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 Objections
Claim 16 is objected to because of the following informalities:
Claim 16 appears to be written in an independent form, yet also refers back to the other independent claim 1. In an interpretation, claim 16 may be construed as an independent claim; and in another interpretation it may also be construed as a dependent claim. In order to prevent any foreseeable ambiguity, it is suggested to bring the entire claim 1 in to the claim 16 to have the claim construed as a proper independent claim; or, correct the dependency of the claim 16 (as shown in other depending claims e.g., claim 15, claim 2, etc.) to have the claim construed as a proper dependent claim. Appropriate correction is required.
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 1-16 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.
Regarding claim 1, lines 3-5 of claim 1 recite “a mammography apparatus including an imaging table on which a breast of a subject is placed and which has an imaging surface on which radiation transmitted through the breast is incident”. It is unclear if the imaging table has an imaging surface or if the mammography apparatus as a whole has an imaging surface. Paragraph [0046] of the specification discloses “The imaging table 24 comprises an imaging surface 24A on which the radiation transmitted through the breast M is incident”. Therefore for examination purposes the claim will be interpreted as “a mammography apparatus including an imaging table on which a breast of a subject is placed, wherein the imaging table has an imaging surface on which radiation transmitted through the breast is incident”. Claims 2-16 are also rejected due to their dependency.
Regarding claim 1, lines 2-6 of claim 1 recite “a flat plate-like protective member that is provided to be attachable to and detachable from a mammography apparatus including an imaging table on which a breast of a subject is placed and which has an imaging surface on which radiation transmitted through the breast is incident, and that protects the imaging surface from a puncture needle for sampling tissue from the breast”. It is unclear if it is the flat plate-like protective member that is protecting the imaging surface from a puncture needle. Paragraph [0055] of the specification discloses “a protective cover 37 is placed on the imaging table 24. The protective cover 37 protects the imaging surface 24A from the puncture needle 43”. Therefore for examination purposes the claim will be interpreted as “a flat plate-like protective member that is provided to be attachable to and detachable from a mammography apparatus including an imaging table on which a breast of a subject is placed and which has an imaging surface on which radiation transmitted through the breast is incident, and wherein the flat plate-like protective member is configured to protect the imaging surface from a puncture needle for sampling tissue from the breast”. Claims 2-16 are also rejected due to their dependency.
Regarding claim 16, in the interpretation of claim 16 being construed as an independent claim, there is insufficient antecedent basis for the puncture needle in claim 16.
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.
Claims 1-4, 7, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Muller (FR2927246A1 – machine translation) and further in view of Tada (US 20120163554).
Regarding claim 1, Muller discloses a protective cover (pg. 5 last para. – “a protective
Cover”) comprising:
a flat plate-like protective member that is provided to be attachable to and detachable from a mammography apparatus (pg. 5 last para. – “The image receiver 2 is equipped with a protective cover whose upper surface forms the breast support plate 3”, Fig. 1, pg. 5-6 bridging para. – “said breast support 3 being advantageously removable and extending just above the image receiver 2”) including an imaging table on which a breast of a subject is placed and which has an imaging surface on which radiation transmitted through the breast is incident (Fig. 1, the image receiver 2 is interpreted as the imaging table and the top surface of the imaging table is interpreted as the imaging surface), and that protects the imaging surface from a puncture needle for sampling tissue from the breast (pg. 5 last para. – “The image receiver 2 is equipped with a protective cover whose upper surface forms the breast support plate 3”, Fig. 1, pg. 8 last paragraph – “a needle 21 of a trocar 22 can be introduced”, one with ordinary skill in the art would recognize the protective cover of the breast support plate would provide protection to the imaging surface from the needle); and
a scattered ray removal grid that removes scattered rays generated by the radiation transmitting through the breast (pg. 2 second para. – “These removable cassettes fit into a cassette holder which includes the breast support shelf, an anti-diffusion grid of the type of "Bucky" grid”),
Conversely Muller does not explicitly teach wherein the scattered ray removal grid is a grid in which a plurality of transmission parts that transmit the radiation and a plurality of absorption parts that absorb the radiation are alternately arranged and a boundary line between the transmission part and the absorption part extends in one direction, and
further, in a case in which, on the imaging surface, a direction connecting a chest wall side on which a chest wall of the subject is located and a side opposite to the chest wall is defined as a first direction and a direction orthogonal to the first direction is defined as a second direction, the scattered ray removal grid is disposed at a facing position that faces the imaging surface in a posture in which a direction in which the boundary line extends is parallel to the second direction.
