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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in China on 2/21/2024. It is noted, however, that applicant has not filed a certified copy of the CN202410193257.7 application as required by 37 CFR 1.55.
Response to Arguments
Applicant’s arguments below filed 6/30/2026 have been fully considered but they are not persuasive | moot in view of the new grounds of rejection.
In response to applicant’s arguments regarding the 35 U.S.C. §112(b) rejections of claims 1-15, not all of the issues were addressed therefore not all of the 35 U.S.C. §112(b) rejections were withdrawn.
The Applicant asserts on page 11 of the Remarks:
“Johnson is presented as teaching a magnetic resonance imaging (MRI) compatible dynamic support control system. However, Johnson does not disclose or suggest changing posture of joints. Macmahon is presented as teaching this feature. However, Macmahon, which is presented for teaching a wearable brace, does not disclose or suggest Applicant's unique and advantageous system. The present invention is directed to the field of MRI-integrated dynamic support control systems, which require real-time feedback loops. In contrast, Macmahon is directed to static orthopedic wearable apparel. The field of endeavor for a standard spinal brace is mechanical stabilization in ambient environments. Moreover, the problem addressed by the present invention is how to provide real-time, adjustable corrective forces to a patient while simultaneously maintaining MRI image integrity for live diagnostic feedback. On the other hand, Macmahon addresses a completely different problem on how to provide passive, long-term stabilization of the spine during daily activities. Because Macmahon is directed to a different problem and operates under entirely different physical constraints, it was not obvious for one having ordinary skill in the art at the time the invention was made to modify Johnson's system with Macmahon's wearable brace in order to create a magnetic resonance imaging (MRI) compatible dynamic support control system, to arrive at the invention as claimed. In addition, Johnson modified by Macmahon fails to disclose or suggest changing posture of a joint that has difficulty to bend, as claimed. In contrast, the padding of the subject invention is designed to work with an air pressure control system to adjust the joint posture in real-time. Furthermore, Johnson is directed to identifying surface body movement inside an MRI environment, with an intended purpose of detecting motion and position in order to correct MRI image alignment. In contrast, the subject invention is directed to determining how pressure can adjust the internal joint postures that are difficult to bend. Moreover, Johnson does not disclose or suggest a system for actively applying corrective forces or dynamically adjusting support pressure. In contrast, in the claimed invention, the system maintains the same trunk position while internally adjusting the spine, allowing operators to visualize the relationship between applied force and the bending angle of joints inside the body. Macmahon is directed to a static scoliosis brace designed based on the pneumatic force sensing pad for passive, long-term stabilization during daily activities.”
In response the examiner respectfully asserts that as cited below Johnson discloses in [0125] “dynamic scanning of the segmented patient table 50a may be used to investigate joints…The system may also allow dynamically reposition the patient during a dynamic scan if patient abnormal movement is detected”. Therefore, the device of Johnson is changing posture of joints by repositioning the patient. Macmahon was presented to teach changing posture of a joint that is difficult to bend using the subject's own muscle force or gravity. Macmahons device is treating Scoliosis which decreases flexibility and affects posture therefore Macmahon is changing posture of a joint that is difficult to bend using the subject's own muscle force or gravity. Additionally, Macmahon discloses in [0072] “the components comprising the system may additionally be fabricated for use in an MRI” and also in [0053] “The apparatus has an exemplary use in an x-ray or other imaging system capable of imaging the position and displacements of the spine as a function of displacement of at least one of the plurality of distenders 101”. Johnson discloses a dynamic composite support device and a pressure adjustment device to adjust corrective pressure to reposition a body part based on MRI scan results showing the body’s position/posture. Macmahon teaches a brace that can be fabricated for use in an MRI that provides dynamic stability on a joint that is difficult to move. Therefore, it would be obvious to combine the brace of Macmahon to the teachings of Johnson where the joint can be imaged to determine position of the joint and therefore determine if corrective pressure is needed. Additionally, the claim does not require the system to maintain the same trunk position while internally adjusting the spine, allowing operators to visualize the relationship between applied force and the bending angle of joints inside the body.
The Applicant asserts on page 12 of the Remarks:
“In contrast, the subject invention enables clinicians to observe how dynamic changes in pressure and positioning affect the joint posture. This allows clinical orthosis and treatment to be optimized accordingly, rather than relying solely on static comparison to determine the effect before and after the bracing or merely maintaining the corrective force and pressure inside the brace. Furthermore, Macmahon does not address real-time feedback or dynamic image-based pressure adjustment. In contrast, in the claimed invention, the system operates within an MRI environment to provide real-time, adjustable corrective forces while maintaining image integrity for diagnostic feedback. Thus, Macmahon's focus on mechanical stabilization in ambient settings is fundamentally different from the subject invention's objective of active, image-guided posture correction. Macmahon's design is specialized for scoliosis (spine) treatment, whereas the subject invention is applicable to any joint that is difficult to bend and cannot be moved by the patient using their own muscle force or gravity.”
