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 .
Response to Amendment
The Amendments and Remarks filed 01/12/2026 in response to the Office Action of 08/11/2025 are acknowledged and have been entered.
Claims 3, 9, 10, 11 and 14 have been amended by Applicant.
Claims 3-7 and 9-18 are currently pending and under examination in the instant Office Action.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office Action.
This Office Action contains a new rejection necessitated by amendments.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 08/21/2025 and 01/12/2026 are being considered by the examiner.
Drawings Objections - Withdrawn
Applicant has amended the drawings stated below and so the objections have been withdrawn:
On Figure 2 (Pg. 3), Figure 6 (Pg. 9), Figure 6 (Pg. 10), Figure 7 (Pg. 11-14 and 16), the figure labels are in a different direction compared to graphs.
The use of the term “ug” in several figures have been replaced with “µg”.
Specification Objections - Withdrawn
Applicant has amended the specification as stated below and so the objections have been withdrawn:
The term “ug” on several pages for example on Pg. 77 Lines 24, 25 and 38, and Pg. 78 Lines 1, 4, 18 and 19 has been amended to “µg”;
The term “CD32B” has been selected and used consistently throughout the specification;
The embedded hyperlinks and/or other form of browser-executable codes on Pg. 10 and Pg. 47 have been amended;
The proper symbols for trademarks/names have been included.
Claim Objections - Withdrawn
Applicant has amended claims 9 and 10 as stated below and so the objections have been withdrawn:
Claim 9 now recites “(w/v)” between “0.05%” and “Polysorbate 20”.
Claim 10 has been amended in terms of format with numerals (i) to (v).
Claim Rejections - 35 USC § 112(b) - Withdrawn
Given that Applicant has now cancelled claim 8, the 112(b) rejection of this claim is hereby withdrawn.
Given that Applicant has now amended claim 9 to delete the words “about”, the 112(b) rejection of this claim is hereby withdrawn.
Given that Applicant has now amended claims 11 and 14 to delete the phrase “an immunological disease”, the 112(b) rejection of these claims is hereby withdrawn.
Claim Rejections 35 U.S.C.112(a) - Withdrawn
Given that Applicant has now amended claims 11 and 14 to include the word “human” before the word “subject, the 112(a) rejection of claims 11-16 is hereby withdrawn.
Claim Rejections - 35 USC § 112(d) - Withdrawn
Given that Applicant has now amended claim 4 include the phrase “wherein the Fc receptor binding antibody binds to an Fcy receptor via its Fc region” to further limit claim 3, the 112(d) rejection of claim 4 is hereby withdrawn.
Claim Rejections - 35 USC § 102 - Withdrawn
The rejection of claims 3-7, 9, 10 and 17-18 under 35 U.S.C. 102 as being anticipated by Frendéus (US 20170107293 A1 Date Published 2017-04-20) is withdrawn. This is because Applicant has amended claim 3 (and therefore dependent claims 4-7, 9, 10, 17 and 18) and has cancelled claim 8.
Claim Rejections - 35 USC § 103 - Withdrawn
The rejection of claims 4, 11-13 and 15 under 35 U.S.C. 103 as being unpatentable over Frendéus (US 20170107293 A1 Date Published 2017-04-20) in view of Rajpal (CA 2724257 A1 Date Published 2009-12-23) and Liu (US10034940B2 Date Published 2018-07-31) is withdrawn. This is because claim 4 has been amended and claims 11-13 and 15 are anticipated by Frendéus (see 102 rejection maintained below).
Double Patenting - Withdrawn
The nonstatutory double patenting rejections of claim 4 as being unpatentable over U.S. Patents 10525129, 12344673, 11623005, and 12371498 have been withdrawn. This is because claim 4 has been amended.
The provisional nonstatutory double patenting rejections of claim 4 as being unpatentable over copending Application Nos. 17/627,385, 18/177,050, 18/281,530 and 18/998,134 have been withdrawn. This is because claim 4 has been amended.
Claim Rejections - Maintained
Claim Rejections - 35 USC § 112(d) - Maintained
Claims 5-7 and 17-18 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.
With regards to claim 5, the claim fails to further limit the therapeutic antibody of claim 3 since claim 3 already recited the exact phrase “the therapeutic antibody is an anti-FcyRIIB antibody” in line 2.
With regards to claim 6, the claim fails to further limit the therapeutic antibody of claims 3 and 5 because the limitation of the therapeutic antibody in claim 6 of “the therapeutic antibody has a light chain with SEQ ID No: 1 and a heavy chain with SEQ ID No: 2” has already been recited in claim 3 line 2 to line 3.
With regards to claim 7, the claim fails to further limit the pharmaceutical formulation of claim 5 because it does not provide further limitations to the formulation composition, instead it recites intended use “for treatment of cancer” which is not given weight in terms of composition limitation.
With regards to claim 17, the claim fails to further limit the therapeutic antibody of claim 4 because claim 3, upon which claim 4 is dependent upon, already recites the limitation that “the therapeutic antibody is an anti-FcyRIIB antibody” in line 2 of claim 3.
With regards to claim 18, the claim fails to further limit the pharmaceutical formulation of claim 6 since it does not provide further limitations to the formulation composition, instead it recites intended use “for treatment of cancer”.
In the Remarks of 01/12/2026, Applicant states that “solely to advance the prosecution, claims 5-7, 17 and 18 are canceled”. However, these claims remain presented in the current claim set dated 01/12/2026 as “(Previously Presented)”.
Claim Rejections - 35 USC § 102 - Maintained
Claims 11-13 and 15 remain rejected under 35 U.S.C. 102(a)(2) as being clearly anticipated by Frendéus (US 20170107293 A1 Date Published 2017-04-20).
Frendéus teaches a composition comprising an antibody molecule and an agent for use in the treatment of refractory cancer and/or relapsed cancer, and of a method of treating refractory cancer and/or relapsed cancer comprising administering an antibody molecule and an agent (Abstract). They teach that the agent prevents or reduces FcγRIIb binding to the Fc domain of the antibody molecule (claim 1) and that the agent is one or more antibody molecule that specifically binds FcγRIIb (claim 28). Frendéus also teaches that composition, and/or antibody, and/or agent, and/or medicament of the invention may be combined with an excipient and/or a pharmaceutically acceptable carrier and/or a pharmaceutically acceptable diluent and/or an adjuvant for treating said conditions whereby the composition, and/or antibody, and/or agent, and/or medicament is adapted for delivery including the subcutaneous route (Paragraphs [0079] and [0083]).
Frendéus teaches a composition, or a use, or a method, or a kit, wherein the agent comprises a variable heavy chain (VH) amino acid sequence of SEQ ID NO: 23 and comprises a variable light chain (VL) amino acid sequence of SEQ ID NO: 47 (Paragraphs [0251], [0252] and [0277]). They also teach the agents of their invention may comprise the antibody clone 6G11 with VH of SEQ ID NO:23 and VL of SEQ ID NO: 47 (Paragraph [0310]). They teach that the agents of their invention may also comprise the heavy constant region (CH) of SEQ ID: NO 1 and light constant region (CL) of SEQ ID NO: 2 (Paragraph [0302]).
It is to be noted that instant specification teaches that the antibody that specifically binds FcyRIIb comprises the sequence of antibody clone 6G11 VH SEQ ID NO: 23 and VL SEQ ID NO: 47 (Pg. 15 and 25). The name of the antibody clone and SEQ ID NO(s) of instant sequence match completely to the VH and VL sequence of SEQ ID NO(s): 23 and 47 respectively of clone 6G11 taught by Frendéus. In addition, the instant heavy chain SEQ ID NO: 2 amino acid residues 1 to 117 matches 100% to the VH SEQ ID NO: 23 of Frendéus, while the instant light chain SEQ ID NO: 1 amino acid residues 1 to 112 matches 100% to the VL SEQ ID NO: 47 of Frendéus. Moreover, the instant heavy chain amino acid residues 118 to 447 of SEQ ID NO: 2 completely matches the heavy constant region (CH) of SEQ ID NO: 1 of Frendéus, while the instant light chain amino acid residues 113 to 217 of SEQ ID NO: 1 match exactly to the light constant region (CL) of SEQ ID NO: 2 of Frendéus. Following the instructions and the four above described sequences provided by Frendéus, one would be able to connect the VH SEQ ID NO: 23 to CH SEQ ID NO: 1, and the VL SEQ ID NO: 47 to CL SEQ ID NO: 2 and in so doing arrive at instant SEQ ID NO(s): 1 and 2. Thus, Frendéus teaches the practitioner how to make instant SEQ ID NOs: 1 and 2 and instructs them to do so and as such anticipates the claims above.
