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 .
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 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.
DETAILED ACTION
Claims 1-23, 26-29, 40-56, 59-60, and 62 are pending in the instant application.
Priority
This application is a 371 of PCT/US2021/062824, filed on 12/10/2021 which claims priority to the provisional application 63124396 filed on 12/11/2020.
Information Disclosure Statement
The information disclosure statements (IDS) dated 10/23/2023 and 10/23/2023 comply with the provisions of 27 CFR 1.97, 1.98, and MPEP § 609. Accordingly, they have been placed in the application file and the information therein has been considered as to the merits.
Claim Interpretation
Applicant has appended the ending “diyl” throughout to indicate a bivalent group (pg 10, para 1). For example methyl, -CH3, is considered alkyl, but a methylene, -CH3-, is categorized as an alkyldiyl.
Applicant has redefined PEG contrary to its literature accepted meaning. In the instant application, PEG is:
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As opposed to –(CH2CH2O)n– .
Objections to the Claims
Claim 1 line 1-2 is redundant. Please replace, “An immunoconjugate comprising an antibody covalently attached to one or more 8-Cyc-2-aminobenzazepine moieties by a linker, and having Formula I:” with “An immunoconjugate of Formula I:”.
Claim 1, pg 4, line 6, lacks the bivalent attachment point dashes (e.g. “-S-“ instead of “S”).
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Claim 1, pg 4, line 9, contains two conjunctions. Please replace “C1-C12 alkyl, and C1-C12 alkyldiyl, or two R5 groups” with “C1-C12 alkyl, C1-C12 alkyldiyl, or two R5 groups”.
Claim 1, pg 7, line 3, lacks the attachment point dashes (e.g. “-F“ instead of “F”).
Claim 62 is objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to other claims in the alternative only. See MPEP § 608.01(n). Accordingly, claim 62 has not been further treated on the merits.
Correction is required. See MPEP § 608.01(m).
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 1-23, 26-29, 40-49, 53-56, and 59-60 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.
All except 20-23, 41, 46, 50-51
Claim 1 is drawn to the structure of the CycBz unit shown below wherein it is unclear where the linker, L, attaches to the CycBz unit. While the examples are limited to the linker being attached to the 8-position of the benzazepine (red arrow), claim 1 refers to subsets of variables for R1, R2, R3, and R4 comprising linkages to L.
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In which case, there are a plurality of interpretations: (i) one could select R1-R4 to be a variable that lacks a covalent linkage to L (e.g. R1-R4 are “-C3-C12 carbocyclyl”); (ii) one could select R1-R4 such that all have linkages to an antibody (e.g. R1-R4 are “-C3-C12 carbocyclyl-*”); or (iii) one could select R1-R4 to create a mixture wherein only R1-R2 are linked to L, whereas R3-R4 are terminated with alkyl groups. As a result of this ambiguity, this claim is rendered indefinite because it is unclear if applicant is or isn’t intending to claim formulas such as Ab-L-CycBz-L-Ab. Examiner recommends adding the line “wherein one of R1, R2, R3, or R4 is covalently linked to L” immediately after line 9 which recites the chemical structure of CycBz. Dependent claims 2-19, 26-29, 40, 42-45, 47-49, 52-56, and 59-60 fail to cure these deficiencies, thus are also rendered indefinite.
all except 46-47, 50-51
Claim 1 defines the bivalent group “Cyc” differently depending on the context. On page 1, applicant defines Cyc as:
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But on page 6, applicant redefines Cyc as:
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As a result of this confusion, one of skill in the art would not know the metes and bounds of “Cyc”. Examiner recommends using unique variable names, as it appears the second definition of Cyc might be limited to the sub-formula for PEP. Dependent claims 2-23, 26-29, 40-45, 48-49, 52-56, and 59-60 fail to cure these deficiencies, thus are also rendered indefinite.
All except 50-51
Claim 1 is drawn to this formula for “PEP” wherein it is unclear how to interpret the language because there are too many instances of “or” and there are several grammatical errors.
