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
The preliminary amendments filed 07/11/2024 are acknowledged.
Claims 1, 9, 18, 29, 32, 35, 39-41, 45, 50-52, 54, 56, 59, 62, 64, and 86-87 are pending.
Claims 2-8, 10-17, 19-28, 30-31, 33-34, 36-38, 42-44, 46-49, 53, 55, 57-58, 60-61, 63, and 65-85 are canceled.
Claims 86-87 are new.
Claims 1, 9, 18, 29, 32, 35, 39-41, 45, 50-52, 54, 56, 59, 62, 64, and 86-87 are under examination.
Priority
The instant application is claims priority to provisional applications 63/453,786, 63/457,188, 63/460,981, 63/525,197, 63/602,616, and 63/551,557 and claims priority to European applications EP24315012.5 and EP24315047.1. Receipt is acknowledged of certified copies of EP24315012.5 as required by 37 CFR 1.55. It is noted, however, that applicant has not filed a certified copy of the EP24315047.1 application as required by 37 CFR 1.55. Priority is given with the earliest effective filing date of 03/22/2023.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 07/11/2024, 01/17/2025, 09/24/2025, 11/19/2025, and 03/26/2026 are in compliance with the provisions of 37 CFR 1.97, except where noted. Accordingly, the information disclosure statement is being considered by the examiner.
The documents lined through on all submitted IDS were not considered because they were not attached, they were illegible, they were not in English, and/or the Examiner could not determine if the attached document corresponded with the cited document.
Notably, the disclosure statement filed lists a Search Report. The listing of the references cited in a Search Report itself is not considered to be an information disclosure statement (IDS) complying with 37 CFR 1.98. 37 CFR 1.98(a)(2) requires a legible copy of: (1) each foreign patent; (2) each publication or that portion which caused it to be listed; (3) for each cited pending U.S. application, the application specification including claims, and any drawing of the application, or that portion of the application which caused it to be listed including any claims directed to that portion, unless the cited pending U.S. application is stored in the Image File Wrapper (IFW) system; and (4) all other information, or that portion which caused it to be listed. In addition, each IDS must include a list of all patents, publications, applications, or other information submitted for consideration by the Office (see 37 CFR 1.98(a)(1) and (b)), and MPEP § 609.04(a), subsection I. states, "the list ... must be submitted on a separate paper." Therefore, the references cited in the Search Report have not been considered. Applicant is advised that the date of submission of any item of information or any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the IDS, including all "statement" requirements of 37 CFR 1.97(e). See MPEP § 609.05(a).
Note: If copies of the individual references cited on the Search Report are also cited separately on the IDS (and these references have not been lined-through) they have been considered.
Drawings
The drawings are objected to because Figures 1, 3-11, 13A-E, 14, 15A-F, 16A-B, 17-19, 20A-F, 21A-B, 22-23, 24A-B, 25-28, 30A-B, 31A-B, 32-69, 70A-B, and 71 are in color. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Specification
The disclosure is objected to because it contains embedded hyperlinks and/or other forms of browser-executable code (see paragraphs [00656] and [00801] of the specification). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http://, www., or other browser-executable code. See MPEP § 608.01.
The disclosure is also objected to because of the following informalities: The specification lists SEQ ID NO: 7 for a skipped sequence [see paragraph 00299 of the instant specification]. Applicant is required to remove the SEQ ID NO. for the skipped sequence and rely only upon the respective amino acid sequence wherever the SEQ ID NO. is referenced in the specification. Appropriate correction is required.
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.
Claims 1, 9, 18, 29, 32, 35, 39-41, 50-52, 54, 56, 59, 62, 64, and 86 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.
Claims 1 and 50 recite the limitation of an anti-IL-4R antibody comprising three heavy chain complementarity determining region (HCDR) sequences of SEQ ID NOs: 3, 4, and 5, respectively, and three light chain complementarity determining region (LCDR) sequences of SEQ ID NOs: 6, 7, and 8, respectively. However, SEQ ID NO: 7 is a skipped sequence. While the specification does specify the three amino acid sequence for SEQ ID NO: 7 [see paragraph 00299 of the instant specification], it is unclear if SEQ ID NO: 7 is referring to the respective three amino acid sequence as listed in the specification or if SEQ ID NO: 7 is referring to a different sequence since the sequence listing does not list the specific three amino acid sequence. Therefore, the scope of this claim is indefinite.
Claims 9, 18, 29, 32, 35, 39-41, 51-52, 54, 56, 59, 62, 64, and 86, which depend from claims 1 and 50, respectively, are therefore indefinite for the same reasons as set forth above.
