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 .
Claims 1-5,7-10 are pending. Claims 1-5,7-10 are rejected herein.
Priority
This Application claims priority to JP 2022-174127, PCT/JP2023/038895. This application has an effective priority date of 31 October 2022.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-10 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 1,8 and 9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
The claims recite a method, a program, and an assistance device for information retrieval, which are within a statutory category or are interpreted to be within a statutory category for subject matter eligibility analysis purposes).
Step 2A1
The limitations of (claim 1 being representative) […] a prediction step of predicting a postoperative course of the patient based on the preoperative information; an alert step of providing an alert based on the predicted postoperative course; and a treatment step wherein nutrition consumed by the patient during the specified period before the scheduled surgery is modified in response to the alert; wherein the preoperative information include nutrition information associated with the nutrition consumed by the patient, and wherein the nutrition consumed by the patient includes at least one of probiotics or prebiotics as drafted, is a process that, under the broadest reasonable interpretation, covers certain methods of organizing human activity (i.e., managing personal behavior including following rules or instructions) but for recitation of generic computer components. The claims encompass a series of rules or instructions for a person or persons to follow, with or without the aid of a computer, to acquire information about a patient undergoing preoperative exercise training and nutrition counseling prior to a surgery in the manner described in the identified abstract idea, supra. The rules or instructions are the claimed steps of acquiring information concerning the patient as indicated supra.
Other than invoking a generic computer, i.e., reciting an assistance method using a computer, the claimed invention amounts to managing personal behavior or interaction between people. 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 methods of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Step 2A2
This judicial exception is not integrated into a practical application. In particular, the claim recites the additional element of a computer that implements the identified abstract idea. The computer is not described by the applicant and is recited at a high-level of generality (i.e., a generic server performing generic computer functions) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this 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 further recites the additional elements of an acquisition step of acquiring preoperative information associated with the patient during a specified period before the scheduled surgery;… This acquisition step is recited at a high level of generality and amounts to the mere data gathering, which is a form of extra-solution activity. MPEP 2106.05(g) indicates that extra-solution data gathering activity cannot provide a practical application. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application.
Step 2B
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 element of using a computer to perform the noted steps amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component 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 an acquisition step of acquiring preoperative information associated with the patient during a specified period before the scheduled surgery;… was considered extra-solution activity. This has been re-evaluated under the “significantly more” analysis and determined to be well-understood, routine, conventional activity in the field. MPEP 2016.05(d) indicates that storing and retrieving information in memory (Vesata Dev. Group, Inc. v SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015) is well understood routine conventional activity. Well-understood, routine, conventional activity cannot provide an inventive concept (“significantly more”). As such the claim is not patent eligible.
Dependent Claims
Claims 2-5,7,10 are similarly rejected because they either further define/narrow 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 even when considered individually or as an ordered combination.
Claim(s) 2 merely describe(s) wherein the nutrition consumed by the patient further includes synbiotics. Claim 3 merely describes wherein the preoperative information includes the stool consistency information associated with the patient’s bowel movements. Claim 4 merely describes wherein the preoperative information includes the patient’s activity level. Claim 5 merely describes wherein the activity level includes the patient’s steps and calories burned. Claim 7 merely describes a recording step of recording the preoperative information using a patient terminal managed by the patient; and a transmission step of transmitting the preoperative information from the patient from the patient terminal to the computer. Claim 10 merely describes recording the preoperative information.
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.
Claim(s) 1-3,8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0392922 A1 (hereafter Bader) in view of Enhancing Recovery After Elective Colorectal Surgery (hereafter Smith).
