DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. This action is in response to the papers filed January 13, 2026. Applicant’s remarks and amendments have been fully and carefully considered but are not found to be sufficient to put the application in condition for allowance. Any new grounds of rejection presented in this Office Action are necessitated by Applicant's amendments. Any rejections or objections not reiterated herein have been withdrawn. This action is made FINAL.
Claims 1-5 and 8-22 are currently pending and have been examined herein.
Claim Rejections - 35 USC § 103
3. 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.
4. Claims 1-5, 8-11 and 13-22 are rejected under 35 U.S.C. 103 as being unpatentable over Carlin (Gastroenterology January 2021 Vol 160 pages 76-87) in view of Smieszek (medRxiv preprint doi: https://doi.org/10.1101/2022.06.22.22276605 posted June 23, 2022).
Regarding Claims 1-5, 13, and 15-18 Carlin teaches that they performed a double-blind trial of 152 adults with gastroparesis. Participants were randomly assigned to groups given oral tradipitant 85 mg (n = 77) or placebo (n = 75) twice daily for 4 weeks. Symptoms were assessed by a daily symptom dairy, Gastroparesis Cardinal Symptom Index scores, and other patient-reported questionnaires. The primary outcome from the intent-to-treat analysis was change from baseline to week 4 in average nausea severity, measured by the Gastroparesis Core Symptom Daily Diary. Carlin teaches that tradipitant resulted in statistically and clinically meaningful improvements in nausea and reduced vomiting, compared with placebo, in patients with idiopathic or diabetic gastroparesis (abstract). Thus Carlin teaches a method comprising selecting an individual for treatment with tradipitant (randomly assigning participants to get tradipitant or placebo) and administering tradipitant at a dose of 150-44 mg/day (85 mg 2x per day + 170 mg/day), wherein the individuals suffer from gastroparesis. Carlin further teaches a method wherein the dose of tradipitant is 150-300 mg/day, 150-200 mg/day, 170 mg/day, and 85 mg twice daily.
Regarding Claims 9 and 19 Carlin teaches that eligible patients aged 18–70 years with a diagnosis of gastroparesis with delayed stomach emptying and symptoms of gastroparesis (nausea, early satiety, fullness, etc.) entered a 4-week screening period. At the conclusion of the screening period, patients meeting all criteria were randomly assigned (1:1) to treatment with tradipitant or placebo for 4 weeks (page 78, col 1). Thus Carlin teaches a method comprising selecting an individual for treatment with tradipitant (randomly assigning participants to get tradipitant or placebo) that has been determined to suffer from gastroparesis, wherein the gastroparesis is idiopathic gastroparesis.
Regarding Claims 10 and 20 Carlin teaches that eligible patients aged 18–70 years with a diagnosis of gastroparesis with delayed stomach emptying and symptoms of gastroparesis (nausea, early satiety, fullness, etc.) entered a 4-week screening period. At the conclusion of the screening period, patients meeting all criteria were randomly assigned (1:1) to treatment with tradipitant or placebo for 4 weeks (page 78, col 1). Thus Carlin teaches a method comprising selecting an individual for treatment with tradipitant (randomly assigning participants to get tradipitant or placebo) that has been determined to suffer from delayed or abnormal gastric emptying.
Carlin does not teach a method comprising selecting an individual for treatment with tradipitant based on the presence of a G allele at SNP rs33990080 (clm 1). Carlin does not teach a method wherein there is one G allele at SNP rs33990080 (clm 21). Carlin does not teach a method wherein there is two G alleles at SNP rs33990080 (clm 22).
However Smieszek teaches that they conducted the first large whole-genome sequencing genome-wide association study (GWAS) analysis of gastroparesis patients. The GWAS focused on idiopathic and diabetic gastroparesis cases as compared to matched controls as well as compared idiopathic versus diabetic cases. They report a novel genetic risk variant for idiopathic gastroparesis - genetic association of the Solute Carrier Family 15 (SLC15) locus. This signal is driven by multiple variants with top missense variant rs33990080. The risk allele is G. The risk variant carriers have a significantly higher nausea score at baseline (abstract).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Carlin by selecting an individual for treatment with tradipitant based on the presence of one or two G alleles of SNP rs33990080. The prior art of Smieszek teaches that SNP rs33990080 is correlated with gastroparesis and high nausea scores. The prior art of Carlin teaches that treatment of gastroparesis with tradipitant reduces nausea. Thus one of skill in the art would have been motivated to select an individual with one or two G alleles of SNP rs33990080 for treatment with tradipitant for the benefit of being able to reduce nausea in a subject with gastroparesis.
