NON-FINAL REJECTION
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 .
Specification
The amendment to the Specification filed 3/5/2025 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows:
“This application is a 35 U.S.C. § 371 National Stage Application of PCT/EP2023/072816, filed on August 18, 2023 which claims the benefit of priority to Serial No. DE 10 2022 209 424.7, filed on September 9, 2022 in Germany, the disclosures of which are incorporated herein by reference in their entirety.”
(emphasis added)
It understood that “[t]he disclosures” includes the German patent application referenced above (DE 10 2022 209 424.7). The statement of incorporation-by-reference of the German patent application is considered new matter for the following reason(s) below:
MPEP 608.01(p), I. B. recites in part:
As a safeguard against the omission of a portion of a prior application for which priority is claimed under 35 U.S.C. 119(a)-(d) or (f), or for which benefit is claimed under 35 U.S.C. 119(e) or 120, applicant may include a statement at the time of filing of the later application incorporating by reference the prior application. See MPEP § 201.06(c) and 211 et seq. where domestic benefit is claimed. See MPEP §§ 213 - 216 where foreign priority is claimed. See MPEP § 217 regarding 37 CFR 1.57(b). The inclusion of such an incorporation by reference statement in the later-filed application will permit applicant to include subject matter from the prior application into the later-filed application without the subject matter being considered as new matter. For the incorporation by reference to be effective as a proper safeguard, the incorporation by reference statement must be filed at the time of filing of the later-filed application. An incorporation by reference statement added after an application’s filing date is not effective because no new matter can be added to an application after its filing date (see 35 U.S.C. 132(a)). Although, as discussed above, an incorporation by reference statement can be used as a safeguard against an omission of a portion of a prior application for which priority is claimed under 35 U.S.C. 119(a)-(d) or (f), or for which benefit is claimed under 35 U.S.C. 119(e) or 120, it should be noted that an incorporation by reference statement will not satisfy the specific reference requirement of 35 U.S.C. 119(e) or 120 or 37 CFR 1.78. See Droplets, Inc. v. E*TRADE Bank, 887 F.3d 1309, 126 USPQ2d 317 (Fed. Cir. 2018).
As stated above in the MPEP, for the incorporation by reference to be effective as a proper safeguard, the incorporation by reference statement must be filed at the time of filing of the later-filed application. An incorporation by reference statement added after an application’s filing date is not effective because no new matter can be added to an application after its filing date (see 35 U.S.C. 132(a)).
The incorporation by reference statement was filed as an amendment dated 3/5/2025. So, what is the filing date of the application? Was the amendment filed on the filed date or after the filing date? In order words, was the Application filed before 3/5/2025 or not?
MPEP 1893.03(b) recites in part:
An international application designating the U.S. has two stages (international and national) with the filing date being the same in both stages. Often the date of entry into the national stage is confused with the filing date. It should be borne in mind that the filing date of the international stage application is also the filing date for the national stage application. Specifically, 35 U.S.C. 363 provides that
An international application designating the United States shall have the effect, from its international filing date under Article 11 of the treaty, of a national application for patent regularly filed in the Patent and Trademark Office.
Similarly, PCT Article 11(3) provides that
...an international filing date shall have the effect of a regular national application in each designated State as of the international filing date, which date shall be considered to be the actual filing date in each designated State.
National stage applications are ordinarily taken up for action based on the date of entry into the national phase. See MPEP § 1893.01 regarding entry into the national stage. Because the date of entry is dependent upon receipt of certain items required under 35 U.S.C. 371(c), this date is also referred to as the "371(c) date." The 371(c) date, not the international filing date, is the date that appears in the "Filing or 371(c) Date" box on the filing receipt and the application data sections of the Patent Data Portal and private PAIR.
In other words, the filing date of a national stage application is the international filing date, not the 371(c) date.
In this case, the instant application (19,109,007) is a national stage application. The filing date of the national stage application is the international filing date (in this case, 8/18/2023); i.e., the filing date of the instant application is 8/18/2023.
