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 .
Receipt is acknowledged of Applicant’s Request for Continued Examination and Amendment filed on 10/28/2025.
Claims 1, 7-8, 17, 19-21, 23, 25 have been amended.
Claims 26-28 have been added.
Claim 16 has been canceled.
Claims 1-2, 5, 7-11, 14, 17-28 are pending in the instant application.
Claims 5, 9, 18, 20-21 have been previously withdrawn from consideration.
Note, rejections and objections not reiterated from previous office actions are hereby withdrawn. The following rejections or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/28/2025 has been entered.
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 1-2, 7-8, 10-11, 14, 17, 19, 22-28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over copending Application No. 17/532,919; 17/822,701; 17/883,434; 18/012,740; 18/025,849; 18/146,149; 18/553,757; 18/557,988; 18/684,103 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the co-applications recite a method for treating a solid cancer in a mammalian subject, the method comprising: administering to the subject a therapeutically effective amount of a radionuclide labeled HER3 targeting agent (see 17/532,919 at claim 1), wherein the radionuclide labeled HER3 targeting agent comprises a radiolabel selected from .sup.131I, .sup.125I, .sup.123I, .sup.90Y, .sup.177Lu, .sup.186Re, .sup.188Re, .sup.89Sr, .sup.153Sm, .sup.32P, .sup.225Ac, .sup.213Bi, .sup.213Po, .sup.211At, .sup.212Bi, .sup.213Bi, .sup.223Ra, .sup.227Th, .sup.149Tb, .sup.137Cs, .sup.212Pb or .sup.103Pd, or a combination thereof. (see claim 2), wherein the immune checkpoint therapy comprises an antibody against PD-1, PD-L1, PD-L2, CTLA-4, CD137, or a combination thereof (see claim 17), wherein the solid cancer is a breast cancer (see claim 8).
The difference between instant application and the patented claims is that the patent claims include additional limitations. Thus, the invention of the patent is in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”, and, therefore, the application claims are not patentably distinct from the claims of the patent and are rejected on the ground of nonstatutory obviousness-type double patenting. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 112, 4th paragraph
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.
Claim 16 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112 is withdrawn in view of Applicant’s amendment.
Note, Applicant’s withdrawn dependent claim 9 has a lack of antecedent 112 issue, because amended claim 7 deleted “131I”, and would be required to be amend properly before any allowance.
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.
Claim(s) 1, 7, 22-24 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAO et al (US 2017/0209574).
COA teaches combination therapies (see title) for treating prostate cancer (see [0024]) comprised of: administering an inhibitor of an immune checkpoint molecule (see [0198), such as PD-1 (see [0202]) and a second therapeutic agent (see [0198]), such as anti-HER3 monoclonal antibody (see [0255] and [0327]), wherein the antibody molecules can be conjugated to a radioisotope (see [0751]), such as 225Ac (see [0196]). The method includes contacting an antibody molecule, with a chelating agent, to thereby produce a conjugated antibody. The conjugated antibody is radiolabeled with a radioisotope, e.g., .sup.111Indium, .sup.90Yttrium and .sup.177Lutetium, to thereby produce a labeled antibody molecule (see [0196]).
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-2, 7-8, 10-11, 14, 17, 19 and 22-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over MODENA et al (Immune checkpoint inhibitors and prostate cancer: a new frontier. Oncology Reviews 2016; 10:293 pg. 6-13) in view of CAO et al (US 2017/0209574), GHANBARI et al (US 2016/0354499) and LINIKER et al (Activity and safety of radiotherapy with anti-PD-1 drug therapy in patients with metastatic melanoma. (2016) 5:9, e1214788.
