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 .
Applicant’s Response
Applicant’s response, filed 04/10/2026, has been fully considered. Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claims Status
Claims 39-41, 44, 49-51, 57, and 66 are canceled.
Claims 56, 58-65, 67-73, 76, and 77 are pending.
Claim 73 is withdrawn from consideration.
Claims 56, 58-65, 67-72, 76, and 77 are examined.
Withdrawn Objections/Rejections
The rejection of claims 39-41, 44, 49-51, 76 and 77 under 35 USC 101 is withdrawn.
The rejection of claims 56, 57, 59, and 63 under 35 USC 102(a)(1) and 102(a)(2) over Dobak et al. is withdrawn.
The rejection of claims 58, 60, 61, and 65 under 35 USC 103 over Dobak et al. in view of Abbas et al. is withdrawn in view of the amendments submitted
The rejection of claims 64, 67, and 68 under 35 USC 103 over Dobak et al. in view of Hamilton et al. is withdrawn in view of the amendments submitted
The rejection of claims 69-72 under 35 USC 103 over Dobak et al. in view of Hamilton et al. and further in view of Subramanian et al. is withdrawn in view of the amendments submitted
Claim Objections
Claim 62 is objected to because of the following informalities:
“to expression of the expression of the plurality of genes” should read “to expression
Appropriate correction is required.
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 70 and 72 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. This is a new grounds of rejection.
With respect to claim 70, the claim recites the limitation of “computing the statistical significance by determining the 95th percentile NES from healthy control samples”. The claim is indefinite because there is no antecedent basis for “the statistical significance”.
With respect to claim 72, the claim recites the limitation of “wherein when the NES of the subject is higher than the NES of a control subject”. The claim is indefinite because there is no antecedent basis for “the NES of the subject” or “the NES of a control subject”. The claim is dependent upon claim 56 which does not any NES.
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.
Claims 56, 59, and 63 are rejected under 35 U.S.C. 103 as being unpatentable over Dobak et al. (US 2021/0222246 A1, published 07/22/2021, cited in prior Office Action) in view of Möbus et al. (“Blood transcriptome profiling identifies 2 candidate endotypes of atopic dermatitis”, Journal of Allergy and Clinical Immunology, available online February 2022). This is a new grounds of rejection.
Regarding claim 56, Dobak et al. teaches a method of treating a subject having a disease or condition suitable for treatment with dupilumab, comprising:
identifying the subject as having a disease or condition suitable for treatment (Abstract) with dupilumab (paragraph [0346]), the identification comprising: screening a dupilumab core gene signature against a whole transcriptome profile from the subject (paragraph [0337]); and
administering dupilumab to the subject having a disease or condition suitable for treatment with dupilumab (paragraph [0346]),
wherein the dupilumab treatment core gene signature comprises a plurality of genes that were differentially expressed from a dupilumab treatment group and a placebo treatment group for a plurality of treatment studies (paragraph [0258]).
Dobak et al. does not teach the claim element of the claimed differentially expressed genes.
However, Möbus et al. teaches blood transcriptome profiling identifying candidate endotypes of atopic dermatitis. Möbus et al. teaches a plurality of genes differentially expressed in patients before and after dupilumab treatment, and teaches screening genes, the genes comprising ALOX15, CCL26, SLC26A4, POSTN, SLC9A3, CLC, DPP4, MMP12, CDH26, CD209, NTRK2, SOCS1, CH25H, TREM2, CPA3, SERPINB4, ILlRL1, PDCD1LG2, F13A1, CDH3, TPSAB1, CMYA5, CD1B, HAS3, TPSB2, IGFBP3, ATF3, P2RY6, IGFBP5, TMC5, ADORA3, RAB44, SERPINB10, P2RY1, P2RY14, AURKA, CLEC10A, CD1C, CDE, NOS2, ALDH5A1, CEACAM3, DGAT2, S100A8, and RNF103-CHMP3., etc. (Supplementary Table E1).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the gene screening of Möbus et al. to the method of Dobak et al. Dobak et al. is directed to a method of detecting altered gene expression levels and treating a patient with atopic dermatitis (Abstract), and Möbus et al. is directed to analyzing expression levels in atopic dermatitis patients treated with dupilumab (Abstract). Möbus et al. teaches a plurality of genes differentially expressed in patients before and after dupilumab treatment, and teaches screening genes (Abstract). Thus, one of ordinary skill in the art would have a reasonable expectation of success of screening an atopic dermatitis patient for responsiveness to treatment using the genes from Möbus et al. by combining the prior art references as the genes of Möbus et al. are determined to be differentially expressed.
