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 .
Response to Amendment/Status of Claims
Receipt of Arguments/Remarks filed on 02/05/2026 is acknowledged. Claims 1-10 were/stand cancelled. Claims 11,14 and 17 were amended.
Claims 12,13,15,16,18 and 19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/22/2025.
Claims 11,14 and 17 are under examination.
Priority
This application is a 371 of PCT/CN2020/132256, filed 11/27/2020. This application claims foreign priority to CN201911283398.3, filed 12/13/2019. However, there is no English translation of the non-English language foreign priority application.
Withdrawn Rejections/Objections
Applicant’s arguments and amendments, see page 7, filed 02/05/2026, with respect to the objection to the specification and objection to the claims have been fully considered and are persuasive due to the amendments correcting the specification and claim objections. The objections have been withdrawn.
Applicant’s arguments and amendments, see pages 9-10, filed 02/05/2026, with respect to the 35 U.S.C. 112(b) rejection of claims 11,14 and 17 have been fully considered and are persuasive due to the amendments to claims 11,14, and 17 removing “sense strand” from the claims. The 35 U.S.C. 112(b) rejection has been withdrawn.
Maintained Rejections
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 11,14 and 17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more.
Regarding Step 1 of the Eligibility Analysis for 35 USC 101, claim 11 recites a siRNA, claim 14 recites an expression vector, and claim 17 recites a pharmaceutical formulation, and are therefore directed to a product, which is one of the statutory categories of invention.
Regarding Step 2A Prong One of the Eligibility Analysis, claims 11,14 and 17 recite at least one judicial exception that is a product of nature, which is an siRNA that has a nucleotide sequence of SEQ ID NO: 5. As seen in the Blast search and alignment below, nucleotides 1-19 of SEQ ID NO: 5 is complementary to nucleotides 432-414 of Homo sapiens HTT, transcript variant 1 mRNA:
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Therefore, as SEQ ID NO: 5 is complementary to the target HTT mRNA, it is an antisense sequence. As shown by Faghihi et al. (Nat Rev Mol Cell Biol 10, 637-643 (2009)), mammalian genomes encode numerous natural antisense transcripts (Abstract), as natural antisense transcripts are RNA molecules that are transcribed from the opposite DNA strand to other transcripts and overlap in part with sense RNA (Page 637, left column). Faghihi et al. teach the presence of antisense transcripts is no longer a curiosity but rather a pervasive feature of mammalian genomes (page 637, middle column). Faghihi et al. teach the ability of antisense mediated regulation of sense mRNA into four main groups including transcription related modulation, RNA-DNA interactions, RNA-RNA interactions in the nucleus and RNA-RNA interactions in the cytoplasm (Page 637, right column). Faghihi et al. supports that claim 11 as recited is a product of nature.
In addition, claim 17 recites the pharmaceutical formulation comprising an expression vector for expressing an siRNA that inhibits the expression of a HTT gene and a pharmaceutically acceptable vehicle. Based on the broadest reasonable interpretation, the vehicle may be water, which is also a product of nature.
Claim 11 does not have markedly different characteristics from HTT antisense sequences found in nature as there are no modifications recited in the siRNA. See also MPEP 2106.04(b) discussing products of nature including isolated DNA and single-stranded DNA fragments.
Regarding claim 14, the preamble recites “an expression vector”, but the body of the claim says the expression vector contains siRNA and said siRNA has the nucleotide sequence of SEQ ID NO: 5. Claim 17 recites a pharmaceutical formulation comprising the expression vector and pharmaceutically acceptable vehicle and does not result in a markedly different characteristic. The siRNA sequence of claims 14 and 17 also do not have markedly different characteristics from HTT antisense sequences found in nature as there are no modifications recited in the siRNA.
Next then, Step 2A Prong Two is analyzed to determine if the claim recites additional elements that integrate the judicial exception into a practical application. Regarding claim 11, no additional elements are recited. Regarding claim 14, the preamble recites an expression vector, and the claim recites that the expression vector contains the siRNA. No additional elements of the vector are recited, such as a heterologous sequence. Regarding claim 17, the preamble is a pharmaceutical formulation, and the body of the claim recites characterized in that said formulation comprises an expression vector for expressing an siRNA that inhibits expression of a HTT gene and a pharmaceutically acceptable vehicle. Claim 17 does recite an additional component to the formulation which is a pharmaceutically acceptable vehicle, but does not integrate the judicial exception into a practical application. See MPEP 2106.04(d)(2) discussing integrating the judicial exception into a practical application, including when the additional elements apply or use the recited judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition.
