Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Claims 4,6-10,12,13, 15-18,22-26,28,30-31,33,38,39,45-47,53,56, 62,63 are pending.
2. Applicant’s election without traverse of Group I, claims in the reply filed on 05/27/26 is acknowledged.
Claims 30-31,33,38,39,45-47, 63 are withdrawn from further consideration by the Examiner, 37 C.F.R. § 1.142(b) as being drawn to nonelected inventions.
Claims 4, 6-10,12,13, 15-18, 22-26,28,53,56,62 read on CAR comprising a Claudin18.2 antigen binding domain and an anti-Claudin 18.2 antibody are under consideration in the instant application.
3. 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.
4. Claims 6, 9, 56 are rejected under 35 U.S.C. 112, first paragraph, as containing 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(s), at the time the application was filed, had possession of the claimed invention.
Applicant is in possession of : CAR comprising a Claudin18.2 antigen binding domain and an anti-Claudin 18.2 antibody each comprising VH of SEQ ID Nos 10, 25,40,55,70,85, 98, 111,124 and VL of SEQ ID Nos 11, 26,41,56,71,86, 99, 112,125 and CAR comprising SEQ ID N0s :13,28,43,58,73,87,100,113126,128,130,132,179-186,195-198,200-201 and 208-211
Applicant is not in possession of : any CAR comprising a Claudin18.2 antigen binding domain and an anti-Claudin 18.2 antibody each comprising VH that is at least 80-99 % identical to SEQ ID Nos 10, 25,40,55,70,85, 98, 111,124 and VL is at least 80-99 % identical to SEQ ID Nos 11, 26,41,56,71,86, 99, 112,125 and CAR comprising SEQ ID N0s is at least 80-99 % identical to SEQ ID Nos:13,28,43,58,73,87,100,113126,128,130,132,179-186,195-198,200-201 and 208-211
The claimed invention is drawn to a genus of antibody that recognize and quantitatively binds to Claudin 18.2, however, structural identifying characteristics of the genus are not disclosed. There is no evidence that there is any per se structure/function relationship between the disclosed
CAR comprising a Claudin18.2 antigen binding domain and an anti-Claudin 18.2 antibody each comprising VH of SEQ ID Nos 10, 25,40,55,70,85, 98, 111,124 and VL of SEQ ID Nos 11, 26,41,56,71,86, 99, 112,125 and CAR comprising SEQ ID N0s :13,28,43,58,73,87,100,113126,128,130,132,179-186,195-198,200-201 and 208-211 and
any CAR comprising a Claudin18.2 antigen binding domain and an anti-Claudin 18.2 antibody each comprising VH that is at least 80-99 % identical to SEQ ID Nos 10, 25,40,55,70,85, 98, 111,124 and VL is at least 80-99 % identical to SEQ ID Nos 11, 26,41,56,71,86, 99, 112,125 and CAR comprising SEQ ID N0s is at least 80-99 % identical to SEQ ID Nos:13,28,43,58,73,87,100,113126,128,130,132,179-186,195-198,200-201 and 208-211.
In determining that the Specification did not support the claimed any CAR comprising a Claudin18.2 antigen binding domain and an anti-Claudin 18.2 antibody each comprising VH that is at least 80-99 % identical to SEQ ID Nos 10, 25,40,55,70,85, 98, 111,124 and VL is at least 80-99 % identical to SEQ ID Nos 11, 26,41,56,71,86, 99, 112,125 and CAR comprising SEQ ID N0s is at least 80-99 % identical to SEQ ID Nos:13,28,43,58,73,87,100,113126,128,130,132,179-186,195-198,200-201 and 208-211, the Specification disclosure is considered. The specification fails to disclose a complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. Thus the skilled artisan could not envision the detailed chemical structure of the encompassed genus of antibodies until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Absent a recitation of distinguishing identifying characteristics, the Specification does not provide adequate written description support of the claimed genus.
Neither is antibody binding seen as sufficiently limiting since an antibody epitope may be as small as 6-15 shared amino acid residues (e.g., Lemer Nature 1982; 299:592-596, see page 595-596) and places no limitations on the function of the protein containing the polypeptide sequence recognized. It is well known in the art of remarkable flexibility of antibody repertoire and that huge variety of antibodies including monoclonal can be made that binds to a single epitope. Thus, disclosing a few antibodies doesn’t describe a genus of antibodies that binds to a particular epitope ( see for example Ferrara et al, 2015 and Lloyd et al., 2009, Protein Engineering, v.22, pages 159-168 and Edwards et al., JMB 2003, v.334,pages 103-118)
Given the well known high level of polymorphism of immunoglobulins / antibodies, the skilled artisan would not have been in possession of the vast repertoire of antibodies and the unlimited number of antibodies encompassed by the claimed invention; one of skill in the art would conclude that applicant was not in possession of the structural attributes of a representative number of species possessed by the members of the genus of any CAR comprising a Claudin18.2 antigen binding domain and an anti-Claudin 18.2 antibody each comprising VH that is at least 80-99 % identical to SEQ ID Nos 10, 25,40,55,70,85, 98, 111,124 and VL is at least 80-99 % identical to SEQ ID Nos 11, 26,41,56,71,86, 99, 112,125 and CAR comprising SEQ ID N0s is at least 80-99 % identical to SEQ ID Nos:13,28,43,58,73,87,100,113126,128,130,132,179-186,195-198,200-201 and 208-211broadly encompassed by the claimed invention.
