DETAILED ACTION
Response to Arguments
Applicant’s arguments with respect to claims 1, 3-12 and 14-17 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by
Rees (US pgPub 2012/0132217).
Regarding claim 1, Rees teaches a method of shielding radiation (inherent in figures 22-22b), comprising:
orienting a rigid radiation shield in a selected position relative to a patient (orienting shield 88 relative to patient 40, note 88 is slidable along track 92 as seen in figures 21 abd 21B, thus relative to the patient), thereby forming a gap (gap formed by base plate 90 between shields 88 and table ) between a bottom of the rigid radiation shield and the patient (gap formed by base plate 90 at bottom of plate 88 and patient best seen in figure 22A), the rigid radiation shield including first and second opposed major faces (front and back surfaces of 88);
covering the rigid radiation shield with a sterile cover by positioning the cover to surround at least the first and second opposed major faces of the rigid radiation shield (sterile cover 14, disclosed in paragraph [0099] to alternatively be modular with one sterile drape 14 to cover upstanding shields 88 (i.e. both major surfaces) and a separate drape 14’ to cover shield 12’); and
attaching a flexible radiation shield to the rigid radiation shield (12’ attached 88 via base 90 by attachment means 97 seen in figure 21B. Paragraph [0099] teaches radiopaque insert 12’ such as those described above. Paragraph [0074] teaches the insert is flexible) such that the flexible radiation shield includes:
a first generally vertical portion that covers the gap between the rigid radiation shield and the patient (as seen in figure 22B, insert 12’ is attached to top of base 90, such that it overlaps the side of the base 90, therefore covering the gap between the shield and the patient via overlap),
wherein the flexible radiation shield is repositionable on a support surface without removing the sterile cover that covers both first and second opposed major faces of the rigid radiation shield (since the sterile cover 14 is modular ([0099]), the shield 12’ is repositionable on support surface 97 without removal of the portion of 14 covering shields 88).
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.
Claim 1, 3-12, 14, and 16-17 arerejected under 35 U.S.C. 103 as being unpatentable over Wilson (US pgPub 2023/0126167) (note the instant application is a CIP. Since the parent teaches either a flexible shield or a rigid shield, there is no disclosure of attaching a flexible shield to the rigid shield or orienting the rigid shield to form a gap between the bottom of the shield and the patient that is covered by the flexible radiation shield, therefore the claims are given the effective filing date of 04/27/2022 later than the date Wilson was effectively filed 10/21/2021) in view of Rees
Regarding claim 1, Wilson teaches a method of shielding radiation (figures 3A-3B), comprising:
orienting a rigid radiation shield in a selected position relative to a patient (fig. 3B rigid shield 408 ([0065] 408 is formed of transparent acrylic material embedded with lead oxide and paragraph [0047] teaches mounted from the ceiling thus rigid in order to maintain shape) oriented relative to patient 500), thereby forming a gap between a bottom of the rigid radiation shield and the patient (gap provided by belt 402 between shield 408 and patient 500), the rigid radiation shield including first and second opposed major faces (two sides of shield 408);
covering the ridged radiation shield with a sterile cover ([0057] and [0062] teach belt inserted into a sterile bag or provided with a sterile barrier. Figure 3C shows contact between vertical portion of 402 and 408, therefore when the belt is in the sterile bag, it covers a portion of the radiation shield 408) and attaching a flexible radiation shield (402 comprises foam 422 and radiation shielding material 424 made of rubber filled with tin, antimony, bismuth, thus shielding and flexible) to the rigid radiation shield (402 is attached to 408 via ferromagnetic material 434 see figure 3c and paragraphs [0054], [0071]) such that the flexible radiation shield includes: a first generally vertical portion that covers the gap between the rigid radiation shield and the patient (belt 402 extends over the patient [0046] having a vertical dimension to engage with the radiation shield portion 408 to prevent x-ray photon leakage at juncture as seen in figure 3c ([0054]) (juncture seen in fig. 3B to include the patient 500).
