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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 1, and dependents, is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claim 1, Applicant directs the instant claims toward an “interventional device system” comprising a telescoping “anti-buckling device” and “an interventional device”. Applicant indicates an “interventional device extending through the telescoping tube when the plurality of tube segments are in an extended configuration” [emphasis added], the extended configuration understood to be a product of the function of the telescoping tube to be “axially extendable”. However, the use of the “when” conditional creates confusion as to the state in which the device must be provided in order for infringement to occur. Specifically, based on the claim language it is unclear if infringement occurs simply by gathering the two components, i.e. the anti-buckling device and the interventional device, together as a system OR if infringement does not occur UNTIL the anti-buckling device assumes the extended configuration AND the interventional device IS extended through the telescoping tube. It is unclear if infringement would occur by simply extending the telescoping tube, but NOT inserting the interventional device given the claim limitation is positively directed toward the “interventional device extending through the telescoping tube” WHEN the extended configuration conditional is met.
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.
Claim(s) 1-4, 6-8, and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2009/0137985 (“Tanghoej”) in view of U.S. Publication No. 2004/0254422 (“Singh”).
Regarding Claim 1, Tanghoej discloses an interventional system comprising:
anti-buckling device for an interventional device assembly, comprising:
a telescoping tube (50; 151) comprising a plurality of concentric telescopically axially extendable and collapsible tube segments (1, 2), the plurality of tube segments comprising an outermost tube segment (1) and one or more inner tube segments (2), the telescoping tube forming a channel (see Fig. 5);
wherein each of the one or more inner tube segments comprises a first tube section having a first outer diameter and a second tube section having a second outer diameter (see Fig. 5; Fig. 18);
wherein each of the one or more inner tube segments further comprises a tapered section (see Fig. 5; Fig. 18) between the first tube section and the second tube section (see Fig. 5; Fig. 18), the tapered section having a diameter which tapers between the first outer diameter and the second outer diameter (see Fig. 5; Fig. 18).
Tanghoej discloses the invention substantially as claimed except that system further comprises an “interventional device” which is “extending through the telescoping tube” when the tubing segments assume an extended configuration. However, Singh discloses a related device (10), wherein the tubular channel/lumen of the device can be used to receive an interventional device (e.g. “fiber-optic instrument 80” or obturator 50). It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide the anti-buckling device of Tanghoej with an interventional device received within the telescoping tube when the segments are in an extended configuration including an obturator to help stiffen the device during insertion and a fiber-optic instrument to allow visualization of the bodily lumen, as disclosed by Singh (Abstract; Par. 12).
Regarding Claim 2, Tanghoej discloses each of the one or more inner tube segments has a uniform inner diameter (see Fig. 5).
Regarding Claim 3, Tanghoej discloses the first tube section is disposed adjacent a distal end of its corresponding tube segment (see Fig. 5; Fig. 18).
Regarding Claim 4, Tanghoej discloses the first outer diameter of the first tube section is greater than the second outer diameter of the second tube section (see Fig. 5; Fig. 18).
Regarding Claim 6, Tanghoej discloses each of the one or more inner tube segments further comprises a shoulder (see Fig. 5 – i.e. the diameter transition between the two sections) between the first tube section and the second tube section. Tanghoej discloses the invention substantially as claimed except that the shoulder is between about 0.002 inches and about 0.0045 inches. However, Tanghoej does establish that the separation force pursuant to the shape and size of the taper is a result effective variable (see Par. 53, 61-64) wherein the length of the taper can be adjusted by altering the angle of the taper between the two sections. Given that the length of the taper is a product of BOTH absolute and relative dimensions of the catheter system AND that it is well known and understood that catheter sizes can be dimensionally varied so as to optimize the catheter for any particular patient having particular physiological dimensions ranging from abnormally large patients to abnormally small patients, Examiner submits that arriving about a scenario wherein the length of the tapered section presents between about 0.002 inches and about 0.0045 inches is an obvious an inevitable construction as the size of the catheter is varied to adapt it to any particular patient and the holding force of the tapered section is likewise modified to optimize the holding force.
