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 1-10 are pending. Claims 1-10 are rejected herein.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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) assisting prehabilitation for a patient who is scheduled to undergo surgery, the method comprising an acquisition step of acquiring preoperative information on the patient’s condition during a specified period before surgery, the preoperative information including at least one of nutrition consumed by the patient and the patient’s strength training status, and the nutrition containing at least one of amino acids, probiotics, and 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.
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”).
The claim further recites “an acquisition step of acquiring preoperative information on the patient’s condition during a specified period before surgery…” Note that this step satisfied consideration (2) outlined by 2106.05(g) Insignificant Extra Solution Activity, which considers whether the limitation is significant (i.e., it imposes meaningful limits on the claims such that it is not nominally or tangentially related to the invention). Note that MPEP 2106.05(g) Insignificant Extra-Solution Activity identifies the state of being not nominally or tangentially related to the invention as being significant and indicates that claim limitations that add insignificant extra-solution activity to the judicial exception (e.g., mere data gathering in conjunction with a law of nature or abstract idea) would prompt an explanation in an eligibility rejection as to why the limitation does not meaningfully limit the claim. Here the data gathering was the abstract idea. Note that the second and third 2106.05(g) Insignificant Extra Solution Activity consideration were considered at Step 2A Prong Two and Step 2B. This comment was included to justify considering the data gathering step as part of the abstract idea.
Claims 2-7,10 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 contains at least one of amino acids and synbiotics. Claim 3 merely describes wherein the preoperative information includes 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 6 merely describes a prediction step of predicting the patient’s postoperative course based on the preoperative information. 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 § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1,2,8 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by 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).
Regarding Claim 1
Beppu teaches:
An assistance method using a computer for assisting prehabilitation for a patient who is scheduled to undergo surgery, the method comprising an acquisition step of acquiring preoperative information on the patient’s condition during a specified period before surgery, the preoperative information including at least one of nutrition consumed by the patient and the patient’s strength training status, and the nutrition containing at least one of amino acids, probiotics, and prebiotics. [Beppu teaches at the Abstract Method section BCAA granules were added two times a day to a conventional diet in the BCAA administration group (BCAA group). Beppu teaches at the Abstract Method section that the secondary end points were volumetric liver regeneration and changes in liver function and laboratory data. Beppu teaches at pg. 1199 that the primary end point was functional liver regeneration of the future remnant liver after PVE and hepatic resection, assessed using 99mTc-GSA SPECT/CT fusion images (images 11-13). Beppu teaches at the Abstract End Points that the secondary end points were volumetric liver regeneration and changes in liver function and blood chemistry data. Beppu teaches at pg. 1199 hemogram and laboratory data were measured regularly before PVE using standard laboratory methods. Beppu teaches at pg. 1199 BCAA, tyrosine, pre-albumin, fasting blood glucose, insulin and hemoglobulin A1C levels and BCAA and tyrosine ratio (BTR) were additionally assessed. Beppu teaches that hemogram data (hemoglobin concentration; white blood cell count, including the ratio of neutrophils and lymphocytes; and platelet count) and laboratory data (serum total protein, albumin, total and direct bilirubin, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, c-glutamyl transferase, cholinesterase, total bile acid, ammonia, total cholesterol, triglyceride, blood urea nitrogen, creatinine, and C-reactive protein levels and prothrombin time activity) were regularly evaluated every 1–2 weeks until 1 month after hepatic resection, and once per month subsequently. This teaches at least one test of blood chemistry data before and after PVE and hepatic resection, which are considered surgeries. The test of blood chemistry data is an acquisition step of acquiring preoperative information on the patient’s condition during a specified period before surgery, the preoperative information including at least one of nutrition consumed by the patient, and the nutrition containing at least amino acids.]