Next, Step 2B of the Eligibility Analysis on whether a claim amounts to significantly more than the judicial exception is evaluated. As shown above, claims 11 and 14 do not include any additional elements in addition to the siRNA of SEQ ID NO: 5, and claim 17 recites a pharmaceutically acceptable vehicle, which as discussed above encompasses water which is also a natural product and does not amount to significantly more than the judicial exception.
Therefore, it is concluded that claims 11,14 and 17 fail all of the steps of the test for subject matter eligibility under 35 USC 101.
Response to Arguments
Applicant's arguments and amendments, filed 02/05/2026 have been fully considered but they are not persuasive.
Applicant argues on page 8 that the Examiner’s characterization of the claimed siRNA as a product of nature is based on a fundamental misunderstanding of the nature of the claimed subject matter, and Faghihi et al. describes natural antisense transcripts as RNA molecules that are transcribed from the opposite DNA strand to other transcripts, and these NATs are endogenously transcribed RNA molecules that exist within the cellular environment as part of the natural regulatory machinery of the genome. Applicant argues that in contrast, the siRNA as recited in claim 11 is a synthetic, isolated molecule specifically designed for therapeutic RNAi mediated gene silencing, and the claimed siRNA is not an endogenously transcribed RNA molecule but a deliberately engineered therapeutic agent with a defined structure and function that does not exist in nature.
This is not found persuasive. MPEP 2106.04(c) describes guidelines for the markedly different characteristics analysis for Step 2A Prong One and states that the markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties, and are evaluated based on what is recited in the claim on a case-by-case basis. If the analysis indicates that a nature-based product limitation does not exhibit markedly different characteristics, then that limitation is a product of nature exception. MPEP 2106.04(c) II. A. describes that the first step in the analysis is to select the appropriate counterpart to the nature-based product: “For example, assume that applicant claims a nucleic acid having a nucleotide sequence derived from naturally occurring gene B. Although gene B occurs in nature as part of a chromosome, the closest natural counterpart for the claimed nucleic acid is gene B, and not the whole chromosome. See, e.g., Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 591-94, 106 USPQ2d 1972, 1979-81 (2013) (comparing isolated BRCA1 genes and BRCA1 cDNA molecules to naturally occurring BRCA1 gene); Roche Molecular System, Inc. v. CEPHEID, 905 F.3d 1363, 1371, 128 USPQ2d 1221, 1227 (Fed. Cir. 2018) (comparing claimed primers to "their corresponding nucleotide sequences on the naturally occurring DNA"). Similarly, assume that applicant claims a single-stranded piece of DNA (a primer) having a nucleotide sequence derived from the sense strand of naturally occurring nucleic acid C. Although nucleic acid C occurs in nature as a double-stranded molecule having a sense and an antisense strand, the closest natural counterpart for the claimed nucleic acid is the sense strand of C only. See, e.g., University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 760, 113 USPQ2d 1241, 1241 (Fed. Cir. 2014) (comparing single-stranded nucleic acid to the same strand found in nature, even though "single-stranded DNA cannot be found in the human body")”.
Regarding identifying appropriate characteristics for analysis, MPEP 2106.04(c) II. B. says that “Examiners can identify the characteristics possessed by the claimed product by looking at what is recited in the claim language and encompassed within the broadest reasonable interpretation of the nature-based product”, and MPEP 2106.04(c) II. C. states “the final step in the markedly different characteristics analysis is to compare the characteristics of the claimed nature-based product to its naturally occurring counterpart in its natural state, in order to determine whether the characteristics of the claimed product are markedly different. The courts have emphasized that to show a marked difference, a characteristic must be changed as compared to nature, and cannot be an inherent or innate characteristic of the naturally occurring counterpart or an incidental change in a characteristic of the naturally occurring counterpart. Myriad, 569 U.S. at 580, 106 USPQ2d at 1974-75. Thus, in order to be markedly different, the inventor must have caused the claimed product to possess at least one characteristic that is different from that of the counterpart. If there is no change in any characteristic, the claimed product lacks markedly different characteristics, and is a product of nature exception”.
