DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
The IDS filed 12/29/2021, 3/17/2023, 7/7/2025 have been considered by the Examiner.
Priority
The instant application does not claim benefit of priority. The instant filing date of 8/20/2021 will be used for purposes of search an consideration.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Step 1: Process, Machine, Manufacture or Composition
Claims 1-18 and 20 are drawn to a method, so a process.
Claim 19 is drawn to an apparatus with a processor, so a machine.
Step 2A Prong One: Identification of an Abstract Idea
The claim(s) recite(s):
1. determine measured subject attributes of the biological subject.
This step reads on a process that can be performed by the human mind and is therefore an abstract idea.
2. determine base model including one or more equations including a non-linear ordinary differential equation or difference equation.
This step reads on a process that can be performed by the human mind and recites math, and is therefore an abstract idea.
3. calculate a model value using the base model.
This step reads on a process that can be performed by the human mind including doing math, and is therefore an abstract idea.
4. compare the measured subject attributes and a corresponding model value to determine a difference therebetween.
This step reads on a process that can be performed by the human mind and is therefore an abstract idea.
5. iteratively modify the base model to thereby generate a subject model representing the condition.
This step reads on a process that can be performed by the human mind to modify a mathematical expression, and is therefore an abstract idea.
6. treat a condition within the subject by using the model to derive a treatment regime including one dosage of a substance.
This step reads on a process of creating a treatment plan which that can be performed by the human mind and is therefore an abstract idea. Also see rejection under 35 USC 112(b).
Step 2A Prong Two: Consideration of Practical Application
The claims do not recite any additional elements that integrate the abstract idea into a practical applications. The claims set forth “using the model” in step (g) to treat a condition without any steps to integrate the previous modeling steps (a) to (f) into how the modeling is used to determine a treatment, which is subsequently administered. Furthermore, independent claim 20 recites a final step of administering medication to the subject in accordance with the medication regime. The claim is not drawn to any particular treatment and condition to be treated.
This judicial exception is not integrated into a practical application because the claims do not meet any of the following criteria:
An additional element reflects an improvement in the functioning of a computer, or an improvement to other technology or technical field;
an additional element that applies or uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition;
an additional element implements a judicial exception with, or uses a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim;
an additional element effects a transformation or reduction of a particular article to a different state or thing; and
an additional element applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than
a drafting effort designed to monopolize the exception.
Step 2B: Consideration of Additional Elements and Significantly More
The claimed method also recites "additional elements" that are not limitations drawn to an abstract idea. The recited additional elements are drawn to:
1. administering at least one dosage of the substance (claims 1 and 19) or medication (claim 20) to the subject in accordance with the treatment/medication regime to thereby treat the subject.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because administering a medication to treat a subject is routine, conventional and well understood.
Viewed as a whole, these additional claim element(s) do not provide meaningful limitation(s) to transform the abstract idea recited in the instantly presented claims into a patent eligible application of the abstract idea such that the claim(s) amounts to significantly more than the abstract idea itself. Therefore, the claim(s) are rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 112-2nd paragraph
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.
Claims 1-20 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 pre-AIA the applicant regards as the invention.
Claim 1, step (g) and claim 19, step (g) recite using the model to derive a treatment regime. Claim 20, step (g) recites using the model to derive a medication regime. Claims 1 and 19-20 recite modeling change of subject attributes such as blood glucose or blood insulin in response to a control variable such as the input of glucose. It is unclear how the model is used to derive a treatment regime. The claim recites a use (of the model) without limitations or steps to set forth how that use is achieved. The limitation render the claim as indefinite. See MPEP 2173.05(q), section “Use” Claims.
Claims 1 and 19-20 in step (b) recite variables representing “rapidly changing” subject attributes and parameters representing “slowly changing” subject attributes. The limitations “rapidly” and “slowly” are relative terms as described in MPEP 2173.05(b). The terms are subjective and the specification does not describe the scope of the terms which would clarify the intended metes and bounds.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 1-20 are rejected under 35 U.S.C. 103(a) as being unpatentable over Greenwood et al. (US 2010/0121618; IDS filed 3/17/2023) in view of Greenwood et al. (US 2020/0302094; herein Greenwood II)
Greenwood et al. teach (par. 0012-0013) a processing system a) for a model including one or more equations and associated parameters, comparing at least one measured subject attribute measured over a time period (par. 0157) and at least one corresponding model value and b) modifying the model in accordance with results of the comparison to thereby more effectively model the biological response; a base model including equations including non-linear ordinary differential or difference equation (par. 0056) is taught (par. 0068)(i.e. using the processing system to determine measured subject attributes of a biological subject and using the processing system to determine a base model including one or more equations), as in claim 1, step (a) and step (b).
