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 .
Status of Claims
Claims 1, 6, 10-12 are amended. Claims 2 and 9 are canceled. Claims 1, 3-8, and 10-13 remain pending.
Response to Remarks
In the REMARKS filed 06/12/2026, the Applicant argues that NAKAMURA fails to teach or make obvious the phrase “wherein the structural framework comprises a first ring located on a first plane and a second ring located on a second plane parallel to the first plane, the first ring and the second ring are fixed relative to each other, at least three of the plurality of markers are located at the first ring, and at least another three of the plurality of markers are located at the second ring” (REMARKS, p. 5-7). The Examiner respectfully disagrees.
The Applicant specifically argues that NAKAMURA discloses the first part 10 and a rotatable part 20 are movable relative to each other, not fixed relative to each other, and to change the arrangement would change the principle of operation of NAKAMURA (Ibid, p. 7). The Examiner respectfully disagrees. The device of NAKAMURA is capable of rotation, but does not necessarily operate by rotation. The device is capable use in a fixed or static operation. Thus, the Applicant arguments are not persuasive.
Additionally, the Applicant argues that paragraphs [0092, 0100, 0112] and claim 9 of the original disclosure support the claim amendments. However, none of the cited passages supports the phrase “wherein … the first ring and the second ring are fixed relative to each other”, and the disclosure does not appear to support such a limitation. Accordingly, the newly amended claims are rejected under 112(a) for lacking written description.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3-8, and 10-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 has been amended to recite the phrase, “wherein … the first ring and the second ring are fixed relative to each other”. The Applicant point to paragraphs [0092, 0100, 0112] and claim 9 of the original disclosure support the claim amendments (REMARKS, p. 4). However, the cited passages and the original disclosure do not appear to support the amended limitations. Accordingly, the claims lack written description. The balance of claims are rejected based on dependence.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3, 7, 10-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over by NAKAMURA (US 20190090953 A1).
Regarding claim 1, NAKAMURA discloses a calibration device for a medical imaging system, comprising:
a structural framework (moveable part 20, fixed part 10; FIG 2; [0044]); and
a plurality of markers arranged on the structural framework (encoder 12, fiducial markers 23, 24, 25; [0044, 0047, 0053]), wherein:
at least two of the plurality of markers are with different absorption rates for a radiation used by the medical imaging system (markers can have different absorptivity relative to one another; [0051, 0053]);
wherein the structural framework further comprises: a first ring located on a first plane (fixed part 10), a second ring located on a second plane parallel to the first plane (rotatable ring 20), and at least 3 of the plurality of markers are located at the first ring (encoder 12 and marker 13 are in recess of fixed part 10; [0053-0054]) and at least three of the plurality of markers are located at the second ring (markers 23-25 are in recess of rotatable part 20; [0054]).
NAKAMURA describes a fixed part 10 and a rotatable ring 20, but does not specifically disclose wherein the fixed part and rotatable ring are configured to be stationary. However, static calibration devices (phantoms) are well-known in the art. Furthermore, the rotating ring is simply a static or stationary ring when not rotated or moved and is still capable of operating as a calibration device. It would have been obvious to one of ordinary skill in the art at the time of filing to operate the calibration device without moving or rotating the device to perform a more simplistic type of calibration. Furthermore, NAKAMURA does not specify at least 3 marks located in the fixed part. Applying a known technique (increasing the number of markers (e.g. +3 markers)) to a known or similar device (imaging phantom) ready for improvement to yield predictable results (improved alignment via increased fiducials) would have been obvious to one of ordinary skill in the art at the time of filing. See KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007); In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Regarding claim 2, NAKAMURA wherein a number of the plurality of markers is greater than or equal to 4 (encoder 12 and markers 13, 23-25; [0047, 0053]).
Regarding claim 3, NAKAMURA discloses wherein one of the plurality of markers comprises a multilayer structure, the multilayer structure comprises at least one imaging layer, and a number of the at least one imaging layer is adjustable in the multilayer structure.
