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
1. Claims 1-3, 6,7,9-16, 18-24 are pending.
2, Applicant’s election without traverse of Group I, claims 1-3, 7,21-23 during phone interview on 12/10/25 is acknowledged.
Claims 6, 9-16,18-20 and 24 are withdrawn from further consideration by the Examiner, 37 C.F.R. § 1.142(b) as being drawn to nonelected inventions.
Claims 1-3,7,21-23 read on NKG2A-targeting antibody are under consideration in the instant application.
3. Applicant’s provision of the foreign priority document CN202011320557.5 is acknowledged. However, an English translation has not been provided in accordance with 37 CFR 1.55. See MPEP § 201.15.
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. Claim 3 is 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 : 1) an NKG2A-targeting antibody, comprising LHVR of SEQ ID Nos 10 and 13 and HCVR of SEQ ID NO:11.
Applicant is not in possession of : ) any NKG2A-targeting antibody, comprising LHVR that is 90% identical to SEQ ID Nos 10 and 13 and HCVR that is 90% identical SEQ ID NO:11.
The claimed invention is drawn to a genus of antibody that recognize and quantitatively binds to NKG2A 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 an NKG2A-targeting antibody, comprising LHVR of SEQ ID Nos 10 and 13 and HCVR of SEQ ID NO:11 and any NKG2A-targeting antibody, comprising LHVR that is 90% identical to SEQ ID Nos 10 and 13 and HCVR that is 90% identical SEQ ID NO:11 The specification does not disclosed any amino acid sequences of an NKG2A-targeting antibody, comprising LHVR of SEQ ID Nos 10 and 13 and HCVR of SEQ ID NO:11 that specifically recognize and quantitatively binds to NKG2A.
In determining that the Specification did not support the claimed anti-TIM-3 antibodies, 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. Two of these factors described in the Specification was "a functional recitation of competing for binding" And “structure of epitope”. 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., Lerner 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 an any NKG2A-targeting antibody, comprising LHVR that is 90% identical to SEQ ID Nos 10 and 13 and HCVR that is 90% identical SEQ ID NO:11 encompassing various structures, specificities and functional limitations, broadly encompassed by the claimed invention.
The claims do not define the relevant identifying characteristics, namely the relevant amino acid sequences of the claimed genus of an any NKG2A-targeting antibody, comprising LHVR that is 90% identical to SEQ ID Nos 10 and 13 and HCVR that is 90% identical SEQ ID NO:11 encompassing various structures, specificities and functional limitations that are essential for targeting NKG2A.
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., binding to NKG2A of any NKG2A-targeting antibody, comprising LHVR that is 90% identical to SEQ ID Nos 10 and 13 and HCVR that is 90% identical SEQ ID NO:11 recited in the claim, 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).
Here, the problem here is that the instant specification fails to provide a disclosure of which amino acids are required for the claimed genus of an any NKG2A-targeting antibody, comprising LHVR that is 90% identical to SEQ ID Nos 10 and 13 and HCVR that is 90% identical SEQ ID NO:11 encompassing various structures, specificities and functional limitations that retain the appropriate structural and functional attributes encompassed by the claimed methods.
Given the claimed broadly class of antibodies and in the absence of sufficient disclosure of relevant identifying characteristics for the broadly claimed genus of an any NKG2A-targeting antibody, comprising LHVR that is 90% identical to SEQ ID Nos 10 and 13 and HCVR that is 90% identical SEQ ID NO:11 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 an any NKG2A-targeting antibody, comprising LHVR that is 90% identical to SEQ ID Nos 10 and 13 and HCVR that is 90% identical SEQ ID NO:11 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 an any NKG2A-targeting antibody, comprising LHVR that is 90% identical to SEQ ID Nos 10 and 13 and HCVR that is 90% identical SEQ ID NO:11 encompassing various structures, specificities and functional limitations by the claimed methods to provide sufficient structure for the an any NKG2A-targeting antibody, comprising LHVR that is 90% identical to SEQ ID Nos 10 and 13 and HCVR that is 90% identical SEQ ID NO:11 encompassing various structures, specificities and functional limitations claimed 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”.
