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 .
Applicant’s 1-26-26 election of Group I, without traverse, and applicant’s further election of the species of anti-CD73 antibody which have the following features:
Clone name: 19F3H2L3(hG1DM);
VH: SEQ ID NO: 10;
VL: SEQ ID NO: 14;
HCDR1-3: SEQ ID NOs: 15-17; and
LCDR1-3: SEQ ID NOs: 18-20,
is acknowledged.
Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-8, 11, 16 and 18-20 are pending.
Claims 1-8, 11, 16 and 19 are under examination as they read on the species of anti-CD73 antibody which have the following features:
Clone name: 19F3H2L3(hG1DM);
VH: SEQ ID NO: 10;
VL: SEQ ID NO: 14;
HCDR1-3: SEQ ID NOs: 15-17; and
LCDR1-3: SEQ ID NOs: 18-20.
Claims 18 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3-6-26.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. However, support for the claimed invention cannot be determined because the foreign priority documents provided for CN202011152518.9 are not in English. Therefore, the instant application is not entitled to the benefit of the foreign priority date of October 23, 2020.
Accordingly, the filing date of the PCT/CN2021/125564 application (October 22, 2021) will be used for the purpose of applying prior art.
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 1-6, 8, 11 and 19 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 and dependent claims thereof recite (emphasis added), “[a]n anti-CD73 (for example, human CD73) antibody or an antigen-binding fragment thereof, wherein according to an IMGT numbering system, the anti-CD73 antibody comprises: HCDR1, HCDR2 and HCDR3 of a heavy chain variable region set forth in SEQ ID NO: 2, SEQ ID NO: 6 or SEQ ID NO: 10; and LCDR1, LCDR2 and LCDR3 of a light chain variable region set forth in SEQ ID NO: 4, SEQ ID NO: 8, SEQ ID NO: 12 or SEQ ID NO: 14; preferably, according to the IMGT numbering system, the anti-CD73 antibody comprises: HCDR1 comprising or consisting of an amino acid sequence set forth in SEQ ID NO: 15….”
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance, claim the highlighted portions of claim 1 above recite various broad recitations while also reciting “exemplary” or “preferable” narrower limitations, as well as reciting both a definite limitation such as “wherein according to an IMGT numbering system, the anti-CD73 antibody comprises: HCDR1…” and then in the same claim uses “preferable” language that calls into question said definite limitation “preferably, according to the IMGT numbering system, the anti-CD73 antibody comprises: HCDR1….”
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 11 is indefinite for the same reasons given above and further because those of ordinarily skill in art will have different interpretations of the “antibody…according to claim 1, which is contained in a material, wherein the material is selected from the group comprising…” language.
For example, with respect to the “conjugate” embodiment, some of one of ordinary skill in the art may believe that an antibody contained in a material that is “a conjugate” is referring to a combination of the antibody of claim 1 and a second “material” which is “a conjugate.”
However, others of ordinary skill in the art may think that for an antibody to be contained in a material that is “a conjugate” said antibody must be somehow physically integrated with the conjugate in a manner that creates “a material.”
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.
Claim 16 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 enablement requirement. The claim contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claim 16 is drawn to “[a] hybridoma cell line, selected from: LT014 deposited at China Center for Type Culture Collection (CCTCC) under CCTCC NO. C2018137.”
Since the LT014 hybridoma cell line is essential to the claimed invention, it must be obtainable by a repeatable method set forth in the specification or otherwise readily available to the public. If the biological materials are not so obtainable or available, the requirements of 35 U.S.C. § 112 may be satisfied by a deposit of the biological materials.
