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 filed 12/12/2024 in regards to the rejection of claim 1 have been fully considered but they are not persuasive.
Regarding claim 1, Applicant contends that it would not have been obvious to one of ordinary skill in the art to have modified the bendable portions of the inner tube and outer tube of Browne to comprise a plurality of floating links, as taught and suggested by Papenfuss, for the benefit of allowing the different sections to be interlocked together while allowing the shaft to be flexible, the triangle-shaped pins and sockets allowing for increased flexibility and further locking of adjacent segments (see Papenfuss Paragraph 26) on the grounds that such a modification would have rendered the device of Browne inoperable. For example, Applicant contends that the outer tube of Browne is solid to allow for irrigation channels (60) to extend along the walls thereof to convey fluid around the bent portions without leaking (Browne Paragraph 49), wherein the outer tube directly carry’s irrigation fluid that would leak out should the outer tube not be a solid tube, and wherein Browne explains that a “tube comprising helical cuts is ‘susceptible to undesirable ingress or egress of fluid through the geometries’, and sealing devices such as a heat-shrunk flexible sheath are susceptible to wear as it rotates against the adjacent surface (see Browne Paragraph 2).
The examiner respectfully disagrees with Applicant’s contention. Firstly, while Browne discloses wherein fluid channels “may” be defined by the outer tube itself (see Browne Paragraph 8), Browne discloses an alternative configuration in which the outer tube “may define longitudinal slots or recesses, and a hypotube or intermediate tube may be secured within the outer tube to define the irrigation channels. This arrangement provides of the irrigation channels defining an irrigation path that is fluidly separated from the aspiration lumen. The irrigation fluid traverses the bend towards the gap without risk of being undesirably drawn into the aspiration lumen through the slots between the segments” (see Paragraph 8). The examiner therefore contends that Browne already discloses a known configuration in which the outer tube comprises longitudinal slots or recesses without rendering the irrigation channels defined therein non-functional due to leakage, since the irrigation channels are disposed within separate tubular channels which pass fluid through the outer tube.
On the second point of wherein Browne explains that a “tube comprising helical cuts is ‘susceptible to undesirable ingress or egress of fluid through the geometries’, and sealing devices such as a heat-shrunk flexible sheath are susceptible to wear as it rotates against the adjacent surface (see Browne Paragraph 2), the examiner notes that this portion of the specification entailed Browne critiquing a separate prior art, U.S. Patent No. 8,623,266 to Adams in which a heat-shrunk sleeve was disposed over a continuous helical cut of an inner tube. While this passage mentions wherein a heat-shrunk tubular member disposed over a helical-cut inner tubular member may undergo wear, the examiner notes that the outer tube is not heat-shrunk to the inner tube of Browne and thus not in direct contacting abutment due additional in part to the presence of fluid channels between the inner and outer tubes of Browne. Therefore, and wear mentioned in regards to the Adams patent is not seen to be relevant in the context of the present combination since the configurations are materially non-similar.
The examiner notes that while the segments floating links are “cut” into the shaft of Papenfuss, as pointed out by Applicant, such cuts would not be in direct abutting contact with the opposing tube since additional hypotubes carrying irrigation fluid are disposed between the inner and outer tubes of Browne and such cuts would not be in direct contact with the opposing tubes due to the gap to allow fluid to pass through. Therefore, any mention of wear in regards to direct abutment (i.e., heat-shrunk) contact are not seen to be applicable in this context – additional due to Browne disclosing that the outer tube may already have longitudinal slots of recesses along its body, which do not seemingly cause wear on any other components within the system.
In regards to the rigidity and malleability of the outer tube of Browne, Applicant contends that, since Browne does not expressly disclose how such malleability is integrated into the outer tube of Browne, such malleability is simply provided by making the outer tube bendable via plastic deformation so as to avoid leaking of the irrigation fluid. The examiner contends that such an interpretation may be too narrow in scope. For example, Browne mentions in Paragraph 45 that the bend of the outer tube may be at an angle of 30, 60, 90 degrees “or more” limited only by the torque transmitting capabilities of the flexible region of the inner tube. The examiner therefore contends that the “malleability’ of the outer tube is in regards to the ability to alter the bend angle to best suit the needs of the procedure at-hand since the recitation of “rigid or malleable” immediately precedes mention of the alternative angles at which the bend may be oriented at. Should such malleability be in regards to the ability to undergo “plastic deformation”, only one angle may be chosen as any alterations thereto would render the device inoperable thereafter.