Regarding Claim 7, Tanghoej discloses (Par. 75) the second tube section has a wall thickness of 0.35mm (0.014”) and the first tube section has a wall thickness between 0.4 and 1mm (0.016” and 0.04”) values which lie within or overlap with the instantly claimed ranges so as to obviate said ranges. Furthermore, variations of such thicknesses to lie within any point of the instant claimed range is held to be obvious in altering the size of the catheter system to adapt it to any particular patient physiology by altering the size of the catheter depending on patient need.
Regarding Claim 8, Tanghoej discloses in some embodiments (see Fig. 18) the first tube section may comprise a shim (166) attached around a portion of the tube segment (see Fig. 18).
Regarding Claim 10, Tanghoej discloses the invention substantially as claimed except that the shim has a thickness of between about 0.002 inches and about 0.0045 inches. However, as discussed above, it would have been obvious for one having ordinary skill in the art at the time the invention was made to vary the size of the catheter system of Tanghoej to adapt it to any particular patient physiology, but also to adjust the holding forces of the various elements. As such, it would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the shim of Tanghoej to have a thickness between about 0.002 inches and about 0.0045 inches as an obvious and inevitable modification to adapt the catheter system to any specific and particular patient need.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2009/0137985 (“Tanghoej”) and U.S. Publication No. 2004/0254422 (“Singh”) as applied above, and further in view of U.S. Patent No. 5,766,184 (“Matsuno”).
Regarding Claim 18, Tanghoej discloses the invention substantially as claimed except that the clearance between adjacent concentric tubes of the plurality tube segments is between about 0.001 inches and about 0.0110 inches. However, it is well understood that in sliding/telescoping tubes such as those described by Tanghoej clearance between respective tubes is required to balance sliding friction while maintaining an optimal, stable connection. For example, Matsuno discloses that in sliding tubes excessively large clearance will cause deformation and buckling, while an excessively small clearance will unduly increase the sliding resistance between the tubes and therefore the value should be optimized (Col. 4, Ln. 32-41). Matsuno provides an exemplary arrange of 0.1mm to 0.5mm (i.e. 0.004” to 0.02”) a range which substantially overlaps the instantly claimed range. It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the invention of Tanghoej with a clearance between about 0.001” to 0.0110”, a range obviated by Matusuno, in order to optimize the clearance to provide a stable interface without large sliding friction as a product of routine and customary optimization of a result effective variable, see In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim(s) 1-4, 6-8, 10, 14-17, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2022/0168049 (“Tanner”) in view of U.S. Publication No. 2009/0137985 (“Tanghoej”).
Regarding Claim 1, Tanner discloses an interventional device assembly, comprising:
An anti-buckling device comprising:
a telescoping tube (500 – see e.g. Fig. 65B and 65G) comprising a plurality of concentric telescopically axially extendable and collapsible tube segments (640), the plurality of tube segments comprising an outermost tube segment and one or more inner tube segments, the telescoping tube forming a channel (see Fig. 65B);
wherein each of the one or more inner tube segments comprises a first tube section having a first outer diameter and a second tube section having a second outer diameter (see Fig. 65B, 65G); and
an interventional device (490) extending through the telescoping tube when the plurality of tube segments are in an extended configuration (see Fig. 65B).
Tanner discloses the invention substantially as claimed except that each of the one or more inner tube segments further comprises a tapered section between the first tube section and the second tube section, the tapered section having a diameter which tapers between the first outer diameter and the second outer diameter. Rather, Tanner utilizes an abrupt diameter transition forming a flange (641) to ensure that tube segments are retained in a nested configuration when extended (see Fig. 65G).