However Tada discloses wherein the scattered ray removal grid is a grid in which a plurality of transmission parts that transmit the radiation and a plurality of absorption parts that absorb the radiation are alternately arranged and a boundary line between the transmission part and the absorption part extends in one direction ([0094] – “The anti-scatter grating 34…has a plurality of X-ray shield units 34 b that absorbs and thus removes the scattered X-ray (hereinafter, referred to as scattered ray)…X-ray penetration units 34 a that allows the X-ray to penetrate therethrough are provided to fill between the X-ray shield units 34 b, 34 b adjacent to each other”), and
further, in a case in which, on the imaging surface, a direction connecting a chest wall side on which a chest wall of the subject is located and a side opposite to the chest wall is defined as a first direction and a direction orthogonal to the first direction is defined as a second direction, the scattered ray removal grid is disposed at a facing position that faces the imaging surface in a posture in which a direction in which the boundary line extends is parallel to the second direction (Fig. 4, [0094] – “The X-ray shield units 34 b extend in the y direction”, Figs. 10 and 11 show that the y direction extends in direction that is parallel to the second direction).
Tada is an analogous art considering it is in the field of a mammography apparatus.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the protective cover of Muller to incorporate the posture of the scattered ray removal grid of Tada to achieve the same results. One would have motivation to combine because “it is possible to easily manufacture an anti-scatter grating having a desired X-ray absorption ability” (Tada [0095]).
Regarding claim 2, Muller and Tada disclose all the elements of the claimed invention as cited in claim 1.
Muller further discloses wherein the scattered ray removal grid is disposed between the protective member and the imaging surface (pg. 5 last para. – “The image receiver 2 is equipped with a protective cover whose upper surface forms the breast support plate 3”, pg. 2 second para. – “These removable cassettes fit into a cassette holder which includes the breast support shelf, an anti-diffusion grid of the type of "Bucky" grid and a drawer suitable for receiving the cassettes”, therefore the grid is disposed between the breast support shelf and the top surface of the image receiver).
Regarding claim 3, Muller and Tada disclose all the elements of the claimed invention as cited in claim 1.
Muller further discloses wherein the scattered ray removal grid is provided on the protective member (pg. 5 last para. – “The image receiver 2 is equipped with a protective cover whose upper surface forms the breast support plate 3”, pg. 2 second para. – “These removable cassettes fit into a cassette holder which includes the breast support shelf, an anti-diffusion grid of the type of "Bucky" grid and a drawer suitable for receiving the cassettes”, therefore the grid is supported by the breast support plate).
Conversely Muller does not teach wherein the scattered ray removal grid is provided […] member in an aspect that allows a displacement between the facing position that faces the imaging surface and a retreat position that retreats from the facing position.
However Tada discloses wherein the scattered ray removal grid is provided […] member in an aspect that allows a displacement between the facing position that faces the imaging surface and a retreat position that retreats from the facing position ([0162] – “the anti-scatter grating 34 is retreated from the X-ray irradiation field by the driving mechanism. Alternatively, by detaching the anti-scatter grating 34 from the housing of the imaging unit 12 to the outside, the anti-scatter grating 34 may be retreated from the X-ray irradiation field”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the protective cover of Muller to incorporate the displacement of the scattered ray removal grid of Tada to achieve the same results. One would have motivation to combine because it provides a way to image the tissue when scattered rays have less influences.
