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 .
Response to Amendment
In light of the amendments, the previous 112(b) rejections have been withdrawn.
In light of the amendments, the claims are rejected under 35 U.S.C. 112(a).
In light of the amendments, claims 17-18 and 46-47 are rejected under 35 U.S.C. 112(b).
In light of the amendments, the claims are rejected under 35 U.S.C. 101.
In light of the amendments, the claims are rejected under 35 U.S.C. 102/103.
Notice to Applicant
In the amendment dated 07/06/2026, the following has occurred: claims 1-3, 15, 30-31, 35, 40, 46-47, 54, 69-73, and 77-78 have been amended; claims 59-68 remain withdrawn; claims 4-14, 16-18, 21-29, 32-34, 36-39, 41-45, 50-53, 55-58, and 74-76 remain unchanged; and claim 79 has been added.
Claims 1-18, 21-47, 50-58, 59-68, and 69-79 are pending.
Effective Filing Date: 09/06/2023
Response to Arguments
35 U.S.C. 112(b) Rejections:
Applicant amended the claims to overcome the previous 112(b) claim rejections. Examiner withdraws these rejections.
35 U.S.C. 101 Rejections:
Step 2A, Prong Two:
Applicant states that the claims are eligible under this prong as any alleged abstract idea is integrated into a practical application. Examiner however respectfully disagrees. The chromatography system is included as an additional element, however it is directed towards well-understood, routine, and conventional (WURC) activity in the form of mere data gathering. The reception of the data does not tie the analysis to a particular type of machine, rather, it is tied to a data generation step for the purposes of data analysis. Additionally, the independent claims do not recite the data generation step in a manner which it would be an additional element, where conventionality of how the data is generated is not being assessed. The data generation is not positively being recited.
Step 2B:
Applicant argues that the claims are eligible under Step 2B where the claims amount to significantly more than the alleged judicial exception. The receiving of chromatography data from a system is included as part of the abstract idea. Data is being generated (not in a positive manner in claim 69) or received (which is part of the abstract idea in claims 1 and 30) and then processed. The additional elements here are not integrated into the abstract idea in a manner which is significantly more.
Applicant also argues that samples being not derivatized is not conventional. As stated above, the data generation is not positively being recited, and the non-derivatization of the samples is included as part of the abstraction as a description of the data.
35 U.S.C. 102/103 Rejections:
Applicant argues with respect to the previous-cited Kurek et al. reference. Examiner now relies upon the Vogelstein et al. reference as the primary reference based on the amendments to the claims.
Claim Rejections - 35 USC § 112(a)
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 1-18, 21-47, 50-58 and 69-79 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.
Claims 1, 15, 30, and 69 each recite an amended limitation involving input features not comprising a presence, an absence, or a quantity of metabolite/analyte present in a sample. There is no specification support however for this limitation, leading Examiner to question whether Applicant had possession over the claimed invention at the time of filing. For example, paragraph [0003] of the specification (among other paragraphs) recites that the set of input features do not comprise a presence or a quantity of a metabolite of the sample. There is no discussion of “an absence” of a metabolite/analyte.
Claims 2-18, 21-29, 31-47, 50-58 and 70-79 are rejected based on their dependency on claims 1, 30, and 69.
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 17-18 and 46-47 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.
Claims 17 and 46 recite “repeating steps (a) – (c)” though the claims from which these claims depend on do not have a step (c), leading for the claims to be unclear. Based on this lack of clarity these claims have been deemed indefinite. Appropriate correction is needed.
Claims 18 and 47 are rejected based on their dependency on claims 17 and 46
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 1-18, 21-47, 50-58 and 69-79 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1-18, 21-47, and 50-58 are drawn to systems and claims 69-79 are drawn to a system, each of which is within the four statutory categories. Claims 1-18, 21-47, 50-58, and 69-79 are further directed to an abstract idea on the grounds set out in detail below. As discussed below, the claims do not include additional elements that are sufficient to amount to significantly more than the abstract idea because the additional computer elements, which are recited at a high level of generality, provide conventional computer functions that do not add meaningful limits to practicing the abstract idea (Step 1: YES).
Step 2A:
Prong One:
Claim 1 recites a method for determining a metabolic profile of a subject, comprising:
1) (a) receiving chromatography data of a biological sample of said subject, wherein said chromatography data is generated by b) a detector of a chromatography system,
wherein said chromatography system comprises a gas chromatography system or a liquid chromatography system, and
wherein said biological sample is not derivatized; and
2) (b) processing, using a) a machine-learning (ML) algorithm, a set of input features of said chromatography data to generate a metabolic profile of said subject, wherein said set of input features do not comprise a presence, an absence, or a quantity of a metabolite present in said biological sample.
Claim 1 recites, in part, performing the steps of 1) (a) receiving chromatography data of a biological sample of said subject, wherein said chromatography data is generated, wherein said biological sample is not derivatized and 2) (b) processing a set of input features of said chromatography data to generate a metabolic profile of said subject, wherein said set of input features do not comprise a presence, an absence, or a quantity of a metabolite present in said biological sample. These step corresponds to Certain Methods of Organizing Human Activity, more particularly, managing personal behavior or relationships or interactions between people (including following rules or instructions). For example, the claims describes how one could process patient data in order to create a profile. Independent claim 30 recites similar limitations and is also directed to an abstract idea under the same analysis.
Claim 69 recites a system, comprising:
b) a chromatography system comprising a detector configured to 3) generate chromatography data comprising a set of input features from at least a portion of a biological sample of a subject,
wherein the chromatography system comprises a gas chromatography system or a liquid chromatography system,
wherein said biological sample is not derivatized; and
wherein the input features do not comprise a presence, an absence, or a quantity of a metabolite present in said biological sample;
c) one or more computer processors operatively coupled to said chromatography system, wherein said one or more computer processors are individually or collectively programmed to 4) process, using a) a machine-learning (ML) algorithm, said chromatography data to generate a metabolic profile of said subject.
