Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Status of the Claims
1. Claims 1-49 are all the original claims filed on 11/22/2019. In the Preliminary Amendment of 6/25/2020, Claims 34-46 are amended, claims 1-33 and 47-49 are canceled, and new Claim 50 is added. In the Response filed 8/31/2022, Claims 34-46 and 50 are canceled and new Claims 51-68 are added. In the Response of 4/21/2023, Claims 51 and 59-64 are amended, and new Claims 69-72 are added. In the Response of 11/21/2023, Claims 51-52, 60, 65-66 and 68 are amended, claims 55, 64 and 69 are canceled and new Claim 73 is added. In the Response of 2/13/2025, Claims 51, 53-54, 56-57, 59-63 and 70-72 are amended. In the Response of 9/24//2025, claims 71-72 are amended, claims 65-68 are canceled and new claims 74-77 are added.
Claims 51-54, 56-63, and 70-77 are all the claims for this application and all the claims under examination.
Applicants’ amendment of the claims raises new grounds for objection. This Office Action is final.
Priority
2. USAN 16/692,676, filed 11/22/2019 and having 2 RCE-type filing therein is a Divisional of 14/351,654, filed 04/14/2014, now U.S. Patent # 11851476 and having 10 RCE-type filing therein, 14/351,654 is a National Stage entry of PCT/JP2012/078103, International Filing Date: 10/31/2012, claims foreign priority to JP 2011-238873, filed 10/31/2011.
Information Disclosure Statement
3. As of 11/10/2025, a total of sixteen (16) IDS are filed for this application: 12/2/2019; 12/4/2019; 1/5/2020; 7/30/2020; 10/29/2020; 12/14/2020; 12/15/2020; 12/27/2021; 3/1/2021; 9/10/2021; 2/7/2022; 8/31/2022; 4/21/2023; 11/21/2023; 2/13/2025; and 9/24/2025. The corresponding initialed and dated 1449 form is considered and of record.
Withdrawal of Objections
Claim Objections
4. The objection to Claims 61-63, 65-68, and 71-72 because of informalities is moot for the canceled claims and withdrawn for the pending claims.
a) The objection to Claim 61 is withdrawn.
b) Claims 65-68 are canceled.
c) The objection to Claim 71 is withdrawn.
Withdrawal of Rejections
Claim Rejections - 35 USC § 112(b)
5. The rejection Claims 71-72 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite is withdrawn.
a) Claims 71-72 are amended to recite “one or more of the.”
Rejections Maintained
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.
6. The provisional rejection of Claims 51-54, 56-63, and 70-77 on the ground of nonstatutory double patenting as being unpatentable over claims 83-84 and 120-122 (and 123) of copending Application No. 17/367,909 (reference application US 20220041756) is maintained.
The reference application is not afforded safe harbor protection under 35 USC 121 because it shares no continuity nor restriction/speciation with the claims for the instant application.
A) Applicants allege no single claim in the ref ‘909 application recites both the positions and the amino acids of instant claims 51 and 73.
Response to Arguments
i) Ref claim 121(a), Ref claim 121(b), and Ref claim 121(f) depend from ref claim 120(iii) or 120(iv), where both residues share or have the same charged amino acid, and ref claim 122 claim defines the residue as either both the charged amino acids are independently selected from glutamic acid and aspartic acid, or both are independently selected from lysine, arginine and histidine. The number of CH1/CL pairs comprising the same electrical charge for ref ‘909 is limited to:
[0261] Specifically, the present invention provides polypeptide complexes with controlled association between the heavy chain and light chain, in which one, two or more pairs selected from the group consisting of the pairs of amino acid residues described in (a) to (f) below have the same electric charges:
[0262] (a) the amino acid residue at position 147 (EU numbering) in CH1 and the amino acid residue at position 180 (EU numbering) in CL;
[0263] (b) the amino acid residue at position 147 (EU numbering) in CH1 and the amino acid residue at position 131 (EU numbering) in CL;
[0267] (f) the amino acid residue at position 175 (EU numbering) in CH1 and the amino acid residue at position 160 (EU numbering) in CL.
See MPEP 804 (B)(1):
The specification can be used as a dictionary to learn the meaning of a term in the claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999) (“[W]ords in patent claims are given their ordinary meaning in the usage of the field of the invention, unless the text of the patent makes clear that a word was used with a special meaning.”); Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1250, 48 USPQ2d 1117, 1122 (Fed. Cir. 1998) (“Where there are several common meanings for a claim term, the patent disclosure serves to point away from the improper meanings and toward the proper meanings.”). “The Patent and Trademark Office (‘PTO’) determines the scope of the claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction ‘in light of the specification as it would be interpreted by one of ordinary skill in the art.’ ” Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005) (en banc) (quoting In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364, 70 USPQ2d 1827, 1830 (Fed. Cir. 2004); see also MPEP § 2111.01.
