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 8, 15-17, 19, 22, 23, and 25-27 are pending.
Claims 18, 21, and 28 are canceled.
Claims 8 and 25 are currently amended.
Claims 8, 15-17, 19, 22, 23, and 25-27 are under examination on the merits.
Rejections Withdrawn
35 U.S.C. 103
The rejection of claims 8, 15-18, and 25-27 under 35 U.S.C. 103 as being unpatentable over Jaiswal et al. (US PG PUB 2011/0014119, publication date: 01/20/2011), in view of Funakoshi et al. (Oncology, 22: 674-687, 2003) and Kohrt et al. (Immunotherapy, 4(5): 511-527, 2012) is withdrawn. Claims 18, 21, and 28 are canceled.
The rejection of claims 22 and 23 under 35 U.S.C. 103 as being unpatentable over Jaiswal et al. (US PG PUB 2011/0014119, publication date: 01/20/2011), Funakoshi et al. (Oncology, 22: 674-687, 2003), and Kohrt et al. (Immunotherapy, 4(5): 511-527, 2012), as applied to claims 8, 15-19, 21, and 25-28, and further in view of Liu et al. (WO 2011/143624, international publication date: 11/17/2011) is withdrawn.
Rejections Maintained
35 U.S.C. 112(a)
The rejection of claims 8, 15-17, 19, 22, and 23 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention, is maintained. Claims 18, 21, and 28 are canceled.
Response to Arguments
With respect to the rejection of the claims under 35 U.S.C. 103, Applicant asserts that “the present claims are not made obvious by the cited combination of Jaiswal and Watt (or Jackson 1992). The present claims relate to the specific finding that a combination of an anti-CD47 agent and an anti-CD24 agent increase depletion of lung cancer cells in a synergistic manner (emphasis added).”
This argument has been fully considered and is deemed persuasive. The combination of references cited do not teach or suggest a method of treating lung cancer by administering an anti-CD47 antibody and anti-CD24 antibody combination that, when administered, provides a synergistic effect, as required by the newly amended claims.
With respect to the rejection of the claims under 35 U.S.C. 112(a), Applicant points out that at p. 46, various examples of anti-CD47 antibodies that are known to block the binding of CD47 to SIRPα are known, such as antibodies 5F9-G4, B6H12, 5F9, 8B6, and C3. Applicant also asserts that “one of skill in the art can readily select from the publicly available antibodies specific for CD47 and for CD24, in order to practice the methods of the disclosure.”
These arguments have been fully considered but are not deemed persuasive. The claims are drawn to any anti-CD47 antibody that blocks the binding of CD47 to SIRPα. At the effective filing date, it was known in the art that there are anti-CD47 antibodies that do not block the binding of CD47 to SIRPα. For example Majeti et al. (Cell, 138(2): 286-299, 2009) teach the following: “We hypothesized that increased CD47 expression on human AML [acute myelogenous leukemia] contributes to pathogenesis by inhibiting phagocytosis of leukemia cells, leading us to predict that disruption of the CD47-SIRPα interaction with a monoclonal antibody directed against CD47 will preferentially enable the phagocytosis of AML LSC. Several anti- human CD47 monoclonal antibodies have been generated including some capable of blocking the CD47-SIRPα interaction (B6H12.2 and BRIC126) and others unable to do so (2D3)” See p. 4. Furthermore based upon the teachings of Stancovski et al. and Jiang et al. (as detailed in the Non-Final Rejection, dated 09/05/2025), one skilled in the art would reason that antibodies specific for the same target protein may have different effects depending upon the epitope specificity of a particular target protein-specific antibody. Accordingly in view of these teachings and absent evidence to the contrary, one skilled in the art would appreciate that the functional characteristics of antibodies binding to the same antigen will differ significantly depending upon epitope specificity, and as such in the absence of screening methodologies, one skilled in the art would be unable to determine whether a particular anti-CD47 antibody is capable of blocking the binding of CD47 to SIRPα.
Applicant further asserts that “a person of skill in the art is well-informed of suitable assays and guidelines for determining whether an antibody that binds to CD47 or to SIRPα also has the property of blocking the interaction between the two proteins. No undue experimentation is required.”
This argument has been fully considered but is not deemed persuasive. The Office agrees that screening techniques can be used to isolate anti-CD47 antibodies that block the binding of CD47 to SIRPα, as well as anti-CD24 antibodies that bind to CD24 on lung cancer cells and provide a synergistic effect when combined with said anti-CD47 antibodies; however Applicant is reminded that the written description requirement of 35 U.S.C. 112 is severable from the enablement provision. As stated in Vas-Cath Inc. v. Mahurkar (CA FC) 19 USPQ2d 1111, 935 F2d 1555, “The purpose of the ‘written description’ requirement is broader than to merely explain how to ‘make and use’; the applicant must also convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.”
It is also noted that the claims have been amended to recite a genus of anti-CD47 antibody/anti-CD24 antibody combinations that provide a synergistic effect; however one skilled in the art would reason that not all anti-CD47 antibody/anti-CD24 antibody combinations will provide a synergistic effect. Absent screening methodologies, one skilled in the art would be unable to determine which anti-CD47 antibody/anti-CD24 antibody combinations are capable of providing a synergistic effect. Based upon [00118] and [00125], it appears that the only anti-CD47 antibody/anti-CD24 antibody combination disclosed includes anti-CD47 antibody Hu5F9-G4 and anti-CD24 antibody clone ML5. No other anti-CD47 antibody/anti-CD24 antibody combinations were shown to provide the claimed synergistic effect. Although the specification describes a species within the genus claimed, specifically, the combination of anti-CD47 antibody Hu5F9-G4 and anti-CD24 antibody clone ML5, given the substantial antibody structure variation within the genus, as well as the high level of unpredictability in the art, the disclosure of a single species comprised within the claimed genus is not sufficiently representative of the entire genus. The specification also does not provide relevant, identifying characteristics of anti-CD47 antibodies and anti-CD24 antibodies that, when combined, provide the claimed synergistic effect. The rejection of the claims under 35 U.S.C. 112(a) has been maintained.
Conclusion
Claims 25-27 are allowed.
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 NELSON B MOSELEY II whose telephone number is (571)272-6221. The examiner can normally be reached on M-F 9:00 am - 6:00 pm EST
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis, can be reached on 571-270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NELSON B MOSELEY II/Primary Examiner, Art Unit 1642
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