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 Status
Applicant’s amendments and remarks, filed 05/02/2024, are acknowledged.
Claims 5, 6, 8, 14, 15, 21, 22, 26, 28, 29, 34, 35, 40, 42, 43, 45, 46, 48, 51, 52, 54, 55, 63, 66-73, and 76-88 are canceled.
Claims 3, 4, 7, 9, 12, 13, 16, 19, 20, 23, 25, 27, 30, 33, 36, 39, 41, 44, 47, 50, 53, 57-60, 62, 64, 65, 75, and 89 are amended.
Claims 1-4, 7, 9-13, 16-20, 23-25, 27, 30-33, 36-39, 41, 44, 47, 49, 50, 53, 56-62, 64, 65, 74, 75, and 89 are pending.
DETAILED ACTION
Election/Restriction
Applicant’s election of Group I, claims 1-4, 7, 9-13, 16-20, 23-25, 27, 30-33, 36-39, 41, 44, 47, 49, 50, 53, and 56-59, in the reply filed on 06/05/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 60-62, 64, 65, 74, 75, and 89 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/05/2026.
As such, claims 1-4, 7, 9-13, 16-20, 23-25, 27, 30-33, 36-39, 41, 44, 47, 49, 50, 53, and 56-59 are pending examination and currently under consideration for patentability under 37 CFR 1.104.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 02/23/2024, 12/16/2025, 4/15/2026, and 7/13/26. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Specification
The disclosure is objected to because of the following informalities:
[0206]: “summarized in Table” should read “summarized in Table 12”.
[0207]: “as summarized in Table” should read “as summarized in Table 13”.
Appropriate correction is required.
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see [0136]). 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:// or other browser-executable code. See MPEP § 608.01.
The use of the term Janssen, ATCC, Sigma, TOSOH Bioscience, GE Healthcare, Agilent, Thermo Scientific, BioPro, Waters, and Optilab, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claims 9, 16, 23, 30, 36, 47, 49, and 56 are objected to because of the following informalities:
Claims 9, 16, 23, 30, 36, and 47: “TSLP” and “TSLPR” are acronyms and/or abbreviations which should be spelled out on first occurrence.
Claim 49: “and or” should read “and/or”.
Claim 56: “SE-HPLC” and “rCE-SDS” are acronyms and/or abbreviations which should be spelled out on first occurrence.
Appropriate correction is required.
Claim Interpretation
Claims 33 and 47 recite the transitional phrase “having”, the scope of which is not defined by the specification. As such, according to MPEP 2111.03(IV), the term will be interpreted as an open-ended transitional term, similar to the transitional phrase “comprising”. For example, the structure recited in the claims can comprise additional, unrecited elements.
Additionally, Examiner acknowledges:
“isomerization derivatives” comprise of alterations to aspartic acid residues (see [0122]);
“deamidation derivatives” comprise of alterations to asparagine residues (see [0123]);
“oxidation derivatives” comprise of alterations to one or more methionine or tryptophan residues in the protein (see [0124]);
“high molecular weight derivatives” comprise of aggregation of antibodies, either into dimers or larger protein aggregates (see [0125]);
“Tezepelumab fragment derivatives” includes protein products that may be cleaved by internal peptidases during production or produced by other steps in the production process (see [0126]);
“glycosylation derivatives of Tezepelumab” comprise of alterations of the profile of sugar residues that can be post-translationally applied to asparagine residues in the Fc region of an antibody (see [0127]);
“Tezepelumab or Tezepelumab derivatives with ‘less clearance’” refers to the amount of clearance from the body (blood or serum) being less when compared to the clearance of a reference antibody, e.g., Tezepelumab or other IgG2 antibody (see [0128]); and,
“disulfide isoform derivatives” comprise an IgG2-B isoform and/or an IgG2-A/B isoform (see [0130]).