The amendment to the Specification (which includes an incorporation by reference statement) was filed after the filing date (because 3/5/2025 is after 8/18/2023). Since the amendment to the Specification (which includes an incorporation by reference statement) was filed after the filing date, the amendment to the Specification is considered to contain new matter.
Applicant is required to cancel the new matter in the reply to this Office Action.
Note: In retrospect, what the Applicant should have done was include the incorporation-by-reference statement of the German patent application in the Application as originally filed on 8/18/2023 (i.e., at the time the international application was filed) instead of waiting until the national stage thereof to file such an amendment.
Note: Moving forward for this application, it is noted that any portion of the Specification/Drawings of the German patent application (DE 10 2022 209 424.7) that may have been inadvertently omitted from the instant application may be amended into the instant application provided the amendment is done so in accordance with 37 CFR 1.57(b) (see MPEP 217) and any other applicable regulation/law governing amendments.
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.
Claims 1-3, 5, 7, 9-11, 13, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Kurkowski et al., US 2022/0015667 A1 (hereinafter “Kurkowski”), Bogdanovic et al., US 2022/0228998 A1 (hereinafter “Bogdanovic”).
Regarding claim 1: Kurkowski discloses a device for detecting magnetic signals generated by a beating heart (Abstract and ¶ [0002], [0054]), comprising:
a support body with a contact surface
(e.g., bed/mattress 115 or chair 117, Fig. 1); and
an arrangement of at least two magnetometer units
(sensors 101/101B/101C)
(“When a sensor (101) is placed on or near the body, […] magnetic field changes to the chest area, amongst other things can be measured” ¶ [0054]; “Physical detection also includes changes to electrical or magnetic fields […] Physical detection can be carried out by a wide variety of instruments, but devices such as […] magnetometers, […] are all capable of physical detection. Physical parameters including, but not limited to, […] change in magnetic field can all be measured.” ¶ [0037]),
the arrangement embedded in the support body
(see Fig. 1)
(“sensors located in a patient’s bed or on a chair”, ¶ [0003])
(“It is generally preferred that the sensors (101) be untethered from the patient (that is not connected to the patient) and placed on or in a bed (patient (105)) or mattress (115) or on or in a chair (117) (patient (107)), regardless of their orientation to the bed or chair, or may be carried by a user or otherwise held in proximity to certain points of their body. When a sensor (101) is placed on or near the body, […] magnetic field changes to the chest area, amongst other things can be measured. External changes to the human condition […] will commonly cause physical changes in the chest while the heart beats […].”, ¶ [0054]),
wherein the support body is configured to accommodate a user sitting or lying on the contact surface
(implied by the bed or chair as discussed above)
(see Fig 1 which illustrates patient 105 lying on the mattress of the bed, and patient 107 sitting on the chair).
Kurkowski does not disclose that the magnetometer units are specifically nitrogen-vacancy centers, NV, magnetometer units.
Bogdanovic teaches at least two nitrogen-vacancy centers, NV, magnetometer units (see ¶ [0026]-[0027] which discusses nitrogen vacancy (NV) magnetometry as a specific type of electron spin defect based magnetometry; further, ¶ [0032] and array of magnetometer pixels).
Bogdanovic teaches ¶ [0026] that “electron spin defect based magnetometers may be operated at room temperature and, in certain cases, within relatively compact structures, allow for portability and reduction in magnetometer costs, which may be advantageous in health related applications such as measuring magnetic fields emanating from the heart”. The ordinarily skilled artisan would understand that this advantage is applicable to NV magnetometers because NV magnetometers are a type of electron spin defect based magnetometers as discussed above.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Kurkowski by implementing the at least two magnetometer units as at least two nitrogen-vacancy centers, NV, magnetometer units, as taught by Bogdanovic; and the ordinarily skilled artisan would have been motivated to make this modification NV magnetometer units may be operated at room temperature, within relatively compact structures, allow for portability, and reduction in costs, which would be understood as advantageous in measuring magnetic fields emanating from the heart such as in Kurkowski.
