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 1-20 are pending and examined on the merits.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter “Legal Framework”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation by reference statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
This application contains sequence disclosures in accordance with the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.831(a) and 1.831(b). However, this application fails to comply with the requirements of 37 CFR 1.831-1.834.
The examiner has noted that (i) SEQ ID NO:9, 14, 15 and 16 are assigned a placeholder of “000” reserved for sequences of less than 4 defined amino acids. However, SEQ ID NO: 9 and 16 have four defined amino acids because XXQAR(A/V)X provides four defined amino acids and because LSGX wherein X is R or K (SEQ ID NO:16) provides four defined amino acids (Table 1). SEQ ID NO: 14 (DEXXXC(A/S), and SEQ ID NO:15 DLXXXT(A/S) (Table 1) also provide 4 specifically defined amino acids. It is noted that ST.26 has no provision requiring that the defined amino acids be contiguous.
The examiner has also noted that paragraph [0070] and claim 11 recite LSGK (SEQ ID NO:16). This is not in compliance with the Sequence Rules because LSGK requires a unique sequence identifier apart from that of LSGX (SEQ ID NO:16).
Applicant must provide:
• A replacement “Sequence Listing XML” part of the disclosure, as described above in item 1. or 2., as well as
• A statement that identifies the location of all additions, deletions, or replacements of sequence information in the “Sequence Listing XML” as required by 1.835(b)(3);
• A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.835(b)(4);
• A statement that the “Sequence Listing XML” includes no new matter in accordance with 1.835(b)(5); and
• A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required incorporation by reference paragraph as required by 37 CFR 1.835(b)(2), consisting of:
o A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
o A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Claim Rejections - 35 USC § 112
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 1-14, 16-18 and 20 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.
(A) Claim 1 is vague and indefinite in the recitation of “preferably 5 A” because it is unclear how this preference affects the metes and bounds of the claim.
(B) 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,
(i)claim 16 recites the broad recitation amino acids 1-118 of SEQ ID NO:1, and the claim also recites “(where Xaa is Ala)” which is the narrower statement of the range/limitation;
(ii)claim 16 recites the broad recitation amino acids 1-108 of SEQ ID NO:2, and the claim also recites “(where Xaa is Cys)” which is the narrower statement of the range/limitation;
(iii)claim 20 recites the broad recitation amino acids 1-118 of SEQ ID NO:1, and the claim also recites “(where Xaa is Cys)” which is the narrower statement of the range/limitation; and
(iv)claim 20 recites the broad recitation amino acids 1-108 of SEQ ID NO:2, and the claim also recites “(where Xaa is Ser)” 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.
(C) Claims 13and 14 are vague and indefinite in the recitation of “Kabat position 67 of the light chain”. When given the broadest reasonable interpretation, a “light chain” encompasses kappa light chains and lambda light chains. Light chains can comprise a residue preceding position 1 and a lambda light chain can contain a deletion at position 10. It is unclear how a deletion at position 10 with or without an addition of the extra residue preceding position 1 affects what residue is designated by applicant as position 67.
(D)Claims 17 and 18 are vague and indefinite in the recitation of “Kabat position 23 of the light chain”. Heavy chains can comprise a residue preceding position 1. It is unclear how an addition of an extra residue preceding position 1 affects what residue is designated by applicant as position 23.
