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
Claims 92-121 are pending in the instant application.
Priority
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and41.202(e).
Failure to provide a certified translation may result in no benefit being accordedfor the non-English application. The effective priority date is the filing date ofPCT/CN2018/120125 filed on 12/10/2018 in the absence of a certified translation ofCN201711347535.6 filed 12/15/2017; CN201810230346.9 filed 3/20/2018; and CN201811071947.6 filed 9/14/2018.
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 92-121 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.
Regarding claims 92-121, the structure of the antibody-drug conjugate of
PNG
media_image1.png
183
775
media_image1.png
Greyscale
shows a sulfur group that connects the linker drug to the antibody, wherein the sulfur is part of the linker within the parentheses. It is unclear if the sulfur is part of the antibody from a cysteine residue or a separate sulfur that is part of the linker that forms a disulfide bond.
To promote compact prosecution, in the structures of instant claims 92, 98, 100, 106, 108, 114, and 116, the sulfur connected to the antibody in the antibody-drug conjugate structure is interpreted as a sulfur that is within the antibody from a cysteine residue and not a separate sulfur that is part of the linker that forms a disulfide bond. The instant specification taught: a) thio groups of antibody cysteine usually exist in the form of disulfide bonds and the disulfide bonds in the antibody can be opened to provide multiple free sulfhydryl groups as coupling sites (page 2, paragraph 3); and b) antibody TCEP reduction and conjugation of the linker-toxin was described on pages 143-147, wherein the reduction of the antibody would prepare the cysteine residues for coupling.
Regarding instant claims 95, 103, 111, and 119 the claimed methods recite administering the antibody drug conjugate of: 1) claim 92; 2) claim 98; 3) claim 106; 4) claim 114, but while claims 92 or 98 include an antibody-drug conjugate, the parental claim is a method not a composition. Thus, the metes and bounds are unclear and the claim is indefinite. Claims: 1) 96-97; 2) 104-105; 3)112-113; and 4) 120-121 are further dependent on the claims 95, 103, 111, and 119 and contain the indefinite subject matter.
Regarding instant claim 114, the meets and bounds of the amino acid sequences of the complementarity determining regions (CDRs) in the heavy chain sequence set forth in SEQ ID NO: 19, and a light chain variable region comprising the amino acid sequences of the CDRs in the light chain sequence set forth in SEQ ID NO: 20 are indefinite to: A) what applicant intends as the scope of the CDRs, wherein it’s unclear what Applicant intends as the CDR because without the specific SEQ ID it’s unclear what applicant is intending to claim; and B) a person having ordinary skill in the art for the scope of the CDRs. For A) and B) separate CDR definitions are known to the prior art such as Kabat, Chothia, and IMGT which have separate definitions of a CDR for a VH and VL, but recitation of the CDR sequences are required to provide exactly what Applicant has determined are the CDR sequences.
MPEP 2171 states Two separate requirements are set forth in 35 U.S.C. 112(b)
and pre-AIA 35 U.S.C. 112, second paragraph, namely that:
(A) the claims must set forth the subject matter that the inventor or a joint inventor
regards as the invention; and
(B) the claims must particularly point out and distinctly define the metes and bounds of
the subject matter to be protected by the patent grant.
The first requirement is a subjective one because it is dependent on what the
inventor or a joint inventor for a patent regards as his or her invention. Note that
although pre-AIA 35 U.S.C. 112, second paragraph, uses the phrase "which applicant
regards as his invention," pre-AIA 37 CFR 1.41(a) provides that a patent is applied for
in the name or names of the actual inventor or inventors.
The second requirement is an objective one because it is not dependent on the views of the inventor or any particular individual, but is evaluated in the context of whether the claim is definite — i.e., whether the scope of the claim is clear to a hypothetical person possessing the ordinary level of skill in the pertinent art.
Thus, the metes and bounds of the claims are indefinite. Recitation of the CDR sequence is required. Instant claims 115-121 further contain the indefinite subject matter without narrowing the claims outside of the rejection.
To promote compact prosecution, the antibody will be interpreted as an antibody comprising a heavy chain sequence as set forth in SEQ ID NO: 19, and a light chain sequence as set forth in SEQ ID NO: 20.
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 1-16 and 18-30 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.
Regarding instant claims 92-121, methods are claimed for treating a cancer or tumor in a patient in need thereof comprising administering an antibody-drug conjugate, wherein the antibody is an anti-Trop-2 monoclonal antibody but the cancer or tumor is not required to express Trop-2. The specification does not show that the claimed antibody-drug conjugate that targets Trop-2 is effective for cancers or tumors that do not express Trop-2.
Regarding instant claims 92-94, 98-102, 106-110, and 114-118, methods are claimed for treating a cancer or tumor in a patient in need thereof comprising administering an antibody-drug conjugate, but only claims 95-97, 103-105, 111-113, and 119-121 require the composition to be a pharmaceutical composition. The specification does not contain effective methods of treatment wherein an antibody-drug conjugate is administered in a non-pharmaceutical composition.
Regarding instant claims 92-97, methods are claimed for treating a cancer or tumor in a patient in need thereof comprising administering an antibody-drug conjugate of:
PNG
media_image2.png
184
772
media_image2.png
Greyscale
wherein γ is an integer from 1 to 10, but the disclosure does not show an effective method of treating cancer or a tumor when γ is more than 8. Cysteine drug conjugates produced via partial reduction of interchain disulfide bonds generate up to eight reactive cysteine thiol groups, thus, only γ values 1-8 are available for conjugation.
Scope of the claimed genus
Regarding instant claims 92-121, methods are claimed for treating a cancer or tumor in a patient in need thereof comprising administering an antibody-drug conjugate, wherein the antibody is an anti-Trop-2 monoclonal antibody but the cancer or tumor is not required to express Trop-2.
