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 .
Response to Arguments
Applicant's arguments filed 09 December 2025 have been fully considered but they are not persuasive. The Applicant did not address the cited portions of Derichs, nor the proposed combination. The Applicant pointed out some portions of Derichs relating to the use of accelerometers. However, Derichs is a secondary reference. The structure of the posts and the use of a magnetometer to determine displacement are taught by Sniadecki. The Combination made at ¶11 of the Non-Final Rejection mailed 26 August 2025 does not suggest incorporating Derichs in its entirety, into Sniadecki. The only teachings from Derichs applied to Sniadecki pertain to the reference magnetometer. Derichs provides sufficient motivation to incorporate a reference magnetomer: “By using a bases [sic] sensor pair 152 and a tip sensor pair 151 and taking the difference of the magnetometer output of each, the probe 150 is able to differentiate the magnetic field of the marker 110 from the general magnetic field in the environment of the probe” (¶70).
Claim Interpretation
No claim limitations are interpreted under 112(f).
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.
Claims 1, 5-10, 12, 13, 16, 17, 20, and 22-29 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. Claims 1 and 22 have each been amended to read “the reference sensor is disposed at a fixed location relative to at least one of the first post or the second post.” The Applicant points out p.28 of the specification and Fig 8 to support this limitation. Upon review, no support can be found. ¶122 (with continued reference to the instant PGPub US 20230265377) describes Fig 8: “a multi-piece assembly comprising a permanent base portion and a disposable culture dish having one or more culture wells. See FIG. 13A-B. In such embodiments, elements of the sensing module 802 are disposed on the culture dish and on a printed circuit board disposed on the base portion, elements of the reference module 804 and computing device 806 are disposed on the printed circuit board.” Since the reference sensors are on the circuit board and the posts are on a disposable culture dish, they are not relatively fixed. Figs 13A-B show the posts with the wells 1348 as a different component than the sensor arrays 1350 with reference sensors (¶162). Furthermore, one reading the specification would not understand the reference sensor disposed at a fixed location relative to the post(s) as critical or implied because ¶125 states “the reference sensor(s) is positioned far enough away from the posts that the reference input is not disturbed by displacement of any posts. Restated, the reference sensor 812a does not sense any signal amplitude from the displacement of any of the posts 808a-b, due to its placement and sensitivity.” This is a new matter rejection.
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.
Claims 1, 5-10, 12-13, 16-17, 20, and 22-29 are rejected under 35 U.S.C. 103 as being unpatentable over Sniadecki (WO 2017156455) in view of Derichs (US 2016/0051164).
Regarding claim 1, Sniadecki discloses:
A tissue analysis device for determining a characteristic of a tissue specimen (¶51), comprising:
a sensing module, comprising:
a first post (104) disposed on a base (102), having a magnetic material (112, ¶28) disposed therein, and configured to have the tissue specimen (116) attached thereto;
a second post (106) disposed on the base and configured to have the tissue specimen attached thereto (see Fig 1); and
a displacement sensor (magnetometer, ¶28) configured to output a displacement signal (122) corresponding to a displacement of the first post (¶28-¶32);
…
a non-transitory machine readable storage medium (¶67) storing logic, which when executed by a processor, causes the processor to perform operations, including:
determining a displacement value based upon the displacement signal (length in Fig 4B, ¶49 “deflection”);
…
determining the characteristic based upon the … displacement value (see Fig 6, 650).
Sniadecki does not disclose:
a reference module comprising a reference sensor configured to output a reference signal corresponding to a reference input, wherein the reference sensor is disposed at a fixed location relative to at least one of the first post or the second post; and
determining a reference value based upon the reference signal;
determining a reference-canceled displacement value based upon the displacement value and the reference value; and
determining the characteristic based upon the reference-canceled displacement value.
Sniadecki also discloses that “The orientation relative to the earth was found to slightly alter the response of the sensors, which is likely due to a move away from the linear range of the sensors while the earth's magnetic field was oriented against the stray magnetic field of the post” (¶40). Thus, there is room for improvement.
