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 .
Response to Amendment
The previous double patenting rejections remain.
In light of the amendments, the claims are rejected under 35 U.S.C. 101.
In light of the amendments, claims 2-8, 10-18, 20-21, and 23-25 are rejected under 35 U.S.C. 103.
In light of the amendments, claim 19 has not been given an art rejection.
Notice to Applicant
In the amendment dated 04/03/2026, the following has occurred: claims 2-5, 7-8, and 10-21 have been amended; claims 1, 9, and 22 have been canceled; claim 6 remains unchanged; and claims 23-25 have been added.
Claims 2-8, 10-21, and 23-25 are pending.
Effective Filing Date: 10/14/2015
Response to Arguments
Double Patenting Rejections:
Applicant would like these rejections held in abeyance until the claims are otherwise in condition for allowance. The rejections shall remain, but the discussion will remain held in abeyance until then.
35 U.S.C. 101 Rejections:
Step 2A, Prong One:
Applicant argues that the present claims are not directed towards an abstract idea under certain methods of organizing human activity. Applicant states that the radiologist’s role is limited to two discrete interactions and that every other step is performed by a processor. The processor however can be viewed as replacing a human, and the steps being performed by the processor are steps which can be classified under human activity (an abstract idea). The recitation of automation does not prevent the claims from such a determination, as there is breadth to automation.
Step 2A, Prong Two:
Applicant argues that the claims are integrated into a practical application and points to the claims reciting a specific technical improvement to computer-implemented medical imaging systems. The supposed technical problem is time pressure which leads to a failure to provide adequate follow-up recommendations. The technical solution to this problem is to provide a graphical user interface where information/recommendations about/for regions of interest are available upon selection. Applicant further states that the claim limitations as an ordered combination define a specific integrated technical system that improves the radiological workflow. Examiner however respectfully disagrees. Improving speed of recommendation via applying a computer to make a determination as opposed to a person can be viewed as taking an abstract idea and “applying it” with computing components.
Step 2B:
Applicant argues that the claims recite significantly more. Examiner however respectfully disagrees as the additional elements generally link the abstract idea to a particular technological environment, “apply” the abstract idea using generic computing components, or add insignificant extra-solution activity in the form of well-understood, routine, and conventional activity.
35 U.S.C. 103 Rejections:
Applicant argues with respect to the newly-added independent claims.
Applicant states that the ring-shaped menu is not taught in the previously-cited references. Examiner however used the newly-cited Fram reference to address this element.
Applicant further argues that the measurement limitation is not adequately supported using the prior art combination. Examiner however respectfully disagrees. The now broader recitation in the claim language does not prevent Examiner from applying the previously-cited narrow citation as the broad scope of the claim still includes the narrow limitation (the 3D volume is a measurement). The additional language involving the automatic initiation was met using the previously-cited references as well and can be seen in the updated 103 rejection section.
Applicant further argues that the radiological guideline limitation is not taught. Examiner however respectfully disagrees. The additional language involving the guideline limitation was met using the previously-cited references as well and can be seen in the updated 103 rejection section.
Applicant further argues that the overlaying positioning limitation is not taught. Examiner however respectfully disagrees. The recommendation 1399 in FIG. 13 of Kreeger et al. does not cover the region of interest 1397. Also, 1399 is in relation to 1397 where it is configured to be displayed away from 1397.
Applicant also argues that the automatic triggering limitation is not taught by Alkasab. Examiner however respectfully disagrees as Alkasab performs a determining and displaying of recommendation information. The distinction of performing a function in response to a selection on a ring-shaped menu is taught using the Fram reference. Also, the limitation of “automatically triggered” is broad and can include a process which received user input and then receives further input to initiate this.
Lastly, Applicant argues with respect to claims 18 and 19 and states that the arguments directed to the ring-shaped menu also apply. Examiner however respectfully disagrees based on Examiner’s explanation above for the ring-menu feature. Additionally, Examiner has withdrawn the art rejection for claim 19.
Non-Statutory Double Patenting
The non-statutory 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 non-statutory 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 non-statutory 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 non-statutory 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.
