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 .
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
The following title is suggested: Correcting Planar Scintigraphy Image (CPSI) Using Two-View Reconstruction Model Having Non-Negativity Constraint, Regularization and Fidelity Terms
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 1-5, 8-10, 13-19, 27-28, and 36 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Schmiedtlein {Schmidtlein, Charles Ross, et al. "A deblurring/denoising corrected scintigraphic planar image reconstruction model for targeted alpha therapy." Medical Imaging 2021: Biomedical Applications in Molecular, Structural, and Functional Imaging. Vol. 11600. SPIE, 2021}.
It is recognized that Schmiedtlein is a grace period reference having common but not completely identical inventorship/authorship including common inventor/authors Schmidtlein, Charles Ross; Krol, Andrzej; Gifford, Howard; and Xu, Yuesheng. As such, Schmidtlein is potentially subject to a 102(b)(1)(A) exception but such an exception has not yet been perfected via a 132 Declaration.
It is further noted that Schmidtlein is the NPL version of the instant application that clearly anticipates the rejected claims as follows:
Claim 1
In regards to claim 1, Schmidtlein discloses a computing system comprising:
one or more processors; and a non-transitory computer-readable medium having instructions stored thereon {see III, IIIA including implementing the algorithms via Matlab, a laptop with Intel processor, and various memories for storing computer programs} that when executed by the one or more processors cause the computing system to:
obtain, by the one or more processors, a plurality of planar scintigraphy images of a subject, wherein the plurality of planar scintigraphy images contain image artifacts caused by one or more physical processes {see title, abstract, Introduction, and section 2.1 including artifacts caused by gamma ray attenuation};
generate, by the one or more processors, a corrected planar scintigraphy image (CPSI) corrected for the image artifacts by applying a planar scintigraphy image reconstruction model to the plurality of planar scintigraphy images, the planar scintigraphy image reconstruction model comprising a non-negativity constraint and being based on a regularization term (parameters) and a fidelity term {see abstract, section 2.1 including equation 1 SPECT image reconstruction model, lambda is the regularization parameter and i+ is the indicator function imposing a non-negativity constraint on f and wherein the KL-divergence norm is the fidelity term consistent with the BRI of this term as per [0009]-[0010] and original claim 28. As to plural images, see abstract, introduction, and 2.1 including anterior/posterior (A/P) planar image pairs}; and
present, by the one or more processors, the CPSI for evaluation of a condition of the subject, wherein presenting the CPSI comprises at least one of transmitting the CPSI to a computing device or displaying the CPSI on a display screen {see abstract, Sections 1 and 5 references to corrected planar scintigraphic images in which the imagery can be used for diagnosis, therapy and response assessment}.
Claim 2
In regards to claim 2, Schmidtlein discloses wherein the plurality of planar scintigraphy images comprise an anterior planar scintigraphy image or a posterior planar scintigraphy image {see abstract, introduction, and 2.1 including anterior/posterior (A/P) planar image pairs.
Claim 3
In regards to claim 3, Schmidtlein discloses wherein the one or more physical processes comprise gamma ray attenuation, gamma ray collimator penetration, or gamma ray scatter {see abstract, introduction and 2.2 including gamma ray attenuation, collimator penetration and gamma ray scatter}.
Claim 4
In regards to claim 4, Schmidtlein discloses wherein obtaining the plurality of planar scintigraphy images comprises using a plurality of gamma ray detectors to generate the plurality of planar scintigraphy images {see abstract, 2.2}
Claim 5
In regards to claim 5, Schmidtlein discloses wherein the regularization term corresponds to a total variation regularization for controlling noise {see abstract, Introduction and section 2.1 for total variation regularization to control noise}.
Claim 8
In regards to claim 8, Schmidtlein discloses wherein the planar scintigraphy image reconstruction model comprises a minimization operation based on the regularization term, the fidelity term, and the non-negativity constraint {see section 2.1 and mapping for claim 1}.
Claim 9
In regards to claim 9, Schmidtlein discloses wherein the minimization operation is based on a divergence norm and a regularization parameter (A) {see abstract, section 2.1 including equation 1 SPECT image reconstruction model, lambda is the regularization parameter and i+ is the indicator function imposing a non-negativity constraint on f and wherein the KL-divergence norm is the fidelity term consistent with the BRI of this term as per [0009]-[0010] and original claim 28. As to plural images, see abstract, introduction, and 2.1 including anterior/posterior (A/P) planar image pairs}.
Claim 10
In regards to claim 10, Schmidtlein discloses wherein the planar scintigraphy image reconstruction model is based on a two-view single photon emission computed tomography (SPECT) physical model, optionally wherein the two-view SPECT physical model comprises an anterior view and a posterior view or optionally wherein generating the CPSI comprises {see mapping of claims 1 and 2}:
estimating an anterior/posterior (A/P) projection of activity bio-distribution using the two-view SPECT physical model as a constraint {sections 1 and 2.1}.
Claim 13
In regards to claim 13, Schmidtlein discloses wherein the two-view SPECT physical model is determined according to: an equation {see section 2.1 matching equation (1)}.
