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 .
DETAILED ACTION
In the response filed on 24 March 2026, the following has occurred: claims 1, 7, 9, 12-13, 16, 30 and 36 have been amended; claims 6, 8 and 25 have been canceled; claims 46-47 are newly added.
Now claims 1-4, 7, 9, 12-18, 27, 30, 36 and 45-47 are pending.
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.
1-4, 7, 9, 12-18, 27, 30, 36 and 45-47 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 1, 30 and 36 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite methods for assessing an anorectal disorder in a patient. The limitations of:
Claim 1
(a) [… obtaining …], a set of attributes associated with a patient having or suspected having an anorectal disorder, wherein the set of attributes comprises a symptom intensity and a symptom impact for symptoms of the patient; (b) automatically inputting, […], the set of attributes to a model, wherein the model is configured to output a score corresponding to the severity of the anorectal disorder of the patient, wherein the score is represented by a Hemorrhoid Quality of Life Index (HQLI); and (c) outputting the score […].
Claim 30
(a) [… collecting …] a first set of attributes associated with a patient prior to a treatment and a second set of attributes associated with the patient during or after the treatment, wherein the patient suffers from an anorectal disorder and wherein the first set of attributes and the second set of attributes comprise a symptom intensity and a symptom impact for symptoms of the patient; (b) inputting, […], the first set of attributes associated with the patient prior to a treatment and the second set of attributes associated with the patient during or after the treatment; (c) automatically inputting, […], the first set of attributes and the second set of attributes to a model, wherein the model is configured to output a first score corresponding to the severity of the anorectal disorder of the patient prior to the treatment and a second score corresponding to the severity of the anorectal disorder of the patient during or after the treatment, wherein the first score and the second score are represented as a Hemorrhoid Quality of Life Index (HQLI); (d) outputting the first score and the second score, or a representation thereof, […]; and (e) determining the effectiveness of the treatment based on the first score and the second score.
Claim 36
(a) receiving, […], a first set of attributes associated with a first plurality of patients receiving a first treatment for an anorectal disorder and a second set of attributes associated with a second plurality of patients receiving a second treatment for the anorectal disorder, wherein the first set of attributes and the second set of attributes comprise a symptom intensity and a symptom impact for symptoms of the patient; (b) automatically inputting, […], the first set of attributes and the second set of attributes to a model, wherein the model is configured to output a first score corresponding to the severity of the anorectal disorder for the first plurality of patients and a second score corresponding to the severity of the anorectal disorder for the second plurality of patients, wherein the first score and the second score are represented as a Hemorrhoid Quality of Life Index (HQLI); (c) outputting the first score and the second score, or a representation thereof, […]; and (d) determining the effectiveness of the first treatment relative to the second treatment based on the first score and the second score.
, as drafted, is a system, which under its broadest reasonable interpretation, covers a method of organizing human activity (i.e., managing personal behavior including following rules or instructions) via human interaction with generic computer components. That is, by a human user interacting with an input device, a processor and an output device the claimed invention amounts to managing personal behavior or interaction between people, the Examiner notes as stated in 2106.04(a)(2), “certain activity between a person and a computer… may fall within the “certain methods of organizing human activity” grouping”. For example, by human interaction with an input device, a processor and an output device, the claim encompasses collection of data about human users, organization of the collected data, and providing to a human user an output of the organized data. If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people but for the recitation of generic computer components, then it falls within the “certain method of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim recites the additional elements of an input device, a processor and an output device, which implements the abstract idea. The input device, a processor and an output device are recited at a high-level of generality (i.e., a general-purpose computers/ computer components implementing generic computer functions; see Applicant’s Specification Figure 5, pages 16-19) such that it amounts no more than mere instructions to apply the exception using generic computer components. Accordingly, these additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim recites the additional elements of “receiving, via an input device…” and “recording…”. The “receiving, via an input device…” steps are recited at a high-level of generality (i.e., as a general means of receiving/transmitting data) and amounts to the mere transmission and/or receipt of data, which is a form of extra-solution activity. The “recording…” is recited at a high-level of generality (i.e., as a general means of storing data) and amounts to the mere storage of data, which is a form of extra-solution activity. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application. The claim is directed to an abstract idea.
The claim does 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 an input device, a processor and an output device, to perform the noted steps amounts to no more than mere instructions to apply the exception using generic hardware components. Mere instructions to apply an exception using generic hardware components cannot provide an inventive concept ("significantly more").
Also, as discussed above with respect to integration of the abstract idea into a practical application, the additional elements of “receiving, via an input device…” and “recording…” were considered extra-solution activity and/or generally linking the abstract idea to particular technological environment. The “receiving, via an input device…” steps have been re-evaluated under the "significantly more" analysis and determined to amount to be well-understood, routine, and conventional elements/functions. As described in MPEP 2106.0S(d)(II)(i) "Receiving or transmitting data over a network" is well-understood, routine, and conventional. The “recording…” has been re-evaluated under the “significantly more” analysis and determined to amount to be well-understood, routine, and conventional elements/functions. As described in MPEP 2106.05(d)(II)(iv) “Storing and retrieving information in memory” is well-understood, routine, and conventional. Well-understood, routine, and conventional elements/functions cannot provide “significantly more.” As such the claim is not patent eligible.
Claims 2-4, 7, 9, 12-18, 27 and 45-47 are similarly rejected because either further define the abstract idea and/or do not further limit the claim to a practical application or provide as inventive concept such that the claims are subject matter eligible.
Claims 2-4 further describe the anorectal disorder, but does not recite any additional elements, therefore the claim cannot provide significantly more and/or a practical application.
Claims 7, 9 and 12-15 further describe the labels of the set of attributes, but does not recite any additional elements, therefore the claim cannot provide significantly more and/or a practical application.
Claims 16-18 describe numerical scales and ratings, but does not recite any additional elements, therefore the claim cannot provide significantly more and/or a practical application.
Claim 27 describes comparison of data (i.e., organization of data), but does not recite any additional elements, therefore the claim cannot provide significantly more and/or a practical application.
Claim 45 recites additional hardware additional elements, however similar to the already considered hardware elements above and incorporated herein, these elements amount to generic off-the-shelf computer components such that it amounts no more than mere instructions to apply the exception using generic computer components. Accordingly, these additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim does 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 hardware elements, to perform the noted steps amounts to no more than mere instructions to apply the exception using generic hardware components. Mere instructions to apply an exception using generic hardware components cannot provide an inventive concept ("significantly more").
Claim 46 describes determination of scores, but does not recite any additional elements, therefore the claim cannot provide significantly more and/or a practical application.
Claim 47 describes how the scores are determined (i.e., math), but does not recite any additional elements, therefore the claim cannot provide significantly more and/or a practical application.
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 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 for establishing a background for determining obviousness under 35 U.S.C. 103 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.
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.
Claim(s) 1-4, 9, 12-16, 18, 27, 30 and 45-47 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 20170228517 (hereafter “Saliman”), in view of ““PNR-Bleed” classification and Hemorrhoid Severity Score—a novel attempt at classifying the hemorrhoids” (hereafter “Khan”).