Based on the guidelines cited above from MPEP, the instantly claimed siRNA that has a nucleotide sequence of SEQ ID NO: 5, is not claimed as double-stranded and only recites a single sequence. It is not recited as a synthetic, isolated molecule as applicant argues above. What is recited in the claim is that said siRNA has a nucleotide sequence of SEQ ID NO: 5. Therefore, what is instantly claimed does not appear to be different than natural antisense transcripts described in Faghihi et al. or have markedly different characteristics from a natural antisense sequence found in nature.
Applicant argues that the fact that SEQ ID NO: 5 is complementary to a portion of the HTT mRNA does not render it a product of nature, as complementarity to a target sequence is a fundamental requirement for any siRNA designed to silence a specific gene which is the basis of RNAi technology, and the claimed siRNA recited by claim 11 represents a synthetic construct engineered for a specific therapeutic purpose, not a naturally occurring transcript. Applicant argues the claimed siRNA possesses markedly different structural and functional characteristics from any naturally occurring antisense transcript, and that siRNAs are short, double-stranded RNA molecules of a defined length (typically 19-23 nucleotides) that are processed by the cellular RNAi machinery to achieve targeted gene silencing, and that natural transcripts are much longer, single-stranded RNA molecules with diverse regulatory functions that do not involve the RNAi pathway in the same manner. Applicant cites MPEP 2106.04(c).
This is not found persuasive. As argued above, the claims do not recite a double-stranded siRNA and does not recite a synthetic engineered construct. The preamble of the claim recites “a siRNA for inhibiting expression of a huntingtin (HTT) gene or a precursor thereof”, while the body of the claim merely recites a nucleotide sequence of SEQ ID NO: 5 that does not have markedly different characteristics from that found in nature. Claim 14 also just recites “an expression vector in the preamble” but the body of the claim only recites the same nucleotide sequence of SEQ ID NO: 5 and therefore there are no markedly different characteristics from a natural antisense sequence.
Applicant argues on page 9, that the field of RNAi therapeutics is highly unpredictable, and that not every sequence to a target mRNA will function effectively as an siRNA, and the selection of effective siRNA sequences requires extensive empirical testing and optimization, and the claimed siRNA sequences represent the result of deliberate design and selection for therapeutic utility, not mere isolation of naturally occurring molecules.
This is not found persuasive. As seen in MPEP 2106.04 (C) 2. “In Myriad, the Supreme Court made clear that not all changes in characteristics will rise to the level of a marked difference, e.g., the incidental changes resulting from isolation of a gene sequence are not enough to make the isolated gene markedly different. Myriad, 569 U.S. at 580, 106 USPQ2d at 1974-75. The patentee in Myriad had discovered the location of the BRCA1 and BRCA2 genes in the human genome, and isolated them, i.e., separated those specific genes from the rest of the chromosome on which they exist in nature. As a result of their isolation, the isolated genes had a different structural characteristic than the natural genes, i.e., the natural genes had covalent bonds on their ends that connected them to the rest of the chromosome, but the isolated genes lacked these bonds. However, the claimed genes were otherwise structurally identical to the natural genes, e.g., they had the same genetic structure and nucleotide sequence as the BRCA genes in nature. The Supreme Court concluded that these isolated but otherwise unchanged genes were not eligible, because they were not different enough from what exists in nature to avoid improperly tying up the future use and study of the naturally occurring BRCA genes. See, e.g., Myriad, 569 U.S. at 585, 106 USPQ2d at 1977 ("Myriad's patents would, if valid, give it the exclusive right to isolate an individual’s BRCA1 and BRCA2 genes … But isolation is necessary to conduct genetic testing") and 569 U.S. at 593, 106 USPQ2d at 1980 (describing how would-be infringers could not avoid the scope of Myriad’s claims). In sum, the claimed genes were different, but not markedly different, from their naturally occurring counterparts (the BRCA genes), and thus were product of nature exceptions”. While Applicant argues the claimed siRNA sequences represent the result of deliberate design and not mere isolation, there is nothing recited in the claims that reflects this difference.
