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 Objections
Claim 29 is objected to because of the following informalities: The term “of” on line 3 should be replaced with the term “are” in order to be grammatically correct. Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 6, 7 and 9-13 are rejected under 35 U.S.C. 103 as being unpatentable over Balbierz et al. (US Pat 5,156,596) in view of Gregorich et al. (PG PUB 2007/0208323) or, in the alternative, as being unpatentable over Balbierz et al. (US Pat 5,156,596) in view of Blanchard (PG PUB 2012/0041419) and Gregorich et al. (PG PUB 2007/0208323).
Re claim 1, Balbierz discloses a delivery device (seen in Fig 7 wherein the hub 70 and interior sheath 52 of Fig 7 is replaced by the hub 94 and interior sheath 52 of Fig 10), comprising: an interior sheath 52 (Fig 10,11) having a proximal end (to the right in Fig 10), a distal end (to the left in Fig 10), a first central axis (extending horizontally in Fig 10), a first channel 90 (Fig 10-12) extending within the interior sheath from the proximal end to the distal end (as seen in Fig 10,12), and a second channel 92 (Fig 10-12) extending within the interior sheath from the proximal end to the distal end (as seen in Fig 10,12); a handle 38+94+22 (hubs 38,94 are labeled in Fig 10; lock 66 of hub 38 and hub 22 are seen and labeled in Fig 7) at the proximal end of the interior sheath, wherein the handle is configured to provide fluid communication between a first port and the first channel and a second port and the second channel (it is noted that the italicized text constitutes functional language and, therefore, “a first port” and “a second port” are only functionally recited and not a part of the claimed “delivery device”; this limitation is met in view of Col 10, Lines 6-10); and an exterior sheath 28 (Fig 10-12) surrounding the interior sheath (as seen in Fig 10-12), the exterior sheath having a second central axis (extending horizontally in Fig 10).
Balbierz does not explicitly disclose (1) that a collective cross-sectional area of the first channel and the second channel is more than 50% of a total cross sectional area of the sheath or (2) a plurality of ribs extending from an internal surface of the exterior sheath or an external surface of the interior sheath, wherein each of the plurality of ribs are configured to maintain a position of the interior sheath relative to the exterior sheath such that the first central axis and the second central axis are coaxial.
However, it would have been obvious to one of ordinary skill in the art at the time the invention was made to provide the channels with a size such that their collective cross-sectional area is more than 50% of a total cross sectional area of the sheath since Applicant has not disclosed that having the channels sized such that their collective cross-sectional area is more than 50% of a total cross sectional area of the sheath solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Absent a teaching as to the criticality of this size, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. Additionally, it would have been an obvious matter of design choice to size the channels such that their collective cross-sectional area is more than 50% of a total cross sectional area of the sheath since such a modification would have involved a mere change in the form or shape of a component; a change in form or shape is generally recognized as being within the level of ordinary skill in the art.
Alternatively, Blanchard teaches a delivery device 10 (Fig 1), comprising: a sheath 12 (Fig 1) having two channels 14,14 (Fig 3A-3C) having a collective cross-sectional area that is more than 50% of a total cross sectional area of the sheath (Para 52 sets forth that at the cross-section seen in Fig 3C, the diameter of the sheath is 0.07 inch, the wall thickness of the sheath is 0.008 inch, and the septum thickness of the sheath is 0.006 inch – this results in a total cross-sectional area of the sheath of 0.00385 sq.in. and a total cross-sectional area of the lumen of 0.00197 sq.in., resulting in the collective cross-sectional area of the channels being 51% of a total cross sectional area of the sheath); Blanchard teaches that providing the sheath and lumens in such a ratio provides a stability to the distal end of the sheath (Para 4). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Balbierz to size the channels such that they have a collective cross-sectional area that is more than 50% of a total cross sectional area of the sheath, as taught by Blanchard, for the purpose of providing stability to the distal end of the sheath (Para 4).
Blanchard does not teach (2) a plurality of ribs extending from an internal surface of the exterior sheath or an external surface of the interior sheath, wherein each of the plurality of ribs are configured to maintain a position of the interior sheath relative to the exterior sheath such that the first central axis and the second central axis are coaxial.