Regarding claim 59, the claim is directed to the plurality of treatment studies comprising five treatment studies, and the plurality of genes having a fold-change of greater than or equal to 2 and/or a q less than 0.05 in at least three of the five treatment studies. Dobak et al. teaches the method of claim 56 in view of Möbus et al. Dobak et al. also teaches the genes in the core gene signature having greater than a 2 fold-change (paragraph [0075]).
Furthermore, Möbus et al. teaches at least five treatment studies (page 394, References)
Regarding claim 63, the claim is directed to the differential gene expression being analyzed by a microarray or RNAseq. Dobak et al. teaches the method of claim 56 in view of Möbus et al. Dobak et al. also teaches analyzing gene expression by a microarray (paragraph [0173]).
Claims 58, 60, 61, and 65 are rejected under 35 U.S.C. 103 as being unpatentable over Dobak et al. in view of Möbus et al., as applied to claims 56, 59, and 63, and further in view of Abbas et al. (US 2020/0165679 A1, published May 2020, cited in prior Office Action). This is a new grounds of rejection.
Regarding claim 58, the claim is directed to the plurality of treatment studies comprising a treatment study for eosinophilic esophagitis, a treatment study for atopic dermatitis, a treatment study for asthma, a treatment study for grass allergy, or a treatment study for chronic rhinosinusitis with nasal polyposis. Dobak et al. teaches the method of claim 56 in view of Möbus et al.
Neither Dobak et al. nor Möbus et al. does not teach the claim elements of the plurality of treatment studies comprising eosinophilic esophagitis, grass allergy, and chronic rhinosinusitis.
However, Abbas et al. teaches methods of diagnosis and treating eosinophilic disorders. Abbas et al. teaches identification of biomarkers that are effective for determining which patients suffering with asthma, atopic dermatitis, allergic rhinitis, nasal polyposis, and eosinophilic esophagitis will respond effectively to which treatment (paragraphs [0008]; [0111]).
Regarding claim 60, the claim is directed to the fold-change comprising subtracting changes in expression in the placebo treatment group from the dupilumab treatment group. Dobak et al. teaches the method of claim 59 in view of Möbus et al.
Neither Dobak et al. nor Möbus et al. explicitly teach the claim element of the fold-change comprising subtracting the changes in expression in the placebo treatment group from the dupilumab treatment group
However, Abbas et al. teaches the expression change comprising taking the difference in expression in the placebo group from the treatment group (paragraph [0384]).
Regarding claim 61, the claim is directed to the differential gene expression for the treatment study for eosinophilic esophagitis, the treatment study for atopic dermatitis, and the treatment study for chronic rhinosinusitis with nasal polyposis being carried out by comparing the baseline expression of the plurality of genes before treatment with dupilumab to the expression of the plurality of genes after treatment with dupilumab. Dobak et al. teaches the method of claim 58 in view of Möbus et al. and further in view of Abbas et al. Dobak et al. teaches a plurality of treatment studies comprising atopic dermatitis (paragraph [0256]).
Neither Dobak et al. nor Möbus et al. teach the claim element of the differential gene expression for eosinophilic esophagitis, atopic dermatitis, and chronic rhinosinusitis with nasal polyposis treatment studies being carried out by comparing the baseline gene expression before treatment with dupilumab to the gene expression after treatment with dupilumab.
However, Abbas et al. teaches monitoring the efficacy of a therapy based on measurements of biomarkers in a sample obtained from a patient before and after the treatment (paragraphs [0100] and [0101]), wherein the conditions can comprise atopic dermatitis, allergic rhinitis, nasal polyposis, and eosinophilic esophagitis will respond effectively to which treatment (paragraphs [0008]; [0111]). Furthermore, Abbas et al. teaches the treatment comprising dupilumab (paragraph [0056]).
Regarding claim 65, the claim is directed to the differential gene expression of the treatment study for the atopic dermatitis and the treatment study for chronic rhinosinusitis with nasal polyposis being analyzed by microarray. Dobak et al. teaches the method of claim 63 in view of Möbus et al. Dobak et al. also teaches an atopic dermatitis treatment study (paragraph [0256]) wherein the expression is analyzed by microarray (paragraph [0173]).
Neither Dobak et al. nor Möbus et al. teach the claim element of the treatment study for chronic rhinosinusitis with nasal polyposis.
