Notice of Pre-AIA or AIA Status
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
Continued Examination Under 37 CFR 1.1141.
1. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 7/8/2026 has been entered.
Status of the Claims
2. Claims 1-15 are the original claims filed 11/18/2022. In the Preliminary Amendment of 5/15/2023, claims 3-7, 9, and 14 are amended. In the Response of 1/20/2026, claims 1, 3-5, and 10-13 are amended, claims 2 and 14 are cancelled, and claims 16-18 are added. In the Response of 7/8/2026, Claims 1, 4, 9-13 and 16-17 are amended.
Claims 1, 3-13, and 15-18 are all the claims.
The Office Action contains new grounds for rejection.
Priority
3. USAN 17/926,283, filed 11/18/2022, and having 1 RCE-type filing therein, is a National Stage entry of PCT/NL2021/ 050322, International Filing Date: 05/20/2021, claims foreign priority to EP 20175903.2, filed 05/21/2020.
Information Disclosure Statement
4. As of 8/25/2026, a total of three (3) IDS is filed: 11/18/2022; 12/8/2023; and 7/27/2026. The corresponding initialed and dated 1449 form is considered and of record.
Withdrawal of Objections
Specification
5. The amended abstract of disclosure overcomes the objection to replace legal language, i.e., “said” with “the.”
Claim Objection
6. The objection to Claims 1, 3-13, and 15-18 because of informalities is withdrawn.
a) Claims 1, 3-13, and 15-18 are amended to recite the amino acid position according to EU numbering.
b) Claims 9 and 15 are amended to the positive phrase “that induce expression.”
c) Claim 4 is amended to replace “comprise” with “is” for the respective 1st and 2nd polypeptides.
7. The objection to Claims 9-13 and 15 because of informalities is withdrawn.
a) Claims 9-13 are amended to recite “the method comprising _” to comport with (Clams 10-11).
b) Claims 9-12 and 15 are amended for consistency to recite positive method steps “the method comprising_”.
c) Claim 13 is amended to replace “a)-c)” with “i)-iii).’
Withdrawal of Rejections
Claim Rejections - 35 USC § 112(b)
8. The rejection of Claims 4 and 16-17 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite is withdrawn.
Claim 4 is amended to replace “comprise” with “is” for the respective 1st and 2nd polypeptides.
Claim Rejections - 35 USC § 103
9. The rejection of Claim(s) 1, 3-13, and 15-18 under 35 U.S.C. 103 as being unpatentable over de Nardis et al (J Biol Chem. 2017 Sep 1;292(35):14706-14717. Epub 2017 Jun 27; IDS 12/8/2023) in view of De Kruif et al., (US 9248182; issued 2016-02-02) or (US 9758805; issued 2017-09-12) or (US 10329596; issued 2019-06-25) or (US 10337045; issued 2019-07-02) is withdrawn.
Applicants allege the results in Example 3 for the 15 selected variants (see Table 2) and that are based on reference DEKK (incorporated by reference to WO 2013/157954; de Nardis (JBC (2017) 292((35) 14706-14717) used as a starting model (see Example 1) “provides concrete technical effects beyond the DEKK technology baseline. In particular, the claimed substitutions improve the efficiency of heterodimer interaction relative to a heterodimer containing only the DEKK substitutions, and further result in reduced homodimer formation together with increased half-body production relative to homodimer formation.” Table 12 (half-body formation is increased for the DE + S364, K360 and/or K409 variant); Table 13 (homodimer formation is reduced for the DE + S364, K360 and/or K409 variant); and Table 14 (overview of homodimer formation for the DE + S364, K360 and/or K409 variant).
Double Patenting
10. The rejection of Claims 1, 3-13, and 15-18 on the ground of nonstatutory double patenting as being unpatentable over claims 1-40 of U.S. Patent No. 9248182 further in view of de Nardis et al (J Biol Chem. 2017 Sep 1;292(35):14706-14717. Epub 2017 Jun 27; IDS 12/8/2023) in view of De Kruif et al., (US 9248182; issued 2016-02-02) or (US 9758805; issued 2017-09-12) or (US 10329596; issued 2019-06-25) or (US 10337045; issued 2019-07-02) is withdrawn.
11. The rejection of Claims 1, 3-13, and 15-18 on the ground of nonstatutory double patenting as being unpatentable over claims 1-43 of U.S. Patent No. 9758805 further in view of de Nardis et al (J Biol Chem. 2017 Sep 1;292(35):14706-14717. Epub 2017 Jun 27; IDS 12/8/2023) in view of De Kruif et al., (US 9248182; issued 2016-02-02) or (US 9758805; issued 2017-09-12) or (US 10329596; issued 2019-06-25) or (US 10337045; issued 2019-07-02) is withdrawn.
12. The rejection of Claims 1, 3-13, and 15-18 on the ground of nonstatutory double patenting as being unpatentable over claims 1-34 of U.S. Patent No. 10329596 further in view of de Nardis et al (J Biol Chem. 2017 Sep 1;292(35):14706-14717. Epub 2017 Jun 27; IDS 12/8/2023) in view of De Kruif et al., (US 9248182; issued 2016-02-02) or (US 9758805; issued 2017-09-12) or (US 10329596; issued 2019-06-25) or (US 10337045; issued 2019-07-02) is withdrawn.
