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 .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a biopsy apparatus” and “imaging apparatus” in claims 1 and 20.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
“biopsy apparatus” will be interpreted as a biopsy needle per para [0051]: “as a biopsy apparatus of the present disclosure illustrated in Fig. 2 includes a biopsy needle 21 that punctures the breast” of applicant’s specification.
“imaging apparatus” will be interpreted as any device capable of capturing an image per para [0035] of applicant’s specification.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-3, 7, 8, 15-18, and 20 is/are rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 1-2, 5-6, 8, 9, 12 and 13 of prior U.S. Patent No. 12672834 (cited as US 20250072850). This is a statutory double patenting rejection.
Regarding claim 1, Patent 12672834 discloses a medical image acquisition apparatus comprising : a biopsy apparatus; an imaging table that is used to capture an image of a living body disposed on an imaging surface with an imaging apparatus; a projector that projects the image; and at least one processor, wherein the processor performs control of projecting information regarding a biopsy that is performed on the living body using the biopsy apparatus, from the projector toward the imaging surface of the imaging table (claim 1: “A medical image acquisition apparatus comprising: a biopsy apparatus; an imaging table that is used to capture an image of a living body disposed on an imaging surface with an imaging apparatus; a projector that projects the image; and at least one processor, wherein the processor performs control of projecting relevant information associated with each execution stage of a biopsy that is performed on the living body using the biopsy apparatus, from the projector toward the imaging surface of the imaging table for each execution stage.”, wherein every execution stage constitutes projecting information regarding a biopsy).
Patent 12672834 further discloses the limitation of claim 2 (claim 2), claim 3 (claim 2), claim 7 (claim 8), claim 15 (claim 5), claim 16 (claim 6) claim 17 (claim 9), claim 18 (claim 12), and claim 20 (claim 13).
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)(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.
Claim(s) 1-3, 7-8, 18, and 20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Tsujioka (JP 6385079 B2).
Regarding claim 1, Tsujioka discloses a medical image acquisition apparatus (abstract) comprising: a biopsy apparatus ([0031]: "puncture needle is punctured in the biopsy", see 112f interpretation above); an imaging table that is used to capture an image of a living body disposed on an imaging surface with an imaging apparatus ([0012]: " an imaging device 300 that captures fluoroscopic imaging data by imaging a patient,", Fig 1 element 304) ; a projector that projects the image (Fig 1 element 600, [0012]: "a projection device 600 that can project an image to a patient,"); and at least one processor ([0007]: “a processing module”), wherein the processor performs control of projecting information regarding a biopsy that is performed on the living body using the biopsy apparatus ([0007]: “and a projection apparatus projecting the tomographic image generated by the image processing module, wherein the projection apparatus acquires a tomographic image of the patient in real time on a surface of the patient's body”, [0033]: “such a tomographic image under CT undergoing biopsy is projected”), from the projector toward the imaging surface of the imaging table (Fig 4).
Regarding claim 2, Tsujioka discloses wherein the processor performs control of projecting a disposing position of the living body in a case where the living body is disposed on the imaging surface of the imaging table (Fig 4), a position of a biopsy needle that has punctured the living body and is attached to the biopsy apparatus, and a collection position where a biological tissue is to be collected using the biopsy needle, from the projector toward the imaging surface of the imaging table.
Regarding claim 3, Tsujioka discloses wherein the processor performs control of, in a case where the living body is punctured with the biopsy needle along the imaging surface of the imaging table, projecting the disposing position of the living body, the position of the biopsy needle, and the collection position ([0045-0046]: "the doctor punctures the puncture needle at a predetermined position (puncture position P1) on the patient's body surface and inserts it into the puncture needle toward the object Trg. Positioning of the puncturing position P1 at this time may be performed, for example, by the doctor presuming the position of the object Trg, or by guiding some sort of predetermined guide device (for example, positioning the patient's body surface in a lattice shape… During puncturing, fluoroscopic imaging is performed by the imaging device 300 (step S1). Based on this data, a tomographic image of the patient (the current needle position is shown) is generated by the projection image processing unit 501, projection And output to the apparatus 600. As a result, a tomographic image indicating the current needle tip position is displayed in the vicinity of the puncture position P 1 from the projection apparatus 600 in real time (see FIG. 3, steps S 2 and S 3)."), from the projector toward the imaging surface of the imaging table (Fig 4).