On 22 February 2018, the USPTO provided a Memorandum clarifying the Written Description Guidelines for claims drawn to antibodies, which can be found at www.uspto.gov/sites/default/files/documents/amgen_22feb2018.pdf. That Memorandum indicates that, in compliance with recent legal decisions, the disclosure of a fully characterized antigen no longer is sufficient written description of an antibody to that antigen. Accordingly, the instant claims have been re-evaluated in view of that guidance.
“[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.
MPEP § 2163 states 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, 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. A “representative number of species” means that the species which are adequately described are representative of the entire genus. See, e.g., AbbVie Deutschland GMBH v. Janssen Biotech, 759 F.3d 1285, 111 USPQ2d 1780 (Fed. Cir. 2014). Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure “indicates that the patentee has invented species sufficient to constitute the gen[us].” See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615. “A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when … the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed.”
Functionally defined genus claims can be inherently vulnerable to invalidity challenge for lack of written description support, especially in technology fields that are highly unpredictable, where it is difficult to establish a correlation between structure and function for the whole genus or to predict what would be covered by the functionally claimed genus. See ABBVIE DEUTSCHLAND GMBH & 2 CO. v. JANSSEN BIOTECH, INC., Appeals from the United States District Court for the District of Massachusetts in Nos. 09-CV-11340-FDS, 10-CV-40003-FDS, and 10-CV-40004-FDS, Judge F. Dennis Saylor, IV. See also Ariad, 598 F.3d at 1351 (“[T]he level of detail required to satisfy the written description requirement varies depending on the nature and scope of the claims and on the complexity and predictability of the relevant technology.”); see also Centocor Ortho Biotech, Inc. v. Abbott Labs., 636 F.3d 1341, 1352 (Fed. Cir. 2011) (noting the technical challenges in developing fully human antibodies of a known human protein).
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.)
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481, 1483.
The Federal Circuit has recognized that "the written description requirement can in some cases be satisfied by functional description," it has made clear that "such functional description can be sufficient only if there is also a structure-function relationship known to those of ordinary skill in the art." In re Wallach, 378 F.3d 1330, 1335 (Fed. Cir. 2004); see also, Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 964 (Fed. Cir. 2002) (holding that the written description requirement would be satisfied "if the functional characteristic of preferential binding ... were coupled with a disclosed correlation between that function and a structure that is sufficiently known or disclosed"); Amgen Inc. v. Sanofi, 782 F.3d 1367, 1378 (Fed. Cir. 2017) (holding that an "adequate written description must contain enough information about the actual makeup of the claimed products"). Here, the specification provides a functional description of the claimed antibody- i.e., that it binding to Claudin 18.2, but the specification does not identify any disclosure of a correlation between the claimed function and the structure of the antibodies that perform that function.
Federal Circuit clarification of the law of written description as it applies to antibodies. The U.S. Court of Appeals for the Federal Circuit (Federal Circuit) decided Amgen v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017), which concerned adequate written description for claims drawn to antibodies. The Federal Circuit explained in Amgen that when an antibody is claimed, 35 U.S.C. § 112(a) requires adequate written description of the antibody itself. Amgen, 872 F.3d at 1378-79. The Amgen court expressly stated that the so-called "newly characterized antigen" test, which had been based on an example in USPTO-issued training materials and was noted in dicta in several earlier Federal Circuit decisions, should not be used in determining whether there is adequate written description under 35 U.S.C. § 112(a) for a claim drawn to an antibody. Citing its decision in Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., the court also stressed that the "newly characterized antigen" test could not stand because it contradicted the quid pro quo of the patent system whereby one must describe an invention in order to obtain a patent. Amgen, 872 F.3d at 1378-79, quoting Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1345 (Fed. Cir. 2010). In view of the Amgen decision, adequate written description of a newly characterized antigen alone should not be considered adequate written description of a claimed antibody to that newly characterized antigen, even when preparation of such an antibody is routine and conventional.
Also, it is noted that the Court has held that the disclosure of screening assays and generalclasses 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).