Gregorich, however, teaches a delivery device (Fig 1) comprising an interior sheath 602 (Fig 6), an exterior sheath 601 (Fig 6) surrounding the interior sheath (as seen in Fig 6), and a plurality of ribs 605,607 (Fig 6) extending from an interior surface of the exterior sheath or an external surface of the interior sheath (as seen in Fig 6), wherein each of the plurality of ribs are configured to maintain a position of the interior sheath relative to the exterior sheath such that the first central axis and the second central axis are coaxial (Claims 7,19,39). Gregorich teaches that providing such ribs aides in transferring torque down the length of the delivery device (Para 39). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Balbierz, or alternatively Balbierz/Blanchard, to include a plurality ribs configured to maintain a position of the interior sheath relative to the exterior sheath such that the first central axis and the second central axis are coaxial, as taught by Gregorich, for the purpose of aiding in transferring torque down the length of the delivery device (Para 39).
Re claim 6, Balbierz as modified by Gregorich in the rejection of claim 1 above discloses all the claimed features with Balbierz disclosing an at-least partly annular space 60 (Fig 11) being defined between the exterior sheath and the interior sheath (as seen in Fig 11) and Gregorich teaching such an annular space 603 (Fig 6) existing even in the presence of ribs 605,607 (as seen in Fig 6).
Re claim 7, Balbierz discloses that the exterior sheath rotates relative to the interior sheath (due to the threaded luer lock mechanism 66, best seen in Fig 4; alternatively, a “simple siding fit” can be utilized that would allow the two sheaths to rotate relative to each other – Col 8, Lines 1-3).
Re claim 9, Balbierz as modified by Gregorich in the rejection of claim 1 above discloses all the claimed features with Balbierz disclosing that the at-least partly annular space completely surrounds the interior sheath (as seen in Fig 11) and Gregorich teaching such an annular space 603 (Fig 6) existing even in the presence of ribs 605,607 (as seen in Fig 6).
Re claim 10, Balbierz as modified by Gregorich in the rejection of claim 1 discloses all the claimed features with Gregorich teaching that the ribs alternately protrude from the internal surface of the exterior sheath and the external surface of the interior sheath (as seen in Fig 6), such that rotation of the interior sheath is limited to a predetermined angle (Para 39). The motivation cited in the rejection of claim 1 also applies to claim 10.
Re claim 11, Balbierz discloses that the first channel and the second channel are separated by an inter-lumen wall (seen in Fig 10-12 but not labeled; labeled in annotated Fig A below) that extends from the proximal end to the distal end of the interior sheath (as seen in Fig 10,12).
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Re claim 12, Balbierz discloses a third port 42 (seen in Fig 10 but not labeled; labeled in Fig 4) of the handle, wherein the third port is in fluid communication with the at-least partly annular space (as seen in Fig 4).
Re claim 13, Balbierz discloses that the handle includes a proximal handle piece 38+94 (Fig 10) and a distal handle piece 22 (Fig 7), wherein the interior sheath is fixed to the proximal handle piece (as seen in Fig 4,7), and the exterior sheath is fixed to the distal handle piece (as seen in Fig 10), wherein a locking mechanism (the flange of end portion 24 and the thread of the shroud surrounding end portion 46, as seen in Fig 4, which form “a luer locking mechanism”, Col 7, Line 65 – Col 8, Line 1) couples the proximal handle piece to the distal handle piece such that the proximal handle piece rotates relative to the distal handle piece and the interior sheath rotates relative to the exterior sheath(Col 7, Line 65 – Col 8, Line 1).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Balbierz et al. (US Pat 5,156,596)/Gregorich et al. (PG PUB 2007/0208323) in view of Arnett (PG PUB 2020/0147360) or, in the alternative, as being unpatentable over Balbierz et al. (US Pat 5,156,596)/Blanchard (PG PUB 2012/0041419)/Gregorich et al. (PG PUB 2007/0208323) in view of Arnett (PG PUB 2020/0147360).