Regarding claim 7, Tsujioka discloses wherein the processor performs control of projecting the position of the biopsy needle in accordance with a motion of the biopsy needle, from the projector toward the imaging surface of the imaging table ([0046]: "And output to the apparatus 600. As a result, a tomographic image indicating the current needle tip position is displayed in the vicinity of the puncture position P 1 from the projection apparatus 600 in real time (see FIG. 3, steps S 2 and S 3).").
Regarding claim 8, Tsujioka discloses wherein the processor performs control of projecting information regarding a distance from a distal end of the biopsy needle to an epidermis of the living body and a depth of the collection position along a direction intersecting the imaging surface of the imaging table ([0025]: “a function of generating an indicator (marker) image representing a position corresponding to the puncture position P1, or a function of generating an image including the same.”, [0031]: “, the projection area P 2 may be a position on the patient's body surface in the vicinity of the puncture position P 1 where the puncture needle is punctured in the biopsy.”, [0047]: “While looking at the tomographic image Im projected in this way, the doctor inserts a puncture needle further while checking how far the needle is inserted, that is, the current needle tip to the target Trg,”), from the projector toward the imaging surface of the imaging table (Fig 4).
Regarding claim 18, Tsujioka discloses wherein the imaging apparatus is a radiography apparatus that captures a radiation image of the living body by irradiating the living body with radiation ([0016]: “An gantry 301 includes an X-ray irradiation unit 331 that includes an X-ray tube, a collimator, and the like and irradiates the patient with X-rays, a detection unit 332 that detects X-rays transmitted through the patient, and the like. Yes. The X-ray irradiation unit 331 and the detection unit 332 perform scanning while rotating around the patient's body axis while maintaining the positional relationship therebetween, and fluoroscopic imaging data (projection data) is collected by the data collection unit 321. .”), and the living body is a breast ([0044]:“In the example of FIG. 1, the vicinity of the patient's chest (P1 in the figure is the puncture position) is located in the imaging region in the gantry”).
Regarding claim 20, Tsujioka discloses a non-transitory computer readable medium storing a control program executed in a medical image acquisition apparatus including a biopsy apparatus (abstract, [0031]: "puncture needle is punctured in the biopsy", see 112f interpretation above), an imaging table that is used to capture an image of a living body disposed on an imaging surface with an imaging apparatus ([0012]: " an imaging device 300 that captures fluoroscopic imaging data by imaging a patient,", Fig 1 element 304), a projector that projects the image (Fig 1 element 600, [0012]: "a projection device 600 that can project an image to a patient,"), and at least one processor ([0007]: “a processing module”), wherein the processor performs control of projecting information regarding a biopsy that is performed on the living body using the biopsy apparatus ([0007]: “and a projection apparatus projecting the tomographic image generated by the image processing module, wherein the projection apparatus acquires a tomographic image of the patient in real time on a surface of the patient's body”), from the projector toward the imaging surface of the imaging table (Fig 4).
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(s) 4-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tsujioka in view of Tajima (US 20120302873 A1).
Regarding claim 4, Tsujioka discloses the apparatus of claim 3, but fails to disclose wherein the processor performs control of projecting a puncturable range of the biopsy needle of the biopsy apparatus, from the projector toward the imaging surface of the imaging table.
Tajima discloses an imaging apparatus (abstract) wherein a processor performs control of projecting a puncturable range of the biopsy needle of the biopsy apparatus ([0014]: “a second specification section that displays on the display section at least one of the plural tomographic images including a region from the object of interest to a side from which a biopsy needle is to be inserted based on the position of the object of interest and a direction of insertion of the biopsy needle, and allows the user to specify, based on the display, a desired pass-through region of the biopsy needle, a non-pass-through region through which it is undesirable for the biopsy needle to pass, or a combination thereof” wherein the specified “pass-through” region is a puncturable range, [0020]: “the second specification section displays on the display section the tomographic image and a region representing the predetermined movement range.”, Fig 7).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the projected image from the projector toward the imaging surface of the imaging table disclosed by Tsujioka to include a display of a puncturable range as disclosed by Tajima in order to allow for the specification of a desirable path for a biopsy needle (Tajima [0006]).
Regarding claim 5, Tajima wherein the processor performs control of projecting the puncturable range of the biopsy needle according to a direction in which the living body is punctured with the biopsy needle ([0014]: “including a region from the object of interest to a side from which a biopsy needle is to be inserted based on the position of the object of interest and a direction of insertion of the biopsy needle”), from the projector toward the imaging surface of the imaging table (As modified above).
