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 § 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, 5, 7-11 and 30-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2016/0081676 to Nock et al. “Nock” in view of U.S. Publication No. 2009/0306494 to Scarth et al. “Scarth” and U.S. Publication No. 2020/0038638 to Gliner.
As for Claims 1, 5 and 30, Nock discloses an MRI compatible biopsy system and method (Abstract; Paragraph [0080]) the biopsy system comprising a control module that controls and powers a biopsy device remote from a body of the control module (Paragraph [0080]). Nock discloses wherein the control module includes one or more ports configured to couple the control module to a biopsy device(Paragraph [0081]). In one embodiment, Nock depicts wherein the control module includes a display configured to provide a graphical user interface for the operator and display operating information relating to the biopsy device (Paragraph [0200]).
However, Nock does not expressly disclose wherein the control module has MRI compatible features including one or more processors configured to initiate an imaging mode and reduce the functionality of one more features of the control module in order to reduce the EM footprint of the control module as claimed.
Scarth teaches from within a similar field of endeavor with respect to MRI systems and methods (Abstract) where a safety control system is configured to remove power from additional devices except for those necessary within the MRI suite when MRI imaging is initiated (Paragraphs [0067]-[0068]). Examiner notes that by removing power, the EM footprint would be reduced in its broadest reasonable interpretation.
Accordingly, one skilled in the art would have been motivated to have modified the biopsy control module described by Nock with a safety control system configured to power down the biopsy system except for those necessary as described by Scarth in order to enhance patient and MRI staff safety. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
As for initiating the imaging mode, Scarth explains wherein the safety controller can initiate MR imaging set up (Paragraphs [0184]-[0185]). Accordingly, one skilled in the art would have been motivated to have integrated some MRI controls into the biopsy controller of Nock in order to further reduce an EM footprint of device controllers within an MRI environment.
Nonetheless, Gliner is also cited herein as evidence to support the obviousness conclusion. For example, Gliner discloses a console 24 configured to operate a catheter system and MRI system (Paragraph [0029]).
Accordingly, one skilled in the art would have been motivated to have integrated some MRI controls into the biopsy controller in order to further reduce an EM footprint of device controllers within an MRI environment.
As for Claims 7-9 and 11, Nock discloses wherein the biopsy system includes a rotary drive motor and vacuum components located near the bottom of the unit (Figs. 53). Examiner notes the vacuum system would include a pump in its broadest reasonable interpretation.
As for Claim 10, Examiner notes the MRI compatible biopsy system has a base and would include non-magnetic components in its broadest reasonable interpretation.
Regarding Claim 31, Nock discloses where biopsy systems include a vacuum module (Paragraphs [0002], [0083]) and cutter control (Paragraphs [0097], [0197], [0210] and [0264]).
With respect to Claims 32-33, Examiner notes the powered off or reduced powered processors in the modified device would have an operational frequency below the range of an MRI coil and below the frequency of an “active mode” (e.g. before imaging initiated) in its broadest reasonable interpretation.
Claim(s) 4 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nock, Scarth and Gliner as applied to claim 1 above, and further in view of U.S. Patent No. 6,385,480 to Bachus et al. “Bachus” and U.S. Publication No. 2012/0120993 to Lin et al. “Lin”.
As for Claim 4, Nock, Scarth and Gliner disclose an MRI compatible biopsy device as described above. While the modified device reduces the power to the biopsy controller, it does to specify the operating frequency as claimed.
Bachus teaches from within a similar field of endeavor with respect to MRI systems and methods where auxiliary devices near the MRI can be shut off or deactivated into a “sleep mode” (Column 2, Lines 1-15). Examiner notes that a sleep mode would operate within the claimed frequency range in its broadest reasonable interpretation.
Nonetheless, Lin teaches where sleep modes include an operational frequency of 32 kHz (Paragraph [0018]).
