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 .
Claim Status
Applicant’s reply filed on 11/25/2025 is acknowledged. Claims 15 and 18-19 are amended. Claims 1-14 are cancelled. Claims 22-23 are newly added.
Claims 15-23 are pending and under examination.
Rejections Withdrawn
The following rejections are withdrawn in view of applicant’s amendments filed 11/25/2025:
The rejection of claims 1-21 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 rejection of claims 1-21 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph for scope of enablement.
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.
Claims 15-21 and newly added 22 remain/are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11,981,741. Although the claims at issue are not identical, they are not patentably distinct from each other because the antibody of the patent reference comprises variable regions of the protein of the instant application .
Regarding instant claims 15-18, ‘741 discloses the following:
‘741 Claim 3 discloses an anti-huCD5 antibody or huCD45 binding fragment comprising the following heavy chain defined by the CDRs:
SEQ ID NO: 53, 58, and 55, respectively
And light chain defined by the CDRs:
SEQ ID NO: 59, 64, and 61, respectively
‘741 Claim 4 discloses a pharmaceutical composition comprising the claimed antibody and a pharmaceutically acceptable excipient.
‘741 Claims 5-8 disclose a radiopharmaceutical composition comprising a radionuclide linked to the claimed antibody and at least one pharmaceutically acceptable excipient, wherein the radionuclide is an alpha particle emitter or a beta particle emitter, wherein the radionuclide comprises 131I, 225Ac, 177Lu, or 90Y.
Regarding instant claims 19-22, ‘741 claims 9-11 disclose a composition comprising the antibody chemically conjugated to a chelator, wherein the chelator comprises DOTA or a DOTA derivative, and further comprising a radionuclide chelated by the chelator.
Applicant requests the non-statutory double patenting issues be stayed pending final disposition
of the claims. As there are additional rejections pending, the double patenting rejections will be maintained herein.
New Rejections Necessitated by Amendment
Claim Objections
Claim 18 is objected to because of the following informalities: In line 2, the radionuclide “177Lu” was inadvertently reformatted during editing to “177Lu”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 19-21 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 19 which recites “A composition comprising the protein of claim 15” was originally dependent on a canceled claim 11, which was directed to a protein. Claim 19 is now dependent on claim 15, which is directed to a radiopharmaceutical composition comprising in addition to a protein, a radionuclide and at least one pharmaceutically excipient. The applicant should amend the claim language to ensure it includes all of the limitations of the independent claim.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Double Patenting
Claims 15-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of copending Application No. 11,981,741 as applied to claims 15-22 and further in view of Simon (US2012/0220754A1, published 08/30/2012).
Co-pending ‘741 does not teach that the radiopharmaceutical composition comprises the product of reacting the protein with p-SCN-Bn-DOTA.
This deficiency is taught by Simon.
The disclosure Simon is directed to methods for generating a radioconjugate IgG monoclonal antibody.
Regarding claim 23, Simon teaches a method of producing a radioconjugate comprising conjugating a chelating agent to an antibody, wherein the chelating agent is the bifunctional chelating agent p-SCN-Bn-DOTA (Simon claims 1, 18, 25-26, Pg. 18).
It would have prima facie been obvious to one having ordinary skill in the art at the time of filing to use p-SCN-Bn-DOTA as a chelating agent to create the claimed product. One would have been motivated to do so because Simon teaches incubation with p-SCN-Bn-DOTA for chelating radionuclides and linking to monoclonal antibodies to generate antibody-drug conjugates. There would be an expectation of success in using p-SCN-Bn-DOTA to generate the claimed radiopharmaceutical because Simon provides a detailed protocol for its use in production of antibody radioconjugates.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAROL ANN CHASE whose telephone number is (571)270-0934. The examiner can normally be reached Monday-Friday 9:00am-6:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gregory Emch can be reached at 571-272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CAROL ANN CHASE/Examiner, Art Unit 1646
/HONG SANG/Primary Examiner, Art Unit 1646