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
Regarding the previous claim objection, the amendment to claim 1 is acknowledged and the claim objection is withdrawn.
Applicant’s arguments, see pages 2-3, filed 01/26/2026, with respect to the 102 rejection(s) of claim(s) 1 under Isaacs and the 103 rejection(s) of claim 16 under Isaacs in view of Weisenburgh, II have been fully considered and are persuasive. The examiner agrees that the Isaacs reference fails to disclose “a first mating feature positioned on the ultrasonic blade assembly…wherein the overmolded distal pipe is directly overmolded upon the ultrasonic blade assembly such that the second mating feature is defined by the first mating feature” as required in claim 1 and modified Isaacs fails to disclose “a first mating feature including a bore extending perpendicularly from the longitudinal axis” as required in claim 16. Therefore, the rejections have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Weisenburgh, II et al. (US 20140135804) (claim 1 and new claim 24) and Isaacs et al. (US 20090099582) in view of Estabrook (US 5935144) (claim 16).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 3, 6-10, 21 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Weisenburgh, II et al. (US 20140135804) [hereinafter Weisenburgh, II].
* The examiner notes that the embodiment of Fig. 19 is relied upon for the rejection. However, other embodiments are relied upon for shared features that are not shown or discussed in the embodiment of Fig. 19 (para. 0179: “In addition, it should be understood that any one or more of the disclosed embodiments, expressions of embodiments, and/or examples thereof, can be combined with any one or more of the other disclosed embodiments, expressions of embodiments, and/or examples thereof, without limitation”).
Regarding claim 1, Weisenburgh, II discloses a surgical instrument 1000 (Fig. 19, para. 0247), comprising:
(a) an ultrasonic blade assembly 1004 including an ultrasonic blade (interpreted as a portion of blade 1004 that extends out of tube 1010 and contacts jaw member 1002, see annotated Fig. 19 below) and at least a portion of a waveguide (not shown in Fig. 19, however, Fig. 20 illustrates that the blade includes a waveguide, see annotated Fig. 20 below), wherein the at least the portion of the waveguide extends along a longitudinal axis (see Fig. 20 for example), and wherein the ultrasonic blade 1004 distally extends from the at least the portion of the waveguide (see Figs. 19-20, para. 0247);
(b) a sheath 1010 positioned over at least a portion of the ultrasonic blade assembly (Fig. 19, para. 0247); and
(c) a first mating feature positioned on the ultrasonic blade assembly 1004 (para. 0245: “One or more retention features may be provided on the blade and/or the tube(s) for retaining the boot (i.e. the overmolded distal pipe 1006, para. 0247) to the blade and/or the tube(s));
(d) an overmolded distal pipe 1006 (see note below in regards to the interpretation of “overmolded”) extending distally from the sheath 1010 (Fig. 19, para. 0247), wherein the overmolded distal pipe includes a second mating feature (para. 0245: “In one embodiment, the retention features may also be located on the boot barrier itself”, see para. 0179 which supports the combination of embodiments), wherein the overmolded distal pipe 1006 is positioned upon the ultrasonic blade assembly 1004 (para. 0247: “A flexible boot barrier 1006 is positioned over a proximal portion 1008 of the blade 1004 and a distal portion of a tube 1010 to seal the blade 1004 to an outer diameter 1012 of the tube 1010”).
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Annotated Fig. 19 of Weisenburgh, II
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Annotated Fig. 20 of Weisenburgh, II
However, the embodiment of Fig. 19 of Weisenburgh, II fails to disclose that the first mating feature has one or more raised portions and the second mating feature has one or more recessed portions configured to mate with the one or more raised portions of the first mating feature, wherein the overmolded distal pipe is directly overmolded upon the ultrasonic blade assembly such that the second mating feature is defined by the first mating feature.