Regarding claim 6, Tajima discloses wherein the processor performs control of, in a case where the collection position is not included in the puncturable range of the biopsy needle, outputting a warning such that the living body is punctured with the biopsy needle from a different direction ([0014]: “and a warning section for issuing a warning if the detected path is outside a predetermined movement range of the biopsy needle.”).
Claim(s) 9-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tsujioka in view of Mahmoodabadi (US 20140100550 A1).
Regarding claim 9, Tsujioka discloses the apparatus according to claim 8 but fails to disclose wherein the processor performs control of projecting a position of a blood vessel in the living body using the image of the living body captured by the imaging apparatus, from the projector toward the imaging surface of the imaging table.
Mahmoodabadi discloses a processor performs control of projecting a position of a blood vessel in the living body using the image of the living body captured by the imaging apparatus ([0076]: “at step 360, the IR imager/projector 200-5 generates and projects a map (location and depth) of veins in close proximity to the vein access point, irrespective of the type and color of the skin”), from the projector toward the imaging surface of the imaging table (Fig 2).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the projection disclosed by Tsujioka to include the projection of a position of a blood vessel disclosed by Mahmoodabadi in order to improve the comfort of the patient by avoiding extraneous blood vessels (Mahmoodabadi [0005]).
Regarding claim 10, Mahmoodabadi further discloses wherein the processor performs control of projecting a position of a blood vessel having a predetermined thickness or more ([0057]: “The incident light intensity can be reduced to a level that substantially all photons are lost within a finite specific skin thickness. This skin thickness behaves like an infinite thickness under normal incident light application. In order to find this specific thickness, a vein contrast concept is used.”), from the projector toward the imaging surface of the imaging table (Fig 2).
Regarding claim 11, Mahmoodabadi further discloses wherein the processor performs control of changing a display form of the position of the blood vessel projected from the projector toward the imaging surface of the imaging table ([0061]: “lluminates the patient's soft tissue 215 with light in the range of 850 +/−40 nm, which is mainly absorbed by blood (haemoglobin) in the vein 220. The unabsorbed light 230 is reflected back and is detected by the IR imager/projector 200-5. The reflected image is processed by the image processing subunit 200-3, and then re-projected on the patient's skin in real-time to show the location of vein 220 beneath the patient's skin.”) depending on the thickness of the blood vessel ([0061]: “The IR imager/projector 200-5 preferably includes a cut-off filter and a polarizer to differentiate reflected imaging light from background IR light in the environment.”).
Regarding claim 12, Mahmoodabadi further discloses wherein the processor performs control of changing a display form of the position of the blood vessel projected from the projector toward the imaging surface of the imaging table, depending on the depth of the blood vessel along the direction intersecting the imaging surface of the imaging table ([0055]: “At the tissue-vein boundary, almost all of the incident beam intensity is absorbed through elastic/inelastic scattering from blood within the vein, resulting in negligible reflectance. For a finite tissue thickness, there is no reflection at the exterior end medium (i.e. air). Using this condition, an equation can be arrived at for depth of the vein that is also irrespective of the tissue scattering parameter”, Fig 11a/11b).
Regarding claim 13, Mahmoodabadi further discloses wherein the processor performs control of projecting a position of a blood vessel passing between the collection position and the epidermis of the living body punctured with the biopsy needle, from the projector toward the imaging surface of the imaging table (Figs 11a and 11b).
Claim(s) 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tsujioka in view of Konno et al. (US 20220101524 A1).
Regarding claim 14, Tsujioka discloses the apparatus according to claim 3, but fails to disclose wherein the processor performs control of projecting the disposing position of the living body from the projector toward the imaging surface of the imaging table such that the collection position is within a range of an opening portion of a compression plate, the compression plate being a plate that compresses the living body against the imaging surface of the imaging table and having the opening portion on a surface facing the imaging surface of the imaging table.
Konno discloses wherein the processor performs control of projecting the disposing position of the living body from the projector toward the imaging surface of the imaging table such that the collection position is within a range of an opening portion of a compression plate ([0019]: “there is provided a control method comprising controlling an image projection unit that projects a projection image onto a projection surface of a compression member in a mammography apparatus which irradiates a breast compressed by the compression member”, Fig 11 and Fig 12), the compression plate being a plate that compresses the living body against the imaging surface of the imaging table and having the opening portion on a surface facing the imaging surface of the imaging table ([0063]: “, a compression plate 40 that compresses a portion of the breast may be used.”).
