DETAILED ACTION
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 .
Priority
Applicant’s claim to priority from Foreign Application KR10-2021-0079272 filed 06/18/2021 is hereby acknowledged.
Application Status
Amendments to claims filed 03/25/2026 are hereby acknowledged. Claims 1, 3, 7, 9-10, 13 are currently amended. Claims 14-17 are cancelled. Claims 18-28 are withdrawn from further consideration. Therefore, claims 1-13 are under examination in this office action.
Any objection or rejection not reiterated herein has been overcome by amendments and is therefore withdrawn.
Applicant’s amendments and arguments have been thoroughly reviewed, but are not persuasive to place the claims in condition for allowance for the reasons that follows.
Drawings
The replacement Drawing sheets filed 03/25/2026 are not satisfactory. The drawings are objected to for the following reasons:
37 CFR 1.84 (u)(1) states “Partial views intended to form one complete view, on one or several sheets, must be identified by the same number followed by a capital letter.”
In the current case, the view numbers for the partial views for Figures 2, 20, and 22 that appear on several sheets are followed by "Continued" instead of a capital letter such as FIG. 2A, FIG. 2B, etc.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The Substitute Specification (clean version) and the marked-up version filed 03/25/2026 are not acceptable, for the following reasons:
The disclosure is objected to because of the following informalities:
At page 37, line 12, “syryp” should be changed to “syrup”.
At page 39, line 14, “partenteral” should be changed to “parenteral”.
At page 81, line 2, “targe” should be changed to “target”.
Appropriate correction is required.
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see page 47, line 25 and page 48, line 5). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
The use of the terms “GelDoc” (page 48, line 10 and page 49, line 4), “Lipofectamine” (page 50, line 7; page 85, line 11), “Clarity” (page 52, line 7), “ChemiDoc” (page 52, line 9), “TRIzol” (page 52, line 15), “RevertAid” (page 52, line 18, “SYBR Green” (page 52, line 23), “StepOnePlus” (page 52, line 24), “Infinite M200” (page 54, line 9), “Invivofectamine” (page 86, line 4), which are trade names or marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claim 1 is objected to because of the following informalities:
At claim 1, line 6, the claim recites “in which the X region in composed in the loop”. The term “in composed” should be read “is composed”.
At line 7, the claim recites “the X region consists of 15 to 32 nt nucleotides”. The claim should recite “the X regio consists of 15 to 32 nucleotides (nt)”.
At lines 9-14, the term “miR-9” is listed three times and the term “miR-29a” is listed twice.
Appropriate correction is required.
Claim Interpretation
Claim 1 recites “the X region consists of 15 to 32 nt nucleotides and comprises a nucleic acid sequence 85% or more complementary to the nucleic acid sequence of the miRNA”. Claim 3 also recites “wherein the X region comprises a nucleic acid sequence 90% or more complementary to the nucleic acid sequence of the miRNA”. Claim 4 also recites : “wherein the Y region comprises a nucleic acid sequence 80% or more complementary to the mRNA of the target gene.”
According to the Broad and Reasonable Interpretation (BRI) of the claims’ language, the use of the terms “comprises” and “a nucleic acid sequence” allows for fragments of nucleic acid sequence. Therefore, the claims are also drawn to and encompass fragments that are 85 to 90% complementary, and molecules that present with 85 to 90% local complementarity to the X region in the nucleic acid molecule binding to the miRNA, or fragments that are 80% complementary in the Y region of the nucleic acid molecule for binding the mRNA target.
The following rejections are maintained from Office Action dated 11/25/2025 but modified as necessitated by Applicant’s amendments filed 03/25/2026:
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.
Non-Patent Eligible Subject Matter- Laws of Nature, Natural Phenomena, and Abstract Ideas.
Claims 1-11 and 13 are rejected under 35 U.S.C. §101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea). In this case, the judicial exception is a product of Nature.
The claims are drawn to a nucleic acid capable of binding an miRNA and mRNA, and capable of forming a stem-loop structure. When considered separately and in combination, these limitations are not sufficient to amount to significantly more than the judicial exception.
Subject Matter Eligibility Test for Products and Processes
Step 1 - Is the Claim to a Process, Machine, Manufacture or Composition of Matter? YES
Claims 1-11 and 13 are directed to "A nucleic acid molecule comprising an X region capable of binding to a miRNA; a Y region capable of binding to an mRNA of a target gene; and a Y* region capable of binding to the Y region, wherein the Y region and the Y* region complementarily match each other to form a stem-loop structure.”
Thus, the claims are directed to a statutory category (e.g., a product, a composition of matter).
Step 2A, Prong One - Does the Claim Recite an Abstract Idea, Law of Nature, or Natural Phenomenon? YES
The claims are directed to a product of Nature or to a synthetic product not different from a naturally occurring product. The claims are drawn to a judicial exception, i.e. a product of Nature. In this case, Gorbea I (Gorbea, C. et al. “ A viral Sm-class RNA base-pairs with mRNAs and recruits microRNAs to inhibit apoptosis”. Nature, Vol. 550 (2017), pp: 275-279; also cited on submitted IDS filed 06/17/2022; cited previously) teaches a nucleic acid isolated from a virus, Herpesvirus saimiri, that is a non-coding RNA capable of base-pairing with two infected host cell’s microRNAs (miR-142-3p and miR-16) and mRNAs (see title and abstract).
