DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. 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.
Response to Arguments
3. Applicant’s arguments with respect to claim(s) 1-20 have been considered but are moot because the new ground of rejection does not rely on any reference or combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 103
4. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
5. Claims 1, 15-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Hundertmark U.S. 9,259,262 (herein referred to as “Hundertmark”) and in view of Pikus U.S. 9,770,606 (herein referred to as “Pikus”).
6. Regarding Claim 1, Hundertmark teaches a thermal ablation device (Figs. 21, 22A, 22B, and 23), comprising:
a. a proximal portion (Fig. 23, ref num 800);
b. a distal portion (Fig. 23, ref num 700) sized and configured for insertion through a cervical opening (Figs. 22A and 22B; Col. 20, lines 59-61, “inserting the seal assembly 700 through the patient’s cervical canal”);
c. a connector disposed between the proximal portion and the distal portion (Fig. 21, ref num 720); and
d. an elongate shaft extending within the proximal portion, the connector, and the distal portion (Figs. 21 and 23, ref num 110/810), the elongate shaft defining a working lumen (understood that ref nums 110/810 define a working lumen);
e. wherein the distal portion includes:
e.1 a distal inner tube disposed radially outward of the elongate shaft (Fig. 21, ref num 715; Col. 20, lines 22-23, “the sleeve has a bore 718 therein that slidably accommodates the probe shaft indicated at 110”) and fixedly attached to the connector (Fig. 21, ref num 715 connected to ref num 720),
e.4 a sealing sleeve fixedly attached to an outer surface of the distal outer tube (Fig. 21, ref num 705), the sealing sleeve including a plurality of deflectable fins extending radially outward from the sealing sleeve (Fig. 21, ref num 736), and
e.5 a sealing balloon (Fig. 21, ref num 708) configured to shift between a deflated configuration and an inflated configuration (see deflated and inflated configurations between Figs. 22A and 22B; Col. 20, line 15, “the seal assembly can be actuated to expand the distal balloon”), the sealing balloon being fixedly attached at a proximal waist distal of the plurality of deflectable fins (see Fig. 21, ref num 708 is attached distal at a proximal waist, ref num 710, distal of ref nums 736).
This embodiment of Hundertmark fails to teach (e.2) a distal outer tube disposed radially outward of the distal inner tube, (e.3) a distal tip member fixedly attached to each of a distal end of the distal inner tube, a distal end of the distal outer tube, and a distal end of the elongate shaft, such that the distal inner tube, the distal outer tube, and the elongate shaft are fixed relative to one another; and (e.5) the sealing balloon is attached to the distal outer tube at a distal waist proximal of the distal tip member.
However, another embodiment of Hundertmark (Figs. 1, 2, 5, 6, and 7), which embodies the embodiment as described above (Col. 20, lines 9-17), teaches a thermal ablation device with an elongate shaft (Fig. 1, ref num 11) and a distal portion (Fig. 1, ref num 112). The distal portion includes a distal inner tube (Fig. 5, ref num 170), a distal outer tube disposed radially outward of the distal inner tube (Figs. 5 and 6, ref num 115), and a distal tip member (Figs. 2, 5, and 6, ref num 122/150) fixedly attached to a distal end of the distal inner tube (see Fig. 5), a distal end of the distal outer tube (Col. 8, lines 45-46, “thin-wall structure 150 is bonded to the exterior of the distal end of sleeve 115”), and a distal end of the elongate shaft (see Figs. 2 and 5). This embodiment also comprises a balloon (Figs. 1, 2, and 5, ref num 225) that the balloon is attached to the distal outer tube (see Fig. 7). The balloon is attached proximal of the distal tip member (Fig. 6, ref num 225 is attached proximal of ref num 122). The first embodiment discussed above may be used in combination with the Fig. 1 embodiment comprising the distal tip member (Col. 20, lines 9-17; Col. 21, lines 1-5; Col. 23, lines 23-26). 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 combined the various embodiments of Hundertmark in order for the distal portion to include a distal outer tube member and a distal tip member, as this would produce the same expected result of sealing the cervical canal (Col. 21, lines 38-39; Col. 4, line 36).