MODENA teaches a method of treating prostate cancer using immune checkpoint inhibitors (see title), such as PD-1 and PD-L1 (see abstract), in combination with radiotherapy and resulting in synergic antitumor activity (se pg. 7, 2nd col; and Conclusion on pg. 11). Additional disclosures include: growing interest of anticancer research aims at blocking immune checkpoints (mainly targeting CTLA-4 and PD1/PD-L1 pathways) to restore and enhance cellular-mediated antitumor immunity and achieve durable tumor regression (see abstract). In particular, increasing the host’s immune response against PC cells could represent a valid and promising therapeutic approach (see pg. 6, 2nd col). Monoclonal antibodies (mAbs) directed against CTLA-4 (ipilimumab) or PD-1/PDL1 (i.e., nivolumab, pembrolizumab, atezolizumab) can stimulate the immune system, reactivating T-cell proliferation and activity. This efficient strategy of checkpoint blockade represents one of the main oncological breakthroughs, with remarkable clinical durable responses and survival advantages observed in several cancer types (see pg. 6, 2nd col).
MODENA does not teach details about radiotherapy, such as 225Ac; antibody against HER3; and DOTA chelating agent.
CAO teaches the prior art had known of similar combination therapies (see title) for treating prostate cancer (see [0024]) comprised of: administering an inhibitor of an immune checkpoint molecule (see [0198), such as PD-1 (see [0202]) and a second therapeutic agent (see [0198]), such as anti-HER3 monoclonal antibody (see [0255] and [0327]), wherein the antibody molecules can be conjugated to a radioisotope (see [0751]), such as 225Ac (see [0196]). The method includes contacting an antibody molecule, with a chelating agent, to thereby produce a conjugated antibody. The conjugated antibody is radiolabeled with a radioisotope, e.g., .sup.111Indium, .sup.90Yttrium and .sup.177Lutetium, to thereby produce a labeled antibody molecule (see [0196]). Additional disclosures include: in combination with radiotherapy (see [0625]).
GHANBARI teaches the prior art had known of chelating agents, such as DOTA, for conjugating antibody to radioisotopes (see [0034])
LINIKER teaches combination therapy using radiotherapy with anti-PD-1 antibody therapy (see title and abstract), wherein the radiotherapy and anti-PD-1 treatment are given sequential with the radiotherapy given prior to the anti-PD-1 treatment, concurrent, or radiotherapy is given 6 weeks after starting anti-PD-1 antibody to test the effectiveness (see abstract; and Figure 1).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate 225Ac conjugated to antibody against HER3 with DOTA as the chelating agent; and optimize the order of administration as taught by LINIKER. The person of ordinary skill in the art would have been motivated to make those modifications, because it would allow synergistic treatment of prostate cancer and other cancers, and reasonably would have expected success because the references dealt in the same field of endeavor, such as cancer treatment.
The references do not specifically teach dosing in the amounts as claimed by Applicant or repeat the dosing. The amount of a dosing in a radiotherapy and repeating dosing to treat cancer is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal radiation dosing and repetition in order to best achieve the desired results, such as effective treatment of the cancer and decreasing adverse effects. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of radiation dosing amount would have been obvious at the time of Applicant's invention.
Claim(s) 1-2, 7-8, 10-11, 14, 17, 19 and 22-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over MODENA et al (Immune checkpoint inhibitors and prostate cancer: a new frontier. Oncology Reviews 2016; 10:293 pg. 6-13) in view of CAO et al (US 2017/0209574), GHANBARI et al (US 2016/0354499) and LINIKER et al (Activity and safety of radiotherapy with anti-PD-1 drug therapy in patients with metastatic melanoma. (2016) 5:9, e1214788.
As discussed above, the references teach Applicant’s invention,
The references do not teach using a specific anti-HER3 antibody, such as full-length IgG
HETTMANN et al teaches the prior art had known of anti-HER3 antibodies, such as seribantumab (see [0225]), which is a full-length IgG.
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate anti-HER3 antibodies, such as seribantumab (see [0225]), which is a full-length IgG. The person of ordinary skill in the art would have been motivated to make those modifications, because and reasonably would have expected success because seribantumab is a functional equivalent of anti-HER3 antibodies.
Telephonic Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAKE MINH VU whose telephone number is (571)272-8148. The examiner can normally be reached Mon-Fri 9:00am-5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at (571) 272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAKE M VU/Primary Examiner, Art Unit 1618
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