Applicant argues on page 8 that regarding claim 14, “an expression vector” represents a man-made construct that doesn’t occur in nature, and which are synthetic tools and the combination of an expression vector with the claimed siRNA sequence creates a composition with markedly different characteristics from anything found in nature. Applicant argues claim 17 reciting “a pharmaceutical formulation” as recited represents a manufactured composition specifically designed for therapeutic administration, and even if the carrier were water, the combination of the synthetic expression vector expressing the claimed siRNA with a carrier in a pharmaceutical formulation represents a composition that does not occur in nature and is specifically designed for therapeutic application.
This is not found persuasive. While claim 14 recites “an expression vector in the preamble” the body of the claim only recites the same nucleotide sequence of SEQ ID NO: 5 and therefore there are no markedly different characteristics from a natural antisense sequence. No additional elements of the vector are recited, such as a heterologous sequence. Regarding claim 17, the recitation of the preamble “A pharmaceutical formulation” and which comprises an expression vector for expressing an siRNA and a pharmaceutically acceptable vehicle recites no other components, and is stating the equivalent of “apply it” and are just generally linking the use of the judicial exception to a particular technological environment or field of us, and is not significantly more than the judicial exception. MPEP 2106.05 A. states: “Limitations that the courts have found not to be enough to qualify as "significantly more" when recited in a claim with a judicial exception include: i. Adding the words "apply it" (or an equivalent) with the judicial exception…. iv. Generally linking the use of the judicial exception to a particular technological environment or field of use”.
Therefore, the Examiner is maintaining the 35 U.S.C. 101 rejection of claims 11,14 and 17.
Claim Rejections - 35 USC § 102
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 11,14 and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Khvorova et al. (US 20160355808, Published 8 December 2016).
Claim Interpretation: Regarding the interpretation of the transitional phrase “has”, this is being treated like the transitional phase “having”. Per MPEP 2111.03, transitional phases such as “having” must be interpreted in light of the specification to determine whether open or closed claim language is intended. Page 7 of the specification states mature siRNAs typically have 18-26 nucleotides (more specifically about 19-22 nt) and may have other numbers of nucleotides. Therefore, in light of the specification, “has a nucleotide sequence” is being interpreted as open claim language as allowing additional nucleotides beyond that of SEQ ID NO: 5 which is 19 nucleotides in length.
Regarding claim 11, Khvorova et al. teach RNA molecules (e.g. siRNAs) that target novel huntingtin target sequences (paragraphs 0009, 0162) and teach the RNA molecule is single stranded RNA (paragraphs 0011,0024,0026). Khvorova teach the antisense sequences of SEQ ID NO: 317-420 (paragraph 0071 and Fig. 21). Nucleotides 2-20 of SEQ ID NO: 414 are a 100% match to all 19 nucleotides of instant SEQ ID NO: 5. See alignment below wherein Qy is instant SEQ ID NO: 5 and Db is SEQ ID NO: 414 of Khvorova et al.
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Regarding claim 14, Khvorova et al. teach a vector for inhibiting expression of HTT gene, wherein the nucleic acid molecules of the invention can be inserted into expression constructs, e.g. viral vectors (paragraphs 0440,0482).
Regarding claim 17, Khvorova et al. teach the modulators (e.g., RNAi agents) of the present invention can be incorporated into pharmaceutical compositions suitable for administration, and such compositions typically comprise the nucleic acid molecule and a pharmaceutically acceptable carrier (paragraphs 0466,0486).
Response to Arguments
Applicant's arguments filed 02/05/2026 have been fully considered but they are not persuasive.
Applicant argues on pages 10-11 that Khvorova does not disclose an siRNA having the exact nucleotide sequence of SEQ ID NO: 5 as now recited by claims 11, 14 and 17 as amended. Khvorova discloses siRNAs targeting the HTT gene with specific target sequences including particularly exemplary target sequences of the human htt gene at positions 10150, 10146 and 10125 (paragraph 0225) and additional target sequences in Table 1 and Fig. 21 (paragraph 0226). Applicant argues that the sequences disclosed in Khvorova, including SEQ ID NO: 414 which contains 21 nucleotides are different from SEQ ID NO: 5 which consists of 19 nucleotides, and since Khvorova does not disclose a siRNA having the specific nucleotide sequence of SEQ ID NO: 5, claims 11,14 and 17 as amended are not anticipated by Khvorova.