Regarding claim 7, NAKAMURA discloses wherein the plurality of markers comprises a grid with a plurality of cells, and adjacent cells of the plurality of cells have different absorption rates for the radiation (FIG 3C; [0047, 0051]).
Regarding claim 10, NAKAMURA discloses the second ring is concentric with the first ring (the fixed part and moving part share the same center; FIG 2).
Regarding claim 11, NAKAMURA discloses wherein the first ring and the second ring define a hollow circular frustum or a hollow cylinder (FIG 2).
Regarding claim 12, NAKAMURA discloses wherein at least one of the plurality of markers is non-coplanar with the other of the plurality of markers (FIG 2 shows first 10 and second parts 20 with respective first 23-25 and second markers 12 in different planes). Applying a known technique (increasing the number of markers (e.g. +3 markers)) to a known or similar device (imaging phantom) ready for improvement to yield predictable results (improved alignment via increased fiducials) would have been obvious to one of ordinary skill in the art at the time of filing. See KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
Regarding claim 13, NAKAMURA discloses wherein the radiation comprises an X-ray (x-ray CT scanner phantom; [0006]).
Claim(s) 4 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over NAKAMURA (US 20190090953 A1) in view of PAUL et al. (US 20080269594 A1).
Regarding claim 4, NAKAMURA discloses wherein one of the plurality of markers comprises a first sphere, but does not specify a second sphere is embedded in the first sphere, and the first sphere and the second sphere have different absorption rates for the radiation. In the same field of endeavor, PAUL discloses a phantom for radiation imager calibration comprising providing a first sphere with a second sphere embedded inside the first sphere, the two having different absorption rates (hollow spherical housing 343 and chamber 344; [0026]; FIG 3), with the benefit of improved image alignment ([0007]). In light of the teachings of PAUL, it would have been obvious to one of ordinary skill in the art at the time of the invention to combine with the teachings of NAKAMURA.
Regarding claim 5, PAUL discloses wherein one of the plurality of markers comprises a first sphere and a second sphere, and the second sphere forms a hollow interior of the first sphere ([0026]; FIG 3).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over NAKAMURA (US 20190090953 A1) in view of BOUTCHKO et al. (US 20100167251).
Regarding claim 6, NAKAMURA discloses the plurality of markers, but does not specify at least one of the markers comprising a housing at least partially transparent for the radiation; and a gate configured to allow a contrast agent to flow into the housing. In the same field of endeavor, BOUTCHKO discloses a phantom for modeling a human torso comprising at least one marker comprising a housing at least partially transparent for the radiation, and a gate configured to allow a contrast agent to flow into the housing (simulated organs made of polymer, and ducts that include air and liquid tanks with delivery and control; [0038]), with the benefit of providing a simulated human torso for imaging calibration and experimentation. In light of the teachings of BOUTCHKO, it would have been obvious to one of ordinary skill in the art at the time of the invention to combine with the teachings of NAKAMURA.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over NAKAMURA (US 20190090953 A1) in view of PIERRE et al. (EP 4215116 A1).
Regarding claim 8, NAKAMURA discloses wherein a first marker of the plurality of markers comprises a protrusion structure on the structural framework (sphere, [0051]), but does not specify a second marker of the plurality of markers comprises a recessed structure on the structural framework. In the same field of endeavor, PIERRE discloses a radiation phantom for imaging calibration comprising a phantom structure 100 having a recess (102), the structure providing a marker for calibration resolving and a fixing means for supporting separated elements ([0062]). In light of the teachings of PIERRE, it would have been obvious to one of ordinary skill in the art at the time of the invention to combine with the teachings of NAKAMURA.
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 CASEY BRYANT whose telephone number is (571)270-7329. The examiner can normally be reached M-F // 7-3P EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, UZMA ALAM can be reached at 571-272-3995. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CASEY BRYANT
Primary Examiner
Art Unit 2884
/CASEY BRYANT/Primary Examiner, Art Unit 2884
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