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 18 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 18 is drawn to the composition of claim 17, wherein the amount of the oxidation derivative in the composition is between about 0.4% to about 7%. However, claim 17 recites that the amount of the oxidation derivative in the composition is less than about 7%. Thus, the “about 7%” limitation in claim 18 broadens the scope of claim 17.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 112(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 1-4, 7, 9-13, 16-20, 23-25, 27, 30-33, 36-39, 41, 44, 47, 49, 50, 53, and 56-59 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.
The term “about” in claims 1, 2, 4, 10, 11, 13, 17, 18, 20, 24, 25, 31, 33, 37, 38, 41, 44, 49, 50, 53, and 56 renders the claim scope indefinite. In determining the range encompassed by the term "about" , one must consider the context of the term as it is used in the specification and claims of the application. Ortho-McNeil Pharm., Inc. v. Caraco Pharm. Labs., Ltd., 476 F.3d 1321, 1326, 81 USPQ2d 1427, 1432 (Fed. Cir. 2007). There is nothing in the specification, prosecution history, or the prior art to provide any indication as to what range of specific activity is covered by the term "about." See MPEP 2173.05(b)(III)(A) and Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991).
Further, claims 1, 4, 10, 13, 17, 20, 24, 31, 33, 37, 38, 41, 44, 49, 50, and 53 recite “less than about” and/or “more than about” which renders the claims indefinite because the phrase “less than” and “more than” indicate a limit but the term “about” means an acceptable error for a particular value without providing a standard to determine what is considered acceptable. As such, one would not be apprised as to what is encompassed by the language.
Claims 1, 10, 17, 24, 31, 37, and 57-58 recite “amino acid sequence set out in SEQ ID NO: XX”. This language is indefinite because it is unclear if the amino acid is limited to the full sequence of the SEQ ID NO., or the amino acid sequence can be of any length as long as the SEQ ID NO. is within the sequence, respectively. The phrase “set out in SEQ ID NO: XX” could refer to any two amino acids joined by a peptide bond that appears within the sequence of SEQ ID NO: XX. As such, claims 1, 10, 17, 24, 31, 37, 57-58, and their dependent claims, are rejected.
Claims 4, 12, 13, 19, and 20 recite amino acid residues that exceed the number of residues of the corresponding SEQ ID NO. For example, claim 4 recites “D49, D50 or D52 of SEQ ID NO: 4”. SEQ ID NO: 4 comprises of 7 amino acid residues. Without knowing the entire structure of the light chain, the amino acid positions recited are relative, especially in reference to a derivative of the reference amino acid that allows alterations (i.e., mutations) of the structure.
Claims 12 and 13 recite two amino acids split between a slash (e.g., “N25/N26”). It is unclear if this is indicating that deamidation is for both residues, or deamidation is at either the first residue or the second.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 25 recites the broad recitation “about 1.7% or less”, and the claim also recites “about 1.4% or less” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
The term “high molecular weight” in claims 24-25, 27, 30, and 56 is a relative term which renders the claim indefinite. The term “ high molecular weight” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As stated above, it is acknowledged that the specification defines a “high molecular weight derivative” to comprise of aggregation of antibodies, either into dimers or larger protein aggregates (see [0125]). However, the term “high” is indefinite because what may be high to one may not be considered high to another, and the claims nor specification provide a standard (i.e., molecular weight) for one to know what is encompassed by the term. As such, claims 24-25, 27, 30, 56, and their dependent claims are rejected.