Claim 69 recites, in part, performing the steps of 3) generate chromatography data comprising a set of input features from at least a portion of a biological sample of a subject, wherein said biological sample is not derivatized, and wherein the input features do not comprise a presence, an absence, or a quantity of a metabolite present in said biological sample and 4) process, using an algorithm, said chromatography data to generate a metabolic profile of said subject. These steps correspond to Certain Methods of Organizing Human Activity, more particularly, managing personal behavior or relationships or interactions between people (including following rules or instructions). For example, the claims describes how one could process patient data in order to create a profile. Independent claim 30 recites similar limitations and is also directed to an abstract idea under the same analysis.
Depending claims 2-18, 21-29, 31-47, 50-58, and 70-79 include all of the limitations of claims 1, 30, and 69, and therefore likewise incorporate the above described abstract idea. Claim 77 adds an additional element to the claims, which is further assessed in Prong Two. Depending claims 2, 11, 17-18, 23-25, 31, 40, 46-47, 52-54, 75, and 77 add additional, functional steps to the claims. Additionally, the limitations of depending claims 3-10, 12-16, 21-22, 26-29, 32-39, 41-45, 50-51, 55-58, 70-74, 76, and 78-79 further specify elements from the claims from which they depend on without adding any additional steps. These additional limitations only further serve to limit the abstract idea. Thus, depending claims 2-18, 21-29, 31-47, 50-58, and 70-79 are nonetheless directed towards fundamentally the same abstract idea as independent claims 1, 30, and 69 (Step 2A (Prong One): YES).
Prong Two:
This judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements of – using a) a machine-learning (ML) algorithm, b) a chromatography system comprising a detector, wherein the chromatography system comprises a gas chromatography system or a liquid chromatography system, c) one or more computer processors operatively coupled to said chromatography system, wherein said one or more computer processors are individually or collectively programmed, and d) an autosampler configured to provide a plurality of cartridges comprising said cartridge to said chromatography system (from claim 77) to perform the claimed steps.
The a) machine-learning (ML) algorithm and c) one or more computer processors in these steps are recited at a high-level of generality (i.e., as generic components performing generic computer functions) such that it amount to no more than mere instructions to apply the exception using generic computer components (see: Applicant’s specification, for lack of description for something other than what may be considered as generic components for these elements, see MPEP 2106.05(f)).
The b) chromatography system comprising a detector and d) autosampler in these steps adds insignificant extra-solution activity to the abstract idea which amounts to mere data gathering, see MPEP 2106.05(g). These limitations can also be directed to “apply it” using generic components to apply the abstract idea.
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea (Step 2A (Prong Two): NO).
Step 2B:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of using a) a machine-learning (ML) algorithm, b) a chromatography system comprising a detector, wherein the chromatography system comprises a gas chromatography system or a liquid chromatography system, c) one or more computer processors operatively coupled to said chromatography system, wherein said one or more computer processors are individually or collectively programmed, and d) an autosampler configured to provide a plurality of cartridges comprising said cartridge to said chromatography system to perform the claimed steps amounts to no more than insignificant extra-solution activity in the form of WURC activity (well-understood, routine, and conventional activity) and mere instructions to apply the exception using generic computer components that does not offer “significantly more” than the abstract idea itself because the claims do not recite an improvement to another technology or technical field, an improvement to the functioning of any computer itself, or provide meaningful limitations beyond generally linking an abstract idea to a particular technological environment. It should be noted that the claims do not include additional elements that amount to significantly more than the judicial exception because the Specification recites mere generic computer components, as discussed above that are being used to apply certain method steps of organizing human activity. Specifically, MPEP 2106.05(d) and MPEP 2106.05(f) recite that the following limitations are not significantly more:
Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d)); and
Adding the words "apply it" (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, e.g., a limitation indicating that a particular function such as creating and maintaining electronic records is performed by a computer, as discussed in Alice Corp., 134 S. Ct. at 2360, 110 USPQ2d at 1984 (see MPEP § 2106.05(f)).
The current invention determines a profile utilizing a) a machine-learning (ML) algorithm and c) one or more computer processors, thus these computing components are adding the words “apply it” with mere instructions to implement the abstract idea on a computer.
Additionally, the b) chromatography system comprising a detector and d) an autosampler in these steps add insignificant extra-solution activity/pre-solution activity in the form of WURC activity to the abstract idea. The following is an example of a court decision demonstrating computer functions as well-understood, routine and conventional activities, e.g. see MPEP 2106.05(d)(II): Receiving or transmitting data over a network, e.g. see Intellectual Ventures v. Symantec – similarly, the current invention receives chromatography data, and transmits the data to system with an algorithm over a network, for example the Internet. These limitations also amount to applying these systems to generate the data.
Mere instructions to apply an exception using generic computer components or insignificant extra-solution activity in the form of WURC activity cannot provide an inventive concept. The claims are not patent eligible (Step 2B: NO).
Claims 1-18, 21-47, 50-58, and 69-79 are therefore rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 12, 14, 30, 41, 43, 69, 73, and 78-79 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. 2019/0256924 to Vogelstein et al.
