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 1, 3, 4, 10, 11, 13, 17, 18, 32, 35, 36, 42, 46, 49-50, and 75-77 are pending and being examined the merit.
Rejections Withdrawn
All previous rejection of claims 28, 29, 33, 40, and 54 are moot in view of claim cancellation.
Previous rejection of claims 17 and 46 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in view of claim amendments.
Previous rejection of claims 1, 3, 4, 10, 11, 13, 17, 32, and 46 under 35 U.S.C. 103 as being unpatentable over Jacobs et. al. (Oncotarget. 2015. Vol 6(15), pages 13462-13475, reference in IDS filed on 04/11/2022) in view of Aftimos et al. (Clin. Cancer Res. 2017, 23(2):6411-6420), and Botting et al. (Plos One, 2015, DOI:10.1371/journal.pone.0136155, pages 1-17) is withdrawn in view of claim amendments.
Previous rejection of claims 18, 49, and 50 under 35 U.S.C. 103 as being unpatentable over Jacobs et. al. (Oncotarget. 2015. Vol 6(15), pages 13462-13475, reference in IDS filed on 04/11/2022) in view of Aftimos et al. (Clin. Cancer Res. 2017, 23(2):6411-6420) and Botting et al. (Plos One, 2015, DOI:10.1371/journal.pone.0136155, pages 1-17) as applied to claims 1 above, and further in view of Heymach et. al. (U.S. Application No. 2014/0155397 A1, reference in IDS filed on 04/11/2022) and Ortiz-Cuaran et al. (Cancer Research, 2016, 74:2320) is withdrawn in view of claim amendments.
Previous rejection of claim 18, 32, 35, 36, 75 and 76 under 35 U.S.C. 103 as being unpatentable over Jacobs et. al. (Oncotarget. 2015. Vol 6(15), pages 13462-13475, reference in IDS filed on 04/11/2022) in view of Aftimos et al. (Clin. Cancer Res. 2017, 23(2):6411-6420, of record) and Botting et al. (Plos One, 2015, DOI:10.1371/journal.pone.0136155, pages 1-17) as applied to claims 1 and 28 above, and further in view of Klussman et. al. (Bioconjugate Chemistry. 2004. Vol 15(4), pages 765-773, of record) is withdrawn in view of claim amendments.
Previous rejection of claims 40 and 42 under 35 U.S.C. 103 as being unpatentable over Jacobs et. al. (Oncotarget. 2015. Vol 6(15), pages 13462-13475, reference in IDS filed on 04/11/2022) in view of Aftimos et al. (Clin. Cancer Res. 2017, 23(2):6411-6420) and Botting et al. (Plos One, 2015, DOI:10.1371/journal.pone.0136155, pages 1-17) as applied to claim 1 above, and further in view of Terrett (WO2019215500, earliest priority date is May 10, 2018) is withdrawn in view of claim amendments.
Rejections Maintained/New Rejections Necessitated by Claim Amendments
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(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.
Claim 1, 3, 4, 10, 11, 13, 17, 18, 32, 35, 36, 42, 46, 49-50, and 75-77 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. This is a NEW MATTER rejection.
Base claim 1 has been amended to treat EGFR TKI resistant NSCLC that is negative for a EGFR T790M mutation comprised of administering a CD70 targeting molecule, wherein the CD70 targeting molecule is:
(a) a cell expressing a CD70 targeting chimeric antigen receptor (CAR),
(b) a CD70 targeting molecule conjugated to a toxic molecule,
(c) a CD27 ligand conjugated to a toxic molecule,
(d) a cell expressing a CAR comprising a CD27 polypeptide or fragment thereof fused to a CAR molecule, or
(e) an anti-CD70 antibody, or antigen binding fragment thereof, conjugated to a toxic molecule,
(f) an anti-CD70 single chain variable fragment (scFv),
(g) an anti-CD70 bi-specific T cell engager (BiTE), or
(h) an anti-CD70 tri-Specific natural killer cell engater therapy (TriNKET).
