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
Claims 10, 18-70, 72, 81, 84 and 86-87 have been cancelled and claims 1 and 71 have been amended, as requested in the amendment filed on 01/09/2026. Following the amendment, claims 1-9, 11-17, 71, 73-80, 82-83, 85, and 88-89 are pending in the instant application.
Claims 1-9, 11-17, 71, 73-80, 82-83, 85, and 88-89 are under examination in the instant office action.
Drawings - Objection Maintained
Applicant has submitted replacement drawing sheets for Figures 12-13 and 15, however it is noted that there is still blurry/illegible text and/or figure labels in the replacement drawing sheets. Notably, none of the axis labels in Figure 12A-B are legible, the text comprised within the shaded portions of the plots of Figures 13A-B is generally illegible, and the text in Figure 15 which overlaps with the shaded bars is generally illegible. As such, the objection to the drawings is maintained.
Claim Objections - Withdrawn
Claim 1 was objected to for not defining the acronym/abbreviation “ATM”. Applicant has amended claim 1 such that “ATM” is defined as “ataxia telangiectasia mutated (ATM)”. In view of the amendment of claim 1, the objection to claim 1 is withdrawn.
Claim Rejections - 35 USC § 112 - Withdrawn
Claims 74-78 were rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite, with regard to the recitation of IHC scores. Applicant argues on Page 10 of Remarks (01/09/2026) that IHC was widely accepted as the gold standard for
determination of HER2 protein expression; the field recognized and followed ASCO practice
guidelines, which were adopted worldwide. While the specifics of IHC scoring requires
some subjectivity, it does not negate that the scoring is done by experts in the field under
accepted standards for determination of protein status (e.g., HER2 status). Thus, Applicant argues that the instant claim limitations and claim language is acceptable because the language is "as accurate as the subject matter permits", as indicated by MPEP § 2173.02.
Applicant’s arguments with regard to IHC scores have been fully considered and are deemed persuasive. As such, the rejection of claims 74-78 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite, with regard to the recitation of IHC scores, is withdrawn.
Claims 10, 72, 81, 84, and 86-87 were rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite due to their dependency on claim 1, which was rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for being drawn to multiple structural interpretations. Claims 10, 72, 81, 84, and 86-87 have been cancelled, rendering their rejection moot. As such, the rejection of claims 10, 72, 81, 84, and 86-87 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite is withdrawn.
Claims 10, 72, 81, 84, and 86-87 were rejected 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. Claims 10, 72, 81, 84, and 86-87 have been cancelled, rendering their rejection moot. As such, the rejection of claims 10, 72, 81, 84, and 86-87 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 is withdrawn.
Claims 10, 72, 81, 84, and 86-87 were rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, with regard to scope of enablement. Claims 10, 72, 81, 84, and 86-87 have been cancelled, rendering their rejection moot. As such, the rejection of claims 10, 72, 81, 84, and 86-87 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, regarding scope of enablement is withdrawn.
Claim Rejections - 35 USC § 112 - Maintained
Claims 1-9, 11-17, 71, 73-80, 82-83, 85, and 88-89 stand as rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite. It is acknowledged that Applicant has amended claim 1 to recite structural features of the claimed HER2 antibody, namely the CDR sequences, and therefore argues at Page 10 of Remarks that claim 1 now recites structural features of the claimed antibody that correspond to its function and tacitly indicate that the term antibody is not simultaneously referring to multiple polyclonal antibodies. However, it is noted that the definition of “antibody” as provided at Page 32 of the specification recites that “[t]he anti-HER2 antibody may be a polyclonal antibody or a monoclonal antibody”. As such, there are still multiple structural interpretations of claim 1, wherein the anti-HER2 antibody may be a single antibody molecule (one antibody molecule comprising all 6 of the now recited CDRs) or a polyclonal antibody which, by definition, would comprise multiple antibody molecules (i.e., the CDRs may be present on multiple antibody molecules which together constitute a polyclonal antibody). As such, the term “anti-HER2 antibody” is still considered to be indefinite. The rejection of claims 1-9, 11-17, 71, 73-80, 82-83, 85, and 88-89 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite is maintained.