Claim 14
In regards to claim 14, Schmidtlein discloses wherein the K(x; y) is related to an attenuation map derived from computed tomography (CT) {section 2.2 attenuation map provided by CT}.
Claim 15
In regards to claim 15\, Schmidtlein discloses wherein applying the planar scintigraphy image reconstruction model comprises equations.
{see section 2.2 matching equations (4)-(6)}.
Claim 16
In regards to claim 16, Schmidtlein discloses wherein the planar scintigraphy image reconstruction model is discretized according to equations.
{see section 2.2 matching equations (6)-(7)}.
Claim 17
In regards to claim 17, Schmidtlein discloses wherein the instructions further cause the computing system to apply the discretized planar scintigraphy image reconstruction model using a fixed point algorithm with higher order total variation regularization (HOTV) according to equations
{see section 2.3 Fixed point algorithm including matching equations (8)}.
Claims 18 and 19
The rejection of system claim 1 above applies mutatis mutandis to the corresponding limitations of method claim 18 while noting that the rejection above cites to both device and method disclosures. Claim 19 is a combination of claims 2-9 loosely strung together by a series of “or” conjunction such that any of rejected claims 3-5, 8 or 9 apply mutatis mutandis to one of the or phrases in claim 19.
Claim 28
The rejection of system claim 10 above applies mutatis mutandis to the corresponding limitations (A) and (B) of method claim 28 while noting that the rejection above cites to both device and method disclosures. Claim 28 is a combination of claims 10, 13, 14, and 17 such that the combined rejection of system claims 10, 13, 14, and 17 apply mutatis mutandis to combined limitations of claim 28
Claim 36
In regards to claim 36, Schmidtlein discloses using the CPSI to evaluate the condition of the subject {Section 1 states that this CPSI is a valuable tool for clinical application}.
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.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Schmidtlein and AAPA and/or Official Notice.
Claim 27
In regards to claim 27, Schmidtlein is not relied upon to disclose determining, according to the generated CPSI, a dosage of radiation administered to the subject that minimizes a risk of toxicity to non-cancerous tissue, while optimizing treatment for cancerous tissue {the instant specification, [0082]-[0084] as published includes AAPA (Applicant Admitted Prior Art) describing a clinician (human) determining the dosage of radiation based on the improved CPSI image and otherwise does not specifically disclose an automated process for determining such dosage. Moreover, determining such dosage using manual judgement of the clinician based on viewing the improved CPSI image is considered conventional (Office Notice).
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 have modified Schmidtlein to include determining, according to the generated CPSI, a dosage of radiation administered to the subject that minimizes a risk of toxicity to non-cancerous tissue, while optimizing treatment for cancerous tissue as taught by AAPA and/or Official Notice because there is a reasonable expectation of success and/or because doing so merely combines prior art elements according to known methods to yield predictable results.
Claims 1, 3-5, 8, 9, 18, 19, and 28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lin {Lin, Yizun, et al. "A Krasnoselskii-Mann algorithm with an improved EM preconditioner for PET image reconstruction." IEEE transactions on medical imaging 38.9 (2019): 2114-2126}.
Claim 1
In regards to claim 1, Lin discloses a computing system comprising:
one or more processors; and a non-transitory computer-readable medium having instructions stored thereon {see III, IIIA including implementing the algorithms via Matlab, a laptop with Intel processor, and various memories for storing computer programs} that when executed by the one or more processors cause the computing system to:
obtain, by the one or more processors, a plurality of planar scintigraphy images of a subject, wherein the plurality of planar scintigraphy images contain image artifacts caused by one or more physical processes {see abstract, Introduction, and section IIA including obtaining/inputting PET (positron emission tomography) images which are within the BRI of plan scintigraphy images of a subject that contain artifacts as per Fig. 10, [0064], [0097] of the instant specification};
generate, by the one or more processors, a corrected planar scintigraphy image (CPSI) corrected for the image artifacts by applying a planar scintigraphy image reconstruction model to the plurality of planar scintigraphy images, the planar scintigraphy image reconstruction model comprising a non-negativity constraint and being based on a regularization term (parameters) and a fidelity term
{see abstract, section IIA HOTV Regularized PET Image Reconstruction Model and Section III, table 1 which includes a non-negativity (and smooth) constraint term and is based on a regularization term and a KL fidelity term, equation (2). Further as to the plurality of planar scintigraphy images note that the restoration model is iterative on plural images until convergence such that the broadly worded claim invites the application of Lin as opposed to claim 2 which more reasonably recites the heart of the invention in a novel and nonobvious fashion by employing a restoration model that ingests a pair of images that comprise an anterior planar scintigraphy image or a posterior planar scintigraphy image.}; and
present, by the one or more processors, the CPSI for evaluation of a condition of the subject, wherein presenting the CPSI comprises at least one of transmitting the CPSI to a computing device or displaying the CPSI on a display screen {see Section I in which PET imagery is used for diagnosis, therapy and response assessment of various tracer’s biodistribution in the imagery}.
