Prosecution Insights
Last updated: April 19, 2026
Application No. 18/284,788

STABLE MULTISPECIFIC MOLECULE AND USE THEREOF

Non-Final OA §101§102§DP
Filed
Sep 28, 2023
Examiner
GAMETT, DANIEL C
Art Unit
1647
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Daiichi Sankyo Company Limited
OA Round
1 (Non-Final)
68%
Grant Probability
Favorable
1-2
OA Rounds
2y 12m
To Grant
96%
With Interview

Examiner Intelligence

Grants 68% — above average
68%
Career Allow Rate
629 granted / 929 resolved
+7.7% vs TC avg
Strong +28% interview lift
Without
With
+28.5%
Interview Lift
resolved cases with interview
Typical timeline
2y 12m
Avg Prosecution
19 currently pending
Career history
948
Total Applications
across all art units

Statute-Specific Performance

§101
2.5%
-37.5% vs TC avg
§103
23.6%
-16.4% vs TC avg
§102
20.9%
-19.1% vs TC avg
§112
31.9%
-8.1% vs TC avg
Black line = Tech Center average estimate • Based on career data from 929 resolved cases

Office Action

§101 §102 §DP
DETAILED ACTION 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. Claims 1-9, 12-17, 19-29, 32-37, 39-45, 47-51, 53-61, and 69-72 are under consideration. 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 Vogel , 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert , 245 F.2d 467, 114 USPQ 330 (CCPA 1957). A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101. Claim s 1, 2, 19, 39, 40, and 53 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 1, 6, and 13 of prior U.S. Patent No. 11618785 . This is a statutory double patenting rejection. Patented claim 1 recites: “ An antibody or an antigen-binding fragment of the antibody, comprising: a heavy chain sequence comprising CDRH1 comprising SEQ ID NO: 26, CDRH2 comprising SEQ ID NO: 98, wherein the first Xaa is selected from the group consisting of R and S, and the second Xaa is S, and CDRH3 comprising SEQ ID NO: 28; and a light chain sequence comprising CDRL1 comprising SEQ ID NO: 29, CDRL2 comprising SEQ ID NO: 99, wherein Xaa is selected from the group consisting of Q, A, G, S, N, and D, and CDRL3 comprising SEQ ID NO: 31; wherein the antibody or antigen-binding fragment binds to human CD3 and to cynomolgus monkey CD3. ” Patented claim 11 recites: “ An antibody or antigen-binding fragment thereof according to claim 1, wherein the antigen-binding fragment is selected from a group consisting of Fab, F(ab)′, Fv , scFv , and sdAb . ” Therefore, the patented claims which recite “ antibody or an antigen-binding fragment of the antibody ” explicitly include Fab and scFv as recited in the pending independent claims. The pending claims encompass two genera of Fab and scFv having identical CDRH1, CDRH3, CDRL1, CDRL3, and which differ from one another by a single amino acid in each of CDRH2 and CDRL2. The relationships among sequences recited in the patented claims and those of pending independent claims 1, 19, 39, and 53 are as follows. SEQ ID NO: 26 of patented claim 1 is identical to SEQ ID NO: 32 and to SEQ ID NO: 40 in the pending claims. SEQ ID NO: 28 of patented claim 1 is identical to SEQ ID NO: 34 and to SEQ ID NO: 42 in the pending claims. SEQ ID NO: 29 of patented claim 1 is identical to SEQ ID NO: 35 and to SEQ ID NO: 43 in the pending claims. SEQ ID NO: 31 of patented claim 1 is identical to SEQ ID NO: 37 and to SEQ ID NO: 45 in the pending claims. SEQ ID NO: 33 and SEQ ID NO: 41 in the pending claims are species of CDRH2 (SEQ ID NO: 98) in patented claim 1, wherein the first Xaa is R and S, respectively, and wherein the second Xaa is S. SEQ ID NO: 36 and SEQ ID NO: 44 are species of CDRL2 (SEQ ID NO: 99) in patented claim 1, wherein the Xaa is N and D, respectively. Therefore, t he patented claims encompass a small genus of Fab and scFv in which CDRH1, CDRH3, CDRL1, and CDRL3 are identical to those of the pending claims, and which includes each recited species of CDRH2 and CDRL2. E ach species recited in pending claims 1, 19, 39, and 53 is fully disclosed and recited in the patented claims. Additional species are recited in both the patented and pending claims . Patented claim 6 recites “ An antibody or antigen-binding fragment thereof according to claim 1, wherein the antibody or antigen-binding fragment comprises a heavy chain variable region comprising SEQ ID NO: 100 and a light chain variable region comprising any one of SEQ ID NOs: 101, 102, and 103. ” SEQ ID NO: 100 comprises 2 Xaa corresponding to CDRH2, of which first may be R or S; these species are recited in patented claims 3 and 4, respectively. The species of SEQ ID NO: 100 wherein the first Xaa is R and the second Xaa is S is 100% identical to positions 1-118 of SEQ ID NO:1 , as recited in pending claim 2. The light chain variable region comprising SEQ ID NO : 103 comprises an Xaa corresponding to CDRL2. The species of SEQ ID NO : 103 wherein the Xaa is D is 100% identical to positions 1-107 of SEQ ID NO: 2, as recited in pending claim 2 . Therefore, pending claim 2 is drawn to a species of the Fab encompassed in patented claim 6 which comprises SEQ ID NO: 100 and SEQ ID NO: 10 3. T he patented species of SEQ ID NO: 100 wherein the first Xaa is S and the second Xaa is S is 100% identical to positions 1-118 of SEQ ID NO: 46, as recited in pending claim 40 . The patented light chain variable region comprising SEQ ID NO : 10 1 comprises an Xaa corresponding to CDRL2. The species of SEQ ID NO : 10 1 wherein the Xaa is N is 100% identical to positions 1-10 9 of SEQ ID NO: 47 , as recited in pending claim 40. Therefore, pending claim 40 is drawn to a species of the Fab encompassed in patented claim 6 which comprises SEQ ID NO: 100 and SEQ ID NO: 10 1. 