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 .
Response to Arguments
Applicant’s arguments in Applicant’s responses filed 04/07/2026 with respect to the 35 U.S.C. 102 rejections of claims 126 and 188 have been fully considered but are moot because the new grounds of rejections do not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Therefore, the claims stand rejected.
Withdrawn Objections - Drawings
The objection made to the drawings are hereby withdrawn in view of Applicant’s responses filed 04/07/2026.
Withdrawn Claim Objections
The objections made to claims 200, 213, 215, and 227 have been withdrawn in view of Applicant’s amendments filed 04/07/2026.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 126, 200-202, 204-205, 209-214 are rejected under 35 U.S.C. 103 as being unpatentable over Germain, et al., US 20170055811 A1 in view of Palushi, et al., US 20190262512 A1.
Regarding claim 126, Germain teaches a system for performing a procedure at a target site within a body of a patient ([0051] discloses that “FIG. 1 illustrates an assembly that comprises endoscope or hysteroscope 50 that may be used for hysteroscopy or other similar procedures together with tissue resecting device 100 extending through a working channel 102 of endoscope 50”, the endoscope/hysteroscope being in connection with a sheath adapter 200 of fig. 3A-3B and 6A-6C. [0063] states that “In at least some embodiments, proximal end 201 of sheath adapter 200 may be configured to connect to an endoscope or hysteroscope. For instance, proximal end 201 may further include J-connection 215 disposed proximate proximal end 201. J-connection 215 may be a slot configured to engage with one or more corresponding projections or pins on an endoscope or hysteroscope to create a non-slidable connection between the endoscope or hysteroscope and sheath adapter 200” . Figs. 1, 3A, and 3B have been reproduced below for reference),
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the system comprising:
a first instrument (resectoscope of [0069]);
a second instrument (tissue-resecting device 100 of [0055]); and
an imaging component (endoscope or hysteroscope 50 of [0051]) comprising a shaft (shaft 105 of [0051]) having a proximal end, a distal end (as can be seen in reproduced fig. 1 above, the shaft 105 includes a proximal end and a distal end), a cavity (working channel 102 of [0051]) extending from the proximal end towards the distal end ([0051] states that “Working channel 102 of endoscope 50 may extend through endoscope 50 and may be round, D-shaped or any other suitable shape”. The disclosure of “extend through” at least connotes a proximal end towards distal end extension of the working channel),
and an elongated opening (channel 205 of [0060]) formed through a wall of the shaft and axially extending along a full length of the shaft ([0060] states that “Sheath adapter 200 comprises elongate shaft 202 extending from proximal end 201 to distal end 203. Elongate shaft 202 may be generally C-shaped and may define a channel 205 running a length of elongate shaft 202 between the proximal end 201 and the distal end 203”); and
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wherein each of the first instrument and the second instrument is axially insertable into the cavity of the shaft ([0054] states that “Working channel 102 of endoscope 50 is generally configured for insertion and manipulation of tissue-resecting device 100, for example to treat and remove fibroid tissue”. The resectoscope is also insertable into the working channel 102 in the same manner), such that the first instrument and the second instrument may be coupled to the imaging component in an exchangeable manner ([0051] states that “FIG. 1 illustrates an assembly that comprises endoscope or hysteroscope 50 that may be used for hysteroscopy or other similar procedures together with tissue resecting device 100 extending through a working channel 102 of endoscope 50”, meaning that in use, the tissue resecting device 100 and the resectoscope are interchangeably coupled to the endoscope/hysteroscope).