Claims 2-8, 10-21, and 23-25 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 12,154,688. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent anticipate the present claims. The present claims contain similar claim language to the patent without any functional distinctions.
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 2-8, 10-21, and 23-25 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 2-8, 16-19, and 23 are drawn to a method, claims 10-15, 20-21, and 24 are drawn to a system, and claim 25 is drawn to a non-transitory medium, each of which is within the four statutory categories. Claims 2-8, 10-21, and 23-25 are further directed to an abstract idea on the grounds set out in detail below. As discussed below, the claims do not include additional elements that are sufficient to amount to significantly more than the abstract idea because the additional computer elements, which are recited at a high level of generality, provide conventional computer functions that do not add meaningful limits to practicing the abstract idea (Step 1: YES).
Step 2A:
Prong One:
Claim 23 recites a method for generating a radiological report, comprising:
1) displaying, on a) a display, d) a digital radiograph image of a patient, the digital radiograph image including a region of interest;
2) receiving a user input, via b) a graphical user interface, designating the region of interest on the display displaying the digital radiograph image, wherein the user input identifies an anatomy of the region of interest, and b) wherein the graphical interface comprises a ring-shaped menu activated by selecting a point on the display corresponding to the region of interest;
3) performing, by c) a processor, a measurement of the anatomy, wherein the processor performs the measurement using image processing techniques, and wherein the measurement is automatically initiated in response to the user input designating the region of interest;
4) determining, by the processor, a radiological recommendation based on the anatomy, the measurement, and a radiological guideline;
5) displaying the radiological recommendation overlaid on the digital radiograph image, wherein the displaying of the radiological recommendation is automatically overlaid on the digital radiograph image in relation to the region of interest such that the overlaid radiological recommendation does not cover the region of interest, and
wherein the determining and displaying the radiological recommendation is automatically triggered when the user input is received;
6) receiving further user input comprising a modification of the radiological recommendation; and
7) generating, by the processor, a report including the modified radiological recommendation.
Claim 23 recites, in part, performing the steps of 1) displaying a radiograph image of a patient, the radiograph image including a region of interest, 2) receiving a user input designating the region of interest on the display displaying the digital radiograph image, wherein the user input identifies an anatomy of the region of interest, 3) performing a measurement of the anatomy, wherein the processor performs the measurement using image processing techniques, and wherein the measurement is automatically initiated in response to the user input designating the region of interest, 4) determining a radiological recommendation based on the anatomy, the measurement, and a radiological guideline, 5) displaying the radiological recommendation overlaid on the radiograph image, wherein the displaying of the radiological recommendation is automatically overlaid on the radiograph image in relation to the region of interest such that the overlaid radiological recommendation does not cover the region of interest, and wherein the determining and displaying the radiological recommendation is automatically triggered when the user input is received, 6) receiving further user input comprising a modification of the radiological recommendation, and 7) generating a report including the modified radiological recommendation. These steps correspond to Certain Methods of Organizing Human Activity, more particularly, managing personal behavior or relationships or interactions between people including following rules or instructions. Independent claims 24 and 25 recite similar limitations and are also directed to an abstract idea under the same analysis.
Depending claims 2-8 and 10-21 include all of the limitations of claims 1 and 9, and therefore likewise incorporate the above-described abstract idea. Depending claims 3 and 11 add the additional steps of “comparing, via the processor, the anatomy and the measurement to a corresponding anatomy and a corresponding measurement stored in a guideline database” and “determining, via the processor, a corresponding guideline recommendation associated with the anatomy and the measurement as the recommendation”; claims 4 and 12 add the additional step of “displaying a plurality of possible radiological recommendations”; claim 5 adds the additional step of “wherein determining the radiological recommendation includes receiving a user input selecting the radiological recommendation”; claims 7 and 14 add the additional step of “displaying the report including the radiological recommendation on a radiological system”; and claims 8 and 15 add the additional step of “changing a display of the digital radiograph image of the region of interest to show a user interface including available options, one of the available options including displaying the radiological recommendation”. Additionally, the limitations of depending claims 2, 6, 10, 13, and 16-21 further specify elements from the claims from which they depend on without adding any additional steps. These additional limitations only further serve to limit the abstract idea. Thus, depending claims 2-8 and 10-21 are nonetheless directed towards fundamentally the same abstract idea as independent claims 1 and 9 (Step 2A (Prong One): YES).
