DETAILED ACTION
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 .
Claims Status
Claim(s) 1-30 is/are currently pending and presented for examination on the merits.
Specification
The specification is objected to because of the status of U.S. Application 17/882,932 [e.g., ¶ 0001] which has been issued as U.S. Patent No. 12,692,302 (Notice of Allowance mailed on 05/06/2026).
Claim Interpretation
Claims 1-14 and 15-30 are drawn to methods comprising the administration of an anti-IL13 antibody comprising (1) HCDR1-3 and LCDR1-3 (SEQ ID NOs: 5-7 and 8-10, respectively); (2) a VH and VL (SEQ ID NOs: 1 and 2, respectively); and/or (3) a HC and LC (SEQ ID NOs: 11-12, respectively). The instant specification ‘Table Of Sequences’ teaches that the above-listed sequences are for the antibody called lebrikizumab [e.g., pgs. 94-95]. A skilled artisan would understand that lebrikizumab is also known as Ebglyss, lbkz, MILR1444A, RG3637, and TNX650. Therefore, any prior art teaching lebrikizumab, Ebglyss, lbkz, MILR1444A, RG3637, or TNX650 are considered to teach the above-listed sequences.
Claims 11 and 28 recite the requirement of a Rajka/Langeland criteria score between 4.5 to 9. Moderate to severe atopic dermatitis has a Rajka/Langeland score of 4.5-9, as evidenced by Draelos et al. (Derm. Ther. 2019 9:71-102; e.g., table 3). Further, the instant specification provides that moderate to severe atopic dermatitis has a Rajka/Langeland score between 4.5-9 [e.g., ¶ 0023]. Therefore, any prior art teachings of moderate to severe atopic dermatitis will be considered to teach a Rajka/Langeland score between 4.5-9.
Claim Objections
Claims 1-14 is/are objected to because of the following informalities: claim 1 line 4 recites “…a subsequent maintenance dose of…” (e.g., singular only) but should be “…one or more subsequent maintenance doses of…” (e.g., singular or plural). This is suggested for clarity of the record because claim 1 lines 5-6 recites “…the maintenance dose is administered for the remainder of treatment duration…” (e.g., singular or plural). Appropriate correction is requested.
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.
Claim(s) 1-4, 9-21, 26-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over NCT02340234 (2015-05-06 update relied upon herein; hereinafter “NCT234”).
Regarding instant claim(s) 1-4, 9-21, 26-30, NCT234 discloses a study of lebrikizumab in participants with moderate to severe atopic dermatitis (AD), wherein the lebrikizumab is administered by subcutaneous injection (e.g., by a subcutaneous administration device) and participants are 18-75 years old with moderate to severe AD that is inadequately controlled by topical steroids [e.g., pgs. 6-8, 10]. Additionally, NCT234 teaches AD as graded by the Rajka/Langeland criteria at screening [e.g., pg. 11]. (Note: see claim interpretations above for additional details)
NCT234 does not expressly teach the anti-IL13 antibody treatment regimen (e.g., dose(s), dose interval(s), duration).
It would have been prima facie obvious to a person having ordinary skill in the art (PHOSITA) before the effective filing date of the claimed invention to optimize the treatment regimen in the method of treating atopic dermatitis taught by NCT234. Regarding the specific treatment regimen (e.g., dosage(s), dosing intervals, treatment duration etc.) recited in the instant claims "[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), and see M.P.E.P. § 2144.05 II.A. Moreover, it is well settled that "discovery 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, 205 USPQ 215, 219 (CCPA 1980). See also Merck & Co. v. Biocraft Labs. Inc., 874 F.2d 804,809, 10 USPQ2d 1843, 1847-48 (Fed. Cir. 1989). This is because, as is made clear from the prior art, the determination of the treatment regimen of a known drug is well within the purview of one of ordinary skill in the art at the time the invention was made, and it would have been obvious to one of ordinary skill in the art at the time Applicants' invention was made to determine optimal treatment regimens (e.g., dose(s), intervals, duration, etc.) of treatment because optimal dose(s), interval(s), and duration is/are an art-recognized result-effective variable which would have been routinely determined and optimized in the pharmaceutical art. Therefore, it would be conventional and within the skill of the art to identify the optimal dosages administered and optimal intervals to achieve target levels and therapeutically effective doses. Further, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. It is clear that both the prior art and claimed method perform the same protocol to achieve the same results. It would be conventional and within the skill of the art to determine the optimal treatment regimens. Accordingly, one can see that the courts, over a period of over 50 years, have consistently held that treatment (i.e. dosage, intervals, etc.) optimization is obvious.
