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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/08/2026 has been entered.
Response to Arguments
Regarding 35 U.S.C. 101
Applicant's arguments filed 01/08/2026 have been fully considered but they are not persuasive. Examiner notes that although amendments are made to the claims, such amendments do not fully address the 101 issue. Specifically, it is noted that the claims now refer to a configuration of the breast (e.g. a breast is configured to be placed), thus remains to encompass a human organism. For at least these reasons, the 101 rejection is maintained/updated in view of the amendments to the claims.
Regarding 35 U.S.C. 112
Examiner notes that the previously set forth 112(b) rejection is withdrawn in view of the amendments to the claims, however, new 112(b) rejections are necessitated by amendment.
Regarding prior art
Applicant's arguments filed 09/26/2025 have been fully considered but they are not persuasive. For example, applicant argues “that Besson fails to disclose a contact surface that is formed to be recessed from a peripheral surface of a back surface of a locating surface on which a breast is placed, as recited in the amended claims and illustrated in Fig. 6 of the present application, for example” (REMARKS pg. 8). Examiner respectfully disagrees in that each of the surfaces are recited broadly and it is noted that the contact surface of currently recited claims is interpreted to be a portion of either an inner or outer surface of the housing 32 and is recessed (e.g. is curved inward/downward or recessed in that it is recessed from the bottom of the housing upward) toward the loading surface with respect to a peripheral surface (i.e. the sides) of the back surface of the loading surface 32. Applicant’s arguments are merely conclusory without providing any explanation nor evidence as to why the contact surface of Besson is not recessed toward the loading surface as recited and applicant’s arguments cannot replace evidence where evidence is necessary (MPEP 2145). For at least these reasons, applicant’s arguments against the teachings of Besson are not found persuasive.
Claim Interpretation
Claim 1 recites “that is provided to dispose an ultrasound probe” and “that is provided to contact with an acoustic matching member”. The limitations are interpreted as intended use. A limitation directed towards intended use must result in a structural difference between the claimed invention and the prior art and the prior art must merely be capable of performing the cited limitations. That is the space in the prior art must merely be capable of disposing an ultrasound probe which outputs an ultrasonic wave from an outside of the loading surface toward the loading surface and acquiring a reflected wave of the ultrasonic wave by the breast and the contact surface must merely be capable of contacting an acoustic matching member which reduces a difference in acoustic impedance between the breast and the ultrasound probe in order to read on the claimed invention.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1, 4-5, 7-10, and 12 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 1 recites the limitation “a loading surface on which a breast is configured to be placed”, thus positively reciting the breast (i.e. human organism/part thereof) as a part of the claimed invention and further recites that the breast is configured to be placed. Examiner recommends amending the claims to be directed to the configuration of the loading surface (e.g. “a loading surface configured/adapted to”) or similar in order to overcome the above 101 rejection.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 4-5, 7-10, 12, and 14 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.
Claims 1 and 14 recite the limitation “a contact surface that is provided on a back surface of the loading surface” and “wherein the contact surface is recessed toward the loading surface”, the limitation is unclear as to the relationship between the contact surface and the loading surface and how it is recessed toward the loading surface when the contact surface is provided on a back surface thereof. For examination purposes, it has been interpreted that any recess formed by a contact surface on a back surface of the loading surface is considered to be recessed toward the loading surface.
Claim 5 recites the limitation “an ultrasonography apparatus comprising: the imaging table according to claim 1 that is attached to the ultrasonography apparatus”. The limitation is unclear as the claim first sets forth that the ultrasonography apparatus comprises the imaging table and then further recites that it is attached to the ultrasonography apparatus making it seem as though it is a separate element from the ultrasonography apparatus. It is therefore unclear if the imaging table is intended to be attached to some other element in the ultrasonography apparatus or if the claim is intending for the imaging table to be separate from the ultrasonography apparatus. For examination purposes, it has been interpreted that the imaging table is a part of the ultrasonography apparatus and is attached to a different element of the ultrasonography apparatus, however, clarification is required.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 4-5, 12, and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Besson et al. (US 20040249271 A1), hereinafter Besson.
