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 .
DETAILED ACTION
Applicants’ arguments filed 07/22/2026 is acknowledged. Claims 1-6, 9-10, 15 and 17-21 are pending and claims 15, 17, 19 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b). See MPEP 803.02. Applicants preserve their right to file a divisional on the non-elected subject matter.
Applicant is reminded that upon cancellation of claims to a nonelected invention, the inventions must be amended in compliance with 37 C.F.R. 1.48(b) if one of the currently named inventors is no longer an inventor of at least one claim remaining in the application. Any amendment of inventorship must be accompanied by a petition under 37 C.F.R. 1.48(b) and by the fee required under 37 C.F.R. 1.17(i).
Therefore, claims 1-6, 9-10, 18 and 21 are examined on merits in this office action.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 1-6, 9-10, 18 and 21 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over of Cai et al (CN106488932A) alone or further in view of Lee et al (US 2019/0106507A1).
In regards to claims 1 and 4, Cai discloses antibody specifically binding to human alpha-enolase (ENO1). Cai teaches that ENO1 expressed on the cell surface of many cancer cells, plasminogen as a receptor, and is expressed on activated hematopoietic cells such as neutrophil, lymphocyte and monocyte. regulation of known plasminogen receptor protein (Introduction). Cai teaches that ENO1 can increase cancer cell invasion activity as plasminogen receptor expressed on the surface of cancer cells and therefore, ENO1 is a potential cancer therapeutic target (Introduction).
Cai discloses an antibody comprising one or more sequences selected from the group consisting of: HCDR1 (GYTFTSCVMN; SEQ ID NO: 3) and HCDR2 (YINPYNDGTKYNEKFKG; SEQ ID NO: 4) and HCDR3 (EGFYYGNFDN; SEQ ID NO: 5) and LCDR1 (RASENIYSYLT; SEQ ID NO: 6), LCDR2 (NAKTLPE; SEQ ID NO: 7) and LCDR3 (QHHYGTPYT; SEQ ID NO: 8) and the CDR sequences correspond to HCDR1 (SEQ ID NO.1), HCDR2 (SEQ ID NO.2), HCDR3 (SEQ ID NO. 3), LCDR1 (SEQ ID NO. 4), LCDR2 (SEQ ID NO. 5) and LCDR3 (SEQ ID NO. 6) of instant claim 1.
Cai teaches that the antibody inhibits cell invasion and tumor metastasis ability of various tumors. Cai teaches that the antibody is useful for diagnosis, prognosis and treatment of various cancers expressing ENO1 at the cell surface (Abstract).
Cai teaches that in one embodiment ENO1 antibody or its segment is coupled to a therapeutic agent. Treating agent can be such as a toxin or a radioactive isotope.
Cai does not teach a general formula for antibody conjugate with therapeutic agent as claimed and does not specifically disclose a conjugate of the antibody with a therapeutic agent. The formula as claimed in claim 1 encompass an anti-ENO1 antibody directly bound to a therapeutic agent of a label when m is 1 and L is bond.
Thus, from the description in mind of Cai, the anti-ENO1 antibody bound to a therapeutic agent directly or through a linker, would be obvious to one of ordinary skilled in the art because Cai teaches ENO1 antibody or its segment coupled to a therapeutic agent. Cai also teaches that the antibody is useful of diagnosis and one of ordinary skilled in the art readily understands that for diagnosis or detection, labeling of antibody with a label is very common and thus would be obvious to one of ordinary skilled in the art.
Moreover, providing a conjugate of the antibody with a therapeutic agent or a label would be obvious in view of Lee. Lee discloses an antibody (anti-Globo H antibody) conjugated to a therapeutic or a label having the formula Ab-(L-D)m, wherein Ab is the anti-Globo H antibody or binding fragment thereof, L is a linker or a direct bond, D is a therapeutic agent or a label and m is an integer of 1-8 (Abstract). Lee teaches that the immunoconjugate is for treating a cancer by administering to a subject in need (Abstract). Lee teaches that that antibody-drug conjugates can provide targeted therapy to treat various diseases or conditions, such as cancer (paragraph [0002]). Lee teaches the antibody coupled to a payload (which can be a drug, a diagnostic agent or a therapeutic agent) ([para [0028]).
Therefore, given the fact that conjugating an antibody to a drug or a diagnostic label is common once the antibody developed that specifically binds to a target antigen related to a disease for treatment and for diagnosis (lee et al) and given the fact that Tsai teaches anti-ENO1 antibody, or fragment thereof, conjugated to a therapeutic agent and the therapeutic agent can be, for example, a toxin or a radioisotope (para [0043]), it would be obvious to one of ordinary skilled in the art to easily envisage the antibody of Cai conjugated to a drug, therapeutic agent or a diagnostic agent with the expectation of expanding the arsenal of the antibody useful as pharmaceutical composition for treatment and for diagnosis with a reasonable expectation of success.
In regards to claims 2 and 3, Cai throughout the reference, teaches the antibody is monoclonal antibody (claim 10) and the antibody can be a chimeric antibody, a humanized antibody.
In regards to claims 5 and 21, as described above, Cai teaches therapeutic agent conjugated to the antibody and lee teaches various therapeutic agents including DM1 and auristatins and thus various commonly known therapeutic agents including cytotoxic agents would be obvious to one of ordinary skilled in the art absent showing of unexpected advantages with the particular therapeutic agent.
In regards to claim 6, as described above, Cai teaches that the antibody is useful for diagnosis and one of ordinary skilled in the art readily understands that for diagnosis or detection, labeling of the antibody with a various commonly known labels would be obvious to one of ordinary skilled in the art absent showing of unexpected advantages with a particular diagnostic agent.
