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 .
Restriction
Applicant's election with traverse of Group I (Claims 1-10), directed to the system for detecting and assessing microbiome diseases, in the reply filed on 05/29/2026 is acknowledged. The traversal is on the ground(s) that no serious search burden is imposed and the groups are directed to the same common inventive concept. This is not found persuasive for the reasons provided in the restriction requirement regarding serious search burden. The requirement is still deemed proper.
However, upon reconsideration and the Applicant’s amendments adding similar limitations to the system of Group I and to the method of Group II, the Examiner withdraws the previous restriction requirement and rejoins Group I and Group II.
Claim Status
Amendments filed 05/29/2026 are entered. Claims 1-20 are pending and under examination.
Priority
This application, filed 04/26/2024, claims priority benefits from Provisional No. 63498616, filed 04/27/2023. However, this provisional application does not provide support for limitations added to the claim amendments filed 05/29/2026, such as the specific devices and systems. Therefore, priority benefit cannot be granted.
Therefore, the effective filing date of this application is 04/26/2024, the filing date of the instant application.
Claim Objections
Claim 1 is objected to because of the following informalities: In part (b), “device configured to isolating the microorganism” is grammatically incorrect. Examiner suggests replacing “isolating” with “isolate”.
Claims 4, 5, 14, and 15 is objected to because of the following informalities: The claim lacks consistency in the recitation of the microorganism. Claim 4 recites “the sequencing system sequences an entire genome or portion of a genome of a microorganism” but depends on claim 1, which recites a sequencing system configured to perform one or more tests on “the isolated microorganism”. For consistency, the Examiner recommends amending Claim 4 to recite “the sequencing system sequences an entire genome or portion of a genome of one or more of the isolated microorganisms”. Claims 5, 14, and 15 have similar inconsistencies in using “a” or “the” microorganisms and is recommended to be amended similarly.
Claim 9 and 19 are objected to because of the following informalities: The claim is not grammatically correct, likely due to a typo in Applicant’s amendment. The Examiner suggests deletion of the recitation of “is measured”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2-10 and 19 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 2 and 3 further limit the biological sample. However, the biological sample itself is not part of the system of claim 1; only the collection kit to obtain the sample and the various devices used to process it are claimed. Therefore, limitations to the biological sample itself does not further limit the system.
Similarly, claim 10 further limit the report, which is not part of the system of claim 1; only the computer system configured to generate and provide the report is claimed. Therefore, limitations to the resultant report itself does not further limit the system.
Claims 4-9 recite intended uses for the sequencing system, PCR device, ELISA system, or mass spectrometry device without further limiting its structure. In claim 4, the sequencing system structure itself does not change whether it sequences an entire genome, a portion of a genome, or any other sequence. In claim 5, the PCR device structure does not change whether it amplifies a specific region of a microorganism genome or any other sequence. In claims 6 and 8 the ELISA system is not structurally limited by what metabolites it measures. In claims 7 and 9, the mass spectrometry device does not change structure depending on what metabolite it measures.
Further, claims 9 and 19 differ from their parent claim, claim 7 or 17, respectively by the limitation “by a mass spectrometry-based test”; however, this feature is already inherent to the parent claim as they already include that the assay is measured by a mass spectrometry device. By using the mass spectrometry device to measure the metabolites, the claim already makes the test a mass spectrometry-based test.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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(s) 1-5, 10-15, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Apte (Apte et al, Method and System for Microbiome Analysis, WO 2015/112352 A8; filed 2015, published 2018) in view of Watanabe (Watanabe et al, Detection of pathogenic bacteria in the blood from sepsis patients using 16S rRNA gene amplicon sequencing analysis; published 2018).
