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.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “dynamic composite pressure support device”, “pressure adjustment device”, “pressure adjustment unit and circuit”, “a pressure adjustment loop”, “a controller and its accompanying circuit”, “a pressure sensor, an electromagnetic valve control loop, and a pump control loop”, and “an external computing device”, must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 1015 in Fig. 4. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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
“pressure adjustment unit” of claim 5
“control system” of claims 7 and 11
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 regards 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 regards 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.
In regards to the pressure adjustment unit, the specification does not disclose a structure for the pressure adjustment unit. The specification only recites “the pressure adjustment unit” in embodiment 5 on page 17 of the specification which is recited word for word identical to claim 5, which does not provide a structure for the pressure adjustment unit. Therefore “a pressure adjustment unit” is rejected under 35 USC § 112(a) and 35 USC § 112(b) below.
In regards to the control system, the specification does not disclose a structure for the claimed control system. The specification discloses, page 7 lines 24-27, “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. The control system 301 also collects pressure data from within the actuator 101 through the conduit 204 and transmits it via a data line 302”. Therefore the specification does not provide a disclosure for the structure of the control system and the “control system” is rejected under 35 USC § 112(a) and 35 USC § 112(b) below.
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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In regards to claim 1, claim 1 recites “dynamic composite pressure support device configured to capture images of MRI scanning”. 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.” The figures show a structure for the dynamic composite pressure support device however the specification does not disclose a structure of the dynamic composite pressure support device that is configured to capture images of MRI scanning. The dynamic composite pressure support device being configured to capture images of MRI scanning is considered to lack sufficient written description. Claims 2-15 are also rejected due to their dependency.
In regards to claim 5, claim 5 recites “wherein the pressure adjustment device comprises a pressure adjustment unit and circuit wherein the pressure adjustment unit is configured for increasing gas pressure to a pressure vessel by an air pump for pre-pressurization to a higher pressure”. The specification does not disclose a structure for the pressure adjustment unit. Therefore the pressure adjustment unit being configured to increase gas pressure to a pressure vessel by an air pump for pre-pressurization to a higher pressure is considered to lack sufficient written description.
In regards to claims 7 and 11, claim 7 recites “a control system is configured to release gas pressure in a pressure vessel to regulate gas pressure, achieving fast pressure adjustment within 1 minute”, and claim 11 recites “the control system is configured to track pressure distribution in real-time through control methods, control pumps and valves in the pressure adjustment system to maintain dynamic balance of required pressure”. The specification does not disclose a structure for the claimed control system. The specification discloses, page 7 lines 24-27, “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. The control system 301 also collects pressure data from within the actuator 101 through the conduit 204 and transmits it via a data line 302”. The control system 301 shown in Figs. 1 and 2 is only shown as a box therefore the structure is also not provided in the drawings. Therefore the control system being configured to release gas pressure in a pressure vessel to regulate gas pressure and track pressure distribution in real-time is considered lack sufficient written description. Claims 12 and 13 are also rejected due to their dependency.
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 regards to claims 1-15, claims 1-15 recite “A/The magnetic resonance imaging (MRI) compatible rapid dynamic support control system”, claim 1 recites “rapidly changing posture”, “rapid MRI scan results”, and “rapid adjustment”, additionally claim 5 recites “rapid pressure distribution” and “rapid MRI scanning”. The terms “rapid” and “rapidly” in claims 1-15 are relative terms which renders the claim indefinite. The terms “rapid” and “rapidly” are 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. The specification discloses, page 8 lines 4-5, “a typical workflow involves analyzing results from routine MRI scans 501 and multiple rapid MRI scans 502, which takes about 1 minute”. However the term about is also a relative term therefore it is unclear what is considered to be rapid for analyzing MRI scans. Additionally the specification does not provide a disclosure for the definition of rapid regarding the magnetic resonance imaging (MRI) compatible rapid dynamic support control system, rapidly changing posture, rapid adjustment, and rapid pressure distribution. Therefore the specification does not provide clarity for the terms rapid and rapidly.
Regarding claim 1, claim 1 recites “at least one dynamic composite pressure support device configured to capture images of MRI scanning”. The specification discloses, page 7 lines 12-14, “The patient wears a dynamic composite pressure support brace 102 and places a composite pressure actuator 101, visible under MRI scanning, at the site where pressure is applied. In the implementation of the present invention, to achieve rapid and accurate support pressure adjustment, the dynamic composite pressure support device includes at least one composite pressure actuator 101 visible under MRI scanning.” The at least one dynamic composite pressure support device is not disclosed as having an RF coil or any type of sensor that would be capable of capturing images. Therefore the dynamic composite pressure support device is at most a brace with pressure actuators, therefore it is unclear how the at least one dynamic composite pressure support device is configured to capture images of MRI scanning. Dependent claims are also rejected due to their dependency.