Carlin does not teach a method wherein the selected Invidia has: a greater proportion of pro-inflammatory M1 macrophages than is observed in an individual having a wild type SLC15A4 genotype, a lower proportion of anti-inflammatory M2 macrophages than is observed in the individual having the wild type SLC15A4 genotype, or the greater proportion of pro-inflammatory M1 macrophages than is observed in the individual having the wild type SLC15A4 genotype and the lower proportion of anti-inflammatory M2 macrophages than is observed in the individual having the wild type SLC15A4 genotype.
However Smieszek teaches that a review of the literature suggests that oxidative stress associated with diabetes activates macrophages. Activation of CD206 +, anti-inflammatory M2 macrophages expressing heme oxygenase 1 (HO1) is protective while activation of pro-inflammatory M1 macrophages which lack HO1 is injurious and leads to the development of delay in gastric emptying. Low numbers of M2 macrophages were correlated with loss of ICC and were associated with both idiopathic and diabetic gastroparesis. Importantly, when the anti-inflammatory M2 macrophages were switched to pro-inflammatory M1 macrophages, delayed GE was evident in animal models (lines 46-52).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Carlin by selecting an individual for treatment with tradipitant based on the individual having a lower proportion of anti-inflammatory M2 macrophages than is observed in an individual having a wild type SLC15A4 genotype. The prior art of Smieszek teaches that low numbers of M2 macrophages are associated with both idiopathic and diabetic gastroparesis. The prior art of Carlin teaches treatment of gastroparesis with tradipitant. Thus one of skill in the art would have been motivated to select an individual having a low number of M2 macrophages for treatment with tradipitant since such individuals have gastroparesis and tradipitant was a known treatment for gastroparesis.
Carlin does not teach a method further comprising: determining the presence or absence of the SLC15A4 variant genotype by: obtaining or having obtained a biological sample from the individual; and performing or having performed a genotyping assay on the biological sample to determine if the individual has the SLC15A4 variant genotype (clm 11).
However Smieszek teaches that whole-genome sequencing was done on 1385 samples obtained from consented gastroparesis patients. Samples were obtained from patients participating in two gastroparesis studies phase II 88 clinical study (VP-VLY-686-2301 and ongoing phase III gastroparesis clinical study (VP-VLY89 686-3301) (lines 87-90).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Carlin by obtaining a biological sample from a patient and performing a genotyping assay on the biological sample to detect the presence or absence of SNP rs33990080. In the instant case Smeiszek teaches performing whole genome sequencing to detect the presence of SNP rs33990080. One of skill in the art would have been motivated to use WGS (which is a genotyping assay) to detect the presence of a SNP since Smeizek teaches that WGS can provide unique insights into genetic determinants of gastroparesis, by uncovering associations between common as well as rare genetic variants (lines 158-159).
5. Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Carlin (Gastroenterology January 2021 Vol 160 pages 76-87) in view of Smieszek (medRxiv preprint doi: https://doi.org/10.1101/2022.06.22.22276605 posted June 23, 2022) as applied to claims 1 and 11 and in further view of De La Vega (Mutation Research 573, 2005 pages 111-135).
The teachings of Carlin and Smieszek are presented above.
The combined references do no teach a method further comprising: extracting or having extracted genomic DNA or mRNA from the biological sample, and sequencing or having sequenced SLC15A4 DNA derived from the extracted genomic DNA or from the extracted mRNA, wherein the sequencing or having sequenced step further comprises: amplifying or having amplified a SLC15A4 region in the extracted genomic DNA or mRNA to prepare a DNA sample enriched in DNA from the SLC15A4 gene region; and sequencing or having sequenced the DNA sample by hybridizing the DNA sample to nucleic acid probes to determine if the patient has a SLC15A4 variant genotype (clm 12).