Regarding (Currently Amended)) claim 1, Saliman teaches a method for assessing [… a disorder …] disorder in a patient (Saliman: Figures 1-4, 10, paragraph [0004], “methods for determining a wellness score, an improvement score, and/or an effectiveness score with regard to a medical condition and/or medical treatment”, paragraph [0060], “uses medical treatment and/or diagnosis outcome data reported via one or more outcome measurement devices (OMDs) to better understand, for example, the effectiveness of treatments for a medical condition and various factors that may affect the effectiveness of the treatments, recovery from a treatment, and/or improvement in the medical condition”), the method comprising:
(a) receiving, via an input device, a set of attributes associated with a patient having or suspected having [… a …] disorder (Saliman: Figures 1-4, 10, paragraphs [0004]-[0006], “a medical questionnaire may be provided to a patient via, for example, a patient's personal electronic device (e.g., smart phone or tablet computer). The medical questionnaire may be, for example, a medical symptom questionnaire, a disease-specific medical symptom questionnaire”, paragraphs [0024]-[0025], “a post-treatment provision of a medical questionnaire to a patient may be facilitated (via, for example, communication of the medical questionnaire to the patient's personal electronic device and/or activation of the medical questionnaire already stored on the patient's personal electronic device) after the patient receives a treatment for a medical condition”, paragraphs [0070]-[0072], “administer an outcome measurement device (OMD) to and/or on that patient… Completed OMDs (also called OMD responses) may be transmitted from patient device 128 and stored in OMD response database 110. More specifically, OMD responses may be stored in OMD response database 110… Upon the patient receiving the treatment… a subsequent post-treatment OMD may be administered on the patient by OMD administrator 112… The response to the post-treatment OMD may similarly be stored in OMD response database 110”. The Examiner notes one of ordinary skill in the art would find it prima facie obvious that responses to questionnaires read on what is required of “set of attributes” under the broadest reasonable interpretation),
wherein the set of attributes comprises a symptom intensity and a symptom impact for symptoms of the patient(Saliman: Figure 17, paragraph [0073], “OMD response analyzer 118 may analyze the OMD responses stored in OMD response database 110 to generate one or more scores (e.g., a wellness score, an improvement score, a treatment effectiveness score, a treatment provider effectiveness score, a treatment facility effectiveness score, etc.)… factors that may directly, or closely, relate to and/or have an impact on, a medical condition, diagnosis, and/or treatment”, paragraph [0080], “a “wellness score” may serve to indicate how severe a patient's symptoms are. In these cases, a low wellness/symptom severity score may indicate that a patient's symptoms are relatively more severe than a higher wellness/symptom severity score such that an increasing wellness/symptom severity score indicates an improvement (i.e., decrease in severity) in the symptoms”, paragraph [0138], “in step 730, it may be determined how the one or more contributing factors for the treatment and/or an underlying diagnosis may impact the baseline recovery from the treatment”, paragraph [0179]-[0183], “FIGS. 17C-17E show exemplary OMDs in the form of questionnaires that may be provided to the patient via interfaces 1702, 1703, and 1704, respectively… provides two sets of possible answers 1730, one for each question, in the form of a ranking of none (1) to extreme (5)”, paragraph [0270], “The questions may take any format (e.g., multiple choice, true/false, sliding scale, etc.) and, in some instances, may be used to gauge the severity of the patient symptom”. Also see, paragraph [0147]. The Examiner notes as seen in Figs. 17C-E, multiple responses of both impact and intensity are collected and used to collect and determine a symptom impact and symptom intensity respectively);
(b) automatically inputting, via a processor, the set of attributes to a model, wherein the model is configured to output a score corresponding to the severity of the […] disorder of the patient (Saliman: Figures 1-4, 10, paragraph [0073], “OMD response analyzer 118 may analyze the OMD responses stored in OMD response database 110 to generate one or more scores”, paragraph [0077], “train a model that can then be used”, paragraphs [0080]-[0081], “OMD response analyzer 118 may comprise wellness score determination module 152. In one embodiment, wellness score determination module 152 retrieves responses to OMD instrument from OMD response database 110… Various scoring procedures may be employed to score a completed OMD, and in one embodiment, the generated score may be known as a “wellness score”. In some cases, a “wellness score” may serve to indicate how severe a patient's symptoms are”, paragraphs [0182]-[0186], “The pre-treatment set of responses may be scored using, for example, a scoring procedure associated with the OMD provided in step 1015 in order to determine a pre-treatment wellness score for the medical condition (step 1035”, paragraph [0364], “a processor 2504”. Also see, paragraph [0292]),
wherein the score is represented by a […] Quality of Life Index (HQLI) (Saliman: paragraph [0082], “improvement scores may be indexed”, paragraph [0097], “Quality of Life Instrument… Quality of Life Questionnaire”, paragraph [0104], “one or more general OMDs, such as a general quality of life questionnaire that includes, for example, questions regarding a patient's general health”, paragraph [0183], “indexing the pre-treatment wellness score”); and
(c) outputting the score via an output device (Saliman: Figures 1-4, 10, 17, paragraph [0075], “reporting module 122 may report the scores to one or more of treatment provider device 124, patient device 128 and treatment facility computer system 134”, paragraph [0168], “providing one or more of a pre-treatment wellness score, post-treatment wellness score and an improvement score to a patient, treatment provider, treatment facility and/or treatment administrator”, paragraph [0188], “feedback including one or more the pre-treatment wellness score, post-treatment wellness score and the improvement score may be provided to the patient via an interface, for example, like interfaces 1705 and 1706 of FIG. 17F and FIG. 17G… The feedback may also be provided, for example, to a treatment provider, a treatment facility, and/or a treatment administrator”).
Saliman may not explicitly teach (underlined below for clarity):
a method for assessing an anorectal disorder in a patient, the method comprising: (a) receiving, via an input device, a set of attributes associated with a patient having or suspected having an anorectal disorder, wherein the set of attributes comprises a symptom intensity and a symptom impact for symptoms of the patient; (b) automatically inputting, via a processor, the set of attributes to a model, wherein the model is configured to output a score corresponding to the severity of the anorectal disorder of the patient, wherein the score is represented by a Hemorrhoid Quality of Life Index (HQLI);
Khan teaches a method for assessing an anorectal disorder in a patient, the method comprising: (a) receiving, via an input device, a set of attributes associated with a patient having or suspected having an anorectal disorder, wherein the set of attributes comprises a symptom intensity and a symptom impact for symptoms of the patient; (b) automatically inputting, via a processor, the set of attributes to a model, wherein the model is configured to output a score corresponding to the severity of the anorectal disorder of the patient, wherein the score is represented by a Hemorrhoid Quality of Life Index (HQLI) (Khan: Table 1, pages 2-3, “Hemorrhoids or piles are symptomatically enlarged and distally displaced anal cushions. It is one of the most common anorectal disorders… The four components of this “PNR-Bleed” classification (Table 1) are… the degree of hemorrhoidal prolapse similar to that of Goligher grading… scoring system for hemorrhoids as the Hemorrhoid Severity Score (HSS). Hemorrhoid Severity Score (HSS) is the total score obtained by the sum of the numerical grades of all four characteristics of hemorrhoids in “PNR-Bleed” classification”);
One of ordinary skill in the art before the effective filing date would have found it obvious to include using a hemorrhoid severity score as taught by Khan within the severity scores for various medical conditions as taught by Saliman with the motivation of “classification system for any disease is useful for not only in choosing an appropriate treatment for a particular class, but also to allow the comparison of various available treatment options” (Khan: Page 2).
Regarding (Original) claim 2, Saliman and Khan teach the limitations of claim 1, and further teach wherein the anorectal disorder is selected from the group consisting of a hemorrhoid, an anal wart, an anal fissure, an anorectal abscess, and an anal fistula (Khan: Table 1, pages 2-3, “Hemorrhoids or piles are symptomatically enlarged and distally displaced anal cushions. It is one of the most common anorectal disorders”).
