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 .
Drawings
The drawings were submitted on 12/26/2024. These drawings are reviewed and accepted by the examiner.
Claim Rejections - 35 USC § 102
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.
Claim(s) 2-37 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Roberge (US 20140052444 A1).
Regarding claims 2, 14, and 26, Roberge (US 20140052444 A1) teaches:
“identifying one or more words or phrases in a voice input comprising natural language speech associated with a patient report” (par. 0092; ‘The present invention is a system and methods configured to receive an utterance made by a user, such as a medical professional, and matches the words in that utterance against at least one template in a set of templates to select the best matching template or set of templates.’);
“obtaining at least one clinical structured report template with medical data comprising medical examination data points associated with the patient report” (par. 0094; ‘As described herein, the present invention utilizes an algorithm to correlate the words of the spoken utterance to a template within a template hierarchy.’)
“determining an action category comprising a navigation action external to the clinical structured report template without a separate explicit voice command for the navigation action external to the clinical structured report template” (par. 0094; ‘In addition, the algorithm selects nodes--specifically data elements or in certain embodiments coded data elements--of the template hierarchical structure to populate the template.’; par. 0110; ‘The data elements corresponding to the terms 132, 141, 153, 166, 181, 191 are used to populate the template such that the utterance is matched to the populated template.’; par. 0175; ‘In some embodiments, when an assessment reveals that an utterance corresponds to a marker, which may be configured to cause the processor to perform a computer-implemented task.’)
“automatically generating a clinical structured report based on the clinical structured report template with medical data comprising medical examination data points associated with the patient report, wherein the generated clinical structured report includes modifications to the clinical structured report template based on the identified one or more words or phrases and the navigation action external to the clinical structured report template” (par. 0114; ‘The radiologist may then complete the report template 200 with the following series of utterances: [0115] history asthma [0116] clear well-inflated lungs [0117] no mass [0118] no pleural effusions [0119] negative chest which are then matched to the associated narrative templates 300 shown in FIG. 4.’); and
“generating and outputting the clinical structured report in a computer displayable format” (par. 0182; ‘Advantageously, in embodiments in which the indicator is hidden, more area of the user interface may be available for displaying a medical image, medical record, information-entry interface, or other information in the record.’).
Regarding claims 3 (dep. on claim 2), 15 (dep. on claim 14), and 27 (dep. on claim 26), Roberge further teaches:
“wherein the action category further comprises one or more of dictation or macros, wherein the modifications to the clinical structured report are based on the determined action category” (par. 0189; ‘Another example of an input utterance associated with a visible indicator may be the phrase "Atypical chest pain", which may cause saving information corresponding to utterance in record, e.g., by invoking an associated macro.’).
Regarding claims 4 (dep. on claim 3), 16 (dep. on claim 15), and 28 (dep. on claim 27), Roberge further teaches:
“wherein the determined action category is dictation, the method further comprising: identifying a focus area of the identified one or more words or phrases, wherein the focus area comprises one of a text area of the clinical structured report or a smart finding associated with the medical examination data points” (par. 0070; ‘For example, a radiologist might invoke a template with the utterance "small mass invading the liver, round, more dense than fat". The matching algorithm uses the words in this utterance to select and populate the appropriate narrative template or, more precisely, to populate the narrative template with the data elements corresponding to the terms of the template.’); and
“modifying the clinical structured report based on the identified focus area” (par. 0070; ‘The matching algorithm uses the words in this utterance to select and populate the appropriate narrative template or, more precisely, to populate the narrative template with the data elements corresponding to the terms of the template.’).
Regarding claims 5 (dep. on claim 4), 17 (dep. on claim 16), and 29 (dep. on claim 28), Roberge further teaches:
“wherein the identified focus area is a text area, the method further comprising: placing the identified one or more words or phrases in the text area of the clinical structured report” (par. 0070; ‘The matching algorithm uses the words in this utterance to select and populate the appropriate narrative template or, more precisely, to populate the narrative template with the data elements corresponding to the terms of the template.’).
Regarding claims 6 (dep. on claim 4), 18 (dep. on claim 16), and 30 (dep. on claim 28), Roberge further teaches:
“wherein the identified focus area is a smart finding associated with the medical examination data points, the method further comprising: determining a finding category of the smart finding, wherein the finding category comprises one or more of a medical finding or a characteristic” (par. 0072; ‘The present invention uses the data elements recorded within the templates to automatically position the edited information in the report template; for instance, to automatically replace the normative impression "negative chest x-ray" with an impression related to the observed abnormality such as "findings consistent with chronic bronchitis".’).