In regards to claims 9-10, Cai teaches pharmaceutical composition comprising the antibody of claim 1 and since as described above, conjugate of the antibody with a therapeutic agent has been found to be obvious, a pharmaceutical composition comprising the antibody conjugated to a therapeutic agent would also be obvious to one of ordinary skilled in the art. In regards to claims 9-10, the recitation “for diagnosing or imaging cells or a tissue expressing ENO1” and “for use in treating an inflammatory disease, an immune disorder or an ENO1-expressing cancer”, are intended use/process utilizing a composition comprising the immunoconjugate. Applicant is reminded that a recitation of the intended use/process of the claimed invention, must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In regards to claim 18, as disclosed in the specification (para [0077]), antibody HuL001 comprises HCDR1 (SEQ ID NO.1), HCDR2 (SEQ ID NO.2), HCDR3 (SEQ ID NO. 3), LCDR1 (SEQ ID NO. 4), LCDR2 (SEQ ID NO. 5) and LCDR3 (SEQ ID NO. 6) as claimed in claim 1 and a conjugate with a cytotoxic agent is obvious in view of Cai and Lee. Lee teaches various cytotoxic agents including DM1 (para [0044]) and auristatins conjugated to antibody through various linkers. Lee discloses antibody conjugated to auristatin MMAE with a linker composition
PNG
media_image1.png
144
568
media_image1.png
Greyscale
, which is the same linker composition as claimed in claim 18 conjugate with MMAE. Therefore, one of ordinary skilled in the art can easily envisage various cytotoxic drugs conjugated to the antibody of Cai through various linker compositions including MMAE through a linker composition disclosed by Lee with a reasonable expectation of success. Various linker composition for conjugating the antibody of Cai to various cytotoxic drugs would be within the purview of one of ordinary skilled in the art.
Claims 1-6, 9-10, 18 and 21 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over of Tsai et al (10,781,266B2) in view of Tsai et al (US 2015/0183884A1; hereinafter Tsai2) and Lee et al (US 2019/0106507A1).
In regards to claims 1, 4 and 6, Tsai discloses antibody specifically binding to human alpha-enolase (ENO1) (Abstract). Tsai teaches ENO1 expression on cancer cell surfaces as a plasminogen receptor can increase invasion activities of the cancer cells. Therefore, ENO1 is also a potential target for cancer therapy. Tsai teaches that the invention relates to antibodies or antigen-binding fragments thereof that specifically bind human ENO1, thereby inhibiting ligand (e.g., plasminogen) binding to ENO1 (col. 3). Tsai teaches that ENO1 protein-related disease may be an inflammatory disease or an immune disorder (col.4). Therefore, the invention may relate to a method for administering the antibody, or the antigen-binding fragment thereof, as described herein to a subject (e.g., a human or a non-human animal) for the treatment of an inflammatory disease or immune disorder (col. 24, lines 11-23).
Tsai discloses antibody comprising one or more sequences selected from the group consisting of: HCDR1 (GYTFT-Xaa-VMN; SEQ ID NO: 50) and HCDR2 (YINPYNDGTKYNEKFKG; SEQ ID NO: 4) and HCDR3 (EGFYYGNFDN; SEQ ID NO: 5) and LCDR1 (RASENIYSYLT; SEQ ID NO: 6), LCDR2 (NAKTLPE; SEQ ID NO: 7) and LCDR3 (QHHYGTPYT; SEQ ID NO: 8) and the CDR sequences correspond to HCDR1 (SEQ ID NO.7), HCDR2 (SEQ ID NO.2), HCDR3 (SEQ ID NO. 3), LCDR1 (SEQ ID NO. 4), LCDR2 (SEQ ID NO. 5) and LCDR3 (SEQ ID NO. 6) of instant claim 1.
Tsai teaches that the invention relates to the uses of the antibody, or the antigen-binding fragment thereof, in the preparation of a medicament for the treatment of an ENO1-related disease or disorder in a subject (e.g., a human or a non-human animal) (col. 23). Tsai teaches that the invention relate to pharmaceutical compositions comprising a therapeutically effective amount of an antibody or an antigen-binding fragment thereof that can bind human ENO1 protein, and a pharmaceutically acceptable carrier (col.4, lines 5-10 and claim 4).
Tsai teaches inhibiting cancer invasion in a subject in need thereof, comprising administering a therapeutically effective amount of the antibody, or the antigen-binding fragment thereof, according to claim 1 to the subject (claim 9). Tsai teaches treating a subject suffering from an ENO1 protein-related disease or disorder, comprising administering a therapeutically effective amount of the antibody, or the antigen-binding fragment thereof (claim 5).
Tsai discloses antibody specifically binding to ENO1 but however does not teach the antibody conjugated to a label for detection or conjugated to a cytotoxic drug or therapeutic for treatment.
Tsai2 discloses antibody specifically binding the ENO1. Tsai2 teaches that the invention relates to method for treating diseases or conditions associated with the expression of ENO1 in a patient and the method may include administering to a patient an effective amount of an anti-ENO antibody (para [0044]). Tsai2 teaches pharmaceutical composition comprising the antibody (paragraph [0043]). Tsai2 teaches that in one embodiment, the anti-ENO1 antibody, or fragment thereof, is conjugated to a therapeutic agent and the therapeutic agent can be, for example, a toxin or a radioisotope (para [0043]).
Lee discloses an antibody (anti-Globo H antibody) conjugated to a therapeutic or a label having the formula Ab-(L-D)m, wherein Ab is the anti-Globo H antibody or binding fragment thereof, L is a linker or a direct bond, D is a therapeutic agent or a label and m is an integer of 1-8 (Abstract). Lee teaches that the immunoconjugate is for treating a cancer by administering to a subject in need (Abstract). Lee teaches that that antibody-drug conjugates can provide targeted therapy to treat various diseases or conditions, such as cancer (paragraph [0002]). Lee teaches the antibody coupled to a payload (which can be a drug, a diagnostic agent or a therapeutic agent) ([para [0028]).
Therefore, given the fact that conjugating an antibody to a drug or a diagnostic label is common once the antibody developed that specifically binds to a target antigen related to a disease for treatment and for diagnosis (lee et al) and given the fact that Tsai2 teaches anti-ENO1 antibody, or fragment thereof, conjugated to a therapeutic agent and the therapeutic agent can be, for example, a toxin or a radioisotope (para [0043]), it would be obvious to one of ordinary skilled in the art to easily envisage the antibody of Tsai conjugated to a drug, therapeutic agent or a diagnostic agent with the expectation of expanding the arsenal of the antibody useful as pharmaceutical composition for treatment and for diagnosis with a reasonable expectation of success.
