DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 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 1-3, 5-7, 13, 16-17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Tal et al. (USPGPub 2008/0294111) in view of Bierman et al. (USPGPub 2012/0316500).
Re Claim 1, Tal discloses an introducer sheath for use during a percutaneous biopsy procedure (Tal Figs. 1A-3B), the introducer sheath comprising: a first elongate member (30) comprising a first lumen that extends through the first elongate member (30) (as seen in cross- sectional Tal Fig. 3B), the first lumen configured to accommodate a portion of a second elongate member (22) (as seen in Tal Fig. 1A); a first hub (32) disposed adjacent a proximal end of the first elongate member (30) (as seen in Tal Figs. 3A-3B), the first hub (32) configured to selectively couple to the second elongate member (22) (Tal ¶ 0047 and 0051); and a second hub (21) disposed adjacent to a proximal end of the second elongate member (22) (as seen in Fig. 2A), the second hub (21) comprising an opening (space between hinged clips 27 as seen in Tal Fig. 1B) configured to receive a portion (33) of the first hub (32) (Tal ¶ 0047; Fig. 1A); wherein the second hub (21) comprises one or more catches (27) configured to engage the portion (33) of the first hub (32) and one or more depressible members (29) (Tal ¶ 0047), wherein actuation of the one or more depressible members (29) displaces the one or more catches (27) (Tal ¶ 0047 0051), wherein the one or more depressible members (29) are circumferentially offset from the one or more catches (27) (Tal Fig. 1A) and wherein the first lumen extends through the first hub (32) (as seen in cross-sectional Tal Fig. 3B).
Tal further teaches the one or more depressible members (29) are circumferentially aligned with the one or more catches (27) such that the one or more depressible members (29) and the one more catches (27) are disposed at similar positions along a circumference of the second hub (21) (Tal Fig. 1A). However, Tal fails to teach wherein the one or more depressible members are circumferentially offset from the one or more catches such that the one or more depressible members and the one more catches are disposed at different positions along a circumference of the second hub. It would have been an obvious matter of design choice to modify Tal to comprise the one or more depressible members being circumferentially offset from the one or more catches such that the one or more depressible members and the one more catches are disposed at different positions along a circumference of the second hub since applicant has not disclosed that having the aforementioned embodiment solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either design.
Furthermore, absent a teaching as to the criticality of the one or more depressible members being circumferentially offset from the one or more catches such that the one or more depressible members and the one more catches are disposed at different positions along a circumference of the second hub, 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. In re Kuhle, 526 F.2d 553, 555, 188 USPQ 7, 9 (CCPA 1975).
Tal fails to teach wherein the second hub surrounds the portion of the first hub when the portion of the first hub is received within the opening. Bierman teaches an introducer sheath (Bierman Figs. 7A-C) comprising a first hub (34) with a first elongate member (22) (Bierman ¶ 0102) and a second hub (46) comprising an opening (46-1) (Bierman Annotated Fig. 7C below) and a second elongate member (44) wherein the opening (46-1) of the second hub (46) is configured to receive a portion (63) of the first hub (34) and wherein the second hub (46) surrounds the portion (63) of the first hub (34) when the portion (63) is received within the opening (46-1) (Bierman ¶ 0151; Annotated Fig. 7C below), the portion (63) comprising a Luer connector for connecting to other medical devices during a medical procedure, the neck (63) completely and securely covered when the first hub and second hub are connected (Bierman ¶ 0110-0111, 0172).
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 had the second hub of Tal to have a female lumen similar to that of Bierman, wherein the second hub surrounds the portion of the first hub when the portion is received within the opening of the second hub, the configuration as disclosed by Bierman wherein the portion comprising a Luer connector can connect to other medical devices during a medical procedure, the portion completely and securely covered when the first hub and second hub are connected (Bierman ¶ 0110-0111, 0172).
Re Claim 2, Tal in view of Bierman teach all of the limitations of Claim 1. Tal discloses wherein the first hub (32) is configured to selectively couple to the second elongate member (22) via a snap fit-type connection (Tal ¶ 0047 and 0051).
Re Claim 3, Tal in view of Bierman teach all of the limitations of Claim 2. Tal discloses wherein the first elongate member (30) is configured to disengage from the second elongate member (22) in response to actuation of the one or more depressible members (29) (Tal ¶ 0047 and 0051).