Prong Two:
This judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements of – using a) a display, b) a graphical user interface wherein the graphical user interface comprises a ring-shaped menu activated by selecting a point on the display corresponding to the region of interest, c) a processor, and d) a digital radiograph image to perform the claimed steps.
The a) display and b) graphical user interface wherein the graphical user interface comprises a ring-shaped menu activated by selecting a point on the display corresponding to the region of interest in these steps add insignificant extra-solution activity to the abstract idea such as recitation of a user interface and a display which amounts to mere data gathering, while recitation of a display also amounts to insignificant application, see MPEP 2106.05(g)).
The c) processor (and alternatively b) a graphical user interface wherein the graphical user interface comprises a ring-shaped menu activated by selecting a point on the display corresponding to the region of interest, if not directed towards extra-solution activity) in these steps is recited at a high-level of generality (i.e., as generic components performing generic computer functions such as determining data from a set of data) such that it amount to no more than mere instructions to apply the exception using a generic computer component (see: Applicant’s specification where is there is a lack of disclosure of anything other than a generic processor being used).
The d) digital radiograph image in these steps generally links the abstract idea to a particular technological environment or field of use (such as digital radiography, see MPEP 2106.05(h)).
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea (Step 2A (Prong Two): NO).
Step 2B:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of using a) a display, b) a graphical user interface wherein the graphical user interface comprises a ring-shaped menu activated by selecting a point on the display corresponding to the region of interest, c) a processor, and d) a digital radiograph image to perform the claimed steps amounts to no more than insignificant extra-solution activity in the form of WURC activity (well-understood, routine, and conventional activity), a general linking to a particular technological environment, or mere instructions to apply the exception using a generic computer component that does not offer “significantly more” than the abstract idea itself because the claims do not recite an improvement to another technology or technical field, an improvement to the functioning of any computer itself, or provide meaningful limitations beyond generally linking an abstract idea to a particular technological environment. It should be noted that the claims do not include additional elements that amount to significantly more than the judicial exception because the Specification recites mere generic computer components, as discussed above that are being used to apply certain method steps of organizing human activity. Specifically, MPEP 2106.05(d), MPEP 2106.05(f), and MPEP 2106.05(h) recite that the following limitations are not significantly more:
Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d));
Adding the words "apply it" (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, e.g., a limitation indicating that a particular function such as creating and maintaining electronic records is performed by a computer, as discussed in Alice Corp., 134 S. Ct. at 2360, 110 USPQ2d at 1984 (see MPEP § 2106.05(f)); and
Generally linking the use of the judicial exception to a particular technological environment or field of use, e.g., a claim describing how the abstract idea of hedging could be used in the commodities and energy markets, as discussed in Bilski v. Kappos, 561 U.S. 593, 595, 95 USPQ2d 1001, 1010 (2010) or a claim limiting the use of a mathematical formula to the petrochemical and oil-refining fields, as discussed in Parker v. Flook, 437 U.S. 584, 588-90, 198 USPQ 193, 197-98 (1978) (MPEP § 2106.05(h)).
The a) display and b) graphical user interface wherein the graphical user interface comprises a ring activated by selecting a point on the display and clicking a specific button in these steps add insignificant extra-solution activity/pre-solution activity to the abstract idea. The following is an example that courts have deemed WURC activity (e.g. see MPEP 2106.05(g)): Presenting offers to potential customers and gathering statistics generated based on the testing about how potential customers responded to the offers; the statistics are then used to calculate an optimized price, e.g. see OIP Technologies – similarly, the current invention presents the user with a a) display and b) graphical user interface, gathers response data in the form of input data, and utilizes the response data to display recommendations.
