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 .
DETAILED ACTION
Claims 1-23 are pending in the instant application.
Claims 5-6, 8-9, 13-15, and 17-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/13/2026.
Restriction Response
Applicant’s election without traverse of Trast-v1a(PF07)(LD11) which comprises:
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in the reply filed on 4/13/2026 is acknowledged.
Claims 1-4, 7, 10-12, 16, and 19-23 encompass the elected species.
Objections to the Claims
Claim 20 is objected to because of the following informalities:
Regarding instant claim 20, the word “and” is missing prior to the last option tenascin. Appropriate correction is required.
Objections to the Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
The websites are referenced in the specification on page 3, paragraph 10 and 11 (www.numab.com and www.affimed.com ) and page 4, paragraph 11 (www.zymeworks.com).
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.
Claims 3-4, 7, 10, 12, and 19-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding instant claims 3-4, 7, 10, 12, and 19-20, the claims list a genus followed by the term “preferable” or most preferably then describes species of the genus. It is not clear whether the recitation of the species are an optionally preferred example—and therefore not limiting—or further limitations of the scope of the claim.
The genus with optional species described are:
claim 3 – line 3;
claim 4 – lines 3, 5, 8, 12, and 15;
claim 7 – line 10;
claim 10 – lines 3, 4, 5,
claim 12 – line 2, (b) line 1; (c) lines 1 and 12-13;
claim 19 – line 7; and
claim 20 – line 2.
Claim 20 contains the trademark/trade name CanAg®. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe cancer antigens and, accordingly, the identification/description is indefinite.
Claim Rejections – 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 21-22 are 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. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 21-22 are for a method for treating a disease and disease species in a subject in need thereof, the method comprising administering to the subject the multifunctional antibody construct according to claim 1, but the claims are not required to express the target of the antibody in the multifunctional antibody. The multifunctional antibody would not be able to target a disease that does not express the antibody target and the Applicant does not have written description of an effective method wherein the disease does not express the target of the antibody in the multifunctional antibody.
Scope of the claimed genus
Claims 21-22 are for a method for treating a disease and disease species in a subject in need thereof, the method comprising administering to the subject the multifunctional antibody construct according to claim 1, but the claims are not required to express the target of the antibody in the multifunctional antibody.
Summary of Species disclosed in the original specification
The instant specification does not show any examples of a successful method for treating a disease and disease species in a subject in need thereof, the method comprising administering to the subject the multifunctional antibody construct according to claim 1, wherein the disease does not express the target of the antibody in the multifunctional antibody.
State of the Relevant Art
Low HER2 expressing tumors have been previously identified to be sensitive to HER2 targeted ADCs. Doi T et al. (Lancet Oncol 2017; 18: 1512–22) taught trastuzumab deruxtecan showed antitumor activity in HER2-low breast and gastric tumors (page 1513, Research in context box, Implications of all the available evidence). Doi taught low HER2-expressing tumors were defined as IHC1+/FISH negative, IHC1+/FISH untested, or IHC2+/FISH negative (page 1518, right column, last sentence), which were tested clinically. Doi taught two responders were IHC1+ or IHC2+/FISH negative (page 1518, right column last paragraph). While Doi further taught that there is precedence for treatment of HER2 targeting agents with low or even negative HER2 IHC expression (page 1513, left column, second to last paragraph), these examples express higher than normal serum concentrations of HER2 extracellular domain and thus are still targeted toward HER2. Thus, the expectation that patients with tumors that do not possess qualities wherein the serum concentrations of HER2 extracellular domain is elevated would not be expected to be targeted by HER2 without HER2 expression.
Claims 21-22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for: 1) treatment of a disease that expresses the target of the antibody in the multifunctional antibody, does not reasonably provide enablement for 1) treatment of a disease that is not required to express the target of the antibody in the multifunctional antibody. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Claims 21-22 are for a method for treating a disease and disease species in a subject in need thereof, the method comprising administering to the subject the multifunctional antibody construct according to claim 1, but the claims are not required to express the target of the antibody in the multifunctional antibody. The multifunctional antibody would not be able to target a disease that does not express the antibody target.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is "undue." These
factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Scope of the claimed genus and nature of the invention.
Claims 21-22 are for a method for treating a disease and disease species in a subject in need thereof, the method comprising administering to the subject the multifunctional antibody construct according to claim 1, but the claims are not required to express the target of the antibody in the multifunctional antibody.
