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 .
1. Formal Matters
A. In the response filed 10/14/25, Applicants elected Group I without traverse, drawn to the elected species of 147F and 183R and the antibody of claim 34. Therefore, the restriction dated 7/14/25 is deemed proper and is therefore made FINAL.
B. Claims 1, 2, 9, 13, 26, 28, 30-32, 34-37, 43-45 and 47-50 are pending. Claims 45 and 47-50 are withdrawn as being drawn to a non-elected invention. Claims 30-32 and 35 are withdrawn as being drawn to non-elected species. Therefore, claims 1, 2, 9, 13, 26, 28, 34, 36, 37, 43 and 44 are the subject of this Office Action.
2. Claim Objections
A. Though not incorrect, it is suggested that claim language be consistent in. Claims 1(a)-(c), for example, recite “is substituted to” and “is substituted with”. Similarly, in claim 1(c), both “is substituted” and “is mutated” are used. Similar issues occur in claim 32.
B. Claim 1(a) is objected to since it should recite “does not comprise an amino acid substitution”.
C. Part 1(e) recites “these are not the only CH1 substitutions”, which is unclear since, based on the preamble, which requires a substitution at other positions, residues 137, 178, 192, 193 and 220 cannot be the only substitutions.
D. Claim 1(h) is objected to since it recites that the substitution be both 150A and 150D.
E. Claim 1(m) is objected to since there should be a space after “(m)”.
F. It is unclear as to why bold lettering appears in claims 2, 13, 26, 28, 30-32, 35-37, 43 and 44.
G. Claim 2 is objected to since there is a parenthesis after “and/or” in part (vi).
H. As discussed further under 35 USC 102, below, the first line of claim 13 recites the limitation “which results in increased pairing” after the preamble. However, after “lambda CL staining” at the end of this limitation, the claim recites an “or” before part (i). Therefore, the claim does not require the limitations after “which results in increased pairing” and before part (i). If this is the intent, it is suggested that “which results in increased pairing” be preceded with an “(i)” and current parts (i)-(x) be amended to “(ii)” to “(xi)”, respectively. Otherwise, the claim should likely read “further wherein (i)”.
I. Claim 13 is objected to since there is an extra space between “polypeptide” and “of” in part (iii). Part (vii) has an extra space between “comprises” and “CH1”.
J. Claim 32 is objected to since it recites “ CH’ ”.
K. Claim 32 is objected to since, in part (ii) under “features (i)-(ix)”, the term “domain” is capitalized.
3. Claim Rejections - 35 USC § 112(b)
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.
Regarding claims 1, 2 and 13, the phrase "preferentially" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
4. Claim Rejections - 35 USC § 102
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.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 13 and 44 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Lazar and Karld (US 2011/0064727 – cited on the IDS filed 3/30/22).
Regarding claim 1, the only requirement is a CH1 domain variant comprising one of the indicated positions. The remainder of the claim recites optional limitations. The IgG1 CH1 of Lazar has a substitution of S at position 131 (EU numbering) compared to C found in IgG2, IgG3 and IgG4 as well as an R at position 214 of IgG3 and IgG4 compared to IgG1 and IgG2). These substitutions also meet the limitation of claim 2.
Regarding claim 13, it is noted that, the first set of limitations regarding increased pairing and the remaining parts is separated by an “or”. Therefore, claim 13 reads as the CHI domain variant polypeptide of claim 1 optionally comprising a specified amino acid substitution in part (i). There is no need to any prior art reference to meet the limitation “which results in increased pairing”.
Furthermore, it is noted that there is no “and” or “or” between parts (ix) and (x) of claim 13. However, given the nature of parts (ii) – (x), it is believed that these should be separated with an “or” between (ix) and (x), which is how the Examiner interpreted the claim with regard to prior art. Given this, part (ii)(gg) is met, since Lazar teaches 214R (Figure 15b-3). Furthermore, though optional, this substitution also meets claim 2(iv)(mm).
Claim 44 is met by paragraph [0105]. Claims 9, 26, 28, 34, 36 and 43 are objected to since it depends from rejected claim 1.
5. Nonstatutory 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.
A. Claims 1, 2, 13, 28, 34 and 44 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 67 and 83 of copending Application No. 18/271,486 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because instant claims 1, 2 and 13(i) are drawn to CH1 domains with overlapping substitutions compared to claim 67 of the copending application. Instant claims 28(i) and 34 are met by copending claim 67(A). The antibody of instant claim 34 is generic to copending claim 69 and would comprise the CH1-CH3 domains of that claim. Claim 44 is obvious over copending claim 83(xiv) and (xv).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
B. Claim 37 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 67 of copending Application No. 18/271,486 (reference application) in view of Brinkmann and Kontermann. Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims do not recite a bispecific antibody. However, Brinkmann does teach these antibodies and their use (e.g. Abstract, Introduction).
6. Conclusion
A. Claims 1, 2, 13 and 44 are not allowable.
B. Claims 28, 34 and 37 are provisionally rejected and, therefore, not allowable.
C. Claims 9, 26, 28, 34, 36 and 43 are objected to since they depend from rejected claims.
Advisory information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT S LANDSMAN whose telephone number is 571-272-0888. The examiner can normally be reached M-F 8 AM – 6 PM (eastern).
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, Joanne Hama, can be reached at 571-272-2911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT S LANDSMAN/Primary Examiner, Art Unit 1647