In response the examiner respectfully asserts that Macmahon is specialized for scoliosis (spine) treatment and scoliosis and scoliosis decreases flexibility and affects posture therefore Macmahon is changing posture of a joint that is difficult to bend using the subject's own muscle force or gravity. Macmahon was not used in the independent claim to teach real-time feedback or dynamic image-based pressure adjustment. However, Macmahon does teach in [0072] “the components comprising the system may additionally be fabricated for use in an MRI” and also in [0053] “The apparatus has an exemplary use in an x-ray or other imaging system capable of imaging the position and displacements of the spine as a function of displacement of at least one of the plurality of distenders 101”. Therefore, one would find it obvious to incorporate the brace into the system of Johnson to have real-time feedback of MRI for dynamic image-based pressure adjustment of the air bladders in the brace.
Therefore, the examiner does not find the arguments to claim 1 persuasive and the claim remain rejected under 35 USC § 103.
In light of the examiner’s responses above the examiner does not find the arguments to dependent claims persuasive and the claims remain rejected under 35 USC § 103.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “204” has been used to designate both a pneumatic supply line, an MRI-compatible material conduit, an air pipe, and a pipeline. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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:
“dynamic composite pressure support device” of claim 1
“pressure adjustment device” of 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.
In regard to the dynamic composite pressure support device, the specification discloses, page 7 lines 12-16, “the dynamic composite pressure support device includes at least one composite pressure actuator 101 visible under MRI scanning.” Therefore, the structure of the dynamic composite pressure support device will be a device that includes at least one pressure actuator.
In regard to the pressure adjustment device, the specification discloses, pg. 7 lines 22-26, “the pressure adjustment device is positioned outside the scanning room and connected to the actuator 101 and brace 102 through an MRI-compatible material conduit 204 passing through the MRI scanning room wall 402. The pressure adjustment circuit includes a pressure valve 201, pressure vessel 202, and air pump 203, which are controlled by a control system 301 to regulate the pressure applied to the actuator”. Fig. 1 shows the pressure valve 201, pressure vessel 202, air pump 203, and control system 301 as the components outside the scanning room and connected to the actuator 101 and brace 102. Therefore, the pressure adjustment device is interpreted as the combination of the pressure valve 201, pressure vessel 202, air pump 203, and control system 301.
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 § 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 1-15 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.
In regard to claim 1, claim 1 recites “changing posture of a joint that is difficult to bend using the subject's own muscle force or gravity”. The terms “difficult” in claim 1 is a relative term which renders the claim indefinite. The term “difficult” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear how difficult it has to be to bend a joint to bend using the subject's own muscle force or gravity to be considered a difficult. Claims 2-15 are also rejected due to their dependency.
In regard to claim 1, claim 1 recites “ensuring dynamic stability of support force received by the test subject on at least one of the joints including cervical, thoracic, and lumbar joints, as well as on a trunk, upper limb, lower limb, neck, or head of the test subject”. Claim 1 previously recites “changing posture of a joint that is difficult to bend using the subject's own muscle force or gravity”, therefore it is unclear if the at least one joint where receiving dynamic stability of support force is insured is the same or different from the joint that is difficult to bend using the subject's own muscle force or gravity that is having its posture changed. For examination purposes the limitation will be interpreted as “ensuring dynamic stability of support force received by the test subject on at the joint that is difficult to bend, the joint that is difficult to bend including at least one of cervical, thoracic, and lumbar joints, as well as on a trunk, upper limb, lower limb, neck, or head of the test subject”. Claims 2-15 are also rejected due to their dependency.
Regarding claim 4, claim 4 recites “by controlling a concentration of the hydrogen atoms in the material, a determination of the support effect is obtained without causing artifact in the MRI image”. It is unclear what is controlling a concentration of the hydrogen atoms in the material. It is also unclear what is making the determination. Additionally, it is unclear what “the support effect” is referring to. The specification discloses, page 8 lines 15-19, “the MRI-visible layer 1011 comprises materials rich in hydrogen atoms, such as hydrogels, fish oils, etc., to reflect the deformation of the actuators under MRI. By controlling the concentration of hydrogen atoms in the MRI-visible layer 1011 material, interference from artifacts on the support effect can be minimized”. Therefore, the specification does not provide clarification for the claimed subject matter.
Regarding claim 5, claims 5 recites “air distribution in the pipe is controlled by air valves and, by controlling the air pump and the air valves”. It is unclear if “the air valves” and “the air pump” are the same or different from the at least one electronic air valve and the at least one pump previously defined in claim 5. For examination purposes the limitation will be interpreted as “air distribution in the pipe is controlled by the at least one electronic air valve and, by controlling the at least one pump and the at least one electronic air valve”.
Regarding claim 5, claims 5 recites “pressure adjustment of the at least one dynamic composite pressure actuator of the at least one composite pressure support device is achieved”, however the at least one dynamic composite pressure actuator and the at least one composite pressure support device have not been previously defined therefore there is insufficient antecedent basis for this limitation in the claim. Claim 1 defines “at least one dynamic composite pressure support device”. Therefore claim 5 will be interpreted as “pressure adjustment of the at least one dynamic composite pressure support device”.
Regarding claim 6, claim 6 recites “wherein a pressure adjustment loop in the pressure adjustment device is controlled by a control system”. However, the specification discloses, page 7 lines 22-26, “the pressure adjustment device is positioned outside the scanning room…The pressure adjustment circuit includes a pressure valve 201, pressure vessel 202, and air pump 203, which are controlled by a control system 301 to regulate the pressure applied to the actuator”. Fig. 1 shows the components of the pressure adjustment circuit and the control system outside the scanning room. Therefore, it is unclear if the pressure adjustment loop is referring to the pressure adjustment circuit disclosed in the specification. For examination purposes the limitation will be interpreted as “wherein a pressure adjustment circuit in the pressure adjustment device is controlled by a control system”.