The examiner notes that Applicant has cited that the use of concentric-segmented floating link-type tubes is counterintuitive, because it would be expected that the links of the inner and outer tubes would clash with each other, leading to operational difficulties or failures (see Spec. P. 10, II 8-15). However, while a known problem may arise within the disclosed specification, limitations or benefits cannot be read into the claims impermissibly from the specification.
Applicant’s arguments, see “Remarks”, filed 12/12/2024, with respect to the rejection(s) of claim(s) 8-9 and 20-21 under Browne in view of Paprocki have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Rosenman (US 2006/0135961 A1).
With regards to Applicant’s contention that the examiner misinterpreted the meaning of the claimed “circular segment” in light of the specification, the examiner agrees that the previous rejection based on the cited prior art of Browne in view of Paprocki did not take into adequate consideration the scope of the claimed limitation in light of its use within the specification. Specifically, within Pg. 11 of the specification, the context of the claimed “circular segment” is as follows: “The illustrated bent section 308 is shaped as a circular segment that lies in a single plane and is defined by a radius R”. This use of the term seeks to establish the “circular segment” as a portion of the bent section (i.e., a portion, 308, of the guide tube) defining a radius, R. There appears to be sufficient evidence within the specification that the claimed terms of “circular segment” is defined to be a shape of curvature, rather than a cross-sectional diameter. The previous rejection has been withdrawn and a new rejection is issued in this second non-final office action below. Additionally, with regards to Applicant’s claim that Paprocki “teaches away” from a bend angle of less than 1 inch, the examiner notes that the portions of the disclosure cited by Applicant (i.e., Col. 6, Lines 3-33), while citing “preferred” bend angles, the examiner contends that the disclosed bend angles are merely exemplary and are not seen to have any disclosed benefit outside of the intended use for the device. For example, the citations of the “preferred” bend angles do not mention wherein such a bend angle is critical to the function of the device. Even still, should a user desire to bend the guide tube less than the 4-5 inches, the guide tube is understood to be fully capable of bending 1 inch should a user desire to use the device in such a manner as the device is capable of bending further as a maximum threshold.
Applicant’s arguments with respect to claim(s) 24-25 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. Specifically, Browne is not longer relied upon to disclose the amended limitations of claims 24 or 25.
Claim Rejections - 35 USC § 112
Applicant’s arguments, see “Remarks”, filed 12/12/2024, with respect to the 112(b) rejection of claims 24 and 25 as being indefinite on the grounds that the nature and/or position of the “flexible sheath” element is not clear have been fully considered and are persuasive in light of Applicant’s amendment to clarify the location of the flexible sheath element. The 112(b) rejection of claims 24-25 has been withdrawn.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3, 14-16 and 24-25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Walen (US 2017/0027597 A1).
Regarding claim 1, Walen discloses:
A surgical instrument shaft assembly (see Fig. 29) comprising:
an outer shaft (outer tube 420, see Fig. 29) extending from a proximal outer shaft end to a distal outer shaft end and having an outer shaft cannula extending from the proximal outer shaft end to the distal outer shaft end (see Fig. 29), wherein at least a portion of the outer shaft comprises an outer shaft flexible section (links 430, see Figs. 29 and 45) located between the proximal outer shaft end and the distal outer shaft end (see Fig. 45), and the outer shaft flexible section comprises a plurality of first segmented floating links (see Figs. 46-49 showing wherein the links are floating links); and
an inner shaft (inner tube 482, see Fig. 29) extending from a proximal inner shaft end to a distal inner shaft end and having an inner shaft cannula extending from the proximal inner shaft end to the distal inner shaft end (see Fig. 29 and 53), wherein at least a portion of the inner shaft comprises an inner shaft flexible section (flexible neck 486, see Fig. 53) located between the proximal inner shaft end and the distal inner shaft end (see Fig. 53), and the inner shaft flexible section comprises a plurality of second segmented floating links (see Fig. 53 – the examiner notes that each segment of the flexible neck is not connected to a unifying connection structure but rather merely joins adjacent links that allows for free movement as evidenced by Paragraph 190);
wherein the inner shaft is configured and dimensioned to be inserted into the outer shaft in an operating position (see Paragraph 195) in which:
at least a portion of the inner shaft flexible section is surrounded by at least a portion of the outer shaft flexible section (see Paragraph 190), such that the inner shaft flexible section and the outer shaft flexible section can flex in unison (see Paragraphs 190 and 199), and the inner shaft is rotatable within the outer shaft (see Paragraph 188).