Therefore, Frendéus anticipates the therapeutic antibody molecule of the instant claims above wherein the therapeutic antibody molecule is an Fc receptor binding antibody that is an anti-FcγRIIb antibody having a light chain comprising amino acid sequence that matches instant SEQ ID No: 1 and a heavy chain comprising amino acid sequence that matches instant SEQ ID No: 2. Frendéus also anticipates the instant method for the treatment of cancer comprising the step of administering to a subject the anticipated therapeutic antibody molecule.
Response to Arguments
In the reply of 01/12/2026, Applicant cites that Claims 3-7 and 11-18 are rejected as anticipated by Frendéus (US20170107293) which Applicant traverses. But solely in the interest of advancing the prosecution, the features of claim 8, which is not rejected, have been included in claim 3. As such, it is believed that the rejection should be overcome, reconsideration and withdrawal of which are therefore respectfully requested.
Examiner’s Response: The arguments found in the Reply of 01/12/2026 have been carefully considered but are not deemed persuasive. The rejection of claims 3-10 and 17-18 have been withdrawn as discussed above. However, instant claims 11-13 and 15 recite a method for the treatment of a disease comprising the step of administering to the subject the claimed therapeutic antibody molecule, wherein the therapeutic antibody molecule is “formulated for” subcutaneous administration, but do not specifically recite that the method for treatment comprises the step of subcutaneously administering claimed therapeutic antibody. Formulation of the antibody of Frendéus is equivalent to a “formulation for” subcutaneous administration. Therefore, Frendéus remains able to anticipate instant claims 11-13 and 15 and the 102 rejection of these claims is therefore maintained.
Claim Rejections - 35 USC § 103 -Maintained
Claims 3, 5-7, 9-18 remain rejected under 35 U.S.C. 103 as being unpatentable over Frendéus (US 20170107293 A1 Date Published 2017-04-20) in view of Liu (US10034940B2 Date Published 2018-07-31) and Rajpal (CA 2724257 A1 Date Published 2009-12-23).
Frendéus teaches a composition comprising an antibody molecule and an agent for use in the treatment of refractory cancer and/or relapsed cancer, and of a method of treating refractory cancer and/or relapsed cancer comprising administering an antibody molecule and an agent (Abstract). They teach that the agent prevents or reduces FcγRIIb binding to the Fc domain of the antibody molecule (claim 1) and that the agent is one or more antibody molecule that specifically binds FcγRIIb (claim 28). Frendéus also teaches that composition, and/or antibody, and/or agent, and/or medicament of the invention may be combined with an excipient and/or a pharmaceutically acceptable carrier and/or a pharmaceutically acceptable diluent and/or an adjuvant for treating said conditions whereby the composition, and/or antibody, and/or agent, and/or medicament is adapted for delivery by a route selected from the group comprising: intravenous; intramuscular; subcutaneous (Paragraphs [0079] and [0083]).
Frendéus teaches a composition, or a use, or a method, or a kit, wherein the agent comprises a variable heavy chain (VH) amino acid sequence of SEQ ID NO: 23 and comprises a variable light chain (VL) amino acid sequence of SEQ ID NO: 47 (Paragraphs [0251], [0252] and [0277]). They also teach the agents of their invention may comprise the antibody clone 6G11 with VH of SEQ ID NO:23 and VL of SEQ ID NO: 47 (Paragraph [0310]). They teach that the agents of their invention may also comprise the heavy constant region (CH) of SEQID NO 1 and light constant region (CL) of SEQ ID NO 2 (Paragraph [0302]).
It is to be noted that instant specification teaches that the antibody that specifically binds FcyRIIb may comprise the sequence of antibody clone 6G11 VH SEQ ID NO: 23 and VL SEQ ID NO: 47 (Pg. 15 and 25). The name of the antibody clone and SEQ ID NO(s) of instant sequence match completely to the VH and VL sequence of SEQ ID NO(s): 23 and 47 respectively of clone 6G11 taught by Frendéus. In addition, the instant heavy chain SEQ ID NO: 2 amino acid residues 1 to 117 matches 100% to the VH SEQ ID NO: 23 of Frendéus, while the instant light chain SEQ ID NO: 1 amino acid residues 1 to 112 matches 100% to the VL SEQ ID NO: 47 of Frendéus. Moreover, the instant heavy chain amino acid residues 118 to 447 of SEQ ID NO: 2 completely matches the heavy constant region (CH) of SEQ ID NO: 1 of Frendéus, while the instant light chain amino acid residues 113 to 217 of SEQ ID NO: 1 match exactly to the light constant region (CL) of SEQ ID NO: 2 of Frendéus. Following the instructions and the four above described sequences provided by Frendéus, one would be able to connect the VH SEQ ID NO: 23 to CH SEQ ID NO: 1, and the VL SEQ ID NO: 47 to CL SEQ ID NO: 2 and in so doing arrive at instant SEQ ID NO(s): 1 and 2. Thus, Frendéus teaches the practitioner how to make instant SEQ ID NO(s): 1 and 2 and instructs them to do so and as such anticipates the claims above.
However, Frendéus does not teach the pharmaceutical formulation comprising the said therapeutic antibody is formulated for subcutaneous administration wherein the therapeutic antibody is present at a concentration of between about 90 mg/ml and about 220 mg/ml; or the pharmaceutical formulation further comprises between 5 mM and 20 mM acetate, and/or between 50mM and 250mM NaCl, and/or 0.05% Polysorbate 20, and/or wherein the pharmaceutical formulation is at a pH of between pH 5.0 and pH 5.8. They also do not teach the pharmaceutical formulation, wherein the formulation comprises: the therapeutic antibody at a concentration of 150 mg/mL; 5mM acetate; 110mM NaCl; 0.05% (w/v) Polysorbate 20; and wherein the formulation is at pH 5.8.
However, these deficiencies are remedied by the teachings of Liu and Rajpal.
Liu teaches highly concentrated antibody and protein formulations with reduced viscosity that are stable, relatively isotonic and are of low turbidity which are particularly suitable for subcutaneous administration (Abstract). Liu also teaches in Column 49 under “Summary of Liquid Formulations”, that the concentration of His-Acetate can range from 10 mM to 100 mM for protein formulations that ranges from 40-150 mg/ml or 40-260 mg/ml comprising an anti-IgE antibody E25.
Rajpal teaches antibodies and antigen-binding portions thereof that bind to human IL-6 (Abstract) and a pharmaceutical composition comprising the antibody or antigen-binding portion and a pharmaceutically acceptable carrier (claim 17). Ragpal also teaches a method for treating, preventing or alleviating the symptoms of an IL-6 mediate disorder in a subject comprising administering said antibody or pharmaceutical composition, wherein the subject is afflicted with one or more conditions or disorders including an inflammatory disorder, an autoimmune disorder and cancer (claims 22 and 23). They also teach the antibody is administered by subcutaneous injection and the antibody is in a formulation as a sterile aqueous solution having a pH that ranges from about 5.0 to about 6.5 and comprising from about 1 mg/ml to about 200 mg/ml of antibody, from about 1 mM to about 100 mM of histidine buffer, from about 0.01 mg/ml (0.01% w/v) to about 10 mg/mI (1% w/v) of polysorbate 20. They also teach that a formulation can contain 5 mg/ml of antibody in a buffer of 20mM sodium citrate, pH 5.5, 140 mM NaCl, and 0.2 mg/mI polysorbate 80 (Paragraph [0124]).
