DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim 100 is withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention. Claims 9, 15, 23, are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected species.
Claims 1-2, 4, 31, 55, 67, 70, 72-74, 77-78, 80, 82-84, 93, and 97 are being acted upon.
In view of Applicant’s claim amendments, the claims are accorded a priority date of the ‘891 provisional, i.e. 3/7/18. The 103 rejection citing US 2021/0177987 is withdrawn in view of Applicant’s common ownership statement.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 1-2, 4, 31, 55, 67, 70, 72-74, 77-78, 80, 82-84, 93, and 97 is/are rejected under 35 U.S.C. 103 as being unpatentable over 2013/0101608, in view of Lassen, 2015, Eaton, 2014 and Seattlegenetics, Sept. 8, 2017, as evidenced by ADC Review, 2016 (all of record)..
The ‘608 publication teaches a method of treating cancer in a patient comprising administering to a patient an anti-TF antibody drug conjugate (see page 1, 10, 18- 20, in particular). The ‘608 publication teaches that the anti-TF antibody comprises a VH of SEQ ID NO: 5 and a VL of SEQ ID NO: 45, which are 100% identical to SEQ ID NO: 7 and 8, and comprise the CDRS of SEQ ID NO: 1-6 of the instant application (see page 7, in particular). The ‘608 publication teaches that the drug is MMAE, and that the antibody drug conjugate has a linker and a formula of instant claims 77-78 (see page 7-8 and 14, in particular). The ‘608 publication teaches treating head and neck cancer and prostate cancer (see page 10 and 19, in particular). The ‘608 publication teaches administration of about 1-2 mg/kg of the antibody drug conjugate (see page 21, in particular). The ‘608 publication teaches administration via an intravenous route via weekly infusion (see page 21, in particular). The ‘608 publication teaches that the treatment can include amelioration or cure of disease states, and that the method induces tumor cell death, inhibits growth of tumor cells, and that the antibody drug conjugate may decreased tumor size (improving therapeutic effect, reducing size of a tumor, and improving survival, see page 6, 10, 18, and 21 in particular). The ‘608 publication teaches that cancer cells overexpressing TF may be particularly good targets for the anti-TF antibody drug conjugates of the invention (See page 18, in particular). The ordinary artisan would at once envisage that treating patients with cancer cells that overexpress TF would mean that “at least about 0.1%” of cancer cells express TF, as recited in present claim 82. The ‘608 publication teaches that the antibody drug conjugate is TF-011-MMAE (see page 25, in particular). As evidenced by ADC review, said TF-011-MMAE is another name for tisotumab vedotin.
The reference differs from the claimed invention in that it does not explicitly teach treating adverse events such as conjunctivitis, that the subject has received prior treatment with standard of cancer therapy, and does not explicitly state that the therapy is a monotherapy.
Lassen teaches the use of HuMax-tissue factor-ADC for treatment of patients with solid tumors, and that the data demonstrate prolonged disease stabilization. Lassen teach dosage of 1.8 mg/kg and treating patients with solid tumors known to express tissue factor, and that the patients have locally advanced or metastatic tumors. Lassen also teaches that patients had a mean number of prior lines of therapy ranging from 1-14 (i.e. patients who have recited prior standard treatment and “failed” ). Lassen describe that the study is designed to evaluate tolerability and preliminary efficacy of said HuMax TF-ADC. Lassen teaches common adverse effects include fatigue.
SeattleGenetics teaches the use of tisotumab vedotin for treating cervical cancer and other solid tumors, including prostate tumors (see entire document). SeattleGenetics teaches that during a clinical trial involving doses ranging from 0.3 to 2.2 mg/kg administered every 3 weeks in a variety of solid tumors, the most common adverse event was conjunctivitis, which was reduced through the introduction of a mitigation plan that involves prophylactic steroid, lubrication eye drops, and cooling eye masks worn during treatment infusion.
Eaton teaches that ocular adverse events like conjunctivitis are associated with antibody-drug conjugates. Eaton teaches that most ocular adverse events can be resolved with ameliorative therapy such as lubricating eye drops or steroid eye drops (see page 589-590, 595, Table 1, and Table 3, in particular).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to apply the treatment methodology of Lassen Eaton, and SeattleGenetics to the cancer treatment method of the ‘608 publication. In particular, as SeattleGenetics teaches that conjunctivitis is a common adverse event occurring during treatment with tisotumab vedotin, the ordinary artisan would be motivated to treat conjunctivitis that may during therapy with said tisotumab vedotin. It would be obvious to provide ameliorative therapy to resolve the conjunctivitis, such as by administering lubricating eye drops or steroid eye drops, as taught by SeattleGenetics and Eaton.
