DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s arguments with respect to claims 1-4, 6-7, 11-12, 18 and 21-31 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 1-4, 6-7, 11-12, 18, 22-24 and 26-29 are rejected under 35 U.S.C. 103 as being unpatentable over Miller et al. (US 2011/0054537) in view of Conte et a l. (US 2007/0293869).
Miller et al. disclose a surgical instrument comprising a handle (104) having a first end (@136), a second end (@132, figure 5) and a first connection surface (surface which engages 102, ¶48), and a passage (134) that extends from the first end to the second end; a shaft (102) having a first end (112), a second end (114), a longitudinal axis (considered the central longitudinal) extending from the first end to the second end, and a coaxial channel (111) that extends completely through the shaft (figure 2), and a second connection surface (surface which engages 104, ¶48) engageable with the first connection surface to releasably connect the shaft to the handle when the first end of the shaft is inserted from the second end of the handle into the passage (¶48, ¶53); and a secondary instrument (106) configured to be inserted from the first end of the shaft into the channel and to extend out of the second end of the shaft when the shaft (figure 15A-15C).
Miller et al. fail to expressly teach or disclose a cannulated adapter configured to connect an auxiliary device to the surgical instrument, the cannulated adapter comprising a third connection surface structured substantially similarly to the second connection surface for engaging the first connection surface, and a fourth connection surface structured substantially similarly to the first connection surface for engaging the second connection surface, such that the cannulated adapter is releasably mountable between the shaft and the handle.
Conte et al. disclose a surgical instrument (10, figure 6) comprising a handle (12) having a first connection surface (see figure below) and a shaft (20) having a second connection surface engageable with the first connection surface (¶81) and a cannulated adapter (46) comprising a third connection surface (see figure below) structured substantially similarly to the second connection surface for engaging the first connection surface (figure 6), and a fourth connection surface (see figure below) structured substantially similarly to the first connection surface for engaging the second connection surface (figure 6), such that the cannulated adapter is releasably mountable between the shaft and the handle (¶83-84) as the adapter allows for the connection of an alignment element to assist with tracking and proper placement of the tool during use to the surgical site.
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Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing to have constructed the surgical instrument of Miller et al. to include a cannulated adapter comprising a third connection surface structured substantially similarly to the second connection surface for engaging the first connection surface, and a fourth connection surface structured substantially similarly to the first connection surface for engaging the second connection surface, such that the cannulated adapter is releasably mountable between the shaft and the handle as taught by Conte et al. as the adapter allows for the connection of an alignment element to assist with tracking and proper placement of the tool during use to the surgical site.
Regarding claim 2, Miller et al. disclose the secondary instrument is insertable from the first end of the handle through the passage of the handle and into the channel of the shaft (figure 15A-15C, ¶55).
Regarding claim 3, Miller et al. disclose the secondary instrument comprises an elongate shaft (140) with a tip portion (142).
Regarding claim 4, Miller et al. disclose the secondary instrument comprises an awl (142, ¶57).
Regarding claim 6, Miller et al. disclose the first connection structure and the second connection structure comprise corresponding standardized connection structures (¶54). Regarding claim 7, Miller et al. disclose the first connection structure and the second connection structure are engaged, the engagement is configured to be locked and released (¶54).
Regarding claim 11, Miller et al. disclose the second end of the shaft comprises a functional section (122, figures 7-8B) configured to perform a primary function of the surgical instrument (¶50).
Regarding claim 12, Miller et al. disclose the functional section comprises a thread cutting portion (122, figures 7-8B, ¶50). Regarding claim 18, Miller et al. disclose a system comprising the surgical instrument of claim 1 and a cannulated bone anchor (¶89, 702, 704, figure 35). Regarding claim 22, Miller et al. in view of Conte et al. al. disclose when the cannulated adapter is mounted between the shaft and the handle, the secondary instrument is configured to extend from the first end of the handle past the second end of the shaft (figures 6-7). Regarding claim 23, Miller et al. in view of Conte et al. disclose the auxiliary device comprises a navigation star or other navigation device (44, 47, figures 6-7, 18).
