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 .
Response to Amendment and Argument
Status of claims
Claims 1-9 are under examination in this office action.
Maintained Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aguilar et al. (WO 2014/113413) in view of Freeman et al. (US 7,981,605) and Skolids et al. (clinical Cancer Research 2017, 23; pg 618-622) and Hata et al. Nature Medicine 2016; 22; 262-269)
With regards to instant claim 1, Aguilar teaches Bcl-2/Bcl-xL compounds (see pg 10, 0054; 0075, pg 21 compound 15) in the treatment of variety cancers wherein the cancers are breast, prostate, non-small cell lung cancer, small cell lung cancer, colon cancer, etc (see pg 28, para 0108-0109) wherein the cancer is a metastatic cancer (see 0109, pg 28, as required by instant claim 2) wherein administration of the Bcl-2/Bcl-xL is from 0.005 mg/day to 500 mg/day (see para 0116, pg 30 as required by instant claim 9).
However, Aguilar fails to teach the specific chemotherapeutic drug for the various types of drugs as required by instant claim 1 and also fails to teach claims 4-8. Nonetheless teaches treatment can involve a second therapeutic agents (see 0075) therefore based on the cancer one of ordinary skill in the art would determine the specific drug for the specific cancer known in the art for an additive or synergistic effect when administered.
Freeman et al. teaches EGFR mutations T790M (see claim 1) where the inhibitor
is erlotinib (see col. 54, lines 50+, as required by instant claims) and therefore if the mutation is present the patient will exhibit diagnosing as expressing the mutant (as required by instant claims 4-8).
Skoulidis teaches osimertinib as a treatment for patients with metastatic EGFR T790M mutation-positive NSCLC who have progressed on or after EGFR tyrosine kinase inhibitor therapy (p. 618, Abstract, lines 4-8). Skoulidis teaches it is unclear whether acquired resistance to EGFR tyrosine kinase inhibitors is a stochastic phenomenon or whether preexisting molecular features of the primary tumor leads to development of resistance toward a specific molecular trajectory (p. 620, right column, first full paragraph, lines 1-4). Skoulidis cites Hata, stating that T790M-mutant clones could as a result of the expansion of preexisting drug-resistant T790M-positive clones or emerge from dormant drug-resistant cells following de novo acquisition of secondary T790M mutations (p. 620, right column, first full paragraph, lines 4-10). Skoulidis states that latent T790M-positive clones exhibited diminished apoptotic response to osimertinib compared with early resistant clones that could be restored with navitoclax, which motivated a phase 1B clinical trial of a combined therapy of osimertinib and navitoclax in EGFR T790M mutation-positive NSCLC (p. 620, right column, first full paragraph, lines 11-18).
Hata teaches that acquired resistance caused by the EGFR T790M gatekeeper mutation can occur by selection of pre-existing EGFR T790M-positive clones or by genetic evolution of initially EGFR T790M-negative drug-tolerant cells (p. 262, Abstract, lines 1-4). Hata also teaches that resistance impacts the biology of the resistant clone, as clones evolved from drug-tolerant cells had a diminished apoptotic response to EGFR inhibitors that target EGFR T790M, and that treatment with navitoclax, an inhibitor of BCL-xL and BCL-2, restored sensitivity to EGFR inhibitors (lines 4-7).
It would have been prima-facie obvious to one of ordinary skill in the art before the effective filing date of the instant application to administer a treatment comprising Compound No. 1 and the additional therapeutic agent osimertinib for the purposes of treating NSCLC. One of ordinary skill in the art would have motivated to administer a treatment that comprises both Compound No. 1 and osimertinib for the purposes of treating NSCLC in view of Skoulidis and Hata teaching that latent T790M-positive clones exhibited diminished apoptotic response to osimertinib that could be restored
with navitoclax. It would have been obvious to one of ordinary skill in the art would have substituted navitoclax in the treatment of non-small cell lung cancer with BCL-xL and BCL-2 and osimertib with a reasonable expectation of success and therefore the claims would have been prima facie obvious at the time the claimed invention was filed.
Applicant argues that the Examiner, Aguilar fails to teach the specific chemotherapeutic agents for the various types of drugs as required by the instant claim 1 and also fails to teach claims 4-8 of the present application and that Aguilar merely lists numerous cancers and a multitude of second therapeutic agents (see Table 1) without providing any selection logic, ranking criteria, or experimental data. A person skilled in the art has no motivation or insight to select a specific drug for a particular cancer.
In response, Applicant’s argument is found unpersuasive, as clearly argued, Aguilar discloses the specific Bcl-2/Bcl-xL inhibitor for the treatment of various cancers of which non-small cell lung cancer, small cell lung cancer as indicated in the rejection above. Although Aguilar did not per se teach the specific second therapeutic agent , nonetheless does specifically teach that the second therapeutic agent is selected from drugs known as useful in treating the disease or the condition (see 0075)
PNG
media_image1.png
242
518
media_image1.png
Greyscale
Specifically, the reference does teach specifically Bcl-2/Bcl-xL inhibitorcan be administered with cisplatin (see 0123). Based on this teaching alone one of ordinary skill in the art would used known chemotherapeutic agents known for the treatment of a specific cancer.
