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 .
Claim Objections
Claim 14 is objected to because of the following informalities: This claim is dependent upon cancelled claim 13. For the purposes of examination, claim 14 will be examined as if it depends from claim 1. Appropriate correction is required.
Additionally, applicant is advised that should claim 8 be found allowable, claim 9 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112b
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.
Claim 14 does not specify the properties of the pharmaceutical composition to be administered, and as such, the scope of the claim cannot be determined with reasonable certainty.
Claim 14 recites the limitation "wherein the IL-5 mediated disease is asthma." There is insufficient antecedent basis for this limitation in the claim.
Therefore, claim 14 is rejected under 35 U.S.C. 112(b) for being indefinite.
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(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 1-12, 14-16, 18, and 20 are rejected under 35 U.S.C. 102a1 as being anticipated by Grant et al., U.S. Patent No. 10787509.
Claims 1-7 and 12 are drawn to a pharmaceutical composition and claims 8-11, 14-16, 18, and 20 are drawn to methods of use.
Regarding instant claims 1-6, Grant et al. discloses an antigen binding protein that binds IL-5, wherein the composition may comprise a pharmaceutically acceptable excipient [see specification, col. 25, line 67] and is administered at a dose of about 100mg [see specification, col. 31, lines 13-14] (instant claims 1 and 2). The antigen binding protein comprises a full-length heavy chain having the amino acid sequence of SEQ ID NO 1 and a full-length light chain having the amino acid sequence of SEQ ID NO 2 [see claim 11]. These sequences correspond to the full length heavy and light chains of the claimed composition of the instant application, as set forth in instant SEQ ID NOs 1 and 2 (instant claim 6), which contain the heavy and light chain variable regions set forth in instant SEQ ID NOs 3 and 4 (instant claim 5), as well as the heavy and light chain CDRs set forth in instant SEQ ID NOs 5-10 (instant claim 1) and heavy chain FR4 amino sequence set forth in instant SEQ ID NO 19 (instant claim 3). Grant et al. further disclose that the heavy chain comprises an IgG1 Fc domain [as enumerated in SEQ ID NO 1, but also see specification, col. 25, lines 36-40] (instant claim 4) containing a tyrosine residue at position 252, a threonine residue at position 254, and a glutamic acid residue at position 256, and that the amino terminus of the Fc domain is connected to a carboxy terminus of the heavy chain variable region [see claim 3] (instant claim 1).
Regarding claims 7-12 and 14-16, Grant et al. discloses that the antigen binding protein may be administered subcutaneously [see specification, col. 26, lines 2-3] (instant claim 7), once every six months [see specification, col. 31, lines 34-38] (instant claims 8 and 9), typically to human subjects [see specification, col. 32, line 11] (instant claim 10). Said subjects may have severe eosinophilic asthma [see specification, col. 6, lines 18-20] (instant claims 14-16), which is characterized by a blood eosinophil count of greater than or equal to 150 cells per uL [see specification, col. 13, lines 21-25] (instant claim 11). The pharmaceutically effective excipient comprises an aqueous liquid formulation at about pH 6.0 and containing about 40mM histidine, 180mM trehalose, 100mM arginine, 8mM methionine, 0.02% weight of polysorbate 80 to volume, and 0.05mM EDTA [see specification, col. 48, lines 58-64] (instant claim 12).
Regarding claims 18 and 20, Grant et al. discloses a method of treating severe eosinophilic asthma (an IL-5 mediated disease) by administering the antigen binding protein of instant claim 1 at about 2mg to 600mg, about once every three to about once every six months [see specification, col. 49, lines 43-46] (instant claim 18). Although the method does not explicitly recite the intended use of decreasing an absolute blood eosinophil count nor does it explicitly state that absolute blood eosinophil count is decreased following treatment (instant claim 20), this is an inherent property of the treatment.
Therefore, claims 1-12, 14-16, 18, and 20 are rejected under 35 U.S.C. 102a1.
Claim Rejections - 35 USC § 103
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.
Claims 21-23 and 25 are rejected under 35 U.S.C. 103 as being obvious over Grant et al., U.S. Patent No. 10787509, in view of Vermeire et al.
Claims 21-23 are drawn to a prefilled syringe and claim 25 is drawn to a safety syringe device or autoinjector.
Grant et al.’s disclosure is discussed above.
Grant et al. do not disclose a pre-filled syringe comprising the antigen binding protein or an additional aqueous liquid formation.
Vermeire et al. discloses the use of pre-filled syringes and autoinjectors for the administration of monoclonal antibodies [see p. 15, abstract].
It would have been obvious to a person having ordinary skill in the art to place the antigen binding protein of Grant et al. into a pre-filled syringe or autoinjector because these devices were routine and conventional delivery systems for administering monoclonal antibodies, and one would have been motivated to do so to provide a convenient and reliable method of administration (instant claims 21-23 and 25). Additionally, it would have been obvious to include the claimed aqueous liquid formulation as Grant et al. state that it is a pharmaceutically effective excipient [see specification, col. 48, lines 58-64], and utilizing this known formulation would better ensure efficacy.
Therefore, claims 21-23 and 25 are rejected under 35 U.S.C. 103.
