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 .
Status of the Application
Claims 1, 4, and 6 have been amended. Claims 2, 3, and 7-16 are cancelled. Claims 1 and 4-6 are currently pending and have been addressed below.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 recites “orthopaedic surgery” on Page 3, Line 28. For examination purposes, examiner interprets the claim to recite “orthopedic surgery”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1 and 4-6 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the medical resource" on Page 3, Line 18. There is insufficient antecedent basis for this limitation in the claim.
Claims 4-6 are dependent from Claim 1 and therefore contain the same deficiencies.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 and 4-6 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “transferring, by the data processing device, the patient from a first location at the hospital to a second location at the hospital based on the plurality of hospital resources”. The specification fails to provide support for the concept of a data processing device transferring a patient to a second location based on the plurality of hospital resources. The specification fails to disclose how a data processing device is capable of transferring a patient to a different location.
Claims 1 also recites “performing, by the surgeon and the nurse at the second location, a surgery operation using the medical device, wherein the surgery operation is selected from a group consisting of digestive surgery, infant surgery, maxillofacial surgery, stomatology surgery, orthopedic surgery, traumatological surgery, plastic surgery, thoracic and cardiovascular surgery, urological surgery, vascular surgery, visceral surgery, and neurosurgery”. The specification fails to provide support for the concept of actually performing a surgery operation at a second location using the medical device.
Claims 4-6 are dependent from Claim 1 and therefore contain the same deficiencies.
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 and 4-6 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea without significantly more.
Step 1 – Statutory Categories of Invention:
Claims 1 and 4-6 are directed to a method, which are statutory categories of invention. (Step 1: YES).
Step 2A – Judicial Exception Analysis, Prong One:
Independent Claim 1 recites a method comprising:
collecting first objective data of one or more pathological states of a plurality of patients, wherein the first objective data comprises temperature data, heart rate data, systolic blood pressure data, respiratory rate data, oxygen saturation data, and glasgow score data;
receiving first administrative data of the plurality of patients, wherein the first administrative data comprises an age of at least one patient among the plurality of patients, a gender of the at least one patient, and a location of the at least one patient;
collecting first hospital resources availability data for a hospital regarding at least one blood pressure measurement device, at least one electrocardiogram (ECG) measurement device, at least one computed tomography device, at least one ultrasonic measurement device, and at least one magnetic resonance imaging device;
determining a plurality of initial paths of the plurality of patients in the hospital with input data comprising the first objective data, the first administrative data, the first hospital resources availability data, and the first subjective data, and receiving, in real time, a first actual path of the patient plurality of recorded paths of the plurality of patients in the hospital;
receiving second objective data for a patient, second administrative data for the patient, and second subjective data for the patient;
determining a predicted path of the patient, the second objective data, the second administrative data, and the second subjective data;
determining a first plurality of hospital resources for the patient based on the predicted path, wherein the first plurality of hospital resources comprise a surgeon, a nurse, and a medical device, and wherein the medical resource is selected from a group consisting of a blood pressure measurement device, an ECG measurement device, a computed tomography device, at least one ultrasonic measurement device, and a magnetic resonance imaging device; and
transferring the patient from a first location at the hospital to a second location at the hospital based on the plurality of hospital resources.
The claim, as drafted, under their broadest reasonable interpretation, are directed to an abstract idea, as they cover certain methods of organizing human activity. Per MPEP 2106.04(a)(2), if a claim limitation, under its broadest reasonable interpretation, covers the management of personal behavior or relationships or interactions between people, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. The present claims are directed to the receiving and analyzing of patient data and hospital resource data to prescribe a clinical plan or “path” to a patient, wherein the recommendation is further informed by a comparison between paths assigned to similarly situated patients. These limitations attempt to address issues of disparate consultations from numerous providers and the stress imposed on facilities from mass casualty events by improving management of hospital resources (see: Specification, pgs. 1-2). The cited limitations involve the behavioral management of patients and healthcare providers in order to resolve an abstract problem – properly directing humans for medical treatment. Therefore, because the claims are demonstrably shown to recite certain methods of organizing human activity, they recite an abstract idea. (Step 2A, Prong One: YES).
Independent Claim 1 further recites training the recurrent convolutional neural network using supervised learning and based on a difference between the plurality of initial paths and the plurality of recorded paths of the plurality of patients.