Regarding claim 3, Walen discloses the invention of claim 1, Walen further discloses wherein, in the operating position, the proximal inner shaft end extends in a proximal direction from the proximal outer shaft end (the inner tube extends proximally into the handle to connect to a motor to allow the inner tube to be rotated, see Paragraph 188 – see also Fig. 29 showing wherein the inner tube extends further proximally than the outer tube).
Regarding claim 14, Walen discloses all of the limitations of claim 1, Walen further discloses wherein:
the distal outer shaft end comprises an outer cutter head (tip 456, see Fig. 46) extending along a first longitudinal axis and having an outer cutter opening (see Paragraph 184) in fluid communication with the outer shaft cannula and facing perpendicular to the first longitudinal axis (see Paragraph 184, see also Figs. 46-49); and
the distal inner shaft end comprises an inner cutter head (cutting feature 490, see Fig. 53) extending along a second longitudinal axis and having an inner cutter opening (see Fig. 53, see also Paragraph 189) in fluid communication with the inner shaft cannula and facing perpendicular to the second longitudinal axis direction (see Fig. 53);
wherein, in the operating position:
at least a portion of the inner cutter head is surrounded by at least a portion of the outer cutter head with the first longitudinal axis collinear with the second longitudinal axis (see Paragraph 190), and the inner cutter opening is rotatable about the second longitudinal axis (see Paragraph 196), upon rotating the inner shaft relative to the outer shaft, to selectively move between a first state of alignment between the inner cutter opening and the outer cutter opening (as the inner shaft is rotated, the alignment of the inner and outer cutting windows changes from an aligned, open configuration to a closed configuration), and a second state of alignment between the inner cutter opening and the outer cutter opening, the second state of alignment being different from the first state of alignment (as the inner shaft is rotated, the alignment of the inner and outer cutting windows changes from an aligned, open configuration to a closed configuration).
Regarding claim 15, Walen discloses the invention of claim 14, Walen further discloses wherein, in the first state of alignment, the outer cutter opening and the inner cutter opening form a fluid communication path of a first cross-sectional size with the inner shaft cannula (see Paragraphs 188 and 196 - examiner notes that the “first state of alignment” is defined to be wherein the inner tip portion and outer tip portion are co-linear, this state defining a first fluid cross-sectional size based on the relative opening of the cutting windows of said inner and outer tip portions), and in the second state of alignment, the outer cutter opening and the inner cutter opening form a fluid communication path of a second cross-sectional size with the inner shaft cannula, the second cross-sectional size being less than the first cross-sectional size (as the inner tip portion is rotated from co-linear with respect to the outer tip portion, the size of the cutting opening is less than when the two tip portions are co-linear, see also Paragraph 188 and 196).
Regarding claim 16, Walen discloses the invention of claim 15, Walen further discloses wherein the inner cutter opening is rotatable about the second longitudinal axis (see Paragraph 196), upon rotating the inner shaft relative to the outer shaft, to selectively move to a third state of alignment between the inner cutter opening and the outer cutter opening (a third state of alignment is any state having a rotational offset between the inner tip portion and outer tip portion that is different from co-linear and the exemplary 5 degrees offset, defining the “second state”. For the purposes of this office action, the “third state” is defined to be a 180 degree relative offset between the two tip portions), and wherein, in the third state of alignment the inner cutter opening and the outer cutter opening do not form a fluid communication path to the inner shaft cannula (with a 180 degree offset, the cutting window is closed as the two tip portions are 180 degrees offset and thus the cutting window would be closed).
Regarding claim 24, Walen discloses the invention of claim 1, Walen further discloses wherein the surgical instrument does not comprise a flexible sheath within the inner shaft flexible section or between the inner shaft flexible section and the outer shaft flexible section (see Fig. 29 showing no additional tubing disposed within either the inner tube or outer tube).
