Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Zerfas et al. US 20170079716 (“Zerfas”) in view of Gafford et al. US 20240138865 (“Gafford) and Vandebroek et al. US 20240122647 (“Vandebroek”).
Re 1: Zerfas teaches An endoscopic apparatus 820, comprising:
a sheath 500 including a first tube 502 (Figs. 5, 7; ¶66, 70); and
a laser fiber 100 disposed in the sheath and movable therein along a longitudinal axis of the sheath, the laser fiber including a glass silica core 102, a cladding layer 104 disposed around the glass silica core 102, and a distal tip 200 (Fig. 7; ¶57, 70-71),
wherein advancing movements of the laser fiber 100 cause the distal tip 200 of the laser fiber to project out of a distal end of the sheath (Fig. 7; ¶57, 70-71).
Zerfas does not explicitly teach the sheath concentrically nested within a second tube; wherein the sheath is actuable to form a first bend by relative axial translation between the first tube and the second tube, wherein retreating movements of the laser fiber cause the distal tip of the laser fiber to retract towards the distal end of the sheath.
Gafford teaches the sheath 12 including the first tube concentrically nested within a second tube (Figs. 1-2; ¶69); wherein the sheath is actuable to form a first bend by relative axial translation between the first tube and the second tube (Figs. 3A-3D; ¶80).
By having the sheath including the first tube concentrically nested within a second tube and having the sheath actuable to form a first bend by relative axial translation between the first tube and the second tube, it allows greater control over movement of the sheath. In turn, it allows steering of the sheath and fiber, allowing for more control over where the device is used.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to modify Zerfas with Gafford’s teachings in order to allow greater control and steering ability of the apparatus, increasing ease of use.
Zerfas and Gafford do not explicitly disclose wherein retreating movements of the laser fiber cause the distal tip of the laser fiber to retract towards the distal end of the sheath.
Vandebroek teaches (¶53) wherein retreating movements of the laser fiber cause the distal tip of the laser fiber to retract towards the distal end of the sheath.
Allowing for retreating movements of the laser fiber to cause the distal tip of the laser fiber to retract towards the distal end of the sheath, it allows for selective engagement of the laser, thereby allowing the user greater control of how to operate the device. For instance, laser light may interfere with certain imaging equipment or other light sources, thus the ability to retract the laser gives the user greater control over the environment the endoscope is used in.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to modify Zerfas and Gafford with Vandebroek’s teachings in order to allow the user greater control over the device, by allowing selective engagement of the laser fiber.
Zerfas and Gafford with Vandebroek disclose:
Re 2: wherein the cladding layer 104 is comprised of reflective silica (¶56).
Re 3: wherein the glass silica core is configured to deliver one of pulsed-dye, Ho:YAG, or Thulium energy (¶59).
Re 4: Zerfas does not explicitly teach wherein the first tube includes a first deflectable section, the second tube includes a second deflectable section, the first and second deflectable sections being selectively weakened portions of the first and second tubes that are angularly oriented, relative to a longitudinal axis of the sheath, in directions that are offset from each other by an angle equal to or less than one-hundred and eighty degrees, and wherein the first and second tubes are joined at a location distal to the first and second deflectable sections.
Gafford teaches: wherein the first tube includes a first deflectable section 14/30, the second tube includes a second deflectable section 14/40, the first and second deflectable sections being selectively weakened portions of the first and second tubes that are angularly oriented, relative to a longitudinal axis of the sheath, in directions that are offset from each other by an angle equal to or less than one-hundred and eighty degrees (Figs. 3A, 5B; ¶75, 79), and wherein the first and second tubes are joined at a location distal to the first and second deflectable sections (¶73, 75, 91).
By having two deflectable sections it permits even greater control and precision over the instrument, allowing the user to more precisely direct it to a specific area.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to modify Zerfas, Gafford, and Vandebroek with Gafford’s further teachings in order to allow for greater control and precision over the device.
