DETAILED ACTION
1. The present application is being examined under pre-AIA first to invent provisions.
2. Claims 2, 7, 9-13 and 15-17 are pending upon entry of amendment filed on 4/16/26.
3. Applicant’s IDS filed on 4/16/26 has been acknowledged.
4. The new title filed on 4/16/26 has been entered.
5. In light of Applicant’s amendment to the claims filed on 4/16/26, the rejection under 35 U.S.C.112(b) has been withdrawn (see sections 7-8 of the office action mailed on 12/16/25).
6. The following rejections remain.
7. The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
8. Claim(s) 2, 7, 9-13 and 15-17 are rejected under pre-AIA 35 U.S.C. 102 (b) as being anticipated by U.S. Pat. 6,267,958 (IDS reference, of record) for the reasons set forth in the office action mailed on 12/16/25.
The ‘958 patent teaches antibody formulation comprising 25mg/ml of antibody, 5mM of histidine, 85mM of sucrose or trehalose and 0.01% polysorbate at pH 6 (Table 10, claims 1-47). Further, the ‘958 patent teaches use of sterile water or bacteriostatic water for reconstituting the lyophilized formulation up to 150mg/ml of antibody (claims 24-47) and addition of glycine and mannitol as bulking agent (note claim 28). In addition, the ‘958 patent teaches the lyophilization results in lyophilized cake (claim 27).
Given that the claimed invention uses lyoprotectant and/or cryoprotectant being sucrose, trehalose, and or mannitol, it meets the limitations of claimed invention. The reference teachings anticipate the claimed invention.
Applicant’s response filed on 4/16/26 has been fully considered but they were not persuasive.
Applicant has asserted that the currently amended claims obviate the rejection and the reference does not teach 1-15% of trehalose at pH of 5-7.5.
Unlike Applicant’s assertion, claims 32-36 recite 80-300mM of trehalose. Given that the molecular weight of trehalose is 342.3 g/mole, it is equivalent of 2.74-10.27% and meets amended limitations. As such, histidine 20mM is disclosed in table 10 as well as the 100mg/ml of antibody, it meets the currently amended limitations and the rejection is maintained.
9. Claim(s) 2, 7, 9-13 and 15-17 are rejected under pre-AIA 35 U.S.C. 102 (b) as being anticipated by U.S. Pub. 2004/0197324 (IDS reference, of record) for the reasons set forth in the office action mailed on 12/16/25.
The ‘324 publication teaches antibody formulations comprising about 100-260mg/ml of antibody, histidine, trehalose at 150mM and about 0.02% polysorbate (claims 1-27, table). Further, the ‘324 publication teaches addition of glycine and/or mannitol as bulking agent and polysorbate is polysorbate 20 or 80 ([202, 216-217]).
The ‘324 publication teaches antibody formulation is lyophilized resulting in cake or powder ([208]) and may be reconstituted in sterile water or bacteriostatic water ([207-209]). The reference teachings anticipate the claimed invention.
Applicant’s response filed on 4/16/26 has been fully considered but they were not persuasive.
Applicant has asserted that the currently amended claims obviate the rejection and the reference does not teach 1-15% of trehalose at pH of 5-7.5.
Unlike Applicant’s assertion, [272] discloses 40mg/ml of antibody, 20mM of histidine, 85mM of trehalose. Given that the molecular weight of trehalose is 342.3 g/mole, it is equivalent of 2.74 % and meets amended limitations. As such, histidine 20mM is disclosed in Examples 1-2 at pH 6, it meets the currently amended limitations and the rejection is maintained.
10. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
11. Claims 2, 7, 9-13 and 15-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 162-191 of U.S. Application No. 18/256,748 (U.S.Pub 2024/0084018).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘748 application recites a pharmaceutical composition comprising species of antibody fragment (e.g. fusion construct) in the presence of buffer, sucrose, trehalose, and/or mannitol in the presence of polysorbate at pH 5-7.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant’s response filed on 4/16/26 has been fully considered but they were not persuasive.
Applicant has asserted that the currently amended claims obviate the rejection and the reference does not teach 1-15% of trehalose at pH of 5-7.5.
Unlike Applicant’s assertion, the claimed embodiments of the ‘748 application includes antibody at 25-250mg/ml, 10-30mM of histidine and 5-15% of trehalose that is readable upon the currently amended claims.
12. The following new ground of rejection is necessitated by Applicants’ amendment filed on 4/16/26.
13. 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.
14. Claims 2, 7, 9-13 and 15-17 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 “10mM-30mM of histidine, 1-15% trehalose wherein the pH of the formulation is about pH 5-7.5”. Applicants assert that no new matter is added. However, the specification does not support such combinations of excipients and concenterations as currently amended. No exemplary formulations that are encompassed by the currently amended claims such as “10mM-30mM of histidine, 1-15% trehalose” and any buffer at any concentration in the context with amended claims are present in the specification.
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.
15. No claims are allowable.
16. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
17. 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
June 16, 2026
/YUNSOO KIM/Primary Examiner, Art Unit 1641
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