Regarding instant claims 92-94, 98-102, 106-110, and 114-118, methods are claimed for treating a cancer or tumor in a patient in need thereof comprising administering an antibody-drug conjugate, wherein only claims 95-97, 103-105, 111-113, and 119-121 require the composition to be a pharmaceutical composition.
Regarding instant claims 92-97, methods are claimed for treating a cancer or tumor in a patient in need thereof comprising administering an antibody-drug conjugate of:
PNG
media_image2.png
184
772
media_image2.png
Greyscale
wherein γ is an integer from 1 to 10, but the disclosure does not show an effective method of treating cancer or a tumor when γ is more than 8.
Summary of Species disclosed in the original specification
MPEP § 2163 states that a “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
1-2) The instant specification taught pharmaceutical compositions of antibody-drug conjugates as effective treatment of cancers or tumors expressing Trop-2 in Fig. 44-49. The instant specification does not have examples of successful treatment of a cancer or tumor that: 1) does not express Trop-2 with the instantly claimed antibody drug conjugate that targets Trop-2; or 2) in a non-pharmaceutical composition.
3) The instant specification taught drug to antibody ratios of less than 8 for BT001004 (Figs 4-6, page 152), BT001012 (Figs 10-11, page 153), BT001013 (Figs 12-13, page 153), BT001018 (Figs 14-15, page 154), BT001021 (Figs 16-17, page 155), BT001023 (Figs 18-19), BT001040- BT001044 (Figs 20-29), BT001046- BT001047 (Figs 30-33). Antibody TCEP reduction and conjugation of the linker-toxin was described on pages 143-147, wherein the reduction of the antibody would prepare the cysteine residues for coupling. The instant specification does not have examples of antibody drug conjugates wherein the number of conjugates is more than 8 in an effective treatment of cancer or a tumor that expressed Trop-2.
State of the Relevant Art
Goldenberg DM et al. (Oncotarget. 2015 Jun 18;6(26):22496–22512) taught Trop-2 appears to have a high prevalence on a number of epithelial cancers, but it is also expressed by several normal tissues, which could have impacted specificity (page 22506, left column, first paragraph). Goldenberg taught expression in normal tissues appears to be lower than in cancers, and Trop-2 appears to be shielded in some normal tissues by their architecture that limits accessibility to an antibody, whereas in cancer, these tissue barriers are compromised by the invading tumor (page 22506, left column, first paragraph). Goldenberg taught Trop-2 is a novel target for ADC therapy because of its high expression by many solid cancers and the anti-Trop-2 ADC, IMMU-132, binds a well-known moderately-cytotoxic drug, SN-38, to the anti-Trop-2 antibody (abstract). Goldenberg taught the anti-Trop-2 ADC, IMMU-132, targets up to 136-fold more SN-38 to a human cancer xenograft than irinotecan, SN-38′s prodrug (abstract). Goldenberg taught a generally accepted and important criterion for ADC therapy is that the antibody should internalize, delivering its chemotherapeutic inside the cell, where it is usually metabolized in lysosomes (page 22506, left column, second paragraph). While bystander effects of a locally released payload can further affect cancer cell toxicity (page 22506, left column, second paragraph), local targeting to Trop-2 expressing cancer cells and tumors would be necessary for the local release.
Compositions intended for medicinal treatment are generally required to be pharmaceutical compositions to provide active drugs for treatment. The prior art has taught a pharmaceutical as of or relating to drugs used in medical treatment or a drug or medicine that is prepared or dispensed in pharmacies and used in medical treatment (Vocabulary.com pharmaceutical 2015 https://web.archive.org/web/20151118012827/https://www.vocabulary.com/dictionary/pharmaceutical page 1). By specifically claiming the antibody drug conjugate outside of a pharmaceutical composition, the claims would include non-pharmaceutical compositions for use in a method of treating cancer. The prior art does not teach antibody-drug conjugate compositions that are not in pharmaceutical compositions for effective treatment of cancer or a tumor.
Goldenberg taught an effective method of treating gastric cancer and breast cancer in a subject comprising administering a pharmaceutical composition comprising a pharmaceutically acceptable excipient and the anti-Trop-2 ADC IMMU-132 (Figs 3 and 5), wherein IMMU-132 is comprised of the antibody sacituzumab (Title), wherein the drug to antibody ratio (DAR) was between 7-8 (Table 1), wherein the method of producing the ADC utilized a limited reduction procedure that breaks only the interchain disulfide bridges between the heavy-heavy and heavy-light chains, but not the intra-domain disulfides, generating up to 8 site-specific thiols per antibody molecule (page 22497, right column, second paragraph), which would conjugate the payload to up to 3 heavy chain sulfurs and 0 or 1 light chain sulfurs. The prior art has taught most ADCs are synthesized by conjugating a cytotoxic compound or “payload” to a monoclonal antibody (Behrens CR et al. (Mol. Pharmaceutics 2015, 12, 11, 3986–3998), page 3986, left column, first paragraph). Behrens taught the payloads are conjugated using amino or sulfhydryl specific linkers that react selectively with lysines or cysteines on the antibody surface, wherein a typical antibody contains over 50 lysines and eight interchain cysteines as potential conjugation sites (page 3986, left column, first paragraph). Behrens taught conjugation through antibody cysteines minimizes ADC heterogeneity relative to lysine conjugation because there are fewer potential conjugation sites (page 3986, right column, first paragraph). The process typically involves partial reduction of four antibody interchain disulfide bonds to generate up to eight reactive cysteine thiol groups, followed by conjugation of payloads containing thiol-specific maleimide linkers (page 3986, right column, first paragraph). Behrens taught ADCs with suboptimal DARs are prone to aggregation, poor solubility, and instability, which often lead to increased toxicity and/or inadequate efficacy in vivo (page 3986, left column, first paragraph). Behrens taught the discrepancy between the number of potential conjugation sites and the desired DAR, combined with the use of linkers that lack site-specificity, results in heterogeneous ADCs that vary in both DAR and the conjugation sites (page 3986, left to right column bridging sentence). Behrens taught consequently, most of the ADCs in clinical development for cancer indications contain dozens or more of chemically distinct ADC molecules, each with unique pharmacological properties (page 3986, right column, first paragraph). Thus, linker-drug conjugates would conjugate up to 8 cysteines on the antibody.