Re claim 14, Balbierz/Gregorich, or alternatively Balbierz/Blanchard/Gregorich, disclose all the claimed features except that the proximal handle piece includes a flange, the distal handle piece includes one or more protrusions proximal of the flange to couple the proximal handle piece to the distal handle piece, each protrusion is integral with a corresponding flexible post, and each flexible post is configured to bend to extend over the flange, permitting the protrusion to enter a space of the handle proximal to the flange. Arnett, however, teaches a delivery device (Fig 1A,1D) comprising a handle 110+222 (Fig 1D), an inner sheath (the proximal end of which is seen in Fig 1A,1D but not labeled; referred to in Para 72 as a “dilator”) attached to a proximal handle piece 222 (Fig 1D) of the handle and an outer sheath (the proximal end of which is seen in Fig 1A,1D but not labeled; referred to in Para 72 as a “sheath”) attached to a distal handle piece 110 (Fig 1D) of the handle, wherein the proximal handle piece includes a flange 226 (Fig 2A(i)) and the distal handle piece includes one or more protrusion 1230 (Fig 2A(i)) proximal of the flange and integral with a corresponding flexible post 1212 (Fig 2A(i)) configured to bend to extend over the flange permitting the protrusion to enter a space 224 (Fig 2A(i)) of the handle proximal to the flange (as seen in Fig 2A(ii)) so as to couple the proximal handle piece to the distal handle piece (Para 80); Arnett teaches that such a flange and protrusion/post arrangement provides a snap-fit that provides a relatively uniform insertion and removal force, provides sufficient retention force, and provides tactile feedback (Para 57). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Balbierz/Gregorich, or alternatively Balbierz/Blanchard/Gregorich, to replace the luer-lok connection with a snap-fit connection having a flange and one or more protrusions with flexible posts, as taught by Arnett, for the purpose of providing a relatively uniform insertion and removal force, sufficient retention force, and tactile feedback (Para 57).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Balbierz et al. (US Pat 5,156,596)/Gregorich et al. (PG PUB 2007/0208323) in view of Martin et al. (US Pat 5,135,599) or, in the alternative, as being unpatentable over Balbierz et al. (US Pat 5,156,596)/Blanchard (PG PUB 2012/0041419)/Gregorich et al. (PG PUB 2007/0208323) in view of Martin et al. (US Pat 5,135,599).
Re claim 15, Balbierz/Gregorich, or alternatively Balbierz/Blanchard/Gregorich, disclose all the claimed features except a third channel extending within the interior sheath from the proximal end to the distal end, wherein a collective cross-sectional area of the first channel, the second channel, and the third channel is more than 75% of a total cross sectional area of the interior sheath. Martin, however, teaches a sheath 26 (Fig 2,3) comprising three channels 50,52,54 (Fig 3,4) extending therein from a proximal end (to the left in Fig 2) to a distal end (to the right in Fig 2), wherein a collective cross-sectional area of the three channels is more than 57.6% of a total cross sectional area of the sheath (Col 9, Lines 34-35 set forth that the sheath has an outer diameter of 0.149 inches, resulting in a cross-sectional area of 0.0174 sq.in.; Col 9, Lines 31-34 set forth that the walls about lumen 54 and the walls forming the septum are 0.01 inches thick and the outer wall is 0.013 inches thick, resulting in the combination of all three lumen forming a collective cross-sectional area of 0.0098 sq.in, which is about 57.6% of the total cross sectional area of the sheath); Martin teaches that a sheath having three channels having a cross-sectional area of about 57.6% of a total cross sectional area of the sheath allows for the sheath to be used with a Seldinger wire in one channel while still allowing adequate fluid flow through the other two channels (Col 9, Lines 29-31 and 37-39). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Balbierz/Gregorich, or alternatively Balbierz/Blanchard/Gregorich, to include a third lumen within the interior sheath such that the collective cross-sectional area of the channels is about 57.6% of a total cross sectional area of the interior sheath, as taught by Martin, for the purpose of allowing the sheath to be used with a Seldinger wire in one channel while still allowing adequate fluid flow through the other two channels (Col 9, Lines 29-31 and 37-39).
Although 57.6% is not more than 75% of the total cross sectional area of the sheath, Applicant’s disclosure does not set forth any criticality between the channel’s cross-sectional area being 50%, two-thirds and three-fourths of a total cross sectional area of the sheath (Para 33,34). Therefore, it would have been an obvious matter of design choice to modify the size of the three channels such that their collective cross-sectional area is more than 75% of the total cross sectional area of the sheath since applicant has not disclosed that having such a size ratio solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to the criticality of this size, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. Additionally, it would have been an obvious matter of design choice to provide the three channels with a collective cross-sectional area that is more than 75% of a total cross sectional area of the sheath since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art.
Claims 1, 6, 11 and 12 are rejected under 35 U.S.C. 103 as being obvious over Neel et al. (PG PUB 2013/0158471) or, in the alternative, as being unpatentable over Neel et al. (PG PUB 2013/0158471) in view of Blanchard (PG PUB 2012/0041419).