However, Tanghoej discloses a related, telescoping tubular medical device (50; 151) comprising a plurality of concentric telescopically axially extendable and collapsible tube segments (1, 2), the plurality of tube segments comprising an outermost tube segment (1) and one or more inner tube segments (2), the telescoping tube forming a channel (see Fig. 5);
wherein each of the one or more inner tube segments comprises a first tube section having a first outer diameter and a second tube section having a second outer diameter (see Fig. 5; Fig. 18);
wherein each of the one or more inner tube segments further comprises a tapered section (see Fig. 5; Fig. 18) between the first tube section and the second tube section (see Fig. 5; Fig. 18), the tapered section having a diameter which tapers between the first outer diameter and the second outer diameter (see Fig. 5; Fig. 18), the tapering being useful for ensuring that the tube sections remain nested in the extended configuration (Par. 18), an alternative to the abrupt flange/ledge used by Tanner. It would have been obvious for one having ordinary skill in the art at the time the invention was made to replace the flange/ledge stop arrangement of Tanner with a tapered stop, as disclosed by Tanghoej, as a product of obvious design choice in providing a known, suitable alternative arrangement recognized in the prior art for its ability to serve as a stop for telescoping tubes in a medical appliance to obtain a predictable and expected outcome. It has been held that simple substitution between known equivalents to obtain a predictable and expected outcome is obvious, see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
Regarding Claim 2, Tanner discloses each of the one or more inner tube segments has a uniform inner diameter (see Fig. 65G; see also Fig. 5, Tanghoej).
Regarding Claim 3, Tanner discloses the first tube section is disposed adjacent a distal end of its corresponding tube segment (see Fig. 65B; see also Fig. 5 or 18, Tanghoej).
Regarding Claim 4, Tanner, as modified, discloses the first outer diameter of the first tube section is greater than the second outer diameter of the second tube section (see Fig. 5 or 18, Tanghoej).
Regarding Claim 6, Tanner, as modified by Tanghoej, discloses each of the one or more inner tube segments further comprises a shoulder (see Fig. 5, Tanghoej – i.e. the diameter transition between the two sections) between the first tube section and the second tube section. The modified Tanner provides the invention substantially as claimed except that the shoulder is between about 0.002 inches and about 0.0045 inches. However, Tanghoej does establish that the separation force pursuant to the shape and size of the taper is a result effective variable (see Par. 53, 61-64) wherein the length of the taper can be adjusted by altering the angle of the taper between the two sections. Given that the length of the taper is a product of BOTH absolute and relative dimensions of the system AND that it is well known and understood that interventional devices such as those employed by Tanner have sizes which can be dimensionally varied so as to optimize the system for any particular patient having particular physiological dimensions ranging from abnormally large patients to abnormally small patients, Examiner submits that arriving about a scenario wherein the length of the tapered section presents between about 0.002 inches and about 0.0045 inches is an obvious an inevitable construction as the size of the interventional device is varied to adapt it to any particular patient and the holding force of the tapered section is likewise modified to optimize the holding force.
Regarding Claim 7, Tanner discloses the invention substantially as claimed except that the first tube section has a wall thickness of between about 0.005 inches and about 0.020 inches and the second tube section has a wall thickness of between about 0.003 inches and about 0.014 inches. However, it will be well understood that the thickness of the tubular walls is a result effective variable to be optimized to find a thickness that provides the tubular structures with sufficient strength, does not provide excessive weight which might cause buckling, and maintains a suitable internal diameter for the passage of interventional devices with respect to the second section and whereby the thickness of the first section is pursuant to the general thickness of the tube with further consideration of the thickness of the flange needed to present a sufficient stop to prevent overextension of the telescoping tubes. Examiner submits that the exact claimed ranges present nothing more than a workable range that the ordinary artisan would have found obvious with respect to construction of the device of Tanner in order to arrive upon a working exemplary telescoping tube construction to the satisfaction of only predictable and expected results.
Regarding Claim 8, Tanghoej discloses in some embodiments (see Fig. 18) the first tube section may comprise a shim (166) attached around a portion of the tube segment (see Fig. 18). It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide such a shim in modification of Tanner, as discussed above, in order to provide fitment of the tubular sections together in the manner described by Tanghoej in order to provide an effective alternative stop configuration to the flange arrangement described by Tanner.
Regarding Claim 10, Tanner, as modified by Tanghoej, provides for the invention substantially as claimed except that the shim has a thickness of between about 0.002 inches and about 0.0045 inches. However, as discussed above, it would have been obvious for one having ordinary skill in the art at the time the invention was made to vary the size of the system of Tanner to adapt it to any particular patient physiology pursuant to the length of the interventional appliance to be inserted, but also to adjust the holding forces of the various elements. As such, it would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the shim of Tanner to have a thickness between about 0.002 inches and about 0.0045 inches as an obvious and inevitable modification to adapt the interventional system to any specific and particular patient need.
