The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Applicant’s amendment, filed 06/23/2025, has been entered.
Claims 1-51, 53-65, 67-83, 85-103 have been canceled.
Claims 104-112 have been added.
Claims 52, 66, 84, 104-112 are pending and currently under examination as they read on a pharmaceutical composition comprising nivolumab and ipilimumab in 3:1 ratio.
The previous written description rejection under first paragraph of 35 U.S.C. 112(a) has withdrawn in view of Applicant’s amendment, filed 06/23/2025.
Claim Rejections - 35 USC § 103
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, 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.
Claims 52, 66, 84, 104-112 are rejected under 35 U.S.C. 103 as being unpatentable over Wolchok et al. (NEJM 2013 369:122-133) in view of Uchiyama (BBA 2014 1844:2041-2052) and Berman et al. (US 2009/0311187).
Applicant’s argument has been considered in full but has not been found convincing for reasons of record as it applies to amended and newly added claims. The rejection of record can be found in the previous Office Action, mailed 03/21/2025.
In response to Applicant’s assertion that the rejection points to no parts of any combination of the cited references that teaches or suggest a pharmaceutical composition comprising each of the components recited in the amended claim 52 at the specific concentration, it is noted that Uchiyama taught ipilimumab in a composition comprising Tris-HCl, mannitol, NaCl, DTPA and PS80 (see Table 1). Furthermore, it is noted that the exact amount of these excipients depends on the antibody and can be adjusted in order to achieve stability of the antibody in solution. For example, Uchiyama taught that polyols such as mannitol are frequently used to enhance conformational stability and PS80 is frequently used to reduce surface tension and aggregate formation of the antibody solution (see sections 1.10 and 1.11). Similarly, Wolchok taught that the pH of the solution, which is controlled by Tris buffer, can influence chemical stability of the antibody (see, section 1.1). Similarly, the dosages of the antibodies recited in the claims are also obviouse given that they are in 1:3 or 3:1 ratio as taught by Wolchok. Taken together, the recited excipients, pH and dosages are routinely determined by the ordinary artisan as of the effective filing date of the claimed invention and are known as result effective variables that can be adjusted in order to achieve optimal stability of the antibody in solution. It is well settled that "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980). See also Merck & Co. v. Biocraft Labs. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1847-48 (Fed. Cir. 1989) (determination of suitable dosage amounts in diuretic compositions considered a matter of routine experimentation and therefore obvious). One of ordinary skill in the art would have reasonable expectation of success to formulate the antibody solution given that Uchiyama taught rationales to find optimum parameters of pH to achieve colloidal stability and add sugars and surfactant to enhance conformational stability. Moreover, Uchiyama taught that high-throughput stability tests are available to find formulation condition for newly developed antibody drugs (see section 1.12).
Therefore, the rejection is maintained.
Double Patenting
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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
The previous NSDP rejection against US Patents 10,512,689 and 11,612,654 has been withdrawn in view of Applicant’s Terminal Disclaimer, filed 06/23/2025.
Claims 52, 66, 84, 104-112 are rejected on the ground of nonstatutory double patenting as being unpatentable over the following claims of US Patents in view of Wolchok et al. (NEJM 2013 369:122-133), Uchiyama (BBA 2014 1844:2041-2052) and Berman et al. (US 2009/0311187)
U.S. Patent
Claims
9856320
1-3, 12-17
10072082
1, 16, 21
12145927
1, 9, 10
11767361
1-15
11649212
3
11447449
7
11400094
13
11351164
16
11337970
3
11332529
1-18
11253525
28, 30
11203592
11
11078278
1-18
12152075
1-15
11072657
1-11
11066383
14
10959986
37, 41
10696648
16, 19
10633342
16
10544099
17
10377824
9-13, 23-26
10174113
1-20
The above listed reference claims are directed to a pharmaceutical composition or a method of treatment comprising both nivolumab and ipilimumab. Although they did not disclose the exact ratios and pharmaceutical composition ingredients, it would have been obvious to make such in view of Wolchok, Uchiyama and Berman for reasons discussed above in 103. Therefore, the reference claims render obvious of the present claims in view of Wolchok, Uchiyama and Berman.
Applicant’s argument and Examiner’s response are essentially same as above (see 103). Therefore, the rejection is maintained.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHARON X WEN whose telephone number is (571)270-3064. The examiner can normally be reached Mon-Fri 8-5.
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.
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/SHARON X WEN/Primary Examiner, Art Unit 1641