Re 5-7: Zerfas does not explicitly teach:
Claim 5: wherein the first tube further includes a third deflectable section, the second tube includes a fourth deflectable section, the third and fourth deflectable sections being selectively weakened portions of the first and second tubes that are angularly oriented, relative to the longitudinal axis of the sheath, in directions that are offset from each other by the angle equal to or less than one-hundred and eighty degrees, wherein the location at which the first and second tubes are joined is distal to the third and fourth deflectable sections, and wherein the sheath is actuable to form a second bend by the relative axial translation between the first tube and the second tube.
Claim 6: wherein the first bend is in an opposite direction of the second bend.
Claim 7: wherein the sheath includes a rigid section located proximal relative to the first and third deflectable sections of the first tube, and the second and fourth deflectable sections of the second tube.
Gafford teaches:
Claim 5: wherein the first tube further includes a third deflectable section 19, the second tube includes a fourth deflectable section 19, the third and fourth deflectable sections being selectively weakened portions of the first and second tubes that are angularly oriented, relative to the longitudinal axis of the sheath, in directions that are offset from each other by the angle equal to or less than one-hundred and eighty degrees (Fig. 5B; ¶88, 91), wherein the location at which the first and second tubes are joined is distal to the third and fourth deflectable sections (¶73, 75), and wherein the sheath is actuable to form a second bend by the relative axial translation between the first tube and the second tube (¶89-90).
Claim 6: wherein the first bend is in an opposite direction of the second bend (¶74).
Claim 7: wherein the sheath includes a rigid section 18 located proximal relative to the first and third deflectable sections of the first tube, and the second and fourth deflectable sections of the second tube (¶88-89).
By having further deflectable sections it permits conformity to a tortuous pathway towards the anatomical region (¶89). Moreover, the inclusion of a rigid section gives mechanical stability to the device to ensure it can be held in place, while opposite bends allows for greater precision, too, by allowing the deflectable section more degrees of freedom.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to modify Zerfas, Gafford, and Vandebroek with Gafford’s further teachings in order to allow for greater control and precision over the device, while maintaining stability.
Re 8: Zerfas teaches An endoscopic apparatus 802 (Fig. 7; ¶70), comprising:
a sheath 502 including a first tube; and
a laser fiber 100 disposed in the sheath and movable therein along a longitudinal axis of the sheath (Figs. 1, 5, 7; ¶56-57, 70-71),
wherein advancing movements of the laser fiber 100 cause the distal tip 200 of the laser fiber to project out of a distal end of the sheath (Fig. 7; ¶57, 70-71).
Zerfas does not explicitly teach a first tube concentrically nested within a second tube; wherein the first tube includes a first deflectable section, the second tube includes a second deflectable section, the first and second deflectable sections being selectively weakened portions of the first and second tubes that are angularly oriented, relative to a longitudinal axis of the sheath, in directions that are offset from each other by an angle equal to or less than one-hundred and eighty degrees, wherein the first and second tubes are joined at a location distal to the first and second deflectable sections, wherein the sheath is actuable to form a first bend by relative axial translation between the first tube and the second tube, and wherein retreating movements of the laser fiber cause the distal tip of the laser fiber to retract towards the distal end of the sheath.
Gafford teaches: a first tube 28 concentrically nested within a second tube 26 (Figs. 1-2; ¶69; claim 1); wherein the first tube includes a first deflectable section 40, the second tube includes a second deflectable section 30, the first and second deflectable sections being selectively weakened portions (¶75) of the first and second tubes that are angularly oriented (Fig. 3A; ¶75, 79), relative to a longitudinal axis of the sheath, in directions that are offset from each other by an angle equal to or less than one-hundred and eighty degrees (Fig. 3A; ¶75, 79), wherein the first and second tubes are joined at a location distal to the first and second deflectable sections (¶73, 75), wherein the sheath is actuable to form a first bend by relative axial translation between the first tube and the second tube (Figs. 3A-3D; ¶80).
