DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This office action is in response to an amendment filed 2/27/2025.
Claims 1, 2, 4, 5, 8, 10-16, 21-28 are pending.
This application claims the benefit of EP 21207284.7 filed 11/9/2021. The priority document is filed in English.
Response to Amendments
Applicants have submitted a new disclosure which obviates the objections raised in the previous action over the disclosure.
Claim 7 previously indicated as free from the art was incorporated into claim 1. Claim 7 previously defined
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Claim 9 previously indicated as free from the art has been incorporated into claim 1. Claim 9 was free of the art are because this structure from claim 9 with o between 8-30 is not shown in the art.
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Hence the rejection under 35 USC 103 has been overcome.
New claims however were found to have issues as set forth below and applicants have requested these in writing.
Claim Objections
Claim 10 is objected to because of the following informalities: SN38 is abbreviated in claim 10 and as it is not a commonly known abbreviation should also be spelled out. . Appropriate correction is required.
Claim 23 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 16. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim 16 and claim 23 are drawn to Formula 1a.
Double Patenting
A rejection based on double patenting of the "same invention" type finds its support in the language of 35 U.S.C. 101 which states that "whoever invents or discovers any new and useful process ... may obtain a patent therefor ..." (Emphasis added). Thus, the term "same invention," in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957); and In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970).
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. See 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);and, 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) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130(b).
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1, 2, 4, 5, 8, 10-16, 21-23 and 25-28 are provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-18, 20 and 21 of copending Application No. 18/489,624 and claims 1-18, 20 and 21 of copending Application No. 18/489,627.
An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim is not patentably distinct from the reference claims because the examined claim is either anticipated by, or would have been obvious over, the reference claims. Although the conflicting claims are not identical, they are not patentably distinct from each other because the cited claims of the instant invention are related to all recited in claims 1-18, 20 and 21 of copending Application No. 18/489,624 and claims 1-18, 20 and 21 of copending Application No. 18/489,627. That is, the cited claims of copending Application No. 18/489,624 and 18/489,627 and the instant claims are both directed to ADC with the same structural requirements of camptothecin and RBM as well as linker sequences. The instant claims are generic in that the RBM is generically recited and the copending claims specific antibodies. Claims 20 and 21 are not occluded from the safe harbor as the copending claims are not related as divisional.
Specifically, as relates to 14/649,624 the claim is drawn to an antibody conjugate with a formula I(a) in claim 4 and an Rf is limited in claim 11 to o with a range of 8-30 as in the instant claims. Kf is one of those provide for in the instant claims.
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Specifically, as regards 18/489,627, the ADC comprises an antibody and the formula of instant claim 1 (see copending claim 4 and 18). The CU (linker in the instant application) is found in claim 11 to match that of instant claim 12 and claim 27+28. Formula I(a) (instant claim 16 and 23) embracing all recited components of the claims is also found in the copending application at claim 18 comprising
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wherein o is 23.
Additionally, if a patent resulting from the instant claims was issued and transferred to an assignee different from the assignee holding the copending Application No. 18/489,624 and 18/489,627, then two different assignees would hold a patent to the claimed invention of copending Application No. 18/489,624 and 18/489,627, and thus improperly there would be possible harassment by multiple assignees.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Conclusion
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 MARIA MARVICH whose telephone number is (571)272-0774. The examiner can normally be reached 8 am - 5 pm.
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, Maria Leavitt can be reached at 571-272-1085. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARIA MARVICH/Primary Examiner, Art Unit 1634
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