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 1-23 are pending.
2. Applicant’s election without traverse of Group I, claims 1-11 and 16 in the reply filed on 10/30/25 is acknowledged.
3.Claims 12-15, 17-23 are withdrawn from further consideration by the Examiner, 37 C.F.R. § 1.142(b) as being drawn to nonelected inventions.
Claims 1-11 and 16 read on a fusion protein comprising ACE2 and Fc region of immunoglobulin are under consideration in the instant application.
4. Claims 5, 6, 7,8, 10,11, 16 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claims. Claims 5, 6, 7,8, 10,11, 16 cannot depends from any other multiple dependent claim and should refer to other claims in the alternative only. See MPEP § 608.01(n). Even though these claims are in improper form, the examiner has chosen to examine claims.
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. Claims 4-11 and 16 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 : a fusion polypeptide comprising a fragment of ACE2 receptor comprising SEQ IDs : 2, and 4 and Fc region is comprises SEQ ID N:3
Applicant is not in possession of : any fusion polypeptide comprising a fragment of ACE2 receptor comprising amino acids that are at least 90% identical to SEQ IDs : 2 or 4 and wherein FC region comprises amino acids that are at least 90% identical to SEQ IDs : 3
There is no description of the identifying characteristics for recognizing that a candidate compound activates the receptor. There is no description of an actual reduction to practice, each step of the claimed method or distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention.
The claimed invention is drawn to a genus of ACE2 fragments 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 fusion polypeptide comprising a fragment of ACE2 receptor comprising SEQ IDs : 2, 4 and any fusion polypeptide comprising a fragment of ACE2 receptor comprising amino acids that are at least 90% identical to SEQ IDs : 2 or 4 and wherein FC region comprises amino acids that are at least 90% identical to SEQ IDs : 3 that can binds to coronavirus and suppresses it entry into the host cell.
Given the well known fact that even a single amino acid substitution or what appears to be an inconsequential chemical modification or will often dramatically affect the biological activity and characteristic of a protein the skilled artisan would not have been in possession of the vast repertoire any fusion polypeptide comprising a fragment of ACE2 receptor comprising amino acids that are at least 90% identical to SEQ IDs : 2 or 4 and wherein FC region comprises amino acids that are at least 90% identical to SEQ IDs : 3 that can binds to coronavirus and suppresses it entry into the host cell 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 any fusion polypeptide comprising a fragment of ACE2 receptor comprising amino acids that are at least 90% identical to SEQ IDs : 2, 3, 4 that can binds to coronavirus and suppresses it entry into the host cell encompassing various structures, specificities and functional limitations.
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 competes for binding an anti-CD3 immune molecule / anti-CD3 antibodrecited 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 any fusion polypeptide comprising a fragment of ACE2 receptor comprising amino acids that are at least 90% identical to SEQ IDs : 2, 3, 4 that can binds to coronavirus and suppresses it entry into the host cell
Note that the claims do not recite and the specification does not provide sufficient written description of the structure-identifying any fusion polypeptide comprising a fragment of ACE2 receptor comprising amino acids that are at any fusion polypeptide comprising a fragment of ACE2 receptor comprising amino acids that are at least 90% identical to SEQ IDs : 2 or 4 and wherein FC region comprises amino acids that are at least 90% identical to SEQ IDs : 3
that can binds to coronavirus and suppresses it entry into the host cell.
