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 .
Status of Application, Amendments and/or Claims
The amendment and Applicant’s arguments, filed 09 June 2026, have been entered in full. Claims 1-62 are canceled. Claims 63-65, 67, 68, 78, 80, 87 and 90 are amended. Claims 63-93 are under examination.
Information Disclosure Statement
The information disclosure statement(s)(IDS) (filed 09 June 2026) was received. It has been placed in the application file and the information referred to therein has been considered as to the merits.
It is noted that some of the references fail to comply with the provisions of 37 CFR §§1.97, 1.98 and MPEP § 609. MPEP 609.05 [R-3] states that information disclosure statements will be reviewed for compliance with the requirements of 37 CFR 1.97 and 37 CFR 1.98 as discussed in MPEP 609.04(a) and MPEP 609.04(b). The references will be lined through and not considered by the Examiner.
The following references not considered by the Examiner for the following reasons:
1. The Vorzheva reference is not considered by the Examiner because it is in a language other than English and does not have an English abstract.
Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Claim Rejections-35 USC § 112(a) or 35 U.S.C. 112 (pre-AIA ), First paragraph, Written description, New Matter
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 contemplated 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 75, 76, 77, 85, 86 and 93 remain 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. This is a New Matter rejection.
The basis for this rejection is set forth at pages 5-6 of the previous Office Action (09 March 2026).
APPLICANT’S ARGUMENTS: Applicant argues that the specification describes "[a] high percentage of subjects had a history of prior swallowed topical steroid use and prior esophageal dilations, as shown in Table 2. Applicant submits that the Office Action fails to notice the baseline disease characteristics of patients summarized in Table 2 (reproduced below), which provides relevant disclosure. Applicant maintains that as shown, Table 2 clearly shows that at baseline (i.e., prior to treatment), the overall number of esophageal dilations prior to treatment of all patients of 2.0 (± 1.27). Thus, the limitation "wherein the subject had two esophageal dilations prior to the treatment" does not constitute new subject matter and is fully supported in the specification as originally filed.
Applicant’s arguments have been fully considered but are not considered for the following reasons:
1. The instant specification teaches In Part A, all patients will receive either 300 mg dupilumab or placebo once weekly (QW) subcutaneous (SC) injections (para 0144).
2. The specification teaches baseline demographics and disease characteristics of patients enrolled in Part A of the study are summarized in Tables 1 and 2 below (para 0173).
3. Table 2, column 1, teaches “number of prior esophageal dilation, mean (SD)”.
Table 2, column 2, teaches for the Placebo Group 2.0 (1.41)
Table 2, column 3, teaches for the 300 mg QW Group 1.9 (1.16)
Table 2, column 4, teaches for the Overall Group 2.0 (1.27)
4. Contrary to the presented arguments, “Overall” would be for all of the subjects.
However, the instant claims are drawn only to those subjects being administered 300 mg QW. Thus, that number would be that which is taught in Table 2, column 3 for the 300 mg QW Group. Additionally, the Examiner notes the listed number are the “mean”, which is the average. The mean number is the average of number of prior esophageal dilations for the Group of patients receiving 300 mg (i.e. 1.9).
The Examiner maintains that the specification teaches "In some embodiments, the subject has had one or more esophageal dilations" (para 0056).
The Examiner maintains that by amending the claims to specifically recite, "wherein the subject had two esophageal dilations prior to the treatment", the claims recite limitations which were not disclosed in the specification as filed, changes the scope of the instant disclosure as-filed, resulting in New Matter.
The scientific reasoning and evidence as a whole indicates that the objection should be maintained.
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 63-68, 87-90 remain rejected under 35 U.S.C. 103 as being unpatentable over Kostic et al. (Reference of record; US 2016/0152718; published 6/2/16) in view of ClinicalTrials.gov NCT03633617 (Record History date of March 15, 2019) and Hudgens et al. (Journal of Patient-Reported Outcomes 1:3, pages 1-11; 2017).
The basis for this rejection is set forth at pages 7-13 of the previous Office Action (09 March 2026).