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It is unclear if AA is simply an amino acid side chain, or the beginning of a peptide chain itself. Presuming AA is a single amino acid side chain, Examiner recommends the language:
“wherein AA is independently selected from a natural or unnatural amino acid side chain, wherein the wavy line indicates a point of attachment;”
Because proline is known to cyclize, it is not necessary to claim its inherent properties. Dependent claims 2-23, 26-29, 40-49, 52-56, and 59-60 fail to cure these deficiencies, thus are also rendered indefinite.
Claim 3-6, 7-10
Claims 3-6 and 7-10 are drawn to “Type A” and “Type B” anti-PD1 antibodies, wherein it is unclear what the metes and bounds of these claims are. Applicant provided an open definition of these terms (pg 17, para 7), wherein in one embodiment, it is merely used to define any antibody that binds PD-1. In another embodiment, it is used to describe having “at least about 70%” sequence identity to SEQ ID NO: 307. Because of these multiple interpretations, one of skill in the art would not be apprised of whether or not a given antibody satisfied the limitation of being Type A, Type B, or neither.
Claim 7
Claim 7 is drawn to particular combinations of CDRs that are mislabeled. For example this claim is drawn to the limitation of HCDR2 being SEQ ID NO: 15-31, however, these are exemplary HCDR1 sequences. This claim is also drawn to HCDR3 being SEQ ID NO: 32-52, however these are exemplary HCDR2 sequences. Similarly, the claim is drawn to LCDR1 being SEQ ID NO: 53-67, however these are HCDR3 sequences. Again, the claim is drawn to LCDR2 being SEQ ID NO: 68-79, however these are LCDR1 sequences. The claim is also drawn to LCDR3 being SEQ ID NO: 80-91, however these are HCDR3 sequences. Because this claim is impossible to interpret, it is rendered indefinite.
Claim 8
Claim 8 is drawn to the VH of SEQ ID NO: 123-143, however none of these are recognized VH sequences, these appear to be LCDR1 and LCDR2 sequences. Because this claim is impossible to interpret, it is rendered indefinite.
Claim 9
Claim 9 is drawn to the VH regions of SEQ ID NO: 123-143, but the sequences cited are not recognized VH regions, these appear to be LCDR2 sequences. Similarly the VL sequences of SEQ ID NOs: 144-164 are also not VL sequences, they appear to be LCDR2 sequence. Because this claim is impossible to interpret, it is rendered indefinite.
Claim 60
The term “about” in claim 60 is a relative term which renders the claim indefinite. The term “about” 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. The instant specification does not give any quantitative measure of determining “about.” For example, “a dosage of about 20 mg/kg” could include a breadth of 15-24 mg/kg for one artisan, while another would may assume this range encompasses 19.5 - 20.4 mg/kg.
Claim Rejections – 35 USC § 112(a)
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 3-10 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.
Claim 3-4, 7-8
Claims 3-4 and 7-8 are drawn to antibodies comprising (i) mixed and matched CDRs wherein not all of the aforementioned combinations have been verified for their binding specificity; (ii) mixed and matched VH and VL sets wherein not all of the aforementioned combinations have been verified for their binding specificity; and (iii) wherein only three of the complete set of six CDRs are defined. The art recognizes that a complete set of six CDRs comprise the binding region of antibody, and a complete set of three CDRs comprise the binding region of a VHH (Sela-Culang 2013). Even single amino acid changes to this region can completely abrogate the binding specificity of an antibody (Kussie 1994 and Chen 1995). Thus, making changes to the CDR sequence of an antibody is a highly unpredictable process and the skilled artisan could not a priori make any predictions regarding such mutations or rearrangements with any reasonable expectation of success nor envisage the breadth of structurally unrelated CDR combinations that would still possess the required functions. Thus applicant has failed to meet the written description of antibodies that are able to bind their target antigen that comprise less than the full set of six CDRs; and comprise untested combinations of CDRs.