Given the claimed broadly class of any fragments ACE2 and in the absence of sufficient disclosure of relevant identifying characteristics for the broadly claimed genus of any fusion polypeptide comprising a fragment of ACE2 receptor comprising amino acids that are at least 90% identical to SEQ IDs : 2, 3, 4 that can binds to coronavirus and suppresses it entry into the host cell 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 fusion polypeptide comprising a fragment of ACE2 receptor comprising amino acids that are at least 90% identical to SEQ IDs : 2, 3, 4 that can binds to coronavirus and suppresses it entry into the host cell 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 fusion polypeptide comprising comprising a fragment of ACE2 receptor comprising amino acids that are at least 90% identical to SEQ IDs : 2 or 4 and wherein FC region comprises amino acids that are at least 90% identical to SEQ IDs : 3 that can binds to coronavirus and suppresses it entry into the host cell 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 a fusion polypeptide comprising a fragment of ACE2 receptor comprising SEQ IDs : 2, 3, 4 there is insufficient written description of the required kind of structure-identifying information about the corresponding makeup of the claimed any fusion polypeptide comprising a fragment of ACE2 receptor comprising amino acids that are at least 90% identical to SEQ IDs : 2, 3, 4 that can binds to coronavirus and suppresses it entry into the host cell 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 any fusion polypeptide comprising a fragment of ACE2 receptor comprising amino acids that are at least 90% identical to SEQ IDs : 2 or 4 and wherein FC region comprises amino acids that are at least 90% identical to SEQ IDs : 3 that can binds to coronavirus and suppresses it entry into the host cell.
7. Prior of setting art rejection it is noted that during patent examination, the pending claims must be "given the broadest reasonable interpretation consistent with the specification." See MPEP 2100. The instant pending claim 1 is drawn to a product, i.e. a fusion polypeptide comprising a fragment of ACE2 and Fc region of immunoglobulin. The preamble of the pending claim 1 i.e. wherein the fusion polypeptide binds the coronavirus and suppresses its entry into the cell is considered as an intended use. A product is a product irrespective of its intendent use in the absence of evidence of structural and/or functional difference.
Thus, it is the Examiner’s position that preamble of claim 1 only limits the claim to the extent that the prior art must be capable of performing the purpose or intended use.
8. Also it is noted that term “optionally” is interpreted in claim 8, that a fusion protein does not comprise a linker VEVD and in claim 11 that fusion polypeptide does not comprise anti-viral agent.
9. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(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.
10. Claims 1- 6, 8, 10, 11 and 16 are rejected under 35 U.S.C. 102(a)(1)/(2) as being anticipated by US Patent 12/123036
US Patent ‘036 teach a fusion polypeptide comprising extracellular fragment of human ACE2 receptor and Fc region of immunoglobulin. US Patent ‘036 teaches that ACE2 receptor and Fc region of immunoglobulin are linked via peptide linker. US Patent’260 teaches a fragment of ACE2 receptor comprising SEQ ID N:10 that is 100% idendical to the instant claim SEQ ID NO:2 ( see entire document, paragraph 2, 5, 40, 92, 96, 99 and sequence alignment in particular)
)
Claim 16 is included because the instant claims are drawn to a product, i.e. a fusion polypeptide. A composition is a composition irrespective of its intended use. The term “pharmaceutical composition” carries little patentable weight in the absence of evidence of structural difference.
The reference teaching anticipates the claimed invention.
11. 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.
12. Claims 1, 7 are rejected under 35 U.S.C. 103 as being unpatentable US Patent 12/123036
in view of US Patent 10428131.
The teaching of US Patent’036 has been discussed supra.
US Patent’036 does not explicitly teaches a Fc region of the fusion protein comprisng SEQ ID N:3.
US Patent’131 teaches a fusion protein comprising Fc region of immunoglobulin of SEQ ID NO:21. It is noted that SEQ ID NO:21 is 100% identical to the instantly claimed SEQ ID NO:3. US Patent’131 teaches that said Fc region of immunoglobulin can be fused to various peptide for therapeutic usage ( see entire document, paragraphs 003, 0047 and sequence alignment )
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 Fc immunoglobulin in fusion protein taught by US Patent’036 with Fc region of immunoglobulin taught by US Patent’131 with a reasonable expectation of success because the prior art teaches that each of said Fc immunoglobulin can be part of the fusion polypeptide used for therapeutic purposes.
From the combined teaching of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
13. No claim is allowed.
14. 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