The motivation to combine is the same as in claim 1, incorporated herein.
Regarding (Original) claim 3, Saliman and Khan teach the limitations of claim 2, and further teach wherein the anorectal disorder is a hemorrhoid (Khan: Table 1, pages 2-3, “Hemorrhoids or piles are symptomatically enlarged and distally displaced anal cushions. It is one of the most common anorectal disorders”).
The motivation to combine is the same as in claim 1, incorporated herein.
Regarding (Original) claim 4, Saliman and Khan teach the limitations of claim 3, and further teach wherein the hemorrhoid is a Goligher Grade II hemorrhoid (Khan: Table 1, pages 2-3, “In Goligher’s classification, internal hemorrhoids are further graded based on the degree of prolapse: (1) Grade I: bleeding but non-prolapsing hemorrhoids; (2) Grade II: hemorrhoids prolapse on straining but reduce spontaneously”).
The motivation to combine is the same as in claim 1, incorporated herein.
Regarding (Currently Amended) claim 9, Saliman and Khan teach the limitations of claim 1, and further teach wherein the symptom intensity is collected daily, wherein the symptom impact comprises a physical summary and a mental summary (Saliman: paragraph [0014], “the provision of the medical questionnaire to the patient at a plurality of time points (e.g., daily”, paragraph [0063], “address physical and/or mental health issues and may be responsive to a particular diagnosis or combination of diagnoses a patient may receive”, paragraph [0081], “responses that are more objective in nature (e.g., heart rate, blood glucose level, etc.… responses that are more subjective in nature (e.g., degree of pain, mood, etc. ”).
The motivation to combine is the same as in claim 1, incorporated herein.
Regarding (Currently Amended) claim 12, Saliman and Khan teach the limitations of claim 9, and further teach wherein the physical summary comprises an anorectal disorder bother and a daily activity impact, and wherein the mental summary comprises an emotional impact (Saliman: paragraph [0063], “address physical and/or mental health issues and may be responsive to a particular diagnosis or combination of diagnoses a patient may receive”, paragraph [0081], “responses that are more objective in nature (e.g., heart rate, blood glucose level, etc.… responses that are more subjective in nature (e.g., degree of pain, mood, etc. ”, paragraph [0213], “how much the patient's pain interferes with his or her daily life”, paragraph [0230], “physical function, and pain interference may be determined”; Khan: Table 1, page 5, “PNR-Bleed classification takes into account all the four main characteristics of the hemorrhoidal disease i.e. the degree of hemorrhoidal prolapse, number of the primary hemorrhoidal columns involved, relation of the hemorrhoidal tissue to dentate line and the amount of bleeding from it”).
The motivation to combine is the same as in claim 1, incorporated herein.
Regarding (Previously Presented) claim 14, Saliman and Khan teach the limitations of claim 1, and further teach wherein the set of attributes comprise one or more demographic factors selected from the group consisting of age, gender, race, ethnicity, income, education, and occupation (Saliman: paragraph [0106], “the OMD may also be linked with relevant patient characteristics such as age, gender, race”).
The motivation to combine is the same as in claim 1, incorporated herein.
Regarding (Previously Presented) claim 15, Saliman and Khan teach the limitations of claim 1, and further teach wherein the set of attributes comprises one or more attributes from a patient reported outcome (PRO), a clinician interview, and/or a cognitive interview (Saliman: paragraphs [0060]-[0064], “Outcome data may be, for example, responses to patient reported outcome (PRO) instruments, responses to questionnaires, laboratory data, physical function tests, and/or responses to other OMDs… presentation of questionnaires (e.g., PRO instruments) to the patients,”, paragraph [0071], “the retrieved OMDs are patient reported outcome (PRO) instruments”).
The motivation to combine is the same as in claim 1, incorporated herein.
Regarding (Currently Amended) claim 16, Saliman and Khan teach the limitations of claim 8, and further teach wherein the symptom intensity and the symptom impact are represented in a numerical rating scale (Saliman: Figure 17, paragraph [0179]-[0183], “FIGS. 17C-17E show exemplary OMDs in the form of questionnaires that may be provided to the patient via interfaces 1702, 1703, and 1704, respectively… provides two sets of possible answers 1730, one for each question, in the form of a ranking of none (1) to extreme (5)”, paragraph [0270], “The questions may take any format (e.g., multiple choice, true/false, sliding scale, etc.) and, in some instances, may be used to gauge the severity of the patient symptom”).
The motivation to combine is the same as in claim 1, incorporated herein.
Regarding (Original) claim 18, Saliman and Khan teach the limitations of claim 16, and further teach wherein the symptom impact is represented in a 5-point numerical rating scale of 0 to 4, wherein a 0 represents no impact and a 4 represents highest impact (Saliman: Figure 17, paragraph [0179]-[0183], “FIGS. 17C-17E show exemplary OMDs in the form of questionnaires that may be provided to the patient via interfaces 1702, 1703, and 1704, respectively… provides two sets of possible answers 1730, one for each question, in the form of a ranking of none (1) to extreme (5)”, paragraph [0270], “The questions may take any format (e.g., multiple choice, true/false, sliding scale, etc.) and, in some instances, may be used to gauge the severity of the patient symptom”. The Examiner notes one of ordinary skill in the art before the effective filing date would find it prima facie obvious to use a binary scale (i.e., 0 to 4) for the 5-point numerical rating scale as taught by Saliman and evidenced in paragraph [0016], as it is not functionally different).
The motivation to combine is the same as in claim 1, incorporated herein.
Regarding (Previously Presented) claim 27, Saliman and Khan teach the limitations of claim 1, and further teach a step of comparing the output score with a predetermined threshold value (Saliman: paragraph [0010], “it may be determined whether the improvement score falls below a minimum threshold”, paragraph [0107], “scoring procedures may also be associated with threshold values”, paragraph [0193], “in step 1080, the pre-treatment wellness score, post-treatment wellness score, and/or improvement score may be compared to a minimum threshold”).
The motivation to combine is the same as in claim 1, incorporated herein.