Furthermore, Lassen teaches administering the same antibodies to patients that have received prior therapy and describes the study as a clinical trial to evaluate the efficacy of the antibody (i.e. a “monotherapy”). It would therefore be obvious to the ordinary artisan, based on the ‘608 publication and Lassen that said tissue factor antibody could be used as a monotherapy. The ordinary artisan would have a reasonable expectation of success, since the ’608 publication teaches that said antibody drug conjugate inhibits tumor growth, and Lassen teach that treated patients demonstrated prolonged disease stabilization. As Lassen teaches treatment can include patients having prior treatments that still present with metastatic or advanced disease, it would be understood that the antibody drug conjugate is suitable for use in patients who had “failed” conventional therapy, as a type of treatment regimen. Furthermore, it would be well within the purview of the ordinary artisan to optimize the treated patients such that they comprise at least 0.1% TF positive tumors, as well as to optimize the dosing and timeframe of administration of the anti-tissue factor drug conjugate based on the teachings of the cited references. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim 1-2, 4, 31, 55, 67, 70, 72-74, 77-78, 80, 82-84, 93, and 97 is/are rejected under 35 U.S.C. 103 as being unpatentable over 2013/0101608, in view of Lassen, 2015, and US 202110177987, as evidenced by ADC Review, 2016 (all of record)..
The ‘608 publication teaches a method of treating cancer in a patient comprising administering to a patient an anti-TF antibody drug conjugate (see page 1, 10, 18- 20, in particular). The ‘608 publication teaches that the anti-TF antibody comprises a VH of SEQ ID NO: 5 and a VL of SEQ ID NO: 45, which are 100% identical to SEQ ID NO: 7 and 8, and comprise the CDRS of SEQ ID NO: 1-6 of the instant application (see page 7, in particular). The ‘608 publication teaches that the drug is MMAE, and that the antibody drug conjugate has a linker and a formula of instant claims 77-78 (see page 7-8 and 14, in particular). The ‘608 publication teaches treating head and neck cancer and prostate cancer (see page 10 and 19, in particular). The ‘608 publication teaches administration of about 1-2 mg/kg of the antibody drug conjugate (see page 21, in particular). The ‘608 publication teaches administration via an intravenous route via weekly infusion (see page 21, in particular). The ‘608 publication teaches that the treatment can include amelioration or cure of disease states, and that the method induces tumor cell death, inhibits growth of tumor cells, and that the antibody drug conjugate may decreased tumor size (improving therapeutic effect, reducing size of a tumor, and improving survival, see page 6, 10, 18, and 21 in particular). The ‘608 publication teaches that cancer cells overexpressing TF may be particularly good targets for the anti-TF antibody drug conjugates of the invention (See page 18, in particular). The ordinary artisan would at once envisage that treating patients with cancer cells that overexpress TF would mean that “at least about 0.1%” of cancer cells express TF, as recited in present claim 82. The ‘608 publication teaches that the antibody drug conjugate is TF-011-MMAE (see page 25, in particular). As evidenced by ADC review, said TF-011-MMAE is another name for tisotumab vedotin.
The reference differs from the claimed invention in that it does not explicitly teach treating adverse events such as conjunctivitis, that the subject has received prior treatment with standard of cancer therapy, and does not explicitly state that the therapy is a monotherapy.
Lassen teaches the use of HuMax-tissue factor-ADC for treatment of patients with solid tumors, and that the data demonstrate prolonged disease stabilization. Lassen teach dosage of 1.8 mg/kg and treating patients with solid tumors known to express tissue factor, and that the patients have locally advanced or metastatic tumors. Lassen also teaches that patients had a mean number of prior lines of therapy ranging from 1-14 (i.e. patients who have recited prior standard treatment and “failed” ). Lassen describe that the study is designed to evaluate tolerability and preliminary efficacy of said HuMax TF-ADC. Lassen teaches common adverse effects include fatigue.
The ‘987 publication teaches tisotumab vedotin for treating cancer, wherein an adverse effect of the treatment is conjunctivitis, and that the conjunctivitis can be treated with preservative-free lubricating eye drops or steroid drops (see claims or paragraph 18-20, 200 in particular).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to apply the treatment methodology of Lassen and the ‘987 publication, to the cancer treatment method of the ‘608 publication. In particular, the ‘987 publication teach that conjunctivitis is an adverse event occurring during treatment with tisotumab vedotin and administering eye drops to treat it. Therefore, the ordinary artisan would be motivated to treat the adverse conjunctivitis effects that may occur during therapy with tisotumab vedotin, by providing ameliorative therapy to resolve it, such as by administering with lubricating eye drops or steroid eye drops, as taught by the ‘987 publication
Furthermore, Lassen teaches administering the same antibodies to patients that have received prior therapy and describes the study as a clinical trial to evaluate the efficacy of the antibody (i.e. a “monotherapy”). It would therefore be obvious to the ordinary artisan, based on the ‘608 publication and Lassen that said tissue factor antibody could be used as a monotherapy. The ordinary artisan would have a reasonable expectation of success, since the ’608 publication teaches that said antibody drug conjugate inhibits tumor growth, and Lassen teach that treated patients demonstrated prolonged disease stabilization. As Lassen teaches treatment can include patients having prior treatments that still present with metastatic or advanced disease, it would be understood that the antibody drug conjugate is suitable for use in patients who had “failed” conventional therapy, as a type of treatment regimen. Furthermore, it would be well within the purview of the ordinary artisan to optimize the treated patients such that they comprise at least 0.1% TF positive tumors, as well as to optimize the dosing and timeframe of administration of the anti-tissue factor drug conjugate based on the teachings of the cited references. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim 1-2, 4, 31, 55, 67, 70, 72-74, 77-78, 80, 82-84, 93, and 97 is/are rejected under 35 U.S.C. 103 as being unpatentable over 2013/0101608, in view of Lassen, 2015 and Eaton, 2014 and GenMab press release, June 16, 2017, Vergote, 2017 (Annals of Oncology, of record), or Vergote II Aug 2017, ESMO slides (of record), as evidenced by ADC Review, 2016 (all of record)..