The embodiment of Fig. 20 of Weisenburgh, II teaches that a first mating feature having one or more raised portions (see the annotated of the embodiment of Fig. 20 below which illustrates one or more raised portions as a retention feature for sealing the blade assembly to the overmolded distal pipe 1006) and a second mating feature having one or more recessed portions (see the embodiment of Fig. 20 annotation below which illustrates one or more recessed portions as a retention feature to seal the blade assembly to the overmolded distal pipe 1006) configured to mate with the one or more raised portions of the first mating feature (see annotated Fig. 20 below) is known in the art; wherein the overmolded distal pipe 1006 is directly overmolded upon the ultrasonic blade assembly 1004 such that the second mating feature is defined by the first mating feature (see annotated Fig. 20 below).
The substitution of one known mating features (one or more raised portions of the first mating feature and one or more recessed portions of the second mating feature as shown in the embodiment of Fig. 20 of Weisenburgh, II) for another (the first and second mating features as discussed in Weisenburgh, II) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since the substitution of the first and second mating features as shown in the embodiment of Fig. 20 of Weisenburgh, II would have yielded predictable results, namely, an alternative way to retain and seal the overmolded distal pipe to the ultrasonic blade assembly (Fig. 20, para. 0248 of Weisenburgh, II).
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Annotated Fig. 20 [a] of Weisenburgh, II
Note: The claimed limitation “an overmolded distal pipe” is being treated as a product by process limitation; that is the product-by-process limitation is limiting only in so far as the final structure necessitated by the process. The final structure necessitated by injection molding is a distal pipe that directly contacts at least a portion of an element in which the distal pipe is attached upon (see para. 0039 of the written description in the instant application). Since Weisenburgh, II discloses the final structure necessitated by the process i.e. a distal pipe 1006 that directly contacts a at least a portion of an element in which the distal pipe is attached upon (para. 0247 of Weisenburgh, II: “A flexible boot barrier 1006 is positioned over a proximal portion 1008 of the blade 1004 and a distal portion of a tube 1010 to seal the blade 1004 to an outer diameter 1012 of the tube 1010. A retention feature 1014 may be provided on the outer diameter 1012 of the tube 1010 to keep the boot barrier 1006 in place), it is considered to meet this product-by-process limitation. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113.
Regarding claim 3, modified Weisenburgh, II discloses wherein the first mating feature is positioned on the waveguide (see annotated Figs. 20 and 20[a] of Weisenbrugh, II above).
Regarding claims 6 and 7, modified Weisenburgh, II discloses all of the limitations set forth above in claim 1. Modified Weisenburgh, II further contemplates a third mating feature positioned on the overmolded distal pipe in para. 0245 (para. 0245: “One or more retention features may be provided on the blade and/or the tube(s) for retaining the boot to the blade and/or the tube(s). In one embodiment, the retention features may also be located on the boot barrier itself”) and further discloses a fourth feature 1014 (Fig. 19, para. 0247: “A retention feature 1014 may be provided on the outer diameter 1012 of the tube 1010 to keep the boot barrier 1006 in place”), wherein the fourth mating feature 1014 is positioned on a distal portion of the sheath to connect to the third mating feature at a proximal portion of the overmolded distal pipe (see Fig. 19, para. 0247).
However, modified Weisenburgh, II fails to explicitly disclose wherein the third mating feature includes a tapered region and the fourth mating feature includes a complimentary tapered region configured to mate with the tapered region of the third mating feature.
The embodiment of Fig. 20 of Weisenburgh, II teaches that a mating feature having a tapered region (see the annotated of the embodiment of Fig. 20 [b] below) and a mating feature having a complimentary tapered region configured to mate with the tapered region of the other mating feature (see the embodiment of Fig. 20 [b] below) is known in the art.
Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to the device of modified Weisenburgh, II to include the third mating feature and the fourth mating feature having complimentary tapered regions to connect the proximal portion of the overmolded distal pipe to the distal portion of the sheath, since it has been held that mere duplication of essential working parts of a device involves only routine skill in the art. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
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Annotated Fig. 20 [b] of Weisengburgh, II
Regarding claim 8, modified Weisenburgh, II discloses wherein one of the third or fourth mating features includes a raised portion and the other of the third or fourth mating feature includes a recessed portion, wherein the raised portion is configured to mate with the recessed portion (see annotated Fig. 20 [b] of Weisenburgh, II above).