Regarding (Currently Amended) claim 30, Saliman teaches a method for assessing treatment effectiveness for [… a …] disorder (Saliman: Figures 1-4, 10, paragraph [0004], “methods for determining a wellness score, an improvement score, and/or an effectiveness score with regard to a medical condition and/or medical treatment”, paragraph [0060], “uses medical treatment and/or diagnosis outcome data reported via one or more outcome measurement devices (OMDs) to better understand, for example, the effectiveness of treatments for a medical condition and various factors that may affect the effectiveness of the treatments, recovery from a treatment, and/or improvement in the medical condition”), the method comprising:
(a) recording a first set of attributes associated with a patient prior to a treatment and a second set of attributes associated with the patient during or after the treatment, wherein the patient suffers from [… a …] disorder (Saliman: Figures 1-4, 10, paragraphs [0004]-[0006], “a medical questionnaire may be provided to a patient via, for example, a patient's personal electronic device (e.g., smart phone or tablet computer). The medical questionnaire may be, for example, a medical symptom questionnaire, a disease-specific medical symptom questionnaire”, paragraph [0019], “a disease or medical condition of the patient is associated with alternate terminology for a name of the respective medical questionnaire, treatment, disease or medical condition”, paragraphs [0024]-[0025], “a post-treatment provision of a medical questionnaire to a patient may be facilitated (via, for example, communication of the medical questionnaire to the patient's personal electronic device and/or activation of the medical questionnaire already stored on the patient's personal electronic device) after the patient receives a treatment for a medical condition… A post-treatment set of responses to the medical questionnaire may be received from the patient”, paragraphs [0070]-[0072], “administer an outcome measurement device (OMD) to and/or on that patient… Completed OMDs (also called OMD responses) may be transmitted from patient device 128 and stored in OMD response database 110. More specifically, OMD responses may be stored in OMD response database 110… Upon the patient receiving the treatment… a subsequent post-treatment OMD may be administered on the patient by OMD administrator 112… The response to the post-treatment OMD may similarly be stored in OMD response database 110”, paragraph [0208], “the medical condition of the patient”. Also see, paragraphs [0096]), and
wherein the first set of attributes and the second set of attributes comprise a symptom intensity and a symptom impact for symptoms of the patient (Saliman: Figure 17, paragraph [0073], “OMD response analyzer 118 may analyze the OMD responses stored in OMD response database 110 to generate one or more scores (e.g., a wellness score, an improvement score, a treatment effectiveness score, a treatment provider effectiveness score, a treatment facility effectiveness score, etc.)… factors that may directly, or closely, relate to and/or have an impact on, a medical condition, diagnosis, and/or treatment”, paragraph [0080], “a “wellness score” may serve to indicate how severe a patient's symptoms are. In these cases, a low wellness/symptom severity score may indicate that a patient's symptoms are relatively more severe than a higher wellness/symptom severity score such that an increasing wellness/symptom severity score indicates an improvement (i.e., decrease in severity) in the symptoms”, paragraph [0138], “in step 730, it may be determined how the one or more contributing factors for the treatment and/or an underlying diagnosis may impact the baseline recovery from the treatment”, paragraph [0179]-[0183], “FIGS. 17C-17E show exemplary OMDs in the form of questionnaires that may be provided to the patient via interfaces 1702, 1703, and 1704, respectively… provides two sets of possible answers 1730, one for each question, in the form of a ranking of none (1) to extreme (5)”, paragraph [0270], “The questions may take any format (e.g., multiple choice, true/false, sliding scale, etc.) and, in some instances, may be used to gauge the severity of the patient symptom”. Also see, paragraph [0147]. The Examiner notes as seen in Figs. 17C-E, multiple responses of both impact and intensity are collected and used to collect and determine a symptom impact and symptom intensity respectively);
(b) inputting, via an input device, the first set of attributes associated with the patient prior to a treatment and the second set of attributes associated with the patient during or after the treatment (Saliman: Figures 1-4, 10, paragraphs [0004]-[0006], “a medical questionnaire may be provided to a patient via, for example, a patient's personal electronic device (e.g., smart phone or tablet computer). The medical questionnaire may be, for example, a medical symptom questionnaire, a disease-specific medical symptom questionnaire”, paragraphs [0024]-[0025], “a post-treatment provision of a medical questionnaire to a patient may be facilitated (via, for example, communication of the medical questionnaire to the patient's personal electronic device and/or activation of the medical questionnaire already stored on the patient's personal electronic device) after the patient receives a treatment for a medical condition”, paragraphs [0070]-[0072], “administer an outcome measurement device (OMD) to and/or on that patient… Completed OMDs (also called OMD responses) may be transmitted from patient device 128 and stored in OMD response database 110. More specifically, OMD responses may be stored in OMD response database 110… Upon the patient receiving the treatment… a subsequent post-treatment OMD may be administered on the patient by OMD administrator 112… The response to the post-treatment OMD may similarly be stored in OMD response database 110”. The Examiner notes one of ordinary skill in the art would find it prima facie obvious that responses to questionnaires read on what is required of “set of attributes” under the broadest reasonable interpretation);
(c) automatically inputting, via a processor, the first set of attributes and the second set of attributes to a model, wherein the model is configured to output a first score corresponding to the severity of the […] disorder of the patient prior to the treatment and a second score corresponding to the severity of the […] disorder of the patient during or after the treatment (Saliman: Figures 1-4, 10, paragraph [0073], “OMD response analyzer 118 may analyze the OMD responses stored in OMD response database 110 to generate one or more scores”, paragraph [0077], “train a model that can then be used”, paragraphs [0080]-[0081], “OMD response analyzer 118 may comprise wellness score determination module 152. In one embodiment, wellness score determination module 152 retrieves responses to OMD instrument from OMD response database 110… Various scoring procedures may be employed to score a completed OMD, and in one embodiment, the generated score may be known as a “wellness score”. In some cases, a “wellness score” may serve to indicate how severe a patient's symptoms are”, paragraphs [0182]-[0186], “The pre-treatment set of responses may be scored using, for example, a scoring procedure associated with the OMD provided in step 1015 in order to determine a pre-treatment wellness score for the medical condition (step 1035)… a post-treatment wellness score for the medical condition may be determined by applying a scoring procedure, and where appropriate, a sub-scoring procedure, to the post-treatment set of responses”, paragraph [0364], “a processor 2504”. Also see, paragraph [0292]),
wherein the first score and the second score are represented as a […] Quality of Life Index (HQLI) (Saliman: paragraph [0082], “improvement scores may be indexed”, paragraph [0097], “Quality of Life Instrument… Quality of Life Questionnaire”, paragraph [0104], “one or more general OMDs, such as a general quality of life questionnaire that includes, for example, questions regarding a patient's general health”, paragraph [0183], “indexing the pre-treatment wellness score”);
(d) outputting the first score and the second score, or a representation thereof, via an output device (Saliman: Figures 1-4, 10, 17, paragraph [0075], “reporting module 122 may report the scores to one or more of treatment provider device 124, patient device 128 and treatment facility computer system 134”, paragraph [0168], “providing one or more of a pre-treatment wellness score, post-treatment wellness score and an improvement score to a patient, treatment provider, treatment facility and/or treatment administrator”, paragraph [0188], “feedback including one or more the pre-treatment wellness score, post-treatment wellness score and the improvement score may be provided to the patient via an interface, for example, like interfaces 1705 and 1706 of FIG. 17F and FIG. 17G… The feedback may also be provided, for example, to a treatment provider, a treatment facility, and/or a treatment administrator”); and
(e) determining the effectiveness of the treatment based on the first score and the second score (Saliman: Figures 1-4, 10, 15, paragraph [0187], “an improvement score may be calculated based on the pre-treatment wellness score and the post-treatment wellness score. In one embodiment, the improvement score may be calculated as the post-treatment wellness score minus the pre-treatment wellness score. More generally, the improvement score may be known as a “health progression” score, accommodating the scenarios in which the patient's condition stays the same or worsens following the treatment”).