A Naturally occurring nucleic acid molecule, whether engineered or not, are not patent-eligible subject matter pursuant to the Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics, Inc., -- U.S. -- (June 13, 2013).
In Myriad, the Supreme Court considered the patent eligibility of several claims directed to isolated DNA related to the human BRCA1 and BRCA2 cancer susceptibility genes. The Supreme Court held that certain of Myriad Genetics' claims to isolated DNA are not patent-eligible, because they read on isolated naturally-occurring DNA that is a "product of nature." The Court held that isolating a "gene from its surrounding genetic material is not an act of invention."
Step 2A, Prong Two - Does the Claim Recite an Additional Elements that Integrate the
Judicial Exception into a Practical Application? NO
The claims 1-11 and 13 are drawn to nucleic acid molecules that can be naturally occurring, without anything more. The Supreme Court has long distinguished between principles themselves, which are not patent eligible, and the integration of those principles into practical applications, which are patent eligible. However, absent are any additional elements recited in the claim beyond the judicial exception(s) which integrate the exception into a practical application of the exception.
The phrase "integration into a practical application" requires an additional element or a
combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that it is more than a drafting effort designed to monopolize the exception.
The claim limitations " A nucleic acid molecule comprising: an X region capable of binding to a miRNA….to form a stem-loop structure” do not apply, rely on, or use integrate the judicial exception into a practical application, See Gorbea, Figure 4e and below.
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Regarding claims 1 and 2, there is no limitation about what constitute an X, Y
or Y* region, therefore one with ordinary skills can find any nucleic acid with these regions. In the example below, HSUR1 can have multiple regions that can be arbitrarily designated as X, Y or Y*.
Also, as shown below, HSUR1 is capable of binding a host mRNA in same region than the binding site for miR-27 (see Guo, Y.E. et al. “Virus meets host microRNA: the Destroyer, the Booster, the Hijacker”. Molecular and Cellular Biology, Vol. 34, No. 20 (2014), pp: 3780-3787; cited previously; Figure 2A and 2B and below).
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Regarding claims 1 and 3, as shown above, and in Guo, miR27 binds to HSUR1, a naturally occurring viral RNA, with a X region that comprises a nucleic acid sequence more than 85% complementary to the miRNA, with the total length being more than 40% complementary (see Guo, Figure 2A).
Guo teaches that some miRNAs are boosted upon cell infection by a viral nucleic acid, such as miR-155 that is upregulated by Epstein-Barr virus (see page 3781, right column, “The booster” section).
Gorbea teaches the miR-27 as a target for HSUR1 (see page 275, left column, second paragraph).
Gorbea teaches that HSUR2 confers resistance to apoptosis (see Extended Data Figure 10). Gorbea also teaches target genes involved in apoptosis (see title).
Gorbea teaches myc-mediated signaling being a target
for HSUR2 (see Figure 2). Nobili (Nobili, L. et al. “Long non-coding RNAs in B-cell
malignancies: a comprehensive overview”. Oncotarget, Vol. 8, No. 36 (2017), pp: 60605-60623; cited previously) also teaches c-Myc (see Table 2).
Regarding claim 4, Gorbea also teaches that viral RNAs can bind to multiple
miRNAs and host mRNAs (see extended data Figures 1 and 3, and page 275, left column). Lanzilloti (Lanzilloti, C. et al. “Long Non-coding RNAs and MicroRNAs
interplay in osteogenic differentiation of mesenchymal stem cells.” Frontiers in Cell and Developmental Biology, Vol. 9 (2021), p: 646032; cited previously ) teaches that a naturally occurring RNA can be a long noncoding RNA that is encoded by the cell’s precursors mRNA’ exons (see Figure 1). Therefore, inherently, the lncRNA can bind a mRNA with an X region that is 80% or more complementary to the mRNA target sequence.
Regarding claim 5, it recites an inherent part of the structure of HSUR2 RNA, i.e. “wherein nucleotide residues of positions 10 and 11 from the 3’ end of the X region is not complementary to the miRNA”. See Gorbea, Extended Data-Figure 1:
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Regarding claim 6, Gorbea teaches that HSUR2 has at least 2 regions that can be designated as X region, since there are two binding sites for different miRNAs, i.e. miR142-3p and miR-16 (see above, and Gorbea , extended data Figure 1).
Regarding claim 7, Gorbea teaches 2 different miRNA being able to bind with the “X” region, i.e. “X” region is at the 3’ end and Y and Y* regions are the regions self-hybridizing into a stem-loop structure at the 5’ end of HSUR2 RNA.
Regarding claim 8, Gorbea teaches an X region consisting of 10 or more nucleotides, since X region can be arbitrarily designated as the sequence binding miR142-3p and before an ARE sequence (see Figure above and Extended data Figure 1). Guo also shows an X region that binds miR-27 that is 17 nucleotides in length on HSUR1 sequence (see Figure 2A).
Regarding claims 9 and 10, Gorbea teaches a set of 10 nucleotides in each stem (Y and Y* regions) capable of hybridizing (see extended data Figure 1).
Regarding claim 11, Guo teaches miR-27 binding to HSUR1 (see Figure 2A). It is inherent that an RNA-RNA interaction can modify the lncRNA structure. Pawlica (Pawlica, P. et al. "Host miRNA degradation by Herpesvirus saimiri small nuclear RNA requires an unstructured interacting region". RNA, Vol. 22 (2016), pp: 1181-1189; cited previously) teaches that the conformation of HSUR1 changes upon miR-27 binding, leading to an unstructured region, required for miR-27 degradation (see title and Figure 2F).
