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
This Office Action is a response to Applicant’s Election filed February 4, 2026.
Claims 2, 8, 11 and 13 have been amended.
Claims 2-4, 8, 11, 13, 17, 18, 28-30, 43, 44, 51, 53, 58, 59, 64, 68 and 69 are pending in the present application.
Election/Restrictions
Applicant’s species election (without traverse) of SEQ ID NO:180 as the antisense strand sequence in the reply filed on February 4, 2026 is acknowledged.
The requirement is still deemed proper and is therefore made FINAL.
Accordingly, claims 2-4, 8, 11, 13, 17, 18, 28-30, 43, 44, 51, 53, 58, 59, 64, 68 and 69 have been examined on the merits as detailed below:
Information Disclosure Statement
Applicant’s information disclosure statement (IDS) filed April 16, 2024 is acknowledged. The submission is in compliance with the provisions of 37 CFR §1.97. Accordingly, the Examiner has considered the information disclosure statement, and a signed copy is enclosed herewith.
Drawings
The Drawings filed April 16, 2024 are acknowledged and have been accepted by the Examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-4, 8, 11, 13, 17, 18, 28-30, 43, 44, 51, 53, 58, 59, 64, 68 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
The claims are indefinite because the term, “LECT2” is not clearly defined. Since abbreviations often have more than one meaning, it is suggested that inserting the full name of the leukocyte chemotactic factor 2 would be appropriate.
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 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.
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)(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.
Claims 2-4, 8, 11, 13, 17, 18, 28-30, 43, 44, 51, 53, 58, 59, 64, 68 and 69 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO 2015050990 A1 to Bettencourt et al. (hereinafter, “Bettencourt”) (submitted and made of record on the IDS filed May 16, 2024).
The claims are drawn to a double-stranded ribonucleic acid (dsRNA) for inhibiting expression of LECT2, wherein said dsRNA comprises a sense strand and an antisense strand, the antisense strand comprising a region of complementarity to a LECT2 RNA transcript, wherein the antisense strand comprises at least 15 contiguous nucleotides differing by no more than 3 nucleotides from the antisense sequence set forth as SEQ ID NO:180.
Regarding claims 2, 4, 8, Bettencourt disclose a dsRNA for inhibiting expression of LECT2, wherein said dsRNA comprises a sense strand and an antisense strand, the antisense strand comprising a region of complementarity to a LECT2 RNA transcript, wherein the antisense strand comprises at least 15 contiguous nucleotides differing by no more than 3 nucleotides from the antisense sequence set forth as SEQ ID NO:180. See SEQ ID 451 of Bettencourt. Also, see the following sequence alignment:
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1022
586
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Greyscale
Regarding claim 11, Bettencourt discloses a sense strand comprising at least 15 contiguous nucleotides differing by no more than 3 nucleotides from SEQ ID NO: 179 of the present invention. See SEQ ID 926 of Bettencourt. Also, see the following sequence alignment:
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974
582
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Regarding claims 3 and 13, Bettencourt disclose the dsRNA for inhibiting expression of LECT2 of their invention comprises at least one modified nucleotide, such as a 2'-O-methyl modified nucleotide, a nucleotide comprising a 5'-phosphorothioate group, or a terminal nucleotide linked to a cholesteryl derivative. See claim 9, for example.
Regarding claims 17, 18, 59, and 69, Bettencourt disclose the dsRNA for inhibiting expression of LECT2 of their invention is conjugated to a GalNAc ligand. See claims 26 and 27, for example.
Regarding claim 28, Bettencourt disclose the dsRNA for inhibiting expression of LECT2 of their invention in contained within a cell. See Bettencourt claim 34.
Regarding claims 29 and 30, Bettencourt disclose the dsRNA for inhibiting expression of LECT2 of their invention comprise a pharmaceutical composition, wherein the pharmaceutical composition comprises dsRNA and is administered in an unbuffered solution. See claims 35 and 36, for example.
Regarding claims 43 and 44, Bettencourt disclose the dsRNA for inhibiting expression of LECT2 of their invention is used in a method of inhibiting LECT2 expression in a cell, wherein the cell is ex vivo, in vitro, or in vivo. See Abstract. Also, see claims 49 and 50.
Regarding claims 51 and 53, Bettencourt disclose the dsRNA for inhibiting expression of LECT2 of their invention is used in a method of treating a disorder related to LECT2 expression, such as amyloidosis. See claims 53 and 58.
Regarding claim 58, Bettencourt disclose the dsRNA for inhibiting expression of LECT2 of their invention is used in a method of reducing LECT2 amyloid deposition in a subject. See claims 63 and 64, for example.