In contrast to applicant’s reliance upon the description of certain NKG2A-targeting antibody,
there is insufficient written description of the required kind of structure-identifying information about the corresponding makeup of the claimed an any NKG2A-targeting antibody, comprising LHVR that is 90% identical to SEQ ID Nos 10 and 13 and HCVR that is 90% identical SEQ ID NO:11 encompassing various structures, specificities and functional limitations to demonstrate possession. Also, see Amgen Inc. v. Sanofi, 124 USPQ2d 1354 (Fed. Cir. 2017).
“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 an any NKG2A-targeting antibody, comprising LHVR that is 90% identical to SEQ ID Nos 10 and 13 and HCVR that is 90% identical SEQ ID NO:11.
5. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
6. Claims 1-3,7,21-23 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent 8,796427 and US Patent Application 20190135938.
US Patent ‘427 teaches a humanized anti-NKG2A antibody, comprising LCVR comprising CDR-L1,CDR-L2 and CDR-L3, HCVR, comprising CDR-H1, CDR-H2 and CDR-H3 that are identical to the instantly claimed LCVR comprising CDR-L1,CDR-L2 and CDR-L3, HCVR, comprising CDR-H1, CDR-H2 and CDR-H3 ( see sequence alignment, attached). US Patent ‘427 teaches that said humanized anti-NKG2A antibody are used for immunotherapy for treating cancer (see entire document, paragraphs 6-8 and 15 in particular)
It is noted that US Patent ’42 does not teaches the presence M at position 21 and T at position of 85 in light chain variable region and M at position of 34, A at position of 49, P at position of 61 and T at position of 97 at HCVR. It is noted that said amino acid substitution are considered to be a conservative amino acid substitution with similar physio-chemical and structural properties and it would be conventional and within the skill of the art to identify/optimized said conservative amino acid substitution.
Further, it has been held that where the general conditions of a claim are disclosed in the prior art , discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 220 F2d 454,456,105 USPQ 233; 235 (CCPA 1955). see MPEP § 2144.05 part II A.
US Patent ‘427 does teaches a multi-specific antibody comprising anti-NKG2A antibody and a second antibody that specifically binds to antigen different from NKG2A.
US Patent Application’ 684 teaches a bi-specific antibody anti-NKG2A antibody and a second antibody that specifically binds to CD138. US Patent Application’ 684 teaches that said bispecific antibody are used for immunotherapy for treating cancer ( see entire document, paragraphs 0017, 0029, 0467 in particular).
All the claimed elements were known in the prior art and one skill in the art could have combine the elements as claimed by known methods with no change in their respective function and the combination would have yield predictable results to one of ordinary skill in the art at the time of the invention ( see KSR International Co v Teleflex Inc., 550U.S.-, 82 USPQ2d 1385, 2007).
Thus it would have been to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute anti-NKG2A antibody taught by US Patent Application ‘684 with anti-NKG2A antibody taught by US Patent ‘427 with a reasonable expectation of success because the prior art taught that each of said antibody can be used for immunotherapy for treating cancer.
Claim 21 is included because it would be conventional and within the skill of the art to add the second functional structure to NKG2A antibody such as detectable marker or radioisotope. Further, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 220 F2d 454,456,105 USPQ 233; 235 (CCPA 1955). see MPEP § 2144.05 part II A.
It is well settled that "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980). See also Merck & Co. v. Biocraft Labs. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1847-48 (Fed. Cir. 1989) (determination of suitable dosage amounts in diuretic compositions considered a matter of routine experimentation and therefore obvious).
7. No claim is allowed.
8. 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, Daniel Kolker can be reached on 571/ 272-3181
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