Claims 1-16 and 18-30 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for:
A) methods for treating a Trop-2 expressing cancer or tumor in a patient in need thereof comprising administering a pharmaceutical composition comprising an antibody-drug conjugate with the structure
PNG
media_image2.png
184
772
media_image2.png
Greyscale
, wherein the antibody is an anti-Trop-2 monoclonal antibody, wherein γ is an integer from 1 to 8, does not reasonably provide enablement for:
A) methods for treating a cancer or tumor that is not required to express Trop-2 in a patient in need thereof comprising administering a non-pharmaceutical composition comprising an antibody-drug conjugate with the structure
PNG
media_image2.png
184
772
media_image2.png
Greyscale
, wherein the antibody is an anti-Trop-2 monoclonal antibody, wherein γ is an integer greater than 8. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims.
Regarding instant claims 92-121, methods are claimed for treating a cancer or tumor in a patient in need thereof comprising administering an antibody-drug conjugate, wherein the antibody is an anti-Trop-2 monoclonal antibody but the cancer or tumor is not required to express Trop-2. The specification and prior art do not teach that the claimed antibody-drug conjugate that targets Trop-2 is effective for cancers or tumors that do not express Trop-2.
Regarding instant claims 92-94, 98-102, 106-110, and 114-118, methods are claimed for treating a cancer or tumor in a patient in need thereof comprising administering an antibody-drug conjugate, wherein only claims 95-97, 103-105, 111-113, and 119-121 require the composition to be a pharmaceutical composition. The specification and prior art do not teach effective methods of treatment wherein an antibody-drug conjugate is administered in a non-pharmaceutical composition.
Regarding instant claims 92-97, methods are claimed for treating a cancer or tumor in a patient in need thereof comprising administering an antibody-drug conjugate of:
PNG
media_image2.png
184
772
media_image2.png
Greyscale
wherein γ is an integer from 1 to 10, but the disclosure and prior art do not show an effective method of treating cancer or a tumor when γ is more than 8. Cysteine drug conjugates produced via partial reduction of interchain disulfide bonds generate up to eight reactive cysteine thiol groups, thus, only γ values 1-8 are available for conjugation.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is "undue." These
factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Scope of the claimed genus and nature of the invention.
Regarding instant claims 92-121, methods are claimed for treating a cancer or tumor in a patient in need thereof comprising administering an antibody-drug conjugate, wherein the antibody is an anti-Trop-2 monoclonal antibody but the cancer or tumor is not required to express Trop-2.
Regarding instant claims 92-94, 98-102, 106-110, and 114-118, methods are claimed for treating a cancer or tumor in a patient in need thereof comprising administering an antibody-drug conjugate, wherein only claims 95-97, 103-105, 111-113, and 119-121 require the composition to be a pharmaceutical composition.
Regarding instant claims 92-97, methods are claimed for treating a cancer or tumor in a patient in need thereof comprising administering an antibody-drug conjugate of:
PNG
media_image2.png
184
772
media_image2.png
Greyscale
wherein γ is an integer from 1 to 10, but the disclosure does not show an effective method of treating cancer or a tumor when γ is more than 8.
Summary of Species disclosed in the original specification; the amount of direction provided by the inventor, existence of working examples; and quality of experimentation needed to make or use the invention based on the content of the disclosure.
1-2) The instant specification taught pharmaceutical compositions of antibody-drug conjugates as effective treatment of cancers or tumors expressing Trop-2 in Fig. 44-49. The instant specification does not have examples of successful treatment of a cancer or tumor that: 1) does not express Trop-2 with the instantly claimed antibody drug conjugate that targets Trop-2; or 2) in a non-pharmaceutical composition.
3) The instant specification taught drug to antibody ratios of less than 8 for BT001004 (Figs 4-6, page 152), BT001012 (Figs 10-11, page 153), BT001013 (Figs 12-13, page 153), BT001018 (Figs 14-15, page 154), BT001021 (Figs 16-17, page 155), BT001023 (Figs 18-19), BT001040- BT001044 (Figs 20-29), BT001046- BT001047 (Figs 30-33). Antibody TCEP reduction and conjugation of the linker-toxin was described on pages 143-147, wherein the reduction of the antibody would prepare the cysteine residues for coupling. The instant specification does not have examples of antibody drug conjugates wherein the number of conjugates is more than 8 in an effective treatment of cancer or a tumor that expressed Trop-2.
State of the Relevant Art; level of one of ordinary skill; and level of predictability of the art.