As per claim 1, Vogelstein et al. teaches a method for determining a metabolic profile of a subject, comprising:
--(a) receiving chromatography data of a biological sample of said subject, (see: paragraph [0218] where there is receiving of chromatography data via liquid chromatography) wherein said chromatography data is generated by a detector of a chromatography system, (see: paragraph [0218] where multiplexing is occurring to determine level of biomarkers. Also see: paragraph [0522] where there is a device (system with a detector) for determining these biomarker levels)
--wherein said chromatography system comprises a gas chromatography system or a liquid chromatography system, (see: paragraph [0218] where there is liquid chromatography and paragraph [0522] where there is a device for performing the chromatography) and
--wherein said biological sample is not derivatized; (see: paragraph [0560] where there is a biological sample which is not derivatized in the form of a 5’ phosphorylated single-stranded nucleic acid or derivative thereof) and
--(b) processing, using a machine-learning (ML) algorithm, a set of input features of said chromatography data to generate a metabolic profile of said subject, (see: paragraphs [0413] and [0507] where there is a machine learning model which is used and an output is generated from the input data. Also see: paragraph [0483] where there is a generation of a somatic mutational (metabolic) profile based on a set of input data (biological test samples). Also see: paragraph [0406] where there is inputting of biomarker data to identify useful biomarkers. A metabolic profile (output data) is being generated for the patient here) wherein said set of input features do not comprise a presence, an absence, or a quantity of a metabolite present in said biological sample (see: paragraphs [0406], [0413], [0483], and [0507] where there is a set of biomarker input data and this does not comprise data about a quantity of metabolite).
As per claim 12, Vogelstein et al. teaches the method of claim 1, see discussion of claim 1. Vogelstein et al. further teaches wherein said biological sample is a urine sample (see: paragraph [0495] where there is a urine sample).
As per claim 14, Vogelstein et al. teaches the method of claim 1, see discussion of claim 1. Vogelstein et al. further teaches wherein said chromatography data is derived from a liquid chromatography system (see: paragraph [0702] where there is liquid chromatography-mass spectrometry).
As per claim 30, claim 30 is similar to claim 1 and is therefore rejected in a similar manner.
As per claim 41, claim 41 is similar to claim 12 and is therefore rejected in a similar manner.
As per claim 43, claim 43 is similar to claim 14 and is therefore rejected in a similar manner.
As per claim 69, claim 69 is similar to claim 1 and is therefore rejected in a similar manner.
As per claim 73, claim 73 is similar to claim 14 and is therefore rejected in a similar manner.
As per claim 78, Vogelstein et al. teaches the system of claim 69, see discussion of claim 69. Vogelstein et al. further teaches wherein said detector comprises one or more of a flame ionization detector (FID), thermal conductivity detector (TCD), electron capture detector (ECD), photoionization detector (PID), mass spectrometer (MS), ion mobility spectrometer (IMS), nitrogen-phosphorus detector (NPD), Raman detector, ultraviolet-visible (UV-Vis) detector, photodiode array detector (PDA), fluorescence detector, evaporative light scattering detector (ELSD), refractive index detector (RID), and conductivity detector (see: paragraph [0702] where mass spectrometry is used).
As per claim 79, claim 79 is similar to claim 78 and is therefore rejected in a similar manner.
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 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.
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.
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.
Claims 2-5, 13, 15-17, 31-34, 42, 44-46, and 72 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2019/0256924 to Vogelstein et al. in view of U.S. 2019/0214145 to Kurek et al.
As per claim 2, Vogelstein et al. teaches the method of claim 1, see discussion of claim 1. Vogelstein et al. may not further, specifically teach (c) processing said metabolic profile to determine a presence or an absence of a disease state.
Kurek et al. teaches:
--(c) processing said metabolic profile to determine a presence or an absence of a disease state (see: paragraph [0496] where there is a method involving calculation of a correlation of a patient metabolite profile data to a disease state metabolite profile and recommend a treatment regime therefrom).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to (c) process said metabolic profile to determine a presence or an absence of a disease state as taught by Kurek et al. in the method as taught by Vogelstein et al. with the motivation(s) of generating valuable information on the pattern and function of biomarkers (see: paragraph [0007] of Kurek et al.).
As per claim 3, Vogelstein et al. and Kurek et al. in combination teaches the method of claim 2, see discussion of claim 2. Kurek et al. further teaches wherein said processing in (c) further comprises processing a characteristic of said subject (see: paragraph [0062] where the processing overview of the recommendation engine uses demographic characteristics of the patient to identify high efficacy treatments).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 2, and incorporated herein.
As per claim 4, Vogelstein et al. and Kurek et al. in combination teaches the method of claim 3, see discussion of claim 3. Kurek et al. further teaches wherein said characteristic is selected from the group consisting of previous tumor, demographics, clinical characteristic, demographic characteristic, and phenotypic characteristic (see: paragraph [0062] where the processing overview of the recommendation engine uses demographic characteristics of the patient to identify high efficacy treatments).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 2, and incorporated herein.
As per claim 5, Vogelstein et al. and Kurek et al. in combination teaches the method of claim 2, see discussion of claim 2. Kurek et al. further teaches wherein said disease state is selected from the group consisting of an oncological disease, an infectious disease, a chronic disease, a nutritional deficiency, an environmental disease, an autoimmune disorder, and a genetic disease (see: paragraph [0118] where there is a chronic disease).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 2, and incorporated herein.
As per claim 13, Vogelstein et al. teaches the method of claim 1, see discussion of claim 1. Vogelstein et al. may not further, specifically teach wherein said chromatography data is derived from a gas chromatography system.
Kurek et al. teaches:
--wherein said chromatography data is derived from a gas chromatography system (see: paragraph [0042] where there is gas chromatography).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute wherein said chromatography data is derived from a gas chromatography system as taught by Kurek et al. for the chromatography system as disclosed by Vogelstein et al. since each individual element and its function are shown in the prior art, with the difference being the substitution of the elements. In the present case, Vogelstein et al. already teaches of using a liquid chromatography system thus one could replace that system with another chromatography system and obtain predictable results of using a chromatography system to generate data. Thus, one of ordinary skill in the art could have substituted the one known element for the other to produce a predictable result (MPEP 2143).
As per claim 15, Vogelstein et al. teaches the method of claim 1, see discussion of claim 1. Vogelstein et al. may not further, specifically teach wherein said set of input features do not comprise a presence, absence, or a quantity of an analyte present in said biological sample.
