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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 October 29, 2025 has been entered.
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) 1, 3-4, 6, 8-9, 11 and 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arai et al. (US Pub No. 2017/0281124) in view of Bambot (US Pub No. 2023/0329653).
With regards to claim 1, Arai et al. disclose a compression plate that is used in a mammography apparatus, the compression plate comprising:
a wall surface portion (i.e. upper acoustic matching member (64, 64a) which is on “the side surface of the compression plate 32 on the nipple side”) facing a chest wall (“chest wall side”) of an examinee (paragraphs [0133]-[0134], Figure 16); and
a bottom surface portion (i.e. 32) connected to the wall surface portion (paragraph [0133]-[0134], referring to the “compression plate 32” which is connected, as depicted in Figure 16, to the bottom of acoustic matching member (64, 64a); Figure 16),
wherein at least a part of the wall surface portion is a low rigidity portion that extends from the bottom surface portion (32), the low rigidity portion having a lower rigidity than other portions of the compression plate (paragraph [0055], referring to the compression plate (32) being made of material such as resin, acrylic, etc. or materials; paragraphs [0072]-[0073], referring to the acoustic matching member being made of material that is flexible, such as non-hydrogel material, a polymeric hydrogel, silicone rubber, etc., wherein the acoustic matching member is lower than the hardness of the compression plate (32), or, in other words, the acoustic matching member is softer than the compression plate, and thus the at least a part of the wall surface portion, which corresponds to an acoustic matching member, has a lower rigidity than other portions (i.e. portions corresponding to the compression plate (32) which are made of a harder material, such as resin) of the compression plate; note that in Applicant’s PG-Pub 2024/0293101, paragraph [0061], the low rigidity portion is disclosed as comprising the material of a rubber member, such as silicone rubber, etc. and the “other portions of the compression plate” are discloses as being made of resins, acrylic, etc.; Figures 1 and 16),
the low rigidity portion (64) is made of an elastically deformable member (i.e. flexible material, such as non-hydrogel material, a polymeric hydrogel, silicone rubber, etc.; note that in Applicant’s PG-Pub 2024/0293101, paragraph [0061], the low rigid portion is disclosed as comprising the material of a rubber member, such as silicone rubber, etc., wherein silicone rubber has the inherent property of being “elastically deformable”) (paragraphs [0050]-[0051], referring to the ultrasound probe (36), which corresponds to the imaging unit; paragraphs [0072]-[0073], referring to the acoustic matching member being made of material that is flexible/deformable, such as non-hydrogel material, a polymeric hydrogel, silicone rubber, etc.; paragraph [0074], referring to the acoustic matching member deforming on the chest wall side (i.e. examinee side) and according to the shape of the breast (N), wherein the deformation on the chest wall side is from the end surface of the imaging unit (36) as depicted in Fig. 1; Figures 1, 4, 16),
the low rigidity portion (64) before deformation (i.e. such as before deformation caused by compression and/or pressure from ultrasound probe (36)) is located between an end surface of an imaging unit (ultrasound probe (36) or the imaging unit including the imaging structure depicted in Figure 1, such as the radiation tube (26), filter (28), etc.) included in the mammography apparatus (10) and an effective imaging region of the imaging unit (paragraphs [0050]-[0051], referring to the ultrasound probe (36), which corresponds to the imaging unit; paragraphs [0072]-[0073], referring to the acoustic matching member being made of material that is flexible/deformable, such as non-hydrogel material, a polymeric hydrogel, silicone rubber, etc.; paragraph [0074], referring to the acoustic matching member deforming on the chest wall side (i.e. examinee side) and according to the shape of the breast (N), wherein the deformation on the chest wall side is from the end surface of the imaging unit (36) as depicted in Fig. 1; Figures 1, 4, 16), and
at least a part of the low rigidity portion after deformation (i.e. such as after deformation caused by compression and/or pressure from ultrasound probe (36)) is movable toward an examinee side (i.e. breast (N)) from the end surface of the imaging unit (paragraphs [0050]-[0051], referring to the ultrasound probe (36), which corresponds to the imaging unit; paragraphs [0072]-[0073], referring to the acoustic matching member being made of material that is flexible/deformable, such as non-hydrogel material, a polymeric hydrogel, silicone rubber, etc.; paragraph [0074], referring to the acoustic matching member deforming on the chest wall side (i.e. examinee side) and according to the shape of the breast (N), wherein the deformation on the chest wall side is from the end surface of the imaging unit (36) as depicted in Fig. 1; Figures 1, 4, 16).