Pikus teaches an ablation device of analogous art (Figs. 2, 5, 6, and 7), wherein the device comprises a distal portion (Fig. 6, ref num 600) that includes a distal inner tube (Fig. 6, ref num 612), a distal outer tube (Fig. 6, ref num 610), and an elongate shaft (Fig. 6, ref num 609). A distal tip member is fixedly attached to each of these structures (Fig. 6, ref num 638 is attached to each of these structures), as well as all of these structures are fixed relative to one another (Col. 27, lines 35-36, 42-45). Pikus discusses that by fixing these structures to distal tip member, and modifying the stiffness of the distal end, this reduces injury to the body when the device is introduced (Col. 17, lines 50-52; Col. 25, 11-16). 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 Hundertmark to have fixed the various structures at the distal portion to one another as well as a distal tip member, in order to properly introduce the instrument to the target area and avoid unwanted damage to the area.
7. Regarding Claim 15, Hundertmark teaches a thermal ablation device (Figs. 21, 22A, 22B, and 23), comprising:
a. a proximal portion (Fig. 23, ref num 800) including a handpiece (Fig. 23, ref num 804) configured to connect to a fluid management system and an inflation port disposed distal of the handpiece (Fig. 23, ref num 820; Fig. 21, ref nums 630, 732);
b. a distal portion (Fig. 23, ref num 700) sized and configured for insertion through a cervical opening (Figs. 22A and 22B; Col. 20, lines 59-61, “inserting the seal assembly 700 through the patient’s cervical canal”);
c. a connector disposed between the proximal portion and the distal portion (Fig. 21, ref num 720); and
d. an elongate shaft extending within the proximal portion, the connector, and the distal portion (Figs. 21 and 23, ref num 110/810), the elongate shaft defining a working lumen (understood that ref nums 110/810 define a working lumen);
e. wherein the distal portion includes:
e.1 a distal inner tube disposed radially outward of the elongate shaft (Fig. 21, ref num 715; Col. 20, lines 22-23, “the sleeve has a bore 718 therein that slidably accommodates the probe shaft indicated at 110”) and fixedly attached to the connector (Fig. 21, ref num 715 connected to ref num 720),
e.4 a sealing sleeve fixedly attached to an outer surface of the distal outer tube (Fig. 21, ref num 705), the sealing sleeve including a plurality of deflectable fins extending radially outward from the sealing sleeve (Fig. 21, ref num 736), and
e.5 a sealing balloon (Fig. 21, ref num 708) configured to shift between a deflated configuration and an inflated configuration (see deflated and inflated configurations between Figs. 22A and 22B; Col. 20, line 15, “the seal assembly can be actuated to expand the distal balloon”), the sealing balloon being fixedly attached at a proximal waist distal of the plurality of deflectable fins (see Fig. 21, ref num 708 is attached distal at a proximal waist, ref num 710, distal of ref nums 736).
This embodiment of Hundertmark fails to teach (e.2) a distal outer tube disposed radially outward of the distal inner tube, (e.3) a distal tip member fixedly attached to each of a distal end of the distal inner tube, a distal end of the distal outer tube, and a distal end of the elongate shaft, such that the distal inner tube, the distal outer tube, and the elongate shaft are fixed relative to one another; and (e.5) the sealing balloon is attached to the distal outer tube at a distal waist proximal of the distal tip member.
However, another embodiment of Hundertmark (Figs. 1, 2, 5, 6, and 7), which embodies the embodiment as described above (Col. 20, lines 9-17), teaches a thermal ablation device with an elongate shaft (Fig. 1, ref num 11) and a distal portion (Fig. 1, ref num 112). The distal portion includes a distal inner tube (Fig. 5, ref num 170), a distal outer tube disposed radially outward of the distal inner tube (Figs. 5 and 6, ref num 115), and a distal tip member (Figs. 2, 5, and 6, ref num 122/150) fixedly attached to a distal end of the distal inner tube (see Fig. 5), a distal end of the distal outer tube (Col. 8, lines 45-46, “thin-wall structure 150 is bonded to the exterior of the distal end of sleeve 115”), and a distal end of the elongate shaft (see Figs. 2 and 5). This embodiment also comprises a balloon (Figs. 1, 2, and 5, ref num 225) that the balloon is attached to the distal outer tube (see Fig. 7). The balloon is attached proximal of the distal tip member (Fig. 6, ref num 225 is attached proximal of ref num 122). The first embodiment discussed above may be used in combination with the Fig. 1 embodiment comprising the distal tip member (Col. 20, lines 9-17; Col. 21, lines 1-5; Col. 23, lines 23-26). 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 combined the various embodiments of Hundertmark in order for the distal portion to include a distal outer tube member and a distal tip member, as this would produce the same expected result of sealing the cervical canal (Col. 21, lines 38-39; Col. 4, line 36).