Regarding claim 1,
Besson discloses an imaging table (at least fig. 3A-3B (32) and corresponding disclosure in at least [0046]) comprising:
A loading surface (at least figs. 3A-3B (32) and corresponding disclosure in at least [0046]. Examiner notes that the housing 32 as a whole including the support layer 36 is considered a loading surface) on which a breast is configured to be placed (See at least fig. 2A-2C (100) and corresponding disclosure in at least [0045])
a space (see at least fig. 3B depicting a space) that is provided below the loading surface (32), and is provided to dispose an ultrasound probe (at least fig. 3B (50) and corresponding disclosure in at least [0043]) which outputs an ultrasonic wave from an outside of the loading surface toward the loading surface and acquires a reflected wave of the ultrasonic wave by the breast (see at least figs. 2A-2B and [0045] which discloses Ultrasound imager 50 transmits/receives ultrasound signals into/from a patient's breast 100);
and a contact surface (Examiner notes that either of the inside surface or the outside surface of the housing 32 including the inside/outside surface of support layer 36 is considered a contact surface in its broadest reasonable interpretation) that is provided on a back surface of the loading surface (see at least figs. 2A-2C and fig. 3B depicting an inner/outer surface of housing 32 has a contact surface considered to be provided on the back surface of the loading surface 32) and that is provided to contact with an acoustic matching member (at least fig. 3B and 4 (59) and corresponding disclosure in at least [0058] and see also [0049] which discloses Further, an acoustic coupling means 56 may be utilized to acoustically couple a patient's breast 100 to a topside of support layer 36. For example, a standard ultrasound gel (e.g. a glycerin-based gel) gel or other flowable acoustic couplant may be contained within a pad located in contact with or otherwise applied to either or both of the top and bottom sides of support layer 36) and reduces a difference in acoustic impedance between the breast and the ultrasound probe (examiner notes that a coupling agent necessarily reduces a difference in acoustic impedance between the breast and the ultrasound probe. See also [0008] which discloses the importance of maintaining acoustic coupling and any kind of acoustic impedance mismatch between the transducer and target tissue can reduce image quality where [0046] discloses the distribution tubes keeps tiny air pockets filled with coupling agent such that acoustic coupling between the transducer and target is facilitated and high image quality is obtained),
wherein the contact surface is recessed toward the loading surface (32) with respect to a peripheral surface of the back surface (see at least figs. 2A-2B, 3 and 4 depicting the contact surface (e.g. at the center of either the top surface or bottom surface of layer 36 or from the bottom up it is considered to be recessed toward the loading surface via the space for example) which are recessed from a peripheral surface (e.g. the sides) of the back surface of housing 32).
Regarding claim 4,
Besson further teaches wherein in a case where the acoustic matching member in contact with the contact surface is jelly, the acoustic matching member is fixed to the contact surface by a holding member that attaches the acoustic matching member to the contact surface ([0049] which discloses for example, a standard ultrasound gel (e.g. a glycerin-based gel) gel or other flowable acoustic couplant may be contained within a pad (i.e. a holding member) located in contact with or otherwise applied to either or both of the top and bottom sides of support layer 36)
Regarding claims 5 and 14,
Besson discloses an ultrasonography apparatus (at least fig. 1 and corresponding disclosure in at least [0038]) comprising:
The imaging table (32) according to claim 1 (see above rejection of claim 1) that is attached to the ultrasonography apparatus (20) and
A controller (at least fig. 1 (16) and corresponding disclosure in at least [0046]) that performs control to capture an ultrasound image of a breast by using the reflected wave of the ultrasonic wave, the reflected wave being acquired by the ultrasound probe ([0073] which discloses the processor 16 may initiate ultrasound scanning operations (step 210) and [0046] which discloses in that regard, each of radiation source 22, x-ray detector 40, ultrasound imager 50 and the drive motor 60 may be operatively interconnected (e.g. via electrical and/or optical lines) to the processor 16 at monitoring station 10, wherein control signals are provided by processor 16 and image signals are received at processor 16 from the imaging station 20).
Examiner notes that the system of claim 5 would comprise the non-transitory storage medium for causing a computer (i.e. the processor 16 which would necessarily comprise a non-transitory storage medium) to perform the method of claim 14.
Regarding 12,
Besson further discloses a mammography apparatus (at least fig. 1) comprising:
The ultrasonography apparatus according to claim 5 (at least fig. 1 see rejection of claim 5 above).
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 7 is rejected under 35 U.S.C. 103 as being unpatentable over Besson in view of Tian et al. (US 20190150895 A1), hereinafter Tian.
