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 .
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
1. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5/15/2026 has been entered.
Status of the Claims
2. Claims 1-21 are the original claims filed 9/6/2022. In the Response of 11/26/2025, claims 1-9 and 11-21 are amended and claim 10 is canceled. In the Response of 5/15/2026, Claim 1 is amended, claims 2 and 21 are canceled and new claims 22-23 are added. Claims 1, 3-9, 11-20 and 22-23 are all the claims.
The Office Action contains new grounds for objection and rejection.
Priority
3. USAN 17/929,874, filed 09/06/2022, and having 1 RCE-type filing therein, is a Continuation in Part of PCT/SG2022/050103, filed 03/01/2022, claims foreign priority to SG 10202102087T, filed 03/01/2021; and claims foreign priority to SG 10202110690S, filed 09/27/2021.
Information Disclosure Statement
4. As of 5/29/2026, a total of two (2) IDS are filed: 3/23/2024; and 11/26/2025. The corresponding initialed and dated 1449 form is considered and of record. The submissions are in compliance with the provisions of 37 CFR 1.97.
Withdrawal of Objections
Specification
5. The objection to the abstract of the disclosure because of exemplary text, i.e., “such as” is withdrawn in view of the amended abstract.
Withdrawal of Rejections
Claim Rejections - 35 USC § 103
6. The rejection of Claims 1-9 and 11-21 under 35 U.S.C. 103 as being obvious over Ward (US 20210277131) as evidenced by “Phase 2b Study of ASLAN004 in Adults With Moderate-to-Severe Atopic Dermatitis” ClinicalTrials.gov ID NCT05158023 (pp. 1-11; 6/23/2025 (PTO 892)) is moot for the canceled claims and withdrawn for the pending claims. The amendment of the claims to recite treating moderate to severe atopic dermatitis for a selected patient population having an IgE total baseline level of at least about 14,000 KU/L is found to overcome the rejection.
Rejections 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.
7. The provisional rejection of Claims 1-9 and 11-21 on the ground of nonstatutory double patenting as being unpatentable over claims 23-47 of copending Application No. 17/272,243 (reference application US 20210277131) is moot for canceled claims and maintained for the pending claims.
Applicants’ response is incomplete. The rejection is maintained.
8. The provisional rejection of Claims 1-9 and 11-21 on the ground of nonstatutory double patenting as being unpatentable over claims 35-54 of copending Application No. 18/841,226 (reference application US 20250163165) is moot for canceled claims and maintained for the pending claims.
Applicants’ response is incomplete. The rejection is maintained.
9. A. The provisional rejection of Claims 1-9 and 11-21 on the ground of nonstatutory double patenting as being unpatentable over claims 26-42 of copending Application No. 18/695502 (reference application US 20250002592) is moot for canceled claims and maintained for the pending claims.
Applicants’ response is incomplete. The rejection is maintained.
B. The provisional rejection of Claims 1-9 and 11-21 on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of copending Application No. 17/929,824 (reference application US 20230002484) 17/929,824 is moot for canceled claims and maintained for the pending claims.
Applicants’ response is incomplete. The rejection is maintained.
C. The provisional rejection of Claims 1-9 and 11-21 on the ground of nonstatutory double patenting as being unpatentable over claims 31-45 of copending Application No. 18/695,464 (reference application US 20250277042) is moot for canceled claims and maintained for the pending claims.
Applicants’ response is incomplete. The rejection is maintained.
New Grounds for Objection
Claim Objections
10. Claims 9, 11-14, 15, and 17-20 are objected to because of the following informalities:
a) Claims 9, 11-14, 15, and 17-20 are inconsistent in the use of the phrase “an antigen binding fragment thereof” (claims 15, 17-20) and “the antigen binding fragment thereof” (Claims 9, 11-14). Claim 1 provides the antecedent basis for the phrase “an antigen binding fragment thereof”, therefore the dependent claims should recite “the antigen binding fragment thereof”.
Appropriate correction is required.
New Grounds for Rejection
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.
11. Claims 1, 3-9, 11-20 and 22-23 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.
Claim construction/ interpretation
Amended claim 1 is now drawn to
A method of treating moderate-to-severe atopic dermatitis in a highly allergic patient, comprising: prior to treatment, establishing that the patient has a baseline total IgE level of at least about 14,000 KU/L and selecting the patient for treatment based on the established baseline total IgE level; and administering to the patient an anti-IL-13Rα1 antibody or an antigen binding fragment thereof comprising a heavy chain variable region comprising the amino acid sequence of SEQ ID NO. 51 and a light chain variable region comprising the amino acid sequence of SEQ ID NO:53.
“about”: the specification provides no per se definition for the term.
MPEP 2173.05(b)(III)(A) stating in part:
A. “About”
In determining the range encompassed by the term “about,” one must consider the context of the term as it is used in the specification and claims of the application. Ortho-McNeil Pharm., Inc. v. Caraco Pharm. Labs., Ltd., 476 F.3d 1321, 1326, 81 USPQ2d 1427, 1432 (Fed. Cir. 2007). In W.L. Gore & Associates, Inc.v.Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983), the court held that a limitation defining the stretch rate of a plastic as “exceeding about 10% per second” is definite because infringement could clearly be assessed through the use of a stopwatch. However, in another case, the court held that claims reciting “at least about” were invalid for indefiniteness where there was close prior art and there was nothing in the specification, prosecution history, or the prior art to provide any indication as to what range of specific activity is covered by the term “about.” Amgen, Inc. v.Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991).
The specification does not define “KU/L” within the context of the term “about”. But the specification does define a range that encompasses 14,000 KU/L and that is not infinite in scope as instantly claimed:
See [0015] “2. An antibody or antigen binding fragment thereof for use according to paragraph 1 wherein the baseline IgE levels are in the range 10,000+/−2,000 to 30,000+/−6,000 KU/L.”
The range from [0015] is not read into the claims from the specification.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
12. Claim 23 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 23 recites “the antibody or antigen-binding fragment” that is a broadening recitation from the phrase “an antigen binding fragment thereof” in Claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Conclusion
13. No claims are allowed.
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN A. BRISTOL whose telephone number is (571)272-6883. The examiner can normally be reached Mon-Fri 9 AM-5 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu Julie can be reached at 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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LYNN ANNE BRISTOL
Primary Examiner
Art Unit 1643
/LYNN A BRISTOL/Primary Examiner, Art Unit 1643
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