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 1-7, 10, 11, 14, and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of Grant et al., U.S. Patent No. 10787509, in view of US Clinical trial NCT03287310. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to an antigen binding protein comprising the same heavy and light chain compositions. Specifically, the claims of Grant et al. recite an antigen binding protein which comprises a full-length heavy chain having the amino acid sequence of SEQ ID NO 1 and a full-length light chain having the amino acid sequence of SEQ ID NO 2 [see claim 11]. These sequences correspond to the full length heavy and light chains of the claimed composition of the instant application, as set forth in instant SEQ ID NOs 1 and 2 (instant claim 6), which contain the heavy and light chain variable regions set forth in instant SEQ ID NOs 3 and 4 (instant claim 5), as well as the heavy and light chain CDRs set forth in instant SEQ ID NOs 5-10 (instant claim 1) and heavy chain FR4 amino sequence set forth in instant SEQ ID NO 19 (instant claim 3). Grant et al. further disclose that the heavy chain comprises an IgG1 Fc domain [as enumerated in SEQ ID NO 1] (instant claim 4) containing a tyrosine residue at position 252, a threonine residue at position 254, and a glutamic acid residue at position 256, and that the amino terminus of the Fc domain is connected to a carboxy terminus of the heavy chain variable region [see claim 3] (instant claim 1).
The differences between the claim sets are as follows. The claims of Grant et al. do not recite a pharmaceutical composition, a pharmaceutically acceptable excipient, administration guidelines, nor subject inclusion criteria.
However, NCT03287310 teaches administration of an IL-5 monoclonal antibody subcutaneously [see p. 3, brief summary, line 5] (instant claim 7) at a concentration of 100mg [see p. 4, col 1, cohort 4] (instant claim 2) for the treatment of moderate asthma (instant claims 14, and 15). Administration of the antibody necessarily requires it to be formulated in a pharmaceutically acceptable excipient (instant claim 1). Subjects in the study included humans (instant claim 10) with blood eosinophil levels >=200 cells per uL [see p. 3, brief summary, line 8] (instant claim 11).
Therefore, claims 1-7, 10, 11, 14, and 15 are rejected on the ground of nonstatutory double patenting.
Claim 12 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of Grant et al., U.S. Patent No. 10787509, in view of US Clinical trial NCT03287310, and in further view of Kang et al.
The claims of Grant et al. in view of NCT03287310 are discussed above.
The differences between the claim sets are as follows. The claims of Grant et al. in view of NCT03287310 do not disclose the specific pharmaceutical composition of claim 12.
Kang et al. discloses that monoclonal antibodies are typically formulated in compositions of pH 4.7-7.4 and comprising histidine, trehalose, arginine, and EDTA [see p. 2, bullets 2, 4, 6, and 7] (instant claim 12). As such, it would have been obvious for one of ordinary skill in the art to combine these teachings and prepare a liquid antibody composition comprising the claimed components as those components were routine in the art to optimize protein stability.
Therefore, claim 12 is rejected on the ground of nonstatutory double patenting.
Claim 16 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of Grant et al., U.S. Patent No. 10787509, in view of US Clinical trial NCT03287310, and in further view of US Clinical trial NCT02559791.
The claims of Grant et al. in view of NCT03287310 are discussed above.
The differences between the claim sets are as follows. The claims of Grant et al. in view of NCT03287310 do not disclose or suggest treatment for severe asthma.
NCT02559791 discloses the use of an IL-5 antibody for the treatment of severe asthma [see p. 7, Conditions]. It would have been obvious for a person having ordinary skill in the art to combine these teachings and administer the claimed IL-5 antibody to patients with severe asthma as utilizing IL-5 antibodies to treat this condition was known in the art, and the antibody effects were predictable. One would have been motivated to do so as this population of patients are those with the greatest need of treatment.
Therefore, claim 16 is rejected on the ground of nonstatutory double patenting.
Claims 8, 9, 18, and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of Grant et al., U.S. Patent No. 10787509, in view of US Clinical trial NCT03287310, and in further view of Domachowske et al.
The claims of Grant et al. in view of NCT03287310 are discussed above.
The differences between the claim sets are as follows. The claims of Grant et al. in view of NCT03287310 do not disclose or suggest treatment about once every 6 months.
Domachowske et al. disclose that YTE modifications extend serum half-life beyond the typical 21-28 days [see p. 3, paragraph 3, line 8], and a single dose of an RSV-neutralizing YTE modified monoclonal antibody provides protection for approximately 5 months in humans, which falls within the claimed range of about 6 months, specifically stating “the extended half-life of MEDI8897 and demonstrated RSV-neutralizing activity support protection from RSV for the duration of a typical 5-month season after a single 50 mg intramuscular (IM) dose” [see p. 3 conclusions, line 3]. Given this, it would have been obvious for one of ordinary skill in the art to combine these teachings and administer the claimed antibody, which comprises a YTE modification, at a dosing interval of about 6 months (instant claims 8, 9, 18, and 20). One would be motivated to do so to align dosing intervals with durations of effect.
Therefore, claims 8, 9, 18, and 20 are rejected on the ground of nonstatutory double patenting.
Claims 21-23 and 25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of Grant et al., U.S. Patent No. 10787509, in view of US Clinical trial NCT03287310, and in further view of Vermeire et al.
The claims of Grant et al. in view of NCT03287310 are discussed above.
The claims of Grant et al. in view of NCT03287310 do not disclose or suggest a prefilled syringe or autoinjector.
However, Vermeire et al. disclose the use of pre-filled syringes and autoinjectors for administration of monoclonal antibodies [see p. 15, abstract] (instant claims 21-23 and 25). It would have been obvious to place the antigen binding protein of Grant et al. and a pharmaceutically acceptable excipient into a pre-filled syringe or autoinjector because these devices were routine and conventional delivery systems for administering monoclonal antibodies, and one would have been motivated to do so to provide a convenient and reliable method of administration.
Therefore, claims 21-23 and 25 are rejected on the ground of nonstatutory double patenting.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tirone D Johnson whose telephone number is (571)272-1256. The examiner can normally be reached M-F, 9-5 ET.
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/TIRONE D. JOHNSON/Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675
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