DETAILED ACTION
This Office Action is responsive to the Amendment filed 08 April 2026. Claims 1 - 21 are now pending. The Examiner acknowledges the amendments to claims 1 – 5.
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 .
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 – 2, 4 – 5, 12 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shibuya (US 20190368191 A1).
Regarding claim 1, Shibuya teaches a shielded chamber system for evaluating of a condition of an individual (Figures 1 - 8; [0025]), comprising:
an enclosure (“shielded room 1” [0025] Figures 1 - 8) comprising a plurality of walls (“an upper shielding body 11, a side periphery shielding body 12, a lower shielding body 13” [0025] Figures 1 - 8), wherein a first wall of the plurality of walls comprises a plurality of layers of magnetic shielding material (“permalloy plates 61, aluminum plates 62 and a nonmagnetic material 63” [0028] Figures 1 - 8);
one or more interchangeable, application-specific modular components configured to be inserted, removed, and/or repositioned within the enclosure (instances of “magnetic sensors 83”; Figure 6; [0027], [0030] - [0031]; Examiner interprets “the measurement equipment such as the magnetic sensors 83 are installed in the first internal space S1” ([0027]) reads on “interchangeable” and “to be inserted, removed, and/or repositioned”.),
wherein a first application-specific modular component of the one or more application-specific modular components comprises an array of biomagnetic field sensors configured to sense an electromagnetic field associated with the individual and generate electromagnetic field data therefrom (instances of “magnetic sensors 83”; Figure 6; [0027], [0030] - [0031]); and
one or more holes or passthroughs inserted into at least one wall of the plurality of walls (“holes 50” [0028] Figure 3 - 4),
wherein a hole or passthrough is configured for passing electrical or data cabling into and out of the enclosure (“A through hole 50 for letting wirings connected to the unshown measurement equipment and the power cords and cables of the unshown supplementary equipment pass therethrough”; Figures 3 - 4; [0028]).
Regarding claim 2, Shibuya teaches all limitations of claim 1. Shibuya teaches the first wall comprises two or more layers (“permalloy plates 61, aluminum plates 62 and a nonmagnetic material 63” [0028] Figures 1 - 8).
Regarding claim 4, Shibuya teaches all limitations of claim 1. Shibuya teaches the first wall comprises a permalloy (“permalloy plates 61” [0028] Figure 8) or a mumetal.
Regarding claim 5, Shibuya teaches all limitations of claim 4. Shibuya teaches the first wall is built around a nonmagnetic frame (“a nonmagnetic material 63 such as timber” [0028] Figure 8).
Regarding claim 12, Shibuya teaches all limitations of claim 1. Shibuya teaches the shielded chamber system comprises a mounting system comprising the one or more application-specific modular components (“measurement jig 80” [0027] [0034] Figures 1 - 8).
Regarding claim 14, Shibuya teaches all limitations of claim 1. Shibuya teaches the array of biomagnetic field sensors comprises at least three biomagnetic field sensors (instances of “magnetic sensors 83”; see annotated Shibuya’s Figure 6 below; [0027], [0030] - [0031]).
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Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Shibuya in view of Erasala et al (US 20190046059 A1, hereinafter “Erasala”).
Regarding claim 3, Shibuya teaches all limitations of claim 2. Shibuya does not teach each of the two or more layers has a thickness of between 0.1 and 10 millimeters.
However, Erasala discloses “systems, devices, and methods for sensing a magnetic field such as an electromagnetic field (“EMF”) or a magnetocardiogram (“MCG”) associated with a tissue of an individual” ([0002]) and teaches each of the two or more layers layers has a thickness of between 0.1 and 10 millimeters (“each of the two or more layers has a thickness of from 0.1 to 10 millimeters” claim 6 [0048] [0119]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Shibuya, as taught by Erasala, such that each of the two or more layers has a thickness of between 0.1 and 10 millimeters, for the benefit of shielding patients and users from magnetic exposure.
Claims 6 – 7 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Shibuya in view of Ishiyama et al (US 20050192502 A1, hereinafter “Ishiyama”).
Regarding claim 6, Shibuya teaches all limitations of claim 1. Shibuya does not teach one of the one or more application-specific modular components is directed to cardiac applications.