However De La Vega teaches the TaqMan SNP genotyping assay. The assay uses two locus-specific PCR primers that flank the SNP of interest, and two allele-specific oligonucleotide TaqMan® probes. The PCR primers amplify a specific locus on the genomic DNA template, and each fluorescent dye-labeled hybridization probe reports the presence of its associated allele in the DNA sample. The use of two probes, one specific to each allele of the SNP and labeled with two fluorophores, allows detection of both alleles in a single tube (page 113).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Carlin and Smieszek by using a genotyping assays that comprises and amplification step and probe hybridization as suggested by De La Vega. One of skill in the art would have been motivated to use the assay of De La Vega to achieve each of the benefits that are taught in section 2.4 of the reference.
Response To Arguments
6. In the response the Applicants traversed the rejection under 35 USC 103. The Applicants argue that the Smieszek reference is unavailable as prior art. They argue that the Smieszek reference published on June 23, 2022, less than three months before the September 08, 2022 effective filing date of the claimed invention. Further, the disclosure in the Smieszek reference was made by the inventors of the claimed invention, Sandra Smieszek and Mihael H. Polymeropoulos, together with co-authors Jesse L. Carlin, Changfu Xiao, Christos M. Polymeropoulos, and Gunther Birznieks. Smieszek's disclosure was therefore made "by the inventor ... or by another who obtained the subject matter disclosed directly or indirectly form the inventor or a joint inventor."
This argument has been fully considered but is not persuasive. The reference includes additional authors (Jesse L. Carlin, Changfu Xiao, Christos M. Polymeropoulos, and Gunther Birznieks) who are not joint inventors of the application and there is no evidence explaining their involvement. Therefore 102(b)(1)(A) exception does NOT apply and the reference qualifies as prior art. Applicant may overcome the rejection by invoking the 102(b)(1)(A) exception by filing a declaration under 37 CFR 1.130(a) establishing that the subject matter disclosed was obtained directly or indirectly from the inventor or a joint inventor of the application AND providing a reasonable explanation of the additional authors of the reference.
Double Patenting
7. 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.
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8a. Claims 1-11 and 13-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,324,735 in view of Smieszek (medRxiv preprint doi: https://doi.org/10.1101/2022.06.22.22276605 posted June 23, 2022). Although the claims at issue are not identical, they are not patentably distinct from each other because.
Regarding Claims 1-5, 13, and 15-18 both sets of claims are drawn to a methods of administering tradipitant to an individual at the claimed dosages of 150-400 mg/day, 150-300 mg/day, 150-200 mg/day, 170 mg/day, and 85 mg twice daily (bid) (see claims 1, 3, 5, and 6 of the Patent). The instant claims are different from the Patent because they recite a step of
selecting an individual for treatment with tradipitant based on a determination that the individual suffers from gastroparesis and has one or two G alleles at SNP rs33990080 (clms 1, 13, 21, and 22). However Smieszek teaches that they conducted the first large whole-genome sequencing genome-wide association study (GWAS) analysis of gastroparesis patients. The GWAS focused on idiopathic and diabetic gastroparesis cases as compared to matched controls as well as compared idiopathic versus diabetic cases. They report a novel genetic risk variant for idiopathic gastroparesis - genetic association of the Solute Carrier Family 15 (SLC15) locus. This signal is driven by multiple variants with top missense variant rs33990080. The risk allele is G. The risk variant carriers have a significantly higher nausea score at baseline (abstract). Accordingly, it would have been obvious to have modified the method of the Patent by selecting an individual for treatment with tradipitant based on a determination that the individual suffers from gastroparesis and has a G allele at SNP rs33990080. The prior art of Smieszek teaches that SNP rs33990080 is correlated with gastroparesis and high nausea scores. The Patent claims encompass treatment of any disorder with tradipitant and specifically disorders that cause nausea and vomiting (which are symptoms of gastroparesis). Thus one of skill in the art would have been motivated to select an individual that suffers from gastroparesis and has a G allele at SNP rs33990080 for treatment with tradipitant for the benefit of being able to reduce nausea in a subject with gastroparesis. The instant claims (8-11, 14, and 19-20) recite limitations that are not recited in the claims of the Patent. However as discussed above in the 103 rejections the prior art of Smieszek teaches these limitations and it would have been obvious to modify the method of the Patent in view of the teachings of Smieszek for the same reasons discussed above.
