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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/23/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claims 1-8, 10-12 and 14-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dahal et al. (“Label-free X-ray estimation of brain amyloid burden”; 2020-11-25; the prior art is provided by applicant).
With respect to claim 1, Dahal et al. teaches a method, comprising (see Figs. 1 and 2; text pages 1-5):
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irradiating a region of interest (ROI) with a collimated, polychromatic x-ray beam (see Fig.1; text section: Methods “disclosing that the mouse head is irradiated at selected locations with a collimated beam of polychromatic X-rays); in response to the irradiating, obtaining energy and angle-resolved scattering intensities (section: Methods disclosing that “the scattered photons recorded at each pixel have a known scatter angle (2θ) and energy (E)”) associated with a reference path (equation 3 AD and WT mice represent the disease and non-disease path) and a measurement path; processing the energy and angle-resolved scattering intensities to produce scattering cross section as a function of a momentum transfer parameter (see equation 1); and combining scattering cross-section within a predetermined range to determine amyloid burden (section: Methods disclosing calculation the area under the peak (AUP) from 3.6 to 8.4 nm-1 . ΔAUP represents the amyloid burden per location).
With respect to claim 2, Dahal et al. teaches the method of claim 1 (see Figs. 1 and 2; text pages 1-5), wherein the predetermined range of momentum transfer parameter corresponds to momentum transfer parameter values between 3/nm and 9/nm, wherein q=4πE sin θ/hc, wherein E is x-ray energy, θ is a scattering angle, and hc is product of Planck's constant h and a vacuum speed of light c (see equation 1 and AUP calculation from 3.6 to 8.4 nm-1).
With respect to claim 3, Dahal et al. teaches the method of claim 2 (see Figs. 1 and 2; text pages 1-5), wherein the momentum transfer parameter is q (see equation 1 and AUP calculation from 3.6 to 8.4 nm-1).
With respect to claim 4, Dahal et al. teaches the method of claim 1 (see Figs. 1 and 2; text pages 1-5), further comprising selecting at least one of the reference path and the measurement path based on a CT image of the ROI (see section Results and Discussion: disclosing acquiring a scout scan to non-invasively locate the selected region of interest (ROI) in the mouse head).
With respect to claim 5, Dahal et al. teaches the method of claim 1 (see Figs. 1 and 2; text pages 1-5), further comprising selecting the reference path to avoid portions of the ROI associated with an amyloid load (see section Results and Discussion: disclosing acquiring a scout scan to non-invasively locate the selected region of interest (ROI) in the mouse head).
With respect to claim 6, Dahal et al. teaches the method of claim 1 (see Figs. 1 and 2; text pages 1-5), further comprising irradiating the region of interest (ROI) with the collimated, polychromatic x-ray beam along a plurality of measurement paths and for each measurement path: processing associated energy- and angle-resolved scattering intensities to produce scattering cross section as a function of the momentum transfer parameter; and combining each of the scattering cross-sections within the predetermined range to determine amyloid burden along each of the measurement paths (see Fig.1; combination the cross sections as area under peak (AUP)).
With respect to claim 7, Dahal et al. teaches the method of claim 6 (see Figs. 1 and 2; text pages 1-5), further comprising irradiating the region of interest (ROI) with the collimated, polychromatic x-ray beam along reference paths associated with respective measurement paths for each measurement path, wherein the associated energy- and angle-resolved scattering intensities for the measurement paths and the respective reference paths are processed to produce scattering cross sections as a function of the momentum transfer parameter along each of the measurement paths (see Fig.1; combination the cross sections as area under peak (AUP)).
With respect to claim 8, Dahal et al. teaches the method of claim 1 (see Figs. 1 and 2; text pages 1-5), wherein the ROI includes in vivo human brain and the amyloid burden is associated with the in vivo human brain (the sSAXS method enables the in vivo estimation of amyloid burden).
With respect to claim 9, Dahal et al. teaches the method of claim 6 (see Figs. 1 and 2; text pages 1-5), wherein the irradiating the region of interest (ROI) with the collimated, polychromatic x-ray beam along a plurality of measurement paths comprises selecting a rotation of the collimated, polychromatic x-ray source and an oppositely situated x-ray detector about the ROI for each measurement path and obtaining energy- and angle-resolved scattering intensities associated with a reference path and a measurement path (see Figs. 1 and 2; text pages 1-5).
