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. Claims 23-39 are pending upon entry of amendment filed on 7/21/23.
Claims 23-39 are under consideration in the instant application.
3. Applicant’s IDS filed on 12/6/23, 4/3/24, 11/21/24 and 1/12/26 have been acknowledged.
4. The oath filed on 9/21/23 has been acknowledged.
5. The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
6. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
7. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
8. Claim(s) 23-32 and 34-37 is/are rejected under 35 U.S.C. 102(a)(1)(2) as being anticipated by U.S. Pub. 2017/0362321.
The ‘321 publication teaches bispecific antibody that comprises DVD-Ig, scFv, Fab or diabodies and the bispecific antibody binds PD-1 and/or GITR or OX40 ([550-566], [747-749] claims). Given that the suggested first binding specificity and the second binding specificity are of the claimed, the functional limitations of the antibody cannot bind the first antigen and the second antigen with the same or different binding affinities as in claims 25-26 are included in this rejection.
Products of identical chemical composition cannot have mutually exclusive properties. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01.
Where the Patent Office has reason to believe that a functional limitation asserted to be critical for establishing novelty in the claimed subject matter may be an inherent characteristic of the prior art, it has the authority to require the applicant to prove that the subject matter shown in the prior art does not possess the characteristics relied on. In re Schreiber, 44 USPQ2d 1429 (Fed. Cir. 1997). The claiming of a new use, new function of unknown property which is inherently present in the prior art does not necessarily make the claims patentable. See In re Best, 194 USPQ 430, 433 (CCPA) and In re Crish 73 USPQ2d 1364, 1368 (Fed. Cir 2004). Also see MPEP 2112. Also, the patentability of a product does not depend on its method of production. In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985) See MPEP 2113. Therefore, the reference teachings anticipate the claimed invention.
9. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
10. Claims 23-39 are rejected under 35 U.S.C. 103(a) as being unpatentable over U.S. Pub. 2017/0362321in view of U.S. Pat. 8,008,449 and U.S. Pat. 8,394,378.
The teachings of the ‘321 publication have been discussed, supra.
The disclosure of the ‘321 publication differs from the instant claimed invention in that it does not teach the use of OX40 or GITR sequences set forth in claims 38-39 of the instant application.
The ‘449 patent teaches OX40 sequences set forth in SEQ ID NO:54, 55, 57, 58, 60, 61, 96 and 97(note SEQ DI NO:4, 45) and the ‘449 patent teaches use of nivolumab that is identical to SEQ ID NO:15-16 of the instant application. The sequences are humanized and more clinically effective (col. 55-63).
Likewise, the ‘378 patent teaches GITR sequences set forth in claim SEQ ID NO:102 and 103 as in claim 39 of the instant application (note SEQ ID NO:75).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize the sequences set forth in ‘449 or ‘378 patents into the dual binding antibody taught by the ‘321 publication.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the utilization of known clinically more effective antibody sequences may improve therapeutical applicability.
From the teachings of references, it would have been obvious to one of ordinary skill in art to combine the teachings of the references and there would have been a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of the ordinary in the art at the time of invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
11. No claims are allowable.
12. 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 at 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
January 26, 2026
/YUNSOO KIM/Primary Examiner, Art Unit 1641