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 .
Response to Amendment
Claims 2 and 4 are cancelled, and claims 1, 3, and 5-15 remain pending in the application in response to the applicant’s amendments to the rejections previously set forth in the Non-Final Office Action mailed 04/08/2026.
Response to Arguments
Applicant’s arguments filed 04/20/2026 with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Given the amendments to claim 1, reference to Nanjappa is being relied upon to teach dependent claim 3, 5-7, 12, and 14 more-consistently with the instant claim language, as shown below.
Given the amendments to claim 1, reference to Dahlberg is being relied upon to teach dependent claims 10-11 more-consistently with the instant claim language, as shown below.
Given the amendments to claim 1, reference to Smith is being relied upon to teach dependent claim 8-9 and 13 more-consistently with the instant claim language, as shown below.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 3, 5-7, 10-12, and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over M. Nanjappa et al, "Magnetic Resonance Elastography of the Liver: Best Practices", MAGNETOM Flash, vol. 80, no. 1, pp. 1-10, 2022 in view of Dahlberg et al. (US 20130085524 A1, published April 4, 2013), hereinafter referred to as Nanjappa and Dahlberg, respectively.
Regarding claim 1, and similarly for claim 15, Nanjappa teaches an elastography apparatus designed to support magnetic resonance elastography (Fig. 2), comprising:
an oscillation generator (see pg. 4, col. 1, para. 2 – “To enable the performance of reliable human liver MRE, the passive driver [oscillation generator] is placed on the upper abdomen centered at the fifth intercostal space but lateral to the midclavicular line as shown in Figure 1.”);
a fixation apparatus comprising a belt, the fixation apparatus designed to fix the oscillation generator to an object under examination (see pg. 4, col. 1, para. 3 – “To maintain the passive driver [oscillation generator] in one fixed position throughout the imaging session [examination], it is necessary to immobilize it with a dedicated elastic belt [fixation apparatus] firmly while ensuring the subjects’ comfort to breathe normally.”);
a compressible pad comprising a covering that encloses a medium (see pg. 4, col. 1, para. 3 – “To improve contact between the subject and the passive driver it is advisable to use extra cushioning material [compressible pad] such as a sponge or clothing materials (as shown in Figure 2)…”), and
the compressible pad is positioned between the fixation apparatus and the object under examination when the oscillation generator is arranged on the object under examination (see pg. 4, col. 1, para. 3 – “To improve contact between the subject [object] and the passive driver [oscillation generator] it is advisable to use extra cushioning material [compressible pad] such as a sponge or clothing materials (as shown in Figure 2) in between the passive driver [oscillation generator] and the belt [fixation apparatus] to tightly hold the driver [oscillation generator] against the body [object under examination]. This enables mechanical waves to be delivered to the region of interest uniformly throughout the imaging session.”); and
an output unit comprising a display (see pg. 8, col. 2, para. 2 – “In Figure 10, it can be observed that planar waves penetrate throughout the liver and the stiffness map shows sufficient coverage of the liver to report the mean stiffness.” Inherent to display images on a display).
Nanjappa teaches a compressible pad, but does not explicitly teach a pressure sensor connected to the compressible pad.
Whereas, Dahlberg, in an analogous field of endeavor, teaches a pressure sensor designed to detect a contact pressure acting between the oscillation generator and the object under examination and/or acting between the fixation apparatus and the object under examination (Fig. 2-3, compression element 15 (pressure) between tightening unit 23 (fixation apparatus) and patient 25 (object under examination); see para. 0020 – “…a pressure transducer 18 [manometer] adapted to sense the pressure within the compression element 15.”),
wherein the pressure sensor comprises a manometer (Fig. 1; see para. 0019 – “To apply pressure to the femoral artery 13, the inflatable semi-spherical air cushion 4 is inflated by the pump 6 to a certain pressure, which is measured by the manometer 8 and displayed on the display 9.”),
a connecting unit comprising a tube and/or a hose connecting the compressible pad to the manometer (see para. 0022 – “…an inflatable compression element 15 [compressible pad] adapted to apply a pressure against the puncture site…a pump 16 adapted to inflate the compression element 15 [inherently via a hose/tube]…a pressure transducer 18 [manometer] adapted to sense the pressure within the compression element 15.”); and
an output unit comprising a display, the output unit designed to output the detected contact pressure (Fig. 2-3; see para. 0028 – “Thus, the control unit 20, or e.g. the pump 16 or the valve 17 may be provided with a display (not shown), which displays the actual pressure, sensed by the pressure transducer 18, within the compression element 15.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified a compressible pad, as disclosed in Nanjappa, by having a pressure sensor connected to the compressible pad, as disclosed in Dahlberg. One of ordinary skill in the art would have been motivated to make this modification in order to control the pressure within the compression element, as taught in Dahlberg (see para. 0026).