Regarding claim 2: In it implied or otherwise obvious that the support body has an elastic material between the arrangement (i.e., the magnetometers) and the contact surface in the sense that (1) the magnetometers are embedded inside a bed/mattress or chair as discussed above and (2) it is implied or otherwise considered well-understood, routine, and conventional, that the bed/mattress or chair is made of elastic materials at the contact surface (e.g., cushioning).
Regarding claim 3: Kurkowski further discloses that the support body is a bed/mattress or a chair (see Fig. 1 and the discussion above).
Regarding claim 5: Detecting both the strength and direction of a magnetic field is known from multi-vector magnetometry (¶ [0067] of Bogdanovic) and therefore obvious to the ordinarily skilled artisan in order to implement multi-vector magnetometry.
Regarding claim 7: Bogdanovic further teaches the arrangement is a two-dimensional arrangement in which the at least two NV magnetometers units are arranged in a plane in order to form an imaging array (¶ [0120]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the invention of Kurkowski such that the arrangement is a two-dimensional arrangement in which the at least two NV magnetometers units are arranged in a plane, as taught by Bogdanovic; and the ordinarily skilled artisan would have been motivated to make this modification in order to form an image array.
Regarding claim 9: Bogdanovic teaches that each NV magnetometer units has, a sensor medium, a diamond crystal, or a section of a diamond crystal having nitrogen-vacancy centers, and the device is configured to detect a magnetic field strength and/or a field direction by reading a spin resonance dependent on the magnetic field strength in the sensor medium (¶ [0025]-[0030]).
It would have been obvious to one having ordinary skill in the art to further modify the invention of Kurkowski such that each of the at least two NV magnetometer units has, a sensor medium, a diamond crystal, or a section of a diamond crystal having nitrogen-vacancy centers, and the device is configured to detect a magnetic field strength and/or a field direction by reading a spin resonance dependent on the magnetic field strength in the sensor medium, as taught by Bogdanovic; and the ordinarily skilled artisan would have been motivated to make this modification in order to implement the magnetometers of Kurkowski as NV magnetometer units (i.e., that is how NV magnetometers work).
Regarding claim 10: Bogdanovic teaches at least one excitation light source configured radiate light into the sensor medium, at least one microwave source configured to generate a resonant field in the sensor medium, and at least one photodetector configured to detect resonance-dependent fluorescent light from the sensor medium (see ¶ [0030]).
It would have been obvious to one having ordinary skill in the art to further modify the invention of Kurkowski by providing at least one excitation light source configured radiate light into the sensor medium, at least one microwave source configured to generate a resonant field in the sensor medium, and at least one photodetector configured to detect resonance-dependent fluorescent light from the sensor medium, as taught by Bogdanovic; and the ordinarily skilled artisan would have been motivated to make this modification in order to implement the magnetometers of Kurkowski as NV magnetometer units (i.e., that is how NV magnetometers work).
Regarding claim 11: Bogdanovic teaches a same excitation light source and/or a same microwave source are associated with the at least two NV magnetometer units (¶ [0030]).
It would have been obvious to one having ordinary skill in the art to further modify the invention of Kurkowski such that a same excitation light source and/or a same microwave source are associated with the at least two NV magnetometer units, as taught by Bogdanovic; and the ordinarily skilled artisan would have been motivated to make this modification in order miniaturize the NV magnetometer units as a whole.
Regarding claim 13: Bogdanovic further teaches that the distance between the sensor media of the at least two NV magnetometer units is from between 1 to 30 millimeters (implied by the ranges of dimensions and parameters in ¶ [0088]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the invention of Kurkowski such that the distance between the sensor media of the at least two NV magnetometer units is from between 1 to 30 millimeters, as taught by Bogdanovic; and the ordinarily skilled artisan would have been motivated to make this modification in order implement a 2D magnetic field imaging geometry.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Kurkowski in view of Bogdanovic as applied to claim 1 above, and further in view of Erasala et al., US 2020/0170528 A1 (hereinafter “Erasala”).