In regards to claims 2-3, Tsai teaches that the antibody is a polyclonal antibody, a monoclonal antibody, a humanized antibody or a fully human antibody (paragraph 20, lines 42-49).
In regards to claims 5 and 21, Lee teaches various drugs including DM1 (paragraph [0045]) and thus various commonly known therapeutic agent would be obvious for the conjugate of Tsai.
In regards to claims 9-10, Tsai teaches pharmaceutical composition comprising the antibody of claim 1 (claim 4) and since as described above, conjugate of the antibody with a therapeutic agent has been found to be obvious by the combination of the references, a pharmaceutical composition comprising the antibody conjugated to a therapeutic agent or a diagnostic agent would also be obvious to one of ordinary skilled in the art. In regards to claims 9-11, the recitation “for diagnosing or imaging cells or a tissue expressing ENO1” and “for use in treating an inflammatory disease, an immune disorder or an ENO1-expressing cancer”, are intended use/process utilizing a composition comprising the immunoconjugate. Applicant is reminded that a recitation of the intended use/process of the claimed invention, must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In regards to claim 18, as disclosed in the specification (para [0077]), antibody HuL001 comprises HCDR1 (SEQ ID NO.1), HCDR2 (SEQ ID NO.2), HCDR3 (SEQ ID NO. 3), LCDR1 (SEQ ID NO. 4), LCDR2 (SEQ ID NO. 5) and LCDR3 (SEQ ID NO. 6) as claimed in claim 1 and a conjugate with a cytotoxic agent is obvious in view of Tsai and Lee. Lee teaches various cytotoxic agents including DM1 (para [0044]) and auristatins conjugated to antibody through various linkers. Lee discloses antibody conjugated to auristatin MMAE with a linker composition
PNG
media_image1.png
144
568
media_image1.png
Greyscale
, which is the same linker composition as claimed in claim 18 conjugate with MMAE. Therefore, one of ordinary skilled in the art can easily envisage various cytotoxic drugs conjugated to the antibody of Cai through various linker compositions including MMAE through a linker composition disclosed by Lee with a reasonable expectation of success. Various linker composition for conjugating the antibody of Tsai to various cytotoxic drugs would be within the purview of one of ordinary skilled in the art.
Claims 1-6, 9-10, 18 and 21 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over of Tsai et al (9,527922) alone or further in view Lee et al (US 2019/0106507A1).
In regards to claims 1 and 4, Tsai discloses antibody specifically binding to human alpha-enolase (ENO1). Tsai teaches that ENO1 expressed on the cell surface of many cancer cells, plasminogen as a receptor, and is expressed on activated hematopoietic cells such as neutrophil, lymphocyte and monocyte. regulation of known plasminogen receptor protein (Col. 1). Tsai teaches that ENO1 can increase cancer cell invasion activity as plasminogen receptor expressed on the surface of cancer cells and therefore, ENO1 is a potential cancer therapeutic target (Col. 1). Tsai teaches that the antibody inhibits cell invasion and tumor metastasis ability of various tumors (col. 1). Tai teaches that the antibody is useful for diagnosis, prognosis and treatment of various cancers expressing ENO1 at the cell surface (Col.2, lines 5-10). Cai teaches that in one embodiment ENO1 antibody or its segment is coupled to a therapeutic agent. Treating agent can be such as a toxin or a radioactive isotope (Col. 6, lines 1-5). Tsai discloses an antibody comprising one or more sequences selected from the group consisting of: HCDR1 (GYTFTSCVMN; SEQ ID NO: 3) and HCDR2 (YINPYNDGTKYNEKFKG; SEQ ID NO: 4) and HCDR3 (EGFYYGNFDN; SEQ ID NO: 5) and LCDR1 (RASENIYSYLT; SEQ ID NO: 6), LCDR2 (NAKTLPE; SEQ ID NO: 7) and LCDR3 (QHHYGTPYT; SEQ ID NO: 8) and the CDR sequences correspond to HCDR1 (SEQ ID NO.1), HCDR2 (SEQ ID NO.2), HCDR3 (SEQ ID NO. 3), LCDR1 (SEQ ID NO. 4), LCDR2 (SEQ ID NO. 5) and LCDR3 (SEQ ID NO. 6) of instant antibody of claim 7.
Tsai does not teach a general formula for antibody conjugate with therapeutic agent as claimed and does not specifically disclose a conjugate of the antibody with a therapeutic agent. The formula as claimed in claim 1 encompass an anti-ENO1 antibody directly bound to a therapeutic agent of a label when m is 1 and L is bond.
Thus, from the description in mind of Tsai, the anti-ENO1 antibody bound to a therapeutic agent directly or through a linker, would be obvious to one of ordinary skilled in the art because Tsai teaches ENO1 antibody or its segment coupled to a therapeutic agent. Cai also teaches that the antibody is useful of diagnosis and one of ordinary skilled in the art readily understands that for diagnosis or detection, labeling of antibody with a label is very common and thus would be obvious to one of ordinary skilled in the art.
Moreover, providing a conjugate of the antibody with a therapeutic agent or a label would be obvious in view of Lee. Lee discloses an antibody (anti-Globo H antibody) conjugated to a therapeutic or a label having the formula Ab-(L-D)m, wherein Ab is the anti-Globo H antibody or binding fragment thereof, L is a linker or a direct bond, D is a therapeutic agent or a label and m is an integer of 1-8 (Abstract). Lee teaches that the immunoconjugate is for treating a cancer by administering to a subject in need (Abstract). Lee teaches that that antibody-drug conjugates can provide targeted therapy to treat various diseases or conditions, such as cancer (paragraph [0002]). Lee teaches the antibody coupled to a payload (which can be a drug, a diagnostic agent or a therapeutic agent) ([para [0028]).
