DETAILED ACTION
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 .
Status of Application, Amendments, and/or Claims
2. The Response filed on 02 March 2026 has been entered in full. Claims 26, 29-33, 37 and 40-41 have been amended, and claims 34-35 and 42 have been canceled. Therefore, claims 26-33 and 36-41 are pending and the subject of this Office Action.
Withdrawn Objections and/or Rejections
3. The objection to claim 26 and 45 (claim 45 was erroneously listed) as set forth at pg. 2 of the previous Office action (mailed 02 October 2025) is withdrawn in view of Applicants amendment of claim 26 (filed 02 March 2026).
4. The rejection of claims 26-42 under 35 U.S.C. 112(b) as set forth at pp. 2-4 of the previous Office action (mailed 02 October 2025) is withdrawn in view of Applicants amendment of claims 26, 30-33 and 41 and cancelation of claims 34 and 42 (filed 02 March 2026).
5. The rejection of claim 35 under 35 U.S.C. 112(d) as set forth at pg. 4 of the previous Office action (mailed 02 October 2025) is moot in view of Applicants cancelation of said claim (filed 02 March 2026).
6. The rejection of claims 26-42 under 35 U.S.C. 112(a) (Written Description) as set forth at pp. 5-10 of the previous Office action (mailed 02 October 2025) is withdrawn in view of Applicants amendment of claim 26 (filed 02 March 2026).
Maintained and/or New Objections and/or Rejections
Claim Rejections - 35 USC § 103
7. 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.
8. 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.
9. 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.
10. 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.
11. Claims 26-33 and 36-41 remain rejected under 35 U.S.C. 103 as being obvious over US20210277131. The basis for this rejection is set forth at pp. 10-13 of the previous Office action (mailed 02 October 2025).
The applied reference has a common inventor and assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
12. The reference disclosure anticipates and/or renders obvious the instant claimed invention for a method of treating atopic dermatitis with the ALSN004 clone (SEQ ID NO: 51 and 53) that is administered as a dosage range overlapping with or proximal to the instant claimed dosage amounts (See pg. 3 paragraph [0048], for example). While the reference does not disclose a particular disease baseline for the subjects, it would be obvious to treat any subject, regardless of the disease baseline, as administration of the antibody results in reduction of IgE levels (See Figure 1; pg. 16, paragraph [0262]).
13. 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. “[VW]here the general conditions of a claim are disclosed in the prior art, itis 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). Notably, it is not inventive to claim a particular dosage and/or administration schedule when the “discovery” of optimum dosage values or workable ranges via routine experimentation within the context of a known process represents an activity well-known to those of ordinarily skill in the art. Note in this regard that it is a well settled principal that “[d]iscovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). See also Merck & Co. vv. Biocraft Labs. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1847-48 (Fed. Cir. 1989) (determination of suitable dosage amounts in diuretic compositions considered a matter of routine experimentation and therefore obvious). See MPEP § 2144.05 part II. Furthermore, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense (see KSA International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQe2d 1385 (2007)). 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(q)). Accordingly, the invention, taken as a whole, is prima facie obvious over the combined teachings of the prior art.
14. This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Response to Arguments
15. Applicant’s arguments as they pertain to the rejections have been fully considered but are not persuasive for the following reasons.
16. Applicant argues at pg. 6 of the response (filed 02 March 2026) that Ward silent regarding the features 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-13Rαl antibody in a treatment cycle comprising a dose of 300mg to 600mg, wherein the subject has a disease baseline characterized by a EASI score of 16 or above...", as recited in independent claim 26, as amended. Applicant asserts the instant specification demonstrates surprising and unexpected results in precisely this refractory, biomarker-defined population (e.g., rapid onset by day 15, high EASI-50/75/90 rates, and superior profile vs. dupilumab-failed patients, and argues that a person of ordinary skill in the art would have no motivation, based on Ward, to select the recited patient population or dosing regimen, nor any reasonable expectation of success in achieving the recited clinical endpoints.
17. Applicant's arguments have been fully considered but are not found persuasive for the following reasons. While the reference does not disclose a particular disease baseline for the subjects, it would be obvious to treat, with a high expectation of success, any subject with AD, regardless of the disease baseline or if the AD was not controlled by existing improved medicaments (including dupilumab), as Ward teaches that administration of the antibody results in reduction of IgE levels (See Figure 1; pg. 16, paragraph [0262]); delivers a rapid onset of action (See pg. 3[005] and pg. 16[0276]), and has a lower Ctrough than dupilumab, thus requiring lower, less frequent doses of the antibody (See pg. 16[0274]-[0275]). Moreover, given the elevated IgE levels of the subjects treated in Ward (See Fig. 1), one of ordinary skill in the art would recognize that the subjects all fit within the range of moderate to severe AD, as evidenced by Vaneckova et al (Food and Agricultural Immunology. 27(5):734-741, published 2016). While Ward does not disclose wherein the disease is modified by a reduction in EASI score, it is noted that a compound and all of its properties are inseparable; they are one and the same thing (In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963)), as are their processes and yields (In re Von Schick, 362 F.2d 821, 150 USPQ 300 (CCPA 1966)). Moreover, even though the claims do not recite an active step of measuring EASI scores, it naturally flows that a reduction in the EASI score would be an obvious means for determining the course of treatment as it was well-known at the time the application was filed.