Kurek et al. teaches:
--wherein said set of input features do not comprise a presence, absence, or a quantity of an analyte present in said biological sample (see: Table 1 and paragraph [0101] where the control has no presence of THC or CBD in the sample. There is a subject that is not a cannabis user here).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to have wherein said set of input features do not comprise a presence, absence, or a quantity of an analyte present in said biological sample as taught by Kurek et al. in the method as taught by Vogelstein et al. with the motivation(s) of generating valuable information on the pattern and function of biomarkers (see: paragraph [0007] of Kurek et al.).
As per claim 16, Vogelstein et al. teaches the method of claim 1, see discussion of claim 1. Vogelstein et al. may not further, specifically teach wherein said ML algorithm comprises a fuzzy decision network.
Kurek et al. teaches:
--wherein said ML algorithm comprises a fuzzy decision network (see: paragraph [0010] where there is a system built using a fuzzy logic algorithm).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute wherein said ML algorithm comprises a fuzzy decision network as taught by Kurek et al. for the network as disclosed by Vogelstein et al. since each individual element and its function are shown in the prior art, with the difference being the substitution of the elements. In the present case, Vogelstein et al. already teaches of using a network thus one could replace that network with another network and obtain predictable results of using a network to generate data. Thus, one of ordinary skill in the art could have substituted the one known element for the other to produce a predictable result (MPEP 2143).
As per claim 17, Vogelstein et al. teaches the method of claim 1, see discussion of claim 1. Vogelstein et al. may not further, specifically teach repeating (a) - (c) for a plurality of biological samples of a plurality of subjects to generate a plurality of metabolic profiles.
Kurek et al. teaches:
--repeating (a) - (c) for a plurality of biological samples of a plurality of subjects to generate a plurality of metabolic profiles (see: Table 1 where these steps are repeated for a plurality of subjects to generate a plurality of profiles).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to repeat (a) - (c) for a plurality of biological samples of a plurality of subjects to generate a plurality of metabolic profiles as taught by Kurek et al. in the method as taught by Vogelstein et al. with the motivation(s) of generating valuable information on the pattern and function of biomarkers (see: paragraph [0007] of Kurek et al.).
As per claim 31, claim 31 is similar to claim 2 and is therefore rejected in a similar manner.
As per claim 32, claim 32 is similar to claim 3 and is therefore rejected in a similar manner.
As per claim 33, claim 33 is similar to claim 4 and is therefore rejected in a similar manner.
As per claim 34, claim 34 is similar to claim 5 and is therefore rejected in a similar manner.
As per claim 42, claim 42 is similar to claim 13 and is therefore rejected in a similar manner.
As per claim 44, claim 44 is similar to claim 15 and is therefore rejected in a similar manner.
As per claim 45, claim 45 is similar to claim 16 and is therefore rejected in a similar manner.
As per claim 46, claim 46 is similar to claim 17 and is therefore rejected in a similar manner.
As per claim 72, claim 72 is similar to claim 13 and is therefore rejected in a similar manner.
Claims 6-10, 18, 35-39, and 47 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2019/0256924 to Vogelstein et al. in view of U.S. 2019/0214145 to Kurek et al. as applied to claim 2, and further in view of U.S. 2015/0276764 to Slupsky.
As per claim 6, Vogelstein et al. and Kurek et al. in combination teaches the method of claim 2, see discussion of claim 2. The combination may not further, specifically teach wherein said disease state comprises a plurality of disease states, and wherein the method further comprises processing the metabolic profile to determine a presence or absence of each of the plurality of disease states.
Slupsky teaches:
--wherein said disease state comprises a plurality of disease states, and wherein the method further comprises processing the metabolic profile to determine a presence or absence of each of the plurality of disease states (see: paragraph [0062] where the staging involves determining the presence or absence of each of the plurality of disease states).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to have wherein said disease state comprises a plurality of disease states, and wherein the method further comprises processing the metabolic profile to determine a presence or absence of each of the plurality of disease states as taught by Slupsky in the method as taught by Vogelstein et al. and Kurek et al. in combination with the motivation(s) of determining the state of disease in a subject (see: paragraph [0023] of Slupsky).
As per claim 7, Vogelstein et al., Kurek et al., and Slupsky in combination teaches the method of claim 6, see discussion of claim 6. Slupsky further teaches wherein said plurality of disease states comprises at least about 5 disease states (see: paragraph [0062] where there are at least 5 disease states).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 6, and incorporated herein.
As per claim 8, Vogelstein et al., Kurek et al., and Slupsky in combination teaches the method of claim 7, see discussion of claim 7. Slupsky further teaches wherein said plurality of disease states comprises at least about 50 disease states (see: paragraph [0062] where there are many disease states. The threshold of 50 states is merely non-functional, descriptive material, and therefore provides little patentable weight).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 6, and incorporated herein.
As per claim 9, Vogelstein et al. and Kurek et al. in combination teaches the method of claim 2, see discussion of claim 2. The combination may not further, specifically teach wherein said presence or said absence of said disease state is determined at an accuracy of at least about 85%.
Slupsky teaches:
--wherein said presence or said absence of said disease state is determined at an accuracy of at least about 85% (see: paragraph [0069] where when used for urinary diagnosis of mycobacterium tuberculosis the method resulted in a 95% specificity).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to have wherein said presence or said absence of said disease state is determined at an accuracy of at least about 85% as taught by Slupsky in the method as taught by Vogelstein et al. and Kurek et al. in combination with the motivation(s) of determining the state of disease in a subject (see: paragraph [0023] of Slupsky).
As per claim 10, Vogelstein et al. and Kurek et al. in combination teaches the method of claim 2, see discussion of claim 2. The combination may not further, specifically teach wherein said presence or said absence of said disease state is determined using a single sample from said subject.
