DETAILED ACTION
This action is in response to the claims set filed on 03/17/2026.
Claims 1, 4-14 and 19-21 are currently pending and have been examined.
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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/17/2026 is in accordance with the provisions of 37 CFR 1.97 and is considered by the Examiner.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/17/2026 has been entered.
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.
Claim 1, 4-14, and 19-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea which is within the four statutory categories (i.e., a machine and a process). without significantly more. Claims 1, 4-14, and 19-21 are further directed to an abstract idea on the grounds set out in detail below.
Under step 2A, prong 1. The claimed invention represents an abstract idea of a series of steps that recite a process for evaluating a medical condition and patient health. This abstract idea could have been performed mentally along with mathematical calculation but for the fact that the claims recite a general-purpose computer to implement the abstract idea for steps citing a process directed to presenting, analyzing and calculating responses for health assessment for which both the instant claims and the abstract idea are defined as Mental Process.
Independent Claim 1, recites the steps of:
“a) presenting a patient reported outcome measure (PROM) for at least partial completion by the patient about hemorrhoid disease, the PROM including questions extending beyond a question about a symptom or sign of hemorrhoid disease; and
b) performing a calculation as a function of responses to the questions to assess the health of the patient; and
c) correlating a result of the calculation with an objective measurement of the symptom or sign to produce patient reported outcome information for assessing the health of the patient;
wherein the questions include at least a subset of the following related to corresponding questions:
symptoms: pain during bowel movement (BM), pain not during BM, burning while urinating, itching, bleeding, anal leakage, discomfort, pain while sitting;
ii) bowel health: plugged up, emptied bowels, number of times went to the bathroom, time in bathroom, clean anal area, and avoid BM while not at home;
iii) manageability: able to cope, manageable symptom effect, treatment effect effective;
iv) mental health impact: worried, aggravated, distracted, unpredictable, isolated, embarrassment, mood, self-esteem;
v) life impact: affect sleep, interfere with daily activities, interfere with enjoyable time with others, affect ability to take care of others, affect physical intimacy, and protect underwear.”
Independent Claim 19 similarly recite the steps in Claim 1, including:
“a computer-implemented method for assessing health of a patient suffering from hemorrhoid disease, the method comprising:
a) enabling a patient to provide at least partial responses to a patient reported outcome measure (PROM) about hemorrhoid disease via an electronic medium, the PROM including questions extending beyond a question about a symptom or sign of hemorrhoid disease;
b) performing a calculation at the electronic medium, or at a server coupled to the electronic medium, as a function of responses to the questions; and
c) correlating a result of the calculation with an objective measurement of the symptom or sign to produce patient reported outcome information for assessing the health of the patient”.
These limitations, as drafted, given the broadest reasonable interpretation, cover performance of the limitations in the mind that constitute Mental Processes along with mathematical calculations and relationships that constitute Mathematical Concepts. For example, “performing a calculation...”, is a Mathematical Concept. The claim recites steps which in the context of this claim encompasses the user manually the ability for providing subjects with questionnaire/survey and collect responses from the subjects for analysis and calculating a score to correlate with symptom and provide a report assessing the subject health, which are steps that could be performed mentally and, therefore are Mental Processes. This abstract idea could have been performed by a human mind citing a process for collecting, analyzing/calculating, evaluating, and provide an assessment, that are steps of observing, evaluating, judgment and opinion which is/are citing a process for which can be performed using a human mind with the aid of pencil and paper, see MPEP § 2106.04(a)(2)(III). Accordingly, the claim limitations (in BOLD) recite an abstract idea. Any limitations not identified above as part of the mental process are deemed "additional elements," and will be discussed in further detail below.
Under step 2A, prong 2. this judicial exception is not integrated into a practical application because the remaining elements amount to no more than general purpose computer components programmed to perform the abstract ideas, linking the abstract idea to a particular technological environment. In particular, the claims recite the additional elements such as “server, electronic medium” that iteratively takes input data and analyzes said data to determine an output to performing generic computer functions for assessing a subject health such that it amounts no more than adding the words "apply it" (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea, see MPEP 2106.05(f), and a mere data gathering process that does not add a meaningful limitation to the above abstract idea, see MPEP 2106.04(d). As set forth in the 2019 Eligibility Guidance, 84 Fed. Reg. at 55 "merely include[ing] instructions to implement an abstract idea on a computer" is an example of when an abstract idea has not been integrated into a practical application. Accordingly, looking at the claim as a whole, individually and 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. The claim is directed to an abstract idea.