Regarding claim 1, Apte teaches a system for detecting and assessing microbiome disease by assay a biological sample of a subject, the system comprising:
a sampling kit to collect the biological sample from the subject (Abstract and p. 5, para. 0004),
a purification module that include one or more of: a centrifuge, a filter, a fluid delivery for purification of nucleic acid content from a sample (p. 19, para. 0035);
a sample processing step to determine microbiome composition aspects and/or to identify features of interest which can be used to characterize the microbiomes of individuals (p. 14, para. 0023) which includes amplification of nucleic acids by a PCR device (p. 15, para. 0027) and a sequencing system (p. 20, para. 0037); and
a computer system comprising a processor and memory (p. 57, para. 00124) used to analyze the microbiome sequencing data to derive microbiome information results, which are then presented to the microbiome’s source (i.e. the subject) by a computer-readable medium storing computer-readable instructions (p. 56-57, para. 00123-00124). Specifically, the instructions can be executed by computer-executable components, wherein the computer-executable component can be a processor (p. 57, para. 00124). Apte further teaches that the information provided to the individual can be in the form of a printed report or an electronic document (p. 54, para. 00116).
Although Apte teaches the centrifugation, filtration, or microfluidic device for purification of the nucleic acids of the microorganism, Apte does not explicitly teach these devices are configured to isolate the microorganism from the biological sample.
Although Apte teaches the devices are used to identify the microbiome composition and features of interest which can be used to characterize the microbiome, Apte does not explicitly teach the devices are configured to perform tests to detect and identify the presence, specifically of a microbiome disease.
However, Watanabe teaches a system for detection of infectious diseases by identifying causative pathogenic bacteria by detecting bacterial DNA in blood using sequencing (Abstract). Watanabe further teaches that bacteria in plasma were sedimented by high speed centrifugation (p. 3, para. 1), thereby isolating the microorganism from the biological sample. Watanabe teaches the sequencing results could be a useful diagnostic tool for determination of pathogenic bacteria in blood (p. 10, section: Conclusion).
It would have been obvious to one skilled in the art, before the effective filing date of the instant application, that the microorganisms can be isolated from the biological sample, such as with a centrifuge, as taught by Watanabe. Secondly, it would have been obvious to one skilled in the art, before the effective filing date of the instant application, that the microbiome composition and features information retrievable by the system taught by Apte can specifically be used to detect and identify the presence of microbiome diseases, such as taught by Watanabe. Watanabe detects the microbiome disease, sepsis, by identifying the presence of specific bacteria in the microbiome. Therefore, the microbiome composition information from Apte can be used to detect microbiome diseases that are characterized by specific microorganisms.
One skilled in the art, before the effective filing date of the instant application, would be motivated to isolate the microorganisms from the rest of the biological sample to isolate the portion of interest from the biological sample and minimize contamination from the other components of the biological sample. In other words, the assay is performed on the microorganism and the rest of the sample, e.g. blood, is not needed and might contain other cells that can contribute to unwanted background effects. Secondly, one skilled in the art, before the effective filing date of the instant application, would be motivated to use the microbiome composition information retrievable by the system taught by Apte, not simply just to know what the microbiome contains, but for the further advantage of diagnosing problems with the microbiome.
One skilled in the art, before the effective filing date of the instant application, would have reasonable expectation of success that the centrifuge device to isolate the microorganism from Watanabe could be integrated into the system from Apte since Watanabe teaches a similar system for successfully sequencing the microorganism after it had been isolated in this way. Secondly, one skilled in the art, before the effective filing date of the instant application, would have reasonable expectation of success of using microbiome composition and feature data to help diagnose microbiome diseases, which are deviations in the microbiome composition, in light of the success by Watanabe.
Regarding claim 11, Apte in view of Watanabe further teaches the steps of the method of this claim using the system previously discussed in claim 1. The teachings of the references regarding claim 1 are incorporated in its entirety for claim 11.
Claims 2-5 and 10 depend on claim 1. Claims 12-15 and 20 depend on claim 11. The teachings of the references regarding the parent claims are incorporated in its entirety for the dependent claims and discussed further below, as is relevant for each claim.
Regarding claims 2, 3, 12, and 13, Apte teaches that samples from individuals can comprise of blood, plasma, and/or serum, which are bodily fluids.
Regarding claims 10 and 20, Apte teaches the analysis can support or provide diagnostic tools that can characterize an individual (e.g. in terms of medical conditions) based upon their microbiome composition results (p. 51, para. 00110).
Regarding claims 4 and 14, Apte teaches that the sequencing system sequences an entire genome or a portion of a genome of the isolated microorganisms to identify the presence of specific genes (p. 27, para. 0053 and 0055).