However, Arai et al. do not specifically disclose that the low rigidity portion is provided at a position where an ultrasound probe can be brought into close contact with the chest wall of the examinee via the low rigidity portion.
Bambot discloses a method for imaging that includes compressing breast tissue with a compression paddle, obtaining x-ray images and obtaining ultrasound images, wherein the breast compression paddle has an extension towards the patient’s neck area to allow scanning of areas near the chest wall (Abstract; paragraph [0063]; Figure 7B). The scan path for the transducer is designed to include this area moving from position (708) which is within the area imaged in mammography to position (709) the area at or near the chest wall which is often not imaged by mammography even with optimal patient positioning and is found to frequently harbor breast cancers (paragraph [0063]; Figure 7B, note that the extended portion (709) of the compression paddle is provided at a position where an ultrasound probe can be brought into close contact with the chest wall of the examinee via the extended portion). As a result, a method can be provided for examining the tissue adjacent the chest wall with the imaging system, wherein the adjacent areas include area at the chest wall and by the chest wall and have been found to harbor breast cancers in a significant number of women (paragraph [0063]; Figure 7B).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the low rigidity portion of Arai et al. be extended towards the patient’s neck area, and thus provided at a position where an ultrasound probe can be brought into close contact with the chest wall of the examinee via the low rigidity portion, as taught by Bambot, in order to examine the tissue adjacent the chest wall, wherein the adjacent areas include area at the chest wall and by the chest wall and have been found to harbor breast cancers in a significant number of women, thus providing a better ability to scan for breast cancer (paragraph [0063]).
Additionally, with regards to the limitations concerning “the low rigidity portion before deformation is located between an end surface of an imaging unit included in the mammography apparatus and an effective imaging region of the imaging unit and at least a port of the low rigidity portion after deformation is movable toward an examinee side from the end surface of the imaging unit”, the limitations are directed to an intended use and/or manner of operating the claimed compression plate/apparatus. Note that claim 1 is directed to a “compression plate”/apparatus, wherein the compression plate is “used in a mammography apparatus”, but the mammography apparatus is not part of the claim compression plate, nor is the imaging unit part of the claimed compression plate. Further, the limitations “before deformation” and “after deformation” describe a manner of operating or an intended use of the claimed compression plate. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Though Arai does disclose the above limitations as set forth above, it is noted that even if Arai did not explicitly teach the above limitations, the low rigidity portion of Arai is capable of being deformed by any object if pressure applied, including an imaging unit, and thus, additionally/alternatively Arai meets the above limitations directed to an intended use of the compression plate.
With regards to claim 3, Arai et al. disclose that the low rigidity portion (i.e. acoustic matching material) includes a part of the bottom surface portion (paragraphs [0133]-[0134], referring to the acoustic matching material of the members (58, 64), wherein at least the acoustic matching member (58) material can be viewed as being part of the bottom surface portion (i.e. combination of compression plate 32 and acoustic matching member (58)), or the surface of acoustic matching member (64) which is on the upper surface of the bottom surface portion (32) can be viewed as being part of the bottom surface portion (32); see Figure 16).
With regards to claim 4, Arai et al. disclose that the compression plate further comprises an intermediate member (58) to be interposed between the examinee and an ultrasound probe (36), wherein the intermediate member (58) is provided at at least one of a chest wall surface of the wall surface portion facing the chest wall of the examinee (N) or a surface of the wall surface portion opposite to the chest wall surface (paragraphs [0133]-[0134], referring to the acoustic matching member (58) provided between the compression plate (32) and the breast (N), wherein, as depicted in Figure 1, the member (58), which is part of the depicted compression plate (32) in Fig. 1, is interposed between the examinee (N) and the ultrasound probe (36) and further is provided at a surface of the wall surface portion opposite to the chest wall surface (i.e. an edge of the member (58) forms the wall surface portion opposite to the chest wall surface); Figures 1, 16).