Claims 1-9, 11-17, 71, 73-80, 82-83, 85, and 88-89 stand as rejected 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. Even as amended, the instant claims are still drawn to a genus of anti-HER2 antibodies (i.e., monoclonal or polyclonal antibodies). As indicated in the previous Office Action (09/10/2025) the instant specification indicates on page 32 that “[t]he anti-HER2 antibody may be a polyclonal antibody” (emphasis added). No examples of polyclonal antibodies are provided in the instant disclosure, the only exemplary antibodies provided are monoclonal antibodies trastuzumab and pertuzumab (page 40). Thus, Applicant does not demonstrate possession of any polyclonal antibodies (i.e., antibodies which comprise the 6 recited CDRs in claim 1 on different antibody molecules) that retain the ability to bind HER2. The rejection of claims 1-9, 11-17, 71, 73-80, 82-83, 85, and 88-89 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 is maintained.
Claims 1-9, 11-17, 71, 73-80, 82-83, 85, and 88-89 stand as rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, with regard to scope of enablement. It is acknowledged that Applicant has: (i) amended claim 1 to recite structural features of the claimed HER2 antibody, namely the CDR sequences; and (ii) amended claim 71 to recite specific types of cancer and administering the anti-HER2 antibody-drug conjugate and ATM inhibitor “to promote a positive therapeutic response”. With regard to claim 1, it is noted that even as amended the claim, and all subsequently dependent claims, by definition still include polyclonal antibodies. Additionally, while the amendment of claim 71 limits the method of treating cancer to treating a patient having cancer (i.e., the recitation of “to promote a positive therapeutic response” is drawn to therapeutic treatment, not prophylactic treatment/cancer prevention), it is noted that general recitation of cancer types is drawn to any and all cancers of that type; claim 71 does not require that the recited cancers express HER2. As indicated in the previous Office Action, the specification is enabling for antibody-drug conjugates comprising and methods of treating HER2 expressing cancers. As such, even as amended, the full scope of the instant claims is not enabled by the instant specification. The rejection of claims 1-9, 11-17, 71, 73-80, 82-83, 85, and 88-89 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, with regard to scope of enablement is maintained.
Claim Rejections - 35 USC § 103 - Withdrawn
Claims 10, 72, 81, 84, and 86-87 were rejected under 35 U.S.C. 103 as being unpatentable over EP 3101032 A1 (previously cited on PTO-892; herein after referred to as “Naito”) in view of non-patent literature by Stagni et. al. (Molecular & Cellular Oncology, 2016, 3(2), 1-2; previously cited on PTO-892; herein after referred to as “Stagni”) and WO 2017/046216 A1 (previously cited on PTO-892; herein after referred to as “Pike”). Claims 10, 72, 81, 84, and 86-87 have been cancelled, rendering their rejection moot. As such, the rejection of claims 10, 72, 81, 84, and 86-87 under 35 U.S.C. 103 in view of Naito, Stagni, and Pike is withdrawn.
Claim Rejections - 35 USC § 103 - Maintained
Claims 1-9, 11-12, 14-17, 71, 73, 80, 82-83, 85, and 88-89 stand as rejected under 35 U.S.C. 103 as being unpatentable over EP 3101032 A1 (previously cited on PTO-892; herein after referred to as “Naito”) in view of non-patent literature by Stagni et. al. (Molecular & Cellular Oncology, 2016, 3(2), 1-2; previously cited on PTO-892; herein after referred to as “Stagni”) and WO 2017/046216 A1 (previously cited on PTO-892; herein after referred to as “Pike”).