Regarding claim 25, Walen discloses the invention of claim 1, Walen further discloses wherein the surgical instrument does not comprise a flexible sheath within the inner shaft flexible section, between the inner shaft flexible section and the outer shaft flexible section, or outside the outer shaft flexible section (see Fig. 29 showing no additional tubing disposed within either the inner tube or outer tube).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Walen (US 2017/0027597 A1), in view of Papenfuss (US 2011/0319896 A1).
Regarding claim 2, Walen discloses all of the limitations of the invention of claim 1, Walen further discloses wherein: the plurality of first segmented floating links comprises alternating first dovetail links and first pin links (Fig. 50 showing alternating dove-tail and pin linkages as part of the links 430), wherein each adjacent first dovetail link and first pin link are connected by a respective floating connection (see Fig. 50 showing no other components connecting the links, constituting a floating connection that allows for bending).
However, while Walen discloses wherein the exact structure of the inner tube and flexible neck are not part of the present invention, Walen does not expressly disclose wherein the plurality of second segmented floating links comprises alternating second dovetail links and second pin links, wherein each adjacent second dovetail link and second pin link are connected by a respective floating connection.
However, in the same field of endeavor, namely articulatable drive shafts for surgical catheter devices, Papenfuss teaches wherein an elongate catheter body (1, see Fig. 10) comprising an articulatable section (region comprised of interlocking sections 6, see Fig. 1, see also Paragraph 26) comprised of a series of floating links (6, see Fig. 1) that comprise alternating first dovetail links and first pin links (see Fig. 1, see also Paragraphs 25-27), wherein each adjacent first dovetail link and first pin link are connected by a respective floating connection (see Paragraphs 25-27) to allow the different sections to be interlocked together while allowing the shaft to be flexible, the triangle-shaped pins and sockets allowing for increased flexibility and further locking of adjacent segments (see Paragraph 26).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the flexible neck of the inner tube of Walen to comprise triangle-shaped interlocking dovetail and pin links, with each segment connected by a floating connection, as taught and suggested by Papenfuss to, in this case, allow the different sections to be interlocked together while allowing the shaft to be flexible, the triangle-shaped pins and sockets allowing for increased flexibility and further locking of adjacent segments (see Papenfuss Paragraph 26). The examiner notes that, since Walen was silent in regards to the type of segments, disclosing expressly that the type of flexible links was “not part of the present invention”, this would leave it to one of ordinary skill in the art to select from known linkage members in the art to incorporate and use with the device of Walen.
Claim(s) 4-6, 17-18 and 22-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Walen (US 2017/0027597 A1), in view of Paprocki (US 9782566 B1).
Regarding claim 4, Walen discloses all of the limitations of the invention of claim 1.
However, Walen does not expressly disclose a guide tube extending from a proximal guide tube end to a distal guide tube end and having a guide tube cannula extending from the proximal guide tube end to the distal guide tube end, and wherein, in the operating position, at least a portion of the outer shaft and at least a portion of the inner shaft are positioned within the guide tube cannula.
However, in the same field of endeavor, namely endoscopic instruments comprising an elongate tubular body for treating parts of the anatomy, Paprocki teaches wherein an access sheath (10, see Fig. 1) may be utilized to establish an accessible, minimally invasive passageway into the body to facilitate and expediate the insertion and removal of devices passed through the lumen of an access sheath (see Col. 1, Lines 15-25).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the device of Walen to include an access sheath as part of the surgical system, as taught and suggested by Paprocki to, in this case, establish an accessible, minimally invasive passageway into the body to facilitate and expediate the insertion and removal of devices passed through the lumen of an access sheath (see Paprocki Col. 1, Lines 15-25).
Regarding claim 5, the combination of Walen and Paprocki disclose the invention of claim 4, Walen, as modified by Paprocki, further discloses wherein at least a portion of the guide tube comprises a bent section (bending section 54, see Paprocki Fig. 6), and, in the operating position: at least a portion of the outer shaft flexible section extends throughout the entire bent section (in order for the working portion at the distal end of the device of Walen to interact with tissue, the device of Walen needs to pass entirely through the access sheath of Paprocki so that the distal end effector is exposed at the distal end thereof); at least a portion of the inner shaft flexible section extends throughout the entire bent section (in order for the working portion at the distal end of the device of Walen to interact with tissue, the device of Walen needs to pass entirely through the access sheath of Paprocki so that the distal end effector is exposed at the distal end thereof); and the outer shaft is rotatable within the guide tube (The examiner notes that, if the access tube is held in-place, a user is able to rotate the outer tube relative thereto as the components are not seen to be integrally connected together).