Greenwood et al. teach that the model includes state variables with rapidly changing attributes (par. 0057), as in claim 1, step (b).
Greenwood et al. teach parameter values with slowly changing or constant attributes (par. 0059), as in claim 1, step (b).
Greenwood et al. teach (par. 0060) control variable values representing attributes of the biological response that can be externally controlled and that the control variables (par. 0147) represent control inputs applied to the subject (i.e. one or more control variables representing attributes that can be externally controlled using control inputs to the subject); control inputs provided can be medication (par. 0134 and 0141)(i.e. control input represents treatment or medication administered to the subject), as in claim 1, step (b).
Greenwood et al. teach (par. 0057-0060) model values include State variable values, Parameter values, and Control variables (i.e. using the processor to calculate a model value using the base model, the value being one of a state variable, control variable or parameter), as in claim 1, step (c).
Greenwood et al. teach comparing subject attribute and model values (par. 0151) to determine if the model is sufficiently accurate (par. 0177)(i.e. compare the measured subject attributes to the model value to determine accuracy); by determining convergence (par. 0178)(i.e. determine a difference), as in claim 1, step (d).
Greenwood et al. teach (par. 0021-0024) deriving a subject trajectory, a model trajectory and performing a comparison of the trajectories, as in claim 1, step (d)(i), (ii), and (iii).
Greenwood et al. teach (par. 0011) modifying the model in accordance with the results of the comparison to more effectively model a biological response; the model is modified until the model and subject trajectories converge (par. 0025), as in claim 1, step (e) and claim 2
Greenwood et al. teach (par. 0070-0072) modifying one equation or model value, as in claim 1, step (e)(i) and (ii).
Greenwood et al. teach (par. 0017-0020) iteratively modifying the model until a) the difference is below a predetermined threshold; b) the difference asymptotically approaches an acceptable limit; and c) the difference is minimized, as in claim 1, step (f)(i), (ii), and (iii).
Greenwood et al. teach using the model to treat and diagnose a condition (par. 0115), derive a treatment regime (par. 0127) such that repeated doses are administered (par. 0250), as in claim 1, step (g).
Greenwood et al. teach using control inputs to induce at least one of a perturbation and agitation (par. 0027) by providing medication to a patient (par. 0141), as in claim 3.
Greenwood et al. teach (Greenwood claim 6) a) using control inputs to induce at least one of a perturbation and agitation of the subject into a non-equilibrium condition; and, b) determining at least one measured subject attribute under the non-equilibrium condition, as in claim 4.
Greenwood et al. teach (Greenwood claim 7) a) forming a linear error equation representing a difference between a desired state of the subject and an actual state; and, b) constructing a control algorithm to minimize the error equation, as in claim 5.
Greenwood et al. teach (Greenwood claim 8) a) using Lyapunov stability methods to ensure convergence of subject and model behavior through use of one or more Lyapunov functions; and, b) using a derivative of one or more Lyapunov functions to impose convergence of subject and model behavior, as in claim 6.
Greenwood et al. teach in claim 9 the limitations of instant claim 7.
Greenwood et al. teach in claim 10 the limitations of instant claim 8.
Greenwood et al. teach in claim 11 the limitations of instant claim 9.
Greenwood et al. teach in claim 12 the limitations of instant claim 10.
Greenwood et al. teach in claim 13 the limitations of instant claim 11.
Greenwood et al. teach in claim 16 the limitations of instant claim 12.
Greenwood et al. teach in claim 18 the limitations of instant claim 13.
Greenwood et al. teach in claim 19 the limitations of instant claim 14.
Greenwood et al. teach in claim 20 the limitations of instant claim 15.
Greenwood et al. teach in claim 21 the limitations of instant claim 16.