Regarding claim 7, claim 7 recites “only the at least one composite pressure support device is placed in a scanning room with an MRI scanner, wherein other devices are placed outside the scanning room”. Claim 1 defines “at least one dynamic composite pressure support device”. Therefore, it is unclear if the other devices are referring to other dynamic composite pressure support devices or if it is referring to the “pressure adjustment device” or both. For examination purposes the limitation will be interpreted as “only the at least one composite pressure support device is placed in a scanning room with an MRI scanner, wherein the pressure adjustment device is placed outside the scanning room”.
Regarding claim 7, claim 7 recites “wherein a pressure adjustment loop is connected to the at least one composite pressure support device through a pipe made of MRI-compatible material”. However, the specification discloses, page 7 lines 22-26, “the pressure adjustment device is positioned outside the scanning room…The pressure adjustment circuit includes a pressure valve 201, pressure vessel 202, and air pump 203, which are controlled by a control system 301 to regulate the pressure applied to the actuator”. Fig. 1 shows the components of the pressure adjustment circuit and the control system outside the scanning room. Therefore, it is unclear if the pressure adjustment loop is referring to the pressure adjustment circuit disclosed in the specification. For examination purposes the limitation will be interpreted as “wherein a pressure adjustment circuit is connected to the at least one composite pressure support device through a pipe made of MRI-compatible material”.
Regarding claim 12, claim 12 recites “through control of the electromagnetic valves”. However, the electromagnetic valves have not been previously defined in claims 1 or 11 therefore there is insufficient antecedent basis for this limitation in the claim. For examination purposes the limitation will be read as “through control of at least one valve”.
Regarding claim 12, claim 12 recites “control operation of the pump to pressurize or depressurize the system”. However, the pump has not been previously defined in claims 1 or 11 therefore there is insufficient antecedent basis for this limitation in the claim. For examination purposes the limitation will be read as “control operation of a pump control loop to pressurize or depressurize the system”.
Regarding claim 13, claim 13 recites “wherein the controller of the control system”. Claim 13 is dependent on claims 1 and 11 which do not define a controller therefore there is insufficient antecedent basis for this limitation in the claim. Therefore, for examination purposes the limitation will be interpreted as “wherein a controller of the control system”.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Johnson (EP 3915480 A1) and further in view of Macmahon (US 20180055660).
Regarding claim 1, Johnson discloses a magnetic resonance imaging (MRI) compatible dynamic support control system ([0121] – “each actuator plate may be equipped with an individual pressure sensor, measuring weight of patient and dynamic motion response of patient” [0125] – “During a fast sequence (dynamic scanning) the patient table 50a may change its geometry and thus the position in a defined way”), comprising:
at least one dynamic composite pressure support device (Figs. 2 and 3, [0125] – “During a fast sequence (dynamic scanning) the patient table 50a may change its geometry and thus the position in a defined way”); and
a pressure adjustment device coupled with the at least one dynamic composite pressure support device ([0119] – “a segmented patient table with an array of actuators. Each of the segments may be adjusted in height and inclination (angulation)”, [0120] – “The array of lamellae 52 form flexible or semi-rigid walls enclosing inflatable chambers 54. The inflatable chambers may be progressively inflated to enable a patient support surface 56 of the segmented patient table 50a to be substantially planner. The inflatable chambers 54 may be locally pressurized to cause one or more lamellae 52 to expand outwards, thus adjusting the local height to move a body part of interest”, therefore there would be a pressure adjustment device to inflate the chambers), configured for generating sufficient corrective pressure to apply on a test subject within a certain period ([0125] – “During a fast sequence (dynamic scanning) the patient table 50a may change its geometry and thus the position in a defined way…The system may also allow dynamically reposition the patient during a dynamic scan if patient abnormal movement is detected. More specifically the system dynamically reposition the patient body during a scan if the patient movement exceeds a given critical range”, [0024] – “compute, for each scan, a respective desired movement of the body part of interest for repositioning the body part of interest for the respective scan”, therefore the corrective pressure is applied in a time period before the next scan), changing posture of a joint […] ([0125] – “dynamic scanning of the segmented patient table 50a may be used to investigate joints…During a fast sequence (dynamic scanning) the patient table 50a may change its geometry and thus the position in a defined way. MRI scan and dynamic segmented table forming is planned using a SW interface. The system may also allow dynamically reposition the patient during a dynamic scan if patient abnormal movement is detected”), adjusting support configuration and contact deformation of the at least one dynamic composite pressure support device based on MRI scan results ([0024] – “compute, for each scan, a respective desired movement of the body part of interest for repositioning the body part of interest for the respective scan. The output unit is configured to transmit, for each scan, a respective control signal to the actuator arrangement to cause the actuator arrangement to effect the respective desired movement of the body part of interest”), achieving adjustment and correction of joint posture for the test subject ([0024] – “compute, for each scan, a respective desired movement of the body part of interest for repositioning the body part of interest for the respective scan”, [0125] – “dynamic scanning of the segmented patient table 50a may be used to investigate joints…The system may also allow dynamically reposition the patient during a dynamic scan if patient abnormal movement is detected”),
Conversely Johnson does not teach changing posture of a joint that is difficult to bend using the subject's own muscle force or gravity,
and ensuring dynamic stability of support force received by the test subject on at least one of the joints including cervical, thoracic, and lumbar joints, as well as on a trunk, upper limb, lower limb, neck, or head of the test subject.