Regarding claim 9, modified Weisenburgh, II discloses wherein the third and fourth mating features are configured to prevent debris from entering an interior of the surgical instrument when the third and fourth mating features are mated together (para. 0246).
Regarding claim 10, modified Weisenburgh, II discloses wherein the first and second mating features are configured to prevent debris from entering an interior of the surgical instrument when the first and second mating features are mated together (para. 0246).
Regarding claim 21, modified Weisenburgh, II discloses wherein the overmolded distal pipe 1006 includes an elastomeric material conformed to match the first mating feature (see annotated Fig. 20 [a] of Weisenburgh, II above; para. 0244: “The boot barrier may be made from any suitable materials including compliant, thermally robust material that has a relatively low coefficient of friction in order to minimize the seal load on the blade. Materials suitable for the boot barrier may include, for example, silicone rubber, parylene coated silicon rubber, Tetrafluoroethylene-hexafluoropropylene (FEP), which has similar properties to those of Polytetrafluoroethylene (PTFE) otherwise known in the trade as Teflon, shrink tubing, or any similar material).
Regarding claim 24, Weisenburgh, II discloses a surgical instrument 1000 (Fig. 19, para. 0247), comprising:
(a) an ultrasonic blade assembly 1004 including an ultrasonic blade (interpreted as a portion of blade 1004 that extends out of tube 1010 and contacts jaw member 1002, see annotated Fig. 19 above) and at least a portion of a waveguide (not shown in Fig. 19, however, Fig. 20 illustrates that the blade includes a waveguide, see annotated Fig. 20 above, wherein the at least the portion of the waveguide extends along a longitudinal axis (see Fig. 20 for example), and wherein the ultrasonic blade 1004 distally extends from the at least the portion of the waveguide (see Figs. 19-20, para. 0247);
(b) a sheath 1010 positioned over at least a portion of the ultrasonic blade assembly (Fig. 19, para. 0247);
(c) a first mating feature positioned on the ultrasonic blade assembly 1004 (para. 0245: “One or more retention features may be provided on the blade and/or the tube(s) for retaining the boot (i.e. the overmolded distal pipe 1006, para. 0247) to the blade and/or the tube(s));
(d) an overmolded distal pipe 1006 (see note above in the rejection of claim 1 in regards to the interpretation of “overmolded”) directly overmolded on the ultrasonic blade assembly 1004 and extending distally from the sheath 1010 (Fig. 19, para. 0247: “A flexible boot barrier 1006 is positioned over a proximal portion 1008 of the blade 1004 and a distal portion of a tube 1010 to seal the blade 1004 to an outer diameter 1012 of the tube 1010”), wherein the overmolded distal pipe includes a second mating feature (para. 0245: “In one embodiment, the retention features may also be located on the boot barrier itself”, see para. 0179 which supports the combination of embodiments).
However, the embodiment of Fig. 19 of Weisenburgh, II fails to disclose wherein the first mating feature is positioned on the at least the portion of the waveguide, wherein the first mating feature includes an annular central rib positioned between a pair of annular side ribs (see annotated Fig. 20 [c] below), wherein the annular central rib and the pair of annular side ribs are raised above a nominal outside diameter of the at least the portion of the waveguide, wherein the annular central rib includes a central outside diameter that is greater than a side outside diameter of the pair of annular side ribs, and wherein the overmolded distal pipe includes a second mating feature including an annular channel that corresponds with the annular central rib and is bonded to the pair of annular side ribs.
The embodiment of Fig. 20 of Weisenburgh, II teaches that a first mating feature positioned on at least the portion of the waveguide (see the annotated of the embodiment of Fig. 20 [c] below), wherein the first mating feature includes an annular central rib positioned between a pair of annular side ribs (see annotated Fig. 20 [c] below), wherein the annular central rib and the pair of annular side ribs are raised above a nominal outside diameter of the at least the portion of the waveguide (see annotated Fig. 20 [c] below), wherein the annular central rib includes a central outside diameter that is greater than a side outside diameter of the pair of annular side ribs (see annotated Fig. 20 [d] below), and wherein an overmolded distal pipe 1006 includes a second mating feature including an annular channel that corresponds with the annular central rib and is bonded to the pair of annular side ribs (see the embodiment of Fig. 20 [c] below).