Goldenberg DM et al. Trop-2 is a novel target for solid cancer therapy with sacituzumab govitecan (IMMU-132), an antibody-drug conjugate (ADC). (Oncotarget. 2015 Jun 18;6(26):22496–22512) taught Trop-2 appears to have a high prevalence on a number of epithelial cancers, but it is also expressed by several normal tissues, which could have impacted specificity (page 22506, left column, first paragraph). Goldenberg taught expression in normal tissues appears to be lower than in cancers, and Trop-2 appears to be shielded in some normal tissues by their architecture that limits accessibility to an antibody, whereas in cancer, these tissue barriers are compromised by the invading tumor (page 22506, left column, first paragraph). Goldenberg taught a generally accepted and important criterion for ADC therapy is that the antibody should internalize, delivering its chemotherapeutic inside the cell, where it is usually metabolized in lysosomes (page 22506, left column, second paragraph). While bystander effects of a locally released payload can further affect cancer cell toxicity (page 22506, left column, second paragraph), local targeting to Trop-2 expressing cancer cells and tumors would be necessary for the local release.
Compositions intended for medicinal treatment are generally required to be pharmaceutical compositions to provide active drugs for treatment. The prior art has taught a pharmaceutical as of or relating to drugs used in medical treatment or a drug or medicine that is prepared or dispensed in pharmacies and used in medical treatment (Vocabulary.com pharmaceutical 2015 https://web.archive.org/web/20151118012827/https://www.vocabulary.com/dictionary/pharmaceutical page 1). By specifically claiming the antibody drug conjugate outside of a pharmaceutical composition, the claims would include non-pharmaceutical compositions for use in a method of treating cancer. The prior art does not teach antibody-drug conjugate compositions that are not in pharmaceutical compositions for effective treatment of cancer or a tumor.
Goldenberg taught an effective method of treating gastric cancer and breast cancer in a subject comprising administering a pharmaceutical composition comprising a pharmaceutically acceptable excipient and the anti-Trop-2 ADC IMMU-132 (Figs 3 and 5), wherein IMMU-132 is comprised of the antibody sacituzumab (Title), wherein the drug to antibody ratio (DAR) was between 7-8 (Table 1), wherein the method of producing the ADC utilized a limited reduction procedure that breaks only the interchain disulfide bridges between the heavy-heavy and heavy-light chains, but not the intra-domain disulfides, generating up to 8 site-specific thiols per antibody molecule (page 22497, right column, second paragraph), which would conjugate the payload to up to 3 heavy chain sulfurs and 0 or 1 light chain sulfurs. The prior art has taught most ADCs are synthesized by conjugating a cytotoxic compound or “payload” to a monoclonal antibody (Behrens CR et al. (Mol. Pharmaceutics 2015, 12, 11, 3986–3998), page 3986, left column, first paragraph). Behrens taught the payloads are conjugated using amino or sulfhydryl specific linkers that react selectively with lysines or cysteines on the antibody surface, wherein a typical antibody contains over 50 lysines and eight interchain cysteines as potential conjugation sites (page 3986, left column, first paragraph). Behrens taught conjugation through antibody cysteines minimizes ADC heterogeneity relative to lysine conjugation because there are fewer potential conjugation sites (page 3986, right column, first paragraph). The process typically involves partial reduction of four antibody interchain disulfide bonds to generate up to eight reactive cysteine thiol groups, followed by conjugation of payloads containing thiol-specific maleimide linkers (page 3986, right column, first paragraph). Behrens taught ADCs with suboptimal DARs are prone to aggregation, poor solubility, and instability, which often lead to increased toxicity and/or inadequate efficacy in vivo (page 3986, left column, first paragraph). Behrens taught the discrepancy between the number of potential conjugation sites and the desired DAR, combined with the use of linkers that lack site-specificity, results in heterogeneous ADCs that vary in both DAR and the conjugation sites (page 3986, left to right column bridging sentence). Behrens taught consequently, most of the ADCs in clinical development for cancer indications contain dozens or more of chemically distinct ADC molecules, each with unique pharmacological properties (page 3986, right column, first paragraph). Thus, linker-drug conjugates would conjugate up to 8 cysteines on the antibody.
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 92-121 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 92-100, 102, 106-109, 116-124, and 129-135 of copending Application No. 18/155,650 in view of Goldenberg DM et al. (Oncotarget. 2015 Jun 18;6(26):22496–22512).
‘650 taught compounds of formula I T-[L1(L2)m1-(L3)m2-(L4)m3-E]}-G, conjugates comprising an anti-Trop-2 monoclonal antibody of M1, M2, or M3, pharmaceutical compositions, and processes for preparing compounds in copending claims 92-100, 102, 106-109, 116-124, and 129-135.
‘650 taught a method of treating a disease with an abnormal cell activity comprising administering an effective amount of a conjugate comprising an anti-Trop-2 monoclonal antibody of M1 comprising a VH of ‘650 SEQ ID NO:11 and a VL of ‘650 SEQ ID NO:12 to an individual in need thereof in copending claim 131. ‘650 taught a conjugate comprising an anti-Trop-2 monoclonal antibody if M1 comprising a VH of ‘650 SEQ ID NO:11 and a VL of ‘650 SEQ ID NO:12 in copending claim 129, wherein the conjugate was combined with a pharmaceutical excipient in a pharmaceutical composition in copending claim 130. ‘650 taught a compound of
PNG
media_image3.png
199
620
media_image3.png
Greyscale
in copending claim 92.
‘650 did not teach: 1) a method of treating wherein the disease with an abnormal cell activity is non-small cell cancer; or 2) a single embodiment wherein the antibody-drug conjugate is
PNG
media_image2.png
184
772
media_image2.png
Greyscale
, but this is obvious in view of Goldenberg.