Regarding Claim 14, Tanner discloses the one or more inner tube segments of the plurality of tube segments comprises an innermost tube segment and a proximal end of the innermost tube segment is attached to a proximal retainer (see Fig. 65B with consideration as to the attachment hardware illustrated in Fig. 65D which establishes the proximal retainer used to connect to the driver 84), the proximal retainer being configured to secure within an interior of a hub of the interventional device assembly between a proximal end of the hub and a distal end of the hub (see generally Fig. 65B where the geometry of the lug of the retainer shown in Fig. 65D demonstrates the intended receipt of the lug within a corresponding hub of the driver 84).
Regarding Claim 15, Examiner notes that the “hub” is not positively required and therefore the system of Tanner is configured for receipt by a hub which is suitably structured to contain the telescoping tube therein without modification.
Regarding Claim 16, Tanner discloses a distal end of the outermost tube segment of the plurality of tube segments is attached to a distal retainer (see generally Fig. 65D as it pertains to understanding the construction of the distal end of the configuration shown in Fig. 65B), the distal retainer being configured to releasably attach to the distal end of the hub or a proximal end of a second hub (see the bayonet connector).
Regarding Claim 17, Tanner discloses the distal retainer comprises a body with one or more tabs (see the tab of the bayonet connector which is provided along the outer circumference of the device) extending radially outward therefrom (i.e. the bayonet tab is radially offset from the longitudinal axis of the retainer); and the second hub comprises a proximal hub attachment comprising a recess and one or more slots configured to receive the body and one or more tabs of the distal retainer, respectively; wherein the distal retainer is configured to be rotated relative to the proximal hub attachment when received within the proximal hub attachment to releasably attach the distal retainer to the proximal hub attachment. Examiner notes that the “second hub” is not positively required by the claim and therefore fails to define and distinguish over the construction of the tab of the distal retainer of Tanner which could be mated with such a suitably dimensioned “second hub” as claimed.
Regarding Claim 20, Tanner discloses the one or more inner tube segments of the plurality of tube segments comprises an innermost tube segment, and wherein the innermost tube segment is bonded to an interventional device of the interventional device assembly (see Fig. 65B).
Claim(s) 8 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2022/0168049 (“Tanner”) in view of U.S. Publication No. 2009/0137985 (“Tanghoej”), and alternatively further in view of U.S. Publication No. 2003/0105451 (“Westlund”).
Regarding Claims 8, Tanner discloses the plurality of tube segments comprises an outermost tube segment and one or more inner tube segments (see Fig. 65G). Tanner, as modified by Tanghoej (particularly the configuration shown in Fig. 5) Tanner discloses the invention substantially as claimed except that that each of the inner tube segments comprise an axial shim attached around a portion of its outer diameter. However, Westlund discloses a related telescoping tube system (Fig. 1) wherein an inner tube segment (101) is telescopically received within an outer tube segment (102). In order to index the two tubes Westlund discloses a shim (202) attached around a portion of the outer diameter with the shim being adjacent of the end of the tube which is received within the outer tube (Par. 43, 44). It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide a shim at the distal end of the outer surface of the inner tube segments of Tanner, as disclosed by Westlund, in order to index the inner tube within the outer tube and prevent relative rotation between the two tubes, thereby rotationally locking the tubes together to reduce misalignment and buckling.
Regarding Claim 10, Tanner, as modified, discloses the invention substantially as claimed except for specifically resolving the thickness of the shim. However, it has been held that mere changes in size and proportion are not among those which will sustain patentability when they present only an expected and predictable outcome, see Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955), and In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976). Here it would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the shim of modified Tanner to have a thickness between about 0.002 inches and about 0.0045 inches in order to present a minimum thickness required to serve as a keyed shim to prevent rotation, without requiring an excessively deep corresponding slot on the outer tube which might compromise the function of the tube.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2022/0168049 (“Tanner”) in view of U.S. Publication No. 2009/0137985 (“Tanghoej”) as applied above, and further in view of U.S. Patent No. 5,766,184 (“Matsuno”).
