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.
Claims 1-9 and 11-21 are all the claims.
The Office Action contains new grounds for objection.
The Office Action is final.
Priority
2. USAN 17/929,874, filed 09/06/2022, 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 1/9/2026, 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
4. The objection to the abstract of the disclosure because it contains legal language, i.e., “said” is withdrawn. The term is deleted in the amended abstract.
5. The objection to the disclosure because of informalities is withdrawn. The amended specification rectifies the improper use of the term, UniProt, which is a trade name or a mark used in commerce.
Claim Objections
6. The objection to Claims 1-21 because of informalities is moot for canceled claim 10 and withdrawn for the pending claims.
a. Claims 1-21 are amended to delete the product invention for a pharmaceutical composition in claim 1.
b. Claim 1 is amended to delete the phrase “the said receptor”.
c. Claim 1 is amended to delete the phrase “comprising same.”
d. Claim 1 is amended to recite “an antiIL-13Rα1 antibody or an antigen binding fragment thereof.”
d. Claims 9, 11-14 and 21 are amended to recite “the antigen binding fragment thereof.”
e. Claim 9 is amended to recite “administered [by] parenterally.”
Withdrawal of Rejections
Claim Rejections - 35 USC § 112(b)
7. The rejection of Claims 1-21 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite is moot for canceled claim 10 and withdrawn for the pending claims.
a. Claims 1-21 are amended to delete the phrase "for example".
b. Claims 1-21 are amended to delete the phrase "such as".
c. Claims 1-21 are amended to delete parenthetical text and/or parentheses.
d. Claim 1 is amended to recite the broad recitation “atopic dermatitis” and to delete the narrower phrases “moderate to severe atopic dermatitis” and “poorly controlled moderate to severe atopic dermatitis”.
e. Claim 10 is canceled and claims 15 and 20 are amended to delete the limitation "the treatment cycle or cycles" (Claim 10) and “the treatment cycle” (Claims 15 and 20).
f. Claims 6-8 are amended to delete the term “about” and claim 10 is canceled.
g. Claim 10 is canceled.
h. Claim 11 is amended to recite the broad recitation “
Claim 12 is amended to recite the broad recitation “once
Claim 13 is amended to recite the broad recitation “once
Claim 14 is amended to recite the broad recitation “once
i. Claims 17-19 are amended to replace the limitation "the dose" with “administered at a dose.”
j. Claim 18 is amended to recite the broad recitation “the range 350 to 450mg”, and to delete the phrase “400mg” which is the narrower statement of the range/limitation.
k. Claim 10 is canceled and claim 20 is amended to delete the general narrative text to conform with current U.S. practice.
Claim Rejections - 35 USC § 112(a)
Written Description
8. The rejection of Claims 1-21 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 is moot for canceled claim 10 and withdrawn for the pending claims.
Applicant’s specification fully discloses the antibody clone, ASLAN004, for treatment of AD in human patients and that decreases IgE and EASI scores at therapeutic doses. See the entirety of Example 2. See “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)). The claims are amended to recite the VH/VL domains from the antibody clone, ASLAN004.
Synonyms: ASLAN004; CSL-334; MK-6105; Eblasakimab.
Objections Withdrawn-in-Part/ Maintained-in-Part
Specification
9. The objection to the abstract of the disclosure because of exemplary text, i.e., “such as” is maintained (and withdrawn for the deleted phrase “for example”).
The response is incomplete because the phrase “such as” is pending.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Rejections 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.
10. The rejection of Claims 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)),
A) Applicants allege Ward does not disclose or suggest treating patients with extremely high baseline IgE levels of at least 10,000 KU/L. The examples in Ward show IgE levels around 1,000-1,400 KU/L (see, e.g., Figure 1, showing baseline -1,234 KU/L reduced to -952 KU/L), an order of magnitude lower than the baseline IgE levels recited in claim 1. There is no teaching or suggestion in Ward to specifically select or treat patients with IgE levels an order of magnitude higher (10,000 KU/L or more) than the patients in Ward.
Response to Arguments
Those data in Figure 1 of Ward show results from a single normal human volunteer given a single dose to evaluate the effect on normal IgE levels.
Single Ascending Dose (SAD) Study
[0259] Healthy volunteers were administered a single dose of the ASLAN004 formulation over a 60-minute intravenous infusion (IV) via a syringe driver or via a subcutaneous injection (SC). The following cohorts were conducted:
TABLE-US-00007 TABLE 1 Cohorts in SAD study Number of Cohort Mode of volunteers number Dose of ASLAN004 given administration tested 1 0.1 mg/kg IV 2 2 0.3 mg/kg IV 3 3 1.0 mg/kg IV 3 4 3.0 mg/kg IV 6 5 10.0 mg/kg IV 6 6* 20.0 mg/kg IV 6 7 75.0 mg SC 6 8 150.0 mg SC 6 9 300.0 mg SC 6 10 600.0 mg SC 6 *Cohort 6 was not actioned because a long PD effect of >29 days was achieved at 10 mg/kg.
[0260] The subcutaneous (SC) cohorts 7 to 10 were conducted in parallel after intravenous (IV) cohort 3 was completed.