One of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to perform a combined method of preparing, producing, and administering a pharmaceutical formulation comprising a therapeutic antibody that is an anti-FcϒRIIB antibody comprising a light chain comprising amino acid sequence of instant SEQ ID No: 1 and a heavy chain comprising amino acid sequence of instant SEQ ID No: 2, and wherein the pharmaceutical formulation comprises a pharmaceutically acceptable diluent or excipient, and is formulated for subcutaneous administration as taught by Frendéus, and specifically formulating said formulation to be suitable for subcutaneous administration comprising a therapeutic antibody at a concentration of between 90mg/mL and 220 mg/mL as taught by Liu, because Liu teaches said concentrations of antibody in formulations are particularly suitable for subcutaneous administration. The motivation to produce such a pharmaceutical formulation would be for the ease of administration via the subcutaneous route which can be increase patient convenience, decrease administration times (minutes versus hours) and the ability to self-administer at home when compared to intravenous administration that is the more common route of administration of therapeutic antibodies. This is an example of (A) Combining prior art elements according to known methods to yield predictable results; and (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention. See MPEP 2143. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, absent unexpected results.
In addition, one of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to perform the combined method to prepare and produce said pharmaceutical formulation, further comprising between 5 mM and 20 mM acetate, and/or between 50mM and 250mM NaCl, and/or 0.05% Polysorbate 20, and/or wherein the pharmaceutical formulation is at a pH of between pH 5.0 and pH 5.8; or wherein the formulation comprises: the therapeutic antibody at a concentration of 150 mg/mL; 5mM acetate; 110mM NaCl; 0.05% (w/v) Polysorbate 20; and wherein the formulation is at pH 5.8, by optimizing these buffer components as guided by the teachings of Liu and Ragpal because buffer compositions and concentrations is a result effective variable and so can be obvious through optimization. Therefore, a prima facie case of obviousness exists. See In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation." Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Application of Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980).
Thus, all values recited for every result effective variable of instant claims will be arrived at by routine experimentation and is obvious. These include the values for the concentrations for acetate, NaCl, Polysorbate 20 and for the pH of the formulation in the instant claims. Since Liu and Ragpal teach antibodies in a formulation comprising these components at such concentrations can provide stability and solubility of the therapeutic antibody, thus efficacy of such a combination and concentration for a treatment method can be expected and would be predictable.
With respect to the compositions of NaCl, Polysorbate 20 and the pH range in claims 9 and 10, the claimed concentrations and pH ranges overlap and lie inside ranges disclosed by Ragpal and so these claim limitations have been met. With respect to the acetate concentration of 5 mM in claim 10, Liu teaches the concentration of His-Acetate of 10 mM to 100 mM, a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of Amer.v.Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985).
Response to Arguments
In the reply of 01/12/2026, Applicant argues that a core inventive concept here lies in s.c. administration of anti-FcyRIIB antibodies and its ability to reduce or prevent IRRs. Frendéus presents combination therapies for relapsed/refractory B-cell malignancies using anti-FcyRIIB antibodies (e.g. 6G11) with other antibodies like rituximab. There is direction pointing the skilled artisan to s.c. administration, whereas the present application specifically concerns s.c. administration of anti-FcyRIIB antibodies to maintain efficacy while reducing infusion-related reactions (IRRs). The Action cites Frendéus at paragraph [0083] for s.c. administration; however, it is immediately evident that the reference to "subcutaneous" methods for administration of an antibody is presented amongst other possible administration routes, e.g. intravenous (i.v.) and intramuscular (i.m.). There is no experimental support in Frendéus for the s.c. method of administration. Rather, that document repeatedly emphasizes i.v. and "i.p." (likely intraperitoneal, though undefined) routes, e.g., in Figures 1, 7, 17, 18, Table 7, and Example F. There is no indication that the 6G 11 antibody was ever administered subcutaneously in any experiment. Moreover, paragraph [0083] specifically states oral administration is preferred. Thus, Frendéus provides no specific teaching to administer the antibody via a s.c. route. As such, a skilled person would not derive any guidance from this reference with regard to s.c. administration. Indeed, Frendéus does not address IRRs or tolerability, much less suggest that s.c. administration mitigates these. In fact, paragraph [0346] states 6G11 "is tolerated and does not result in toxicity". In contrast, the present application shows (e.g., Example 4A, Figures 12- 15) that AT-130-2 (BI-1206 surrogate) causes IRRs, which are avoided via s.c. administration.
Applicant also directs the Examiner to two post-filed publications demonstrating this technical effect. These were filed in an Information Disclosure Statement on August 21, 2025. They are:
EHA 2024 abstract (filename: "Abstract EHA 2024"), which reports on a Phase 1/2a trial of BI-1206 with rituximab in relapsed/refractory non-Hodgkin lymphoma. It compares i.v. and s.c. administration, showing improved tolerability and early clinical benefit with s.c. administration.
ASCO 2024 abstract ("Abstract ASCO 2024"), which describes a trial of BI-1206 with pembrolizumab in solid tumors, evaluating both i.v. and s.c. routes. The Phase 2a strategy will be based on pharmacokinetic, pharmacodynamic, and safety data.
Applicant continues to argue that much as with the present application (see pages 1-4), both of these publications highlight that i.v. administration may cause tolerability issues, such as IRRs, and that s.c. administration can mitigate these effects. Thus, at the time of the invention there was a clear yet unmet need for methods that prevent, suppress, or overcome such issues. And as stated in the passage bridging pages 4 and 5 of the application, the inventors surprisingly discovered that s.c. delivery of anti- FcyRIIB antibodies maintains therapeutic efficacy while reducing or preventing IRRs. This is supported by experimental data (e.g., Example 4A), as well as the aforementioned post-filed publications discussed above.
Applicant further cites that Frendéus, does not teach or suggest the presently claimed subject matter. Rajpal and Liu also fail to describe that which is now being claimed. In sum, none of the cited art describes, much less provides evidence, that the antibodies should be administered subcutaneously, and certainly does not even hint such s.c., administration would result in the surprising tolerability benefits demonstrated in the application. Indeed, Frendéus even teaches away from the invention, stating that i.v. and i.p. administration of 6G11 are well tolerated, and that oral administration is preferred. Liu focuses on formulations for s.c. delivery (see "Abstract"), describing it as practical for high-dose biologics (page 1, lines 29-46 of Liu et al.), but does not state that s.c. delivery mitigates i.v.-related tolerability issues for anti-FcyRIIB antibodies. Rajpal concerns anti-IL-6 antibodies only, with no mention of FcyRIIB antibodies or i.v.-related tolerability issues. As such, selecting these particular references for combination out of what can only be thousands upon thousands of antibody references smacks of impermissible hindsight driven by applicant's own disclosure.
Examiner’s Response: The arguments found in the Reply of 01/12/2026 have been carefully considered but are not deemed persuasive. This is because firstly, the EHA 2024 abstract which reported on a Phase 1/2a trial of i.v. or s.c. administration of BI-1206 with rituximab in relapsed/refractory non-Hodgkin lymphoma stated that improved tolerability was observed in preclinical experimental models and is currently evaluated in Phase 1 of said trial and there was no explicit report on s.c. administration of BI-1206 describing or showing decreased frequency of IRR events using this administration route. Secondly, the ASCO 2024 abstract which described a trial of BI-1206 with pembrolizumab in solid tumors did not provide data on IRR events from s.c. dosing of BI-1206, even though it reported that the most frequent related adverse events for the i.v. administration of BI-1206 were IRRs. Thirdly, Applicant referred to instant specification Example 4A (starting on Pg 92) which disclosed that in the clinical study 17-BI-1206-02, premedication with dexamethasone before i.v. infusion of BI-1206 improved IRRs. There were no reports on s.c. administration of BI-1206 in this clinical study and hence no related findings on the IRRs outcome of s.c. BI-1206 administration in patients. Also described in Example 4A was the testing of anti-mouse CD32B IgG2a clone AT130-2 monoclonal (murine surrogate antibody) in mice, where three different injection routes namely i.v., i.p. and s.c. were evaluated for IRRs post administration (Pg 95). The instant specification on Pg 96 disclosed that when AT-130-2 was administered at 200 pg to mice via the s.c. route, no IRRs were seen (up to 24h post injection) and even when the s.c. dose was increased to 400 pg, treated mice remained unaffected (Figure 12). In short, the mice studies in Example 4A that showed decreased IRRs with s.c. administration were done with AT-130-2, the surrogate antibody, and not the BI-1206 antibody of the instant claims.