Claims 5, 9
Claims 5 and 9 are drawn to VH and VL sets wherein the variation in amino acid residues can occur in the CDR regions and wherein the VH and VL regions are mixed and matched. The art recognizes that the CDRs define the binding properties of an antibody and that even single amino acid changes to this region can completely abrogate the binding specificity of an antibody (Kussie 1994 and Chen 1995). Thus, making changes to the CDR sequence of an antibody is a highly unpredictable process and the skilled artisan could not a priori make any predictions regarding such mutations with any reasonable expectation of success nor envisage the breadth of structurally unrelated CDR combinations that would still possess the required functions. Thus applicant has failed to meet the written description of 90% similarity to SEQ ID NO: X
Claims 3-10
Claims 3-10 are drawn to the genus “Type A” and “Type B” anti-PD1 antibodies. A search of the prior art shows that this is not a well-known genus. Applicant provided an open definition of these terms (pg 17, para 7), wherein in one embodiment, it is merely used to define any antibody that binds PD-1. Applicant has failed to meet the written description requirement for “Type A” and “Type B” anti-PD1 antibodies because it is unclear what conserved structure classifies an anti-PD1 antibody as belonging to either of these groups. The representative number of species provided in Fig. 1A-D and Fig. 8A-D fail to provide a unifying structure, as the collection of CDRs listed are all variant. Thus Applicant has failed to provide a representative number of species and also has failed to provide the core structure required to classify a given antibody as Type A, Type B, or neither.
Claim Rejections – 35 USC § 102
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 1-2, 11-22, 26-29, 41-43, 52-56, and 59-60 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Coburn (US10442790).
Claims 1-2, 22, 26, 28, 41
Regarding claims 1-2, 22, 26, 28, and 41, Coburn teaches an antibody drug conjugate (ADC) comprising Formula (IA), shown below (col 88, para 4).
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Coburn teaches R1 and R2 are optionally hydrogen (col 89, para 3).
Coburn teaches L1 is optionally -X2, wherein X2 is a bond (col 88, para 5; col 89, para 2) and R3 is an optionally C2-12 carbocycle, or optionally substituted heterocycle (col 89, para 4), wherein the substituent is -C(O)N(R10)2 (col 89, para 4), wherein R10 is hydrogen or C1-10 alkyl (col 89, para 6).
Coburn teaches L2 is optionally -X2, wherein X2 is -C(O)N(R10)2, wherein R10 is “A”: any linear chain, carbocycle, heterocycle, or hydrogen (col 89, para 4).
Coburn teaches the linker may comprise a maleimide-PEG linker (col 169, para 2), using a group such as maleimidocaproyl (MC) (col 173, para 1), or related versions shown below (col 179, para 1).
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Coburn teaches the antibody can target PD-L1, such as atezolizumab (col 84, para 2). In sum, Coburn teaches the limitations below:
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Specifically, Coburn teaches instant variable X4-R4 is hydrogen; instant variable X2-R2 is (bond)-(R10), wherein R10 is C1-10 alkyl (col 102, para 2); instant variable X3-R3 is (bond)-(R10, wherein R10 is C1-10 alkyl optionally substituted with -OH or -O-C1-10 alkyl (col 102, para 2); instant variable Cyc is a carbocycle or heterocycle optionally substituted with C(O)NH; instant variable L is instant “-succinimidyl-(CH2)m-C(=O)N(R6)-PEG-“ wherein instant variable m is 4 and instant variable n is 2.
Claim 11
Regarding claim 11, Coburn teaches L1-R3 can be placed at any position of the 6-membered ring of benzazepine, thus satisfying the limitation of X1 being a bond, and R1 being H (col 88, para 4).
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Claim 12
Regarding claim 12, Coburn teaches instant variable X2-R2 is (bond)-(R10), wherein R10 is C1-10 alkyl (col 102, para 2).
Claim 13
Regarding claim 13, Coburn teaches instant variable X2-R2 is (bond)-(R10), wherein R10 is C1-10 alkyl (col 102, para 2). Coburn teaches instant variable X3-R3 is (bond)-(R10, wherein R10 is C1-10 alkyl optionally substituted with -OH or -O-C1-10 alkyl (col 102, para 2).