Note that the claims do not recite and the specification does not provide sufficient written description of the structure-identifying any CAR comprising a Claudin18.2 antigen binding domain and an anti-Claudin 18.2 antibody each comprising VH that is at least 80-99 % identical to SEQ ID Nos 10, 25,40,55,70,85, 98, 111,124 and VL is at least 80-99 % identical to SEQ ID Nos 11, 26,41,56,71,86, 99, 112,125 and CAR comprising SEQ ID N0s is at least 80-99 % identical to SEQ ID Nos:13,28,43,58,73,87,100,113126,128,130,132,179-186,195-198,200-201 and 208-211 that can binds to Claudin 18.2
Given the claimed broadly class of antibodies and in the absence of sufficient disclosure of relevant identifying characteristics for the broadly claimed genus of any CAR comprising a Claudin18.2 antigen binding domain and an anti-Claudin 18.2 antibody each comprising VH that is at least 80-99 % identical to SEQ ID Nos 10, 25,40,55,70,85, 98, 111,124 and VL is at least 80-99 % identical to SEQ ID Nos 11, 26,41,56,71,86, 99, 112,125 and CAR comprising SEQ ID N0s is at least 80-99 % identical to SEQ ID Nos:13,28,43,58,73,87,100,113126,128,130,132,179-186,195-198,200-201 and 208-211.
encompassing various structures, specificities and functional limitations encompassed by the claimed methods,
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 a genus of any CAR comprising a Claudin18.2 antigen binding domain and an anti-Claudin 18.2 antibody each comprising VH that is at least 80-99 % identical to SEQ ID Nos 10, 25,40,55,70,85, 98, 111,124 and VL is at least 80-99 % identical to SEQ ID Nos 11, 26,41,56,71,86, 99, 112,125 and CAR comprising SEQ ID N0s is at least 80-99 % identical to SEQ ID Nos:13,28,43,58,73,87,100,113126,128,130,132,179-186,195-198,200-201 and 208-211.
encompassing various structures, specificities and functional limitations
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).
Therefore, there is insufficient written description for the genus of any CAR comprising a Claudin18.2 antigen binding domain and an anti-Claudin 18.2 antibody each comprising VH that is at least 80-99 % identical to SEQ ID Nos 10, 25,40,55,70,85, 98, 111,124 and VL is at least 80-99 % identical to SEQ ID Nos 11, 26,41,56,71,86, 99, 112,125 and CAR comprising SEQ ID N0s is at least 80-99 % identical to SEQ ID Nos:13,28,43,58,73,87,100,113126,128,130,132,179-186,195-198,200-201 and 208-211.
at the time the invention was made and as disclosed in the specification as filed under the written description provision of 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph.
Applicant has been reminded that Vas-Cath makes clear that the written description provision of 35 USC 112 is severable from its enablement provision. (See page 1115.)
A skilled artisan cannot, as one can do with a fully described genus, visualize or recognize the identity of the members of the genus that exhibit this functional property.
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.
The USPTO has released a Memo on the Clarification of Written Description Guidance For Claims Drawn to Antibodies and Status of 2008 Training Materials, 02/22/2018.
See https://www.uspto.gov/sites/default/files/documents/amgen_22feb2018.pdf.
The Memo clarifies the applicability of USPTO guidance regarding the written description requirement of 35 U.S.C. § 112(a) concerning the written description requirement for claims drawn to antibodies, including the following.
“In view of the Amgen decision, adequate written description of a newly characterized antigen alone should not be considered adequate written description of a claimed antibody to that newly characterized antigen, even when preparation of such an antibody is routine and conventional”.
“When a patent claims a genus using functional language to define a desired result, the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus.” See Capon v. Eshhar, 418 F.3d 1349 (Fed. Cir. 2005).
“A sufficient description of a genus . . . requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can "visualize or recognize" the members of the genus.” See AbbVie, 759 F.3d at 1297, reiterating Eli Lilly, 119 F.3d at 1568-69.
In Amgen Inc. v. Sanofi, 124 USPQ2d 1354 (Fed. Cir. 2017), relying upon Ariad Pharms., Inc. v. Eli Lily & Co., 94 USPQ2d 1161 (Fed Cir. 2010), the following is noted.
To show invention, a patentee must convey in its disclosure that is “had possession of the claimed subject matter as of the filing date. Demonstrating possession “requires a precise definition” of the invention. To provide this precise definition” for a claim to a genus, a patentee must disclose “a representative number of species within the scope of the genus of structural features common to the members of the genus so that one of skill in the art can visualize or recognize the member of the genus” (see Amgen at page 1358).