Furthermore, the current invention generates a report including a recommendation utilizing c) a processor (and alternatively b) a graphical user interface wherein the graphical user interface comprises a ring-shaped menu activated by selecting a point on the display corresponding to the region of interest, if not directed towards extra-solution activity), thus the processor is adding the words “apply it” with mere instructions to implement the abstract idea on a computer.
Lastly, the d) digital radiograph image generally links the abstract idea to a particular technological environment or field of use. The following represent an example that courts have identified as generally linking the abstract idea to a particular technological environment (e.g. see MPEP 2106.05(h)): Limiting the abstract idea to a digital radiograph image, because limiting application of the abstract idea to a digital image is simply an attempt to limit the use of the abstract idea to a particular technological environment, e.g. see Electric Power Group, LLC v. Alstom S.A.
Mere instructions to apply an exception using generic computer components, a general linking to a particular technological environment, and WURC activity cannot provide an inventive concept. The claims are not patent eligible (Step 2B: NO).
Claims 2-8, 10-21, and 23-25 are therefore rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
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.
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.
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 2-8, 10-18, 20-21, and 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over W.O. 2015/031296 A1 to Alkasab in view of U.S. Patent No. 9,146,663 to Kreeger et al. further in view of U.S. 2014/0365232 to Sadeghi and further in view of U.S. Patent No. 10,162,483 to Fram.
As per claim 23, Alkasab teaches a method for generating a radiological report, comprising:
--displaying, on a display, an image of a patient, the image including a region of interest; (see: paragraph [0019] where there is an annotation that may include graphical symbols generated on the medical image. The annotation is displayed, and thus, an image of a region of interest is being displayed. The image here is of a patient)
--receiving a user input, via a graphical user interface, designating the region of interest on the display displaying the image, wherein the user input identifies an anatomy of the region of interest; (see: 112 and 114 of FIG. 2 and paragraph [0019] where input data is being collected from the radiologists via the display displaying the image, thus user input is being received designating an image characteristic such as points of interest. Also see: paragraph [0033])
--determining, by the processor, a recommendation based on the anatomy and the measurement; (see: paragraph [0019] and FIG. 6 where a standardized specification is generated that may be a recommendation. The recommendation is based on the inputted characteristics of the lesion or nodule. The input can include a lesion size (a measurement) and the nodule itself including the regions of interest is the anatomy) and
--displaying the recommendation; (see: paragraph [0038] where there is standardized specifications (recommendation) are being displayed to a radiologist)
--wherein the determining and displaying the recommendation is automatically triggered when the user input is received; (see: paragraph [0019] where the input data is forwarded to the decision support engine to generate the standard specification. Also see: paragraphs [0008] and [0009] where after a recommendation (report) is generated automatically user’s manual input)
--receiving further user input comprising a modification of the recommendation; (see: paragraph [0018] where a modification of a recommendation via a modification to a decision support algorithm) and
--generating, by the processor, a report including the modified recommendation (see: paragraph [0019] where the standardized specification may be sent back to the report system to integrate the standardized specification (recommendation) into the current report. Also see: paragraph [0018] where the modified recommendation is the one that could be generated).
Alkasab teaches the above-mentioned limitations. The difference between Alkasab and the claimed invention is that while Alkasab does disclose a method of selecting regions of interest and displaying recommendations, it does not explicitly teach wherein the recommendation is overlaid on the image. More specifically, Alkasab may not further, specifically teach:
1) --wherein the graphical user interface comprises a ring-shaped menu activated by selecting a point on the display corresponding to the region of interest;
2) --performing, by a processor, a measurement of the anatomy, wherein the processor performs the measurement using image processing techniques, and wherein the measurement is automatically initiated in response to the user input designating the region of interest;
3) --determining a radiological recommendation based on a radiological guideline;
4) --displaying the radiological recommendation overlaid on the digital radiograph image, wherein the displaying of the radiological recommendation is automatically overlaid on the digital radiograph image in relation to the region of interest such that the overlaid radiological recommendation does not cover the region of interest;
5) --an image as a digital radiograph image, and
6) --a recommendation as a radiological recommendation.
