25-26,28-30Notice 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 .
RESPONSE TO APPLICANT’S AMENDMENT
1. Applicants amendment filed on 02/09/26 is acknowledged.
2. Claims 1,2,4-8,15-18,25,26,28-41 are pending.
3. Claims 15-18,25,26, 28,30 stand withdrawn from further consideration by the Examiner, 37 C.F.R. § 1.142(b) as being drawn to nonelected inventions.
Claims 1,2,4-8 ,29,31-41 read on an isolated polynucleotide comprising nucleic acid sequence having at least 90 % identity of SEQ ID :1 2,3,6,7,8,9 ,isolated polypeptide comprising the amino acid sequence having at least 90 % identity of SEQ ID NO: 4,5,,14,15, a therapeutic composition and a kit comprising said nucleic and amino acid sequences are under consideration in the instant application.
4. 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.
5. Claims 1, 2,4-8 ,29,32, 40, 41 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 for the same reasons set forth in the previous Office Action, mailed on 11/07.25.
Applicant’s arguments filed on 02/09/26 have been fully considered but have not been found convincing.
Applicant asserts that one skilled in the art possessed extensive knowledge about the structure-functional relationship of the viral U83A gene ant its truncated version U 83A-Npep. More specifically, Applicant first submits that the presently claimed invention is partly based on a surprising technical feature - the identification that the splice products of the U83A gene of the human germline chromosomally integrated endogenous form of human herpesvirus 6A virus (HHV6A) (gene referred to in the application as iciU83A) encodes polypeptides which have agonist or antagonist activity to cytokine receptors, including CCR1, CCR4, CCR5, CCR6 and CCR8.
Contrary to Applicant’s assertion it is the issue raised in the previous Office action was not about very specific splice products of the U83A gene having specifically identify structure (SEQ ID NO ) and function ( agonistic or antagonistic activity to cytokine receptor)
As has been stated previously, applicant is in possession of : 1) an isolated polynucleotide comprising nucleic acid sequence of SEQ ID :1 2,3,6,7,8,9 ,isolated polypeptide comprising the amino acid sequence of SEQ ID NO: 4,5,,14,15, a therapeutic composition and a kit comprising said nucleic and amino acid sequences
Applicant is not in possession of : any isolated polynucleotide comprising any variant of nucleic acid sequence of having at least 90 % identity of SEQ ID :1 2,3,6,7,8,9 , or any isolated polypeptide comprising any variant having at least 90% identity to the amino acid sequence of SEQ ID NO: 4,5,14,15, a therapeutic composition and a kit comprising any variants of said nucleic and amino acid sequences
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 polynucleotides and polypeptides, 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 isolated polynucleotide comprising nucleic acid sequence of SEQ ID :1 2,3,6,7,8,9 ,isolated polypeptide comprising the amino acid sequence of SEQ ID NO: 4,5,,14,15 any isolated polynucleotide comprising any variant of nucleic acid sequence of SEQ ID :1 2,3,6,7,8,9 , or any isolated polypeptide comprising any variant the amino acid sequence of SEQ ID NO: 4,5,14,15,
In determining that the Specification did not support the claimed any isolated polynucleotide comprising any variant of nucleic acid sequence having at least 90 % sequence identity of SEQ ID :1 2,3,6,7,8,9 , or any isolated polypeptide comprising any variant the amino acid sequence having at least 90% identity of SEQ ID NO: 4,5,14,15 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 any isolated polynucleotide comprising any variant of nucleic acid sequence any variant of nucleic acid sequence having at least 90 % sequence identity of SEQ ID :1 2,3,6,7,8,9 , or any isolated polypeptide comprising any variant the amino acid sequence of SEQ ID NO: 4,5,14,15. Thus the skilled artisan could not envision the detailed chemical structure of the encompassed genus of any isolated polynucleotide comprising any variant of nucleic acid sequence any variant of nucleic acid sequence having at least 90 % sequence identity of SEQ ID :1 2,3,6,7,8,9 , or any isolated polypeptide comprising any variant the amino acid sequence of SEQ ID NO: 4,5,14,15 until reduction to practice has occurred, regardless of the complexity or simplicity of Absent a recitation of distinguishing identifying characteristics, the Specification does not provide adequate written description support of the claimed genuses.
Given the well known fact that even a single amino acid or nucleic acid substitution or what appears to be an inconsequential chemical modification will often dramatically affect the biological activity and characteristic of a polynucleotide and polypeptide the skilled artisan would not conclude that applicant have been in possession of any isolated polynucleotide comprising any variant of nucleic acid sequence any variant of nucleic acid sequence having at least 90 % sequence identity of SEQ ID :1 2,3,6,7,8,9 , or any isolated polypeptide comprising any variant the amino acid sequence any variant of nucleic acid sequence having at least 90 % sequence identity of SEQ ID NO: 4,5,14,15 which have agonistic or antagonistic activity to cytokine receptors broadly encompassed by the claimed invention.