The ‘608 publication teaches a method of treating cancer in a patient comprising administering to a patient an anti-TF antibody drug conjugate (see page 1, 10, 18- 20, in particular). The ‘608 publication teaches that the anti-TF antibody comprises a VH of SEQ ID NO: 5 and a VL of SEQ ID NO: 45, which are 100% identical to SEQ ID NO: 7 and 8, and comprise the CDRS of SEQ ID NO: 1-6 of the instant application (see page 7, in particular). The ‘608 publication teaches that the drug is MMAE, and that the antibody drug conjugate has a linker and a formula of instant claims 77-78 (see page 7-8 and 14, in particular). The ‘608 publication teaches treating head and neck cancer and prostate cancer (see page 10 and 19, in particular). The ‘608 publication teaches administration of about 1-2 mg/kg of the antibody drug conjugate (see page 21, in particular). The ‘608 publication teaches administration via an intravenous route via weekly infusion (see page 21, in particular). The ‘608 publication teaches that the treatment can include amelioration or cure of disease states, and that the method induces tumor cell death, inhibits growth of tumor cells, and that the antibody drug conjugate may decreased tumor size (improving therapeutic effect, reducing size of a tumor, and improving survival, see page 6, 10, 18, and 21 in particular). The ‘608 publication teaches that cancer cells overexpressing TF may be particularly good targets for the anti-TF antibody drug conjugates of the invention (See page 18, in particular). The ordinary artisan would at once envisage that treating patients with cancer cells that overexpress TF would mean that “at least about 0.1%” of cancer cells express TF, as recited in present claim 82. The ‘608 publication teaches that the antibody drug conjugate is TF-011-MMAE (see page 25, in particular). As evidenced by ADC review, said TF-011-MMAE is another name for tisotumab vedotin.
The reference differs from the claimed invention in that it does not explicitly teach treating adverse events such as conjunctivitis, that the subject has received prior treatment with standard of cancer therapy, and does not explicitly state that the therapy is a monotherapy.
Lassen teaches the use of HuMax-tissue factor-ADC for treatment of patients with solid tumors, and that the data demonstrate prolonged disease stabilization. Lassen teach dosage of 1.8 mg/kg and treating patients with solid tumors known to express tissue factor, and that the patients have locally advanced or metastatic tumors. Lassen also teaches that patients had a mean number of prior lines of therapy ranging from 1-14 (i.e. patients who have recited prior standard treatment and “failed” ). Lassen describe that the study is designed to evaluate tolerability and preliminary efficacy of said HuMax TF-ADC. Lassen teaches common adverse effects include fatigue.
Both Vergote references and the GenMab press release, describe administering tisotumab vedotin to treat cancer, wherein an adverse event was conjunctivitis.
Eaton teaches that ocular adverse events, including conjunctivitis and are associated with antibody-drug conjugates. Eaton teaches that most ocular adverse events can be resolved with ameliorative therapy such as lubricating eye drops or steroid eye drops (see page 589-590, 595, Table 1, and Table 3, in particular).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to apply the treatment methodology of Lassen Eaton, and Vergote, Vergote II or GenMab to the cancer treatment method of the ‘608 publication. In particular, either Vergote, Vergote II, or GenMab teach that conjunctivitis is an adverse event occurring during treatment with tisotumab vedotin. Therefore, the ordinary artisan would be motivated to treat the adverse conjunctivitis effects that may during therapy with said tisotumab vedotin, by providing ameliorative therapy to resolve it, such as by administering with lubricating eye drops or steroid eye drops, as taught by Eaton.
Furthermore, Lassen teaches administering the same antibodies to patients that have received prior therapy and describes the study as a clinical trial to evaluate the efficacy of the antibody (i.e. a “monotherapy”). It would therefore be obvious to the ordinary artisan, based on the ‘608 publication and Lassen that said tissue factor antibody could be used as a monotherapy. The ordinary artisan would have a reasonable expectation of success, since the ’608 publication teaches that said antibody drug conjugate inhibits tumor growth, and Lassen teach that treated patients demonstrated prolonged disease stabilization. As Lassen teaches treatment can include patients having prior treatments that still present with metastatic or advanced disease, it would be understood that the antibody drug conjugate is suitable for use in patients who had “failed” conventional therapy, as a type of treatment regimen. Furthermore, it would be well within the purview of the ordinary artisan to optimize the treated patients such that they comprise at least 0.1% TF positive tumors, as well as to optimize the dosing and timeframe of administration of the anti-tissue factor drug conjugate based on the teachings of the cited references. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Applicant’s arguments and the declaration under 130(a) have been fully considered, but they are not persuasive.