Re claim 1, Neel discloses a delivery device (seen in Fig 1, wherein all reference characters cited below refer to Fig 1 unless otherwise noted), comprising: an interior sheath 20 having a proximal end 22, a distal end 24, a first central axis (extending out of page in Fig 3B), a first channel 26 (Fig 4D) extending within the interior sheath from the proximal end to the distal end (Para 37), and a second channel 28 (Fig 4D) extending within the interior sheath from the proximal end to the distal end (Para 37); a handle 30 + 14 (Fig 1,2) at the proximal end of the interior sheath (when the interior sheath is inserted within the exterior sheath as furthest as possible), wherein the handle is configured to provide fluid communication between a first port and the first channel and a second port and the second channel (it is noted that the italicized text constitutes functional language and, therefore, “a first port” and “a second port” are only functionally recited and not a part of the claimed “delivery device”; this limitation is met in view of ports 36,38 and Para 37); an exterior sheath 10 surrounding the interior sheath (as seen in Fig 1), the exterior sheath having a second central axis (extending out of the page in Fig 3B); and a plurality of ribs 18 (Fig 3B) extending from an internal surface of the exterior sheath or an external surface of the interior sheath (as seen in Fig 3B, Para 33), wherein each of the plurality of ribs are configured to maintain a position of the interior sheath relative to the exterior sheath such that the first central axis and the second central axis are coaxial (as seen in Fig 3B, the ribs contact the interior sheath and therefore maintain its position relative to the exterior sheath).
Neel does not explicitly disclose that a collective cross-sectional area of the first channel and the second channel is more than 50% of a total cross sectional area of the sheath.
However, it would have been obvious to one of ordinary skill in the art at the time the invention was made to provide the channels with a size such that their collective cross-sectional area is more than 50% of a total cross sectional area of the sheath since Applicant has not disclosed that having the channels sized such that their collective cross-sectional area is more than 50% of a total cross sectional area of the sheath solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Absent a teaching as to the criticality of this size, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. Additionally, it would have been an obvious matter of design choice to size the channels such that their collective cross-sectional area is more than 50% of a total cross sectional area of the sheath since such a modification would have involved a mere change in the form or shape of a component; a change in form or shape is generally recognized as being within the level of ordinary skill in the art.
Alternatively, Blanchard teaches a delivery device 10 (Fig 1), comprising: a sheath 12 (Fig 1) having two channels 14,14 (Fig 3A-3C) having a collective cross-sectional area that is more than 50% of a total cross sectional area of the sheath (Para 52 sets forth that at the cross-section seen in Fig 3C, the diameter of the sheath is 0.07 inch, the wall thickness of the sheath is 0.008 inch, and the septum thickness of the sheath is 0.006 inch – this results in a total cross-sectional area of the sheath of 0.00385 sq.in. and a total cross-sectional area of the lumen of 0.00197 sq.in., resulting in the collective cross-sectional area of the channels being 51% of a total cross sectional area of the sheath); Blanchard teaches that providing the sheath and lumens in such a ratio provides a stability to the distal end of the sheath (Para 4). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Neel to size the channels such that they have a collective cross-sectional area that is more than 50% of a total cross sectional area of the sheath, as taught by Blanchard, for the purpose of providing stability to the distal end of the sheath (Para 4).
Re claim 6, Neel discloses that an at-least partly annular space (between ridges 18 in Fig 3B) is defined between the exterior sheath and the interior sheath (as seen in Fig 3B).
Re claim 11, Neel discloses that the first channel and the second channel are separated by an inter-lumen wall (extending horizontally in Fig 4D) that extends from the proximal end to the distal end of the interior sheath (Para 37).
Re claim 12, Neel discloses a third port 15 (Fig 2A) of the handle, wherein the third port is in fluid communication with the at-least partly annular space (Para 32).
Claims 7, 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Neel et al. (PG PUB 2013/0158471) in view of Gregorich et al. (PG PUB 2007/0208323) or, in the alternative, as being unpatentable over Neel et al. (PG PUB 2013/0158471)/Blanchard (PG PUB 2012/0041419) in view of Gregorich et al. (PG PUB 2007/0208323).