Kreeger et al. teaches:
2) --performing, by a processor, a measurement of the anatomy, wherein the processor performs the measurement using image processing techniques, (see: column 22, line 35 to column 23, line 7 where there are density metrics (measurement of the anatomy) for fibroglandular tissue. The metric here is a measurement comprising a volume of the anatomy and it is CAD-computed (image processing aided as recited in column 25, lines 61-67)) and wherein the measurement is automatically initiated in response to the user input designating the region of interest; (see: column 12, lines 13-26 where there is a selection of a ROI and then the density assessment which occurs in the previous limitation would occur after the ROI is selected) and
4) --displaying the radiological recommendation overlaid in the digital radiograph image, wherein the displaying of the radiological recommendation is automatically overlaid on the digital radiograph image in relation to the region of interest such that the overlaid radiological recommendation does not cover the region of interest (see: FIG. 13 and column 24, lines 20-28 where there is a recommendation (1399) automatically being displayed and overlaid on the medical image in relation to the region of interest 1397. The recommendation also does not cover the region of interest 1397, and it is in relation to the image).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute 2) performing, performing, by a processor, a measurement of the anatomy, wherein the processor performs the measurement using image processing techniques, and wherein the measurement is automatically initiated in response to the user input designating the region of interest as taught by Kreeger et al. for the measurement as disclosed by Alkasab since each individual element and its function are shown in the prior art, with the difference being the substitution of the elements. In the present case, Alkasab talks about generating a measurement of a tumor size thus one could substitute this size with a measurement of volume to obtain the predictable results of using the physical properties of the tumor to determine a recommendation. Thus, one of ordinary skill in the art could have substituted the one known element for the other to produce a predictable result (MPEP 2143).
Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute 4) displaying the recommendation overlaid in the image, wherein the displaying of the recommendation is automatically overlaid on the image in relation to the region of interest such that the overlaid recommendation does not cover the region of interest as taught by Kreeger et al. for displayed recommendations as disclosed by Alkasab since each individual element and its function are shown in the prior art, with the difference being the substitution of the elements. In the present case, Alkasab talks about generating and displaying a report (recommendations) thus one could substitute wherein these recommendations are displayed over the medical image in relation to the region of interest to obtain the predictable results of displaying recommendations. Thus, one of ordinary skill in the art could have substituted the one known element for the other to produce a predictable result (MPEP 2143).
Sadeghi teaches:
3) --determining a radiological recommendation based on a radiological guideline (see: paragraphs [0122] – [0123] where there is a determination of a recommendation based on Fleischner guidelines. The recommendations here are specified by the Fleischner guideline risk factor. Also see: paragraph [0036] where there are radiology reports)
5) --an image as a digital radiograph image, (see: paragraph [0036] where there are images from a radiology report) and
6) --a recommendation as a radiological recommendation (see: paragraph [0122] where there are recommendations).
One of ordinary skill at the time of the invention was filed would have found it obvious to 3) determine a radiological recommendation based on a radiological guideline as taught by Sadeghi in the method as taught by Alkasab with the motivation(s) of identifying problems in real time to improve efficiency (see: paragraph [0036] of Sadeghi).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute 5) a digital radiograph image as taught by Sadeghi for the image as disclosed by Alkasab and Kreeger et al. in combination since each individual element and its function are shown in the prior art, with the difference being the substitution of the elements. In the present case, Alkasab already teaches of using an image and one could swap that image with another image to obtain predictable results of using an image to assess it. Thus, one of ordinary skill in the art could have substituted the one known element for the other to produce a predictable result (MPEP 2143).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute 6) a radiological recommendation as taught by Sadeghi for the recommendation as disclosed by Alkasab and Kreeger et al. in combination since each individual element and its function are shown in the prior art, with the difference being the substitution of the elements. In the present case, Alkasab already teaches of using a recommendation and one could swap that recommendation with another recommendation to obtain predictable results of using generating a recommendation. Thus, one of ordinary skill in the art could have substituted the one known element for the other to produce a predictable result (MPEP 2143).