Goldenberg taught Trop-2 is a novel target for ADC therapy because of its high expression by many solid cancers and the anti-Trop-2 ADC, IMMU-132, binds a well-known moderately-cytotoxic drug, SN-38, to the anti-Trop-2 antibody (abstract). Goldenberg taught an effective method of treating gastric cancer and breast cancer in a subject comprising administering a pharmaceutical composition comprising a pharmaceutically acceptable excipient and the anti-Trop-2 ADC IMMU-132 (Figs 3 and 5), wherein IMMU-132 is comprised of the antibody sacituzumab (Title), wherein the drug to antibody ratio (DAR) was between 7-8 (Table 1), wherein the method of producing the ADC utilized a limited reduction procedure that breaks only the interchain disulfide bridges between the heavy-heavy and heavy-light chains, but not the intra-domain disulfides, generating up to 8 site-specific thiols per antibody molecule (page 22497, right column, second paragraph), which would conjugate the payload to up to 3 heavy chain sulfurs and 0 or 1 light chain sulfurs. Goldenberg taught the anti-Trop-2 antibody-drug conjugate (ADC) IMMU-132, carrying a moderately-toxic drug targeting Trop-2 represents a novel cancer therapeutic that is showing promising activity in patients with several metastatic cancer types, including triple-negative breast cancer, non-small-cell and small-cell lung cancers (abstract).
Regarding instant claims 92-121, it would have been obvious for a person having ordinary skill in the art to modify ‘650 copending claims 129-131 of a method of treating a disease with an abnormal cell activity comprising administering a pharmaceutical composition comprising a pharmaceutically acceptable excipient and an effective amount of a conjugate comprising an anti-Trop-2 monoclonal antibody of M1 to an individual in need thereof, wherein the conjugate contained the payload
PNG
media_image3.png
199
620
media_image3.png
Greyscale
- by:
Exchanging the anti-Trop antibody with the effective anti-Trop-2 antibody of Sacituzumab of Goldenberg;
Conjugate the payload
PNG
media_image2.png
184
772
media_image2.png
Greyscale
to the anti-Trop-2 antibody at a DAR of 7-8, wherein a limited reduction procedure that breaks only the interchain disulfide bridges between the heavy-heavy and heavy-light chains, but not the intra-domain disulfides, generating up to 8 site-specific thiols per antibody molecule (page 22497, right column, second paragraph), which would conjugate the payload to up to 3 heavy chain sulfurs and 0 or 1 light chain sulfurs in view of Goldenberg;
Treat non-small cell lung cancer patients in view of Goldenberg
This is obvious because:
1) Goldenberg taught the anti-Trop-2 ADC IMMU-132 comprised sacituzumab and that the ADC was effective at treating subjects with cancer and that Trop-2 represents a novel cancer therapeutic that is showing promising activity in patients with several metastatic cancer types, including non-small-cell lung cancers;
2) Goldenberg taught an effective method of treating gastric cancer and breast cancer in a subject comprising administering a pharmaceutical composition comprising a pharmaceutically acceptable excipient and the anti-Trop-2 ADC IMMU-132, wherein the drug to antibody ratio (DAR) was between 7-8, wherein the method of producing the ADC utilized a limited reduction procedure that breaks only the interchain disulfide bridges between the heavy-heavy and heavy-light chains, but not the intra-domain disulfides, generating up to 8 site-specific thiols per antibody molecule, which would conjugate the payload to up to 3 heavy chain sulfurs and 0 or 1 light chain sulfurs.
3) Goldenberg taught the anti-Trop-2 antibody-drug conjugate (ADC) IMMU-132, carrying a moderately-toxic drug targeting Trop-2 represents a novel cancer therapeutic that is showing promising activity in patients with several metastatic cancer types, including non-small-cell lung cancers;
There is a reasonable expectation of success because:
1) Goldenberg taught the anti-Trop-2 ADC IMMU-132 comprised sacituzumab and that the ADC was effective at treating subjects with cancer and that Trop-2 represents a novel cancer therapeutic that is showing promising activity in patients with several metastatic cancer types, including non-small-cell lung cancers. Thus, Sacituzumab is an effective antibody for an ADC;
2) Goldenberg taught an effective method of treating gastric cancer and breast cancer in a subject comprising administering a pharmaceutical composition comprising a pharmaceutically acceptable excipient and the anti-Trop-2 ADC IMMU-132, wherein the drug to antibody ratio (DAR) was between 7-8, wherein the method of producing the ADC utilized a limited reduction procedure that breaks only the interchain disulfide bridges between the heavy-heavy and heavy-light chains, but not the intra-domain disulfides, generating up to 8 site-specific thiols per antibody molecule, which would conjugate the payload to up to 3 heavy chain sulfurs and 0 or 1 light chain sulfurs. Thus, conjugating the payload
PNG
media_image3.png
199
620
media_image3.png
Greyscale
with a DAR of 8 would be expected to be effective;
3) Goldenberg taught the anti-Trop-2 antibody-drug conjugate (ADC) IMMU-132, carrying a moderately-toxic drug targeting Trop-2 represents a novel cancer therapeutic that is showing promising activity in patients with several metastatic cancer types, including non-small-cell lung cancers. Thus, treating non-small-cell lung cancers with the ADC would be expected to be effective.
This would produce a method of ‘650 and Goldenberg of treating a patient with non-small cell lung cancer (instant claims 93-94, 96-97, 101-102, 104-105, 109-110, 112-113, 117-118, and 120-121) that expressed Trop-2 comprising administering to the patient in need thereof a pharmaceutical composition (instant claims 95, 103, 111, and 119) comprising a pharmaceutically acceptable excipient and a therapeutically effective amount of an antibody-drug conjugate comprising an anti-Trop-2 monoclonal antibody of Sacituzumab, which is evidenced by the instant specification on page 89 to contain a heavy chain of instant SEQ ID NO:19 and a light chain of SEQ ID NO:20 (instant claims 98 and 114) conjugated to the payload of:
PNG
media_image3.png
199
620
media_image3.png
Greyscale
which would produce an ADC of
PNG
media_image4.png
160
643
media_image4.png
Greyscale
wherein mAb is Sacituzumab, wherein γ is an integer from 7 to 8 (instant claims 99, 106, and 115) for a DAR of 7-8, wherein the cysteine attached payload of
PNG
media_image5.png
168
653
media_image5.png
Greyscale
is conjugated to up to 3 heavy chain sulfurs and 0 or 1 light chain sulfurs (instant claims 100, 108, and 116) (instant claims 92, 106, and 114).