Claim 13 stands as rejected under 35 U.S.C. 103 as being unpatentable over EP 3101032 A1 (previously cited on PTO-892; herein after referred to as “Naito”), Stagni et. al. (Molecular & Cellular Oncology, 2016, 3(2), 1-2; previously cited on PTO-892; herein after referred to as “Stagni”) and WO 2017/046216 A1 (previously cited on PTO-892; herein after referred to as “Pike”) as applied to claims 1-12, 14-17, 71-73, 80-89 above, and further in view of US 6,339,142 B1 (previously cited on PTO-892; herein after referred to as “Basey”).
Claims 74-79 stand as rejected under 35 U.S.C. 103 as being unpatentable over EP 3101032 A1 (previously cited on PTO-892; herein after referred to as “Naito”), Stagni et. al. (Molecular & Cellular Oncology, 2016, 3(2), 1-2; previously cited on PTO-892; herein after referred to as “Stagni”) and WO 2017/046216 A1 (previously cited on PTO-892; herein after referred to as “Pike”) as applied to claims 1-12, 14-17, 71-73, 80-89 above, and further in view of non-patent literature by Tarantino et. al. (Journal of Clinical Oncology, April 2020, 38(17), 1951-1963; previously cited on PTO-892; herein after referred to as “Tarantino”).
With regard to the above-maintained claim rejections under 35 USC § 103, Applicant argues on Pages 11-12 of Remarks that arriving at the specifically claimed combination based on Naito, Stagni, and Pike could only be the result of hindsight given the breadth of disclosure of these references. Applicant argues that those skilled in the art would understand that there is no expectation of success when randomly combining different anticancer agents; some combinations may prove wholly ineffective, and some may be dangerously toxic. Thus, Applicant argues that a person of ordinary skill in the art could not glean a reasonable expectation of success in combining the claimed elements when: (i) Naito fails to mention ATM inhibitor at all; (ii) Stagni merely discusses the concept of inhibiting ATM without any mention of ADCs at all; and (iii) Pike mentions ADCs generically and only once among dozens of alternatives with which its ATM could allegedly be combined (and without referring to specific ADCs, targets, or payloads). Applicant also asserts that there is no motivation (empirical motivation nor scientific rationale) to arrive at the instantly claimed combination.
Applicant’s arguments have been fully considered, but are deemed not persuasive.
It is specifically noted, with regard to the combination of Naito, Stagni, and Pike that: (i) Naito was relied upon for its disclosure of the instantly claimed ADC of claim 1 and the teaching that said ADC could be used in combination with an additional anti-cancer agent; (ii) Stagni is relied upon for its teaching that modulation of ATM activity may modulate HER2 activity (i.e., in HER2-expressing cancers) and for response to trastuzumab and tamoxifen; and (iii) Pike is relied upon for its teaching of specific ATM inhibitors, including those instantly claimed that are of formula (I) of claim 2. It is noted that there is no requirement that an “express, written motivation to combine must appear in prior art references before a finding of obviousness.” See Ruiz v. A.B. Chance Co., 357 F.3d 1270, 1276, 69 USPQ2d 1686, 1690 (Fed. Cir. 2004). The motivation provided to combine the teachings of the prior art references, as presented in the previous Office Action, is amenable to the type of analysis set forth in In re Kerkhoven, wherein “[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted); thus combining the ADC of Naito and the ATM inhibitors of Pike, both disclosed as useful in cancer treatments (i.e., HER2-expressing cancers), would have been obvious and is further motivated by Stagni who discloses a connection between cancer, HER2, and ATM inhibitors. Additionally, with regard to the argument of hindsight reasoning, it is noted that “[a]ny judgement on obviousness is in a sense necessarily a reconstruction based on hindsight reasoning, but so long as it takes into account only knowledge which was within the level of ordinary skill in the art at the time the claimed invention was made and does not include knowledge gleaned only from applicant’s disclosure, such a reconstruction is proper.” In re McLaughlin 443 F.2d 1392, 1395, 170 USPQ 209, 212 (CCPA 1971). The claim rejections rely only on knowledge which was within the level of ordinary skill in the art at the time the claimed invention was made. Additionally, with regard to the arguments of predictability and a reasonable expectation of success, it is noted that obviousness does not require absolute predictability, only a reasonable expectation of success, i.e., a reasonable expectation of obtaining similar properties. See, e.g., In re O’Farrell, 853 F.2d 894, 903, 7 USPQ2d 1673, 1681 (Fed. Cir. 1988). Stagni, which was relied upon to motivated the combination of the instantly claimed ADC and an ATM inhibitor, explicitly suggests that (i) ATM modulation may be directly tied to HER2 modulation in the context of cancer, and (ii) explicitly suggests ATM modulation may further modulate therapeutic response to trastuzumab (i.e., the antibody of which is used in the instantly claimed ADC). As such, based on Stagni there would have been a reasonable expectation that combining ATM inhibitors with HER2-targeting modalities would be therapeutically beneficial in the context of HER2-expressing cancers.