The specification does not disclose a repeatable process to obtain the LT014 hybridoma cell line and it is not apparent if the LT014 hybridoma cell line is readily available to the public. It is noted that Applicant has deposited the claimed cell line at the China Center for Type Culture Collection (CCTCC) on June 21, 2018 (e.g., Example 1 at page 19 of the specification), but there is no indication in the specification as to public availability. If the deposit was made under the Budapest Treaty, then an affidavit or declaration by Applicant, or a statement by an attorney of record over his or her signature and registration number, stating that the claimed LT014 hybridoma cell line was deposited under the Budapest Treaty and that the claimed LT014 hybridoma cell line will be irrevocably and without restriction or condition released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein. If the claimed LT014 hybridoma cell line was deposited under the Budapest Treaty, then in order to certify that the deposit meets the criteria set forth in 37 C.F.R. 1.801-1.809, Applicant may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number, showing that:
during the pendency of this application, access to the invention will be afforded to the Commissioner upon request;
all restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
the deposit will be maintained in a public depository for a period of 30 years or 5 years after the last request or for the effective life of the patent, whichever is longer;
a test of the viability of the biological material at the time of the deposit will be made (see 37 C.F.R. 1.807); and
the deposit will be replaced if it should ever become inviable.
Applicant’s attention is directed to MPEP § 2400 in general, and specifically to § 2402, 2407, 2408, 2409, 2410, and 2411.05; see also 37 C.F.R. 1.801-1.809. These section of the MPEP § and 37 C.F.R. set forth the regulations and rules associated with claimed deposited material.
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 1, 2, 4-8, 11 and 19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
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., Vas-Cath, Inc., v. Mahurkar, 935 F.2d at 1563, 19 U.S.P.Q.2d at 1116.
“[T]he purpose of the written description requirement is to ‘ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor’s contribution to the field of art as described in the patent specification.’” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1353-54 (Fed. Cir. 2010) (en banc) (quoting Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920 (Fed. Cir. 2004)). To satisfy the written description requirement, the 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. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562-63, 19 USPQ2d 1111 (Fed. Cir. 1991). See also MPEP 2163.04.
For a claim to a genus, a generic statement that defines a genus of substances by only their functional activity does not provide an adequate written description of the genus. Reagents of the University of California v. Eli Lilly, 43 USPQ2d 1398 (CAFC 1997). The recitation of a functional property alone, which must be shared by the members of the genus, is merely descriptive of what the members of the genus must be capable of doing, not of the substance and structure of the members. The Federal Circuit has cautioned that, for claims reciting a genus of antibodies with particular functional properties (e.g., high affinity, neutralization activity, competing with a reference antibody for binding, binding to a certain epitope), claiming antibodies with specific properties, e.g., CD73-binding, can result in a claim that does not meet written description even when the antigen(s) bound by the antibody is known, because antibodies with those properties have not been adequately described. See Centocor Ortho Biotech Inc. v. Abbott Labs., 97 USPQ2d 1870, 1875, 1877-78 (Fed. Cir. 2011).
Along these same lines, as more recent Federal Circuit decision, Amgen v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017), describes how when an antibody is claimed, 35 U.S.C. § 112(a) requires adequate written description of the antibody itself not just a description of the sequence to which the antibody binds. Amgen, 872 F.3d at 1378-79.
The importance of this court decision was expounded upon by Robert W. Bahr, Deputy Commissioner for Patent Examination Policy in a memorandum clarifying the applicability of USPTO guidance regarding the written description requirement of 35 U.S.C. § 112(a) as it relates to claims drawn to antibodies (see Memorandum of February 22, 2018, 2 pages, available at https://www.uspto.gov/sites/default/files/documents/amgen_22feb2018.pdf). Bahr’s memo describes how the so-called “newly characterized antigen” test, which was based on an example in previously issued USPTO training materials and had been used in the past for determining whether there is adequate written description under 35 U.S.C. § 112(a) for a claim drawn to an antibody, is defunct. The Memorandum explains that USPTO personnel should continue to follow the relevant sections of the MPEP pertaining to the written description requirement of 35 U.S.C. § 112(a), except insofar as the MPEP indicates that disclosure of a fully characterized antigen may provide written descriptive support of an antibody to that antigen.
In particular, MPEP § 2163 instructs that 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. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (Claims directed to a functionally defined genus of antibodies were not supported by a disclosure that "only describe[d] one type of structurally similar antibodies" that "are not representative of the full variety or scope of the genus.").”
