DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
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The following rejections are with regard to US Patent Nos. 8113713, 8439564, 9370331, 9907519, 10244996, and 11076819.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 8113713 (hereinafter USPN ‘713) in view of Heesch (US 6325538) and Lipthay et al. (US 4122350; hereinafter Lipthay).
USPN ‘713 claims a device for performing fluoroscopy with radiation protection (claim 1, preamble), said device comprising: a first end of a first radiation shield around the X-ray source (claim 1, par. 1 in the body of the claim) and a second end of the first radiation shield engageable against (claim 12) the procedure table and/or a patient’s body on the procedure table (claim 1, par. 1); necessarily wherein positioning the second end of the first radiation shield comprises conforming a conformable edge surrounding the second end of the first radiation shield against the patient’s body and/or the table (claim 12); a first end of a second radiation shield around the X-ray detector/image intensifier (claim 1, par. 2) and a second end of the second radiation shield conformable (claim 13) to the procedure table and/or the patient’s body on the procedure table (claim 1, par. 2), necessarily wherein positioning the second end of the second radiation shield comprises conforming a conformable edge surrounding the second end of the second radiation shield against the patient’s body and/or the table (claim 13).
However, USPN ‘713 fails to claim a method comprising: providing an X-ray source and an X-ray detector/image intensifier mounted on a C-arm adjacent a procedure table; directing x-rays from the x-ray source through the patient's body to the X-ray detector/image intensifier while the patient lies on the procedure table within the C-arm, wherein the first radiation shield and the second radiation shield block stray radiation being emitted beyond the patient's body; and conically shaped shielding.
Heesch teaches a method comprising: providing an X-ray source (36) and an X-ray detector/image intensifier (35) mounted on a C-arm (26) adjacent a procedure table (14); directing x-rays from the x-ray source through the patient's body (18) to the X-ray detector/image intensifier while the patient lies on the procedure table within the C-arm, wherein the first radiation shield and the second radiation shield (52/53) block stray radiation being emitted beyond the patient's body (18). Lipthay teaches conically shaped shielding (figs. 1-2c).
It would have been obvious, to one having ordinary skill in the art, to conclude that the invention defined in the claims of the instant application would have been an obvious variation of the invention defined in the claims of USPN ‘713 with the teaching of Heesch, since one would have been motivated to make such a modification for protection and quick adjustment (Heesch: col. 4:1-7).
It would have been obvious, to one having ordinary skill in the art, to conclude that the invention defined in the claims of the instant application would have been an obvious variation of the invention defined in the claims of USPN ‘713 with the teaching of Lipthay, since such a modification would have involved a mere change in the shape of a component. A change in shape is generally recognized as being within the level of ordinary skill in the art. One would have been motivated to make such a modification for better shape control (Lipthay: col. 49-63).
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 8439564 (hereinafter USPN ‘564) in view of Heesch and Lipthay.
USPN ‘564 claims a device for fluoroscopy with radiation protection (claim 1, preamble), said device comprising: a first end of a first radiation shield around the X-ray source (claim 1, par. 1) and a second end of the first radiation shield engageable (par. 3) against the procedure table and/or a body of a patient on the procedure table (pars. 1 and 3); necessarily wherein positioning the second end of the first radiation shield comprises conforming a conformable edge surrounding the second end of the first radiation shield against the patient’s body and/or the table (pars. 1 and 3); a first end of a second radiation shield around the X-ray detector/image intensifier (par. 2) and a second end of the second radiation shield conformable (par. 4) to the procedure table and/or a body of a patient on the procedure table (pars. 2 and 4), necessarily wherein positioning the second end of the second radiation shield comprises conforming a conformable edge surrounding the second end of the second radiation shield against the patient’s body and/or the table (pars. 2 and 4).
However, USPN ‘564 fails to claim a method comprising: providing an X-ray source and an X-ray detector/image intensifier mounted on a C-arm adjacent a procedure table; directing x-rays from the x-ray source through the patient's body to the X-ray detector/image intensifier while the patient lies on the procedure table within the C-arm, wherein the first radiation shield and the second radiation shield block stray radiation being emitted beyond the patient's body, and conically shaped shielding.
Heesch teaches a method comprising: providing an X-ray source (36) and an X-ray detector/image intensifier (35) mounted on a C-arm (26) adjacent a procedure table (14); directing x-rays from the x-ray source through the patient's body (18) to the X-ray detector/image intensifier while the patient lies on the procedure table within the C-arm, wherein the first radiation shield and the second radiation shield (52/53) block stray radiation being emitted beyond the patient's body. Lipthay teaches conically shaped shielding (figs. 1-2c).
It would have been obvious, to one having ordinary skill in the art, to conclude that the invention defined in the claims of the instant application would have been an obvious variation of the invention defined in the claims of USPN ‘564 with the teaching of Heesch, since one would have been motivated to make such a modification for protection and quick adjustment (Heesch: col. 4:1-7).