Slupsky teaches:
--wherein said presence or said absence of said disease state is determined using a single sample from said subject (see: paragraph [0019] where the biological test sample may be one of blood, blood plasma, blood serum, cerebrospinal fluid, bile acid, saliva, synovial fluid, pleural fluid, pericardial fluid, peritoneal fluid, feces, nasal fluid, ocular fluid, intracellular fluid, intercellular fluid, lymph fluid, and urine).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to have wherein said presence or said absence of said disease state is determined using a single sample from said subject as taught by Slupsky in the method as taught by Vogelstein et al. and Kurek et al. in combination with the motivation(s) of determining the state of disease in a subject (see: paragraph [0023] of Slupsky).
As per claim 18, Vogelstein et al. and Kurek et al. in combination teaches the method of claim 17, see discussion of claim 17. The combination may not further, specifically teach analyzing said plurality of metabolic profiles to determine a differential feature of said plurality of metabolic profiles.
Slupsky teaches:
--analyzing said plurality of metabolic profiles to determine a differential feature of said plurality of metabolic profiles (see: paragraph [0037] where differential metabolic profiles pertaining to specific states of a disease based on biomarker identifications are created and the ample metabolic profile is compared to each to determine what state the disease is in).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to analyze said plurality of metabolic profiles to determine a differential feature of said plurality of metabolic profiles as taught by Slupsky in the method as taught by Vogelstein et al. and Kurek et al. in combination with the motivation(s) of determining the state of disease in a subject (see: paragraph [0023] of Slupsky).
As per claim 35, Vogelstein et al. and Kurek et al. in combination teaches the method of claim 31, see discussion of claim 31. The combination may not further, specifically teach herein said disease state comprises a plurality of disease states, and wherein the method further comprises processing the multi-omic profile to determine a presence or absence of each of the plurality of disease states.
Slupsky teaches:
--wherein said disease state comprises a plurality of disease states, and wherein the method further comprises processing the multi-omic profile to determine a presence or absence of each of the plurality of disease states (see: paragraph [0062] where the staging involves determining the presence or absence of each of the plurality of disease states).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to have wherein said disease state comprises a plurality of disease states, and wherein the method further comprises processing the multi-omic profile to determine a presence or absence of each of the plurality of disease states as taught by Slupsky in the method as taught by Vogelstein et al. and Kurek et al. in combination with the motivation(s) of determining the state of disease in a subject (see: paragraph [0023] of Slupsky).
As per claim 36, Vogelstein et al., Kurek et al., and Slupsky in combination teaches the method of claim 35, see discussion of claim 35. Slupsky further teaches wherein said plurality of disease states comprises at least about 5 disease states (see: paragraph [0062] where there are at least 5 disease states).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 35, and incorporated herein.
As per claim 37, Vogelstein et al., Kurek et al., and Slupsky in combination teaches the method of claim 36, see discussion of claim 36. Slupsky further teaches wherein said plurality of disease states comprises at least about 50 disease states (see: paragraph [0062] where there are many disease states. The threshold of 50 states is merely non-functional, descriptive material, and therefore provides little patentable weight).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 35, and incorporated herein.
As per claim 38, Vogelstein et al. and Kurek et al. in combination teaches the method of claim 31, see discussion of claim 31. The combination may not further, specifically teach wherein said presence or said absence of said disease state is determined at an accuracy of at least about 85%.
Slupsky teaches:
--wherein said presence or said absence of said disease state is determined at an accuracy of at least about 85% (see: paragraph [0069] where when used for urinary diagnosis of mycobacterium tuberculosis the method resulted in a 95% specificity).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to have wherein said presence or said absence of said disease state is determined at an accuracy of at least about 85% as taught by Slupsky in the method as taught by Vogelstein et al. and Kurek et al. in combination with the motivation(s) of determining the state of disease in a subject (see: paragraph [0023] of Slupsky).
As per claim 39, Vogelstein et al. and Kurek et al. in combination teaches the method of claim 31, see discussion of claim 31. The combination may not further, specifically teach wherein said presence or said absence of said disease state is determined using a single sample from said subject.
Slupsky teaches:
--wherein said presence or said absence of said disease state is determined using a single sample from said subject (see: paragraph [0019] where the biological test sample may be one of blood, blood plasma, blood serum, cerebrospinal fluid, bile acid, saliva, synovial fluid, pleural fluid, pericardial fluid, peritoneal fluid, feces, nasal fluid, ocular fluid, intracellular fluid, intercellular fluid, lymph fluid, and urine).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to have wherein said presence or said absence of said disease state is determined using a single sample from said subject as taught by Slupsky in the method as taught by Vogelstein et al. and Kurek et al. in combination with the motivation(s) of determining the state of disease in a subject (see: paragraph [0023] of Slupsky).
As per claim 47, Vogelstein et al. and Kurek et al. in combination teaches the method of claim 46, see discussion of claim 46. The combination may not further, specifically teach analyzing said plurality of multi-omic profiles to determine a differential feature of said plurality of multi-omic profiles.
Slupsky teaches:
--analyzing said plurality of multi-omic profiles to determine a differential feature of said plurality of multi-omic profiles (see: paragraph [0037] where differential metabolic profiles pertaining to specific states of a disease based on biomarker identifications are created and the ample metabolic profile is compared to each to determine what state the disease is in).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to analyze said plurality of multi-omic profiles to determine a differential feature of said plurality of multi-omic profiles as taught by Slupsky in the method as taught by Vogelstein et al. and Kurek et al. in combination with the motivation(s) of determining the state of disease in a subject (see: paragraph [0023] of Slupsky).
Claims 11, 21-29, 40, and 50-58 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2019/0256924 to Vogelstein et al. as applied to claim 1, and further in view of U.S. 2015/0276764 to Slupsky.
As per claim 11, Vogelstein et al. teaches the method of claim 1, see discussion of claim 1. Vogelstein et al. may not further, specifically teach processing said metabolic profile to determine a presence or an absence of use of a compound by said subject.