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 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 . Claims 19-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 7 of U.S. Patent No. 12344674 . Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons. The pending claims are drawn to an scFv that specifically binds CD3. The scFv is structurally defined by comprising 6 CDRs in claim 19, and by comprising heavy and light chain variable domains together in either SEQ ID NO: 3 (claims 20 and 21) or SEQ ID NO: 39 (claims 22 and 23). Patented claim 7 is drawn to a bispecific antibody having a region that binds CD3. In embodiments CH7CL7 , CH8CL8 , and CH9CL9 , the CD3-binding domains comprise heavy and light chain variable regions in SEQ ID NO’s 155, 156, and 157 respectively. Patented SEQ ID NO’s 155 and 156 comprise 100% identity with pending SEQ ID NO: 3, and patented SEQ ID NO: 39 comprises 100% identity with pending SEQ ID NO: 39. Thus, the patented bispecific antibody comprises an scFv component that is identical to that of pending claims 19-23. The scFv of the pending claims is fully disclosed within the patented claims, and it would necessarily be made and used in order make the patented bispecific antibody. Claims 19 and 53 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of copending Application No. 18 / 194987 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons. Application No. 18 / 194987 is the same disclosure as U.S. Patent No. 11618785, cited above. Copending claim 1 is drawn to an anti-CD3 scFv having the same CDRs as in U.S. Patent No. 11618785, which as detailed above, includes all of the same CDRs recited in pending claims 19 and 53. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Claim Rejections - 35 USC § 102 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. Claim s 1, 2, 19, 39, 40, and 53 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by US 20190359712 ( Takahashi ; of record ) . Takahashi is the pre-grant publication of U.S. Patent No. 11618785 . Takahashi is available as prior art under 35 U.S.C. 102 (a)(1) by virtue of its Nov. 19, 2019 publication date. The Takahashi discloses species of Fab and scFv having the same CDR and variable domain sequences as recited in claims 1, 2, 19, 39, 40, and 53 , for the same reasons detailed above with re spect to Double Patenting . Claim s 1 , 4 -9, 13-17, 19 , 24 -29, 33-37, 39 , 42- 45, 47-51, 53 , 58 -61, and 69-72 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by WO 2019244107 , published De c . 29, 2019 (of record). WO 2019244107 teaches anti-CD3 antibody or antigen binding fragment , including Fab and scFv , comprising the same CDR sequences recited in the pending claims ([0007] claim 1, [0041]) , thereby anticipating claims 1, 19, 39, and 53 . WO 2019244107 further teaches bispecific antibodies comprising an anti-CD3 antigen binding fragment together with at least one other arm that specifically binds to a second target antigen ; the target antigens include numerous antigens that are not complexed with HLA [0012][00167][00212] , as in pending claims 4-9, 24-29, 42-45, and 59-61. WO 2019244107 discloses nucleic acid sequences encoding the antibodies or antigen binding fragments as well vectors and cells expressing the nucleic acids [ 00122] [ 00143-00156], as in claims 13-17, 33-37, 47-51. WO 2019244107 teaches pharmaceutical compositions comprising the disclosed anti-CD3 antibody compositions [00228-00243], as in claims 69-72. Conclusion Claims 1, 2, 4-9, 13-17, 19-29, 33-37, 39, 40, 42-45, 47-51, 53, 58-61, and 69-72 are rejected. Claims 3, 12, 41, 54-57 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT DANIEL C GAMETT , Ph.D., whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-1853 . The examiner can normally be reached on FILLIN "Work schedule?" \* MERGEFORMAT M-W 9:00 am-5:30pm, EST . Please note the examiner’s part-time schedule . Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration t ool. To schedule an interview, a pplicant 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, FILLIN "SPE Name?" \* MERGEFORMAT Joanne Hama can be reached on FILLIN "SPE Phone?" \* MERGEFORMAT 5712722911 . 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. FILLIN "Value?" \* MERGEFORMAT /DANIEL C GAMETT/ Primary Examiner Art Unit 1647
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Prosecution Timeline

Sep 28, 2023
Application Filed
Mar 18, 2026
Non-Final Rejection — §101, §102, §DP (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
68%
Grant Probability
96%
With Interview (+28.5%)
2y 12m
Median Time to Grant
Low
PTA Risk
Based on 929 resolved cases by this examiner. Grant probability derived from career allow rate.

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