The terms “low molecular weight” and “middle molecular weight” in claim 32 are relative terms which render the claim indefinite. The terms “low molecular weight” and “middle molecular weight” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. While the specification indications that a low molecular weight species is less than about 25kD and a middle molecular weight is between 25 to 50 kD, these values are merely exemplary and are not definitive. Further, as stated above, the phrase “less than” indicates a limit but the term “about” means an acceptable error for a particular value without providing a standard to determine what is considered acceptable. As such, claim 32 are rejected.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 38 recites the broad recitation “less than about 35%”, and the claim also recites “about 30%, about 25%, about 20%, about 15%, about 10%, or about 5%” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 44 recites the broad recitation “no more than about 25%”, and the claim also recites “about 23%, about 21%, about 19%, about 17%, about 15%, about 13%, about 11%, about 8%, or about 5%” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 50 recites the broad recitation “less than about 20%”, and the claim also recites “less than about 5%” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 53 recites the broad recitation “less than about 75%”, and the claim also recites “about 38% to about 43%” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
The term “reduced peptide mapping” in claim 56 is a relative term which renders the claim indefinite. The term “reduced peptide mapping” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear whether the term “reduced peptide mapping” is in reference to the run time being lowered, or if the disulfide bonds are broken (i.e., reduced).
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.
Claims 1-3, 7, 10-13, 37-39, 58, and 59 are rejected under 35 U.S.C. 103 as being unpatentable over Parnes et al (US 2018/0296669 A1, publication date: 10/18/2018) and further in view of Venkataramani et al (Biochemical and Biophysical Research Communications 504 (2018) 19-24; previously submitted with the Restriction Requirement mailed 04/08/2026) and Tezepelumab - STATEMENT ON A NONPROPRIETARY NAME ADOPTED BY THE USAN COUNCIL (published: 12/30/2014; previously submitted with the Restriction Requirement mailed 04/08/2026).
Parnes et al teach methods of treating asthma, including severe asthma and eosinophilic asthma, using an antibody specific for thymic stomal lymphopoietin (TSLP) (see Abstract). Specifically, Parnes et al disclose of Tezepelumab, a human IgG2 monoclonal antibody that binds to TSLP comprising CDR SEQ ID Nos: 3-8, VH SEQ ID NO: 10, and VL SEQ ID NO: 12 (see [0119]-[0124]). SEQ ID Nos: 3-8 of Parnes et al share 100% identity with instant SEQ ID Nos: 3-8. Additionally, SEQ ID Nos: 10 and 12 of Parnes et al share 100% with instant SEQ ID Nos: 10 and 12, respectively.
With respect to instant claims 37-39, Parnes et al disclose that derivatives of the antibody include tetrameric glycosylated antibodies wherein the number and/or type of glycosylation site has been altered compared to the amino acid sequences of a parent polypeptide (see [0129]). While Parnes et al does not disclose which site is glycosylated, it is known that Tezepelumab is glycosylated at N298 as evidenced by the STATEMENT ON A NONPROPRIETARY NAME ADOPTED BY THE USAN COUNCIL; therefore, the percentage of glycosylation is less than 40%.
Additionally, with respect to instant claims 1-3, 7, and 10-13, Venkataramani et al disclose that Tezepelumab (also known as AMG157) has deamidation and isomerization below 5% in CDRs which may not have significant impact on in vivo biological function (see page 21, left col.; Table 3). Specifically, deamidation of the light chain CDR1 was 0.5% when unstressed and 0.8% when stressed day 7; and, isoaspartic acid was non-detectable at the heavy chain CDR2 (see Table 3(A)).
Further, with respect to instant claim 59, Parnes et al disclose of pharmaceutical formulations comprising the anti-TSLP antibody and variants thereof with a pharmaceutical excipient (see [0149]-[0154]).
Thus, the claimed compositions (i.e., isomerization, deamidation, and glycosylation) would have been obvious based on the teachings of the art as it appears to be a known characteristic of tezepelumab’s composition. Further, one would want to develop a pharmaceutical formulation comprising the claimed compositions to provide a stable and safe drug delivery for patients in need.
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.