Regarding claim 4: Kurkowski modified in view of the teachings of Bogdanovic teaches the invention of claim 1, but does not further teach a structure made of a material with a magnetic permeability greater than 1 on a side of the arrangement facing away from the contact surface and/or a contact body containing the structure.
Erasala teaches a magnetic field shield (301, Fig. 3) that surrounds the patient when measuring magnetic fields of the patient (¶ [0097]). For example, the patient can be placed in the internal volume of the shield via the open end 303, and sensor (401, such as a magnetometer, ¶ [0098]) can be brought in proximity of the body the patient via the same open end 303 using device 400 (see Fig. 4). Further, the shield has a high permeability greater than 1 (¶ [0052], [0069]-[0071]).
Erasala teaches that the shield can “reduce noise and enhance signal collection” (Abstract).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modification the invention of Kurkowski by providing a magnetic field shield, as taught by Erasala; and the ordinarily skilled artisan would have been motivated to make this modification in order to reduce noise and enhance signal collection.
By making the above modification, the shield surrounding the patient/bed would therefore read on a structure made of a material with a magnetic permeability greater than 1 on a side of the arrangement facing away from the contact surface and/or a contact body containing the structure because portions of the shield could be considered to face away from the contact surface in the sense that the shield would entirely surround the bed including the contact surface thereof.
Claims 6, 8, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Kurkowski in view of Bogdanovic as applied to claim 1 above, and further in view of Masuyama et al., “Gradiometer Using Separated Diamond Quantum Magnetometers” Sensors 2021 (see IDS dated 3/5/2025) (hereinafter “Masuyama”).
Regarding claim 6: Kurkowski modified in view of the teachings of Bogdanovic teaches the invention of claim 1; and further teaches a signal processing unit to which the at least two NV magnetometer units are connected (¶ [0052]); however, Kurkowski does not teach the device is configured to determine, using the signal processing unit, an effective magnetic field strength and/or field direction as a difference of magnetic field strengths and/or field directions detected using the at least two NV magnetometer units.
Masuyama teaches determining an effective magnetic field strength and/or field direction as a difference of magnetic field strengths and/or field directions detected using at least two NV magnetometer units in order to implement a gradiometer (see Fig. 1). The ordinarily skilled artisan would have recognized that implementing the magnetometers as a gradiometer can reduce environmental noise by isolating environmental noise measured by sensor 2 and subtracting it from the sensor 1, thereby isolating the signal from the target as desired.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the invention of Kurkowski by configuring the device/signal processor to determine an effective magnetic field strength and/or field direction as a difference of magnetic field strengths and/or field directions detected using at least two NV magnetometer units in the manner of a gradiometer, as taught by Masuyama; and the ordinarily skilled artisan would have been motivated to make this modification in order to reduce environmental noise.
Regarding claim 8: Kurkowski modified in view of the teachings of Bogdanovic teaches the invention of claim 1.
Bogdanovic further teaches at least four NV magnetometer units (¶ [0086]-[0088]); but does not teach that the arrangement is a three-dimensional arrangement in which at least one of the at least four NV magnetometer units is not arranged in a plane in which at least three others of the at least four NV magnetometer units are arranged.
However, applying the gradiometer concepts as taught by Masuyama (as discussed above regarding claim 6) to the 2D arrangement of Bogdanovic would result in the 3D arrangement as claimed.
It therefore would have been obvious to one having ordinary skill in the art to further modify the invention of Kurkowski such that the at least two NV magnetometer units comprise at least four NV magnetometer units, and the arrangement is a three-dimensional arrangement in which at least one of the at least four NV magnetometer units is not arranged in a plane in which at least three others of the at least four NV magnetometer units are arranged, because it would have merely involved applying a known technique (i.e., 2D NV magnetometer arrangement as taught by Bogdanovic and the gradiometer technique as taught by Masuyama) to a base device ready for improvement (i.e., the modified Kurkowski invention as discussed above regarding claim 1) to yield predictable results (2D magnetic field imaging with reduced environment noise).