Regarding claim 6, the combination of Walen and Paprocki disclose the invention of claim 5, Walen, as modified by Paprocki, further discloses wherein, in the operating position, the proximal outer shaft end extends in a proximal direction from the proximal guide tube end, and the proximal inner shaft end extends in the proximal direction from the proximal outer shaft end (see Walen Fig. 29 showing wherein the inner and outer tubes of Brown extend proximally up to and into the handle. The examiner notes that the proximal portions of the inner and outer tubes of Walen extend proximally relative to the proximal-most point of the access sheath of Paprocki, as incorporated into the device of Walen since the access sheath does not extend into the handle of Walen but merely provides a passageway for the inner and outer tubes of Walen to be inserted through, external of the proximal handle).
Regarding claim 17, Walen discloses all of the limitations of the invention of claim 14.
However, Walen does not expressly disclose a guide tube extending from a proximal guide tube end to a distal guide tube end and having a guide tube cannula extending from the proximal guide tube end to the distal guide tube end, and wherein, in the operating position: at least a portion of the outer shaft and at least a portion of the inner shaft are positioned within the guide tube cannula, and at least a portion of outer cutter opening and at least a portion of the inner cutter opening extend in a distal direction from the distal guide tube end.
However, in the same field of endeavor, namely endoscopic instruments comprising an elongate tubular body for treating parts of the anatomy, Paprocki teaches wherein an access sheath (10, see Fig. 1) may be utilized to establish an accessible, minimally invasive passageway into the body to facilitate and expediate the insertion and removal of devices passed through the lumen of an access sheath (see Col. 1, Lines 15-25).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the device of Walen to include an access sheath as part of the surgical system, as taught and suggested by Paprocki to, in this case, establish an accessible, minimally invasive passageway into the body to facilitate and expediate the insertion and removal of devices passed through the lumen of an access sheath (see Paprocki Col. 1, Lines 15-25). The examiner notes that the inner tube and outer tube of Walen extend further proximally than the proximal-most point of the access sheath (the inner and outer tubes of Walen extend up to an into the handle. The examiner notes that the proximal portions of the inner and outer tubes of Walen extend proximally relative to the proximal-most point of the access sheath of Paprocki, as incorporated into the device of Brown since the access sheath does not extend into the handle of Walen but merely provides a passageway for the inner and outer tubes of Walen to be inserted through, external of the proximal handle), in addition to the distal-most point of Walen extending further distally than the distal-most point of the access sheath to allow the inner tip portion and outer tip portion to extend and contact tissue without being impeded by the lumen of the access sheath).
Regarding claim 18, the combination of Walen and Paprocki disclose the invention of claim 17, Walen, as modified by Paprocki, further discloses wherein at least a portion of the guide tube comprises a bent section (bending section 54, see Paprocki Fig. 6), and, in the operating position: at least a portion of the outer shaft flexible section extends throughout the entire bent section (in order for the working portion at the distal end of the device of Walen to interact with tissue, the device of Walen needs to pass entirely through the access sheath of Paprocki so that the distal end effector is exposed at the distal end thereof); at least a portion of the inner shaft flexible section extends throughout the entire bent section (in order for the working portion at the distal end of the device of Walen to interact with tissue, the device of Walen needs to pass entirely through the access sheath of Paprocki so that the distal end effector is exposed at the distal end thereof); and the outer shaft is rotatable within the guide tube (The examiner notes that, if the access tube is held in-place, a user is able to rotate the outer tube relative thereto as the components are not seen to be integrally connected together).
Regarding claim 22, the combination of Walen and Paprocki disclose all of the limitations of the invention of claim 18.
However, none of either Walen or Paprocki expressly disclose wherein each first segmented floating link has an outer diameter of 0.150 inches or less.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause each first segmented floating link of Papenfuss, as incorporated into the device of Walen, to comprise a diameter of 0.150 inches less since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the first segmented floating link of Papenfuss would not operate differently with the claimed diameter and since the floating links are configured to bend relative to one-another within the anatomy of a patient, one of ordinary skill would have expected the floating links to function properly having the claimed diameter since Papenfuss does not disclose any criticality to the dimensions thereof, allowing one of ordinary skill in the art to expect the flexible nature of the floating links function appropriately having the claimed diameter. Further, applicant places no criticality on the range claimed, indicating simply that the diameters “may” be within the claimed ranges (specification Pg. 11, Lines 20-25).
