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 .
Status of Application/Amendment/Claims
This Office action is in response to the communications filed on March 11, 2026.
Currently, claims 1 and 7-18 are pending and under examination on the merits in the instant application.
The following rejections are either newly applied or are reiterated and are the only rejections and/or objections presently applied to the instant application.
Response to Arguments and Amendments
Withdrawn Rejections
Any rejections/objections not repeated in this Office action are hereby withdrawn.
Maintained Rejections
Claim Rejections - 35 USC § 112
Claims 9-12 remain rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement for the reasons as set forth in the Office action mailed on December 11, 2025 and for the reasons stated below.
Applicant's arguments filed on March 11, 2026 have been fully considered but they are not persuasive. Applicant argues that the claims as amended comply with the written description requirement by pointing out page 27, lines 1-3. It is noted that the passage pointed out by applicant merely mentions that the disease “other than cancer is for example diabetic, nephropathy.” This generic mention of “diabetic, nephropathy” as an “example” of a disease “other than cancer” that can be treated by the oligonucleotide of SEQ ID NO:79 is far from adequately describing the required structure-function correlation for SEQ ID NO:79 in treating the genus of “disorder” as claimed in claim 9 or “diabetic nephropathy” recited in claim 10 because the well-known oncogenic function of MTDH in cancer cells, thereby teaching the nexus between inhibition of MTDH and the potential of cancer treatment cannot translate to treatment of all types of disorders overexpressing human MTDH or treatment of diabetic nephropathy. The instant specification does not identify which “disorder” involves “human MTDH mRNA overexpression”, nor does the relevant prior art teach a representative number of disorders having overexpressed human MTDH mRNA. In fact, neither the instant specification nor the prior art identifies “diabetic nephropathy” as a disorder overexpressing human MTDH mRNA. Again, the ovarian cancer cell lines, EFO-21 and SKOV-3, exemplified in the instant specification are not representative of a subject having all types of disorders having MTDH mRNA overexpression. Moreover, the instant specification including the passage pointed out by applicant regarding “diabetic, nephropathy” fails to reasonably convey that the instant co-inventors had possession of the entire genus of the claimed disorder treatment method as of the filing date sought in the instant case. Accordingly, this rejection is maintained.
Claims 9-12 remain rejected under 35 U.S.C. 112(a) as failing to comply with the enablement requirement for the reasons as set forth in the Office action mailed on December 11, 2025 and for the reasons stated below.
Applicant's arguments filed on March 11, 2026 have been fully considered but they are not persuasive. Applicant argues that the claims as amended are fully enabled by pointing out Liu et al. (2016) submitted as “EXHIBIT A”, which is not disclosed as being a relevant prior art reference in any of the IDS filed in this application, nor is it incorporated by reference in the instant specification, which means that the instant co-inventors did not acknowledge the teachings of “EXHIBIT A” as being relevant when the application was originally filed. Now, it is noted that the reference submitted as “EXHIBIT A” does not teach human MTDH overexpression is involved in diabetic nephropathy. The reference instead expressly teaches the following: “The inhibition of [mouse] Mtdh expression, using small interfering RNA, but not Mtdh overexpression, was shown to inhibit HG-induced MPC5 apoptosis and p38 MAPK pathway” (emphasis added). See abstract. Hence, the alleged evidence submitted by applicant is not related to human MTDH overexpression, nor is it related to diabetic nephropathy having human MTDH mRNA overexpression. In addition, even if “EXHIBIT A” were to explicitly demonstrate that a diabetic nephropathy patient overexpresses MTDH mRNA and that MTDH mRNA overexpression is the pathological cause or contributes to the pathology of diabetic nephropathy, such teaching would not be deemed sufficient to fully enable the entire scope of claims 9 and 12.
Accordingly, this rejection is maintained.
New Rejections Necessitated by Amendment
Claim Rejections - 35 USC § 112
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 8 and 13-18 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.
Claim 8 is drawn to a pharmaceutical composition comprising SEQ ID NOs:3-78 and 80-221, wherein all of the recited SEQ ID NOs are inherently required to have the “antisense oligonucleotide” function that inhibits targeted MTDH expression as well as a “pharmaceutical” function. It is noted that the instant specification expressly discloses that not all recited SEQ ID NOs have the “antisense” oligonucleotide function. For instance, the specification expressly discloses that SEQ ID NO:7 increased MTDH expression as evidenced by the “1.10” residual MTDH mRNA expression in EFO-21 cells in vitro. See Table 4. The specification also discloses that SEQ ID NO:91 increased or had no effect on MTDH expression inhibition as evidenced by the “1.02” residual MTDH mRNA expression in SKOV-3 cells in vitro. See Table 5. Hence, since not all of the recited SEQ ID NOs have the “antisense” function of inhibiting the intended target mRNA expression in cells in vitro, it necessarily follows that not all recited SEQ ID NOs would have the requisite “pharmaceutical” function. Further, it remains unknown whether the less effective/active SEQ ID NOs that provided very little target mRNA expression inhibition levels (e.g., 0.94 remaining) in vitro can possibly correlate with the required in vivo pharmaceutical function. Note that SEQ ID NO:79 claimed to constitute a pharmaceutical composition (see claim 8) provided 90% MTDH mRNA reduction in EFO-21 cells in vitro and 72% MTDH mRNA reduction in SKOV-3 cells in vitro, thereby expressly demonstrating that the same antisense oligonucleotide does not provide the same or similar level of human MTDH mRNA expression inhibition in two different ovarian cancer cell lines in vitro, which does suggest a high level of unpredictability pertaining to the antisense activity that is highly dependent on cell types. Accordingly, the instant specification fails to adequately describe the structure-function correlation for all of the expressly recited SEQ ID NOs for their “antisense” and “pharmaceutical” function.
Claims 13-18 merely limit the type of cancer species recited in claim 11, which merely recites limitations pertaining to the tumor recited in claim 10. That is, claim 11 and dependent claims thereof are not limited to treating a tumor. Rather, the claims merely characterize the tumor in a method of treating a tumor or diabetic nephropathy. As explained in detail above, the instant specification does not describe that diabetic nephropathy involves human MTDH mRNA overexpression, and furthermore, the instant specification is so deficient in reasonably conveying that the instant co-inventors had possession of the diabetic nephropathy treatment method that is merely mentioned in passing in the instant specification.
Allowable Subject Matter
Claims 1 and 7 are in condition for allowance.
Conclusion
Claims 8-18 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 DANA H SHIN whose telephone number is (571)272-8008. The examiner can normally be reached Monday-Thursday: 8am - 6:30pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, RAM 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DANA H SHIN/Primary Examiner, Art Unit 1635
Prosecution Insights