Regarding claim 13, Gorbea teaches that miR-16 and miR-142-3p are interacting with HSUR2 but also with Argonaute (Ago) proteins (see Figure 3). These interactions lead to HSUR2-mediated mRNA repression (see Figure 3 and page 277, left column).
Kobayashi (Kobayashi, H. et al. “ RISC assembly: coordination between small RNAs and Argonaute proteins”. Biochemica et Biophysica Acta, Vol. 1859 (2016), pp: 71-81; cited previously) teaches that the RISC assembly depends upon small RNAs and Argonaute proteins (see title, abstract and Figure 2). Kobayashi provides evidence that Gorbea teaches a naturally occurring nucleic acid, with inherent abilities to recruit Ago proteins and interact with an RISC.
There are no further/additional limitation which applies either the identified judicial exception into a practical application. Thus, the claims do not provide for any element/step that integrates the law of nature into a practical application, nor do they provide for molecules that are markedly different from molecules found in Nature.
Step 2B - Does the Claim Recite Additional Elements that Amount to Significantly More than the Judicial Exception? NO
The Supreme Court has identified a number of considerations for determining whet her a claim with additional elements amounts to "significantly more" than the judicial exception(s) itself. The claim as a whole is evaluated as to whether it amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim. M.P.E.P. 2106.05. However, the additional elements, individually and in combination, do not amount to "significantly more".
Under the Step 2B analysis, claims 1-11 and 13 provide no additional "physical" elements. As explained with respect to Step2A Prong Two, the limitations claimed in claims 1-11 and 13 do not require any particular application of the judicial exception. Absent from the claims is a limitation(s) that has more than a nominal relationship to the judicial exception. There is no limitation(s) that utilize the recited product of nature in a manner that imposes a meaningful limit on it structurally. There is no limitation(s) that integrates the recited judicial exception into a practical application, such that the claims are not just directed to the judicial exception.
Thus, when viewed both individually and as an ordered combination, the claimed
elements in addition to the identified judicial exception are found insufficient to supply an inventive concept because the elements are considered inherent to the naturally occurring structure and/or specified at a high level of generality. The claim limitations do not transform the natural product that they recite into patent-eligible subject matter because the claims simply instruct the practitioner about inherent properties verifiable through routine and conventional activities.
Accordingly, the claims do not qualify as patent-eligible subject matter.
Claim Rejections - 35 USC § 112(a)
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 1-13 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.
MPEP 2163.II.A.3.(a).i) states, “Whether the specification shows that applicant was in possession of the claimed invention is not a single, simple determination, but rather is a factual determination reached by considering a number of factors. Factors to be considered in determining whether there is sufficient evidence of possession include the level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention”.
For claims drawn to a genus, MPEP § 2163 states 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, reduction to drawings, 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. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
Nature of the Invention:
Claim 1 recites “A nucleic acid molecule comprising:
an X region capable of binding to a miRNA;
a Y region capable of binding to an mRNA of a target gene; and
a Y* region capable of binding to the Y region,
wherein the Y region and the Y* region complementarily match each other to form a stem-loop structure, in which the X region in composed in the loop, the X region consists of 15 to 32 nt nucleotides and comprises a nucleic acid sequence 85% or more complementary to the nucleic acid sequence of the miRNA, the miRNA is at least one selected from the group consisting of miR-141, miR-21, miR-200c, miR-222, let-7f, miR-155, miR-24, miR-29a, miR-27a, miR-200a, miR-200b, miR-429, miR-205, miR-30a, miR-34, miR-203, miR-10b, miR-31, miR-9, miR-490, miR-29a, miR-204, miR-221, miR-138, miR-17, miR-19, miR-569, miR-9, miR-22, miR-29b, miR-125b, miR-126, miR-146a, miR-193a, miR-196b, miR-223, miR-492, miR-135b, miR-331, miR-374a, miR-519a, miR-191, miR-210, miR-24, miR-9, miR-27, miR-103, and miR-107, and, the target gene is at least one selected from the group consisting of at least one selected from the group consisting of mcl-1, bcl-xL, bcl-2, Snail1, Twist1, SLUG, Zeb1, TCF4, TCF3, FLT3, STAT3, c-Sis, EGFR, Ras, CYCD, Her2, Myc, Raf, VIM, CDH2, FN1, ACTA2, COL1A1, and SNAI2.”
The claim as written, is drawn to a nucleic acid molecule comprising regions
named X, Y and Y* without any specification on residue types and numbers, and/or specific sequences to further limit the regions. The claim does encompass any nucleic acid, in which anyone can put random/arbitrary limits and definitions of what corresponds to a region X, Y or Y*. The only specific limitation is that the nucleic acid should have a region with a stem-loop, in which the complementary bases can be grouped in a region Y and region Y*.
The claim is so broad that it encompasses any nucleic acid capable of binding miRNA listed and mRNA of the genes listed, not necessarily at the same time, which comprises in its sequence a stretch of bases capable of forming a stem-loop.