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Annotated Fig. 20 [c] of Weisenburgh, II
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Annotated Fig. 20 [d] of Weisenburgh, II
The substitution of one known mating features (first mating feature comprising annular central rib and annular side ribs on the waveguide and second mating feature comprising the annular channel on the overmolded distal pipe as shown in the embodiment of Fig. 20 of Weisenburgh, II) for another (the first and second mating features between the ultrasonic blade assembly and overmolded distal pipe as discussed in Weisenburgh, II) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since the substitution of the first and second mating features as shown in the embodiment of Fig. 20 of Weisenburgh, II would have yielded predictable results, namely, an alternative way to retain and seal the overmolded distal pipe to the waveguide (Fig. 20, para. 0248 of Weisenburgh, II).
Modified Weisenburgh, II further contemplates a third mating feature positioned on an exterior of the overmolded distal pipe in para. 0245 of Weisenburgh, II (para. 0245: “One or more retention features may be provided on the blade and/or the tube(s) for retaining the boot to the blade and/or the tube(s). In one embodiment, the retention features may also be located on the boot barrier itself”) and further discloses a fourth feature 1014 positioned on a distal portion of the sheath (Fig. 19, para. 0247: “A retention feature 1014 may be provided on the outer diameter 1012 of the tube 1010 to keep the boot barrier 1006 in place”), wherein the fourth mating feature 1014 is positioned on a distal portion of the sheath to connect to the third mating feature at a proximal exterior the overmolded distal pipe (see Fig. 19, para. 0247).
However, modified Weisenburgh, II fails to disclose wherein the third and fourth mating features include complementary tapered sections configured to produce a liquid tight seal between the overmolded distal pipe and the sheath.
The embodiment of Fig. 20 of Weisenburgh, II teaches that a mating feature having a tapered region (see the annotated of the embodiment of Fig. 20 [b] above) and a mating feature having a complimentary tapered region configured to mate with the tapered region of the other mating feature (see the embodiment of Fig. 20 [b] above) is known in the art.
Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to the device of modified Weisenburgh, II to include the third mating feature and the fourth mating feature having complimentary tapered regions to connect the proximal portion of the overmolded distal pipe to the distal portion of the sheath, since it has been held that mere duplication of essential working parts of a device involves only routine skill in the art. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Claim(s) 11, 13-15, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Weisenburgh, II et al. (US 20140135804) [hereinafter Weisenburgh, II] in view of Isaacs et al. (US 20090099582) [hereinafter Isaacs].
Regarding claim 13, modified Weisenburgh, II discloses all of the limitations set forth above in claim 1. However, Weisenburgh, II fails to disclose wherein at least a portion of the overmolded distal pipe is positioned within an interior diameter of the sheath.
Isaacs in the same field of endeavor of tubular member connections teaches that it is known in the art for a distal pipe 76 to be positioned within an interior diameter of a sheath 72 as an alternative way to connect one tubular member to another (Fig. 2, para. 0113: “During assembly the outer shroud 72 is passed over the blade 79 and then the distal shroud 76 is passed over the curved portion of the blade 79a…the distal shroud 76 is pressed fit onto the outer shroud 72 (or other attachment means, such as glue or mechanical fastering)”).
In light of this teaching, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify overmolded distal pipe in Weisenburgh, II such that at least a portion of the overmolded distal pipe is positioned within the interior diameter of the sheath, as taught by Isaacs, since such a modification is a substitution for one known connection means for another and would yield a predictable result, namely an alternative way to attach the distal end of the sheath externally to the overmolded distal pipe rather than internally as discussed by Weisneburgh, II (para. 0247: “A flexible boot barrier 1006 is positioned over…a distal portion of a tube 1010 to seal the blade 1004 to an outer diameter 1012 of the tube 1010”).