Pikus teaches an ablation device of analogous art (Figs. 2, 5, 6, and 7), wherein the device comprises a distal portion (Fig. 6, ref num 600) that includes a distal inner tube (Fig. 6, ref num 612), a distal outer tube (Fig. 6, ref num 610), and an elongate shaft (Fig. 6, ref num 609). A distal tip member is fixedly attached to each of these structures (Fig. 6, ref num 638 is attached to each of these structures), as well as all of these structures are fixed relative to one another (Col. 27, lines 35-36, 42-45). Pikus discusses that by fixing these structures to distal tip member, and modifying the stiffness of the distal end, this reduces injury to the body when the device is introduced (Col. 17, lines 50-52; Col. 25, 11-16). 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 Hundertmark to have fixed the various structures at the distal portion to one another as well as a distal tip member, in order to properly introduce the instrument to the target area and avoid unwanted damage to the area.
8. Regarding Claim 16, Hundertmark teaches the sealing balloon is monolithically formed with the plurality of deflectable fins (see Figs. 16A and 16B).
9. Regarding Claim 17, Hundertmark teaches the sealing balloon is fixedly attached to the distal outer tube independent of the plurality of deflectable fins (see Fig. 21).
10. Regarding Claim 18, Hundertmark discusses the sealing balloon having a fluid capacity (Col. 11, lines 37-67 – Col. 12, lines 1-33), but fails to teach the capacity being less than 5 milliliters of inflation fluid. However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to have the fluid capacity less than 5 milliliters of inflation fluid, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
11. Regarding Claim 20, Hundertmark teaches a thermal ablation device (Figs. 21, 22A, 22B, and 23), comprising:
a. a proximal portion (Fig. 23, ref num 800) having a first outer diameter (see Fig. 23);
b. a distal portion (Fig. 23, ref num 700) having a second outer diameter less than the first outer diameter (see Fig. 23, diameter of ref num 700 is less than 800);
c. a connector disposed between the proximal portion and the distal portion (Fig. 21, ref num 720) wherein an outer surface of the connector is tapered from the first outer diameter to the second outer diameter (Col. 22, lines 66-67, “the cuff 905 can have a tapered axial profile with a taper in the proximal direction”); and
d. wherein the distal portion includes:
d.1 a distal inner tube fixedly attached to the connector and a distal tip member (Fig. 21, ref num 715; Col. 20, lines 22-23, “the sleeve has a bore 718 therein that slidably accommodates the probe shaft indicated at 110”; Fig. 21, ref num 715 connected to ref num 720 and tip of ref num 110),
d.4 a sealing sleeve fixedly attached to an outer surface of the distal outer tube (Fig. 21, ref num 705), the sealing sleeve including a plurality of deflectable fins extending radially outward from the sealing sleeve (Fig. 21, ref num 736), and
d.5 a sealing balloon (Fig. 21, ref num 708) configured to shift between a deflated configuration and an inflated configuration (see deflated and inflated configurations between Figs. 22A and 22B; Col. 20, line 15, “the seal assembly can be actuated to expand the distal balloon”), the sealing balloon being fixedly attached at a proximal waist distal of the plurality of deflectable fins (see Fig. 21, ref num 708 is attached distal at a proximal waist, ref num 710, distal of ref nums 736).
This embodiment of Hundertmark fails to teach (d.2) a distal outer tube disposed radially outward of the distal inner tube and fixedly attached to the connector and the distal tip member, (d.3) a distal tip member fixedly attached to each of a distal end of the distal inner tube, a distal end of the distal outer tube, and a distal end of the elongate shaft, such that the distal inner tube and the distal outer tube are fixed relative to one another, and (d.5) the sealing balloon is attached to the distal outer tube at a distal waist proximal of the distal tip member.
