DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/2/26 has been entered.
3. Claims 86-94 and 98 are pending upon entry of amendment filed on 10/1/25.
Claims 86-94 and 98 are under consideration in the instant application.
4. Applicant’s submission of IDS filed on 3/2/26 has been considered.
5. The following rejection remains.
6. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(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.
7. Claims 86-94 and 98 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for a method of stabilizing composition comprising a margetuximab from 20-100mg/ml, sodium phosphate buffer, sodium chloride, arginine and sucrose, does not reasonably provide enablement for more.
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/or use of the invention commensurate in scope with these claims.
The specification does not enable one of skill in the art to practice the invention as claimed without undue experimentation. Factors to be considered in determining whether undue experimentation is required to practice the claimed invention are summarized In re Wands (858 F2d 731, 737, 8 USPQ2d 1400, 1404 (Fed.Cir.1988)). The factors most relevant to this rejection are the scope of the claim, the amount of direction or guidance provided, the lack of sufficient working examples, the unpredictability in the art and the amount of experimentation required to enable one of the skilled in the art to practice the claimed invention.
There is insufficient guidance in the specification as filed as to how the skilled artisan would make and use margetixumab composition in treatment of any cancer set forth in claims 95-98.
Examples 1-4 of the instant application disclose extensive studies on particle reduction in terms of extending stability in the presence of excipients. No examples show treatment of cancer as required by the claimed invention. At most, after the extensive stability study, purity of margetuximab, potency of HER2 or FcγRIIIa binding ELISA are disclosed but no studies that may correlate cancer treatment encompassed by the scope of cancer species set forth in claims 95-98 of the instant application.
As in the U.S. Pat, 8,802,093, the HER2/neu antibodies as defined as margetuximab of the instant application. Although the ‘093 patent lists some proliferative disorders and shows some anticancer activities of HER2 antibody that may be used in adenocarcinoma cell lines of xenograft tumors (Examples, col. 50-53 and col. 60), the ‘093 patent fails to disclose any treatment dosage or regimen to support treatment methods encompassed by the claimed invention.
The claims of the instant application relate treatment of any cancer regardless of the source (note claim 96) whether is AIDS associated or sarcoma, gastroesophageal junction cancer or lung cancer. As such, the current art or instant application does not support treatment of any cancer listed by the claims or instant application in [0064, 0065, 142, 143]. Mere listing of cancers cannot be extrapolated to actual treatment of cancer lack of any regimen, studies or dosage associated with various unrelated cancer types encompassed by the claimed invention.
It is unpredictable to develop cancer treatment by the binding efficiency or potency of HER2 or FcγRIIIa binding ELISA in the example and potency assay with cell growth inhibition assay cannot be extrapolated to cancer treatment methods encompassed by the claimed invention.
To summarize, reasonable correlation must exist between the scope of the claims and scope of the enablement set forth. In view or the quantity of experimentation necessary, the limited working example, the unpredictability of the art, the lack of sufficient guidance in the specification, and the breath of the claims, it would take undue trials and errors to practice the claimed invention.
Applicant’s response filed on 3/2/26 has been fully considered but they were not persuasive.
Applicant has asserted that the administration of margetuximab treats cancer as evidenced by U.S. Pat. 11,459,399 and the instant application provides sufficient guidance for the treatment.
Unlike Applicant’s assertion, the treatment disclosed by the asserted ‘399 patent relates treatment of breast cancer and the cancer recited in claim 86 is not limited to breast cancer as in claim 98. Applicant is reminded that the instant claims encompass any cancer including sarcoma, gastroesophageal junction cancer, lymphomas or lung cancer and is advised to incorporate the limitation of claim 98. Rejection is maintained.
8. No claims are allowed.
9. Any inquiry concerning this communication or earlier communications from the examiner should be directed to YUNSOO KIM whose telephone number is (571)272-3176. The examiner can normally be reached Mon-Fri 8:30-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached on 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Yunsoo Kim
Patent Examiner
Technology Center 1600
March 13, 2026
/YUNSOO KIM/Primary Examiner, Art Unit 1641
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