Regarding claim 14, modified Weisenburgh, II discloses wherein the first mating feature includes a bore with a progressively decreasing diameter as the bore approaches the longitudinal axis, and the second mating feature is defined by the first mating feature (see annotated Fig. 20 [a] of Weisenburgh, II above).
Regarding claims 11 and 15, modified Weisenburgh, II discloses all of the limitation set forth above in claims 1 and 14. However, modified Weisenburgh, II fails to disclose further including an insulated pin configured to secure the sheath to the ultrasonic blade assembly, wherein the insulated pin is positioned proximally relative to the first mating feature.
Isaacs further teaches that it is known in the art for an ultrasonic device like Weisenburgh, II’s to include an insulated pin 27 (para. 0114: “pin 27 is partially coated with an elasto-meric material 30, such as silicon”) for coupling a waveguide 80 of an ultrasonic blade assembly 79, 80 to handle assembly 68 (Fig. 2, para. 0114). The insulated pin 27 is configured to secure the sheath 72 to the ultrasonic blade assembly by way of their common connection to the handle assembly 68 (Fig. 2, para. 0114) for the purpose of providing insulation from the vibrating blade during use (para. 0114).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the surgical instrument in modified Weisenburgh, II to include the insulated pin, as taught by Isaacs, in order to minimize overheating generated by the ultrasonic blade assembly and maximize ultrasonic output power available at the blade tip for cutting and coagulation (para. 0114 of Isaacs).
The combination of modified Weisenburgh, II and Isaacs would result in a product wherein the insulated pin 27 of Isaacs would be positioned proximally relative to the first mating feature positioned at the overmolded distal pipe of modified Weisenburgh, II because the insulated pin 27 is located at the proximalmost end of the waveguide, connecting it to the handle assembly (Fig. 2, para. 0090 of Isaacs).
Regarding claim 26, modified Weisenburgh, II discloses all of the limitations set forth above in claim 25. However, modified Weisenburgh, II fails to disclose further comprising an overmolded support formed on an exterior surface of the at least the portion of the waveguide between the second mating feature and a proximal portion of the ultrasonic blade assembly, wherein the overmolded support includes an annular shape and is configured to extend radially from the at least the portion of the waveguide and engage an inner surface of the sheath.
Isaacs further teaches that it is known in the art for an ultrasonic device like Weisenburgh, II’s to include an overmolded support (interpreted as o-ring 83) formed on an exterior surface of at least a portion of a waveguide 80 (Fig. 2, para. 0104), wherein the overmolded support 83 includes an annular shape and is configured to extend radially from the at least the portion of the waveguide 80 and engage an inner surface of a distal shroud 76 for the purpose of isolating the vibrating blade of the ultrasonic blade assembly from the distal shroud to avoid metal to metal contact and provide stiffness to the blade system (para. 0112).
In light of these teachings, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the ultrasonic blade assembly of modified Weisenburgh, II to include the overmolded support within the sheath such that the overmolded support is between the second mating feature and the proximal portion of the ultrasonic blade assembly as taught by Isaacs in order to isolate the vibrating blade within the sheath to avoid metal to metal contact and provide stiffness to the blade system (para. 0112 of Isaacs).
Claim(s) 12 is rejected under 35 U.S.C. 103 as being unpatentable over Weisenburgh, II et al. (US 20140135804) [hereinafter Weisenburgh, II] in view of Isaacs et al. (US 20090099582) [hereinafter Isaacs] as applied to claim 11 above, and further in view of Faller et al. (US 20150142031) [hereinafter Faller].
Regarding claim 12, modified Weisenburgh, II discloses all of the limitations set forth above in claim 11. However, modified Weisenburgh, II fails to disclose further including an overmolded support configured to support the ultrasonic blade within the sheath, wherein the overmolded support is distally positioned relative to the insulated pin and proximally relative to the first and second mating feature.
