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
Status of Application/Amendment/Claims
Applicant's response filed 12/24/2025 has been considered. Rejections and/or objections not reiterated from the previous office action mailed 08/25/2025 are hereby withdrawn. The following rejections and/or objections are either newly applied or are reiterated and are the only rejections and/or objections presently applied to the instant application. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
With entry of the amendment filed on 12/24/2025, claims 1-10 and 12-18 are pending in the application. Claims 1, 8-10 and 12-18 are currently under examination. Claims 2-7 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 103 – necessitated by amendment
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1, 8-10 and 12-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kanda, M., et al. ("Synaptotagmin XIII expression and peritoneal metastasis in gastric cancer." Journal of British Surgery 105.10 (2018): 1349-1358 of record cited on 892 08/25/2025), Miyagishi et al. (Antisense and Nucleic Acid Drug Development, 2003, 13:1-7 of record cited on 892 08/25/2025) Bennet et al. (US 2003/0054354 of record cited on 892 08/25/2025) and Zhang et al. ("Antisense technology." Cancer Gene Therapy. Totowa, NJ: Humana Press, 2005. 35-49).
Kanda et al. teach gastric cancer is the fifth most common cancer worldwide and the third highest cause of cancer mortality (see intro page 1350). Kanda et al. teach Synaptotagmin XIII was expressed at significantly higher levels in patients with peritoneal recurrences in gastric cancer and found that inhibition of SYT13 expression with a siRNA inhibitor decreased growth of the peritoneal nodules and prolonged survival in mice (see abstract, page 1351 and Fig. 1). Kanda et al. teach SYT13 may be a promising target for the treatment of peritoneal metastasis of gastric cancer (page 1349).
Given the results of Kanda, one of skill in the art would have wanted to try using an inhibitory oligonucleotide targeted to STY13 in efforts of finding a treatment for peritoneal metastasis of gastric cancer given the high mortality rate. The prior art teach antisense oligonucleotides (ASO) and siRNA are functionally equivalent. Miyagishi et al. teach that ASO and siRNAs can be designed to be targeted to the same target sites with a reasonable expectation to observe reduced target expression levels with both molecules. (See siRNAs and antisense ASOs targeted to target sites 3, 4, 5, and 6 in Figure 1, wherein the ASO comprise all first 19 nucleotides of the antisense strand sequence of the siRNAs). Thus one of skill in the art would have been capable of making an antisense oligonucleotide which is functionally equivalent to a siRNA.
KSR states that the simple substitution of one known element for another would have yielded predictable results to one of ordinary skill in the art at the time of the invention. See Board Decision Ex parte Smith, --USPQ2d--, slip op. at 20, (Bd. Pat. App. & Interf. June 25, 2007) (citing KSR, 82 USPQ2d). Also, see M.P.E.P. §2144.07 which states, "The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).” When substituting equivalents known in the prior art for the same purpose, an express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982). M.P.E.P. §2144.06.
Zhang et al teach that antisense technology has rapidly developed and been widely applied for investigating gene function and regulation, modulation of gene expression and validation of new drugs (see page 35). Zhang et al. teach there are well known reliable approaches to select an optimal antisense sequence, such as sequence-walking, from a known gene which has yielded good results or computer aided target selection which allows antisense to be designed to known target regions of mRNA (see page 40).
Bennett et al. teach antisense oligonucleotides are preferably 12-30 nucleotides in length (0063), which encompasses the lengths of the claimed oligonucleotides, to inhibit a target gene function involved in various diseases. Bennett et al. teach the antisense oligonucleotide has a preferred modified backbone to include phosphonothioates (0066) and teach the antisense also includes 5-methylcytosine (0075) and bicyclic sugar moieties (see 0073). Bennett et al. teach gapmers (0081). Bennett et al. teach the antisense oligonucleotide can be in a pharmaceutical compositions for treatment (0098-0100) and teach using functional moieties to affect the efficient delivery of the antisense oligonucleotides to a cell or subject (0144) and further teach linking conjugates to the antisense (0078)..
The SYT13 gene and coding sequences is known (Genbank BC093832) and because there is a need to find a treatment of peritoneal metastasis of gastric cancer and because it has been shown that inhibition of SYT13 expression decreased growth of the peritoneal nodules and prolonged survival in mice, it would have been obvious to one of ordinary skill in the art to use the methods as discussed in Zhang et al, to make antisense oligonucleotides, having any of SEQ ID Nos. 39 or 79-93, targeted to SYT13. Zhang et al. teach making antisense oligonucleotide by gene walking and thus the specifically claimed oligonucleotides would have been identified and given Zhang et al. teach it was routine to make and test these sequences for optimal activity, one of skill would have been capable of identifying oligonucleotides to SYT13.
In KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court held that "obvious to try" was a valid rationale for an obviousness finding, for example, when there is a "design need" or "market demand" and there are a "finite number" of solutions. 550 U.S. at 421 ("The same constricted analysis led the Court of Appeals to conclude, in error, that a patent claim cannot be proved obvious merely by showing that the combination of elements was ‘[o]bvious to try.’ ... When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under §103."). Thus, after KSR, the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process.
Thus in the absence of evidence to the contrary, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed.
Conclusion
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).
706.07(a) Final Rejection, When Proper on Second Action [R-07.2015]
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Second or any subsequent actions on the merits shall be final, except where the examiner introduces a new ground of rejection that is neither necessitated by applicant’s amendment of the claims, nor based on information submitted in an information disclosure statement filed during the period set forth in 37 CFR 1.97(c) with the fee set forth in 37 CFR 1.17(p). Where information is submitted in an information disclosure statement during the period set forth in 37 CFR 1.97(c) with a fee, the examiner may use the information submitted, e.g., a printed publication or evidence of public use, and make the next Office action final whether or not the claims have been amended, provided that no other new ground of rejection which was not necessitated by amendment to the claims is introduced by the examiner. See MPEP § 609.04(b).
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KIMBERLY CHONG at 571-272-3111. The examiner can normally be reached Monday thru Friday 9-5 pm.
If attempts to reach the examiner by telephone are unsuccessful please contact the SPE for 1636 Neil Hammell at 571-272-5919. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KIMBERLY CHONG/Primary Examiner, Art Unit 1636