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 .
Priority
Acknowledgement is made of this application being a continuation-in-part of U.S. Patent Application No. 18/179,331, filed on March 6, 2023, now U.S. Patent No. 11,900,602 issued on February 13, 2024, which is a continuation of U.S. Patent Application No. 16, 854,838, filed on April 21, 2020, now U.S. Patent No. 11,599,995, issued on March 7, 2023, which claims priority to Chinese Application No. CN201910335013.7, filed on April 24, 2019.
Information Disclosure Statement
The information disclosure statement (“IDS”) filed on 04/29/2024 was reviewed and the listed references were noted.
Drawings
The 12-page drawings have been considered and placed on record in the file.
Status of Claims
Claims 1-20 are pending.
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.
Claim Objections
Claims 4, 14, and 19 are objected to because of the following informalities:
(i) in line 4 of the claim, “a anatomical” should be changed to “an anatomical”; and the last line of the claim, “for scaning” should be changed to “for scanning”; and
(ii) in Claim 14, line 2, and 19, line 3, “regional paramters” should be changed to “regional parameters”.
Appropriate corrections are required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Independent Claims 1, 15, and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable at least over Claims 1 of U.S. Patent Nos. 11,599,995 and 11,900,602. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the present application are anticipated by the scopes and contents of the patented claims “Anticipation is the epitome of obviousness”, Realtime Data, LLC v. Iancu; also MPEP 1207.03(a)(II)(2). See below tables for comparison of Claim 1 of the instant application with respect to Claim 1 of the two above-referenced patents.
Application 18/437,162 (Present Application)
US 11,900,602
A system, comprising: at least one storage device including a set of instructions; and
at least one processor configured to communicate with the at least one storage device, wherein when executing the set of instructions, the at least one processor is configured to direct the system to perform operations including:
obtaining scanning data of a subject acquired using a scanner;
determining a reconstruction parameter of an objective function, wherein the reconstruction parameter includes one or more global components that control an image quality over an entire image to be reconstructed and one or more local components that control the image quality over a portion of the image to be reconstructed; and
generating the image of the subject by reconstructing the scanning data based on the objective function..
A system, comprising: at least one storage device including a set of instructions; and
at least one processor configured to communicate with the at least one storage device, wherein when executing the set of instructions, the at least one processor is configured to direct the system to perform operations including:
obtaining a preliminary image and scanning data of a subject acquired using a scanner;
determining a regularization parameter for a regularization item of an objective function based at least in part on the scanning data, wherein the regularization parameter includes a component characterizing a feature of the subject; and
generating an image of the subject by reconstructing the preliminary image based on the objective function, wherein the component of the regularization parameter relates to attenuation information and boundary information of the subject, and the attenuation information is combined with a spatial sensitivity of the scanner via a spatial sensitivity map that includes the spatial sensitivity of the scanner and the attenuation information of the subject.
Application 18/437,162 (Present Application)
US 11,599,995
A system, comprising: at least one storage device including a set of instructions; and
at least one processor configured to communicate with the at least one storage device, wherein when executing the set of instructions, the at least one processor is configured to direct the system to perform operations including:
obtaining scanning data of a subject acquired using a scanner;
determining a reconstruction parameter of an objective function, wherein the reconstruction parameter includes one or more global components that control an image quality over an entire image to be reconstructed and one or more local components that control the image quality over a portion of the image to be reconstructed; and
generating the image of the subject by reconstructing the scanning data based on the objective function..
A system, comprising: at least one storage device including a set of instructions; and
at least one processor configured to communicate with the at least one storage device, wherein when executing the set of instructions, the at least one processor is configured to direct the system to perform operations including:
obtaining a preliminary image and scanning data of a subject acquired using a scanner;
determining a regularization parameter for a regularization item of an objective function based at least in part on the scanning data, wherein the regularization parameter includes a first component characterizing quality of the scanning data, and at least one of a second component characterizing the scanner, or a third component characterizing a feature of the subject, wherein the scanning data is positron emission tomography (PET) data, and the first component relates to a noise equivalent counts relating to the PET data, the noise equivalent counts being obtained by processing the PET data; and
generating an image of the subject by reconstructing the preliminary image based on the objective function.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
a. Determining the scope and contents of the prior art.
b. Ascertaining the differences between the prior art and the claims at issue.
c. Resolving the level of ordinary skill in the pertinent art.
d. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 1-19 are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (US 2020/0105032).