This is a provisional nonstatutory double patenting rejection.
Claims 92-99, 101-107, 109-115, and 117-121 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 3, 6, 8-11, 14-15, 17-18, 20, 25-28, 33-34, 36-43 of copending Application No. 18/557,900. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding instant claims 92-99, 101-107, 109-115, and 117-121, ‘900 taught a method of treating a tumor disease, comprising administering to a patient in need thereof a therapeutically effective amount of an antibody-drug conjugate having the following structure:
PNG
media_image6.png
146
600
media_image6.png
Greyscale
wherein γ is an integer from 5 to 8, and wherein the tumor disease is an unresectable locally advanced or metastatic solid tumor in copending claim 1, wherein the tumor disease comprises lung cancer in copending claim 3, and wherein the lung cancer is non-small cell lung cancer in copending claim 14. Administration of a therapeutically effective amount of an antibody-drug conjugate would require a pharmaceutical composition comprising a pharmaceutically acceptable excipient of water for administration. This meets the claim limitations of instant claims 92-99, 101-107, 109-115, and 117-121.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 92-121 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 6, 8-11, 14-15, 17-18, 20, 25-28, 33-34, 36-43 of copending Application No. 18/557,900 in view of Goldenberg DM et al. (Oncotarget. 2015 Jun 18;6(26):22496–22512).
The claims of copending ‘900 teach the limitations of claims 92-99, 101-107, 109-115, and 117-121 for the reasons set forth above.
‘900 is described above. ‘900 taught methods of treating a tumor disease comprising administering an antibody drug conjugate having the structure:
PNG
media_image6.png
146
600
media_image6.png
Greyscale
in claims 1, 3, 6, 8-11, 14-15, 17-18, 20, 25-28, 33-34, 36-43.
‘900 did not teach: 1) a cysteine attached payload of
PNG
media_image5.png
168
653
media_image5.png
Greyscale
is conjugated to up to 3 heavy chain sulfurs and 0 or 1 light chain sulfurs, but this is obvious in view of Goldenberg.
Goldenberg taught Trop-2 is a novel target for ADC therapy because of its high expression by many solid cancers and the anti-Trop-2 ADC, IMMU-132, binds a well-known moderately-cytotoxic drug, SN-38, to the anti-Trop-2 antibody (abstract). Goldenberg taught an effective method of treating gastric cancer and breast cancer in a subject comprising administering a pharmaceutical composition comprising a pharmaceutically acceptable excipient and the anti-Trop-2 ADC IMMU-132 (Figs 3 and 5), wherein IMMU-132 is comprised of the antibody sacituzumab (Title), wherein the drug to antibody ratio (DAR) was between 7-8 (Table 1), wherein the method of producing the ADC utilized a limited reduction procedure that breaks only the interchain disulfide bridges between the heavy-heavy and heavy-light chains, but not the intra-domain disulfides, generating up to 8 site-specific thiols per antibody molecule (page 22497, right column, second paragraph), which would conjugate the payload to up to 3 heavy chain sulfurs and 0 or 1 light chain sulfurs. Goldenberg taught the anti-Trop-2 antibody-drug conjugate (ADC) IMMU-132, carrying a moderately-toxic drug targeting Trop-2 represents a novel cancer therapeutic that is showing promising activity in patients with several metastatic cancer types, including triple-negative breast cancer, non-small-cell and small-cell lung cancers (abstract).
Regarding instant claims 100, 108, and 116, it would have been obvious for a person having ordinary skill in the art to modify ‘900 copending claims 1, 3, and 14 of a method of treating a tumor disease, comprising administering to a patient in need thereof a therapeutically effective amount of an antibody-drug conjugate having the following structure:
PNG
media_image6.png
146
600
media_image6.png
Greyscale
wherein γ is an integer from 5 to 8, and wherein the tumor disease is an unresectable locally advanced or metastatic solid tumor, wherein the tumor disease comprises lung cancer, and wherein the lung cancer is non-small cell lung cancer – to: 1) Conjugate the payload
PNG
media_image2.png
184
772
media_image2.png
Greyscale
to the anti-Trop-2 antibody at a DAR of 7-8, wherein a limited reduction procedure that breaks only the interchain disulfide bridges between the heavy-heavy and heavy-light chains, but not the intra-domain disulfides, generating up to 8 site-specific thiols per antibody molecule (page 22497, right column, second paragraph), which would conjugate the payload to up to 3 heavy chain sulfurs and 0 or 1 light chain sulfurs in view of Goldenberg;
This is obvious because:
1) Goldenberg taught an effective method of treating gastric cancer and breast cancer in a subject comprising administering a pharmaceutical composition comprising a pharmaceutically acceptable excipient and the anti-Trop-2 ADC IMMU-132, wherein the drug to antibody ratio (DAR) was between 7-8, wherein the method of producing the ADC utilized a limited reduction procedure that breaks only the interchain disulfide bridges between the heavy-heavy and heavy-light chains, but not the intra-domain disulfides, generating up to 8 site-specific thiols per antibody molecule, which would conjugate the payload to up to 3 heavy chain sulfurs and 0 or 1 light chain sulfurs.
