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
Status of the Claims
1. 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. In the Response of 9/2/2026, claims 1, 15, 17-20 and 23 are amended.
Claims 1, 3-9, 11-20 and 22-23 are all the claims.
The Office Action contains new grounds for objection and is final.
Priority
2. 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
3. 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 Objection(s)
Claim Objections
4. The objection to Claims 9, 11-14, 15, and 17-20 because of informalities is withdrawn.
a) Claims 9, 11-14, 15, and 17-20 are consistent in comporting with the phrase “the antigen binding fragment thereof.”
Withdrawal of Rejections
Claim Rejections - 35 USC § 112(d)
5. The rejection of Claim 23 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form is withdrawn.
Claim 23 is amended to recite “the antibody or the antigen-binding fragment thereof”.
Double Patenting
6. 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being unpatentable over claims 23-47 of copending Application No. 17/272,243 (reference application US 20210277131) is withdrawn. None of the allowed claims in Application No. 17/272,243 recite IgE or total IgE much less being associated with a KU/L measurement.
7. 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being unpatentable over claims 35-54 of copending Application No. 18/841,226 (reference application US 20250163165) is withdrawn. None of the claims in Application No. 18/841,226 recite IgE or total IgE much less that being associated with a KU/L measurement.
8. 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 withdrawn. None of the claims in Application No. 17/929,824 recite IgE or total IgE much less that being associated with a KU/L measurement. Further KU/L of the instant claims does not directly correspond to or form a part of the Eczema Area and Severity Index (EASI) of the reference method claims because they are two completely different types of clinical measurements.
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.
9. A. The provisional rejection of Claims 1, 3-9, 11-20 and 22-23 on the ground of nonstatutory double patenting as being unpatentable over claims 26-33, 36-41 of copending Application No. 18/695502 (reference application US 20250002592) is maintained.
Ref claim 33 recites “a method according to claim 26, wherein the subject has baseline IgE levels that are at a level of at least 150 KU/L”, and
Ref claim 26 recites a “method of treating a subject for moderate, severe or very severe atopic dermatitis poorly controlled by existing approved medicaments, including topical medicine, oral medicines and/or biological medicines, the method comprising: administering subcutaneously an anti-IL-13Ral antibody in a treatment cycle comprising a dose of 300mg to 600mg, wherein the subject has a disease baseline characterised by a EASI score of 16 or above; and wherein the antibody comprises a VH domain comprising the amino acid sequence of SEQ ID NO: 51, and a VL domain comprising the amino acid sequence of SEQ ID NO: 53” where the antibody administered to the patient is identical.
The ref phrase “IgE levels that are at a level of at least 150 KU/L” encompasses and is overlapping with the instant claimed phrase “total IgE level of at least 14,000 KU/L.” The claims are anticipated by and/or rendered obvious by the reference application.
The provisional rejection is maintained.
10. The provisional rejection of Claims 1, 3-9, 11-20 and 22-23 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 maintained.
Ref claim 34 recites “wherein the patient is a highly allergic patient, where the baseline IgE levels have been established and are at a level of at least 10,000 KU/L+/- 2,000”, and
Ref claim 31 recites a “method of treating pruritus in a patient, comprising: subcutaneously administering one or more treatment cycles comprising a dose in the range 200mg to 600mg of an antibody, which is an inhibitor of signalling through IL-13Ra1 by binding the said receptor, wherein the disease is modified by a percentage reduction in pruritus numerical rating score (P-NRS), in the range -15 to -100% from the baseline; and wherein the anti-lL-13R antibody comprises a VH domain comprising the amino acid sequence of SEQ ID NO: 51, and a VL domain comprising the amino acid sequence of SEQ ID NO: 53” where the antibody administered to the patient is identical to the instant claimed.
The ref phrase “IgE levels have been established and are at a level of at least 10,000 KU/L+/- 2,000” encompasses and is overlapping with the instant claimed phrase “total IgE level of at least 14,000 KU/L.” The claims are anticipated by and/or rendered obvious by the reference application.
The provisional rejection is maintained.
Rejections Maintained
Claim Rejections - 35 USC § 112(b)
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. The rejection of 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 is maintained.
Applicants allege amendment of claim 1 removes the term “about” and “Claim 1 now requires an objectively measurable baseline total IgE level of at least 14,000 KU/L. Amended claim 1 recites a precise numerical lower boundary and leaves no uncertainty about the threshold that must be established before treatment.”
Response to Arguments
A) Whilst Applicants focus on the lower limit of the range, the upper limit is infinite in scope and therefore indefinite. Applicants have not addressed the outstanding aspect of the original grounds for rejection, namely, that while the specification does define a range that encompasses 14,000 KU/L, it does not define nor support an infinite scope as instantly claimed:
[0010] The present inventors have treated patients with a baseline IgE level in the region of 14,000 KU/L. This represents a potentially more allergic patient population.”
[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.”
[0080] “In one embodiment, the highly allergic patient's baseline IgE levels have been established and are at a level of at least at least 10,000 KU/L+/−2,000, such as 8000, 8500, 9000, 9500, 10000, 10500, 11000, 11500 or 12000 KU/L.”
B) The assertion that “a precise numerical lower boundary” is an objective determination, is only if as taught in the specification, a precise and specific assay is used for measuring the total IgE levels at
[0252] Total IgE concentrations were determined in duplicate using the validated ImmunoCap.
[0253] Total IgE assay (Thermo Fisher Scientific).
The rejection is maintained because the POSA cannot reasonably determine the full meets and bounds of the claimed method invention.
New Grounds for Objection
Claim Objections
12. Claims 1, 3-9, 11-20 and 22-23 are objected to because of the following informalities: Claims 1, 3-9, 11-20 and 22-23 are inconsistent in the use of the phrase “total IgE level” and “the IgE levels”. According to claim 1, the total IgE levels are what establish the baseline.
Appropriate correction is required.
Conclusion
13. No claims are allowed.
14. 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.
15. 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LYNN A BRISTOL/Primary Examiner, Art Unit 1643