However, lshiyama discloses “a magnetocardiograph having a heart disease diagnosis assisting function capable of supporting a doctor's diagnosis” ([0010]) and teaches a system (Figure 1; [0037]), comprising: one of the one or more application-specific modular components is directed to cardiac applications (“magnetocardiograph” abstract [0026] [0010] [0037]; Figure 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Shibuya to incorporate one of the one or more application-specific modular components is directed to cardiac applications, as taught by Ishiyama, for the benefit of effectively and safely monitoring a patient's cardiac activity (Ishiyama: [0011]).
Regarding claim 7, Shibuya teaches all limitations of claim 1. Shibuya does not teach one of the one or more application-specific modular components is a magnetocardiography ("MCG") module.
However, lshiyama discloses “a magnetocardiograph having a heart disease diagnosis assisting function capable of supporting a doctor's diagnosis” ([0010]) and teaches a system (Figure 1; [0037]), comprising: one of the one or more application-specific modular components is a magnetocardiography ("MCG") module ( “magnetocardiography” and “MCG” Figure 1, [0037] [0039]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Shibuya to incorporate one of the one or more application-specific modular components is a magnetocardiography ("MCG") module, as taught by Ishiyama, for the benefit of effectively and safely monitoring a patient's cardiac activity (Ishiyama: [0011]).
Regarding claim 20, Shibuya and Ishiyama teach all limitations of claim 6. The modified invention of Shibuya and Ishiyama teaches one of the one or more application-specific modular components is a module for fetal magnetocardiography (Ishiyama: fetal magnetocardiograph, Figure 1 [0002], [0037]).
Claims 8 - 9 are rejected under 35 U.S.C. 103 as being unpatentable over Shibuya and Ishiyama, as applied in claim 6, in view of Matsui et al (US 20080108504 A1, hereinafter “Matsui”).
Regarding claim 8, Shibuya and Ishiyama teach all limitations of claim 6. The modified invention of Shibuya and Ishiyama does not teach one of the one or more application-specific modular components is directed to neurological applications.
However, Matsui discloses a “measuring structure for a magneto encephalographic equipment superconducting magnetic-shield” (abstract) and teaches one of the one or more application-specific modular components is directed to neurological applications (“magnetoencephalography” Figure 1, [0024]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Shibuya and Ishiyama such that one of the one or more application-specific modular components is directed to neurological applications, as taught by Matsui, for the benefit of effectively and safely monitoring a patient's neurological activity.
Regarding claim 9, Shibuya and Ishiyama teach all limitations of claim 8. The modified invention of Shibuya, Ishiyama and Matsui teach one of the one or more application-specific modular components is a magnetoencephalography ("MEG") module (Matsui: “magnetoencephalography” Figure 1 [0024]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Shibuya and Ishiyama, as applied in claim 6, in view of Goodwill et al (WO 2011116229 A2, hereinafter “Goodwill”).
Regarding claim 10, Shibuya and Ishiyama teach all limitations of claim 6. The modified invention of Shibuya and Ishiyama does not teach one of the one or more application-specific modular components is a module for magnetorelaxometry, employing magnetization coils for site-specific magnetorelaxometry measurements.
However, Goodwill discloses a “magnetic particle imaging device” (abstract) and teaches one of the one or more application-specific modular components is a module for magnetorelaxometry (Figures 6A-B; page 1 Iine 21 to page 2 Iine 2, page 75 Iine 1 - 14),
employing magnetization coils for site-specific magnetorelaxometry measurements (Figures 6A-B; page 6 Iines 18-19, page 75 Iines 1-14).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Shibuya and Ishiyama such that one of the one or more application-specific modular components is a module for magnetorelaxometry, employing magnetization coils for site-specific magnetorelaxometry measurements, as taught by Goodwill, for the benefit of effectively and safely monitoring a patient's neurological activity.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Shibuya and Ishiyama, as applied in claim 6, in view of Feenan (US 7599728 B2).
Regarding claim 11, Shibuya and Ishiyama teach all limitations of claim 6. The modified invention of Shibuya and Ishiyama does not teach one of the one or more application-specific modular components is a module for ultra-low field magnetic resonance imaging ("MRI") employing magnetization coils to produce an image of the individual.
