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
Applicant’s election without traverse of Group I, claims 1 and 3-15, in the reply filed on 06/09/2026 is acknowledged. Applicant also elected an anti-OAcGD2 antibody that comprises the light chain variable region (VL) of SEQ ID NO: 1, but Applicant did not elect a SEQ ID NO: corresponding to a heavy chain variable region (VH). Applicant also failed to indicate which claims encompass the elected anti-OAcGD2 antibody. For the purposes of examination, it is presumed that Applicant intended to elect an anti-OAcGD2 antibody that comprises the VL of SEQ ID NO: 1 and the VH of SEQ ID NO: 2.
Claims 1-20 are pending.
Claims 2 and 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/09/2026.
Claim 8 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 06/09/2026.
Claims 1, 3-7, and 9-15 are under examination on the merits.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Claims 1, 3-7, and 9-15 have an effective filing date of 12/05/2016, corresponding to EP16002576.3.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 05/22/2023, 12/19/2023, and 05/14/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections
35 U.S.C. 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 1, 3-7, and 9-15 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.
Claim 1 recites “measuring the CI50 index according to the method as disclosed by Chou and Talalay, wherein a CI50 below 1 is indicative of synergism.” It is known in the art that Chou and Talalay provide equations for determining combination index (CI) values, see, for example, Chou (Cancer Res., 70(2): 440-450, 2010), and it is known that said CI values can determine whether drugs have a synergistic or additive effect when administered in combination; however the claim does not provide any equations or steps for determining how to arrive at a CI value for a particular drug combination, and as such the metes and bounds of the claim are unclear. The claim is therefore indefinite.
Applicant is informed that this rejection of the claims under 35 U.S.C. 112(b) may be overcome by amending the claim to provide equations or steps for determining how to arrive at a CI value for a particular drug combination.
Claims 3-7 and 9-15 are included in this rejection, because these claims depend from claim 1 but do not cure the deficiencies of claim 1 with respect to 35 U.S.C. 112(b).
35 U.S.C. 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 3, 4, and 7 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The purpose of the written description requirement is to ensure that the inventor had possession, at the time the invention was made, of the specific subject matter claimed. To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116.
Claim 3 is drawn to an anti-OAcGD2 ganglioside antibody that comprises the VL of SEQ ID NO: 1 and the VH of SEQ ID NO: 2. Each of SEQ ID NO(s): 1 and 2 comprise numerous variable amino acid sequences, which include variability within the complementarity-determining regions (CDRs). Upon a review of the specification, various VLs and VHs have been adequately described by CDR amino acid sequence, specifically, the VLs of SEQ ID NO(s): 34-40 and the VHs of SEQ ID NO(s): 41-51; however even though Applicant has disclosed multiple species within said genus, the specification does not provide adequate written description for the entire claimed genus, because one skilled in the art would be unable to immediately envision, recognize, or distinguish at least most of the members comprised within the genus claimed, specifically, which light and heavy chain CDR sequences (and combinations of said CDR sequences) give rise to antibody molecules capable of binding OAcGD2. As detailed below Applicant’s disclosure is not sufficient to demonstrate possession of the entire claimed genus, and as such Applicant’s disclosure does not satisfy the written description requirement of 35 U.S.C. 112(a).
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
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A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. In the instant case, Applicant has disclosed multiple species within the genus claimed; however given the substantial antibody structure variation within the genus, as well as the high level of unpredictability in the art, the disclosure of said species comprised within the claimed genus is not sufficiently representative of the entire genus.
Furthermore Applicant has not disclosed relevant, identifying characteristics of CDR region amino acid sequences (or combinations thereof) that confer upon an antibody the ability to bind OAcGD2, because the instant specification does not provide structural antibody features that correlate with a functional ability to bind OAcGD2. To elaborate on why the claimed antibodies lack adequate written description, Mariuzza (Annu. Rev. Biophys. Biophys. Chem., 16: 139-159, 1987, in IDS from 05/22/2023) reviews the structural basis of antigen-antibody recognition and teach that naturally occurring conventional antibodies comprise two polypeptides, the so-called light and heavy chains. The antigen-combining site of an antibody is a three-dimensional structure that fully comprises six CDRs, three each from the light and heavy chains. The amino acid sequences of the CDRs are hypervariable, as the amino acid residues contained within the CDRs determine much of the antibody’s antigen-binding specificity. In view of Mariuzza, it is apparent that antibodies having less than all six CDRs that form the antigen binding site of a conventional antibody in their proper context of heavy and light chain variable domains do not describe the particularly identifying structural feature of the antibody that correlates with the antibody’s ability to bind antigen. Absent a description of the at least minimal structural features correlating with a functional ability to bind OAcGD2 which are shared by members of a genus commonly sharing this function, it is submitted that the skilled artisan could not immediately envision, recognize, or distinguish which heavy and light chain CDR amino acid sequences (or combinations thereof) may be combined such that the resultant heavy and light chain variable regions comprise six CDRs that confer the ability to bind OAcGD2.