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
Claim(s) 5, 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over NCT02340234 (2015-05-06 update relied upon herein; hereinafter “NCT234”) as applied to claim(s) 1, 4, 15, 21 above, and further in view of WO 2013/148232 A1 (hereinafter “WO232”).
The teachings of NCT234 as recited above are applied.
NCT234 does not expressly teach the that the subcutaneous administration device is a prefilled syringe.
Regarding claims 5, 22, WO232 teaches subcutaneous injection of Lebrikizumab with a prefilled syringe [e.g., ¶ 0230].
Further, it would have been obvious to a PHOSITA to modify the modified method of treating moderate to severe atopic dermatitis (AD) comprising subcutaneous administration of Lebrikizumab as taught by NCT234 (see above) to include the that the subcutaneous administration advice is a prefilled syringe as taught by WO232. A PHOSITA would have understood that the prior art for a known in the art therapeutic (e.g., lebrikizumab) should teach appropriate subcutaneous administration device(s) for the lebrikizumab antibody. There is an expectation of success for a PHOPSITA to substitute the general subcutaneous administration in the modified method of treating moderate to severe atopic dermatitis (AD) comprising subcutaneous administration of Lebrikizumab, with the specific subcutaneous lebrikizumab administration by prefilled syringe as taught by WO232, because NCT234 teaches the base method comprising subcutaneous lebrikizumab administration but dose not specify the subcutaneous administration device, and WO232 teaches that lebrikizumab subcutaneous administration by a prefilled syringe. This rationale aligns with the principle of simple substitution of one known element for another to obtain predictable results, supporting a conclusion of obviousness (see MPEP § 2141).
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
Claim(s) 6-8, 23-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over NCT02340234 (2015-05-06 update relied upon herein; hereinafter “NCT234”) as applied to claim(s) 1, 4, 15, 21 above, and further in view of US 2009/0060906 A1 (hereinafter “US906”), as evidenced by Buys (American Family Physician. 2007;75(4):523-528.; hereinafter “Buys”).
The teachings of NCT234 as recited above are applied.
NCT234 does not expressly teach the that the anti-IL13 antibody is co-administered in combination with hydrocortisone.
Regarding claims 6-8, 23-25, US903 teaches anti-IL13 antibody therapy for the treatment of IL-13-associated diseases or disorders including atopic dermatitis [e.g., title, abstract; ¶ 0015, 0067, 0097]. US903 further teaches combination therapy comprising an anti-IL13 antibody and hydrocortisone co-administration, wherein the IL13 antibody may be different than those taught by US903 [e.g., ¶ 0014, 0105].
Further, it would have been obvious to a PHOSITA to modify the modified method of treating moderate to severe atopic dermatitis (AD) comprising subcutaneous administration of Lebrikizumab as taught by NCT234 (see above) to include the co-administration of hydrocortisone as taught by US903, because NCT234 teaches the base method, and US903 teaches anti-IL13 antibodies (e.g., lebrikizumab) co-administered with hydrocortisone as an effective therapy for IL13 mediated diseases including atopic dermatitis. US903 does not expressly teach that the hydrocortisone is topical, however, one of ordinary skill in the art would understand that hydrocortisone is a common topical therapy for atopic dermatitis, as evidenced by Buys [e.g., tbl. 3], and therefore the use of a topical form of hydrocortisone for atopic dermatitis combination treatment is considered obvious. There is an expectation of success for a PHOPSITA to further modify the modified method of treating moderate to severe atopic dermatitis (AD) comprising subcutaneous administration of Lebrikizumab as taught by NCT234 (see above) to include the co-administration of a topical hydrocortisone as taught by US903 and evidenced by Buys (see above), because NCT234 teaches the base method, and US903 teaches anti-IL13 antibodies (e.g., lebrikizumab) co-administered with hydrocortisone as an effective therapy for IL13 mediated diseases including atopic dermatitis, and Buys evidences that topical application of hydrocortisone is common in the art for atopic dermatitis treatment. This rationale aligns with the principle of applying a known technique to a known method to yield predictable results, supporting a conclusion of obviousness (see MPEP § 2143).
