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 .
Response to Arguments
Applicant’s arguments and amendment have persuasively overcome the title objection, the 112a rejections, many of the 112b rejections, and (along with the declaration) the rejection over Onishi.
The remaining issues are addressed below.
101
Applicant argues:
The human mind is not equipped to process thousands of 2D X-ray pixels and mathematically reconstruct them into a 3D volumetric data set.
Examiner responds:
The claim reads on a trivially small amount of data that one could imagine in their mind.
Applicant argues:
Furthermore, the claims are based on physical data inputs
Examiner responds:
The inputs are data, not physical (i.e., the claim does not involve physically moving the markers). One can mentally receive information describing the real world as part of a mental process, such as in Electric Power Grp.
Applicant argues:
The present invention solves specific technical problems identified in the Background of the Specification:
Examiner responds:
MPEP 2106.04(d)(1) “the claim must be evaluated to ensure that the claim itself reflects the disclosed improvement.” Here, the claim is too broad to reflect the asserted improvement because the asserted improvements are narrow way to use technology within the broad scope of the claim. In other words, the claim reflects the known art, and reading the claims does not convey a new technique that provides the asserted advantages.
Applicant argues:
The use of isotropic markers to align multiple 3D CT data sets is an unconventional and non-generic configuration
Examiner responds:
See the Mandava reference – from 1992.
102
Applicant argues:
A set of 2D projection data is technically and legally distinct from a 3D CT data set reconstructed from such projections.
Examiner responds:
One of ordinary skill in the art would be familiar with the reconstruction process and would understand each of the set of 2D projection data and the 3D CT data set as teaching the other because the reconstruction process is so well known.
See, for example, Applicant’s statements regarding 101 including “Reconstructing a 3D volume from 2D projection data is a computer-specific task that involves complex back-projection algorithms and geometric transformations” and Applicant’s background section. Further, claim 1’s “generating a three-dimensional second CT data set based on a second X-ray image data set acquired by X-ray imaging” includes the prior art process because “based on” is so broad.
Applicant argues:
2. Distinction Between 2D-3D Registration and 3D-3D Alignment (Stitching)
Examiner responds:
At the bottom of p. 10 of the remarks, Applicant describes their technology as “a clear improvement in the accuracy of 3D image registration.”
After reviewing Applicant’s remarks, the examiner believes that the distinction that Applicant is trying to make is that their technology is for stitching/aligning, where the two 3D volumes have little or no overlap, such as putting images together for a panoramic shot. In contrast, the spaces being considered in Lavallee are directed to sharing one volume (or at least largely overlapping).
The examiner has two responses. First, the claims are not directed to this “stitching,” and an important part of this is that US practice applies the broadest reasonable interpretation and forbids importing limitations from the specification. For example, the independent claims recite “a part of the subject different from the first part,” but the parts in question could be very small (e.g., a fingernail or eyebrow), particularly as compared to the imaged volume. Second, the examiner believes that, to the extent that there is a difference between registration and stitching, the two are known substitutes. MPEP 2144.06(II).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-13 (all claims) are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea (mental process) without significantly more.
Step 1: Claim 1 (and its dependents) recite a method, and processes satisfy Step 1 of the eligibility test.
Claim 11 (and its dependents) recite an apparatus, and machines satisfy Step 1 of the eligibility test.
Step 2A, prong one: All of the elements of the claims are a mental process because a person can look at CT images and align them. Note that the placement of the positioning elements is not a part of the claim, rather the X-ray image data is an input to this claim. MPEP 2106.04(a)(2)(III)(C) explains that use of a generic computer or in a computer environment is still a mental process. In particular, this section begins by citing Gottschalk v. Benson, 409 US 63 (1972). “The Supreme Court recognized this in Benson, determining that a mathematical algorithm for converting binary coded decimal to pure binary within a computer’s shift register was an abstract idea.” In Benson the Supreme Court did not separately analyze the computer hardware at issue; the specifics of what hardware was claimed is only included in an appendix to the decision.
Because there are no additional elements, no further analysis is required for Step 2A, prong two or Step 2B.
Additionally, Applicant describes a significant part of what is claimed as “mathematically reconstruct” (remarks, p. 9, bottom). Math is also an abstract idea.
The aspects of the claims that Applicant argues are not abstract result from placing this invention in the field of endeavor/technological environment of working with CT scans. Further, Applicant’s specification’s background section admits that these are well-understood, routine, conventional by virtue of their description in the background.
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 1-13 (all claims) 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.
Claims 1 and 13 recite “a second part of the subject that includes a part of the subject different from the first part,” but this is new matter. Applicant has not pointed out where the amended claim is supported, nor does there appear to be a written description of this claim limitation in the application as filed. MPEP 2163.04(I)(B). While the specification discloses different relative angles, there is not support for different parts. The examiner notes that Figs. 2 and 3 discuss upper parts versus lower parts, but this is a specie within the genus of possible differences.