Re Claim 5, Tal in view of Bierman teach all of the limitations of Claim 4. Tal discloses wherein the first elongate member (30) is configured to disengage from the second elongate member (22) without rotation of the first elongate member (30) relative to the second elongate member (22) (Tal ¶ 0047, 0051, 0054).
Re Claim 6, Tal in view of Bierman teach all of the limitations of Claim 5. Tal discloses wherein the first hub (32) comprises a component configured to function as a portion of a detent (37) (Tal ¶ 0053).
Re Claim 7, Tal in view of Bierman teach all of the limitations of Claim 1. Tal discloses wherein the first elongate member (30) comprises a rigid hypotube (Tal ¶ 0110 describing high- density polyethylene); and the introducer sheath is not configured for use in vascular procedures (Tal ¶ 0043, 0111).
Re Claim 13, Tal discloses a method of selectively coupling components of an introducer sheath (Tal Figs. 1A-3B), the method comprising: obtaining an introducer sheath, the introducer sheath comprising a first elongate member (32), wherein a first lumen extends through the first elongate member (as seen in cross-sectional Tal Fig. 3B); disposing a second elongate member (21) relative to the first elongate member (32), such that a portion of the second elongate member (21) is disposed within the first lumen (Tal Fig. 1A); and coupling the second elongate member (21) to the first elongate member (32) (Tal ¶ 0047 and 0051 - snap fit-type connection) by longitudinally translating the second elongate member (21) with respect to the first elongate member (32) (Tal ¶ 0047 and 0051; Figs. 1A-1B and 2C), wherein the second elongate member (21) comprises one or more catches (27) configured to engage a portion (33) of the first elongate member (32) and one or more depressible members (29) (Tal ¶ 0047), wherein actuation of the one or more depressible members (29) displaces the one or more catches (27) (Tal ¶ 0047 0051).
Tal teaches wherein the one or more depressible members (29) are circumferentially aligned with the one or more catches (27) such that the one or more depressible members (28) and the one more catches (27) are disposed at similar positions along a circumference of the second hub (21) (Tal Fig. 1A). However, Tal fails to teach wherein the one or more depressible members are circumferentially offset from the one or more catches such that the one or more depressible members and the one more catches are disposed at different positions along a circumference of the second hub. It would have been an obvious matter of design choice to modify Tal to comprise the one or more depressible members being circumferentially offset from the one or more catches such that the one or more depressible members and the one more catches are disposed at different positions along a circumference of the second hub since applicant has not disclosed that having the aforementioned embodiment solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either design.
Furthermore, absent a teaching as to the criticality of the one or more depressible members being circumferentially offset from the one or more catches such that the one or more depressible members and the one more catches are disposed at different positions along a circumference of the second hub, 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. In re Kuhle, 526 F.2d 553, 555, 188 USPQ 7, 9 (CCPA 1975).
However, Tal fails to teach a second type of engagement mechanism that is different than the first type of engagement mechanism. Bierman teaches a method of selectively coupling components of an introducer sheath (Bierman Figs. 7A-C) comprising a first elongate member (34) and a second elongate member (46) configured to engage the first component (34) (Bierman ¶ 0102), wherein coupling the second elongate member (46) to the first elongate member (34) comprises an engagement mechanism different from the engagement mechanism of Tal (Tal teaching a snap fit-type connection - ¶ 0047 and 0051) the second engagement mechanism comprising a Luer connector for connecting to other medical devices during a medical procedure, the neck (63) completely and securely covered when the first hub and second hub are connected (Bierman ¶ 0110-0111, 0172).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the claimed invention to have included in the method of selectively coupling components of the introducer sheath of Tal a second type of engagement mechanism that is different than the first type of engagement mechanism (Tal teaching a snap fit-type connection - ¶ 0047 and 0051) as disclosed by Bierman, the method of Bierman comprising an engagement mechanism comprising a Luer connector for connecting to other medical devices during a medical procedure, the neck completely and securely covered when the first hub and second hub are connected (Bierman ¶ 0110-0111, 0172).
Re Claim 16, Tal in view of Bierman teach all of the limitations of Claim 13. Tal discloses uncoupling the second elongate member (21) from the first elongate member (32) (Tal ¶ 0047 and 0051).
