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 .
Status of Claims
Claims 1-19 and 21 are pending as of the response and amendments filed on 10/30/25. Claim 20 has been canceled, claim 21 has been newly added.
The rejection for nonstatutory double patenting over the claims of US 11549147 is withdrawn in consideration of the acceptance of the terminal disclaimer filed on 10/30/25.
The rejection of claim 20 under 35 USC 101 is withdrawn as this claim has been canceled.
Claims 1, 4-10, and 15-19 were previously rejected under 35 USC 103 as being unpatentable over Ardern-Jones in view of Polymeropoulos. Applicants’ reasons for traversal are summarized and addressed below.
Applicants have requested clarification regarding the citation of “Mitterman” mentioned in the previous Office action, p. 6, lines 7-8. Applicants have stated this reference was not cited in the statement of the rejection, nor listed on the PTO-892. Applicants have argued the proposed combination of Ardern-Jones and Polymeropoulos fails to teach or suggest the claimed improvement, as while Ardern-Jones concludes “combined molecular and clinical characterization of patients for stratification is likely to hold the key to the future success of new targeted therapies for AD”, Ardern-Jones doesn’t provide any suggestions regarding how new targeted therapies for AD might be developed. Applicants have further stated Ardern-Jones offers no hypothesis nor evidence as to which of the targets of Table 1 is most likely to be useful in treating patients having a particular AD endotype. Applicants have further reminded the Office of the obligation to provide more than a mere conclusory statement to establish a case for obviousness.
Applicants’ arguments have been fully considered but they are not persuasive. Regarding the reference to “Mitterman”, the examiner acknowledges this citation was a typographical error, and that the 103 rejection relied on the teachings of Ardern-Jones and Polymeropoulos as previously cited. Ardern-Jones teaches subjects with extrinsic AD to have IgE levels greater than 200 kU/L, and new current targets under development for treating AD include VLY-686, i.e., tradipitant among a small list of 13 agents. It is maintained by the examiner that based on the teachings of Ardern-Jones, it would have been prima facie obvious to have treated a patient with AD and an IgE > 200 kU/L by administering tradipitant, since patients having IgE > 200 kU/L are taught to include those having extrinsic AD, and tradipitant is taught as a potential therapy for this condition.
Applicants have stated should the examiner persist in the rejection, Applicants request the examiner provide an articulated reason with some rational underpinning for modifying the teachings of Ardern-Jones in view of Polymeropoulos to arrive at Applicants’ claimed invention. Applicants have further argued if the examiner persists in this rejection by offering a new, articulated rational for combining the teachings of Ardern-Jones and Polymeropoulos, it is requested such a rejection be made non-final, as the new grounds of rejection would not be necessitated by amendment.
Applicants’ arguments are not persuasive. As discussed in the previous Office action and above, Ardern-Jones teaches patients with extrinsic AD to have IgE > 200 kU/L, with tradipitant included within new targeted therapies for AD, in a list of 13 other agents under current evaluation. It is noted Applicants’ claims don’t exclude patients with extrinsic AD; as Ardern-Jones teaches patients with AD to include subjects having IgE > 200 kU/L, and as tradipitant is cited by Ardern-Jones within a defined, small list of current therapies under evaluation for AD, it is maintained a POSITA would have found it prima facie obvious to have treated a subject having AD comprising administering tradipitant, wherein the subject has been determined to have an IgE level of greater than 200 kU/L, which meets the claimed limitation of greater than 100 kU/L. Polymeropoulos teaches treatment of conditions such as pruritis and pruritic associated with AD comprising administering a therapeutically effective amount of tradipitant of 100-400 mg/day, to provide plasma concentration of > 100 ng/mL. Since it has already been established that patients with AD include subjects having an IgE level > 200 kU/L, and as tradipitant is taught as a therapeutic agent for pruritic in AD, it would have been prima facie obvious to one of ordinary skill in the art to have treated AD in a subject having an IgE level > 200 kU/L by administering tradipitant at the dosage amounts taught by Polymeropoulos and have had a reasonable expectation of success, in the absence of unexpected results. The rejection under 103 over claims 1 and 4-9 is maintained; however, the rejection over claims 10 and 15-19 is withdrawn in view of the amendments.