Regarding claim 4, Muller and Tada disclose all the elements of the claimed invention as cited in claims 1 and 3.
Muller further discloses the scattered ray removal grid being provided on the protective member (pg. 5 last para. – “The image receiver 2 is equipped with a protective cover whose upper surface forms the breast support plate 3”, pg. 2 second para. – “These removable cassettes fit into a cassette holder which includes the breast support shelf, an anti-diffusion grid of the type of "Bucky" grid and a drawer suitable for receiving the cassettes”, therefore the grid is supported by the breast support plate).
Conversely Muller does not teach wherein the […] member includes a positioning part that regulates the displacement of the scattered ray removal grid at the facing position.
However Tada discloses wherein the […] member includes a positioning part that regulates the displacement of the scattered ray removal grid at the facing position ([0162] – “the anti-scatter grating 34 is retreated from the X-ray irradiation field by the driving mechanism. Alternatively, by detaching the anti-scatter grating 34 from the housing of the imaging unit 12 to the outside, the anti-scatter grating 34 may be retreated from the X-ray irradiation field”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the protective cover of Muller to incorporate the displacement of the scattered ray removal grid of Tada to achieve the same results. One would have motivation to combine because it provides a way to image the tissue when scattered rays have less influences.
Regarding claim 7, Muller and Tada disclose all the elements of the claimed invention as cited in claim 1.
Conversely Muller does not teach wherein the scattered ray removal grid is attachable to and detachable from the protective member.
However Tada discloses wherein the scattered ray removal grid is attachable to and detachable from the protective member ([0162] – “the anti-scatter grating 34 is retreated from the X-ray irradiation field by the driving mechanism. Alternatively, by detaching the anti-scatter grating 34 from the housing of the imaging unit 12 to the outside, the anti-scatter grating 34 may be retreated from the X-ray irradiation field”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the protective cover of Muller to incorporate the displacement of the scattered ray removal grid of Tada to achieve the same results. One would have motivation to combine because it provides a way to image the tissue when scattered rays have less influences.
Regarding claim 15, Muller and Tada disclose all the elements of the claimed invention as cited in claim 1.
Muller further discloses wherein the scattered ray removal grid is integrated with the protective member (pg. 2 second para. – “These removable cassettes fit into a cassette holder which includes the breast support shelf, an anti-diffusion grid of the type of "Bucky" grid”).
Claims 8, 9, 10, 13, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Muller (FR2927246A1 – machine translation) and Tada (US 20120163554) as applied to claim 7 above, and further in view of Meer (DE102006002905A1 – machine translation).
Regarding claim 8, Muller and Tada disclose all the elements of the claimed invention as cited in claims 1 and 7.
As cited above Muller discloses a protective member that protects the scattered ray removal grid.
Conversely Muller does not teach wherein the […] member is provided with a guide part that guides the scattered ray removal grid to the facing position by engagement with the scattered ray removal grid.
However Meer discloses wherein the […] member is provided with a guide part that guides the scattered ray removal grid to the facing position by engagement with the scattered ray removal grid (Fig. 1, [0026] – “The displacement mechanism comprises a rail-like guide with two guide rails 15 arranged laterally within the displacement shaft 12 with respect to the displacement direction 14; this rail-like guide enables particularly smooth and precise positioning of the scattering beam grid 4”).
Meer is an analogous art considering it is in the field of a mammography apparatus.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the protective cover of Muller to incorporate the guide part to guide the scattered ray removal grid of Meer to achieve the same results. One would have motivation to combine because “enables flexible use both with and without a scattering grid in a simple manner” (Meer [0005]) and it “can easily perform an X-ray diagnostic examination either with or without a scatter radiation grid” (Meer [0007]).