With regard to the above-maintained claim rejections under 35 USC § 103, Applicant further presents arguments of unexpected results at Page 13 of Remarks. Specifically, Applicant Examples 3-7 of the instant specification wherein:
Example 3 shows that the combination of an ATM inhibitor and an ADC within the scope of the amended claims provides synergistic improvements in activity in breast and gastric cell lines;
Example 4 shows synergistic effects in breast cancer and ovarian cancer, with improved combinatorial effects in multiple other cell lines;
Example 5 provides an in vivo example of synergistic tumor regression with the claimed combination therapy in a gastric cancer model;
Example 6 shows experimental proposal of how the claimed combination works in concert, with the ATM inhibitor halting ADC-induced ATM signaling; and
Example 7 shows a similar synergistic improvement in an in vivo lung cancer model treated with the claimed combination of agents.
Applicant’s arguments and the Examples above have been fully considered; however they are deemed not persuasive as the results are deemed to not be commensurate in scope with the claims.
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It is specifically noted that the synergistic results demonstrated in the above-argued Examples are drawn to: (i) treatment of HER2 expressing breast, gastric, lung, and ovarian cancers, not any and all breast, gastric, lung, or ovarian cancers; and (ii) the specific combination of the antibody-drug conjugate of claim 1 designated as DS-8201 (i.e., trastuzumab deruxtecan; presented below) and the ATM inhibitor designated as AZD1390 (presented below) which is represented by formula I presented in claim 2; AZD1390 is considered to be sufficiently representative of ATM inhibitors of formula (I), however it is not sufficiently represented of any and all ATM inhibitors.
In view of the above, the arguments presented by Applicant regarding unexpected results are not considered to be sufficiently commensurate in scope with the instant claims.
As such, the rejections of: (i) claims 1-9, 11-12, 14-17, 71, 73, 80, 82-83, 85, and 88-89 under 35 U.S.C. 103 in view of Naito, Stagni, and Pike; (ii) claim 13 under 35 U.S.C. 103 in view of Naito, Stagni, and Pike and in further view of Basey; and (iii) claims 74-79 under 35 U.S.C. 103 in view of Naito, Stagni, and Pike and in further view of Tarantino are maintained.
Double Patenting - Withdrawn
With regard to claim rejections under nonstatutory double patenting, Applicant argues the following on Pages 16-19 of Remarks:
The double patenting rejections are improper because the Examiner has failed to provide any reasoned analysis with respect to the cited reference claims.
The double patenting rejections are made in view of Naito, Pike, Stagni, Basey, and/or Tarantino, which Applicant asserts is improper use of secondary references since they cannot be used to fill a complete void of a primary reference under a double patenting rejection; additionally, Naito, Pike, Stagni, Basey, and/or Tarantino cannot render the claims obvious for reasons argued above.
