DETAILED ACTION
Notice of 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 filed 09/01/2026 have been fully considered but they are not persuasive | moot in view of the new grounds of rejection. The Examiner respectfully submits that the broadly recited “printing” is not limited to an additive-only approach. Even assuming that the machining process of Kast is subtractive, a subtractive modification to a material can still result to the creation of a print. Given the breadth of the limitation, “modifying data”, the data processing of Kast is considered sufficient to meet the requirement of the claim.
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 may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claim(s) 1-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kast (US 2009/0281623, of record).
Regarding claim 1, Kast discloses a method comprising: measuring a head of a subject to obtain measurement data; generating a measured curvature based at least in part the measurement data (Abstract; [0033], [0044]: magnetic resonance imaging); modifying data defining a generic human shape based at least in part on the measured curvature to generate customized head shape data; generating a customized attachment puck shape based on the customized head shape data; and printing, using a printing device, a customized attachment puck corresponding to the customized attachment puck shape ([0046]: a manufacturing system “prints”; [0068]: a CNC machine tool “prints”; Figs. 10A-C, 11). While Kast does not explicitly disclose that the attachment puck is “external to the head”, Kast does teach that their device does sit on top of the skull, which is considered external to a part of the head ([0006], [0027]). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the external attachment of Kast, as to provide a placement where the shape of the skull can be accurately elucidated.
Regarding claim 2, Kast discloses the measurement data is based on data obtained using a Magnetic Resonance Imaging (MRI) device ([0044]: magnetic resonance imaging).
Regarding claim 3, Kast discloses generating location data based at least in part on the measurement data ([0044]: magnetic resonance imaging comprises ‘location data’).
Regarding claim 4, Kast discloses the customized head shape data is based on the location data ([0044]: magnetic resonance imaging comprises ‘location data’).
Regarding claim 5, Kast discloses a customized attachment puck, comprising: at least one coupling layer for interfacing with a head of a patient; a customized attachment puck shape based on customized head shape data (Abstract; [0033], [0044]: magnetic resonance imaging), wherein the customized attachment puck shape is generated based on measured curvature data associated with the head of the patient ([0046]: manufacturing system; [0068]: CNC machine tool; Figs. 10A-C, 11). While Kast does not explicitly disclose that the attachment puck is “external to the head”, Kast does teach that their device does sit on top of the skull, which is considered external to a part of the head ([0006], [0027]). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the external attachment of Kast, as to provide a placement where the shape of the skull can be accurately elucidated.
Claim(s) 6-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kast (US 2009/0281623, of record) in view of Liu (US 2016/0302765, of record).
Regarding claim 6, Kast does not explicitly disclose a membraned hydrogel. However, Liu teaches the attachment of a hydrogel layer ([0047]). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the hydrogel of Liu to the custom head-fitted device of Kast, as to provide a robust integration of a hydrogel to a custom head-fitted device for effective acoustic conduction.
Regarding claims 7 and 8, Kast does not explicitly disclose that the at least one coupling layer is attachable to a holder unit by at least one of: adhesive tape, latch, snap-fit, or screws, and that the holder comprises one or more ultrasound transducers. However, Liu teaches the use of adhesive tape and the attachment of an ultrasound probe ([0042]…[0048]). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the tape and ultrasound transducer of Liu to the custom head-fitted device of Kast, as to provide a robust integration of an ultrasound transducer to a custom head-fitted device.
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 extension fee 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 date of this final action.
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/JASON M IP/Primary Examiner, Art Unit 3793