It is therefore expected in the instant application a disclosure of products that belong to different classes of nucleic acids such as long noncoding RNAs, siRNAs, dsRNAs, ssRNAs, tRNAs, gapmers, or DNAs. In this group of undefined nucleic acids, one is expected to find molecules from viral, archaeal, prokaryotic, plant, eukaryotic, vertebrate or invertebrate sources. The claim also encompasses naturally occurring molecules as well as synthetic molecules.
It is also expected in the disclosure the “naming” of such molecules and their sources.
It is therefore expected to find in the disclosure the description of a specific composition, in different embodiments, including a nucleic acid molecule representative of each categories.
The State of the Art:
Berkhout (Berkhout, B. et al. “The interplay between virus infection and the
cellular RNA interference machinery”. FEBS Letters, Vol. 580 (2006), pp: 2896-2902; cited previously) teaches that RNA interference plays a pivotal role in the regulation of gene expression to control cell development and differentiation, but in plants, insects and nematodes RNAi also functions as an innate defense response against viruses (see abstract).
Berkhout also teaches that eukaryotic cells also get infected by viruses which trigger an antiviral RNAi response, citing HIV-1 as an example of virus that encodes for an siRNA precursor with a hairpin structure composed of a 19 base pair perfectly complementary stem and a large loop (see page 2897, left column, second paragraph).
Guo (Guo, Y.E. et al. “Virus meets host microRNA: the Destroyer, the
Booster, the Hijacker”. Molecular and Cellular Biology, Vol. 34, No. 20 (2014), pp: 3780-3787; cited previously) teaches that an example of virus infecting mammalian cells, is the Herpesvirus saimiri (HSV), an oncogenic gamma-herpesvirus that can transform primate and human T cells (see page 3780, left column, “The Destroyer” section). Guo teaches that viral transcripts such as small U-rich Sm-class ncRNAs called HSURs are capable of binding mRNAs and miRNAs (same paragraph). Guo teaches that HSUR1 of HSV is capable of binding miR-27 leading to its degradation (see page 3782, Figure 2A and below).
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Guo teaches that different viruses have different mode of interference with host machinery, such as triggering degradation of miR-27 in the case of HSV (i.e. “the destroyer”, see Figure 2A), inducing mimicry and/or upregulation of miR-155 in the case of Kaposi’s sarcoma-associated herpesvirus (KSHV) (i.e., “the booster”, see page 3782, left column), or hijacking the host machinery such as using miR-122 to positively regulate Hepatitis C virus replication (see page 3783, right column). In all these cases, the infecting organism is capable of producing nucleic acid molecules that bind and interfere with host’s miRNAs and mRNAs.
- Gorbea II (Gorbea, C. et al. “Viral miRNA adaptor differentially recruits miRNAs to target mRNAs through alternative base-pairing”. eLIFE, Vol. 8 (2019), p: e50530; cited previously) teaches that the HSUR2 is actually capable of binding to mRNA and miRNA simultaneously, based on a psoralen-dependent crosslinking experiment (see page 1, “Introduction” section and Figure 1).
Gorbea II teaches that the position of mRNA-binding sites and the number of binding sites vary with the gene targets (see Figure 2 A). Therefore, one of ordinary skills in the art could define X, Y and Y* regions differently and according to specific molecule. For example (annotated Figure 2C):
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Gorbea II teaches that the binding of miR-16 and Argonaute proteins (Ago) recruitment via miR-16 are necessary for HSUR2-miR16-mediated repression of target mRNA (see page 11, Figure 7 and below).
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Lanzilloti (Lanzilloti, C. et al. “Long Non-coding RNAs and MicroRNAs
interplay in osteogenic differentiation of mesenchymal stem cells.” Frontiers in Cell and Developmental Biology, Vol. 9 (2021), p: 646032; cited previously) teaches that long noncoding RNAs are naturally occurring in eukaryotic cells as well, and play important roles in many tissues for growth and development (see abstract). Lanzilloti teaches that there are multiple types of lncRNAs, sense, antisense, intronic, intergenic and bidirectional, capable of regulating gene expression (see Figure 1). Lanzilloti presents lncRNAs as competing with mRNAs for miRNAs binding, essentially (see Figure 3). For example, Lanzilloti teaches that LncRNA H19 competes for SPAG9 mRNA by interfering with miR-141 (see Table 1).
However, Nobili (Nobili, L. et al. “Long non-coding RNAs in B-cell
malignancies: a comprehensive overview”. Oncotarget, Vol. 8, No. 36 (2017), pp: 60605-60623; cited previously) teaches that long noncoding RNAs can operate in epigenetic, transcriptional and translational regulation, capable of binding directly to mRNA for subnuclear sequestration, splicing modulation, control of mRNA decay and translational control (see Figure 1). Nobili teaches a long list of lncRNAs involved in cell development, cell cycle processes, apoptosis, and neoplastic transformation (see Tables 1 and 2).
Seo (Seo, D. et al. “Long non-coding RNA linc00152 acting as a
promising oncogene in cancer progression.” Genomics & Informatics, Vol. 17, No. 4 (2019), p:e36; cited previously) teaches that long noncoding RNAs can act via multiple pathways, via direct binding to mRNAs and splice factors and participate into the splicing processes, or bind to promoter region, i.e. DNA, of genes to be regulated (see page 1/6, “Introduction” section ). Seo also teaches that a long noncoding RNA, named Linc00152, is acting as a sponge for multiple miRNAs, binding directly to them, e.g. miR-125b and upregulates Mcl-1 (myeloid cell leukemia-1) gene expression as a result (see page 2/6, right column and Table 1). This Linc00152 is capable of binding DNA, i.e. promoter regions, and directly regulate gene expression of genes such as EpCAM and IL24 (see page 3/6, right column and Figure 1).