Regarding claims 5 and 15, Apte teaches that the PCR device amplifies a specific region of a microorganism genome to detect the presence of specific DNA sequences (p. 15, para. 0027).
Regarding claim 4, 5, 14, and 15, Apte does not specifically teach the genes or DNA sequences are associated with a microbiome disease.
However, Watanabe teaches amplification and sequence of seven variable regions the 16S rRNA gene in the DNA samples from the isolated microorganism (p. 3, section: 16S rRNA amplicon sequencing with Ion PGM) and that this sequence data is used to identify the bacterial species and microbial composition (p. 4, section: NGS data analysis) and used to diagnose to sepsis (p. 6, 8-9, section: Application of 16S rRNA amplicon analysis to clinical samples). In other words, the presence of specific DNA sequences identify the presence of specific bacteria, which are associated with different microbiome diseases.
It would have been obvious to one skilled in the art, before the effective filing date of the instant application, that sequences associated with specific bacteria that cause microbiome diseases are therefore associated with microbiome diseases, and therefore, the genes to be amplified and sequenced can be selected to identify bacteria and associated microbiome diseases, as taught by Watanabe.
One skilled in the art, before the effective filing date of the instant application, would be motivated to sequence either the whole genome or part of the genome of the microorganisms that is sufficient to identify the microorganism for the advantage of identifying pathogenic perturbations in the microbiome.
One skilled in the art, before the effective filing date of the instant application, would have reasonable expectation of success as both Arte and Watanabe teaches the possibility of identifying the microorganisms by sequencing parts of its genome.
Claim(s) 6 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Apte (published 2018) in view of Watanabe (published 2018), as applied to claim 1 and 11 above, and further in view of Daugherty (Daugherty et al, Methods and Compositions for Assessing Antibody Specificities, US 2018/0267056 A1; published 2018).
Claim 6 depend on claim 1. Claim 16 depend on claim 11. The teachings of the references regarding the parent claims are incorporated in its entirety for their dependent claims and discussed further below, as is relevant for each claim.
Regarding claims 6 and 16, Apte and Watanabe does not explicitly teach the system and method, respectively, includes an ELISA system.
However, Daugherty teaches a method to determine a peptide signature (i.e. profiling the target antigen(s)) for an antibody repertoire in a sample comprising multiple antibodies that can be used to characterize a phenotype of the sample, such as providing a diagnosis, prognosis, or theranosis of a medical condition (Abstract). Within that method, Daugherty specifically teaches diagnosis of Lyme disease is based on a combination of symptoms, history of tick exposure, and possibly testing for specific antibodies in the blood (p. 26, para. 0268). Specifically, Lime disease diagnosis was made via ELISA (ELISA defined on p. 8, para. 0116) and Western blot (p. 26, para. 0269).
It would have been obvious to one skilled in the art, before the effective filing date of the instant application, that in addition to sequencing the microorganism to identify it, identifying the antibody that are made in response to the microorganism by ELISA could also be a method of diagnosing the microbiome disease. As noted in Daugherty, it is known that the amount of antibody depends on the stage of the infection.
One skilled in the art, before the effective filing date of the instant application, would be motivated to further confirm the microbiome disease by both direct sequencing of the pathogen and ELISA of the antibody response to the pathogen and potentially elucidate the stage of infection.
One skilled in the art, before the effective filing date of the instant application, would have reasonable expectation of success that the ELISA taught by Daugherty could be integrated into the system and method taught by Apte in view of Watanabe since the microorganism is isolated from the blood for sequencing and the remaining blood contains the antibody in suspension. Therefore, the antibodies in the blood be processed for an ELISA without interrupting the sequencing workflow.
Claim(s) 7-9 and 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Apte (published 2018) in view of Watanabe (published 2018) and Daugherty (Daugherty et al, Methods and Compositions for Assessing Antibody Specificities, US 2018/0267056 A1; published 2018), as applied to claim 6 and 16 above, and further in view of Wu (Wu et al, Integrative metagenomic and metabolomic analyses reveal severity-specific signatures of gut microbiota in chronic kidney disease; published 2020).