Regarding claim 7,
Besson further discloses further comprising a movement mechanism (at least fig. 1 (60) and corresponding disclosure in at least [0043]) that moves the ultrasound probe in the space formed by the imaging table ([0012] To effect scanning movement, the radiation detection means and ultrasound transducer may be operably interconnected to a common or separate corresponding drive means (e.g. one or more stepper motor(s)) for moving the radiation detection means and ultrasound transducer in a controlled manner relative to the predetermined imaging frame of reference),
Wherein the controller causes the movement mechanism to move the ultrasound probe in a state where the ultrasound probe is in contact with a back surface of the imaging table via the acoustic matching member ([0056] which discloses wherein the ultrasound transducer 52 may be disposed for driven movement in a raster-like or return carriage manner for multi-pass imaging (e.g. via bi-directional or unidirectional scanning) and [0058] which discloses In turn, ultrasound transducer 50 is disposed for sliding engagement with the coupling pad 59 during ultrasound scanning operations), and performs control of acquiring an ultrasound image of the breast placed on the loading surface of the imaging table ([0056] which discloses in that regard, each of radiation source 22, x-ray detector 40, ultrasound imager 50 and the drive motor 60 may be operatively interconnected (e.g. via electrical and/or optical lines) to the processor 16 at monitoring station 10, wherein control signals are provided by processor 16 and image signals are received at processor 16 from the imaging station 20).
Besson fails to explicitly teach the movement mechanism includes a movement rail to which the ultrasound probe is attached and a belt suspended between at least two rollers rotated by a motor.
Nonetheless, Tian in a similar field of endeavor involving ultrasound breast imaging, teaches a movement mechanism (at least fig. 5 (5) and corresponding disclosure in at least [0092]) including a movement rail (at least fig. 5 (16) and corresponding disclosure in at least [0092]) to which an ultrasound probe (at least fig. 5 (4) and corresponding disclosure in at least [0050]) is attached and a belt suspended between at least two rollers (see at least fig. 5 depicting two rollers between which the belt is suspended) rotated by a motor ([0093] which discloses the belt pulley is driven by the driving motor, and the belt is wound around the belt pulley; preferably, the driving motor is a stepping motor)
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Besson to include the movement mechanism as taught by Tian in order to provide a fully automatic ultrasonic scanner that has self-adaptive effect, can adjust the scan trace and the probe angle in real time according to different curves of the human body, and ensure that the ultrasonic probe scans against the skin surface and keeps perpendicular to the skin surface, which improves the quality of the scanned images, so as to enhance the detection rate and accuracy rate of early screening, and reduces the probability of missed diagnosis (Tian Abstract and [0020]).
Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Besson and Tian, as applied to claim 7 above, and further in view of O’brien et al. (US 20190175144 A1), hereinafter O’brien.
Regarding claim 8,
Besson, teaches the elements of claim 7 as previously stated. Besson fails to explicitly teach further comprising: a sliding plate that scrapes off the acoustic matching member while spreading the acoustic matching member on the back surface of the loading surface of the imaging table in a movement direction of the ultrasound probe, the sliding plate being attached to the ultrasound probe.
O’brien, in a similar field of endeavor involving ultrasound imaging, teaches a sliding plate that scrapes off an acoustic matching member while spreading the acoustic matching member on a surface in a movement direction of the ultrasound probe, the sliding plate being attached to the ultrasound probe ([0045] which discloses the applicator 116 is attached to and fixed to a housing of the probe 112 and [0043] which discloses the applicator is shaped to collect gel and to translate the gel from one area of the skin to another area of the skin. For example, the applicator may have one or more suitable surfaces and edges to collect and retain the gel in one area of the skin and move the gel to another area of the skin. In that regard the applicator 116 may have a cone shape, a skirt shape, a bell shape, a flat shape…. Examiner notes that such an applicator is considered a sliding plate that scrapes off an acoustic matching member while spreading the acoustic matching member on a surface).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Besson to include an applicator as taught by Obrien in order to assure that the acoustic matching member (such as the acoustic oil) is appropriately applied before the probe begins to collect physiological data, thus improving data accuracy (O’brien [0074]).