Therefore, given the fact that conjugating an antibody to a drug or a diagnostic label is common once the antibody developed that specifically binds to a target antigen related to a disease for treatment and for diagnosis (lee et al) and given the fact that Tsai teaches anti-ENO1 antibody, or fragment thereof, conjugated to a therapeutic agent and the therapeutic agent can be, for example, a toxin or a radioisotope (para [0043]), it would be obvious to one of ordinary skilled in the art to easily envisage the antibody of Tsai conjugated to a drug, therapeutic agent or a diagnostic agent with the expectation of expanding the arsenal of the antibody useful as pharmaceutical composition for treatment and for diagnosis with a reasonable expectation of success.
In regards to claims 2 and 3, Tsai throughout the reference, teaches the antibody is monoclonal antibody (claim 11) and the antibody can be a chimeric antibody, a humanized antibody.
In regards to claims 5 and 21, as described above, Tsai teaches therapeutic agent conjugated to the antibody and lee teaches various therapeutic agents including DM1 and auristatins and thus various commonly known therapeutic agents including cytotoxic agents would be obvious to one of ordinary skilled in the art absent showing of unexpected advantages with the particular therapeutic agent.
In regards to claim 6, as described above, Tsai teaches that the antibody would be useful for diagnosis and one of ordinary skilled in the art readily understands that for diagnosis or detection, labeling of the antibody with a various commonly known labels would be obvious to one of ordinary skilled in the art absent showing of unexpected advantages with a particular diagnostic agent.
In regards to claims 9-11. Tsai teaches pharmaceutical composition comprising the antibody of claim 1 (claim 12) and since as described above, conjugate of the antibody with a therapeutic agent has been found to be obvious, a pharmaceutical composition comprising the antibody conjugated to a therapeutic agent would also be obvious to one of ordinary skilled in the art. In regards to claims 9-11, the recitation “for diagnosing or imaging cells or a tissue expressing ENO1” and “for use in treating an inflammatory disease, an immune disorder or an ENO1-expressing cancer”, are intended use/process utilizing a composition comprising the immunoconjugate. Applicant is reminded that a recitation of the intended use/process of the claimed invention, must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In regards to claim 18, as disclosed in the specification (para [0077]), antibody HuL001 comprises HCDR1 (SEQ ID NO.1), HCDR2 (SEQ ID NO.2), HCDR3 (SEQ ID NO. 3), LCDR1 (SEQ ID NO. 4), LCDR2 (SEQ ID NO. 5) and LCDR3 (SEQ ID NO. 6) as claimed in claim 1 and a conjugate with a cytotoxic agent is obvious in view of Tsai and Lee. Lee teaches various cytotoxic agents including DM1 (para [0044]) and auristatins conjugated to antibody through various linkers. Lee discloses antibody conjugated to auristatin MMAE with a linker composition
PNG
media_image1.png
144
568
media_image1.png
Greyscale
, which is the same linker composition as claimed in claim 18 conjugate with MMAE. Therefore, one of ordinary skilled in the art can easily envisage various cytotoxic drugs conjugated to the antibody of Cai through various linker compositions including MMAE through a linker composition disclosed by Lee with a reasonable expectation of success. Various linker composition for conjugating the antibody of Tsai to various cytotoxic drugs would be within the purview of one of ordinary skilled in the art.
Claims 1-7, 9-10, 18 and 21 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over of Tsai et al (9,382,331) alone or further in view Lee et al (US 2019/0106507A1).
In regards to claims 1 and 4, Tsai discloses antibody specifically binding to human alpha-enolase (ENO1) (Abstract). Tsai teaches that the antibody of the invention are useful for diagnosis, prognosis and treatment of cancers that have been reported to express cell-surface ENO1 (Abstract). Tsai teaches that ENO1 expressed on the cell surface of many cancer cells, plasminogen as a receptor, and is expressed on activated hematopoietic cells such as neutrophil, lymphocyte and monocyte. regulation of known plasminogen receptor protein. Tsai teaches that ENO1 can increase cancer cell invasion activity as plasminogen receptor expressed on the surface of cancer cells and therefore, ENO1 is a potential cancer therapeutic target (Cols 1-2). Tsai teaches that the antibody inhibits cell invasion and tumor metastasis ability of various tumors (Abstract).
Tsai discloses an antibody comprising one or more sequences selected from the group consisting of: HCDR1 (GYTFTSCVMN; SEQ ID NO: 3) and HCDR2 (YINPYNDGTKYNEKFKG; SEQ ID NO: 4) and HCDR3 (EGFYYGNFDN; SEQ ID NO: 5) and LCDR1 (RASENIYSYLT; SEQ ID NO: 6), LCDR2 (NAKTLPE; SEQ ID NO: 7) and LCDR3 (QHHYGTPYT; SEQ ID NO: 8) and the CDR sequences correspond to HCDR1 (SEQ ID NO.1), HCDR2 (SEQ ID NO.2), HCDR3 (SEQ ID NO. 3), LCDR1 (SEQ ID NO. 4), LCDR2 (SEQ ID NO. 5) and LCDR3 (SEQ ID NO. 6) of instant antibody of claim 1.
Tai teaches that the antibody is useful for diagnosis, prognosis and treatment of various cancers expressing ENO1 at the cell surface (Col.2, lines 1-3). Cai teaches that in one embodiment ENO1 antibody or its segment is coupled to a therapeutic agent. Treating agent can be such as a toxin or a radioactive isotope (Col. 6, lines 1-4).
Tsai does not teach a general formula for antibody conjugate with therapeutic agent as claimed and does not specifically disclose a conjugate of the antibody with a therapeutic agent. The formula as claimed in claim 1 encompass an anti-ENO1 antibody directly bound to a therapeutic agent of a label when m is 1 and L is bond.
Thus, from the description in mind of Cai, the anti-ENO1 antibody bound to a therapeutic agent directly or through a linker, would be obvious to one of ordinary skilled in the art because Cai teaches ENO1 antibody or its segment coupled to a therapeutic agent. Cai also teaches that the antibody is useful of diagnosis and one of ordinary skilled in the art readily understands that for diagnosis or detection, labeling of antibody with a label is very common and thus would be obvious to one of ordinary skilled in the art.