Regarding Claim 2
Beppu teaches the assistance method according to claim 1. Beppu further teaches:
wherein the nutrition contains at least one of amino acids and synbiotics. [Beppu teaches at the Abstract Method section BCAA granules were added two times a day to a conventional diet in the BCAA administration group (BCAA group). Beppu teaches at the Abstract Method section that the secondary end points were volumetric liver regeneration and changes in liver function and laboratory data. Beppu teaches at pg. 1199 that the primary end point was functional liver regeneration of the future remnant liver after PVE and hepatic resection, assessed using 99mTc-GSA SPECT/CT fusion images (images 11-13). Beppu teaches at the Abstract End Points that the secondary end points were volumetric liver regeneration and changes in liver function and blood chemistry data. Beppu teaches at pg. 1199 hemogram and laboratory data were measured regularly before PVE using standard laboratory methods. Beppu teaches at pg. 1199 BCAA, tyrosine, pre-albumin, fasting blood glucose, insulin and hemoglobulin A1C levels and BCAA and tyrosine ratio (BTR) were additionally assessed. Beppu teaches that hemogram data (hemoglobin concentration; white blood cell count, including the ratio of neutrophils and lymphocytes; and platelet count) and laboratory data (serum total protein, albumin, total and direct bilirubin, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, c-glutamyl transferase, cholinesterase, total bile acid, ammonia, total cholesterol, triglyceride, blood urea nitrogen, creatinine, and C-reactive protein levels and prothrombin time activity) were regularly evaluated every 1–2 weeks until 1 month after hepatic resection, and once per month subsequently. This teaches at least one test of blood chemistry data before and after PVE and hepatic resection. The test of blood chemistry data is an acquisition step of acquiring preoperative information on the patient’s condition during a specified period before surgery, the preoperative information including at least one of nutrition consumed by the patient, and the nutrition containing at least amino acids.]
Regarding Claim 8
Beppu teaches:
An assistance program for assisting prehabilitation for a patient who is scheduled to undergo surgery, the assistance program causing a computer to execute an acquisition step of acquiring preoperative information on the patient’s condition during a specified period before surgery, the preoperative information including at least one of nutrition consumed by the patient and the patient’s strength training status, and the nutrition contains at least one of amino acids, probiotics, and prebiotics. [Beppu teaches at the Abstract Method section BCAA granules were added two times a day to a conventional diet in the BCAA administration group (BCAA group). Beppu teaches at the Abstract Method section that the secondary end points were volumetric liver regeneration and changes in liver function and laboratory data. Beppu teaches at pg. 1199 that the primary end point was functional liver regeneration of the future remnant liver after PVE and hepatic resection, assessed using 99mTc-GSA SPECT/CT fusion images (images 11-13). Beppu teaches at the Abstract End Points that the secondary end points were volumetric liver regeneration and changes in liver function and blood chemistry data. Beppu teaches at pg. 1199 hemogram and laboratory data were measured regularly before PVE using standard laboratory methods. Beppu teaches at pg. 1199 BCAA, tyrosine, pre-albumin, fasting blood glucose, insulin and hemoglobulin A1C levels and BCAA and tyrosine ratio (BTR) were additionally assessed. Beppu teaches that hemogram data (hemoglobin concentration; white blood cell count, including the ratio of neutrophils and lymphocytes; and platelet count) and laboratory data (serum total protein, albumin, total and direct bilirubin, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, c-glutamyl transferase, cholinesterase, total bile acid, ammonia, total cholesterol, triglyceride, blood urea nitrogen, creatinine, and C-reactive protein levels and prothrombin time activity) were regularly evaluated every 1–2 weeks until 1 month after hepatic resection, and once per month subsequently. This teaches at least one test of blood chemistry data before and after PVE and hepatic resection. The test of blood chemistry data is an acquisition step of acquiring preoperative information on the patient’s condition during a specified period before surgery, the preoperative information including at least one of nutrition consumed by the patient, and the nutrition containing at least amino acids.]
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) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beppu (Effect of branched-chain amino acid supplementation on functional liver regeneration in patients undergoing portal vein embolization and sequential hepatectomy: a randomized controlled trail) in view of Olsen (preoperative bowel preparation versus no preparation before spinal surgery: a randomized clinical trial).
