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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 11/03/2023 and 11/03/2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3, 4, 12, 13 and 15-18 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 recites the limitation “the strain” and "the vaccine" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 4 recites the limitation “the strain” in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation “the concentration” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation “the heterogeneity” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitation "the distribution" in line 2. There is insufficient antecedent basis for this limitation in the claim. It is recommended to amend this claim to depend upon claim 14.
Claim 16 recites the limitation "the distributed sample" in line 2. There is insufficient antecedent basis for this limitation in the claim. It is recommended to amend this claim to depend upon claim 15.
Claim 17 recites the limitation "each predicted result" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 18 is rejected under 35 U.S.C. 112b since the claim depends upon and incorporates all the limitations of claim 17.
Appropriate corrective action is required.
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.
Claim(s) 1, 5, 6, 8-10, 12 and 16 are rejected under 35 U.S.C. 102a1 as being anticipated by Webb et al. (US 2017/0024536 A1 – hereafter ‘536).
‘536 discloses a method for gathering activity data describing a user’s activities (Abstract) that includes the following limitations for claim 1:
“A system for developing a predictive immunity profile on the basis of the quantitative analysis of one or more samples from an individual”: ‘536 discloses a system the creates and refines immune-response prediction models for a user ([0005]) that bases this of the analysis of data from a user ([0006]).
“a device configured to perform quantitative analysis of the interaction between one or more target species and one or more probes in solution on a fluid sample to provide(d) quantitative analysis data”: ‘536 discloses a system (system 100; Fig. 1; [0035]) that performs an analysis of a user’s blood sample data (i.e. a fluid sample) from a cytometric assay ([0042]). The cytometric assay would include a target species and probes.
“a data store storing”: ‘536 discloses a memory (memory 110; Fig. 1; [0036]) that stores data.
“personal data relating to at least one individual”: The memory (memory 110; [0036]) stores personal data of a user such as age, weigh and gender.
“at least one model of target/probe interaction”: ‘536 discloses that immune-response prediction models are stored within the memory ([0006]).
“processing circuitry configured to”: ‘536 discloses processing circuitry such as a processor (processor 108; Fig. 1; [0035]).
“access the data store and identify and retrieve data relevant to the sample”: The processor executes instructions stored in the memory and accesses the data stored that is related to the user ([0036]) and therefore is relevant to the sample.
“receive quantitative analysis data of the sample from the device”: The processor receives the quantitative analysis data, i.e. the blood sample analysis data (data 124; Fig. 1) from the device ([0036]).
“perform analysis to fit the model to the received quantitative analysis data”: ‘536 discloses that the data is analyzed by a prediction engine (engine 106; Fig. 1; [0038]) that creates a model, i.e. fits the data to a model stored in the memory.
“extrapolate, through the model, to create a predictive immunity profile for the individual”: The analysis creates a personalized immune-response model for a user ([0039]) that is being interpreted as extrapolating the data to be a predictive profile as this model is predictive in nature.
“update the data store with the quantitative analysis data.”: The memory is updated with the new data and model ([0041]; [0067]; [0068]).
For claim 5, ‘536 discloses storing and distributing data for a plurality of users ([0051]).
For claim 6, ‘536 discloses that memory holds data such as age, gender and weight (Fig. 1; [0036]).
For claim 8, ‘536 discloses using a clinically-created immune-response model ([0013]) that is being interpreted as a general model and the processor uses this model to generate a personalized immune-response model.
For claim 9, ‘536 discloses using a machine learning algorithm ([0043]; [0053]).
For claim 10, ‘536 discloses that the data is updated relating to the user’s analyzed sample updated with the new data and model ([0041]; [0067]; [0068]).
For claim 12, ‘536 measures the concentration of white blood cells, i.e. a target species, within the sample ([0030]).
For claim 16, the blood sample analysis device (device 124) is fully capable of dividing a distributed sample into two parts in order to carry out the measurement.
Therefore ‘536 meets the limitations of claims 1, 5, 6, 8-10, 12 and 16.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Webb et al. (US 2017/0024536 A1 – hereafter ‘536) in view of Giusti et al. (CN 110268383 A – hereafter ‘383 with reference made to the attached machine translation).
For claim 19, since ‘536 uses cytometric assay ([0043]) which intrinsically uses fluorescence to analyze the sample.
While this would be intrinsic within ‘536, this step is not explicitly disclosed.
‘383 a patient registration system (Abstract) that for claim 19 includes using flow cytometry data (page 15, last paragraph) that uses fluorescence-activated cell sorting (page 28, fifth paragraph). This allows for the characterization of a biological sample.
Therefore, it would have been obvious to one of ordinary skill in the art to employ the cytometric methods of ‘383 within ‘536 in order to identify a target molecule. The suggestion for doing so at the time would have been in order to uses a process that allows for multiple parameter condition of the analysis with minimal signal overlap and can compare the signal strength of the simultaneous measurement of a single cell (page 31, first full paragraph).
Allowable Subject Matter
Claims 2, 7, 11 and 14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: for claim 2, the prior art fails to teach or fairly suggest where the predictive immunity profile includes a date on which the patient’s immunity is predicted to fall below a predetermined threshold.
For claim 7, the prior art fails to teach or fairly suggest where he data store further comprises stratification labels and wherein the processing circuitry is further configured to use the stratification labels when performing analysis to fit the received quantitative analysis data to the model.
For claim 11, the prior art fails to teach or fairly suggest where ethe quantitative analysis includes a measurement of the affinity of a target/probe interaction.
For claim 14, the prior art fails to teach or fairly suggest where the device comprises a microfluidic network configured to enable combination and distribution of a sample fluid and an auxiliary fluid to create a distributed sample and subsequent division of the distributed sample into two or more parts and measurement of at least one of the parts.
The closest prior art is Webb et al. (US 2017/0024536 A1) which uses a predictive model to develop an immunity profile of a user, but does not teach or suggest the claimed limitations of claims 2, 7, 11, 14 and 19.
Claims 3, 4, 13, 15, 17 and 18 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
For claim 3, the prior art fails to teach or fairly suggest where the predictive immunity profile includes a confidence level that the individual will exhibit immunity to a different disease strain from the strain on which the vaccine was based.
For claim 4, the prior art fails to teach or fairly suggest where the predictive immunity profile includes a confidence level that the individual will exhibit immunity to a different disease strain from the strain that the individual contracted.
For claim 13, the prior art fails to teach or fairly suggest where the quantitative analysis of the sample includes analysis of the heterogeneity of the sample.
For claim 15, the prior art fails to teach or fairly suggest where the distribution is created by one or more of diffusion, electrophoresis or magnetophoresis, thermophoresis, chromatography and isoelectric focusing.
For claim 17, the prior art fails to teach or fairly suggest where each predicted result generated by the system has an associated accuracy score.
Claim 18 would be allowable for the same reasons as claim 17.
The closest prior art is Webb et al. (US 2017/0024536 A1) which uses a predictive model to develop an immunity profile of a user, but does not teach or suggest the claimed limitations of claims 3, 4, 13, 15, 17 and 18.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Fernando (US 11,500,359 B1) discloses an laboratory data management system, a medical data management system and external data source.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL L HOBBS whose telephone number is (571)270-3724. The examiner can normally be reached Variable, but generally 8AM-5PM M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at 571-272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL L HOBBS/Primary Examiner, Art Unit 1799