Moreover, providing a conjugate of the antibody with a therapeutic agent or a label would be obvious in view of Lee. Lee discloses an antibody (anti-Globo H antibody) conjugated to a therapeutic or a label having the formula Ab-(L-D)m, wherein Ab is the anti-Globo H antibody or binding fragment thereof, L is a linker or a direct bond, D is a therapeutic agent or a label and m is an integer of 1-8 (Abstract). Lee teaches that the immunoconjugate is for treating a cancer by administering to a subject in need (Abstract). Lee teaches that that antibody-drug conjugates can provide targeted therapy to treat various diseases or conditions, such as cancer (paragraph [0002]). Lee teaches the antibody coupled to a payload (which can be a drug, a diagnostic agent or a therapeutic agent) ([para [0028]).
Therefore, given the fact that conjugating an antibody to a drug or a diagnostic label is common once the antibody developed that specifically binds to a target antigen related to a disease for treatment and for diagnosis (lee et al) and given the fact that Tsai teaches anti-ENO1 antibody, or fragment thereof, conjugated to a therapeutic agent and the therapeutic agent can be, for example, a toxin or a radioisotope (para [0043]), it would be obvious to one of ordinary skilled in the art to easily envisage the antibody of Tsai conjugated to a drug, therapeutic agent or a diagnostic agent with the expectation of expanding the arsenal of the antibody useful as pharmaceutical composition for treatment and for diagnosis with a reasonable expectation of success.
In regards to claims 2 and 3, Tsai throughout the reference, teaches the antibody is monoclonal antibody (claim 14) and the antibody can be a chimeric antibody, a humanized antibody (col. 5, lines 1-3)
In regards to claims 5 and 21, as described above, Tsai teaches therapeutic agent conjugated to the antibody and lee teaches various therapeutic agents including DM1 and auristatins and thus various commonly known therapeutic agents including cytotoxic agents would be obvious to one of ordinary skilled in the art absent showing of unexpected advantages with the particular therapeutic agent.
In regards to claim 6, as described above, Tsai teaches that the antibody would be useful for diagnosis and one of ordinary skilled in the art readily understands that for diagnosis or detection, labeling of the antibody with a various commonly known labels would be obvious to one of ordinary skilled in the art absent showing of unexpected advantages with a particular diagnostic agent.
In regards to claims 9-10, Tsai teaches pharmaceutical composition comprising the antibody of claim 1 (claim 15) and since as described above, conjugate of the antibody with a therapeutic agent has been found to be obvious, a pharmaceutical composition comprising the antibody conjugated to a therapeutic agent would also be obvious to one of ordinary skilled in the art. In regards to claims 9-11, the recitation “for diagnosing or imaging cells or a tissue expressing ENO1” and “for use in treating an inflammatory disease, an immune disorder or an ENO1-expressing cancer”, are intended use/process utilizing a composition comprising the immunoconjugate. Applicant is reminded that a recitation of the intended use/process of the claimed invention, must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In regards to claim 18, as disclosed in the specification (para [0077]), antibody HuL001 comprises HCDR1 (SEQ ID NO.1), HCDR2 (SEQ ID NO.2), HCDR3 (SEQ ID NO. 3), LCDR1 (SEQ ID NO. 4), LCDR2 (SEQ ID NO. 5) and LCDR3 (SEQ ID NO. 6) as claimed in claim 1 and a conjugate with a cytotoxic agent is obvious in view of Tsai and Lee. Lee teaches various cytotoxic agents including DM1 (para [0044]) and auristatins conjugated to antibody through various linkers. Lee discloses antibody conjugated to auristatin MMAE with a linker composition
PNG
media_image1.png
144
568
media_image1.png
Greyscale
, which is the same linker composition as claimed in claim 18 conjugate with MMAE. Therefore, one of ordinary skilled in the art can easily envisage various cytotoxic drugs conjugated to the antibody of Cai through various linker compositions including MMAE through a linker composition disclosed by Lee with a reasonable expectation of success. Various linker composition for conjugating the antibody of Tsai to various cytotoxic drugs would be within the purview of one of ordinary skilled in the art.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-6, 9-10, 18 and 21 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 9,527922 in view Lee et al (US 2019/0106507A1).
In regards to claims 1 and 4, Claims of US patent ‘922 discloses antibody specifically binding to ENO1 (claims 1 and 10) and also teaches a pharmaceutical composition comprising the antibody for treating cancers (claim 11). US patent ‘922 discloses an antibody comprising one or more sequences selected from the group consisting of: HCDR1 (GYTFTSCVMN; SEQ ID NO: 3) and HCDR2 (YINPYNDGTKYNEKFKG; SEQ ID NO: 4) and HCDR3 (EGFYYGNFDN; SEQ ID NO: 5) and LCDR1 (RASENIYSYLT; SEQ ID NO: 6), LCDR2 (NAKTLPE; SEQ ID NO: 7) and LCDR3 (QHHYGTPYT; SEQ ID NO: 8) and the CDR sequences correspond to HCDR1 (SEQ ID NO.1), HCDR2 (SEQ ID NO.2), HCDR3 (SEQ ID NO. 3), LCDR1 (SEQ ID NO. 4), LCDR2 (SEQ ID NO. 5) and LCDR3 (SEQ ID NO. 6) of instant antibody of claim 1.
Claims of US patent ‘922 discloses antibody specifically binding to ENO1 and the antibody comprising the same CDR sequences as claimed in claim 1, but however does not teach the antibody conjugated to a label for detection or conjugated to a cytotoxic drug or therapeutic for treatment.
Lee discloses an antibody (anti-Globo H antibody) conjugated to a therapeutic or a label having the formula Ab-(L-D)m, wherein Ab is the anti-Globo H antibody or binding fragment thereof, L is a linker or a direct bond, D is a therapeutic agent or a label and m is an integer of 1-8 (Abstract). Lee teaches that the immunoconjugate is for treating a cancer by administering to a subject in need (Abstract). Lee teaches that that antibody-drug conjugates can provide targeted therapy to treat various diseases or conditions, such as cancer (paragraph [0002]). Lee teaches the antibody coupled to a payload (which can be a drug, a diagnostic agent or a therapeutic agent) ([para [0028]).