The claims do not define the relevant identifying characteristics, namely the relevant nucleic acid and amino acid sequences of the claimed genus of any isolated polynucleotide comprising any variant of nucleic acid sequence of SEQ ID :1 2,3,6,7,8,9 , or any isolated polypeptide comprising any variant the amino acid sequence any variant of nucleic acid sequence having at least 90 % sequence identity of SEQ ID NO: 4,5,14,15 that are essential for maintaining the specific structural and functional properties of the disclosed polynucleotide comprising nucleic acid sequence of SEQ ID :1 2,3,6,7,8,9 , or isolated polypeptide comprising the amino acid sequence any variant of nucleic acid sequence having at least 90 % sequence identity of SEQ ID NO: 4,5,14,15 which have agonistic or antagonistic activity to cytokine receptors broadly 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 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 nucleic acid and amino acids of the claimed genus of any isolated polynucleotide comprising any variant of nucleic acid sequence of SEQ ID :1 2,3,6,7,8,9 , or any isolated polypeptide comprising any variant the amino acid sequence of SEQ ID NO: 4,5,14,15 are required and are essential for maintaining the specific structural and functional properties of the disclosed polynucleotide comprising nucleic acid sequence of SEQ ID :1 2,3,6,7,8,9 , or isolated polypeptide comprising the amino acid sequence of SEQ ID NO: 4,5,14,15
Given the claimed broadly claimed genus of any isolated polynucleotide comprising any variant of nucleic acid sequence of SEQ ID :1 2,3,6,7,8,9 , or any isolated polypeptide comprising any variant the amino acid sequence of SEQ ID NO: 4,5,14,15 and in the absence of sufficient disclosure of relevant identifying characteristics for the broadly claimed genus of any isolated polynucleotide comprising any variant of nucleic acid sequence of SEQ ID :1 2,3,6,7,8,9 , or any isolated polypeptide comprising any variant the amino acid sequence of SEQ ID NO: 4,5,14,15 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 any isolated polynucleotide comprising any variant of nucleic acid sequence of SEQ ID :1 2,3,6,7,8,9 , or any isolated polypeptide comprising any variant the amino acid sequence of SEQ ID NO: 4,5,14,15 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 isolated polynucleotide comprising any variant of nucleic acid sequence of having at least 90 % identity to SEQ ID :1 2,3,6,7,8,9 , or any isolated polypeptide comprising any variant the amino acid sequence of having at least 90 % identity SEQ ID NO: 4,5,14,15 which have agonistic or antagonistic activity to cytokine receptors broadly encompassed by the claimed invention encompassing various structures, specificities and functional limitations by the claimed methods to provide sufficient structure for the any isolated polynucleotide comprising any variant of nucleic acid sequence of SEQ ID :1 2,3,6,7,8,9 , or any isolated polypeptide comprising any variant the amino acid sequence of SEQ ID NO: 4,5,14,15 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”.
“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 genus of any isolated polynucleotide comprising any variant of nucleic acid sequence having at least 90 % identity of SEQ ID :1 2,3,6,7,8,9 , or any isolated polypeptide comprising any variant of the amino acid sequence having at least 90 % identity of SEQ ID NO: 4,5,14,15 which have agonistic or antagonistic activity to cytokine receptors broadly encompassed by the claimed invention.
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. See 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); and 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) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.131(c). 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. 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 filing date of the application will determine what form 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 https://www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
6 The claims 1,2,4-8 ,29,31-41 are provisionally rejected on the grounds of nonstatutory double patenting of the claims of copending Application No.18/697913 and 18/030633 . Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims of copending Application No.18/697913 and 18/030633 recited a composition comprising a mixture of polynucleotides that are 100% identical to the instantly claimed ( see sequence alignment, attached).
Claims 4 and 8 are included because it would be obvious to one skill in the art to transformed a host cell with a construct comprising said nucleic acid to obtained a polypeptides corresponding to said polynucleotides
This is a provisional nonstatutory double patenting rejection because the conflicting claims have not in fact been patented.
It is noted that Applicant requested that said rejection be held in abeyance until patentable subject matter has been identified by the Office.
7. No claim is allowed.
8. THIS ACTION IS MADE FINAL even though it is a first action in this case. See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no, however, event will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
9. 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
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/MICHAIL A BELYAVSKYI/Primary Examiner, Art Unit 1644