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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/26/2025 has been considered by the examiner.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “fixation apparatus” and “output unit” in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. The fixation apparatus is a belt (see para. 0011), and the output unit is a display (see para. 0035).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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, 5-12, and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Ehman et al. (US 20090299168 A1, published December 3, 2009) in view of Sandrin et al. (US 20210052250 A1, published February 25, 2021), hereinafter referred to as Ehman and Sandrin, respectively.
Regarding claim 1, and similarly for claim 15, Ehman teaches an elastography apparatus designed to support magnetic resonance elastography (Fig. 1), comprising:
an oscillation generator (see para. 0040 – “The band or strap may be disposed around the Subject's body and the passive actuator [oscillation generator] is held between the subject and the strap.”);
a fixation apparatus designed to fix the oscillation generator to an object under examination (see para. 0040 – “The band or strap [fixation apparatus] may be disposed around the Subject's body and the passive actuator [oscillation generator] is held between the subject and the strap.”).
Ehman inherently teaches an output unit (see para. 0034 – “Using the above-described system, the physical properties of tissue can be measured using MR elastography (MRE) by applying the stress (e.g., tension, pressure, or shear) and observing [via an output unit] the resulting strain (e.g., elongation, compression, rotation).”), but does not explicitly teach a pressure sensor detecting a contact pressure active between the oscillation generator/fixation apparatus and the object under examination.
Whereas, Sandrin, 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; and an output unit designed to output the detected contact pressure (see para. 0063 – “…if the contact force between the vibrator [oscillation generator] and the viscoelastic medium [object under examination] is above a predetermined lower threshold;”; see para. 0161 – “The force F may be measured using a force [pressure] sensor placed on the hybrid elastography probe…deduce the average contact force…”).
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 the MR elastography apparatus, as disclosed in Ehman, by including a pressure sensor detecting a contact pressure active between the oscillation generator/fixation apparatus and the object under examination, as disclosed in Sandrin. One of ordinary skill in the art would have been motivated to make this modification in order to provide a minimal contact force value to make it possible to ensure a good transmission of the low frequency pulse to the viscoelastic medium and a correct propagation of the transient shear wave generated within the medium, as taught in Sandrin (see para. 0163).
Furthermore, regarding claim 5, Ehman further teaches wherein the fixation apparatus comprises an elastic belt (see para. 0040 – “The band or strap may be disposed around the subject's body and the passive actuator is held between the subject and the strap.”).
Furthermore, regarding claim 6, Ehman 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 (see para. 0040 – “The strap or band may include a non-elastic material such as a fabric including a hook-and-loop fastener, or an elastic material such as neoprene. The band or strap may be disposed around the subject's body and the passive actuator is held between the subject and the strap.”).
Furthermore, regarding claim 7, Ehman further teaches wherein the oscillation generator is arranged on a side of the belt facing the chest (see para. 0040 – “Referring to FIGS. 7-9, passive driver 22 includes a disk-shaped back plate 200 and a circular rim 202. The back plate 200 is made of a thin, flexible, non-elastic polymer such as polycarbonate or ABS plastic, and as shown best in FIG. 9, it can bend to fit the curved contour of a subject when strapped into place over the region of interest.”).
Furthermore, regarding claim 8, Sandrin further 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. 0161 – “The force F may be measured using a force [pressure] sensor placed on the hybrid elastography probe…average contact force…”).
Furthermore, regarding claim 9, Sandrin further teaches wherein the output unit comprises a scale for measuring the tensile force (see para. 0161 – “The force F may be measured using a force [pressure] sensor [scale] placed on the hybrid elastography probe…average contact force…”).
Furthermore, regarding claim 10, Sandrin 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. 0161 – “The force F may be measured using a force [pressure] sensor [scale] placed on the hybrid elastography probe…deduce the average contact force…” known in the art to detect a difference in contact pressure based on a reference (i.e., zero) contract pressure value).
Furthermore, regarding claim 11, Sandrin 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. 0063 – “…if the contact force between the vibrator and the viscoelastic medium is above a predetermined lower threshold [classified manner];”; see para. 0161 – “The force F may be measured using a force [pressure] sensor [scale] placed on the hybrid elastography probe…deduce the average contact force…” known in the art to detect a difference in contact pressure based on a reference (i.e., zero) contract pressure value).
Furthermore, regarding claim 12, Ehman further teaches wherein the output unit comprises a visual display unit (see para. 0034 – “Using the above-described system, the physical properties of tissue can be measured using MR elastography (MRE) by applying the stress (e.g., tension, pressure, or shear) and observing [via a visual display unit] the resulting strain (e.g., elongation, compression, rotation).”).
Furthermore, regarding claim 14, Ehman further teaches a vibration-generating unit and a connector connecting the vibration-generating unit to the oscillation generator (Fig. 1; see para. 0033 – “It includes a passive driver 22 [vibration generating unit] positioned over the region of interest in the subject 10 and connected by means of a tube 24 [connector] to a remotely located active acoustic driver 26 [oscillation generator].”).
Claims 2 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Ehman in view of Sandrin, as applied to claim 1 above, and in further view of Herr et al. (US 20210145608 A1, published May 20, 2021), hereinafter referred to as Herr.
