DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s election without traverse of group I, claims 1-10, 13-15, 23, and 27, in the reply filed on 7/2/26, is acknowledged. Applicant has elected SEQ ID NO: 5 as species of VH, SEQ ID NO: 14 as species of VL, and a CAR construct as the species of molecule comprising the claimed antibody. Claims 18-20, 25, and 29 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention. Applicant indicates that claim 10 reads on the elected species. However, the species election was to elect between an immunoconjugate, the CAR and the multispecific binding protein as distinct species. The instant specification discloses that an immunoconjugate refers to a polypeptide containing an antibody and an effector molecule, wherein the effector molecule has a desired effect on cells targeted by the immunoconjugate, and that an effector molecule is, for example, a therapeutic agent, or a diagnostic agent. Therefore, an immunoconjugate is distinct from a CAR. For example, an immunoconjugate comprises an effector molecule, such as a therapeutic agent, that has a desired effect on cells targeted by the immunoconjugate, while a CAR does not. Rather, a CAR comprises an antibody binding domain fused to a transmembrane domain and in intracellular domain, and is configured to transmit a signal into the cell which expressed the CAR. Therefore, claims 10 and 15 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to non-elected species.
Claims 1-9, 13-14, 23, and 27 are being acted upon.
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 1-9, 13-14, 23, and 27 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 is indefinite in the recitation that the CDR1 comprises “amino acid sequences set forth in SEQ ID NO: 18 and 21”. The scope of the claimed CDR1 is unclear and indefinite. SEQ ID NO: 18 and 21 are nearly identical sequences, with a single amino acid difference. Does the claim require that both complete sequences are present, i.e. comprises “amino acid sequences” set for in SEQ ID NO 18 “and” 21? Is the claim intending to encompass any partial sequence from either sequence? Does the claim mean to recite that CDR1 comprises SEQ ID NO:18 or 21? It is noted that the dependent claims set forth VL sequences that have either SEQ ID NO; 18 or 21 as CDR1, and therefore for the purposes of applying prior art, the claim is being interpreted as encompassing a VL with either SEQ ID NO: 18 or SEQ ID NO: 21 as VL CDR1.
The scope of the CDRs required in claim 1 and 7 is unclear and indefinite. Claim 1 recites that the antibody comprises a VH and/or a VH region, wherein the VH comprises CDR1, CDR2, and CDR3 comprising an amino acid sequence set forth in SEQ ID NO: 15, 16, and 17, respectively, and the VL comprises an amino acid sequence set forth in SEQ ID NO: 18/21, SEQ ID NO: 19, and SEQ ID NO: 20. This would appear to require that the antibody comprises at least comprises 3 defined CDRs, i.e. CDR1 having SEQ ID NO: 15, CDR2 having SEQ ID NO: 16, and CDR3 having SEQ ID NO: 17, for example. However, dependent claim 7 refers to the CDR1, the CDR2, and the CDR3 with certain percent identity and/or substitutions. It is therefore unclear if claim 1 is intending to encompass CDR variants. Is the recitation of, for example, “an” amino acid sequence set forth in SEQ ID NO: 15 meant to encompass a subsequence from SEQ ID NO: 15? For example, would claim 1 encompass 3 amnio acids in common with SEQ ID NO: 15, which would represent “a” sequence of amino acids set for in SEQ ID NO: 15.