Therefore, given the fact that conjugating an antibody to a drug or a diagnostic label is common once the antibody developed that specifically binds to a target antigen related to a disease for treatment and for diagnosis (lee et al), it would be obvious to one of ordinary skilled in the art to easily envisage the antibody of Tsai conjugated to a drug, therapeutic agent or a diagnostic agent with the expectation of expanding the arsenal of the antibody useful as pharmaceutical composition for treatment and for diagnosis with a reasonable expectation of success.
In regards to claims 2 and 3, US patent discloses the antibody is monoclonal antibody (claim 11) and is a humanized antibody (claim 1).
In regards to claim 5, US patent ‘922 in view of Lee suggest the antibody conjugated to a therapeutic agent and lee teaches various therapeutic agents including DM1 and auristatins and thus various commonly known therapeutic agents including cytotoxic agents would be obvious to one of ordinary skilled in the art absent showing of unexpected advantages with the particular therapeutic agent.
In regards to claim 6, as described above, claims of US patent ‘922 in view of Lee teaches conjugation to a diagnostic agent useful for diagnosis and one of ordinary skilled in the art readily understands that for diagnosis or detection, labeling of the antibody with a various commonly known labels would be obvious to one of ordinary skilled in the art absent showing of unexpected advantages with a particular diagnostic agent.
In regards to claims 9-10, claim 12 of US patent teaches pharmaceutical composition comprising the antibody of claim 1 and in view of Lee makes obvious of a conjugate of the antibody with a pharmaceutical agent of a label and since conjugate of the antibody with a therapeutic agent has been found to be obvious, a pharmaceutical composition comprising the antibody conjugated to a therapeutic agent would also be obvious to one of ordinary skilled in the art. In regards to claims 9-10, the recitation “for diagnosing or imaging cells or a tissue expressing ENO1” and “for use in treating an inflammatory disease, an immune disorder or an ENO1-expressing cancer”, are intended use/process utilizing a composition comprising the immunoconjugate. Applicant is reminded that a recitation of the intended use/process of the claimed invention, must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In regards to claim 18, antibody HuL001 comprises HCDR1 (SEQ ID NO.1), HCDR2 (SEQ ID NO.2), HCDR3 (SEQ ID NO. 3), LCDR1 (SEQ ID NO. 4), LCDR2 (SEQ ID NO. 5) and LCDR3 (SEQ ID NO. 6) as claimed in claim 1 and a conjugate with a cytotoxic agent is obvious in view of US patent ‘922 and Lee. Lee teaches various cytotoxic agents including DM1 (para [0044]) and auristatins conjugated to antibody through various linkers. Lee discloses antibody conjugated to auristatin MMAE with a linker composition
PNG
media_image1.png
144
568
media_image1.png
Greyscale
, which is the same linker composition as claimed in claim 18 conjugate with MMAE. Therefore, one of ordinary skilled in the art can easily envisage various cytotoxic drugs conjugated to the antibody of US patent ‘922 through various linker compositions including MMAE through a linker composition disclosed by Lee with a reasonable expectation of success. Various linker composition for conjugating the antibody of Tsai to various cytotoxic drugs would be within the purview of one of ordinary skilled in the art.
Claims 1-7, 9-10, 18 and 21 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 9382331 in view Lee et al (US 2019/0106507A1).
In regards to claims 1 and 4, Claims of US patent ‘331 discloses antibody specifically binding to ENO1 (claim 1) and also teaches a pharmaceutical composition comprising the antibody for treating cancers (claim 16). claim 1 of US patent ‘331 discloses an antibody comprising one or more sequences selected from the group consisting of: HCDR1 (GYTFTSCVMN; SEQ ID NO: 3) and HCDR2 (YINPYNDGTKYNEKFKG; SEQ ID NO: 4) and HCDR3 (EGFYYGNFDN; SEQ ID NO: 5) and LCDR1 (RASENIYSYLT; SEQ ID NO: 6), LCDR2 (NAKTLPE; SEQ ID NO: 7) and LCDR3 (QHHYGTPYT; SEQ ID NO: 8) and the CDR sequences correspond to HCDR1 (SEQ ID NO.1), HCDR2 (SEQ ID NO.2), HCDR3 (SEQ ID NO. 3), LCDR1 (SEQ ID NO. 4), LCDR2 (SEQ ID NO. 5) and LCDR3 (SEQ ID NO. 6) of instant antibody of claim 7.
Claims of US patent ‘331 discloses antibody specifically binding to ENO1 and teaches diagnosis of cancer utilizing the antibody, but however does not teach the antibody conjugated to a label for detection or conjugated to a cytotoxic drug or therapeutic for treatment.
Lee discloses an antibody (anti-Globo H antibody) conjugated to a therapeutic or a label having the formula Ab-(L-D)m, wherein Ab is the anti-Globo H antibody or binding fragment thereof, L is a linker or a direct bond, D is a therapeutic agent or a label and m is an integer of 1-8 (Abstract). Lee teaches that the immunoconjugate is for treating a cancer by administering to a subject in need (Abstract). Lee teaches that that antibody-drug conjugates can provide targeted therapy to treat various diseases or conditions, such as cancer (paragraph [0002]). Lee teaches the antibody coupled to a payload (which can be a drug, a diagnostic agent or a therapeutic agent) ([para [0028]).
Therefore, given the fact that conjugating an antibody to a drug or a diagnostic label is common once the antibody developed that specifically binds to a target antigen related to a disease for treatment and for diagnosis (lee et al), it would be obvious to one of ordinary skilled in the art to easily envisage the antibody of US patent ‘331 conjugated to a drug, therapeutic agent or a diagnostic agent with the expectation of expanding the arsenal of the antibody useful as pharmaceutical composition for treatment and for diagnosis with a reasonable expectation of success.
In regards to claims 2 and 3, US patent discloses the antibody is monoclonal antibody and is a humanized antibody (claim 14).
In regards to claims 5 and 21, US patent ‘331 in view of Lee suggest the antibody conjugated to a therapeutic agent or a label and lee teaches various therapeutic agents including DM1 and auristatins and thus various commonly known therapeutic agents including cytotoxic agents would be obvious to one of ordinary skilled in the art absent showing of unexpected advantages with the particular therapeutic agent.