Regarding claim 24, Miller et al. disclose surgical instrument comprising a handle (104) having a first end (@136), a second end (@132), and a passage (134) that extends from the first end to the second end; a shaft (102) having a first end (112), a second end (114), a longitudinal axis (considered the central longitudinal axis) extending from the first end to the second end, and a coaxial channel (111) that extends completely through the shaft (figure 2), wherein the shaft is releasably connectable to the handle when the first end of the shaft is inserted from the second end of the handle into the passage (¶48); a secondary instrument (106) configured to be inserted from the first end of the shaft into the channel and to extend out of the second end of the shaft (figures 15A-15C)
Miller et al. fail to expressly teach or disclose a cannulated adapter comprising a body releasably mountable between the shaft and the handle in a manner such that the shaft and the handle are completely spaced apart from one another, and an arm that extends laterally away from the body for laterally connecting an auxiliary device to the surgical instrument.
Conte et al. disclose a surgical instrument (10, figure 6) comprising a handle (12) and a shaft (20) and a cannulated adapter (44) comprising a body (46) releasably mountable between the shaft and the handle in a manner such that the shaft and the handle are completely spaced apart from one another (figure 6), and an arm (45) that extends laterally away from the body for laterally connecting an auxiliary device to the surgical instrument (figure 18) as the adapter allows for the connection of an alignment element to assist with tracking and proper placement of the tool during use to the surgical site.
Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing to have constructed the surgical instrument of Miller et al. to include a cannulated adapter as taught by Conte et al. as the adapter allows for the connection of an alignment element to assist with tracking and proper placement of the tool during use to the surgical site. Regarding claim 26, Miller et al. in view of Conte et al. disclose when the cannulated adapter is mounted between the shaft and the handle, the secondary instrument is configured to extend from the first end of the handle past the second end of the shaft (figures 6-7 of Conte).
Regarding claim 27, Miller et al. in view of Conte et al. disclose the auxiliary device comprises a navigation star or other navigation device (47, figure 18).
Regarding claim 28, Miller et al. disclose a surgical kit comprising a handle (104) having a first end (@136), a second end (@132), and a passage (134) that extends from the first end to the second end; a first shaft (102) having a first end (112), a second end (114), a longitudinal axis (considered the central longitudinal axis) extending from the first end to the second end, and a coaxial channel that extends completely through the first shaft; (figures 2, 5, 27); a secondary instrument (106) configured to be inserted from the first end of the connected shaft into the channel of the connected shaft and to extend out of the second end of the connected shaft (figures 15A-15C).
Miller et al. fail to expressly teach or disclose a second shaft having a first end, a second end, a longitudinal axis extending from the first end to the second end, a coaxial channel that extends completely through the second shaft, and an arm that extends laterally away from the longitudinal axis for laterally connecting an auxiliary device to the handle, wherein the first and second shafts are interchangeably and releasably connectable to the handle by inserting the first end of the selected shaft from the second end of the handle into the passage.
Conte et al. disclose a surgical instrument (10, figure 6) comprising a handle (12) having a first connection surface (see figure above) and a first shaft (20) engageable with the handle and a second shaft (44) having a first end (see figure below), a second end (see figure below), a longitudinal axis (considered the central longitudinal axis of opening formed via 92’s) extending from the first end to the second end, a coaxial channel (channel formed via 92’s) that extends completely through the second shaft, and an arm (45) that extends laterally away from the longitudinal axis for laterally connecting an auxiliary device to the handle (e.g. 47), wherein the first and second shafts are interchangeably and releasably connectable to the handle (figures 6-7, ¶81, ¶84) by inserting the first end of the selected shaft from the second end of the handle into the passage (¶81, ¶84) as the second shaft allows for the connection of an alignment element to assist with tracking and proper placement of the tool during use to the surgical site.
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Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing to have constructed the surgical instrument of Miller et al. to include a second shaft as taught by Conte et al. as the adapter allows for the connection of an alignment element to assist with tracking and proper placement of the tool during use to the surgical site.
Regarding claim 29, Miller et al. in view of Conte et al. disclose the first end of the first shaft is further connectable to the second end of the second shaft, such that the second shaft is releasably mountable between the first shaft and the handle (¶81 of Conte).
Allowable Subject Matter
Claims 21, 25 and 30-31 are 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.
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 MATTHEW JAMES LAWSON whose telephone number is (571)270-7375. The examiner can normally be reached Mon - Fri 6:30-3:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anita Coupe can be reached at 571-270-3614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW J LAWSON/Primary Examiner, Art Unit 3619
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