Regarding Claim 1
Bader teaches:
A method using a computer for prehabilitation treatment of a patient scheduled to undergo a surgery, the method comprising; an acquisition step of acquiring preoperative information associated with the patient during a specified period before the scheduled surgery; [Bader teaches at Fig. 2, Item 210 a patient questionnaire filled out prior to a surgical office visit (Item 230). This is the specified period before the surgical office visit leading to the schedule surgery.]
a prediction step of predicting a postoperative course of the patient based on the preoperative information; an alert step of providing an alert based on the predicted postoperative course; [Bader teaches at para. [0074] in addition to the traditional questions to establish medical history and the like for the surgery itself, perioperative system will ask a series of questions designed to predict needs and support decisions for each phase of the surgical episode: at para. [0075] suitability of this specific surgery for this specific patient. Bader teaches at para. [0076] whether patient 10 is a candidate for a telephone screen preoperative evaluation, or should come in for an in-person preoperative evaluation (step 330). Bader teaches at the Abstract a computer evaluates the EMR information and questionnaire answers together to evaluate risk characteristics of the patient. Bader teaches at the Abstract based on the evaluating, the computer recommends at least one pathway to be implemented by the medical staff in the patients care. Bader teaches at Fig. 2 Item 282 pathway recommendations impacting the recovery (i.e. pathway recommendations occurring in the postoperative course. Bader also teaches at Fig. 2 that the questionnaire filled out in the preoperative time impacts the postoperative suggestions (see connecting arrow through recommend at risk pathways and evaluate for frailty, cognitive competence, delirium, non-home discharge and other complications).]
and a treatment step wherein nutrition consumed by the patient during the specified period before the scheduled surgery is modified in response to the alert; [Bader teaches at para. [0164] based on the EMR and questionnaire, perioperative system will develop and record certain initial estimations of at risk issues for patient 10 and off recommendations for pathways 140. Bader teaches at para. [0164] these at risk categorizations and recommendations will be offered to patient and medical staff at relevant stages of the care episode. Bader teaches at para. [0165] once the surgeon knows that patient 10 is frail, there Is certain things that prehabilitation will do to improve this patient’s outcome. Bader teaches at Fig. 2 Item 260,360 timed messages relating to nutrition/hydration occurring prior to the surgery. Bader teaches at para. [0165] for example, for a patient known to be frail, the surgeon might decide to delay the surgery for 30 days to build up their nutrition or respiratory function. Bader teaches at para. [0165] determination that patient 10 is frail will affect the booking date for surgery, preoperative prehabilitation, and the like. Bader teaches at para. [0183] in some cases, it will be desirable for patient to engage in some pre-surgical prehabilitation or prep. Bader teaches at para. [0183] for example, some patients will desirably obtain physical therapy, change medication, change diet, or other change of behavior to improve fitness for surgery.]
wherein the preoperative information includes nutrition information associated with the nutrition consumed by the patient, [Bader teaches at para. [0183] in some cases, it will be desirable for patient to engage in some pre-surgical prehabilitation or prep. Bader teaches at para. [0183] for example, some patients will desirably obtain physical therapy, change medication, change diet, or other change of behavior to improve fitness for surgery. Bader teaches at para. [0183] perioperative system will provide patient with education to assist patient in complying with these pre-surgical instructions, for example, as an instructional video.]
Bader may not explicitly teach:
and wherein the nutrition consumed by the patient includes at least one of probiotics or prebiotics.
Smith teaches:
and wherein the nutrition consumed by the patient includes at least one of probiotics or prebiotics. [Smith teaches at pg. 34 an RCT comparing synbiotics in two different forms, to pre-operative bowel preparation in elective colorectal surgery, found significantly higher Interleukin 6 (IL-6) and fibrinogen levels following surgery in the patients receiving synbiotics. This teaches wherein the nutrition consumed by the patient further includes synbiotics. Synbiotics are taken by broadest reasonable interpretation to contain probiotics and prebiotics.]
Therefore, it would have been prima facie obvious to one or ordinary skill in the art of healthcare, at the time of filing, to modify the perioperative education and engagement of surgical patients of Bader to the enhancing recovery after colorectal surgery of Smith with the motivation of improving preoperative surgical care.
Regarding Claim 8 and 9
Due to their similarity to Claim 1, Claim 8 and 9 are similarly analyzed and rejected in a manner consistent with the rejection of Claim 1.