With respect to claim 10, Dahal et al. teaches the method of claim 1 (see Figs. 1 and 2; text pages 1-5), wherein the energy- and angle-resolved scattering intensities associated with a reference path and a measurement path are obtained with an x-ray detector array (a 2D spectroscopy detector (CdTe) is used to collect SAXS data simultaneously in angle and energy-dispersive modes for each location.” Each pixel acts as an energy-dispersive detector.).
With respect to claim 11, Dahal et al. teaches the method of claim 10 (see Figs. 1 and 2; text pages 1-5), wherein the x-ray detector array comprises a plurality of individual x-ray detectors (a 2D spectroscopy detector (CdTe) is used to collect SAXS data simultaneously in angle and energy-dispersive modes for each location.” Each pixel acts as an energy-dispersive detector.)
With respect to claim 12, Dahal et al. teaches the method of claim 4 (see Figs. 1 and 2; text pages 1-5), wherein the CT image is obtained with an uncollimated x-ray beam from an x-ray source, and further comprising situating at least one aperture with respect to the x-ray source to produce the collimated, polychromatic x-ray beam (see teachings about a dual-pinhole collimated beam of polychromatic X-rays).
With respect to claim 13, Dahal et al. teaches the method of claim 1 (see Figs. 1 and 2; text pages 1-5), wherein polychromatic x-ray beam has x-ray photon energies between 30 and 80 keV (see Fig.1).
With respect to claim 14, Dahal et al. teaches an apparatus, comprising (see Figs. 1 and 2; text pages 1-5):
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an x-ray source operable to produce a collimated, polychromatic x-ray beam and direct the collimated, polychromatic x-ray beam to a specimen (see Fig.1); an x-ray detector situated to receive scattered portions of the collimated (see Fig.1), polychromatic x-ray beam from the specimen and produce signals corresponding to energy- and angle-resolved scattering intensities associated with a measurement path and a reference path through the specimen (see Fig.1; text section: Methods “disclosing that the mouse head is irradiated at selected locations with a collimated beam of polychromatic X-rays); and logic configured to process the signals and produce an indication of a tissue load from a scattering cross-section dependence on a momentum transfer parameter (section: Methods disclosing that “the scattered photons recorded at each pixel have a known scatter angle (2θ) and energy (E)”), wherein the scattering cross section is based on the signals corresponding to the energy and angle-resolved scattering intensities associated with the measurement path and the reference path (section: Methods disclosing calculation the area under the peak (AUP) from 3.6 to 8.4 nm-1 . ΔAUP represents the amyloid burden per location).
With respect to claim 15, Dahal et al. teaches the apparatus of claim 14 (see Figs. 1 and 2; text pages 1-5), wherein the logic is configured to select a measurement path based on a CT image of the specimen (see section Results and Discussion: disclosing acquiring a scout scan to non-invasively locate the selected region of interest (ROI) in the mouse head).
With respect to claim 16, Dahal et al. teaches the apparatus of claim 14 (see Figs. 1 and 2; text pages 1-5), wherein the logic is configured to select a reference path based on a CT image of the specimen (see section Results and Discussion: disclosing acquiring a scout scan to non-invasively locate the selected region of interest (ROI) in the mouse head).
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.
Claims 17-22 are rejected under 35 U.S.C. 103 as being unpatentable over Dahal et al. (“Label-free X-ray estimation of brain amyloid burden”; 2020-11-25; the prior art is provided by applicant) as applied to claim 14 above, and further in view of Ziegler et al. (US PAP2010/0232669 A1).
With respect to claim 17, Dahal et al. teaches the apparatus of claim 14 but fails to explicitly mention a gantry operable to rotate the x-ray source and an x-ray detector about a specimen to and direct the polychromatic, collimated x-ray along a plurality of measurement paths.
Ziegler et al. discloses a system/method for polychromatic X-ray imaging which explicitly teaches a gantry (101) operable to rotate an x-ray source (105) and an x-ray detector (115) about a specimen (110) to and direct the polychromatic, collimated x-ray along a plurality of measurement paths (see Fig.1) in order to provide user with the capabilities to irradiate the specimen at a plurality of different projection angles, for each of the various
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projection angles calculating for a variety of combinations of different first and second X-ray energies with further reconstruction capabilities to generate desired images as needed (see abstract; Figs. 1-5; paragraphs 0017-0023, 0083, 0084, 0090 and 0124-0129).
