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 .
Claim Status
Claims 1-8 are currently pending and examined on the merits.
Claims 1-8 are rejected.
Claims 2-4 and 6 are objected to.
Priority
The instant application does not claim priority to any other applications. At this point in examination, the effective filing date of claims 1-8 is 28 July 2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 16 August 2022 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "23" and "24" have both been used to designate "Initial values" in Fig. 2. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 2-4 and 6 are objected to because of the following informalities:
In claim 2, line 1, "for discover" should read "to discover"
In claim 3, line 2, “and/” should read either “and/or” or “and”
In claim 4, lines 2-3, “and/” should read either “and/or” or “and”
In claim 4, line 3, “determined step c)” should read “determined in step c)”
In claim 6, line 7, “concentration of that the drug” should read “concentration of the drug”
These are typographical errors. Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
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 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, step h), lines 17-18 recites calculating a non-dimensional Deborah rate number for the data from steps c)-g) representing the transport and/or efficacy properties. Claim 6, step h), line 17 recites calculating the non-dimensional Deborah rate number for the data from steps c)-g). .
Because dependent claims 2-5 and 7-8 incorporate the unsupported limitations of independent claims 1 and 6, they are likewise rejected under 35 U.S.C. 112(a).
Claim Rejections - 35 USC § 112(b)
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 1-4 and 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.
The term “desired time” in claim 1, step f), line 14 and claim 6, step f), line 14 is a relative term which renders the claim indefinite. The term “desired time” is not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what the "desired time" is for an experiment. The specification is also silent as to what time is desired
Claims 1 and 6 recite the limitation "the experiment" in step f), line 14 for both claims. There is insufficient antecedent basis for this limitation in the claim. It is unclear what the experiment is and which steps the experiment encompasses. The rejection might be overcome by amending the claim to introduce clear antecedent basis for “the experiment”. For compact prosecution, it is assumed that the preceding suggested will be implemented and that the experiment is interpreted as steps c)-e) in the method of claims 1 and 6, respectively.
Claims 1 and 6 recite the limitation "the data" in step h), line 17 for both claims. There is insufficient antecedent basis for this limitation in the claim. It is unclear what the data is and which steps of steps c)-g) the data is from. The rejection might be overcome by amending the claim to introduce clear antecedent basis for “the data”. For compact prosecution, it is assumed that the preceding suggested will be implemented.
The term “the specimens” in claim 1, step i), line 19 and claim 6, step i), line 18 is a relative term which renders the claim indefinite. The term “the specimens” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what specimens are used to calculate a comparison criterion between since only one drug or chemical compound specimen is recited in claim 1. The specification is also silent as to what "the specimens" are. One skilled in the art would not recognize what "the specimens" Therefore, claim 1 is rendered indefinite and rejected under 35 U.S.C. 112(b).
Claims 1 and 6 recite the limitation "the reference or control specimen" in step i), line. There is insufficient antecedent basis for this limitation in the claim. It is unclear what the reference or control specimen is. The rejection might be overcome by amending the claim to introduce clear antecedent basis for “the specimens or with the reference or control specimen”. For compact prosecution, it is assumed that the preceding suggested will be implemented.
The term “data analysis” in claim 2, line 1 is a relative term which renders the claim indefinite. The term “data analysis” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear which steps in the method of claim 1 the term "data analysis" encompasses. The specification is also silent as to which definition the term "data analysis" takes. For examination purposes, the term "data analysis" has been construed to be step f) in the method of claim 1.
Claim 3 recites the limitation "the data analysis" in line 1. There is insufficient antecedent basis for this limitation in the claim. It is unclear what the data analysis is and which steps the data analysis encompasses. The rejection might be overcome by amending the claim to introduce clear antecedent basis for “the data analysis”. For compact prosecution, it is assumed that the preceding suggested will be implemented and that the data analysis is interpreted as step i) in the method of claim 1.
Claim 3 recites the limitation "the experiments, control(s) and/ reference(s)" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. It is unclear what the experiments, controls, and references are. The rejection might be overcome by amending the claim to introduce clear antecedent basis for “the experiments, control(s) and/ reference(s)”. For compact prosecution, it is assumed that the preceding suggested will be implemented.
