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 June 30, 2026.
Claim 1 has been amended.
Claims 1, 9, 10, 16, 21, 26, 28-35, 45, 46, 52, 59, 61, 66, 72, and 75 are pending in the present application.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on June 30, 2026 is acknowledged. Applicants’ further species election of SEQ ID NOs: 149 or SEQ ID NO: 419 in the reply filed on June 30, 2026 is also acknowledged.
Claims 52, 59, 61, 66 and 72 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Accordingly, claims 1, 9, 10, 16, 21, 26, 28-35, 45, 46 and 75 have been examined on the merits as detailed below:
The requirement is still deemed proper and is therefore made FINAL.
Information Disclosure Statement
Applicant’s information disclosure statement (IDS) filed June 30, 2026 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 June 29, 2023 are acknowledged and have been accepted by the Examiner.
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 therefore, subject to the conditions and requirements of this title.
Claim 45 is 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.
Claim 45 is 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 present case, the claims are drawn to a cell comprising a double-stranded ribonucleic acid (dsRNA) for inhibiting expression of complement component 9 (C9) in a cell, wherein said the dsRNA comprises a sense strand and an antisense strand forming a double stranded region, wherein the antisense strand comprises at least 15 contiguous nucleotides differing by no more than 3 nucleotides from the nucleotide sequence 5'- AAGGCUGACAUGCUGCUCUUGCU-3' of SEQ ID NO: 149 or SEQ ID NO: 419. 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 claim such that it is limited to “an isolated cell” would obviate this rejection.
******
Claims 1, 9, 10, 16, 21, 26, 28-35, 45, 46 and 75 are rejected under 35 U.S.C. 101.
The claims are drawn to a double-stranded ribonucleic acid (dsRNA) for inhibiting expression of complement component 9 (C9) in a cell, wherein said the dsRNA comprises a sense strand and an antisense strand forming a double stranded region, wherein the antisense strand comprises at least 15 contiguous nucleotides differing by no more than 3 nucleotides from the nucleotide sequence 5'- AAGGCUGACAUGCUGCUCUUGCU-3' of SEQ ID NO: 149 or 419. SEQ ID NO: 419 is a modified C9 antisense strand nucleotide sequence as shown in Table 3 of the present Specification. According to Applicant’s Disclosure, SEQ ID NO: 149 is an unmodified C9 antisense strand nucleotide sequence. See Table 2.
The Specification discloses:
“unmodified” or “natural” nucleobases include the purine bases adenine (A) and guanine (G), and the pyrimidine bases thymine (T), cytosine (C), and uracil (U)
The dsRNA for inhibiting expression of C9, wherein the antisense strand comprises at least 15 contiguous nucleotides differing by no more than 3 nucleotides from the nucleotide sequence of SEQ ID NO: 149 is a product of nature as it is not modified and therefore a naturally-occurring (natural) nucleic acid. That is, 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 reciting SEQ ID NO: 149 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 those claims 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 claim 46) 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 C9, wherein the antisense strand comprises at least 15 contiguous nucleotides differing by no more than 3 nucleotides from the nucleotide sequence of SEQ ID NO: 149 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. 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 1, 9, 10, 16, 21, 26, 28-35, 45, 46 and 75 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
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