Accordingly, one skilled in the art would have been motivated to have adjusted the operating frequency of the biopsy controller described above to include a sleep mode setting described by Bachus and Lin in order to efficiently power up auxiliary devise when needed. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
As for Claim 6, Lin’s system includes a timer to recover from a sleep mode (Paragraphs [0005]). Accordingly, one skilled in the art would have been motivated to have used a timing means to automatically switch the controller between modes (e.g. imaging and sleep mode). Such a modification would save power switching to a sleep mode and time when the controller recovers from the sleep mode.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nock, Scarth and Gliner as applied to claim 11 above, and further in view of U.S. Publication No. 2015/0097756 to Ziarati et al. “Ziarati”.
As for Claim 12, Nock, Scarth and Gliner disclose an MRI compatible biopsy device as described above including a rotary drive cable. However, the art of record does not specify the material of the cable.
Ziarati teaches from within a similar field of endeavor with respect to MRI compatible devices where nonferrous materials such as brass, phosphor bronze or aluminum can be used for MRI applications (Paragraph [0033]).
Accordingly, one skilled in the art would have been motivated to have used any conventionally known MRI safe material such as Ziarati for device components in order to enhance patient safety. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nock, Scarth and Gliner as applied to claim 1 above, and further in view of U.S. Publication No. 2019/0328596 to Rapoport et al. “Rapoport”.
As for Claim 13, Nock, Scarth and Gliner disclose an MRI compatible biopsy device as described above. However, the art of record does not wherein the biopsy system used a battery (e.g. direct current).
Rapoport teaches from within a similar field of endeavor with respect to MRI compatible devices where the device can be powered by a portable power supply (e.g. battery; Paragraph [0164]).
Accordingly, one skilled in the art would have been motivated to have used conventional MRI safe portable power supplies as described by Rapoport in order to reduce wired connections within an MRI environment. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
Claim(s) 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nock, Scarth and Gliner as applied to claim 9 above, and further in view of Rapoport and U.S. Publication No. 2015/0231012 to Rapoport et al. “Rapoport 2”.
Regarding Claims 14-15, Nock, Scarth and Gliner disclose an MRI compatible biopsy device as described above. However, the art of record does not wherein the biopsy system uses a battery and locking mechanism as claimed.
Rapoport teaches from within a similar field of endeavor with respect to MRI compatible devices where the device can be powered by a portable power supply (e.g. battery; Paragraph [0164]). Rapoport discloses wherein the cart includes a storage compartment 1260 in Fig. 12C. However, it is not clear if the storage compartment includes the battery and fitted with a lock to automatically lock the door during MRI use.
Examiner notes one skilled in the art would appreciate the need to secure items in an MRI environment to prevent them from becoming projectiles toward the magnet. Thus, one skilled in the art would have been motivated to have included a storage compartment in the base of Nock’s biopsy system to store the portable battery as such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
Regarding the locking feature, Rapoport 2 teaches from within a similar field of endeavor with respect to MRI compatible devices where the device includes an interlock mechanism connected to a CPU (Paragraphs [0160]-[0161] and [0486]).
Accordingly, one skilled in the art would have been motivated to have equipped the storage compartment with a locking mechanism connected to a CPU as described by Rapoport 2 in order to protect patient and MRI staff during an MRI exam.
Claim(s) 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nock, Scarth, Gliner, Bachus, Lin and U.S. Patent No. 5,746,697 to Swedlow et al. “Swedlow”.
As for Claim 34, Nock discloses an MRI compatible biopsy system and method (Abstract; Paragraph [0080]) the biopsy system comprising a control module that controls and powers a biopsy device remote from a body of the control module (Paragraph [0080]). Nock discloses wherein the control module includes one or more ports configured to couple the control module to a biopsy device(Paragraph [0081]). In one embodiment, Nock depicts wherein the control module includes a display configured to provide a graphical user interface for the operator and display operating information relating to the biopsy device (Paragraph [0200]).
However, Nock does not expressly disclose wherein the control module has MRI compatible features including one or more processors configured to initiate an imaging mode, save a current state and reduce the functionality of one more features of the control module in order to reduce the EM footprint of the control module as claimed.
Scarth teaches from within a similar field of endeavor with respect to MRI systems and methods (Abstract) where a safety control system is configured to remove power from additional devices except for those necessary within the MRI suite when MRI imaging is initiated (Paragraphs [0067]-[0068]). Examiner notes that by removing power, the EM footprint would be reduced in its broadest reasonable interpretation.
