DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
This application is a continuation in part of U.S. Application No. 17/797,867 filed on August 5, 2022 which is a national stage entry of PCT/CN2021/074371 filed on January 29, 2021. Acknowledgment is made of applicant's claim for foreign priority based on an application filed in China on February 5, 2020 under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 17/797,867, filed on 08/05/2022.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12,257,251. Although the claims at issue are not identical, they are not patentably distinct from each other because the cited claims of the instant application and the cited claims of copending ‘303 are substantially overlapping in scope and not mutually exclusive or patentably distinct.
Claims 1-16 of the instant application claim a pharmaceutical combination including BI853520 or a pharmaceutically acceptable salt thereof, and a chemotherapeutic drug which is etoposide or cisplatin; wherein the BI853520 has a structural formula of:
PNG
media_image1.png
201
179
media_image1.png
Greyscale
, as well as a method for treating a tumor in a subject comprising administering to the subject said combination.
Claims 1-15 of ‘251 claim a method of treating melanoma having an NRAS mutation comprising administration of BI853520 tartrate and further comprising administering a second therapeutic agent such as cisplatin.
Thus the cited claims of the instant application would be anticipated over the claims of ‘251 since the claims of ‘251 encompass a combination of BI853520 and a chemotherapeutic drug such as cisplatin for the treatment of melanoma in a subject as claimed in the instant claims.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 5-16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance, claim 5 recites the broad recitation “i) BI853520 or a pharmaceutically acceptable salt thereof and ii) a chemotherapeutic drug”, and the claim also recites “especially i) an effective amount of BI853520 or a pharmaceutically acceptable salt thereof and ii) an effective amount of a chemotherapeutic drug”, which is the narrower statement of the range/limitation.
In the present instance, claim 15 recites the broad recitation “ovarian cancer”, and the claim also recites “especially platinum-resistant ovarian cancer”, which is the narrower statement of the range/limitation.
The claims are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Thus claim 5 and all claims dependent upon claim 5 (claims 6-16) are rejected.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3, 5, 7 and 9-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Laszlo et al. (Journal of Molecular Medicine, 97:231-242, published December 11, 2018 Provided on IDS).
Claims 1, 3, 5, 7 and 9-11 of the instant application claim a pharmaceutical combination including BI853520 or a pharmaceutically acceptable salt thereof, and a chemotherapeutic drug such as cisplatin; wherein the BI853520 has a structural formula of:
PNG
media_image1.png
201
179
media_image1.png
Greyscale
, as well as a method for treating a tumor such as lung cancer in a subject comprising administering to the subject said combination.
Laszlo et al. teaches the treatment of malignant plural mesothelioma (MPM) with BI 853520 (see abstract and page 232). Laszlo et al. further teaches the combination of BI 853520 and cisplatin for the treatment of MPM (page 235).
Accordingly, the cited claims of the instant application are anticipated since Laszlo et al. teaches a pharmaceutical combination including BI853520 and a chemotherapeutic drug such as cisplatin, as well as a method for treating a tumor such as lung cancer comprising administering the combination of BI853520 and the chemotherapeutic drug cisplatin.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claims 1-3, 5-7 and 9-16 are rejected under 35 U.S.C. 103 as being unpatentable over Pachter et al. U.S. Publication No. 2018/0177788 A1 (Provided on IDS).
Claims 1-3, 5-7 and 9-16 of the instant application claim a pharmaceutical combination including BI853520 or a pharmaceutically acceptable salt thereof, and a chemotherapeutic drug which is etoposide or cisplatin; wherein the BI853520 has a structural formula of:
PNG
media_image1.png
201
179
media_image1.png
Greyscale
, as well as a method for treating a tumor in a subject comprising administering to the subject said combination.
Pachter et al. teaches methods comprising administering a FAK inhibitor and an immunotherapeutic agent such as anti-PD-1 or anti-PD-L1; that are useful in the treatment of abnormal cell growth, such as cancer, in mammals, especially humans (abstract and [0002]).
