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
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.
Claim(s) 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Hoey et al (Pub. No.: US 2010/0179416) in view of Taylor et al (Pub. No.: US 2007/0293787)
Regarding claim 1, Hoey et al disclose a system for providing water vapor energy therapy to a desired region of a prostate and for use with an ultrasound probe (ultrasound probe 112) configured to provide imaging of the prostate [see 0034, 0038];
the system comprising:
a tubular structure (needle 145) including one or more openings (an outlet or a plurality of outlets) at a distal end of the tubular structure [see 0034] by disclosing the distal end of the needle can also include an outlet or a plurality of outlets configured to deliver high temperature condensable vapor from the vapor source to tissue [see 0034];
a water vapor delivery system including a control unit (computer controller), a water reservoir (high temperature condensable vapor source 140), and a tube (a vapor delivery mechanism 122, see fig 3) in fluid communication (as shown in fig 3 where 122 is in communication with sleeve 125 that contains the needle 145, emphasis added) with the tubular structure [see 0034, 0038, fig 3] by disclosing a vapor delivery mechanism 122 configured to deliver condensable vapor from a source 140 through the tool or needle 145 into the prostate to apply ablative energy to the prostate (see FIGS. 3 and 4) [see 0038];
an access needle (introducer member 110) for use as a conduit to deliver the distal end of the tubular structure (needle 145) into the desired region of the prostate [see 0038, fig 3] by disclosing an introducer member 110 or access assembly configured for transrectal positioning with the working end adapted for positioning adjacent to the patient's prostate 106 [see 0038];
wherein, when activated (via a computer controller, 0034), the water vapor delivery system delivers water vapor out of the one or more openings at the distal end of the tubular structure into the desired region of the prostate [see 0038, 0046] by disclosing delivering flow media through the flow channel into the targeted region to treat the targeted region. In one method, the flow media comprises a high temperature condensable vapor that applies ablative energy upon condensation to the targeted neoplastic region [see 0046]
Hoey et al don’t disclose a guide for coupling to the ultrasound probe, the guide comprising a platform that is slidably displaceable relative to the ultrasound probe, the platform configured to be coupled to the access needle.
Nonetheless, Taylor et al disclose a guide (cradle) for coupling to the ultrasound probe, the guide comprising a platform (needle guide positioning assembly, 0028) that is slidably displaceable (by moving longitudinally along the probe, emphasis added) relative to the ultrasound probe, the platform configured to be coupled to the access needle [see 0028-0029, 0128, 0130] by disclosing a biopsy needle guide which can be affixed to or associated with existing side-imaging transrectal ultrasound probes [see 0018, 0130] and the redirecting needle guide positioning assembly is also affixed to the cradle [see 0029, 0130] and the needle guide is moved longitudinally along the probe and is also rotated around the probe [see 0020, 0082, 0124-0125, 0134, claim 61] and a computer controlled ultrasound system [see 0028]
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Hoey et al and Taylor et al by using a guide for coupling to the ultrasound probe, the guide comprising a platform that is slidably displaceable relative to the ultrasound probe, the platform configured to be coupled to the access needle;
Regarding claim 2, Hoey et al wherein the tubular structure includes a needle [see 0034, 0038, 0046, figs 3-4].
Regarding claim 3, Hoey et al disclose wherein the tubular structure is part of the water vapor deliver system [see 0034, 0038, 0046, figs 3-4].
Regarding claim 4, Hoey et al disclose wherein the water vapor delivery system is activated via the control unit [see 0034] by disclosing the system can further comprise a computer controller configured to deliver vapor for an interval of time [see 0034].
Regarding claim 5, Hoey et al disclose wherein the control unit includes a computer [see 0034] by disclosing the system can further comprise a computer controller configured to deliver vapor for an interval of time [see 0034].
Regarding claim 6, Hoey et al disclose wherein the water vapor is delivered in controlled doses (by delivering via an interval of time, emphasis added) [see 0033-0034] by disclosing the system can further comprise a computer controller configured to deliver vapor for an interval of time [see 0034] and All these parameters can be controlled with a high level of precision to achieve controlled dosimetry, no matter whether the particular treatment calls for very low pressures (e.g., 1-5 psi) over a treatment interval or very high pressures (200 psi or greater) and no matter whether the treatment interval is in the 1-10 second range or 2 to 5 minute range [see 0033].
Regarding claim 7, Hoey et al disclose wherein the controlled doses include at least one of a set time (interval of time), pressure or fluid flow rate [see 0034] by disclosing the system can further comprise a computer controller configured to deliver vapor for an interval of time [see 0034].
Regarding claim 8, Hoey et al don’t disclose wherein the platform displaces the access needle along a trajectory that is parallel to a longitudinal axis of the ultrasound probe.
Nonetheless, Taylor et al disclose wherein the platform (needle guide) displaces (via longitudinal slides 42) the access needle along a trajectory that is parallel to a longitudinal axis of the ultrasound probe [see 0020, 0082, 0124-0125, 0134, claim 61] by disclosing the needle guide is moved longitudinally along the probe [see 0020]
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Hoey et al and Taylor et al by having the platform displaces the access needle along a trajectory that is parallel to a longitudinal axis of the ultrasound probe; to provide precise settings for the guide body [see claim 61].
Regarding claim 9, Hoey et al disclose wherein the ultrasound probe includes a transrectal probe [see 0007-0008, 0027, 0034] by disclosing the imaging system comprises transrectal ultrasound [see 0008].
Regarding claim 10, Hoey et al disclose wherein the tubular structure is extendable from, and retractable into the access needle [see 0033, 0046, 0132] by disclosing extension member 840 comprising a needle [see 0033] and by moving the needle in/out [see 0132].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOEL F BRUTUS whose telephone number is (571)270-3847. The examiner can normally be reached Mon-Sat, 11:00 AM to 7:00 PM.
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/JOEL F BRUTUS/ Primary Examiner, Art Unit 3798