However, another embodiment of Hundertmark (Figs. 1, 2, 5, 6, and 7), which embodies the embodiment as described above (Col. 20, lines 9-17), teaches a thermal ablation device with an elongate shaft (Fig. 1, ref num 11) and a distal portion (Fig. 1, ref num 112). The distal portion includes a distal inner tube (Fig. 5, ref num 170), a distal outer tube disposed radially outward of the distal inner tube (Figs. 5 and 6, ref num 115), and a distal tip member (Figs. 2, 5, and 6, ref num 122/150) fixedly attached to a distal end of the distal inner tube (see Fig. 5), a distal end of the distal outer tube (Col. 8, lines 45-46, “thin-wall structure 150 is bonded to the exterior of the distal end of sleeve 115”), and a distal end of the elongate shaft (see Figs. 2 and 5). This embodiment also comprises a balloon (Figs. 1, 2, and 5, ref num 225) that the balloon is attached to the distal outer tube (see Fig. 7). The balloon is attached proximal of the distal tip member (Fig. 6, ref num 225 is attached proximal of ref num 122). The first embodiment discussed above may be used in combination with the Fig. 1 embodiment comprising the distal tip member (Col. 20, lines 9-17; Col. 21, lines 1-5; Col. 23, lines 23-26). 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 combined the various embodiments of Hundertmark in order for the distal portion to include a distal outer tube member and a distal tip member, as this would produce the same expected result of sealing the cervical canal (Col. 21, lines 38-39; Col. 4, line 36).
Pikus teaches an ablation device of analogous art (Figs. 2, 5, 6, and 7), wherein the device comprises a distal portion (Fig. 6, ref num 600) that includes a distal inner tube (Fig. 6, ref num 612), a distal outer tube (Fig. 6, ref num 610), and an elongate shaft (Fig. 6, ref num 609). A distal tip member is fixedly attached to each of these structures (Fig. 6, ref num 638 is attached to each of these structures), as well as all of these structures are fixed relative to one another (Col. 27, lines 35-36, 42-45). Pikus discusses that by fixing these structures to distal tip member, and modifying the stiffness of the distal end, this reduces injury to the body when the device is introduced (Col. 17, lines 50-52; Col. 25, 11-16). 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 Hundertmark to have fixed the various structures at the distal portion to one another as well as a distal tip member, in order to properly introduce the instrument to the target area and avoid unwanted damage to the area.
12. Claims 2-7 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Hundertmark and Pikus, and further in view of Schewe U.S. 7,985,063 (herein referred to as “Schewe”).
13. Regarding Claim 2, Hundertmark fails to teach the sealing balloon includes a first cuff, a second cuff, and a central portion extending from the first cuff to the second cuff in the deflated configuration.
Schewe teaches a balloon of analogous art (Figs. 9-11) wherein the balloon includes a first cuff (Fig. 10, ref num 106a), a second cuff (Fig. 10, ref num 106b), and a central portion (Fig. 10, ref num 104) that extends from the first cuff to the second cuff in a deflated configuration (Fig. 10 displays the deflated configuration). The first and second cuff with a central portion illustrate a different shape of the balloon. Therefore, it would have been an obvious matter of design choice to make the different portions of the balloon whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
14. Regarding Claim 3, Hundertmark fails to teach the second cuff is spaced axially apart from the first cuff in the deflated configuration by the central portion of the sealing balloon.
Schewe teaches a balloon of analogous art (Figs. 9-11) wherein the balloon includes a first cuff (Fig. 10, ref num 106a), a second cuff (Fig. 10, ref num 106b), and a central portion (Fig. 10, ref num 104). The second cuff is spaced axially apart from the first cuff in the deflated configuration by the central portion of the sealing balloon (see Fig. 10, ref num 104 spaces 106a and 106b apart from one another in deflated configuration). This illustrates another shape of the balloon. Therefore, it would have been an obvious matter of design choice to make the different portions of the balloon whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
15. Regarding Claim 4, Hundertmark fails to teach the first cuff defines a generally annular shape in the deflated configuration.
Schewe teaches a balloon of analogous art (Figs. 9-11) wherein the balloon includes a first cuff (Fig. 10, ref num 106a) that defines a generally annular shape in the deflated configuration (see Fig. 10, ref num 106a defines an annular shape). It would have been an obvious matter of design choice to make the different portions of the first cuff whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
16. Regarding Claim 5, Hundertmark fails to teach the second cuff defines a generally annular shape in the deflated configuration.
