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. Upon grant of the petition filed on 3/24/26, the unintentionally abandoned application is revived.
3. Claims 1-23 are pending upon entry of amendment filed on 3/24/26.
The species election in the response mailed on 3/24/26 is acknowledged.
Claims 16-19 and 21-23 are withdrawn from further consideration by the examiner, 37 CFR 1.142 (b) as being drawn to a nonelected invention.
Claims 1-15 and 20 readable upon elected species of SEQ ID NO:7-8 and a pharmaceutical composition comprising 10mg/ml of bintrafusp alfa, 10mM histidine, 40mM of sodium chloride, 159mM trehalose, 0.5mg/ml of polysorbate 20 and 5mM methionine at pH 5.5 are under consideration in the instant application.
4. Applicant’s IDS filed on 6/16/22 and 4/7/25 have been acknowledged.
5. The oaths filed on 6/16/22 have been acknowledged.
6. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
7. Claim 13 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
The use of the term “optionally” in claim 13 renders the claim indefinite because it is unclear whether the limitations following such terms or phrases are part of the claimed invention. See MPEP 2173.05 (h).
8. 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.
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 1-15 and 20 are rejected under 35 U.S.C. 103(a) as being unpatentable over WO2015/118175 (IDS reference) as evidenced by the [0089] of the specification of instant application in view of U.S. Pub. 2010/0203056 and U.S. Pub. 2018/0369377.
The ‘175 publication teaches fusion constructs of PD-L1 antibody and TGFβR and a pharmaceutical composition comprising the antibody (p.2, 32-33). As evidenced by the [0089] of the instant application, the antibody of the ‘175 publication includes bintrafusp alfa and claims 11-12 are included in this rejection. The ‘175 publication discloses the composition comprises tonicity adjusting agents, buffering agents, fillers and/or other conventional delivery forms.
The disclosure of the ‘175 publication differs from the instant claimed invention in that it does not teach the use of specific combination of excipients and concentrations of excipients as set forth in claims 1-10, 13-15 and 20 of the instant application.
The ‘056 publication teaches the PD-L1 antibody is being stabilized with histidine buffer, amino acid of arginine, lysine or methionine, trehalose at 1-5% and polysorbate at about 0.2-0.5mg/ml at about pH 5-6 (p. 42-43). The antibody concentration is about 1mg/ml ([395]).
Further, the ‘377 publication teaches use of about 1-30 mg/ml of avelumab (PD-L1 antibody), about 200mM of trehalose, 10mM histidine, about 150mM of arginine, 5mM of methionine, and 0.5mg/ml of polysorbate 20 (Tables, claims 1-33) at pH 5.5-6 that reduces aggregates in antibody composition. As the claims 13-14 allow addition of HCl in the buffer comprising sodium, the composition is expected to have NaCl and the instant claim 20 is included in this rejection. The ‘377 publication teaches such composition reduces aggregates and stabilizes antibody. Given that the fusion construct comprises PD-L1 antibody, the stabilizing composition that stabilizes PD-L1 antibody is expected to stabilizes bintrafusp alfa.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize known stabilizing excipient combinations and concentrations as taught by the ‘056 and ‘377 publications into the bintrafusp alfa composition taught by the ‘175 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 specific excipient combination and concentration stabilizes fusion construct comprising PD-L1 antibody.
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
July 8, 2026
/YUNSOO KIM/Primary Examiner, Art Unit 1641
Prosecution Insights