In conclusion, Applicant has not demonstrated that the anti-FcϒRIIB antibody comprising SEQ ID NOs: 1 and 2 as recited in instant claim 1, and as disclosed in the instant specification to be the antibody denoted as BI-1206 (Pg 74), showed better IRRs with subcutaneous (s.c.) administration. See MPEP 716.02(d) the “objective evidence of nonobviousnes must be commensurate in scope with the claims which the evidence is offered to support”.
Double Patenting - Maintained
First NSDP: U.S. Patent No. 10525129B2
Claims 3, 5-7, 9-18 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13, 17-19, 21-24, 28-30 and 32 of U.S. Patent No. 10525129B2 (Date of Patent 2020-01-07) in view of Frendéus (US 20170107293 A1 Date Published 2017-04-20), Liu (US10034940B2 Date Published 2018-07-31) and Rajpal (CA 2724257 A1 Date Published 2009-12-23).
Although the claims at issue are not identical, patented claims and instant claims are drawn to an antibody that binds to FcγRIIb.
Patented claim 13 is drawn in part to a method of treating a patient comprising: administering to the patient an antibody that specifically binds FcγRIIb comprising the following amino acid sequences as the VH and VL regions, respectively: SEQ ID NO: 12 and SEQ ID NO: 25.
Patented claim 23 is drawn in part to a method of treating B cell lymphoma or chronic lymphocytic leukaemia (CLL), the method comprising: administering to the patient a composition comprising: an antibody that specifically binds FcγRIIb comprising specified amino acid sequences of CDRH1, CDRH2, CDRH3, CDLH1, CDLH2 and CDLH3. Patented claim 24 recites the method of patented claim 23, wherein the antibody comprises amino acid sequences as the VH and VL regions, respectively of SEQ ID NO: 12 and SEQ ID NO: 25.
The instant heavy chain SEQ ID NO: 2 amino acid residues 1 to 117 matches 100% to the VH SEQ ID NO: 12 of US Pat 10525129B2, while the instant light chain SEQ ID NO: 1 amino acid residues 1 to 112 matches 100% to the VL SEQ ID NO: 25 of US Pat 10525129B2.
Patented claims do not recite a pharmaceutical formulation comprising the recited therapeutic antibody and pharmaceutically acceptable diluent or excipient formulated for subcutaneous administration, wherein the antibody is present at a concentration of between 90 mg/mL and 220 mg/mL; or wherein the Fc receptor binding antibody binds to an Fcγ receptor via its Fc region; or the pharmaceutical formulation further comprises specific buffers at specific concentrations at pH between 5.0 and 5.8; or wherein the formulation comprises: the therapeutic antibody at a concentration of 150 mg/mL; 5mM acetate; 110mM NaCl; 0.05% (w/v) Polysorbate 20; and wherein the formulation is at pH 5.8.
However, these deficiencies are remedied by the teachings of Liu and Rajpal.
The teachings of Liu and Rajpal have been discussed in the 103 rejection above.
Therefore, it would be obvious to perform a combined method of preparing and producing a pharmaceutical formulation comprising a therapeutic antibody that is an anti-FcϒRIIB antibody comprising a light chain and a heavy chain as recited by the patent, and wherein the pharmaceutical formulation comprises a pharmaceutically acceptable diluent or excipient, and is formulated for subcutaneous administration as taught by Frendéus, and specifically formulating said formulation to be suitable for subcutaneous administration comprising a therapeutic antibody at a concentration of between 90mg/mL and 220 mg/mL as taught by Liu, because Liu teaches said concentrations of antibody in formulations are particularly suitable for subcutaneous administration. The motivation to produce such a pharmaceutical formulation would be for the ease of administration via the subcutaneous route which can be increase patient convenience, decrease administration times (minutes versus hours) and the ability to self-administer at home when compared to intravenous administration that is the more common route of administration of therapeutic antibodies.
In addition, it would be obvious to perform said combined method, further comprising between 5 mM and 20 mM acetate, and/or between 50mM and 250mM NaCl, and/or 0.05% Polysorbate 20, and/or wherein the pharmaceutical formulation is at a pH of between pH 5.0 and pH 5.8; or wherein the formulation comprises: the therapeutic antibody at a concentration of 150 mg/mL; 5mM acetate; 110mM NaCl; 0.05% (w/v) Polysorbate 20; and wherein the formulation is at pH 5.8, by optimizing these buffer components as guided by the teachings of Liu and Ragpal because buffer compositions and concentrations is a result effective variable and so can be obvious through optimization. Therefore, a prima facie case of obviousness exists. See In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
With respect to the compositions of NaCl, Polysorbate 20 and the pH range in instant claims 9 and 10, the claimed concentrations and pH ranges overlap and lie inside ranges disclosed by Ragpal and so these claim limitations have been met. With respect to the acetate concentration of 5 mM in instant claim 10, Liu teaches the concentration of His-Acetate of 10 mM to 100 mM, a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of Amer.v.Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985).
Second NSDP: U.S. Patent No. 12344673B2
Claims 3, 5-7, 9-18 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3 and 6-10 of U.S. Patent No. 12344673B2 (Date of Patent 2025-07-01) in view of Frendéus (US 20170107293 A1 Date Published 2017-04-20), Liu (US10034940B2 Date Published 2018-07-31) and Rajpal (CA 2724257 A1 Date Published 2009-12-23).
Although the claims at issue are not identical, patented claims and instant claims are drawn to an antibody that binds to FcγRIIb.
Patented claim 1 is drawn in part to a method of treating cancer in a subject, the method comprising administering: an antibody molecule that specifically binds FcγRIIb.
Patented claim is drawn in part to the antibody molecule that comprises the following amino acid sequences: SEQ ID NO: 23 and SEQ ID NO: 47.
The instant heavy chain SEQ ID NO: 2 amino acid residues 1 to 117 matches 100% to the SEQ ID NO: 23 of US Pat 12344673B2, while the instant light chain SEQ ID NO: 1 amino acid residues 1 to 112 matches 100% to the VL SEQ ID NO: 47 of US Pat 12344673B2.
Patented claims do not recite a pharmaceutical formulation comprising the recited therapeutic antibody and pharmaceutically acceptable diluent or excipient formulated for subcutaneous administration, wherein the antibody is present at a concentration of between 90 mg/mL and 220 mg/mL; or wherein the Fc receptor binding antibody binds to an Fcγ receptor via its Fc region; or the pharmaceutical formulation further comprises specific buffers at specific concentrations at pH between 5.0 and 5.8; or wherein the formulation comprises: the therapeutic antibody at a concentration of 150 mg/mL; 5mM acetate; 110mM NaCl; 0.05% (w/v) Polysorbate 20; and wherein the formulation is at pH 5.8.
However, these deficiencies are remedied by the teachings of Liu and Rajpal.
The teachings of Liu and Rajpal have been discussed in the 103 rejection above.
Therefore, it would be obvious to perform a combined method of preparing and producing a pharmaceutical formulation comprising a therapeutic antibody that is an anti-FcϒRIIB antibody comprising a light chain and a heavy chain as recited by the patent, and wherein the pharmaceutical formulation comprises a pharmaceutically acceptable diluent or excipient, and is formulated for subcutaneous administration as taught by Frendéus, and specifically formulating said formulation to be suitable for subcutaneous administration comprising a therapeutic antibody at a concentration of between 90mg/mL and 220 mg/mL as taught by Liu, because Liu teaches said concentrations of antibody in formulations are particularly suitable for subcutaneous administration. The motivation to produce such a pharmaceutical formulation would be for the ease of administration via the subcutaneous route which can be increase patient convenience, decrease administration times (minutes versus hours) and the ability to self-administer at home when compared to intravenous administration that is the more common route of administration of therapeutic antibodies.
