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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/20/2026 has been entered.
Drawings
The drawings were received on 04/20/2026. These drawings are acceptable.
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, 17 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 directed toward an apparatus for communicating a message but fails to disclose communicating a message. In other words, it is unclear if the communication signal indicative of an instruction is the message. Claim 1 is also rejected because it is unclear if the communicating signal indicative of an instruction is the pressurized air released into the tube.
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, 17 and 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”, U.S. Publication No. 2015/0196367 to Muller et al. “Muller” and U.S. Publication No. 2008/0161830 to Sutherland et al. “Sutherland”.
As for Claims 1 and 17, 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. Weinbruch also does not disclose a portable support structure having an arm with a distal end portion that is receivable into the MRI device as claimed.
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 the portable structure comprising an arm, Sutherland teaches from within similar field of endeavor with respect to MRI systems and methods (Abstract; Paragraph [0046]) where a portable structure (Paragraph [0042]) is provided with an arm in order to interact with the patient inside the MRI device (Paragraphs [0029]-[0032] and [0041]; also see Fig. 1A).
Accordingly, one skilled in the art would have been motivated to have modified the MRI system and method described by Weinbruch with a portable support structure and arm as described by Sutherland in order to selectively and safely position the tube at any location of the patient inside the MRI system. Such a modification merely involves combining prior art element 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.
As for Claim 21, Examiner 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) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weinbruch, Leonard and Muller.
As for Claim 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 instructions or messages including breath hold instructions 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).
Claim(s) 21 is/are alternatively rejected under 35 U.S.C. 103 as being unpatentable over Weinbruch, Leonard, Muller and Sutherland 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, Muller and Sutherland 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, Muller and Sutherland 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).
Claim(s) 22-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2012/0143040 to Goswami et al. “Goswami” in view of Sutherland.
As for Claims 22 and 33, Goswami discloses an apparatus for communicating a message to a patient in an MRI device (Abstract) comprising a visual communication device (72 in Fig. 2 and corresponding descriptions) connected to a light drive and control circuity which includes a light drive and one more light sources (Paragraph [0026]). Goswami discloses wherein one or more fiber optic lines (76 in Fig. 2 and corresponding descriptions) transmit light generated at the light drive to the visual communication panel (82 and 84 in Fig 2 and corresponding descriptions). The light is used to illuminate segments on the panel to provide instructions to the patient such as for example, breath hold instructions (Paragraphs [0027]-[0028]. Goswami further discloses wherein the panel includes a display for communicating the instructions (Paragraphs [0028] and [0040]) and wherein the system includes an input means in the control circuitry to allow the user choose which segments on the panel are activated and with what color (Paragraph [0029]). Examiner notes such input means would include a button or switch in its broadest reasonable interpretation. Such disclosures are considered to read on the claimed limitations of the apparatus comprising at least one light, at least one fiber optic cable free of magnetic metal having a first and second end and in communication with the light, a display device coupled to fiber optic cable and an input device configured to receive input from a medical professional that causes the light to illuminate thereby providing a communicating signal at the display device via the fiber optic cable in its broadest reasonable interpretation.
However, while Goswami depicts a support arm for holding the aforementioned panel (Fig. 6 and corresponding descriptions), the support arm is not part of a portable frame as claimed.
Sutherland teaches from within similar field of endeavor with respect to MRI systems and methods (Abstract; Paragraph [0046]) where a portable structure (Paragraph [0042]) is provided with an arm in order to interact with the patient inside the MRI device (Paragraphs [0029]-[0032] and [0041]; also see Fig. 1A).
Accordingly, one skilled in the art would have been motivated to have modified the MRI system and method described by Goswami with a portable support structure and arm as described by Sutherland in order to selectively and safely position the panel relative to the patient inside the MRI system. Such a modification merely involves combining prior art element according to known techniques to yield predictable results (MPEP 2143).
As for claims 23-27, Goswami discloses wherein the light is a muti-color LED that is configured to transmit a separate color to each segment (Paragraph [0029]). Examiner notes that one skilled in the art would have been motivated to use any combination of colors including red, yellow and green as such a modification is a matter of pure design choice.
Regarding Claim 28, the display panel includes multiple outlet areas wherein each area may be selectively illuminated via optic lines (e.g. channels) (Paragraphs [0030]-[0032] and Fig. 3).
