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 .
Election/Restrictions
Applicant’s election without traverse of claims 1-10 in the reply filed on 9/17/2025 is acknowledged.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11,644,520. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims are directed to “a method for magnetic resonance (MR) based thermometry, comprising: acquiring, by a variable flip-angle (VFA) T1 mapping sequence, MR data in an area of interest of a subject corresponding to cortical bone of at least part of the skull that is heated by the application of focused ultrasound (FUS) to a selective portion of the brain of the subject, wherein the MR data comprises a plurality of T1 values over time that include a first point in time and a second, later point time, and wherein the acquisition of the MR data comprises applying an accelerated three-dimensional (3D) ultra-short (UTE) spiral acquisition sequence with a nonselective excitation pulse (claim 1 of current application). Claims 2-10 of the ‘520 patent are similar to corresponding claim 2-10 of current application. Claim 2 of the ‘520 patent is directed to “ the acceleration of the accelerated 3D UTE spiral acquisition sequence comprises the use of at least one of partial kz acquisition and variable density of spiral interleaves” (similar to claim 2 of current application). Claim 3 of the ‘520 patent is directed to the mathematical relationship is a linear relationship between T1 values and temperature (similar to claim 3 of current application). Claim 4 of the ‘520 patent is directed to “the mathematical relationship is a linear relationship between the change in T1 values over time and a change in temperature over time (similar to claim 4 of current application). Claim 5 of the ‘520 patent is directed to “the change in the FUS corresponds to ceasing of the application of FUS for a period of time determined at least in part on the temperature change in the cortical bone (similar to claim 5 of current application). Claim 6 of the ‘520 patent is directed to “the ceasing for the period of time corresponds to a period of time selected to allow the selective portion of the brain to cool and prevent unintended damage to the brain (similar to claim 6 of current application). Claim 7 of the ‘520 patent is directed to “the FUS resumes after the period of time” (similar to claim 7 of current application). Claim 8 of the ‘520 patent is directed to wherein the change in the FUS corresponds to decreasing the energy applied by the FUS (similar to claim 8 of current application). Claim 9 of the ‘520 patent is directed to “the decreasing of energy applied by the FUS is performed for a period of time selected to allow the skull to cool and prevent unintended damage to the brain” (similar to claim 9 of current application). Claim 10 of the ‘520 patent is directed to “the change in the FUS corresponds to decreasing the energy applied by FUS to one or more regions of the skull” (similar to claim 10 of current application). Claim 1 of the ‘520 patent is also directed to “implementing a spiral readout focused on rapid 3D UTE imaging that comprises changing phase encoding gradient waveform and echo time as a function of the kz-axis” which is more specific than the current application claim 1 and therefore anticipates claims of current application.
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) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gilbo et al. (2021/0208225) in view of Svedin et al. (2020/0333417).
With respect to claims 1, Gilbo et al. teach of an method for magnetic resonance based thermometry (see abstract). Gilbo et al. teach of acquiring by a variable flip angle (VFA) T1 mapping sequence, MR data in an area of interest of the subject corresponding to cortical bone of the skull of a subject that is heated by the application of focus ultrasound (FUS) to a selective portion of the brain of the subject [0007, 0008]. Gilbo et al. teach of calculating a corresponding temperature change in the cortical bone by tracking changes in a proton resonance frequency during the application of the focused ultrasound [0050, 0051]. Gilbo et al. teach of determining a temperature change in the cortical bone that occurs between the first point in time and the second point in time, based on the mathematical relationship established by T1 mapping thermometry produced according to the VFA T1 mapping sequency [0071] and wherein the temperature change is caused in part by change in the application of FUS [0086, 0087]. Gilbo et al. teach of the MR data to comprise a plurality of T1 values over time that include a first point in time, second point in time wherein the acquisition of the MR data comprises applying an accelerated ultra-short (UTE) spiral acquisition sequence with a nonselective excitation pulse [0072].
Gilbo et al. do not teach of temperature change in the cortical bone by tracking changes in the proton resonance frequency. In a similar field of endeavor Svedin et al. teach of performing simultaneous proton resonance frequency shift and T1 measurements using a variable flip angle method to facilitate thermometry in different types of tissue [0004, 0023] during the application of the focused ultrasound (FUS) (fig. 10, 0034, 0051). It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Svedin et al. to modify Gilbo et al. to provide a method that allows for simultaneous thermometry in different types of tissue [Svedin, 0001]with increased monitoring accuracy of mixed tissue type targets [Svedin, 0052].
With respect to claim 2, Gilbo et al. in view of Svedin et al. teach of the use of variable density spiral-in-out scan [Gilbo, 0071, 0085, 0093].
With respect to claim 3, Gilbo et al. in view of Svedin et al teach of the mathematical relationship being a linear relationship between T1 values and temperature [Gilbo, 0082, 0087, 0088].
With respect to claim 4, Gilbo et al. in view of Svedin et al teach of the mathematical relationship being a linear relationship between changes in T1 values over time and change in temperature over time [Gilbo, 0086].
With respect to claims 5-10, Gilbo et al. in view of Svedin et al. teach of the change in application of FUS by ceasing application of FUS for a period of time based on temperature change in the cortical bone [Gilbo, 0086] where FUS is administered to a patient to either increase or decrease the intensity of FUS and therefore determine the optimal level of FUS to apply to a patient to treat the condition and avoid damage to surrounding tissue [Gilbo, 0089, claim 9]. Gilbo et al. therefore teach of controlling the FUS for a selected period of time to allow the selected portion of the brain to cool and prevent united damage to the brain [0009, 0069, 0090]. Gilbo et al. also teach of resuming FUS after a period of time (claims, 6, 7) and decrease in energy by the FUS (claim 8), decreasing for a selected period of time selected to allow the skull to cool, prevent unintended damage to the brain (claim 9), and wherein the change in the FUS corresponds to decreasing the energy applied by FUS to one or more regions of the skull (claim 10).
Conclusion
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BR
/BAISAKHI ROY/Primary Examiner, Art Unit 3797