Under step 2B, the claims do not include additional elements that are sufficient to amount to "significantly more" than the judicial exception because as mentioned above, the additional elements amount to no more than generic computing components, recited at a high level of generality, do not present improvements to another technology or technical field, nor do they affect an improvement to the functioning of the computer itself, that amount to no more than mere instruction to perform the abstract idea such that it amounts no more than adding the words "apply it" (or an equivalent) to apply the exception using generic computer component, see MPEP 2106.05(f). There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and mere instructions to apply an exception using a generic computer component cannot provide an inventive concept, See Alice, 573 U.S. at 223 ("mere recitation of a generic computer cannot transform a patent-ineligible abstract idea into a patent-eligible invention."). The claims are not patent eligible.
Dependent Claims 4-14 and 20-21 include all of the limitations of claim(s) 1 and 19, and therefore likewise incorporate the above-described abstract idea.
As for claims 4-5, 7, 10-13, and 20-21, the claim(s) recite limitations that are under the broadest reasonable interpretation, further define the abstract idea noted in the independent claim(s) that covers a performing the steps using a human mind with the aid of pen and paper, which is a mental process, which are similarly rejected because, neither of the claims, further, defined the abstract idea and do not further limit the claim to a practical application or provide an inventive concept such that the claims are subject matter eligible.
As for claims 6, 8-9, the claim(s) recite limitations that are under the broadest reasonable interpretation, further define the abstract idea noted in the independent claim(s) that covers a performing the steps using a human mind with the aid of pen and paper, which is a mental process, along with mathematical calculations that constitute Mathematical Concepts, which are similarly rejected because, neither of the claims, further, defined the abstract idea and do not further limit the claim to a practical application or provide an inventive concept such that the claims are subject matter eligible.
As for claims 14, the claim(s) recite limitations that are under the broadest reasonable interpretation, further define the abstract idea noted in the independent claim(s) that covers performance by a human mind with the aid of pen and paper which are similarly rejected because, neither of the claims, further, defined the abstract idea and do not further limit the claim to a practical application or provide an inventive concept such that the claims are subject matter eligible. In particular, the claim(s) recite additional elements such as “device” disclosed at a high - level of generality that it amounts no more than adding the words "apply it" (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea, see MPEP 2106.05(f). The additional elements amount to more than mere instruction to apply the exception using generic computer component and have been re-evaluated under the “significantly more” analysis. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept ("significantly more").
Claim Rejections - 35 USC § 103
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
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.
Claims 1, 4-14, and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Parsons ("The development of a patient reported outcome measure and imaging modalities in the evaluation of haemorrhoidal disease") in view of Turner et al. (US 2024/0358321 A1 – “Turner”)
Regarding Claim 1 (Previously Presented), Parsons teaches a method of assessing health of a patient suffering from hemorrhoid disease, the method comprising:
a) presenting a patient reported outcome measure (PROM) for at least partial completion by the patient about hemorrhoid disease, the PROM including questions extending beyond a question about a symptom or sign of hemorrhoid disease Parsons discloses providing a patient reported outcomes measure (PROM) for hemorrhoidal disease and gather information about the patient to include information related to haemorrhiods disease symptoms and other information such as, medication, medical history (Parsons: [Fig. 2-1, 8-2], [2.1.3-2.1.4], [2.3.1], [2.3.2.3-2.3.2.4], [Appendix 8.1] ; and
b) performing a calculation as a function of responses to the questions to assess the health of the patient Parsons discloses processing the input data comprising patient reported outcomes (PROs) for hemorrhoidal disease via scoring algorithm and provide quality of life index (Parsons: [Table 2-5, 2-11], [2.1.4], [2.3.1]).