In addition, it would be obvious to perform said combined method, further comprising between 5 mM and 20 mM acetate, and/or between 50mM and 250mM NaCl, and/or 0.05% Polysorbate 20, and/or wherein the pharmaceutical formulation is at a pH of between pH 5.0 and pH 5.8; or wherein the formulation comprises: the therapeutic antibody at a concentration of 150 mg/mL; 5mM acetate; 110mM NaCl; 0.05% (w/v) Polysorbate 20; and wherein the formulation is at pH 5.8, by optimizing these buffer components as guided by the teachings of Liu and Ragpal because buffer compositions and concentrations is a result effective variable and so can be obvious through optimization. Therefore, a prima facie case of obviousness exists. See In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
With respect to the compositions of NaCl, Polysorbate 20 and the pH range in instant claims 9 and 10, the claimed concentrations and pH ranges overlap and lie inside ranges disclosed by Ragpal and so these claim limitations have been met. With respect to the acetate concentration of 5 mM in instant claim 10, Liu teaches the concentration of His-Acetate of 10 mM to 100 mM, a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of Amer.v.Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985).
Third NSDP: U.S. Patent No. 11623005B2
Claims 3, 5-7, 9-18 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 11623005B2 (Date of Patent 2023-04-11) in view of Frendéus (US 20170107293 A1 Date Published 2017-04-20), Liu (US10034940B2 Date Published 2018-07-31) and Rajpal (CA 2724257 A1 Date Published 2009-12-23).
Although the claims at issue are not identical, patented claims and instant claims are drawn to an antibody that binds to FcγRIIb.
Patented claim 1 is drawn in part to an antibody molecule that binds to human FcγRIIb, wherein the antibody molecule comprises: a heavy chain variable region (VH) comprising: a VH CDR1; a VH CDR2; and a VH CDR3; and a light chain variable region (VL) comprising: a VL CDR1; a VL CDR2; and a VL CDR3.
Patented claim 2 is drawn to the antibody molecule of claim 1, wherein the VH consists of the amino acid sequence of SEQ ID NO: 12; and the VL consists of the amino acid sequence of SEQ ID NO: 25.
The instant heavy chain SEQ ID NO: 2 amino acid residues 1 to 117 matches 100% to the SEQ ID NO: 12 of reference US Pat 11623005B2, while the instant light chain SEQ ID NO: 1 amino acid residues 1 to 112 matches 100% to the VL SEQ ID NO: 25 of reference US Pat 11623005B2.
Patented claims do not recite a pharmaceutical formulation comprising the recited therapeutic antibody and pharmaceutically acceptable diluent or excipient formulated for subcutaneous administration, wherein the antibody is present at a concentration of between 90 mg/mL and 220 mg/mL; or wherein the Fc receptor binding antibody binds to an Fcγ receptor via its Fc region; or the pharmaceutical formulation further comprises specific buffers at specific concentrations at pH between 5.0 and 5.8; or wherein the formulation comprises: the therapeutic antibody at a concentration of 150 mg/mL; 5mM acetate; 110mM NaCl; 0.05% (w/v) Polysorbate 20; and wherein the formulation is at pH 5.8.
However, these deficiencies are remedied by the teachings of Liu and Rajpal.
The teachings of Liu and Rajpal have been discussed in the 103 rejection above.
Therefore, it would be obvious to perform a combined method of preparing and producing a pharmaceutical formulation comprising a therapeutic antibody that is an anti-FcϒRIIB antibody comprising a light chain and a heavy chain as recited by the patent, and wherein the pharmaceutical formulation comprises a pharmaceutically acceptable diluent or excipient, and is formulated for subcutaneous administration as taught by Frendéus, and specifically formulating said formulation to be suitable for subcutaneous administration comprising a therapeutic antibody at a concentration of between 90mg/mL and 220 mg/mL as taught by Liu, because Liu teaches said concentrations of antibody in formulations are particularly suitable for subcutaneous administration. The motivation to produce such a pharmaceutical formulation would be for the ease of administration via the subcutaneous route which can be increase patient convenience, decrease administration times (minutes versus hours) and the ability to self-administer at home when compared to intravenous administration that is the more common route of administration of therapeutic antibodies.
In addition, it would be obvious to perform said combined method, further comprising between 5 mM and 20 mM acetate, and/or between 50mM and 250mM NaCl, and/or 0.05% Polysorbate 20, and/or wherein the pharmaceutical formulation is at a pH of between pH 5.0 and pH 5.8; or wherein the formulation comprises: the therapeutic antibody at a concentration of 150 mg/mL; 5mM acetate; 110mM NaCl; 0.05% (w/v) Polysorbate 20; and wherein the formulation is at pH 5.8, by optimizing these buffer components as guided by the teachings of Liu and Ragpal because buffer compositions and concentrations is a result effective variable and so can be obvious through optimization. Therefore, a prima facie case of obviousness exists. See In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
With respect to the compositions of NaCl, Polysorbate 20 and the pH range in instant claims 9 and 10, the claimed concentrations and pH ranges overlap and lie inside ranges disclosed by Ragpal and so these claim limitations have been met. With respect to the acetate concentration of 5 mM in instant claim 10, Liu teaches the concentration of His-Acetate of 10 mM to 100 mM, a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of Amer.v.Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985).
Fourth NSDP: U.S. Patent No. 12371498
Claims 3, 5-7, 9-18 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 11 of U.S. Patent No. 12371498 (Date of Patent 2025-07-29) in view of Frendéus (US 20170107293 A1 Date Published 2017-04-20), Rajpal (CA 2724257 A1 Date Published 2009-12-23) and Liu (US10034940B2 Date Published 2018-07-31).
Although the claims at issue are not identical, patented claims and instant claims are drawn to an antibody that binds to FcγRIIb.
Patented claims 1 and 13 are drawn in part to a method for treatment of a cancer in a patient, the method comprising: administering to the patient: an antibody molecule that specifically binds FcγRIIb, wherein the antibody molecule comprises a variable heavy chain (VH) and variable light chain (VL) comprising the following amino acid sequences: the VH comprising SEQ ID NO: 23 and the VL comprising SEQ ID NO: 47.
The instant heavy chain SEQ ID NO: 2 amino acid residues 1 to 117 matches 100% to the VH comprising SEQ ID NO: 23 of reference US Pat 12371498, while the instant light chain SEQ ID NO: 1 amino acid residues 1 to 112 matches 100% to the VL comprising SEQ ID NO: 47of reference US Pat 12371498.
Patented claims do not recite a pharmaceutical formulation comprising the recited therapeutic antibody and pharmaceutically acceptable diluent or excipient formulated for subcutaneous administration, wherein the antibody is present at a concentration of between 90 mg/mL and 220 mg/mL; or wherein the Fc receptor binding antibody binds to an Fcγ receptor via its Fc region; or the pharmaceutical formulation further comprises specific buffers at specific concentrations at pH between 5.0 and 5.8; or wherein the formulation comprises: the therapeutic antibody at a concentration of 150 mg/mL; 5mM acetate; 110mM NaCl; 0.05% (w/v) Polysorbate 20; and wherein the formulation is at pH 5.8.
However, these deficiencies are remedied by the teachings of Liu and Rajpal.
The teachings of Liu and Rajpal have been discussed in the 103 rejection above.