Applicant argues that the 1.130(a) declaration of Inventor Rangwala disqualifies Seattle Genetics, GenMab press release, Vertgote I and Vergote II as prior art references under the 35 U.S.C. 102(b)(1)(A) exception.
The declaration is not sufficient, since if fails to clearly establish which inventor or inventors actually invented the subject matter disclosed in the cited references In paragraphs 6-7, the declaration states that “I and certain co-inventors of this application, were the sole contributors..”, which does not convey anything about inventorship or conception. It is not clear what a “contributor” would mean. It is also not clear which co-inventors, beyond the declarant, were involved. Essentially, Applicant describes a “contribution” but has not seen fit to characterize the subject matter of the relevant references as his “invention”. See In re Facius, 408 F.2d 1396, 56 C.C.P.A. 1348, 161 U.S.P.Q. 294 (C.C.P.A. 1969).
It is noted that none of the inventors of the instant application are listed as authors in any of the cited references. The cited references describe a clinical trial of Tisotumab Vedotin in cervical cancer, wherein a common adverse event was conjunctivitis. The instant claims are drawn to treating different cancers (colorectal, non-small cell lung, pancreatic, and head and neck) with an TF antibody drug conjugate, wherein the subject has one or more adverse events a comprising one or more of conjunctivitis and keratitis and is further treated with an additional therapeutic agents that is one or more of a preservative-free lubricating eye drop, an ocular vasoconstrictor, or a steroid eye drop. Thus, the present claims are a combination treatment method.
The fact that Applicant has invented the claimed subject matter is therefore not sufficient to establish inventorship of the subject matter in the cited references. See In re Facius, the existence of combination claims does not evidence inventorship of the individual elements or sub-combinations thereof, and the inventor of a combination may not have invented any element of that combination.
Applicant has not clearly established the they invented the relevant subject matter disclosed in the references. For example, if Applicant’s “contribution” was to bring to the attention of the relevant subject matter to the authors of the cited references, the disclosure of the cited references would still be an invention of another and would be available as prior art. See In re Facius.
The following are new grounds of rejection.
Claim 1-2, 4, 31, 55, 67, 70, 72-74, 77-78, 80, 82-84, 93, and 97 is/are rejected under 35 U.S.C. 103 as being unpatentable over 2013/0101608, in view of Lassen, 2015, (all of record), Fu, 2017 and Davis, 2016, as evidenced by ADC Review, 2016 (of record).
The ‘608 publication teaches a method of treating cancer in a patient comprising administering to a patient an anti-TF antibody drug conjugate (see page 1, 10, 18- 20, in particular). The ‘608 publication teaches that the anti-TF antibody comprises a VH of SEQ ID NO: 5 and a VL of SEQ ID NO: 45, which are 100% identical to SEQ ID NO: 7 and 8, and comprise the CDRS of SEQ ID NO: 1-6 of the instant application (see page 7, in particular). The ‘608 publication teaches that the drug is MMAE, and that the antibody drug conjugate has a linker and a formula of instant claims 77-78 (see page 7-8 and 14, in particular). The ‘608 publication teaches treating head and neck cancer (see page 10 and 19, in particular). The ‘608 publication teaches administration of about 1-2 mg/kg of the antibody drug conjugate (see page 21, in particular). The ‘608 publication teaches administration via an intravenous route via weekly infusion (see page 21, in particular). The ‘608 publication teaches that the treatment can include amelioration or cure of disease states, and that the method induces tumor cell death, inhibits growth of tumor cells, and that the antibody drug conjugate may decreased tumor size (improving therapeutic effect, reducing size of a tumor, and improving survival, see page 6, 10, 18, and 21 in particular). The ‘608 publication teaches that cancer cells overexpressing TF may be particularly good targets for the anti-TF antibody drug conjugates of the invention (See page 18, in particular). The ordinary artisan would at once envisage that treating patients with cancer cells that overexpress TF would mean that “at least about 0.1%” of cancer cells express TF, as recited in present claim 82. The ‘608 publication teaches that the antibody drug conjugate is TF-011-MMAE (see page 25, in particular). As evidenced by ADC review, said TF-011-MMAE is another name for tisotumab vedotin. The ‘608 publication teaches that the anti-TF antibody drug conjugate can be administered in combination with other agents for treating cancer, including chemotherapeutic agents such as EGFR inhibitors (See paragraphs 221-237, in particular).
The reference differs from the claimed invention in that it does not explicitly teach treating adverse events such as conjunctivitis, that the subject has received prior treatment with standard of cancer therapy.
Lassen teaches the use of HuMax-tissue factor-ADC for treatment of patients with solid tumors, and that the data demonstrate prolonged disease stabilization. Lassen teach dosage of 1.8 mg/kg and treating patients with solid tumors known to express tissue factor, and that the patients have locally advanced or metastatic tumors. Lassen also teaches that patients had a mean number of prior lines of therapy ranging from 1-14 (i.e. patients who have recited prior standard treatment and “failed” ). Lassen describe that the study is designed to evaluate tolerability and preliminary efficacy of said HuMax TF-ADC. Lassen teaches common adverse effects include fatigue.