Claims 7-8 depend on claim 6. Claim 9 further depends on claim 7. Claims 17-18 depend on claim 16. Claim 19 further depends on claim 17. The teachings of the references regarding the parent claims are incorporated in its entirety for their dependent claims and discussed further below, as is relevant for each claim.
Regarding claims 7, 9, 17, and 19, Apte teaches the sample processing module of the system can include any other suitable elements, e.g. spectrophotometric apparatus for quantification, which is a type of mass spectrometry.
Apte, Watanabe, and Daugherty do not explicitly teach the mass spectrometry device measures the presence of specific metabolites associated with the microbiome disease.
However, Wu teaches metabolomics profiling of serum samples using a mass spectrometry device (p. 5400-5401, section Targeted metabolomics profiling of serum samples) to identify circulating metabolites indicative of specific changes in the microbiota that are associated with specific diseases (Abstract).
Regarding claims 8 and 18, The references do not explicitly teach the ELISA system measures the presence of specific metabolites associated with the microbiome disease.
However, Daugherty teaches the use of ELISA in measuring antibodies associated with microbiome diseases, as previously presented. Daugherty teaches an ELISA uses antibodies to identify a substance (p. 8, para. 0016).
Additionally, Wu teaches the measurement of specific metabolites associated with microbiome diseases, as previously presented. Wu further teaches the measurement of serum levels of LPS using a double antibody sandwich method, which is a type of ELISA by its description (p. 5401, section: Measurement of lipopolysaccharide). Wu teaches that the combination of genetic and metabolite information reveal severity-specific information about the disease state (Abstract).
It would have been obvious to one skilled in the art, before the effective filing date of the instant application, that the mass spectrometry option taught in the system and method of diagnosing microbiome diseases from Apte can be used according to Wu to measure the metabolites associated with specific diseases to diagnose the disease. Secondly, it would have been obvious to one skilled in the art, before the effective filing date of the instant application, that the ELISA assay taught by Daugherty, and previously already integrated into the system and method of diagnosing microbiome diseases from Apte, could be used to not only measure the presence of antibodies but also metabolites associated with microbiome diseases.
One skilled in the art, before the effective filing date of the instant application, would be motivated to combine the genomic and metabolomic information, like in Wu, to arrive at more specific disease information, such as severity of disease, which is advantages for clinical decision making.
One skilled in the art, before the effective filing date of the instant application, would have reasonable expectation of success that the ELISA and mass spectrometry devices and methods could detect metabolites based on the successful mass spectrometry methods of measuring metabolites by Wu and the ability of ELISA to identify substances at high level of specificity, using antibodies, as taught by Daugherty.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Application No. 18647007
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 18647007 (claims filed 07/09/2024) in view of Apte (published 2018) in view of Watanabe (published 2018), Daugherty (published 2018), and Wu (published 2020).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding instant claims 1 and 11, App ‘007 claims 10 and 1, respectively, teach a system or method for diagnosing medical conditions using microbiome diagnostics, which encompasses assessing microbiome diseases by assaying a biological sample of a subject. App ‘007 claim 10 and 1 further teach the system and method comprises of a sample collection means, a means for isolating the microbial strains, a means detecting certain pathogens using PCR, a means for interpreting the results to determine if the patient has a medical condition, and a means for providing a diagnosis based on the interpretation of the results.
App ‘007 claims do not explicitly teach a centrifuge, filter, or microfluidic device to isolate the microorganism from the biological sample. App ‘007 claims do not explicitly teach a computer system comprising a processor and memory to generate and provide a report based on results of the tests.
However, the teachings of the prior art references regarding the devices and method to isolate the microorganisms from the biological sample and the computer system configured to generate and provide the report are previously presented in the rejection under 35 USC § 103 and incorporated here. The rationale to incorporate these components or steps into the base system or method of detecting a microbiome disease is also previously presented in the rejection under 35 USC § 103 and incorporated here.
The teachings of the independent claims are incorporated in their entirety for their dependent claims and further explained below.
Regarding the dependent claims, the mapping of the relevant claims to the instant claims are provided in the table below.