The term “the ” in claim 4, line 4 is a relative term which renders the claim indefinite. The term “the determined efficacy coefficient(s)” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what "the determined efficacy coefficient(s)" are further compared with if there is only one efficacy coefficient that is determined. The specification is also silent as to what th Therefore, claim 4 is rendered indefinite and rejected under 35 U.S.C. 112(b).
Claim 6 recites the limitation "the non-dimensional Deborah rate number" in step h), line 17. There is insufficient antecedent basis for this limitation in the claim. It is unclear what the non-dimensional Deborah rate number is as it has not been mentioned prior to step h) in the method of claim 6. The rejection might be overcome by amending the claim to introduce clear antecedent basis for “the non-dimensional Deborah rate number”. For compact prosecution, it is assumed that the preceding suggested will be implemented.
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 1-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite: (a) mathematical concepts, (e.g., mathematical relationships, formulas or equations, mathematical calculations); and (b) mental processes, i.e., concepts performed in the human mind, (e.g., observation, evaluation, judgement, opinion).
Subject matter eligibility evaluation in accordance with MPEP 2106:
Eligibility Step 1: Claims 1-5 are directed to a method (process) for determining model-free time-invariant transport and/or efficacy properties of a chemical compound. Claims 6-8 are directed to a method (process) for determining whether a drug or chemical compound is suitable for an intended purpose. Therefore, these claims are encompassed by the categories of statutory subject matter, and thus satisfy the subject matter eligibility requirements under Step 1. [Step 1: YES]
Eligibility Step 2A: First, it is determined in Prong One whether a claim recites a judicial exception, and if so, then it is determined in Prong Two whether the recited judicial exception is integrated into a practical application of that exception.
Eligibility Step 2A, Prong One: In determining whether a claim is directed to a judicial exception, examination is performed that analyzes whether the claim recites a judicial exception, i.e., whether a law of nature, natural phenomenon, or abstract idea is set forth described in the claim.
Claims 1-7 recite the following steps which fall within the mental processes and/or mathematical concepts groups of abstract ideas, as noted below.
Independent claim 1 further recites:
determining model-free time-invariant transport and/or efficacy properties of a chemical compound (i.e., mental processes);
d) processing the measured data by time convolution procedure in real numbers without application of a preselected kinetic model (i.e., mental processes, mathematical concepts);
e) calculation of time-invariant parameters comprising a set including at least a transport constant, coefficient of partition, kinetic parameter and optionally efficacy coefficient, from the processed data (i.e., mental processes, mathematical concepts);
f) repeating steps c)-e) until desired time of the experiment is reached (i.e., mental processes, mathematical concepts);
g) generating a model-free equation for the compound transport between the compartments (i.e., mental processes, mathematical concepts);
h) calculating a non-dimensional Deborah rate number for the data from steps c)-g) representing the transport and/or efficacy properties (i.e., mental processes, mathematical concepts);
i) optionally calculating a comparison criterion between the specimens or with the reference or control specimen (i.e., mental processes, mathematical concepts).
Dependent claim 2 further recites:
wherein data analysis is executed iteratively for discover unknown coefficient of partition of the compound between the compartments, and/or efficacy coefficient, and/or unknown volume of distribution (i.e., mental processes, mathematical concepts).
Dependent claim 3 further recites:
wherein the data analysis and comparison between the experiments, control(s) and/ reference(s) are being made versus non-dimensional Deborah rate number (i.e., mental processes, mathematical concepts).
Dependent claim 4 further recites:
wherein at least one efficacy coefficient is also determined step c) for the multitude of experiments, control(s) and/ reference(s), respectively (i.e., mental processes);
where the determined efficacy coefficient(s) are further compared with each other to provide comparative transport and/or efficacy properties of the drug or chemical compound (i.e., mental processes).
Dependent claim 5 further recites:
composing a comparison criterion for an intended application of the drug or chemical composition from a set of variables (i.e., mental processes).
