-step in which the body of the first elongate flexible medical instrument is driven in translation along the longitudinal first direction by at least two of said pairs of drive surfaces (see Fig. 26b, [0139-0140], and [0164-0167], wherein throughout the cycle of jaw assembly 120a-120c strokes, the lead catheter is often gripped and translated by two of jaw assemblies 120a-120c, as is depicted in Fig. 26b), a second sub-step in which the body of the elongate flexible medical instrument is driven in translation along the longitudinal first direction by only one of said pairs of drive surfaces (see Fig. 26a, [0139-0140], and [0164-0166], wherein for at least momentary points throughout the cycle of jaw assembly 120a-120c strokes, the lead catheter is only gripped and translated by a single one of jaw assemblies 120a-120c, as is depicted in Fig. 26a).
Claim(s) 29 are rejected under 35 U.S.C. 103 as being unpatentable over Yu as modified by Trost and Callan according to claim 27, and in further view of Richards (NPL, “What are single-acting pneumatic cylinders?”).
Regarding claim 29, Yu discloses, in the second embodiment, that the first drive module comprises an actuator (gripping force adjustment mechanism 368) for driving said two platforms in translation along the transverse second direction (see Fig. 44-49 and [0192-0197]), wherein the actuator is a linear actuator in the form of a worm screw system (see Fig. 44-49 and [0192-0197], wherein the gripping force adjustment mechanism comprises a worm screw assembly of lead screw 420 and lead nut 422). While Yu discloses that the actuator is embodied as a worm screw type linear actuator, it is well known within the art that linear actuators of the actuating cylinder type, such as exemplified in Richards (see entire document), may serve as functional equivalents to linear actuators of the worm screw type, and present several benefits, including being cheap, lightweight, and reliable linear actuators with low maintenance requirements (see Richards, lines 1-5). Thus, it would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to substitute an actuating cylinder type linear actuator configuration for the worm screw type linear actuator configuration of Yu as a matter of simple substitution of one known linear actuator type for another, thereby achieving expected results that the actuating cylinder may function equivalently. See MPEP 2143(I)(B).
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. This art includes
Deboeuf (U.S. Pat. Pub. No. 2018/0185616 A1) exhibits a catheterization robot comprising a driving module with moving drive surfaces for translating a catheter in a similar manner to those claimed and to those of Yu.
Fournier (WIPO Pub. No. 2018/189473 A1) exhibits a drive module for driving a catheter comprising drive surfaces for translating a catheter in a similar manner to those claimed and to those of Yu.
Wenderow (U.S. Pat. Pub. No. 2010/0069833 A1) exhibits a catheterization robot comprising a driving module with roller style retractable drive surfaces for translating a catheter in a similar manner to those claimed and to those of Yu.
Conclusion
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/ERIC A LANGE/Examiner, Art Unit 3783
/CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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