This is not found persuasive. The examiner provided claim interpretation for the above rejection regarding the interpretation of the transitional phrase “has”, as being treated like the transitional phase “having” and that per MPEP 2111.03, transitional phases such as “having” must be interpreted in light of the specification to determine whether open or closed claim language is intended. Page 7 of the specification states mature siRNAs typically have 18-26 nucleotides (more specifically about 19-22 nt) and may have other numbers of nucleotides. Therefore, in light of the specification, “has a…nucleotide sequence” is being interpreted as open claim language as allowing additional nucleotides beyond that of SEQ ID NO: 5 which is 19 nucleotides in length.
Therefore, the examiner clearly indicated the interpretation of the claim language “has” in light of the specification and Applicant did not amend the claims to remove “has” and replace with more limiting language, such as “consists of”. Applicant argues the amendments to claims 11,14 and 17 now recite a siRNA having “a nucleotide sequence of SEQ ID NO: 5”. This does not change the scope of the claim as applicant removed “sense strand” and “selected from the group consisting” and the other sequences from the claims, but this did not change the scope regarding “said siRNA has a nucleotide sequence of SEQ ID NO: 5”, which encompasses that the sequence may contain additional nucleotides. The amendments made do not overcome the anticipation rejection and in light of the claim interpretation as open claim language as allowing additional nucleotides beyond that of SEQ ID NO: 5 which Applicant did not respond to or provide arguments to, the 35 U.S.C. 102(a)(1) rejection stands.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 11,14 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Davidson et al. (US 20050255086, Published 17 Nov 2005) in view of Holen et al. (Nucleic Acids Research, 2003, Vol. 31, No. 9 pages 2401-2407).
Regarding claim 11, Davidson et al. teach compounds and compositions for modulating Huntington’s Diseases (htt) gene expression using short interfering nucleic acid (siNA) molecules, including short interfering RNA molecules, dsRNA, micro-RNA and short hairpin RNA (shRNA) molecules (paragraph 0004). Davidson et al. teach Huntington hairpins, and teach an antisense sequence of SEQ ID NO: 65 which is:
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Nucleotides 2-20 of SEQ ID NO: 65 has 100% identity to instant SEQ ID NO: 5. See alignment below wherein Qy is instant SEQ ID NO: 5, Db is SEQ ID NO: 65 of Davidson et al.
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Regarding claim 14, Davidson et al. teach an expression vector comprising a nucleic acid sequence encoding at least one of the siRNA molecules of the invention in a manner that allows expression of that siRNA molecule (paragraph 0257). Davidson et al. teach the recombinant DNA can be readily introduced into host cells by transfection with an expression vector composed of DNA encoding the siRNA, and DNA is introduced into host cells via a vector (paragraph 0239).
Regarding claim 17, Davidson et al. teach pharmaceutical compositions comprising sufficient genetic material to produce a therapeutically effective amount of the siRNA of interest, and the pharmaceutical compositions will also contain a pharmaceutically acceptable excipient (paragraph 0082) and teach combining the therapeutic agents of the invention with a pharmaceutically acceptable carrier, diluent or excipient to form a pharmaceutical formulation (paragraph 0311).
Davidson et al. do not teach that the siRNA is a single-stranded sequence.
However, before the effective filing date, Holen et al. teach that RNA interference mediated by either long double-stranded RNA or short interfering RNA (siRNA) is a routine tool for transient knockdown of gene expression, and the antisense strand of the siRNA duplex (antisense siRNA) was recently shown to have substantial mRNA depleting activity on its own (Abstract). Holen et al. teach that 21 nt single-stranded antisense siRNA is almost as potent as the siRNA duplex (Intro page 2401). Holen et al. teach that maximum depletion of target mRNA expression occurs significantly faster with antisense siRNA than with double-stranded siRNA, suggesting that the former enters the RNAi pathway at a later stage than ds siRNA, thereby requiring less time to exert its activity (Abstract and Intro, page 2401).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to provide the antisense sequence of SEQ ID NO: 65 of Davidson et al. as a single-stranded antisense siRNA with a reasonable expectation of success as this would have amounted to simple substitution of one known element for another to obtain predictable results, as Holen et al. teach both dsRNA or single-stranded antisense siRNA are effective for mediating RNA interference. One of ordinary skill in the art would have been motivated to provide the antisense sequence of SEQ ID NO: 65 of Davidson et al. as an siRNA which is a single-stranded antisense sequence to inhibit the expression of a HTT gene because Holen et al. teach that it was known in the art to use a single-stranded antisense siRNA and that a single stranded antisense siRNA has substantial mRNA depleting activity, and also teach that maximum depletion of target mRNA expression occurs significantly faster with antisense siRNA than with double-stranded siRNA.
