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 1-4, 6, 12, 14, 16, 21, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. PG Pub. No. 2008/0064962 A1 to Oonuki et al. in view of U.S. Patent 4,742,829 to Law et al.
Regarding claims 1 and 12, Oonuki discloses a surgical system, comprising: a surgical tool (see entire document, noting Figs. 3, 4, and 6 and para 29-42); an ultrasound body including a shaft and an ultrasound sensor assembly disposed at a distal end portion of the shaft, the ultrasound sensor assembly configured to enable ultrasound imaging (see entire document, noting Figs. 3, 4, and 6 and para 29-42); and a clip configured for positioning about a first portion of the surgical tool, the clip configured to releasably engage the ultrasound body to thereby releasably couple the surgical tool with the ultrasound body (see entire document, noting Figs. 3, 4, and 6 and para 29-42), wherein the shaft of the ultrasound body defines a longitudinal recess configured to receive a second portion of the surgical tool distal to the first portion of the surgical tool, the longitudinal recess aligning the surgical tool relative to the ultrasound body (see entire document, noting Figs. 3, 4, and 6 and para 29-42).
Law discloses a similar ultrasound device with a clip, wherein the distal end portion of the shaft defines an asymmetrically protruding foot that includes a curved distally-facing surface (see Figs 1-4 and abstract).
It would have been obvious and predictable to have optimized the shape of the Oonuki device to include the foot of Law because doing so would allow the device to fit into and manipulate the anatomy of the subject as shown in Figure 2 of Law. Further, it would have been an obvious matter of design choice to modify the distal end shape to fit the specific anatomy of the patient and to facilitate the medical procedure taught in Oonuki and Law, 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). The change in shape rationale applies to the amended subject matter submitted June 27, 2025.
Regarding claims 2-4 and 14, Oonuki discloses a device, wherein the ultrasound body further includes a proximal handle, and wherein the shaft extends distally from the proximal handle; wherein the shaft extends distally from the proximal handle at an angle relative to the proximal handle; and wherein the shaft extends distally from the proximal handle at a perpendicular angle relative to the proximal handle (see entire document, noting Figs. 3, 4, and 6 and para 29-42).
Regarding claims 6 and 16, Law discloses a similar ultrasound device with a clip, wherein the ultrasound body defines a saddle configured to receive a portion of the clip (see Figs. 1-3 and col 3 ln 4-27, noting element 36).
It would have been obvious and predictable to have included a saddle with the Oonuki device because doing so would allow the guide to be locked into place, thus improving the connection between elements when desired.
Regarding claims 21 and 22, Oonuki discloses a device, wherein the shaft of the ultrasound body is configured for insertion into an internal surgical site within a patient while the clip remains external of the patient (see entire document, noting Figs. 3, 4, and 6 and para 29-42). Examiner also notes that claims 21 and 22 recite only functional limitations and the device of Oonuki is capable of performing said functional limitations.
Claims 7-11 and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Oonuki and Law as applied to claims 1 and 12 above, and further in view of U.S Patent No. 6,368,280 B1 to Cermak et al.
Regarding claims 7 and 17, Cermak discloses a similar tool guide imaging device, wherein the clip defines an aperture configured to receive the portion of the surgical tool through the aperture of the clip (see Figs 1-5 and col 4 ln 26-col 6 ln 67, noting at least 20 and 30).
It would have been obvious and predictable to have added an aperture to the clip of Oonuki because doing so would provide a more secure attachment and also allow for angled insertions.
Regarding claims 8 and 18, Cermak discloses a similar tool guide imaging device, wherein the clip is configured to slidably receive the portion of the surgical tool through the aperture of the clip (see Figs 1-5 and col 4 ln 26-col 6 ln 67, noting at least 20 and 30).
It would have been obvious and predictable to have added an aperture to the clip of Oonuki because doing so would provide a more secure attachment and also allow for angled insertions.
Regarding claim 9, Cermak discloses a similar tool guide imaging device, wherein the clip is configured to releasably engage the ultrasound body via at least one snap-fit engagement (see Figs 1-5 and col 4 ln 26-col 6 ln 67).
It would have been obvious and predictable to have used clip a snap fit clip with the Oonuki device because doing so would provide an easier to use connection that securely holds elements in place.
Regarding claims 10, 11, 19, and 20, Cermak discloses a similar tool guide imaging device, further comprising a sterile barrier configured for positioning about the ultrasound body; wherein the clip is configured to releasably engage the ultrasound body with the sterile barrier disposed between the clip and the ultrasound body (see col 3 ln 7-15 and col 4 ln 26-col 6 ln 67).
It would have been obvious and predictable to have used a sterile barrier because doing so would predictably keep the device clean and sterile for reuse and for reducing contamination.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Oonuki and Law as applied to claim 12 above, and further in view of U.S. PG Pub. No. 2009/0036773 A1 to Lau et al.
Regarding claim 13, Lau discloses a similar ultrasound surgical device, wherein the surgical tool is a hysteroscope (see para 75).
It would have been obvious and predictable to have included a hysteroscope with the Oonuki device because doing so would allow for optical visualization of the target area.
Response to Arguments
Applicant’s arguments with respect to the pending claims have been considered but are moot in view of the new grounds of rejection.
Examiner notes that Applicant has not addressed the concern that the shape of the device is a mere matter of design so that the device is able to fit the anatomy of the patient and complete the surgical objectives of the prior art.
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 communications from the examiner should be directed to RAJEEV P SIRIPURAPU whose telephone number is (571)270-3085.
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/RAJEEV P SIRIPURAPU/Primary Examiner, Art Unit 3798
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