c) correlating a result of the calculation with an objective measurement of the symptom or sign to produce patient reported outcome information for assessing the health of the patient Parsons discloses examining the relationship of the scores generated by the items in the PROM and comparing the score to symptoms such as comparing score of hemorrhoids degree to symptoms and measurements (Parsons: [Table 2-7, 2-11], [2.3.2.1], [6.1], [6.1.1]).
wherein the questions include at least a subset of the following related to corresponding questions:
i) symptoms: pain during bowel movement (BM), pain not during BM, burning while urinating, itching, bleeding, anal leakage, discomfort, pain while sitting (Parsons: [Fig. 8-6 to 8-8]);
ii) bowel health: plugged up, emptied bowels, number of times went to the bathroom, time in bathroom, clean anal area, and avoid BM while not at home (Parsons: [Fig. 8-6 to 8-8]);
iii) manageability: able to cope, manageable symptom effect, treatment effect effective (Parsons: [Fig. 8-5])
iv) mental health impact: worried, aggravated, distracted, unpredictable, isolated, embarrassment, mood, self-esteem;
v) life impact: affect sleep, interfere with daily activities, interfere with enjoyable time with others, affect ability to take care of others, affect physical intimacy, and protect underwear (Parsons: [Fig. 8-7, 8-8]).
However, Parson does not expressly disclose mental health that includes embarrassment worrying/anxiety, frustration.
Turner discloses patient reported outcomes (PROs) and attributes correlated to anorectal/hemorrhoidal disorder symptoms comprise pain, burning, itching, swelling, and/or bleeding, wherein the disorder includes a bowel movement interference and/or a bowel pressure, wherein the daily activity impact comprises a normal daily activity impact, an exercise or strenuous activity impact, and/or a sitting impact, and wherein the emotional impact comprises a psychological distress impact, a discomfort impact, and/or a social impact, wherein the symptom impact comprises discomfort (e.g., mild pain, irritation, tenderness); interference with normal, comfortable bowel movement; pressure in the bowels (e.g., fullness, heaviness); interference with normal daily activities ( e.g., tasks that involve walking, standing for extended time, or frequent bending); affecting participation in social activities; difficulty in performing strenuous physical activity or exercise (e.g., lifting or carrying heavy objects, hiking, swimming, golf); difficulty in sitting for long periods of time (e.g., on a hard surface, riding in a vehicle, when working or studying); anxiety; embarrassment; and/or frustration (Turner: [0005-0006], [0008]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have Parsons disclosing the haemorrhoid PROM for calculating scores to associate with symptoms and to incorporate the patient reported outcomes (PROs) and attributes comprising mental, social, emotional impact, as taught by Turner, which facilitate clinical diagnosis and treatment of hemorrhoids (Turner: [0004]).
Regarding Claim 4 (Previously Presented), the combination of Parsons and Turner teaches the method according to claim 1, wherein the questions include a question about whether burning while urinating is experienced or whether pain occurs during and/or not during bowel movements Parsons discloses questions. Turner discloses symptoms including burning (Turner: [0008]).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 1, and incorporated herein.
Regarding Claim 5 (Previously Presented), the combination of Parsons and Turner teaches the method according to claim 1, wherein the questions about the symptom or sign prompt responses relating to the symptom or sign at its best and at its worst Parsons discloses questions prompt to a subject includes responses associated with symptoms at a worst and best, for example, pain and discomfort effecting the subject at 0 (best) or 10 (worst) (Parsons: [table 2-5], [Fig. 8-2, 8-8], [2.3.2.3]).
Regarding Claim 6 (Original), the combination of Parsons and Turner teaches the method according to claim 1 wherein the calculation produces mean and standard deviation of unweighted scores based on the responses from the patient Parsons discloses mean score of bases on responses (Parsons [table 2-5], [Fig. 2-5, 2-6]).
Regarding Claim 7 (Original), the combination of Parsons and Turner teaches the method according to claim 1 further comprising characterizing severity of the hemorrhoid disease into categories of at least severe, moderate, and mild Parsons discloses classifying severity stages of haemorrhoids (Parsons: [Fig. 2-28], [2.1.2]).