Regarding Claim 18, Tanner, as modified, discloses the invention substantially as claimed except that the clearance between adjacent concentric tubes of the plurality tube segments is between about 0.001 inches and about 0.0110 inches. However, it is well understood that in sliding/telescoping tubes such as those described by Tanner clearance between respective tubes is required to balance sliding friction while maintaining an optimal, stable connection. For example, Matsuno discloses that in sliding tubes excessively large clearance will cause deformation and buckling, while an excessively small clearance will unduly increase the sliding resistance between the tubes and therefore the value should be optimized (Col. 4, Ln. 32-41). Matsuno provides an exemplary arrange of 0.1mm to 0.5mm (i.e. 0.004” to 0.02”) a range which substantially overlaps the instantly claimed range. It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the invention of Tanner with a clearance between about 0.001” to 0.0110”, a range obviated by Matusuno, in order to optimize the clearance to provide a stable interface without large sliding friction as a product of routine and customary optimization of a result effective variable, see In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim(s) 1-4, 8, 10, 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2003/0105451 (“Westlund”) in view of U.S. Publication No. 2009/0137985 (“Tanghoej”).
Regarding Claim 1, Westlund discloses an intervention device system comprising:
an anti-buckling device for an interventional device assembly, comprising:
a telescoping tube (Fig. 1) comprising a plurality of concentric telescopically axially extendable and collapsible tube segments (101, 102), the plurality of tube segments comprising an outermost tube segment (102) and one or more inner tube segments (101), the telescoping tube forming a channel (see Fig. 1);
wherein each of the one or more inner tube segments comprises a first tube section having a first outer diameter and a second tube section having a second outer diameter (see Fig. 1); and
an interventional device (not shown; see the “payload”, Par. 2, 3, 20, 22, 36; Clm. 31) extending through the telescoping tube when the plurality of tube segments are in an extended configuration.
Westlund discloses the invention substantially as claimed except that each of the one or more inner tube segments further comprises a tapered section between the first tube section and the second tube section, the tapered section having a diameter which tapers between the first outer diameter and the second outer diameter. Westlund rather uses a “stop member” or “leaflets” to provide for maintaining the tubes in a nested configuration when extended. However, Tanghoej discloses a related, telescoping tubular medical device (50; 151) comprising a plurality of concentric telescopically axially extendable and collapsible tube segments (1, 2), the plurality of tube segments comprising an outermost tube segment (1) and one or more inner tube segments (2), the telescoping tube forming a channel (see Fig. 5);
wherein each of the one or more inner tube segments comprises a first tube section having a first outer diameter and a second tube section having a second outer diameter (see Fig. 5; Fig. 18);
wherein each of the one or more inner tube segments further comprises a tapered section (see Fig. 5; Fig. 18) between the first tube section and the second tube section (see Fig. 5; Fig. 18), the tapered section having a diameter which tapers between the first outer diameter and the second outer diameter (see Fig. 5; Fig. 18), the tapering being useful for ensuring that the tube sections remain nested in the extended configuration (Par. 18), an alternative to the stop or leaflets used by Westlund. It would have been obvious for one having ordinary skill in the art at the time the invention was made to replace the flange/ledge stop arrangement of Westlund with a tapered stop, as disclosed by Tanghoej, as a product of obvious design choice in providing a known, suitable alternative arrangement recognized in the prior art for its ability to serve as a stop for telescoping tubes in a medical appliance to obtain a predictable and expected outcome. It has been held that simple substitution between known equivalents to obtain a predictable and expected outcome is obvious, see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
Regarding Claim 2, Westlund discloses the one or more inner tube segments has a uniform inner diameter (see Fig. 1, see also Fig. 4A for added clarity).
Regarding Claim 3, Westlund discloses the first tube section is disposed adjacent a distal end of its corresponding tube segment (see Fig. 2).
Regarding Claim 4, Westlund, particularly as modified by Tanghoej, discloses the first outer diameter of the first tube section is greater than the second outer diameter of the second tube section (see Fig. 5 or 18, Tanghoej).