Although screening techniques can be used to isolate antibodies that possess the ability to bind OAcGD2, Applicant is reminded that the written description requirement of 35 U.S.C. 112 is severable from the enablement provision. As stated in Vas-Cath Inc. v. Mahurkar (CA FC) 19 USPQ2d 1111, 935 F2d 1555, “The purpose of the ‘written description’ requirement is broader than to merely explain how to ‘make and use’; the applicant must also convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.”
Accordingly given the unpredictability associated with antibody CDR region changes on antigen binding and given the lack of particularity with which the claimed antibodies are described in the specification, it is submitted that the skilled artisan could not immediately envision, recognize, or distinguish at least most of the members of the genus to which the claims are directed, and therefore the specification would not reasonably convey to the skilled artisan that Applicant was in possession of the claimed invention at the time the application was filed.
With respect to claims 4 and 7, these claims encompass anti-OAcGD2 antibodies that comprise a one of multiple VLs and one of multiple VHs. The issue with respect to written description, as it pertains to these two claims, is that absent empirical determination, the skilled artisan could not immediately envision, recognize, or distinguish which VL amino acid sequences and which VH amino acid sequences may be combined such that a resultant antigen-binding domain comprises six VH and VL CDRs that confer the ability to bind OAcGD2.
Accordingly given the lack of particularity with which the claimed anti-OAcGD2 antibodies are described in the specification, it is submitted that the skilled artisan could not immediately envision, recognize, or distinguish at least most of the anti-OAcGD2 antibodies to which the claims are directed, and therefore the specification does not demonstrate adequate possession of the claimed invention.
35 U.S.C. 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.
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.
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.
Claims 1, 5, 6, 9-11, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Birkle et al. (US PG PUB 2010/0150910, publication date: 06/17/2010) in view of Sravan et al. (International Journal of Novel Trends in Pharmaceutical Sciences, 5(5): 198-208, 2015) and Chou (Cancer Res., 70(2): 440-446, 2010).
At the Abstract, Birkle et al. teach that “[t]he monoclonal antibodies that only recognise the O-acetylated form of the GD2 [OAcGD2] ganglioside, or fragments of the antibody, for the diagnosis and the treatment of cancers in which the cells express the O-acetylated GD2, the antibody or the fragment recognising the O-acetylated GD2 molecules expressed by the tumoral cells and not recognising the GD2 molecules expressed at the surface of the peripheral nerves, in order to increase the specificity of the diagnosis and reduce the toxicity of the treatments.” At [0041], Birkle et al. teach an anti-OAcGD2 ganglioside antibody that comprises the heavy chain variable region (VH) of SEQ ID NO: 1, which comprises the heavy chain complementarity-determining regions (CDRs) 1-3 of the instant SEQ ID NO(s): 16-18, respectively, and the light chain variable region (VL) of SEQ ID NO: 2, which comprises the light chain CDRs 1-3 of the instant SEQ ID NO(s): 19-21, respectively. At [0210], Birkle et al. teach that “[t]he antibody specificity was examined on IMR32 cells expressing O-acetylated GD2…”
Although Birkle et al. teach the use of an anti-OAcGD2 ganglioside antibody in the treatment of OAcGD2-expressing cancers, Birkle et al. do not teach or suggest an in vitro/ex vivo method of identifying synergistic combination of (i) at least one anti-cancer agent having a molecular mass ranging from 100 Daltons to 200,000 Daltons and, (ii) at least one multimeric antibody or multimeric fragment thereof recognizing the OAcGD2 ganglioside, comprising the steps of: a) incubating primary tumor cells or cancer cell lines cells expressing the O-acetylated form of GD2 ganglioside in vitro with a composition comprising (i) at least one anti-cancer agent having a molecular mass ranging from 100 Daltons to 200,000 Daltons and, (ii) at least one multimeric antibody or multimeric fragment thereof recognizing the OAcGD2 ganglioside, and b) measuring the CI50 index according to the method as disclosed by Chou and Talalay, wherein a CI50 below 1 is indicative of synergism. These deficiencies are remedied by Sravan et al. and Chou.
Sravan et al. teach various FDA-approved drug types for use in treating cancer, including bevacizumab (an angiogenesis inhibitor with a molecular weight of 149KDa), crizotinib (a tyrosine kinase inhibitor with a molecular weight of approx. 450Da), pembrolizumab (a checkpoint molecule inhibitor with a molecular weight of 149KDa), and idelalisib (a PI3Kδ inhibitor with a molecular weight of approx. 415Da), see throughout.