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Germain discloses in [0062] that channel 205 may be designed to accommodate a variety of different shaft sizes but fails to teach wherein a cross-section of the first instrument is greater than a cross-section of the cavity, and wherein the elongate opening allows distortion of the cavity of the shaft when the first instrument is axially inserted into the cavity of the shaft
However, within the same field of endeavor, Palushi teaches an apparatus for ENT procedures ([0022]), the apparatus including a cannula, a suction port, and a guidewire channel. The cannula includes a proximal end, a distal end, and a first lumen. The suction port is configured to communicate suction to the distal end of the cannula via the first lumen. The guidewire channel includes an open proximal end, an open distal end, and a second lumen extending from the open proximal end to the open distal end (abstract). wherein a cross-section of the first instrument is greater than a cross-section of the cavity, and wherein the elongate opening allows distortion of the cavity of the shaft when the first instrument is axially inserted into the cavity of the shaft ([0050] states that “guidewire channel (580) has an effectively negligible diameter when in a default contracted or collapsed state, as shown in FIGS. 4-5. In this state, the diameter of lumen (588) is less than the outer diameter or cross-sectional profile of a guidewire such as navigation guidewire (130)” and [0054] states that “The elasticity of proximal end (582) accommodates the relatively rigid configuration of distal end (592) such that an effective diameter of proximal end (582) increases to thereby enable guidewire (590) to enter lumen (588)”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Germain, wherein a cross-section of the first instrument is greater than a cross-section of the cavity, and wherein the elongate opening allows distortion of the cavity of the shaft when the first instrument is axially inserted into the cavity of the shaft, as taught by Palushi, as such modification would allow the surgeon to precisely achieve more precise movement and positioning of surgical instruments at the region of interest ([0003]).
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Regarding claim 200, Germain in view of Palushi teaches all the limitations of claim 126 above.
Germain further teaches wherein the elongated opening is formed in the wall of the shaft, such that cavity is open for less than half a perimeter of the cavity ([0007] discloses that the shaft is a C-shaped elongate shaft extending from a proximal end to a distal end. Also see figs. 3A and 3B. That is, the C-shape of the shaft forms the elongated opening).
Regarding claim 201, Germain in view of Palushi teaches all the limitations of claim 126 above.
Germain further teaches wherein an edge of the elongated opening is bent towards an interior of the cavity ([0062] discloses edges 210a, and 210b (also shown in reproduced figs. 6A-6C below), the edges bent towards the channel 205).
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Regarding claim 202, Germain in view of Palushi teaches all the limitations of claim 126 above.
Germain further teaches wherein the first and second instruments have different sizes ([0062] states that “Channel 205 may be designed to accommodate a variety of different shaft sizes, for example shafts having sizes between about 21 French to about 29 French, which correspond to outer diameters of about 6.5 mm to about 9.0 mm. These shaft sizes may correspond to various available endoscope or hysteroscope sizes”).
Regarding claim 204, Germain in view of Palushi teaches all the limitations of claim 126 above.
Germain further teaches wherein the wall of the shaft is cylindrical (see reproduced figs. 6A-6C above which show a cross-sectional view of the shaft 202 as cylindrical. Also see [0016] which states that “the C-shaped elongate shaft may have a circularly shaped cross-section with a gap having a gap width”).
Regarding claim 205, Germain in view of Palushi teaches all the limitations of claim 126 above.
Germain further teaches wherein the cavity of the shaft is cylindrical (see reproduced figs. 6A-6C which depict the lumen 205 as a cylindrical cavity. [0068] also states that “As shown, channel 205 may be formed by an exterior wall of elongate shaft 202 and may be shaped similar to a C or an incomplete circle”).
Regarding claim 209, Germain in view of Palushi teaches all the limitations of claim 126 above.
Germain further teaches wherein each of the first instrument and the second instrument comprises one of a diagnostic or therapeutic instrument ([0051] discloses a tissue resecting device 100 to treat and remove fibroid tissue [0054]).
Regarding claim 210, Germain in view of Palushi teaches all the limitations of claim 126 above.
Germain further teaches wherein each of the first instrument and the second instrument comprises one of a tissue collector, a biopsy needle, an optical scope, an implantation device, a tissue ablation element, or instrumentation for providing detailed mapping of a uterus ([0069] discloses that the instrument is a resectoscope).
Regarding claim 211, Germain in view of Palushi teaches all the limitations of claim 126 above.
Germain further teaches wherein the imaging component further comprises a handle portion connected to the shaft ([0051] discloses a handle 104 of the endoscope 50. See fig. 1 of Germain above),
wherein each of the first instrument and the second instrument comprises a shaft and a handle portion connected to the shaft (the tissue-resecting device 100, as shown in fig. 1 above, includes a handle 142 according to [0055]), and
wherein the handle portion of the imaging component and the handle portion of each of the first instrument and the second instrument form a two-part handle when each of the first instrument and the second instrument are coupled to the imaging component ([0057] states that “FIG. 1 further illustrates seal housing 162 that hysteroscope 50 my include which carries flexible seal 164 carried by endoscope handle 104 for sealing shaft 140 of tissue-resecting device 100 in working channel 102 to prevent distending fluid from escaping from the operating cavity”. As in, the seal housing 162 provides a coupling of the handle 104 and 142 during use).
