DETAILED ACTION
This Action is in response to the communication filed on 04/15/2026.
Claims 1-20 are pending.
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 .
Election/Restrictions
Applicant’s election without traverse of Group I, the species miR-3202, and the species SEQ ID NO: 36, in the reply filed on 04/15/2026 is acknowledged.
Claims 4, 7-14, 17-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) – claim 4 being drawn to a nonelected species and claims 7-14, 17-18 being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/15/2026.
Claims 1-3, 5-6, 15-16, 19-20 are under consideration as they are drawn to elected subject matter.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-3, 5-6, 15-16, 19-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
The fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, applicant was in possession of the invention as now claimed. See, e.g., Vas-Cath, Inc., 935 F.2d at 1563-64, 19 USPQ2d at 1117.
To satisfy the written description requirement, MPEP §2163 states, in part “…a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention.” Moreover, the written description requirement for a genus may be satisfied through sufficient description of a representative number of species 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 functional and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus.”
In their broadest embodiments, the claims are drawn to a target site blocker for enhancing Arginase 2 (Arg2) expression in macrophages, wherein the target site blocker is specific to miRNA binding sites in Arg2 (e.g., see claim 1), and the elected species is a target site blocker is specific for miR-3202 (e.g., see claim 3), and is a nucleic acid molecule comprising the nucleotide sequence of SEQ ID NO: 36 or a fragment or variant thereof (e.g., see claim 5). Thus, the claims encompass a genus of target site blockers that includes fragments and variants of the nucleotide of SEQ ID NO: 36. Accordingly, the claims encompass a genus comprising an enormous number of different species considering every fragment and variant of the nucleotide sequence of SEQ ID NO: 36 (the elected species).
Regarding the elected species (SEQ ID NO: 36), the application discloses the nucleotide sequence that is SEQ ID NO: 36, but does not appear to disclose any fragments or variants of SEQ ID NO: 36 which would have the required function – the ability to block miR-3202 from binding to its target site in the Arg2 mRNA.
The limited disclosure of the specification in view of the vast genus of molecules encompassed by the claims does not adequately describe the entire genus of target site blocker molecules encompassed by the claims.
“Possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features.” Ex parte Kubin, 83 USPQ2d 1410, 1417 (Bd. Pat. App. & Int. 2007) citing University of Rochester, 358 F.3d at 927, 69 USPQ2d at 1895. Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states 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).
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co., the court stated:
“A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials. Fiers, 984 F.2d at 1171, 25 USPQ2d at 1606; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284-85 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus. . . ."). Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is “not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.” (See MPEP 2163). The MPEP does state that for generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. (MPEP 2163). If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. (See MPEP 2163). Although the MPEP does not define what constitute a sufficient number of representative, the Courts have indicated what do not constitute a representative number species to adequately describe a broad generic. In Gosteli, the Court determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gosteli, 872 F.2d at 1012, 10 USPQ2d at 1618.
The court and the Board have repeatedly held (Amgen Inc. v. Chugai Pharmaceutical Co. Ltd.,18 USPQ2d 1016 (CA FC, 1991); Fiers v. Revel, 25 USPQ2d 1601 (CA FC 1993); Fiddes v. Baird, 30 USPQ2d 1481 (BPAI 1993) and Regents of the Univ. Calif. v. Eli Lilly & Co., 43 USPQ2d 1398 (CA FC, 1997)) that an adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it, irrespective of the complexity or simplicity of the method; what is required is a description of the nucleic acid itself.
The specification provides no description or guidance that would allow one of skill in the art to distinguish the functional species of the recited structural genus from the non-functional members without empirical determination. Thus one of skill at the time of the invention could not have concluded that Applicant was in possession of the genus of functional target site blockers that is required by the claims.
It is noted that the application does disclose the nucleotide sequence of SEQ ID NO: 36 as a functional target site blocker for the miR-3203 target site (the elected species), and limiting the claims to this specific molecule (i.e., limit to SEQ ID NO: 36) would obviate this rejection.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-3, 5, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO2004048511 (hereinafter “Bentwich”; of record – IDS citation).
