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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the pneumatically actuated vibrator must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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, 13-18 and 21 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. Claim 1 is rejected because it is unclear if the communicating signal is the pressurized air released into the tube. Claim 18 appears to have the same issue.
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, 13 and 17-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over NPL “A portable and low-cost fMRI compatible pneumatic system for the investigation of the somatosensory system in clinical and research environments” to Weinbruch et al. “Weinbruch” in view of U.S. Publication No. 2019/0220010 to Leonard et al. “Leonard” and U.S. Publication No. 2015/0196367 to Muller et al. “Muller”.
As for Claims 1 and 17-19, Weinbruch discloses an apparatus for stimulating a patient undergoing an MRI scan with “puffs” of air (Abstract; Pages 183-184). The pneumatic stimulus device includes a compressed air bottle, air pressure regulator, valve, controller, PC and tube (Fig. 1 and corresponding descriptions). Examiner notes the combination of the air bottle, regulator, valve, controller and PC are considered to read on an indication source configured to selectively provide air in the tube according to user input in its broadest reasonable interpretation. Weinbruch explains the tube length is approximately 5m (about 16 ft) to connect the air stimulus system to the patient in an MRI scanner. Examiner notes that the second end (e.g. connected to the patient) would be free of any magnetic metal in order to be safely used in the MRI system in its broadest reasonable interpretation.
However, Weinbruch does not expressly disclose wherein the air puffs are used as a communication/feedback/prompting means.
Leonard teaches from within a similar field of endeavor with respect to stimulation systems and methods (Paragraph [0031]) where tactile and/or haptic feedback may be used to communicate information to blind and/or deaf users (Paragraph [0040]). In one embodiment haptic and/or tactile feedback includes air puffs to prompt the user (Paragraph [0034]).
Muller is also cited to support the conclusion of obviousness for stimulating the patient to convey messages in an MRI setting. For example, Muller discloses a system and method to communicate a message to a patient in an MRI device (Abstract; Paragraphs [0026] and [0039]) comprising a control unit configured to control at least one indication source (e.g. visual feedback device) (Paragraphs [0019]-[0020] and [0031]). In one embodiment, Muller explains that the patient is told before an examination what certain stimulus means such as a red lighting scheme may be used to instruct the patient to hold his/her breath (Paragraph [0034]). Examiner notes that a medical processional would provide inputs to the control unit to command the lighting controls (Paragraph [0044]).
Accordingly, one skilled in the art would have been motivated to have used Weinbruch’s MRI air stimulus system and method to communicate with and/or prompt deaf and/or blind patient’s as described by Leonard and Muller in order to safely and efficiently communicate with deaf and/or blind patients undergoing an MRI exam. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
As for Claim 13, Weinbruch’s control unit (collectively the controller and PC depicted in Fig. 1) is considered to have a switch to activate the puffs of air.
Regarding Claim 20, Examiner notes the haptic/tactile feedback can represent any standard messaging inside an MRI (e.g. hold still, hold breath, etc.) and one skilled in the art would have been motivated to use the modified feedback system to convey any pertinent messaging to the patient undergoing MRI examination. Furthermore, as explained above, Muller discloses wherein one type of patient stimulus is considered a message for a breath hold.
As for Claim 21, Examine notes the pneumatic system described above would impart vibrations to the patient via the air puff and tube connected to the patient in its broadest reasonable interpretation.
Claim(s) 14-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weinbruch, Leonard and Muller as applied to claim 1 above, and further in view of U.S. Publication No. 2019/0231229 to Sturgeon et al. “Sturgeon”.
As for Claim 14, Weinbruch, Leonard and Muller disclose a haptic/tactile feedback system for communicating with a patient undergoing an MRI exam using puffs of air through a tube as described above.
However, the art of record does not expressly disclose a support structure for the tube as claimed.
Sturgeon teaches from within a similar field of endeavor with respect to patient stimulation systems and methods where a patient interface device (e.g. touchscreen display tablet) is coupled with a support arm (110, 90 in Fig. 14 and corresponding descriptions) so as to facilitate positioning within the MRI bore. Sturgeon explains wherein the support arm is coupled to a display means and a cable 28 (Paragraphs [0056] and [0058]).
Accordingly, one skilled in the art would have been motivated to have modified the MRI system and method described by Weinbruch, Leonard and Muller to include a support structure configured to support cables and a display described by Sturgeon in order to efficiently route cables, interaction systems and tubes within the MRI bore. Such a modification would also appear to reduce clutter within the MRI bore and merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weinbruch, Leonard and Muller as applied to claim 1 above, and further in view of U.S. Publication No. 2018/0140219 to Yin et al. “Yin”.
Alternatively regarding Claim 21, Weinbruch, Leonard and Muller disclose a haptic/tactile feedback system for communicating with a patient undergoing an MRI exam using puffs of air through a tube as described above.
While the tube and puffs of air would be considered a pneumatically actuated “vibrator” in its broadest reasonable interpretation, Yin is also provide to teach an MRI stimulation device comprising a tube (Paragraph [0039]) and a pneumatic based pressure activated driver (Paragraph [0045]).
Accordingly, one skilled in the art would have been motivated to have modified the MRI system and method described by Weinbruch, Leonard and Muller to include a pneumatic based vibration means to alternatively stimulate the patient as described by Yin as such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 13-21 have been considered but are moot in view of the updated grounds of rejection necessitated by amendment.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER L COOK whose telephone number is (571)270-7373. The examiner can normally be reached M-F approximately 8AM-5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Kozak can be reached at 571-270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTOPHER L COOK/Primary Examiner, Art Unit 3797