Claims 1-19 and 21 were examined. Claims 1 and 4-9 are rejected. Claims 2-3 are objected to. Claims 10-19 and 21 are allowed.
Claim Rejections-35 USC § 103
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 1 and 4-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ardern-Jones., Exp. Dermatology, vol. 27, pp. 433-434, publ. 8/4/2016, in view of Polymeropoulos et. al., WO 2016141341 A1 (publ. 9/9/2016, cited in an IDS).
Ardern-Jones teaches efforts have been made to establish phenotypes of atopic dermatitis (AD), and that extrinsic AD, defined as having a skin defect and allergy, is associated with an IgE level of > 200 kU/L (p. 433, 1st 2 para). Ardern-Jones further teaches VLY-686, also known as tradipitant, as one of the target therapeutics for AD (p. 433, Table 1).
Ardern-Jones doesn’t teach the claimed doses of tradipitant.
Polymeropoulos teaches a method of treating pruritis with tradipitant, comprising internally administering to the patient an amount of the drug and at a frequency sufficient to achieve and maintain a plasma concentration of >100 ng/mL (Title & abstract; p. 2, 1st para of description of the invention). Polymeropoulos teaches the effective amount to range from 100-400 mg/day, wherein the drug is administered twice daily, i.e., 85 mg bid (p. 2, 2nd para of description of invention). Treatment of pruritis associated with atopic dermatitis with tradipitant, i.e., VLY-686, is exemplified (p. 4, Ex. 1 paras; p. 7, 1st para under Conclusions). Polymeropoulos teaches bid administration provides greater and/or more sustained relief of pruritis symptoms compared to qd administration (p. 10, 2nd para).
It would have been prima facie obvious to one of ordinary skill in the art, at the time of the invention, to have selected a patient for treatment of atopic dermatitis or pruritis comprising determining the patient had an IgE level greater than 100 kU/L, such as >200 kU/L by obtaining a biological sample from the patient and testing the level of IgE, and have administered a therapeutically effective amount of tradipitant to this patient, including a dose from 100-400 mg/day, e.g., about 170 mg/day, administered as 85 mg. bid, in consideration of Ardern-Jones and Polymeropoulos. Ardern-Jones teaches extrinsic AD, defined as having a skin defect and allergy, is associated with an IgE level of > 200 kU/L, and that VLY-686 is a therapeutic target for AD, while Polymeropoulos teaches administration of tradipitant for treating atopic dermatitis at a daily dose from 100-400 mg/day, including about 170 mg/day, administered as 85 mg. bid. As patients with AD include subjects having an IgE level of greater than 100 kU/L, e.g., > 200 kU/L as taught by Ardern-Jones, it would have been prima facie obvious to have determined the IgE level in a patient with AD, and to have administered an effective amount of tradipitant to patients having IgE levels greater than 100 kU/L, e.g., greater than 200 kU/L, and have had a reasonable expectation of success.
Claim Objections
Claims 2-3 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: the method of claims 10-19 and 21 is not taught or suggested by the prior art. Ardern-Jones., Exp. Dermatology, vol. 27, pp. 433-434, publ. 8/4/2016, represents the closest prior art. Ardern-Jones teaches efforts have been made to establish phenotypes of atopic dermatitis (AD), and that extrinsic AD, defined as having a skin defect and allergy, is associated with an IgE level of > 200 kU/L (p. 433, 1st 2 para). Ardern-Jones further teaches VLY-686, also known as tradipitant, as one of the target therapeutics for AD (p. 433, Table 1). However, Ardern-Jones doesn’t teach or suggest administering tradipitant at a dose of 170 mg/day if the patient has a genotype associated with a high IgE level; and administering tradipitant at a dose greater than 170 mg/day if the patient has a genotype not associated with a high IgE level, as recited by claim 10.
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH PIHONAK whose telephone number is (571)270-7710. The examiner can normally be reached Monday-Friday 9:00-5:30 EST.
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SARAH . PIHONAK
Primary Examiner
Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627