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
Status of Application, Amendments, and/or Claims
1. Claims 1-5 are pending and currently under consideration.
Information Disclosure Statement
2. It is noted that Applicant has not filed information disclosure statement in this application yet.
Drawings
3. The drawings filed on 05/21/2024 are accepted by the examiner.
Claim Rejections[Symbol font/0xBE]Statutory Double Patenting
4. A rejection based on double patenting of the "same invention" type finds its support in the language of 35 U.S.C. 101 which states that "whoever invents or discovers any new and useful process ... may obtain a patent therefor ..." (Emphasis added). Thus, the term "same invention," in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957); and In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the conflicting claims so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
5. Claims 1-2 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-2 of prior US Patent No. 10,098968 B2. This is a double patenting rejection.
Claim Rejections[Symbol font/0xBE]35 USC § 112 (a)
6. The following is a quotation of the first paragraph of 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.
7. Claim 5 is rejected under 35 U.S.C. 112(a), because the specification, while being enabling for a method of a method for treating a subject having lung cancer or glioblastoma that overexpress EGFR, does not reasonably provide enablement for a method for treating a subject having cancer. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The factors that are considered when determining whether a disclosure satisfies enablement requirement include: (i) the quantity of experimentation necessary; (ii) the amount of direction or guidance presented; (iii) the existence of working examples; (iv) the nature of the invention; (v) the state of the prior art; (vi) the relative skill of those in the art; (vii) the predictability or unpredictability of the art; and (viii) the breadth of the claims. Ex Parte Forman, 230 USPQ 546 (Bd Pat. App. & Int. 1986); In re Wands, 858 F. 2d 731, 8 USPQ 2d 1400 (Fed. Cir. 1988).
Claim 5 is drawn to a method for treating a subject having cancer, comprising administering an effective amount of an antibody drug conjugate (ADC) comprising an anti-EGFR antibody conjugated to at least one auristatin, wherein the anti-EGFR antibody is an IgG isotype and comprises a heavy chain variable region comprising a CDR3 domain comprising the amino acid sequence set forth in SEQ ID NO: 12, a CDR2 domain comprising the amino acid sequence set forth in SEQ ID NO: 11, and a CDRI domain comprising the amino acid sequence set forth in SEQ ID NO: 10; and comprises a light chain variable region comprising a CDR3 domain comprising the amino acid sequence set forth in SEQ ID NO: 8, a CDR2 domain comprising the amino acid sequence set forth in SEQ ID NO: 7, and a CDRI domain comprising the amino acid sequence set forth in SEQ ID NO: 6. The claims are broad and encompass a method of treating a broad genus of cancer. It is noted that the anti-EGFR antibody is allowed in US 9493568 B2.
The specification discloses antibodies that binds to truncated EGFR (1-525) and EGFRvIII, including AbA, which comprises the recited six CDRs in claim 5 (page 139, lines 5-17; page 147, lines 19-21; Fig. 3; Table on page 154). The specification discloses that an antibody drug conjugate (ADC) comprising an anti-EGFR antibody AbA conjugated to at least one auristatin inhibits tumor growth in vivo in mouse xenograft assay using NCI-H1703 and EBCI NSCLC cell lines (Examples 7 and 9) or using U87MGde2-7 glioblastoma cells, which express EGFRvIII (Example 11). However, the specification does not provide sufficient guidance/direction or working examples on how to treat any types of cancer other than lung cancer or glioblastoma.
Furthermore, since there is no evidence on the record showing that all types of cancer overexpress EGFR or EGFRvIII (see page 2 of the instant Specification), it is unpredictable whether administering the antibody-drug conjugate can treat any types of cancer. For example, Rutkowska et al teach that EGFRvIII seems to constitute the perfect therapeutic target for glioblastoma, as it is specifically present on up to 28–30% of GB cells. In case of other tumor types, expression and possible role of this oncogene still remain controversial (Journal of Oncology Volume 2019, pages 1-20, 2019). Moreover, recent observations that EGFRvIII amplicons can hide during therapy, only to re-emerge; combined with the recent failure of a phase III clinical trial (ACT IV) testing an anti-EGFRvIII vaccine on newly diagnosed EGFRvIII-positive patients, indicates that targeting EGFRvIII will be challenging (Oncogene 37(12): 1561-1575, 2018; in particular, last three lines of page 2 to 1st line of page 3).Therapies directed against EGFR and EGFRvIII have not yet shown clear benefit clinically in glioblastoma (Oncogene 37(12):1561-1575, 2018; in particular, page 11, under Conclusions and future directions).
The courts have stated that patent protection is granted in return for an enabling disclosure. Reasonable detail must be provided in order to enable members of the public to understand and carry out the invention. See Genetech v. Novo Nordick A/S (CAFC) 42 USPQ2d 1001 (1997). Similarly, as stated in Rasmusson v SmithKline Beecham Corp., 75 USPQ2d 1297-1303 (CAFC 2005), “if mere plausibility were the test for enablement under section 112, Applicants could obtain patent rights to ‘inventions’ consisting of little more than respectable guesses as to the likelihood of their success. When one of the guesses later proved true, the 'inventor’ would be rewarded the spoils instead of the party who demonstrated that the method actually worked. The scenario is not consistent with the statutory requirement that the inventor enable an invention rather than merely proposing an unproved hypothesis. In the instant case, the evidence on the record supports that the specification does not enable the claimed invention commensurate in scope with these claims.
Due to the large quantity for experimentation necessary to make and use the broad genus of types of cancer, the limited directions guidance presented in the specification regarding the same, the limited working example directed to the same, the complex nature of the invention, the unpredictability in the art, and the breadth of the claims, undue experimentation would be required for the skilled artisan to make and use the claimed invention commensurate in scope with these claims.
Conclusion
8. Claims 3-4 are allowed.
Advisory Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ruixiang Li whose telephone number is (571) 272-0875. The examiner can normally be reached on Monday through Friday from 8:30 am to 5:00 pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Vanessa Ford, can be reached on (571) 272-0857. The fax number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/RUIXIANG LI/ Examiner, Art Unit 1674
September 17, 2026
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