Derichs teaches:
a probe for precisely locating a magnetic object in a patient (¶32). A magnetometer (151, see Fig 4) in the tip detects the object, and a magnetometer (152) in the base measures background. The values are subtracted, and they may be amplified by a gain (¶90, ¶80-¶84), to isolate the magnetic field of the object from the background magnetic field (¶87, ¶88). The probe is able to determine the location of a magnetic piece with a resolution of about 0.1 mm (¶43). “By using a bases [sic] sensor pair 152 and a tip sensor pair 151 and taking the difference of the magnetometer output of each, the probe 150 is able to differentiate the magnetic field of the marker 110 from the general magnetic field in the environment of the probe” (¶70).
a reference module comprising a reference sensor (152) configured to output a reference signal (¶86 “each of the tip sensor pair 151 and base sensor pair 152 outputs substantially real time accelerometer and magnetometer data to the microprocessor 157”) corresponding to a reference input (¶71-¶72), wherein the reference sensor is disposed at a fixed location relative to at least one of the first post or the second post (¶105 “rigidly attached”); and
determining a reference value (a voltage) based upon the reference signal;
determining a reference-canceled displacement value based upon the displacement value and the reference value (910 and 915 in Fig 9); and
determining the characteristic based upon the reference-canceled displacement value (Derichs 915 teaches determining the distance; Sniadecki discloses calculating force from magnetometer output at ¶66, and at ¶39 “The force exerted by the cardiac tissue on the flexible post 104 is directly proportional to the distance the tip 110 of the flexible post 104 moves.” Thus, the distance produced by the teachings of Derichs can be used to determine the force.).
COMBINATION
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Sniadecki to include a reference magnetometer, as taught by Derichs, to obtain the benefit of differentiating the magnetic field of the magnetic device in the post from the general magnetic field in the environment.
Regarding claim 22, Sniadecki modified as described above by Derichs teaches:
A method, comprising:
affixing (Sniadecki: ¶21) a tissue specimen (Sniadecki: 116) to a first post (Sniadecki: 104) and a second post (Sniadecki: 106);
sensing a displacement of the first post relative to the second post (Sniadecki: ¶28);
sensing a reference input while sensing the displacement of the first post relative to the second post (Derichs: ¶70, ¶71);
outputting a displacement signal based upon the displacement of the first post relative to the second post (Sniadecki: ¶30);
outputting a reference signal based upon the reference input (Derichs: ¶86 “each of the tip sensor pair 151 and base sensor pair 152 outputs substantially real time accelerometer and magnetometer data to the microprocessor 157”);
determining a displacement value (a voltage representative of displacement) based upon the displacement signal (Derichs: ¶88 “tip sensor pair's 151 magnetometer data” gain corrected as in ¶90 and Fig 8);
determining a reference value based upon the reference signal (Derichs: ¶88 “base sensor pair's 152 magnetometer data” gain corrected as in ¶90 and Fig 8);
determining a reference-canceled displacement value based upon the reference value and the displacement value (Derichs 915b based on subtraction at 910); and
determining a characteristic (force) of the tissue specimen based upon the reference- canceled displacement value (Sniadecki discloses calculating force from magnetometer output at ¶66, and at ¶39 “The force exerted by the cardiac tissue on the flexible post 104 is directly proportional to the distance the tip 110 of the flexible post 104 moves.” Thus, the distance produced by the teachings of Derichs can be used to determine the force.).
Regarding claim 5, Sniadecki as modified by Derichs teaches:
determining the reference- canceled displacement value is based upon subtracting the reference value from the displacement value (Derichs Figs 9-10, ¶24).
Regarding claims 6 and 23, Sniadecki as modified by Derichs teaches:
determining the displacement value comprises multiplying the displacement signal by a linear factor (Derichs: ¶91 “convert the raw output data to Gauss,” even though this is performed after the subtraction in Derichs, it is equivalent to multiplying the displacement signal, by the distributive property (LF1)*(displacement-reference) = LF*displacement – LF*reference) and by a non-linear factor (Derichs: Fig 9 step 915, ¶95-¶96, use lookup table as in Fig 12A to determine distance based on Gauss, which is an exponential relationship. Converting the value via the table is equivalent to multiplying by a factor of the table value for distance/Gauss value input. For example, a magnetic field strength of 602.232 Gauss becomes 0.5 mm. This is equivalent to multiplying by a factor of 0.5 mm/602.232 Gauss.).
Regarding claims 7 and 24, Sniadecki as modified by Derichs does not explicitly teach:
determining the displacement value does not comprise frequency filtering the displacement signal before multiplying the displacement signal by the linear factor.
Sniadecki ¶31-¶34 specifies a filter. Sniadecki discloses that “Filter 130 may be effective to offset drift in the detected signals due to temperature fluctuations and/or due to ambient magnetic fields of the environment in which device 100 is situated” (¶33). However, the reference sensor of Derichs already accounts for drift and fluctuations, such that the difference yields a calculated distance that only reflects the movement of the magnet relative to the displacement sensor. MPEP 2144.04 §A states that omission of an element and its function is obvious if the function is not desired or required. In this case, the function of the filter is not required because the reference sensor provides the same function, or better. Thus, it would be obvious to omit the filtering.