Applicant can overcome this rejection by amending the claims to recite the specific amino acid sequence for the LCDR2.
For purposes of examination, the Examiner is interpreting SEQ ID NO: 7 as referring to the three amino acid sequence as set forth in paragraph 00299 of the instant specification (i.e. LGS).
Claim Interpretation
Claims 18, 29, 32, 52, and 59 recite the word “optionally.” The Examiner is interpreting everything that succeeds the “optionally” as optional and not required claim limitations, and as such, these limitations are not necessarily included in the rejections below.
Claim Rejections - 35 USC § 102
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.
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 9, 18, 29, 32, 35, 39-41, 45, 50-52, 54, 56, 59, 62, 64, and 86-87 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by NCT03930732, 2022 (instant PTO-892).
Regarding claims 1, 39-40, 45, 50, 64, and 87, NCT03930732 teaches administering dupilumab (IL-4R antagonist; antibody that specifically binds IL-4R) every 2 weeks to treat patients with moderate-or severe Chronic Obstructive Pulmonary Disease (COPD) for a 52 week treatment period [pages 11-12; Study Description]. NCT03930732 also teaches that the inclusion criteria for patients is a history of one or more severe exacerbations or two moderate exacerbations within the year prior to treatment [page 17; Inclusion Criteria]. The Examiner is interpreting this as uncontrolled COPD as evidenced by Roche et al., 2025 that teaches uncontrolled COPD is classified by one or more severe exacerbations or two moderate exacerbations within 12 months [see Abstract; Methods].
Applicant defines dupilumab as an antibody comprising the HCVR/LCVR amino acid sequence pair of SEQ ID NOs: 1 and 2, which comprises the HCDRs 1-3 of SEQ ID NOs: 3-5 and the LCDRs 1-3 of SEQ ID NOs: 6-8 [see paragraphs 00290-00300 of the instant specification]. Thus, the dupilumab of NCT03930732 is the same as the anti-IL-4R antibody/dupilumab with the recited sequences as claimed.
Regarding claims 9, 62, and 86, NCT03930732 teaches that an inclusion criteria is patients with evidence of type 2 inflammation that have blood eosinophils greater than or equal to 300 cells/microliter at visit 1 [page 18; Inclusion Criteria]. Absent evidence to the contrary, the Examiner is interpreting this to be at baseline since this is the inclusion criteria measure for participation in the study.
Regarding claims 18, 52, and 54, NCT03930732 teaches that the dupilumab is administered in combination with an inhaled corticosteroid, inhaled long-acting beta antagonist (LABA), and/or an inhaled long-acting muscarinic antagonist (LAMA) (i.e. background therapies) [page 13; Arms and Interventions]. Further, NCT03930732 teaches that the patients receive background triple therapy of ICS, LABA, and LAMA, or receive double therapy of LABA and LAMA if ICS is contraindicated [page 18; Inclusion Criteria].
Regarding claim 29, this claim merely recites effects or results of administering the claimed anti-IL-4R antibody (i.e. dupilumab). Therefore, since NCT03930732 teaches administering an identical antibody as claimed to treat COPD, a person of ordinary skill in the art would have reasonably expected these effects to occur, absent evidence to the contrary.
Regarding claim 32, NCT03930732 teaches administering dupilumab every 2 weeks (q2w) for a 52 week treatment period [pages 11-12; Study Description]. Thus, this encompasses and first dose (i.e. initial dose) followed by secondary doses every two weeks.
Regarding claims 35 and 51, NCT03930732 teaches that the minimum age for inclusion is 40 years (i.e. an adult) [page 16; Eligibility].
Regarding claim 41, NCT03930732 teaches that the dupilumab is administered subcutaneously [page 13; Arms and Interventions].
Regarding claim 56, since NCT03930732 teaches that the dupilumab is administered in combination with an inhaled corticosteroid, inhaled long-acting beta antagonist (LABA), and/or an inhaled long-acting muscarinic antagonist (LAMA) [page 13; Arms and Interventions and page 18; Inclusion Criteria], the Examiner is interpreting the dupilumab as an add-on treatment.
Regarding claim 59, NCT03930732 teaches that the inclusion criteria for patients is a history of one or more severe exacerbations or two moderate exacerbations within the year prior to treatment [page 17; Inclusion Criteria]. Thus, the patient has a history of COPD exacerbations.
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.