Re claim 7, Neel, or alternatively Neel/Blanchard, disclose all the claimed features except explicitly disclosing that the exterior sheath rotates relative to the interior sheath. Gregorich, however, teaches a delivery device (Fig 1) comprising an interior sheath 602 (Fig 6), an exterior sheath 601 (Fig 6) surrounding the interior sheath (as seen in Fig 6), and a plurality of ribs 605,607 (Fig 6) extending from an interior surface of the exterior sheath or an external surface of the interior sheath (as seen in Fig 6), wherein each of the plurality of ribs are configured to maintain a position of the interior sheath relative to the exterior sheath such that the first central axis and the second central axis are coaxial (Claims 7,19,39 – as required by claim 1) and do not directly contact each other or the opposite sheath from which they extend so as to allow the exterior sheath to rotate relative to the interior sheath (Para 39). Gregorich teaches that providing such ribs – that extend from both of the sheaths and do not directly contact the other of the sheaths from which they extend – aides in transferring torque down the length of the delivery device while the device travels through the tortuous vasculature to avoid bending and kinking of the device (Para 39,4). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Balbierz, or alternatively Balbierz/Blanchard, to replace ribs 18 (that only extend from the internal surface of the exterior sheath and are in direct contact with the interior sheath) with ribs extending from the external surface of the interior sheath and ribs extending the internal surface of the exterior sheath such that they do not directly contact each other or the opposite sheath from which they extend and allow the exterior sheath to rotate relative to the interior sheath, as taught by Gregorich, for the purpose of aiding in transferring torque down the length of the delivery device while the device travels through the tortuous vasculature to avoid bending and kinking of the device (Para 39,4).
Re claim 9, Neel, or alternatively Neel/Blanchard, as modified by Gregorich in the rejection of claim 7 (which replaces Neel’s ribs 18 with Gregorich’s ribs 605,607) above disclose all the claimed features with Gregorich teaching that the at-least partly annular space 603 (Fig 6) completely surrounds the interior sheath (as seen in Fig 6). The motivation cited in the rejection of claim 7 above also applies to this claim.
Re claim 10, Neel, or alternatively Neel/Blanchard, as modified by Gregorich in the rejection of claim 7 above (which replaces Neel’s ribs 18 with Gregorich’s ribs 605,607) disclose all the claimed features with Gregorich teaching that the ribs alternately protrude from an internal surface of the exterior sheath and the external surface of the interior sheath (as seen in Fig 6), such that the rotation of the interior sheath is limited to a predetermined angle (Para 39). The motivation cited in the rejection of claim 7 above also applies to this claim.
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Neel et al. (PG PUB 2013/0158471) in view of Arnett (PG PUB 2020/0147360) or, in the alternative, as being unpatentable over Neel et al. (PG PUB 2013/0158471)/Blanchard (PG PUB 2012/0041419) in view of Arnett (PG PUB 2020/0147360).
Re claims 13 and 14, Neel, or alternatively Neel/Blanchard, discloses that the handle includes a proximal handle piece 30 (Fig 1) and a distal handle piece 14 (Fig 2A), wherein the interior sheath is fixed to the proximal handle piece (as seen in Fig 1) and the exterior sheath is fixed to the distal handle portion (Fig 1), but does not disclose a locking mechanism coupling the proximal handle piece to the distal handle piece such that the proximal handle piece rotates relative to the distal handle piece and the interior sheath rotates relative to the exterior sheath (as required by claim 13), wherein the proximal handle piece includes a flange, the distal handle piece includes one or more protrusions proximal of the flange to couple the proximal handle piece to the distal handle piece, each protrusion is integral with a corresponding flexible post, and each flexible post is configured to bend to extend over the flange, permitting the protrusion to enter a space of the handle proximal to the flange (as required by claim 14). Arnett, however, teaches a delivery device (Fig 1A,1D) comprising a handle 110+222 (Fig 1D) comprising a proximal handle piece 222 (Fig 1D) and a distal handle piece 110 (Fig 1D), an inner sheath (the proximal end of which is seen in Fig 1A,1D but not labeled; referred to in Para 72 as a “dilator”) fixed to the proximal handle piece (as seen in Fig 1D), and an outer sheath (the proximal end of which is seen in Fig 1A,1D but not labeled; referred to in Para 72 as a “sheath”) fixed to the distal handle piece (as seen in Fig 1D), wherein a locking means (formed by flange 226 and protrusion 1230, Fig 2A(i)) couples the proximal handle piece to the distal handle piece such that the proximal handle piece rotates relative to the distal handle piece and the interior sheath rotates relative to the exterior sheath (Para 80, since space 224 is annular), wherein the proximal handle piece includes a flange 226 (Fig 2A(i)) and the distal handle piece includes one or more protrusion 1230 (Fig 2A(i)) proximal of the flange and integral with a corresponding flexible post 1212 (Fig 2A(i)) configured to bend to extend over the flange permitting the protrusion to enter a space 224 (Fig 2A(i)) of the handle proximal to the flange (as seen in Fig 2A(ii)) so as to couple the proximal handle piece to the distal handle piece (Para 80); Arnett teaches that such a flange and protrusion/post arrangement provides a snap-fit that provides a relatively uniform insertion and removal force, provides sufficient retention force, and provides tactile feedback (Para 57). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Neel, or alternatively Neel/Blanchard, to include a handle comprising a proximal handle piece fixed to the interior sheath and a distal handle piece fixed to the exterior sheath and a snap-fit connection having a flange and one or more protrusions with flexible posts, as taught by Arnett, for the purpose of providing a relatively uniform insertion and removal force, sufficient retention force, and tactile feedback (Para 57).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Neel et al. (PG PUB 2013/0158471) in view of Martin et al. (US Pat 5,135,599) or, in the alternative, as being unpatentable over Neel et al. (PG PUB 2013/0158471)/Blanchard (PG PUB 2012/0041419) in view of Martin et al. (US Pat 5,135,599).
