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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1, 10, and 15 recite “attachment portion is configured for attachment to at least one of a stereotactic frame or to a head fixation pin”. It is not clear from the claim language how the attachment portion is attached to the frame via the head fixation pin. The claim language appears to provide the option of the attachment portion attaching to the frame or to the head fixation pin.
However, upon reviewing the specification, “each head fixation pin 102 includes an attachment portion 108 at a first end thereof. The attachment portion 108 includes attachment surfaces 110 for engaging an inner edge of a corresponding aperture 104 in the stereotactic frame 100. In order to initially secure an attachment pin 102 to the stereotactic frame 100, the attachment portion 108 is inserted into an aperture 104 such that the attachment surfaces 110 abut the inner surface of the stereotactic frame 100, and the attachment ring 106 is secured to the proximal end 112 of the attachment portion 108 such that the attachment ring 106 abuts the outer side of the stereotactic frame 100, thereby securing the head fixation pin 102 to the stereotactic frame 100”[0051].
According to the specification, the head fixation pin includes the attachment portion at a first end and the attachment portion includes surface for engaging the inner edge of the corresponding apertures in the frame such that the attachment surface abut the inner surface of the frame. It is suggested claims 1, 10, and 15 provide further clarity (in view of the above citation from the specification) to the arrangement of the attachment portion/head fixation pin/attachment surface/inner edge of aperture of the frame.
Claims 10 and 15 recite “second part coupled to the first part, the second part being height-adjustable relative to the attachment portion”. It is not clear from the claim language exactly how the second part is height-adjustable relative to the first part. Claim 2 recites “second part is threaded onto the first part, wherein a height of the second part relative to the attachment portion is adjustable by rotating the second part relative to the first part”. As per the specification, “by rotating the second part 304 relative to the first part 302, the height of the second part 304 relative to the first part 302 can be increased and decreased” [0059]. It is suggested claim 10 and 15 provide further clarity with respect to the attachment of the second part relative to the first part and the how the height is adjusted relative to the attachment portion by rotating the second part relative to the first part.
The dependent claims stand rejected under 112(b) due to lack of additional clarity.
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.
Claim(s) 1, 2, 4-10, and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rurling et al. (2015/0119902) in view of Sayler et al. (2021/0236229).
With respect to claims 1, 9, 10, and 15, Rurling et al. teach of an MRI head coil adapter for stereotactic frame and method for securing a patient’s head relative to a MRI head coil [0016, 0025] but arranging a stereotactic frame 1 around the patient’s head [0038, fig. 1]. Rurling et al. teach of securing a head fixation pin to the frame and adapted to fixate the frame 1 to a bone in the head [0038] and the frame is secured to the patient’s head [0031, 0038]. Rurling et al. teach of attaching an MRI head coil adaptor to the fixation pin or the frame at a location adjacent the pin where the adaptor comprises a first part comprising an attachment portion configured for attachment to the frame or the mounting slots 2 adapted to receive the fixation pins [0038] and fixate the frame to a bone in the head. Rurling et al. teach of arranging the mounting slots 2 in the anterior portion 5 and posterior portion 6 and the frame has a curved shape adapted to the shape of the head [0042].