Regarding claim 14: See above regarding claim 8. The out-of-plane NV magnetometer discussed above can read on the further NV magnetometer unit recited in claim 14. Masuyama teaches that a base length (the distance between the signal sensor and the environmental noise sensor) can be optimized based on the depth (the distance between the target and the signal sensor): “Ideally, to detect small signals efficiently, the optimum base length should be selected depending on the distance between the measurement target and sensors, the sensor sensitivity, and the inhomogeneity of magnetic noise. In general, to improve the signal-to-noise ratio (SNR), the base length should be longer than the distance between the measuring object and sensors. However, in previous studies, two fixed detection points in a diamond chip were used for the gradiometers. Thus, the distance between each point was the length of the order of micrometers. On the other hand, when we apply the gradiometer methodology to MEG, the base length should be of the order of a centimeter or more. It is also worth mentioning that we can expand the NV center magnetometry not only inside of rooms but also outdoors if the NV center gradiometer method is developed.”
Masuyama further teaches: “To realize sensing with high sensitivity, the base length is the important parameter for the gradiometer. Thus, the distance between the target and sensor 1, called “depth”, should be minimized for highly sensitive sensing, although the base length should be longer than the depth. For example, for sensing a deep brain signal, a base length of 50 mm or more is preferable.”
Further: “Figure 1b shows a schematic setup of the gradiometer using two diamond quantum sensors that enabled us to change in a wide range of the base length.”
Further: “As above-mentioned, the distance of the base length to the target depth is a key parameter for magnetometry (noise cancelation) by gradiometer. We measured the base length dependence of the acquired signal. One sensor of the gradiometer was placed at 50 mm apart from the target magnet assuming the target object is in a deep part of the body, such as in the brain. By varying the position of the other sensor, i.e., the base length, we measured the differential signal level. The results of Figure 6 clearly demonstrated that the differential signal dramatically increased with increasing base length, and the saturation was observed at a base length above 50 mm. This result indicates that the gradiometer with variable base length demonstrated in this study is useful to sense a target with deep regions. To obtain large signals of the gradiometer, the base length should be longer than the depth. On the other hand, to cancel the magnetic noise, sensor 1 and sensor 2 should detect the same level. Therefore, the base length should be set appropriately, considering the distance between the measurement target and the noise source. In this respect, the gradiometer using the optical fiber has an advantage since the base length can be easily changed without the adjustment of the optical path.”
In this sense, the ordinarily skilled artisan would have recognized that the base length as discussed in Masuyama (which would correspond to the “distance” as recited in claim 14) is a result-effective variable because increasing the distance results in a increasing the differential signal. The general conditions of the claim are therefore disclosed in the prior art with the difference being that the claim recites a what appears to merely be a optimum or workable range that could be found by routine experimentation such an experiment similar to Masuyama’s experiment.
The courts have held: "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
It would have been obvious to one having ordinary skill in the art to further modify the invention of Kurkowski such that the distance between the further NV magnetometer unit and the at least two NV magnetometer units is at least 1 m because as a matter of routine optimization because it is not inventive to disclose the optimum or workable ranges by routine optimization where the generation conditions of the claim are already taught in the prior art.
Allowable Subject Matter
Claim 12 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 12: Within the context the context of the invention of claim 9, the prior art of record does not teach or reasonably suggest that the sensor medium of the at least two NV magnetometer units each has a portion of a same diamond crystal.
Bogdanovic is closest to this limitation by teaching NV magnetometer units sharing the same substrate (e.g., fabricated on the same chip) but does not teach sharing the same diamond crystal. For example, each pixel has its own diamond crystal (see Fig. 7 which illustrates an array of pixels; and Fig. 4 which illustrates a pixel which has its own respective electron spin defect body 402).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COLIN T. SAKAMOTO whose telephone number is (571)272-4958. The examiner can normally be reached Monday - Friday, ~9AM-5PM Pacific.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KEITH M. RAYMOND can be reached at (571) 270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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COLIN T. SAKAMOTO
Primary Examiner
Art Unit 3798
/COLIN T. SAKAMOTO/Primary Examiner, Art Unit 3798
January 24, 2026