However, Macmahon discloses changing posture of a joint that is difficult to bend using the subject's own muscle force or gravity ([0006] – “a diagnostic method of distorting a patient's spine as part of a brace making procedure”, [0022] -“generate a force on the patient at a targeted location to treat scoliosis”, one with scoliosis would have a joint that is difficult to bend correctly),
and ensuring dynamic stability of support force received by the test subject on at least one of the joints including cervical, thoracic, and lumbar joints, as well as on a trunk, upper limb, lower limb, neck, or head of the test subject ([0006] – “a diagnostic method of distorting a patient's spine as part of a brace making procedure”, [0022] – “generate a force on the patient at a targeted location to treat scoliosis”, [0115] – “exemplary sensing and dynamic correction assembly”).
Macmahon is an analogous art considering it is in the field of positioning a patient using air filled bladders during an MRI scan.
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 Johnson to include the adjustment and stability of a stiff joint of Macmahon to achieve the same results. One would have motivation to combine because it would provide motion compensation for joints and provide correction of a patient’s spinal deformity during imaging.
Claims 2, 8, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson (EP 3915480 A1) and Macmahon (US 20180055660) as applied to claim 1 above, and further in view of Petropoulos (US 20150112187).
Regarding claim 2, Johnson and Macmahon disclose all the elements of the claimed invention as cited in claim 1.
Conversely Johnson does not teach wherein the at least one dynamic composite pressure support device comprises at least one composite pressure actuator that is visible under MRI scanning, and an MRI-compatible brace configured to cooperate with the at least one composite pressure actuator to provide corrective support force.
However Macmahon discloses wherein the at least one dynamic composite pressure support device comprises at least one composite pressure actuator ([0073] – “Each of the distenders 301 comprises a distender interface 303 which in turn may comprise features as described herein for other distender interfaces described herein”, [0053] – “The distender interfaces may comprise any selection or combination of foams, fluid or air filled bladders”, [0053] – “pressures associated with the distenders (e.g., air pressure within a bladder)”) that is visible under MRI scanning ([0073] – “Each of the distenders 301 comprises a distender interface 303 which in turn may comprise features as described herein for other distender interfaces described herein”, [0054] – “The distender interfaces can have one or more radiopaque markers that allow their location and/or orientation to be monitored when visualized”, [0072] – “the components comprising the system may additionally be fabricated for use in an MRI”, therefore it would be obvious to use a bladder that is visible under MRI scanning), and an […] brace configured to cooperate with the at least one composite pressure actuator to provide corrective support force ([0073] – “illustrates a portable and wearable diagnostic brace 300 configured and adapted for use in an imaging system…The brace structure 302 is fabricated of a stiff material capable of supporting the loads generated by the plurality of distenders 301, which can be like any of the distenders herein”).
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 Johnson to include the actuators and brace of Macmahon to achieve the same results. One would have motivation to combine because “Rather than relying on subjective years of experience to approximate the forces and geometry that will be necessary to correct the patient's spinal deformity, the systems and methods herein can provide actual force measurements applied to the patient as well as an image of the “corrected” patient” (Macmahon – [0052]).
Conversely Johnson and Macmahon do not teach an MRI-compatible brace.
However, Petropoulos discloses an MRI-compatible brace ([0185] – “thoracic casting and braces that made from a set of materials compatible with the requirements of Magnetic resonance Imaging”).
Petropoulos is an analogous art considering it is in the field of patient positioning during an MRI scan.
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 Johnson to include the MRI-compatible brace of Petropoulos to achieve the same results. One would have motivation to combine because it can provide means for supporting joints that is safe for the patient to use while decreasing the amount of noise that may be caused by other materials.
Regarding claim 8, Johnson, Macmahon, and Petropoulos disclose all the elements of the claimed invention as cited in claims 1 and 2.
Conversely Johnson does not teach wherein a shape of the at least one composite pressure actuator is configured to change according to different positions, and different shapes under different pressures are changed to ensure sufficient support force while uniformly distributing pressure on a contact surface with a joint of the test subject, including joints of the trunk, upper limbs, lower limbs, neck, and head; wherein pressure, stretching force, or bending force is applied to the joint.
However Macmahon discloses wherein a shape of the at least one composite pressure actuator is configured to change according to different positions ([0053] – “The distender interfaces may comprise any selection or combination of foams, fluid or air filled bladders, and elements adapted and configured to conform to the contour of the body”, therefore the shape of the air filled bladder would change according to different positions based on the contour of the body), and different shapes under different pressures are changed to ensure sufficient support force while uniformly distributing pressure on a contact surface with a joint of the test subject, including joints of the trunk, upper limbs, lower limbs, neck, and head ([0092] – “the distender interfaces each include a relatively rigid member…The configurations of the relatively rigid members can vary, and can be a variety of shapes, such as rectangular and triangular”, [0090] – “each of the distender interfaces can have individually controlled pressures and or forces”, [0104] – “Once the bladder(s) are filled to a desired level, the brace can apply corrective forces until an additional refill is needed or desired”); wherein pressure, stretching force, or bending force is applied to the joint ([0104] – “fluid can be delivered into the bladders until an upper pressure limit is reached (e.g., 2.5 psi, 2 psi) or until a desired force is a measured”).
