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 § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-8 and 10-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gordon et al. (US 2019/0192298).
Gordon et al. discloses a cranial implant (10) replacing a section of a skull for functional ultrasound imaging (Figs. 3A-3D, 3G, 6A-6B, and 7), the cranial implant comprising: a support section shaped to replace a removed section of the skull (Fig. 3C-3D, 3G; [0054]); and a window of sonolucent material in the support section allowing functional ultrasound imaging through an ultrasound probe on the window, wherein the window is shaped to allow access to a region of interest in the brain ([0014]; [0059]).
With respect to claim 2, Gordon et al. discloses wherein the window of the sonolucent material includes the entire support section (Fig. 3G).
With respect to claim 3, Gordon et al. discloses wherein the sonolucent window is fabricated from one of polymethyl methacrylate (PMMA) or polyether ether ketone (PEEK) ([0005]).
With respect to claim 4, Gordon et al. discloses wherein the sonolucent window is a titanium mesh ([0005]).
With respect to claim 5, Gordon et al. discloses wherein the sonolucent window is positioned above at least one of a primary motor cortex, a primary somatosensory cortex, or a posterior parietal cortex of the brain when the support section replaces the removed section of the skull ([0054]; Figs. 6A-6B).
With respect to claim 6, Gordon et al. discloses wherein the sonolucent window has a thickness of between 1 and 10 mm ([0005]; [0085]).
With respect to claim 7, Gordon et al. discloses wherein the sonolucent window is a subsection of the support section, and wherein the sonolucent window has a thickness less than the thickness of the support section ([0075]).
With respect to claim 8, Gordon et al. discloses wherein the ultrasound probe is positioned near a postcentral gyrus (poCG) and a Supramarginal gyrus (SMG) of the brain (Fig. 6B).
With respect to claim 10, Gordon et al. discloses a method for producing a customized cranial implant for collecting functional ultrasound images, the method comprising: performing a craniectomy on a patient ([0065]); imaging the brain underneath a skull section removed through the craniotomy ([0065]; [0083]); fabricating a cranial implant to replace the skull section removed through the craniotomy ([0065]); creating a sonolucent window in the implant above a region of the brain based on the imaging to allow collection of functional ultrasound images via an ultrasound transducer probe ([0065]; [0083]).
With respect to claim 11, Gordon et al. discloses wherein the imaging is performed via either a magnetic resonance imaging system ([0058]) or a functional ultrasound system ([0083]).
With respect to claim 12, Gordon et al. discloses wherein the window of the sonolucent material includes the entire support section (Fig. 3G).
With respect to claim 13, Gordon et al. discloses wherein the sonolucent window is fabricated from one of polymethyl methacrylate (PMMA) or polyether ether ketone (PEEK) ([0005]).
With respect to claim 14, Gordon et al. discloses wherein the sonolucent window is a titanium mesh ([0005]).
With respect to claim1 5, Gordon et al. discloses wherein the sonolucent window is positioned above at least one of a primary motor cortex, a primary somatosensory cortex, or a posterior parietal cortex of the brain when the support section replaces the removed section of the skull ([0054]; Figs. 6A-6B).
With respect to claim 6, Gordon et al. discloses wherein the sonolucent window has a thickness of between 1 and 10 mm ([0005]; [0085]).
With respect to claim1 7, Gordon et al. discloses wherein the sonolucent window is a subsection of the support section, and wherein the sonolucent window has a thickness less than the thickness of the support section ([0075]).
With respect to claim 18, Gordon et al. discloses wherein the ultrasound probe is positioned near a postcentral gyrus (poCG) and a Supramarginal gyrus (SMG) of the brain (Fig. 6B).
With respect to claim 19, Gordon et al. discloses a functional ultrasound imaging system comprising: an ultrasound probe including a transducer for functional ultrasound imaging (Figs. 6b and 7; 220); a cranial implant including an imaging window constructed of sonolucent material (Fig. 3C-3D, 3G; [0014]; [0054]), wherein the functional ultrasound probe is positioned on the imaging window (Figs. 6B and 7); and a functional ultrasound controller coupled to the ultrasound probe, the functional ultrasound controller taking functional ultrasound images of the brain via the ultrasound probe ([0083]; [0093]; [0096]).
With respect to claim 20, Gordon et al. discloses wherein the sonolucent window is fabricated from polymethyl methacrylate (PMMA).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gordon et al. (US 2019/0192298).
Gordon et al. discloses the subject matter substantially as claimed except for wherein the window is a parallelogram shape. However, Gordon et al. discloses a trimming to a desired size and shape and a change in shape is well within the skill level of one of ordinary skill in the art (MPEP 2144.04(IV)(B)). Therefore, it would have been obvious to one of ordinary skill in the art to have provided Gordon et al. with a parallelogram shape as it is a well known shape and a change in shape is well within the skill level of one of ordinary skill in the art (MPEP 2144.04(IV)(B)).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Sampath et al. (US 2020/0030099 and US 2021/0267762), Christopher et al. (US 2020/0197180 and US 2023/0020551), and Gordon et al. (US 2022/0296375) all disclose a cranial implant with ultrasound window.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER LUONG whose telephone number is (571)270-1609. The examiner can normally be reached M-F 9-6.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan T Nguyen can be reached at (571)272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PETER LUONG/Primary Examiner, Art Unit 3797
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