Regarding claim 9, Muller, Tada, and Meer disclose all the elements of the claimed invention as cited in claims 1, 7, and 8.
Conversely Muller does not teach wherein the guide part is able to accept the scattered ray removal grid from a side opposite to the chest wall side on which the chest wall of the subject is located.
However Meer discloses wherein the guide part is able to accept the scattered ray removal grid from a side opposite to the chest wall side on which the chest wall of the subject is located (Fig. 1, [0026] – “The displacement mechanism comprises a rail-like guide with two guide rails 15 arranged laterally within the displacement shaft 12 with respect to the displacement direction 14; this rail-like guide enables particularly smooth and precise positioning of the scattering beam grid 4”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the protective cover of Muller to incorporate the guide part to guide the scattered ray removal grid of Meer to achieve the same results. One would have motivation to combine because “enables flexible use both with and without a scattering grid in a simple manner” (Meer [0005]) and it “can easily perform an X-ray diagnostic examination either with or without a scatter radiation grid” (Meer [0007]).
Regarding claim 10, Muller, Tada, and Meer disclose all the elements of the claimed invention as cited in claims 1, 7, 8, and 9.
As cited above Muller discloses a protective member that protects the scattered ray removal grid.
Conversely Muller does not teach in a case in which a direction of the scattered ray removal grid along the first direction is defined as a depth direction of the protective member and a direction of the scattered ray removal grid along the second direction is defined as a width direction of the protective member, the guide part is a pair of guide rails that are provided on both ends in the width direction and extend in the depth direction.
However Meer discloses in a case in which a direction of the scattered ray removal grid along the first direction is defined as a depth direction of the protective member and a direction of the scattered ray removal grid along the second direction is defined as a width direction of the protective member, the guide part is a pair of guide rails that are provided on both ends in the width direction and extend in the depth direction (Fig. 1, [0026] – “The displacement mechanism comprises a rail-like guide with two guide rails 15 arranged laterally within the displacement shaft 12 with respect to the displacement direction 14; this rail-like guide enables particularly smooth and precise positioning of the scattering beam grid 4”, claim 1 defines the first direction as a direction connecting a chest wall side and a side opposite to the chest wall and as seen in Figs. 1 and 2 the guide rails would be extending in the first/depth direction and as shown in Fig. 3 the guide rails are provided on both ends which would be in the second/width direction).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the protective cover of Muller to incorporate the guide part to guide the scattered ray removal grid of Meer to achieve the same results. One would have motivation to combine because “enables flexible use both with and without a scattering grid in a simple manner” (Meer [0005]) and it “can easily perform an X-ray diagnostic examination either with or without a scatter radiation grid” (Meer [0007]).
Regarding claim 13, Muller and Tada disclose all the elements of the claimed invention as cited in claims 1 and 7.
Muller further discloses the scattered ray removal grid attached to the protective member (pg. 2 second para. – “cassette holder which includes the breast support shelf, an anti-diffusion grid of the type of "Bucky" grid and a drawer suitable for receiving the cassettes”).
Conversely Muller does not teach wherein a positioning part that regulates the scattered ray removal grid […] at the facing position that faces the imaging surface is provided.
However Meer discloses wherein a positioning part that regulates the scattered ray removal grid […] at the facing position that faces the imaging surface is provided (Fig. 1, [0030] – “externally driven positioning using an electric motor enables particularly user-friendly positioning of the scattering beam grid 4”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the protective cover of Muller to incorporate the positioning part of the scattered ray removal grid of Meer to achieve the same results. One would have motivation to combine because “enables particularly user-friendly positioning of the scattering beam grid 4” (Meer [0030]).
Regarding claim 14, Muller and Tada disclose all the elements of the claimed invention as cited in claims 1 and 7.
Conversely Muller does not teach wherein the scattered ray removal grid is provided with a grip part.