However, Abbas et al. teaches determining the efficacy of a therapy based on measurements of biomarkers wherein the conditions can comprise atopic dermatitis, allergic rhinitis, nasal polyposis (paragraphs [0008]; [0111]) and teaches analyzing expression levels using a microarray (paragraph [0280]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the analysis steps and treatment studies of Abbas et al. to the method of Dobak et al. in view of Möbus et al. because Dobak et al. is directed to analyzing gene expression levels in atopic dermatitis (Abstract), and discloses IL-31 being involved in the promotion of allergic skin disorder and in regulation other allergic diseases such as asthma (paragraph [0195]). Abbas et al. is directed to methods of diagnosis and treating eosinophilic disorders, including atopic dermatitis and asthma, and teaches biomarkers that are effective for determining which patients suffering with asthma, atopic dermatitis, allergic rhinitis, nasal polyposis, and eosinophilic esophagitis will respond effectively to which treatment (paragraphs [0008]; [0111]). Thus, one of ordinary skill in the art would have a reasonable expectation of success of analyzing expression biomarkers to evaluate treatment effectiveness in atopic dermatitis by combining the prior art references.
Claim 62 is rejected under 35 U.S.C. 103 as being unpatentable over Dobak et al., in view of Möbus et al., further in view of Abbas et al., as applied to claims 58, 60, 61, and 65 above, and further in view of Röschmann et al. (“Comparison of Timothy grass pollen extract- and single major allergen-induced gene expression and mediator release in airway epithelial cells: a meta-analysis”, Basis Mechanisms in Allergic Disease, published 2012). This is a new grounds of rejection.
The claim is directed to the differential gene expression for the treatment study for asthma and the treatment study for grass allergy being carried out by comparing expression of the plurality of genes with allergen challenge to expression of the plurality of genes without allergen challenge. Dobak et al. teaches the method of claim 58 in view of Möbus et al. and further in view of Abbas et al.
Dobak et al., Möbus et al., and Abbas et al. do not teach the claim element of comparing expression of genes with allergen challenge to expression of genes without allergen challenge.
However, Röschmann et al. is directed to comparison of allergen-induced gene expression in airway epithelial cells (Abstract). Röschmann et al. teaches performing an allergen challenge using major grass pollen allergens and a control (page 1480, column 2, Section Materials and methods, paragraph 2), and teaches that several transcription factors have been implicated in the inflammatory process in asthma and allergy and in previous experiments, showing that nasal epithelial cells from house dust mite allergic patients show a different expression pattern of prominent transcription factors when compared to healthy individuals (page 1488, column 1, paragraph 2). Furthermore, Röschmann et al. teaches that recent studies have strengthened the idea that aberrant expression of genes within the epithelium might be a key driver of the immune response, confirming the important role of structural cells like AECs within the initiation of complex disorders like allergy or atopic dermatitis (page 1480, column 2, paragraph 1).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the gene expression analysis after an allergen challenge of Röschmann et al. to the method of Dobak et al. in view of Möbus et al., and further in view of Abbas et al. because Dobak et al. is directed to detecting altered gene expression levels in a subject with atopic dermatitis (Abstract), and Röschmann et al. is directed to analysis of allergen-induced gene expression. Röschmann et al. teaches that recent studies have strengthened the idea that aberrant expression of genes within the epithelium might be a key driver of the immune response, confirming the important role of structural cells like AECs within the initiation of complex disorders like allergy or atopic dermatitis (page 1480, column 2, paragraph 1). Thus, one of ordinary skill in the art would find the association between atopic dermatitis and allergy disorders as discuss in Röschmann et al. and would be motivated to combine the prior art references to analyze the gene expression levels as taught by Dobak et al. with an allergen challenge.
Claims 64, 67, and 68 are rejected under 35 U.S.C. 103 as being unpatentable over Dobak et al. in view of Möbus et al., as applied to claims 56, 59, and 63 above, in view of Hamilton et al. (US 2021/0363264 A1, filed 05/21/2021, cited in prior Office Action). This is a new grounds of rejection.
The applied reference has a common Applicant with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Regarding claim 64, the claim is directed to the differential gene expression of the treatment study for eosinophilic esophagitis, the treatment study for asthma, and the treatment study for grass allergy being analyzed by RNAseq. Dobak et al. teaches the method of claim 63 in view of Möbus et al.
Neither Dobak et al. nor Möbus et al. teach the claim elements of the differential gene expression of the eosinophilic esophagitis, asthma, and grass allergy treatment studies being analyzed by RNAseq.
However, Hamilton et al. teaches performing differential gene expression analysis (paragraph [0121]) of eosinophilic esophagitis (paragraph [0002]), asthma, or allergic rhinitis (paragraph [0010]), with the allergy comprising a grass allergy (paragraph [0054]), analyzed using RNA sequencing data (paragraph [0158]).