Summary of Species disclosed in the original specification; the amount of direction provided by the inventor, existence of working examples; and quality of experimentation needed to make or use the invention based on the content of the disclosure.
The instant specification does not show any examples of a successful method for treating a disease and disease species in a subject in need thereof, the method comprising administering to the subject the multifunctional antibody construct according to claim 1, wherein the disease does not express the target of the antibody in the multifunctional antibody.
State of the Relevant Art; level of one of ordinary skill; and level of predictability of the art.
Low HER2 expressing tumors have been previously identified to be sensitive to HER2 targeted ADCs. Doi T et al. (Lancet Oncol 2017; 18: 1512–22) taught trastuzumab deruxtecan showed antitumor activity in HER2-low breast and gastric tumors (page 1513, Research in context box, Implications of all the available evidence). Doi taught low HER2-expressing tumors were defined as IHC1+/FISH negative, IHC1+/FISH untested, or IHC2+/FISH negative (page 1518, right column, last sentence), which were tested clinically. Doi taught two responders were IHC1+ or IHC2+/FISH negative (page 1518, right column last paragraph). While Doi further taught that there is precedence for treatment of HER2 targeting agents with low or even negative HER2 IHC expression (page 1513, left column, second to last paragraph), these examples express higher than normal serum concentrations of HER2 extracellular domain and thus are still targeted toward HER2. Thus, the expectation that patients with tumors that do not possess qualities wherein the serum concentrations of HER2 extracellular domain is elevated would not be expected to be targeted by HER2 without HER2 expression.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-4, 7, 10-12, 16, and 19-23 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2017/137458 (Van Berkel et al.), Song MY et al. (Cancer Res (2020) 80 (16_Supplement): 6524), US 2018/0193477 (Ng GYK et al.), Wagner K et al. (PNAS. 2014 111(47):16820-5, IDS reference), Chen X et al. (Advanced Drug Delivery Reviews 2013 65(10) 1357-1369), WO 2020/252329 (Schultz P et al.), and WO 2020/081744 (Pons J et al.).
Van Berkel taught a multifunctional antibody drug conjugate comprising the antibody cAC10 conjugate 53 comprising
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(page 105). Van Berkel taught an effective method of treating a subject with cancer that expresses the protein target of cAC10 comprising administering the subject a pharmaceutical composition comprising a pharmaceutically acceptable carrier and the multifunctional antibody drug conjugate 53 (Figure 8B).
Van Berkel taught the multifunctional antibody drug conjugate comprising a D as an antibody (page 34, lines 3-7) and that the target molecule D as the same or different (page 34 lines 9-10).
Van Berkel taught the term antibody includes scFv antibodies (page 20, lines 7-10). Van Berkel taught trastuzumab which targets HER2 as an antibody (page 20 lines 13-14).
Van Berkel did not teach the elected species of:
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wherein the multifunctional antibody is specific for HER2 and is conjugated to two separate payloads of:
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; and
an immune cell engager, the T-cell engaging polypeptide anti-4-1BB of
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, but this is obvious in view of Song, Kon, Wagner, Chen, Schultz, and Pons.
Song taught a HER2/4-1BB bispecific antibody YH32367 (ABL105) was effective and significantly inhibited tumor growth in a HER2 expression dependent manner and showed potent in vivo efficacy when administered to subjects with cancer through tumor-directed T cell activation without non-specific systemic T-cell activation (abstract). Song taught YH32367 (ABL105) had more potent efficacy on tumor growth inhibition in both mouse models compared to the equimolar dosing of trastuzumab (abstract).
Ng taught a bispecific T cell engager drug conjugate can be developed to preferentially bind and kill target B cells, while not impacting the T cells and as result of to the preferential binding and activity, the bispecific T cell engager drug conjugate has the potential to have a dual mechanism of action of: i) T cell redirected B cell killing and ii) B cell killing through internalization of the conjugated toxin payload. (page 46, [0414]).
Ng taught bispecific anti-CD3-CD19 drug conjugates showed potent killing of NHL and ALL tumor B cells lines while not significantly impacting the growth of the Jurkat T cells (page 48, [0429]). Ng taught all anti-CD3-CD19 conjugates showed no off-target activity against the cell line K562, which does not express CD19 or CD3, similar to the non-specific IgG-SMCC-DM1 control (page 48, [0429]). Ng taught a bispecific anti-CD19-CD3 conjugated to MMAE via a cleavable linker (maleimidocaproyl-valine-citrulline-p-aminobenzyloxycarbonyl (mc-vc-PABC) was effective towards the allogeneic target B cells, but not T cells (pages 50-51, [0465-0466]). Ng taught a bispecific anti-HER2-CD3 conjugate V13792 exhibited potent killing of breast and ovarian tumor cell lines but did not significantly impact the growth of the Jurkat T cells (page 53, [0495]).