Slupsky teaches:
--processing said metabolic profile to determine a presence or an absence of use of a compound by said subject (see: paragraph [0113] where there is a database of hundreds of metabolite compounds is used to determine the presence or absence of compounds in the subject’s sample).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to process said metabolic profile to determine a presence or an absence of use of a compound by said subject as taught by Slupsky in the method as taught by Vogelstein et al. with the motivation(s) of determining the state of disease in a subject (see: paragraph [0023] of Slupsky).
As per claim 21, Vogelstein et al. teaches the method of claim 1, see discussion of claim 1. Vogelstein et al. may not further, specifically teach wherein said biological sample is an unpreserved biological sample.
Slupsky teaches:
--wherein said biological sample is an unpreserved biological sample (see: paragraph [0080] where the biological sample is processed using a point-of-care device thereby indicating the sample has just been received from the subject and is not preserved and is raw).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to have wherein said biological sample is an unpreserved biological sample as taught by Slupsky in the method as taught by Vogelstein et al. with the motivation(s) of determining the state of disease in a subject (see: paragraph [0023] of Slupsky).
As per claim 22, Vogelstein et al. and Slupsky in combination teaches the method of claim 21, see discussion of claim 21. Slupsky further teaches wherein said unpreserved biological sample is a raw biological sample (see: paragraph [0080] where the biological sample is processed using a point-of-care device thereby indicating the sample has just been received from the subject and is not preserved and is raw).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 21, and incorporated herein.
As per claim 23, Vogelstein et al. teaches the method of claim 1, see discussion of claim 1. Vogelstein et al. may not further, specifically teach subsequent to (a), processing said sample with a mass spectrometer.
Slupsky teaches:
--subsequent to (a), processing said sample with a mass spectrometer (see: paragraph [0022] where the respective concentration of each of the identified metabolites is determined using a spectrometric technique wherein the spectrometric technique is mass spectrometry).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to subsequent to (a), process said sample with a mass spectrometer as taught by Slupsky in the method as taught by Vogelstein et al. with the motivation(s) of determining the state of disease in a subject (see: paragraph [0023] of Slupsky).
As per claim 24, Vogelstein et al. teaches the method of claim 1, see discussion of claim 1. Vogelstein et al. may not further, specifically teach determining said presence or said quantity of said metabolite.
Slupsky teaches:
--determining said presence or said quantity of said metabolite (see: paragraphs [0024] – [0025] where the metabolite profile indicative of the disease state is made up of the respective concentrations of individual metabolite biomarkers in the sample).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to determine said presence or said quantity of said metabolite as taught by Slupsky in the method as taught by Vogelstein et al. with the motivation(s) of determining the state of disease in a subject (see: paragraph [0023] of Slupsky).
As per claim 25, Vogelstein et al. and Slupsky in combination teaches the method of claim 24, see discussion of claim 24. Vogelstein et al. may not further, specifically teach determining said metabolic profile based further on said presence or said quantity of said metabolite.
Slupsky teaches:
--determining said metabolic profile based further on said presence or said quantity of said metabolite (see: paragraphs [0024] – [0025] where the metabolite profile indicative of the disease state is made up of the respective concentrations of individual metabolite biomarkers in the sample).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to determine said metabolic profile based further on said presence or said quantity of said metabolite as taught by Slupsky in the method as taught by Vogelstein et al. with the motivation(s) of determining the state of disease in a subject (see: paragraph [0023] of Slupsky).
As per claim 26, Vogelstein et al. teaches the method of claim 1, see discussion of claim 1. Vogelstein et al. may not further, specifically teach wherein said output data comprises said presence or said quantity of said metabolite.
Slupsky teaches:
--wherein said output data comprises said presence or said quantity of said metabolite (see: paragraph [0022] where the respective concentration of each of the identified metabolites is determined using a spectrometric technique wherein the spectrometric technique is chromatography).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to have wherein said output data comprises said presence or said quantity of said metabolite as taught by Slupsky in the method as taught by Vogelstein et al. with the motivation(s) of determining the state of disease in a subject (see: paragraph [0023] of Slupsky).
As per claim 27, Vogelstein et al. teaches the method of claim 1, see discussion of claim 1. Vogelstein et al. may not further, specifically teach wherein said chromatography data comprises a first gas chromatography data and a second liquid chromatography data.
Slupsky teaches:
--wherein said chromatography data comprises a first gas chromatography data and a second liquid chromatography data (see: paragraph [0009] where the method uses input features from samples of serum, plasma, and urine. Also see: paragraph [0022] which may be analyzed using a number of methods including liquid chromatography or gas chromatography).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to have wherein said chromatography data comprises a first gas chromatography data and a second liquid chromatography data as taught by Slupsky in the method as taught by Vogelstein et al. with the motivation(s) of determining the state of disease in a subject (see: paragraph [0023] of Slupsky).
As per claim 28, Vogelstein et al. teaches the method of claim 1, see discussion of claim 1. Vogelstein et al. may not further, specifically teach wherein said set of input features further comprises additional data.
Slupsky teaches:
--wherein said set of input features further comprises additional data (see: paragraph [0009] where the method uses input features from samples of serum, plasma, and urine. Also see: paragraph [0022] which may be analyzed using a number of methods including liquid chromatography or gas chromatography).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to have wherein said set of input features further comprises additional data as taught by Slupsky in the method as taught by Vogelstein et al. with the motivation(s) of determining the state of disease in a subject (see: paragraph [0023] of Slupsky).
As per claim 29, Vogelstein et al. and Slupsky in combination teaches the method of claim 28, see discussion of claim 28. Slupsky further teaches wherein said additional data comprises additional data selected from the group consisting of additional chromatography data and additional optical data (see: paragraph [0009] where the method uses input features from samples of serum, plasma, and urine. Also see: paragraph [0022] which may be analyzed using a number of methods including liquid chromatography or gas chromatography).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 28, and incorporated herein.
