Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of Claims
This action is in response to application 19/027178 filled on 04/21/2025.
Claims 1-20 are currently pending and have been examined.
Detailed Action
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12380976; over claims 1-20 of US Patent No. 11901054; over claims 1-20 of US Patent No. 11195603 and over claims 1-20 of US Patent # 10290369 . Although the claims at issue are not identical, they are not patentably distinct from each other because: referring to MPEP 804 II.B.2. Anticipation Analysis, “The claim under examination is not patentably distinct from the reference claim(s) if the claim under examination is anticipated by 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, 1052, 29 USPQ2d 2010, 2015-16 (Fed. Cir. 1993). This type of nonstatutory double patenting situation arises when the claim being examined is, for example, generic to a species or sub-genus claimed in a conflicting patent or application, i.e., the entire scope of the reference claim falls within the scope of the examined claim.” Here, claim under examination is anticipated by the reference claim(s) since the claims recite substantially similar limitations. Particularly, the entire scope of independent claims of Patents above fall within the scope of independent claims of the present application.
The following is a mapping of the claims of the Patent against the claims of the present application:
Present Application
1. A processor-implemented method comprising: accessing test result data; interrogating grids of medical information logic for a plurality of diseases to pull one or more content tags; producing, using medical practice guideline data and based on the one or more content tags, medical treatment text for a specific patient condition associated with the test result data; accessing a recommended course of action corresponding to the test result data as determined at least in part by the medical treatment text; building, using an embedded language protocol, a patient-specific treatment recommendation using the medical treatment text and the recommended course of action; and causing the patient-specific treatment recommendation to be displayed.
Patent US 12380976
A method for providing information related to test results, the method comprising: receiving, by a processor executing software code, test result data; querying, by the processor, standard-of-care data for the test result data using a matrix associated with medical information logic, wherein the medical information logic is extensible apart from compilation of the software code; associating, by the processor, in response to the querying, the test result data with the standard-of-care data using medical information logic; condensing, by the processor, using medical practice guideline data and the medical information logic, a medical treatment content tag for a specific patient condition; accessing, by the processor, the medical treatment content tag for the specific patient condition and a recommended course of action corresponding to the test result data as determined at least in part by the medical treatment content tag; building, by the processor, using an embedded language protocol, a patient-specific treatment recommendation using the medical treatment content tag and the recommended course of action; and providing, by the processor, a report including the patient-specific treatment recommendation.
Identified differences and rationale as to why that does not amount to a patentable difference.
The language varies slightly between the claims but there is no patentable difference because the present claim is anticipated by the patented claim.
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 1-20 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.
Step 1:
Claims 1-20 are drawn to a method and system, which is/are statutory categories of invention (Step 1: YES).
Step 2A Prong One:
Independent claims 1 and 11 recite accessing test result; interrogating grids of medical information logic; producing medical treatment text; accessing a recommended course of action; and building a patient specific treatment recommendation which are directed to a mental process involving observation, evaluation, judgment, and opinion. Accordingly, the claims recite an abstract idea (Step 2A Prong One: YES).
Step 2A Prong Two:
This judicial exception is not integrated into a practical application. The claims are abstract but for the inclusion of the additional elements including a “a processor”, which is additional element that is recited at a high level of generality such that it amounts to no more than mere instruction to apply the exception using generic computer components. See: MPEP 2106.05(f).
The claims recite the additional elements of accessing test result which constitutes insignificant data gathering activity, and displaying the recommendation constitutes insignificant post solution activity. Further, the grids, protocol, and logic are cited functionally without specifying a particular technological structure that improves the computer functionality or another technical field. Rather, these limitations describe tools used to organize, process, and display information. The claim also merely generates recommendation and does not affirmatively affect a particular treatment of the patient.
The combination of these additional elements is no more than mere instructions to apply the exception using generic computer components. Accordingly, even in combination, 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.
