DETAILED ACTION
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 Claims
Claims 1-20 are under presently under examination.
Drawings
The drawings filed 03/07/2022 are acceptable.
Information Disclosure Statement(s)
The information disclosure statement (IDS) document(s) submitted is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS document(s) has/have been fully considered by the examiner.
Priority
Applicant’s claim for the benefit of priority under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) to U.S. Provisional Application 63/157,566, filed 03/05/2021, is acknowledged.
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 a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
The United States Patent and Trademark Office published revised guidance on the application of 35 U.S.C. § 101. USPTO’s 2019 Revised Patent Subject Matter Eligibility Guidance (“Guidance”). Under the Guidance, in determining what concept the claim is “directed to,” we first look to whether the claim recites:
(1) any judicial exceptions, including certain groupings of abstract ideas (i.e., mathematical concepts, certain methods of organizing human activity such as a fundamental economic practice, or mental processes) (Guidance Step 2A, Prong 1); and
(2) additional elements that integrate the judicial exception into a practical application (see MPEP § 2106.05(a)-(c), (e)-(h)) (Guidance Step 2A, Prong 2).
Only if a claim (1) recites a judicial exception and (2) does not integrate that exception into a practical application, do we then look to whether the claim contains an “‘inventive concept’ sufficient to ‘transform’” the claimed judicial exception into a patent-eligible application of the judicial exception. Alice, 573 U.S. at 221 (quoting Mayo, 566 U.S. at 82). In so doing, we thus consider whether the claim:
(3) adds a specific limitation beyond the judicial exception that are not “well-understood, routine and conventional in the field” (see MPEP § 2106.05(d)); or 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50-57 (January 7, 2019).
(4) simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception.(Guidance Step 2B). See Guidance, 84 Fed. Reg. at 54-56.
Guidance Step 1:
The instant invention (claim 1 being representative) is directed to a method that performs a process. Thus, the claims are directed to one of the statutory categories of invention. MPEP 2106.03.
A. Guidance Step 2A, Prong 1
The Revised Guidance instructs us first to determine whether any judicial exception to patent eligibility is recited in the claim. The Revised Guidance identifies three judicially-excepted groupings identified by the courts as abstract ideas: (1) mathematical concepts, (2) certain methods of organizing human behavior such as fundamental economic practices, and (3) mental processes. Regarding claim(s) 34 and 49 the claimed steps that are part of the abstract idea are as follows:
predicting, based on the first drug's drug concentration data, future pharmacokinetic parameters associated the first drug in the patient; providing, based on the first drug's predicted pharmacokinetic parameters, a first medical-related notification to a clinician.
Mental Processes
Under the broadest reasonable interpretation, the italicized steps are all nominally recited without any details specifying how the claimed functions are being performed and generally encompass performing predictive analysis and providing advice. In addition, the specification provides sufficient evidence that the claims are directed to an abstract idea since the specific descriptions provided for accomplishing these tasks include algorithms for performing data analysis [0007, 0022, 0023, 0067]. Accordingly, but for the recitation of a computer, the above steps clearly fall within the mental process groupings of abstract ideas because they cover concepts performed in the human mind, including observation, evaluation, judgment, and opinion. See MPEP 2106.04(a)(2), subsection III [Step 2A, Prong 1: YES].
Mathematical Concept
In addition, the above predicting step requires predicting parameters associated with a drug, which amounts to mathematical calculations and/or mathematically relating data. It is noted that the grouping of “mathematical concepts” is not limited to formulas or equations, as words used in a claim operating on data to solve a problem can serve the same purpose as a formula. Therefore, the above steps clearly encompass a mathematical concept. See MPEP 2106.04 and 2106.05(II) [Step 2A, Prong 1: YES].
B. Guidance Step 2A, Prong 2
This part of the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception into a practical application of the exception or whether the claim is “directed to” the judicial exception. This evaluation is performed by (1) identifying whether there are any additional steps/elements recited in the claim beyond the judicial exception, and (2) evaluating those additional steps/elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. See MPEP 2106.04(d). In this case, the additional steps/elements recited in the claim beyond the judicial exception are as follows:
obtaining, from a catheter-based electrochemical sensor, drug concentration data associated with a first drug in a patient; (claims 1, 10, 20)
electrochemical sensor; a processor; computer readable storage medium, and memory (claims 10, 20)
In this case, the claimed obtaining step amounts to nothing more than collecting data for use by the abstract idea. Accordingly, these steps amount to extra-solution activity and are not indicative of an integration into a practical application. See MPEP 2106.05(g).
With regards to the electrochemical sensor; processor; computer readable storage medium, and memory, these features are generically recited and merely used as tools to obtain information or perform the abstract idea. Moreover, applicant is reminded that “generic computer components such as a computer and database do not satisfy the inventive concept requirement.” See MPEP 2106.05(f) and 2106.05(h). Even when viewed in combination, these additional steps/elements do not integrate the recited judicial exception into a practical application. See MPEP 2106.04(d)(1) for a list of considerations when evaluating whether additional elements integrate a judicial exception into a practical application. [Step 2A, Prong 2: NO].