To avoid improperly treating what is disclosed in a reference patent or copending application as if it were prior art in the context of a nonstatutory double patenting analysis, the examiner must first properly construe the scope of the reference claims. The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim. In particular, when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed. See Sun Pharm. Indus., 611 F.3d at 1386-88, 95 USPQ2d at 1801-02.
ii) Ref claim 121(a), Ref claim 121(b), and Ref claim 121(f) depend from ref claim 120(i) or 120(ii), where both residues are charged opposites, and ref claim 122 claim defines the residue is oppositely charged as one of the charged amino acids is selected from glutamic acid and aspartic acid, and the other is selected from lysine, arginine and histidine. The number of CH1/CL pairs comprising the opposite electrical charge for ref ‘909 is limited to:
Lys at position 175 (EU numbering) in the CH1 domain, and Glu at positions 131, 160, and 180 (EU numbering) in the CL domain;
Glu at positions 147 and 175 (EU numbering) in the CH1 domain, and Lys at positions 131, 160, and 180 (EU numbering) in the CL domain.
See MPEP 804 (B)(1) (supra).
B) Applicants allege no explanation is provided why the combination of the particular amino acids and the particular positions of the ref application render the claims obvious.
Response to Arguments
See the above-referenced explanation that is fully responsive to Applicants allegations.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Examiner comment: in view of the new grounds for objection, ref ‘909 claim 123 in depending from ref ‘909 claim 121(g) that renders obvious claim 52 comprising CH1 213 and CL123 is included under the provisional rejection.
7. The provisional rejection of Claims 51 -54, 56-63, and 70-77 on the ground of nonstatutory double patenting as being unpatentable over claims 26-37 and 44-45 of copending Application No. 16/936,575 (reference application US 20200354473) is maintained.
The reference application is not afforded safe harbor protection under 35 USC 121 because it shares no continuity nor restriction/speciation with the claims for the instant application.
Applicants allege this rejection is improperly applied at least to present claims 52, 54, 65-68, and 70-73. The cited claims of the '575 application all require that the residue at position 160 of the second CL not have the same charge as the residues at CL positions 131 and 180. The Office has not explained why any of the present claims requiring position 160 of the CL to have the same charge as CL positions 131 and 180 (i.e., claims 54, 65-68, and 70-73).
Response to Arguments
The negative proviso set forth in ref ‘575 generic claim 26 at position 160 of the second CL does not set forth with a positive recitation the corresponding amino acid for that position in order for the POSA to reasonable ascertain the breadth and scope of the invention. Generic ref ‘757 claims 44 and 45 require position 160 is occupied by a glutamine. The specification supports 2nd CL 160 position being substituted in with combination with 131 and 180 CL positions as
[0032] [10] the antigen-binding molecule of any one of [7] to [9], wherein the amino acid residues that do not mutually repel electrically are the amino acid residue comprised in CH1 at position 175 as indicated by EU numbering which is lysine (K); and the amino acid residues comprised in CL at position 180, position 131, and position 160 as indicated by EU numbering which are all glutamic acid (E);
[0033] [11] the antigen-binding molecule of any one of [7] to [9], wherein the amino acid residues that do not mutually repel electrically are the amino acid residues comprised in CH1 at position 147 and position 175 as indicated by EU numbering which are glutamic acid (E); and the amino acid residues comprised in CL at position 180, position 131, and position 160 as indicated by EU numbering which are all lysine (K).
See MPEP 804 (B)(1):
The specification can be used as a dictionary to learn the meaning of a term in the claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999) (“[W]ords in patent claims are given their ordinary meaning in the usage of the field of the invention, unless the text of the patent makes clear that a word was used with a special meaning.”); Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1250, 48 USPQ2d 1117, 1122 (Fed. Cir. 1998) (“Where there are several common meanings for a claim term, the patent disclosure serves to point away from the improper meanings and toward the proper meanings.”). “The Patent and Trademark Office (‘PTO’) determines the scope of the claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction ‘in light of the specification as it would be interpreted by one of ordinary skill in the art.’ ” Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005) (en banc) (quoting In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364, 70 USPQ2d 1827, 1830 (Fed. Cir. 2004); see also MPEP § 2111.01.
To avoid improperly treating what is disclosed in a reference patent or copending application as if it were prior art in the context of a nonstatutory double patenting analysis, the examiner must first properly construe the scope of the reference claims. The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim. In particular, when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed. See Sun Pharm. Indus., 611 F.3d at 1386-88, 95 USPQ2d at 1801-02.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
New Grounds for Objection
Claim Objections
8. Claim 77 is objected to because of the following informalities:
a) Claim 77 is objected to for the phrase “regulating proper heavy/light chain association”.
The specification does not provide a definition for “proper” much less within the context of regulation of the expression of “heavy/light chain” (or more properly, an “association between an antibody heavy chain and an antibody light chain to form an arm of an antibody” (claim 73)).
The specification does not provide a definition for the phrase “heavy/light chain” whereas claim 73 recites more clearly “association between an antibody heavy chain and an antibody light chain to form an arm of an antibody.”
Appropriate correction is required.
Conclusion
9. No claims are allowed.
10. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
11. 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.
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, Wu Julie can be reached on 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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LYNN ANNE BRISTOL
Primary Examiner
Art Unit 1643
/LYNN A BRISTOL/Primary Examiner, Art Unit 1643