Regarding Claim 3
Beppu teaches the assistance method according to claim 1. Beppu may not explicitly teach:
wherein the preoperative information includes the patient’s bowel movements.
Olsen teaches:
wherein the preoperative information includes the patient’s bowel movements. [Olsen teaches at pg. 5 The Interventions, the participants in this study were randomized to the control group or to one of the two experimental groups. Olsen teaches at pg. 5, The Interventions, the control group received no bowel preparation. Olsen teaches at pg. members of the nursing staff were instructed to follow the recommendation of Tyler et al. (2008) for administering an enema; to insert the enema catheter 7.5-10 centimeters in to the rectum with the patient lying on the left side with the legs tucked up. Olsen teaches at pg. 5 the liquid was slowly inserted and the patient was encouraged to allow the drug to work for ten minutes. Olsen teaches at pg. 5 the suppository was inserted into the rectal ampulla the evening before surgery. Olsen teaches at pg. 5 the type of bowel preparation given and its effect were document on the preoperative form. Collectively, this teaches wherein the preoperative information includes the patient’s bowel movements.]
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 effect of branched-chain amino acid supplementation on functional liver regeneration in patients undergoing portal vein embolization and sequential hepatectomy: a randomized controlled trial of Beppu to the system and method for optimizing the preoperative bowel preparation versus no preparation before spinal surgery: a randomized clinical trial of Olsen with the motivation of decreasing constipation, as there was a tendency for a patients who received no bowel preparation to recover from constipation more quickly than patients in the bowel preparation groups (Olsen at the Abstract-Results Section).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beppu (Effect of branched-chain amino acid supplementation on functional liver regeneration in patients undergoing portal vein embolization and sequential hepatectomy: a randomized controlled trail) 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
Beppu teaches the assistance method according to claim 1. Beppu may not explicitly teach:
wherein the preoperative information includes the patient’s activity level.
Nakajima teaches:
wherein the preoperative information includes the patient’s activity level. [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 effect of branched-chain amino acid supplementation on functional liver regeneration in patients undergoing portal vein embolization and sequential hepatectomy: a randomized controlled trial of Beppu 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) 5,6,7,9,10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beppu (Effect of branched-chain amino acid supplementation on functional liver regeneration in patients undergoing portal vein embolization and sequential hepatectomy: a randomized controlled trail) 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
Beppu teaches the assistance method according to claim 4. Beppu teaches
wherein the activity level includes the patient’s steps and calories burned.
Richards teaches:
wherein the activity level includes the patient’s steps and calories burned. [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 of ordinary skill in the art of healthcare, at the time of filing, to modify the effect of branched-chain amino acid supplementation on functional liver regeneration in patients undergoing portal vein embolization and sequential hepatectomy: a randomized controlled trial of Beppu 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 6
Beppu teaches the assistance method according to claim 1. Beppu may not explicitly teach:
further comprising a prediction step of predicting the patient’s postoperative course based on the preoperative information.
Richards teaches:
further comprising a prediction step of predicting the patient’s postoperative course based on the preoperative information. [Richards teaches at pg. 5 after adjusting for preoperative clinicopathological variables, low step count remained a significant independent predictor of prolonged length of stay with an IRR = 2.09 (1.55-2.83), (p<0.01). Richards teaches at pg. 5 that multivariate analysis was conducted using backward stepwise selection to assess the association between preoperative patient factors and the development of post-operative complications. Richards teaches at pg. 5 all pre-operative demographic factors, including the presence of a low pre-operative step count, were included in the model. Richards teaches at pg. 5 a low pre-operative step count remained a significant predictor of developing a post-operative complication (p = 0.04). Here the patients post-operative course is the length of stay outcome predicted by Richards.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of healthcare, at the time of filing, to modify the effect of branched-chain amino acid supplementation on functional liver regeneration in patients undergoing portal vein embolization and sequential hepatectomy: a randomized controlled trial of Beppu 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) (Richards at the Abstract-Results).