Saliman may not explicitly teach (underlined below for clarity):
a method for assessing treatment effectiveness for an anorectal disorder, (a) recording a first set of attributes associated with a patient prior to a treatment and a second set of attributes associated with the patient during or after the treatment, wherein the patient suffers from an anorectal disorder and wherein the first set of attributes and the second set of attributes comprise a symptom intensity and a symptom impact for symptoms of the patient; (c) automatically inputting, via a processor, the first set of attributes and the second set of attributes to a model, wherein the model is configured to output a first score corresponding to the severity of the anorectal disorder of the patient prior to the treatment and a second score corresponding to the severity of the anorectal disorder of the patient during or after the treatment, wherein the first score and the second score are represented as a Hemorrhoid Quality of Life Index (HQLI);
Khan teaches a method for assessing treatment effectiveness for an anorectal disorder, (a) recording a first set of attributes associated with a patient prior to a treatment and a second set of attributes associated with the patient during or after the treatment, wherein the patient suffers from an anorectal disorder and wherein the first set of attributes and the second set of attributes comprise a symptom intensity and a symptom impact for symptoms of the patient; (c) automatically inputting, via a processor, the first set of attributes and the second set of attributes to a model, wherein the model is configured to output a first score corresponding to the severity of the anorectal disorder of the patient prior to the treatment and a second score corresponding to the severity of the anorectal disorder of the patient during or after the treatment, wherein the first score and the second score are represented as a Hemorrhoid Quality of Life Index (HQLI) (Khan: Table 1, pages 2-3, “Hemorrhoids or piles are symptomatically enlarged and distally displaced anal cushions. It is one of the most common anorectal disorders… The four components of this “PNR-Bleed” classification (Table 1) are… the degree of hemorrhoidal prolapse similar to that of Goligher grading… scoring system for hemorrhoids as the Hemorrhoid Severity Score (HSS). Hemorrhoid Severity Score (HSS) is the total score obtained by the sum of the numerical grades of all four characteristics of hemorrhoids in “PNR-Bleed” classification”);
One of ordinary skill in the art before the effective filing date would have found it obvious to include using a hemorrhoid severity score as taught by Khan within the severity scores for various medical conditions as taught by Saliman with the motivation of “classification system for any disease is useful for not only in choosing an appropriate treatment for a particular class, but also to allow the comparison of various available treatment options” (Khan: Page 2).
Regarding (Previously Presented) claim 45, Saliman and Khan teach the limitations of claim 1, and further teach an electronic device, comprising: a display; one or more processors; a memory; and one or more programs, wherein the one or more programs are stored in the memory and configured to be executed by the one or more processors (Saliman: paragraph [0004], “Systems and methods for determining a wellness score, an improvement score, and/or an effectiveness score with regard to a medical condition and/or medical treatment”, paragraph [0363]-[0366], “System 2500 includes a bus 2502 or other communication mechanism for communicating information, and a processor 2504 coupled with the bus 2502 for processing information. Computer system 2500 also includes a main memory 2506, such as a random access memory (RAM) or other dynamic storage device, coupled to the bus 2502 for storing information and instructions to be executed by processor 2504… Computer system 2500 may be coupled via the bus 2502 to a display 2512… The processes referred to herein may be implemented by processor 2504 executing appropriate sequences of computer-readable instructions”),
the one or more programs including instructions for performing the method of any one of claim 1 (See claim 1, above incorporated herein).
The motivation to combine is the same as in claim 1, incorporated herein.
Regarding (New) claim 46, Saliman and Khan teach the limitations of claim 1, and further teach wherein the HQLI comprises a symptom intensity score and a symptom impact score (Saliman: paragraph [0063], “address physical and/or mental health issues and may be responsive to a particular diagnosis or combination of diagnoses a patient may receive”, paragraph [0081], “responses that are more objective in nature (e.g., heart rate, blood glucose level, etc. responses that are more subjective in nature (e.g., degree of pain, mood, etc.”, paragraph [0212], “In some cases, these may be separate scores and, in other cases, the scores may be combined into a single overall post-treatment wellness score”, paragraph [231], “the post-treatment wellness scores for pain interference and pain behavior may be combined into a single pain post-treatment wellness score.”).
The motivation to combine is the same as in claim 1, incorporated herein.
Regarding (New) claim 47, Saliman and Khan teach the limitations of claim 1, and further teach wherein the symptom intensity score is represented by the mean of the symptom intensity across seven days and wherein the symptom impact score is represented by the mean of the symptom intensity across seven days (Saliman: paragraph [0182], “responses may be scored using, for example, a scoring procedure… retrieve a scoring procedure from scoring procedure database 116. Example scoring procedures include taking an average of all the patient responses (e.g., assuming all responses are numeric), taking a weighted average of the patient responses (e.g., weighting certain responses higher than other responses)”, paragraph [0315], “a set of frequency options may include weekly, bi-weekly, daily, etc.”. The Examiner notes a weekly average is taught under the broadest reasonable interpretation).
The motivation to combine is the same as in claim 1, incorporated herein.
Claim(s) 7 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 20170228517 (hereafter “Saliman”) and ““PNR-Bleed” classification and Hemorrhoid Severity Score—a novel attempt at classifying the hemorrhoids” (hereafter “Khan”) as applied to claim 16 above, and further in view of U.S. Patent Pub. No. 20060004094 (hereafter “Agism”).
Regarding (Currently Amended) claim 7, Saliman and Khan teach the limitations of claim 1, and further teach wherein the symptom intensity comprise pain, […], and bleeding (Saliman: paragraph [0081], “where an OMD is a questionnaire… certain responses that are more objective in nature (e.g., heart rate, blood glucose level, etc.… responses that are more subjective in nature (e.g., degree of pain, mood, etc.)”, paragraph [0108], “questions regarding a patient's general health (e.g., level of pain, mobility, and so on) or an OMD related to a blood pressure reading or a patient's weight”; Khan: page 3, “the amount of Bleeding (B) from it”).
Saliman and Khan may not explicitly teach (underlined below for clarity):
wherein the symptom intensity comprise pain, burning, itching, swelling, and bleeding.
Agism teaches wherein the symptom intensity comprise pain, burning, itching, swelling, and bleeding (Agism: paragraph [0032], “treatment of hemorrhoids can include the following: constriction of the blood vessels of the hemorrhoidal tissue and/or providing relief from the discomfort or pain from the burning, itching, swelling, irritation, soreness and/or inflammation of hemorrhoidal tissue”).
One of ordinary skill in the art before the effective filing date would have found it obvious to include using burning, itching and swelling as taught by Agism with the symptom intensity as taught by Saliman and Khan with the motivation of “reducing the hemorrhoid, and/or healing affected tissues” (Agism: paragraph [0032]).
Claim(s) 13 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 20170228517 (hereafter “Saliman”) and ““PNR-Bleed” classification and Hemorrhoid Severity Score—a novel attempt at classifying the hemorrhoids” (hereafter “Khan”) as applied to claim 16 above, and further in view of U.S. Patent Pub. No. 20200038419 (hereafter “Barbut’419”), in view of U.S. Patent Pub. No. 20200038414 (hereafter “Barbut’414”).
Regarding (Currently Amended) claim 13, Saliman and Khan teach the limitations of claim 12, and further teach […], wherein the daily activity impact comprises a normal daily activity impact, an exercise or strenuous activity impact, […], and wherein the emotional impact comprises a psychological distress impact, a discomfort impact, […] (Saliman: paragraph [0014], “the provision of the medical questionnaire to the patient at a plurality of time points (e.g., daily”, paragraph [0063], “address physical and/or mental health issues and may be responsive to a particular diagnosis or combination of diagnoses a patient may receive”, paragraph [0073], “OMD response analyzer 118 may analyze the OMD responses stored in OMD response database 110 to generate one or more scores (e.g., a wellness score, an improvement score, a treatment effectiveness score, a treatment provider effectiveness score, a treatment facility effectiveness score, etc.)… factors that may directly, or closely, relate to and/or have an impact on, a medical condition, diagnosis, and/or treatment”, paragraph [0081], “responses that are more objective in nature (e.g., heart rate, blood glucose level, etc.… responses that are more subjective in nature (e.g., degree of pain, mood, etc. ”, paragraph [0193], “level of pain, mobility… a chronic pain wellness score”, , paragraph [0213], “how much the patient's pain interferes with his or her daily life”, paragraph [0230], “physical function, and pain interference may be determined”. The Examiner notes a user’s condition may be determined daily (i.e., a daily activity impact), a physical function (exercise or strenuous activity impact) a mood (i.e., a phycological distress), a pain interference (i.e., a discomfort impact)).