Fu teach that ocular toxicities are among the most common adverse events associated with targeted chemotherapy agents, due to the delicate homeostatic environment of vascular formation in the eye that can be disrupted by many targeted agents. Fu teach that conjunctivitis and keratitis are adverse events after treatment with various anti-cancer drugs (see Table 1, in particular).
Davis teach that anti-cancer therapeutics commonly cause ocular side effects. Davis teaches that EGFR inhibitors can cause conjunctivitis and keratitis and that treatment can include preservative free artificial tears and lubricants and steroid drops (see page 5-6 and 8, Table 1, in particular).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to further treat ocular side effects such as conjunctivitis or keratitis as taught by Davis and Fu, in the cancer treatment method of the ‘608 publication. In particular, as Davis and Fu teaches that conjunctivitis is a common adverse event occurring during cancer treatment, and, the ordinary artisan would be motivated to treat conjunctivitis that may arise during the combination therapy of the ‘608 publication. It would be obvious to provide ameliorative therapy to resolve the conjunctivitis, such as by administering preservative free lubricating eye drops or steroid eye drops, as taught by Davis and Fu.
Furthermore, as Lassen teaches treatment can include patients having prior treatments that still present with metastatic or advanced disease, it would be understood that the antibody drug conjugate combination therapy is suitable for use in patients who had “failed” conventional therapy, as a type of treatment regimen. Furthermore, it would be well within the purview of the ordinary artisan to optimize the treated patients such that they comprise at least 0.1% TF positive tumors, as well as to optimize the dosing and timeframe of administration of the anti-tissue factor drug conjugate based on the teachings of the cited references. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 97 which recites that the antibody drug conjugate is administered as a monotherapy, the instant specification discloses in paragraph 79 that the term “monotherapy” means that the antibody drug conjugate is the only anti-cancer agent administered to the subject during the treatment cycle. The ‘608 publication teaches combination therapy can be sequential (see paragraph 222, in particular). For example, it would be obvious to administer the anti-TF antibody in one treatment cycle, and then to administer the other chemotherapy, such as EGFR inhibitor sequentially thereafter in a second treatment cycle given several weeks later. This would be within the scope of anti-TF “monotherapy”. Alternatively, it would also be obvious to use anti-TF therapy alone for treatment cancer. It is noted that the ‘608 publication teaches that tissue factor is a vascular factor present in endothelial tissue that is involved in blood vessel formation and can play a role in vascular eye disease (See paragraphs 1-3, and 191 in particular). Given that Fu teaches that anti-cancer agents frequently are associated with adverse ocular events due to the delicate homeostatic environment of vascular formation in the eye, it would be obvious that the anti-TF antibody of the ‘608 publication, which modulates vascular endothelial cell function, would likely be a type of anti-cancer agent associated with adverse ocular toxicity that could be treated as taught by Fu and Davis.
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2, 4, 31, 55, 67, 70, 72-74, 77-78, 80, 82-84, 93, and 97 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 9,168,314, in view of 2013/0101608, Lassen, 2015, Fu, 2017 and Davis, 2016 OR in view of Lassen, 2015 and Eaton, 2014 and GenMab press release, June 16, 2017, Vergote, 2017 (Annals of Oncology, of record), or Vergote II Aug 2017, ESMO slides (of record), as evidenced by ADC Review, 2016 (all of record).
The ‘314 patent claims an antibody drug conjugate, wherein the antibody comprises VH chain of SEQ ID NO: 4 and a VL chain of SEQ ID NO: 45, which are identical to SEQ ID NO: 7 and 8 of the instant application, and comprise CDRs of SEQ ID NO: 1-6 of the instant application. The ‘314 patent claims that the drug is MMAE, and claims a linker and structure identical to that of the instant claims 77-78. Although the ‘314 patent does not explicitly claim the anti-cancer use recited in the present claims, it would be obvious to use the antibody drug conjugate in a combination therapy to treat cancer based on the teachings of the ‘608 publication, for the same reason set forth above. Furthermore, the dosing parameters, parameters of the subjects to be treated, and treating adverse events would be obvious optimizations based on the teachings the ‘608 publication, Lassen, 2015, Fu, and Davis, for the same reasons set forth above.
Alternatively, the dosing parameters, parameters of the subjects to be treated, and treating adverse events would be obvious optimizations based on the teachings the ‘608 publication, Lassen, 2015, Eaton, 2014, Seattlegenetics, Sept. 8, 2017, GenMab press release, June 16, 2017, Vergote, 2017, or Vergote II Aug 2017, for the same reasons set forth above.
Claims 1-2, 4, 31, 55, 67, 70, 72-74, 77-78, 80, 82-84, 93, and 97 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 9,492,565, in view of 2013/0101608, Lassen, 2015, Fu, 2017 and Davis, 2016 OR in view of Lassen, 2015 and Eaton, 2014 and GenMab press release, June 16, 2017, Vergote, 2017 (Annals of Oncology, of record), or Vergote II Aug 2017, ESMO slides (of record), as evidenced by ADC Review, 2016 (all of record).