In regards to claim 6, as described above, claims of US patent ‘331 in view of Lee teaches conjugation to a diagnostic agent useful for diagnosis and one of ordinary skilled in the art readily understands that for diagnosis or detection, labeling of the antibody with a various commonly known labels would be obvious to one of ordinary skilled in the art absent showing of unexpected advantages with a particular diagnostic agent.
In regards to claims 9-10, claim 12 of US patent ‘331 teaches pharmaceutical composition comprising the antibody of claim 1 and in view of Lee makes obvious of a conjugate of the antibody with a pharmaceutical agent of a label and since conjugate of the antibody with a therapeutic agent has been found to be obvious, a pharmaceutical composition comprising the antibody conjugated to a therapeutic agent would also be obvious to one of ordinary skilled in the art. In regards to claims 9-11, the recitation “for diagnosing or imaging cells or a tissue expressing ENO1” and “for use in treating an inflammatory disease, an immune disorder or an ENO1-expressing cancer”, are intended use/process utilizing a composition comprising the immunoconjugate. Applicant is reminded that a recitation of the intended use/process of the claimed invention, must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In regards to claim 18, antibody HuL001 comprises HCDR1 (SEQ ID NO.1), HCDR2 (SEQ ID NO.2), HCDR3 (SEQ ID NO. 3), LCDR1 (SEQ ID NO. 4), LCDR2 (SEQ ID NO. 5) and LCDR3 (SEQ ID NO. 6) as claimed in claim 1 and a conjugate with a cytotoxic agent is obvious in view of US patent ‘922 and Lee. Lee teaches various cytotoxic agents including DM1 (para [0044]) and auristatins conjugated to antibody through various linkers. Lee discloses antibody conjugated to auristatin MMAE with a linker composition
PNG
media_image1.png
144
568
media_image1.png
Greyscale
, which is the same linker composition as claimed in claim 18 conjugate with MMAE. Therefore, one of ordinary skilled in the art can easily envisage various cytotoxic drugs conjugated to the antibody of US patent ‘331 through various linker compositions including MMAE through a linker composition disclosed by Lee with a reasonable expectation of success. Various linker composition for conjugating the antibody of Tsai to various cytotoxic drugs would be within the purview of one of ordinary skilled in the art.
Claims 1-6, 9-10, 18 and 21 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 10,781,266 in view of Tsai et al (US 2015/0183884A1) and Lee et al (US 2019/0106507A1).
In regards to claims 1, 4 and 6, US patent ‘266 discloses antibody specifically binding to human alpha-enolase (ENO1) (Claim 1). Claim 4 of the US patent ‘266 discloses the antibody in a pharmaceutical composition and claims 5-8 of the US patent ‘266 discloses the antibody for treating subject suffering from ENO1 protein-related disease or disorder. Claim 1 of US patent ‘266 discloses antibody comprising one or more sequences selected from the group consisting of: HCDR1 (GYTFT-Xaa-VMN; SEQ ID NO: 50) and HCDR2 (YINPYNDGTKYNEKFKG; SEQ ID NO: 4) and HCDR3 (EGFYYGNFDN; SEQ ID NO: 5) and LCDR1 (RASENIYSYLT; SEQ ID NO: 6), LCDR2 (NAKTLPE; SEQ ID NO: 7) and LCDR3 (QHHYGTPYT; SEQ ID NO: 8) and the CDR sequences correspond to HCDR1 (SEQ ID NO.7), HCDR2 (SEQ ID NO.2), HCDR3 (SEQ ID NO. 3), LCDR1 (SEQ ID NO. 4), LCDR2 (SEQ ID NO. 5) and LCDR3 (SEQ ID NO. 6) of instant antibody of claim 1.
The claims of the US patent ‘266 however does not teach the antibody conjugated to a label for detection or conjugated to a cytotoxic drug or therapeutic for treatment.
Tsai discloses antibody specifically binding the ENO1. Tsai teaches that the invention relates to method for treating diseases or conditions associated with the expression of ENO1 in a patient and the method may include administering to a patient an effective amount of an anti-ENO antibody (para [0044]). Tsai teaches pharmaceutical composition comprising the antibody (paragraph [0043]). Tsai teaches that in one embodiment, the anti-ENO1 antibody, or fragment thereof, is conjugated to a therapeutic agent and the therapeutic agent can be, for example, a toxin or a radioisotope (para [0043]).
Lee discloses an antibody (anti-Globo H antibody) conjugated to a therapeutic or a label having the formula Ab-(L-D)m, wherein Ab is the anti-Globo H antibody or binding fragment thereof, L is a linker or a direct bond, D is a therapeutic agent or a label and m is an integer of 1-8 (Abstract). Lee teaches that the immunoconjugate is for treating a cancer by administering to a subject in need (Abstract). Lee teaches that that antibody-drug conjugates can provide targeted therapy to treat various diseases or conditions, such as cancer (paragraph [0002]). Lee teaches the antibody coupled to a payload (which can be a drug, a diagnostic agent or a therapeutic agent) ([para [0028]).
Therefore, given the fact that conjugating an antibody to a drug or a diagnostic label is common once the antibody developed that specifically binds to a target antigen related to a disease for treatment and for diagnosis (lee et al) and given the fact that Tsai teaches anti-ENO1 antibody, or fragment thereof, conjugated to a therapeutic agent and the therapeutic agent can be, for example, a toxin or a radioisotope (para [0043]), it would be obvious to one of ordinary skilled in the art to easily envisage the antibody of Tsai conjugated to a drug, therapeutic agent or a diagnostic agent with the expectation of expanding the arsenal of the antibody useful as pharmaceutical composition for treatment and for diagnosis with a reasonable expectation of success.
In regards to claims 2-3, claim 1 of US patent discloses CDR sequences for the antibody and thus it is highly expected that the antibody is monoclonal and is humanized as the antibody is for treating human subject.
In regards to claims 5 and 21, US patent ‘266 in view of Tsai and Lee, suggest the antibody conjugated to a therapeutic agent or a label. Lee teaches various therapeutic agents including DM1 and auristatins and thus various commonly known therapeutic agents including cytotoxic agents would be obvious to one of ordinary skilled in the art absent showing of unexpected advantages with the particular therapeutic agent.