Regarding claim 23, the combination of Walen and Paprocki disclose all of the limitations of the invention of claim 22.
However, none of either Walen or Paprocki expressly disclose wherein each first segmented floating link has an outer diameter of 0.120 inches or less.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause each first segmented floating link of Papenfuss, as incorporated into the device of Walen, to comprise a diameter of 0.120 inches less since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the first segmented floating link of Papenfuss would not operate differently with the claimed diameter and since the floating links are configured to bend relative to one-another within the anatomy of a patient, one of ordinary skill would have expected the floating links to function properly having the claimed diameter since Papenfuss does not disclose any criticality to the dimensions thereof, allowing one of ordinary skill in the art to expect the flexible nature of the floating links function appropriately having the claimed diameter. Further, applicant places no criticality on the range claimed, indicating simply that the diameters “may” be within the claimed ranges (specification Pg. 11, Lines 20-25).
Claim(s) 7-13 and 19-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Walen (US 2017/0027597 A1), in view of Paprocki (US 9782566 B1), further in view of Rosenman (US 2006/0135961 A1).
Regarding claim 7, the combination of Walen and Paprocki discloses all of the limitations of the invention of claim 5.
However, none of either Walen or Paprocki does not expressly disclose wherein the bent section comprises a bend of at least a 90 degrees.
However, in the same field of endeavor, namely deflectable guide catheters, Rosenman teaches wherein guide sheaths for deflectable catheter devices should be able to bend in a curve of at least 135 degrees from straight to access renal arteries that take off from the abdominal aorta at acute angles (see Paragraph 45).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the guide sheath of Paprocki, as incorporated into the device of Walen, to be configured to bend in a curve of at least 135 degrees from straight, as taught and suggested by Rosenman to, in this case, better access arteries that bend at acute angles (see Rosenman Paragraph 45). The examiner notes that the device of Walen is disclosed to be configured for use within the vasculature (see Walen Paragraph 147) and thus the benefit of having a guide sheath that allows for bending to accommodate acute angle changes in the vasculature would allow for a wider applicable access in using the device of Walen.
Regarding claim 8, the combination of Walen and Paprocki disclose all of the limitations of the invention of claim 5.
However, none of either Walen or Paprocki expressly disclose wherein the bent section comprises a circular segment having a radius of one inch or less (the examiner notes that the term “radius” in this context refers to a radius of curvature as defined within the specification Pg. 11).
However, in the same field of endeavor, namely deflectable guide catheters, Rosenman teaches wherein guide sheaths for deflectable catheter devices, Rosenman teaches wherein it is known in the art to have a deflectable guide catheter comprise a sweep distance of preferably 1 inch (see Paragraph 40) to be able to access and navigate carotid arteries effectively.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the guide sheath of Paprocki, as incorporated into the device of Walen, to comprise a sweep distance of 1 inch, since Rosenman teaches wherein such a sweep distance would allow for navigation within the vasculature system effectively.
Regarding claim 9, the combination of Walen and Paprocki disclose all of the limitations of the invention of claim 5.
However, none of either Walen or Paprocki expressly disclose wherein the bent section comprises a circular segment having a radius of one inch or less, and a bend of at least 90 degrees.
However, in the same field of endeavor, namely deflectable guide catheters, Rosenman teaches wherein guide sheaths for deflectable catheter devices should be able to bend in a curve of at least 135 degrees from straight to access renal arteries that take off from the abdominal aorta at acute angles (see Paragraph 45) and wherein it is known in the art to have a deflectable guide catheter comprise a sweep distance of preferably 1 inch (see Paragraph 40) to be able to access and navigate carotid arteries effectively.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the guide sheath of Paprocki, as incorporated into the device of Walen, to be configured to bend in a curve of at least 135 degrees from straight, as taught and suggested by Rosenman to, in this case, better access arteries that bend at acute angles (see Rosenman Paragraph 45). The examiner notes that the device of Walen is disclosed to be configured for use within the vasculature (see Walen Paragraph 147) and thus the benefit of having a guide sheath that allows for bending to accommodate acute angle changes in the vasculature would allow for a wider applicable access in using the device of Walen. Additionally, it would have been obvious to have modified the guide tube of Paprocki, as incorporated into the device of Walen to comprise a sweep distance of 1 inch, since Rosenman teaches wherein such a sweep distance would allow for navigation within the vasculature system effectively.