8b. Claim 12 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,324,735 in view of Smieszek (medRxiv preprint doi: https://doi.org/10.1101/2022.06.22.22276605 posted June 23, 2022) in view of De La Vega (Mutation Research 573, 2005 pages 111-135). Although the claims at issue are not identical, they are not patentably distinct from each other because.
The claims of the Patent in view of Smieszek are discussed above. The instant claims are different from the patent because they require extracting or having extracted genomic DNA or mRNA from the biological sample, and sequencing or having sequenced SLC15A4 DNA derived from the extracted genomic DNA or from the extracted mRNA, wherein the sequencing or having sequenced step further comprises: amplifying or having amplified a SLC15A4 region in the extracted genomic DNA or mRNA to prepare a DNA sample enriched in DNA from the SLC15A4 gene region; and sequencing or having sequenced the DNA sample by hybridizing the DNA sample to nucleic acid probes to determine if the patient has a SLC15A4 variant genotype (clm 12). However as discussed in the 103 rejection the prior art of De La Vega teaches these limitations and provides motivation for modify the method of the Patent in view of Smieszek.
9a. Claims 1-11 and 13-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 6, and 16-24 of US Application 18/450,564 in view of Smieszek (medRxiv preprint doi: https://doi.org/10.1101/2022.06.22.22276605 posted June 23, 2022). Although the claims at issue are not identical, they are not patentably distinct from each other because.
Regarding Claims 1-5, 13, and 15-18 both sets of claims are drawn to a methods of administering tradipitant to an individual at the claimed dosages of 150-400 mg/day, 150-300 mg/day, 150-200 mg/day, 170 mg/day, and 85 mg twice daily (bid) (see claims 1, 16-22 of the copending application). The instant claims are different from the Patent because they recite a step of selecting an individual for treatment with tradipitant based on a determination that the individual suffers from gastroparesis and has one or two G alleles at SNP rs33990080 (clms 1, 13, 21, and 22). However Smieszek teaches that they conducted the first large whole-genome sequencing genome-wide association study (GWAS) analysis of gastroparesis patients. The GWAS focused on idiopathic and diabetic gastroparesis cases as compared to matched controls as well as compared idiopathic versus diabetic cases. They report a novel genetic risk variant for idiopathic gastroparesis - genetic association of the Solute Carrier Family 15 (SLC15) locus. This signal is driven by multiple variants with top missense variant rs33990080. The risk variant carriers have a significantly higher nausea score at baseline (abstract). Accordingly, it would have been obvious to have modified the method of the copending application by selecting an individual for treatment with tradipitant based on a determination that the individual suffers from gastroparesis and has a G allele at SNP rs33990080. The prior art of Smieszek teaches that SNP rs33990080 is correlated with gastroparesis and high nausea scores. The copending application claims encompass treatment of gastroparesis with tradipitant and specifically delayed gastric emptying and nausea. Thus one of skill in the art would have been motivated to select an individual that suffers from gastroparesis and has a G allele at SNP rs33990080 for treatment with tradipitant for the benefit of being able to reduce nausea in a subject with gastroparesis. The instant claims (8-11, 14, and 19-20) recite limitations that are not recited in the claims of the copending application. However as discussed above in the 103 rejections the prior art of Smieszek teaches these limitations and it would have been obvious to modify the method of the copending application in view of the teachings of Smieszek for the same reasons discussed above.
9b. Claim 12 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 6, and 16-24 of US Application 18/450,564 in view of Smieszek (medRxiv preprint doi: https://doi.org/10.1101/2022.06.22.22276605 posted June 23, 2022) and De La Vega (Mutation Research 573, 2005 pages 111-135). Although the claims at issue are not identical, they are not patentably distinct from each other because.