Independent claim 6 further recites:
determining whether a drug or chemical compound is suitable for an intended purpose (i.e., mental processes);
d) processing the measured data by time convolution procedure in real numbers without application of a preselected kinetic model (i.e., mental processes, mathematical concepts);
e) calculating time-invariant parameters comprising a set including at least a transport constant, coefficient of partition, kinetic parameter and optionally efficacy coefficient, from the processed data (i.e., mental processes, mathematical concepts);
f) repeating steps c)-e) until desired time of the experiment is reached (i.e., mental processes, mathematical concepts);
g) generating a model-free equation for the compound transport between the compartments (i.e., mental processes, mathematical concepts);
h) calculating the non-dimensional Deborah rate number for the data from steps c)-g) (i.e., mental processes, mathematical concepts);
i) optionally calculating a comparison criterion between the specimens or with the reference or control specimen (i.e., mental processes, mathematical concepts);
k) based on model-free time-invariant transport and/or efficacy properties determine whether the drug or compound is suitable for the intended purpose (i.e., mental processes).
Dependent claim 7 further recites:
based on the determined model-free invariant transport and/or efficacy properties in step j), the drug or compound is included into or excluded from the lead design, lead optimization and/or clinical trial (i.e., mental processes).
The abstract ideas recited in the claims are evaluated under the broadest reasonable interpretation (BRI) of the claim limitations when read in light of and consistent with the specification. As noted in the foregoing section, the claims are determined to contain limitations that can practically be performed in the human mind with the aid of a pencil and paper, and therefore recite judicial exceptions from the mental process grouping of abstract ideas. Additionally, the recited limitations that are identified as judicial exceptions from the mathematical concepts grouping of abstract ideas are abstract ideas irrespective of whether or not the limitations are practical to perform in the human mind.
Therefore, claims 1-7 recite an abstract idea.
[Step 2A, Prong One: YES]
Eligibility Step 2A, Prong Two: In determining whether a claim is directed to a judicial exception, further examination is performed that analyzes if the claim recites additional elements that, when examined as a whole, integrates the judicial exception(s) into a practical application (MPEP 2106.04(d)). A claim that integrates a judicial exception into a practical application will apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception. The claimed additional elements are analyzed to determine if the abstract idea is integrated into a practical application (MPEP 2106.04(d)(I); MPEP 2106.05(a-h)). If the claim contains no additional elements beyond the abstract idea, the claim fails to integrate the abstract idea into a practical application (MPEP 2106.04(d)(III)).
The judicial exceptions identified in Eligibility Step 2A, Prong One are not integrated into a practical application because of the reasons noted below.
Claims 4 and 5 do not recite any elements in addition to the judicial exception, and thus are part of the judicial exception.
Claims 1-2 and 6 recite the additional non-abstract elements of data gathering:
a) placing a defined amount of a drug or chemical compound specimen in a source compartment (claims 1 and 6);
b) establishing a contact of the specimen with a transfer media which is able to transport the compound to at least one target compartment (claims 1 and 6);
c) measuring the concentration of the drug or chemical compound or its derivatives, or at least one efficacy coefficient, in at least one of the target compartments (claims 1 and 6);
f) repeating steps c)-e) until desired time of the experiment is reached (claims 1 and 6);
wherein data analysis is executed iteratively for discover unknown coefficient of partition of the compound between the compartments, and/or efficacy coefficient, and/or unknown volume of distribution (claim 2);
based on the calculated non-dimensional Deborah rate number in step h), provide a model-free time-invariant transport and/or efficacy properties of the drug or chemical compound (claim 6).
which are each a data gathering step, or a description of the data gathered.
Data gathering steps are not an abstract idea, they are extra-solution activity, as they collect the data needed to carry out the JE. The data gathering does not impose any meaningful limitation on the JE, or how the JE is performed. The additional limitation (data gathering) must have more than a nominal or insignificant relationship to the identified judicial exception. (MPEP 2106.04/.05, citing Intellectual Ventures LLC v. Symantee Corp, McRO, TLI communications, OIP Techs. Inc. v. Amason.com Inc., Electric Power Group LLC v. Alstrom S.A.).
Thus, the additionally recited elements merely invoke a computer as a tool, and/or amount to insignificant extra-solution data gathering activity, and as such, when all limitations in claims 1-8 have been considered as a whole, the claims are deemed to not recite any additional elements that would integrate a judicial exception into a practical application. Claims 1-2 and 6 contain additional elements that would not integrate a judicial exception into a practical application and are further probed for inventive concept in Step 2B.