Saliman and Khan may not explicitly teach (underlined below for clarity):
wherein the anorectal disorder bother comprises a bowel movement interference […], wherein the daily activity impact comprises a normal daily activity impact, an exercise or strenuous activity impact, and a sitting impact, and wherein the emotional impact comprises a psychological distress impact, a discomfort impact, and a social impact.
Barbut’419 teaches wherein the anorectal disorder bother comprises a bowel movement interference and a bowel pressure, wherein the daily activity impact comprises a normal daily activity impact, an exercise or strenuous activity impact, and a sitting impact, and wherein the emotional impact comprises a psychological distress impact, a discomfort impact, and a social impact (Barbut’419: paragraph [0040], “utilizing an MSA symptom to be evaluated, the MSA symptom can be… difficulty standing from sitting, difficulty standing unsupported, difficulty sitting unsupported difficulty transferring from one seat to another,… difficulty controlling emotions”, paragraph [0183], “contributing to social isolation and depression”).
One of ordinary skill in the art before the effective filing date would have found it obvious to include using bowel movements, sitting impact and social impact as taught by Barbut’419 with the hemorrhoid quality of life determination as taught by Saliman and Khan with the motivation of “treating, preventing, and/or slowing the onset or progression” (Barbut’419: paragraph [0002]).
Saliman, Khan and Barbut’419 may not explicitly teach (underlined below for clarity):
wherein the anorectal disorder bother comprises a bowel movement interference and a bowel pressure, wherein the daily activity impact comprises a normal daily activity impact, an exercise or strenuous activity impact, and a sitting impact, and wherein the emotional impact comprises a psychological distress impact, a discomfort impact, and a social impact.
Barbut’414 teaches wherein the anorectal disorder bother comprises a bowel movement interference and a bowel pressure, wherein the daily activity impact comprises a normal daily activity impact, an exercise or strenuous activity impact, and a sitting impact, and wherein the emotional impact comprises a psychological distress impact, a discomfort impact, and a social impact (Barbut’414: paragraph [0030], “the symptom can be selected from the group consisting of frequency of constipation, duration of constipation symptoms, frequency of bowel movements”, paragraph [0158], “the Constipation Assessment Scale (CAS)… rectal fullness or pressure; (6) rectal pain with bowel movement”).
One of ordinary skill in the art before the effective filing date would have found it obvious to include using bowel pressure as taught by Barbut’414 with the hemorrhoid quality of life determination as taught by Saliman, Khan and Barbut’419 with the motivation of “improving or resolving constipation and/or the constipation-related symptom in the subject” (Barbut’414: paragraph [0028]).
Claim(s) 17 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 20170228517 (hereafter “Saliman”) and ““PNR-Bleed” classification and Hemorrhoid Severity Score—a novel attempt at classifying the hemorrhoids” (hereafter “Khan”) as applied to claim 16 above, and further in view of U.S. Patent Pub. No. 20220325234 (hereafter “Biffi”).
Regarding (Original) claim 17, Saliman and Khan teach the limitations of claim 16, but may not explicitly teach wherein the symptom intensity is represented in an 11-point numerical rating scale of 0 to 10, wherein a 0 represents no intensity (no symptom), a 5 represents moderate intensity (moderate symptom), and a 10 represents highest intensity (worst symptom).
Biffi teaches wherein the symptom intensity is represented in an 11-point numerical rating scale of 0 to 10, wherein a 0 represents no intensity (no symptom), a 5 represents moderate intensity (moderate symptom), and a 10 represents highest intensity (worst symptom) (Biffi: paragraph [0177], “Relief from IBS symptoms, evaluated by means of IBS symptom severity scale (IBS-SSS) score, evaluated at V1, V2, V3, V4 and V5… Evaluation of the daily abdominal pain/discomfort evaluated by means of the standard 11-point numerical rating scale (NRS) (from 0=none to 10=worst possible pain)”.
It would have been prima facie obvious to one of ordinary skill in the art at the time of the invention was made to combine the noted features of Biffi within teaching of Saliman and Khan since the combination of the two references is merely simple substitution of one known element for another producing a predictable result (KSR rationale B). Since each individual element and its function are shown in the prior art, albeit shown in separate references, the difference between the claimed subject matter and the prior art rests not on any individual element or function but in the very combination itself—that is, in the substitution of the 11-point scale as taught by Biffi for the 5-point scale as taught by Saliman and Khan. Thus, the simple substitution of one known element for another producing a predictable result renders the claim obvious.
Claim(s) 36 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 20170228517 (hereafter “Saliman”), in view of U.S. Patent Pub. No. 20210260319 (hereafter “Huesgen”), in further view of ““PNR-Bleed” classification and Hemorrhoid Severity Score—a novel attempt at classifying the hemorrhoids” (hereafter “Khan”).
Regarding (Currently Amended) claim 36, Saliman teaches a method for assessing treatment effectiveness for [… a …] disorder (Saliman: Figures 1-4, 10, paragraph [0004], “methods for determining a wellness score, an improvement score, and/or an effectiveness score with regard to a medical condition and/or medical treatment”, paragraph [0060], “uses medical treatment and/or diagnosis outcome data reported via one or more outcome measurement devices (OMDs) to better understand, for example, the effectiveness of treatments for a medical condition and various factors that may affect the effectiveness of the treatments, recovery from a treatment, and/or improvement in the medical condition”), the method comprising:
(a) receiving, via an input device, a first set of attributes associated with a first plurality of patients receiving a first treatment for [… a …] disorder and a second set of attributes associated with a […] patients […] (Saliman: Figures 1-4, 10, paragraphs [0004]-[0006], “a medical questionnaire may be provided to a patient via, for example, a patient's personal electronic device (e.g., smart phone or tablet computer). The medical questionnaire may be, for example, a medical symptom questionnaire, a disease-specific medical symptom questionnaire”, paragraphs [0024]-[0025], “a post-treatment provision of a medical questionnaire to a patient may be facilitated (via, for example, communication of the medical questionnaire to the patient's personal electronic device and/or activation of the medical questionnaire already stored on the patient's personal electronic device) after the patient receives a treatment for a medical condition”, paragraphs [0070]-[0072], “administer an outcome measurement device (OMD) to and/or on that patient… Completed OMDs (also called OMD responses) may be transmitted from patient device 128 and stored in OMD response database 110. More specifically, OMD responses may be stored in OMD response database 110… Upon the patient receiving the treatment… a subsequent post-treatment OMD may be administered on the patient by OMD administrator 112… The response to the post-treatment OMD may similarly be stored in OMD response database 110”. The Examiner notes one of ordinary skill in the art would find it prima facie obvious that responses to questionnaires read on what is required of “set of attributes” under the broadest reasonable interpretation),
wherein the first set of attributes and the second set of attributes comprise a symptom intensity and a symptom impact for symptoms of the patient (Saliman: Figure 17, paragraph [0073], “OMD response analyzer 118 may analyze the OMD responses stored in OMD response database 110 to generate one or more scores (e.g., a wellness score, an improvement score, a treatment effectiveness score, a treatment provider effectiveness score, a treatment facility effectiveness score, etc.)… factors that may directly, or closely, relate to and/or have an impact on, a medical condition, diagnosis, and/or treatment”, paragraph [0080], “a “wellness score” may serve to indicate how severe a patient's symptoms are. In these cases, a low wellness/symptom severity score may indicate that a patient's symptoms are relatively more severe than a higher wellness/symptom severity score such that an increasing wellness/symptom severity score indicates an improvement (i.e., decrease in severity) in the symptoms”, paragraph [0138], “in step 730, it may be determined how the one or more contributing factors for the treatment and/or an underlying diagnosis may impact the baseline recovery from the treatment”, paragraph [0179]-[0183], “FIGS. 17C-17E show exemplary OMDs in the form of questionnaires that may be provided to the patient via interfaces 1702, 1703, and 1704, respectively… provides two sets of possible answers 1730, one for each question, in the form of a ranking of none (1) to extreme (5)”, paragraph [0270], “The questions may take any format (e.g., multiple choice, true/false, sliding scale, etc.) and, in some instances, may be used to gauge the severity of the patient symptom”. Also see, paragraph [0147]. The Examiner notes as seen in Figs. 17C-E, multiple responses of both impact and intensity are collected and used to collect and determine a symptom impact and symptom intensity respectively);