Regarding claim 212, Germain in view of Palushi teaches all the limitations of claim 211 above.
Germain further teaches wherein the handle portion of the imaging component and the handle portion of each of the first instrument and the second instrument respectively have complementary positioning elements that mate with each other ([0057] discloses a seal housing 162 of the hysteroscope 50, including a flexible seal 164 for sealing shaft 140 to prevent distending fluid from escaping from the operating cavity. As can be seen in fig. 1, the handle 142 of the tissue-resecting device 100 includes a corrugated protrusion that engages with the seal housing 162 for the function of sealing the shaft 140).
Regarding claim 213, Germain in view of Palushi teaches all the limitations of claim 126 above.
Germain further teaches wherein each of the first instrument and the second instrument are rotatably relative to the shaft when disposed within the cavity of the shaft ([0055] states that “Handle 142 of tissue-resecting device 100 may be adapted for manipulating the electrosurgical working end 145 of the device. In use, handle 142 can be manipulated both rotationally and axially, for example, to orient working end 145 to resect targeted fibroid tissue”).
Regarding claim 214, Germain in view of Palushi teaches all the limitations of claim 126 above.
Germain further teaches wherein the first instrument and second instrument are configured for being exchanged within the cavity of the shaft of the imaging component while the imaging component is at the target site within the body of the patient([0051] states that “FIG. 1 illustrates an assembly that comprises endoscope or hysteroscope 50 that may be used for hysteroscopy or other similar procedures together with tissue resecting device 100 extending through a working channel 102 of endoscope 50”, meaning that in use, the tissue resecting device 100 and the resectoscope are interchangeably coupled to the endoscope/hysteroscope).
Claims 188, 215-216, 218-220, 224-230 are rejected under 35 U.S.C. 103 as being unpatentable over Nakao, N.L., US 20050085694 A1 in view of Germain.
(NB: US 20050085694 A1 carries some typographical errors. For instance, [0056] refers to the shaft or insertion member with numeral 154, instead of numeral 188 as shown in both figs. 10 and 11. However, the rejection clearly sets forth each and every element that is taught by document)
Regarding claim 188, Nakao teaches a system for performing a procedure at a target site within a body of a patient ([0034] discloses that “As depicted in FIGS. 1 and 2, an endoscope assembly comprises a flexible elongate insertion member or shaft 10, a pair of catheters 12 and 14, a sheath 16, and optionally an end cap 18”. Figs. 2 and 3 of the endoscope system have been reproduced below for reference as these figures appear to show a more completed depiction of the endoscope assembly), the system comprising:
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a first instrument (endoscopic accessories such as forceps, snares, needles etc. of [0041]);
an imaging component (endoscope assembly of [0034]) comprising a shaft (flexible elongate insertion member or shaft 10 of figs. 1-3 and [0034]) having a proximal end (proximal end of the endoscope is depicted in reproduced fig. 11 below), a distal end (fig. 2 depicts a distal end 24 ([0034]) of the endoscope where the with a cap 18 is configured to fit), and a cavity extending from the proximal end towards the distal end ([0035] discloses that “As further depicted in FIGS. 1 and 2, insertion shaft 10 is provided along an external surface (not separately designated) with a pair of C-profile channels 28 and 30 approximately opposing one another. Channels 28 and 30 communicate with the ambient environment not only via respective distal end openings 32 and 34 and proximal end openings (not shown) but also via respective longitudinal slots 36 and 38”); and
a removable adapter tube (channel liner 184 of fig. 11 and [0056], which disclose a proximal end portion of the endoscope in figs. 1-3) comprising only a single lumen configured for slidably receiving the first instrument ([0056] indicates that the liner is in the form of a catheter and [0057] indicates the liner receiving an endoscopic instrument and hence at least suggesting the liner includes a single lumen for receiving endoscopic instrument) ,
the tube configured for being slidably disposed in the cavity of the shaft for coupling the first instrument to the imaging component ([0056] discloses that once an endoscopic procedure has been completed using the endoscope of FIG. 10 or 11, one can…then pull it [liner 184] out of the open biopsy channel 156, 180, at least suggesting that the liner 184 is slidably disposed in the open biopsy channel 180 for coupling endoscopic instruments [0057] such as forceps, snares, needles, etc. [0041]).