In regards to claim 1, claim 1 recites “rapidly changing posture of relevant stiff joints”. The terms “relevant” and “stiff” in claim 1 are relative terms which renders the claim indefinite. The terms “relevant” and “stiff” are 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 to what degree of relevance the stiff joint has to be additionally it is unclear how stiff a joint has to be to be considered a stiff joint. Claims 2-15 are also rejected due to their dependency.
In regards to claim 1, claim 1 recites “ensuring dynamic stability of the support force received by the test subject on a stiff joint 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 “relevant stiff joints”, therefore it is unclear if a stiff joint including cervical, thoracic, and lumbar joints, as well as on a trunk, upper limb, lower limb, neck, or head of the test subject is the same or different from the relevant stiff joints. For examination purposes the limitation will be interpreted as “ensuring dynamic stability of the support force received by the test subject on the relevant stiff joints including 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.
In regards to claim 1, claim 1 recites “ensuring dynamic stability of the support force received by the test subject on a stiff joint including cervical, thoracic, and lumbar joints, as well as on a trunk, upper limb, lower limb, neck, or head of the test subject”. The claim is reciting a singular stiff joint but also recites that it includes multiple joints. Therefore it is unclear if the stiff joint is multiple joints including all of the claimed joints or one of the multiple joints claimed. For examination purposes and in light of the claim interpretation above, the claim will be interpreted as “ensuring dynamic stability of the support force received by the test subject on at least one of the relevant stiff joints including cervical, thoracic, and lumbar joints, as well as on a trunk, upper limb, lower limb, neck, or head of the test subject”.
Regarding claim 1, claim 1 recites “the support force received by the test subject”. Claim 1 does not previously define a support force that is provided to the test subject therefore there is insufficient antecedent basis for this limitation in the claim. Therefore the limitation will be interpreted as “a support force received by the test subject”. Dependent claims 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, claim 5 recites “wherein the pressure adjustment device comprises a pressure adjustment unit and circuit”. The specification discloses, page 7 lines 22-25, “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”. As seen in Fig. 1 the pressure valve 201, pressure vessel 202, and air pump 203 are all positioned outside the scanning room and the control system is the only other item placed outside of the scanning room. Additionally the pressure adjustment unit is not disclosed in this section of the specification and it is not shown in the drawings. Therefore it is unclear if the pressure adjustment device is the combination of the pressure adjustment circuit and the control system, if the pressure adjustment device is the same as the pressure adjustment circuit, and if the pressure adjustment unit is the control system. For examination purposes the claim will be interpreted as “wherein the pressure adjustment device comprises a control system and a pressure adjustment circuit”.
Regarding claim 5, claim 5 recites “allowing at least one composite pressure actuator to cooperate with rapid MRI scanning for adjustment to quickly reach a target pressure”. The term “quickly” is a relative term which renders the claim indefinite. The term “quickly” 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. For examination purposes the claim will be interpreted as “allowing at least one composite pressure actuator to cooperate with rapid MRI scanning for adjustment to reach a target pressure”
Regarding claims 5 and 7, claims 5 and 7 recite “the at least one composite pressure support device”, however the at least one composite pressure support device has 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 claims 5 and 7 will be interpreted as “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 11, claim 11 recites “wherein the control system is configured to track pressure distribution in real-time through control methods, control pumps and valves in the pressure adjustment system”. It is unclear if “the control system” is referring to the MRI-compatible rapid dynamic support control system or a different control system. As recited above the specification discloses “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”. Therefore for examination purposes the limitation will be read as “wherein a control system is configured to track pressure distribution in real-time through control methods, control pumps and valves in the pressure adjustment system”. Dependent claims are also rejected due to their dependency.
Regarding claim 11, claim 11 recites “control pumps and valves in the pressure adjustment system”. However a pressure adjustment system has not been previously defined. As recited above the specification discloses that the pressure adjustment device is positioned outside the scanning room and also discloses the pressure adjustment circuit includes a pressure valve and an air pump. 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 system is the pressure adjustment device or the pressure adjustment circuit. For examination purposes the limitation will be interpreted as “control pumps and valves in the pressure adjustment device”. Dependent claims are also rejected due to their dependency.