Note well: even if a selection procedure is disclosed that was, at the time of the invention, sufficient to enable the skilled artisan to identify antibodies with the recited functional properties, the written description provision of 35 U.S.C § 112 is severable from its enablement provision. Ariad, 94 USPQ2d at 1167; Centocor at 1876 (“The fact that a fully-human antibody could be made does not suffice to show that the inventors of the '775 patent possessed such an antibody.”)
In the instant case, the claims are drawn to anti-CD73 antibodies comprising CDR or variable heavy/light chains having less than 100% identity and/or substitutions, insertions or deletions. The instant claims read on antibodies comprising alterations within the CDR regions (<100% identity) which can affect antigen binding to CD73.
Thus, the breadth of the claimed genus is enormous encompassing antibodies having any number of amino acid substitutions, insertions or deletions to the elected species of anti-CD73 antibody sequences, i.e., to the HCDRs of SEQ ID NOs: 15-17 and/or to the LCDRs of SEQ ID NOs: 18-20 and/or to the variable heavy or light chains of SEQ ID NOs: 10 and 14, be they radical or conservative.
However, simply reciting a structure, e.g., antibodies having any number of amino acid substitutions, insertions or deletions to the elected species of anti-CD73 antibody sequences, be they radical or conservative, and its function, e.g., having binding specificity for CD73, provides insufficient identifying characteristic for written description purposes, even when accompanied by a method of obtaining the biomolecule of interest. In re Bell, 991 F.2d 781, 26 U.S.P.Q.2d 1529 (Fed. Cir. 1993). In re Deuel, 51 F.3d 1552, 34 U.S.P.Q.2d 1210 (Fed. Cir. 1995).
Indeed, as shown below the heavy and light chain CDRs of the disclosed anti-CD73 antibodies are completely conserved:
VH:
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VL:
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It is further noted that the specification states the following at page 20, line 21 to page 21, line 7 (emphasis added):
“Example 3. Design and Preparation of Light and Heavy Chains of Humanized Anti-Human
CD73 Antibodies
The variable region sequences of 19F3H1L1(hG1DM), 19F3H2L2(hG1DM) and 19F3H2L3(hG1DM) were obtained by computer modeling antibody models according to model design mutations based on the sequences of the antibody 19F3 obtained in Example 2 and based on the three-dimensional crystal structure of human CD73 protein (Hage T, Reinemer P, Sebald W., Crystals of a 1:1 complex between human interleukin-4 and the extracellular domain of its receptor alpha chain. Eur J Biochem. 1998; 258(2):831-6); [0109] the designed variable region sequences of the humanized antibodies were as follows:
(1) Heavy and Light Chain Variable Region Sequences of Humanized Monoclonal Antibody 19F3H1L1(hG1DM)
The nucleotide sequence of the heavy chain variable region is set forth in SEQ ID NO: 5 with a length of 363 bp.
The encoded amino acid sequence is set forth in SEQ ID NO: 6 with a length of 121 aa, and the sequences of heavy chain CDR1, CDR2 and CDR3 are set forth in SEQ ID NOs: 15, 16 and 17, respectively….”
However, the skilled artisan would not know how to use the above highlighted teachings to understand which variants contained within the vast genus of claimed antibodies will preserve their ability bind to CD73 to the extent necessary to, e.g., inhibit the enzymatic activity of cell surface CD73 (see Example 6), or to inhibit the growth of mouse colon cancer cells ectopically growing the right forelimb of a C57BL/6-hPDl/hPDLl/hCD73 mouse tumor model (see Example 5).
Conservation of the CDR residues is of particular importance because any number of Vh and VL CDR residues are expected, a priori, to contribute to antigen binding and yet the instant specification and the knowledge in the art do not establish which residues of the disclosed CD73-binding antibodies are structurally essential to antigen binding versus those that are tolerant to change, and to what degree, i.e., conservative or radical.