Regarding Claim 1, Yang discloses “A system” (Figure 8B), “comprising: at least one storage device including a set of instructions” (Figure 8B:878); “and at least one processor configured to communicate with the at least one storage device, wherein when executing the set of instructions, the at least one processor is configured to direct the system to perform operations including (Figure 8B:870; Paragraph [0073] discloses “The processor 870 can be configured to perform various steps of methods 100 and/or 200 described herein and variations thereof”): obtaining a preliminary image and scanning data of a subject acquired using a scanner (Paragraph [0044] discloses “method 200 begins at step 210 by obtaining emission data 205 for tomographic reconstruction of a PET image”); “determining a reconstruction parameter of an objective function, wherein the reconstruction parameter includes one or more global components that control an image quality over an entire image to be reconstructed” (Paragraph [0054] discloses “In certain implementations, the β-map can also include additional factors such as a scaling by the system sensitivity, in which case the final β-map can be given by βj=ƒ(xjOSEM)×Sensitivityj, wherein Sensitivityj is a system sensitivity corresponding to the jth voxel/pixel in the reconstructed image xOSEM”, which in effect is considered a global component which controls the quality of scanning data) “and one or more local components that control the image quality over a portion of the image to be reconstructed” (Paragraphs [0034] and [0035] disclose “when the same regularization penalty function with the same penalty strength and parameters is applied to datasets with different amounts of acquired activity (e.g., due to different scan times), then noise level in the reconstructed image increases inversely with the acquired activity (e.g., scan time), suggesting that a large smoothing parameter (i.e., penalty strength) can be used for low-count datasets to suppress the greater noise level in the reconstructed image.” “Choosing regularization parameters that stabilize resulting image properties can be advantageous. Since different organs have different background activity levels, the regularization parameter can be position dependent (e.g., organ-activity dependent) in addition to being PET scan dependent (e.g., image and/or acquisition time dependent)” In addition, Paragraph [0037] discloses “when the regularization term penalizes variations/noise in the reconstructed PET image, increasing the value of the regularization parameter β increases the degree of smoothing, reducing both the noise level and the resolution.); “and generating an image of the subject by reconstructing the preliminary image based on the objective function” (Paragraph [0049] discloses “In the step 240, the PET image is refined and improved using an IR algorithm that includes spatially-varying regularization, resulting in the PET image from the final iteration of the IR algorithm being the reconstructed image.”)
Accordingly, before the effective date of the instant application, it would have been obvious to one of ordinary skill in the art to combine different implementations taught by Yang to arrive at a reconstruction parameter that includes one or more global component that control an image quality over an entire image and one or more local component that control the image quality over a portion of the image to be constructed. One of ordinary skill in the art could have combined the various implementations of Yang in order to control the smoothness of the portion of the image and increase the quality of the overall scan by optimizing the objective function as taught by Yang (Yang, Paragraphs [0025] and [0058]). Therefore, it would have been obvious to combine the implementations taught in Yang to obtain the invention in Claim 1.
Consider Claim 2, Yang discloses “The system of claim 1, wherein the image quality includes at least one of an accuracy of the image, an accuracy of quantitative information on metabolism related to the image, an image noise level, a convergence level, an image resolution, an image style, or an image smoothness” (Emphasis added) (Yang, Abstract) .
Consider Claim 3, Yang discloses “The system of claim 1, wherein the one or more global components include at least one of a component characterizing a quality of the scanning data, a component characterizing a type of a radionuclide injected into the subject, or a component characterizing global subject information of the subject” (emphasis added) (Yang, Paragraph [0054] discloses “In certain implementations, the β-map can also include additional factors such as a scaling by the system sensitivity, in which case the final β-map can be given by βj=ƒ(xjOSEM)×Sensitivityj, wherein Sensitivityj is a system sensitivity corresponding to the jth voxel/pixel in the reconstructed image xOSEM”, which in effect is considered a global component which controls the quality of scanning data) .
Consider Claim 4, Yang discloses “The system of claim 1, wherein the one or more local components include at least one of a component characterizing hardware or software configurations of the scanner, a component characterizing a [sic] anatomical structure of the subject; a component characterizing local subject information of the subject, or a component characterizing a scanning condition for scaning [sic] the subject” (Emphasis added) (Yang, Paragraph [0035] discloses “Since different organs have different background activity levels, the regularization parameter can be position dependent (e.g., organ-activity dependent), therefore, the component characterizes an anatomical structure of the subject) .
Consider Claim 5, Yang discloses “The system of claim 1, wherein the objective function relates to analytic reconstruction” (Yang, Paragraph [0037], where reconstructed image is generated solving the optimization problem of the objective function).
Consider Claim 6, Yang discloses “The system of claim 5, wherein the reconstruction parameter includes at least one of a type of a filter function used in filtered back projection or a filter parameter of the filter function” (emphasis added) (Yang, Paragraph [0046]) .