Re claim 15, Neel, or alternatively Neel/Blanchard, disclose all the claimed features except a third channel extending within the interior sheath from the proximal end to the distal end, wherein a collective cross-sectional area of the first channel, the second channel, and the third channel is more than 75% of a total cross sectional area of the interior sheath. Martin, however, teaches a sheath 26 (Fig 2,3) comprising three channels 50,52,54 (Fig 3,4) extending therein from a proximal end (to the left in Fig 2) to a distal end (to the right in Fig 2), wherein a collective cross-sectional area of the three channels is more than 57.6% of a total cross sectional area of the sheath (Col 9, Lines 34-35 set forth that the sheath has an outer diameter of 0.149 inches, resulting in a cross-sectional area of 0.0174 sq.in.; Col 9, Lines 31-34 set forth that the walls about lumen 54 and the walls forming the septum are 0.01 inches thick and the outer wall is 0.013 inches thick, resulting in the combination of all three lumen forming a collective cross-sectional area of 0.0098 sq.in, which is about 57.6% of the total cross sectional area of the sheath); Martin teaches that a sheath having three channels having a cross-sectional area of about 57.6% of a total cross sectional area of the sheath allows for the sheath to be used with a Seldinger wire in one channel while still allowing adequate fluid flow through the other two channels (Col 9, Lines 29-31 and 37-39). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Neel, or alternatively Neel/Blanchard, to include a third lumen within the interior sheath such that the collective cross-sectional area of the channels is about 57.6% of a total cross sectional area of the interior sheath, as taught by Martin, for the purpose of allowing the sheath to be used with a Seldinger wire in one channel while still allowing adequate fluid flow through the other two channels (Col 9, Lines 29-31 and 37-39).
Although 57.6% is not more than 75% of the total cross sectional area of the sheath, Applicant’s disclosure does not set forth any criticality between the channel’s cross-sectional area being 50%, two-thirds and three-fourths of a total cross sectional area of the sheath (Para 33,34). Therefore, it would have been an obvious matter of design choice to modify the size of the three channels such that their collective cross-sectional area is more than 75% of the total cross sectional area of the sheath since applicant has not disclosed that having such a size ratio solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to the criticality of this size, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. Additionally, it would have been an obvious matter of design choice to provide the three channels with a collective cross-sectional area that is more than 75% of a total cross sectional area of the sheath since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art.
Claims 21, 22, 24 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over McClure (US Pat 5,507,732) in view of Chesnin (PG PUB 2009/0247868).
Re claim 21, McClure discloses a delivery device (Fig 1; it is noted that all reference characters cited below refer to Fig 1 unless otherwise noted), comprising: an interior sheath 135 having a proximal end (to the left in Fig 1), a distal end (not shown but directed to the right in Fig 1), and a first channel 35 extending within the interior sheath from the proximal end to the distal end (“guidewire lumen”, Col 4, Lines 3-6); an exterior sheath 70 surrounding the interior sheath (as seen in Fig 1); a proximal handle piece 10+15 fixed to the interior sheath (as seen in Fig 1), wherein the proximal handle piece includes a flange 90 (Fig 2,3) and a planar surface (labeled in annotated Fig B below), wherein the planar surface is proximal to the flange (as seen in Fig 2); and a distal handle piece 20+25 fixed to the exterior sheath (as seen in Fig 1), wherein the distal handle piece includes a protrusion (the portion of post 85 extending proximally from the distal surface of slot 95, as seen in Fig 4 and labeled in annotated Fig B below) proximal of the flange (as seen in Fig 1) to couple the proximal handle piece to the distal handle piece (Col 5, Lines 14-21), wherein, when the distal handle piece is coupled to the proximal handle piece, the protrusion contacts1 the flange and the planar surface (as seen in Fig 1, the protrusion directly contacts the flange and indirectly contacts the planar surface). McClure does not disclose that the interior sheath includes a second channel extending within the interior sheath from the proximal end to the distal end. Chesnin, however, teaches a delivery device (Fig 2) comprising a sheath with a first channel 303 (Fig 3) extending from a proximal end to a distal end of the sheath (Para 30) – used for passage of a guide wire (Para 33) like in McClure – and a second channel 302 (Fig 3) extending from the proximal end to the distal end of the sheath (Para 30) for the purpose of allowing for power injection of agents while still providing easy insertion over a guide wire (Para 8). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify McClure to include a second channel, as taught by Balbierz, for the purpose of allowing for power injection of agents while still providing easy insertion over a guide wire (Para 8).