The claims also recite mathematical concepts and is not subject matter eligible. MPEP 2106.04(a)(2)(I) states that if a claim limitation, under its broadest reasonable interpretation, recites a relationship between numbers or variables, a numerical formula or equation, or a mathematical calculation, then it falls within the “Mathematical Concepts” grouping of abstract ideas. Per the cited claim limitations and page 15 of the Specification, the recited training protocol is implemented using a supervised learning algorithm. Examiner has given the recited “supervised learning” its broadest reasonable interpretation – a generic, widely known algorithm – because the Specification merely references the supervised learning in a nominal manner, in which it fails to include any detail or features that would distinguish the recited training technique from commonplace equivalents. Under this broad construction, the use of supervised learning techniques to train a machine learning model amounts to the leveraging and performance of mathematical concepts, calculations, and relationships to achieve predictive outcomes. Therefore, the training, by way of supervised learning, recited in the present claims constitutes activity properly categorized as Mathematical Concepts, as defined in the MPEP. Accordingly, the claims recite an additional abstract idea. (Step 2A, Prong One: YES).
Dependent Claim 4 recites comparing the plurality of initial paths of the plurality of patients in the hospital with the plurality of initial paths by identifying a plurality of differences between a second plurality of hospital resources actually used and a plurality of initially calculated probabilities of using a third plurality of hospital resources; and recording said plurality of differences.
Dependent Claim 5 recites determining an emergency level of the patient; and using said emergency level to determine said predicted path.
Dependent Claim 6 recites calculating an expected presence time of the patient within the hospital based on a use of the first plurality of hospital resources.
Each of the preceding features of the above dependent claims only serve to further limit or specify the features of independent Claim 1, and, hence, are nonetheless directed towards fundamentally the same abstract idea as the independent claim.
Step 2A – Judicial Exception Analysis, Prong Two:
The judicial exception is not integrated into a practical application because the additional elements within the claims only amount to instructions to implement the judicial exception using a computer (MPEP § 2106.05(f)).
The claims are abstract but for the recitation of additional elements including “by a/the data processing device comprising a computer processor,” “using a plurality of measurement devices,” “from a first database,” “from a second database,” “using a/the recurrent convolutional neural network,” “wherein the recurrent convolutional neural network comprises a first sub-network that is a convolutional neural network comprising a plurality of convolutional layers that extracts features and a second sub-network that is a neural network on top of the first sub-network which accumulates through time a plurality of outputs of the convolutional neural network,” and “using a plurality of GPS units that are worn by the plurality of patients.”
The above-identified additional elements are recited in the limitations, described in the Specification, and represented in the Drawings in such a way that they can be reasonably construed to be generic computer or technological components implemented on or in conjunction with a general purpose computer. For example, the recited recurrent convolutional neural network appears to be a generic recurrent CNN model, as the Specification does not describe any features that would distinguish the present CNN from its generic equivalent(s). Furthermore, pages 6-7 of the Specification only detail the structure and theory underlying neural networks as class of models, not the particular model embodied in the invention. The lack of detailed structure, along with the interchangeability of the neural networks in executing the claimed method, lend more credence to the determination that the present invention are merely employing a run-of-the-mill neural network to perform the operations of the claims, such that it amounts to the high level recitation of a generic technology to implement the abstract idea (MPEP 2106.05(f)(2)). The same is true of the processor, memory, and various units, wherein the units are defined using exemplary language (e.g., the communication unit may comprise any one of a CPU, GPU, FPGA, ASIC, or and/or any type of such processing unit known in the art), and thus understood to be generic computer components claimed at a high level of generality that amount to mere instructions to apply the abstract idea (MPEP § 2106.05(f)(2) see case involving a commonplace business method or mathematical algorithm being applied on a general purpose computer within the “Other examples.. i.”). Alice Corp. Pty. Ltd. V. CLS Bank Int’l, 134 S. Ct. 2347, 1357 (2014)).