Applicant cited paragraph 0031, figure 7, and example 2 of the instant specification for providing support for administering a CD70 targeting molecule to treat EGFR TKI resistant NSCLC that is negative for a EGFR T790M mutation. However, figure legend (paragraph 0031) and figure 7 showed that EGFR TKI resistant NSCLC cells have increased CD70 expression in cells with and without EGFR T790M mutation. Example 2 discussed EGFR TKI resistant cells have an increased in CD70 expression and concluded that “these findings that CD70 expression is enhanced in EGFR TKI resistant cells suggests that targeting CD70 may be clinically useful in the setting of EGFR TKI resistant NSCLC” (paragraph 00216).
These sections of the specification do not states administering a CD70 molecules to treat EGFR TKI resistant NSCLC cells that is negative for the EGFR T790M mutation, where in the CD70 molecule is (a) a cell expressing a CD70 targeting chimeric antigen receptor (CAR), (b) a CD70 targeting molecule conjugated to a toxic molecule, (c) a CD27 ligand conjugated to a toxic molecule, (d) a cell expressing a CAR comprising a CD27 polypeptide or fragment thereof fused to a CAR molecule, (e) an anti-CD70 antibody, or antigen binding fragment thereof, conjugated to a toxic molecule, (f) an anti-CD70 single chain variable fragment (scFv), (g) an anti-CD70 bi-specific T cell engager (BiTE), or (h) an anti-CD70 tri-Specific natural killer cell engater therapy (TriNKET).
Other sections of the specification disclosed “[[A]]aspects of the disclosure relate to a method for treating EGFR-mutant non-small- cell lung cancer (NSCLC) in a patient comprising administering a CD70 targeting molecule to the patient. Further aspects of the disclosure relate to a method for treating an epithelial-to- mesenchymal transition (EMT)-positive NSCLC in a patient comprising administering a CD70-targeting molecule to the patient” (paragraph 0006). This and other sections of the speciation that discussed administering a CD70-targeting molecule does not distinguish treating patients with EGFR TKI resistant NSCLC cells that is negative for the EGFR T790M mutation.
Thus, the instant claimed limitations of administering a CD70 molecule to treat EGFR TKI resistant NSCLC cells that is negative for the EGFR T790M mutation, wherein the CD70 molecule is (a) a cell expressing a CD70 targeting chimeric antigen receptor (CAR), (b) a CD70 targeting molecule conjugated to a toxic molecule, (c) a CD27 ligand conjugated to a toxic molecule, (d) a cell expressing a CAR comprising a CD27 polypeptide or fragment thereof fused to a CAR molecule, (e) an anti-CD70 antibody, or antigen binding fragment thereof, conjugated to a toxic molecule, (f) an anti-CD70 single chain variable fragment (scFv), (g) an anti-CD70 bi-specific T cell engager (BiTE), or (h) an anti-CD70 tri-Specific natural killer cell engager therapy (TriNKET) lacks support in the original disclosure.
Claims 1, 3-4, 10-11, 13, 17-18, 42, 49, 50, and 75-76 remained rejected and new claim 77 is 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. This is a written description rejection.
The claims are drawn to a method for treating a patient with EGFR-mutant NSCLC and/or EMT-positive NSCLC comprising administering a CD70-targeting molecule that inhibits CD70 activity to treat the cancer. Dependent claim 17 further limits the patient to one that has been previously treated for NSCLC via an EGFR TKI therapy comprising a list of antibodies. Dependent claim 35 further limits the CD70-targeting molecule to comprise an anti-CD70 antibody or CD70-binding fragment that is linked to a toxic molecule comprising a list of toxic molecules.