Dahal et al. and Ziegler et al. disclose related methods/apparatuses for polychromatic X-ray imaging.
It 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 to provide the teachings of the gantry operable to rotate the x-ray source and an x-ray detector about a specimen to and direct the polychromatic, collimated x-ray along a plurality of measurement paths as suggested by Ziegler et al. in the method/apparatus of (base reference), since such a modification would provide user with the capabilities to provide user with the capabilities to irradiate the specimen at a plurality of different projection angles, for each of the various
projection angles calculating for a variety of combinations of different first and second X-ray energies with further reconstruction capabilities to generate desired images as needed.
It would have been obvious to treat Dahal et al. and Ziegler et al. as related art whereby an improvement on one of the systems/methods would readily be apparent as an improvement on either of the systems.
The Examiner’s conclusion that claim 17 would have been obvious is based on the fact that all the claimed elements were known in the prior art, that one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and that the combination teaches nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. 398, 82 USPQ2d at 1385 (2007); Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson ’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atlantic & P. Tea Co. v. Supermarket Equipment Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950).
With respect to claim 18, Dahal et al. (see Figs. 1 and 2; text pages 1-5) as modified by Ziegler et al. (see abstract; Figs. 1-5; paragraphs 0017-0023, 0083, 0084, 0090 and 0124-0129) teaches the apparatus of claim 17, wherein the logic is operable to determine tissue load by combining scattering cross-section values within a predetermined range of momentum transfer parameter values.
With respect to claim 19, Dahal et al. (see Figs. 1 and 2; text pages 1-5) as modified by Ziegler et al. (see abstract; Figs. 1-5; paragraphs 0017-0023, 0083, 0084, 0090 and 0124-0129) teaches the apparatus of claim 18, wherein the predetermined range of momentum transfer parameter values corresponds to momentum transfer parameter values between 3.5 and 8.5 nm.sup.−1 or 7.3 and 9.7 nm.sup.−1 (see Figs. 1 and 2; text pages 1-5).
With respect to claim 20, Dahal et al. (see Figs. 1 and 2; text pages 1-5) as modified by Ziegler et al. (see abstract; Figs. 1-5; paragraphs 0017-0023, 0083, 0084, 0090 and 0124-0129) teaches the apparatus of claim 17, wherein Ziegler et al further teaches that the logic is operable to reconstruct a tissue load image and display the tissue load image superimposed with a CT image, since such a modification would provide user with the capabilities to provide user with the capabilities to irradiate the specimen at a plurality of different projection angles, for each of the various projection angles calculating for a variety of combinations of different first and second X-ray energies with further reconstruction capabilities to generate desired images as needed.
With respect to claim 21, Dahal et al. (see Figs. 1 and 2; text pages 1-5) as modified by Ziegler et al. (see abstract; Figs. 1-5; paragraphs 0017-0023, 0083, 0084, 0090 and 0124-0129) teaches the apparatus of claim 17, wherein wherein Ziegler et al further teaches that the x-ray source and the x-ray detector are operable to produce CT data for generation of a CT image, since such a modification would provide user with the capabilities to provide user with the capabilities to irradiate the specimen at a plurality of different projection angles, for each of the various projection angles calculating for a variety of combinations of different first and second X-ray energies with further reconstruction capabilities to generate desired images as needed.
With respect to claim 22, Dahal et al. (see Figs. 1 and 2; text pages 1-5) as modified by Ziegler et al. (see abstract; Figs. 1-5; paragraphs 0017-0023, 0083, 0084, 0090 and 0124-0129) teaches the apparatus of claim 17, wherein the x-ray detector is situated to receive scattered portions at angles of less than 5 degrees (see Figs. 1 and 2; text pages 1-5).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IRAKLI KIKNADZE whose telephone number is (571)272-6494. The examiner can normally be reached 9:00 AM - 6:00 PM.
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Irakli Kiknadze
/IRAKLI KIKNADZE/
Primary Examiner, Art Unit 2884
/I.K./ February 7, 2026