There is a reasonable expectation of success because:
1) Goldenberg taught an effective method of treating gastric cancer and breast cancer in a subject comprising administering a pharmaceutical composition comprising a pharmaceutically acceptable excipient and the anti-Trop-2 ADC IMMU-132, wherein the drug to antibody ratio (DAR) was between 7-8, wherein the method of producing the ADC utilized a limited reduction procedure that breaks only the interchain disulfide bridges between the heavy-heavy and heavy-light chains, but not the intra-domain disulfides, generating up to 8 site-specific thiols per antibody molecule, which would conjugate the payload to up to 3 heavy chain sulfurs and 0 or 1 light chain sulfurs. Thus, conjugating the payload
PNG
media_image3.png
199
620
media_image3.png
Greyscale
with a DAR of 8 would be expected to be effective;
This meets the limitations of instant claims 100, 108, and 116.
This is a provisional nonstatutory double patenting rejection.
Claims 92-93, 95-96, 98-99, 101, 103-104, 106-107, 109, 111-112, 114-115, 117, and 119-120 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-20 of copending Application No. 18/532,428. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding instant claims 92-99, 101-107, 109-115, and 117-121, ‘428 taught an effective method of treating ovarian cancer in a patient comprising administering to the patient an immunoconjugate of formula I with the structure
PNG
media_image7.png
151
601
media_image7.png
Greyscale
, wherein Ab is an antibody that binds to Trop-2, wherein n is 1-10 in copending claim 1, wherein the antibody comprises a VH of ‘428 SEQ ID NO:35 and a VL of ‘428 SEQ ID NO:36 in copending claim 5, wherein the antibody is Sacituzumab in copending claim 6.
Administration of an antibody-drug conjugate would require a pharmaceutical composition comprising a pharmaceutically acceptable excipient of water for administration. This meets the claim limitations of instant claims 92-93, 95-96, 98-99, 101, 103-104, 106-107, 109, 111-112, 114-115, 117, and 119-120.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 92-121 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over:
claims 1-6, 8-10, 12, 17-24, 30, 35, 42-48 of copending Application No. 18/833,326;
claims 1-20 of copending Application No. 18/532,428; or
claims 1-14, 16-21, and 35-53 of copending Application No. 19/157,729,
in view of Goldenberg DM et al. (Oncotarget. 2015 Jun 18;6(26):22496–22512).
‘326 taught compositions of pharmaceutical compositions comprising an excipient and an antibody-drug conjugate of formula I of {D-[L1(L2)m1-(L3)m2-(L4)m3-E]} γ-A and methods for treating a tumor disease the pharmaceutical composition in claims 1-6, 8-10, 12, 17-24, 30, 35, 42-48.
‘326 taught a pharmaceutical composition comprising an antibody drug conjugate of Formula I and an excipient in copending claim 1, wherein the antibody-drug conjugate is conjugate A with the structure:
PNG
media_image8.png
149
626
media_image8.png
Greyscale
wherein γ is 3 to 8 in copending claim 8
‘326 taught a method for treating a tumor disease comprising the step of administering to a subject a therapeutically effective amount of a pharmaceutical composition comprising an antibody drug conjugate of Formula I and an excipient in copending claim 42, wherein the tumor is selected from esophageal cancer in copending claim 44.
‘428 taught pharmaceutical compositions comprising an immunoconjugate of formula I with the structure
PNG
media_image7.png
151
601
media_image7.png
Greyscale
and methods of cancer treatment in copending claims 1-20.
‘428 taught an effective method of treating ovarian cancer in a patient comprising administering to the patient an immunoconjugate of formula I with the structure
PNG
media_image7.png
151
601
media_image7.png
Greyscale
, wherein Ab is an antibody that binds to Trop-2, wherein n is 1-10 in copending claim 1, wherein the antibody comprises a VH of ‘428 SEQ ID NO:35 and a VL of ‘428 SEQ ID NO:36 in copending claim 5, wherein the antibody is Sacituzumab in copending claim 6.
‘729 taught methods of treating breast cancer comprising administering a pharmaceutical composition comprising a therapeutically effective amount of a conjugate of Formula I {D-[L1(L2)m1-(L3)m2-(L4)m3-E]} γ-A, wherein A is an antibody against Trop-2, and wherein γ is an integer from 1 to 10 in copending claims 1-14, 16-21, and 35-53.
‘729 taught a method of treating breast cancer comprising administering a pharmaceutical composition comprising a therapeutically effective amount of a conjugate of Formula I {D-[L1(L2)m1-(L3)m2-(L4)m3-E]} γ-A, wherein A is an antibody against Trop-2, and wherein γ is an integer from 1 to 10 in copending claim 1, wherein the conjugate has the following structure:
PNG
media_image6.png
146
600
media_image6.png
Greyscale
in copending claim 16, wherein γ is an integer from 5 to 8 in copending claim 16, wherein the pharmaceutical composition further comprises a pharmaceutically acceptable excipient in copending claim 35.
‘326, ‘428, or ‘729 did not teach: 1) a single embodiment of a method of treating cancer, wherein the antibody-drug conjugate has the structure of
PNG
media_image2.png
184
772
media_image2.png
Greyscale
and an antibody of Sacituzumab, wherein the cancer is non-small cell lung cancer; and 2) a cysteine attached payload of
PNG
media_image5.png
168
653
media_image5.png
Greyscale
is conjugated to up to 3 heavy chain sulfurs and 0 or 1 light chain sulfurs, but this is obvious in view of Goldenberg.