Instant Claims
App ‘007 claims
2, 3, 12, and 13
1, 2, 10, and 11
4, 14
3
5, 15
4, 12
6, 16
5, 6, 13
7, 17
7, 8, 14
8, 18
7
9, 19
7, 8, 14
10, 20
9, 15
Regarding instant claim 8, App ‘007 claims do not explicitly teach the ELISA system or step measures the metabolites. However, the teachings of the prior art references regarding the use of the ELISA system or step to measure metabolites are previously presented in the rejection under 35 USC § 103 and incorporated here. The rationale to incorporate these components or steps into the base system or method of detecting a microbiome disease is also previously presented in the rejection under 35 USC § 103 and incorporated here.
Application No. 18646962
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of copending Application No. 18646962 (claims filed 04/26/2024) in view of Apte (published 2018) in view of Watanabe (published 2018), Daugherty (published 2018), and Wu (published 2020).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding instant claims 1 and 11, App ‘962 claims 10 and 7, respectively, teach a system or method for diagnosing medical conditions using microbiome data, which encompasses assessing microbiome diseases by assaying a biological sample of a subject. App ‘962 claim 10 further teaches the system and method comprises of a sample collection means, a means for isolating the microbial strains from the sample, a means for analyzing the microbiome data to identify patterns and specific microbes associated with medical conditions, and interpreting the results to determine if the patient has a medical condition. App ‘962 claim 7 further teaches a computer implemented system of diagnosing a medical condition using microbiome data comprising of sample collection and microbiome extraction, wherein the microbiome data includes DNA, RNA or proteins present in the sample; and means to analyze the data and provide a diagnosis.
App ‘962 claims do not explicitly teach a centrifuge, filter, or microfluidic device to isolate the microorganism from the biological sample. App ‘962 claims do not explicitly teach the sequencing, PCR, ELISA, or mass spectrometry devices, but do recite means to acquire sequencing and protein data from the microbiome data. App ‘962 claims do not explicitly teach a computer system comprising a processor and memory to generate and provide a report based on results of the tests but does recite the computer-based system that has an analysis unit and intelligent diagnosis unit.
However, the teachings of the prior art references regarding the devices and method to isolate the microorganisms from the biological sample; the devices and methods to extract sequence, metabolic, and antibody information; and the computer system configured to generate and provide the report are previously presented in the rejection under 35 USC § 103 and incorporated here. The rationale to incorporate these components or steps into the base system or method of detecting a microbiome disease is also previously presented in the rejection under 35 USC § 103 and incorporated here.
The teachings of the independent claims are incorporated in their entirety for their dependent claims and further explained below.
Regarding the dependent claims, the mapping of the relevant claims to the instant claims are provided in the table below.
Instant Claims
App ‘007 claims
2, 3, 12, and 13
4
4, 14
3, 7, 8
5, 15
3, 7, 8
6, 16
7, 8
7, 17
7, 8
8, 18
7, 8
9, 19
7, 8
10, 20
7, 11
Regarding instant claim 5, App ‘962 claims do not explicitly teach a PCR device or step but does teach the measurement and sequencing of DNA or RNA. Regarding instant claim 6, App ‘962 claims do not explicitly teach detecting antibodies associated with microbiome disease, but does teach measuring proteins from the sample. Regarding instant claim 7, App ‘962 claims do not explicitly teach measuring metabolites with mass spectrometry. Regarding instant claim 8, App ‘962 claims do not explicitly teach the ELISA system or step measures the metabolites.
However, the teachings of the prior art references regarding the use of the PCR, ELISA, and mass spectrometry systems or steps to amplify target DNA sequences and measure metabolites and antibodies are previously presented in the rejection under 35 USC § 103 and incorporated here. The rationale to incorporate these components or steps into the base system or method of detecting a microbiome disease is also previously presented in the rejection under 35 USC § 103 and incorporated here.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BONIRATH CHHAY whose telephone number is (571)272-0682. The examiner can normally be reached Mon-Thu 8AM-5PM EST.
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/BONIRATH CHHAY/ Examiner, Art Unit 1645 Tuesday, July 7, 2026
/BAO-THUY L NGUYEN/Supervisory Patent Examiner, Art Unit 1677 July 14, 2026
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