Copending Application No. 19/545,216
Claims 1, 9, 18, 29, 32, 39-41, 45, 50, 52, 56, 59, 62, 64, and 86-87 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 86-87, 89, 94-95, 100, 107-109, 111, and 113 of copending Application No. 19/545,216 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claims 1, 39-40, 45, 50, 56, 59, 64, and 87 of the instant application, claims 86, 95, 100, and 113 of the reference application teach a method of treating chronic obstructive pulmonary disease (COPD) in a subject in need thereof, the method comprising: administering to the subject an anti-interleukin-4 receptor (IL-4R} antibody as an add-on maintenance treatment to a COPD background maintenance therapy, wherein the anti-IL-4R antibody is a full antibody molecule comprising three heavy chain complementarity determining region (HCDR) sequences comprising the amino acid sequences of SEQ ID NOs: 3, 4, and 5, respectively, and three light chain complementarity determining region (LCDR) sequences comprising the amino acid sequences of SEQ ID NO: 6, LGS, and SEQ ID NO: 8, respectively; wherein the anti-IL-4R antibody is administered subcutaneously at a dose of 300 mg every other week (q2w); wherein the subject has a history of COPD exacerbations; wherein the subject has a history of greater than or equal to 1 severe or 2 moderate COPD exacerbations in the year prior to treatment, wherein the method does not comprise administering an IL-33 antagonist to the subject for the treatment of COPD; and wherein the subject achieves a reduction in the risk of moderate or severe COPD exacerbations, in bronchodilator (BD) forced expiratory volume in 1 second (FEV1) and an improvement in St. George's Respiratory Questionnaire (SGRQ) score of at least 4 points from baseline by week 52 of the treatment (i.e. improves one or more symptoms), and claim 87 of the reference application teaches that the anti-IL-4R antibody comprises a heavy chain variable region (HCVR) amino acid sequence of SEQ ID NO: 1 and a light chain variable region (LCVR) amino acid sequence of SEQ ID NO: 2, and claim 88 teaches that the anti-IL-4R antibody is dupilumab, and claim 94 teaches that the COPD is not adequately controlled (i.e. uncontrolled) on the COPD background maintenance therapy.
Applicant defines dupilumab as an antibody comprising the HCVR/LCVR amino acid sequence pair of SEQ ID NOs: 1 and 2, which comprises the HCDRs 1-3 of SEQ ID NOs: 3-5 and the LCDRs 1-3 of SEQ ID NOs: 6-8 [see paragraphs 00290-00300 of the instant specification]. Thus, the dupilumab of reference application is the same as the anti-IL-4R antibody/dupilumab with the recited sequences as claimed.
Regarding claims 9, 62, and 86 of the instant application, claim 107 of the reference application teaches that the subject has a baseline blood eosinophil count of greater than or equal to 300 cells/microliter.
Regarding claims 18 and 52 of the instant application, claim 89 of the reference application teaches that the COPD background maintenance therapy comprises two or more (i.e. double or triple therapy) of the following: a long-acting muscarinic antagonist (LAMA), a long-acting beta agonist (LABA), and an inhaled corticosteroid (ICS).
Regarding claim 29 of the instant application, claim 108 of the reference application teaches that the subject achieves an improvement in St. George's Respiratory Questionnaire (SGRQ) score of at least 4 points from baseline by week 52 of the treatment, claim 109 of the reference application teaches that the subject achieves an improvement in the ratio of post-BD FEV1 to forced vital capacity (FVC) (FEV1/FVC), and claim 111 of the reference application teaches that the subject achieves an improvement in post-BD FEV1/FVC by week 52 of the treatment.
Regarding claims 32 and 41 of the instant application, claims 86, 95, 100, and 113 teach that the dupilumab is administered subcutaneously at a dose of 300 mg every other week (q2w). Thus, this encompasses and first dose (i.e. initial dose) followed by secondary doses every two weeks.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 9, 18, 29, 32, 35, 39-41, 45, 50-52, 54, 56, 59, 62, 64, and 86-87 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 86-87, 89, 94-95, 100, 107-109, 111, and 113 of copending Application No. 19/545,216 (reference application), as applied to claims 1, 9, 18, 29, 32, 39-41, 45, 50, 52, 56, 59, 62, 64, and 86-87 above, and further in view of NCT03930732, 2022 (instant PTO-892).
The teachings of the reference application are above.
However, the reference application does not specifically teach that the subject is at least 40 years old (i.e. an adult) or that ICS use is contraindicated in the patient and that the subject receives double therapy in addition to the antibody or antigen-binding fragment thereof.