Regarding claims 8 and 25, Sniadecki as modified by Derichs teaches:
determining the reference value comprises multiplying the reference signal by a linear factor (Derichs: ¶90 gain, also ¶91 “convert the raw output data to Gauss,” even though this is performed after the subtraction in Derichs, it is equivalent to multiplying the reference signal, by the distributive property (LF)*(displacement-reference) = LF*displacement – LF*reference).
Regarding claims 9 and 26, Sniadecki as modified by Derichs teaches:
determining the characteristic comprises multiplying the reference-canceled displacement value by a linear factor (Derichs offers guidance on determining displacement from two magnetometers. Sniadecki discloses calculating force from magnetometer output at ¶66, and at ¶39 “The force exerted by the cardiac tissue on the flexible post 104 is directly proportional to the distance the tip 110 of the flexible post 104 moves.” Since the force is directly proportional to the distance, the calculation of force from distance involves multiplying by a linear factor.).
Regarding claims 10 and 27, Sniadecki as modified by Derichs teaches:
the linear factor is a correlation factor between the displacement of the first post and a force exerted by the tissue specimen (Derichs offers guidance on determining displacement from two magnetometers. Sniadecki discloses calculating force from magnetometer output at ¶66, and at ¶39 “The force exerted by the cardiac tissue on the flexible post 104 is directly proportional to the distance the tip 110 of the flexible post 104 moves.” Since the force is directly proportional to the distance, the calculation of force from distance involves multiplying by a linear factor.).
Regarding claim 12, Sniadecki as modified by Derichs teaches:
the displacement sensor is disposed a first distance away from the first post and the fixed location (Derichs: ¶105 “rigidly attached”) of the reference sensor is disposed a greater second distance away from the first post (Derichs: ¶44, ¶88).
Regarding claim 13, Sniadecki as modified by Derichs teaches:
the second distance is sufficiently large that the reference sensor does not sense any signal amplitude from the tissue specimen (Derichs: ¶88 “the marker 110 is not within range of the base sensor pair 152, its magnetometer data output is not affected by the marker 110,” ¶5).
Regarding claim 16, Sniadecki as modified by Derichs teaches:
the first post and the second post are disposed in a well of a culture dish (Sniadecki: ¶24-¶25), and the displacement sensor is disposed directly beneath (an array of magnetometers on a printed circuit board, as described in ¶31 can only go above or below a multi-well plate, ¶42) the first post (Sniadecki: ¶28 “magnetometer 120 may be positioned within 0.1-10 millimeters from post 104”) on a printed circuit board (Sniadecki: ¶31).
Regarding claim 17, Sniadecki as modified by Derichs teaches:
the displacement sensor is configured to sense a change in a local magnetic field caused by displacement of the magnetic material (Derichs: ¶88 “the marker 110 is within the range 153 of the tip sensor pair 151, the magnetic field of the marker 110 is also reflected in the tip sensor pair's magnetometer data output”), the displacement signal corresponds to a change in a local magnetic field caused by the displacement of the first post (Sniadecki: ¶28), the reference sensor is configured to sense a change in an ambient magnetic field (Derichs: “¶88 “the marker 110 is not within range of the base sensor pair 152, its magnetometer data output is not affected by the marker 110”), and the reference signal corresponds to the ambient magnetic field (Derichs: ¶88, ¶71, ¶72).
Regarding claims 20 and 29, Sniadecki as modified by Derichs teaches:
the characteristic is an absolute force (Sniadecki: ¶66).
Regarding claim 28, Sniadecki as modified by Derichs teaches:
determining the displacement value comprises multiplying the displacement signal by a first linear factor (Derichs ¶90 “gain”) and by a non-linear factor (Derichs: using a lookup table to convert field strength to distance, see Fig 12A), wherein determining the reference value comprises multiplying the reference signal by a second linear factor (Derichs ¶90 “gain”), and
wherein determining the characteristic comprises multiplying the reference-canceled displacement value by a third linear factor (Sniadecki discloses calculating force from magnetometer output at ¶66, and at ¶39 “The force exerted by the cardiac tissue on the flexible post 104 is directly proportional to the distance the tip 110 of the flexible post 104 moves.” Since the force is directly proportional to the distance, the calculation of force from distance involves multiplying by a linear factor.).
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Okatake (JP 2019045496) is cited by JPO and teaches using a first magnetometer and subtracting a background magnetic field detected by a second magnetometer.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TOPAZ L ELLIOTT whose telephone number is (571)270-5851. The examiner can normally be reached Monday-Friday 7 a.m. - 4 p.m. EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Courtney Heinle can be reached on (571) 270-3508. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TOPAZ L. ELLIOTT/Primary Examiner, Art Unit 3761
1 LF = Linear Factor