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 Johnson to include the actuators of Macmahon to achieve the same results. One would have motivation to combine because “Rather than relying on subjective years of experience to approximate the forces and geometry that will be necessary to correct the patient's spinal deformity, the systems and methods herein can provide actual force measurements applied to the patient as well as an image of the “corrected” patient” (Macmahon – [0052]).
Regarding claim 14, Johnson, Macmahon, and Petropoulos disclose all the elements of the claimed invention as cited in claims 1 and 2.
Conversely Johnson does not teach wherein the MRI-compatible brace is made of soft materials including pure cotton textiles, or hard materials including plastics, or other MRI-compatible materials.
However, Petropoulos discloses wherein the MRI-compatible brace is made of soft materials including pure cotton textiles, or hard materials including plastics, or other MRI-compatible materials ([0185] – “thoracic casting and braces that made from a set of materials compatible with the requirements of Magnetic resonance Imaging”).
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 Johnson to include the MRI-compatible brace of Petropoulos to achieve the same results. One would have motivation to combine because it can provide means for supporting joints that is safe for the patient to use while decreasing the amount of noise that may be caused by other materials.
Claims 3 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson (EP 3915480 A1), Macmahon (US 20180055660), and Petropoulos (US 20150112187) as applied to claim 2 above, and further in view of Yan (US 20230051255).
Regarding claim 3, Johnson, Macmahon, and Petropoulos disclose all the elements of the claimed invention as cited in claims 1 and 2.
Conversely Johnson does not teach wherein the at least one composite pressure actuator visible under MRI scanning comprises multiple layers of materials including a sealing layer and an MRI-visible layer.
However Macmahon discloses wherein the at least one composite pressure actuator […] comprises […] a sealing layer […] ([0053] – “The distender interfaces may comprise any selection or combination of foams, fluid or air filled bladders, and elements adapted and configured to conform to the contour of the body being evaluated” Macmahon discloses that the air pressure can be manually controlled and does not disclose that air is continuously pumped into all of the air filled bladders therefore one with ordinary skill in the art would recognize the air filled bladders would be bade of a sealing material).
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 Johnson to include the actuators of Macmahon to achieve the same results. One would have motivation to combine because “Rather than relying on subjective years of experience to approximate the forces and geometry that will be necessary to correct the patient's spinal deformity, the systems and methods herein can provide actual force measurements applied to the patient as well as an image of the “corrected” patient” (Macmahon – [0052]).
Conversely Johnson and Macmahon do not teach wherein the at least one composite pressure actuator visible under MRI scanning comprises multiple layers of materials including […] an MRI-visible layer.
However Yan discloses wherein the at least one composite pressure actuator ([0048] – “the pressure within the given flexible actuator”) visible under MRI scanning ([0044] – “imaging system 106 can be implemented as…a magnetic resonance imaging (“MRI”) imaging system…imaging markers (e.g., imaging fiducials) that can be placed on a patient, such as, for example, on one or more of the flexible actuators 114, 116, 118 and used by the imaging system 106”) comprises multiple layers of materials including […] an MRI-visible layer ([0044] – “imaging system 106 can be implemented as…a magnetic resonance imaging (“MRI”) imaging system…imaging markers (e.g., imaging fiducials) that can be placed on a patient, such as, for example, on one or more of the flexible actuators 114, 116, 118 and used by the imaging system 106”, therefore the imaging marker [MRI marker] is a layer that is placed on another layer of the actuator).
Yan is an analogous art considering it is in the field of a pressure actuator that can be used with MRI imaging.
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 Johnson to include the MRI-visible layer of Yan to achieve the same results. One would have motivation to combine because it can “used by the imaging system 106, as appropriate, to track the position of the markers” (Yan – [0044]) and therefore the position of the actuators can be known.
Regarding claim 9, Johnson, Macmahon, Petropoulos, and Yan disclose all the elements of the claimed invention as cited in claims 1, 2, and 3.
Conversely Johnson does not explicitly teach wherein the sealing layer of the composite pressure actuator is configured to withstand gas pressure, thereby providing a pressure required for support or correction and ensuring the support configuration of the at least one composite pressure actuator.
However Macmahon discloses wherein the sealing layer of the composite pressure actuator is configured to withstand gas pressure, thereby providing a pressure required for support or correction and ensuring the support configuration of the at least one composite pressure actuator ([0092] – “The apparatus can be adapted such that the bladder can be filled with a fluid (e.g., liquid or gas)”, [0056] – “The bladders are inflated to maximize patient comfort in the effort to evenly distribute the correcting 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 Johnson to include the actuators of Macmahon to achieve the same results. One would have motivation to combine because “Rather than relying on subjective years of experience to approximate the forces and geometry that will be necessary to correct the patient's spinal deformity, the systems and methods herein can provide actual force measurements applied to the patient as well as an image of the “corrected” patient” (Macmahon – [0052]).