As per claim 40, Vogelstein et al. teaches the method of claim 30, see discussion of claim 30. Vogelstein et al. may not further, specifically teach processing said multi-omic profile to determine a presence or an absence of use of a compound by said subject.
Slupsky teaches:
--processing said multi-omic profile to determine a presence or an absence of use of a compound by said subject (see: paragraph [0113] where there is a database of hundreds of metabolite compounds is used to determine the presence or absence of compounds in the subject’s sample).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to process said multi-omic profile to determine a presence or an absence of use of a compound by said subject as taught by Slupsky in the method as taught by Vogelstein et al. with the motivation(s) of determining the state of disease in a subject (see: paragraph [0023] of Slupsky).
As per claim 50, Vogelstein et al. teaches the method of claim 30, see discussion of claim 30. Vogelstein et al. may not further, specifically teach wherein said biological sample is an unpreserved biological sample.
Slupsky teaches:
--wherein said biological sample is an unpreserved biological sample (see: paragraph [0080] where the biological sample is processed using a point-of-care device thereby indicating the sample has just been received from the subject and is not preserved and is raw).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to have wherein said biological sample is an unpreserved biological sample as taught by Slupsky in the method as taught by Vogelstein et al. with the motivation(s) of determining the state of disease in a subject (see: paragraph [0023] of Slupsky).
As per claim 51, Vogelstein and Slupsky in combination teaches the method of claim 50, see discussion of claim 50. Slupsky further teaches wherein said unpreserved biological sample is a raw biological sample (see: paragraph [0080] where the biological sample is processed using a point-of-care device thereby indicating the sample has just been received from the subject and is not preserved and is raw).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 50, and incorporated herein.
As per claim 52, Vogelstein et al. teaches the method of claim 30, see discussion of claim 30. Vogelstein et al. may not further, specifically teach teaches subsequent to (a), processing said sample with a mass spectrometer.
Slupsky teaches:
--subsequent to (a), processing said sample with a mass spectrometer (see: paragraph [0022] where the respective concentration of each of the identified metabolites is determined using a spectrometric technique wherein the spectrometric technique is mass spectrometry).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to subsequent to (a), process said sample with a mass spectrometer as taught by Slupsky in the method as taught by Vogelstein et al. with the motivation(s) of determining the state of disease in a subject (see: paragraph [0023] of Slupsky).
As per claim 53, Vogelstein et al. teaches the method of claim 30, see discussion of claim 30. Vogelstein et al. may not further, specifically teach determining said presence or said quantity of said metabolite.
Slupsky teaches:
--determining said presence or said quantity of said metabolite (see: paragraphs [0024] – [0025] where the metabolite profile indicative of the disease state is made up of the respective concentrations of individual metabolite biomarkers in the sample).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to determine said presence or said quantity of said metabolite as taught by Slupsky in the method as taught by Vogelstein et al. with the motivation(s) of determining the state of disease in a subject (see: paragraph [0023] of Slupsky).
As per claim 54, Vogelstein et al. and Slupsky in combination teaches the method of claim 53, see discussion of claim 53. Vogelstein et al. may not further, specifically teach determining said multi-omic profile based further on said presence or said quantity of said metabolite.
Slupsky teaches:
--determining said multi-omic profile based further on said presence or said quantity of said metabolite (see: paragraphs [0024] – [0025] where the metabolite profile indicative of the disease state is made up of the respective concentrations of individual metabolite biomarkers in the sample).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to determine said multi-omic profile based further on said presence or said quantity of said metabolite as taught by Slupsky in the method as taught by Vogelstein et al. with the motivation(s) of determining the state of disease in a subject (see: paragraph [0023] of Slupsky).
As per claim 55, Vogelstein et al. teaches the method of claim 1, see discussion of claim 1. Vogelstein et al. may not further, specifically teach wherein said output data comprises said presence or said quantity of said metabolite.
Slupsky teaches:
--wherein said output data comprises said presence or said quantity of said metabolite (see: paragraph [0022] where the respective concentration of each of the identified metabolites is determined using a spectrometric technique wherein the spectrometric technique is chromatography).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to have wherein said output data comprises said presence or said quantity of said metabolite as taught by Slupsky in the method as taught by Vogelstein et al. with the motivation(s) of determining the state of disease in a subject (see: paragraph [0023] of Slupsky).
As per claim 56, Vogelstein et al. teaches the method of claim 30, see discussion of claim 30. Vogelstein et al. may not further, specifically teach wherein said chromatography data comprises a first gas chromatography data and a second liquid chromatography data.
Slupsky teaches:
--wherein said chromatography data comprises a first gas chromatography data and a second liquid chromatography data (see: paragraph [0009] where the method uses input features from samples of serum, plasma, and urine. Also see: paragraph [0022] which may be analyzed using a number of methods including liquid chromatography or gas chromatography).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to have wherein said chromatography data comprises a first gas chromatography data and a second liquid chromatography data as taught by Slupsky in the method as taught by Vogelstein et al. with the motivation(s) of determining the state of disease in a subject (see: paragraph [0023] of Slupsky).
As per claim 57, Vogelstein et al. teaches the method of claim 30, see discussion of claim 30. Vogelstein et al. may not further, specifically teach wherein said set of input features further comprises additional data.
Slupsky teaches:
--wherein said set of input features further comprises additional data (see: paragraph [0009] where the method uses input features from samples of serum, plasma, and urine. Also see: paragraph [0022] which may be analyzed using a number of methods including liquid chromatography or gas chromatography).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to have wherein said set of input features further comprises additional data as taught by Slupsky in the method as taught by Vogelstein et al. with the motivation(s) of determining the state of disease in a subject (see: paragraph [0023] of Slupsky).