Regarding Claim 8 (Original), the combination of Parsons and Turner teaches the method according to claim 1 wherein the calculation produces a score along a continuum within an available range of the responses Parsons discloses the haemorrhoid PROM and analysis of the reposes of the initial symptoms is used to develop a second PROM to be analyzed (Parsons: [6.1.1]).
Regarding Claim 9 (Previously Presented), the combination of Parsons and Turner teaches method according to claim 1 performed at a beginning and end of a study period; and
further comprising taking at least one physical measurement of afflicted bodily tissues as at least part of the objective measurement at the beginning and the end of the study period, wherein correlating the result of the calculation includes correlating the patient reported output information at the beginning and end of the study period with the at least one physical measurement of the afflicted bodily tissues Parsons discloses assessing measurements of haemorrhoids before and after treatment (Parsons: [2.1], [2.4.6], [3.6.1], [3.8.4], [4.1.6], [4.1.7.2], [6.1]).
Regarding Claim 10 (Original), the combination of Parsons and Turner teaches the method according to claim 9 wherein a treatment of the hemorrhoid disease is applied during the study period, and further comprising determining if the afflicted bodily tissues correlate to progression of the hemorrhoid disease based on multiple physical measurements of the afflicted bodily tissues Parsons discloses monitoring treatment and changes indicating progression of the disease over the haemorrhoids treatment period (Parsons: [Fig. 2-5 to 2-14], [2.4.6.1]).
Regarding Claim 11 (Original), the combination of Parsons and Turner teaches the method according to claim 10 wherein the at least one physical measurement includes a measurement of blood flow through the hemorrhoidal vein or artery Parson discloses measurement of blood flow for haemorrhoid (Parsons: [3.1.2.2], [3.1.4.2]).
Regarding Claim 12 (Original), the combination of Parsons and Turner teaches the method according to claim 11 wherein the at least one measurement includes a Doppler measurement to quantify size, shape, and volume at the beginning and end of the study period Parson discloses using Doppler for measurements (Parsons: [3.1.2.2], [3.6]).
Regarding Claim 13 (Previously Presented), the combination of Parsons and Turner teaches the method according to claim 1, further comprising reporting the patient reported outcome information in a manner enabling selection of a treatment profile Parsons discloses the outcomes used for classifying the heamorrhoids severity stage which may be used to compare and select or choose the most appropriate treatment for the subject (Parsons: [2.1.2]).
Regarding Claim 14 (Original), the combination of Parsons and Turner teaches the method according to claim 1 performed on multiple test patients that have been administered a drug or treated with a device and performed on multiple patients of a control population that have not been administered the drug or treated with the device, and wherein the method further comprises reporting patient reported outcome information for both the multiple test patients and the multiple patients of the control population to a regulatory body responsible for approving the drug or device Parson discloses study comprising haemorrhoid group and placebo control group for assessing treatment (e.g., drug) and outcome such as preventing relapse of symptoms [approving the drug or device] (Parson: [1.5], [1.9], [2.1.3], [4.1.10]).
Regarding Claim 19 (Previously Presented), Parsons teaches a computer-implemented method for assessing health of a patient suffering from hemorrhoid disease, the method comprising:
a) enabling a patient to provide at least partial responses to a patient reported outcome measure (PROM) about hemorrhoid disease via an electronic medium, the PROM including questions extending beyond a question about a symptom or sign of hemorrhoid disease Parsons discloses providing a patient reported outcomes measure (PROM) for hemorrhoidal disease and gather information about the patient to include information related to haemorrhiods disease symptoms and other information such as, medication, medical history (Parsons: [Fig. 2-1, 8-2], [2.1.3-2.1.4], [2.3.1], [2.3.2.3-2.3.2.4], [Appendix 8.1]);
b) performing a calculation at the electronic medium, or at a server coupled to the electronic medium, as a function of responses to the questions Parsons discloses processing the input data comprising patient reported outcomes (PROs) for hemorrhoidal disease via scoring algorithm and provide quality of life index (Parsons: [Table 2-5, 2-11], [2.1.4], [2.3.1])
c) correlating a result of the calculation with an objective measurement of the symptom or sign to produce patient reported outcome information for assessing the health of the patient Parsons discloses examining the relationship of the scores generated by the items in the PROM and comparing the score to symptoms such as comparing score of hemorrhoids degree to symptoms and measurements (Parsons: [Table 2-7, 2-11], [2.3.2.1], [6.1], [6.1.1]).