[Step 2A, Prong Two: NO]
Eligibility Step 2B: Because the claims recite an abstract idea, and do not integrate that abstract idea into a practical application, the claims are probed for a specific inventive concept. The judicial exception alone cannot provide that inventive concept or practical application (MPEP 2106.05). Identifying whether the additional elements beyond the abstract idea amount to such an inventive concept requires considering the additional elements individually and in combination to determine if they amount to significantly more than the judicial exception (MPEP 2106.05A i-vi).
The claims do not include any additional elements that are sufficient to amount to significantly more than the judicial exception(s) because of the reasons noted below.
With respect to claims 1-2 and 6: The limitations identified above as non-abstract elements (EIA) related to data gathering do not rise to the level of significantly more than the judicial exception. Activities such as data gathering do not improve the functioning of a computer, or comprise an improvement to any other technical field. The limitations do not require or set forth a particular machine, they do not affect a transformation of matter, nor do they provide an unconventional step (citing McRO and Trading Technologies Int’l v. IBG). Data gathering steps constitute a general link to a technological environment. Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception are insufficient to provide significantly more (as discussed in Alice Corp.,).
The additional element of a) placing a defined amount of a drug or chemical compound specimen in a source compartment (claims 1 and 6) is conventional. Evidence for conventionality is shown by Yartsev (Deranged Physiology, CICM Primary Exam, Pharmacokinetics, 2017, 1-20). Yartsev reviews “Again, the same dose of drug is administered into the same compartment. Let us call it the “central” compartment.” (pg. 4, para. 4, lines 1-2). Also, further reviews “This is the drug. Its dose is 1g.” (pg. 3, Figure in Section “The single compartment model”). This shows that a defined amount of a drug is administered in a source compartment, which makes it a conventional practice in the art.
The additional element of b) establishing a contact of the specimen with a transfer media which is able to transport the compound to at least one target compartment (claims 1 and 6) is conventional. Evidence for conventionality is shown by Yartsev (Deranged Physiology, CICM Primary Exam, Pharmacokinetics, 2017, 1-20). Yartsev reviews “Again, the same dose of drug is administered into the same compartment. Let us call it the “central” compartment. There is now also a “peripheral” compartment in the system. Though the drug is still distributed instantly and homogeneously into all of the central compartment, it now also diffuses gradually into (and out of) the peripheral compartment.” (pg. 4-5, para. 4, lines 1-5). Also, further reviews “Let us assume that each compartment has the volume of 1L.” (pg. 5, para. 2, line 1). This shows that the central compartment contains a volume of 1L, which is the transfer media that allows the administered drug to be transported to the peripheral compartment. Therefore, establishing contact of a specimen with a transfer media is a conventional practice in the art.
The additional element of c) measuring the concentration of the drug or chemical compound or its derivatives, or at least one efficacy coefficient, in at least one of the target compartments (claims 1 and 6) is conventional. Evidence for conventionality is shown by Yartsev (Deranged Physiology, CICM Primary Exam, Pharmacokinetics, 2017, 1-20). Yartsev reviews “If there is no elimination taking place, the compartments will achieve an equilibrium. If we were to sample the central compartment, the concentration of the drug will be measured as 0.5g/L.” (pg. 5, para. 2, lines 4-6). This shows that the concentration of a drug can be measured in a target compartment, which is further supported by the figure at the bottom of page 5 depicting the peripheral compartment concentration as 0.5 g/L after both the central compartment and peripheral compartments reach equilibrium. Therefore, measuring the concentration of a drug in a target compartment is a conventional practice in the art.
[Step 2B: NO]
Therefore, claims 1-8 are patent ineligible under 35 U.S.C. § 101.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jammy Luo whose telephone number is (571)272-2358. The examiner can normally be reached Monday - Friday, 9:00 AM - 5:00 PM EST.
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/J.N.L./Examiner, Art Unit 1686
/LARRY D RIGGS II/Supervisory Patent Examiner, Art Unit 1686