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
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.
Claims 1-30 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 13-14, 16-25, 30-31 of U.S. Patent No. 11,434,286 (hereinafter “US286”). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claim(s) 1-4, , US286 claim 1 teaches A method of treating atopic dermatitis in a patient in need thereof, the method comprising subcutaneously administering to the patient an anti-IL-13 antibody, wherein administering comprises administering a loading dose of 500 mg of the anti-IL-13 antibody and administering a subsequent maintenance dose of 250 mg of the anti-IL-13 antibody, wherein the loading dose is administered once or twice, and the maintenance dose is administered for the remainder of treatment duration, wherein the anti-IL-13 antibody is an antibody comprising a heavy chain having the amino acid sequence of SEQ ID NO: 11 and a light chain having the amino acid sequence of SEQ ID NO: 12 (see alignments below; comprises the CDRs and VH/VL of the instant invention too- see claim interpretation above).
Alignment of instant anti-IL13 lebrikizumab HC (SEQ ID NO: 11) with US286 anti-IL13 antibody HC (SEQ 11):
CLUSTAL O(1.2.4) multiple sequence alignment
Instant_Seq11 QVTLRESGPALVKPTQTLTLTCTVSGFSLSAYSVNWIRQPPGKALEWLAMIWGDGKIVYN 60
US286_Seq11 QVTLRESGPALVKPTQTLTLTCTVSGFSLSAYSVNWIRQPPGKALEWLAMIWGDGKIVYN 60
************************************************************
Instant_Seq11 SALKSRLTISKDTSKNQVVLTMTNMDPVDTATYYCAGDGYYPYAMDNWGQGSLVTVSSAS 120
US286_Seq11 SALKSRLTISKDTSKNQVVLTMTNMDPVDTATYYCAGDGYYPYAMDNWGQGSLVTVSSAS 120
************************************************************
Instant_Seq11 TKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGL 180
US286_Seq11 TKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGL 180
************************************************************
Instant_Seq11 YSLSSVVTVPSSSLGTKTYTCNVDHKPSNTKVDKRVESKYGPPCPPCPAPEFLGGPSVFL 240
US286_Seq11 YSLSSVVTVPSSSLGTKTYTCNVDHKPSNTKVDKRVESKYGPPCPPCPAPEFLGGPSVFL 240
************************************************************
Instant_Seq11 FPPKPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWYVDGVEVHNAKTKPREEQFNSTYRV 300
US286_Seq11 FPPKPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWYVDGVEVHNAKTKPREEQFNSTYRV 300
************************************************************
Instant_Seq11 VSVLTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISKAKGQPREPQVYTLPPSQEEMTKNQ 360
US286_Seq11 VSVLTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISKAKGQPREPQVYTLPPSQEEMTKNQ 360
************************************************************
Instant_Seq11 VSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSRLTVDKSRWQEGNV 420
US286_Seq11 VSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSRLTVDKSRWQEGNV 420
************************************************************
Instant_Seq11 FSCSVMHEALHNHYTQKSLSLSLGK 445
US286_Seq11 FSCSVMHEALHNHYTQKSLSLSLGK 445
*************************
Alignment of instant anti-IL13 lebrikizumab LC (SEQ ID NO: 12) with US286 anti-IL13 antibody HC (SEQ 12):
CLUSTAL O(1.2.4) multiple sequence alignment
Instant_Seq12 DIVMTQSPDSLSVSLGERATINCRASKSVDSYGNSFMHWYQQKPGQPPKLLIYLASNLES 60
US286_Seq12 DIVMTQSPDSLSVSLGERATINCRASKSVDSYGNSFMHWYQQKPGQPPKLLIYLASNLES 60
************************************************************
Instant_Seq12 GVPDRFSGSGSGTDFTLTISSLQAEDVAVYYCQQNNEDPRTFGGGTKVEIKRTVAAPSVF 120
US286_Seq12 GVPDRFSGSGSGTDFTLTISSLQAEDVAVYYCQQNNEDPRTFGGGTKVEIKRTVAAPSVF 120
************************************************************
Instant_Seq12 IFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLS 180
US286_Seq12 IFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLS 180
************************************************************
Instant_Seq12 STLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 218
US286_Seq12 STLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 218
**************************************
Regarding instant claim(s) 4-5 , US286 claim 8 teaches the anti-IL13 antibody is administered using a subcutaneous administration device selected from a prefilled syringe, disposable pen injection device, microneedle device, microinfuser device, needle-free injection device, or autoinjector device.