Chou teaches that “[d]rug combination is most widely used in treating the most dreadful diseases, such as cancer and AIDS. The main aims are to achieve synergistic therapeutic effect, dose and toxicity reduction, and to minimize or delay the induction of drug resistance. Toxicity reduction and resistance minimization benefits could also be the outcomes of synergism…” At the Abstract, Chou teaches that “[t]he Chou-Talalay method for drug combination is based on the median-effect equation, derived from the mass-action law principle, which is the unified theory that provides the common link between single entity and multiple entities, and first order and higher order dynamics. This general equation encompasses the Michaelis-Menten, Hill, Henderson-Hasselbalch, and Scatchard equations in biochemistry and biophysics. The resulting combination index (CI) theorem of Chou-Talalay offers quantitative definition for additive effect (CI = 1), synergism (CI < 1), and antagonism (CI > 1) in drug combinations.”
One of ordinary skill in the art would have been motivated with a reasonable expectation of success at the effective filing date of the invention to combine the teachings of Birkle et al., Sravan et al., and Chou to arrive at an in vitro/ex vivo method of identifying synergistic combination of (i) at least one anti-cancer agent having a molecular mass ranging from 100 Daltons to 200,000 Daltons and, (ii) at least one multimeric antibody or multimeric fragment thereof recognizing the OAcGD2 ganglioside, comprising the steps of: a) incubating primary tumor cells or cancer cell lines cells expressing the O-acetylated form of GD2 ganglioside in vitro with a composition comprising (i) at least one anti-cancer agent having a molecular mass ranging from 100 Daltons to 200,000 Daltons and, (ii) at least one multimeric antibody or multimeric fragment thereof recognizing the OAcGD2 ganglioside, and b) measuring the CI50 index according to the method as disclosed by Chou and Talalay, wherein a CI50 below 1 is indicative of synergism. One of ordinary skill in the art would have been motivated to do so, because Birkle et al. teach the use of an anti-OAcGD2 ganglioside antibody in the treatment of OAcGD2-expressing cancers. Furthermore Sravan et al. teach various FDA-approved drug types for use in treating cancer, including bevacizumab (an angiogenesis inhibitor), crizotinib (a tyrosine kinase inhibitor), pembrolizumab (a checkpoint molecule inhibitor), and idelalisib (a PI3Kδ inhibitor), and each of these anti-cancer agents have a molecular mass ranging from 100 Daltons to 200,000 Daltons. Lastly the Chou-Talalay method provides a means for determining whether a particular drug combination is additive, synergistic, or antagonistic.
Based upon these teachings, one of ordinary skill in the art would have been motivated to 1) introduce the anti-OAcGD2 ganglioside antibody of Birkle et al. into cells expressing O-acetylated GD2 in combination with other common anti-cancer agents, such as those of Sravan et al., each of which have a molecular mass ranging from 100 Daltons to 200,000 Daltons, and 2) employ the method of Chou-Talalay to determine whether a particular drug combination is additive, synergistic, or antagonistic. Such a method would provide a means for determining anti-OAcGD2 ganglioside antibody / drug combinations that synergize to provide a therapeutic benefit to patients having cancers that express the OAcGD2 ganglioside. The method of Birkle et al., Sravan et al., and Chou meets the limitations of claim 1 and 9.
With respect to claims 5 and 6, at [0260]-[0261], Birkle et al. teach the preparation of chimeric antigen receptor (CAR) constructs made from an anti-OAcGD2 ganglioside antibody, wherein said CAR comprises an anti-OAcGD2 ganglioside scFv molecule.
With respect to claim 10, at [0031], Birkle et al. teach anti-OAcGD2 ganglioside antibody derivatives, including bispecific antibodies and immunoconjugates.
With respect to claim 11, as indicated above, Sravan et al. teach various FDA-approved drug types for use in treating cancer, including crizotinib (a tyrosine kinase inhibitor).
With respect to the instant claim 13, Birkle et al. teach that “the tumor or cancer expressing the OAcGD2 ganglioside is selected from the group comprising or consisting of neuroblastoma, glioma, retinoblastoma, Ewing’s family of tumors, sarcoma small cell lung cancer, breast cancer, melanoma, metastatic renal carcinoma, head and neck cancer and hematological cancers.” See claim 13 of Birkle et al.
Therefore the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective filing date of the invention, as evidenced by the references.
Claims 12, 14, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Birkle et al. (US PG PUB 2010/0150910, publication date: 06/17/2010) in view of Sravan et al. (International Journal of Novel Trends in Pharmaceutical Sciences, 5(5): 198-208, 2015) and Chou (Cancer Res., 70(2): 440-446, 2010), as applied to claims 1, 5, 6, 10, 11, and 13, and further in view of Chabot (Clinical Pharmacokinet., 33(4): 245-259, 1997).