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wherein the first instrument, with the adapter tube, is axially insertable into the cavity of the shaft ([0056] states that “As depicted in FIG. 11, a channel liner 184 in the form of a catheter lays in an open biopsy channel 180 along the shaft or insertion member 154 of the endoscope” and [0057] discloses that the endoscopic instrument is disposed inside the liner 184),
Nakao fails to teach a second instrument having a cross-section larger than a cross-section of the first instrument; and the second instrument, without the adapter tube, is axially insertable into the cavity of the shaft, such that the first instrument and the second instrument may be coupled to the imaging component in an exchangeable manner.
However, within the same field of endeavor, Germain teaches an assembly that comprises endoscope or hysteroscope 50 that may be used for hysteroscopy or other similar procedures together with tissue resecting device 100 extending through a working channel 102 of endoscope 50 ([0051]), the system further comprising a second instrument having a cross-section larger than a cross-section of the first instrument ([0062] states that “Channel 205 may be designed to accommodate a variety of different shaft sizes, for example shafts having sizes between about 21 French to about 29 French, which correspond to outer diameters of about 6.5 mm to about 9.0 mm. These shaft sizes may correspond to various available endoscope or hysteroscope sizes”), and the second instrument, without the adapter tube, is axially insertable into the cavity of the shaft, such that the first instrument and the second instrument may be coupled to the imaging component in an exchangeable manner ([0051] states that “FIG. 1 illustrates an assembly that comprises endoscope or hysteroscope 50 that may be used for hysteroscopy or other similar procedures together with tissue resecting device 100 extending through a working channel 102 of endoscope 50”, meaning that in use, the tissue resecting device 100 and the resectoscope are interchangeably coupled to the endoscope/hysteroscope).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Nakao with a second instrument having a size larger than a size of the first instrument, and the second instrument, without the adapter tube, is axially insertable into the cavity of the shaft, such that the first instrument and the second instrument may be coupled to the imaging component in an exchangeable manner, as taught by Germain, to improve the versatility of the assembly through design ([0062]), with a reasonable expectation of success, as Nakao similarly directs to improving the design of endoscopic systems for various applications ([0003]).
Regarding claim 215, Nakao in view of Germain teaches all the limitations of claim 188 above.
Nakao further teaches wherein the adapter tube is rotatable relative to the shaft while the shaft remains stationary when the adapter tube is slidably disposed within the cavity of the shaft ([0056] discloses that As depicted in FIG. 11, a channel liner 184 in the form of a catheter lays in an open biopsy channel 180 along the shaft or insertion member 154 of the endoscope until a bifurcation 179 between the shaft or insertion member and a biopsy channel entry port 176, which is not flexible. Meaning, that since the liner 184 is a catheter, generally shown in fig. 11 as a tube or cylinder lying within the channel 180, the liner is rotatable with respect to the biopsy channel 180).
Regarding claim 216, Nakao in view of Germain teaches all the limitations of claim 188 above.
Nakao further teaches wherein the tube is disposable ([0056] states that “Once an endoscopic procedure has been completed using the endoscope of FIG. 10 or 11, one can cut off end cap or port element 160 or 182 from the respective biopsy channel liner 164 or 184, plug up the channel liner, and then pull it out of the open biopsy channel 156, 180. This procedure facilitates the maintenance of cleanliness. Brushing, cleaning and rinsing procedures are simplified if not obviated”, suggesting that in the obviating of brushing, cleaning and rinsing amounts to disposing of the liner).
Regarding claim 218, Nakao in view of Germain teaches all the limitations of claim 188 above.
Nakao further teaches wherein the single lumen of the adapter tube has a geometry that is different from an exterior surface of the adapter tube (figs. 1 and 2 depict the catheters 12 and 14, tantamount to the liner 184 of fig. 11, with cylindrical outer shapes and circular lumen within the shaft 10 that is depicted as oblong or oval),
wherein the geometry of the single lumen of the adapter tube matches a geometry of the first instrument, and the geometry of the exterior surface of the adapter tube matches a geometry of the cavity of the shaft ([0057] indicates that the endoscopic instrument lying inside the liner 184. As demonstrated above, the liner comprises a circular shape lumen, exemplified by catheters 12 and 14 as shown in figs. 1 and 2 which matches the cylindrical shape of the endoscopic instrument).