13. The rejection of amended Claims 1, 3-13, and 15-18 on the ground of nonstatutory double patenting as being unpatentable over claims 1-56 of U.S. Patent No. 10337045 further in view of de Nardis et al (J Biol Chem. 2017 Sep 1;292(35):14706-14717. Epub 2017 Jun 27; IDS 12/8/2023) in view of De Kruif et al., (US 9248182; issued 2016-02-02) or (US 9758805; issued 2017-09-12) or (US 10329596; issued 2019-06-25) or (US 10337045; issued 2019-07-02) is withdrawn.
14. The rejection of Claims 1, 3-13, and 15-18 on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11926859 further in view of de Nardis et al (J Biol Chem. 2017 Sep 1;292(35):14706-14717. Epub 2017 Jun 27; IDS 12/8/2023) in view of De Kruif et al., (US 9248182; issued 2016-02-02) or (US 9758805; issued 2017-09-12) or (US 10329596; issued 2019-06-25) or (US 10337045; issued 2019-07-02) is withdrawn.
15. The rejection of Claims 1, 3-13, and 15-18 on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 12123043 is moot for the canceled claims and maintained further in view of de Nardis et al (J Biol Chem. 2017 Sep 1;292(35):14706-14717. Epub 2017 Jun 27; IDS 12/8/2023) in view of De Kruif et al., (US 9248182; issued 2016-02-02) or (US 9758805; issued 2017-09-12) or (US 10329596; issued 2019-06-25) or (US 10337045; issued 2019-07-02) is withdrawn.
New Grounds for Objection
Specification
16. The attempt to incorporate subject matter into this application by reference to WO 2013157954 A1 (2013-10-24) and DeNardis et al (JBC (2017) 292(35): 14706-14717 is ineffective because the references teach the specific and only wild-type human IgG Fc used as the starting model for the variants of the claimed invention. The incorporation of essential material in the specification by reference to an unpublished U.S. application, foreign application or patent, or to a publication is improper. Applicant is required to amend the disclosure to include the material incorporated by reference, if the material is relied upon to overcome any objection, rejection, or other requirement imposed by the Office. The amendment must be accompanied by a statement executed by the applicant, or a practitioner representing the applicant, stating that the material being inserted is the material previously incorporated by reference and that the amendment contains no new matter. 37 CFR 1.57(g).
New Grounds for Rejection
Claim Rejections - 35 USC § 112
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.
Written Description
17. Claims 1, 3-13, and 15-18 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Applicants allege the results in Example 3 for the 15 selected variants (see Table 2) and that are based on reference DEKK (incorporated by reference to WO 2013/157954; de Nardis (JBC (2017) 292((35) 14706-14717) used as a starting model (see Example 1) “provides concrete technical effects beyond the DEKK technology baseline. In particular, the claimed substitutions improve the efficiency of heterodimer interaction relative to a heterodimer containing only the DEKK substitutions, and further result in reduced homodimer formation together with increased half-body production relative to homodimer formation.” Table 12 (half-body formation is increased for the DE + S364, K360 and/or K409 variant); Table 13 (homodimer formation is reduced for the DE + S364, K360 and/or K409 variant); and Table 14 (overview of homodimer formation for the DE + S364, K360 and/or K409 variant).
Applicants have not demonstrated the existence of a universal IgG Fc domain on which to base the success of the recited amino acid substitutions in obtaining heterodimers with improved stability, decreasing stability of homodimers, improving yield of heterodimers, and increasing purity of heterodimers. The interpretation encompasses a genus of heterodimeric protein variants beyond those taught in the specification. Because Applicant seeks patent protection for all such variants, this genus must be adequately described. A description adequate to satisfy 35 U.S.C. § 112(a) must clearly allow persons of ordinary skill in the art to recognize that the inventor invented what is claimed (Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc) (citation omitted, alteration in original). The purpose of the written description requirement is to “ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor’s contribution to the field of art as described in the patent’s specification” (In re Katz Interactive Call Processing Patent Litig. 639 F.3d 1303, 1319 (Fed. Cir 2011).
Disclosure in the Specification
The specification does not disclose the IgG Fc domain used to construct the variants in at one of the working Examples 1-3.
The specification in Example 1 teaches WO 2013/157954 as the source of the wild type IgG Fc domain without the actual sequence.
WO 2013/157954 teaches the MV1057 construct as comprising the wild type IgG1 comprised within a construct at
Figure 1: A) schematic representation of construct vector MV1057. The stuffer region is the region into which an antibody VH region is cloned. B) schematic representation of phage display vector MV1043.
Figure 2: amino acid sequence of wildtype IgGl Fc, as present in construct vector MV1057 (EU numbering scheme applied).
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At the very least, Applicants have not shown themselves to be in possession of a universal wild-type IgG Fc domain. The specification incorporates by reference a sequence specifically taught as being a critical essential element in the making of the inventive variants without reference to actual sequence used.
Conclusion
18. No claims are allowed.
19. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN A. BRISTOL whose telephone number is (571)272-6883. The examiner can normally be reached Mon-Fri 9 AM-5 PM.
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/LYNN A BRISTOL/Primary Examiner, Art Unit 1643
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