The claim recites “performing, by the surgeon and the nurse at the second location, a surgery operation using the medical device, wherein the surgery operation is selected from a group consisting of digestive surgery, infant surgery, maxillofacial surgery, stomatology surgery, orthopedic surgery, traumatological surgery, plastic surgery, thoracic and cardiovascular surgery, urological surgery, vascular surgery, visceral surgery, and neurosurgery.” When determining if a particular treatment and prophylaxis as a practical application under Step 2A Prong Two, Examiner considered the factors presented in MPEP § 2106.04(d)(2). • Factor A. The treatment plan determined from the abstract idea is not "particular," i.e., specifically identified so that it does not encompass all applications of the judicial exception(s). Here, the specific surgery being performed is not specified. The claims recites any and all types of digestive surgery, infant surgery, maxillofacial surgery, stomatology surgery, orthopedic surgery, traumatological surgery, plastic surgery, thoracic and cardiovascular surgery, urological surgery, vascular surgery, visceral surgery, and neurosurgery that can be performed. Secondly, the claim fails to recites what particular medical condition is being treated. As such, the surgery step is not particular, and is instead merely instructions to “apply” the exception in a generic way. Thus the surgery step does not integrate the abstract idea into a practical application.• Factor B. The treatment limitation does not have a significant relationship to the judicial exception – that is it does not integrate the law of nature into a practical application. The concept of performing a surgery has at best a nominal connection to the law of nature, because the surgery performed is not recited to treat a particular medical condition. This step therefore does not apply or use the exception in any meaningful way. Thus, the step of performing a surgery does not integrate the law of nature into a practical application. • Factor C. The treatment or prophylaxis limitation does not impose meaningful limits on the judicial exception and is only extra-solution activity or a field-of-use (see MPEP § 2106.05(g))). The performing of surgeries which include any and all types of digestive surgery, infant surgery, maxillofacial surgery, stomatology surgery, orthopedic surgery, traumatological surgery, plastic surgery, thoracic and cardiovascular surgery, urological surgery, vascular surgery, visceral surgery, and neurosurgery are well known, nominally related to the inventive concept of determining a path of a patient in a hospital. The step does not add a meaningful limitation to the process of determining a path of a patient in a hospital.Therefore, the claims only recite the prophylactic step as a tool which only serves to as insignificant post solution activity (MPEP § 2106.05(g) - insignificant pre/post-solution activity) and is therefore not a practical application of the recited judicial exception.
Step 2B – Additional Elements that Amount to Significantly More:
The present claims do not include additional elements that are sufficient to amount to more than the abstract idea because the additional elements or combination of elements amount to no more than a recitation of instructions to implement the abstract idea on a computer. Therefore, the additional elements in isolation do not amount to significantly more than the abstract idea (see: MPEP 2106.05(f) for additional guidance on the “mere instruction to apply an exception.”).
The arrangement of the additional claim elements does not demonstrably alter the performance of the individual elements. Multiple categories of conventional medical data are received by commonplace measurement devices (e.g., ECG, CT, etc.), input into a generically trained model that is implemented by a standard processor, memory, and ordinary computer “units”, wherein a treatment plan or “path” is generated based on the received data and comparisons made to other similarly situated patients. This organization of computer system components is widely prevalent in the fields of machine learning and healthcare, and not shown in the disclosure to amount to an inventive concept. Therefore, the additional elements, as an ordered combination, do not amount to significantly more than the abstract idea.
In regards to the “performing, by the surgeon and the nurse at the second location, a surgery operation using the medical device, wherein the surgery operation is selected from a group consisting of digestive surgery, infant surgery, maxillofacial surgery, stomatology surgery, orthopedic surgery, traumatological surgery, plastic surgery, thoracic and cardiovascular surgery, urological surgery, vascular surgery, visceral surgery, and neurosurgery” step. The concept of performing such surgeries are well understood, routine, and conventional activities. The specification fails to describe or define what particular type of surgery is being performed to treat what particular condition. The concept of performing an orthopedic surgery at a location, for example, is well understood, routine, and conventional. This is supported in the Background of US 6,711,432; US 2005/0054917; and US 2007/0212672. Therefore, the performing of a surgery is not sufficient to amount to significantly more than the recited judicial exception.
Accordingly, the additional elements, alone or in combination, do not amount to significantly more than the abstract idea. (Step 2B: NO).
Response to Arguments
Applicant's arguments filed 09/18/2025 have been fully considered but they are not persuasive.