Regarding claim 219, Nakao in view of Germain teaches all the limitations of claim 188 above.
Nakao further teaches wherein the shaft has an elongated opening formed through a wall of the shaft ([0035] states that “As further depicted in FIGS. 1 and 2, insertion shaft 10 is provided along an external surface (not separately designated) with a pair of C-profile channels 28 and 30 approximately opposing one another. Channels 28 and 30 communicate with the ambient environment not only via respective distal end openings 32 and 34 and proximal end openings (not shown) but also via respective longitudinal slots 36 and 38”).
Regarding claim 220, Nakao in view of Germain teaches all the limitations of claim 188 above.
Nakao further teaches wherein the cavity of the shaft is cylindrical (see reproduced fig. 2 above for the depiction of the cylindrical shape of the cavities 30 and 28 of the insertion shaft 10).
Regarding claim 224, Nakao in view of Germain teaches all the limitations of claim 188 above.
Nakao further teaches wherein the first instrument comprises one of a diagnostic or therapeutic instrument ([0041] discloses endoscopic accessories such as forceps, snares, needles etc.).
Regarding claim 225, Nakao in view of Germain teaches all the limitations of claim 188 above.
Nakao further teaches wherein the first instrument comprises one of a tissue collector, a biopsy needle, an optical scope, an implantation device, a tissue ablation element, or instrumentation for providing detailed mapping of a uterus ([0041] discloses endoscopic accessories such as forceps, snares, needles etc.).
Regarding claim 226, Nakao teaches all the limitations of claim 188 above.
Nakao fails to teach wherein the imaging component further comprises a handle portion connected to the shaft, wherein the first instrument comprises a shaft and a handle portion connected to the shaft, and wherein the handle portion of the imaging component and the handle portion of the first instrument form a two-part handle when the first instrument is coupled to the imaging component.
However, Germain further teaches wherein the imaging component further comprises a handle portion connected to the shaft ([0051] discloses a handle 104 of the endoscope 50. See fig. 1 of Germain above),
wherein each of the first instrument and the second instrument comprises a shaft and a handle portion connected to the shaft (the tissue-resecting device 100, as shown in fig. 1 above, includes a handle 142 according to [0055]), and
wherein the handle portion of the imaging component and the handle portion of each of the first instrument and the second instrument form a two-part handle when each of the first instrument and the second instrument are coupled to the imaging component ([0057] states that “FIG. 1 further illustrates seal housing 162 that hysteroscope 50 my include which carries flexible seal 164 carried by endoscope handle 104 for sealing shaft 140 of tissue-resecting device 100 in working channel 102 to prevent distending fluid from escaping from the operating cavity”. As in, the seal housing 162 provides a coupling of the handle 104 and 142 during use).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Nakao wherein the imaging component further comprises a handle portion connected to the shaft, wherein the first instrument comprises a shaft and a handle portion connected to the shaft, and wherein the handle portion of the imaging component and the handle portion of the first instrument form a two-part handle when the first instrument is coupled to the imaging component, as taught by Germain, to improve the versatility of the assembly through design ([0062]), with a reasonable expectation of success, as Nakao similarly directs to improving the design of endoscopic systems for various applications ([0003]).
Regarding claim 227, Nakao in view of Germain teaches all the limitations of claim 226 above.
Nakao fails to teach wherein the handle portion of the imaging component and the handle portion of the first instrument respectively have complementary positioning elements that mate with each other.
However, Germain further teaches wherein the handle portion of the imaging component and the handle portion of each of the first instrument and the second instrument respectively have complementary positioning elements that mate with each other ([0057] discloses a seal housing 162 of the hysteroscope 50, including a flexible seal 164 for sealing shaft 140 to prevent distending fluid from escaping from the operating cavity. As can be seen in fig. 1, the handle 142 of the tissue-resecting device 100 includes a corrugated protrusion that engages with the seal housing 162 for the function of sealing the shaft 140).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Nakao wherein the handle portion of the imaging component and the handle portion of each of the first instrument and the second instrument respectively have complementary positioning elements that mate with each other, as taught by Germain, to improve the versatility of the assembly through design ([0062]), with a reasonable expectation of success, as Nakao similarly directs to improving the design of endoscopic systems for various applications ([0003]).