Fram teaches:
1) --wherein the graphical user interface comprises a ring-shaped menu activated by selecting a point on the display corresponding to the region of interest (see: FIGS. 1b, 7a, and 7b where there is a radial (ring-shaped) menu activated via selecting a region on the screen. The region being selected as being a region of interest was already taught in the base references above).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to have 1) wherein the graphical user interface comprises a ring-shaped menu activated by selecting a point on the display corresponding to the region of interest as taught by Fram in the method as taught by Alkasab, Kreeger et al., and Sadeghi in combination with the motivation(s) of preventing user fatigue when interacting with an interface (see: column 1, lines 37-40 of Fram).
As per claim 2, Alkasab, Kreeger et al., Sadeghi, and Fram in combination teaches the method of claim 23, see claim 23. Alkasab further teaches wherein the recommendation includes a modality (see: FIGS. 3 and 6 where there are recommendations of “adrenal mass protocol CT” (modality) in “6 months” (timeframe)).
Sadeghi further teaches radiological recommendation (see: paragraph [0122] where there are recommendations).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 23, and incorporated herein.
As per claim 3, Alkasab, Kreeger et al., Sadeghi, and Fram in combination teaches the method of claim 23, see claim 23. Alkasab further teaches wherein determining the recommendation includes:
--comparing, via the processor, the anatomy and the measurement to a corresponding anatomy and a corresponding measurement stored in a guidelines database; (see: 116 of FIG. 2 and paragraph [0021] where a comparison of characteristics is occurring based on stored, predetermined guidelines) and
--determining, via the processor, a corresponding guideline recommendation associated with the anatomy and the measurement as the recommendation (see: 118, 120, and 124 of FIG. 2 and paragraphs [0034] - [0036] where a standardized specification/annotation is being generated as a recommendation with respect to the compared characteristics).
Sadeghi further teaches radiological recommendation (see: paragraph [0122] where there are recommendations).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 23, and incorporated herein.
As per claim 4, Alkasab, Kreeger et al., Sadeghi, and Fram in combination teaches the method of claim 23, see claim 23. Alkasab further teaches displaying a plurality of possible recommendations (see: paragraphs [0023] – [0024] where the user or radiologist are notified of important results and appropriate follow-up recommendations).
Sadeghi further teaches radiological recommendation (see: paragraph [0122] where there are recommendations).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 23, and incorporated herein.
As per claim 5, Alkasab, Kreeger et al., Sadeghi, and Fram in combination teaches the method of claim 1, see claim 1. Alkasab further teaches wherein determining the recommendation includes receiving a user input selecting the recommendation (see: paragraph [0037] where user input is the button 64 hit).
Sadeghi further teaches radiological recommendation (see: paragraph [0122] where there are recommendations).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 23, and incorporated herein.
As per claim 6, Alkasab, Kreeger et al., Sadeghi, and Fram in combination teaches the method of claim 5, see claim 5. Alkasab further teaches wherein the user input includes at least one of a manual input and a voice input (see: paragraph [0037] where a user can select the recommendation via a button 64 that, when hit (manual input), indicates a satisfaction of the standardized specification 22).
As per claim 7, Alkasab, Kreeger et al., Sadeghi, and Fram in combination teaches the method of claim 23, see claim 23. Alkasab further teaches displaying the report including the recommendation (see: paragraph [0019] where the current report is displayed for the radiologist to view. The report includes the recommendation (standardized specification)).
Sadeghi further teaches radiological recommendation (see: paragraph [0122] where there are recommendations).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 23, and incorporated herein.
As per claim 8, Alkasab, Kreeger et al., Sadeghi, and Fram in combination teaches the method of claim 23, see claim 23. Alkasab further teaches changing a display of the image of the region of interest to show a user interface including available options, one of the available options including displaying the recommendation (see: paragraphs [0033] – [0034] where the patient data may be input by a radiologist on a display screen, and then a standard specification is generated and displayed in a report section on the display).
Sadeghi further teaches radiological recommendation (see: paragraph [0122] where there are recommendations) and digital radiograph image (see: paragraph [0036] where there are images from a radiology report).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 23, and incorporated herein.