To illustrate this point, consider Vajdos et al. (J Mol Biol. 2002 Jul 5;320(2):415-28, cited herewith) which teaches “[t]he specificity and affinity of an antibody for its cognate antigen is determined by the sequence and structure of the variable fragment (Fv): a heterodimer consisting of the N-terminal domains of the heavy and light chains. Even within the Fv, antigen binding is primarily mediated by the complementarity determining regions (CDRs), six hypervariable loops (three each in the heavy and light chains) which together present a large contiguous surface for potential antigen binding. Aside from the CDRs, the Fv also contains more highly conserved framework segments which connect the CDRs and are mainly involved in supporting the CDR loop conformations, although in some cases, framework residues also contact antigen. As an important step to understanding how a particular antibody functions, it would be very useful to assess the contributions of each CDR side-chain to antigen binding, and in so doing, to produce a functional map of the antigen-binding site.” (see, page 416, column bridging paragraph, emphasis added).
Vajdos goes on to teach that "[b]y analyzing panels of point mutants, a detailed map of the
binding energetics can be obtained, but the process can be very laborious because individual
mutant proteins must be made and analyzed separately. In particular, a comprehensive analysis
of an antigen binding site would ideally encompass all CDR residues, and this would require the
analysis of dozens or even hundreds of point mutants." (see page 416, right column, first
paragraph). Vajdos solution to this dilemma was to make use of a shotgun scanning mutagenesis
which "uses phage displayed libraries of protein mutants constructed using degenerate codons
with restricted diversity." While this method of making libraries of mutants representative of the
potential antigen binding CDR residues was an improvement over previous strategies as taught
by Vajdos, it nonetheless required extensive experimentation to comprehensively scan the
potential CDR sequence space (see page 416, right column, 2nd paragraph and pages 425-427,
Materials and Methods.)
Furthermore, even after performing this comprehensive scanning mutagenesis of all CDR
residues from the particular anti-ErB2 antibody under study, Vajdos would still not have been
able to say which CDR residues were actually involved in antigen binding, and which were
involved in stabilizing the secondary and tertiary structure of the CDRs within the context of the
heavy and light chains as a whole, without the structure of the unbound antigen-binding site of
the antibody to aid in their analysis (see, in particular, Discussion, pages 422-425).
Rather, Vajdos needed to perform not only a comprehensive shotgun scanning mutagenesis of all
CDR residues of the antibody under study, but also needed a structure of the unbound antigen binding site in hand to gain a sufficient understanding of the contribution of each CDR to
antigen-binding to adequately predict which CDR residues can be changed, and to what extent,
or in what context of additional compensatory mutations in other regions of the antibody.
Moreover, given an amino acid substitution that ablated binding, without the crystal structure in
hand, still further experimentation would have been required to determine the flexibility in this
particular residue, i.e., it's general tolerance or intolerance to change.
As yet another example to illustrate the sensitivity of some antibodies to changes in their CDR residues, especially CDR3, consider the teachings of Bedouelle et al. (FEBS J. 2006 Jan;273(1):34-46, cited herewith). While Bedouelle did not comprehensively scan all the CDR residues of their antibody using a combination of alanine and homologous substitutions as shown in Vajdos, Bedouelle did examine the effects of alanine substitutions on each of the residues of the antibody heavy and light chain CDR3 regions and showed mutation of certain residues cause a >100 fold drop in binding affinity (see Table 1). As described by Bedouelle, some of these loss of function mutations were hypothesized to have a direct effect on antigen binding while others were hypothesized to indirectly affect the conformation of the antigen binding site, thereby indirectly affecting antigen binding (see Discussion Section). Thus, the teachings of Bedouelle provide further illustration of the unpredictability of making mutations within the CDR region of an antibody.
Notably, while the teachings of Vajdos and Bedouelle demonstrate the unpredictable effects of even single amino acid changes on antibody:antigen binding, there is an additional level of unpredictability in the art associated with making multiple changes in any given CDR(s).