Hence, the 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. Accordingly, 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, using the additional elements to perform the abstract idea amounts to no more than mere instructions to apply the exception using generic components. Mere instructions to apply an exception using a generic components cannot provide an inventive concept. See: MPEP 2106.05(f).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are not integrated into the claim because they are merely incidental or token additions to the claim that do not alter or affect how the process steps or functions in the abstract idea are performed. Therefore, the claimed additional elements do not add meaningful limitations to the indicated claims beyond a general linking to a technological environment. See: MPEP 2106.05(h).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are configured to perform well-understood, routine, and conventional activities previously known to the industry. See: MPEP 2106.05(d). Said additional elements are recited at a high level of generality and provide conventional functions that do not add meaningful limits to practicing the abstract idea. The originally filed specification supports this conclusion at Figure 1, and
Paragraph 16-17, where “In another embodiment, a system is provided, the system including a processor, a software adapted to be executed on said processor, said software comprising instructions for receiving a test result data, wherein said test result data represents a result of a test on a physical specimen, associating said test result data with a standard-of-care data, wherein said standard-of-care data represents a recommended course of action for the condition represented by the test result data, and transforming said specimen data and said standard-of-care data into a human-readable form. [0017] In a further embodiment, a method for providing a Disease-Specific Patient Report is provided, the method including receiving a test result data, wherein said test result data represents a result of a test on a physical specimen, performing a quality control step on the test result data, processing the test result data in order to identify whether the data fits into an acceptable range, or if the data is above or below the acceptable range, associating said test result data with a standard-of-care data, wherein said standard-of-care data represents a recommended course of action for the condition represented by the test result data, and transforming said specimen data and said standard-of-care data into a human-readable form, and providing said test result data and said standard-of-care data.”
Paragraph 84, where “Figure 5 is the portion of a Patient Results Report displaying summary eGFR, blood pressure, and proteinuria according to one embodiment. The summary eGFR, blood pressure, and proteinuria depicted in figures 5 and 10 may graphically present one or more eGFR test results over time, (e.g., from the oldest recorded test to the most recent test). The Summary eGFR may present the eGFR test results in a format that also shows the stage of CKD disease for the patient over time. In one embodiment, the 10 most recent tests are highlighted in brackets.”
The claims recite the additional element of displaying data, which amounts to extra-solution activity concerning mere data displaying. The specification (e.g., as excerpted above) does not provide any indication that the additional elements are anything other than well‐understood, routine, and conventional functions when claimed in a merely generic manner (as they are here). See: MPEP 2106.05(g).
Viewing the limitations as an ordered combination, the claims simply instruct the additional elements to implement the concept described above in the identification of abstract idea with routine, conventional activity specified at a high level of generality in a particular technological environment.
Hence, the claims as a whole, considering the additional elements individually and as an ordered combination, do not amount to significantly more than the abstract idea (Step 2B: NO).
Dependent claim(s) 2-10 and 12-20 when analyzed as a whole, considering the additional elements individually and/or as an ordered combination, are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to an abstract idea without significantly more. These claims fail to remedy the deficiencies of their parent claims above, and are therefore rejected for at least the same rationale as applied to their parent claims above, and incorporated herein.
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 (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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 1-20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Littenberg (WO 2007/070684 A2) in view of Iliff (US 2005/0154616 A1).
In claim 1, a processor-implemented method comprising:
Littenberg teaches:
accessing test result data (Page 8 lines 25-30 lab data is collected);
interrogating grids of medical information logic for a plurality of diseases to pull one or more content tags (Fig. 4, Page 54, and Page 14 lines 27-30 wherein truth tables are used to select output based on test code. See also Page 90 wherein Canned text lookup, i.e. pull one or more tags is taught).