Regarding claim 228, Nakao in view of Germain teaches all the limitations of claim 188 above.
Nakao further teaches wherein the single lumen is concentrically disposed within the adapter tube (figs. 1 and 2 depict the catheters 12 and 14, tantamount to the liner 184 of fig. 11, with cylindrical outer shapes and circular lumen within the shaft 10 that is depicted as oblong or oval and [0057] indicates that the endoscopic instrument, which is cylindrical lying inside the liner 184. As demonstrated above, the liner comprises a circular shape lumen, exemplified by catheters 12 and 14 as shown in figs. 1 and 2 which matches the cylindrical shape of the endoscopic instrument. Meaning, that since the liner 184 is a catheter, generally shown in fig. 11 as a tube or cylinder lying within the channel 180, the liner is rotatable with respect to the biopsy channel 180).
Regarding claim 229, Nakao in view of Germain teaches all the limitations of claim 188 above.
Nakao further teaches wherein the adapter tube has no diagnostic or therapeutic function ([0056]-[0057] describe that Liner 184 resiliently and removably snaps into the open channel 180 End caps or port elements 160 and 182 are placed on the channel liners 164, 184 about 2-3 inches from the endoscope insertion member 154. Once an endoscopic procedure has been completed using the endoscope of FIG. 10 or 11, one can cut off end cap or port element 160 or 182 from the respective biopsy channel liner 164 or 184, plug up the channel liner, and then pull it out of the open biopsy channel 156, 180. This procedure facilitates the maintenance of cleanliness, suggesting that the liner is for maintaining a sterile environment during the procedure but not diagnostic or therapeutic functions).
Regarding claim 230, Nakao in view of Germain teaches all the limitations of claim 188 above.
Nakao further teaches wherein the removable adapter is configured for being axially inserted into the cavity of the shaft of the imaging component ([0056] states that “a channel liner 184 in the form of a catheter lays in an open biopsy channel 180 along the shaft or insertion member 154 of the endoscope until a bifurcation 179 between the shaft or insertion member and a biopsy channel entry port 176, which is not flexible”).
Claim 206-208 are rejected under 35 U.S.C. 103 as being unpatentable over Germain in view of Palushi, as applied to claim 126 above, and further in view of Dietz, et al., US 20100280316 A1.
Regarding claim 206, Germain in view of Palushi teaches all the limitations of claim 126 above.
Germain in view of Palushi fails to teach wherein the imaging component comprises an imaging device affixed to the distal end of the shaft.
However, within the same field of endeavor, Dietz teaches a catheter including a deflectable member located at a distal end of a catheter body. The deflectable member may comprise an ultrasound transducer array (abstract). The catheter comprises a catheter body 862 (claimed shaft), connected by a hinge 864 to a deflectable member 866 according to [0341]. Dietz then teaches wherein the imaging component comprises an imaging device ([0341] discloses a two dimensional transducer array 868) affixed to the distal end of the shaft (the array 868 can be seen disposed at a distal end of the catheter 860 in reproduced fig. 53 below).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Germain as modified by Palushi, wherein the imaging component comprises an imaging device affixed to the distal end of the shaft, as taught by Dietz, to enhance the imaging of the region during the medical procedure through improved compactness and maneuverability of the catheter ([0006]), with a reasonable expectation of success, as Germain is also concerned with improvements to the catheter system that allow optimal viewing of the surgical or target site ([0097]).
Regarding claim 207, Germain in view of Palushi and Dietz teaches all the limitations of claim 206.
Germain in view of Palushi fails to teach wherein the imaging device is non-slidable relative to the shaft.
However, Dietz further teaches wherein the imaging device is non-slidable relative to the shaft (the array 868 is disposed at the distal end of the catheter in a non-slidable manner with respect to the catheter body 862 of the catheter 860 as can be seen in fig. 53. Also refer to [0341] for description of how the array 868 is hinged at the distal end of the catheter body) .
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Germain, as modified by Palushi, wherein the imaging device is non-slidable relative to the shaft, as taught by Dietz, to enhance the imaging of the region during the medical procedure through improved compactness and maneuverability of the catheter ([0006]), with a reasonable expectation of success, as Germain is also concerned with improvements to the catheter system that allow optimal viewing of the surgical or target site ([0097]).