Pachter et al. teaches a method for treating a human subject suffering from a disease or disorder e.g., abnormal cell growth, e.g., cancer comprising administering a FAK inhibitor in combination with an immunotherapeutic agent or procedure [0006]. Pachter et al. teaches the cancer is a solid tumor, soft tissue tumor, metastasis, or non-solid cancer [0007]. In some embodiments, the cancer is sarcomas, adenocarcinomas, and carcinomas of an organ such as the lung, breast, lymphoid, gastrointestinal (e.g., colon), and genitourinary (e.g., renal, urothelial, or testicular tumors) tracts, pharynx, prostate, and ovary) [0007]. In some embodiments, the cancer is a mesothelioma; neurofibromatosis; e.g., neurofibromatosis type 2, neurofibromatosis type 1; renal cancer; lung cancer, non-small cell lung cancer; liver cancer; thyroid cancer; ovarian; breast cancer; a nervous system tumor; schwannoma; meningioma; schwannomatosis; neuroma acoustic; adenoid cystic carcinoma; ependymoma; or ependymal tumors [0007]. In some embodiments, the cancer is mesothelioma (e.g., malignant pleural mesothelioma, e.g., surgical resectable malignant pleural mesothelioma), breast cancer (e.g., triple negative breast cancer), ovarian cancer (e.g., advanced ovarian cancer), lung cancer (e.g., non-small cell lung cancer (NSCLC), e.g., KRAS mutant NSCLC)), or a non-hematologic malignancy [0007]. In some embodiments, the cancer is melanoma (e.g., N-Ras mutated locally advanced or metastasis malignant cutaneous melanoma), colorectal cancer (e.g., metastatic colorectal cancer), leukemia (e.g., acute myeloid leukemia), adenocarcinoma (e.g., pancreatic adenocarcinoma), or a solid tumor (e.g., locally advanced solid tumor, metastatic solid tumor, hepatocellular carcinoma) [0007]. In some embodiments, the method is effective in treating pancreas, non-small cell lung carcinoma (NSCLC), small cell lung carcinoma (SCLC), mesothelioma, melanoma, breast and ovarian cancer [0025]. In an embodiment, the breast cancer is triple-negative breast cancer ; in an embodiment, the lung cancer is non-small cell lung cancer (NSCLC), e.g., KRAS mutant NSCLC; in an embodiment, the ovarian cancer is advanced ovarian cancer (e.g., advanced ovarian cancer or metastatic ovarian cancer); in an embodiment, the method is effective in treating mesothelioma (e.g., malignant pleural mesothelioma, e.g., surgically resectable malignant pleural mesothelioma) [0025]. Pachter et al. further teaches in some embodiments, the solid tumor is locally advanced or metastatic and some embodiments, the solid tumor is refractory (e.g., resistant) after standard therapy [0037].
Pachter et al. teaches that in some embodiments, the FAK inhibitor is BI 853520 ([0009] and [0049]). Pachter et al. teaches in some embodiments, the method further comprises administering an additional chemotherapeutic agent or radiation therapy, or the method further comprises administering a cytotoxic agent [0016]. In some embodiments, the cytotoxic agent is gemcitabine or paclitaxel [0016]. Pachter et al. further teaches, in some embodiments, the method further comprises administering an additional chemotherapeutic agent or radiation therapy, wherein the additional therapeutic agent is selected from: Alkylating agents, Anti-metabolites, Antibiotics, Hormonal therapy agents, Plant derived anti-tumor substances, Cytotoxic topoisomerase inhibiting agents, Immunologicals, Biological response modifiers, Other anticancer agents, Other anti-angiogenic compounds, Platinum-coordinated compounds, Tyrosine kinase inhibitors, Antibodies, and Interferons ([0017] and [0062]).
Pachter et al. teaches in some embodiments, the methods and compositions described therein (e.g., a FAK inhibitor in combination with an immunotherapy) is administered together with an additional therapy (e.g., cancer treatment) [0063]. In one embodiment, a mixture of one or more compounds or pharmaceutical compositions may be administered with the combination described therein, e.g., a FAK inhibitor in combination with an immunotherapy, to a subject in need thereof [0063]. In some embodiments, the additional treatment (e.g., an additional cancer treatment) can be administered simultaneously (e.g., at the same time), in the same or in separate compositions, or sequentially [0063]-[0064]. In addition to being able to be administered in combination with one or more additional therapies (e.g., cancer treatment, e.g., surgery, additional drug(s) or therapeutic agents), methods of the invention may be administered either simultaneously (as a combined preparation) or sequentially in order to achieve a desired effect [0065]. Exemplary cancer treatments include, for example: chemotherapy, targeted therapies such as antibody therapies, immunotherapy, and hormonal therapy, including platinum-coordinated alkylating compounds such as cisplatin, antibiotics such as doxorubicin, plant derived anti-tumor substances such as docetaxel (Taxotere) and paclitaxel, as well as cytotoxic topoisomerase inhibiting agents such as etoposide [0066]-[0079].