Regarding claims 35, 51, and 54 of the instant application, NCT03930732 teaches administering dupilumab (IL-4R antagonist; antibody that specifically binds IL-4R) every 2 weeks to treat patients with moderate-or severe Chronic Obstructive Pulmonary Disease (COPD) for a 52 week treatment period [pages 11-12; Study Description]. NCT03930732 also teaches that the inclusion criteria for patients is a history of one or more severe exacerbations or two moderate exacerbations within the year prior to treatment [page 17; Inclusion Criteria]. NCT03930732 further teaches that the minimum age for inclusion is 40 years (i.e. an adult) [page 16; Eligibility], and that the patients receive background triple therapy of ICS, LABA, and LAMA, or receive double therapy of LABA and LAMA if ICS is contraindicated [page 18; Inclusion Criteria].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have treated the patient population of NCT03930732 with the method of the reference application. One would have been motivated to have treated the patient population NCT03930732 with the method of the reference application because NCT03930732 teaches a method of treating patients with COPD by administering dupilumab and that this patient population is in need of treatment, and the reference application teaches a method of treating COPD comprising administering dupilumab. Thus, there would be a reasonable expectation of success in treating the patient population NCT03930732 with the method of the reference application.
U.S. Patent No. 11,866,503
Claims 1, 39-40, 45, and 87 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 19 of U.S. Patent No. 11,866,503 (‘503). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claims 1, 39-40, 45, and 87, claim 19 of ‘503 teaches a method for treating (i.e. improving one or more symptoms) chronic obstructive pulmonary disease in a subject in need thereof, the method comprising administering to the subject one or more doses of a therapeutically effective amount of an interleukin-33 (IL-33) antagonist in combination with one or more doses of a therapeutically effective amount of an interleukin-4 receptor (IL-4R) antagonist, wherein the IL-33 antagonist is a monoclonal antibody comprising three heavy chain complementarity determining regions, HCDR1, HCDR2, and HCDR3 comprising the amino acid sequences of SEQ ID NOs: 276, 278, and 280, respectively, and a heavy chain variable region (HCVR) comprising an amino acid sequence with 10 or fewer amino acid substitutions relative to SEQ ID NO: 274, and three light chain complementarity determining regions, LCDR1 , LCDR2, and LCDR3, comprising the amino acid sequences of SEQ ID NOs: 284, 286, and 288, respectively, and a light chain variable region (LCVR) comprising an amino acid sequence with 10 or fewer amino acid substitutions relative to SEQ ID NO: 282, and wherein the IL-4R antagonist is a monoclonal antibody (i.e. full antibody) comprising three heavy chain complementarity determining regions, HCDR1, HCDR2, and HCDR3, comprising the amino acid sequences of SEQ ID NOs: 339, 340, and 341, respectively, and a HCVR comprising an amino acid sequence with 10 or fewer amino acid substitutions relative to SEQ ID NO: 337, and three light chain complementarity determining regions, LCDR1 , LCDR2, and LCDR3, comprising the amino acid sequences of SEQ ID NOs: 342, 343, and 344, respectively, and a LCVR comprising an amino acid sequence with 10 or fewer amino acid substitutions relative to SEQ ID NO: 338.
Applicant defines dupilumab as an antibody comprising the HCVR/LCVR amino acid sequence pair of SEQ ID NOs: 1 and 2, which comprises the HCDRs 1-3 of SEQ ID NOs: 3-5 and the LCDRs 103 of SEQ ID NOs: 6-8 [see paragraphs 00290-00300 of the instant specification]. SEQ ID NOs: 337 and 338 of ‘503 have 100% sequence identity to SEQ ID NOs: 1 and 2 of the instant application. Therefore, the IL-4R antagonist of ‘503 is the same as the anti-IL-4R antibody/dupilumab with the recited sequences as claimed.
Claims 1, 9, 18, 29, 32, 35, 39-41, 45, 50-52, 54, 56, 59, 62, 64, and 86-87 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 19 of U.S. Patent No. 11,866,503 (‘503), as applied to claims 1, 39-40, 45, and 87 above, in view of NCT03930732, 2022 (instant PTO-892).
The teachings of the reference application are above.
However, the reference application does not specifically teach that the COPD is uncontrolled.
Regarding claim 50 of the instant application, NCT03930732 teaches administering dupilumab (IL-4R antagonist; antibody that specifically binds IL-4R) every 2 weeks to treat patients with moderate-or severe Chronic Obstructive Pulmonary Disease (COPD) for a 52 week treatment period [pages 11-12; Study Description]. NCT03930732 also teaches that the inclusion criteria for patients is a history of one or more severe exacerbations or two moderate exacerbations within the year prior to treatment [page 17; Inclusion Criteria]. The Examiner is interpreting this as uncontrolled COPD as evidenced by Roche et al., 2025 (instant PTO-892) that teaches uncontrolled COPD is classified by one or more severe, or two moderate exacerbations within 12 months [see Abstract; Methods].