The ‘565 patent claims a method of treating cancer comprising administering to an individual an antibody drug conjugate, wherein the antibody comprises VH chain of SEQ I D NO: 4 and a VL chain of SEQ ID NO: 45, which are identical to SEQ ID NO: 7 and 8 of the instant application and comprise the CDRs of SEQ ID NO: 1-6 of the instant application. The ‘565 patent claims that the drug is MMAF (i.e. a derivative of MMAE), and claims a linker and structure identical to that of the instant claims. The ‘565 patent claims that the method induces tumor cell death and inhibits tumor growth and claims treating head and neck cancer or prostate cancer. Furthermore, the dosing parameters, combination treatment, parameters of the subjects to be treated, and treating adverse events would be obvious optimizations based on the teachings the ‘608 publication, Lassen, 2015, Fu, and Davis, for the same reasons set forth above.
Alternatively, the dosing parameters, parameters of the subjects to be treated, and treating adverse events would be obvious optimizations based on the teachings the ‘608 publication, Lassen, 2015, Eaton, 2014, Seattlegenetics, Sept. 8, 2017, GenMab press release, June 16, 2017, Vergote, 2017, or Vergote II Aug 2017, for the same reasons set forth above.
Claims 1-2, 4, 31, 55, 67, 70, 72-74, 77-78, 80, 82-84, 93, and 97 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 12,246,025 or claims 1-28 of 12,324,841, in view of 2013/0101608, Lassen, 2015, Fu, 2017 and Davis, 2016.
The patents claims a method of treating cancer comprising administering to an individual an antibody drug conjugate, wherein the antibody comprises VH chain of SEQ I D NO: 4 and a VL chain of SEQ ID NO: 45, which are identical to SEQ ID NO: 7 and 8 of the instant application and comprise the CDRs of SEQ ID NO: 1-6 of the instant application. The patents claim that the drug is MMAE and that the antibody drug conjugate is tisotumab vedotin. The patents claim dosing and times within the scope of the instant claims. The patents claim that the patient has one or more adverse events such as conjunctivitis and fatigue and claims further administration of steroid or lubricating eye drops. Treating other types of cancer such as prostate or head and neck would be obvious based on the teachings of the ‘608 publication.
Furthermore, the dosing parameters (i.e. sequential), parameters of the subjects to be treated, and treating adverse events would also be obvious optimizations based on the teachings the ‘608 publication, Lassen, 2015, Fu, and Davis, for the same reasons set forth above.
Claim 1-2, 4, 31, 55, 67, 70, 72-74, 77-78, 80, 82-84, 93, and 97 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of copending Application No. 18/526,959, in view of 2013/0101608, Lassen, 2015, Fu, 2017 and Davis, 2016 OR in view of Lassen, 2015 and Eaton, 2014 and GenMab press release, June 16, 2017, Vergote, 2017 (Annals of Oncology, of record), or Vergote II Aug 2017, ESMO slides (of record), as evidenced by ADC Review, 2016 (all of record).
The ‘959 application claim anti-TF antibody drug conjugates wherein the drug is MMAF (i.e. a derivative of MMAE), and that the antibody drug conjugate can be used in treatment of cancer, such as head and neck cancer. The ‘959 application also claims the same anti-TF antibody VH/VL and CDRs, and said VH/VL CDRs are obvious to use based on teachings of the ‘608 publication described above. Furthermore, the dosing parameters, combination treatment parameters of the subjects to be treated, and treating adverse events would be obvious optimizations based on the teachings the ‘608 publication, Lassen, 2015, Fu, and Davis, for the same reasons set forth above.
Alternatively, the dosing parameters, parameters of the subjects to be treated, and treating adverse events would be obvious optimizations based on the teachings the ‘608 publication, Lassen, 2015, Eaton, 2014, Seattlegenetics, Sept. 8, 2017, GenMab press release, June 16, 2017, Vergote, 2017, or Vergote II Aug 2017, for the same reasons set forth above.
This is a provisional nonstatutory double patenting rejection.
Claim 1-2, 4, 31, 55, 67, 70, 72-74, 77-78, 80, 82-84, 93, and 97 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6-17, 21, 25-26, and 31 of copending Application No. 17/548,436 in view of 2013/0101608, Lassen, 2015, Fu, 2017 and Davis, 2016 OR in view of Lassen, 2015 and Eaton, 2014 and GenMab press release, June 16, 2017, Vergote, 2017 (Annals of Oncology, of record), or Vergote II Aug 2017, ESMO slides (of record), as evidenced by ADC Review, 2016 (all of record).
The application claims a method of treating a solid cancer comprising administering to a subject an anti-TF antibody drug conjugates wherein the drug is to an auristatin, and that the antibody drug conjugate can be used in treatment of cancer, such as head and neck cancer. The application also claims the same anti-TF antibody VH/VL and CDRs, and said VH/VL CDRs. (see SEQ ID NO: 1 and 17 of the ‘436 application). The applications claim a linker and the structure of the present claims. The applications claim administration once a week and a dose of between 0.8 to 2.4 mg/kg and wherein the subject has refractory TF-expressing solid cancer, and wherein the antibody drug conjugate is administered as a monotherapy. Furthermore, the dosing parameters, combination treatment parameters of the subjects to be treated, and treating adverse events would be obvious optimizations based on the teachings the ‘608 publication, Lassen, 2015, Fu, and Davis, for the same reasons set forth above.