Claims 5, 6, 11, 12, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson (EP 3915480 A1) and Macmahon (US 20180055660) as applied to claim 1 above, and further in view of Streeter (US 20230372128).
Regarding claim 5, Johnson and Macmahon disclose all the elements of the claimed invention as cited in claim 1.
Johnson further discloses allowing at least one composite pressure actuator to cooperate with MRI scanning for adjustment to reach a target pressure ([0125] – “During a fast sequence (dynamic scanning) the patient table 50a may change its geometry and thus the position in a defined way. MRI scan and dynamic segmented table forming is planned using a SW interface. The system may also allow dynamically reposition the patient during a dynamic scan”);
Conversely Johnson does not teach wherein the pressure adjustment device comprises at least one pump, at least one pressure vessel, and at least one electronic air valve with a pipe for shortening inflation time and achieving pressure distribution, […] wherein air distribution in the pipe is controlled by air valves and, by controlling the air pump and the air valves, pressure adjustment of the at least one dynamic composite pressure actuator of the at least one composite pressure support device is achieved.
However, Macmahon discloses air distribution in the pipe is controlled by air valves and, by controlling the air pump and the air valves, pressure adjustment of the at least one dynamic composite pressure actuator of the at least one composite pressure support device is achieved ([0075] – “In some embodiments bladders are inflated manually, such as by a syringe or hand or powered pump. In others, the inflations may be controlled by a manifold comprising controllable valves and sourced by a pump”, [0128] – “control inflation and deflation of the bladder”, [0115] – “the fluid line is in fluid communication with the bladder”).
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 Johnson to include the pressure adjustment of Macmahon to achieve the same results. One would have motivation to combine because it provides a means for adjusting the pressure in each actuator.
Conversely Johnson and Macmahon do not teach wherein the pressure adjustment device comprises at least one pump, at least one pressure vessel, and at least one electronic air valve with a pipe for shortening inflation time and achieving pressure distribution.
However Streeter discloses herein the pressure adjustment device comprises at least one pump, at least one pressure vessel, and at least one electronic air valve with a pipe (Figs. 16 and 17 show a circuit for air pressure transmission including a pump, a manifold and fluid path connectors which are interpreted as pipes, [0155] – “bladder inflation may be accomplished by using compressed gas from a tank…the CO2 cartridges are themselves refillable”, [0117] – “control unit 8052 is able to control the pump 8048, shown in FIG. 19B and one or more valves 8043”) for shortening inflation time and achieving rapid pressure distribution ([0155] – “The CO2 cartridges are advantageous because they may quickly fill the bladders 28”).
Streeter is an analogous art considering it is in the field of fluid filled actuators.
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 Johnson to include the pressure vessel of Streeter to achieve the same results. One would have motivation to combine because “the CO2 cartridges are advantageous because they may quickly fill the bladders” (Streeter – [0155]).
Regarding claim 6, Johnson and Macmahon disclose all the elements of the claimed invention as cited in claim 1.
Conversely Johnson does not teach wherein a pressure adjustment loop in the pressure adjustment device is controlled by a control system, the control system being configured to monitor pressure distribution of multiple composite pressure actuators in real-time through pressure sensor detection, and to adjust the pressure adjustment loop according to system setting.
However Streeter discloses wherein a pressure adjustment loop in the pressure adjustment device is controlled by a control system ([0144] – “send signals to the control unit 10052 of the active control system 10018 so that the control unit 10052 may adjust the dynamic interface 10016 of the support apparatus”), the control system being configured to monitor pressure distribution of multiple composite pressure actuators in real-time through pressure sensor detection, and to adjust the pressure adjustment loop according to system setting ([0121] – “The control system 18, shown in FIG. 1 , may be an active control system that provides real-time adjustments in each actuator 24…the control unit 8052 may include an active control system with various control modes for activating the inflation/deflation of the bladders 28”, [0122] – “the input mechanism includes sensors, such as pressure transducers…Controlled by a computer or processor, the sensor(s) determine the pressure in the actuator(s) and, with the feedback loops, signals are sent to the control unit to either increase or decrease the actuator's pressure”).
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 Johnson to include the control system of Streeter to achieve the same results. One would have motivation to combine because it allows the device to be computer controlled and therefore decreases the chance of any human error.
Regarding claim 11, Johnson and Macmahon disclose all the elements of the claimed invention as cited in claim 1.
Conversely Johnson does not teach wherein if the dynamic or real-time pressure of the at least one composite pressure actuator exceeds a set value, the at least one composite pressure actuator is depressurized, while if the pressure of the at least one composite pressure actuator is lower than a set value, the at least one composite pressure actuator is pressurized.
However Streeter discloses wherein if the dynamic or real-time pressure of the at least one composite pressure actuator exceeds a set value, the at least one composite pressure actuator is depressurized, while if the pressure of the at least one composite pressure actuator is lower than a set value, the at least one composite pressure actuator is pressurized ([0122] – “the sensor(s) determine the pressure in the actuator(s) and, with the feedback loops, signals are sent to the control unit to either increase or decrease the actuator's pressure, possibly by inflation or deflation, thereby changing the volume of the actuator to exert the needed force to maintain the support apparatus's secure fit with the user's body”, [0122] – “control unit 8052 to first activate the pump 8048…Once the desired pressure is achieved, the control unit 8052 may then open the valve 8043, shown in FIG. 19C, connected to the actuator 24, shown in FIG. 3 , to increase the pressure within the actuator 24”, [0171] – “where the sampled instantaneous pressure is greater than the desired setpoint pressure, at 167, the control system 18, shown in FIG. 63 , may open the valve 8043…to vent air from the channel in order to decrease the pressure in the actuator”).