Rurling et al. teach of the stereotactic frame 10 comprising a stereotactic arc 19 and needle holder 20 which is adjustable mounted on the arc 19 but do not teach of a height adjustable part coupled to the attachment portion. In a related field of endeavor Sayler et al. teach of a head support system to be used in MRI environments that includes a head fixation frame assembly 25 [0025, 0102] or frame 212 [0131] with fixation pin 125 that resides in an aperture 115a of the support platform [0078]. Sayler et al. teach of apertures 115a with plurality of segments 115s provided at different height positions coupled to one or more end portions 122 of the respective support leg 120 to accommodate different size heads of respective patients [0072, 0074] or vertically spaced apertures 33 at different height positions to accommodate different size heads 0098]. Sayler et al. also teach of the support legs 120 to be independently extendable and retractable in length into desired lengths [0069] where positional adjustments can be made to the support legs 120 by sliding the first and second length segments relative to each other to adjust a length, selecting an appropriate aperture 115a in the platform 115 to align the bracket 100 over a selected entry site S [116]. Sayler et al. also teach of the trajectory guide body can be attached to the base 212 of the bracket 100 and trajectory guide 201 can be positionally adjusted using actuators 205 for MRI images [0117]. Therefore, under broadest reasonable interpretation, Sayler et al. teach of positional adjustments to the support legs to adjust a length, selecting an appropriate apertures to align the bracket over the selected entry site of the brain and applies pressure against the MRI head coil. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Sayler et al. to modify Rurling et al. to provide different lockable orientations accommodating supine and occipital access for neurological procedures (Sayler, abstract).
With respect to claim 2, Rurling et al. do not teach of the second part that is height-adjustable. Sayler et al. teach of the plurality of disks that couple to the support legs coupled to a bracket and platform [008] where each disk is coupled to different one of the first end portion of the plurality of support legs and the disks may be rotatable relative to another [0010, 0011]. Sayler et al teach of a threaded member that extends through the open center through channel of each disk with attachment members on outer ones of the disks coupled to the threaded member to thereby lock the disks together [0023]. Sayler et al also teach of rotating one of the disks of the set of disks to orient an attachment member [0027] and therefore change the height [0083, 0129]. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Sayler et al. to modify Rurling et al. to provide different lockable orientations accommodating supine and occipital access for neurological procedures (Sayler, abstract).
With respect to claims 4-7, Rurling et al. do not teach of the claimed materials. Sayler et al. teach of the components of the system to be formed of any suitable material formed of polymer, or non-ferromagnetic, or deformable, or rigid polymer [0104]. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Sayler et al. to modify Rurling et al. to provide different lockable orientations accommodating supine and occipital access for neurological procedures (Sayler, abstract).
Claim(s) 3 and 11-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rurling et al. in view of Sayler et al. and further in view of Gribetz et al. (2020/0330749). With respect to claims 3, 11, and 14, the previous references do not explicitly teach of the attachment part to include a male bayonet attachment or a female bayonet attachment. In a related field of endeavor Gribetz et al. teach of an intra calvarial implant with electrodes for sensing electrical signals from a brain which is implanted in the skull [0121] with MRI based stereotactic navigation [0183]. Gribetz et al. teach of male bayonet type attachment member in the part of the shim 190 facing the lid 82 and forming a suitable matching female bayonet type recess in the upper surface of the lid [0264].
With respect to claims 12 and 13, Rurling et al. teach of an MRI head coil adapter for stereotactic frame and method for securing a patient’s head relative to a MRI head coil [0016, 0025] and arranging a stereotactic frame 1 around the patient’s head [0038, fig. 1]. Rurling et al. teach of securing a head fixation pin to the frame and adapted to fixate the frame 1 to a bone in the head [0038] and the frame is secured to the patient’s head [0031, 0038]. Rurling et al. teach of attaching an MRI head coil adaptor to the fixation pin or the frame at a location adjacent the pin where the adaptor comprises a first part comprising an attachment portion configured for attachment to the frame or the mounting slots 2 adapted to receive the fixation pins [0038] and fixate the frame to a bone in the head. Rurling et al. teach of arranging the mounting slots 2 in the anterior portion 5 and posterior portion 6 and the frame has a curved shape adapted to the shape of the head [0042]. Rurling et al. therefore teach of the head fixation pin including attachment portion for attachment to the stereotactic frame and MRI head coil adapter and the attachment surface is configured for insertion into a corresponding aperture so the frame.
It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Gribetz et al. to modify the previous teachings to provide a fast, one-handed secure lock and locks securely into place with a brief twist.
Conclusion
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BR
/BAISAKHI ROY/ Primary Examiner, Art Unit 3797