The claims of the copending application in view of Smieszek are discussed above. The instant claims are different from the copending application because they require extracting or having extracted genomic DNA or mRNA from the biological sample, and sequencing or having sequenced SLC15A4 DNA derived from the extracted genomic DNA or from the extracted mRNA, wherein the sequencing or having sequenced step further comprises: amplifying or having amplified a SLC15A4 region in the extracted genomic DNA or mRNA to prepare a DNA sample enriched in DNA from the SLC15A4 gene region; and sequencing or having sequenced the DNA sample by hybridizing the DNA sample to nucleic acid probes to determine if the patient has a SLC15A4 variant genotype (clm 12). However as discussed in the 103 rejection the prior art of De La Vega teaches these limitations and provides motivation for modify the method of the copending application in view of Smieszek.
10a. Claims 1-11 and 13-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14, 15, 20-21, 27-32, 34-38, and 40-43 of US Application 17/296331 in view of Smieszek (medRxiv preprint doi: https://doi.org/10.1101/2022.06.22.22276605 posted June 23, 2022). Although the claims at issue are not identical, they are not patentably distinct from each other because.
Regarding Claims 1-5, 13, and 15-18 both sets of claims are drawn to a methods of administering tradipitant to an individual at the claimed dosages of 150-400 mg/day, 150-300 mg/day, 150-200 mg/day, 170 mg/day, and 85 mg twice daily (bid) (see claims 14, 15 of the copending application). The instant claims are different from the Patent because they recite a step of selecting an individual for treatment with tradipitant based on a determination that the individual suffers from gastroparesis and has one or two G alleles at SNP rs33990080 (clms 1, 13, 21, and 22). However Smieszek teaches that they conducted the first large whole-genome sequencing genome-wide association study (GWAS) analysis of gastroparesis patients. The GWAS focused on idiopathic and diabetic gastroparesis cases as compared to matched controls as well as compared idiopathic versus diabetic cases. They report a novel genetic risk variant for idiopathic gastroparesis - genetic association of the Solute Carrier Family 15 (SLC15) locus. This signal is driven by multiple variants with top missense variant rs33990080. The risk variant carriers have a significantly higher nausea score at baseline (abstract). Accordingly, it would have been obvious to have modified the method of the copending application by selecting an individual for treatment with tradipitant based on a determination that the individual suffers from gastroparesis and has a G allele at SNP rs33990080. The prior art of Smieszek teaches that SNP rs33990080 is correlated with gastroparesis and high nausea scores. The copending application claims encompass treatment of gastroparesis with tradipitant and specifically nausea. Thus one of skill in the art would have been motivated to select an individual that suffers from gastroparesis and has a G allele at SNP rs33990080 for treatment with tradipitant for the benefit of being able to reduce nausea in a subject with gastroparesis. The instant claims (8-11, 14, and 19-20) recite limitations that are not recited in the claims of the copending application. However as discussed above in the 103 rejections the prior art of Smieszek teaches these limitations and it would have been obvious to modify the method of the copending application in view of the teachings of Smieszek for the same reasons discussed above.
10b. Claim 12 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14, 15, 20-21, 27-32, 34-38, and 40-43 of US Application 17/296331 in view of Smieszek (medRxiv preprint doi: https://doi.org/10.1101/2022.06.22.22276605 posted June 23, 2022) and De La Vega (Mutation Research 573, 2005 pages 111-135). Although the claims at issue are not identical, they are not patentably distinct from each other because.
The claims of the copending application in view of Smieszek are discussed above. The instant claims are different from the copending application because they require extracting or having extracted genomic DNA or mRNA from the biological sample, and sequencing or having sequenced SLC15A4 DNA derived from the extracted genomic DNA or from the extracted mRNA, wherein the sequencing or having sequenced step further comprises: amplifying or having amplified a SLC15A4 region in the extracted genomic DNA or mRNA to prepare a DNA sample enriched in DNA from the SLC15A4 gene region; and sequencing or having sequenced the DNA sample by hybridizing the DNA sample to nucleic acid probes to determine if the patient has a SLC15A4 variant genotype (clm 12). However as discussed in the 103 rejection the prior art of De La Vega teaches these limitations and provides motivation for modify the method of the copending application in view of Smieszek.
