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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3/19/2026 has been entered.
Claim Objections
Claim 10 is objected to because the claim prematurely ends with a period at the end of line 11. In the interest of expediting prosecution, the Examiner shall consider all of the limitations following the period according to all applicable statutes.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 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 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.
Claims 1, 3, 6-8, 10, 12, 15-17, 19 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zylka (US 6,471,399 B1).
Regarding claim 1, Zylka discloses an x-ray imaging system (Figs.1-5), including:
a) an x-ray source 3 located on a first side of an object;
b) an x-ray sensor 2 oriented in a first plane and located on an opposite side of the object; and
c) a calibration array 9 oriented in a second plane substantially parallel to the first plane and located only between the x-ray sensor 2 and the object (Figs.1 and 2; col.4, lines 45-56, describe an embodiment where only the calibration array 9 is used; while col.4, lines 31-44 describe an embodiment where only calibration array 7 is used; and col.4, lines 57-67 describe an embodiment where both calibration arrays are used), the calibration array having multiple calibration targets 8 located within or on a substrate 9, each calibration target 8 including an element with an x-ray absorption the same as or different than that of the substrate 9 (col.3, lines 55-57), where the multiple calibration targets 8 are in a fixed spatial relationship relative to each other (Figs.2, 4 and 5).
With respect to claim 3, Zylka further discloses that the multiple calibration targets 8 have a cross-section of spheres (col.3, lines 55-57) or other geometric shapes (col.5, lines 8-11).
With respect to claim 6, Zylka further discloses that the multiple calibration targets 8 have a substantially similar shape (col.3, lines 55-57).
With respect to claim 7, Zylka further discloses that the multiple calibration targets 8 have cross sections of similar shape (col.3, lines 55-57).
With respect to claim 8, Zylka further discloses that the multiple calibration targets 8 are on a surface of the substrate 9 (Fig.2).
Regarding claim 10, Zylka discloses an imaging method (Figs.1-5), including:
a) using an imaging device to capture multiple 2D images (col.2, line 65, through col.3, line 16); the imaging device including:
i) an x-ray source 3 located on a first side of an object;
ii) an x-ray sensor 2 oriented in a first plane and located on an opposite side of the object; and
iii) a calibration array 9 oriented in a second plane substantially parallel to the first plane and located only between the x-ray sensor 2 and the object (Figs.1 and 2; col.4, lines 45-56, describe an embodiment where only the calibration array 9 is used; while col.4, lines 31-44 describe an embodiment where only calibration array 7 is used; and col.4, lines 57-67 describe an embodiment where both calibration arrays are used), the calibration array having multiple calibration targets 8 located within or on a substrate 9, each calibration target 8 including an element with an x-ray absorption the same as or different than that of the substrate 9 (col.3, lines 55-57), where the multiple calibration targets 8 are in a fixed spatial relationship relative to each other (Figs.2, 4 and 5); and
b) assembling the multiple 2D images into a 3D image, where the location of each 2D image is calibrated using the calibration array 9 (col.2, line 65, through col.3, line 16).
With respect to claim 12, Zylka further discloses that the multiple calibration targets 8 have a cross-section of spheres (col.3, lines 55-57) or other geometric shapes (col.5, lines 8-11).
With respect to claim 15, Zylka further discloses that the multiple calibration targets 8 have a substantially similar shape (col.3, lines 55-57).
With respect to claim 16, Zylka further discloses that the multiple calibration targets 8 have cross sections of similar shape (col.3, lines 55-57).
With respect to claim 17, Zylka further discloses that the multiple calibration targets 8 are on a surface of the substrate 9 (Fig.2).
Regarding claim 19, Zylka discloses a calibration apparatus for an x-ray imaging system (Figs.1 and 2), including:
a) a substrate 9; and
b) a calibration array 8 oriented in a plane substantially parallel to a plane of an x-ray sensor 2 of the x-ray imaging system, the calibration array 9 having multiple calibration targets 8 located within or on the substrate9, each calibration target 8 having an element with an x-ray absorption coefficient different than that of the substrate 9 (col.3, lines 55-57), where the multiple calibration targets 8 are in a known spatial relationship relative to each other and determine the geometric location of the x-ray source 3 with respect to the x-ray sensor or vice versa (col.4, lines 45-56, describe an embodiment where only the calibration array 9 is used to determine the location of the detector 2 relative to the source 3).