Applicant defines dupilumab as an antibody comprising the HCVR/LCVR amino acid sequence pair of SEQ ID NOs: 1 and 2, which comprises the HCDRs 1-3 of SEQ ID NOs: 3-5 and the LCDRs 1-3 of SEQ ID NOs: 6-8 [see paragraphs 00290-00300 of the instant specification]. Thus, the dupilumab of NCT03930732 is the same as the anti-IL-4R antibody/dupilumab of the reference application.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have treated the patient population of NCT03930732 with the method of the reference application. One would have been motivated to have treated the patient population NCT03930732 with the method of the reference application because NCT03930732 teaches a method of treating patients with COPD by administering dupilumab and that this patient population is in need of treatment, and the reference application teaches a method of treating COPD comprising administering dupilumab. Thus, there would be a reasonable expectation of success in treating the patient population NCT03930732 with the method of the reference application.
Claims 9, 62, and 86 are included in this rejection because NCT03930732 teaches that an inclusion criteria is patients with evidence of type 2 inflammation that have blood eosinophils greater than or equal to 300 cells/microliter at visit 1 [page 18; Inclusion Criteria]. Absent evidence to the contrary, the Examiner is interpreting this to be at baseline since this is the inclusion criteria measure for participation in the study.
Claims 18, 52, and 54 are included in this rejection because NCT03930732 teaches that the dupilumab is administered in combination with an inhaled corticosteroid, inhaled long-acting beta antagonist (LABA), and/or an inhaled long-acting muscarinic antagonist (LAMA) (i.e. background therapies) [page 13; Arms and Interventions]. Further, NCT03930732 teaches that the patients receive background triple therapy of ICS, LABA, and LAMA, or receive double therapy of LABA and LAMA if ICS is contraindicated [page 18; Inclusion Criteria].
Claim 29 is included in this rejection because this claim merely recites effects or results of administering the claimed anti-IL-4R antibody (i.e. dupilumab). Therefore, since NCT03930732 teaches administering an identical antibody as claimed to treat COPD, a person of ordinary skill in the art would have reasonably expected these effects to occur, absent evidence to the contrary.
Claim 32 is included in this rejection because NCT03930732 teaches administering dupilumab every 2 weeks (q2w) for a 52 week treatment period [pages 11-12; Study Description]. Thus, this encompasses and first dose (i.e. initial dose) followed by secondary doses every two weeks.
Claims 35 and 51 are included in this rejection because NCT03930732 teaches that the minimum age for inclusion is 40 years (i.e. an adult) [page 16; Eligibility].
Claim 41 is included in this rejection because NCT03930732 teaches that the dupilumab is administered subcutaneously [page 13; Arms and Interventions].
Claim 56 is included in this rejection because since NCT03930732 teaches that the dupilumab is administered in combination with an inhaled corticosteroid, inhaled long-acting beta antagonist (LABA), and/or an inhaled long-acting muscarinic antagonist (LAMA) [page 13; Arms and Interventions and page 18; Inclusion Criteria], the Examiner is interpreting the dupilumab as an add-on therapy.
Claim 59 is included in this rejection because NCT03930732 teaches that the inclusion criteria for patients is a history of one or more severe exacerbations or two moderate exacerbations within the year prior to treatment [page 17; Inclusion Criteria]. Thus, the patient has a history of COPD exacerbations.
Claim 64 is included in this rejection because claim 19 of ‘503 teaches that the IL-4R antagonist is a monoclonal antibody (i.e. full antibody) comprising a HCVR comprising an amino acid sequence with 10 or fewer amino acid substitutions relative to SEQ ID NO: 337, and a LCVR comprising an amino acid sequence with 10 or fewer amino acid substitutions relative to SEQ ID NO: 338.
Applicant defines dupilumab as an antibody comprising the HCVR/LCVR amino acid sequence pair of SEQ ID NOs: 1 and 2, which comprises the HCDRs 1-3 of SEQ ID NOs: 3-5 and the LCDRs 103 of SEQ ID NOs: 6-8 [see paragraphs 00290-00300 of the instant specification]. SEQ ID NOs: 337 and 338 of ‘503 have 100% sequence identity to SEQ ID NOs: 1 and 2 of the instant application. Therefore, the IL-4R antagonist of ‘503 is the same as the anti-IL-4R antibody/dupilumab with the recited sequences as claimed.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brittney E Donoghue whose telephone number is (571)272-9883. The examiner can normally be reached Mon - Fri 7:30 - 3:30.
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, Jeffrey Stucker can be reached at (571) 272-0911. 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.
/B.E.D./Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675
Prosecution Insights