wherein the questions include at least a subset of the following related to corresponding questions: (Parsons: [Fig. 8-6 to 8-8]);
i) symptoms: pain during bowel movement (BM), pain not during BM, burning while urinating, itching, bleeding, anal leakage, discomfort, pain while sitting;
ii) bowel health: plugged up, emptied bowels, number of times went to the bathroom, time in bathroom, clean anal area, and avoid BM while not at home (Parsons: [Fig. 8-6 to 8-8]);
iii) manageability: able to cope, manageable symptom effect, treatment effect effective (Parsons: [Fig. 8-5])
iv) mental health impact: worried, aggravated, distracted, unpredictable, isolated, embarrassment, mood, self-esteem;
v) life impact: affect sleep, interfere with daily activities, interfere with enjoyable time with others, affect ability to take care of others, affect physical intimacy, and protect underwear (Parsons: [Fig. 8-7, 8-8]).
However, Parsons does not expressly discloses enabling a patient to provide responses to via an electronic medium and perform the calculation at the electronic medium or server and does not expressly disclose mental health that includes embarrassment worrying/anxiety, frustration.
Turner discloses a computer-readable storage media and electronic devices for performing method for assessing the severity of an anorectal/hemorrhoidal disorder using patient reported outcomes (PROs) and calculating a score where patient reported outcomes (PROs) and attributes correlated to anorectal/hemorrhoidal disorder symptoms comprise pain, burning, itching, swelling, and/or bleeding, wherein the disorder includes a bowel movement interference and/or a bowel pressure, wherein the daily activity impact comprises a normal daily activity impact, an exercise or strenuous activity impact, and/or a sitting impact, and wherein the emotional impact comprises a psychological distress impact, a discomfort impact, and/or a social impact, wherein the symptom impact comprises discomfort (e.g., mild pain, irritation, tenderness); interference with normal, comfortable bowel movement; pressure in the bowels (e.g., fullness, heaviness); interference with normal daily activities ( e.g., tasks that involve walking, standing for extended time, or frequent bending); affecting participation in social activities; difficulty in performing strenuous physical activity or exercise (e.g., lifting or carrying heavy objects, hiking, swimming, golf); difficulty in sitting for long periods of time (e.g., on a hard surface, riding in a vehicle, when working or studying); anxiety; embarrassment; and/or frustration (Turner: [0005-0006], [0008], [0068], [0077])
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have Parsons disclosing the haemorrhoid PROM for calculating scores to associate with symptoms and to incorporate the patient reported outcomes (PROs) and attributes comprising mental, social, emotional impact and score performed by electronic device, as taught by Turner, which facilitate clinical diagnosis and treatment of hemorrhoids (Turner: [0004]).
Regarding Claim 20 (Previously Presented), the combination of Parsons and Turner teaches the method of claim 1, comprising performing the method before and after a drug or device for treating hemorrhoid disease is administered to the subject Parsons discloses assessing change before and after administration treatment of haemorrhoids (Parsons: [4.1.7.2], [4.1.10]).
Regarding Claim 21 (Previously Presented), the combination of Parsons and Turner teaches the method of claim 7, further comprising treating a subject with a treatment that corresponds to the category of severe, moderate, or mild hemorrhoid disease identified in the subject Parsons discloses the outcomes used for classifying the heamorrhoids severity stage which may be used to compare and select or choose the most appropriate treatment for the subject (Parsons: [Fig. 2-28], [2.1.2]).
Declaration Under 37 CFR 1.132
The declaration under 37 CFR 1.132 filed 01/24/2024 by Dr. Mukul Agrawal filed 03/17/2026 is insufficient to overcome the 35 USC § 101 and 35 USC § 103 rejections of claims 1, 4-14 and 19-21 as set forth in the last Office action Applicant submitted declaration traversing rejections.