18/287,597
Claims 1-4, 7, 9-13, 16-20, 23, 56, 58, and 59 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-6, 8, 13, 16-19, 21, 25, 30, 36-40, 42, 43, 48, 49, 51-54, 59, 60, 62, and 63 of copending Application No. 18/287,597 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
With respect to instant claims 1-4, 7, 10-13, 17-20, 56, 58, and 59, the ‘597 application is drawn to an anti-TSLP immunoglobulin, antigen binding protein or fragment thereof, or antibody or fragment thereof comprising (A) a light chain variable domain comprising: (i) a light chain CDR1 sequence comprising the amino acid sequence set forth in SEQ ID NO:3; (ii) a light chain CDR2 sequence comprising the amino acid sequence set forth in SEQ ID NO:4; and (iii) a light chain CDR3 sequence comprising the amino acid sequence set forth in SEQ ID NO:5; and (B) a heavy chain variable domain comprising: (i) a heavy chain CDR1 sequence comprising the amino acid sequence set forth in SEQ ID NO:6; (ii) a heavy chain CDR2 sequence comprising an amino acid sequence with a mutation at one of the following residues, D54 or G55 set forth in SEQ ID NO:7, and (iii) a heavy chain CDR3 sequence comprising the amino acid sequence set forth in SEQ ID NO: 8 (see claim 1). SEQ ID Nos: 3-8 of the ‘597 application share 100% identity with instant SEQ ID Nos: 3-8. Additionally, SEQ ID Nos: 10 and 12 of the ‘597 application share 100% with instant SEQ ID Nos: 10 and 12, respectively.
The ‘597 application is drawn to a composition comprising IgG2 anti-TSLP monoclonal antibodies, each comprising a light chain CDR1 sequence comprising the amino acid sequence set forth in SEQ ID NO: 3; a light chain CDR2 sequence comprising the amino acid sequence set forth in SEQ ID NO: 4; a light chain CDR3 sequence comprising the amino acid sequence set forth in SEQ ID NO: 5; a heavy chain CDR1 sequence comprising the amino acid sequence set forth in SEQ ID NO: 6; a heavy chain CDR2 sequence comprising the amino acid sequence set forth in SEQ ID NO: 7; and a heavy chain CDR3 sequence comprising the amino acid sequence set forth in SEQ ID NO: 8, wherein at least one of: no more than 0.9% of the anti-TSLP monoclonal antibodies comprise isomerized HC D54; no more than 2% of the anti-TSLP monoclonal antibodies comprise oxidized HC W102; no more than 0.9% of the anti-TSLP monoclonal antibodies comprise isomerized LC D49 or LC D50; no more than 0.5% of the anti-TSLP monoclonal antibodies comprise deamidated LC N65; or no more than 0.9% of the anti-TSLP monoclonal antibodies comprise isomerized LC D91 (see claims 53 and 54). Lastly, the ‘597 application is drawn to a composition comprising anti-TSLP monoclonal antibodies, each comprising a light chain CDR1 sequence comprising the amino acid sequence set forth in SEQ ID NO: 3; a light chain CDR2 sequence comprising the amino acid sequence set forth in SEQ ID NO: 4; a light chain CDR3 sequence comprising the amino acid sequence set forth in SEQ ID NO: 5; a heavy chain CDR1 sequence comprising the amino acid sequence 11 set forth in SEQ ID NO: 6; a heavy chain CDR2 sequence comprising the amino acid sequence set forth in SEQ ID NO: 7; and a heavy chain CDR3 sequence comprising the amino acid sequence set forth in SEQ ID NO: 8, wherein at least one of: greater than 98% of the anti-TSLP monoclonal antibodies of the composition comprise L-aspartate at HC position 54, relative to isoAsp or cAsp at HC position 54; at least 99% of the anti-TSLP monoclonal antibodies of the composition comprise non-oxidized HCW102 relative to oxidized HCW102; at least 97% of the anti-TSLP monoclonal antibodies of the composition comprise L- aspartate at LC position 49 or 50, relative to isoAsp or cAsp at LC position 49 or position 50; at least 99.1% of the anti-TSLP monoclonal antibodies of the composition comprise LC N65 relative to deamidated LC N65; or at least 99.1% of the anti-TSLP monoclonal antibodies of the composition comprise L- aspartate at LC position 91, relative to isoAsp or cAsp at LC position 91 (see claim 63).