In summary, there are numerous noncoding RNAs, with a hairpin structure, from viruses or from eukaryotic cells, with the ability to bind mRNAs and miRNAs, and regulate gene expression of a target gene involved in multiple pathways such as cell growth and differentiation (see Lanzilloti, Table 1), apoptosis (Berkhout, page 2898, sections 4 and 10), epithelial-mesenchymal transition and cell transformation (Guo, Table 1). Many of the gene targets and miRNAs listed in claims 15 and 17 are found naturally regulated and listed in the references cited above.
What the Specification does and does not teach:
The Specification discloses the invention as being “a novel nucleic acid molecule that can regulate the expression of a target gene in a manner specific for the site where a disease-related miRNA is present, with the miRNA being not complementary to the target gene” (see page 3, lines 1-5).
The Specification discloses that the molecule is a complex/chimera between miRNA (see Table 3, page 58, miR-141, miR-200a-c) and a hairpin miRNA trigger (see table 2, page 54), with targets described in Table 1 ( see page 53, PKR, Mcl-1, Bcl-XL and Bcl-2). Applicant also discloses examples of modifications of resulting oligonucleotides for stability (see Table 5, pages 60-61).
While claim 1 is broad and encompasses nucleic acid molecules that are naturally occurring and synthetic, the Specification only provides for a set of defined synthetic chimeric molecules.
There are no example, or reduction to practice of siRNAs used or dsRNAs, ssRNAs, tRNAs, gapmers, and DNAs. The claim is drawn to an undefined group of nucleic acids, where one is expected to find molecules from viral, archaeal, prokaryotic, plant, eukaryotic, vertebrate or invertebrate sources. The claim also encompasses naturally occurring molecules as well as synthetic molecules. The Specification does not discloses species of long noncoding RNAs from viruses or from naturally occurring long noncoding RNAs involved in cellular processes.
Conclusion:
Taking into consideration the factors outlined above, including the nature of the
invention, the state of the art, the guidance provided by the applicant and the specific examples, it is the conclusion that Applicant does not possess the entire genus of species of the claimed invention. There is no specific written example within the Specification that would lead one with ordinary skills in the art to a different conclusion.
Claims 2-13 are dependent of claim 1 and do not remedy the deficiencies of claim 1. Therefore, they are rejected as well.
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, 5-11 and 13 are rejected under 35 U.S.C. §102(a)(1) as being anticipated by Gorbea I (Gorbea, C. et al. “ A viral Sm-class RNA base-pairs with mRNAs and recruits microRNAs to inhibit apoptosis”. Nature, Vol. 550 (2017), pp: 275-279; also cited on submitted IDS filed 06/17/2022; cited previously), as evidenced by Guo (Guo, Y.E. et al. “Virus meets host microRNA: the Destroyer, the Booster, the Hijacker”. Molecular and Cellular Biology, Vol. 34, No. 20 (2014), pp: 3780-3787; cited previously), Cazalla (Cazalla, D. et al. “Down-regulation of a host microRNA by a viral noncoding RNA”. Cold Spring Harb. Symp. Quant. Biol. Vol. 75 (2010), pp: 321-324; cited previously), Pawlica (Pawlica, P. et al. "Host miRNA degradation by Herpesvirus saimiri small nuclear RNA requires an unstructured interacting region". RNA, Vol. 22 (2016), pp: 1181-1189; cited previously) and Kobayashi (Kobayashi, H. et al. “ RISC assembly: coordination between small RNAs and Argonaute proteins”. Biochemica et Biophysica Acta, Vol. 1859 (2016), pp: 71-81; cited previously).
Regarding claim 1, according to the Broad and Reasonable Interpretation (BRI) of the claims’ language, the use of the terms “comprises” and “a nucleic acid sequence” allows for fragments of nucleic acid sequence of longer miRNA molecules. Therefore, the claims are also drawn to and encompass fragments that are 85 to 90% identical, and molecules that present with 85 to 90% local similarity to the X region in the nucleic acid molecule binding to the miRNA.
Regarding claim 1, it recites “ A nucleic acid molecule comprising:
an X region capable of binding to a miRNA;
a Y region capable of binding to an mRNA of a target gene; and
a Y* region capable of binding to the Y region,
wherein the Y region and the Y* region complementarily match each other to form a
stem-loop structure, in which the X region in composed in the loop, the X region consists of 15 to 32 nt nucleotides and comprises a nucleic acid sequence 85% or more complementary to the nucleic acid sequence of the miRNA, the miRNA is at least one selected from the group consisting of miR-141, miR-21, miR-200c, miR-222, let-7f, miR-155, miR-24, miR-29a, miR-27a, miR-200a, miR-200b, miR-429, miR-205, miR-30a, miR-34, miR-203, miR-10b, miR-31, miR-9, miR-490, miR-29a, miR-204, miR-221, miR-138, miR-17, miR-19, miR-569, miR-9, miR-22, miR-29b, miR-125b, miR-126, miR-146a, miR-193a, miR-196b, miR-223, miR-492, miR-135b, miR-331, miR-374a, miR-519a, miR-191, miR-210, miR-24, miR-9, miR-27, miR-103, and miR-107, and, the target gene is at least one selected from the group consisting of at least one selected from the group consisting of mcl-1, bcl-xL, bcl-2, Snail1, Twist1, SLUG, Zeb1, TCF4, TCF3, FLT3, STAT3, c-Sis, EGFR, Ras, CYCD, Her2, Myc, Raf, VIM, CDH2, FN1, ACTA2, COL1A1, and SNAI2.”