However, Feenan discloses a “neonate imaging system” and teaches one of the one or more application-specific modular components is a module for ultra-low field magnetic resonance imaging ("MRI") employing magnetization coils to produce an image of the individual (“MRI system 104”, Figure 1, column 3 Iines 1-5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Shibuya and Ishiyama such teach one of the one or more application-specific modular components is a module for ultra-low field magnetic resonance imaging ("MRI") employing magnetization coils to produce an image of the individual, as taught by Feenan, for the benefit of effectively and safely monitoring a patient's neurological activity.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Shibuya in view of Igarashi et al (JP 2007117669 A, see attached translation, hereinafter “Igarashi”).
Regarding claim 13, Shibuya teaches all limitations of claim 1. Shibuya does not teach the array of biomagnetic field sensors are actuated to create a multi-frame stitched data image.
However, Igarashi discloses “stitching method and device for an MRI image and an MRI apparatus” (abstract) and teaches the array of biomagnetic field sensors are actuated to create a multi-frame stitched data image (“MRI image stitching” page 2 paragraphs 6 – 10, Figure 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Shibuya such that the array of biomagnetic field sensors are actuated to create a multi-frame stitched data image, as taught by Igarashi, for the benefit of providing a holistic rendering of a patient's affected area (Igarashi: page 2 paragraph 12).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Shibuya in view of Matsui.
Regarding claim 15, Shibuya teaches all limitations of claim 1. Shibuya does not teach the array of biomagnetic field sensors is arranged to match a generalized contour of a portion of a body of the individual.
However, Matsui discloses a “measuring structure for a magneto encephalographic equipment superconducting magnetic-shield” (abstract) and teaches the array of biomagnetic field sensors is arranged to match a generalized contour of a portion of a body of the individual (“plurality of SQUID magnetic sensors 15 are mounted on a sensor block 20, which is arranged in the cryogenic vessel 13, spreading over the head accommodating area 131” Figure 1, [0026]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Shibuya such that the array of biomagnetic field sensors is arranged to match a generalized contour of a portion of a body of the individual, as taught by Matsui, for the benefit of effectively fitting a sensor system to a patient's body and ensure effective data collection.
Claims 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Shibuya in view of Khitun (US 20200081079 A1).
Regarding claim 16, Shibuya teaches all limitations of claim 1. Shibuya does not explicitly teaches the array of biomagnetic field sensors comprises optically pumped magnetometer sensors, magnetic induction sensors, magneto- resistive sensors, SQUID sensors, nitrogen vacancy diamonds, fluxgate magnetometers, or a combination thereof.
However, Khitun discloses a “magnetic field detector” (abstract) and teaches an array of biomagnetic field sensors comprises optically pumped magnetometer sensors, magnetic induction sensors, magneto- resistive sensors (“magneto-resistive” [0058]), SQUID sensors (“superconducting quantum interference devices (SQUID)” [0058]), nitrogen vacancy diamonds, fluxgate magnetometers (“solid state magnetometers (e.g. fluxgate” [0058]), or a combination thereof.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Shibuya such that the array of biomagnetic field sensors comprises optically pumped magnetometer sensors, magnetic induction sensors, magneto- resistive sensors, SQUID sensors, nitrogen vacancy diamonds, fluxgate magnetometers, or a combination thereof, as taught by Khitun, for the benefit of monitoring a patient's safety and activity.
Regarding claim 17, Shibuya and Khitun teach all limitations of claim 16. The modified invention of Shibuya and Khitun teaches the fluxgate magnetometers (Khitun: “solid state magnetometers (e.g. fluxgate” [0058]) comprise Yttrium Iron Garnet film (Khitun: [0022]).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Shibuya in view of Hu et al (US 20050285492 A1, hereinafter “Hu”).
Regarding claim 18, Shibuya teaches all limitations of claim 1. Shibuya teaches a mounting system to insert the one or more application-specific modular components within the enclosure (“measurement jig 80” [0027] [0034] Figures 1 - 8).
Shibuya does not teach the mounting system comprises a magnetic rail system.