Regarding claim 2, Ehman in view of Sandrin teaches all of the elements disclosed in claim 1 above.
Ehman in view of Sandrin teaches a pressure sensor, but does not explicitly teach connecting the compressible pad to the pressure sensor.
Whereas, Herr, in an analogous field of endeavor, teaches wherein: the pressure sensor comprises a manometer, a compressible pad, and a connecting unit connecting the compressible pad to the manometer, 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 para. 0052 – “Further details of a tip 500 of the hand-held device are shown in FIG. 33B. The tip 500 includes an ultrasonic transducer 502 [oscillation generator] and force sensor 504 [pressure sensor/manometer]. The force sensor 504 is pre-loaded with a rubber pad 512 [compressible pad] where fixed pressure is applied by Loctite fixed screws 514, as shown in FIG. 33B.”).
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 Ehman in view of Sandrin, by connecting a compressible pad to the pressure sensor, as disclosed in Herr. One of ordinary skill in the art would have been motivated to make this modification in order to improve the durability of the pressure sensor.
Furthermore, regarding claim 4, Ehman further teaches wherein the connecting unit comprises a tube and/or a hose (Fig. 1; see para. 0033 – “It includes a passive driver 22 positioned over the region of interest in the subject 10 and connected by means of a tube 24 to a remotely located active acoustic driver 26.”).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Ehman in view of Sandrin and Herr, as applied to claim 2 above, and in further view of Tomiha (US 20150057525 A1, published February 26, 2015), hereinafter referred to as Tomiha.
Regarding claim 3, Ehman in view of Sandrin and Herr teaches all of the elements disclosed in claim 2 above.
Ehman in view of Sandrin and Herr teaches the oscillation generator, but does not explicitly teach the compressible pad is arranged on the first side of the oscillation generator.
Whereas, Tomiha, in an analogous field of endeavor, 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 is positioned between the first side of the oscillation generator and the object under examination (Fig. 1; see para. 0027 – “The coil pad 130 [compression pad] is interposed between the receiving coil 120 [oscillation generator] and the subject S.”).
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 the oscillation generator, as disclosed in Ehman in view of Sandrin and Herr, by having a compressible pad arranged on the first side of the oscillation generator, as disclosed in Tomiha. One of ordinary skill in the art would have been motivated to make this modification in order to prevent heat generated from the receiving coil from being directly transmitted to the subject, as taught in Tomiha (see para. 0027).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Ehman in view of Sandrin, as applied to claim 1 above, and in further view of Chopra et al. (US 20100045289 A1, published February 25, 2010), hereinafter referred to as Chopra.
Regarding claim 13, Ehman in view of Sandrin teaches all of the elements disclosed in claim 1 above.
Ehman in view of Sandrin teaches an output unit, but does not explicitly teach where the output unit includes an audio signal unit.
Whereas, Chopra, in an analogous field of endeavor, teaches wherein the output unit comprises an audio signal unit (Fig. 9; see para. 0069 – “Audio output device 66 comprising function generator 62 and audio amplifier 64 induces a time-varying pneumatic pressure at one or more desired frequencies, and acoustic energy is transferred to distal member 74 through hose 68.”).
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 an output unit, as disclosed in Ehman in view of Sandrin, by including an audio signal unit, as disclosed in Chopra. One of ordinary skill in the art would have been motivated to make this modification in order to impart waves into the tissue surrounding the lumen, as taught in Chopra (see para. 0066).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
M. Nanjappa et al, “Magnetic Resonance Elastography of the Liver: Best Practices”, MAGNETOM Flash, vol. 80, no. 1, pp. 1-10, 2022 discloses to improve contact between the subject and the passive driver it is advisable to use extra cushioning material such as a sponge or clothing materials (as shown in Figure 2) in between the passive driver and the belt to tightly hold the driver against the body. This enables mechanical waves to be delivered to the region of interest uniformly throughout the imaging session.
T. Diba et al, “A Novel Ultrasound Elastography Configuration for Simultaneous Measurement of Contact Forces”, Sensing and Imaging, vol. 24, no. 30, pp. 1-31, 2023 discloses the pressure sensor arrays are able to detect initial contact and measure contact pressure, and can depict the stress distribution and facilitates assessing the contract pressure during ultrasound strain elastography imaging.
Salcudean et al. (US 20120053450 A1, published March 1, 2012) discloses positioning the vibration assembly against the perineal region of the patient, vibrating the mechanical exciter to cause deformational excitation of a tissue region contacted in the perineum, capturing a series of images in time (snapshots) of the tissue region using the MR scanner, and finally processing the displacement images to generate maps of mechanical properties of images tissue.
Vernickel et al. (US 20150148663 A1, published May 28, 2015) discloses the oscillation applicator comprises at least one transducer which generates a reciprocating motion at a given frequency and a belt mechanically coupled to the transducer, which belt is designed to be wrapped around a patient's body.
Neumann et al. (US 20180292501 A1, published October 11, 2018) discloses a mechanical actuator comprises a passive driver including a rotational turbine vibrator having an eccentric weight, the turbine vibrator being powered by a fluid (e.g. compresses air or water), and an active driver configured to control the pressure of the fluid powering the turbine vibrator.
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/N.C./Examiner, Art Unit 3798
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