As per claim 58, Vogelstein et al. and Slupsky in combination teaches the method of claim 57, see discussion of claim 57. Slupsky further teaches wherein said additional data comprises additional data selected from the group consisting of additional chromatography data and additional optical data (see: paragraph [0009] where the method uses input features from samples of serum, plasma, and urine. Also see: paragraph [0022] which may be analyzed using a number of methods including liquid chromatography or gas chromatography).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 57, and incorporated herein.
Claims 70-71 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2019/0256924 to Vogelstein et al. in view of U.S. 2018/0217068 to Tabb et al.
As per claim 70, Vogelstein et al. teaches the system of claim 69, see discussion of claim 69. Vogelstein et al. may not further, specifically teach further comprising a cartridge, wherein said cartridge comprises a test strip.
Tabb et al. teaches:
--further comprising a cartridge, wherein said cartridge comprises a test strip (see: paragraph [0107] where there is a test strip).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to further comprise a cartridge, wherein said cartridge comprises a test strip as taught by Tabb et al. in the system as taught by Vogelstein et al. with the motivation(s) of being a type of collection device (see: paragraph [0107] of Tabb et al.).
Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute further comprising a cartridge, wherein said cartridge comprises a test strip as taught by Tabb et al. for the collection device as disclosed by Vogelstein et al. since each individual element and its function are shown in the prior art, with the difference being the substitution of the elements. In the present case, Vogelstein et al. already teaches of a collection device thus swapping this device for another collection device would produce predictable results of using a collection device in order to make a determination. Thus, one of ordinary skill in the art could have substituted the one known element for the other to produce a predictable result (MPEP 2143).
As per claim 71, Vogelstein et al. teaches the system of claim 69, see discussion of claim 69. Vogelstein et al. may not further, specifically teach further comprising a cartridge, wherein said cartridge comprises a collection cup.
Tabb et al. teaches:
--further comprising a cartridge, wherein said cartridge comprises a collection cup (see: paragraph [0107] where there is a test strip).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to further comprise a cartridge, wherein said cartridge comprises a collection cup as taught by Tabb et al. in the system as taught by Vogelstein et al. with the motivation(s) of being a type of collection device (see: paragraph [0107] of Tabb et al.).
Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute further comprising a cartridge, wherein said cartridge comprises a collection cup as taught by Tabb et al. for the collection device as disclosed by Vogelstein et al. since each individual element and its function are shown in the prior art, with the difference being the substitution of the elements. In the present case, Vogelstein et al. already teaches of a collection device thus swapping this device for another collection device would produce predictable results of using a collection device in order to make a determination. Thus, one of ordinary skill in the art could have substituted the one known element for the other to produce a predictable result (MPEP 2143).
Claims 74-76 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2019/0256924 to Vogelstein et al. in view of U.S. 2015/0137992 to Potyrailo et al.
As per claim 74, Vogelstein et al. teaches the system of claim 69, see discussion of claim 69. Vogelstein et al. may not further, specifically teach wherein said chromatography system is a single use chromatography system.
Potyrailo et al. teaches:
--wherein said chromatography system is a single use chromatography system (see: paragraph [0032] where there are such single-use systems).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute wherein said chromatography system is a single use chromatography system as taught by Potyrailo et al. for the system as disclosed by Vogelstein et al. since each individual element and its function are shown in the prior art, with the difference being the substitution of the elements. In the present case, Vogelstein et al. already teaches of using a system to measure data thus one could switch with a single-use system and obtain predictable results of using a system to perform measurements. Thus, one of ordinary skill in the art could have substituted the one known element for the other to produce a predictable result (MPEP 2143).
As per claim 75, Vogelstein et al. teaches the system of claim 69, see discussion of claim 69. Vogelstein et al. may not further, specifically teach a data connection configured to transmit data associated with said at least a portion of said biological sample from said chromatography system to the one or more computer processors.
Potyrailo et al. teaches:
--a data connection configured to transmit data associated with said at least a portion of said biological sample from said chromatography system to the one or more computer processors (see: paragraphs [0025] and [0051] where there is transmission of data between devices, from a system to a computer).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to use a data connection configured to transmit data associated with said at least a portion of said biological sample from said chromatography system to the one or more computer processors as taught by Potyrailo et al. in the system as taught by Vogelstein et al. with the motivation(s) of helping facilitate real-time control over a system (see: paragraph [0033] of Potyrailo et al.).
As per claim 76, Vogelstein et al. and Potyrailo et al. in combination teaches the system of claim 75, see discussion of claim 75. Vogelstein et al. may not further, specifically teach wherein said data connection comprises a wireless data connection.
Potyrailo et al. teaches wherein said data connection comprises a wireless data connection (see: paragraph [0027] where there is data transmission via a wireless communication path).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 75, and incorporated herein.
Claim 77 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2019/0256924 to Vogelstein et al. in view of U.S. 2019/0049353 to Henion et al.
As per claim 77, Vogelstein et al. teaches the system of claim 69, see discussion of claim 69. Vogelstein et al. may not further, specifically teach an autosampler configured to provide a plurality of cartridges comprising a cartridge to said chromatography system.
Henion et al. teaches:
--an autosampler configured to provide a plurality of cartridges comprising a cartridge to said chromatography system (see: paragraph [0166] where there is such an autosampler).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to use an autosampler configured to provide a plurality of cartridges comprising a cartridge to said chromatography system as taught by Henion et al. in the system as taught by Vogelstein et al. with the motivation(s) of improving robustness of the device (see: paragraph [0130] of Henion et al.).
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 Steven G.S. Sanghera whose telephone number is (571)272-6873. The examiner can normally be reached M-F 7:30-5:00 (alternating Fri).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shahid Merchant can be reached at 571-270-1360. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/STEVEN G.S. SANGHERA/Primary Examiner, Art Unit 3684
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