As per claim 10, claim 10 is similar to claim 2 and is therefore rejected for similar reasons as claim 2 using the Alkasab, Kreeger et al., Sadeghi, and Fram references in combination.
As per claim 11, claim 11 is similar to claim 3 and is therefore rejected for similar reasons as claim 3 using the Alkasab, Kreeger et al., Sadeghi, and Fram references in combination.
As per claim 12, claim 12 is similar to claim 4 and is therefore rejected for similar reasons as claim 4 using the Alkasab, Kreeger et al., Sadeghi, and Fram references in combination.
As per claim 13, claim 13 is similar to claim 6 and is therefore rejected for similar reasons as claim 6 using the Alkasab, Kreeger et al., Sadeghi, and Fram references in combination.
As per claim 14, Alkasab, Kreeger et al., Sadeghi, and Fram in combination teaches the system of claim 24, see claim 24. Alkasab further teaches wherein a display displays the report including the recommendation (see: paragraph [0019] where the current report is displayed for the radiologist to view. The report includes the recommendation (standardized specification)).
Sadeghi further teaches radiological recommendation (see: paragraph [0122] where there are recommendations).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 24, and incorporated herein.
As per claim 15, claim 15 is similar to claim 8 and is therefore rejected for similar reasons as claim 8 using the Alkasab, Kreeger et al., Sadeghi, and Fram references in combination.
As per claim 16, Alkasab, Kreeger et al., Sadeghi, and Fram in combination teaches the method of claim 23, see claim 23. Sadeghi further teaches wherein the radiological recommendation comprises an audio file (see: paragraph [0141] where there is an audio recording which can convey a recommendation. Also see: paragraph [0066] where there are audible alerts).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 23, and incorporated herein.
As per claim 17, Alkasab, Kreeger et al., Sadeghi, and Fram in combination teaches the method of claim 23, see claim 23. Sadeghi further teaches wherein the radiological recommendation is a follow up radiology procedure to occur within 3-12 months (see: paragraph [0090] where a follow-up CT is called for within 12 months based on the guidelines).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 23, and incorporated herein.
As per claim 18, Alkasab, Kreeger et al., Sadeghi, and Fram in combination teaches the method of claim 23, see claim 23. Sadeghi further teaches wherein the Fleischner Guideline risk factor is nodule size and location (see: paragraph [0062] where the Fleischner Guideline risk factor is nodule size and other guidelines. Location would be another guideline. Location is also taught as a guideline in Alkasab in paragraph [0022]).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 23, and incorporated herein.
As per claim 20, Alkasab, Kreeger et al., Sadeghi, and Fram in combination teaches the system of claim 24, see claim 24. Sadeghi further teaches a radiological follow up recommendation (see: paragraph [0090] where a follow-up CT is called for within 12 months based on the guidelines).
Kreeger et al. further teaches wherein a pop-up or menu is overlaid on the displayed digital radiograph (see: FIG. 13 and column 24, lines 20-28 where there is a recommendation automatically being displayed and overlaid on the medical image in relation to the image characteristic 1397).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 24, and incorporated herein.
As per claim 21, Alkasab, Kreeger et al., Sadeghi, and Fram in combination teaches the system of claim 24, see claim 24. Alkasab further teaches wherein the radiological system for generating a radiological report is a Picture Archive and Communications System used by a radiologist for reading an image or set of images and reporting findings (see: paragraph [0026] where a PACS system is integrated with the system).
As per claim 24, claim 24 is similar to claim 23 and is therefore rejected for similar reasons as claim 23 using the Alkasab, Kreeger et al., Sadeghi, and Fram references in combination.
As per claim 25, claim 25 is similar to claim 23 and is therefore rejected for similar reasons as claim 23 using the Alkasab, Kreeger et al., Sadeghi, and Fram references in combination.
No Art Rejections
Claim 19 has not been given an art rejection based on the combination of references which could be used to reject this claim not being a reasonable combination.
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 Steven G.S. Sanghera whose telephone number is (571)272-6873. The examiner can normally be reached M-F 7:30-5:00 (alternating Fri).
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/STEVEN G.S. SANGHERA/Primary Examiner, Art Unit 3684
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