Maintained 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-9 arestand rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1- 11 of U.S. Patent 11491168 in view of Clegg et al. (clinical and cost effectiveness of Paclitaxel….. (2001). Although the conflicting claims are not identical, they are not patentably distinct from each other. The reasons are as follows:
Both sets of claims refer to treating cancer administering to the subject a Bcl-2/Bcl-xL that can be combined with other treatments such as chemotherapy drugs.
However the Patent is silent of administering docetaxel or paclitaxel in the treatment of small cell lung cancer as required by the instant claims.
Nonetheless Clegg is introduced to show that both these drugs are known to be used in the treatment of small cell lung cancer (see entire review article).
Additionally The specification of the patent teaches the chemotherapeutic agents such as paclitaxel and docetaxel (see Fig 11(a) and col. 77 for the types of chemotherapeutic drugs used in the treatment of cancers.
It would have been obvious to one of ordinary skill in the art to have expanded the patented claims to include docetaxel and paclitaxel in the use of treating cancers such as small cell lung cancer with a reasonable expectation of success. since the drugs overlap and the cancers overlap.
In view of the foregoing, the patented claims and the current application claims are obvious variations of each other..
Applicant argues that instant claim 1 is directed to treating specific cancers with specific chemotherapeutic agents. Specifically that the patent failed to mention chemotherapeutic agents.
In response, Applicant’s argument is found unpersuasive. Firstly, the patented claims recite an open term “comprising” which does not exclude other actives to be present. Secondly, Claim 3 of the patent recites that wherein the prior treatment comprises surgery, chemotherapy, radio therapy, targeted therapy, immunotherapy, or any combination thereof. Thus, indicating the use of chemotherapeutic agent known for the treatment of specific cancers. Again, as stated in the rejection above Clegg was introduced to show that both these drugs are known to be used in the treatment of small cell lung cancer (see entire review article). Therefore, motivating one of ordinary skill in the art to add these chemotherapeutic drugs in the treatment of cancer
Claims 1-9 stand rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1- 4 of U.S. Patent 12083136 in view of Clegg et al. (clinical and cost effectiveness of Paclitaxel….. (2001). Although the conflicting claims are not identical, they are not patentably distinct from each other. The reasons are as follows:
The patent recites a method of treating cancer comprising administering to a subject in need thereof a therapeutically effective amount of a Bcl-2/Bcl-xL inhibitor and a therapeutically effective amount of a chemotherapeutic agent, wherein the Bcl-2/Bcl-xL inhibitor is a pharmaceutically acceptable salt thereof, wherein the chemotherapeutic agent is docetaxel or paclitaxel, and wherein the cancer is small cell lung cancer and the instant claims recite a method of treating cancer comprising administering to a subject in need thereof a therapeutically effective amount of a Bcl-2/Bcl-xL inhibitor and a therapeutically effective amount of a chemotherapeutic agent, wherein the Bcl-2/Bcl-xL inhibitor is or a pharmaceutically acceptable salt thereof, wherein the chemotherapeutic agent is selected from the group consisting of cisplatin, docetaxel, 5-fluorouracil, irinotecan; wherein the cancer is selected from the group consisting of breast cancer, small cell lung cancer, non-small cell lung cancer etc
It would have been obvious to one of ordinary skill in the art to have used the patented claims to practice the instant claimed as the patented claims recite the use of an additional chemotherapeutic agents in the treatment of a specific cancer with the specific chemotherapeutic agent. Therefore a known therapeutic treatment therapy can be incorporated in the teachings to practice.
Applicant argues that Claims 1-4 of the '136 patent recite a method of treating small cell lung cancer with specific chemotherapeutic agents (docetaxel or paclitaxel) in combination with the Claimed Bcl-2/Bcl-xL inhibitor, rather than cisplatin and irinotecan required in the instant claim 1.
In response, while this is so, Applicant should note that Clegg specifically teach (see abstract that paclitaxel and doxetaxel are first and second line of treatment for non-smallcell lung cancer and therefore one of ordinary skill in the art would be motivated to use these chemotherapeutic drugs in combination with other drugs for the treatment of the same cancer.
Claims 1-9, stand rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim of U.S. Patent Application No. 17428692 (now allowed).
The claims of the instant refer to treating cancer administering to the subject a Bcl-2/Bcl-xl that can be combined with other treatments such as chemotherapy drugs and the claims of copending refers to the same compound and an additional therapeutic agent in the treatment of various cancer.
Thus, one of ordinary skill in the art would have been motivated to use the instant claims in practicing the copending claims with a reasonable expectation of success as the scope overlaps.
See 35 USC 103 rejection above.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIRLEY V GEMBEH whose telephone number is (571)272-8504. The examiner can normally be reached M-F 9am-6pm.
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, Robert A. Wax can be reached on 571-272-0623. 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.
/SHIRLEY V GEMBEH/ Primary Examiner, Art Unit 1615
9/22/26