Regarding Claim 2
Bader/Smith teach the method according to claim 1. Bader/Smith further teach:
wherein the nutrition consumed by the patient further includes synbiotics. [Smith teaches at pg. 34 an RCT comparing synbiotics in two different forms, to pre-operative bowel preparation in elective colorectal surgery, found significantly higher Interleukin 6 (IL-6) and fibrinogen levels following surgery in the patients receiving synbiotics. This teaches wherein the nutrition consumed by the patient further includes synbiotics.]
Regarding Claim 3
Bader/Smith teach the method according to claim 1. Bader/Smith further teach:
wherein the preoperative information further includes stool consistency information associated with the patient’s bowel movements. [Smith teaches at pg. 10 the variable analyzed during the study were: LARS Scale Weekly, defecatory diary (frequency and dosage of product application, depositional frequency, consistency of stools measured according to the Bristol scale, size and color, subjectively assessed, in comparison with their natural stools prior to surgery). The comparison of the Bristol scale of the stools prior to surgery is preoperative information further includes stool consistency information associated with the patient’s bowel movements.]
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0392922 A1 (hereafter Bader) in view of Enhancing Recovery After Elective Colorectal Surgery (hereafter Smith) in view of Nakajima (How Many Steps Per Day are Necessary to Prevent Postoperative Complications Following Hepato-Pancreato-Biliary Surgeries for Malignancy?).
Regarding Claim 4
Bader/Smith teach the method according to claim 1. Bader/Smith may not explicitly teach:
wherein the preoperative information further includes activity level information associated with an activity level of the patient.
Nakajima teaches:
wherein the preoperative information further includes activity level information associated with an activity level of the patient. [Nakajima teaches at pg. 1388 the average steps per day recorded by the pedometer were calculated for each patient. Nakajima teaches at pg. 1388 each patient was asked to continuously wear the pedometer during the preoperative waiting period to record daily step, and they were free to confirm their daily steps. Nakajima teaches at pg. 1388 physical activity levels were classified according to the average daily steps as poor physical activity (<5000 steps/day) and good physical activity (greater than or equal to 5000 steps per day) according to the report by Tudor Locke et al. Collectively, this teaches wherein the preoperative information includes the patient’s activity level.]
Therefore, it would have been prima facie obvious to one or ordinary skill in the art of healthcare, at the time of filing, to modify the perioperative education and engagement of surgical patients of Bader to the enhancing recovery after colorectal surgery of Smith to the inquiry of how many steps per day are necessary to prevent postoperative complication following hepato-pancreato-biliary surgeries for malignancy of Nakajima with the motivation of averting poor physical activity, which revealed a significantly higher rate of major complications with Clavien grade ≥ 3 (63% vs. 35%, p =0.016), a higher rate of infectious complications (53% vs 23%, p=0.0006), and a longer postoperative hospital stay (median, 30 vs 21 days, p<0.0001) compared those with good physical activity.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0392922 A1 (hereafter Bader) in view of Enhancing Recovery After Elective Colorectal Surgery (hereafter Smith) in view of Nakajima (How Many Steps Per Day are Necessary to Prevent Postoperative Complications Following Hepato-Pancreato-Biliary Surgeries for Malignancy?) in view of Richards (The association between low pre-operative step count and adverse post-operative outcomes in older patients undergoing colorectal cancer surgery).
Regarding Claim 5
Bader/Smith/Nakajima teach the method according to claim 4. Bader/Smith/Nakajima may not explicitly teach:
wherein the activity level includes steps and calories burned by the patient.
Richards teaches:
wherein the activity level includes steps and calories burned by the patient. [Richards teaches at pg. 3 at the point of recruitment, patients were issued with a Garmin vivofit 3(Garmin, Olathe, KS, USA) wrist-worn activity tracker, with a battery life of approximately 1 year allowing the patients to wear the device continuously without the need for charging. Richards teaches at pg. 3 steps taken, distance travelled and calories burned were monitored by the wearable activity tracker and stored on the device for up to 90 days.]