It would have been obvious, to one having ordinary skill in the art, to conclude that the invention defined in the claims of the instant application would have been an obvious variation of the invention defined in the claims of USPN ‘564 with the teaching of Lipthay, since such a modification would have involved a mere change in the shape of a component. A change in shape is generally recognized as being within the level of ordinary skill in the art. One would have been motivated to make such a modification for better shape control (Lipthay: col. 49-63).
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 9370331 (hereinafter USPN ‘331) in view of Heesch and Lipthay.
USPN ‘331 claims a device for fluoroscopy with radiation protection (claim 1, preamble), said device comprising: a first end of a first radiation shield around the X-ray source (claim 1, par. 1 in the body of the claim) and a second end of the first radiation shield engageable against (claim 7) the procedure table and/or a body of a patient on the procedure table (claim 1, par. 1), necessarily wherein positioning the second end of the first radiation shield comprises conforming a conformable edge surrounding the second end of the first radiation shield against the patient’s body and/or the table (claim 7); a first end of a second radiation shield around the X-ray detector/image intensifier (claim 1, par. 2) and a second end of the second radiation shield conformable (claim 7) to the procedure table and/or a body of a patient on the procedure table (claim 1, par. 2), necessarily wherein positioning the second end of the second radiation shield comprises conforming a conformable edge surrounding the second end of the second radiation shield against the patient’s body and/or the table (claim 6).
However, USPN ‘331 fails to claim a method comprising: providing an X-ray source and an X-ray detector/image intensifier mounted on a C-arm adjacent a procedure table; directing x-rays from the x-ray source through the patient's body to the X-ray detector/image intensifier while the patient lies on the procedure table within the C-arm, wherein the first radiation shield and the second radiation shield block stray radiation being emitted beyond the patient's body, conically shaped shielding.
Heesch teaches a method comprising: providing an X-ray source (36) and an X-ray detector/image intensifier (35) mounted on a C-arm (26) adjacent a procedure table (14); directing x-rays from the x-ray source through the patient's body (18) to the X-ray detector/image intensifier while the patient lies on the procedure table within the C-arm, wherein the first radiation shield and the second radiation shield (52/53) block stray radiation being emitted beyond the patient's body. Lipthay teaches conically shaped shielding (figs. 1-2c).
It would have been obvious, to one having ordinary skill in the art, to conclude that the invention defined in the claims of the instant application would have been an obvious variation of the invention defined in the claims of USPN ‘331 with the teaching of Heesch, since one would have been motivated to make such a modification for protection and quick adjustment (Heesch: col. 4:1-7).
It would have been obvious, to one having ordinary skill in the art, to conclude that the invention defined in the claims of the instant application would have been an obvious variation of the invention defined in the claims of USPN ‘331 with the teaching of Lipthay, since such a modification would have involved a mere change in the shape of a component. A change in shape is generally recognized as being within the level of ordinary skill in the art. One would have been motivated to make such a modification for better shape control (Lipthay: col. 49-63).
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 9907519 (hereinafter USPN ‘519) in view of Lipthay.
USPN ‘519 claims a method for performing fluoroscopy with radiation protection (claim 1, preamble), said method comprising: providing an X-ray source and an X-ray detector/image intensifier mounted on a C-arm adjacent a procedure table (claim 1, par. 1); positioning a first end of a first radiation shield around the X-ray source and engaging (claim 3) a second end of the first radiation shield to the procedure table and/or a patient’s body on the procedure table (claim 1, par. 2), necessarily wherein positioning the second end of the first radiation shield comprises conforming a conformable edge surrounding the second end of the first radiation shield against the patient’s body and/or the table (claim 3); positioning a first end of a second radiation shield around the X-ray detector/image intensifier (claim 1, par. 3) and conforming (claim 4) a second end of the second radiation shield to the procedure table and/or the patient’s body on the procedure table (claim 1, par. 3), necessarily wherein positioning the second end of the second radiation shield comprises conforming a conformable edge surrounding the second end of the second radiation shield against the patient’s body and/or the table (claim 4); and directing x-rays from the x-ray source through the patient's body to the X-ray detector/image intensifier while the patient lies on the procedure table within the C-arm, wherein the first radiation shield and the second radiation shield block stray radiation being emitted beyond the patient's body (claim 1, par. 4).
However, USPN ‘519 fails to claim conically shaped shielding.
Lipthay teaches conically shaped shielding (figs. 1-2c).
It would have been obvious, to one having ordinary skill in the art, to conclude that the invention defined in the claims of the instant application would have been an obvious variation of the invention defined in the claims of USPN ‘519 with the teaching of Lipthay, since such a modification would have involved a mere change in the shape of a component. A change in shape is generally recognized as being within the level of ordinary skill in the art. One would have been motivated to make such a modification for better shape control (Lipthay: col. 49-63).