Isaacs teaches that it is known in the art to include an overmolded support (interpreted as o-ring 83) configured to support the ultrasonic blade 79 within the sheath 72 (Fig. 2, para. 0104), wherein the overmolded support is distally positioned relative to the insulated pin (Fig. 2, para. 0104) for the purpose of isolating the vibrating blade of the ultrasonic blade assembly from the distal shroud to avoid metal to metal contact and provide stiffness to the blade system (para. 0112).
Faller in the same field of endeavor of ultrasonic surgical instruments 210 (Fig. 11, para. 0104-0105) further teaches that it is known in the art to provide an overmolded support (interpreted as o-ring shown in Fig. 12A) may be positioned proximally relative to a first and second mating feature of cap 233 and in between waveguide 280 of an ultrasonic blade assembly 242, 280 and clamp arm assembly 250 (see Fig. 12A, para. 0105-0106).
In light of these teachings, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the ultrasonic blade assembly of modified Weisenburgh, II to include the overmolded support proximally relative to the first and second mating feature as taught by Isaacs and Faller in order to isolate the vibrating blade of the ultrasonic blade assembly from the clamp arm assembly to avoid metal to metal contact and provide stiffness to the blade system relative to the clamp arm assembly to thereby maintain the appropriate clamp force of the instrument (para. 0112 of Isaacs).
Claim(s) 16-17 and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Isaacs et al. (US 20090099582) [hereinafter Isaacs] in view of Estabrook (US 5935144).
Regarding claim 16, Isaacs discloses a surgical instrument 19 (Fig. 1, para. 0084), comprising:
(a) an ultrasonic blade assembly 71 including an ultrasonic blade 79 and at least a portion of a waveguide 80 (Fig. 2, para. 0088), wherein the at least the portion of the waveguide 80 extends along a longitudinal axis (Figs. 1-2, para. 0114), and wherein the ultrasonic blade 79 distally extends from the at least the portion of the waveguide 80 (Figs. 1-2, para. 0091);
(b) a sheath 72 positioned over at least a portion of the ultrasonic blade assembly 71 (Figs. 1-2, para. 0113);
(d) an overmolded distal pipe (interpreted as distal shroud 76, see interpretation of “overmolded” in note below) including a proximal portion and a distal portion (see annotated Fig. 15C of Isaacs below, para. 0113), wherein the proximal portion includes a proximal tube (see annotated Fig. 15C of Isaacs below, para. 0113).
Isaacs further discloses a first mating feature as an internal lumen of the sheath 72 which mates with a second mating feature of the proximal tube of the overmolded distal pipe (Figs. 2, 15B-C, para. 0104: “the outer shroud 72 and distal shroud 76 may attach via a snap fit, press fit, glue or other mechanical means”; para. 0113: “the distal shroud 76 is pressed fit onto the outer shroud 72 (or other attachment means, such as glue or mechanical fastering)”).
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Annotated Fig. 15C of Issacs
However, Isaacs fails to disclose (c) a first mating feature including a bore extending perpendicularly from the longitudinal axis having a progressively decreasing diameter as the bore approaches the longitudinal axis, wherein the second mating feature is defined by the first mating feature such that the second mating feature is complementary to the first mating feature and is configured to engage the first mating feature to retain the overmolded distal pipe upon the sheath.
Estabrook in the same field of endeavor of ultrasonic surgical instruments teaches an attachment means between an inner tubular member 20 and an outer sheath 30 comprising a first mating feature (interpreted as injection openings 49, 50) including a bore extending perpendicularly from the longitudinal axis (Fig. 6, col. 3 lines 59-65: “Acoustic isolation element 75 is fixed to wave guide 20 by, for example, molding seal 75 onto waveguide 20 utilizing an injection molding process. Acoustic isolation element 75 is bonded to outer sheath 30 by, for example, injecting sealant 52” and col. 4 lines 23-26: “. Sealant 52 may be injected by, for example, forcing sealant 52 through a first injection opening 49, replacing air which is forced out of a second injection opening 50”), wherein a second mating feature (interpreted as sealant 52) (Fig. 6, see , col. 3 lines 59-65 above) is defined by the first mating feature 49, 50 such that the second mating feature 52 is complementary to the first mating feature 49, 50 (see Fig. 6, col. 4 lines 47-53: “ Annular recess 53 is accessible through first injection opening 49 (shown in FIG. 3) and second injection opening 50…Sealant 52 fills annular recess 53”), and is configured to engage the first mating feature 49, 50 to retain the inner tubular member 20 within the sheath 30 (see col. 3 lines 59-65 above).