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While Wilson teaches covering the belt with a sterile barrier or bag ([0057] and [0062]), Wilson fails to expressly suggest covering the rigid radiation shield with a sterile cover by positioning the cover to surround at least the first and second opposed major faces of the rigid radiation shield; and wherein the flexible radiation shield is repositionable on a support surface without removing the sterile cover that covers both first and second opposed major faces of the rigid radiation shield.
However, Rees teaches covering the rigid radiation shield with a sterile cover by positioning the cover to surround at least the first and second opposed major faces of the rigid radiation shield ([0099]); and wherein the flexible radiation shield is repositionable on a support surface without removing the sterile cover that covers both first and second opposed major faces of the rigid radiation shield ([0099] see discussion in the rejection above in view of Rees).
Rees modifies Wilson by suggesting a sterile drape to cover the rigid support surface such that the flexible shield is repositionable without removing the sterile drape. That is, Rees modifies Wilson by suggesting providing a separate sterile drape for the rigid shield.
Since both inventions are directed towards radiation shields in sterile environments, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide a separate sterile cover on the ridge shield as suggested in Rees in the device of Wilson because extra sterile cover adds protection of sterility without passage of any non-sterile contaminants from the radiation shield ([0071]). Moreover, as evidenced by Wilson’s disclosure of a sterile bag or barrier covering the belt and positioned between magnets, such a modification would still result in connection via magnetic force (see claim 3 below). Moreover, as further evidenced by Yadegari et al. (US pgPub 2021/0401383) magnetically securing a shield can prevent the shield from slipping, particularly when the shield is covered with a sterile bag ([0082]). Therefore, the addition of a sterile bag suggested by Rees over the rigid shield of Wilson would not interfere with the magnetic engagement between the belt and the ridged shield.
Regarding claim 3, Wilson teaches wherein after attaching the flexible radiation shield to the rigid radiation shield, the sterile cover is at least partially located between the rigid radiation shield and the flexible radiation shield while the flexible radiation shield is at least partially supported by the rigid radiation shield (when belt is in sterile bag [0062] there would be the sterile bag between 434 and 416 of figure 3. The connection between 408 and 402 is magnetic, thus partially supported by rigid radiation shield by magnetic force see paragraphs [0055]-[0056] “FIG. 3C is a cross-sectional view showing details of a potential arrangement of ferromagnetic material 434 disposed along a vertically-oriented surface of foam 422 of belt portion 402. As noted, this arrangement may facilitate forming a positive engagement or mating between belt portion 402 and shield portion 408” and further discussion in [0070]-[0071]).
Regarding claim 4, Wilson teaches, wherein the flexible radiation shield includes a second portion oriented transverse to the first portion while the first portion is attached to the rigid radiation shield (fig. 3C horizontal portion 424).
Regarding claim 5, Wilson teaches wherein the second portion is at least partially supported by the patient while the first portion is at least partially supported by the rigid radiation shield (402 including 424 is positioned on the patient thus partially supported ([0053] and [0055]) by the patient and as seen in figure 3C vertical portion 424 (as seen in figure 1D and annotated figure 3C above) includes magnets that allow it to be partially supported by shield 408 ([0054] teaches vertical dimension of 402 for engagement with 408 as seen in figure 3C)).
Regarding claim 6, Wilson teaches comprising positioning the flexible radiation shield relative to the patient (402 as seen in figure 3B relative to patient 500).
Regarding claim 7, Wilson teaches wherein positioning the flexible radiation shield comprises folding the first portion relative to the second portion (best seen in figure 1b, 424 has folds from first vertical portion relative to second horizonal portion).
Regarding claim 8, Wilson teaches wherein attaching the flexible radiation shield comprises attaching by an attachment component of the flexible radiation shield (as seen in figure 3C 434 attached to vertical flexible component 424).