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Re claim 22, McClure discloses that the flange is exposed to an environment exterior to the delivery device (as seen in Fig 1 because it extends through slot 95).
Re claim 24, McClure discloses that the protrusion is integral with a corresponding flexible post (the portion of post 85 extending distally from the distal surface of slot 95, as seen in Fig 4 and labeled in annotated Fig B above), wherein the flexible post is configured to bend to extend over the flange, permitting the protrusion to enter a space between the flange and the planar surface (as seen in Fig 1).
Re claim 25, McClure discloses that the flexible post is positioned at a radially outermost surface of the distal handle piece (as seen in Fig 1,4).
Claims 21, 23 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Arnett et al. (PG PUB 2020/0147360) in view of Chesnin (PG PUB 2009/0247868).
Re claim 21, Arnett discloses a delivery device (as seen in Fig 1A, with the coupling mechanism 300 of Fig 5F(ii)), comprising: an interior sheath 202 (“dilator”, Para 72) having a proximal end (upward in Fig 1A), a distal end (not shown but downward in Fig 1A), and a first channel (seen in Fig 14A) extending within the interior sheath from the proximal end (as seen in Fig 14A); an exterior sheath 102 (“delivery catheter”, Para 72) surrounding the interior sheath (as seen in Fig 1A); a proximal handle piece 200 (Fig 1A) fixed to the interior sheath (Para 74), wherein the proximal handle piece includes a flange (labeled in annotated Fig C below) and a planar surface (labeled in annotated Fig C below), wherein the planar surface is proximal to the flange (as seen in Fig 5F(i)); and a distal handle piece 100 (best seen in Fig 1A, wherein housing 124 of 110 is seen in Fig 5F(ii)) fixed to the exterior sheath (Para 73), wherein the distal handle piece includes a protrusion 1333 (seen in Fig 5F(i) but not labeled; labeled in Fig 3B) proximal of the flange (as seen in Fig 5F(ii)) to couple the proximal handle piece to the distal handle piece (Para 86), wherein, when the distal handle piece is coupled to the proximal handle piece, the protrusion contacts2 the flange and the planar surface (as seen in Fig 5F(ii), the protrusion directly contacts the flange and indirectly contacts the planar surface). Arnett does not disclose that the first channel extends within the interior sheath from the proximal end to the distal end or that the interior sheath includes a second channel extending within the interior sheath from the proximal end to the distal end.
Chesnin, however, teaches a delivery device (Fig 2) comprising a sheath with a first channel 303 (Fig 3) extending from a proximal end to a distal end of the sheath (Para 30) and a second channel 302 (Fig 3) extending from the proximal end to the distal end of the sheath (Para 30) for the purpose of allowing for power injection of agents and providing easy insertion over a guide wire (Para 8). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Arnett to include the first channel such that it extends to the distal end of the sheath and to include a second channel, as taught by Balbierz, for the purpose of allowing for power injection of agents and providing easy insertion over a guide wire (Para 8).
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Re claim 23, Arnett discloses that the proximal handle piece rotates relative to the distal handle piece, and wherein the interior sheath rotates relative to the exterior sheath (since the space between the flange and the planar surface is annular and completely open).
Re claim 24, Arnett discloses that the protrusion is integral with a corresponding flexible post 1312 (seen in Fig 5F(i) but not labeled; labeled in Fig 3C), and wherein the flexible post is configured to bend to extend over the flange, permitting the protrusion to enter a space between the flange and the planar surface (seen in Fig 5F(ii); Para 86).
Claims 26-29 are rejected under 35 U.S.C. 103 as being unpatentable over Euteneuer et al. (US Pat 5,129,887) in view of Chesnin (PG PUB 2009/0247868).