While the ‘597 application is also drawn to methods of using the product, the Federal Circuit has held that obviousness-type double patenting exists for method claims that simply claim the disclosed use of a composition in the specification. See Sun Pharmaceutical Industries v. Eli Lilly and Co., 611 F.3d 1381, 1389 (2010). The instant application and the copending application are not divisional applications resulting from restriction, and therefore no protection under the provisions of 35 USC 121. As such, the ‘597 application anticipates the present invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
19/123,647
Claims 1-4, 7, 9-13, 16-20, 23-25, 27, 30-33, 36-39, 41, 44, 47, 49, 50, 53, and 56-59 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 8, 15, 19, 30-34, and 36 of copending Application No. 19/123,647 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
With respect to instant claims 1-4, 10-13, 17-20, 24-25, 27, 31-33, 37-39, 41, 44, and 56-59, the ‘647 application is drawn to a composition comprising an anti-TSLP antibody and one or more anti- TSLP antibody derivatives, wherein the composition comprises less than 97% acidic peak species as determined by cation exchange ultra-high performance liquid chromatography (CEX-UHPLC), wherein anti-TSLP antibody comprises: I. (A) a light chain variable domain comprising: (i) a light chain CDR1 amino acid sequence set out in SEQ ID NO: 3; (ii) a light chain CDR2 amino acid sequence set out in SEQ ID NO: 4; and (iii) a light chain CDR3 amino acid sequence set out in SEQ ID NO: 5; and (B) a heavy chain variable domain comprising: (i) a heavy chain CDR1 amino acid sequence set out in SEQ ID NO:6; (ii) a heavy chain CDR2 amino acid sequence set out in SEQ ID NO: 7 and (iii) a heavy chain CDR3 amino acid sequence set out in SEQ ID NO:8;. II. (A) a light chain variable domain selected from the group consisting of: i. a sequence of amino acids at least 80% identical to SEQ ID NO: 12; ii. a sequence of amino acids encoded by a polynucleotide sequence that is at least 80% identical to SEQ ID NO: 11; iii. a sequence of amino acids encoded by a polynucleotide that hybridizes under moderately stringent conditions to the complement of a polynucleotide consisting of SEQ ID NO: 11; wherein the light chain variable domain retains the complementary determining regions (CDRs) set out in SEQ ID NO: 3-5, and,(B) a heavy chain variable domain selected from the group consisting of: i. a sequence of amino acids that is at least 80% identical to SEQ ID NO: 10; ii. a sequence of amino acids encoded by a polynucleotide sequence that is at least 80% identical to SEQ ID NO: 9; iii. a sequence of amino acids encoded by a polynucleotide that hybridizes under moderately stringent conditions to the complement of a polynucleotide consisting of SEQ ID NO: 9; wherein the heavy chain variable domain retains the complementary determining regions (CDRs) set out in SEQ ID NO: 6-8; wherein the antibody or antibody derivative specifically binds to a TSLP polypeptide as set forth in amino acids 29-159 of SEQ ID NO: 2; or III. a light chain variable domain comprising the amino acid sequence set out in SEQ ID NO: 12; and a heavy chain variable domain comprising the amino acid sequence set out in et out in SEQ ID NO: 10 (see claim 1). The ‘647 application is drawn to the composition of claim 1, wherein the acidic peak species are selected from the group consisting of antibody fragments, partially reduced species, sialylated glycan variants, β-galactosylated glycan variants, deamidated species, disulfide isoforms B and A/B, and glycation variants (see claim 5).