When reference claims do not overlap with the pending claims-such as situations in which the reference claims are directed to an ADC or combination that is mutually exclusive with the present claims-double patenting cannot exist.
Applicant’s arguments with regard to the claim rejections under nonstatutory double patenting have been fully considered, and are deemed persuasive with regard to the below-listed rejections.
The provisional rejection of claims 1-17 and 71-89 over the pertinent claims of the below-listed copending applications in view of Naito, Pike, Stagni, Basey, and/or Tarantino have been withdrawn:
Application No.
Brief Description of the Invention
Pertinent Claims
16485777
Therapeutic Method for Resistant Non-Small Cell Lung Cancer Comprising Administering Anti-HER3 Antibody-Drug Conjugate
19, 26, 31-33
17276394
Method for Treating a HER3-Mutated Cancer Comprising Administering an Anti-HER3 Antibody-Drug Conjugate
18, 26, 31-35
17612765
Method of Treating TROP2-Expressing Cancer Comprising Administering an Anti-TROP2 Antibody-Drug Conjugate
23-24, 35-36, 44, 67-69
17668904
Anti-HER3 Antibody-Drug Conjugate, Drug, Pharmaceutical Composition, and Method of Treatment Thereof
1-9
18016308
Method for Producing an Antibody-Drug Conjugate and Antibody-Drug Conjugate Thereof
1, 17-18, 30-31, 43-44, 56
18016864
Pharmaceutical Composition Comprising an Anti-HER2 Antibody-Drug Conjugate and HER Dimerization Inhibitor and Method of Treatment Thereof
1-7, 10-11, 26-32, 35-36, 38-47
18036290
Therapeutic Agent for Mesothelioma Comprising an Anti-B7-H3 Antibody-Drug Conjugate
1, 12
18272050
Anti-DLL-3 Antibody-Drug Conjugate, Pharmaceutical Composition, and Method of Treatment Thereof
1, 22-25, 27, 32-41, 43
18578705
Anti-CD37 Antibody-Drug Conjugate, Compositions, and Uses Thereof
1, 6-9, 14-24, 26, 28-31
18711411
Pharmaceutical Product Comprising an Anti-TROP2 Antibody-Drug Conjugate and PARP1 Inhibitor and Method of Treatment Thereof
1, 14, 17-18, 77-79, 83
18724710
Pharmaceutical Composition Comprising an Anti-TROP2 Antibody-Drug Conjugate and ATR Inhibitor and Method of Treatment Thereof
1, 14, 17-18, 71-80
19069955
Anti-TROP2 Antibody-Drug Conjugate
1
19195073
Therapeutic Method for Cancer Comprising Administering an Anti-TROP2 Antibody-Drug Conjugate and Immune Checkpoint Inhibitor
1, 3, 20-30
19222453
Pharmaceutical Product Comprising an Anti-TROP2 Antibody-Drug Conjugate and DNMT Inhibitor, Compositions, Uses, and Method of Treating Cancer Thereof
1, 10-11, 14-19, 22-27
The rejection of claims 1-17 and 71-89 over the pertinent claims of the below-listed U.S. Patents in view of Naito, Pike, Stagni, Basey, and/or Tarantino have been withdrawn:
Patent No.