Regarding claim 9, Wilson teaches wherein the attachment component includes a first and a second magnetic component (416/434 when attached as seen in figure 3c), wherein the first magnetic component comprises a magnet and the second magnetic component comprises a ferrous material (sensor 416 is ferromagnetic [0071] and 434 is ferromagnetic [0056] thus both magnetic and ferrous materials).
Regarding claim 10, Wilson in view of Reese teaches wherein the sterile cover is flexible ([0062] of Wilson teaches a sterile bag thus flexible and Reese teaches sterile drawpe 14 is of a aflexible material ([0071])).
Regarding claim 11, Wilson teaches wherein the radiation shield comprises a predetermined fold location (fold locations of 424 seen in figure 1d), and positioning the flexible radiation shield comprises folding the flexible radiation shield about the predetermined fold location ([0053] radiation shielding material 424 may be formed around the foam 422 and also extend horizontally from foam 422. The fold location is predetermined by the shape of the foam 422 (see figures 1c-1d)).
Regarding claim 12, Wilson teaches wherein the radiation shield comprises a radiation shielding sheet (horizontal portion 424 as seen in figure 3c).
Regarding claim 14, Wilson teaches wherein the attachment component includes a first magnetic component (416), and attaching the flexible radiation shield includes securing the flexible radiation shield by magnetic engagement of the first magnetic component (via 434 magnetic engagement, see discussion above).
Regarding claim 16, Wilson teaches a method of shielding radiation, comprising: orienting a rigid radiation shield in a selected position relative to a patient (see claim 1) the ridged radiation shield including first and second opposed major faces (see claim 1); coving the ridged radiation shield with a sterile cover (see claim 1)
attaching a flexible radiation shield to the rigid radiation shield such that the flexible radiation shield includes a first generally vertical portion at least partially supported by the rigid radiation shield and that covers a gap between the rigid radiation shield and the patient (see annotated figure 3C above), and a second generally horizontal portion that is at least partially supported by the patient (fig. 3C horizontal portion of 424 ).
Wilson has the same deficiencies as discussed above in claim 1 that are resolved by Reese. The modification and the rationale for the combination is the same as discussed above in claim 1.
Regarding claim 17, Wilson teaches comprising positioning the flexible radiation shield relative to the patient (as seen in figures 3a-3c patient 500 having belt 402 over the patient), wherein the radiation shield comprises a predetermined fold location (figure 1d, predetermined by size of foam 422) and positioning the flexible radiation shield comprises folding the flexible radiation shield about the predetermined fold location (forming 424 as seen in figure 1d to result in flexible shield see 1e and positioning flexible shield 424 via magnetic engagement as seen in figure 3c).
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.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Wilson in view Ress and further in view of Wemyss (USPN 6,305,656)(submitted with IDS).
Regarding claim 15, Wilson teaches comprising securing a second magnetic component to the rigid radiation shield (416 secured to shield 408), and wherein attaching the flexible radiation shield comprises magnetically engaging the first magnetic component with the second magnetic component (434 magnetically engages with 416).
Wilson differs from the claimed invention by not disclosing how 416 is secured to 408.
However, Wemyss teaches securing a magnet to a surface via an adhesive (col. 6, lines 53-57).
Wemyss modifies Wilson by suggesting an adhesive means to secure a magnet to a surface.
Since both inventions are directed towards securing magnets to surfaces, it would have been obvious to one of ordinary skill in the art to secure the magnet of Wilson to the shield of Wilson with the adhesive suggested by Wemyss because it would resolve the problem as to how to secure the magnet to the wall in Wilson. Moreover, it provides a permanent attachment such that the magnetic engagement at that location may be assured overtime.
Relevant art of interest to the applicant:
US2016/0158082 see figure 69
US2013/0320246 teaches orienting a radiation shield
Belson et al. (2009/0232282) teaches magnetic attachment between shields see [0042]
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 MICHAEL J LOGIE whose telephone number is (571)270-1616. The examiner can normally be reached M-F: 7:00AM-3:00PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Kim can be reached at (571)272-2293. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL J LOGIE/Primary Examiner, Art Unit 2881