Therefore, it would be obvious to perform a combined method of preparing and producing a pharmaceutical formulation comprising a therapeutic antibody that is an anti-FcϒRIIB antibody comprising a light chain and a heavy chain as recited by the patent, and wherein the pharmaceutical formulation comprises a pharmaceutically acceptable diluent or excipient, and is formulated for subcutaneous administration as taught by Frendéus, and specifically formulating said formulation to be suitable for subcutaneous administration comprising a therapeutic antibody at a concentration of between 90mg/mL and 220 mg/mL as taught by Liu, because Liu teaches said concentrations of antibody in formulations are particularly suitable for subcutaneous administration. The motivation to produce such a pharmaceutical formulation would be for the ease of administration via the subcutaneous route which can be increase patient convenience, decrease administration times (minutes versus hours) and the ability to self-administer at home when compared to intravenous administration that is the more common route of administration of therapeutic antibodies.
In addition, it would be obvious to perform said combined method, further comprising between 5 mM and 20 mM acetate, and/or between 50mM and 250mM NaCl, and/or 0.05% Polysorbate 20, and/or wherein the pharmaceutical formulation is at a pH of between pH 5.0 and pH 5.8; or wherein the formulation comprises: the therapeutic antibody at a concentration of 150 mg/mL; 5mM acetate; 110mM NaCl; 0.05% (w/v) Polysorbate 20; and wherein the formulation is at pH 5.8, by optimizing these buffer components as guided by the teachings of Liu and Ragpal because buffer compositions and concentrations is a result effective variable and so can be obvious through optimization. Therefore, a prima facie case of obviousness exists. See In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
With respect to the compositions of NaCl, Polysorbate 20 and the pH range in instant claims 9 and 10, the claimed concentrations and pH ranges overlap and lie inside ranges disclosed by Ragpal and so these claim limitations have been met. With respect to the acetate concentration of 5 mM in instant claim 10, Liu teaches the concentration of His-Acetate of 10 mM to 100 mM, a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of Amer.v.Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985).
Fifth NSDP: Copending Application No. US/17627385
Claims 3, 5-7, 9-18 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5, 27 and 28 of copending Application No. US/17627385 in view of Frendéus (US 20170107293 A1 Date Published 2017-04-20), Liu (US10034940B2 Date Published 2018-07-31) and Rajpal (CA 2724257 A1 Date Published 2009-12-23).
Copending claims 5 and 28 are drawn in part to a method for treatment of cancer in a patient comprising administering: an antibody molecule that specifically binds FcyRIIb, wherein the antibody molecule comprises amino acid sequences SEQ ID NO: 23 and SEQ ID NO: 47.
The instant heavy chain SEQ ID NO: 2 amino acid residues 1 to 117 matches 100% to the VH comprising SEQ ID NO: 23 of copending application US/17627385, while the instant light chain SEQ ID NO: 1 amino acid residues 1 to 112 matches 100% to the VL comprising SEQ ID NO: 47of copending application US/17627385.
Copending claims do not recite a pharmaceutical formulation comprising the recited therapeutic antibody and pharmaceutically acceptable diluent or excipient formulated for subcutaneous administration, wherein the antibody is present at a concentration of between 90 mg/mL and 220 mg/mL; or wherein the Fc receptor binding antibody binds to an Fcγ receptor via its Fc region; or the pharmaceutical formulation further comprises specific buffers at specific concentrations at pH between 5.0 and 5.8; or wherein the formulation comprises: the therapeutic antibody at a concentration of 150 mg/mL; 5mM acetate; 110mM NaCl; 0.05% (w/v) Polysorbate 20; and wherein the formulation is at pH 5.8.
However, these deficiencies are remedied by the teachings of Liu and Rajpal.
The teachings of Liu and Rajpal have been discussed in the 103 rejection above.
Therefore, it would be obvious to perform a combined method of preparing and producing a pharmaceutical formulation comprising a therapeutic antibody that is an anti-FcϒRIIB antibody comprising a light chain and a heavy chain as recited by the copending application, and wherein the pharmaceutical formulation comprises a pharmaceutically acceptable diluent or excipient, and is formulated for subcutaneous administration as taught by Frendéus, and specifically formulating said formulation to be suitable for subcutaneous administration comprising a therapeutic antibody at a concentration of between 90mg/mL and 220 mg/mL as taught by Liu, because Liu teaches said concentrations of antibody in formulations are particularly suitable for subcutaneous administration. The motivation to produce such a pharmaceutical formulation would be for the ease of administration via the subcutaneous route which can be increase patient convenience, decrease administration times (minutes versus hours) and the ability to self-administer at home when compared to intravenous administration that is the more common route of administration of therapeutic antibodies.
In addition, it would be obvious to perform said combined method, further comprising between 5 mM and 20 mM acetate, and/or between 50mM and 250mM NaCl, and/or 0.05% Polysorbate 20, and/or wherein the pharmaceutical formulation is at a pH of between pH 5.0 and pH 5.8; or wherein the formulation comprises: the therapeutic antibody at a concentration of 150 mg/mL; 5mM acetate; 110mM NaCl; 0.05% (w/v) Polysorbate 20; and wherein the formulation is at pH 5.8, by optimizing these buffer components as guided by the teachings of Liu and Ragpal because buffer compositions and concentrations is a result effective variable and so can be obvious through optimization. Therefore, a prima facie case of obviousness exists. See In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
With respect to the compositions of NaCl, Polysorbate 20 and the pH range in instant claims 9 and 10, the claimed concentrations and pH ranges overlap and lie inside ranges disclosed by Ragpal and so these claim limitations have been met. With respect to the acetate concentration of 5 mM in instant claim 10, Liu teaches the concentration of His-Acetate of 10 mM to 100 mM, a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of Amer.v.Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985).
This is a provisional nonstatutory double patenting rejection.
Sixth NSDP: Copending Application No. US/18177050
Claims 3, 5-7, 9-18 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21, 22 and 24 of copending Application No. US/18177050 in view of Frendéus (US 20170107293 A1 Date Published 2017-04-20), Liu (US10034940B2 Date Published 2018-07-31) and Rajpal (CA 2724257 A1 Date Published 2009-12-23).
Copending application claims 21 and 22 are drawn in part to an antibody molecule that binds to human FcyRIIb, wherein the antibody molecule comprises: a heavy chain variable region (VH) comprising: a VH CDR1; a VH CDR2; a VH CDR3; a light chain variable region (VL) comprising: a VL CDR1; a VL CDR2; and a VL CDR3, wherein the VH consists of the amino acid sequence of SEQ ID NO: 12; and the VL consists of the amino acid sequence of SEQ ID NO: 25.
Copending application claim 24 is drawn to the antibody molecule of claim 21, wherein the antibody molecule comprises a light chain constant region (CL) consisting of the amino acid sequence of SEQ ID NO:2.
The instant heavy chain SEQ ID NO: 2 amino acid residues 1 to 117 matches 100% to the VH comprising SEQ ID NO: 12 of copending application US/18177050, while the instant light chain SEQ ID NO: 1 amino acid residues 1 to 112 matches 100% to the VL comprising SEQ ID NO: 25 of copending application US/18177050. In addition, the instant light chain SEQ ID NO: 1 amino acid residues 113 to 217 matches 100% to the CL consisting of the amino acid sequence of SEQ ID NO:2 of copending application US/18177050.
Copending claims do not recite a pharmaceutical formulation comprising the recited therapeutic antibody and pharmaceutically acceptable diluent or excipient formulated for subcutaneous administration, wherein the antibody is present at a concentration of between 90 mg/mL and 220 mg/mL; or wherein the Fc receptor binding antibody binds to an Fcγ receptor via its Fc region; or the pharmaceutical formulation further comprises specific buffers at specific concentrations at pH between 5.0 and 5.8; or wherein the formulation comprises: the therapeutic antibody at a concentration of 150 mg/mL; 5mM acetate; 110mM NaCl; 0.05% (w/v) Polysorbate 20; and wherein the formulation is at pH 5.8.
However, these deficiencies are remedied by the teachings of Liu and Rajpal.
The teachings of Liu and Rajpal have been discussed in the 103 rejection above.