By having deflectable portions with selectively weakened portions that are angularly oriented to each other, it allows for the device to conform to a tortuous pathway towards the anatomical region (¶89). Similarly, deflectable portions as well as an actuable sheath to form a bend also allows for the device to conform to different obstructions by deflecting around them and conforming to different obstructions.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to modify Zerfas with Gafford’s teachings in order to allow greater control and steering ability of the apparatus by permitting the device to conform to tortuous pathways and overcome obstacles.
Zerfas and Gafford do not explicitly disclose wherein retreating movements of the laser fiber cause the distal tip of the laser fiber to retract towards the distal end of the sheath.
Vandebroek teaches (¶53) wherein retreating movements of the laser fiber cause the distal tip of the laser fiber to retract towards the distal end of the sheath.
Allowing for retreating movements of the laser fiber to cause the distal tip of the laser fiber to retract towards the distal end of the sheath, it allows for selective engagement of the laser, thereby allowing the user greater control of how to operate the device. For instance, laser light may interfere with certain imaging equipment or other light sources, thus the ability to retract the laser gives the user greater control over the environment the endoscope is used in.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to modify Zerfas and Gafford with Vandebroek’s teachings in order to allow the user greater control over the device, by allowing selective engagement of the laser fiber.
Zerfas, Gafford, and Vandebroek disclose:
Re 9: wherein the laser fiber includes a glass silica core (Zerfas ¶56).
Re 10: wherein the glass silica core is configured to deliver one of pulsed-dye, Ho:YAG, or Thulium energy (Zerfas ¶59).
Re 11: wherein the laser fiber includes a cladding layer disposed around the glass silica core, the cladding layer 104 comprised of reflective silica (Zerfas ¶56-58).
Re 12: Zerfas does not explicitly teach wherein the first tube further includes a third deflectable section, the second tube includes a fourth deflectable section, the third and fourth deflectable sections being selectively weakened portions of the first and second tubes that are angularly oriented, relative to the longitudinal axis of the sheath, in directions that are offset from each other by the angle equal to or less than one-hundred and eighty degrees, wherein the location at which the first and second tubes are joined is distal to the third and fourth deflectable sections, and wherein the sheath is actuable to form a second bend by the relative axial translation between the first tube and the second tube.
Gafford teaches wherein the first tube further includes a third deflectable section 19, the second tube includes a fourth deflectable section 19, the third and fourth deflectable sections being selectively weakened portions of the first and second tubes that are angularly oriented, relative to the longitudinal axis of the sheath, in directions that are offset from each other by the angle equal to or less than one-hundred and eighty degrees (Fig. 5B; ¶88, 91), wherein the location at which the first and second tubes are joined is distal to the third and fourth deflectable sections (¶73, 75), and wherein the sheath is actuable to form a second bend by the relative axial translation between the first tube and the second tube (¶89-90).
By having further deflectable sections it permits conformity to a tortuous pathway towards the anatomical region by giving the device more degrees of freedom to maneuver (¶89).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to modify Zerfas, Gafford, and Vandebroek with Gafford’s further teachings in order to allow for greater control and precision over the device, while maintaining stability.
Re 13: wherein the first bend is in an opposite direction of the second bend (note: this is a necessary consequence of the combination of claim 12 – see ¶74,79 of Gaffford).
Re 14: Zerfas does not explicitly teach wherein the sheath includes a rigid section located proximal relative to the first deflectable section of the first tube and the second deflectable section of the second tube.
Gafford teaches wherein the sheath includes a rigid section 18 located proximal relative to the first deflectable section of the first tube and the second deflectable section of the second tube (Fig. 5A; ¶¶88-89).
By having a rigid secton it allows for a linear force to be applied to extend the sheath through a given route, as well as actuate the sheath to form a bend. As a result, the device may more easily overcome obstacles in the anatomical region allowing for greater inspection.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to modify Zerfas, Gafford, and Vandebroek with Gafford’s further teachings in order to allow for greater control and precision over the device, while maintaining stability.
Claims 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Zerfas in view of Gafford.