Therefore, it would have been prima facie obvious to one or ordinary skill in the art of healthcare, at the time of filing, to modify the perioperative education and engagement of surgical patients of Bader to the enhancing recovery after colorectal surgery of Smith to the inquiry of how many steps per day are necessary to prevent postoperative complication following hepato-pancreato-biliary surgeries for malignancy of Nakajima to the association between low pre-operative step count and adverse post-operative outcomes in older patients undergoing colorectal cancer surgery of Richards with the motivation of avoiding a low preoperative step count, which was associated with a significantly increased length of stay (14 vs. 6 days, IRR 2.09, 95% CI 1.55-2.83, p≤ 0.01) and rate of major post-operative complications (29.4% vs. 8.8%, OR 3.34, 95% CI 1.03-14.3, p=0.04).
Claim(s) 7 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0392922 A1 (hereafter Bader) in view of Enhancing Recovery After Elective Colorectal Surgery (hereafter Smith) in view of Richards (The association between low pre-operative step count and adverse post-operative outcomes in older patients undergoing colorectal cancer surgery).
Regarding Claim 7
Bader/Smith teach the method according to claim 1. Bader/Smith may not explicitly teach:
further comprising, before the acquisition step: a recording step of recording the preoperative information using a patient terminal managed by the patient;
Richards teaches:
further comprising, before the acquisition step: a recording step of recording the preoperative information using a patient terminal managed by the patient; [Richards teaches at the Abstract-Methods section a prospective analysis of 85 older patients undergoing major elective colorectal surgery was performed at a tertiary centre between October 2017 and October 2018. Richards teaches at the Abstract-Methods patients aged 65 years and over who met inclusion criteria were provided with an activity tracker to wear for 14 days prior to planned surgery. The activity tracker is the patient terminal managed by the patient. Richards teaches at the Abstract-Methods multivariable logistic regression analyses were used to analyze the influence of low pre-operative step count and other preoperative variables, on post-operative outcomes including mortality, prolonged hospital admission, and complication rates.]
and a transmission step of transmitting the preoperative information from the patient terminal to the computer. [Richards teaches at pg. 3 patients were asked to wear their device continuously, and daily step count was recorded for 14 days pre-operatively. The worn device is the patient terminal managed by the patient. Richards teaches at pg. 3 the device was retrieved, and data downloaded on the day of surgery.]
Therefore, it would have been prima facie obvious to one or ordinary skill in the art of healthcare, at the time of filing, to modify the perioperative education and engagement of surgical patients of Bader to the enhancing recovery after colorectal surgery of Smith to the association between low pre-operative step count and adverse post-operative outcomes in older patients undergoing colorectal cancer surgery of Richards with the motivation of avoiding a low preoperative step count, which was associated with a significantly increased length of stay (14 vs. 6 days, IRR 2.09, 95% CI 1.55-2.83, p≤ 0.01) and rate of major post-operative complications (29.4% vs. 8.8%, OR 3.34, 95% CI 1.03-14.3, p=0.04).
Regarding Claim 10
Bader/Smith teach a system comprising: the device according to claim 9. Bader/Smith may not explicitly teach:
and a patient terminal communicably connected to the device, wherein the patient terminal records the preoperative information.
Richards teaches:
and a patient terminal communicably connected to the device, wherein the patient terminal records the preoperative information. [Richards teaches at pg. 3 at the point of recruitment, patients were issued with a Garmin vivofit 3(Garmin, Olathe, KS, USA) wrist-worn activity tracker, with a battery life of approximately 1 year allowing the patients to wear the device continuously without the need for charging. Richards teaches at pg. 3 steps taken, distance travelled and calories burned were monitored by the wearable activity tracker and stored on the device for up to 90 days. The Garmin Vivofit is the patient terminal communicably connected to the assistance device and recording the preoperative information.]
Therefore, it would have been prima facie obvious to one or ordinary skill in the art of healthcare, at the time of filing, to modify the perioperative education and engagement of surgical patients of Bader to the enhancing recovery after colorectal surgery of Smith to the association between low pre-operative step count and adverse post-operative outcomes in older patients undergoing colorectal cancer surgery of Richards with the motivation of avoiding a low preoperative step count, which was associated with a significantly increased length of stay (14 vs. 6 days, IRR 2.09, 95% CI 1.55-2.83, p≤ 0.01) and rate of major post-operative complications (29.4% vs. 8.8%, OR 3.34, 95% CI 1.03-14.3, p=0.04).