With respect to claim 20, Zylka further discloses that the multiple calibration targets 8 are located on a surface of the substrate 9.
Claims 19 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Inglese (US 2020/0352530 A1).
Regarding claim 19, Inglese discloses a calibration apparatus for an x-ray imaging system (Figs.28-30), including:
a) a substrate 2802; and
b) a calibration array 2512 oriented in a second plane substantially parallel to the plane of an x-ray sensor 2400 of the x-ray imaging system; the calibration array having multiple calibration targets 2512 located on or within the substrate 2802; each calibration target 2512 including an element with an x-ray absorption different than that of the substrate; where the multiple calibration targets 2512 are in a known spatial relationship relative to each other and determine the geometric location of the x-ray source 10 with respect to the x-ray sensor 20 or vice versa (pars.0202-0206).
With respect to claim 20, Inglese further disclose that the multiple calibration targets 2512 are located on a surface of the substrate 2802.
Claims 1 and 3-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lang (US 2008/0219412 A1).
Regarding claim 1, Lang discloses an x-ray imaging system (Figs.5-7 and 11-12(C)), including:
a) an x-ray source located on a first side of an object (not illustrated);
b) an x-ray sensor 205 oriented in a first plane and located on an opposite side of the object (Figs.6 and 11); and
c) a calibration array oriented in a second plane substantially parallel to the first plane and located only between the x-ray sensor and the object (Figs.6, 7 and 11); the calibration array having multiple calibration targets located within or on a substrate (Fig.6); each calibration target having an element with an x-ray absorption the same as or different than that of the substrate (see at least pars.0023 and 0038); where the multiple calibration targets are in a fixed spatial relationship relative to each other (Figs.5-7 and 12(A)-(C)).
With respect to claim 3, Lang further discloses that the multiple calibration targets have a cross-section selected from circles, rectangles or polygons (pars.0023 and 0119).
With respect to claim 4, Lang further discloses that the calibration array 104 is contained in an aligner for an x-ray source of the x-ray imaging system (Fig.11).
With respect to claim 5, Lang further discloses that the calibration array 120 is contained in a housing 600 for the x-ray sensor 205 (Fig.6).
With respect to claim 6, Lang further discloses that the multiple calibration targets have a substantially similar shape (Figs.5-7 and 12(A)-12(C)).
With respect to claim 7, Lang further discloses that the multiple calibration targets have cross-sections of a similar shape (Figs.5-7 and 12(A)-12(C)).
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 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.
Claims 2, 9, 11 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Zylka, as applied to claims 1 and 10, respectively, in view of Farrokhnia (US 6,231,231 B1).
With respect to claims 2 and 11, Zylka does not specifically disclose that the multiple calibration targets of the calibration array includes a tessellated pattern.
Farrokhnia teaches a calibration phantom 1300 (Fig.13) with multiple calibration targets 1320 formed as a tessellated pattern (mesh 1310) as a functionally equivalent means of providing a regular, predetermined pattern of known dimensions for calibration, where meshes have a manufacturing advantage of uniformity and/or scalability over the application of discrete structures on a substrate, subject to availability and cost constraints.
It would have been obvious to one of ordinary skill in the art at the time of the invention for Zylka to have the calibration array includes a tessellated pattern, as suggested by Farrokhnia, in order to provide a cost-effective, equally suitable spatial calibration standard with a reasonable expectation of success and without undue experimentation.
With respect to claims 9 and 18, Zylka does not specifically disclose that the multiple calibration targets are holes located within the substrate. Zylka teaches the more common practice of providing radio-opaque markers on a radio-translucent substrate.
Farrokhnia teaches the practice of providing a calibration phantom 1300 with multiple calibration targets 1320 which are holes 1320 within a radio-opaque substrate 1310 (Fig.13). As recognized in the art, a negative space arrangement (transparent holes in an opaque substrate) is a functionally equivalent substitution to the positive space arrangement (opaque markers on a transparent substrate) that serves the same purpose, while having a manufacturing advantage of uniformity and/or scalability over the application of discrete structures on a substrate, subject to availability and cost constraints.