Gorbea I teaches in Extended Data Figure 1a ( and see below) a nucleic acid molecule, namely HSUR2, having a 3’ end (left side) that has an “X region” capable of binding miRNAs, i.e. miR142-3p and miR-16, a “Y region” on 5’ end capable of forming a stem-loop structure by hybridizing with a “Y* region”, complementary over a stretch of 10 nucleotides (See Gorbea I, Extended Data-Figure 1).
Gorbea I teaches that HSUR1 binds to miR-27 (see page 275, left column, second paragraph).
Gorbea I teaches HSUR1, and as evidenced by Guo, the HSUR1 ‘s region of miRNA-binding miR-27 , i.e., “X region” is included within a loop (see figure 2A of Guo).
Gorbea I teaches target genes involved in apoptosis (see title and Figure 2C). In Figure 2C, Gorbea I teaches the use of “Ingenuity pathway analysis and show selected pathways for HSUR2 targets, among which p53, JAK1-2 and TYK2 signaling, and Myc-mediated apoptosis (see title and Figure 2C).
Gorbea I teaches that target genes are those involved in c-myc pathway (see Figure 2C). Therefore, inherently, c-Myc is a target gene (see page 279, left column, second paragraph and reference 24).
As evidenced by Casalla, the targets of miR-16 are cell cycle and apoptosis regulator such as Bcl-2 and cyclins D1 and E1 (see page 4, second paragraph).
Regarding claim 2, there is no limitation about what constitute an X, Y or Y*
region, therefore one with ordinary skills can find any nucleic acid with these regions. In the example below, HSUR1 can have multiple regions that can be arbitrarily designated as X, Y or Y*.
Gorbea teaches that HSUR1 binds miR-27 (see page 275, left column, second paragraph). As shown below, HSUR1 is capable of binding a host mRNA in same region than the binding site for miR-27 (see Guo, Y.E. et al. “Virus meets host microRNA: the Destroyer, the Booster, the Hijacker”. Molecular and Cellular Biology, Vol. 34, No. 20 (2014), pp: 3780-3787; Figure 2A and 2B and below).
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Therefore, Gorbea also teaches a nucleic acid molecule, i.e. HSUR1, that can be represented with the general formula Y-X-Y*, with multiple stem-loop regions.
Regarding claim 3, Gorbea I teaches that HSUR1 binds to miR-27 (see page 275, left column, second paragraph). As evidenced by Cazalla, miR-27 which is 21 nucleotides in length, binds HSUR1 with 15 complementary nucleotides, i.e. a region comprising more than 40% complementary of the total sequence of the miRNA (see page 7, Figure 1).
However, Examiner interprets that Gorbea I teaches the limitation in view of the language “wherein the X region comprises a nucleic acid sequence 90% or more complementary to the nucleic acid sequence of the miRNA”, since HSUR1 has two fragments of nucleic acid sequence capable of binding the miRNA with a local complementarity of 100%.
Regarding claim 5, it recites an inherent part of the structure of HSUR2 RNA, i.e. “wherein nucleotide residues of positions 10 and 11 from the 3’ end of the X region is not complementary to the miRNA”. Gorbea I teaches a structure that is not complementary at positions 10 and 11 from the 3’ end of HSUR2 (See Gorbea I, Extended Data-Figure 1 and below):
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Regarding claim 6, Gorbea I teaches two regions capable of binding a miRNA, therefore, with two X regions (see above and Extended Data-Figure 1).
Regarding claim 7, Gorbea I teaches 2 different miRNA being able to bind with the “X” region, i.e. “X” region is at the 3’ end and Y and Y* regions are the regions self-hybridizing into a stem-loop structure at the 5’ end of HSUR2 RNA (see above and Extended Data-Figure 1). miR 142-3p is binding 10 nucleotides in 3’ region, first X region, and miR 16 is binding another 7 nucleotides in a second X region (see above and Extended Data Figure 1).
Regarding claim 8, Gorbea I teaches an X region consisting of 10 nucleotides (binding site for miR 142-3p), since X region can be arbitrarily designated as the sequence binding miR142-3p and before an ARE sequence (see Figure above and Extended data Figure 1). Guo also shows an X region that binds miR-27 that is 17 nucleotides in length on HSUR1 sequence (see Figure 2A).
Regarding claims 9 and 10, Gorbea I teaches a set of 10 nucleotides in each stem (Y and Y* regions) capable of hybridizing (see Extended Data Figure 1).
Examiner interprets that the hybridizing stretches can be 10 nucleotides while the length of the region Y and Y* can be longer, since there is no specific definitions for Y and Y*, nor a specific number of contiguous base pairs and percentage of homology required in the claims.
Regarding claim 11, Gorbea I teaches that HSUR1 is capable of binding miR-27. Guo teaches miR-27 binding to HSUR1 (see Figure 2A). It is inherent that an RNA-RNA interaction can modify the lncRNA structure. Pawlica (Pawlica, P. et al. "Host miRNA degradation by Herpesvirus saimiri small nuclear RNA requires an unstructured interacting region". RNA, Vol. 22 (2016), pp: 1181-1189) teaches that the conformation of HSUR1 changes upon miR-27 binding, leading to an unstructured region, required for miR-27 degradation (see title and Figure 2F).