Claim 14
Regarding claim 14, Coburn teaches instant variable X2-R2 is (bond)-(R10), wherein R10 is C1-10 alkyl (col 102, para 2). Coburn teaches instant variable X3-R3 is (bond)-(R10), wherein R10 is C1-10 alkyl optionally substituted with -NHC(O)OCH2C6H5 (col 102, para 2). This satisfies the limitation of -N(R5)CO2R5 wherein R5 is H or C6 aryldiyl.
Claim 15-17
Regarding claims 15-17, Coburn teaches instant R2 and R3 can both be n-propyl as shown below (col 130).
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Claim 18, 23
Regarding claims 18 and 23, Coburn teaches instant variable X2-R2 is (bond)-(R10), wherein R10 is C1-10 alkyl (col 102, para 2). Coburn teaches instant variable X3-R3 is (bond)-(R10, wherein R10 is C1-10 alkyl optionally substituted with -OH or -O-C1-10 alkyl (col 102, para 2).
Claim 20, 43
Regarding claims 20 and 43, Coburn teaches instant variable X4-R4 is hydrogen, by virtue of the formula below allowing for the L1 substituent to fall at any position of the 6-membered ring. This satisfies the limitation of X4 being a bond, and R4 being H (col 88, para 4).
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Claim 27
Regarding claim 27, Coburn teaches the cysteine residue on the antibody can be used for attaching the linker (col 220, para 2).
Claim 29
Regarding claim 29, Coburn teaches the PEG moiety can be up to 32 repetitions in length (col 178, para 1).
Claim 52
Regarding claim 52, Coburn teaches a composition comprising a therapeutically effective amount of the conjugate (col 243, para 2) and a pharmaceutically acceptable carrier (col 240, para 3).
Claim 53
Regarding claim 53, Coburn teaches the cancer is breast cancer (col 245, para 2).
Claim 54
Regarding claim 54, Coburn teaches the cancer is responsive to a TLR7/TLR8 agonist therapy (col 67, para 13-14).
Claim 55
Regarding claim 55, Coburn teaches the cancer expresses a cancer antigen, such as PD-L1 (pg 245, col 2).
Claim 56
Regarding claim 56, Coburn teaches the cancer is Merkel cell cancer (col 246, para 1).
Claim 59
Regarding claim 59, Coburn teaches the conjugate can be administered subcutaneously (col 244, para 2).
Claim 60
Regarding claim 60, Coburn teaches the conjugate is administered at 5-20 mg/kg of body weight (col 340, para 5).
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 1-2, 11-22, 26-29, 40-45, 48-49, 52-56, and 59-60 are rejected under 35 U.S.C. 103 as being unpatentable over Coburn (US10442790) as applied to claims 1-2, 11-22, 26-29, 41-43, 52-56, and 59-60 above.
Claim 40
Regarding claim 40, Coburn teaches the linker can comprise a disulfide unit as shown below, wherein R is H or methyl (Formula IIa; col 174; col 172, para 4).
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As discussed in the rejection of claim 1, Coburn teaches the linker can comprise PEG, which is optionally appended with -OC(O)R10 wherein R10 is a carbocycle or heterocycle (col 156, para 1-2).
While Coburn teaches all of the explicit parts of the linker, Coburn does not exemplify the specific combination of parts in claim 40. Nonetheless, one of skill in the art would have found it obvious to stitch the linker parts of Coburn together to generate a structure such as the instant structure claimed below, because Coburn teaches the linker is designed to function as part of an ADC designed to treat cancer (abstract) that uses the same antibody and drug as the instant application.