The ‘647 application is drawn to a composition comprising anti-TSLP antibody and one or more anti-TSLP antibody derivatives, wherein the composition comprises (i) less than 64% basic peak species as determined by cation exchange ultra-high performance liquid chromatography (CEX-HPLC), or (ii) comprises no more than 5.3%, or no more than 5%, of a basic peak species three that is, in order of retention time in CEX-HPLC, a third peak after the main peak wherein anti-TSLP antibody comprises:1. (A) a light chain variable domain comprising: (i) a light chain CDR1 amino acid sequence set out in SEQ ID NO: 3; (ii) a light chain CDR2 amino acid sequence set out in SEQ ID NO: 4; and (iii) a light chain CDR3 amino acid sequence set out in SEQ ID NO: 5; and (B) a heavy chain variable domain comprising: (i) a heavy chain CDR1 amino acid sequence set out in SEQ ID NO: 6; (ii) a heavy chain CDR2 amino acid sequence set out in SEQ ID NO: 7 and (iii) a heavy chain CDR3 amino acid sequence set out in SEQ ID NO:8; or II. (A) a light chain variable domain selected from the group consisting of: i. a sequence of amino acids at least 80% identical to SEQ ID NO: 12; ii. a sequence of amino acids encoded by a polynucleotide sequence that is at least 80% identical to SEQ ID NO: 11; iii. a sequence of amino acids encoded by a polynucleotide that hybridizes under moderately stringent conditions to the complement of a polynucleotide consisting of SEQ ID NO: 11; wherein the light chain variable domain retains the complementary determining regions (CDRs) set out in SEQ ID NO: 3-5, and, (B) a heavy chain variable domain selected from the group consisting of: i. a sequence of amino acids that is at least 80% identical to SEQ ID NO: 10; ii. a sequence of amino acids encoded by a polynucleotide sequence that is at least 80% identical to SEQ ID NO: 9; iii. a sequence of amino acids encoded by a polynucleotide that hybridizes under moderately stringent conditions to the complement of a polynucleotide consisting of SEQ ID NO: 9; wherein the heavy chain variable domain retains the complementary determining regions (CDRs) set out in SEQ ID NO: 6-8; wherein the antibody or antibody derivative specifically binds to a TSLP polypeptide as set forth in amino acids 29-159 of SEQ ID NO: 2 (see claim 8). The ‘647 application is drawn to the composition of claim 8, wherein the basic peak species are selected from the group consisting of high molecular weight species, antibody fragments, partially reduced species, heavy chain C terminal lysine and N- terminal signaling peptide, glycosylation variants, heavy chain oxidized methionine species, CDR aspartic acid isomerized species, and Disulfide isoform A (see claim 15).
SEQ ID Nos: 3-8 of the ‘647 application share 100% identity with instant SEQ ID Nos: 3-8. Additionally, SEQ ID Nos: 10 and 12 of the ‘597 application share at least 80% identity to instant SEQ ID Nos: 10 and 12, respectively. The ‘647 application is drawn to the composition of claim 1, wherein the anti-TSLP antibody is Tezepelumab (see claim 30). Lastly, the ‘647 application is drawn to a pharmaceutical formulation comprising the composition of claim 1 and one or more pharmaceutically acceptable excipients.
While the ‘647 application is also drawn to methods of using the product, the Federal Circuit has held that obviousness-type double patenting exists for method claims that simply claim the disclosed use of a composition in the specification. See Sun Pharmaceutical Industries v. Eli Lilly and Co., 611 F.3d 1381, 1389 (2010). The instant application and the copending application are not divisional applications resulting from restriction, and therefore no protection under the provisions of 35 USC 121. As such, the ‘647 application anticipates the present invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Haberger et al (mAbs 6:2, 327–339; March/April 2014) teach of the assessment of chemical modifications of sites in the CDRs of recombinant antibodies (see title).
Sreedhara et al (Pharm Res (2012) 29:187–197) teach of the characterization of the isomerization products of aspartate residues at two different sites in a monoclonal antibody (see title).
Verstraete et al (NATURE COMMUNICATIONS 8 (2017):14937) teach of the structure and antagonism of the receptor complex mediated by human TSLP in allergy and asthma (see title).
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/DANAYA L MIDDLETON/Examiner, Art Unit 1674
/VANESSA L. FORD/Supervisory Patent Examiner, Art Unit 1674
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