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.
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) 1-8 and 10-21 are rejected under 35 U.S.C. 103 as being unpatentable over Garcia (US 2014/0180065) in view of Schuurman et al (US 2022/0304770, published as WO 2020/263092 before EFD of instant application).
Regarding claims 1, 12, and 14, Garcia discloses and teaches a marker arrangement, medical device, and system for trajectory planning/management including a marker arrangement with multiple series markers along a trajectory, aligned with a source trajectory, made from a first material, coated with a second material which is detectable under MR imaging, and are capable of being detected (0022-0024, 0087, 0037).
Additionally, the inclusion of an imaging modality for detection (0022-0024), whereby the trajectory of an attached device can be ascertained by the markers (Fig 5, 0026, 0028, 0075), and the controller can assist in dose planning (0103).
Garcia fails to disclose and teach the setting of dwell time, the sizing of coating as smaller than 1 micrometer, and where the interdistance between markers is less than 3 millimeters (though they do disclose placements around 3mm apart, 0022-0024).
Attention is hereby directed to the teaching reference to Schuurman et al which expressly discloses and teaches coatings in the sub micrometer range (abs, 0005, 0006, 0042), interdistances at 3mm or less (0028-0031, 0068), and the setting and adjustment of dwell times for the determined trajectory of the medical device(s) based on the marker arrangement (0041-0045, 0049-0058).
With respect to claims 2-8, Schuurman et al discloses and teaches the patterning of markers to identify, the markers indicate radioactive seeds, the trajectory and markers span a length, and the markers include a ring coaxially aligned with the source trajectory (Fig 3-4, 0033-0036, 0051). The ring specifically is disclosed as having length between 2-3mm, outer diameter smaller than 2mm, and wall thickness can be .3mm or smaller (0029-0033, 0128). Additionally, primary reference to Garica also discloses these limitations as the markers are disclosed as 3x.9mm (0089, 0119), inner and outer rings (0023), the thickness around .25mm (0031).
With respect to claims 10 and 13, Schuurman et al discloses and teaches an inner ring with copper, brass, gold, silver (0005, also disclosed in Garcia (0119 and 0089), the use of nickel or iron oxide coatings (0005), as well as an applicator for implanting the markers (Fig 3-4).
With respect to claims 15-21, Schuurman et al discloses the detection of the markers (0038, 0047, 0076, 0059, multiple markers for placement/pattern), the comparison to stored data for the orientation/position (0049, 0054-0058), the planning and comparison to a plan for the direction/placement of the device(s) (0044-0046, 0048-0049, 0054-0055), the margin between the markers/devices, dwell time(s) (0044-0045, 0049), and the optimization under CT and MR based on the coating (0004, 0029). It would have been obvious to one of ordinary skill in the art at the time of the invention to have utilized the coating, planning system, and feedback control of Schuurman et al with the system of Garica for the purpose of facilitating brachytherapy treatment, implantation, and planning thereof (0009, claim 49, Garcia; 0044-0045, Schuurman et al).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOEL M. LAMPRECHT whose telephone number is (571)272-3250. The examiner can normally be reached Mon - Fri 9:00-5:30.
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/JOEL LAMPRECHT/ Primary Examiner, Art Unit 3798