APPLICANT’S ARGUMENTS: Applicant states that the Office Action acknowledges that Kostic does not teach "using a Dysphagia Symptom Questionnaire (DSQ) or that the subjects have a DSQ score that is ≥ 30 prior to treatment" or "24 weeks of treatment."
Applicant agrees and further submits that Kostic also does not teach a method of treating a subject with EoE comprising the active step of "decreasing the subject's DSQ score by at least 10 [or 20] points after 24 weeks of the treatment, relative to the subject's DSQ score prior to treatment," as recited in the present claims.
Applicant submits that because this step "requir[es] specific decreases" and states a "specific requirement[]" of the claimed method, it must be considered for patentability. Applicant cites L'Oréal USA, Inc. V. Olaplex, Inc., 844 Fed.Appx. 308 (Fed. Cir. Ct. of App. 2021) at 324; see also Allergan Sales, LLC V. Sandoz, Inc., 935 F.3d 1370, 1379 (Fed. Cir. 2019) at 1379.
Applicant argues that none of NCT03633617, Hudgens, and Radin remedies these defects or provides any guidance to perform the claimed methods. Applicant argues that while NCT03633617 mentions DSQ scores, it does not teach administering an anti-IL-4R antibody (e.g., dupilumab) to a subject having a DSQ score ≥ 30 prior to treatment or decreasing a subject's DSQ score by at least 10 (or 20) points after 24 weeks of treatment or even discloses the claimed dosing regimen.
Applicant argues that Hudgens similarly fails to provide the requisite teachings. Applicant maintains that Hudgens is not relevant to the claimed methods at all because Hudgens describes use of DSQ scores with EoE patients treated with an oral suspension of budesonide, a corticosteroid. Applicant argues that Radin is entirely silent regarding DSQ scores so it similarly cannot bridge the gaps present in the other cited references.
Applicant argues that neither Kostic's method nor Hudgens's and Radin's disclosures implicitly provide the active step of "decreasing the subject's DSQ score by at least 10 [or 20] points after 24 weeks of the treatment, relative to the subject's DSQ score prior to treatment."
Applicant argues that "[I]n order to rely on inherency to establish the existence of a claim limitation in the prior art in an obviousness analysis - the limitation at issue necessarily must be present, or the natural result of the combination of elements explicitly disclosed by the prior art." MPEP §2112 (IV) citing PAR Pharmaceutical, Inc. v. TWI Pharmaceuticals, Inc., 773 F.3d 1186 (Fed. Cir. 2014). Applicant argues that the suggestion that "a certain result or characteristic may occur or be present in the prior art is not sufficient to establish the inherency of that result or characteristic." Applicant lists MPEP §2112 (IV) citing In re Rijckaert, 9 F.3d 1531, 1534 (Fed. Cir. 1993) (reversed rejection because inherency was based on what would result due to optimization of conditions, not what was necessarily present in the prior art); In re Oelrich, 666 F.2d 578, 581-82 (CCPA 1981).
Applicant’s arguments have been fully considered but are not found persuasive for the following reasons:
1. The limitation "decreasing the subject's DSQ score by at least 10 [or 20] points after 24 weeks of the treatment, relative to the subject's DSQ score prior to treatment," is NOT an active method step.
The instant limitation purportedly occurs when 300 mg of dupilumab is administered subcutaneously once every week (QW) to an EoE subject (who is 12 or over and weighs over 40 kg) after 24 weeks of treatment, wherein prior to treatment the subject had a DSQ score > 30.
Kostic et al. teach subcutaneously administering 300 mg of dupilumab once every week (QW) to an EoE subject (who is 12 or over and weighs over 40 kg).
Kostic et al. do not teach 24 weeks of treatment. Kostic et al. teach do not teach that the subjects have a DSQ score that is ≥ 30 prior to dupilumab treatment.