Regarding claims 7 (dep. on claim 6), 19 (dep. on claim 18), and 31 (dep. on claim 30), Roberge further teaches:
“wherein the finding category is a medical finding, the method further comprising: determining whether the medical finding comprises an abnormal finding; and modifying the clinical report to identify the abnormal finding when the medical finding comprises the abnormal finding” (par. 0072; ‘The present invention uses the data elements recorded within the templates to automatically position the edited information in the report template; for instance, to automatically replace the normative impression "negative chest x-ray" with an impression related to the observed abnormality such as "findings consistent with chronic bronchitis".’).
Regarding claims 8 (dep. on claim 6), 20 (dep. on claim 18), and 32 (dep. on claim 30), Roberge further teaches:
“wherein the finding category is a medical finding, the method further comprising: determining whether the medical finding comprises an identifying keyword; and inserting the medical finding into the clinical structured report based on the identifying keyword” (par. 0072; ‘The present invention uses the data elements recorded within the templates to automatically position the edited information in the report template; for instance, to automatically replace the normative impression "negative chest x-ray" with an impression related to the observed abnormality such as "findings consistent with chronic bronchitis".’).
Regarding claims 9 (dep. on claim 6), 21 (dep. on claim 18), and 33 (dep. on claim 30), Roberge further teaches:
“wherein the finding category is a characteristic, the method further comprising: determining a characteristic type of the characteristic, wherein the characteristic type comprises one of an anatomy item, a text item, or a display item; and adjusting the clinical structured report based on the determined characteristic type” (par. 0152; ‘For example, given the utterance "very large mass invading the left lobe of the lung" and the template shown in FIG. 2, the matching process described above (and shown in FIG. 6) would progress through the following steps:’; par. 0157; ‘Step 5: Finally, the root template returns the populated template "The patient has a large mass invading the left lobe of the lung".’).
Regarding claims 10 (dep. on claim 3), 22 (dep. on claim 15), and 34 (dep. on claim 27), Roberge further teaches:
“wherein the determined category is the navigation, the method further comprising:determining another navigation action within the clinical structured report based on the identified one or more words or phrases; and adjusting the display of the clinical structured report based on the another navigation action” (par. 0013; ‘Some structured reporting systems may include the limited use of speech recognition software to support navigation and data entry, in which a user selects an item on-screen by reading its name aloud instead of clicking it with a mouse or enters a numeric value into an on-screen data entry box by speaking it aloud instead of typing it in.’).
Regarding claims 11 (dep. on claim 10), 23 (dep. on claim 22), and 35 (dep. on claim 34), Roberge further teaches:
“wherein the another navigation action comprises focusing on a section of the clinical structured report” (par. 0013; ‘Some structured reporting systems may include the limited use of speech recognition software to support navigation and data entry, in which a user selects an item on-screen by reading its name aloud instead of clicking it with a mouse or enters a numeric value into an on-screen data entry box by speaking it aloud instead of typing it in.’).
Regarding claims 12 (dep. on claim 11), 24 (dep. on claim 23), and 36 (dep. on claim 35), Roberge further teaches:
“wherein the another navigation action comprises the focusing on a section of the clinical structured report, the method further comprising: determining whether the focusing relates to a smart finding associated with the medical examination data points; and adjusting the display of the clinical structured report to open the smart finding when the focusing relates to the smart finding” (par. 0075; ‘Examples of computer-implemented tasks include displaying a specific information item (defined in more detail below) or set of information items, adding a specific information item or set of information items to a record (possibly without displaying that information item or items), opening an information-entry interface, closing an information-entry interface, or otherwise navigating through a user interface.’).
Regarding claims 13 (dep. on claim 3), 25 (dep. on claim 15), and 37 (dep. on claim 27), Roberge further teaches:
“wherein the determined action category is macros, wherein the method further comprises: identifying one or more macros based on the identified one or more words or phrases; modifying the clinical structured report based on the identified one or more macros” (par. 0190; ‘Another example of an input utterance associated with a hidden indicator may be the phrase "severe chest pain", which may cause saving information corresponding to utterance in record, e.g., invoking an associated macro.’).
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.
Claims 2-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-36 of US 12216990 B2. Although the conflicting claims are not identical, they are not patentably distinct from each other because removing inherent and/or unnecessary limitations/step and rearranging the claims would be within the level of one of ordinary skill in the art. It is well settled that the omission of an element, e.g. a navigation action that navigates active focus external to the clinical structured report, etc. (see claim 1 of US Patent) and its function is an obvious expedient if the remaining elements perform the same function as before. In re Karlson, 136 USPQ 184 (CCPA 1963). Also note Ex parte Rainu, 168 USPQ 375 (Bd. App. 1969). Omission of a reference element or step whose function is not needed would be obvious to one of ordinary skill in the art.
Conclusion
Other pertinent prior art are cited in the PTO-892 for the applicant's consideration.
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MARK . VILLENA
Examiner
Art Unit 2658
/MARK VILLENA/Examiner, Art Unit 2658
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