Therefore, it would be obvious to perform a combined method of preparing and producing a pharmaceutical formulation comprising a therapeutic antibody that is an anti-FcϒRIIB antibody comprising a light chain and a heavy chain as recited by the copending application, and wherein the pharmaceutical formulation comprises a pharmaceutically acceptable diluent or excipient, and is formulated for subcutaneous administration as taught by Frendéus, and specifically formulating said formulation to be suitable for subcutaneous administration comprising a therapeutic antibody at a concentration of between 90mg/mL and 220 mg/mL as taught by Liu, because Liu teaches said concentrations of antibody in formulations are particularly suitable for subcutaneous administration. The motivation to produce such a pharmaceutical formulation would be for the ease of administration via the subcutaneous route which can be increase patient convenience, decrease administration times (minutes versus hours) and the ability to self-administer at home when compared to intravenous administration that is the more common route of administration of therapeutic antibodies.
In addition, it would be obvious to perform said combined method, further comprising between 5 mM and 20 mM acetate, and/or between 50mM and 250mM NaCl, and/or 0.05% Polysorbate 20, and/or wherein the pharmaceutical formulation is at a pH of between pH 5.0 and pH 5.8; or wherein the formulation comprises: the therapeutic antibody at a concentration of 150 mg/mL; 5mM acetate; 110mM NaCl; 0.05% (w/v) Polysorbate 20; and wherein the formulation is at pH 5.8, by optimizing these buffer components as guided by the teachings of Liu and Ragpal because buffer compositions and concentrations is a result effective variable and so can be obvious through optimization. Therefore, a prima facie case of obviousness exists. See In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
With respect to the compositions of NaCl, Polysorbate 20 and the pH range in instant claims 9 and 10, the claimed concentrations and pH ranges overlap and lie inside ranges disclosed by Ragpal and so these claim limitations have been met. With respect to the acetate concentration of 5 mM in instant claim 10, Liu teaches the concentration of His-Acetate of 10 mM to 100 mM, a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of Amer.v.Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985).
This is a provisional nonstatutory double patenting rejection.
Seventh NSDP: Copending Application No. US/18281530
Claims 3, 5-7, 9-18 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 6, 10, 11, 12, 13, 15, 41, 42, 43, 44 of copending Application No. US/18281530 in view of Frendéus (US 20170107293 A1 Date Published 2017-04-20), Liu (US10034940B2 Date Published 2018-07-31) and Rajpal (CA 2724257 A1 Date Published 2009-12-23).
Copending application claim 1 is drawn in part to a combination comprising: an antibody molecule that specifically binds to FcyRllb for use in treating cancer in a patient.
Copending application claim 3 is drawn in part to a method for treating cancer in a patient, the method comprising administering to the patient: an antibody molecule that specifically binds to FcyRllb.
Copending application claim 6 is drawn in part to a pharmaceutical composition comprising: an antibody molecule that specifically binds to FcyRllb.
Copending application claim 15 is drawn in part to a combination for use, a use, a method, an antibody molecule for use, a pharmaceutical composition according to claim 1, wherein the antibody molecule comprises the amino acid sequences: SEQ ID NO: 23 and SEQ ID NO: 47.
The instant heavy chain SEQ ID NO: 2 amino acid residues 1 to 117 matches 100% to the VH comprising SEQ ID NO: 23 of copending application US/18281530, while the instant light chain SEQ ID NO: 1 amino acid residues 1 to 112 matches 100% to the VL comprising SEQ ID NO: 47 of copending application US/18281530.
Copending claims do not recite a pharmaceutical formulation comprising the recited therapeutic antibody and pharmaceutically acceptable diluent or excipient formulated for subcutaneous administration, wherein the antibody is present at a concentration of between 90 mg/mL and 220 mg/mL; or wherein the Fc receptor binding antibody binds to an Fcγ receptor via its Fc region; or the pharmaceutical formulation further comprises specific buffers at specific concentrations at pH between 5.0 and 5.8; or wherein the formulation comprises: the therapeutic antibody at a concentration of 150 mg/mL; 5mM acetate; 110mM NaCl; 0.05% (w/v) Polysorbate 20; and wherein the formulation is at pH 5.8.
However, these deficiencies are remedied by the teachings of Liu and Rajpal.
The teachings of Liu and Rajpal have been discussed in the 103 rejection above.
Therefore, it would be obvious to perform a combined method of preparing and producing a pharmaceutical formulation comprising a therapeutic antibody that is an anti-FcϒRIIB antibody comprising a light chain and a heavy chain as recited by the copending application, and wherein the pharmaceutical formulation comprises a pharmaceutically acceptable diluent or excipient, and is formulated for subcutaneous administration as taught by Frendéus, and specifically formulating said formulation to be suitable for subcutaneous administration comprising a therapeutic antibody at a concentration of between 90mg/mL and 220 mg/mL as taught by Liu, because Liu teaches said concentrations of antibody in formulations are particularly suitable for subcutaneous administration. The motivation to produce such a pharmaceutical formulation would be for the ease of administration via the subcutaneous route which can be increase patient convenience, decrease administration times (minutes versus hours) and the ability to self-administer at home when compared to intravenous administration that is the more common route of administration of therapeutic antibodies.
In addition, it would be obvious to perform said combined method, further comprising between 5 mM and 20 mM acetate, and/or between 50mM and 250mM NaCl, and/or 0.05% Polysorbate 20, and/or wherein the pharmaceutical formulation is at a pH of between pH 5.0 and pH 5.8; or wherein the formulation comprises: the therapeutic antibody at a concentration of 150 mg/mL; 5mM acetate; 110mM NaCl; 0.05% (w/v) Polysorbate 20; and wherein the formulation is at pH 5.8, by optimizing these buffer components as guided by the teachings of Liu and Ragpal because buffer compositions and concentrations is a result effective variable and so can be obvious through optimization. Therefore, a prima facie case of obviousness exists. See In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
With respect to the compositions of NaCl, Polysorbate 20 and the pH range in instant claims 9 and 10, the claimed concentrations and pH ranges overlap and lie inside ranges disclosed by Ragpal and so these claim limitations have been met. With respect to the acetate concentration of 5 mM in instant claim 10, Liu teaches the concentration of His-Acetate of 10 mM to 100 mM, a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of Amer.v.Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985).
This is a provisional nonstatutory double patenting rejection.
Eighth NSDP: Copending Application No. US/ US/18008134
Claims 3, 5-7, 9-18 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13, 14 and 27 of copending Application No. US/18008134 in view of Frendéus (US 20170107293 A1 Date Published 2017-04-20), Liu (US10034940B2 Date Published 2018-07-31) and Rajpal (CA 2724257 A1 Date Published 2009-12-23).
Copending application claim 13 is drawn in part to a method of preventing or mitigating a tolerability issue in connection with intravenous administration of a therapeutic antibody molecule to a subject comprising administering to said subject the therapeutic antibody molecule.
Copending application claim 14 is drawn to a method according to claim 13, wherein the therapeutic antibody is an Fc receptor binding antibody such as an anti-FcyRIIB antibody.
Copending application claim 27 is drawn to a method according to claim 14, wherein the anti-FcyRIIB antibody is the antibody having a light chain with SEQ ID No: 1 and a heavy chain with SEQ ID No: 2.
The instant heavy chain SEQ ID NO: 2 matches 100% to the heavy chain SEQ ID No: 2 of copending application US/18008134, while the instant light chain SEQ ID NO: 1 matches 100% to the light chain of SEQ ID No: 1 of copending application US/18008134.
Copending claims do not recite a pharmaceutical formulation comprising the recited therapeutic antibody and pharmaceutically acceptable diluent or excipient formulated for subcutaneous administration, wherein the antibody is present at a concentration of between 90 mg/mL and 220 mg/mL; or wherein the Fc receptor binding antibody binds to an Fcγ receptor via its Fc region; or the pharmaceutical formulation further comprises specific buffers at specific concentrations at pH between 5.0 and 5.8; or wherein the formulation comprises: the therapeutic antibody at a concentration of 150 mg/mL; 5mM acetate; 110mM NaCl; 0.05% (w/v) Polysorbate 20; and wherein the formulation is at pH 5.8.