This it is the Examiner’s position that one of skill in the art would conclude that the specification fails to disclose a representative number of species to describe the claimed genus of any CAR comprising a Claudin18.2 antigen binding domain and an anti-Claudin 18.2 antibody each comprising VH that is at least 80-99 % identical to SEQ ID Nos 10, 25,40,55,70,85, 98, 111,124 and VL is at least 80-99 % identical to SEQ ID Nos 11, 26,41,56,71,86, 99, 112,125 and CAR comprising SEQ ID N0s is at least 80-99 % identical to SEQ ID Nos:13,28,43,58,73,87,100,113126,128,130,132,179-186,195-198,200-201 and 208-211.
5. 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.
6. 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.
7. Claims 4, 6,-10,12,13, 15-18, 22-26,28,53,56,62 are rejected under 35 U.S.C. 112( a,b )on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of variant species of anti-Claudin18.2 antigen-binding domain is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons:
It is known in the art that the amino acid residues that define the structure of the
complementarity determining regions (CDR) of an antibody are critical to the functional specificity and affinity of the antibody for the target antigen, such that the 3 CDRs of the heavy and light chains form the antigen-binding domain of the antibody paratope, where critical contacts with the antigen epitope occur during binding (for review see MacCallum et al., 1996). Further, it is known that the heavy chain CDR2 and CDR3 regions contain most of the residues that have a major contribution to the binding free energy of the antigen binding domain (Dondelinger et al., 2018; pg. 8, col. 1, para. 2 – col. 2, para. 1). The CDR3, in particular, is highly variable. The assembly of the variable regions from the V(D)J genes is such that, following the recombination mechanisms, the joined regions are part of CDR3. The CDR3 loops are often critical for antigen binding in Igs and appear to provide the principal peptide binding residues in TCRs as well. Structural analysis has demonstrated that one or both of the CDR3 loops of the Ig heavy or light chain are always involved in antigen contact (Rock et al., 1994). Thus, when assessing the functional identity of an antibody, or antigen binding protein, the length and amino acid sequences of the set of CDRs are a critical structural characteristic of the protein as a whole.
Regarding the “single structural similarity” of a proper Markush grouping, the alternatives must share a substantial structural feature from which the common use flows. In the case of the instant a Claudin 18.2 antigen binding domain, which are interpreted as antibodies, the common functionality of binding to Claudin18.2 would flow from the CDRs, and in particular the CDR3 regions. Applicants present various alternative embodiments, each comprising a light chain CDR3 and a heavy chain CDR3, wherein there are 16 different L-CDR3s and 28 different H-CDR3s. When comparing the sharedness of amino acid structure of the alternate CDR3 regions, it is clear they may be quite distinct. That is, a common base sequence structure from which techniques such as affinity maturation may be used to determine specific point mutations in order to generate variant embodiments. However, in this case, it may be as applicants claimed at least 10 variants.
Section 803.04 of the MPEP states that “sequences that encode different proteins are structurally distinct and are deemed to constitute distinct and independent inventions.” The 10 variants of Claudin 18.2 antigen binding domain described are not all members of the same recognized physical or chemical class or the same art-recognized class, as the disclosed binding proteins are novel. Also, 10 variants of Claudin 18.2 antigen binding domain described do not share a single structural similarity from which the common functionality of binding to Claudin 18.2 naturally flows. Therefore, the 10 distinct species of binding proteins do no comprise a “proper” Markush grouping. The elected species of anti-Claudin 18.2 antibodies comprising VH of SEQ ID NO: 10 and VL of SEQ ID N:11, respectively, has been searched and found to be free of the prior art. As the alternative species of claims 4 and 53 are not a proper Markush grouping, the examiner has not extended the search beyond the elected species, as per MPEP section 803.03(III)(C)(2). As claims 4 and 53 are rejected, so too are claims 6,-10,12,13, 15-18, 22-26,28, 56,62, as they depend from rejected claims, but are not limited to a single species of anti-Claudin 18.2 antibodies and therefore do not rectify the issue.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
8. 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.
9. The claims 4, 6,-10,12,13, 15-18, 22-26,28,53,56,62 are provisionally rejected on the grounds of nonstatutory double patenting of the claims of copending Application No 17/005757.
Although the conflicting claims are not identical, they are not patentably distinct from each other because claims of copending Application No 17/005757 recited CAR comprising a Claudin18.2 antigen binding domain and an anti-Claudin 18.2 antibody.
This is a provisional nonstatutory double patenting rejection because the conflicting claims have not in fact been patented.
10. No claim is allowed.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michail Belyavskyi whose telephone number is 571/272-0840. The examiner can normally be reached Monday through Friday from 9:00 AM to 5:30 PM. A message may be left on the examiner's voice mail service. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Gregory Emch can be reached on 571/ 272-8149
The fax number for the organization where this application or proceeding is assigned is 571/273-8300
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/MICHAIL A BELYAVSKYI/Primary Examiner, Art Unit 1644
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