The scope of claim 2 is unclear and indefinite. The claim recites that the antibody comprises certain heavy chain and light chain framework regions from certain SEQ ID Nos, using Kabat numbering. The claim depends from claim 1, which is directed to an antibody comprising a humanized heavy chain variable region and/or a humanized light chain variable region, wherein the heavy chain variable region comprises “a human derived heavy chain framework region”, and the light chain variable region comprises “a human-derived light chain framework region”. Claim 2 specifies that “the heavy chain framework region” and “the light chain framework” region comprise, for example, HFR1, HRF2, HRFR3 of IgHV-13*-1 set forth in SEQ ID NO: 11. It is unclear what “the heavy chain framework region” refers to, or what is the antecedent basis for the limitation. For example, does the claim intend that the human derived heavy chain framework region comprises the recited framework regions from SEQ ID NO: 11? Or does the claim mean that the framework regions are derived from a human framework region set forth in SEQ ID NO: 11? The former interpretation would require, for example, HFR1, HRF2, HRFR3 of IgHV-13*-1 set forth in SEQ ID NO: 11, while the latter interpretation would encompass sequences derived therefrom, which would include substitutions. Given that claims 3 and 4, which depend from claim 2, encompass mutations to the framework regions of claim 2, the latter interpretation is given for claim 2, i.e. that framework region of claim 1 is derived from a human heavy chain framework region comprising HFR1, HRF2, HRFR3 of IgHV-13*-1 set forth in SEQ ID NO: 11, for example.
Claim 4 is also unclear in that it recites that the light chain framework region comprises “at most one mutation”. The claim does not specify what the mutations are relative to, and the scope of the claims is unclear since there are numerous recitations of “framework regions” in claim 2, from which the claim depends. For example claim 2, recites that the light chain comprises “framework regions” LFR1, LFR2, LFR3 and “a framework region” LFR3. Does claim 4 intend that the antibody must comprise all of light chain framework regions LFR1-LFR4 having the sequences from SEQ ID NO: 9 and 10, with only 1 mutation in the entire framework region? Would the claim encompass a light chain framework region LFR4 with at most one mutation? The scope of the claim is unclear. For the purposes of applying prior art, the claim is being interrupted as requiring at least one light chain framework region comprising at most one amino acid residue compared with one of the framework regions recited in claim 2. For example, the claim would encompass an antibody comprising a light chain framework region LFR2 with at most one mutation as compared to LFR2 from SEQ ID NO: 9.
Regarding claims 3-5, 7-8, and 14 the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 9 is 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. Claim 9 recites that the antigen binding fragment is “CDR fragments”. However, the claim depends from claim 1 which requires an antibody having either a VH or a VL, each with 3 CDRs. Claim 9 appears to encompass a CDR as the antigen binding fragment thereof which is broader in scope than claim 1, from which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 1-9, 13-14, 23, and 27 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. Specifically, there is insufficient written description to demonstrate that applicant was in possession of the claimed genus of antibodies or antigen binding fragments specifically binding to GPC3.
The guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112, § 1 "Written Description" Requirement make clear that if a claimed genus does not show actual reduction to practice for a representative number of species, then the Requirement may be alternatively met by 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 genus (Federal Register, Vol. 66, No. 4, pages 1099-1111, Friday January 5, 2001, see especially page 1106 column 3).
The instant claims are directed to a genus of antibodies or antigen binding fragments specifically binding to GPC3, wherein the antibodies are defined by a partial structure, i.e. comprising a humanized heavy chain variable region “and/or” a humanized light chain variable region, wherein the heavy chain variable comprises a CDR1, a CDR2, and a CDR3 comprising an amino acid sequence set forth in SEQ ID NO: 15, 16, or 17, respectively, and wherein the light chain variable region comprising a CDR1, a CDR2, and a CDR3 comprising an amino acid sequence set forth in SEQ ID NO: 18/21, 19, or 20, respectively. The state of the art is such that antibody variable regions are composed of a heavy and light chain, each involved in providing for binding specificity. Variability in the antigen binding site is achieved by V(D)J recombination via heavy and light chain pairing, with the most diverse regions being the 6 CDR regions in the heavy and light chain. While the heavy chain is the most diverse, light chains are also important for binding specificity of antibodies, and swapping light chains can change the antigen specificity of the antibody (see Townsend et al., 2016, pages 1-2, in particular). Furthermore, the light chain repertoire is extremely diverse being encoded by kappa and lambda gene segments, each with different V and J genes. For example, Townsend teaches analysis of 29,000 distinct light chains having significant differences in physiochemical properties. See also Janeway, which teaches that the antibody repertoire in humans is at least 1011, with a large degree of diversity in both heavy and light chains. For kappa light chains, there are approximately 40 functional V gene segments and five J gene segments, and thus potentially 200 different Vkappa regions. Janeway teaches that for lambda light chains, there are approximately 30 functional V lambda segments and four J gene segments yielding 12 possible V lambda regions, so in all 320 different light chains can be make as a result of combination different light chain gene segments. These can also be further varied by a process of somatic hyper mutation. Furthermore, the diversity of the immunoglobulin repertoire is mediated in part by different combinations of heavy and light chain V regions that pair to form a unique antibody binding site. See, for example, Rabia, 2018, which teaches that the maximal chemical diversity of antibody CDRs is unimaginably large and is extremely challenging to define the sequence determinant of antibody specificity (see page 4).