The specification discloses that anti-CD70 antibody drug conjugates, such as cuzatuzumab-MMAE or vorsetuzumab-MMAE, are a valid approach for targeting EGFR TKI-resistant cells because EGFR TKI-resistant cells are known to enhance expression of CD70. In addition, the inclusion of osimertinib alongside anti-CD70 antibody drug conjugates improved the anti-tumor cell effect (see entire document, but specifically page 55, Example 2, lines 16-22). The specification further discloses that, besides anti-CD70 antibody drug conjugates, anti-CD70 CAR-T cells, TriNKETs, EGFR-CD70 BiTEs, Axl-CD70 BiTEs, or other CD70-directed therapies alone or in combination with other treatments may be effective for EGFR mutant, TKI-resistant tumors (page 53, Example 1, lines 16-20). Finally, the specification also discloses that the secondary antibody binds to the CD70-targeting antibody while conjugated to a toxic molecule linked through a cleavable linker (page 5, paragraph 14).
However, there is insufficient written description in the specification as-filed of the genus of anti-CD70 single variable fragment (scFv) as required by the instant claims.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. However, a showing of possession alone does not cure the lack of a written description. Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 969-70, 63 USPQ2d 1609, 1617 (Fed. Cir. 2002). For example, it is now well accepted that a satisfactory description may be found in originally-filed claims or any other portion of the originally-filed specification. See In re Koller, 613 F.2d 819, 204 USPQ 702 (CCPA 1980); In re Gardner, 475 F.2d 1389, 177 USPQ 396 (CCPA 1973); In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). However, that does not mean that all originally-filed claims have adequate written support. The specification must still be examined to assess whether an originally-filed claim has adequate support in the written disclosure and/or the drawings. An applicant shows that the inventor was in possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. Amer. Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was “ready for patenting” such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the inventor was in possession of the claimed invention. See MPEP 2163.
Here, Applicant has claimed a method for treating a patient with EGFR-mutant NSCLC and/or EMT-positive NSCLC comprising administering a genus of anti-CD70 single chain variable fragment. The specification discloses working examples of treating EGFR TKI-resistant cells with increasing concentrations of the CD70 antibody drug conjugate cuzatuzumab-MMAE or vorsetuzumab-MMAE (page 56, Example 2, lines 16-28).
Artisans are well aware that knowledge of a given antigen (for instance CD70) provides no information concerning the sequence/structure of antibodies that bind the given antigen. For example, Briney et al. (Nature 2019. 566:393-399, of record) teaches that “the diversity of naïve antibody repertoire in humans is estimated to be at least 1012 unique antibodies” and that “the circulating B cell population samples only a small fraction of this diversity” (paragraph 1, lines 3-6). In other words, without complete structural information, consisting at least of both heavy and light chain CDRs 1, 2, and 3, an immune response to a single antigen can produce a vast array of unique antibody configurations. As such, the two species of specific anti-CD70 antibody disclosed in the specification is not sufficient to support the entire genus of the anti-CD70 scFV that can be administered to induce a therapeutic effect. Identifying an antibody simply on the basis of what it binds rather than by identifying the sequence/structure of the antibody in question is generally insufficient to provide sufficient written description of the antibody in question.
It does not appear based upon the limited disclosure of the anti-CD70 antibody drug conjugates cuzatuzumab-MMAE and vorsetuzumab-MMAE that Applicant was in possession of the claimed genus of the methods of treating a patient with EGFR-mutant NSCLC and/or EMT-positive NSCLC of for the composition comprising the claimed genus of anti-CD70 scFv.
In the absence of disclosure of relevant, identifying characteristics of a method of treating comprised of administering an anti-CD70 scFv, there is insufficient written disclosure under 35 U.S.C. 112, first paragraph.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIE WU whose telephone number is (571)272-5205. The examiner can normally be reached M-F 9-5PM.
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, Bonnie Eyler can be reached at 571-272-1200. 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.
/JULIE WU/Supervisory Patent Examiner, Art Unit 1643