Response to Arguments
As amended, claims 1, 8 and 9 are all patent eligible under Step 2A, prong two pursuant to Vanda Pharmaceutics Inc. v. West-Ward Pharmaceuticals, 887 F. 3d 1117, 1135-36,126 USPQ2d 1266, 1281 (Fed. Cir. 2018). More specifically, “method of treatment” claims are considered patent eligible under Step 2A prong two according to MPEP 2106.04(B) I and 2106.04(d)(2). Moreover, the court held Vanda’s claims eligible at the first part of the Alice/Mayo test (Step 2A) because the claims were not “directed to” the recited judicial exception 887 F.3d at 1136, 126 USPQ2d at 1281
First of all, the Examiner does not dispute applicant’s characterization or quotation of the Vanda pharmaceuticals case, only its application. One way to demonstrate integration is when the additional elements apply or use the recited judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition. The application or use of the judicial exception in this manner meaningfully limits the claim by going beyond generally linking the use of the judicial exception to a particular technological environment, and thus transforms a claim into patent-eligible subject matter.
When determining whether a claim applies or uses a recited judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, the following factors are relevant.
The Particularity Or Generality Of The Treatment Or Prophylaxis
The generality of the treatment or prophylaxis is high. For example, there is no dosage given and there is no indication that any dosage is explicitly acceptable.
Whether The Limitation(s) Have More Than A Nominal Or Insignificant Relationship To The Exception(s)
Whether The Limitation(s) Are Merely Extra-Solution Activity Or A Field Of Use
There are limitations that are merely extra-solution activity.
Applicant argues that the claims are eligible at step 2a Prong two because as amended herein, there is a method of treatment claim that practically applies such a relationship by modifying the “nutrition consumed by the patient during the specified period before the scheduled surgery.”
This is a redundant question, please see the first response. The generality of the treatment or prophylaxis was high and there are limitations that are extra-solution activity and so the limitations do not meaningfully integrate the judicial exception into a practical application of the exception at Step 2 a prong two or provide significantly more at step 2B.
Finally Applicant alleges that any alleged judicial exception present in the previously pending version of claim 1 has, through amendment, been integrated into a practical application. For example, Applicant argues, that claims 8 and 9 as amended therein, practically apply any such relationship by modifying the “nutrition consumed by the patient during the specified period before the scheduled surgery.”
This is a redundant question, please see the first response. The generality of the treatment or prophylaxis was high and there are limitations that are extra-solution activity and so the limitations do not meaningfully integrate the judicial exception into a practical application of the exception at Step 2 a prong two or provide significantly more at step 2B.
Applicant argues that the prior art does not teach the amended claims.
The arguments are moot in light of the introduction of new prior art to the rewritten 35 U.S.C. 103 rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20240233952 A1 (hereafter Morin): Systems and Methods for Continuous Cancer Treatment and Prognostics. Morin teaches obtaining electronic medical records and performing natural language processing on them, which is potentially relevant to the collection of pre-surgery information.
Hijazi, Yasser, Umair Gondal, and Omer Aziz. "A systematic review of prehabilitation programs in abdominal cancer surgery." International journal of surgery 39 (2017): 156-162. Yasser teaches on the subject of prehabilitation programs in abdominal cancer surgery.
İsa Aykut Özdemir et al., Impact of pre-operative walking on post-operative bowel function in patients with gynecologic cancer, International Journal of Gynecological Cancer, Volume 29, Issue 8, 2019, Pages 1311-1316, ISSN 1048-891X. Ozdemir teaches on the subject of exercise prior to surgery impacting post-operative bowel function.
Beppu (Effect of branched-chain amino acid supplementation on functional liver regeneration in patients undergoing portal vein embolization and sequential hepatectomy: a randomized controlled trial).
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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/T.I.E./Examiner, Art Unit 3683
/CHRISTOPHER L GILLIGAN/Primary Examiner, Art Unit 3683
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