Clinical Trial NCT03633617 determines the efficacy of dupilumab treatment compared with placebo in adult and adolescent patients with EoE after 24 weeks of subcutaneously administering dupilumab. The trial teaches a primary outcome measure includes changes in dysphagia symptom Questionnaire (DSQ) score. The trial teaches the DSQ is used to measure the frequency and intensity of dysphagia. The trial teaches DSQ scores can range from 0 to 84, with a lower score indicating less-frequent or less-severe dysphagia. The trial teaches that patients are excluded if they weigh 40 kg or less.
2. Regarding the Hudgens reference, the Examiner thoroughly explained the teachings of Hudgens (see the previous Office Action, 09 March 2026, specifically at pages 12-13). Based off the teachings of Hudgens, a DSQ score of 30 or more would mean that the patient is answering Question 3: wherein at least some day(s), the patient had to drink liquid to get relief (a score of 1); they had to cough and/or gag to get relief (a score of 2); they had to vomit to get relief (a score of 3) or they had to seek medical attention (a score of 4). This indicates more frequent or more severe dysphagia.
Based on the teachings, it would be obvious that a patient with EoE would have a DSQ score > 30 prior to treatment and to further employ DSQ after 24 weeks of treatment with dupilumab.
3. The Examiner takes no issue with the citation of case law and MPEP 2112 (IV). However, the Examiner has provided rationale to show that the combined teachings of Kostic, ClinicalTrials.gov NCT03633617 and Hudgens et al. would result in "decreasing the subject's DSQ score by at least 10 [or 20] points after 24 weeks of the treatment, relative to the subject's DSQ score prior to treatment".
The scientific reasoning and evidence as a whole indicates that the objection should be maintained.
Claims 69-74, 91 and 92 remain rejected under 35 U.S.C. 103 as being unpatentable over Kostic et al. in view of ClinicalTrials.gov NCT03633617 and Hudgens et al., as applied to claims 63 and 87 above, and further in view of Radin et al. (US 2019/0040126; published Feb 7, 2019).
The basis for this rejection is set forth at pages 13-15 of the previous Office Action (09 March 2026).
APPLICANT’S ARGUMENTS: Applicant incorporates their response to the rejection to claims 63-68, 87-90 under 35 U.S.C. 103 as being unpatentable over Kostic et al. in view of ClinicalTrials.gov NCT03633617 and Hudgens et al., in response to the instant rejection.
Applicant argues that Radin does not remedy the defects or provides any guidance to perform the claimed methods. Applicant argues that Radin is entirely silent regarding DSQ scores so it similarly cannot bridge the gaps present in the other cited references. Applicant argues that Radin's disclosure does not implicitly provide the active step of “decreasing the subject’s DSQ score by at least 10 [or 20] points after 24 weeks of the treatment, relative to the subject’s DSQ score prior to treatment.”
Applicant’s arguments have been fully considered but are not found persuasive for the following reasons:
1. The Examiner has discussed the Kostic, ClinicalTrials.gov NCT03633617 and Hudgens references above. As discussed at page 14 of the previous Office Action (09 March 2026), Radin was cited because Kostic, ClinicalTrials.gov NCT03633617 and Hudgens do not teach that the subjects had prior esophogeal dilations prior to treatment.
2. Radin et al. teach subcutaneously administering dupilumab 300 mg once a week to treat EoE patients. Radin et al. teach that the methods are for the treatment of adults or adolescents. Radin et al. teach that an adult is ≥18 years of age and an adolescent is ≥12 and <18 years of age. Radin et al. teach that the patient has had at least one prior esophageal dilation. Radin et al. teach that an EoE-related parameter may be measured at week 24 or longer, after the initial treatment with a pharmaceutical composition of the present invention.
The scientific reasoning and evidence as a whole indicates that the rejection should be maintained.
Claims 78-84 remain rejected under 35 U.S.C. 103 as being unpatentable over Radin et al. (US 2019/0040126; published Feb 7, 2019) in view of ClinicalTrials.gov NCT03633617).
The basis for this rejection is set forth at pages 15-18 of the previous Office Action (09 March 2026).