Accordingly, one skilled in the art would have been motivated to have modified the biopsy control module described by Nock with a safety control system configured to power down the biopsy system except for those necessary as described by Scarth in order to enhance patient and MRI staff safety. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
As for initiating the imaging mode, Scarth explains wherein the safety controller can initiate MR imaging set up (Paragraphs [0184]-[0185]). Accordingly, one skilled in the art would have been motivated to have integrated some MRI controls into the biopsy controller of Nock in order to further reduce an EM footprint of device controllers within an MRI environment.
Nonetheless, Gliner is also cited herein as evidence to support the obviousness conclusion. For example, Gliner discloses a console 24 configured to operate a catheter system and MRI system (Paragraph [0029]).
Accordingly, one skilled in the art would have been motivated to have integrated some MRI controls into the biopsy controller in order to further reduce an EM footprint of device controllers within an MRI environment.
Regarding the particular operating frequencies of a reduced functionality mode, while the modified device reduces the power to the biopsy controller, it does to specify the operating frequency as claimed.
Bachus teaches from within a similar field of endeavor with respect to MRI systems and methods where auxiliary devices near the MRI can be shut off or deactivated into a “sleep mode” (Column 2, Lines 1-15). Examiner notes that a sleep mode would operate within the claimed frequency range in its broadest reasonable interpretation.
Nonetheless, Lin teaches where sleep modes include an operational frequency of 32 kHz (Paragraph [0018]).
Accordingly, one skilled in the art would have been motivated to have adjusted the operating frequency of the biopsy controller described above to include a sleep mode setting described by Bachus and Lin in order to efficiently power up auxiliary devise when needed. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
As for the step of saving device data prior to sleep mode activation, Swedlow teaches from within a similar field of endeavor with respect to medical diagnostics apparatuses with sleep mode (Abstract) where the processor can automatically save state data in order to be able to resume from where it left off in its program (Column 1, Line 63-Column 2, Line 15).
Accordingly, one skilled in the art would have been motivated to have stored device state data prior to initiating the sleep mode as described by Swedlow in order to quickly resume device functions when necessary. 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 filed 05/08/2026 have been fully considered and 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 rejection above. For example, Applicant argues “…amended independent claim 1 recites ‘the imaging mode including a reduced function mode in which the functionality of one or more features of the control module is reduced in order to reduce the electromagnetic footprint of the control module.’ These limitations, among others recited in amended claim 1, are neither taught or suggested by the combined art of record” (REMARKS, Page 8). Examiner respectfully disagrees and notes the modified device described by the combination of Nock, Scarth and Gliner disclose all claimed limitations. As described in the rejections above, Scarth teaches from within a similar field of endeavor with respect to MRI systems and methods (Abstract) where a safety control system is configured to remove power from additional devices except for those necessary within the MRI suite when MRI imaging is initiated (Paragraphs [0067]-[0068]). Examiner notes that by removing power, the EM footprint would be reduced in its broadest reasonable interpretation. Accordingly, one skilled in the art would have been motivated to have modified the biopsy control module described by Nock with a safety control system configured to power down the biopsy system except for those necessary as described by Scarth in order to enhance patient and MRI staff safety. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143). As for initiating the imaging mode, Scarth explains wherein the safety controller can initiate MR imaging set up (Paragraphs [0184]-[0185]). Accordingly, one skilled in the art would have been motivated to have integrated some MRI controls into the biopsy controller of Nock in order to further reduce an EM footprint of device controllers within an MRI environment. Nonetheless, Gliner is also cited herein as evidence to support the obviousness conclusion. For example, Gliner discloses a console 24 configured to operate a catheter system and MRI system (Paragraph [0029]). Accordingly, one skilled in the art would have been motivated to have integrated some MRI controls into the biopsy controller in order to further reduce an EM footprint of device controllers within an MRI environment.
Examiner also notes it is unclear what other limitations Applicant is referring to using the phrase “among others” (REMARKS, Page 8). Thus, the rejections have been maintained.
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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/CHRISTOPHER L COOK/Primary Examiner, Art Unit 3797
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