Claim 3
In regards to claim 3, Lin discloses wherein the one or more physical processes comprise gamma ray attenuation, gamma ray collimator penetration, or gamma ray scatter {PET images employ gamma ray detectors to detect images and Lin’s artifacts include gamma ray collimator penetration and scatter as per sections IIA and IIIA}.
Claim 4
In regards to claim 4, Lin discloses wherein obtaining the plurality of planar scintigraphy images comprises using a plurality of gamma ray detectors to generate the plurality of planar scintigraphy images {PET images employ gamma ray detectors to detect images. As also noted in claim 1, further as to the plurality of planar scintigraphy images note that the restoration model is iterative on plural images until convergence such that the broadly worded claim invites the application of Lin}
Claim 5
In regards to claim 5, Lin discloses wherein the regularization term corresponds to a total variation regularization for controlling noise {see abstract, Introduction, IIA, IIIB(3) including total variation regularized model and total variation (TV) penalty and higher order total variation (HOTV).
Claim 8
In regards to claim 8, Lin discloses wherein the planar scintigraphy image reconstruction model comprises a minimization operation based on the regularization term, the fidelity term, and the non-negativity constraint {see abstract, section IIA HOTV Regularized PET Image Reconstruction Model and Section III, table 1 which includes a minimization operation based on non-negativity (and smooth) constraint term, regularization term and a KL fidelity term, equation (2).}
Claim 9
In regards to claim 9, Lin discloses wherein the minimization operation is based on a divergence norm and a regularization parameter (A). {Section IIA including minimization of fidelity term and applying regularization terms to avoid over-fitting. As to divergence norm see “The two functions ϕ1, ϕ2 are defined by the l1-norm for the anisotropic TV or the l2-norm for the isotropic TV, and thus they are convex. Here B1 ∈ Rm1×d , B2 ∈ Rm2×d are the first-order and second order difference matrices, respectively, and λ1, λ2 ∈ R+ are the corresponding regularization parameters” in Section IIA}.
Claims 18 and 19
The rejection of system claim 1 above applies mutatis mutandis to the corresponding limitations of method claim 18 while noting that the rejection above cites to both device and method disclosures. Claim 19 is a combination of claims 2-9 loosely strung together by a series of “or” conjunction such that any of rejected claims 3-5, 8 or 9 apply mutatis mutandis to one of the or phrases in claim 19.
Claim 28
The rejection of system claim 10 above applies mutatis mutandis to the corresponding limitations (A) and (B) of method claim 28 while noting that the rejection above cites to both device and method disclosures. Claim 28 is a combination of claims 10, 13, 14, and 17 such that the combined rejection of system claims 10, 13, 14, and 17 apply mutatis mutandis to combined limitations of claim 28
Claim 27 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Lin and AAPA and/or Official Notice.
Claim 27
In regards to claim 27, Lin is not relied upon to disclose determining, according to the generated CPSI, a dosage of radiation administered to the subject that minimizes a risk of toxicity to non-cancerous tissue, while optimizing treatment for cancerous tissue {the instant specification, [0082]-[0084] as published includes AAPA (Applicant Admitted Prior Art) describing a clinician (human) determining the dosage of radiation based on the improved CPSI image and otherwise does not specifically disclose an automated process for determining such dosage. Moreover, determining such dosage using manual judgement of the clinician based on viewing the improved CPSI image is considered conventional (Office Notice).
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 have modified Lin to include determining, according to the generated CPSI, a dosage of radiation administered to the subject that minimizes a risk of toxicity to non-cancerous tissue, while optimizing treatment for cancerous tissue as taught by AAPA and/or Official Notice because there is a reasonable expectation of success and/or because doing so merely combines prior art elements according to known methods to yield predictable results.
Claim 36
In regards to claim 36, Lin is not relied upon to disclose using the CPSI to evaluate the condition of the subject {the instant specification, [0082]-[0084] as published includes AAPA (Applicant Admitted Prior Art) describing a clinician (human)
evaluating the condition of the subject based on the improved CPSI image and otherwise does not specifically disclose an automated process for such an evaluation. Moreover, evaluating the condition of the patent using manual judgement of the clinician based on viewing the improved CPSI image is considered conventional (Office Notice).
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 have modified Lin to include disclose using the CPSI to evaluate the condition of the subject as taught by AAPA and/or Official Notice because there is a reasonable expectation of success and/or because doing so merely combines prior art elements according to known methods to yield predictable results.
Claims 11, 12, 20-26 and 29-35. (Canceled)
Allowable Subject Matter
Claims 6 and 7 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 an examiner’s statement of reasons for allowance:
Although Lin and Schmiedtlein disclose regularization terms none of the prior art discloses or fairly suggests wherein the regularization term corresponds to tight framelets based on a transform. Claim 7 depends from claim 6.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20130211247 A1 discloses a PET, SPECT system that includes a restoration model with regularization and non-negativity constraints. See [0099], [0135], [0214], [0255]-[0292].
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael R Cammarata whose telephone number is (571)272-0113. The examiner can normally be reached M-Th 7am-5pm EST.
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/MICHAEL ROBERT CAMMARATA/Primary Examiner, Art Unit 2667