(b) automatically inputting, via a processor, the first set of attributes and the second set of attributes to a model, wherein the model is configured to output a first score corresponding to the severity of the […] disorder for the first plurality of patients and a second score corresponding to the severity of the […] disorder for the second plurality of patients (Saliman: Figures 1-4, 10, paragraph [0073], “OMD response analyzer 118 may analyze the OMD responses stored in OMD response database 110 to generate one or more scores”, paragraph [0077], “train a model that can then be used”, paragraphs [0080]-[0081], “OMD response analyzer 118 may comprise wellness score determination module 152. In one embodiment, wellness score determination module 152 retrieves responses to OMD instrument from OMD response database 110… Various scoring procedures may be employed to score a completed OMD, and in one embodiment, the generated score may be known as a “wellness score”. In some cases, a “wellness score” may serve to indicate how severe a patient's symptoms are”, paragraphs [0182]-[0186], “The pre-treatment set of responses may be scored using, for example, a scoring procedure associated with the OMD provided in step 1015 in order to determine a pre-treatment wellness score for the medical condition (step 1035)… a post-treatment wellness score for the medical condition may be determined by applying a scoring procedure, and where appropriate, a sub-scoring procedure, to the post-treatment set of responses”, paragraph [0364], “a processor 2504”. Also see, paragraph [0292]),
wherein the first score and the second score are represented as a […] Quality of Life Index (HQLI) (Saliman: paragraph [0082], “improvement scores may be indexed”, paragraph [0097], “Quality of Life Instrument… Quality of Life Questionnaire”, paragraph [0104], “one or more general OMDs, such as a general quality of life questionnaire that includes, for example, questions regarding a patient's general health”, paragraph [0183], “indexing the pre-treatment wellness score”);
(c) outputting the first score and the second score, or a representation thereof, via an output device (Saliman: Figures 1-4, 10, 17, paragraph [0075], “reporting module 122 may report the scores to one or more of treatment provider device 124, patient device 128 and treatment facility computer system 134”, paragraph [0168], “providing one or more of a pre-treatment wellness score, post-treatment wellness score and an improvement score to a patient, treatment provider, treatment facility and/or treatment administrator”, paragraph [0188], “feedback including one or more the pre-treatment wellness score, post-treatment wellness score and the improvement score may be provided to the patient via an interface, for example, like interfaces 1705 and 1706 of FIG. 17F and FIG. 17G… The feedback may also be provided, for example, to a treatment provider, a treatment facility, and/or a treatment administrator”); and
(d) determining the effectiveness of the first treatment relative to the second treatment based on the first score and the second score (Saliman: Figures 1-4, 10, 15, paragraph [0062], “compared to other patients with similar treatments”, paragraph [0187], “an improvement score may be calculated based on the pre-treatment wellness score and the post-treatment wellness score. In one embodiment, the improvement score may be calculated as the post-treatment wellness score minus the pre-treatment wellness score. More generally, the improvement score may be known as a “health progression” score, accommodating the scenarios in which the patient's condition stays the same or worsens following the treatment”). Saliman may not explicitly teach (underlined below for clarity):
(a) receiving, via an input device, a first set of attributes associated with a first plurality of patients receiving a first treatment for [… a …] disorder and a second set of attributes associated with a second plurality of patients receiving a second treatment for the […] disorder, wherein the first set of attributes and the second set of attributes comprise a symptom intensity and a symptom impact for symptoms of the patient; […]; (d) determining the effectiveness of the first treatment relative to the second treatment based on the first score and the second score.
Huesgen teaches (a) receiving, via an input device, a first set of attributes associated with a first plurality of patients receiving a first treatment for [… a …] disorder and a second set of attributes associated with a second plurality of patients receiving a second treatment for the […] disorder, wherein the first set of attributes and the second set of attributes comprise a symptom intensity and a symptom impact for symptoms of the patient; […]; (d) determining the effectiveness of the first treatment relative to the second treatment based on the first score and the second score (Huesgen: Figure 2, paragraph [0013], “a method for determining an effectiveness of a treatment”, paragraph [0044], “the invention can be utilized in assessing the effectiveness of different treatments or therapies for medical conditions”, paragraphs [0077]-[0084], “a first value of a composite score for the two or more neurological biomarkers is determined for one or more patients undergoing a first treatment… a second value of a composite score for the two or more neurological biomarkers is determined for one or more patients undergoing a second treatment that is different from the first treatment… the effectiveness of the first or second treatments is determined based on a difference between the first or second value of the composite score and the threshold composite score… determine a relative effectiveness between the first and second treatments by merely comparing the first value and the second value of the composite scores and/or comparing the first change with the second change in the value of the one or more neurological biomarker levels”, claim 5, “obtaining, on the processor, preliminary first data for the values… during treatment of a plurality of patients””).
One of ordinary skill in the art before the effective filing date would have found it obvious to include using data from various other treatments as taught by Huesgen within the condition efficacy determination as taught by Saliman with the motivation of “overcomes these drawbacks of conventional methods used to assess the effectiveness of treatments or interventions” (Huesgen: paragraph [0084]).
Saliman and Huesgen may not explicitly teach (underlined below for clarity):
a method for assessing treatment effectiveness for an anorectal disorder, the method comprising: (a) receiving, via an input device, a first set of attributes associated with a first plurality of patients receiving a first treatment for an anorectal disorder and a second set of attributes associated with a second plurality of patients receiving a second treatment for the anorectal disorder wherein the first set of attributes and the second set of attributes comprise a symptom intensity and a symptom impact for symptoms of the patient; (b) automatically inputting, via a processor, the first set of attributes and the second set of attributes to a model, wherein the model is configured to output a first score corresponding to the severity of the anorectal disorder for the first plurality of patients and a second score corresponding to the severity of the anorectal disorder for the second plurality of patients, wherein the first score and the second score are represented as a Hemorrhoid Quality of Life Index (HQLI);
Khan teaches a method for assessing treatment effectiveness for an anorectal disorder, the method comprising: (a) receiving, via an input device, a first set of attributes associated with a first plurality of patients receiving a first treatment for an anorectal disorder and a second set of attributes associated with a second plurality of patients receiving a second treatment for the anorectal disorder wherein the first set of attributes and the second set of attributes comprise a symptom intensity and a symptom impact for symptoms of the patient; (b) automatically inputting, via a processor, the first set of attributes and the second set of attributes to a model, wherein the model is configured to output a first score corresponding to the severity of the anorectal disorder for the first plurality of patients and a second score corresponding to the severity of the anorectal disorder for the second plurality of patients, wherein the first score and the second score are represented as a Hemorrhoid Quality of Life Index (HQLI) (Khan: Table 1, pages 2-3, “Hemorrhoids or piles are symptomatically enlarged and distally displaced anal cushions. It is one of the most common anorectal disorders… The four components of this “PNR-Bleed” classification (Table 1) are… the degree of hemorrhoidal prolapse similar to that of Goligher grading… scoring system for hemorrhoids as the Hemorrhoid Severity Score (HSS). Hemorrhoid Severity Score (HSS) is the total score obtained by the sum of the numerical grades of all four characteristics of hemorrhoids in “PNR-Bleed” classification”);
One of ordinary skill in the art before the effective filing date would have found it obvious to include using a hemorrhoid severity score as taught by Khan within the severity scores for various medical conditions as taught by Saliman and Huesgen with the motivation of “classification system for any disease is useful for not only in choosing an appropriate treatment for a particular class, but also to allow the comparison of various available treatment options” (Khan: Page 2).