The instant claims also recite that the VH and VL domains comprise CDRs comprising “an” amino acid sequence set forth in the claimed SEQ ID Nos.. For example, three amino acids in common with the 16 amino acid CDR2 of SEQ ID NO: 16 could be “an” amino acid sequence shown in SEQ ID NO: 16. See also dependent claim 7, wherein the antibodies can comprise CDRs having mutations relative to the CDRs in the recited SEQ ID Nos. The state of the art is such that the 6 CDRs of an antibody are critically involved in antigen binding, that even single amino acid changes can alter antigen specificity of binding, and that CDR mutations are unpredictable in terms of affinity, specificity, and solubility, and are also context dependent (see Hall, 1992, and Rabia, 2018). The specification discloses VH/VL pairs comprising CDRS disclosed of SEQ ID NO: 15-17 and 18-21. These are not sufficiently representative of the genus of antibodies or fragments thereof encompassed by the instant claims, which comprise only a VH or VL with defined CDRs, while the corresponding VH or VL could by any sequence. This is also not representative of the genus of CDRs encompassing those having as little as 80% identity or having numerous mutations to said SEQ ID NO:s.
The instant application has not provided a sufficient description showing possession of the necessary 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 genus of antibodies and inhibitors encompassing various structures, specificities and functions. Further, the Court has interpreted 35 U.S.C. §112, first paragraph, to require the patent specification to “describe the claimed invention so that one skilled in the art can recognize what is claimed. Enzo Biochem, Inc. v. Gen-Probe Inc, 63 USPQ2d 1609 and 1618 (Fed. Cir. 2002).
In evaluating whether a patentee has fulfilled this requirement, our standard is that the patent’s “disclosure must allow one skilled in the art ‘to visualize or recognize the identity of’ the subject matter purportedly described.” Id. (quoting Regents of Univ. of Cal. v. Eli Lilly & Co., 43 USPQ2d 1398 (Fed Cir. 1997)).
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that "applicant must 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." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116.)
Also, it is noted that the Court has held that the disclosure of screening assays and general classes of compounds was not adequate to describe compounds having the desired activity: without disclosure of which peptides, polynucleotides, or small organic molecules have the desired characteristic, the claims failed to meet the description requirement of § 112. See University of Rochester v. G.D. Searle & Co., lnc., 69 USPQ2d 1886,1895 (Fed. Cir. 2004).
Meeting the written description threshold requires showing that the applicant was in “possession” of the claimed invention at the time of filing. Vas-Cath, 935 F.2d at 1563-1564. Support need not describe the claimed subject matter in exactly the same terms as used in the claims. Eiselstein v. Frank, 52 F.3d 1035, 1038 (Fed. Cir. 1995). This support cannot be based on obviousness reasoning – i.e., what the written description and knowledge in the art would lead one to speculate as to modifications the inventor might have envisioned, but failed to disclose. Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997). Ariad points out, the written description requirement also ensures that when a patent claims a genus by function, the specification recites sufficient materials to accomplish that function - a problem that is particularly acute in biological arts." Ariad, 598 F.3d at 1352-3. Note the following Court Decisions regarding the written description of antibodies in the context of the current claims.