Regarding Claim 7
Beppu teaches the assistance method according to claims 1. Beppu 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;
and a transmission step of transmitting the preoperative information using a patient terminal managed by the patient;
and a transmission step of transmitting the preoperative information from the patient terminal to the computer.
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 using a patient terminal managed by the patient; [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.]
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 of ordinary skill in the art of healthcare, at the time of filing, to modify the effect of branched-chain amino acid supplementation on functional liver regeneration in patients undergoing portal vein embolization and sequential hepatectomy: a randomized controlled trial of Beppu 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) (Richards at the Abstract-Results).
Regarding Claim 9
Beppu teaches:
the preoperative information including at least one of nutrition consumed by the patient and the patient’s strength training status, and the nutrition containing at least one of amino acids, probiotics, and prebiotics. [Beppu teaches at the Abstract Method section BCAA granules were added two times a day to a conventional diet in the BCAA administration group (BCAA group). Beppu teaches at the Abstract Method section that the secondary end points were volumetric liver regeneration and changes in liver function and laboratory data. Beppu teaches at pg. 1199 that the primary end point was functional liver regeneration of the future remnant liver after PVE and hepatic resection, assessed using 99mTc-GSA SPECT/CT fusion images (images 11-13). Beppu teaches at the Abstract End Points that the secondary end points were volumetric liver regeneration and changes in liver function and blood chemistry data. Beppu teaches at pg. 1199 hemogram and laboratory data were measured regularly before PVE using standard laboratory methods. Beppu teaches at pg. 1199 BCAA, tyrosine, pre-albumin, fasting blood glucose, insulin and hemoglobulin A1C levels and BCAA and tyrosine ratio (BTR) were additionally assessed. Beppu teaches that hemogram data (hemoglobin concentration; white blood cell count, including the ratio of neutrophils and lymphocytes; and platelet count) and laboratory data (serum total protein, albumin, total and direct bilirubin, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, c-glutamyl transferase, cholinesterase, total bile acid, ammonia, total cholesterol, triglyceride, blood urea nitrogen, creatinine, and C-reactive protein levels and prothrombin time activity) were regularly evaluated every 1–2 weeks until 1 month after hepatic resection, and once per month subsequently. This teaches at least one test of blood chemistry data before and after PVE and hepatic resection, which are surgeries. The test of blood chemistry data is an acquisition step of acquiring preoperative information on the patient’s condition during a specified period before surgery, the preoperative information including at least one of nutrition consumed by the patient, and the nutrition containing at least amino acids.]
Beppu may not explicitly teach:
An assistance device for assisting prehabilitation for a patient who is scheduled to undergo surgery, the assistance device comprising an acquisition unit for acquiring preoperative information on the patient’s condition during a specified period before surgery,
Richards teaches:
An assistance device for assisting prehabilitation for a patient who is scheduled to undergo surgery, the assistance device comprising an acquisition unit for acquiring preoperative information on the patient’s condition during a specified period before surgery, [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 on the patient’s condition during a specified period before surgery.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of healthcare, at the time of filing, to modify the effect of branched-chain amino acid supplementation on functional liver regeneration in patients undergoing portal vein embolization and sequential hepatectomy: a randomized controlled trial of Beppu 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) (Richards at the Abstract-Results).
Regarding Claim 10
Beppu/Richards teach an assistance system comprising: the assistance device according to claim 9. Beppu/Richards further teach:
and a patient terminal communicably connected to the assistance device and recording 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.]
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRISTAN ISAAC EVANS whose telephone number is (571)270-5972. The examiner can normally be reached Mon-Thurs 8:00am-12:00pm & 1:00pm-7:00pm, off Fridays.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Morgan can be reached at 571-272-6773. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/T.I.E./Examiner, Art Unit 3683
/CHRISTOPHER L GILLIGAN/Primary Examiner, Art Unit 3683