Response to Arguments
Applicant's arguments filed on 24 March 2026 have been fully considered but they are not persuasive. Applicant’s arguments will be addressed herein below in the order in which they appear in the response filed on 24 March 2026.
Rejections under 35 U.S.C. § 112
Regarding the rejection of claim 25, the claim has been canceled, and the rejection removed.
Rejections under 35 U.S.C. § 101
Regarding the rejection of claims 1-4,6-9,12-18,25,27,30,36 and 45, the Examiner has considered the Applicant’s arguments but does not find them persuasive. The Examiner has attempted to address all of the arguments presented by the Applicant; however, any arguments inadvertently not addressed are not persuasive for at least the following reasons:
Applicant argues:
The instant claims are not directed to managing personal behavior or interactions between people and thus are not directed to an abstract idea. Rather the claims are directed to a specific technical methodology, requiring specific types of patient information (i.e. symptom intensity and symptom impact) as inputs and produce a specific output score (e.g. output score is represented by a HQLI) that quantifies the severity of an anorectal disorder… These specific attributes are specifically combined and processed by a model… The claims are directed to how the system operates to generate the HQLI, not to manage behaviors or interactions… Specifically, the claims require particular types of patient attributes… Thus the claims recite a distinct type of output score that represents assessing anorectal disorders… As amended, the claims recite receiving a particular type of set of attributes (symptom intensity and symptom impact) and further recite that these attributes are processed through a model to output a particular score…. The combination of obtaining and subsequent analysis of the set of attributes represent a non-routine methodology for assessing anorectal disorders that amounts to significantly more than any alleged abstract idea.
The Examiner respectfully disagrees.
It is respectfully submitted, the claims under the broadest reasonable interpretation are directed toward collection and organization of data to provide output for a human user to use in their assessment of an anorectal disorder for a patient via the use and interaction of various generic computer components, which as stated in 2106.04(a)(2), “certain activity between a person and a computer… may fall within the “certain methods of organizing human activity” grouping”. The claims amount to assisting a human user in performing an anorectal assessment via their interaction with generic computer components and is directed at an abstract idea.
With respect to practical application the labels of the data used are not additional elements, they are merely descriptions of the data that is being organized and cannot provide a practical application. Additionally, no portions of the specification are argued for any recitations of a technical problem, the claims and specification appear to at best be directed at a human activity problem of assessing an anorectal disorder, which the claims may improve upon, nevertheless, an improved abstract idea is still an abstract idea, as the claimed additional element do not recite a technical solution to a technical problem recited in Applicant’s specification the argument is not persuasive.
Rejections under 35 U.S.C. § 103
Regarding the rejection of claims 1-4,6-9,12-18,25,27,30,36 and 45, the Examiner has considered the applicant’s arguments; however, the arguments are not persuasive as addressed herein. Any arguments inadvertently not addressed are unpersuasive for at least the following reasons:
Applicant argues:
First, the cited references of Saliman and Khan, either alone or in combination, fail to teach or suggest "the set of attributes comprises a symptom intensity and a symptom impact for symptoms of the patient" as recited in the amended claims… Saliman's Figure 17 does not distinguish between symptom intensity and symptom impact as two separate and distinct types of attributes. The questions depicted in Figure 17 are directed to a single dimension of patient experience (i.e., general impact), and do not separately capture the intensity of individual symptoms (e.g., pain severity, bleeding severity) as a distinct attribute from the impact of those symptoms on the patient's quality of life ( e.g., interference with daily activities, emotional distress). The amended claims require "a symptom intensity and a symptom impact", as separate inputs to the model… However, even assuming arguendo that Saliman discloses physical and mental summaries in a general sense, Saliman does not disclose an index that combines a symptom intensity score and a symptom impact score to produce the HQLI output score… However, even assuming arguendo that Saliman discloses physical and mental summaries in a general sense, Saliman does not disclose an index that combines a symptom intensity score and a symptom impact score to produce the HQLI output score.
The Examiner respectfully disagrees.
It is respectfully submitted, Applicant specification does not explicitly define either “symptom intensity” or “symptom impact”, respectively, as such the Examiner must treat these terms under the broadest reasonable interpretation. The Examiner notes Saliman: Figs. 17C-E explicitly show capture of both a severity (i.e., a intensity) as well, as an impact via the slider, and at multiple points teaches using the response to determine an impact and severity (see above but at least paragraphs [0073], [0080] and [0138]) and further uses this information to determine a QoL index (see above but at least paragraph [0097]), although the quality of life index may not be for Hemorrhoids, Khan (see above but at least Table 1, pages 2-3) is directed at assessments of hemorrhoids and would be prima facie obvious to combine with the motivation of “classification system for any disease is useful for not only in choosing an appropriate treatment for a particular class, but also to allow the comparison of various available treatment options” (Khan: Page 2). Therefore, it is the combination that teaches the argued claims under the broadest reasonable interpretation.
In addition, the Examiner respectfully notes that the cited reference was never applied as a reference under 35 U.S.C. 102 against the pending claims. As such, the Examiner respectfully submits that the issue at hand is not whether the applied prior art specifically teaches the claimed features, per se, but rather, whether or not the prior art, when taken in combination with the knowledge of average skill in the art, would put the artisan in possession of these features. Regarding this issue, it is well established that references are evaluated by what they suggest to one versed in the art, rather than by their specific disclosures, In re Bozek, 163 USPQ 545 (CCPA 1969). The issue of obviousness is not determined by what the references expressly state but by what they would reasonably suggest to one of ordinary skill in the art, as supported by decisions in In re DeLisle 406 Fed 1326, 160 USPQ 806; In re Kell, Terry and Davies 208 USPQ 871; and In re Fine, 837 F.2d 1071, 1074, 5 USPQ 2d 1596, 1598 (Fed. Cir. 1988) (citing In re Lalu, 747 F.2d 703, 705, 223 USPQ 1257, 1258 (Fed. Cir. 1988)). Further, it was determined in In re Lamberti et al, 192 USPQ 278 (CCPA) that:
(i) obviousness does not require absolute predictability;
(ii) non-preferred embodiments of prior art must also be considered; and
(iii) the question is not express teaching of references, but what they would suggest.
According to In re Jacoby, 135 USPQ 317 (CCPA 1962), the skilled artisan is presumed to know something more about the art than only what is disclosed in the applied references. In In re Bode, 193 USPQ 12 (CCPA 1977), every reference relies to some extent on knowledge of persons skilled in the art to complement that which is disclosed therein.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/A.E.L./Examiner, Art Unit 3684
/Shahid Merchant/Supervisory Patent Examiner, Art Unit 3684
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