However, these deficiencies are remedied by the teachings of Liu and Rajpal.
The teachings of Liu and Rajpal have been discussed in the 103 rejection above.
Therefore, it would be obvious to perform a combined method of preparing and producing a pharmaceutical formulation comprising a therapeutic antibody that is an anti-FcϒRIIB antibody comprising a light chain and a heavy chain as recited by the copending application, and wherein the pharmaceutical formulation comprises a pharmaceutically acceptable diluent or excipient, and is formulated for subcutaneous administration as taught by Frendéus, and specifically formulating said formulation to be suitable for subcutaneous administration comprising a therapeutic antibody at a concentration of between 90mg/mL and 220 mg/mL as taught by Liu, because Liu teaches said concentrations of antibody in formulations are particularly suitable for subcutaneous administration. The motivation to produce such a pharmaceutical formulation would be for the ease of administration via the subcutaneous route which can be increase patient convenience, decrease administration times (minutes versus hours) and the ability to self-administer at home when compared to intravenous administration that is the more common route of administration of therapeutic antibodies.
In addition, it would be obvious to perform said combined method, further comprising between 5 mM and 20 mM acetate, and/or between 50mM and 250mM NaCl, and/or 0.05% Polysorbate 20, and/or wherein the pharmaceutical formulation is at a pH of between pH 5.0 and pH 5.8; or wherein the formulation comprises: the therapeutic antibody at a concentration of 150 mg/mL; 5mM acetate; 110mM NaCl; 0.05% (w/v) Polysorbate 20; and wherein the formulation is at pH 5.8, by optimizing these buffer components as guided by the teachings of Liu and Ragpal because buffer compositions and concentrations is a result effective variable and so can be obvious through optimization. Therefore, a prima facie case of obviousness exists. See In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
With respect to the compositions of NaCl, Polysorbate 20 and the pH range in instant claims 9 and 10, the claimed concentrations and pH ranges overlap and lie inside ranges disclosed by Ragpal and so these claim limitations have been met. With respect to the acetate concentration of 5 mM in instant claim 10, Liu teaches the concentration of His-Acetate of 10 mM to 100 mM, a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of Amer.v.Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985).
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
In the reply of 01/12/2026, Applicant cites that:
First, with respect to the '129 patent, the claims concern a combination therapy using anti-CD20 and anti-FcyRIIB antibodies. The Action notes that BI-1206 is disclosed in the patent; but there is no mention of s.c. administration in the claims. Rather, s.c. administration route is mentioned on page 45: Methods of administering the compositions of the invention include, but are not limited to, parenteral administration (e.g., intradermal, intramuscular, intraperitoneal, intravenous and subcutaneous), epidural, and mucosal (e.g., intranasal and oral routes). In a specific embodiment, the compositions of the invention are administered intramuscularly, intravenously, or subcutaneously. (Emphasis added).
Second, with respect to the '673 patent, the claims concern treatment of relapsed B-cell cancer with anti-FcyRIIB antibodies. The claims are similar to the '129 patent, with added emphasis on relapsed/refractory cancer and specific antibody formats (e.g., IgG2, IgG4, N297Q variants). Again, the Action alleges that BI-1206 is disclosed, but no claims refer to s.c. administration. Rather, on page 9 of the specification, it says: Preferably, the composition, and/or antibody, and/or agent, and/or medicament is adapted for delivery by a route selected from the group comprising: intravenous; intramuscular; subcutaneous." (Emphasis added). This mirrors paragraph [0083] of Frendéus et al., and a similar statement appears on page 29 of the '498 patent.
Third, the '005 patent is a continuation of the '129 patent and concerns on the 6G11 antibody molecule per se. No therapeutic use or administration route is claimed. On page 47, the patent includes the same paragraph as the '129 patent, relating to various administration routes.
Finally, the '498 patent concerns treatment of FcyRIIB-negative cancers using an anti- FcyRIIB antibody (Fc:FcyR impaired) and an antibody targeting immune-suppressive cells (e.g., CTLA-4, PD-L1). Again, no claims relate to s.c. administration.
Further Applicant argues that while the cited patents mention the BI-1206 antibody, and all include s.c. administration among various options in the specification (albeit without supporting data), the claims do not mention s.c. delivery, much less recite that tolerability issues associated with i.v. administration of the BI-1206 antibody can be mitigated by this specific route of administration.
In addition, Applicant cites that for the rejections of Copending applications 17/627,385, 18/177,050, 18/281,530 and 18/998,134, as each of these rejections is provisional in nature, and the claims and subject in the cited applications may vary substantially prior to allowance, applicant therefore respectfully requests that the rejections be held in abeyance until one or both of the involved applications are allowed.
Examiner’s Response: The arguments found in the Reply of 01/12/2026 have been carefully considered but are not deemed persuasive. This is because the secondary references of Liu and Rajpal teach antibody formulations that are prepared for “subcutaneous administration”. In addition, as discussed in the Examiner’s Response to the maintained 103 rejection of the present Office Action, Applicant has not demonstrated unexpected or superior results of subcutaneous administration of the instant antibody.
With respect to the provisional double patenting rejections of Copending applications 17/627,385, 18/177,050, 18/281,530 and 18/998,134, these rejections cannot be held in abeyance and therefore the rejections remain.
New Objections Necessitated by Amendments
Drawings Objections - New
The amended drawings are objected to because:
In Fig 15 (Pg 23), the label for the y-axis has been deleted and currently illegible wordings are present in the figure;
In Fig 20A and 20B, there appear to be typographical errors for the label of the third data sets from the left. The unit “µg” is missing after the number “200”. In addition, the fourth data sets are labeled with “ug” which should be amended to “µg”.
Specification Objections - New
The amended disclosure is objected to because of the following informalities:
In specification submitted on 01/12/2026 and specifically referring to the clean copy, a typographical error appears in the title which currently reads ”µIMPROVING ANTIBODY TOLERABILITY ASSOCIATED WITH INTRAVENOUS ADMINISTRATION”. As a note, this typographical error does not appear to be in the marked up copy of the specification.
Appropriate correction is required.
Claim Objections - New
Claims 3, 4 and 10 are objected to because of the following informalities:
Claim 3 appears to have a typographical error in line 6. There should be a space inserted between “90” and “mg/mL”.
Claim 4 appears to have a typographical error in line 3. The term “Fcy” should be amended to “Fcϒ”.
Claim 10 appears to have two typographical errors in line 5 and line 7. The numerals “(ii)” in line 5 should be amended to “(iii)”. The word “a” before “pH 5.8” should be deleted so that the phrase recites “wherein the formulation is at pH5.8.”.
Appropriate correction is required.
New Rejections Necessitated by Amendments
Claim Rejections - 35 USC § 112 - New
Claim 4 is 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 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. This is a NEW MATTER rejection.
Amended claim 4 recites “wherein the Fc receptor binding antibody binds to an Fcy receptor via its Fc region”. On Pg 11 of the instant specification, it is disclosed that the antibody molecule according to the invention that specifically binds FcyRIIb, binds to or interacts with this Fcy receptor via the Fab region of the antibody, i.e. via the antigen- binding region on an antibody that binds to antigens which is composed of one constant and one variable domain of each of the heavy and the light chain; in particular, it binds to FcyRIIb present on an immune effector cell, and in particular to FcyRIIb present on the surface of an immune effector cell (lines 22-27). The specification also disclosed on Pg 11 lines 29-30 that in some preferred embodiments, the antibody molecule according to the invention that specifically binds FcyRIIb can also bind to Fcy receptors via its Fc region. However, the specification and the originally filed claims do not specifically disclose that an antibody molecule that is anti-FcϒRIIB, having a light chain with SEQ ID No: 1 and a heavy chain with SEQ ID No: 2, binds to Fcϒ receptors via its Fc region or interacts with this Fcϒ receptor via the Fab region of the antibody.
Conclusion
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.
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/YIE-CHIA LEE (TONYA)/Examiner, Art Unit 1642
/SEAN E AEDER/Primary Examiner, Art Unit 1642
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