DETAILED ACTION
1. The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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.
2. Claims 20, 21, 24, 27, 31, 34, 35 and 40-42 are pending upon entry of amendment filed on 3/2/26.
Claim 20, 21, 24, 27, 31, 34, 35 and 40-42 are under consideration in the instant application.
3. Applicant’s IDS filed on 3/2/26 has been acknowledged.
4. No oath is of record.
5. In light of Applicant’s amendment to the claims filed on 3/2/26, the rejection under 35 U.S.C. 103 (see sections 6-8 of the office action mailed on 8/29/25) has been withdrawn.
6. The following rejection remains.
7. 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.
8. Claims 20, 21, 24, 27, 31, 34, 35 and 40-42 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a New Matter rejection.
The specification or the original claims as filed does not provide a written description the phrases “a liquid formulation comprising at least 300mg” as in claim 20 of the instant application. Applicants assert that the currently added limitation is found from previously entered claims 24-26, 32-33. However, the specification or claims does not support for freezing a liquid formulation comprising at least 300mg as currently amended. Rather, the lyophilized cake comprises 300mg as in claim 32 filed on 11/8/24. The specification in p. 54 discloses 60mg/ml antibody in the presence of 50mM histidine, 125mM arginine, 0.06% of polysorbate and 10% sucrose at pH 6 at most.
The currently amended range is not supported by the original claims or instant specification.
The instant claims now recite a limitation which was not clearly disclosed in the specification as filed, and now changes the scope of instant disclosure as filed.
Such limitations recited in the present claims, which did not appear in the specification as filed, introduce new concepts and violate the description requirement of the first paragraph of 35 U.S.C.112.
Applicant’s response filed on 3/2/26 has been fully considered but they were not persuasive.
Applicant has asserted that the currently amended claims obviate the rejection as the currently amended claims recite lyophilized cake contains at least 300mg of antibody.
However, the initial liquid formulation is supported to comprise 60mg/ml antibody in the presence of 50mM histidine, 125mM arginine, 0.06% of polysorbate and 10% sucrose at pH 6 as in p.54 of the specification and the examples do not support layering nitrogen gas after forming lyophilized cake. The rejection is maintained.
9. No claims are allowable.
10. 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.
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, 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.
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.
Yunsoo Kim
Patent Examiner
Technology Center 1600
March 31, 2026
/YUNSOO KIM/Primary Examiner, Art Unit 1641
Prosecution Insights