Brief Description of the Invention
Pertinent Claims
9808537
Antibody-Drug Conjugate, Drugs, Method of Treatment, and Pharmaceutical Composition Thereof
1-4, 7-13, 15-18
9850312
Anti-TROP2 Antibody-Drug Conjugate, Drugs, Method of Treatment, and Pharmaceutical Composition Thereof
1-8
10155821
Antibody-Drug Conjugate, Drugs, Method of Treatment, and Pharmaceutical Composition Thereof
1-8
10195288
Antibody-Drug Conjugate, Drugs, Method of Treatment, and Pharmaceutical Composition Thereof
1-9, 13-35
10227417
Anti-TROP2 Antibody-Drug Conjugate, Drugs, Method of Treatment, and Pharmaceutical Composition Thereof
1-10
10383878
Anti-HER3 Antibody-Drug Conjugate, Drugs, Method of Treatment, and Pharmaceutical Composition Thereof
1-9, 13-16
10906974
Anti-GPR20 Antibody-Drug Conjugate and Method of Treatment Thereof
1, 13-15, 17-18, 21-25, 27, 29-30
11008398
Anti-TROP2 Antibody-Drug Conjugate, Drugs, Method of Treatment, and Pharmaceutical Composition Thereof
1-8
11077202
Anti-CDH6 Antibody-Drug Conjugate
1-6, 11-14, 20-30
11298359
Antibody-Drug Conjugate, Method of Treatment, and Pharmaceutical Composition Thereof
1-17
11434289
Anti-GPR20 Antibody-Drug Conjugate and Pharmaceutical Composition Thereof
1, 18-25, 27,30-34, 40-41
11633493
Anti-B7-H3 Antibody-Drug Conjugate, Drug, Method of Treatment, and Pharmaceutical Composition Thereof
1, 8-14
Double Patenting - Maintained
The provisional rejection of claims 1-9, 11-17, 71, 73-80, 82-83, 85, and 88-89 over the pertinent claims of the below-listed copending applications in view of Naito, Pike, Stagni, Basey, and/or Tarantino have been maintained:
Application No.
Brief Description of the Invention
Pertinent Claims
16640914
Pharmaceutical Composition Comprising an Antibody-Drug Conjugate Useful for Treating Cancer
1, 8-10, 44
17058838
Method for Treatment of HER2-Mutated Non-Small Cell Lung Cancer Comprising Administering an Anti-HER2 Antibody-Drug Conjugate
1, 16-17, 19, 47-49
17262590
Method of Producing an Antibody-Drug Conjugate and Pharmaceutical Compositions Thereof
1, 23-26, 38, 42, 45, 61-64, 76, 80
17266465
Method of Treatment Comprising Administering an Antibody-Drug Conjugate and a Tubulin Inhibitor
1-6, 31-36, 73
17312084
Method for treating Cancer Comprising Administering an Antibody-Drug Conjugate and PARP Inhibitor
1-8, 35-42, 85-89
17416487
Method for treating Cancer Comprising Administering an Antibody-Drug Conjugate and Kinase Inhibitor
1, 31-37, 54-62, 125-127,
18012434
Pharmaceutical Composition Comprising an Anti-HER2 Antibody-Drug Conjugate and CDK9 Inhibitor and Method of Treatment Thereof
1, 19-26, 80-98
18012705
Pharmaceutical Composition Comprising an Anti-HER2 Antibody-Drug Conjugate and ATR Inhibitor and Method of Treatment Thereof
1, 10-17, 77-93, 96-97
18036289
Method Comprising Administering an Anti-HER2 Antibody-Drug Conjugate and Anti-SIRPα Antibody for Treating Cancer
59, 62-64, 86-87, 117
18367446
Method of Treating Non-Small Cell Lung Cancer Comprising Administering an Anti-HER2 Antibody-Drug Conjugate
1-16
18724593
Method for Treating Cancer Comprising Administering an Anti-HER2 Antibody-Drug Conjugate and a RASG12C Inhibitor
64, 69-87
18859141
Method for Treating Cancer Comprising Administering an Antibody-Drug Conjugate and a EZH1, EZH2, or EZH1/2 Dual Inhibitor
67, 70-74, 118-119, 125-132
18863639
Therapeutic Method Comprising Administering an Antibody-Drug Conjugate and a CD47 Inhibitor
81, 93-99, 120-121
18997624
Pharmaceutical Product Comprising an Antibody-Drug Conjugate and Bispecific Checkpoint Inhibitor, Compositions, and Uses Thereof
1, 9-15, 47-57, 60-70, 73-93
19001254
Therapeutic Agent for Metastatic Brain Tumor Comprising an Antibody-Drug Conjugate
1-11, 32-42
The rejection of claims 1-9, 11-17, 71, 73-80, 82-83, 85, and 88-89 over the pertinent claims of the below-listed U.S. Patents in view of Naito, Pike, Stagni, Basey, and/or Tarantino have been maintained:
Patent No.