Furthermore, regarding claim 3, Nanjappa further teaches wherein: the oscillation generator has a first side designed to be arranged on the object under examination, and the compressible pad is arranged on the first side of the oscillation generator, and when the oscillation generator is arranged on the object under examination, it (the compressible pad) is positioned between the first side of the oscillation generator and the object under examination (see pg. 4, col. 1, para. 3 – “To improve contact between the subject [object] and the passive driver [oscillation generator] it is advisable to use extra cushioning material [compressible pad] such as a sponge or clothing materials (as shown in Figure 2) in between the passive driver [oscillation generator] and the belt [fixation apparatus] to tightly hold the driver [oscillation generator] against the body [object under examination]. This enables mechanical waves to be delivered to the region of interest uniformly throughout the imaging session.”).
Furthermore, regarding claim 5, Nanjappa further teaches wherein the fixation apparatus comprises an elastic belt (see pg. 4, col. 1, para. 3 – “To maintain the passive driver [oscillation generator] in one fixed position throughout the imaging session [examination], it is necessary to immobilize it with a dedicated elastic belt [fixation apparatus] firmly while ensuring the subjects’ comfort to breathe normally.”).
Furthermore, regarding claim 6, Nanjappa further teaches wherein the fixation apparatus comprises a belt and a closure unit, the belt is placable around a chest of an object under examination, and the closure unit is designed to fasten the belt placed around the chest of an object under examination (Fig. 2, belt around chest of patient for liver imaging; see pg. 4, col. 1, para. 3 – “To maintain the passive driver in one fixed position throughout the imaging session, it is necessary to immobilize it with a dedicated elastic belt firmly while ensuring the subjects’ comfort to breathe normally.”).
Furthermore, regarding claim 7, Nanjappa further teaches wherein the oscillation generator is arranged on a side of the belt facing the chest (Fig. 2, passive driver (oscillation generator) between belt and chest of patient; see pg. 4, col. 1, para. 3 – “To maintain the passive driver in one fixed position throughout the imaging session, it is necessary to immobilize it with a dedicated elastic belt firmly while ensuring the subjects’ comfort to breathe normally.”).
Furthermore, regarding claim 10, Dahlberg further teaches wherein the output unit is designed to output a reference value for the contact pressure and/or a difference between the detected contact pressure and a reference value for the contact pressure (see para. 0020 – “…a pressure transducer 18 adapted to sense the pressure within the compression element 15.” inherent and known in the art to detect a difference in contact pressure based on a reference (i.e., zero) contact pressure value).
Furthermore, regarding claim 11, Dahlberg further teaches wherein the difference between the detected contact pressure and a reference value for the contact pressure is output in a classified manner (see para. 0028 – “Thus, the control unit 20, or e.g. the pump 16 or the valve 17 may be provided with a display (not shown), which displays the actual pressure, sensed by the pressure transducer 18, within the compression element 15. The operator may then read the displayed pressure, and subsequently manually release an optional amount of the pressure, by means of the valve 17.”).
Furthermore, regarding claim 12, Nanjappa further teaches wherein the output unit comprises a visual display unit (see pg. 8, col. 2, para. 2 – “In Figure 10, it can be observed that planar waves penetrate throughout the liver and the stiffness map shows sufficient coverage of the liver to report the mean stiffness.” Inherent to display images on a display).