Dependent claims are likewise rejected.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-13 (all claims) are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “positioning members,” but this is new terminology. MPEP 2173.05(a). Using a known term of art is expected to overcome this rejection (and the other “new terminology” rejections). Alternatively, defining the term in the claim is expected to overcome this rejection (and the other “new terminology” rejections).
Claims 6 and 12 recite “positioning members holding part,” but this is new terminology. MPEP 2173.05(a).
Claims 6, 8, and 9 recite a linear line connecting an X-ray source to a detector, but neither the source nor detector are specified by the claim, and thus it is unclear how to determine the linear (or which of multiple possible lines are at issue).
Claim 11 recites “processor configured to …,” but it is unclear what structure is intended. See, e.g., In re Blue Buffalo (Fed. Cir. January 14, 2026, non-precedential, slip opinion retrieved from https://www.cafc.uscourts.gov/opinions-orders/24-1611.OPINION.1-14-2026_2632686.pdf), interpreting “configured to” as “capable of.”
Claim 12 recites “subject placement part,” but this is new terminology. MPEP 2173.05(a).
Dependent claims are likewise rejected.
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 (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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-13 (all claims) are rejected under 35 U.S.C. 102(a)(1) and/or (a)(2) as being anticipated by US20170164919A1 (“Lavallee”).
1. A three-dimensional image data alignment method comprising:
a step of generating a three-dimensional first CT data set based on a first X-ray image data set acquired by X-ray imaging of a first part of a subject together with at least three positioning members having isotropic shapes; (Lavallee, abstract “a) receiving a set of 2D X-ray images of a region of a patient with said X-ray imaging system.” See also, [0119] “Spherical shaped radiopaque markers 56.”)
a step of generating a three-dimensional second CT data set based on a second X-ray image data set acquired by X-ray imaging of a second part of the subject that includes a part of the subject different from the first part and an overlapping area overlapping an imaging area of the first CT data set having (Lavallee, abstract, “b) computing an initial 3D image within the coordinate system of the X-ray imaging system by using at least part of said 2D X-ray images with their respective projective geometry data.”)
a part of the first part together with the at least three positioning members; and (Lavallee, Fig. 3, markers 64.)
a step of aligning the first CT data set with the second CT data set based on the positioning members having the isotropic shapes and included in the first CT data set and the second CT data set for combining the first CT data set and the second CT data set together. (Lavallee, abstract “d) computing an updated 3D image using the complete set of 2D X-ray images with their respective adjusted projective geometry data.”)
2. The three-dimensional image data alignment method according to claim 1, wherein the positioning members have point-symmetrical shapes symmetric with respect to centers of the positioning members as the isotropic shapes; and (Lavallee, [0119] “Spherical shaped radiopaque markers 56.”)
the first CT data set is aligned with the second CT data set based on the point-symmetrical shapes of the positioning members in the step of aligning. (Lavallee, abstract “d) computing an updated 3D image using the complete set of 2D X-ray images with their respective adjusted projective geometry data.”)
3. The three-dimensional image data alignment method according to claim 2, wherein the positioning members have spherical shapes as the point-symmetrical shapes symmetric with respect to the centers; and (Lavallee, [0119] “Spherical shaped radiopaque markers 56.”)
the first CT data set is aligned with the second CT data set based on the center positions of the spherical positioning members in the step of aligning. (Lavallee, abstract “d) computing an updated 3D image using the complete set of 2D X-ray images with their respective adjusted projective geometry data.”)
4. The three-dimensional image data alignment method according to claim 1, wherein in the step of aligning, a first distance between at least two positioning members in the at least three positioning members in the first CT data set and a second distance between the at least two positioning members corresponding to the first distance in the second CT data set are acquired; and (Lavallee, Fig. 3, markers 64.)
the first CT data set is aligned with the second CT data set by enlarging or reducing at least one of the first CT data set and the second CT data set so as to make the first distance agree with the second distance. (Lavallee, [0176] “In another embodiment, the adjustments of the nominal projective geometry data include … the scaling factors in the image to determine the pixel to millimeters ratio”)
5. The three-dimensional image data alignment method according to claim 1, wherein the center positions of the at least three positioning members are not aligned on one linear line but lie in one plane. (Lavallee, Fig. 4, markers 72)
6. The three-dimensional image data alignment method according to claim 1 further comprising a step of acquiring the first X-ray image data set and the second X-ray image data set by X-ray imaging with a positioning members holding part that includes the at least three positioning members being held to a subject placement part on which the subject is placed rotating about a rotation axis orthogonal to a linear line that connects an X-ray source to a detector. (Lavallee, Fig. 1a)
7. The three-dimensional image data alignment method according to claim 6, wherein the positioning members holding part is formed of a cylindrical tubular element that includes the at least three positioning members, and surrounds a subject. (Lavallee, [0007] “computer tomography is a well-established class of stationary X-ray imaging systems used for 3D reconstruction in a radiology department.” The stationary X-ray system teaches the claimed tubular element.)