Regarding claim 208, Germain in view of Palushi and Dietz teaches all the limitations of claim 206.
Germain in view of Palushi fails to teach wherein the imaging device is rotatably attached to the shaft via a hinge.
However, Dietz further teaches wherein the imaging device is rotatably attached to the shaft via a hinge ([0341] states that “FIG. 53 illustrates a distal end of a catheter 860 that includes a catheter body 862 connected by a live hinge 864, to a deflectable member 866 having a two dimensional transducer array 868 and electrical interconnection member 870”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Germain, as modified by Palushi, wherein the imaging device is rotatably attached to the shaft via a hinge, as taught by Dietz, to enhance the imaging of the region during the medical procedure through improved compactness and maneuverability of the catheter ([0006]), with a reasonable expectation of success, as Germain is also concerned with improvements to the catheter system that allow optimal viewing of the surgical or target site ([0097]).
Claim 221-223 are rejected under 35 U.S.C. 103 as being unpatentable over Nakao in view of Germain, as applied to claim 188 above, and further in view of Dietz, et al., US 20100280316 A1.
Regarding claim 221, Nakao in view of Germain teaches all the limitations of claim 188 above.
Nakao in view of Germain fails to teach wherein the imaging component comprises an imaging device affixed to the distal end of the shaft.
However, within the same field of endeavor, Dietz teaches a catheter including a deflectable member located at a distal end of a catheter body. The deflectable member may comprise an ultrasound transducer array (abstract). The catheter comprises a catheter body 862 (claimed shaft), connected by a hinge 864 to a deflectable member 866 according to [0341]. Dietz then teaches wherein the imaging component comprises an imaging device ([0341] discloses a two dimensional transducer array 868) affixed to the distal end of the shaft (the array 868 can be seen disposed at a distal end of the catheter 860 in reproduced fig. 53 below).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Nakao, as modified by Germain, wherein the imaging component comprises an imaging device affixed to the distal end of the shaft, as taught by Dietz, to enhance the imaging of the region during the medical procedure through improved compactness and maneuverability of the catheter ([0006]), with a reasonable expectation of success, as Nakao similarly directs to improving the design of endoscopic systems for various applications (([0003]).
Regarding claim 222, Nakao in view of Germain and Dietz teaches all the limitations of claim 221.
Nakao in view of Germain fails to teach wherein the imaging device is non-slidable relative to the shaft.
However, Dietz further teaches wherein the imaging device is non-slidable relative to the shaft (the array 868 is disposed at the distal end of the catheter in a non-slidable manner with respect to the catheter body 862 of the catheter 860 as can be seen in fig. 53. Also refer to [0341] for description of how the array 868 is hinged at the distal end of the catheter body) .
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Nakao, as modified by Germain, wherein the imaging device is non-slidable relative to the shaft, as taught by Dietz, to enhance the imaging of the region during the medical procedure through improved compactness and maneuverability of the catheter ([0006]), with a reasonable expectation of success, as Nakao similarly directs to improving the design of endoscopic systems for various applications (([0003]).
Regarding claim 223, Nakao in view of Germain and Dietz teaches all the limitations of claim 221 above.
Nakao in view of Germain fails to teach wherein the imaging device is rotatably attached to the shaft via a hinge.
However, Dietz further teaches a catheter including a deflectable member located at a distal end of a catheter body. The deflectable member may comprise an ultrasound transducer array (abstract). [0341] states that “FIG. 53 illustrates a distal end of a catheter 860 that includes a catheter body 862 connected by a live hinge 864, to a deflectable member 866 having a two dimensional transducer array 868 and electrical interconnection member 870”.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Nakao, as modified by Germain, wherein the imaging device is rotatably attached to the shaft via a hinge, as taught by Dietz, providing catheter features that facilitate selective positioning and control of componentry located at a distal end of a catheter, while maintaining a relatively small profile, thereby yielding enhanced functionality for various clinical applications ([0006]), with a reasonable expectation of success, as Nakao similarly directs to improving the design of endoscopic systems for various applications (([0003]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/FAROUK A BRUCE/ Examiner, Art Unit 3793
/CHRISTOPHER KOHARSKI/ Supervisory Patent Examiner, Art Unit 3797
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