18. While Applicant argues that Ward does not disclose administering subcutaneously an anti-IL-13Rαl antibody in a treatment cycle comprising a dose of 300mg to 600mg, Ward discloses subcutaneous administering 200mg-600mg every 2 weeks, 3 weeks or 4 weeks (i.e., a cycle), which falls withing the range of a “loading dose” or maintenance does” (See pg. 2, [0024]; 3, [0049]). Moreover, as previously stated, it is not inventive to claim a particular dosage and/or administration schedule when the “discovery” of optimum dosage values or workable ranges via routine experimentation within the context of a known process represents an activity well-known to those of ordinarily skill in the art. Note in this regard that it is a well settled principal that “[d]iscovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). See also Merck & Co. vv. Biocraft Labs. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1847-48 (Fed. Cir. 1989) (determination of suitable dosage amounts in diuretic compositions considered a matter of routine experimentation and therefore obvious). See MPEP § 2144.05 part II. Furthermore, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense (see KSA International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQe2d 1385 (2007)).
Double Patenting
19. 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 claims at issue 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); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
20. 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
21. The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
22. Claims 26-33 and 36-41 remain provisionally rejected 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). The reference application is not afforded safe harbor protection under 35 USC 121 because the claims do not share continuity nor a restriction/speciation with the claims of the instant application. The basis for this rejection is set forth at pp. 15-16 of the previous Office action (mailed 02 October 2025).
23. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims anticipate and/or render obvious the instant claimed invention for a method of treating atopic dermatitis with the ALSN004 clone (SEQ ID NO: 51 and 53) that is administered as a dosage range overlapping within or proximal to the instant claimed dosage amounts. 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, itis 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(q)). While the claims do not recite a particular disease baseline for the subjects, it would be obvious to treat any subject with atopic dermatitis, regardless of the disease baseline.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
24. Claims 26-33 and 36-41 remain provisionally rejected 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). The reference application is not afforded safe harbor protection under 35 USC 121 because the claims do not share continuity nor a restriction/speciation with the claims of the instant application. The basis for this rejection is set forth at pp. 16-17 of the previous Office action (mailed 02 October 2025).
25. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims anticipate and/or render obvious the instant claimed invention for a method of treating atopic dermatitis with the ALSN004 clone (CDR1-3 of SEQ ID NO: 51 and CDR1-3 of SEQ ID NO: 53). 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, itis 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(q)). While the claims do not recite a particular disease baseline for the subjects, it would be obvious to treat any subject with atopic dermatitis, regardless of the disease baseline.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
26. Claims 26-33 and 36-41 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of copending Application No. 17/929,874 (reference application US 20230091430). The reference application is not afforded safe harbor protection under 35 USC 121 because the claims do not share continuity nor a restriction/speciation with the claims of the instant application. The basis for this rejection is set forth at pp. 17-18 of the previous Office action (mailed 02 October 2025).
27. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims anticipate and/or render obvious the instant claimed invention for a method of treating atopic dermatitis using with the ALSN004 clone (SEQ ID NO: 51 and 53) that is administered in a dosage range within or proximal to the instant claimed dosage amounts. 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, itis 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(q)). While the claims do not recite a particular disease baseline for the subjects, it would be obvious to treat any subject with atopic dermatitis, regardless of the disease baseline.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
28. Claims 26-33 and 36-41 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 31-49 of copending Application No. 18/695,464 (reference application NOT PUBLISHED). The basis for this rejection is set forth at pp. 18-19 of the previous Office action (mailed 02 October 2025).
29. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims anticipate and/or render obvious the instant claimed invention for a method of treating atopic dermatitis using with an antibody comprising a VH of SEQ ID NO: 51 and a VL of SEQ ID NO: 53 that is administered in a dosage range within or proximal to the instant claimed dosage amounts. While the claims of ‘464 recite treating pruritus, treatment of atopic dermatitis would be obvious since it is well understood in the art that chronic pruritus is a disease-defining symptom of atopic dermatitis, as evidenced by Legat (Frontiers in Medicine. 8: 64476).
30. 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).
31. 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, itis 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(q)). While the claims do not recite a particular disease baseline for the subjects, it would be obvious to treat any subject with atopic dermatitis, regardless of the disease baseline.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
32. Applicants indicate at pg. 7 of the response (filed 02 March 2026) these provisional rejections will be addressed once they become the only remaining rejected is acknowledged. However, it is noted that deferral of arguments until after the claims have been found otherwise allowable will not be considered timely.
Conclusion
33. 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.
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.
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/J.L/Examiner, Art Unit 1647 April 2, 2026
/Christine J Saoud/Primary Examiner, Art Unit 1645