Regarding claim 15, Konno further discloses wherein in a case where there are a plurality of collection positions and not all the collection positions are within the range of the opening portion of the compression plate, the processor performs control of projecting a disposing position of the living body, which is adjusted such that the collection position having a higher priority for collection of a biological tissue than other collection positions is within the range of the opening portion, from the projector toward the imaging surface of the imaging table ([0141]: “the shutter may be opened or closed to control the projection of the projection image P onto the projection surface 45. Specifically, in a case in which the projection of the projection image P is started, control is performed such that the shutter is opened to transmit the projection light. On the other hand, in a case in which the projection of the projection image P is ended, control is performed such that the shutter is closed to block the projection light. In addition, in a case in which the shutter that blocks the projection light is provided in this way, an opening portion of the shutter may be provided to be the same as the opening portion”, [0056], wherein the projection may be moved).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tsujioka in view of Park (US 20070078346 A1).
Tsujioka discloses the apparatus according to claim 2, but fails to disclose wherein the processor performs control of further projecting information regarding a position where an anesthetic needle is inserted and a depth to which the anesthetic needle is inserted along a direction intersecting the imaging surface of the imaging table, from the projector toward the imaging surface of the imaging table, before the living body is punctured with the biopsy needle.
Park discloses projecting information regarding a position where an anesthetic needle ([0065]: “when applying a local anesthesia”) is inserted and a depth to which the anesthetic needle is inserted along a direction intersecting the imaging surface of the imaging table ([0020]: “and needle path data generated by the needle guidance portion, wherein the needle path data locates the intersection of the needle path and the scanning plane.”, [0067]: “. On the ultrasound screen, indirect or secondary signs of needle location may include soft tissue deformation indicating that the needle is passing through that tissue, and a hypoechoic acoustic shadow and ring down artifact when the sound beam hits the needle”), from the projector toward the imaging surface of the imaging table (Fig 1A), before the living body is punctured with the biopsy needle ([0065]).
As Tsujioka discloses a method for tracking a needle, it would have been obvious to a person of ordinary skill in the art prior to the effective filing date to substitute the known method of projecting the location of a biopsy needle with the known method of displaying the location of an anesthetic needle disclosed by Park for the predictable result of monitoring a medical procedure.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tsujioka in view of Green (US 20130197357 A1).
Regarding claim 17, Tsujioka discloses the apparatus according to claim 2, but fails to disclose wherein the processor performs control of projecting an elapsed time after the biopsy needle puncturing the living body is pulled out from the living body, from the projector toward the imaging surface of the imaging table.
Green discloses wherein a processor performs control of projecting an elapsed time after the biopsy needle puncturing the living body is pulled out from the living body ([0197]: “. determining the first needle is removed from the predetermined area after the first medical procedure; causing the display device to display an altered image of the first virtual needle based at least on the emplacement information received during the first medical procedure and on an amount of time that has passed since the first medical procedure;”), from the projector toward the imaging surface of the imaging table (Fig 1B).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the apparatus disclosed by Tsujioka to include the display of an elapsed time as disclosed by Green in order to provide information to the user about the procedure.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tsujioka in view of Braido et al. (US 20230157762 A1).
Regarding claim 19, Tsujioka fails to disclose wherein the processor performs control of projecting a position of a blood vessel and a position of a mammary gland in the living body using the radiation image of the living body captured by the radiography apparatus, from the projector toward the imaging surface of the imaging table.
Braido discloses wherein the processor performs control of projecting a position of a blood vessel ([0025]: “generated one or more recommendations comprising three-dimensional (“3D”) or four-dimensional (“4D”) mapped guides toward, in, and around the one or more soft tissue luminal portions of the patient, wherein the one or more soft tissue luminal portions comprise at least one of … a blood vessel,”) and a position of a mammary gland in the living body ([0050]: “and merging several image modalities to visualize smooth muscle, cartilage, gland, etc.;”) using the radiation image of the living body captured by the radiography apparatus ([0152]: “an X-ray system”), from the projector toward the imaging surface of the imaging table (Fig 6).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the apparatus disclosed by Tsujioka with the projection of a position of a blood vessel and a position of a mammary gland in the living body in order increase the accuracy of the procedure with an improved projection (Braido [0048]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAVYA SHOBANA BALAJI whose telephone number is (703)756-5368. The examiner can normally be reached Monday - Friday 8:30 - 5:30 ET.
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/KAVYA SHOBANA BALAJI/Examiner, Art Unit 3791
/DEVIN B HENSON/Primary Examiner, Art Unit 3791
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