Regarding Claim 6, Westlund, as modified by Tanghoej, discloses each of the one or more inner tube segments further comprises a shoulder (see Fig. 5 – i.e. the diameter transition between the two sections - Tanghoej) between the first tube section and the second tube section. Tanghoej discloses the invention substantially as claimed except that the shoulder is between about 0.002 inches and about 0.0045 inches. However, Tanghoej does establish that the separation force pursuant to the shape and size of the taper is a result effective variable (see Par. 53, 61-64) wherein the length of the taper can be adjusted by altering the angle of the taper between the two sections. Given that the length of the taper is a product of BOTH absolute and relative dimensions of the catheter system AND that it is well known and understood that catheter sizes can be dimensionally varied so as to optimize the catheter for any particular patient having particular physiological dimensions ranging from abnormally large patients to abnormally small patients, Examiner submits that arriving about a scenario wherein the length of the tapered section presents between about 0.002 inches and about 0.0045 inches is an obvious an inevitable construction as the size of the catheter is varied to adapt it to any particular patient and the holding force of the tapered section is likewise modified to optimize the holding force.
Regarding Claim 7, Westlund discloses the invention substantially as claimed except that the first tube section has a wall thickness of between about 0.005 inches and about 0.020 inches and the second tube section has a wall thickness of between about 0.003 inches and about 0.014 inches. However, it will be well understood that the thickness of the tubular walls is a result effective variable to be optimized to find a thickness that provides the tubular structures with sufficient strength, does not provide excessive weight which might cause buckling, and maintains a suitable internal diameter for the passage of interventional devices with respect to the second section and whereby the thickness of the first section is pursuant to the general thickness of the tube with further consideration of the thickness of the flange needed to present a sufficient stop to prevent overextension of the telescoping tubes. Examiner submits that the exact claimed ranges present nothing more than a workable range that the ordinary artisan would have found obvious with respect to construction of the device of Westlund in order to arrive upon a working exemplary telescoping tube construction to the satisfaction of only predictable and expected results.
Regarding Claim 8, Westlund discloses the first tube section comprises a shim (202) attached around a portion of the tube segment (see Fig. 2).
Regarding Claim 10, Westlund, as modified, discloses the invention substantially as claimed except for specifically resolving the thickness of the shim. However, it has been held that mere changes in size and proportion are not among those which will sustain patentability when they present only an expected and predictable outcome, see Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955), and In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976). Here it would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the shim of modified Westlund to have a thickness between about 0.002 inches and about 0.0045 inches in order to present a minimum thickness required to serve as a keyed shim to prevent rotation, without requiring an excessively deep corresponding slot on the outer tube which might compromise the function of the tube.
Regarding Claim 19, Westlund discloses an outer tube segment of the plurality of tube segments is shorter in length than an inner tube segment that is concentrically adjacent thereto (see Par. 37 – i.e. the length of the outer tube is about 15cm which is when creating an OAL of 55 to 60cm necessitates an inner tube which is longer than the outer tube).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2003/0105451 (“Westlund”) in view of U.S. Publication No. 2009/0137985 (“Tanghoej”) as applied above, and further in view of U.S. Patent No. 5,766,184 (“Matsuno”).
Regarding Claim 18, Westlund discloses the invention substantially as claimed except that the clearance between adjacent concentric tubes of the plurality tube segments is between about 0.001 inches and about 0.0110 inches. However, it is well understood that in sliding/telescoping tubes such as those described by Westlund clearance between respective tubes is required to balance sliding friction while maintaining an optimal, stable connection. For example, Matsuno discloses that in sliding tubes excessively large clearance will cause deformation and buckling, while an excessively small clearance will unduly increase the sliding resistance between the tubes and therefore the value should be optimized (Col. 4, Ln. 32-41). Matsuno provides an exemplary arrange of 0.1mm to 0.5mm (i.e. 0.004” to 0.02”) a range which substantially overlaps the instantly claimed range. It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the invention of Westlund with a clearance between about 0.001” to 0.0110”, a range obviated by Matusuno, in order to optimize the clearance to provide a stable interface without large sliding friction as a product of routine and customary optimization of a result effective variable, see In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim(s) 1-4, 6-8, 10-13, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2022/0313375 (“Zhang”) in view of U.S. Publication No. 2009/0137985 (“Tanghoej”).