Greenwood et al. teach modeling instances of medication or drug administration such that repeated doses are administered over time to maintain drug or ligand concentrations at a desired level or interval of levels (par. 0101 and 193)(i.e. treatment regime is indicative of volume, concentration, a time of dosage and duration), as in claim 17.
Claim 19 recites substantially the same process limitations as the method of claim 1. Claim 19 is drawn to an apparatus with a processor. Greenwood et al. teach a processing system which includes a processor (par. 0150) which executes stored algorithms for the process (par. 0151), as in claim 19.
Claim 20 differs from claim 1 at step (b). Greenwood et al. teach control inputs in the form of medication and other external stimulus (par. 0146) that are provided to the subject (par. 0134) and applied to the model by modifying the control variables (par. 0175), as in claim 20, step (b).
Claim 20 differs from claim 1 at step (f). Greenwood et al. teach (Greenwood claim 8) a) using Lyapunov stability methods to ensure convergence of subject and model behavior through use of one or more Lyapunov functions; and, b) using a derivative of one or more Lyapunov functions to impose convergence of subject and model behavior, as in claim 20, step (f).
Greenwood et al. teach modeling insulin dependent diabetes (par. 0099).
Greenwood et al. do not teach measuring a blood glucose subject attribute, as in claim 1, step (a) and claims 19-20.
Greenwood et al. do not teach a model with a state variable representing a glucose attribute and parameters including glucose or insulin disappearance rate constant, plasma glucose concentration increase for a given dosage of glucose administered to the subject, or plasma insulin concentration increase for a dosage of insulin administered to the subject, as in claim 1, step (b) and claims 19-20.
Greenwood et al. do not teach administering insulin or glucose to a subject, as in claim 1 and claims 19-20.
Greenwood et al. do not teach a state variable indicative of blood insulin levels, parameter including an insulin release rate and a control variable including dosage of glucose administered to a subject, as in claim 18.
Greenwood II teach insulin and blood glucose time series measurements from a subject’s medical history (par. 0319-0320)(i.e. blood glucose attribute at least partially indicative of blood glucose levels), as in claim 1, step (a).
Greenwood II teach parameter values to project (i.e. model) the likely effect on blood glucose after a meal (par. 1410-1411) (i.e. parameters representing plasma glucose concentration increase for a given dosage of glucose administered to a subject), as in claim 1, step (b).
Greenwood II teach that their system decides an appropriate therapy such as a need for a meal (i.e. administer glucose) in response to low blood glucose and administering the therapy or dose (par. 0612-0614); applying insulin as therapy for insulin-using diabetics is taught (par. 0618 and 01320)(i.e. administering a dosage of a substance according to a treatment regime wherein the substance is insulin and glucose), as in claims 1, 19 and 20.
Greenwood II teach plasma insulin as a state variable (par. 01421)(i.e. state variable includes blood insulin level), as in claim 18.
Greenwood II teach modeling blood glucose levels to form an artificial pancreas and tracking blood glucose levels in response to changes in diet (par. 0640)(i.e. a blood glucose concentration due to baseline liver glucose release), as in claim 18.
Greenwood II teach modeling system dynamics of a meal (i.e. control variable) including carbohydrate intake and the time series effect on blood glucose (par. 1297)(i.e. control variable including at least one dosage of glucose administered to a subject), as in claim 18.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to have combined the subject modelling where a base model is compared to subject attribute measurements of Greenwood et al. with the substance trajectory modeling of Greenwood II where parameters and variables for blood glucose are used to model an artificial pancreas. Greenwood II provide motivation by teaching that a physical system can be modeled (Abstract) and applied to medical applications including diabetes (par. 0617) to track blood glucose levels in patients (par. 0640). One of skill in the art would have had a reasonable expectation of success at combining Greenwood et al. with Greenwood II because both teach a model of changing subject attributes wherein the model incudes state variables that dictate model behavior, parameters and control variables for input to perturb model behavior.
E-mail communication Authorization
Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting the following statement via EFS Web (using PTO/SB/439) or Central Fax (571-273-8300):
Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.
Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anna Skibinsky whose telephone number is (571) 272-4373. The examiner can normally be reached on 12 pm - 8:30 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Ram Shukla can be reached on (571) 272-7035. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Anna Skibinsky/
Primary Examiner, AU 1635