Re 15: Zerfas teaches a method of performing endoscopic surgery (Fig. 7; ¶49, 70):
providing a sheath 500 and a laser fiber 100 disposed in the sheath 500 (Figs. 5, 7; ¶56, 66, 70);
advancing the laser fiber 100 relative to the sheath 500, wherein advancing the laser fiber relative to the sheath causes a distal tip 200 of the laser fiber to project out of the distal end of the sheath, such that the distal tip of the laser fiber is positioned about an object located within the anatomical region (Fig. 7; ¶57, 70-71); and
transmitting energy along the laser fiber and from the distal tip of the laser fiber to the object (¶71).
Zerfas does not explicitly teach forming a first bend in the sheath, wherein forming the first bend causes a distal end of the sheath to be steered toward an anatomical region within a patient.
Gafford teaches (Figs. 3A-3D; ¶80) forming a first bend in the sheath, wherein forming the first bend causes a distal end of the sheath to be steered toward an anatomical region within a patient.
As Gafford teaches, having a bend it permits “steering the distal end 22 of the steerable sheath 12 in a bi-directional fashion.” This steering allows for greater control an precision of the apparatus within a patient, permitting greater visibility within the patient.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to modify Zerfas with Gafford’s teachings in order to allow greater precision in steering the apparatus, allowing for greater ease of use within a patient.
Re 16-17: Zerfas does not explicitly teach:
Claim 16: wherein sheath includes a first tube concentrically nested within a second tube.
Claim 17: wherein the first tube includes a first deflectable section, the second tube includes a second deflectable section, the first and second deflectable sections being selectively weakened portions of the first and second tubes that are angularly oriented, relative to a longitudinal axis of the sheath, in directions that are offset from each other by an angle equal to or less than one-hundred and eighty degrees,wherein the first and second tubes are joined at a location distal to the first and second deflectable sections, andwherein the sheath is actuable to form the first bend by relative axial translation between the first tube and the second tube.
Gafford teaches:
Claim 16: (Figs. 1-2; ¶69) wherein sheath includes a first tube 28 concentrically nested within a second tube 26.
Claim 17: wherein the first tube includes a first deflectable section 40, the second tube includes a second deflectable section 30, the first and second deflectable sections being selectively weakened portions (¶75) of the first and second tubes that are angularly oriented (Fig. 3A; ¶75, 79), relative to a longitudinal axis of the sheath, in directions that are offset from each other by an angle equal to or less than one-hundred and eighty degrees (Fig. 3A; ¶75, 79), wherein the first and second tubes are joined at a location distal to the first and second deflectable sections (¶73, 75), wherein the sheath is actuable to form a first bend by relative axial translation between the first tube and the second tube (Figs. 3A-3D; ¶80).
By having deflectable portions with selectively weakened portions that are angularly oriented to each other, it allows for the device to conform to a tortuous pathway towards the anatomical region (¶89). Similarly, deflectable portions as well as an actuable sheath to form a bend also allows for the device to conform to different obstructions by deflecting around them and conforming to different obstructions.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to modify Zerfas with Gafford’s teachings in order to allow greater control and steering ability of the apparatus by permitting the device to conform to tortuous pathways and overcome obstacles.
Zerfas and Gafford disclose:
Re 18: wherein the laser fiber includes a glass silica core 104 (Zerfas ¶56).
Re 19: wherein the glass silica core is configured to deliver one of pulsed-dye, Ho:YAG, or Thulium energy (Zerfas ¶59).
Re 20: wherein the laser fiber includes a cladding layer disposed around the glass silica core, the cladding layer 104 comprised of reflective silica (Zerfas ¶56-58).
Conclusion
Relevant prior art considered: US 20200390456 teaching a treatment device that includes an elongated member having a proximal portion and a distal portion configured to be positioned within a blood vessel at a treatment site at or near a thrombus.
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GERALD J. SUFLETA II
Primary Examiner
Art Unit 2875
/GERALD J SUFLETA II/Primary Examiner, Art Unit 2875