In regards to claims 9-10, Claim 4 of US patent ‘266 teaches pharmaceutical composition comprising the antibody of claim 1 and since as described above, conjugate of the antibody with a therapeutic agent has been found to be obvious by the combination of the references, a pharmaceutical composition comprising the antibody conjugated to a therapeutic agent or a diagnostic agent would also be obvious to one of ordinary skilled in the art. In regards to claims 9-11, the recitation “for diagnosing or imaging cells or a tissue expressing ENO1” and “for use in treating an inflammatory disease, an immune disorder or an ENO1-expressing cancer”, are intended use/process utilizing a composition comprising the immunoconjugate. Applicant is reminded that a recitation of the intended use/process of the claimed invention, must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In regards to claim 18, antibody HuL001 comprises HCDR1 (SEQ ID NO.1), HCDR2 (SEQ ID NO.2), HCDR3 (SEQ ID NO. 3), LCDR1 (SEQ ID NO. 4), LCDR2 (SEQ ID NO. 5) and LCDR3 (SEQ ID NO. 6) as claimed in claim 1 and a conjugate with a cytotoxic agent is obvious over US patent ‘266 in view of Tasi and Lee. Lee teaches various cytotoxic agents including DM1 (para [0044]) and auristatins conjugated to antibody through various linkers. Lee discloses antibody conjugated to auristatin MMAE with a linker composition
PNG
media_image1.png
144
568
media_image1.png
Greyscale
, which is the same linker composition as claimed in claim 18 conjugate with MMAE. Therefore, one of ordinary skilled in the art can easily envisage various cytotoxic drugs conjugated to the antibody of US patent ‘331 through various linker compositions including MMAE through a linker composition disclosed by Lee with a reasonable expectation of success. Various linker composition for conjugating the antibody of Tsai to various cytotoxic drugs would be within the purview of one of ordinary skilled in the art.
Response to argument
Applicant's arguments filed 07/22/2026 and affidavit filed 4/16/2026 have been fully considered and but are not found persuasive to overcome the pending rejections under 35 USC 103 and obviousness double patenting.
Applicant’s arguments are based on unexpected result from claimed antibody conjugate and the Affidavit filed 04/16/2026 is also directed unexpected results utilizing conjugates of HuL001 with certain drugs with certain linkers.
However, the examiner notes that according to MPEP 716.02(d) unexpected results shall commensurate in scope with claimed invention:
“Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980) (Claims were directed to a process for removing corrosion at "elevated temperatures" using a certain ion exchange resin (with the exception of claim 8 which recited a temperature in excess of 100C). Appellant demonstrated unexpected results via comparative tests with the prior art ion exchange resin at 110C and 130C. The court affirmed the rejection of claims 1-7 and 9-10 because the term "elevated temperatures" encompassed temperatures as low as 60C where the prior art ion exchange resin was known to perform well. The rejection of claim 8, directed to a temperature in excess of 100C, was reversed.). See also In re Peterson, 315 F.3d 1325, 1329-31, 65 USPQ2d 1379, 1382-85 (Fed. Cir. 2003) (data showing improved alloy strength with the addition of 2% rhenium did not evidence unexpected results for the entire claimed range of about 1-3% rhenium); In re Grasselli, 713 F.2d 731, 741, 218 USPQ 769, 777 (Fed. Cir. 1983) (Claims were directed to certain catalysts containing an alkali metal. Evidence presented to rebut an obviousness rejection compared catalysts containing sodium with the prior art. The court held this evidence insufficient to rebut the prima facie case because experiments limited to sodium were not commensurate in scope with the claims.).”
Claims are directed to various antibodies having various SEQ IDS SEQ IDs 1-7) linked to various therapeutic agents via various types of linkers and the various antibodies with various therapeutic agents linked with various types of linkers are not representative of the specific antibody (HuL001) linked to few specific therapeutic drugs with very specific linkers as described in the affidavit (HuL001-SMCC-DMI and HuL001-mel-vc-MMAE). Therefore, Applicant’s assertion of unexpected advantages with the claimed antibody conjugates are not commensurate in scope of the claims.
Furthermore, it is noted that if Applicant wants to include specific conjugates having specific monoclonal HuL001, Applicant should provide evidence that the specific antibody is widely known, reproduceable and is readily available to public or a deposit is required to satisfy biological deposit requirement.
Moreover, regarding combination of the references, the disclosure in the reference of Gou would not deter one of ordinary skilled from conjugating all monoclonal antibodies against ENO-1 to cytotoxic payloads because at the time of the effective filing date of claimed invention, it was known that different monoclonal antibodies directed against the same cell surface antigen behave differently with respect to binding affinity and cell internalization (see the attached reference of Glatt et al, Molecular Pharmaceutics 2016). The reference discloses that different monoclonal antibodies (CD44 mABs; mAb B, C, G and J) against the same cell surface antigen CD44 exhibit different affinity to A549 cells expressing CD44 and different internalization by the A549 cells (Figs. 3-5). Therefore, at the time of the effective filling date of claimed invention, one of ordinary skilled in the would readily understand that disclosure of the anti-ENO-1 antibody, which is not effective of internalization cannot be generalized to all monoclonal anti-ENO-1 monoclonal antibodies as different monoclonal antibody against the same surface antigen provides antibody with different binding affinity and different internalization capability. Thus, the reference of Guo cannot be considered as teaching away which discloses only a single species of monoclonal antibody against ENO-1. Moreover, contrary to Applicant’s assertion, as evidenced from the reference of Tsai (WO2015/095863A2) drug conjugated to anti-ENOI is taught or suggested by Tsai (see claim 5) and one of ordinary skilled in the art would obviously envisage combining the references to provides conjugate of the monoclonal antibody with the drug payload and the conjugate would be show the property of internalization.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAFIQUL HAQ whose telephone number is (571)272-6103. The examiner can normally be reached on Mon-Fri 8-4:30.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gregory S. Emch can be reached on 571-272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/SHAFIQUL HAQ/
Primary Examiner, Art Unit 1678
Prosecution Insights