Regarding claim 13, Gorbea I teaches that miR-16 and miR-142-3p are interacting with HSUR2 but also with Argonaute (Ago) proteins (see Figures 3 and 4e, also shown below).
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These interactions lead to HSUR2-mediated mRNA repression (see Figures 3, 4e and page 277, left column).
Kobayashi teaches that the RISC assembly depends upon small RNAs and Argonaute proteins (see title, abstract and Figure 2). Kobayashi provides evidence that Gorbea I teaches a naturally occurring nucleic acid, with inherent abilities to recruit miRNAs interacting with Ago proteins, and therefore interacting with a RISC.
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 4 and 12 are rejected under 35 U.S.C. §103 as being unpatentable over Gorbea I (Gorbea, C. et al. “ A viral Sm-class RNA base-pairs with mRNAs and recruits microRNAs to inhibit apoptosis”. Nature, Vol. 550 (2017), pp: 275-279; also cited on submitted IDS filed 06/17/2022; cited previously), as evidenced by Guo (Guo, Y.E. et al. “Virus meets host microRNA: the Destroyer, the Booster, the Hijacker”. Molecular and Cellular Biology, Vol. 34, No. 20 (2014), pp: 3780-3787; cited previously), Cazalla (Cazalla, D. et al. “Down-regulation of a host microRNA by a viral noncoding RNA”. Cold Spring Harb. Symp. Quant. Biol. Vol. 75 (2010), pp: 321-324; cited previously), Pawlica (Pawlica, P. et al. "Host miRNA degradation by Herpesvirus saimiri small nuclear RNA requires an unstructured interacting region". RNA, Vol. 22 (2016), pp: 1181-1189; cited previously) and Kobayashi (Kobayashi, H. et al. “ RISC assembly: coordination between small RNAs and Argonaute proteins”. Biochemica et Biophysica Acta, Vol. 1859 (2016), pp: 71-81; cited previously), as applied to claim 1 above, and in view of Lanzilloti (Lanzilloti, C. et al. “Long Non-coding RNAs and MicroRNAs interplay in osteogenic differentiation of mesenchymal stem cells.” Frontiers in Cell and Developmental Biology, Vol. 9 (2021), p: 646032; cited previously ) and Helm ( Helm, M. Post-transcriptional nucleotide modification and alternative folding of RNA”. Nucleic Acids Research, Vol. 34, No. 2 (2006), pp: 721-733; cited previously).
Regarding claim 1, it recites “ A nucleic acid molecule comprising:
an X region capable of binding to a miRNA;
a Y region capable of binding to an mRNA of a target gene; and
a Y* region capable of binding to the Y region,
wherein the Y region and the Y* region complementarily match each other to form a
stem-loop structure, in which the X region in composed in the loop, the X region consists of 15 to 32 nt nucleotides and comprises a nucleic acid sequence 85% or more complementary to the nucleic acid sequence of the miRNA, the miRNA is at least one selected from the group consisting of miR-141, miR-21, miR-200c, miR-222, let-7f, miR-155, miR-24, miR-29a, miR-27a, miR-200a, miR-200b, miR-429, miR-205, miR-30a, miR-34, miR-203, miR-10b, miR-31, miR-9, miR-490, miR-29a, miR-204, miR-221, miR-138, miR-17, miR-19, miR-569, miR-9, miR-22, miR-29b, miR-125b, miR-126, miR-146a, miR-193a, miR-196b, miR-223, miR-492, miR-135b, miR-331, miR-374a, miR-519a, miR-191, miR-210, miR-24, miR-9, miR-27, miR-103, and miR-107, and, the target gene is at least one selected from the group consisting of at least one selected from the group consisting of mcl-1, bcl-xL, bcl-2, Snail1, Twist1, SLUG, Zeb1, TCF4, TCF3, FLT3, STAT3, c-Sis, EGFR, Ras, CYCD, Her2, Myc, Raf, VIM, CDH2, FN1, ACTA2, COL1A1, and SNAI2”.
Gorbea I teaches in Extended Data Figure 1a ( and see below) a nucleic acid molecule, namely HSUR2, having a 3’ end (left side) that has an “X region” capable of binding miRNAs, i.e. miR142-3p and miR-16, a “Y region” on 5’ end capable of forming a stem-loop structure by hybridizing with a “Y* region”, complementary over a stretch of 10 nucleotides (See Gorbea I, Extended Data-Figure 1).
Gorbea I teaches HSUR1, and as evidenced by Guo, the HSUR1 ‘s region of miRNA-binding miR-27 , i.e., “X region” is included within a loop (see figure 2A of Guo).
Gorbea I also teaches that miR-16 and miR-142-3p are interacting with HSUR2 but also with Argonaute (Ago) proteins (see Figures 3 and 4e, also shown below).
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These interactions lead to HSUR2-mediated mRNA repression (see Figures 3, 4e and page 277, left column).
Gorbea I teaches that HSUR1 binds to miR-27 (see page 275, left column, second paragraph).
Gorbea I teaches target genes involved in apoptosis (see title and Figure 2C). In Figure 2C, Gorbea I teaches the use of “Ingenuity pathway analysis and show selected pathways for HSUR2 targets, among which p53, JAK1-2 and TYK2 signaling, and Myc-mediated apoptosis (see title and Figure 2C).