producing, using medical practice guideline data and based on the one or more content tags, medical treatment text for a specific patient condition associated with the test result data (Page 9 and 21 wherein comparing data to threshold in order to recommend a treatment is taught);
accessing a recommended course of action corresponding to the test result data as determined at least in part by the medical treatment text (Table 1 in page 24 wherein patient recommendations are taught);
Littenberg does not explicitly teach however Iliff teaches:
building, using an embedded language protocol, a patient-specific treatment recommendation using the medical treatment text and the recommended course of action (Para. 118 taches a medical authoring language that encodes medical knowledge to produce recommendation and controls algorithm execution based on the information related to a patient. Para. 125 wherein treatments are based on specific parameters of the patient such as his/her age or sex. Paraa. 446 teaches wherein the algorithms are implanted using authoring language having commands embedded in text files. See also Para. 539-541.); and
Littenberg further teaches:
causing the patient-specific treatment recommendation to be displayed (Page 46 line 1).
It would have been obvious to one of ordinary skill in the art at the time of the invention was made to modify Littenberg clinical decision system to incorporate Iliff embedded medical language protocols. Littenberg recognizes that converting published medical guidelines into an operational system requires adianta logic and generates patient specific reports. Iliff teaches a known technique for implementing such medical logic by embedding commands within text files to control the selection and presentation of patient specific treatment information. The combination would lead to an more efficient system that can facilitate the efficient encoding and updating medical guidelines of patient specific treatment recommendations.
As per claim 2, Littenberg teaches the processor-implemented method of claim 1, further comprising providing a graphical representation of the test result data (Page 58).
As per claim 3, Littenberg teaches the processor-implemented method of claim 1, wherein producing the medical treatment text further comprises determining whether medication is being used (Page 26 lines 27-30).
As per claim 4, Littenberg in view of Iliff teach the processor-implemented method of claim 1. Littenberg does explicitly teach however Iliff teaches wherein the grids of medical information logic comprise linked matrix trees to associate the test result data with standard-of-care data corresponding to the test result data (Fig. 7a and Para. 351). The motivation to combine references is the same as seen in claim 1.
As per claim 5, Littenberg teaches the processor-implemented method of claim 4, further comprising: determining information regarding any change in the test result data from prior test results; and causing the information to be displayed (Page 14 lines 30-35).
As per claim 6, Littenberg in view of Iliff teach the processor-implemented method of claim 1. Littenberg does explicitly teach however Iliff teaches processor-implemented method of claim 4, further comprising accessing an attribute for interrogating the grids of medical information logic, wherein the attribute corresponds to a node within the linked matrix trees (Para. 140-143 and Fig. 3). The motivation to combine references is the same as seen in claim 1.
As per claim 7, Littenberg teaches the processor-implemented method of claim 1, wherein producing the medical treatment text further comprises associating at least one of demographic data, medication data, or prior test results with standard-of-care data (Page 20 lines 25-30).
As per claim 8, Littenberg teaches the e processor-implemented method of claim 1 wherein the test result data is associated with at least one of chronic kidney disease, osteoporosis, or thyroid disease (Page 21 lines 23-26).
As per claim 9, Littenberg teaches the processor-implemented method of claim 8 further comprising:
performing quality control on the test result data (Page 26 lines 5-10); and
evaluating the test result data to identify when at least a portion of the test result data fits into an acceptable range and when at least the portion of the test result data is above or below the acceptable range (Page 26 lines 5-10); and
causing information regarding the test result data compared to the acceptable range to be displayed (page 6 lines 19-22).
As per claim 10 Littenberg teaches the processor-implemented method of claim 1 wherein producing the medical treatment text further comprises condensing the medical treatment text from narrative advice in a set of medical practice guidelines (Page 6 lines 10-12).
Claims 11-20 recite substantially similar limitations as seen above and hence are rejected for similar rationale as noted above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAROUN P KANAAN whose telephone number is (571)270-1497. The examiner can normally be reached Monday-Friday 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mamon Obeid can be reached at (571) 270-1813. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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MAROUN P. KANAAN
Primary Examiner
Art Unit 3687
/MAROUN P KANAAN/Primary Examiner, Art Unit 3687
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