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 Johnson to include the control system of Streeter to achieve the same results. One would have motivation to combine because it allows the device to be computer controlled and therefore decreases the chance of any human error and allows for a more precise control of the pressure.
Regarding claim 12, Johnson, Macmahon, and Streeter disclose all the elements of the claimed invention as cited in claims 1 and 11.
Conversely Johnson does not teach wherein the control system comprises a controller and its accompanying circuit, the accompanying circuit includes at least one pressure sensor, the controller is configured to read at least one composite pressure actuator through the pressure sensor, to change pressure distribution through control of the electromagnetic valves, and to control operation of the pump to pressurize or depressurize the system.
However Streeter discloses wherein the control system comprises a controller and its accompanying circuit ([0115] – “the control unit 8052 includes…circuit board 8057”), the accompanying circuit includes a pressure sensor ([0006] – “The control unit also includes a sensor detecting a pressure”, [0108] – “The control system 18 may be hydraulic, pneumatic, electromechanical, mechanical, or any other actuator type mechanism”), the controller is configured to read at least one composite pressure actuator through the pressure sensor ([0122] – “The sensors may be placed…on the actuator(s), on the connector(s) connected to the actuator(s)…Controlled by a computer or processor, the sensor(s) determine the pressure in the actuator(s)”), to change pressure distribution through control of the electromagnetic valves, and to control operation of the pump to pressurize or depressurize the system ([0122] – “Controlled by a computer or processor, the sensor(s) determine the pressure in the actuator(s) and, with the feedback loops, signals are sent to the control unit to either increase or decrease the actuator's pressure”, [0115] – “one or more processors (not shown), a power supply 8059, shown in FIG. 19B, and the like for connecting the pump control 8050 to the electric pump 8048 and the one or more valves 8043 to allow the user to control the operation thereof”, [0108] – “The control system 18 may be hydraulic, pneumatic, electromechanical, mechanical, or any other actuator type mechanism”).
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 Johnson to include the control system of Streeter to achieve the same results. One would have motivation to combine because it allows the device to be computer controlled and therefore decreases the chance of any human error and allows for a more precise control of the pressure.
Regarding claim 13, Johnson, Macmahon, and Streeter disclose all the elements of the claimed invention as cited in claims 1 and 11.
Conversely Johnson does not teach wherein the controller of the control system is connected to an external computing device, by wire or wirelessly, and wherein the controller is configured to receive instructions from the external computing device to adjust pressure control strategy parameters and target pressure parameters.
However Streeter discloses wherein the controller of the control system is connected to an external computing device, by wire or wirelessly, and wherein the controller is configured to receive instructions from the external computing device to adjust pressure control strategy parameters and target pressure parameters ([0212] – “the control system 18 for the dynamic support system 142, shown in FIG. 63 , may be configured using a software application through, for example, a personal computer… using this software application, the number and types of actuators 8024, shown in FIG. 64A, may be configured along with their operating pressures. The software application may be, in some embodiments, used to configure user inputs, for example, whether integral to the control unit 8052, or remote, for controlling operation of one or more features of the dynamic support system 142”, One with ordinary skill in the art would recognize a wired or wireless connection would be necessary for a remote 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 Johnson to include the remote input device of Streeter to achieve the same results. One would have motivation to combine because it allows for a medical professional to adjust pressures when they are not able to be present with the subject.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Johnson (EP 3915480 A1) and Macmahon (US 20180055660) as applied to claim 1 above, and further in view of Yao (JP 2006043077A).
Regarding claim 7, Johnson and Macmahon disclose all the elements of the claimed invention as cited in claim 1.
Conversely Johnson does not teach wherein during MRI scanning, only the at least one dynamic composite pressure support device is placed in a scanning room with an MRI scanner, wherein other devices are placed outside the scanning room, wherein a pressure adjustment loop is connected to the at least one dynamic composite pressure support device through a pipe made of MRI-compatible material.
However Macmahon discloses during MRI scanning, […] the at least one dynamic composite pressure support device is placed in a scanning room with an MRI scanner ([0072] – “the components comprising the system may additionally be fabricated for use in an MRI”, [0006] – “a diagnostic method of distorting a patient's spine as part of a brace making procedure”, [0022] – “generate a force on the patient at a targeted location to treat scoliosis”, [0115] – “exemplary sensing and dynamic correction assembly”),
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 Johnson to include the pressure support device being placed in a scanning room with an MRI scanner of Macmahon to achieve the same results. One would have motivation to combine because “the systems and methods herein can provide actual force measurements applied to the patient as well as an image of the “corrected” patient” (Macmahon – [0052]).
As cited above Macmahon teaches the at least one composite pressure support device conversely Johnson and Macmahon does not teach wherein other devices are placed outside the scanning room, wherein a pressure adjustment loop is connected to the […] device through a pipe made of MRI-compatible material.