Dr. Mukul Agrawal declared as an expert in Pharmaceutical Sciences with focus on Biopharn1aceutics and Pharmacokinetics stated on page 2, “I understand the claims of the '941 application relate to diagnosing HD based on i) symptoms: ...; ii) bowel health: ...; iii) manageability: ...; iv) mental health impact: ...; v) life impact: ...”, ... “However, a person of ordinary skill in the art trying to combine these 2 disclosures would not simply pick one more item out of Turner's list to add to Parson's list, especially given that Parsons expressly counsels against use of any additional quality of life type items, stating at p. 34 that adding such items would increase "burden to the participant", do not "appear to have any direct relevance to the participant's haemorrhoid symptoms" and also have not "been validated in a haemorrhoid patient population.". This is not persuasive because Dr. Agrawal fails to consider the broadest reasonable interpretation of the claims as written and improperly reads limitations from the specification into the claims. MPEP 716 states that it is the responsibility of the examiner "to personally review and decide whether affidavits or declarations submitted under 37 CFR 1.132 for the purpose of traversing grounds of rejection are responsive to the rejection and present sufficient facts to overcome the rejection." In reviewing the declaration, the Examiner has not identified fact in the declarations that would change the factual determinations underlying the eligibility analysis in the previous action.
While Dr. Agrawal expressed his expertise in Pharmaceutical Sciences, there is no indication or evidence that the declaration presented any expertise in construction of assessment for evaluating validity of the proposed heamorrhoid PROM, any health-related quality of life (HRQoL) measure associated with heamorrhoid, or even performing statistical analyses related to heamorrhoid. Dr. Agrawal continues on page 3 stating “Overall, the combination of these 4 items (items ii-v from above) … In my opinion, the ability to achieve this level of reliability with a short and easy to use questionnaire would not have been obvious from the combination of Parsons and Turner.”. Dr. Agrawal fail to describe how the current application method of assessment and evaluating validity of the proposed heamorrhoid PROM is different than the disclosed in the combination of Parsons and Turner.
Moreover, Dr. Agrawal goes on to make legal conclusions such as “However, a person of ordinary skill in the art trying to combine these 2 disclosures would not simply pick one more item out of Turner's list to add to Parson's list, especially given that Parsons expressly counsels against use of any additional quality of life type items, stating at p. 34 that adding such items would increase "burden to the participant", do not "appear to have any direct relevance to the participant's haemorrhoid symptoms…”, Examiner finds the declaration statement is not addressing the 101 nor 103 rejections of the limitations nor relevant to address why combining the references would not teach the claim limitation. Rather Dr. Agrawal argues the disclosed in Persons, p. 34 advising not to use any additional quality of life items for evaluation that would increase burden to participant... where Persons (p. 33-34) describes the different options for evaluating validity of the proposed haemorrhoid PROM which is does not address any rejection or any reason why a person of ordinary skill in the art cannot combine these 2 disclosures in Persons and Turner.
The Declaration under 37 CFR 1.132 filed 01/24/2024 is insufficient to overcome the 101 and 103 rejections of claims 1, 4-14 and 19-21 as set forth in the last Office action.
Response to Amendment
Applicant's arguments filed 03/17/2026 have been fully considered by the Examiner and addressed as the following:
In the remarks, Applicant argues in substance that:
Applicant's arguments with respect to the 35 U.S.C. § 101 rejection on page 7-8.
On page 7-8 of the remarks, the Applicant argues “First, Applicant points out that the presently claimed invention represents a marked improvement over the existing approach for diagnosing and treating hemorrhoid disease... In further support of this argument, Applicant submits herewith a Rule 132 Declaration of Dr. Mukul Agrawal, a co-inventor of the present application... the presently claimed invention is not abstract and requires specific questions which create patient reported data that is then subjected to a calculation and correlation against an objective measurement pertaining to hemorrhoid disease...”, Examiner respectfully disagree. Examiner respectfully asserts that the claims are given their broadest reasonable interpretation for the purpose of determining whether they encompass a judicial exception. The claims limitations are directed towards evaluating a medical condition (hemorrhoid disease) and patient health, which are still reciting an abstract idea performing the steps of gathering patient(s) responses that includes attributes, performing calculation and correlate results to assess the patient health which are steps that recite a mental process because the claim(s) contain limitations that can practically be performed in the human mind, including for example, observations, evaluations, judgments, and opinions, see MPEP § 2106.04(a)(2)(III).