Wagner taught generation of an effective bispecific antibody via fusion of antibodies through sortase transpeptidation and click chemistry (abstract). Wagner taught a bispecific antibody comprising a (G4S) linker followed by a sortase recognition tag LPETGG which was fused together via sortase transpeptidation to produce a bispecific antibody comprising antibody-(G4S)-LPETGGG-click-antibody (page 16821, right column, third paragraph and Fig. 1).
Chen taught Flexible linkers are usually applied when the joined domains require a certain degree of movement or interaction (page 1359, right column, last paragraph).
Chen taught the most commonly used flexible linkers have sequences primarily consisting of stretches of Gly and Ser residues (“GS” linker), wherein the most widely used flexible linker has the sequence of (Gly-Gly-Gly-Gly-Ser)n (page 1360, left column, first paragraph). Chen taught by adjusting the copy number “n”, the length of this GS linker can be optimized to achieve appropriate separation of the functional domains, or to maintain necessary inter-domain interactions (page 1360, left column, first paragraph). Chen taught a (G4S)2 linker was effective (page 1360, Table 3)
Schultz taught a bispecific antibody wherein an anti-PD-L1 tumor targeting antibody is conjugated to an NDP-MSH protein that targets a separate protein target, which comprises a BCN and a PEG24 linker (Fig 1) which was effective against cancer cells (Fig. 4).
Pons taught an anti-SIRPa-CpG nucleotide conjugate wherein an anti-SIRPa antibody was conjugated to the nucleotide agent via a linker that comprised a PEG23 linker (pages 199-200, [00482]) which was effective in treating a subject with cancer (Fig. 7B and 7C).
Regarding instant claims 1-4, 7, 10-12, 16, and 19-20, it would have been obvious for a person having ordinary skill in the art to take the effective method of treating a subject with cancer that expresses the protein target of cAC10 of Van Berkel comprising administering the subject a pharmaceutical composition comprising a pharmaceutically acceptable carrier and the multifunctional antibody drug conjugate 53 comprising
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and modify it by:
Exchanging the cAC10 targeting antibody for trastuzumab in view of Van Berkel;
Exchanging one
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for a scFv in view of Van Berkel;
Including the scFv as an anti-4-1BB scFv in view of Song;
Conjugating the 4-1BB antibody to trastuzumab via a (G4S)-LPETGGG-click linker in view of Wagner;
Including the (G4S) linker as a (G4S)2 flexible linker in view of Chen; and
Including a PEG linker prior to the BCN attachment in view of Schultz, wherein the PEG linker is 23 or 24 PEG units long in view of Schultz and Pons.
This is obvious because:
1a) Van Berkel taught trastuzumab which targets HER2 as an antibody. Thus, exchange of one cancer targeting antibody for another is obvious;
2a) Van Berkel taught the multifunctional antibody drug conjugate comprising a D as an antibody and that the target molecule D as the same or different;
2b)Van Berkel taught an antibody as a scFv antibody;
3a) Song taught a HER2/4-1BB bispecific antibody was effective and significantly inhibited tumor growth in a HER2 expression dependent manner and showed potent in vivo efficacy when administered to subjects with cancer through tumor-directed T cell activation without non-specific systemic T-cell activation
3b) Ng taught a bispecific T cell engager drug conjugates can bind and kill target B cancer cells with a dual mechanism of action of: i) T cell redirected B cell killing and ii) B cell killing through internalization of the conjugated toxin payload, while not negatively impacting the T cells;
3c) Ng taught: i) a bispecific anti-CD19-CD3 conjugated to MMAE via a cleavable linker was effective towards target B cells, but not T cells; and ii) a bispecific anti-HER2-CD3 conjugate V13792 exhibited potent killing of breast and ovarian tumor cell lines but did not significantly impact the growth of the Jurkat T cells;
4a) Wagner taught generation of an effective bispecific antibody via fusion of antibodies through sortase transpeptidation and click chemistry, wherein the bispecific antibody comprised a (G4S) linker followed by a sortase recognition tag LPETGG which was fused together via sortase transpeptidation to produce a bispecific antibody comprising antibody-(G4S)-LPETGGG-click-antibody;
5a) Chen taught: i) the most commonly used flexible linkers have sequences primarily consisting of stretches of Gly and Ser residues (“GS” linker), wherein the most widely used flexible linker has the sequence of (Gly-Gly-Gly-Gly-Ser)n, wherein by adjusting the copy number “n”, the length of this GS linker can be optimized to achieve appropriate separation of the functional domains, or to maintain necessary inter-domain interactions; and ii) a (G4S)2 linker was effective;
6a) Schultz taught a bispecific antibody wherein an anti-PD-L1 tumor targeting antibody is conjugated to an NDP-MSH protein that targets a separate protein target, which comprises a BCN and a PEG24 linker which was effective against cancer cells; and
6b) Pons taught an anti-SIRPa-CpG nucleotide conjugate wherein an anti-SIRPa antibody was conjugated to the nucleotide agent via a linker that comprised a PEG23 linker which was effective in treating a subject with cancer. Thus, PEG linkers of (PEG)23 or (PEG)24 are known to the art to be effective at conjugating agents to antibodies.