However Yao teaches wherein other devices are placed outside the scanning room, wherein a pressure adjustment loop is connected to the […] device through a pipe made of MRI-compatible material ([0017] – “it is desirable to arrange the pressure regulating valve 3, the circulation pump 4, the condenser 5, and the vacuum pump 7 outside the shield room so as not to affect MR imaging”, [0015] – “flow path 6 is formed so as to circulate within the gradient magnetic field coil 2 , the pressure regulating valve 3 , the circulation pump 4 and the condenser 5”, [0017] – “a copper pipe is used as part of the coolant flow path 6”, copper is non-magnetic therefore it is interpreted to be MRI-compatible).
Yao is an analogous art considering it is in the field of an MRI scanner with pressure adjustment means.
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 Johnson to include the other devices being outside of the scanning room of Yao to achieve the same results. One would have motivation to combine “so as not to affect MR imaging” (Yao – [0017]).
In light of the teaching above one with ordinary skill in the art would find it obvious in view of the teachings of Macmahon and Yao for only the at least one dynamic composite pressure support device is placed in a scanning room with an MRI scanner. As taught by Macmahon the composite pressure support device is a brace used to adjust the spine during diagnostic imaging and therefore it is placed in the scanning room and Yao teaches that the other devices are placed outside of the scanning room so as not to affect MR imaging.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Johnson (EP 3915480 A1), Macmahon (US 20180055660), Petropoulos (US 20150112187), and Yan (US 20230051255) as applied to claim 3 above, and further in view of Streeter (US 20230372128).
Regarding claim 10, Johnson, Macmahon, Petropoulos and Yan disclose all the elements of the claimed invention as cited in claims 1, 2, and 3.
Conversely Johnson does not teach wherein an exterior of the at least one composite pressure actuator is wrapped with fabric to enhance comfort at the support location and separate the imaging layer inside the at least one composite pressure actuator from surfaces of the test subject.
However Streeter discloses wherein an exterior of the at least one composite pressure actuator is wrapped with fabric to enhance comfort at the support location and separate the imaging layer inside the at least one composite pressure actuator from surfaces of the test subject ([0126] – “temperature control mechanism 19 may include…integrating sports or outdoor recreation clothing…The temperature control mechanism 19 may be placed in a separate layer between the dynamic interface 16 or top surface 22 and the residuum 12”, [0142] – “a temperature control system to increase the comfort of the dynamic support apparatus”).
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 Johnson to include the layer of clothing material of Streeter to achieve the same results. One would have motivation to combine because it increases the comfort of the dynamic support apparatus (Streeter [0142]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Johnson (EP 3915480 A1), Macmahon (US 20180055660), and Petropoulos (US 20150112187) as applied to claim 2 above, and further in view of Stark (US 20010020143).
Regarding claim 15, Johnson, Macmahon and Petropoulos disclose all the elements of the claimed invention as cited in claims 1 and 2.
Conversely Johnson does not teach wherein a shape of the MRI-compatible brace is changed according to a different target body segment including the trunk, upper limbs, lower limbs, neck, and head of the test subject.
However, Petropoulos discloses the MRI-compatible brace ([0185] – “thoracic casting and braces that made from a set of materials compatible with the requirements of Magnetic resonance Imaging”).
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 Johnson to include the MRI-compatible brace of Petropoulos to achieve the same results. One would have motivation to combine because it can provide means for supporting joints that is safe for the patient to use while decreasing the amount of noise that may be caused by other materials.
However, Johnson and Petropoulos do not teach wherein a shape of the […] brace is changed according to a different target body segment including the trunk, upper limbs, lower limbs, neck, and head of the test subject.
However Stark discloses wherein a shape of the […] brace is changed according to a different target body segment including the trunk, upper limbs, lower limbs, neck, and head of the test subject As seen in Figs. 1, 5, 6, 11, and 12 there are different orthoses [braces] with different shapes for the trunk and lower limbs, one with ordinary skill in the art would recognize an orthosis for the upper limbs, neck, and head would also each have a different shape).
Stark is an analogous art considering it is in the field of fluid filled bladders to correct a patient position .
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 Johnson to include the differently shaped braces of Stark to achieve the same results. One would have motivation to combine because it would allow one to provide the most efficient correction to a desired part of the body.
Examiner’s Note
Claim 4 is found to distinguish from the prior art collectively, however, allowability is not determined at this time due to pending 112 issues. Regarding claim 4, as recited in the rejection of claim 3 Yan teaches an imaging marker placed on the actuator and that the imaging system can be an MRI system. Yan also discloses a flexible actuator which can be interpreted as a deformable actuator and therefore the marker would provide an indication of deformation of the actuator in an image. However, Yan does not teach that the marker is made of hydrogen atoms in a concentration for a determination of the support effect. It would not have been obvious to a person having ordinary skill in the art before the effective filing date to have modified the MRI-visible layer of Johnson, as modified by Macmahon, Petropoulos and Yan, to include a material comprising hydrogen atoms such that the deformation of the at least one composite pressure actuator is imaged by the MRI and controlling the concentration of hydrogen atoms to obtain a determination of the support effect. Thus, the combination of elements is found to distinguish over the prior art collectively.
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.
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/R.C.L./ Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/ Supervisory Patent Examiner, Art Unit 3797
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