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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5/1/26 has been entered.
3. Claims 32-35, 39, 41-45, 49, 52 and 54 are pending upon entry of amendment filed on 4/3/26.
4. IN light of Applicant’s response filed on 4/3/26, the rejection under 35 U.S.C. 112(a) (see sections 5-6 of the office action mailed on 2/3/26) has been withdrawn.
5. The following rejections remain.
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. Claims 32-35, 39, 41-45, 49, 52 and 54 are rejected under 35 U.S.C. 102 (a)(1)(2) as being anticipated by U.S. 2010/0278822A1 (IDS reference, of record) for the reasons set forth in the office action mailed on 2/3/26.
The ‘822 publication teaches adalimumab formulations in polysorbate and such formulations have gone through particulate studies based on the storage (Table 2-6). The antibody concentration is above 150mg/ml (Example 2) and meets the limitations of claim 32. IgG4 is taught in [0134].
As is evidence by the specification [0034] that the oleic acid content of polysorbate 80 is >98%, claims 33-35 are included in the rejection. Note that the prior art polysorbate includes Tween 80. Further, Table 26 discloses the sub-visible particles that are greater than 1um is less than 4000 in the presence of 0.1% tween. The test condition includes 12week storage at 40oC that is much more stringent than 5oC and meets the limitations of the claim 32 (Examples 6). Thus, the reference teachings anticipate the claimed invention.
Applicant’s response filed on 4/3/26 has been fully considered but they were not persuasive.
Applicant has asserted that the ‘822 publication fails to teach currently amended limitations of that the composition is free of detectable phospholipase B-like 2 esterase activity and the molar ratio of the intact fatty acid ester to free fatty acid of the composition is greater than 4:1 has not been taught and the ‘822 publication is not available as an anticipatory reference.
As discussed previously, in lack of specific concentration or structure of intact fatty acid ester comprising aliphatic tail of at least 18 carbons, the prior art polysorbate reads on the intact fatty acid ester. As such, the intact fatty acid ester is associated with the degradation and specific visible particle sizes is met after storage. Therefore, the composition comprising fatty acid ester with aliphatic tail of 18 carbons and a monoclonal antibody will inherently have no detectable phospholipase B-like 2 esterase activity especially the composition exhibit no more than 400 subvisible particles having a diameter greater than or equal to 10 microns.
Given the teachings of the prior art, the prior art teaches the polysorbate that reads on intact fatty acid ester. 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). Therefore, the rejection is maintained.
9. 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.
10. Claims 32-35, 39, 41-45, 49, 52 and 54 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21-40 of U.S. Application No. 18/757848.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘848 application recite composition comprising antibody and polysorbate for reducing subvisible particles in the drug product comprising at least 100mg/ml antibody with mixture of fatty acid esters of polyoxyethylene sorbitan.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
In light of discussion above in sections 7-8 of this office action, the rejection is maintained.
11. Claims 32-35, 39, 41-45, 49, 52 and 54 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Application No. 19/029726.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘726 application recite composition comprising antibody and polysorbate for reducing subvisible particles in the drug product comprising at least 100mg/ml antibody with mixture of fatty acid esters of polyoxyethylene sorbitan.
In light of discussion above in sections 7-8 of this office action, the rejection is maintained.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
12. Claims 32-35, 39, 41-45, 49, 52 and 54 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Application No. 18/752089.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘089 application recite composition comprising antibody and polysorbate for reducing subvisible particles in the drug product comprising at least 100mg/ml antibody with mixture of fatty acid esters of polyoxyethylene sorbitan.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
In light of discussion above in sections 7-8 of this office action, the rejection is maintained.
13. Claims 32-35, 39, 41-45, 49, 52 and 54are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 26-35 of U.S. Application No. 19/248893.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘893 application recite composition comprising antibody and polysorbate for reducing subvisible particles in the drug product comprising at least 100mg/ml antibody with mixture of fatty acid esters of polyoxyethylene sorbitan.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
In light of discussion above in sections 7-8 of this office action, the rejection is maintained.
14. No claims are allowable.
15. 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 on 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 an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Yunsoo Kim
Primary Examiner
Technology Center 1600
July 6, 2026
/YUNSOO KIM/Primary Examiner, Art Unit 1641
Prosecution Insights