Re claim 26, Euteneuer discloses a delivery device (Fig 1 with the handle assembly of Fig 7; all reference characters cited below refer to Fig 7 unless otherwise noted), comprising: an interior sheath 16+162 having a proximal end (to the right in Fig 7), a distal end (not shown in Fig 7 but directed to the left), and a first channel 20, seen in Fig 7 but not labeled; labeled in Fig 1) extending within the interior sheath from the proximal end of the distal end (Col 3, Lines 1-3); an exterior sheath 14 surrounding the interior sheath (as seen in Fig 7); a proximal handle piece 26” fixed to the interior sheath (as seen in Fig 7), wherein the proximal handle piece includes a distally-extending collar 158 and a collar lumen (within which portion 162 of the interior sheath resides in Fig 7), wherein the interior sheath is extended through the collar lumen (as seen in Fig 7); and a distal handle piece 24”+148 fixed to the exterior sheath (as seen in Fig 7), wherein the distal handle piece includes a seal 168 configured to radially surround a distal portion of the collar (as seen in Fig 7; Col 6, Lines 49-50). Euteneuer does not disclose that the interior sheath includes a second channel also extending within the interior sheath from the proximal end to the distal end.
Chesnin, however, teaches a delivery device (Fig 2) comprising a sheath with a first channel 303 (Fig 3) extending from a proximal end to a distal end of the sheath (Para 30) – used for passage of a guide wire (Para 33) like in Euteneuer – and a second channel 302 (Fig 3) extending from the proximal end to the distal end of the sheath (Para 30) for the purpose of allowing for power injection of agents while still providing easy insertion over a guide wire (Para 8). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Euteneuer to include a second channel, as taught by Balbierz, for the purpose of allowing for power injection of agents while still providing easy insertion over a guide wire (Para 8).
Re claim 27, Euteneuer discloses that the collar includes a flange 160 extending radially outward from an external surface of the collar (as seen in Fig 7; wherein the flange is an “external thread”, Col 6, Line 36, wherein the flange is positioned proximal to the seal (as seen in Fig 7).
Re claim 28, Euteneuer discloses that the collar extends distally from a planar surface (labeled in annotated Fig D below) of the proximal handle piece (seen in Fig 7).
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Re claim 29, Euteneuer discloses that the proximal handle piece is removably coupled to the distal handle piece (via threads 160,170; Col 6, Lines 45-48), wherein, when the proximal handle piece and the distal handle piece are removably coupled to one another, a space between the flange and the planar surface is configured to receive a portion 170 of the distal handle piece (Col 6, Lines 45-48).
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Euteneuer et al. (US Pat 5,129,887)/Balbierz et al. (US Pat 5,156,596) in view of Valley et al. (US Pat 5,766,151).
Re claim 30, Euteneuer does not explicitly disclose that the seal includes an o-ring. Valley, however, teaches using an o-ring 542 (Fig 9A,9B; Col 26, Lines 5-7) between a proximal handle portion 508 (Fig 9A,9b) of an interior sheath 502 (Fig 9A,9B) and a distal handle portion 540 (Fig 9A,9B) of an exterior sheath 504 (Fig 9A,9B) for the purpose of allowing the proximal handle portion to rotate easily within the distal handle portion (Col 25, Lines 61-64). Since Euteneuer’s proximal housing portion is intended to rotate within the distal housing portion, it would have been obvious to one of ordinary skill in the art at the time the invention was made to provide Euteneuer’s seal 168 as an o-ring, as taught by Valley, for the purpose of ensuring that the proximal handle portion can rotate easily within the distal handle portion (Col 25, Lines 61-64).
Response to Arguments
Applicant's arguments filed 10/1/2025 have been fully considered but they are not persuasive. Applicant argues that Gregorich does not disclose the amended subject matter of claim 1 (specifically that “each of the plurality of ribs are configured to maintain a position of the interior sheath relative to the exterior sheath such that the first central axis and the second central axis are coaxial”). The Examiner respectfully disagrees as claims 7, 19 and 39 of Gregorich recite that “the inner and outer members are tubular and substantially coaxial with one another”.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAMI A BOSWORTH whose telephone number is (571)270-5414. The examiner can normally be reached Monday - Thursday 8 am - 4 pm.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
1 It is noted that Applicant’s own protrusion 526 does not directly contact Applicant’s planar surface 520 and, therefore, the term “contacts” is interpreted as covering both direct contact and indirect contact.
2 It is noted that Applicant’s own protrusion 526 does not directly contact Applicant’s planar surface 520 and, therefore, the term “contacts” is interpreted as covering both direct contact and indirect contact.