Alternatively, the dosing parameters, parameters of the subjects to be treated, and treating adverse events would be obvious optimizations based on the teachings the ‘608 publication, Lassen, 2015, Eaton, 2014, Seattlegenetics, Sept. 8, 2017, GenMab press release, June 16, 2017, Vergote, 2017, or Vergote II Aug 2017, for the same reasons set forth above.
This is a provisional nonstatutory double patenting rejection.
Claim 1-2, 4, 31, 55, 67, 70, 72-74, 77-78, 80, 82-84, 93, and 97 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of 18/798,557, or claims 1-3, 5, 7, 9, 11, 13, 15, 19-20, 22, 24, 27, 30, 31, 33-34, 38-39, 41-44, 47-51, 53, 55-56, 64-65, 71 and 76 of copending Application No. 17/289,616, or the claims of 17/771,784, or the claims of copending application 17/775,279,or the claims of 18/451,780, or the claims of 19/044,486, or the claims of 18/010,783, in view of 2013/0101608, Lassen, 2015, Fu, 2017 and Davis, 2016 OR in view of Lassen, 2015 and Eaton, 2014 and GenMab press release, June 16, 2017, Vergote, 2017 (Annals of Oncology, of record), or Vergote II Aug 2017, ESMO slides (of record), as evidenced by ADC Review, 2016 (all of record).
The copending applications all claim combination treatment regimens for cancer wherein one of the administered treatments is an anti-tissue factor ADC comprising MMAF (i.e. an MMAE derivative) identical to that recited in the present claims. The copending applications claim the same limitations of the dependent claims of the instant application, or alternatively, the other dosing parameters, parameters of the subjects to be treated, and treating adverse events would be obvious optimizations based on the teachings of the ‘608 publication, Lassen, 2015, for the same reasons set forth above. Some of applications also claim treating adverse conjunctivitis. The combination treatment regimen would fall within the scope of the instant claims, since it involves administration of anti-TF-ADC, and represents a species of the more generic invention now claimed. Furthermore, combination treatment, the dosing parameters, parameters of the subjects to be treated, and treating adverse events would be obvious optimizations based on the teachings the ‘608 publication, Lassen, 2015, Fu, and Davis, for the same reasons set forth above.
Alternatively, the dosing parameters, parameters of the subjects to be treated, and treating adverse events would be obvious optimizations based on the teachings the ‘608 publication, Lassen, 2015, Eaton, 2014, Seattlegenetics, Sept. 8, 2017, GenMab press release, June 16, 2017, Vergote, 2017, or Vergote II Aug 2017, for the same reasons set forth above.
This is a provisional nonstatutory double patenting rejection.
Claims 1-2, 4, 31, 55, 67, 70, 72-74, 77-78, 80, 82-84, 93, and 97 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-43 of U.S. Patent No. 9,150,658, in view of 2013/0101608, Lassen, 2015, Fu, 2017 and Davis, 2016 OR in view of Lassen, 2015 and Eaton, 2014 and GenMab press release, June 16, 2017, Vergote, 2017 (Annals of Oncology, of record), or Vergote II Aug 2017, ESMO slides (of record), as evidenced by ADC Review, 2016 (all of record).
The ‘658 patent claims an anti-TF antibody, wherein the antibody comprises VH chain of SEQ ID NO: 9 and a VL chain of SEQ ID NO: 65, which are identical to SEQ ID NO: 7 and 8 of the instant application and comprise the CDRs of SEQ ID NO: 1-6 of the instant application. The ‘658 patent claims that the antibody is conjugated to another moiety, and the use of the anti-TF antibody for administration to an individual to inhibit growth and proliferation of tumor cells expressing tissue factor. Although the ‘658 patent does not specifically claim that the moiety is MMAE, or the specific dosages or cancer types recited in the instant claims, these would be obvious based on the teachings of the ‘608 publication and Lassen, 2015, for the same reasons set forth above. For example, the ‘608 publication teaches that MMAE is suitable for use as a conjugated moiety for therapeutic efficacy in treating cancer, including head and neck and prostate cancer, and the ordinary artisan would be motivated to use MMAE as the moiety in the antibody claimed in the ‘658 patent in order to enhance therapeutic efficacy in treating cancer, as taught by the ‘608 publication. Furthermore, the combination treatment dosing parameters, parameters of the subjects to be treated, and treating adverse events would be obvious optimizations based on the teachings the ‘608 publication, Lassen, 2015, Fu, and Davis, for the same reasons set forth above.
Alternatively, the dosing parameters, parameters of the subjects to be treated, and treating adverse events would be obvious optimizations based on the teachings the ‘608 publication, Lassen, 2015, Eaton, 2014, Seattlegenetics, Sept. 8, 2017, GenMab press release, June 16, 2017, Vergote, 2017, or Vergote II Aug 2017, for the same reasons set forth above.