Re Claim 17, Tal in view of Bierman teach all of the limitations of Claim 16. Tal discloses wherein uncoupling the second elongate member (21) from the first elongate member (32) does not comprise rotating the second elongate member (21) relative to the first elongate member (32) (Tal ¶ 0047, 0051, 0054).
Re Claim 19, Tal in view of Bierman teach all of the limitations of Claim 16. Tal discloses wherein uncoupling the second elongate member (21) from the first elongate member (32) is performed with one hand (Tal Figs. 1A-1B - wherein both clip sides 29 can be depressed single handedly).
Claims 20 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Tal et al. (USPGPub 2008/0294111) in view of Bierman et al. (USPGPub 2012/0316500) as applied to Claims 1 or 16 respectively, in view of Nelson (USPGPub 2006/0264911).
Re Claim 20, Tal in view of Bierman teach all of the limitations of Claim 1. Tal in view of Bierman fail to teach wherein the actuation of the one or more depressible members deforms a cross-sectional shape of the second hub from a first cross-sectional shape to a second cross-sectional shape which displaces the one or more catches. Nelson teaches a catheter connector (100) comprising a first hub (202) and a second hub (104) configured to receive the first hub (202), the second hub (104) comprising one or more catches (113) configured to engage a portion (206) of the first hub (202) and one or more depressible members (117) (Nelson Figs. 6-7), wherein actuation of the one or more depressible members (117) displaces the one or more catches (113) (as seen in Nelson Fig. 6; ¶ 0037), wherein the one or more depressible members (117) are circumferentially offset from the one or more catches (113) such that the one or more depressible members (117) and the one more catches (113) are disposed at different positions along a circumference of the second hub (104) (as seen in Nelson Fig. 6), and wherein the actuation of the one or more depressible members (117) deforms a cross-sectional shape of the second hub (104) from a first cross-sectional shape to a second cross-sectional shape which displaces the one or more catches (113) (Nelson ¶ 0037-0043), the configuration for better withstanding tensile forces (Nelson ¶ 0008-0009).
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 configured the one or more depressible members and one or more catches of Tal in view of Bierman to be configured such that actuation of the one or more depressible members deforms a cross-sectional shape of the second hub from a first cross-sectional shape to a second cross-sectional shape which displaces the one or more catches, a similar configuration as disclosed by Nelson for better withstanding tensile forces (Nelson ¶ 0008-0009).
Re Claim 22, Tal in view of Bierman teach all of the limitations of Claim 16. Tal in view of Bierman fail to teach wherein the actuation of the one or more depressible members deforms a cross-sectional shape of the second hub from a first cross-sectional shape to a second cross-sectional shape which displaces the one or more catches. Nelson teaches a catheter connector (100) comprising a first hub (202) and a second hub (104) configured to receive the first hub (202), the second hub (104) comprising one or more catches (113) configured to engage a portion (206) of the first hub (202) and one or more depressible members (117) (Nelson Figs. 6-7), wherein actuation of the one or more depressible members (117) displaces the one or more catches (113) (as seen in Nelson Fig. 6; ¶ 0037), wherein the one or more depressible members (117) are circumferentially offset from the one or more catches (113) such that the one or more depressible members (117) and the one more catches (113) are disposed at different positions along a circumference of the second hub (104) (as seen in Nelson Fig. 6), and wherein the actuation of the one or more depressible members (117) deforms a cross-sectional shape of the second hub (104) from a first cross-sectional shape to a second cross-sectional shape which displaces the one or more catches (113) (Nelson ¶ 0037-0043), the configuration for better withstanding tensile forces (Nelson ¶ 0008-0009).
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 configured the one or more depressible members and one or more catches of Tal in view of Bierman to be configured such that actuation of the one or more depressible members deforms a cross-sectional shape of the second hub from a first cross-sectional shape to a second cross-sectional shape which displaces the one or more catches, a similar configuration as disclosed by Nelson for better withstanding tensile forces (Nelson ¶ 0008-0009).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Tal et al. (USPGPub 2008/0294111).