Regarding instant claim(s) 6-8 , US286 claims 13-14 teaches the method further comprises the administration of one or more topical corticosteroids selected from triamcinolone acetonide, hydrocortisone, and a combination of triamcinolone acetonide and hydrocortisone.
Regarding instant claim(s) 9, US286 claim 5 teaches the patient is 12 years of age or older.
Regarding instant claim(s) 10, US286 claim 6 teaches the patient’s atopic dermatitis is inadequately controlled by topical corticosteroids.
Regarding instant claim(s) 11, US286 claim 7 teaches the patient has moderate to severe atopic dermatitis as determined by Rajka/Langeland criteria score and wherein the Rajka/Langeland criteria score is determined to be between 4.5 and 9.
Regarding instant claim(s) 12, US286 claim 2 teaches the maintenance dose is administered once every four weeks for the treatment duration.
Regarding instant claim(s) 13, US286 claim 3 teaches the treatment duration is 16-24 weeks.
Regarding instant claim(s) 14, US286 claim 4 teaches the treatment duration is 24 weeks or more.
Regarding instant claim(s) 15-17, US286 claim 16 teaches A method of treating atopic dermatitis in a patient in need thereof, the method comprising subcutaneously administering to the patient an anti-IL-13 antibody, wherein administering comprises:
a first loading dose of 500 mg of the anti-IL-13 antibody;
a second loading dose of 500 mg of the anti-IL-13
antibody; and
a maintenance dose of250 mg of the anti-IL-13 antibody;
wherein the anti-IL-13 antibody is an antibody comprising a heavy chain having the amino acid sequence of SEQ ID NO: 11 and a light chain having the amino acid sequence of SEQ ID NO: 12 (see sequence alignments above).
Regarding instant claim(s) 18, US286 claim 17 teaches the second loading dose is administered 15 days after the first loading dose.
Regarding instant claim(s) 19, US286 claim 18 teaches the maintenance dose is administered two weeks after the second loading dose.
Regarding instant claim(s) 20, US286 claim 19 teaches the maintenance dose is administered more than once.
Regarding instant claim(s) 21-22, US286 claim 25 teaches the anti-IL-13 antibody is administered to the patient using a subcutaneous administration device selected from a prefilled syringe, disposable pen injection device, microneedle device, microinfuser device, needle-free injection device, or autoinjector device.
Regarding instant claim(s) 23-25, US286 claims 30-31 teaches the method further comprises administration of one or more topical corticosteroids selected from triamcinolone acetonide, hydrocortisone, and a combination of triamcinolone acetonide and hydrocortisone.
Regarding instant claim(s) 26, US286 claim 22 teaches the patient is 12 years of age or older.
Regarding instant claim(s) 27, US286 claim 23 teaches the patient's atopic dermatitis is inadequately controlled by topical corticosteroids.
Regarding instant claim(s) 28, US286 claim 24 teaches the patient has moderate to severe atopic dermatitis as determined by Rajka/Langeland criteria score and wherein the Rajka/Langeland criteria score is determined to be between 4.5 and 9.
Regarding instant claim(s) 29, US286 claim 20 teaches the anti-IL-13 antibody is administered for a treatment duration of 16-24 weeks.
Regarding instant claim(s) 30, US286 claim 21 teaches the anti-IL-13 antibody is administered for a treatment duration of 24 weeks or more.
Conclusion
No claims are currently allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY M CHATTIN whose telephone number is (571)270-0646. The examiner can normally be reached T-F 0600-1600 PST.
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/AMY M. CHATTIN/Examiner, Art Unit 1643
/GARY B NICKOL/Primary Examiner, Art Unit 1643
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