11a. Claims 1-11 and 13-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of US Patent 10,772,880 in view of Smieszek (medRxiv preprint doi: https://doi.org/10.1101/2022.06.22.22276605 posted June 23, 2022). Although the claims at issue are not identical, they are not patentably distinct from each other because.
Regarding Claims 1-5, 13, and 15-18 both sets of claims are drawn to a methods of administering tradipitant to an individual at the claimed dosages of 150-400 mg/day, 150-300 mg/day, 150-200 mg/day, 170 mg/day, and 85 mg twice daily (bid) (see claims 1-3 of the Patent). The instant claims are different from the Patent because they recite a step of selecting an individual for treatment with tradipitant based on a determination that the individual suffers from gastroparesis and has one or two G alleles at SNP rs33990080 (clms 1, 13, 21, and 22). However Smieszek teaches that they conducted the first large whole-genome sequencing genome-wide association study (GWAS) analysis of gastroparesis patients. The GWAS focused on idiopathic and diabetic gastroparesis cases as compared to matched controls as well as compared idiopathic versus diabetic cases. They report a novel genetic risk variant for idiopathic gastroparesis - genetic association of the Solute Carrier Family 15 (SLC15) locus. This signal is driven by multiple variants with top missense variant rs33990080. The risk variant carriers have a significantly higher nausea score at baseline (abstract). Accordingly, it would have been obvious to have modified the method of the Patent by selecting an individual for treatment with tradipitant based on based on a determination that the individual suffers from gastroparesis and has a G allele at SNP rs33990080. The prior art of Smieszek teaches that SNP rs33990080 is correlated with gastroparesis and high nausea scores. The Patent claims encompass treatment of any disorder with tradipitant and specifically those with nausea. Thus one of skill in the art would have been motivated to select an individual that suffers from gastroparesis and has a G allele at SNP rs33990080 for treatment with tradipitant for the benefit of being able to reduce nausea in a subject with gastroparesis. The instant claims (8-11, 14, and 19-20) recite limitations that are not recited in the claims of the copending application. However as discussed above in the 103 rejections the prior art of Smieszek teaches these limitations and it would have been obvious to modify the method of the copending application in view of the teachings of Smieszek for the same reasons discussed above.
11b. Claim 12 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of US Patent 10,772,880 in view of Smieszek (medRxiv preprint doi: https://doi.org/10.1101/2022.06.22.22276605 posted June 23, 2022) and De La Vega (Mutation Research 573, 2005 pages 111-135). Although the claims at issue are not identical, they are not patentably distinct from each other because.
The claims of the Patent in view of Smieszek are discussed above. The instant claims are different from the Patent because they require extracting or having extracted genomic DNA or mRNA from the biological sample, and sequencing or having sequenced SLC15A4 DNA derived from the extracted genomic DNA or from the extracted mRNA, wherein the sequencing or having sequenced step further comprises: amplifying or having amplified a SLC15A4 region in the extracted genomic DNA or mRNA to prepare a DNA sample enriched in DNA from the SLC15A4 gene region; and sequencing or having sequenced the DNA sample by hybridizing the DNA sample to nucleic acid probes to determine if the patient has a SLC15A4 variant genotype (clm 12). However as discussed in the 103 rejection the prior art of De La Vega teaches these limitations and provides motivation for modify the method of the Patent in view of Smieszek.
Response To Arguments
12. In the response the Applicants traversed the double patenting rejections. They argue that all the rejections are based in part on the Smieszek reference which is unavailable as prior art.
This argument has been fully considered but is not persuasive. The reference includes additional authors (Jesse L. Carlin, Changfu Xiao, Christos M. Polymeropoulos, and Gunther Birznieks) who are not joint inventors of the application and there is no evidence explaining their involvement. Therefore 102(b)(1)(A) exception does NOT apply and the reference qualifies as prior art. Applicant may overcome the rejection by invoking the 102(b)(1)(A) exception by filing a declaration under 37 CFR 1.130(a) establishing that the subject matter disclosed was obtained directly or indirectly from the inventor or a joint inventor of the application AND providing a reasonable explanation of the additional authors of the reference.
13. 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 extension fee 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 date of this final action.
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