Pachter et al. further teaches in some embodiments, first-line-therapy, e.g., for Hodgkin lymphoma comprises administration of a combination of therapeutic agents, for example, the combination may comprise Doxorubicin Hydrochloride (Adriamycin), Bleomycin, Vinblastine Sulfate, and Etoposide (i.e., ABVE) [0094]. In some embodiments, the combination comprises Doxorubicin Hydrochloride (Adriamycin), Bleomycin, Vinblastine Sulfate, Etoposide, Prednisone, and Cyclophosphamide (i.e., ABVE-PC) [0094].
Pachter et al. does not specifically exemplify a combination of BI 853520 and a chemotherapeutic agent which is etoposide or cisplatin.
However, as detailed above Pachter et al. specifically teaches that the FAK inhibitor can be selected as BI 853520 and the combination can further comprise chemotherapeutic agents such as cisplatin and etoposide. Accordingly, prior to the effective filing date, it would have been obvious to a person of ordinary skill in the art to combine the FAK inhibitor selected as BI 853520 with an additional chemotherapeutic agent such as cisplatin or etoposide based on the teachings of Pachter et al. with a reasonable expectation of success in providing an improved treatment for cancer. Thus although Pachter et al. includes cisplatin and etoposide on lists that include other chemotherapeutic agents, a prima facie case of obviousness can still be established since picking one of a finite number of known solutions to a known problem is prima facie obvious. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007).
Thus the cited claims of the instant application are rendered obvious in view of the cited prior art teachings.
Claims 4 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Pachter et al. U.S. Publication No. 2018/0177788 A1 (Provided on IDS) as applied to claims 1-3, 5-7 and 9-16 above and further in view of Gupta et al. (Molecules, 2018, 23, 1719 Provided on IDS).
Claims 4 and 8 of the instant application claim the pharmaceutically acceptable salt of BI853520 is tartrate.
Pachter et al. is as set forth above.
Pachter et al. does not teach BI853520 tartrate.
However, Pachter et al. teaches in some embodiments, the compounds described therein, or pharmaceutically acceptable salts thereof [0044]. Pachter et al. teaches that the term, “pharmaceutically acceptable salts,” as used herein, refers to derivatives of a compound described herein, wherein the compound is modified by converting an existing acid or base moiety to its salt form [0117]. Examples of pharmaceutically acceptable salts include, but are not limited to, mineral or organic acid salts of basic residues such as amines; alkali or organic salts of acidic residues such as carboxylic acids; and the like [0117].
Gupta et al. teaches that specific salts of active pharmaceutical ingredients (APIs) are often formed to achieve desirable properties and the choice of the appropriate salt form is dictated by various factors including physical and chemical properties of the API (page 1). Gupta et al. teaches a list of currently available counterions for salt formation which includes tartrate (Table 1).
Accordingly, prior to the effective filing date, it would have been within the skill of an ordinary artisan to form a suitable salt for BI853520 to improve the properties of the compound based on techniques well-known in the art. Thus, in the absence of secondary considerations such as unexpected results the use of BI853520 tartrate is rendered obvious over the use of BI853520 or a pharmaceutically acceptable salt as taught in the prior art. Thus claims 4 and 8 are rendered obvious in view of the cited prior art teachings.
Conclusion
Claims 1-16 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARA R. MCMILLIAN whose telephone number is (571)270-5236. The examiner can normally be reached Tuesday-Friday 12:00 PM-6:00 PM.
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, Adam C. Milligan can be reached at (571)270-7674. 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.
/KARA R. MCMILLIAN/Primary Examiner, Art Unit 1623
KRM
Prosecution Insights