Brief Description of the Invention
Pertinent Claims
9872924
Antibody-Drug Conjugate, Drugs, Method of Treatment, and Pharmaceutical Composition Thereof
1-2,6-8, 11-21, 32-37, 41-47
10729782
Drug-Linker
1-13
11173213
Method of Producing Antibody-Drug Conjugate
1-26
11185594
Anti-HER2 Antibody-Drug Conjugate and Method of Treatment Thereof
1-11
11584800
Method of Producing Anti-HER2 Antibody-Drug Conjugate
1-7
11795236
Method of Treating HER2-Low Expressing Cancer Comprising Administering an anti-HER2 Antibody-Drug Conjugate
1-12
11945882
Method for Producing an Antibody-Drug Conjugate
43-48, 61, 63
12220604
Method of Treating Metastatic Brain Tumor Comprising Administering an Antibody-Drug Conjugate
1-11, 32-33, 42-53
12319736
Therapeutic Method for Treating Cancer Comprising Administering an Anti-HER2 Antibody-Drug Conjugate and Immune Checkpoint Inhibitor
1-7, 21-31
The maintained claim rejections under nonstatutory double patenting are deemed proper wherein all of the cited reference patents and copending reference applications are generally drawn to drug-linkers, antibody-drug conjugates, methods of making antibody-drug conjugates, compositions thereof, and/or methods of treatment using said antibody-drug linkers wherein it is specifically noted that the reference applications all teach/suggest the drug-linker of instant claim 1, or slight variants thereof, wherein said drug-linker is attached to HER2 antibodies. Thus, the overlap of the reference claims with the copending claims is the drug-linker and/or ADCs of structures corresponding to instant claim 1, wherein the drug-linkers can be conjugated to anti-HER2 antibodies and the ADCs comprise anti-HER2 antibodies. However, it is noted that the reference patents do not necessarily disclose: the instantly claimed HER2 antibody, the ADCs in combination with ATM inhibitors, nor methods of treating cancer comprising administering such a combination. These deficiencies are addressed by the cited references, as previously described. It would have been obvious to one of ordinary skill in the art that the pharmaceutical products comprising ADCs, methods of producing ADCs, and methods of treatment comprising ADCs, of the reference patents and/or copending reference applications could be modified such that an ATM inhibitor was administered in combination with said ADCs, as suggested by Stagni and Tarantino, and the antibodies of the ADCs could comprise the instantly claimed anti-HER2 antibody, as suggested by Naito and Tarantino, because combining prior art elements according to known methods would be expected to yield predictable results with a reasonable expectation of success. “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted); thus combining the ADCs, methods of producing ADCs, and methods of treatment comprising ADCs of the reference applications and the teachings of the cited references would suggest an anti-HER2 ADC/ATM inhibitor combination useful/effective in the treatment of cancer. The arguments regarding obviousness in view of the cited prior art have been addressed above.
Conclusion
Claims 1-9, 11-17, 71, 73-80, 82-83, 85, and 88-89 are pending. Claims 1-9, 11-17, 71, 73-80, 82-83, 85, and 88-89 are rejected. No claims are allowed.
THIS ACTION IS MADE FINAL. 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 ALYSSA RAE STONEBRAKER whose telephone number is (571)270-0863. The examiner can normally be reached Monday-Thursday 7:00 am - 5:00 pm.
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/ALYSSA RAE STONEBRAKER/Examiner, Art Unit 1642
/SAMIRA J JEAN-LOUIS/Supervisory Patent Examiner, Art Unit 1642