Re Claim 8, Tal discloses a hub assembly for selectively coupling two components of a medical device (Tal Figs. 1A-3B), the hub assembly comprising: a first component (32) comprising a first lumen (as seen in cross-sectional Tal Fig. 3B), the proximal end comprising a detent (37) (Tal ¶ 0047, 0053; Figs. 1A and 3B); and a second component (21) configured to engage the first component (32) (Tal ¶ 0047 and 0051; Figs. 1A-1B); wherein the second component (21) comprises one or more catches (27) configured to engage a portion (33) of the first component (32) and one or more depressible members (29) (Tal ¶ 0047), wherein actuation of the one or more depressible members (29) displaces the one or more catches (27) (Tal ¶ 0047 0051), and wherein the one or more depressible members (29) are circumferentially offset from the one or more catches (27) (Tal Fig. 1A).
Tal teaches the one or more depressible members (29) are circumferentially and longitudinally aligned with the one or more catches (27) such that the one or more depressible members (29) and the one more catches (27) (Tal Fig. 1A). However, Tal fails to teach wherein the one or more depressible members are circumferentially offset and longitudinally unaligned from the one or more catches. It would have been an obvious matter of design choice to modify Tal to comprise the one or more depressible members being circumferentially offset and longitudinally unaligned from the one or more catches since applicant has not disclosed that having the aforementioned embodiment solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either design.
Furthermore, absent a teaching as to the criticality of the one or more depressible members being circumferentially offset and longitudinally unaligned from the one or more catches, 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. In re Kuhle, 526 F.2d 553, 555, 188 USPQ 7, 9 (CCPA 1975).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Tal et al. (USPGPub 2008/0294111) in view of Nelson (USPGPub 2006/0264911).
Re Claim 21, Tal teaches all of the limitations of Claim 8. Tal fails to teach wherein the actuation of the one or more depressible members deforms a cross-sectional shape of the second hub from a first cross-sectional shape to a second cross-sectional shape which displaces the one or more catches. Nelson teaches a catheter connector (100) comprising a first hub (202) and a second hub (104) configured to receive the first hub (202), the second hub (104) comprising one or more catches (113) configured to engage a portion (206) of the first hub (202) and one or more depressible members (117) (Nelson Figs. 6-7), wherein actuation of the one or more depressible members (117) displaces the one or more catches (113) (as seen in Nelson Fig. 6; ¶ 0037), wherein the one or more depressible members (117) are circumferentially offset from the one or more catches (113) such that the one or more depressible members (117) and the one more catches (113) are disposed at different positions along a circumference of the second hub (104) (as seen in Nelson Fig. 6), and wherein the actuation of the one or more depressible members (117) deforms a cross-sectional shape of the second hub (104) from a first cross-sectional shape to a second cross-sectional shape which displaces the one or more catches (113) (Nelson ¶ 0037-0043), the configuration for better withstanding tensile forces (Nelson ¶ 0008-0009).
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 configured the one or more depressible members and one or more catches of Tal to be configured such that actuation of the one or more depressible members deforms a cross-sectional shape of the second hub from a first cross-sectional shape to a second cross-sectional shape which displaces the one or more catches, a similar configuration as disclosed by Nelson for better withstanding tensile forces (Nelson ¶ 0008-0009).
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Pisula et al. (USPGPub 2012/0068457); and
Dalle et al. (USPGPub 2005/0225082).
Response to Arguments
Applicant's arguments filed 06/27/2025 have been fully considered but they are not persuasive. In the last paragraph of Page 8 and first two paragraphs of Page 9 of the response, applicant argues “modifying Tal to comprise the one or more depressible members being circumferentially offset from the one or more catches such that the one or more depressible and the one or more catches are disposed at different positions along a circumference of the second hub as required by independent claim 1, 8, and 13 is an obvious matter of design choice.” Applicant goes on to state “the Office Action is requiring more for an obvious design choice analysis than what is required by law.” However, examiner has presented applicant with prior art Nelson, and two additional pieces of prior art Pisula and Dalle, not relied upon but considered pertinent to applicant’s argument regarding the claimed feature “wherein the one or more depressible members are circumferentially offset from the one or more catches such that the one or more depressible members and the one more catches are disposed at different positions along a circumference of the second hub.” In light of prior art Nelson, the provision of novel results, provided for at the top of Page 12 of the response is insufficient in overcoming the rejections in the present case.
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 WILLIAM R FREHE whose telephone number is (571)272-8225. The examiner can normally be reached 10:30AM-7:30PM.
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/WILLIAM R FREHE/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783