However Meer discloses wherein the scattered ray removal grid is provided with a grip part (Fig. 3, [0023] – “This manual change of position is particularly easy with the help of a positioning handle 13, which in this embodiment protrudes laterally from the holding arm 2 in relation to the positioning direction 14”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the protective cover of Muller to incorporate the grip of the scattered ray removal grid of Meer to achieve the same results. One would have motivation to combine because “this manual change of position is particularly easy with the help of a positioning handle” (Meer [0023]).
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Muller (FR2927246A1), Tada (US 20120163554), and Meer (DE102006002905A1) as applied to claim 8 above, and further in view of Kojima (US 20090310749).
Regarding claim 11, Muller, Tada, and Meer disclose all the elements of the claimed invention as cited in claims 1, 7, and 8.
As cited above Muller discloses a protective member that protects the scattered ray removal grid.
Conversely Muller does not teach wherein, in a case in which a direction of the scattered ray removal grid along the first direction is defined as a depth direction of the protective member and a direction of the scattered ray removal grid along the second direction is defined as a width direction of the protective member, the guide part is able to accept the scattered ray removal grid from an end portion of the protective member in the width direction.
However Kojima discloses wherein, in a case in which a direction of the scattered ray removal grid along the first direction is defined as a depth direction of the protective member and a direction of the scattered ray removal grid along the second direction is defined as a width direction of the protective member, the guide part is able to accept the scattered ray removal grid from an end portion of the protective member in the width direction (Fig. 11 shows the grid being guided in a D direction using a guide rail 136, claim 1 defines the second direction as a direction orthogonal to the direction connecting a chest wall side and a side opposite to the chest wall and as seen in Fig. 3 the D direction would be the second/width direction).
Kojima is an analogous art considering it is in the field of a mammography apparatus.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the protective cover of Muller to incorporate the guide part to guide the scattered ray removal grid of Kojima to achieve the same results. One would have motivation to combine because it allows one to easily and correctly position the grid.
Regarding claim 12, Muller, Tada, and Meer disclose all the elements of the claimed invention as cited in claims 1, 7, 8, and 11.
Conversely Muller does not teach wherein the guide part is provided only on a side opposite to the chest wall side in the depth direction.
However Kojima discloses wherein the guide part is provided only on a side opposite to the chest wall side in the depth direction (Fig. 11 shows the grid being guided in a D direction using a guide rail 136, Fig. 11 also shows only one guide rail, the description does not disclose which side the guide rail is on however one with ordinary skill in the art would recognize that the guide rail and the feed screw could be on opposite sides and the guidance/positioning would perform the same).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the protective cover of Muller to incorporate the guide part to guide the scattered ray removal grid of Kojima to achieve the same results. One would have motivation to combine because it allows one to easily and correctly position the grid.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Toba (US 20160183887) and further in view of Muller (FR2927246A1) and Tada (US 20120163554).
Regarding claim 16, Toba discloses a biopsy unit that movably holds the puncture needle (Fig. 1, Abstract – “The biopsy needle is driven based on a biopsy coordinate system calibrated with respect to the stereotactic coordinate system”), the biopsy unit comprising:
Conversely Tuba does not teach the protective cover according to claim 1.
However as cited above Muller and Tada disclose the protective cover according to claim 1.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the biopsy unit of Toba to incorporate the protective cover of Muller to achieve the same results. One would have motivation to combine because it will protect the image receive from accidental puncture from the biopsy needle.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the biopsy unit of Toba to incorporate the posture of the scattered ray removal grid of Tada to achieve the same results. One would have motivation to combine because “it is possible to easily manufacture an anti-scatter grating having a desired X-ray absorption ability” (Tada [0095]).
Allowable Subject Matter
Claims 5 and 6 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RENEE C LANGHALS whose telephone number is (571)272-6258. The examiner can normally be reached Mon.-Thurs. alternate Fridays 8:30-6.
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/R.C.L./ Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/ Supervisory Patent Examiner, Art Unit 3797