In regards to the 101 rejection, applicant argues that the claims recites a technical improvement analogous to that of Example 39 in the 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Federal Register 4 (7 January 2019). Example 39 states that the claims fail to recite a judicial exception. Examiner respectfully disagrees. The claims were directed to providing a robust face detection model that can detect faces in distorted images while limiting the number of false positives. In contrast, the instant claims are directed to determining a path of a patient in a hospital by collecting data and determining a plurality of initial paths of the patients and a predicted path based on the received data. This concept is directed to the management of personal behavior or relationships or interactions between people, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. The cited limitations involve the behavioral management of patients and healthcare providers in order to resolve an abstract problem – properly directing humans for medical treatment. Therefore, because the claims are demonstrably shown to recite certain methods of organizing human activity, they recite an abstract idea. The use and training of a recurrent convolutional neural network using supervised learning under broadest reasonable interpretation in light of the disclosure are mathematical calculations. On page 6 of the specification, it states “the term “neural network” refers to a mathematical structure taking an object as input and producing another object as output through a set of linear and non-linear operation called layers”. As such, it is the claim recites computing neural network parameters using a series of mathematical calculations. The limitation is also recited as being performed by a computer. The recited computer is recited at a high level of generality which amounts to no more than mere instructions to apply the exception using a generic computer component.
In regards to the 101 rejection, applicant argues that the claims integrate the judicial exception into a practical application. Examiner respectfully disagrees. The concept of transferring a patient does not integrate the abstract idea into a practical application. The concept of transferring a patient is not a technical improvement. It is more directed to the human activity of a person going to another location. It does represent any sort of particular treatment or prophylaxis. In regards to “performing, by the surgeon and the nurse at the second location, a surgery operation using the medical device, wherein the surgery operation is selected from a group consisting of digestive surgery, infant surgery, maxillofacial surgery, stomatology surgery, orthopedic surgery, traumatological surgery, plastic surgery, thoracic and cardiovascular surgery, urological surgery, vascular surgery, visceral surgery, and neurosurgery.” When determining if a particular treatment and prophylaxis as a practical application under Step 2A Prong Two, Examiner considered the factors presented in MPEP § 2106.04(d)(2). • Factor A. The treatment plan determined from the abstract idea is not "particular," i.e., specifically identified so that it does not encompass all applications of the judicial exception(s). Here, the specific surgery being performed is not specified. The claims recites any and all types of digestive surgery, infant surgery, maxillofacial surgery, stomatology surgery, orthopedic surgery, traumatological surgery, plastic surgery, thoracic and cardiovascular surgery, urological surgery, vascular surgery, visceral surgery, and neurosurgery that can be performed. Secondly, the claim fails to recites what particular medical condition is being treated. As such, the surgery step is not particular, and is instead merely instructions to “apply” the exception in a generic way. Thus the surgery step does not integrate the abstract idea into a practical application.• Factor B. The treatment limitation does not have a significant relationship to the judicial exception – that is it does not integrate the law of nature into a practical application. The concept of performing a surgery has at best a nominal connection to the law of nature, because the surgery performed is not recited to treat a particular medical condition. This step therefore does not apply or use the exception in any meaningful way. Thus, the step of performing a surgery does not integrate the law of nature into a practical application. • Factor C. The treatment or prophylaxis limitation does not impose meaningful limits on the judicial exception and is only extra-solution activity or a field-of-use (see MPEP § 2106.05(g))). The performing of surgeries which include any and all types of digestive surgery, infant surgery, maxillofacial surgery, stomatology surgery, orthopedic surgery, traumatological surgery, plastic surgery, thoracic and cardiovascular surgery, urological surgery, vascular surgery, visceral surgery, and neurosurgery are well known, nominally related to the inventive concept of determining a path of a patient in a hospital. The step does not add a meaningful limitation to the process of determining a path of a patient in a hospital.Therefore, the claims only recite the prophylactic step as a tool which only serves to as insignificant post solution activity (MPEP § 2106.05(g) - insignificant pre/post-solution activity) and is therefore not a practical application of the recited judicial exception.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FONYA M LONG whose telephone number is (571)270-5096. The examiner can normally be reached Monday-Thursday, 8:00am-5:30pm; Friday 7:00am-11:00am.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Namrata Boveja can be reached at 571-272-8105. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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FONYA M. LONG
Supervisory Patent Examiner
Art Unit 3682
/FONYA M LONG/Supervisory Patent Examiner, Art Unit 3682