In addition, not the claims nor the specification disclose a particular improvement of computer’s functionality or a technical field, rather using additional elements, to perform the steps abstract idea such as collecting/generating, calculating, correlating, through leveraging computing technology in a well understood manner. As such, even when considering the claims additional elements, the claims as a whole, individually and in combination, provide no integration of the abstract ideas into a practical application that no meaningful limits on practicing the abstract idea are introduced, see MPEP 2106. The claims as a whole are therefore directed to an abstract idea.
Moreover, in the declaration of Dr. Agrawal on making legal conclusions such as on page 2 of the declaration, “However, a person of ordinary skill in the art trying to combine these 2 disclosures would not simply pick one more item out of Turner's list to add to Parson's list, especially given that Parsons expressly counsels against use of any additional quality of life type items, stating at p. 34…”, Examiner finds the declaration statement is not addressing the 101 rejections of the limitations where the limitations have been analyzed reciting an abstract idea using a human mind.
Therefore, the Examiner has addressed the Applicant argument(s) and found this argument is not found to be persuasive. Hence, Examiner remains the 101 rejections of claims which have been updated to address Applicant's amendments.
Applicant's arguments with respect to the 35 U.S.C. § 103 rejection on page 9-10.
On page 9 of the remarks, the Applicant argues “This rejection should be withdrawn in view of the accompanying Rule 132 Declaration of Dr. Agrawal. Paragraphs 5-7 set forth the reasons why one of ordinary skill in the art would not have been motivated to combine the references in the manner asserted in the rejection, including that one "would not simply pick one more item out of Turner's list to add to Parson's list, especially given that Parsons expressly counsels against use of any additional quality of life type items, stating at p. 34 that adding such items would increase 'burden to the participant', do not 'appear to have any direct relevance to the participant's haemorrhoid symptoms' and also have not 'been validated in a haemorrhoid patient population." Further, as noted above, Dr. Agrawal explains the unexpected results of the particular combination of items required by the presently claimed invention, noting in par. 9 ... These unexpected results more than rebut any case of prima facie obviousness”, Examiner respectfully disagrees. Although the argument of Dr. Agrawal does not address why the combination of reference do not teach the claims of the current application, the reference “Parsons” discloses assessment and evaluation of haemorrhoidal disease, the reference “Turner” discloses assessing the severity of a hemorrhoids disorder. The Examiner asserts the prior arts of the rejection are directed to assessing and evaluating haemorrhoidal disease based on collected user inputs to score and validate the condition as such modifying the combination of the references teaches the claim elements and hence establishes a prima facie case of obviousness.
Moreover, while the combination of the references, under BRI, teaches the claimed steps, Examiner finds the Applicant argument is directed to each reference individually and ignoring the teaching of the combination of references to teach all the claim elements and ignoring the fact that the Examiner rejection is based on nonobviousness 35 USC 103 whereas one cannot show nonobviousness by arguing references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413,208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Therefore, Examiner finds the Applicant argument unpersuasive.
Prior Art Cited but not Applied
The following document(s) were found relevant to the disclosure but not applied:
US20250006370 “Lipsky” discloses analyzing patient-reported outcome (PRO) data and receiving PRO data for evaluation and validating the PRO data and treatment for patients may include.
The reference(s) is/are relevant since it discloses obtaining patient input using patient-reported outcome (PRO) for symptoms and correlating the input to a condition and provide a treatment.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALAAELDIN ELSHAER whose telephone number is (571)272-8284. The examiner can normally be reached M-Th 8:30-5:30.
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/ALAAELDIN M. ELSHAER/Primary Examiner, Art Unit 3687