APPLICANT’S ARGUMENTS: Applicant incorporates their response to the rejection to claims 63-68, 87-90 under 35 U.S.C. 103 as being unpatentable over Kostic et al. in view of ClinicalTrials.gov NCT03633617 and Hudgens et al., in response to the instant rejection.
Applicant’s arguments have been fully considered but are not found to be persuasive for the reasons discussed above and reasons of record.
The scientific reasoning and evidence as a whole indicates that the rejection should be maintained.
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.
1. Claims 63-74, 78-84, 87-92 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 6-12, 14-16 of U.S. Patent No. 11,421,036 in view of Radin et al. (US 2019/0040126; published Feb 7, 2019), ClinicalTrials.gov NCT03633617 (Record History date of March 15, 2019) and Hudgens et al. (Journal of Patient-Reported Outcomes 1:3, pages 1-11; 2017).
The basis for this rejection is set forth at pages 18-27 of the previous Office Action (09 March 2026).
APPLICANT’S ARGUMENTS: Applicant argues that as set out above, none of Radin, NCT03633617 or Hudgens teaches or suggests the claimed methods. Applicant argues that the claims of US Patent Nos. 11,421,036, 10,730,948, and 9,290,574 are silent regarding DSQ scores, and therefore similarly do not teach or suggest all the features of the claimed methods. For this reason, the double patenting rejections against claims 63-93 cannot be maintained.
Applicant’s arguments have been fully considered but are not found to be persuasive for the reasons discussed above and reasons of record.
The scientific reasoning and evidence as a whole indicates that the rejection should be maintained.
2. Claims 63-74, 78-84, 87-92 remains rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 9-12, 15-20 of U.S. Patent No. 10,730,948 in view of Radin et al. (US 2019/0040126; published Feb 7, 2019), ClinicalTrials.gov NCT03633617 (Record History date of March 15, 2019) and Hudgens et al. (Journal of Patient-Reported Outcomes 1:3, pages 1-11; 2017).
The basis for this rejection is set forth at pages 28-33 of the previous Office Action (09 March 2026).
Applicant incorporates their response to the rejection to claims 63-74, 78-84, 87-92 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 6-12, 14-16 of U.S. Patent No. 11,421,036 in view of Radin et al. (US 2019/0040126; published Feb 7, 2019), ClinicalTrials.gov NCT03633617 (Record History date of March 15, 2019) and Hudgens et al. (Journal of Patient-Reported Outcomes 1:3, pages 1-11; 2017), in response to the instant rejection.
Applicant’s arguments have been fully considered but are not found to be persuasive for the reasons discussed above and reasons of record.
The scientific reasoning and evidence as a whole indicates that the rejection should be maintained.
3. Claims 63-74, 78-84, 87-92 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 7-11, 13, 31-33, 38-43 of U.S. Patent No. 9,290,574 in view of Radin et al. (US 2019/0040126; published Feb 7, 2019), ClinicalTrials.gov NCT03633617 (Record History date of March 15, 2019) and Hudgens et al. (Journal of Patient-Reported Outcomes 1:3, pages 1-11; 2017).
The basis for this rejection is set forth at pages 33-38 of the previous Office Action (09 March 2026).
Applicant incorporates their response to the rejection to claims 63-74, 78-84, 87-92 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 6-12, 14-16 of U.S. Patent No. 11,421,036 in view of Radin et al. (US 2019/0040126; published Feb 7, 2019), ClinicalTrials.gov NCT03633617 (Record History date of March 15, 2019) and Hudgens et al. (Journal of Patient-Reported Outcomes 1:3, pages 1-11; 2017), in response to the instant rejection.
Applicant’s arguments have been fully considered but are not found to be persuasive for the reasons discussed above and reasons of record.
The scientific reasoning and evidence as a whole indicates that the rejection should be maintained.
Conclusion
No claims are allowed.
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.
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/R.M.D/Examiner, Art Unit 1647 8/17/2026
/BRIDGET E BUNNER/Primary Examiner, Art Unit 1647
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