The substitution of one known attachment means between the overmolded distal pipe and the sheath (the openings and injectable sealant as the first mating feature and second mating feature as shown in Estabrook) for another (attachment means as discussed in Isaacs) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since the substitution of the first and second mating features shown in Estabrook would have yielded predictable results, namely, an alternative way to seal and secure the sheath to the proximal tube of the overmolded distal pipe of Isaacs.
However, modified Isaacs fails to disclose the first mating feature being a tapered bore such that a diameter of the bore progressively decreases as the bore approaches the longitudinal axis.
It would have been an obvious matter of design choice to modify the shape of the first mating feature of modified Isaacs to be the tapered shape as claimed, 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. In re Dailey, 149 USPQ 47 (CCPA 1976).
Note: The claimed limitation “an overmolded distal pipe” is being treated as a product by process limitation; that is the product-by-process limitation is limiting only in so far as the final structure necessitated by the process. The final structure necessitated by injection molding is a distal pipe that directly contacts at least a portion of an element in which the distal pipe is attached upon (see para. 0039 of the written description in the instant application). Since Isaacs discloses the final structure necessitated by the process i.e. a distal pipe 76 that directly contacts a at least a portion of an element in which the distal pipe is attached upon (Figs. 1-2, para. 0104: “Attached to the distal end of the outer shroud 72 is a distal shroud 76. Both the outer shroud 72 and distal shroud 76 may attach via a snap fit, press fit, glue or other mechanical means”), it is considered to meet this product-by-process limitation. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113.
Regarding claim 17, modified Isaacs discloses wherein the first and second mating features are transversely positioned relative to the longitudinal axis (see Fig. 6 of Estebrook), wherein the proximal tube is positioned within an inside diameter of the sheath (Fig. 2, para. 0113 of Isaacs) and the distal portion includes an exterior that tapers distally (see annotated Fig. 15C of Isaacs above).
Regarding claim 22, modified Isaacs discloses wherein the first mating feature includes a dovetail shape (see rejection of claim 16 above which modified the first mating feature to have a tapered shape such that the diameter of the bore progressively decreases as the bore approaches the longitudinal axis which is equivalent to a dovetail shape).
Regarding claim 23, modified Isaacs discloses wherein the overmoldeded distal pipe is directly overmoldeded upon the sheath such that the proximal tube extends within an inner surface of the sheath (see note below).
Note: The limitation “wherein the overmoldeded distal pipe is directly overmoldeded upon the sheath such that the proximal tube extends within an inner surface of the sheath” is being treated as a product by process limitation; that is the product-by-process limitation is limiting only in so far as the final structure necessitated by the process. The final structure necessitated by injection molding is a distal pipe that directly contacts at least a portion of an element in which the distal pipe is attached upon (see para. 0039 of the written description in the instant application). Since modified Weisenburgh, II discloses the final structure necessitated by the process i.e. the distal pipe comprising the proximal tube extending within the inner surface of the sheath (see Figs. 2, 15B-C, para. 0113 of Isaacs), it is considered to meet this product-by-process limitation. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113.
Allowable Subject Matter
Claim 25 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Regarding claim 25, modified Weisenburgh, II fails to disclose or suggest “wherein the pair of annular side ribs space apart the overmolded distal pipe from the at least the portion of the waveguide”. As shown in the annotated Fig. 20 [c] of Weisenburgh, II above, the pair of annular side ribs does not space apart the overmolded distal pipe and at least a portion of the waveguide due to the angled structure of the annular side ribs compared to applicant’s planar side ribs (see Fig. 6 of the instant application).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/LAUREN DUBOSE/Examiner, Art Unit 3771
/SARAH A LONG/Primary Examiner, Art Unit 3771
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