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
1. Applicant’s amendments/responses filed 8/22/23, 11/14/23, 3/13/24 and 4/27/26 are acknowledged and have been entered.
2. Applicant's election without traverse of Group I and species of SEQ ID NO: 5-10 as the CDRs and SEQ ID NO: 1 and 2 as the VH and VL in Applicant’s response filed 4/27/26 is acknowledged.
Claims 1-12 read on the elected species.
Accordingly, claims 13-18 (non-elected Groups II and III) are withdrawn from further consideration by the Examiner, 37 CFR 1.142(b), as being drawn to non-elected inventions.
Upon consideration of the prior art, search and examination has been extended to all of the species recited in the claims.
Claims 1-12 are presently being examined.
3. Claims 11 and 12 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from any other multiple dependent claims. See MPEP § 608.01(n). Accordingly, claims 11 and 12 have not been further treated on the merits.
4. The disclosure is objected to because of the following informalities:
The Brief Description of the drawings for Figure 17 discloses Figure 17A, 17B, 17C and 17D, however there is no Figure 17D in the Drawings.
Appropriate correction is required.
5. The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which Applicant may become aware in the specification.
6. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
7. Claim 10 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 10 is indefinite in the recitation of “an antibody according to any one of claim 5” because it is not clear what is meant.
8. 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 (i.e., changing from AIA to pre-AIA ) 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.
9. Although there are presently no prior art rejections of record, for completeness of the record, for the purpose of prior art rejections, the filing date of the instant claims is deemed to be the filing date of provisional application serial no. 63/240,399, i.e., 9/3/21, provisional application serial no. 63/155,304 does not support the claimed limitations of the instant application, as it does not recite the full complement of antibodies recited in the claims (‘304 only discloses SEQ ID NO: 1-16).
10. 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.
11. Court rulings have been quite clear that ONLY DIVISIONAL applications are entitled to the shield from double patenting under 35 USC 121. Indeed, in AMGEN INC v. HOFFMANN LA ROCHE LTD GMBH LA (Nos. 2009-1020, 2009-1096) the court discusses this issue at length and states:
Turning to the legislative history, the court observed that a House Report also referred specifically to “divisional application[s].” Id. Notably absent from the legislative history, in the court's view, was a suggestion “that the safe-harbor provision was, or needed to be, directed at anything but divisional applications.” Id. at 1361. From there, the court “conclude^] that the protection afforded by section 121 to applications (or patents issued therefrom) filed as a result of a restriction requirement is limited to divisional applications.” Id. at 1362. Accordingly, the court decided that the § 121 safe harbor did not apply to the patent before it, which issued from a continuation-in-part application. Id.
We are persuaded by the reasoning in Pfizer that the § 121 safe harbor provision does not protect continuation applications or patents descending from only continuation applications. The statute on its face applies only to divisional applications, and a continuation application, like a continuation-in-part application, is not a divisional application.
Given that Applicant chose to file the 18/688,630 case as a separate unrelated application, not as a DIV of the instant application, the instant rejection has been set forth.
Claims 1-3 and 6-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7, 9, 17, 20, 22, 26, 27, 38, 58 and 61-67 of copending Application No. 18/688,630.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 7, 9, 17, 20, 22, 26, 27, 38, 58, 61 and 62 of 18/688,630 are drawn to a bispecific binding protein that comprises an antigen-binding site that binds to a tumor associated antigen that is Claudin 6, 18.2 or Nectin 4, and a pharmaceutical composition thereof comprising a pharmaceutically acceptable carrier, wherein:
claim 7 recites VH/VL comprising CDRs consisting of SEQ ID NO: 45-50 (that are identical to instantly recited SEQ ID NO: 5-10, respectively) as well as CDRs consisting of SEQ ID NO: 51-56 (that are identical to instantly recited SEQ ID NO: 11-16, respectively);
claims 9 and 38 recite that the VH/VL correspond to SEQ ID NO: 25/26 or SEQ ID NO: 27/28 (that are identical to instantly recited SEQ ID NO: 23/2 or SEQ ID NO: 3/4, respectively);
claims 58 and 61 recite that the antibody scaffold module further comprises a constant region (i.e., it is a full length antibody).
Claim 63 of 18/688,630 recites a method of treating or preventing cancer comprising administering the bispecific binding protein of claim 1 to a patient in need thereof.
Claims 64-67 recite a nucleic acid composition comprising one or more nucleic acids encoding the bispecific binding protein of claim 1, expression vector and host cell thereof and a method for producing the protein comprising culturing the host cell.
Although the claims at issue are not identical, they are not patentably distinct from each other because: the instant claims recite that the antibody “comprises” the recited limitations, “comprises” being an open transitional phrase encompassing portions or additions of/to the antibody that are not recited; the VH/VL with their cognate CDRs recited in the claims of 18/688,630 are a subset of those that are recited in the instant claims; the VH/VL are human sequences (made in human Ig transgenic mice, see the instant specification at [0212] and Example 1) and when not comprising a constant region, are antigen-binding antibody fragments. With regard to instant dependent claim 8, as a scFv antibody fragment was an obvious art known variant of an antibody binding site, it would have been prima facie obvious to one of ordinary skill in the art to have constructed an scFv fragment, and with a reasonable expectation of success in doing so. See for example, Ahamadi-Fesharaki et al. (Mol. Ther. Oncolytics, 2019, 14: 38-56) who teach that an scFv antigen -binding antibody fragment consists of two variable domains connected by a flexible linker and is an attractive fragment used as the building block of most bispecific antibodies, with advantages such as preservation of the binding activity of the parental antibody, efficient expression in a wide range of hosts and a great tumor tissue penetration. Ahamadi-Fesharaki et al. teach that two scFvs may be fused by a peptide linker in order to improve retention time in target tissues. Ahamadi-Fesharaki et al. teach bispecific antibodies comprising the tandom scFv that binds to CD3 on T cells and a second one that binds to an antigen on a tumor cell (see entire reference). Note that the bispecific protein recited in claim 1 of 18/688,630 that binds a tumor associated antigen and CD137 comprises an antibody scaffold module that comprises a first-antigen binding site that binds the tumor associated antigen Claudin-6 and a second antigen-binding site that binds the tumor associated antigen Claudin-6, and at least one first binding module comprising a third antigen-binding site that binds to CD137 (that is, this construct has two binding sites that bind to the tumor antigen Claudin 6 and one binding site that binds to CD137 on a T cell to co-stimulate the T cell for tumor cell killing, and to bridge the tumor cell with the T cell).
12. Claim 5 is objected to because of the following informality: “anyone” recited at line 1 of claim 5 should be ‘any one’.
Appropriate correction is required.
13. Claim 4 is 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.
14. No claim is allowed.
15. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIANNE DIBRINO whose telephone number is (571)272-0842. The examiner can normally be reached on M, T, Th, F.
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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/Marianne DiBrino/
Marianne DiBrino, Ph.D.
Patent Examiner
Group 1640
Technology Center 1600
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641
Prosecution Insights