C. Guidance Step 2B:
This part of the eligibility analysis evaluates whether the claim as a whole amount to significantly more than the recited exception i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim. See MPEP 2106.05.
As discussed above, the non-abstract steps/elements do not recite significantly more than the recited judicial exception. Moreover, a review of the specification teaches a plurality of routine and conventional sensors for obtaining drug concentration data [pages 3-4, 7-8, and Figures 3-9]. In addition, the courts have explained that the use of generic computer elements do not alone transform an otherwise abstract idea into patent-eligible subject matter. See DDR Holdings (Fed. Cir. 2014). Taken alone or in combination, the additional steps/elements fail to transform the exception into a patent-eligible application of that exception. Even upon reconsideration, there is nothing unconventional with regards to the above non-abstract elements/steps. See MPEP 2106.05(d)(Part II). Therefore, the independent claim(s) as a whole do not amount to significantly more than the exception itself and are not patent eligible. [Step 2B: NO].
D. Dependent Claims
Dependent claims 2-9, 11-19 have also been considered under the two-part analysis but do not include additional steps/elements appended to the judicial exception that are sufficient to amount to significantly more than the judicial exception(s) for the following reasons. In particular, claims 2-9, 11-13, 19 are directed to limitations that further limit the specificity of the abstract idea or the nature of the data being used by the abstract idea. Accordingly, these claims are also directed to an abstract idea for the reasons set forth above (Step 2A, prong 1 analysis). Regarding claim(s) 14-18, these claims further limit type of sensors and materials being used in the device. Accordingly, these steps are not indicative of an integration into a practical application and do not amount to significant more for reasons set forth above (Step 2A, prong 2 analysis, and Step 2B analysis). Therefore, the instantly rejected claims are not drawn to eligible subject matter as they are directed to an abstract idea (and/or natural correlation) without significantly more.
Claim Rejections - 35 USC § 112
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 1-20 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The written description requirement is separate and distinct from the enablement requirement. The specification must: (1) describe the claimed invention in a manner understandable to a person of ordinary skill in the art, and (2) show that the inventor actually invented the claimed subject matter.
Regarding claim(s) 1, 10, 20 the specification fails to provide written description support for the following steps:
predicting, based on the first drug's drug concentration data, future pharmacokinetic parameters associated the first drug in the patient; providing, based on the first drug's predicted pharmacokinetic parameters, a first medical-related notification to a clinician.
In this case, the claimed “predicting” step is not associated with any particular prediction model for achieving the claimed function nor does it impose any boundaries on the type of “future pharmacokinetic parameters” that are being predicted or any particular medical-related condition associated with a patient. A review of the specification does not provide any significant structural or functional details with regards to how the claimed parameters are actually being predicted. The specification does provide a limited embodiment directed to “Bayesian models” and a “3-compartment model” [pages 8-9]. However, it is improper to import narrowing limitations into the claims. MPEP 2111.01. Moreover, there is no information with regards to how this model was trained, validated, or other specific details with regards to how the models operate. In other words, the claimed “predicting” and “providing” steps amount to black box to achieve the claimed functions. Furthermore, one of ordinary skill in the art of pharmacokinetics would recognize that methods of using predictive models for therapeutic drug monitoring are not trivial. As supporting evidence on this point, applicant is directed to the following:
Agustin et al. (US10,796,799; Pub. Date: May 2017) teaches methods for predicting personalized dosages in the treatment of anemia. Unlike the instant claims, Augustic’s method is directed to a particular condition (anemia) and particular agents (ESA) and uses well-defined mathematical models to achieve this goal [Abstract, Figure 1, claims 1-8].
Strandolini et al. (2016 IEEE International Symposium on Circuits and Systems, 2016, pp. 834-837) teaches methods for monitoring patient response to various drug treatments. In particular, Strandolini teaches such methods are challenging and highly dependent upon the type of drug being monitored and the medical condition of the patient [Introduction].
Therefore, neither the instant claims nor the specification provides sufficient written description such that one of skill in the art would have been aware that applicants were actually in possession of mathematical models configured to perform the claimed function. “[A] sufficient description of a genus . . . requires the disclosure of either a representative number* of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can 'visualize or recognize' the members of the genus” (AbbVie, 759 F.3d at 1297, reiterating Eli Lilly, 119 F.3d at 1568-69)(emphasis added).
For the reasons discussed above, the specification does not satisfy the written description requirement with respect to the full scope of what is being claimed. For more information regarding the written description requirement, see MPEP §2161.01- §2163.07(b).
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. Claims that depend directly or indirectly from claim(s) 1, 10 are also rejected due to said dependency.