[0261] Safety assessments included adverse events (AEs), vital signs and other clinical laboratory parameters. Serial blood samples were drawn for assessment of PK and PD parameters. Samples were taken pre-dose, 1 hour after dose, 24 hours after dose, 1 week after dose (Day 8), 2 weeks after dose (Day 15), 4 weeks after dose (Day 29) and 12 weeks after dose (Day 85). IgE levels were measured and pSTAT6 and RO assays were conducted.
IgE Test
[0262] FIG. 1 shows a sample result for a volunteer who was given the 3 mg/kg IV dose. As a reference point, the normal expected IgE range is 0 to 87 IU/ml. As can be seen from FIG. 1, ASLAN004 resulted in an approximately 34% reduction in IgE levels, with the lowest levels of IgE measured on Day 15 (2 weeks after dose). The PD effect was lost around Day 29 (4 weeks after dose).
Ward teaches the effect of ASLAN004 in suppressing IgE levels in a normal volunteer that provides the motivation to consider its use in the treatment of inflammatory disorders. Ward teaches and encourages the use of the antibody in the treatment of disorders including AD.
[0263] Accordingly, the results demonstrate the efficacy of ASLAN004 in suppressing IgE levels and suggests its potential for treating inflammation disorders.
[0275] Thus, the pharmacodynamic profile of ASLAN004 indicates that ASLAN004 compares very favourably to Duplilumab and suggests ASLAN004's the potential for monthly dosing to treat inflammatory disorders, such as atopic dermatitis.
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)), ASLAN004 was proven effective to consider its evaluation in clinical trials for the assessment on the reduction of EASI in severe AD.
B) Applicants allege Ward does not recognize or suggest that patients with an order of magnitude higher baseline IgE (> 10,000 KU/L) would respond to the claimed treatment. Highly allergic patients with extreme IgE levels (10 times higher than those in Ward) represent a subpopulation with distinct treatment challenges.
Response to Arguments
Applicants rely on Attorney arguments which are not substantiated by intrinsic and/or extrinsic evidence showing that “Highly allergic patients with extreme IgE levels (10 times higher than those in Ward) represent a subpopulation with distinct treatment challenges.” MPEP 716.01 and 2145 (The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997)).
C) Applicants allege the present specification demonstrates that the claimed method achieves significant IgE reductions and disease modification in this specific high-IgE subpopulation. For example, see Example 1, page 20, Tables 1-2 and FIG. 13A-13E. The specification as filed states on page 20 that "in highly allergic population of patients (IgE 41.6 % cfbl) ASLAN004 [an example anti-IL- 13Ral antibody according to pending claim 1] reduced the IgE levels by -34%. In real terms this is a more significant reduction than the -15 to -30% in a population with lower allergic response in dupilumab." This result is unexpected given Ward's focus on patients with lower IgE levels.
Response to Arguments
Dispositive to Applicants statement is the fact that Ward relies on data from normal human volunteers to demonstrate that ASLAN004 works to lower IgE levels (and not AD volunteers with high IgE levels). Ward specifically motivates the POSA to use ASLAN004 in treating AD at [0275] and
[0276] When greater than or equal to 600 mg ASLAN004 was administered intravenously (10 mg/kg) it demonstrated 100% receptor occupancy and complete inhibition of STAT6 phosphorylation in less than 1 hour after dosing. These effects were maintained for over 29 days following a single dose of ASLAN004, suggesting monthly dosing may be achievable. The rapid inhibition of IL-4 and IL-13 signaling by ASLAN004 could also lead to a fast onset of symptom relief in atopic dermatitis and allergic asthma patients.
As regards to what Ward teaches about dosing, see the abstract
“The present disclosure provides a method of treatment comprising inhibiting IL-13R with an antibody or binding fragment thereof specific for the receptor with a VH sequence of SEQ ID NO: 51 or a sequence at least 95% identical thereto, and VL sequence of SEQ ID NO: 53 or a sequence at least 95% identical thereto, wherein said antibody or binding fragment is administered at a dose in the range 600 mg to 900 mg at least once each month, in particular less than twice a month.”
Instant claims 9, 15 and 17-20 are drawn to the dose ranges for the method invention. The dose ranges in Ward are overlapping with the instant claims to the extent the POSA could reasonably practice the method invention using the dose range of Ward as an example for treating AD.
Under MPEP 2144.05 In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Similarly, a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985).
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960) (MPEP 716.02(d)).
Rationales for arriving at a conclusion of obviousness suggested by the Supreme Court’s decision in KSR include
(E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; and
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in
Here is the case based on the record evidence, that the POSA could reasonably conclude that any AD patient could be treated with an overlapping dose of ASLAN004, that was shown to lower IgE levels in normal volunteers, with the reasonable expectation that IgE levels would be lowered in those patients absent a showing to the contrary.
The rejection is 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.
11. 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 claim 10 and maintained for the pending claims.
Applicants’ response is incomplete. The rejection is maintained.
12. 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 claim 10 and maintained for the pending claims.
Applicants’ response is incomplete. The rejection is maintained.
13. 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 claim 10 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) is moot for canceled claim 10 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 claim 10 and maintained for the pending claims.
Applicants’ response is incomplete. The rejection is maintained.
Conclusion
14. No claims are allowed.
15. 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.
16. 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.
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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