There is a reasonable expectation of success because:
1a) exchange of one cancer targeting antibody of cAC10 for another cancer targeting antibody that targets HER2 would be expected to be effective;
2-3a) Song taught a HER2/4-1BB bispecific antibody was effective and significantly inhibited tumor growth in a HER2 expression dependent manner and showed potent in vivo efficacy when administered to subjects with cancer through tumor-directed T cell activation without non-specific systemic T-cell activation
2-3b) Ng taught a bispecific T cell engager drug conjugates can bind and kill target cancer cells with a dual mechanism of action of: i) T cell redirected B cell killing and ii) B cell killing through internalization of the conjugated toxin payload, while not negatively impacting the T cells;
2-3c) Ng taught: i) a bispecific anti-CD19-CD3 conjugated to MMAE via a cleavable linker was effective towards target B cells, but not T cells; and ii) a bispecific anti-HER2-CD3 conjugate V13792 exhibited potent killing of breast and ovarian tumor cell lines but did not significantly impact the growth of the Jurkat T cells; Thus, a multifunctional HER2 antibody conjugated to MMAE and a T-cell engager would be expected to effectively kill HER2 expressing cancer cells but not T cells;
4a) Wagner taught generation of an effective bispecific antibody via fusion of antibodies through sortase transpeptidation and click chemistry, wherein the bispecific antibody comprised a (G4S) linker followed by a sortase recognition tag LPETGG which was fused together via sortase transpeptidation to produce a bispecific antibody comprising antibody-(G4S)-LPETGGG-click-antibody;
5a) Chen taught: i) the most commonly used flexible linkers have sequences primarily consisting of stretches of Gly and Ser residues (“GS” linker), wherein the most widely used flexible linker has the sequence of (Gly-Gly-Gly-Gly-Ser)n, wherein by adjusting the copy number “n”, the length of this GS linker can be optimized to achieve appropriate separation of the functional domains, or to maintain necessary inter-domain interactions; and ii) a (G4S)2 linker was effective;
6a) Schultz taught a bispecific antibody wherein an anti-PD-L1 tumor targeting antibody is conjugated to an NDP-MSH protein that targets a separate protein target, which comprises a BCN and a PEG24 linker which was effective against cancer cells; and
6b) Pons taught an anti-SIRPa-CpG nucleotide conjugate wherein an anti-SIRPa antibody was conjugated to the nucleotide agent via a linker that comprised a PEG23 linker which was effective in treating a subject with cancer. Thus, PEG linkers of (PEG)23 or (PEG)24 are known to the art to be effective at conjugating agents to antibodies.
This would produce a method of treating a subject with HER2 expressing cancer (instant claims 21-22) comprising administering the subject a pharmaceutical composition comprising a pharmaceutically acceptable carrier (instant claim 23) and the multifunctional antibody drug conjugate comprising
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wherein the multifunctional antibody is specific for HER2 and is conjugated to two separate payloads of:
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; and
an immune cell engager, the T-cell engaging polypeptide anti-4-1BB of
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which meets the claim limitations of the elected species in instant claims 1-4, 7, 10-12, 16, and 19-20.
Conclusion
Claims 1-4, 7, 10-12, 16, and 19-23 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN J SKOKO III whose telephone number is (571)272-1107. The examiner can normally be reached M-F 8:30 - 5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Julie Z Wu can be reached at (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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/J.J.S./Examiner, Art Unit 1643
/Karen A. Canella/Primary Examiner, Art Unit 1643
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