As indicated above one of ordinary skill in the art would have been motivated with a reasonable expectation of success at the effective filing date of the invention to combine the teachings of Birkle et al., Sravan et al., and Chou to arrive at an in vitro/ex vivo method of identifying synergistic combination of (i) at least one anti-cancer agent having a molecular mass ranging from 100 Daltons to 200,000 Daltons and, (ii) at least one multimeric antibody or multimeric fragment thereof recognizing the OAcGD2 ganglioside, comprising the steps of: a) incubating primary tumor cells or cancer cell lines cells expressing the O-acetylated form of GD2 ganglioside in vitro with a composition comprising (i) at least one anti-cancer agent having a molecular mass ranging from 100 Daltons to 200,000 Daltons and, (ii) at least one multimeric antibody or multimeric fragment thereof recognizing the OAcGD2 ganglioside, and b) measuring the CI50 index according to the method as disclosed by Chou and Talalay, wherein a CI50 below 1 is indicative of synergism. These references do not teach or suggest an anti-cancer agent having a molecular mass ranging from 100 Daltons to 200,000 Daltons, wherein said anti-cancer agent is irinotecan.
Chabot teaches that “[i]n animal models, irinotecan presents a good antitumour activity against various experimental tumour models of mouse or human origins, following intravenous, intraperitoneal and oral administration. Of particular importance, irinotecan has demonstrated remarkable activity against neuroblastomas…” See p. 248.
One of ordinary skill in the art would have been motivated with a reasonable expectation of success at the effective filing date of the invention to combine the teachings of Birkle et al., Sravan et al., Chou, and Chabot to arrive at an in vitro/ex vivo method of identifying synergistic combination of (i) at least one anti-cancer agent having a molecular mass ranging from 100 Daltons to 200,000 Daltons and, (ii) at least one multimeric antibody or multimeric fragment thereof recognizing the OAcGD2 ganglioside, comprising the steps of: a) incubating primary tumor cells or cancer cell lines cells expressing the O-acetylated form of GD2 ganglioside in vitro with a composition comprising (i) at least one anti-cancer agent having a molecular mass ranging from 100 Daltons to 200,000 Daltons and, (ii) at least one multimeric antibody or multimeric fragment thereof recognizing the OAcGD2 ganglioside, and b) measuring the CI50 index according to the method as disclosed by Chou and Talalay, wherein a CI50 below 1 is indicative of synergism, wherein said anti-cancer agent is irinotecan. One of ordinary skill in the art would have been motivated to do so, because one of ordinary skill in the art would have been motivated with a reasonable expectation of success at the effective filing date of the invention to combine the teachings of Birkle et al., Sravan et al., and Chou to arrive at an in vitro/ex vivo method of identifying synergistic combination of (i) at least one anti-cancer agent having a molecular mass ranging from 100 Daltons to 200,000 Daltons and, (ii) at least one multimeric antibody or multimeric fragment thereof recognizing the OAcGD2 ganglioside, comprising the steps of: a) incubating primary tumor cells or cancer cell lines cells expressing the O-acetylated form of GD2 ganglioside in vitro with a composition comprising (i) at least one anti-cancer agent having a molecular mass ranging from 100 Daltons to 200,000 Daltons and, (ii) at least one multimeric antibody or multimeric fragment thereof recognizing the OAcGD2 ganglioside, and b) measuring the CI50 index according to the method as disclosed by Chou and Talalay, wherein a CI50 below 1 is indicative of synergism. Furthermore Chabot teaches that irinotecan has demonstrated remarkable activity against neuroblastomas. By combining the teachings of Birkle et al., Sravan et al., and Chou with those of Chabot, one of ordinary skill in the art would arrive at means of determining whether the administration of an anti-OAcGD2 ganglioside in combination with irinotecan can have a synergistic effect in the treatment of neuroblastomas, which would be useful in determining whether to treat neuroblastoma patients with the combination of an anti-OAcGD2 ganglioside and irinotecan. The invention of Birkle et al., Sravan et al., and Chou with those of Chabot meets the limitations of claims 14 and 15.
With respect to claim 12, it is known in the art that irinotecan is a transport-dependent drug, which means that the drug is unable to cross the cell membrane of cancer cells by itself.
Therefore the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective filing date of the invention, as evidenced by the references.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NELSON B MOSELEY II whose telephone number is (571)272-6221. The examiner can normally be reached on M-F, 9:00-6:00 EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis, can be reached at 571-270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NELSON B MOSELEY II/Primary Examiner, Art Unit 1642
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