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Claim 43
Regarding claim 43, Coburn teaches Coburn teaches L1 is optionally -X2, wherein X2 is a bond (col 88, para 5; col 89, para 2) and R3 is an optionally substituted heterocycle (col 89, para 4),
While Coburn does not teach a specific heterocycle, one of skill in the art would readily recognize pyridine (a.k.a. “pyridyldiyl”) as a commonly employed heterocycle as an obvious choice, given the teaching of “select any heterocycle.”
claims 44-45, 48-49
Regarding claims 44-45 and 48-49, Coburn teaches instant variable X2-R2 is (bond)-(R10), wherein R10 is C1-10 alkyl (col 102, para 2). Coburn teaches instant variable X3-R3 is (bond)-(R10, wherein R10 is C1-10 alkyl optionally substituted with -OH or -O-C1-10 alkyl (col 102, para 2).
Allowable Subject Matter
Claim 3-5
Anti-PD-L1 antibodies labeled 1-42 mentioned in claims 3-5 comprising the distinct sets of six CDRs described in Fig 1A-D were found allowable over the prior art. The VH and VL regions comprising these distinct sets of CDRs mentioned in claims 4 and 5 were also not found in the prior art. Note: while claims 3-5 mention these sequences, they fail to meet the written description requirement by failing to claim the distinct and complete set of six CDRs necessary to define the binding region of these antibodies.
The closest prior art is that of Steven (US20190153471; SEQ ID NO: 11954), shown below with the CDR regions of instant SEQ ID NOs: 3, 57, and 95 underlined. The sequence below is a 79.1% sequence match.
instant_264 QVQLVQSGAEVKKPGSSVKVSCKASGYTFTRHLLHWVRQAPGQGLEWMGWVSPIHGLTGY 60
Steven_11954 QVQLVQSGAEVKKPGSSVKVSCKASGFTFTDYKIHWVRQAPGQGLEWMGYFNPNSGYSTY 60
**************************:*** : :***************:..* * : *
instant_264 APRFQGRVTITADESTSTAYMELSSLRSEDTAVYYCARVHGSGSDGMDVWGQGTTVTVSS 120
Steven_11954 AQKFQGRVTITADKSTSTAYMELSSLRSEDTAVYYCARLSPGGYYGMDAWGQGTTVTVSS 120
* :**********:************************: .* ***.***********
Steven also teaches the closest VL (SEQ ID NO: 8939) shown below with the CDR regions of instant SEQ ID NOs: 127, 137, and 176 underlined. The sequence below is a 89.7% sequence match.
instant_305 DIQMTQSPSSLSASVGDRVTITCRASQVIRNDLAWYQQKPGKAPKLLIYAASTLQSGVPS 60
Steven_8939 DIQMTQSPSSLSASVGDRVTITCRASQGIRNDLGWYQQKPGKAPKLLIYAASSLQSGVPS 60
*************************** *****.******************:*******
instant_305 RFSGSGSGTDFTLTISSLQPEDFATYYCQQSLQYPSHFFGQGTKVEIK- 108
Steven_8939 RFSGSGSGTDFTLTISSLQPEDFATYYCQQDNNYPST-FGQGTKVEIKR 108
******************************. :*** **********
It is understood in the art that changes to CDRs are unpredictable, thus there was no guidance to arrive at the specific CDR’s recited, given the art of record.
Claim 23
Structures attaching the linker L to the structures of R3-X3 described in claim 23, to the 3 position of the benzazepine ring, in the context of the invention of claim 1, were not found in the prior art.
Claim 46-47
Structures comprising a heterocycle at the 8-position of benzazepine of claims 46-47 were not found in the prior art.
Claim 50-51
Structures comprising the substituted phenyldiyl groups at the 8-position of benzazepine of claim 50-51 were not found in the prior art.
The closest prior art is that of Coburn (US10442790) discussed in detail in the 102/103 rejections above.
Relevant prior art
Baum (US10239862) who teaches similar benzazepine conjugates as Coburn, a shown below.
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Gau (EP3453707) teaches bicyclic heterocycles bound to the 8-position of benzazepine (shown below).
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA ANN ESSEX whose telephone number is 571-272-1103. The examiner can normally be reached Mon - Fri 8:30-5:00.
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 on 571-272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.A.E./
Examiner, Art Unit 1675
/JEFFREY STUCKER/
Supervisory Patent Examiner, Art Unit 1675
Prosecution Insights