Regarding Claim 1, Zhang discloses an interventional device system, comprising:
an anti-buckling device, comprising:
a telescoping tube comprising a plurality of concentric telescopically axially extendable and collapsible tube segments (Fig. 18A), the plurality of tube segments comprising an outermost tube segment and one or more inner tube segments (see Fig. 18A), the telescoping tube forming a channel (see Fig. 18A);
wherein each of the one or more inner tube segments comprises a first tube section having a first outer diameter and a second tube section having a second outer diameter (see Fig. 18A); and
an interventional device (not labeled; see Fig. 18A) extending through the telescoping tube when the plurality of segments are in an extended configuration.
Zhang discloses the invention substantially as claimed except that each of the one or more inner tube segments further comprises a tapered section between the first tube section and the second tube section, the tapered section having a diameter which tapers between the first outer diameter and the second outer diameter. Rather, Zhang utilizes an abrupt diameter transition forming a flange (1805) to ensure that tube segments are retained in a nested configuration when extended (see Fig. 18A).
However, Tanghoej discloses a related, telescoping tubular medical device (50; 151) comprising a plurality of concentric telescopically axially extendable and collapsible tube segments (1, 2), the plurality of tube segments comprising an outermost tube segment (1) and one or more inner tube segments (2), the telescoping tube forming a channel (see Fig. 5);
wherein each of the one or more inner tube segments comprises a first tube section having a first outer diameter and a second tube section having a second outer diameter (see Fig. 5; Fig. 18);
wherein each of the one or more inner tube segments further comprises a tapered section (see Fig. 5; Fig. 18) between the first tube section and the second tube section (see Fig. 5; Fig. 18), the tapered section having a diameter which tapers between the first outer diameter and the second outer diameter (see Fig. 5; Fig. 18), the tapering being useful for ensuring that the tube sections remain nested in the extended configuration (Par. 18), an alternative to the abrupt flange/ledge used by Zhang. It would have been obvious for one having ordinary skill in the art at the time the invention was made to replace the flange/ledge stop arrangement of Zhang with a tapered stop, as disclosed by Tanghoej, as a product of obvious design choice in providing a known, suitable alternative arrangement recognized in the prior art for its ability to serve as a stop for telescoping tubes in a medical appliance to obtain a predictable and expected outcome. It has been held that simple substitution between known equivalents to obtain a predictable and expected outcome is obvious, see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
Regarding Claim 2, Zhang discloses each of the one or more inner tube segments has a uniform inner diameter (see Fig. 18A; see also Fig. 5, Tanghoej).
Regarding Claim 3, Zhang discloses the first tube section is disposed adjacent a distal end of its corresponding tube segment (see Fig. 18A).
Regarding Claim 4, Zhang, as modified by Tanghoej, discloses the first outer diameter of the first tube section is greater than the second outer diameter of the second tube section (see Fig. 5 or 18, Tanghoej).
Regarding Claim 6, Zhang, as modified by Tanghoej, discloses each of the one or more inner tube segments further comprises a shoulder (see Fig. 5 – i.e. the diameter transition between the two sections - Tanghoej) between the first tube section and the second tube section. Tanghoej discloses the invention substantially as claimed except that the shoulder is between about 0.002 inches and about 0.0045 inches. However, Tanghoej does establish that the separation force pursuant to the shape and size of the taper is a result effective variable (see Par. 53, 61-64) wherein the length of the taper can be adjusted by altering the angle of the taper between the two sections. Given that the length of the taper is a product of BOTH absolute and relative dimensions of the interventional system AND that it is well known and understood that interventional device sizes can be dimensionally varied so as to optimize the interventional system for any particular patient having particular physiological dimensions ranging from abnormally large patients to abnormally small patients, Examiner submits that arriving about a scenario wherein the length of the tapered section presents between about 0.002 inches and about 0.0045 inches is an obvious an inevitable construction as the size of the interventional device is varied to adapt it to any particular patient and the holding force of the tapered section is likewise modified to optimize the holding force.
