Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
2. 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 allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). 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, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 18 May 2026 has been entered.
Information Disclosure Statement
3. The information disclosure statement (IDS) submitted on 18 May 2026 has been considered by the examiner.
Claim Objections
4. Claim 1 is objected to because of the following informalities: The claim recites “EASI” without first providing the full name of the term. It is suggested that the term be spelled out at its first use and in all independent claims. Appropriate correction is required.
5. Claim 9 is objected to because of the following informalities: The claim recites “approx..” in line 2 of the claim, whereas the term “approximately” is recited at all other occurrences. It is suggested for the consistency that the term be spelled out at each occurrence. Appropriate correction is required.
6. Claim 13 and 20 are objected to because of the following informalities: The term “EASI” should recite “EASI score”. Appropriate correction is required.
7. Claims 16 and 22 are objected to because of the following informalities: The term “EASI 50” should recite “EASI-50”. Appropriate correction is required.
8. Claim 16 is objected to because of the following informalities: The term “day 57” in line 3 of the claim should recite “about day 57”. Appropriate correction is required.
9. Claim 23 is objected to because of the following informalities: The term “cycles comprises” in line 2 of the claim should recite “cycles comprise”. Appropriate correction is required.
10. Claim 24 is objected to because of the following informalities: The term “modification, occurs” in line 2 should recite “modification occurs”, “antibody wherein” in lines 2-3 should recite “antibody, wherein”, “score, from” in line 4 should recite “score from”, and “-10 to 55%” in line 4 should recite “-10 to -55%”. Appropriate correction is required.
11. Claim 25 is objected to because of the following informalities: The phrase “following first administration on day 1” in lines 2-3 should recite “following the first administration of the antibody”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
12. 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.
13. Claims 13 and 24 are 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. In the instant case, claim 13 recites -15% as the lower range of the reduction in EASI score and claim 24 recites -10% as the lower range of the reduction in EASI score, both of which are lower than the claim from which they depend (claim 1), which recites -20% as the lower range of the reduction in EASI score. 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.
Claim Rejections - 35 USC § 112
14. 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.
15. Claims 1-25 are 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.
16. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation “an anti-IL-13R antibody having 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”, and the claim also recites “wherein the anti-IL13R antibody is ASLAN004” which is the narrower statement of the range/limitation. An antibody which is defined by only the heavy and light chain variable region sequences is broader in scope that the antibody designated as ASLAN004, which has defined sequences for not only the variable regions, but for the constant domains as well. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
17. Claim 8 is rejected as being indefinite because there is no reference for the terms “less frequently”, “lower dose”, “same frequency”, or “”less frequently”, therefor it is not clear what is encompassed by the claim. Amending the claim to recite, for example, “… less frequently, or a lower does administered as the same frequency or less frequently as the treatment cycle” would be remedial.
18. Claims 24 and 25 recite the limitation "disease modification. There is insufficient antecedent basis for this limitation in the claim. Claim 1, from which these claims depend, does not recite “disease modification”. Amending the claims to recite, for example, “… wherein the reduction in EASI score” would be remedial. It is noted that the limitation “wherein disease modification is a reduction in EASI score” should then be deleted from claim 24.
19. Claims 2-25 are rejected for depending from an indefinite claim.
Summary
20. No claim is allowed.
Advisory Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JON M LOCKARD whose telephone number is (571) 272-2717. The examiner can normally be reached M-F 9-6 EST.
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, Joanne Hama can be reached on (571) 272-2911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JON M LOCKARD/Examiner, Art Unit 1647 May 28, 2026
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