Regarding claim 12, claim 12 recites “control operation of the electromagnetic pump to pressurize or depressurize the system”. However the electromagnetic pump has not been previously defined therefore there is insufficient antecedent basis for this limitation in the claim. For examination purposes the limitation will be read as “control operation of the 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 rapid 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 configured to capture images of MRI scanning (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”, the patient table is part of the medical imaging apparatus which captures MRI images); 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), rapidly changing posture of relevant […] joints ([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 rapid 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 rapid 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 relevant stiff joints,
achieving […] adjustment and correction of stiff joint posture for the test subject,
and ensuring dynamic stability of the support force received by the test subject on a stiff joint 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 relevant stiff joints ([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”),
achieving […] adjustment and correction of stiff joint posture for 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”),
and ensuring dynamic stability of the support force received by the test subject on a stiff joint 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 patients 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 stiff 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 stiff 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 rapid MRI scanning for adjustment to quickly 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 a pressure adjustment unit and circuit wherein the pressure adjustment unit is configured for increasing gas pressure to a pressure vessel by an air pump for pre-pressurization to a higher pressure, thereby shortening inflation time and achieving rapid pressure distribution, […] wherein the circuit comprises pipes and pressure transmission, wherein distribution in the pipes is controlled by air valves, and by controlling the air pump and the air valves, pressure adjustment of the at least one composite pressure actuator of the at least one composite pressure support device is achieved.
However Macmahon discloses […] the pressure adjustment unit is configured for increasing gas pressure […] by an air pump ([0075] – “the inflations may be controlled by a manifold comprising controllable valves and sourced by a pump”) […] by controlling the air pump and the air valves, pressure adjustment of the at least one 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”)).
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 a pressure adjustment unit and circuit wherein the pressure adjustment unit is configured for increasing gas pressure to a pressure vessel […] for pre-pressurization to a higher pressure, thereby shortening inflation time and achieving rapid pressure distribution , […] wherein the circuit comprises pipes and pressure transmission, […].
However Streeter discloses wherein the pressure adjustment device comprises a pressure adjustment unit ([0155] – “the control system”) and circuit (Figs. 16 and 17 show a circuit for air pressure transmission including a pump, a manifold and fluid path connectors) wherein the pressure adjustment unit is configured for increasing gas pressure to a pressure vessel ([0155] – “bladder inflation may be accomplished by using compressed gas from a tank…the CO2 cartridges are themselves refillable”) […] for pre-pressurization to a higher pressure, thereby shortening inflation time and achieving rapid pressure distribution ([0155] – “The CO2 cartridges are advantageous because they may quickly fill the bladders 28”), […] wherein the circuit comprises pipes and pressure transmission (Figs. 16 and 17 show a circuit for air pressure transmission including fluid path connectors which are interpreted as pipes, [0113] – “The fluid path connectors are attached to manifold outlets 6054, allowing adjustment of each bladder using the pump control 6050”), […].
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 for the device to be computer controlled an 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 the control system is configured to track pressure distribution in real-time through control methods, control pumps and valves in the pressure adjustment system to maintain dynamic balance of required pressure, and 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 the control system is configured to track pressure distribution in real-time through control methods, control pumps and valves in the pressure adjustment system to maintain dynamic balance of required pressure, and 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 for 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 a pressure sensor, an electromagnetic valve control loop, and a pump control loop, and wherein the controller is configured to obtain values of gas pressure inside the pressure vessel and the at least one composite pressure actuator through the pressure sensor, to change pressure distribution through control of the electromagnetic valve control loop, and to control operation of the electromagnetic 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, an electromagnetic valve control loop, and a pump control loop ([0115] – “the control unit 8052 includes a housing 8053 having the pump control 8050 integrated therein. Disposed within the housing are the electric pump 8048, shown in FIG. 19B, the one or more valves 8043, shown in FIG. 19C and the manifold 8044, shown in FIG. 19C, as well as electrical connections, such as circuit board 8057, shown in FIG. 19B, 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”, [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”), and wherein the controller is configured to obtain values of gas pressure inside the pressure vessel and the at least one composite pressure actuator through the pressure sensor ([0098] – “The dynamic interface also includes one or more connectors 26 that connect the actuator(s) 24 to the control system 18. The connector(s) may be fluid paths, tubes, wires, or other similar channels”, the connectors are interpreted as the pressure vessel, [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)”, the connectors are in fluid communication with the actuator therefore the sensor would also provide values of the pressure within the connectors), to change pressure distribution through control of the electromagnetic valve control loop, and to control operation of the electromagnetic 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 for 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.
Johnson further discloses wherein a control system is configured to release gas pressure in a pressure vessel to regulate gas pressure, achieving fast pressure adjustment within 1 minute ([0120] – “The array of lamellae 52 form flexible or semi-rigid walls enclosing inflatable chambers 54…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 control system for a pressure adjustment device to inflate the chambers, [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”, [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”, therefore the corrective pressure is applied in a time period before the next scan during a fast sequence).
Conversely Johnson does not teach wherein during MRI scanning, 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, 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 Macmahon discloses during MRI scanning, […] the at least one 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 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, Petropolous 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
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/R.C.L./ Examiner, Art Unit 3797
/BROOKE LYN KLEIN/ Primary Examiner, Art Unit 3797