8. The three-dimensional image data alignment method according to claim 1, wherein in the step of generating the second CT data set, the second CT data set is generated so as to include, as the overlapping area overlapping the imaging area of the first CT data set, at least a first area overlapping the imaging area of the first CT data set in an axial direction of the rotation axis of the subject orthogonal to a linear line, which connects an X-ray source to a detector. (Lavallee, Fig. 1b.)
9. The three-dimensional image data alignment method according to claim 1, wherein in the step of generating the second CT data set, the second CT data set is generated so as to include, as the overlapping area overlapping the imaging area of the first CT data set, at least a second area overlapping the imaging area of the first CT data set in a horizontal plane that includes a linear line, which connects an X-ray source to a detector. (Lavallee, Fig. 1b.)
10. The three-dimensional image data alignment method according to claim 1, wherein in the step of aligning, a first distance between at least two positioning elements in the at least three positioning members in the first CT data set and a second distance between the at least two positioning members corresponding to the first distance in the second CT data set are acquired; and (Lavallee, Fig. 4)
a measured distance between the at least two positioning members in the at least three positioning members acquired based on three-dimensional coordinate measurement of the positioning members is acquired; and (Lavallee, Fig. 4)
the first CT data set is aligned with the second CT data set by enlarging or reducing the first CT data set so as to make the measured distance agree with the first distance, and by enlarging or reducing the second CT data set so as to make the measured distance agree with the second distance. (Lavallee, [0176] “In another embodiment, the adjustments of the nominal projective geometry data include … the scaling factors in the image to determine the pixel to millimeters ratio”)
11. An X-ray imaging apparatus comprising: an imager including an X-ray source configured to irradiate a subject with X-rays and a detector configured to detect the X-rays with which the subject is irradiated by the X-ray source for imaging of the subject; and (Lavallee, Fig. 1b)
an image processor configured to generate CT data based on a plurality of X-ray image data sets of the imaging of the subject at a plurality of angles corresponding to different relative angles between the subject and the image capturer, (Lavallee, [0093] “Said data processing unit (not illustrated) typically comprises a processor that is adapted in particular to compute a 3D image from a set of acquired 2D images, to compute transformations between different coordinate systems, etc.”)
The remainder of claim 11 is mapped as per claim 1.
12. The X-ray imaging apparatus according to claim 11 further comprising a subject placement part that is arranged between the X-ray source and the detector, on which the subject is placed, and configured to be rotated about a rotation axis orthogonal to a linear line that connects the X-ray source to the detector, (Lavallee, Fig. 1b)
wherein the positioning members are included in a positioning members holding part held by the subject placement part. (Lavallee, Fig. 1b)
13. The X-ray imaging apparatus according to claim 12, wherein the positioning members holding part is formed of a cylindrical tubular element that includes the at least three positioning members, and surrounds the subject. (Lavallee, [0007] “computer tomography is a well-established class of stationary X-ray imaging systems used for 3D reconstruction in a radiology department.” The stationary X-ray system teaches the claimed tubular element.)
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.
Claims 1-13 (all claims) are rejected under 35 U.S.C. 103 as being unpatentable over US20170164919A1 (“Lavallee”) in view of Mandava VR, Fitzpatrick JM, Maurer Jr CR, Maciunas RJ, Allen GS. Registration of multimodal volume head images via attached markers. InMedical Imaging VI: Image Processing 1992 Jun 1 (Vol. 1652, p. 271). SPIE. (“Mandava”)
Claims 1-13 are mapped to Lavallee as per the above 102 rejection. However, Lavallee’s set of 2D data is replaced with Mandava’s “volume images of the human head” (Mandava, abstract). Mandava describes these as “three dimensional,” p. 2, middle. Mandava describes this process as “aligning.” Mandava, abstract.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the teachings of Mandava to the teachings of Lavallee such that Manadava’s aligning of volume spaces is used with Lavallee’s data for the purpose of implementation details.
Based on the above, this is an example of “combining prior art elements according to known methods to yield predictable results.” MPEP 2143.
Additionally, it appears that Mandava anticipates all of the limitations in the present claim (see, e.g., abstract). Applying the teachings of Mandava instead of Lavallee is not considered a new ground of rejection because the abstract of Mandava has been applied. MPEP 1207.03(a)(II).
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 DAVID ORANGE whose telephone number is (571)270-1799. The examiner can normally be reached Mon-Fri, 9-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gregory Morse can be reached at 571-272-3838. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID ORANGE/Primary Examiner, Art Unit 2663
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