Consider Claim 7, Yang discloses “The system of claim 1, wherein the objective function relates to iterative reconstruction” (Yang, for example, Paragraphs [0029], [0030], and [0057]).
Consider Claim 8, Yang discloses “The system of claim 7, wherein the reconstruction parameter includes a count of subsets of the scanning data used in the iterative reconstruction” (Yang, Paragraph [0064]).
Consider Claim 9, Yang discloses “The system of claim 7, wherein the reconstruction parameter includes a size of pixels or voxels used in the iterative reconstruction” (Yang, Paragraph [0052]).
Consider Claim 10, Yang discloses “The system of claim 7, wherein the reconstruction parameter includes a size of pixels or voxels used in the iterative reconstruction” (Yang, Paragraph [0050]).
Consider Claim 11, Yang discloses “The system of claim 7, wherein the reconstruction parameter includes at least one regularization item” (Yang, Paragraph [0037] discloses “ϕ(x) is the regularization term (also known as regularizer)”).
Consider Claim 12, Yang discloses “The system of claim 11, wherein the reconstruction parameter includes at least one regularization parameter each of which corresponds to one of the at least one regularization item” (Yang, Paragraph [0037] discloses “β is the regularization parameter that controls the degree of regularization (also referred to as a penalty strength”).
Consider Claim 13, Yang discloses “The system of claim 1, wherein the objective function relates to regional reconstruction” (Yang, Paragraph [0041] discloses “ As illustrated in FIG. 3B, when the smoothing level is increased to mitigate noise in the lung region”).
Consider Claim 14, Yang discloses “The system of claim 13, wherein the reconstruction parameter includes a plurality of regional paramters [sic] each of which corresponds to reconstruction of one of at least two region of the subject.” (Yang, Paragraph [0041] discloses “ As illustrated in FIG. 3B, where both lung and heart regions are disclosed”).
Claim 15 recites a method with steps corresponding to the elements of the system recited in Claim 1. Therefore, the recited steps of this claim are mapped to the proposed combination in the same manner as the corresponding elements in its corresponding system claim. Additionally, the rationale and motivation to combine the implementations of Yang, presented in rejection of Claim 1, apply to this claim.
Claim 16 recites a method with steps corresponding to the combined elements of the systems recited in Claims 3 and 4. Therefore, the recited steps of this claim are mapped to the proposed combination in the same manner as the corresponding elements in its corresponding system claims. Additionally, the rationale and motivation to combine the implementations of Yang, presented in rejection of Claim 1, apply to this claim.
Claim 17 recites a method with steps corresponding to the combined elements of the systems recited in Claims 5 and 6. Therefore, the recited steps of this claim are mapped to the proposed combination in the same manner as the corresponding elements in its corresponding system claims. Additionally, the rationale and motivation to combine the implementations of Yang, presented in rejection of Claim 1, apply to this claim.
Claim 18 recites a method with steps corresponding to the combined elements of the systems recited in Claims 7-12. Therefore, the recited steps of this claim are mapped to the proposed combination in the same manner as the corresponding elements in its corresponding system claims. Additionally, the rationale and motivation to combine the implementations of Yang, presented in rejection of Claim 1, apply to this claim.
Claim 19 recites a method with steps corresponding to the combined elements of the systems recited in Claims 13 and 14. Therefore, the recited steps of this claim are mapped to the proposed combination in the same manner as the corresponding elements in its corresponding system claims. Additionally, the rationale and motivation to combine the implementations of Yang, presented in rejection of Claim 1, apply to this claim.
Allowable Subject Matter
Claim 20 is not rejected over prior art, and would be allowable if the above-described rejection of this claim under non-statutory double patenting is overcome. The following is a statement of reasons for the indication of allowable subject matter: none of the cited prior art references, alone or in combination, provides a motivation to teach the ordered combination of “generating an image of the subject by reconstructing the preliminary image and the scanning data based on the objective function, wherein the component of the regularization parameter relates to attenuation information and boundary information of the subject, and the attenuation information is combined with a spatial sensitivity of the scanner via a spatial sensitivity map that includes the spatial sensitivity of the scanner and the attenuation information of the subject” (emphasis added).
Conclusion and Contact Information
The prior art made of record and not relied upon is considered pertinent to Applicant’s disclosure: Boas et al. (US 2003/0190066).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Siamak HARANDI whose telephone number is (571)270-1832. The examiner can normally be reached Monday - Friday 9:30 - 6:00 ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amandeep Saini can be reached on (571)272-3382. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For
additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Siamak Harandi/Primary Examiner, Art Unit 2662
Prosecution Insights