However, Hu discloses a “sliding rail mounting structure” and teaches a mounting system comprises a magnetic rail system (Figures 2 - 3; [0013] - [0014], [0016]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Shibuya such that the mounting system comprises a magnetic rail system, as taught by Hu, for the benefit of effectively releasably mounting the sensor assembly within the chamber (Hu: [0006]).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Shibuya in view of Feenan.
Regarding claim 19, Shibuya teaches all limitations of claim 1. Shibuya does not teach the shield chamber system further comprising a viewing area for patient monitoring.
However, Feenan discloses a “neonate imaging system” and teaches a system further comprising a viewing area for patient monitoring (“a viewing window (not shown) into magnet bore 132 for visually monitoring the neonate during imaging. According to this illustrative embodiment, at least a portion of neonate carriage 111 is composed of a clear material, such as a clear plastic material, that permits viewing through a viewing window in magnet 115 and into neonate carriage 111” col 7 In 31 – 37, Figure 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Shibuya such that the shield chamber system further comprising a viewing area for patient monitoring, as taught by Feenan, for the benefit of allowing a user to monitor a patient during system operation while being shielded from magnetic field activity.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Shibuya, Ishiyama and Matsui, as applied in claim 8, in view of Koninklijke et al (JP 2016530019 A, see attached translation, hereinafter “Koninklijke”).
Regarding claim 21, Shibuya, Ishiyama and Matsui teach all limitations of claim 8. The modified invention of Shibuya, Ishiyama and Matsui does not teach one of the one or more application-specific modular components is a module for fetal magnetoencephalography.
However, Koninklijke discloses a “system for extracting a fetal heart rate from a maternal signal by a computer processor” and teaches one of the one or more application-specific modular components is a module for fetal magnetoencephalography (“fetal magnetocardiogram (MCG)”, page 7 paragraph 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Shibuya, Ishiyama and Matsui such that one of the one or more application-specific modular components is a module for fetal magnetoencephalography, as taught by Koninklijke, for the benefit of effectively and safely monitoring a patient's biological activity.
Response to Arguments
Applicant’s arguments, see page 6, filed 08 April 2026, with respect to claim objections have been fully considered and are persuasive in light of the amendments. The claim objections for claim 1 of 09 January 2026 has been withdrawn.
Applicant’s arguments, see pages 6 - 7, filed 08 April 2026, with respect to 35 U.S.C. 112(b) rejections have been fully considered and are persuasive. The 35 U.S.C. 112(b) rejections for claims 4 and 5 of 09 January 2026 has been withdrawn.
Applicant's arguments, page 7, filed 09 January 2026 have been fully considered but they are not persuasive. Applicant contends “Shibuya's disclosure of magnetic sensors supported by a holding stand of a jig body does not teach or suggest an "interchangeable application-specific modular component that is configured to be "inserted, removed, and/or repositioned within the enclosure.”. However, Shibuya discloses instances of “magnetic sensors 83” (Figure 6; [0027], [0030] - [0031]) and examiner interprets “the measurement equipment such as the magnetic sensors 83 are installed in the first internal space S1” ([0027]) reads on “interchangeable” and “to be inserted, removed, and/or repositioned”.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Srinivasan (US 20050113668 A1) discloses “neonate imaging sub-system 12 includes an incubator 14, which can be a portable, modular unit (e.g., it may be detached and removed from the sub-system 12)” ([0035]).
Alford et al (US 20210369166 A1) discloses a “shielding arrangement for a magnetoencephalography (MEG) system includes a passively shielded enclosure having a plurality of walls defining the passively shielded enclosure” (abstract) and “a modular wearable active shielding system; arrays of OPMs within each active shielding module” ([0082]).
Griffith et al (US 20220062081 A1) discloses an “isolation room system comprising a plurality of walls defining a first chamber; and including an air filtration system that pulls air from within at least the first chamber through a filter” (abstract) and “interfaces 170 or portions thereof can be modular” ([0067] – [0068], [0070]).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIE T TRAN whose telephone number is (703)756-4677. The examiner can normally be reached Monday - Friday from 8:30 am - 5:00 pm.
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/JULIE THI TRAN/Examiner, Art Unit 3791
/ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
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