Regarding claim 9,
Besson, as modified, teaches the elements of claim 8 as previously stated. Besson, as currently modified, fails to explicitly teach in a case where the ultrasound probe is moved from a first point to a second point, and the ultrasound probe is in contact with the back surface of the loading surface of the imaging table via the acoustic matching member at the second point, the controller performs control of separating the ultrasound probe from the surface at the second point such that the ultrasound probe is not brough into contact with an acoustic matching member pool, the acoustic matching member being formed in front of the ultrasound probe in the movement direction by the acoustic matching member scraped off from the surface due to movement of the ultrasound probe from the first point to the second point, moving the ultrasound probe to a position passing over the acoustic matching member pool bringing the ultrasound probe into contact with the surface, and moving the ultrasound probe toward the first point again
Nonetheless, O’brien further teaches in a case where the ultrasound probe is moved from a first point to a second point, and the ultrasound probe is in contact with the back surface of the loading surface of the imaging table via the acoustic matching member at the second point, a controller performs control of:
separating the ultrasound probe from the surface at the second point such that the ultrasound probe is not brought into contact with an acoustic matching member pool, which is formed in front of the ultrasound probe in the movement direction by the acoustic matching member scraped off from the surface due to movement of the ultrasound probe, moving the ultrasound probe to a position passing over the acoustic matching member pool bringing the ultrasound probe into contact with the surface, and moving the ultrasound probe toward the first point again (see at least fig. 5A-5D where the probe is moved from a first point to a second point is separated above the second point, brought back into contact with the surface and moved back toward the first position, the controller performs control of separating the ultrasound probe from the surface at the second point (i.e. 420 such that the probe is not brought into contact with an acoustic matching member pool (i.e. 420) [0023] which discloses a processor of a controller provides gel on a first area of a subject by controlling the transducer to move to a second area of the subject and controlling the transducer to move the gel to the first area from the second area and [0079] which discloses in response to determining that the amount of gel on the area of the skin is insufficient, the robotics control controls the applicator to apply an additional amount of ge. For example, the robotics control circuit can control the applicator 116 to move gel from another (second area) (e.g. an area with superfluous gel) to the area that is lacking gel. Examiner notes that such a superfluous gel is considered an acoustic member matching pool, thus if the probe were moved along the surface and formed an acoustic member matching pool, the system would thus function accordingly)
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Besson to include performing control as taught by Obrien in order to assure that the acoustic matching member (such as the acoustic oil) is appropriately applied before the probe begins to collect physiological data, thus improving data accuracy (O’brien [0074]).
Examiner notes that operations of the controller would thus occur in any case including in a case where the ultrasound probe is moved from the first point to the second point and the ultrasound probe is in contact with the back surface of the loading surface of the imaging table via the acoustic matching member at the second point and would occur due to the acoustic matching member pool being formed in any stat including due to movement of the ultrasound probe from the first point to the second point.
Regarding claim 10,
Besson, as modified, teaches the elements of claim 9 as previously stated. Besson further teaches wherein in a case where imaging other than capturing of an ultrasound image is performed on the breast placed on the loading surface of the imaging table, the controller performs control to move the ultrasound probe outside an imaging range of the other imaging ([0071] which discloses in one embodiment, the method may further include the step of scanning the ultrasound imager 50 relative to the patient breast 100 (step 206) substantially synchronously with x-ray scanning (step 204) see fig. 4 in which the ultrasound probe is outside of the imaging range of the other imaging and is moved under the control of the controller as previously cited. See also [0072] which discloses for example, after x-ray imaging (step 204) the ultrasound imager 50 may be positioned for imaging operations (step 208). More particularly, the x-ray detector 40 may be replaced by the ultrasound imager 50. Alternatively, the ultrasound imager 50 may be displaced from a retracted position to an advanced position relative to the support layer 36 of housing 32, wherein acoustic coupling means 54 only engages the bottom side of the support layer 36 when located in the advanced position)
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Arai (US 20200305836 A1) teaches a loading surface (33) and a contact surface (35) provided on a back surface of the loading surface wherein the loading surface is recessed toward the loading surface with respect to peripheral sides of the back surface of the loading surface (33) (see at least fig. 6B) where a space provided below the loading surface is capable of having an ultrasound probe disposed therein and the contact surface is provided to be in contact with an acoustic matching member.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE L KLEIN whose telephone number is (571)270-5204. The examiner can normally be reached Mon-Fri 7:30-4.
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/BROOKE LYN KLEIN/Primary Examiner, Art Unit 3797