Given the claimed broadly class of antibodies, in the absence of sufficient disclosure of relevant identifying characteristics, the patentee must establish “a reasonable structure-function correlation” either within the specification or by reference to the knowledge of one skilled in the art with functional claims. AbbVie Deutschland GmbH & Co. v. Janssen Biotech, Inc. (Fed. Cir. 2014) and the specification at best describes plan for making antibodies with the “limitations above” and then identifying those that satisfy claim limitations, but mere “wish or plan” for obtaining claimed invention is not sufficient. Centocor Ortho Biotech Inc. v. Abbott Laboratories, 97 USPQ2d 1870 (Fed. Cir. 2011). There is insufficient written description of the required kind of structure-identifying information about the corresponding makeup of the claimed antibodies to demonstrate possession. Also, see Amgen Inc. v. Sanofi, Aventisub LLC, No. 2017-1480 (Fed. Cir. 2017). Thus, one of skill in the art would conclude that the specification fails to provide adequate written description to demonstrate that Applicant was in possession of the claimed genus. See Eli Lilly, 119 F. 3d 1559, 43, USPQ2d 1398.
Claims 1-5, 7-9, 13-14, 23, and 27 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for:
An antibody or an antigen binding fragment specifically binding to GPC3 comprising a humanized heavy chain variable region and a humanized light chain variable region;.
does not reasonably provide enablement for:
An antibody or an antigen binding fragment specifically binding to GPC3 comprising a humanized heavy chain variable region or a humanized light chain variable region.
The specification disclosure is insufficient to enable one skilled in the art to practice the invention as claimed without an undue amount of experimentation. Undue experimentation must be considered in light of factors including: the breadth of the claims, the nature of the invention, the state of the prior art, the level of one of ordinary skill in the art, the level of predictability of the art, the amount of direction provided by the inventor, the existence of working examples, and the quantity of experimentation needed to make or use the invention, in re Wands, 858 F.2d at 737, 8 USPQ2d at 1404 (Fed. Cir. 1988).
“The amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art.” In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). The “amount of guidance or direction” refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention. The more that is known in the prior art about the nature of the invention, how to make, and how to use the invention, and the more predictable the art is, the less information needs to be explicitly stated in the specification. In contrast, if little is known in the prior art about the nature of the invention and the art is unpredictable, the specification would need more detail as to how to make and use the invention in order to be enabling (MPEP 2164.03)” The MPEP further states that physiological activity can be considered inherently unpredictable.
The instant claims encompass an antibody or antigen binding fragment specifically binding to GPC3, wherein the antibody or fragment comprises only a VH or VL. See also dependent claim 9, which recites numerous species that encompass an antibody fragment with only a VH or a VL, such as a domain antibodies, a VH single domain antibody, a CDR fragment, or a minimal recognition unit. The state of the art is such conventional antibodies are exclusively expressed as parried heavy and light chains, and simply removing the VL domain in antibodies that were selected for binding in the presence of a cognate VL does not result in a functional, stable, domain antibody (see Rouet, 2015 and Holt et al., page 485, in particular). VH only antibody binding regions are found in camels, and screening can be performed to isolated camelid VHH sequences. However, conventional VH only domains, are difficult to produce and problems relating to stability and poor biophysical properties hamper their isolation (see Rouet, page 11905). Thus, making and using the genus of antibodies or antibody fragments that binds GPC3 and comprises a VH or a VL, as encompassed by the present claims, would be highly unpredictable.
Thus, based on the breadth of the claims and the unpredictability of the art, the instant specification must provide a sufficient and enabling disclosure, commensurate in scope with the instant claims. The instant specification only discloses antibodies that bind GPC3 that have a VH and a VL. Thus, based on the breadth of the claims, the unpredictability of the art, and the lack of guidance provided by the instant specification, it would require undue experimentation to make and use the antibodies and antigen binding fragments thereof, as broadly claimed.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-9, 23, and 27 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20070190599.