Regarding claim 67, the claim is directed to the screening comprising: i) transforming the whole transcriptome profile into z-scores; ii) ranking the z-scores; and iii) generating a normalized enrichment score (NES) for all ranked z-scores. Dobak et al. teaches the method of claim 56 in view of Möbus et al.
Neither Dobak et al. nor Möbus et al. teach the claim elements of i) transforming the whole transcriptome profile from the subject into z-scores; ii) ranking the z-scores; and iii) generating a normalized enrichment score (NES) for all ranked z-scores using the plurality of genes that are differentially expressed and are in the dupilumab treatment core gene signature, thereby representing the dupilumab signature enrichment for the subject.
However, Hamilton et al. teaches transforming the whole transcriptome profile from the subject into z-scores, ranking the z-scores, and generating an NES for all ranked z-scores using the plurality of genes that are differentially expressed (paragraphs [0194]-[0196]).
Regarding claim 68, the claim is directed to the NES being generated using a gene set enrichment analysis tool that takes both positive and negative gene sets into consideration. Dobak et al. teaches the method of claim 67 in view of Möbus et al. and further in view of Hamilton et al.
Neither Dobak et al. nor Möbus et al. teach the claim element of the NES being generated using a gene set enrichment analysis tool that takes both positive and negative gene sets into consideration.
However, Hamilton et al. teaches calculating an NES using a gene set enrichment analysis tool that takes both positive and negative gene sets into consideration (paragraph [0194]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the differential expression analysis using an NES score of Hamilton et al. to the method of Dobak et al. in view of Möbus et al. because both Dobak et al. and Hamilton et al. are directed to analyzing gene expression levels with respect to inflammatory conditions (see Abstract of both), such as atopic dermatitis (see Abstract of Dobak et al. and Hamilton et al. [0005]). Hamilton et al. teaches that the NES reflects the degree to which the activity level of a set of transcripts is overrepresented at the extremes (paragraph [0121]). Thus, one of ordinary skill in the art would have a reasonable expectation of success of using an NES for quantifying the gene enrichment of the biomarkers involved in atopic dermatitis and would be motivated to do so in order to reflect the degree to which the transcript is overrepresented.
Claims 69-72 are rejected under 35 U.S.C. 103 as being unpatentable over Dobak et al. in view of Möbus et al., further in view of Hamilton et al., as applied to claims 64, 67, and 68 above, and further in view of Subramanian et al. (“Gene set enrichment analysis: A knowledge-based approach for interpreting genome-wide expression profiles”, PNAS, published 2005, cited in prior Office Action). This is a new grounds of rejection.
Regarding claim 69, Dobak et al. teaches the method of claim 68 in view of Möbus et al. and further in view of Hamilton et al.
Neither Dobak et al. nor Möbus et al. teach the claim elements of generating the NES.
However, Hamilton et al. teaches a) transforming each gene expression within the plurality of genes into a z-score (paragraph [0194]), and ordering the plurality of genes that are differentially expressed from the most up-regulated to the most down-regulated (paragraphs [0194]; [0171]). Hamilton et al. teaches using a gene set enrichment tool that takes both positive and negative gene sets into consideration (paragraph [0194]).
Hamilton et al. does not explicitly teach the claim elements of identifying hits, and step d)-g).
However, Subramanian et al. teaches identifying hits for the independent gene sets and teaches computing a running score by walking down the ranking, wherein the score increases by the equation as limited by the claim if the ith gene is a hit, or decreases by 1/(2N-S), where S is the combined total number of genes (page 15550, column 1, Section “Enrichment Score (ES(S), 2.). Subramanian et al. also teaches determining an Enrichment Score as a maximum deviation from zero along the running score (page 15550, column 1, Section “Enrichment Score (ES(S)), repeating the steps with a random gene set for 1,000 times to compute the ES null distribution (page 15550, column 2, Section “Estimating Significance”), and generating the NES as the enrichment score divided by the mean of the enrichment score null distribution (page 15546, column 1, “Step 2”; ). Furthermore, Subramanian et al. also teaches performing multiple hypothesis testing using multiple gene sets (page 15546, column 1, Section “Step 3”).
Regarding claim 70, the claim is directed to computing the statistical significance by determining the 95th percentile NES from healthy control samples. Dobak et al. teaches the method of claim 69 in view of Möbus et al., further in view of Hamilton et al., and further in view of Subramanian et al.
Dobak et al. does not teach the claim element of computing the statistical significance by determining the 95th percentile NES from healthy control samples.