Regarding Claim 7, Zhang discloses the invention substantially as claimed except that the first tube section has a wall thickness of between about 0.005 inches and about 0.020 inches and the second tube section has a wall thickness of between about 0.003 inches and about 0.014 inches. However, it will be well understood that the thickness of the tubular walls is a result effective variable to be optimized to find a thickness that provides the tubular structures with sufficient strength, does not provide excessive weight which might cause buckling, and maintains a suitable internal diameter for the passage of interventional devices with respect to the second section and whereby the thickness of the first section is pursuant to the general thickness of the tube with further consideration of the thickness of the flange needed to present a sufficient stop to prevent overextension of the telescoping tubes. Examiner submits that the exact claimed ranges present nothing more than a workable range that the ordinary artisan would have found obvious with respect to construction of the device of Zhang in order to arrive upon a working exemplary telescoping tube construction to the satisfaction of only predictable and expected results.
Regarding Claim 8, Tanghoej discloses in some embodiments (see Fig. 18) the first tube section may comprise a shim (166) attached around a portion of the tube segment (see Fig. 18). It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide such a shim in modification of Zhang, as discussed above, in order to provide fitment of the tubular sections together in the manner described by Tanghoej in order to provide an effective alternative stop configuration to the flange arrangement described by Tanner.
Regarding Claim 10, Zhang, as modified by Tanghoej, provides for the invention substantially as claimed except that the shim has a thickness of between about 0.002 inches and about 0.0045 inches. However, as discussed above, it would have been obvious for one having ordinary skill in the art at the time the invention was made to vary the size of the system of Zhang to adapt it to any particular patient physiology pursuant to the length of the interventional appliance, but also to adjust the holding forces of the various elements. As such, it would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the shim of modified Zhang to have a thickness between about 0.002 inches and about 0.0045 inches as an obvious and inevitable modification to adapt the interventional system to any specific and particular patient need.
Regarding Claim 11, Zhang discloses the one or more inner tube segments of the plurality of tube segments comprises an innermost tube segment, wherein each of the plurality of tube segments except for the innermost tube segment is coupled to a cap (1803) at a proximal end thereof, the cap having a through hole (1804) configured to receive an interventional device of the interventional device assembly therethrough (see Fig. 18A).
Regarding Claim 12, Zhang discloses the cap has an outer diameter greater than the second outer diameter of the second tube section (see Fig. 18A – in the interpretation wherein the first outer diameter and the second outer diameter are not required to be different).
Regarding Claim 13, Zhang discloses the through hole of the cap has a diameter smaller than an inner diameter of the tube segment to which the cap is coupled (see Fig. 18A).
Regarding Claim 20, Zhang discloses the one or more inner tube segments of the plurality of tube segments comprises an innermost tube segment, and wherein the innermost tube segment is bonded to an interventional device of the interventional device assembly (see Fig. 18B).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2022/0313375 (“Zhang”) in view of U.S. Publication No. 2009/0137985 (“Tanghoej”) as applied above, and further in view of U.S. Patent No. 5,766,184 (“Matsuno”).
Regarding Claim 18, Zhang discloses the invention substantially as claimed except that the clearance between adjacent concentric tubes of the plurality tube segments is between about 0.001 inches and about 0.0110 inches. However, it is well understood that in sliding/telescoping tubes such as those described by Zhang clearance between respective tubes is required to balance sliding friction while maintaining an optimal, stable connection. For example, Matsuno discloses that in sliding tubes excessively large clearance will cause deformation and buckling, while an excessively small clearance will unduly increase the sliding resistance between the tubes and therefore the value should be optimized (Col. 4, Ln. 32-41). Matsuno provides an exemplary arrange of 0.1mm to 0.5mm (i.e. 0.004” to 0.02”) a range which substantially overlaps the instantly claimed range. It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the invention of Westlund with a clearance between about 0.001” to 0.0110”, a range obviated by Matusuno, in order to optimize the clearance to provide a stable interface without large sliding friction as a product of routine and customary optimization of a result effective variable, see In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Allowable Subject Matter
Claim 9 is allowed.
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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/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 09/09/2026
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