The ‘599 publication teaches a humanized anti-glypican 3 (i.e. GPC3) antibody having a VH sequence of SEQ ID NO: 88 and a VL of SEQ ID NO: 92 (see paragraph 320, in particular). Said VH and VL comprise CDR1-3 of SEQ ID NO; 15-17 and SEQ ID NO: 18-20, respectively. Said SEQ ID NO: 88 is 96.7% identical to SEQ ID NO: 5 of the instant application, and said SEQ ID NO: 92 is 98.6% identical to SEQ ID NO: 14 of the instant application, thus meeting the limitation of claim 5-6 (see attached alignments). Regarding claim 2, given the overall similarity above, the antibody of the prior art would comprising HFR according to the claims with certain mutations, and are within the scope of the claim. In other words ,the VH and VL would comprise framework regions derived from human frameworks set forth in SEQ ID NO: 9-12 of the instant claims and thus meet the limitations of claim 2. Regarding claim 3, said SEQ ID NO: 88 comprises I69L as compared to SEQ ID NO: 9. Regarding claim 4, SEQ ID NO: 92 comprises a light chain variable region FR4 100% identical to SEQ ID NO: 10 of the instant application (i.e. a light chain framework region comprising zero mutations which is within the scope of at most one). The ‘599 publication teaches KD not greater than 1E-7M (see Fig. 15, for example). The ‘599 publication teaches full length antibodies (See examples, in particular). The ‘599 publication teaches pharmaceutical compositions comprising said antibody and a pharmaceutically acceptable carrier (See paragraph 412, in particular). The ‘599 application teaches said antibodies in a plate for testing affinity (see page 7, 22, and Fig. 15, in particular), which meets the limitation of a “kit” comprising said antibody.
Claims 1, 7, 9, 13-14, 23, 27 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2020/017479, as evidenced by the English translation in national stage entry published as US 2023/0071098 (both of record).
WO 2020/017479 teaches a CAR comprising an scFV antigen binding domain that specifically binds to GPC3, a transmembrane domain, and an intracellular signaling domain. Said scFV comprises a VH and VL of SEQ ID NO: 7 and 8, respectively, which comprise the CDRs 100% identical to SEQ ID NO: 15-20 of the instant application (see page 2 of the translation, in particular). WO 2020/017479 teaches that the scFV can comprise human framework regions, i.e. it comprises a humanized VH and VL (see page 4 of the translation, in particular). WO 2020/017479 teaches immunocompetent cell, such as T cells expressing the CAR (see page 2 of the translation, in particular). WO 2020/017479 teaches pharmaceutical compositions and said CAR in a container, which meets the limitation of a kit (See page 6 and 11, in particular).
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-9, 13-14, 23, and 27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3 , 6, 7-8, 10, 14-15, 24, and 28 of copending Application No. 18/275,529, in view of US 20070190599.
The ‘529 application claims a GPC3 antibody or antigen-binding moiety, wherein the antibody comprises a VH, and a VL having CDR1-3 of SEQ ID NO: 537, 538, and 539 which are 100% identical to SEQ ID NO: 18-20 of the instant application, respectively. The ‘529 application claims that the antibody binds to human GPC3 (disclosed as having an affinity of not greater than 1.E-7), a full-length antibody, and wherein the antibody is a humanized antibody. The ‘529 application claims a CAR comprising said antibody and an immunocompetent cell comprising said CAR. The ‘529 application claims pharmaceutical compositions and kits. The ‘529 application claims that the VH comprises SEQ ID NO: 28, which is 75% identical to SEQ ID NO: 5 of the instant application and comprises at least three residues in common with each CDR of claim 1 (i.e. an amino acid sequence set forth in SEQ ID NO: 15-17). The ‘529 application claims that the VL comprises SEQ ID NO 62 which is 91% identical to SEQ ID NO: 14 of the instant application.
Regarding the limitations of claims 2-4, it would be obvious to use the human framework regions taught by the ‘599 application for humanization, thus rendering the limitations obvious.
This is a provisional nonstatutory double patenting rejection.
No claim is allowed.
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Amy E. Juedes
Patent Examiner
Technology Center 1600
/AMY E JUEDES/Primary Examiner, Art Unit 1644
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