However, Hamilton et al. teaches determining the 95th percentile NES from healthy control samples (Table 9; paragraph [0197]).
Regarding claim 71, the claim is directed to computing the NES for the plurality of treatment studies by preparing a ranked list for each disease study of the plurality of treatment studies. Dobak et al. teaches the method of claim 69 in view of Möbus et al., further in view of Hamilton et al. and further in view of Subramanian et al.
Neither Dobak et al. nor Möbus et al. teach the claim element of computing the NES for the plurality of treatment studies by preparing a ranked list for each disease study of the plurality of treatment studies.
However, Hamilton et al. teaches calculating the NES for entire ranked lists of transcripts for the study groups (paragraph [0171]).
Furthermore, Subramanian et al. teaches the inputs to GSEA for calculating enrichment scores comprising a ranked gene list (page 15550, Section “Appendix: Mathematical Description of Methods”, Inputs to GSEA).
Regarding claim 72, the claim is directed to when the NES of the subject is higher than the NES of a control subject, the subject being suitable for dupilumab treatment. Dobak et al. teaches the method of claim 56 in view of Möbus et al.
Neither Dobak et al. nor Möbus et al. teach the claim element of when the NES of the subject is higher than the NES of a healthy control, the subject is suitable for dupilumab treatment.
However, Hamilton et al. teaches the NES score being strongly correlated with histological severity, demonstrating a biological association of the molecular signature with the clinical measure (paragraph [0201]).
Furthermore, Subramanian et al. teaches the NES of the subjects being higher than the control and thus the treatment seeming applicable for the subject (page 15549, column 1 and column 2, paragraph 1).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the calculation of the NES of Subramanian to the method of Dobak et al. in view of Möbus et al., further in view of Hamilton et al., because Hamilton et al. discloses calculating the NES using this GSEA method as taught by Subramanian et al. for calculating it (Hamilton et al. paragraph [0171]). Thus, one of ordinary skill in the art would have a reasonable expectation of success and would find it obvious to do so because the prior art teaches using this method for calculating the NES.
Claims 76 and 77 are rejected under 35 U.S.C. 103 as being unpatentable over Möbus et al. in view of Dobak et al. This is a new grounds of rejection.
Regarding claim 76, Möbus et al. teaches a method of administering dupilumab to a subject, the method comprising:
administering dupilumab to the subject (Abstract; page 386, column 2, paragraph 1);
sequencing at least ten nucleic acid molecules (page 386, column 2, Section RNA sequencing), wherein the nucleotide sequences are ALOX15, IL1RL1, SOCS1 (page 389, column 1, paragraph 1), CLC (page 393, column 2, paragraph 3), F13A1, CCL26, POSTN, SLC9A3P3, DPP4, MMP12, CDH26, CD209, etc. (Supplementary Table E1);
detecting the presence or absence of the at least ten nucleic acid molecules (Supplementary Figure 3; Supplementary Table E1),
wherein the subject is from the TREATgermany registry, and thus registered in a clinical trial (page 386, column 1, Section Patient characteristics and blood samples).
Möbus et al. does not teach the claim elements of contacting a biological sample from the subject with nucleic molecules complementary to the nucleotide sequences.
However, Dobak et al. teaches detecting an altered gene expression level in a subject suspected of having atopic dermatitis. Dobak et al. teaches contacting a sample with a set of probes that recognizes target sequences and detects expression levels (paragraph [0004]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the use of probes of Dobak et al. to the method of Möbus et al. because Möbus et al. is directed to analyzing expression levels in atopic dermatitis patients treated with dupilumab (Abstract), and Dobak et al. is directed to detecting altered gene expression levels and treating a patient with atopic dermatitis (Abstract). Thus, one of ordinary skill in the art would have a reasonable expectation of success in analyzing expression levels after treatment by using probes as disclosed in Dobak et al. to detect expression levels instead of using the sequencing methods of Möbus et al. and it would be obvious to do so because the prior art references are measuring the same type of data and thus substituting the method of measuring expression to instead use probes would be obvious.
Regarding claim 77, the claim is directed to detecting the amount of the at least ten nucleic acid molecules. Möbus et al. teaches the method of claim 76 in view of Dobak et al. Möbus et al. also teaches detecting the amount of the at least ten nucleic acid molecules (Figure 3, Supplementary Figure 3).
Conclusion
No claims are allowed.
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/E.A.S./Examiner, Art Unit 1686
/OLIVIA M. WISE/Supervisory Patent Examiner, Art Unit 1685
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