Regarding claims 64 and 68, Bettencourt disclose the dsRNA for inhibiting expression of LECT2 of their invention is comprised in a vector and further includes a cell comprising the vector. See Bettencourt claims 70-74.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 28 and 68 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
The claimed invention is directed to non-statutory subject matter because Section 33(a) of the America Invents Act (AIA ) reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 28 and 68 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). In the instant case, the claims are drawn to a cell comprising a double-stranded ribonucleic acid (dsRNA) for inhibiting expression of LECT2, wherein said dsRNA comprises a sense strand and an antisense strand, the antisense strand comprising a region of complementarity to a LECT2 RNA transcript, wherein the antisense strand comprises at least 15 contiguous nucleotides differing by no more than 3 nucleotides from the antisense sequence set forth as SEQ ID NO:180 . Since the claims are not limited to “an isolated cell”, the claims are broadly interpreted to encompass stem cells which ultimately, include a human subject. Applicant is reminded that a claim directed to or including within its scope a human being will not be considered to be patentable subject matter. Section 33(a) of the AIA clearly indicates that no patent may issue on a claim encompassing a human organism, therefore, the claim is rejected under 35 U.S.C. 101.
It is noted that amending the claims such that they are limited to “an isolated cell” would obviate this rejection.
******
Claims 2, 4, 8, 11, 17, 18, 28-30, 43, 44, 51, 53, 58, 59 and 69 are rejected under 35 U.S.C. 101.
The claims are drawn to a double-stranded ribonucleic acid (dsRNA) for inhibiting expression of LECT2, wherein said dsRNA comprises a sense strand and an antisense strand, the antisense strand comprising a region of complementarity to a LECT2 RNA transcript, wherein the antisense strand comprises at least 15 contiguous nucleotides differing by no more than 3 nucleotides from the antisense sequence set forth as SEQ ID NO:180. The present Specification discloses:
The term "double- stranded RNA" or "dsRNA," as used herein, refers to an iRNA that includes an RNA molecule or complex of molecules having a hybridized duplex region that comprises two anti-parallel and substantially complementary nucleic acid strands, which will be referred to as having "sense" and "antisense" orientations with respect to a target RNA; and
The iRNA molecules featured herein can include naturally occurring nucleotides or can include at least one modified nucleotide
The claimed invention is directed to a naturally-occurring nucleic acid fragment thereof, whether isolated or not that is not patent-eligible pursuant to the Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics, Inc. -- U.S.-- (June 13, 2013). The claims read on naturally occurring nucleic acids that are a product of nature. The claims do not require any type of chemical modification that would differentiate the compound from a product of nature.
The fragments as claimed do not have to be shown to exist in nature, but only be shown to be a fragment of a naturally occurring gene. The Myriad decision clearly includes naturally-occurring nucleic acid fragments, whether isolated or not, and the claimed oligonucleotide is a naturally occurring unmodified nucleic acid fragment.
The logic in the Myriad decision was that snipping a nucleic acid out of the chromosome which contains it does not change it enough to make it eligible under 35 USC 101. That same logic applies whether it is a nucleic acid encoding a full-length protein or a part of the nucleic acid; either way it is a nucleic acid whose sequence is identical to what occurs in nature.
Also, it should be noted that regarding claims 17 and 18 which recite that the dsRNA comprises a ligand, ligands can include a naturally occurring substance, such as cholesterol.
Further, recitation of “A pharmaceutical composition” (instant claims 29 and 30) is not enough to make the claim patent eligible. There is no limiting definition in the specification of what constitutes a pharmaceutical composition. The broadest reasonable interpretation of this term includes water. If the nucleic acid itself is not patent eligible, the addition of water does not make the nucleic acid patent eligible.
The dsRNA for inhibiting expression of LECT2 of the claimed invention is a product of nature because it is a fragment of a naturally occurring sequence and the fragment sequence is not markedly different than that found in nature. That is, the sequence is not modified or structurally different than the natural sequence. Furthermore, adding the natural product cholesterol or water to the dsRNA of the present invention does not make the nucleic acid patent eligible.
Thus, claims 2, 4, 8, 11, 17, 18, 28-30, 43, 44, 51, 53, 58, 59 and 69 are not patent-eligible.
Conclusion
No claims are allowable at this time.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Terra C. Gibbs whose telephone number is 571-272-0758. The Examiner can normally be reached from 8 am - 5 pm M-F.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner's supervisor, Ram Shukla can be reached on 571-272-0735. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TERRA C GIBBS/Primary Examiner, Art Unit 1635