Schewe teaches a balloon of analogous art (Figs. 9-11) wherein the balloon includes a second cuff (Fig. 10, ref num 106b) that defines a generally annular shape in the deflated configuration (see Fig. 10, ref num 106b defines an annular shape). It would have been an obvious matter of design choice to make the different portions of the second cuff whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
17. Regarding Claim 6, Hundertmark fails to teach in the inflated configuration of the sealing balloon, the central portion of the sealing balloon defines a radially outermost extent of the sealing balloon.
Schewe teaches a balloon of analogous art (Figs. 9-11) wherein in the inflated configuration (Fig. 11) the central portion of the sealing balloon defines a radially outermost extent of the sealing ballon (see Fig. 11, ref num 104 defines the outermost extent of the balloon compared to the cuffs, ref nums 106a, 106b). This produces the same expected result of expanding the balloon into an inflated configuration to fit within the body cavity (Col. 8, lines 48-55). Therefore, it would have been an obvious matter of design choice to make the different portions of the central portion and balloon whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
18. Regarding Claim 7, Hundertmark fails to teach in the deflated configuration of the sealing balloon, the first cuff and the second cuff each extend radially outward a greater distance from the distal outer tube than the central portion of the sealing balloon.
Schewe teaches a balloon of analogous art (Figs. 9-11) wherein in the deflated configuration (Fig. 10) the first cuff and the second cuff each extend radially outward a greater distance from the distal outer tube than the central portion of the sealing balloon (see Fig. 10, ref nums 116, 106a, and 106b). This illustrates another shape of the balloon. Therefore, it would have been an obvious matter of design choice to make the different portions of the balloon whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
19. Regarding Claim 19, Hundertmark fails to teach in the deflated configuration, the sealing balloon defines a first chamber and a second chamber spaced apart from the first chamber, and in the inflated configuration, the sealing balloon defines a single interior chamber.
Schewe teaches a balloon of analogous art (Figs. 9-11) wherein the balloon in the deflated configuration defines a first chamber (Fig. 10, ref num 106a) and a second chamber (Fig. 10, ref num 106b), and in the inflated configuration (Fig. 11) the sealing balloon defines a single interior chamber (see Fig. 11, the balloon comprises one chamber). This produces the same expected result of expanding the balloon into an inflated configuration to fit within the body cavity (Col. 8, lines 48-55). Therefore, it would have been an obvious matter of design choice to make the different portions balloon whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
20. Claims 8-12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Hundertmark and Pikus, and further in view of Oepen U.S. 2007/0021771 (herein referred to as “Oepen”).
21. Regarding Claim 8, Hundertmark fails to teach the proximal portion includes: a proximal inner tube disposed radially outward of the elongate shaft and fixedly attached to the connector, a proximal middle tube disposed radially outward of the proximal inner tube and spaced apart proximally from the connector, and a proximal outer tube disposed radially outward of the proximal middle tube and fixedly attached to the connector.
Oepen teaches an device of analogous art (Fig. 1), wherein the device includes a proximal portion (Fig. 1, ref nums 102 and 104), wherein the proximal portion includes:
a. a proximal inner tube (Fig. 1, ref num 20) disposed radially outward of an elongate shaft (Fig. 1, ref num 30; ref num 20 is radially outward of ref num 30) and fixedly attached to a connector (Fig. 1, ref num 110 is the connector; para 0089, “proximal end region 20a…is secured to adapter 110 by suitable structure or method”),
b. a proximal middle tube disposed radially outward of the proximal inner tube (Fig. 1, ref num 26) and spaced apart proximally from the connector (spaced apart from connected; see Fig. 1), and
c. a proximal outer tube disposed radially outward of the proximal middle tube (Fig. 2, ref num 22).
While Oepen fails to explicitly teach that the proximal outer tube is fixedly attached to the connector, they do contemplate that the outer tube overlap the entirety of the inner tube (para 0093, “intermediate member can overlap the entire length of the bonding region”). This would indicate that the connector and outer tube be fixed to one another, therefore reading on the claim language.
This configuration of the device improves the pushability of the device through the body lumen and prevents kinking of the device (para 0111). 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 Hundertmark to have the proximal portion of the device be made up of a plurality of tubes in order to increase the strength of the device and reduce kinking when advancing the device through the body lumen.
22. Regarding Claim 9, Hundertmark teaches an inflation lumen in fluid communication with the sealing balloon (understood that inflation source, Fig. 21, ref num 630, would have an inflation lumen in communication with the balloon; Col. 20, lines 18-40).