Claims 1 and 11 recite “predicting…future pharmacokinetic parameters associated the first drug in the patient.” Firstly, it is unclear what is meant by “associated the first drug”. This appears to be a grammatical error. Clarification is requested via amendment. Secondly, it is unclear as to the metes and bounds of “future pharmacokinetic parameters”. A review of the specification does not provide any limiting definition that would serve to clarify the scope. Moreover, one of ordinary skill in the art would recognize that parameters are generally associated with some type of mathematical model. In this case, however, the claimed parameters are not associated with any particular model such that the artisan would recognize what computational operations are intended. The specification teaches “Bayesian models” and a “3-compartment model” [pages 8-9]. However, it is improper to import narrowing limitations into the claims. MPEP 2111.01. Clarification is requested via amendment.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-8, 10-14, 20 are rejected under 35 U.S.C. 103 as being unpatentable over Benaboud et al. (WO2020/245458; Pub. Date: 12/10/2020).
Regarding claim(s) 1, 10, 20, Benaboud teaches a method for determining an optimum drug dosing regimen in a patient. In particular, Benaboud teaches obtaining patient-related data and obtaining a concentration of said drug measured in the patient's body at an arbitrary time [ref. claim 1]. Benaboud teaches using sensors for measuring drug concentration in a patient’s blood [page 14], which reasonably suggests catheter-based sensors (since these are routinely used for analyzing blood samples).
Benaboud teaches computing (i.e. predicting) an estimated drug concentration time-course and possible drug targets using a Bayesian model [ref. claim 1, pages 14-15], which reads on predicting a future pharmacokinetic parameter as claimed.
Benaboud teaches determining an optimum drug dosing regimen to treat said patient based on the above analysis [ref. claim 1], wherein the drug dosing regimen is broadly interpreted as a “medical-related notification” (absent any limiting definition to the contrary). Benaboud using conventional processors and memory for practicing the claimed invention [page 10].
Regarding claim(s) 2, 11, Benaboud teaches functionality for measuring concentration in real time measurements [page 9]. Regarding claim(s) 3, 4, 12, Benaboud teaches a PK model based on Bayesian analysis that requires inputting (i.e. constructing) a variety of different datasets [ref. claim 1]. Regarding claim(s) 5, 6, Benaboud teaches obtaining various types of patient data [page 13], i.e. demographic data, and drug concentration data (as discussed ab0ve). Regarding claim(s) 7, Benaboud teaches adjusting parameters and providing optimum dosing regimens [pages 24-25]. Regarding claim(s) 8, 13, Benaboud teaches adapting their method for multiple drug targets and/or dosing regimens [page 30, ¶4; ref. claims 4], which reasonably suggest the use of a first and second drug.
Claims 9 and 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over Benaboud et al. (WO2020/245458; Pub. Date: 12/10/2020), as applied to claims Claims 1-8, 10-14, 20, and further in view of Moonla et al. (Talanta, Volume 218, May 2020, 121205, pp.1-7).
Benaboud teaches a method for determining an optimum drug dosing regimen in a patient, as set forth above.
Benaboud does not specifically teach obtaining drug concentration data for fentanyl, as in claims 9 and 19.
Benaboud does not specifically teach structural limitations directed to the sensor type and material, as in claims 15-18.
However, Moonla teaches a system for obtaining drug concentration data from patient blood samples using a real-time integrated microcatheter-based dual-analyte sensor [Abstract]. Moonla additionally teaches the dual PPF/FTN catheter sensor relies on embedding two different modified carbon paste (CP)-packed working electrodes [Abstract], as claimed.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to alter the method/system of by Benaboud measuring drug concentration data for fentanyl, as taught by Moonla, and additionally using a catheter sensor (with carbon paste materials and electrodes), as taught by Moonla, since Benaboud already teaches using sensors for measuring drug concentration in a patient’s blood [page 14] and since the choice of drug is nothing more than an arbitrary design consideration. In this case, the rationale would have been to improve patient case using real-time sensors.
Prior Art Rejection of Indefinite Claims
The following prior art made of record and not relied upon is considered pertinent to applicant' s disclosure.
Agustin et al. (US10,796,799; Pub. Date: May 2017) teaches methods for predicting personalized dosages in the treatment of anemia [Abstract, Figure 1, claims 1-8]. In particular, Agustin teaches obtaining hemoglobin concentration and ESA (drug) concentration data from a patient [ref. claim 1]. Agustin teaches predicting ESA binding sites (which are broadly interpreted as pharmacokinetic parameters absent any limiting definition to the contrary) based on ESA concentration data using a pharmacokinetic model [ref. claims 1, 8]. Agustin teaches adjusting the ESA dosage administered to the patient based on the number of ESA binding sites [ref. claim 1], which reads on providing a “medical-related notification” to a clinician.
Barvais et al. (EP 1 547 631; Pub. Date: 12/24/2003) teaches a computer controlled IV-drug delivery method and system [Abstract].
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PABLO S WHALEY whose telephone number is (571)272-4425. The examiner can normally be reached between 1pm-9pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Anita Coope can be reached at 571-270-3614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PABLO S WHALEY/Primary Examiner, Art Unit 3619