Furthermore, regarding claim 14, Nanjappa further teaches a vibration-generating unit and a connector connecting the vibration-generating unit to the oscillation generator (see pg. 4, col. 1, para. 3 – “Finally, it is important to ensure that the passive driver [oscillation generator] is connected tightly to the active driver [vibration generating unit] via plastic tubing [connector] so that there is no air leakage.”).
The motivation for claims 10-11 was shown previously in claim 1.
Claims 8-9 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Nanjappa in view of Dahlberg, as applied to claim 6 above, and in further view of Smith et al. (US 20050083207 A1, published April 21, 2005), hereinafter referred to as Smith.
Regarding claim 8, Nanjappa in view of Dahlberg teaches all of the elements disclosed in claim 6 above.
Nanjappa in view of Dahlberg teaches a pressure sensor, but does not explicitly teach the pressure sensor quantifying tensile force acting on the belt.
Whereas, Smith, in an analogous field of endeavor, teaches wherein the pressure sensor is designed to quantify a tensile force acting on the closure unit and/or the belt and/or the fixation apparatus (see para. 0068 – “Still further, in some instances it might be possible to measure the tension [tensile force] on the strap or belt indirectly, e.g., by monitoring the amount of stress or pressure [via pressure sensor] experienced by the patient on the inside of the vest or other restraint device.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified a pressure sensor, as disclosed in Nanjappa in view of Dahlberg, by having the pressure sensor quantifying tensile force acting on the belt, as disclosed in Smith. One of ordinary skill in the art would have been motivated to make this modification in order to obtain the circumstances of the patient as an indicator of a possible patient emergency, as taught in Smith (see para. 0068).
Furthermore, regarding claim 9, Smith further teaches wherein the output unit comprises a scale for measuring the tensile force (see para. 0090 – “In the preferred arrangement, the caregiver will be able to digitally select a tension threshold to match the needs of each patient (whether that threshold is expressed in units of force or via a “high/“medium/or low” ordinal scale, etc.).”).
Furthermore, regarding claim 13, Smith further teaches wherein the output unit comprises an audio signal unit (see para. 0054 – “In the event that the tension on the belt 410 extends/causes the arms of the device 400 to separate for more than a few seconds, for example about 3 to 15 seconds, the attached patient monitor will sense that fact and determine that the patient is likely in need of assistance. Upon making that assistance determination, an alarm will be sounded [audio signal unit] by the monitor to notify a caregiver that the patient might be in distress.”).
The motivation for claims 9 and 13 was shown previously in claim 8.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
X. Jiang et al, “In vivo high-resolution magnetic resonance elastography of the uterine corpus and cervix”, European Radiology, vol. 24, pp. 3025-3033, March 2014 discloses non-magnetic driver setup for MRE of the uterus (Fig. 1).
D. Gao et al, “A wearable pneumatic-piezoelectric system for quantitative assessment of skeletomuscular biomechanics”, Device, vol. 2, no. 100288, pp. 1-33, March 15, 2024 discloses a wearable device that integrates a pneumatic actuator and a piezoelectric sensor for in vivo measurements of muscular elasticity, where machine learning models are adopted to evaluate the severity of neuromuscular diseases.
R. Reiter et al, “Feasibility of Intestinal MR Elastography in Inflammatory Bowel Disease”, Journal of Magnetic Resonance Imaging, vol. 55, pp. 815-822, 2022 discloses an MR elastography setup that includes a belt with pockets for driver positioning and a sand-filled cushion placed above the driver for optimal wave transmission to the gut (Fig. 1).
Timberg et al. (US 20160051207 A1, published February 25, 2016) discloses a plurality of pressure sensors are distributed across the support plate and/or the compression plate (4) for sensing local pressure distribution across the compression area of the compressed object.
Wiese et al. (US 20210045687 A1, published February 18, 2021) discloses taking a measurement of pressure and/or tension by at least one pressure and/or tension sensor in a strap coupling the device to a subject.
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 Nyrobi Celestine whose telephone number is 571-272-0129. The examiner can normally be reached on Monday - Thursday, 7:00AM - 5:00PM EST.
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/N.C./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798
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