Regarding claim 10, the combination of Walen, Rosenman and Paprocki disclose all of the limitations of the invention of claim 9.
However, none of either Walen, Rosenman or Paprocki expressly disclose wherein each first segmented floating link has an outer diameter of 0.150 inches or less.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause each first segmented floating link of Papenfuss, as incorporated into the device of Walen, to comprise a diameter of 0.150 inches less since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the first segmented floating link of Papenfuss would not operate differently with the claimed diameter and since the floating links are configured to bend relative to one-another within the anatomy of a patient, one of ordinary skill would have expected the floating links to function properly having the claimed diameter since Papenfuss does not disclose any criticality to the dimensions thereof, allowing one of ordinary skill in the art to expect the flexible nature of the floating links function appropriately having the claimed diameter. Further, applicant places no criticality on the range claimed, indicating simply that the diameters “may” be within the claimed ranges (specification Pg. 11, Lines 20-25).
Regarding claim 11, the combination of Walen, Rosenman and Paprocki disclose all of the limitations of the invention of claim 10.
However, none of either Walen, Rosenman or Paprocki expressly disclose wherein each first segmented floating link has an outer diameter of 0.120 inches or less.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause each first segmented floating link of Papenfuss, as incorporated into the device of Walen, to comprise a diameter of 0.120 inches less since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the first segmented floating link of Papenfuss would not operate differently with the claimed diameter and since the floating links are configured to bend relative to one-another within the anatomy of a patient, one of ordinary skill would have expected the floating links to function properly having the claimed diameter since Papenfuss does not disclose any criticality to the dimensions thereof, allowing one of ordinary skill in the art to expect the flexible nature of the floating links function appropriately having the claimed diameter. Further, applicant places no criticality on the range claimed, indicating simply that the diameters “may” be within the claimed ranges (specification Pg. 11, Lines 20-25).
Regarding claim 12, the combination of Walen, Rosenman and Paprocki disclose all of the limitations of the invention of claim 5.
However, none of either Walen, Rosenman or Paprocki expressly disclose wherein each first segmented floating link has an outer diameter of 0.150 inches or less.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause each first segmented floating link of Papenfuss, as incorporated into the device of Walen, to comprise a diameter of 0.150 inches less since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the first segmented floating link of Papenfuss would not operate differently with the claimed diameter and since the floating links are configured to bend relative to one-another within the anatomy of a patient, one of ordinary skill would have expected the floating links to function properly having the claimed diameter since Papenfuss does not disclose any criticality to the dimensions thereof, allowing one of ordinary skill in the art to expect the flexible nature of the floating links function appropriately having the claimed diameter. Further, applicant places no criticality on the range claimed, indicating simply that the diameters “may” be within the claimed ranges (specification Pg. 11, Lines 20-25).
Regarding claim 13, the combination of Walen, Rosenman and Paprocki disclose all of the limitations of the invention of claim 12.
However, none of either Walen, Rosenman or Paprocki expressly disclose wherein each first segmented floating link has an outer diameter of 0.120 inches or less.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause each first segmented floating link of Papenfuss, as incorporated into the device of Walen, to comprise a diameter of 0.120 inches less since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the first segmented floating link of Papenfuss would not operate differently with the claimed diameter and since the floating links are configured to bend relative to one-another within the anatomy of a patient, one of ordinary skill would have expected the floating links to function properly having the claimed diameter since Papenfuss does not disclose any criticality to the dimensions thereof, allowing one of ordinary skill in the art to expect the flexible nature of the floating links function appropriately having the claimed diameter. Further, applicant places no criticality on the range claimed, indicating simply that the diameters “may” be within the claimed ranges (specification Pg. 11, Lines 20-25).
Regarding claim 19, the combination of Walen and Paprocki discloses all of the limitations of the invention of claim 8.
However, none of either Walen or Paprocki does not expressly disclose wherein the bent section comprises a bend of at least a 90 degrees.