In particular, even in those instances where one can show certain residues of a given CDR are generally tolerant of single amino acid changes, this does not necessarily mean a combination of single amino acid changes, even to the same residues shown to tolerate change when mutated in isolation, will be tolerated. As an example consider Brown et al. (J Immunol. 1996 May 1;156(9):3285-91, cited on an IDS) which describes how the Vh CDR2 in a particular antibody was generally tolerant of single amino acid changes; however, the antibody lost binding upon the introduction of pairs of single amino changes in the same region (see, in particular Tables I and II and column bridging paragraph on page 3290).
Additionally, as emphasized by the teachings of Colman (Research in Immunology, 145:33-36, 1994, cited herewith) the type of CDR amino acid substitution, i.e., conservative vs. non-conservative, is not necessarily a good predictor of antigen binding: "[t]he above examples paint a confusing picture of the specificity of antibody-antigen interaction. In one structural context, a very conservative substitution may abolish binding; in another, a nonconservative substitution may have very little effect on the binding affinity.” (see pg. 35, top of left column). Rudikoff et al. (Proc. Natl. Acad. Sci. USA, 79: 1979-1983, March 1982, cited herewith) provides another example of how even a conservative change to a single amino acid residue in a CDR region of an antibody can ablate antigen binding (see, for example, Abstract).
Given the above the skilled artisan cannot extrapolate from the disclosure of the instant specification to establish possession of the breadth of the breadth of CD73-binding variants encompassed by the instant claims which will preserve their ability bind to CD73 to the extent necessary to, e.g., inhibit the enzymatic activity of cell surface CD73 (see Example 6), or to inhibit the growth of mouse colon cancer cells ectopically growing the right forelimb of a C57BL/6-hPDl/hPDLl/hCD73 mouse tumor model (see Example 5).
Without a correlation between structure and function, the claim does little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (“definition by function … does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is”).
Without this guidance or direction the skilled artisan would not consider applicant to be in possession of the claimed genus of anti-CD73 antibodies because the skilled artisan recognizes that even seemingly minor changes made without guidance or direction as to the relationship between the particular amino acid sequence of the instantly claimed antibody and its ability to bind antigen, can dramatically affect antigen-antibody binding.
Applicant has not described the claimed invention sufficiently to show they had possession of the claimed genus of antibodies.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-8, 11, 16 and 19 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by the following patent application publications:
20240218074, hereinafter ‘074, cited herewith;
20230159655, hereinafter ‘655, cited on an IDS; and
20230151111, hereinafter ‘111, cited herewith.
The applied references have common inventors and/or a common listed applicant(s), e.g., “Akeso Biopharma, Inc.,” with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Each of the ‘074, ‘655 and ‘111 applications disclose the anti-CD73 antibodies of the instant claims (see obviousness-type double patenting rejections set forth below), and thus the teachings of the ‘074, ‘655 and ‘111 applications anticipate claimed invention.
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 1-8, 11, 16 and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 9-10, 14-15, 16, 22, 30-39 of copending Application No. 17/996,878 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims and those of copending application 17/996,878 are both drawn to the same anti-CD73 antibody comprising the same CDRs, VH, and VL sequences.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-8, 11, 16 and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10-13, 17-20, 22-30, 32 and 33 of copending Application No. 18/264,242 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims and those of copending application 18/264,242 are both drawn to the same anti-CD73 antibody comprising the same CDRs, VH, and VL sequences and methods comprising administering the same anti-CD73 antibody.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-8, 11, 16 and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, 11, 15, 16, 17, 18-23 of copending Application No. 17996841 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims and those of copending application 17996841 are both drawn to the same anti-CD73 antibody comprising the same CDRs, VH, and VL sequences and methods comprising administering the same anti-CD73 antibody.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
It is noted that the above mentioned claims of copending Application No. 17996841 have been allowed as of 6-3-26 and may issue at a future date. Assuming the above mentioned claims issue as a patent in the future, the provisional rejection set forth above may become a non-provisional, nonstatutory double patenting rejection.
No claims are allowed.
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/ZACHARY S SKELDING/Primary Examiner, Art Unit 1644
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