With regards to claims 6, 8 and 9, Arai et al. disclose a mammography apparatus comprising the compression plate according to claim 1, 2, 3, 4 and 5 [see rejection of claims 1-5] (paragraphs [0049]-[0053], referring to the medical imaging apparatus (10) which has a function of a radiation mammography apparatus and includes the compression plate (32), etc.; Figures 1, 16-17).
With regards to claims 11 and 13-14, Arai et al. disclose an image capturing system (10) comprising:
an ultrasonography apparatus including an ultrasound probe (36) (paragraph [0051]; Figure 1); and
a mammography apparatus including the compression plate (32) according to claims 1, 2, 3, 4 and 5 [see rejections of claims 1-5] (paragraphs [0049]-[0053], referring to the medical imaging apparatus (10) which has a function of a radiation mammography apparatus and includes the compression plate (32), etc.; Figures 1, 16-17).
Response to Arguments
Applicant's arguments filed October 29, 2025 have been fully considered but they are not persuasive.
With regards to Bambot, Applicant argues that Bambot does not disclose that a low rigidity portion is provided at a position where an ultrasonic probe can be brought into close contact with the chest wall of the patient via the low rigidity portion and further asserts that the extension is merely an extension of the breast compression paddle itself and is not a low rigidity portion, and thus Bambot does not disclose the features previously recited in claim 2 that are now recited in amended independent claim 1.
However, Examiner notes that claim 1 is rejected under the combination of Arai and Bambot, wherein Arai discloses the low rigidity portion (64, Figure 16) which is part of the compression plate (see Figure 16). Bambot is relied upon to teach that the compression plate/paddle can include an extended portion (709) provided at a position where an ultrasound probe can be brought into close contact with the chest wall of the patient/examinee. In view of the above teaching of Bambot, it would have been obvious to one of ordinary skill in the art to extend the compression plate portion (64) of Arai that comes into contact with the ultrasound probe (36) [which includes the low rigidity portion (64) as depicted in Figure 16; also see Figure 1 which depicts the ultrasound probe (36) coming into contact with the compression plate portion that would correspond to the low rigidity portion (64) of Figure 16) such that the low rigidity portion is provided at a position where an ultrasound probe can be brought into close contact with the chest wall of the examinee via the low rigidity portion (i.e. low rigidity portion (64) modified to extend to the position in view of the teachings of Bambot). The above combined references therefore meet the above limitation.
Applicant further argues that the low rigidity acoustic matching member of Arai is provided on the upper surface of the compression plate and between the compression plate and the breast, but the compression plate itself of Arai does not have a low rigidity portion.
Examiner respectfully disagrees and notes that, under broadest reasonable interpretation (BRI), the compression “plate” is viewed as corresponding to element (32) of Arai along with the other materials that are provided and/or associated with the element (32), which includes the acoustic matching members. Specifically, under BRI, a “compression plate” is interpreted to be a structure comprising at least one flat surface that is used during compression. Therefore, as set forth in the above rejection, Arai does disclose a compression plate (i.e. element 32 along with the acoustic matching members, which, as depicted in Figures 1 and 16 would be used during compression of the breast; note in particular that it is not element (32) that is solely used during compression of the breast as depicted in Figure 16, but it is the element (32) combined with the acoustic matching members (i.e. 64) that is used during the compression of the breast, wherein, under BRI, element (32) along with the acoustic matching members (i.e. 64, etc.) forms the “compression plate”) that includes a low rigidity portion (i.e. acoustic matching member made of flexible material, such as silicone rubber, etc.)). Note that the BRI of “compression plate” is consistent with Applicant’s disclosure of the “compression plate” which, for example, is depicted in Figure 3A as not just including a flat surface/plate, but walls (23, 24,21A, etc) and materials (i.e. 21A) that form part of the structure defined as the compression “plate”.
The claims therefore remain rejected under the previously applied prior art.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 KATHERINE L FERNANDEZ whose telephone number is (571)272-1957. The examiner can normally be reached Monday-Friday 9:00 AM - 5:30 PM (ET).
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/KATHERINE L FERNANDEZ/Primary Examiner, Art Unit 3798