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. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 12, 2026 has been entered. Any rejections or objections not reiterated herein have been withdrawn.
Claims 1-5 and 8-22 are currently pending and have been examined herein.
Response to Declaration Filed Under 37 CFR 1.130
3. The declaration under 37 CFR 1.130 filed on June 12, 2026 is sufficient to overcome rejections under 35 USC 103 and obviousness double patenting based upon the teachings of Smieszek (medRxiv preprint doi: https://doi.org/10.1101/2022.06.22.22276605 posted June 23, 2022).
Claim Rejections - 35 USC § 112(b)
4. 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 11-20 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 11 and 12 are rejected over the recitation of the following phrases: “determining the presence or absence of the SLC15A4 variant” (clm 11) and “if the individual has the SLC15A4 variant” (clms 11 and 12). These claims encompass determining that the individual does NOT have a SLC15A4 variant. These phrases are confusing because they depend from claim 1 and claim 1 requires that the individual being treated has an SLC15A4 variant genotype comprising rs33990080-G allele. For this reason the claims are considered to be indefinite.
Claims 13-20 are rejected over the recitation of the phrase “wherein the biomarker is consistent with a SLC15A4 variant genotype comprising an rs33990080-G allele”. “Consistent” is not an art recognized term to describe the relationship between a biomarker and a variant genotype. The specification (para 0029) teaches the following:
Therefore, the presence of a greater proportion of pro-inflammatory M1 macrophages than is observed in an individual having a wild type SLC15A4 genotype may be considered a biomarker consistent with a SLC15A4 variant genotype. Similarly, the presence of a lower proportion of anti-inflammatory M2 macrophages than is observed in an individual having a wild type SLC15A4 genotype, may also be considered a biomarker consistent with a SLC15A4 variant genotype. Such biomarkers may be employed in the method described herein in place of direct determination of the individual's genotype.
While the specification provides examples of a biomarker “consistent” with a SLC15A4 variant, a complete definition for this term is not provided. The specification provides two examples of biomarkers that may be considered to be “consistent” with a SLC15A4 variant ((i) a greater proportion of M1 macrophages than is observed in an individual having a wild type SLC15A4 and (ii) a lower proportion of M2 macrophages than is observed in an individual having a wild type SLC15A4). It is unclear if the claims which recite that the biomarker is “consistent” with a SLC15A4 variant are limited only to (i) and (ii) OR if additional biomarkers could meet this limitation. Since the specification only provides examples of what may be considered a biomarker “consistent” with a SLC15A4 variant, these teachings are not considered to be sufficient to provide a complete and fixed definition for this term. Thus one of skill in the art would not be able to determine the metes and bounds of the claimed subject matter so as to avoid infringement.
Claim 14 is rejected over the recitation of the phrase “wherein the biomarker inlcudes…”. This recitation of the word “includes” is confusing because it is unclear if the biomarker that is “consistent” with the SLC15A4 variant genoype comprising an rs33990080-G allele is (i) a greater proportion of pro-inflammatory M1 macrophages than is observed in an individual having a wild type SLC15A4 genotype, (ii) a lower proportion of anti-inflammatory M2 macrophages than is observed in the individual having the wild type SLC15A4 genotype, or (iii) the greater proportion of pro-inflammatory M1 macrophages than is observed in the individual having the wild type SLC 15A4 genotype and the lower proportion of anti- inflammatory M2 macrophages than is observed in the individual having the wild type SLC15A4 genotype OR if (i-iii) are detected in addition to the biomarker that is “consistent” with the SLC15A4 variant genoype comprising an rs33990080-G allele. Clairification is requested.
Claim Rejections - 35 USC § 112(a)
5. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplted by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 13-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are drawn to a method comprising: selecting an individual for treatment with tradipitant based on:
a determination that the individual suffers from a condition selected from a group consisting of: gastroparesis, delayed gastric emptying, and abnormal gastric emptying, and
a presence of a biomarker in a biological sample taken from the individual, wherein the biomarker is consistent with a SLC15A4 variant genotype comprising an rs33990080-G allele; and
administering to the individual tradipitant at a dose of 150-400 mg/day.
The claims do not define the biomarkers that are consistent with a SLC15A4 variant genotype comprising an rs33990080-G allele in terms of their complete structure or any other relevant identifying characteristics. A biomarker that is consistent with a SLC15A4 variant could be any type of biomarker (i.e., another SNP in the SLC15A4 gene, a SNP in another gene, a protein, a chemical, a metabolite, a cell type, etc.).
The specification teaches the following:
[0029] Because SLC15A4 has been shown to mediate M1-prone metabolic shifts, the individual's SLC15A4 genotype may also be determined based on an inference as to the individual's SLC15A4 genotype made from the relative proportion of M1- and M2-macrophages present in a biological sample taken from the individual. SLC has been shown to mediate Nil-prone metabolic shifts in macrophages and guard immune cells from metabolic stress. When the anti-inflammatory M2 macrophages are switched to pro-inflammatory M1 macrophages, delayed gastric emptying may result. Therefore, the presence of a greater proportion of pro-inflammatory M1 macrophages than is observed in an individual having a wild type SLC15A4 genotype may be considered a biomarker consistent with a SLC15A4 variant genotype. Similarly, the presence of a lower proportion of anti-inflammatory M2 macrophages than is observed in an individual having a wild type SLC15A4 genotype, may also be considered a biomarker consistent with a SLC15A4 variant genotype. Such biomarkers may be employed in the method described herein in place of direct determination of the individual's genotype.
The specification discloses two examples of biomarkers that may be considered to be “consistent” with a SLC15A4 variant ((i) a greater proportion of M1 macrophages than is observed in an individual having a wild type SLC15A4 and (ii) a lower proportion of M2 macrophages than is observed in an individual having a wild type SLC15A4). However the disclosure of these two biomarkers is insufficient to demonstrate possession of the genus as a whole. The breadth of the claims encompasses biomarkers which the present inventors were not in the possession of, or which were not known to the inventors. The instant disclosure does not allow one of skill in the art to visualize or recognize the structure of additional biomarkers that are consistent with a SLC15A4 variant. Therefore, the claims fail to meet the written description requirement because the claims encompass a potentially large genus of biomarkers consistent with a SLC15A4 variant which are not adequately described in the specification.
6. Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA HANEY whose telephone number is (571)272-8668. The examiner can normally be reached Monday-Friday, 8:15am-4:45pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu-Cheng Shen can be reached at 571-272-3157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMANDA HANEY/Primary Examiner, Art Unit 1682
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