With respect to Claim 29, Goswami discloses wherein the outlet areas are arranged relative to one another (Fig. 3). One skilled in the art would have been motivated to have rearranged the particular order of outlet areas into a single axis as such a modification is a matter of pure design choice in order to present instructions to the user.
Regarding Claims 30-31, Goswami discloses a label indicating the instruction for the light (e.g. hold, resume, starting scan) (Fig. 3). Examiner notes such labels can be removable (e.g. changed out for something else) in its broadest reasonable interpretation.
As for Claim 32, Examiner notes that providing the colored indication to the user with colored lights or colored windows is considered an obvious design choice in the absence of showing any criticality or unexpected result.
With respect to Claim 34, Goswami discloses wherein the one or more fiber optic lines 76 can be used to couple the light drive receiver and control circuity at a distance from the scanner to avoid interference and can be located in another room or disposed away from the scanner (Paragraph [0026]). One skilled in the art would have been motivated to use any length of cable to facilitate the appropriate distancing (e.g. at least 15 ft) in order to avoid interference.
As for Claim 35, Sutherland’s portable unit has wheels (Fig. 1A).
With respect to Claim 36, arm includes a plurality of segments (Fig. 1A) that can be oriented in various directions (e.g. flexible) in its broadest reasonable interpretation.
Claim(s) 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goswami and Sutherland as applied to claim 23 above, and further in view of U.S. Publication No. 2005/0116920 to Park et al. “Park”.
As for Claim 32, Goswami and Sutherland disclose an MRI system and method for communicating messages to a patient inside the bore using colored lights. Examiner notes that providing the colored indication to the user with colored lights or colored windows is considered an obvious design choice in the absence of showing any criticality or unexpected result.
Nonetheless, Park teaches where color may be provided to the user with white light and color filters (Fig. 1) or colored lights (Fig. 2).
Accordingly, one skilled in the art would have been motivated to have used colored filters on the panel segments in order to enhance the displayed color. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
Claim(s) 19 is/are alternatively rejected under 35 U.S.C. 103 as being unpatentable over Goswami, Leonard and Weinbruch.
As for Claim 19, Goswami discloses an apparatus and method for communicating a message to a patient in an MRI device (Abstract) comprising a visual communication device (72 in Fig. 2 and corresponding descriptions) connected to a light drive and control circuity which includes a light drive and one more light sources (Paragraph [0026]). The light is used to illuminate segments on the panel to provide instructions to the patient such as for example, breath hold instructions (Paragraphs [0027]-[0028] but Goswami makes it clear that other instructions may be provided (Paragraph [0028]). Goswami further discloses wherein the panel includes a display for communicating the instructions (Paragraphs [0028] and [0040]) and wherein the system includes an input means in the control circuitry to allow the user choose which segments on the panel are activated and with what color (Paragraph [0029]).
However, Goswami does not disclose wherein the conveyed message is applied to the patient in the form of pressurized air via a tube.
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]).
In addition, 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. 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.
Accordingly, one skilled in the art would have been motivated to have modified the patient communicating system and method in an MRI setting as described by Goswami with a tube configured to deliver pressurized air to the patient to deliver prompts to blind and/or deaf patients. Such a modification merely involves combining prior art elements and would reduce patient anxiety by allowing messages to be delivered to the patient during an MRI procedure.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 13, 17, 19 and 21-36 have been considered but are moot in view of the updated grounds of rejection necessitated by amendment. However, Examiner will address Applicant’s remarks which may still pertain to the current rejection. For example, regarding Claim 19, Applicant argues Weinbruch is directed to somatosensory investigations during fMRI and the delivery of air is not for providing a message indicative of an instruction but is solely for creating a physical stimulus to the body of a patient and using air for providing a message is fundamentally inconsistent with the principle operation of Weinbruch and any breath holding in fMRI confers no advantage. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). As set forth in the rejection above, 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. 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 instructions or messages including breath hold instructions with deaf and/or blind patients undergoing any type of MRI exam. MRI systems are not limited to fMRI techniques and the MRI system is utilized for variety of imaging protocols. The proposed modification does not destroy and principle in the primary reference. Thus, the rejection has been maintained.
Conclusion
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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/CHRISTOPHER L COOK/Primary Examiner, Art Unit 3797
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