However, Hundertmark fails to teach at least a portion of the inflation lumen is defined by the proximal middle tube and the proximal outer tube.
Oepen teaches an inflation lumen (Fig. 1, ref num 24c) is defined by the proximal middle tube (ref num 26) and the proximal outer tube (ref num 22; para 0149, “intermediate tubular member 22 can be provided in an overlapping configuration with the proximal end region 24a”; also see Fig. 10). This strengthens the device as well as provides means for the balloon to be inflated (para 0151). 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 Hundertmark to have the inflation lumen be defined by the proximal middle tube and the proximal outer tube as this achieves the same expected result of inflating the balloon.
23. Regarding Claim 10, Hundertmark fails to teach at least a portion of the inflation lumen is defined by a recess formed in a wall of the proximal outer tube or a recess formed in a wall of the proximal middle tube.
Oepen teaches an inflation lumen (Fig. 1, ref num 24c) defined by a recess formed in a wall of the proximal middle tube (see Figs. 10-13, ref num 24c [typo displays it as 22c in figs. 11-13] is formed in a recess of the wall of ref num 26). This strengthens the device as well as provides means for the balloon to be inflated (para 0151). 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 Hundertmark to have the inflation lumen be defined by a recess formed in a wall of the proximal outer tube or a recess formed in a wall of the proximal middle tube.
24. Regarding Claim 11, Hundertmark fails to teach an outer surface of the proximal middle tube is in contact with an inner surface of the proximal outer tube.
Oepen teaches an outer surface of the proximal middle tube is in contact with an inner surface of the proximal outer tube (see Fig. 1, outer surface of ref num 26 is in contact with inner surface of ref num 22). This strengthens the device as well as provides means for the balloon to be inflated (para 0111). 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 Hundertmark to have the outer surface of the proximal middle tube be in contact with an inner surface of the proximal outer tube.
25. Regarding Claims 12 and 14, Hundertmark fails to teach the proximal middle tube is radially spaced apart from the proximal inner tube by a first distance and the proximal middle tube is radially spaced apart from the proximal outer tube by a second distance, such that the first distance is greater than the second distance.
Oepen teaches the proximal middle tube (ref num 26) is radially spaced apart from the proximal inner tube by a first distance (see Fig. 1, ref num 26 is spaced apart from ref num 20; para 0093) and the proximal middle tube is radially spaced apart from the proximal outer tube by a second distance that is greater than the first distance (see Fig. 1, ref num 26 is spaced apart from ref num 22 at a distance). It would have been an obvious matter of design choice to have the spacing of the inner and outer tubes compared to the intermediate tube be of a first and second distance, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
26. Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Hundertmark, Pikus, Oepen, and further in view of Nishimura U.S. 2023/0062912 (herein referred to as “Nishimura”).
27. Regarding Claim 13, Hundertmark fails to teach the proximal portion further includes: a first O-ring disposed between the proximal inner tube and the proximal middle tube; and a second O-ring disposed between the proximal inner tube and the proximal middle tube; wherein the proximal inner tube, the first O-ring, the second O-ring, and the proximal middle tube define an insulating air gap extending along a majority of the proximal portion.
Oepen teaches a tight seal between the proximal inner tube and proximal middle tube (Fig. 1, ref nums 20 and 26; para 0092, 0096) in order to provide reinforcement to the device (para 0027). However, Hundertmark as modified by Oepen fails to teach a first O-ring disposed between the proximal inner tube and the proximal middle tube; and a second O-ring disposed between the proximal inner tube and the proximal middle tube; wherein the proximal inner tube, the first O-ring, the second O-ring, and the proximal middle tube define an insulating air gap extending along a majority of the proximal portion.
Nishimura teaches a connection in which there is a first O-ring and a second O-ring disposed between an inner tube and middle tube (Fig. 3, ref nums 73 and 74). The O-rings provide a liquid-tight seal between these tubes, indicating an insulating air gap extending along the connector (para 0036). 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 substituted the sealing and utilized a plurality of O-rings in order to achieve a fluid tight sealing between the tubes.
Conclusion
28. 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.
29. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNIE L SHOULDERS whose telephone number is (571)272-3846. The examiner can normally be reached Monday-Friday (alternate Fridays) 8AM-5PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at 571-272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ANNIE L SHOULDERS/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794