However, in the same field of endeavor, namely deflectable guide catheters, Rosenman teaches wherein guide sheaths for deflectable catheter devices should be able to bend in a curve of at least 135 degrees from straight to access renal arteries that take off from the abdominal aorta at acute angles (see Paragraph 45).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the guide sheath of Paprocki, as incorporated into the device of Walen, to be configured to bend in a curve of at least 135 degrees from straight, as taught and suggested by Rosenman to, in this case, better access arteries that bend at acute angles (see Rosenman Paragraph 45). The examiner notes that the device of Walen is disclosed to be configured for use within the vasculature (see Walen Paragraph 147) and thus the benefit of having a guide sheath that allows for bending to accommodate acute angle changes in the vasculature would allow for a wider applicable access in using the device of Walen.
Regarding claim 20, the combination of Walen and Paprocki disclose all of the limitations of the invention of claim 18.
However, none of either Walen or Paprocki expressly disclose wherein the bent section comprises a circular segment having a radius of one inch or less (the examiner notes that the term “radius” in this context refers to a radius of curvature as defined within the specification Pg. 11).
However, in the same field of endeavor, namely deflectable guide catheters, Rosenman teaches wherein guide sheaths for deflectable catheter devices, Rosenman teaches wherein it is known in the art to have a deflectable guide catheter comprise a sweep distance of preferably 1 inch (see Paragraph 40) to be able to access and navigate carotid arteries effectively.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the guide sheath of Paprocki, as incorporated into the device of Walen, to comprise a sweep distance of 1 inch, since Rosenman teaches wherein such a sweep distance would allow for navigation within the vasculature system effectively.
Regarding claim 21, the combination of Walen and Paprocki disclose all of the limitations of the invention of claim 18.
However, none of either Walen or Paprocki expressly disclose wherein the bent section comprises a circular segment having a radius of one inch or less, and a bend of at least 90 degrees.
However, in the same field of endeavor, namely deflectable guide catheters, Rosenman teaches wherein guide sheaths for deflectable catheter devices should be able to bend in a curve of at least 135 degrees from straight to access renal arteries that take off from the abdominal aorta at acute angles (see Paragraph 45) and wherein it is known in the art to have a deflectable guide catheter comprise a sweep distance of preferably 1 inch (see Paragraph 40) to be able to access and navigate carotid arteries effectively.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the guide sheath of Paprocki, as incorporated into the device of Walen, to be configured to bend in a curve of at least 135 degrees from straight, as taught and suggested by Rosenman to, in this case, better access arteries that bend at acute angles (see Rosenman Paragraph 45). The examiner notes that the device of Walen is disclosed to be configured for use within the vasculature (see Walen Paragraph 147) and thus the benefit of having a guide sheath that allows for bending to accommodate acute angle changes in the vasculature would allow for a wider applicable access in using the device of Walen. Additionally, it would have been obvious to have modified the guide tube of Paprocki, as incorporated into the device of Walen to comprise a sweep distance of 1 inch, since Rosenman teaches wherein such a sweep distance would allow for navigation within the vasculature system effectively.
Claim(s) 26-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Walen (US 2017/0027597 A1), in view of Paprocki (US 9782566 B1), further in view of Tada (US 2022/0354530 A1).
Regarding claim 26, Walen discloses:
A method for operating a surgical instrument comprising:
an outer shaft (outer tube 420, see Fig. 29) having an outer shaft cannula (see Fig. 29) and a first plurality of first segmented floating links (see Figs. 46-49 showing wherein the links are floating links defining an outer shaft flexible section (links 430, see Figs. 29 and 45); and
an inner shaft (inner tube 482, see Fig. 29) having an inner shaft cannula (see Fig. 29) and a plurality of second segmented floating links (see Fig. 53 – the examiner notes that each segment of the flexible neck is not connected to a unifying connection structure but rather merely joins adjacent links that allows for free movement as evidenced by Paragraph 190) defining an inner shaft flexible section (flexible neck 486, see Fig. 53);
the method comprising:
inserting the inner shaft and the outer shaft into the guide tube (see Paragraph 195);
positioning the inner shaft flexible section concentrically within the outer shaft flexible section (see Paragraph 190);
rotating the inner shaft relative to the outer shaft (see Paragraphs 188 and 196).
However, Walen does not expressly disclose
a guide tube; and
the step of rotating the outer shaft relative to the guide tube.
However, in the same field of endeavor, namely endoscopic instrum