The claims are drawn to a target site blocker for enhancing Arg2 expression in macrophages, wherein the target site blocker is specific to miRNA binding sites in Arg2 (e.g., see claim 1), wherein the elected species is a target site blocker is specific for miR-3202 (e.g., see claim 3), wherein the target site blocker is a nucleic acid molecule comprising the nucleotide sequence of SEQ ID NO: 36 or a fragment or variant thereof (e.g., see claim 5l emphasis added for clarity). Thus, the claims encompass nucleotide sequences that are fragments or variants of the nucleotide of SEQ ID NO: 36.
Bentwich teaches an nucleic acid sequence that is a variant of SEQ ID NO: 36. Specifically, Bentwich teaches a sequence identified as a “Viral regulatory miRNA” and has the nucleotide sequence of SEQ ID NO: 157586 which meets the structural limitations of the claims and thus would necessarily have the same function (see sequence alignment information below).
See MPEP 2112.01 II (Composition claims – If the composition is physically the same, it must have the same properties), which states:
"Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. (Applicant argued that the claimed composition was a pressure sensitive adhesive containing a tacky polymer while the product of the reference was hard and abrasion resistant. "The Board correctly found that the virtual identity of monomers and procedures sufficed to support a prima facie case of unpatentability of Spada’s polymer latexes for lack of novelty.").
Since Bentwich teaches a nucleic acid sequence that meets the structural limitations of the claims, which would necessarily have the same functions including having the ability to be a target site blocker specific to the miR-3202 binding site(s) in Arg2, Bentwich anticipates the instant claims.
SEQUENCE ALIGNMENT INFORMATION:
DE Viral regulatory miRNA SEQ ID NO 157586.
CC PN WO2004048511-A2.
CC PD 10-JUN-2004.
XX
CC PA (ROSE-) ROSETTA GENOMICS LTD.
XX
CC PI Bentwich I;
XX
DR WPI; 2004-460760/43.
XX
CC PT New bioinformatically detectable novel viral gene encoding substantially
CC PT pure nucleic acid, useful for preventing or treating viral diseases, and
CC PT for detecting expression of VGAM and VCR genes.
XX
CC PS Disclosure; SEQ ID NO 157586; 74pp; English.
XX
CC The invention relates to a bioinformatically detectable novel viral gene.
CC Also disclosed are a vector comprising the DNA, a method of selectively
CC inhibiting translation of at least one gene comprising introducing the
CC vector into a cell, a gene expression system comprising the vector, and a
CC vector inserter, functional to insert the vector into a cell, thus
CC selectively inhibiting translation of at least one gene, a probe
CC comprising the DNA, a method of selectively detecting expression of at
CC least one gene by using the probe, a gene expression system comprising
CC the probe, and a gene expression detector functional to selectively
CC detect expression of at least one gene, an antiviral substance capable of
CC neutralizing the RNA and an antiviral treatment comprising neutralizing
CC the RNA. The genes are useful for preventing or treating viral diseases,
CC for detecting expression of VGAM and VCR genes, and for selectively
CC enhancing and inhibiting translation of their respective target genes.
CC The present sequence represents a viral regulatory miRNA.
XX
SQ Sequence 32 BP; 7 A; 5 C; 10 G; 0 T; 10 U; 0 Other;
Qy 3 GAAGGGTTTGTGGACCA 19 (INSTANT SEQ IE NO: 36)
||||||:::|:||||||
Db 1 GAAGGGUUUGUGGACCA 17 (BENTWICH SEQ ID NO: 157586)
Relevant Post-Filing Art
De Santi et al. Molecular Therapy Nucleic Acids, vol. 29(13), Sept. 2022, pages 643-655, is not eligible as prior art, but is made of record as it is a relevant post-filing reference.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to J. E. Angell whose telephone number is (571)272-0756. The examiner can normally be reached Monday-Friday (8:30-5:00).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Dunston can be reached at (571) 272-2916. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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J. E. Angell
Primary Examiner
Art Unit 1637
/J. E. ANGELL/ Primary Examiner, Art Unit 1637
Prosecution Insights