Goldenberg taught Trop-2 is a novel target for ADC therapy because of its high expression by many solid cancers and the anti-Trop-2 ADC, IMMU-132, binds a well-known moderately-cytotoxic drug, SN-38, to the anti-Trop-2 antibody (abstract). Goldenberg taught an effective method of treating gastric cancer and breast cancer in a subject comprising administering a pharmaceutical composition comprising a pharmaceutically acceptable excipient and the anti-Trop-2 ADC IMMU-132 (Figs 3 and 5), wherein IMMU-132 is comprised of the antibody sacituzumab (Title), wherein the drug to antibody ratio (DAR) was between 7-8 (Table 1), wherein the method of producing the ADC utilized a limited reduction procedure that breaks only the interchain disulfide bridges between the heavy-heavy and heavy-light chains, but not the intra-domain disulfides, generating up to 8 site-specific thiols per antibody molecule (page 22497, right column, second paragraph), which would conjugate the payload to up to 3 heavy chain sulfurs and 0 or 1 light chain sulfurs. Goldenberg taught the anti-Trop-2 antibody-drug conjugate (ADC) IMMU-132, carrying a moderately-toxic drug targeting Trop-2 represents a novel cancer therapeutic that is showing promising activity in patients with several metastatic cancer types, including triple-negative breast cancer, non-small-cell and small-cell lung cancers (abstract).
Regarding instant claims 92-121, it would have been obvious for a person having ordinary skill in the art to modify:
‘326 copending claims 1, 8, 42, and 44;
‘428 copending claims 1, 5, and 6; or
‘729 copending claims 1, 16, and 35,
- by:
Conjugating the payload
PNG
media_image2.png
184
772
media_image2.png
Greyscale
to the anti-Trop-2 antibody at a DAR of 7-8, wherein a limited reduction procedure that breaks only the interchain disulfide bridges between the heavy-heavy and heavy-light chains, but not the intra-domain disulfides, generating up to 8 site-specific thiols per antibody molecule (page 22497, right column, second paragraph), which would conjugate the payload to up to 3 heavy chain sulfurs and 0 or 1 light chain sulfurs in view of Goldenberg;
Treat non-small cell lung cancer patients in view of Goldenberg
This is obvious because:
1) Goldenberg taught an effective method of treating gastric cancer and breast cancer in a subject comprising administering a pharmaceutical composition comprising a pharmaceutically acceptable excipient and the anti-Trop-2 ADC IMMU-132, wherein the drug to antibody ratio (DAR) was between 7-8, wherein the method of producing the ADC utilized a limited reduction procedure that breaks only the interchain disulfide bridges between the heavy-heavy and heavy-light chains, but not the intra-domain disulfides, generating up to 8 site-specific thiols per antibody molecule, which would conjugate the payload to up to 3 heavy chain sulfurs and 0 or 1 light chain sulfurs.
2) Goldenberg taught the anti-Trop-2 antibody-drug conjugate (ADC) IMMU-132, carrying a moderately-toxic drug targeting Trop-2 represents a novel cancer therapeutic that is showing promising activity in patients with several metastatic cancer types, including non-small-cell lung cancers;
There is a reasonable expectation of success because:
1) Goldenberg taught an effective method of treating gastric cancer and breast cancer in a subject comprising administering a pharmaceutical composition comprising a pharmaceutically acceptable excipient and the anti-Trop-2 ADC IMMU-132, wherein the drug to antibody ratio (DAR) was between 7-8, wherein the method of producing the ADC utilized a limited reduction procedure that breaks only the interchain disulfide bridges between the heavy-heavy and heavy-light chains, but not the intra-domain disulfides, generating up to 8 site-specific thiols per antibody molecule, which would conjugate the payload to up to 3 heavy chain sulfurs and 0 or 1 light chain sulfurs. Thus, conjugating the payload
PNG
media_image3.png
199
620
media_image3.png
Greyscale
with a DAR of 8 would be expected to be effective;
2) Goldenberg taught the anti-Trop-2 antibody-drug conjugate (ADC) IMMU-132, carrying a moderately-toxic drug targeting Trop-2 represents a novel cancer therapeutic that is showing promising activity in patients with several metastatic cancer types, including non-small-cell lung cancers. Thus, treating non-small-cell lung cancers with the ADC would be expected to be effective.
This would produce a method of ‘326, ‘428, or ‘729 and Goldenberg of treating a patient with non-small cell lung cancer (instant claims 93-94, 96-97, 101-102, 104-105, 109-110, 112-113, 117-118, and 120-121) that expressed Trop-2 comprising administering to the patient in need thereof a pharmaceutical composition (instant claims 95, 103, 111, and 119) comprising a pharmaceutically acceptable excipient and a therapeutically effective amount of an antibody-drug conjugate comprising an anti-Trop-2 monoclonal antibody of Sacituzumab, which is evidenced by the instant specification on page 89 to contain a heavy chain of instant SEQ ID NO:19 and a light chain of SEQ ID NO:20 (instant claims 98 and 114)
which would produce an ADC of
PNG
media_image4.png
160
643
media_image4.png
Greyscale
wherein mAb is Sacituzumab, wherein γ is an integer from 7 to 8 (instant claims 99, 106, and 115) for a DAR of 7-8, wherein the cysteine attached payload of
PNG
media_image5.png
168
653
media_image5.png
Greyscale
is conjugated to up to 3 heavy chain sulfurs and 0 or 1 light chain sulfurs (instant claims 100, 108, and 116) (instant claims 92, 106, and 114).
This is a provisional nonstatutory double patenting rejection.
Conclusion
All claims are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN J SKOKO III whose telephone number is (571)272-1107. The examiner can normally be reached M-F 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, Julie Z 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/J.J.S./Examiner, Art Unit 1643
/Karen A. Canella/Primary Examiner, Art Unit 1643
Prosecution Insights