Gorbea I teaches that target genes are those involved in c-myc pathway (see Figure 2C). Therefore, inherently, c-Myc is a target gene (see page 279, left column, second paragraph and reference 24).
As evidenced by Casalla, the targets of miR-16 are cell cycle and apoptosis regulator such as Bcl-2 and cyclins D1 and E1 (see page 4, second paragraph).
Regarding claim 4, Gorbea also teaches that viral RNAs can bind to multiple
miRNAs and host mRNAs (see extended data Figures 1 and 3, and page 275, left column). However, Gorbea does not teach a lncRNA that binds a mRNA with a X region that is 80% or more complementary to the mRNA target sequence.
However, Lanzilloti teaches that a naturally occurring RNA can be a long noncoding RNA that is encoded by the cell’s precursors mRNA’ exons (see Figure 1). Therefore, a lncRNA can bind a mRNA with a nucleic acid sequence, i.e., an X region, that is 80% or more complementary to the mRNA target sequence.
It would have been obvious to one with ordinary skills, before the effective filing date, to have modified a synthetic nucleic acid molecule known to bind a miRNA as taught by Gorbea, with a sequence 80% complementary to a specific gene mRNA as taught by Lanzilloti. One with ordinary skills in the art, motivated in targeting an mRNA that is responsive to miR-16 or miR-142-3p, for mRNA repression, could have performed this modification and made sure of obtaining repression, as taught by Gorbea (Figure 4e). One with ordinary skills in the art could have performed this modification with a reasonable expectation of success and arrived at the claimed invention.
Regarding claim 12, Gorbea does not teach modifications of the nucleic acid molecule.
However, Helm does teach nucleotide modifications to reinforce RNA structures and stabilize them (see page 722, right column, “Impact of nucleotide modifications on local structure” section). Helm teaches methylations at the 2’-OH (see page 722, right column, “Impact of nucleotide modifications on local structure” section, second paragraph; see Figure 1).
Therefore, it would have been obvious to one with ordinary skills in the art before the effective filing date of the claimed invention to have modified the nucleic acid molecule (HSUR1 or HSUR2) taught by Gorbea, and added methylations modifications as taught by Helm. One with ordinary skills in the art, motivated in a stable molecule with stable stem-loop conformation, could have performed this modification with a reasonable expectation of success and arrived at the claimed invention.
Response to Arguments
Applicant's arguments filed 03/25/2026 have been fully considered but they are not persuasive.
In response to Applicant’s arguments in the section “Claim Rejections under 35 U.S.C. §101” on page 11 of Remarks, Applicant affirms that the “claimed invention is a specifically designed, non-natural molecule”. However, the claim language, without a specific enumeration in residues and sequence ID number, encompasses naturally occurring molecules. Applicant must amend the claim to specifically add limitations drawn to structures that are unique to the specifically designed molecule.
In response to Applicant’s arguments in the section “Claim Rejection under 35 U.S.C. §112 (a)” on page 11 of Remarks, the amendments do not limit the claims to a synthetic molecules, but encompass structures that are found in Nature as well. Therefore, the Written Description rejections are maintained.
Applicant’s arguments on page 12 of Remarks, in the section “Rejections under 35 U.S.C. §102” in which Applicant specifically traverses the rejection because the claim must disclose each and every limitation of the claim, are not found persuasive since the claim is drawn to a nucleic acid molecule, having a structure comprising an X region, a Y region and a Y* region, without any specific limitation on residues and identity, that can both binds any miRNA listed within the claim, and an mRNA of a target gene listed within the claim. The claim does not give any specific as to which specific miRNA is associated to a specific mRNA target. Gorbea teaches the existence of naturally occurring nucleic acid capable of binding both miRNAs and mRNAs, and two specific nucleic acids. The evidentiary references show that the two naturally occurring nucleic acids comprise the structures as claimed, and are capable of targeting and binding some of the miRNAs listed in claim 1, as well as their mRNA targets, also listed in claim 1.
The amendments of claim 1 do not further limit the structures in a way that would specifically point to a synthetically designed molecule and to Applicant’s invention. Therefore, the rejections are maintained.
Applicant’s arguments on page 13 of Remarks, in the section “Rejections under 35 U.S.C. §103” are not found persuasive.
In response to applicant's argument that “resulting effect of regulating target mRNA expression specifically in the presence of microRNA”, recitations of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “it includes a microRNA-binding region in the loop region, whereby the stem structure opens in the presence of the corresponding microRNA, allowing the molecule to act on the target mRNA”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Gorbea I teaches naturally occurring nucleic acid molecules that can both ding miRNAs and mRNA targets. Guo, Cazalla, Pawlica and Kobayashi teaches evidences that the limitations recited on structures for said nucleic acid molecules are inherent to the naturally occurring molecules. Lanzilloti teaches the function associated with long non-coding nucleic acid molecules. One with ordinary skills in the art cold be motivated in using such molecules in vitro or in vivo to regulate gene expression, and one method of stabilizing a synthetically made molecule for this purpose is taught by Helm.
Therefore, Applicant’s arguments are not found persuasive. The rejections are maintained.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/A.D./Examiner, Art Unit 1636
/NANCY J LEITH/Primary Examiner, Art Unit 1636
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