Prosecution Insights
Last updated: October 02, 2026
Application No. 18/474,172

PROTECTIVE COVER AND BIOPSY UNIT

Final Rejection §103
Filed
Sep 25, 2023
Priority
Sep 27, 2022 — JP 2022-154076
Examiner
LANGHALS, RENEE C
Art Unit
3797
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Fujifilm Holdings Corporation
OA Round
2 (Final)
58%
Grant Probability
Moderate
3-4
OA Rounds
6m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 58% of resolved cases
58%
Career Allowance Rate
91 granted / 156 resolved
-11.7% vs TC avg
Strong +43% interview lift
Without
With
+43.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 7m
Avg Prosecution
33 currently pending
Career history
189
Total Applications
across all art units

Statute-Specific Performance

§101
3.0%
-37.0% vs TC avg
§103
58.6%
+18.6% vs TC avg
§102
9.2%
-30.8% vs TC avg
§112
25.4%
-14.6% vs TC avg
Black line = Tech Center average estimate • Based on career data from 156 resolved cases

Office Action

§103
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 below filed 6/18/2026 have been fully considered but they are not persuasive | moot in view of the new grounds of rejection. The Applicant asserts on page 7 of the Remarks: “Amended claims 1 and 16 recite, in part, "the scattered ray removal grid being disposed outside the imaging table." At least para. 0050 of the specification supports this feature. Applicant contends that neither Muller nor Tada discloses or suggests the above-noted feature. For example, Muller describes that the grid is included in the holder 3 (page 2 of the English translation). Applicant contends that Fig. 1 of Muller also clearly shows that no grid is provided outside the holder 3, which serves as an imaging table. Tada describes that a grid 34 is disposed between grids 31, 32, which are all stored inside the imaging unit 12 (please also see Fig. 1 of Tada).” In response the examiner respectfully asserts that the holder 3 has been interpreted as the flat plate-like protective member and as cited below it is removable from the image receiver 2. As recited below the image receiver 2 has been interpreted as the imaging table. Therefore because the holder 3 is removable and the grid is included in the holder 3 the grid would be disposed outside the imaging table [image receiver 2]. Additionally the claim does not require the breast to be directly placed on the table and Fig. 3 of the current application shows the breast being placed on the detachable protective cover which covers the imaging table. This is similar to Muller which shows in Fig. 1 the breast support plate 3 covering the image receiver 2 which has been interpreted as the image table. Muller discloses the grid being included in the breast support plate 3 therefore the grid is disposed outside the imaging table. Therefore the examiner finds the arguments to be not persuasive. 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, the imaging table having 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 the flat plate-like protective member being configured to protect 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”), the scattered ray removal grid being disposed outside the imaging table (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”, as recited above the breast support 3 [breast support shelf] is separate from and can be removable from the image receiver 2 which has been interpreted as the imaging table as recited above and therefore the grid is disposed outside of the image receiver 2 [imaging table]), 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: The remainder of claim 16 mirrors the protective cover of claim 1 and Tuba does not teach the protective cover of claim 1. However as cited above Muller and Tada disclose the protective cover of 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 are allowed. The prior art does not teach a protective member of a mammography apparatus that includes a support shaft to support the scattered removal grid and provide rotation of the scattered removal grid about the support shaft. 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 RENEE C LANGHALS whose telephone number is (571)272-6258. The examiner can normally be reached Mon.-Thurs. alternate Fridays 8:30-6. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Koharski can be reached at 571-272-7230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /R.C.L./ Examiner, Art Unit 3797 /CHRISTOPHER KOHARSKI/ Supervisory Patent Examiner, Art Unit 3797
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Prosecution Timeline

Sep 25, 2023
Application Filed
Mar 18, 2026
Non-Final Rejection mailed — §103
Jun 18, 2026
Response Filed
Aug 19, 2026
Final Rejection mailed — §103 (current)

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