(D)Claims 13, and 17 are vague and indefinite in the recitation of “having” a Cys at position 67 of the light chain or position 23 of the heavy chain. It is unclear if the Cys is limited to a substitution of the amino acid at position 23 of the heavy chain for Cys, and substitution of the amino acid at position 67 of the light chain for Cys, or if the cysteine can be attached as a handle to the variable chains at the required positions.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-5, and 8-11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
Claims 1-5, and 8-11 are drawn to a genus of pro-drugged antibodies having a blocking moiety that inhibits the binding of the antibody to its antigen. When given the broadest reasonable interpretation, the blocking moiety includes any type of compound that has the required function of inhibiting the binding of the antibody to the cognate antigen. Stagliano et al (U.S. 2012/0149061) teach antibodies modified with masking moieties by linking through a cleavable moiety to provide activatable antibodies (abstract). Stagliano et al teach that that for optimal binding and dissociation characteristics, libraries of candidate masking moieties are screened to assess the effects of variable amino acid sequences, various lengths of the moiety and the like (paragraph [0421]) . Stagliano et al teach that masking moieties not containing the native amino acid sequence of the binding partner of the antibody are selected for the construction of the modified antibodies. Thus, the masking moiety of Stagliano et al, corresponds to the instant blocking moiety, and is empirically selected for each antibody of interest. The instant specification fails to provide an adequate written description for the blocking moieties required by the claims, which encompass antibodies with any binding specificity. The disclosure of PEG as a blocking moiety fails to be representative of the blocking moieties encompassed by the instant claims as evidenced by Stagliano et al. The claims do not correlate a partial structure of the required blocking moiety with the desired ability to block or inhibit the binding of every antibody encompassed by the claims with the cognate antigens thereof. One of skill in the art would reasonably conclude that applicant was not in possession of a genus of blocking moieties required by the instant claims.
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.
Claim 13 is rejected under 35 U.S.C. 102(A)(1) as being anticipated by Cartilage et al (WO2008/019290). Cartilage et al disclose the sequence of the variable light chain of the anti-ErbB2 antibody (SEQ ID NO:20) :
CN Immunoglobulin, anti-(human neu receptor) (Human clone 1.100.1 light chain
V region) (CA INDEX NAME)
SEQ 1 DIVMTQSPDS LAVSLGERAT ITCKSSQSVF FRSNNKNCLA WYQQRPGQPP
51 NLLIYWASTR ESGVPDRFSG SGCGTDFTLT ISSLQAEDVA VYYCQQYFGS
101 PFTFGPGTKV DIK
having a Cys at a position corresponding to Kabat position 67 (underlined).
Claim 13 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gu et al (WO2016/205427).
Gu et al disclose the seunences of clones CL-27791 (page 260), CL-29990 (page 263) and CL-30147(page 270) comprising kappa light chains of anti-human VEGF antibodies:
SEQ 1 EIVLTQSPAT LSLSPGERAT FSCRASESVS THMHWYQQKP GQAPRLLIYG
51 ASNLESGVPA RFSGSGCGTD FTLTISSLEP EDFAVYXCQQ SGNDPFTFGQ
101 GTKLEIK
SEQ 1 EIVLTQSPAT LSLSPGERAT LSCRASQSVG THMHWYQQKP GQAPRLLIYG
51 ASNLESGVPA RFSGSGCGTD FTLTISSLEP EDFAVYFCQQ SWHDPLTFGQ
101 GTKLEIK
SEQ 1 EIVLTQSPAT LSLXPGERAT LSCRASESVS THMHWYQQKP GQAPRLLIYG
51 ASNLEYGVPA RFSGSGCGTD FTLTISSIEH EDFAVYFCQQ SWNDPFTFGQ
101 GTKLEIK,
all of which have Cys at Kabat position 67 (underlined).
Claim 17 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chan et al (WO2018/023121).
Claim 17 is rejected under 35 U.S.C. 102(a)(2) as being anticipated by Chan et al (WO2018/023121, priority to 62/368,407).
Chan et al disclose an anti-globo-series antigen antibody (J-5N) VH region, SEQ ID 27 (claim 2):
SEQ 1 qvqlvewggg vvqpggslrl scCaasgfsl rsfgmhwvrq apgkglewva
51 viwprrsqiq yadsvkgrvt isrddsrstv clqmnslrve dtalyrcard
101 pgednpidyw gqgtlvivss
having a Cys at Kabat position 23 (underlined) of the heavy chain.
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 1-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No.11,623,965. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent anticipate the instant claims. Claim 1 of the patent requires that the BM is a polyethylene glycol, which meets the limitation of instant claim 6.
Allowable Subject Matter
Claims 15 and 19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAREN A CANELLA whose telephone number is (571)272-0828. The examiner can normally be reached M-F 10-6:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Julie Wu can be reached at 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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KAREN A. CANELLA
Examiner
Art Unit 1643
/Karen A. Canella/Primary Examiner, Art Unit 1643