Claims 1-2, 4, 31, 55, 67, 70, 72-74, 77-78, 80, 82-84, 93, and 97 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 9,714,297, in view of 2013/0101608, Lassen, 2015, Fu, 2017 and Davis, 2016 OR in view of Lassen, 2015 and Eaton, 2014 and GenMab press release, June 16, 2017, Vergote, 2017 (Annals of Oncology, of record), or Vergote II Aug 2017, ESMO slides (of record), as evidenced by ADC Review, 2016 (all of record).
The ‘297 patent claims an anti-TF antibody, wherein the antibody comprises VH chain of SEQ ID NO: 9 and a VL chain of SEQ ID NO: 65, which are identical to SEQ ID NO: 7 and 8 of the instant application and comprise the CDRs of SEQ ID NO: 1-6 of the instant application. The ‘297 patent claims that the antibody is conjugated to another moiety, and the use of the anti-TF antibody for administration to an individual to inhibit growth and proliferation of tumor cells expressing tissue factor. Although the ‘297 patent does not specifically claim that the moiety is MMAE, or the specific dosages or cancer types recited in the instant claims, these would be obvious based on the teachings of the ‘608 publication and Lassen, 201, for the same reasons set forth above. For example, the ‘306 publication teaches that MMAE is suitable for use as a conjugated moiety for therapeutic efficacy in treating cancer, including head and neck and prostate cancer, and the ordinary artisan would be motivated to use MMAE as the moiety in the antibody claimed in the ‘297 patent in order to enhance therapeutic efficacy in treating cancer, as taught by the ‘608 publication. Furthermore, the combination therapy, dosing parameters, parameters of the subjects to be treated, and treating adverse events would be obvious optimizations based on the teachings the ‘608 publication, Lassen, 2015, Fu, and Davis, for the same reasons set forth above.
Alternatively, the dosing parameters, parameters of the subjects to be treated, and treating adverse events would be obvious optimizations based on the teachings the ‘608 publication, Lassen, 2015, Eaton, 2014, Seattlegenetics, Sept. 8, 2017, GenMab press release, June 16, 2017, Vergote, 2017, or Vergote II Aug 2017, for the same reasons set forth above.
Claims 1-2, 4, 31, 55, 67, 70, 72-74, 77-78, 80, 82-84, 93, and 97 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 84 of copending application 18/062,473, in view of 2013/0101608, Lassen, 2015, Fu, 2017 and Davis, 2016 OR in view of Lassen, 2015 and Eaton, 2014 and GenMab press release, June 16, 2017, Vergote, 2017 (Annals of Oncology, of record), or Vergote II Aug 2017, ESMO slides (of record), as evidenced by ADC Review, 2016 (all of record).
The ‘473 application claims a method to inhibit tumor growth or proliferation in an individual comprising administration of an anti-TF antibody. Although the ‘473 application does not specifically claim that the antibody is conjugated to MMAE, or the specific dosages or cancer types recited in the instant claims, these would be obvious based on the teachings of the ‘608 publication, Lassen, 2015, for the same reasons set forth above. For example, the ‘608 publication teaches that MMAE is suitable for use as a conjugated moiety in tissue factor antibodies for therapeutic efficacy in treating cancer, including head and neck and prostate cancer, and the ordinary artisan would be motivated to use MMAE as the moiety in the antibody claimed in the ‘473 application in order to enhance therapeutic efficacy in treating cancer, as taught by the ‘608 publication. Furthermore, the combination treatment, dosing parameters, parameters of the subjects to be treated, and treating adverse events would be obvious optimizations based on the teachings the ‘608 publication, Lassen, 2015, Fu, and Davis, for the same reasons set forth above.
Alternatively, the dosing parameters, parameters of the subjects to be treated, and treating adverse events would be obvious optimizations based on the teachings the ‘608 publication, Lassen, 2015, Eaton, 2014, Seattlegenetics, Sept. 8, 2017, GenMab press release, June 16, 2017, Vergote, 2017, or Vergote II Aug 2017, for the same reasons set forth above.
This is a provisional nonstatutory double patenting rejection.
Applicant argues that the rejections relying upon Seattle Genetics, GenMab, Vergote I and II are overcome for the same reasons set forth above.
This is not persuasive for the reasons set forth above.
Regarding the rejection over the ‘025 patent, Applicant argues that the method claimed in the ‘025 patent is a combination treatment method with a platinum based agent and anti-TF ADC for treating cancer, while the present claims are directed to treating cancer with an anti-TF ADC wherein the cancer is selected from the group consisting of colorectal cancer, non-small cell lung cancer, pancreatic cancer, and head and neck cancer
The present claims do no exclude combination treatment with a platinum agent since they are directed to a method “comprising” the recited elements. Furthermore, even the claimed monotherapy as recited in claim 97 would be obvious for the reasons set forth above. Furthermore, as noted above, it would be obvious to treat head and neck cancer based on the teachings of the ‘608 publication which teach combination therapy of various cancers with anti-TF ADC, including bladder, cervical, or head and neck cancer.
No claim is allowed.
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Amy E. Juedes
Patent Examiner
Technology Center 1600
/AMY E JUEDES/Primary Examiner, Art Unit 1644