Accordingly, claims 11, 14 and 17 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date.
Response to Arguments
Applicant's arguments filed 02/05/2026 have been fully considered but they are not persuasive.
Applicant argues on pages 11-12 that neither Davidson nor Holen, alone or in combination discloses or suggests a siRNA having the specific nucleotide sequence of SEQ ID NO: 5 as now recited by claims 11, 14 and 17 as amended, and Davison discloses specific shRNA sequence targeting human exons 1-3 and which are different from the claimed SEQ ID NO: 5, and Holen discloses that antisense siRNA provides an efficient tool for transient knockdown of gene expression and compares antisense siRNA oligos to their corresponding double-stranded siRNA but does not disclose or suggest the specific nucleotide sequence of SEQ ID NO: 5.
Applicant argues the field of RNAi therapeutics is highly unpredictable and not every sequence complementary to a target mRNA with function efficiently as an siRNA, and Davidson demonstrates this unpredictability disclosing that in vitro screening was used to identify effective shRNAs and that not effective shRNAs were found in exon 1 while several against exon 2 and 3 were effective, and demonstrates that extensive empirical testing is required to identify functional sequences. Applicant argues the prior art also shows unpredictability in identifying effective siRNA sequence as Khvorova discloses a panel of 94 hsiRNA compounds targeting huntintin mRNA was designed and synthesized and only 7% of sequences showing more than 70% silencing. Applicant argues a person of ordinary skill in the art would not have been motivated to arrive at the specific nucleotide sequence of SEQ ID NO: 5 as recited by claims 11, 14 and 17 as amended based on Davidson and Holen as neither reference discloses or suggests this specific sequence and there would not be a reasonable expectation of success and cites In re Kahn.
This is not found persuasive. Applicant’s amendments to claims 11,14 and 17 did not change the scope of the claim, as applicant removed “sense strand” and “selected from the group consisting” and the other sequences from the claims, but this did not change the scope regarding “said siRNA has a nucleotide sequence of SEQ ID NO: 5”, which encompasses that the sequence may contain additional nucleotides as “has” based on the specification is open claim language allowing additional nucleotides beyond that of SEQ ID NO: 5. Applicant did not amend the claim to recite more restrictive language such as “wherein said siRNA consists of the nucleotide sequence of SEQ ID NO: 5” which does not allow additional nucleotides and requires that exact sequence.
Regarding Applicant’s argument about unpredictability in identifying effective siRNA sequences, what is recited is a product. The preamble recites “A siRNA for inhibiting the expression of a huntingtin (HTT) gene” but the body of the claim recites the specific structure of the product. "The patentability of apparatus or composition claims depends on the claimed structure, not on the use or purpose of that structure." Catalina Mktg. Int'l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801,809 (Fed. Cir. 2002). Note: MPEP 2111.02. Therefore, as Davidson et al. teaches the sequence targeting the same gene as the instant claims and that meets the structural limitations of the instant claims and Holen et al. provides sufficient motivation for the siRNA to be single-stranded (it was known in the art to use a single-stranded antisense siRNA and that a single stranded antisense siRNA has substantial mRNA depleting activity, and also teach that maximum depletion of target mRNA expression occurs significantly faster with antisense siRNA than with double-stranded siRNA), the examiner maintains that sufficient reasoning and motivation was provided in the rejection and the rejection stands.
Conclusion
Claims 11,14 and 17 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHANIE L SULLIVAN whose telephone number is (703)756-4671. The examiner can normally be reached Monday-Friday, 7:30-3:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ram R Shukla can be reached at 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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/STEPHANIE L SULLIVAN/Examiner, Art Unit 1635
/ABIGAIL VANHORN/Primary Examiner, Art Unit 1636
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