It would have been obvious to one of ordinary skill in the art at the time of the invention for Zylka to have the multiple calibration targets formed as holes in an opaque substrate, as suggested by Farrokhnia, in order to provide a cost-effective, equally suitable spatial calibration standard with a reasonable expectation of success and without undue experimentation.
Allowable Subject Matter
Claims 13 and 14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the prior art teaches most aspects of the claimed invention; however, the prior art neither teaches nor reasonably suggests the additional limitation that the calibration array is further:
a) contained in an aligner for an x-ray source of the x-ray imaging system (claim 13); or
b) contained in a housing for the x-ray sensor (claim 14).
In particular, Webber (US 6,081,577) teaches an x-ray imaging system having one or more fiducial markers for determining the imaging geometry of each 2D projection from which a final tomographic image is generated. The fiducials, most of which lie in a common plane parallel to the detector plane in some embodiments, are either located in front of the object (Figs.10, 12 and 13), both in front of and behind the object (Figs.1, 5, 9, 11, 14 and 15), or are located within the detector housing in the same plane as the image sensor (Figs.20 and 21) or in a plane behind the image sensor (Fig.19). In all cases, there is no illustrated embodiment or clear suggestion that the calibration array lies only between the object and the x-ray detector, where the multiple 2D images are assembled into a 3D image based on the location of each 2D image being calibrated by the calibration array, all as required by parent claim 10 as amended.
This distinction appears to be due to the limited space in the illustrated intraoral imaging environment of Webber, where at least some of the markers have to be placed at an appreciable distance from the detector in order for the spatial deviations to be measurable in the 2D images. This can also be seen in the intraoral environment of Inglese, where the calibration array has markers placed between the source and the object as well as between the object and the sensor (both sides of the teeth along the x-ray beam axis, Figs.28-30).
By contrast, the calibration array of Lang, exemplary of many such devices in the prior art, are for intrinsic density calibration of the image, and are unable to be used, by themselves, for calibrating the acquisition geometry of a given 2D projection image.
Applicant’s contribution to the art appears to be the ability to determine the arbitrary orientation between the x-ray source and the detector in intraoral 3D tomosynthesis based on a sole calibration array sandwiched between the teeth and the x-ray detector.
Response to Arguments
Applicant's arguments with respect to the anticipation of claims 19 and 20 by Inglese have been fully considered but they are not persuasive. Applicant argues a variety of features that do not appear to be claimed. Further, claim 19 was not amended in a like manner to that of claims 1 and 10; thus the rejection has been maintained.
Claim 19 simply requires that at least some of the markers of the calibration array lie in a common plane that is parallel to the detector plane, that the markers have known spatial relationship relative to each other, the markers include an element with an x-ray absorption that is different from the substrate, and where the calibration array is intended for determining the geometric location of the x-ray source with respect to the x-ray sensor or vice versa.
The intended use notwithstanding, Inglese specifically discloses each of these structural requirements (Figs.28-31), and further states that the calibration array of Figs.28-31 is used for determining the relative geometry of the source and detector in order to reconstruct a valid 3D image from the 2D projections that include the markers (Figs.27A-27C; par.0202).
Applicant appears to argue that the plane of the calibration array is not parallel to the detector plane, as required by the claim, due to the illustrated flimsy clips. First, it is clear that the figures are crude schematics and not representative of the exact details of implementation. Second, paragraph 0202 states that the attachment means of the calibration array to the detector are more substantial, with a variety of clips, sleeves, and/or adhesives. If the calibration array is glued to the detector, then they can be in no other orientation than perfectly parallel to one another. Given the more robust disclosure of par.0202 compared to the drawings, it is clear to one of ordinary skill in the art that the plane of the calibration array is substantially parallel to the plane of the detector in at least one contemplated embodiment.
For at least these reasons, Applicant’s arguments are not persuasive, and the rejection has been maintained.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Simon (US 6,118,845, previously cited) and Chinese patent document to Shao (see attached PTO-892) each teach similar C-arm geometric calibration phantoms and corresponding methods to that of Zylka.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS R ARTMAN whose telephone number is (571)272-2485. The examiner can normally be reached Monday-Thursday 10am-6:30pm.
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THOMAS R. ARTMAN
Primary Examiner
Art Unit 2884
/THOMAS R ARTMAN/ Primary Examiner, Art Unit 2884