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 10244996 (hereinafter USPN ‘996) in view of Lipthay.
USPN ‘996 claims a method for performing fluoroscopy with radiation protection (claim 1, preamble), said method comprising: providing an X-ray source and an X-ray detector/image intensifier mounted on a C-arm adjacent a procedure table (claim 1, par. 1); positioning a first end of a first radiation shield around the X-ray source and engaging a second end of the first radiation shield against the procedure table and/or a body of a patient on the procedure table (par. 2), necessarily wherein positioning the second end of the first radiation shield comprises conforming a conformable edge surrounding the second end of the first radiation shield against the patient’s body and/or the table (claim 3); positioning a first end of a second radiation shield around the X-ray detector/image intensifier and conforming a second end of the second radiation shield to the procedure table and/or a body of a patient on the procedure table (par. 3), necessarily wherein positioning the second end of the second radiation shield comprises conforming a conformable edge surrounding the second end of the second radiation shield against the patient’s body and/or the table (claim 4); and directing x-rays from the x-ray source through the patient's body to the X-ray detector/image intensifier while the patient lies on the procedure table within the C-arm, wherein the first radiation shield and the second radiation shield block stray radiation being emitted beyond the patient's body (par. 4).
However, USPN ‘996 fails to claim conically shaped shielding.
Lipthay teaches conically shaped shielding (figs. 1-2c).
It would have been obvious, to one having ordinary skill in the art, to conclude that the invention defined in the claims of the instant application would have been an obvious variation of the invention defined in the claims of USPN ‘996 with the teaching of Lipthay, since such a modification would have involved a mere change in the shape of a component. A change in shape is generally recognized as being within the level of ordinary skill in the art. One would have been motivated to make such a modification for better shape control (Lipthay: col. 49-63).
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 11076819 (hereinafter USPN ‘819) in view of Heesch and Lipthay.
USPN ‘819 claims a method for performing fluoroscopy with radiation protection (claim 1, preamble), said method comprising: positioning a first end of a first radiation shield around the X-ray source and engaging a second end of the first radiation shield against the procedure table and/or a body of a patient on the procedure table (claim 1, par. 1 in the body of the claim), necessarily wherein positioning the second end of the first radiation shield comprises conforming a conformable edge surrounding the second end of the first radiation shield against the patient’s body and/or the table (claim 3); positioning a first end of a second radiation shield around the X-ray detector/image intensifier and conforming a second end of the second radiation shield to the procedure table and/or a body of a patient on the procedure table (claim 1, par. 2), necessarily wherein positioning the second end of the second radiation shield comprises conforming a conformable edge surrounding the second end of the second radiation shield against the patient’s body and/or the table (claim 4); and directing x-rays from the x-ray source through the patient's body to the X-ray detector/image intensifier while the patient lies on the procedure table within the C-arm, wherein the first radiation shield and the second radiation shield block stray radiation being emitted beyond the patient's body (claim 1, par. 3).
However, USPN ‘819 fails to claim providing an X-ray source and an X-ray detector/image intensifier mounted on a C-arm adjacent a procedure table, and conically shaped shielding.
Heesch teaches providing an X-ray source (36) and an X-ray detector/image intensifier (35) mounted on a C-arm (26) adjacent a procedure table (14). Lipthay teaches conically shaped shielding (figs. 1-2c).
It would have been obvious, to one having ordinary skill in the art, to conclude that the invention defined in the claims of the instant application would have been an obvious variation of the invention defined in the claims of USPN ‘819 with the teaching of Heesch, since one would have been motivated to make such a modification for protection and quick adjustment (Heesch: col. 4:1-7).
It would have been obvious, to one having ordinary skill in the art, to conclude that the invention defined in the claims of the instant application would have been an obvious variation of the invention defined in the claims of USPN ‘819 with the teaching of Lipthay, since such a modification would have involved a mere change in the shape of a component. A change in shape is generally recognized as being within the level of ordinary skill in the art. One would have been motivated to make such a modification for better shape control (Lipthay: col. 49-63).
Response to Arguments
Applicant’s arguments with respect to the conical shielding of claim 1 have been considered but are moot in view of the new ground of rejection.
Applicant’s other arguments filed March 31, 2026, have been fully considered but are not persuasive.
In response to Applicant's argument that it would not be obvious to structurally adjust the claims of their patents with the teaching of Heesch, the test for obviousness is not whether the features of a secondary reference (i.e., Heesch) may be bodily incorporated into the structure of the claims of Applicant’s other patents; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings would have suggested to those of ordinary skill in the art.
Furthermore, in response to Applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper.
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 Chih-Cheng Kao whose telephone number is (571)272-2492. The examiner can normally be reached on M-F 9-5.
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/Chih-Cheng Kao/Primary Examiner, Art Unit 2884