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
1. The Applicant’s response to the office action filed on November 21, 2025 is acknowledged.
Status of the Application
2. Claims 1, 9-10 and 18 are pending under examination. Claims 2-7 and 13-17 were withdrawn as being drawn to nonelected group. Claims 8 and 11-12 were canceled. New claim 19 is added. The Applicant’s arguments have been fully considered and found persuasive in-part for the following reasons.
Objection to Claim Informalities-Withdrawn
3. The objection to the claim informalities has been withdrawn in view of the amendment.
Claim Rejections - 35 USC § 112-Withdrawn
4. The rejection of claims under 35 USC 112(b) has been withdrawn in view of the amendment.
Claim Rejections - 35 USC § 103-Maintained
5. 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.
A. Claims 1, 9-10 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Gibbings et al. (WO 2009/147519) in view of Anand et al. (US 2017/0362590).
Gibbings et al. teach a method of claim 1, 10, 19, for determining expression of at least one artificial miRNA produced by a viral delivered miRNA scaffold in a brain of a patient comprising:
(a) obtaining a sample of serum or plasma from a patient having been treated with the miRNA scaffold (page 17, line 7-10, line 16-30, page 82-83, example 3, page 64, line 9-24, page 11, line 16 to page 15 line 1, page 20, line 12-16, line 22-31, page 24, line 1-3);
(b) determining the abundance the artificial miRNA in extracellular vesicles containing at least part of the at least one artificial miRNA in said sample (page 17, line 11-15, line 31 to page 18, line 3, page 23, line 4-9).
With reference to claims 9-10, Gibbings et al. teach enrichment of extracellular vesicles and isolating RNA, and determining the expression of mi RNA by qRT-PCR or hybridization (page 13, line 1 to page 15, line 13, page 17, line 16 to line 3 on page 18, page 24, line 24-31, page 25, line 1-4, page 35, line 6-13).
Although Gibbings et al. teach viral vectors could be used for delivering miRNA in patients (page 27, line 1-12). However, Gibbins et al. did not specifically teach viral delivered miRNA to the patients.
Anand et al. teach a pharmaceutical composition comprising miRNA for treating cancer, wherein the pharmaceutical composition comprises effective amount of miRNA for treating cancer (para 0005-0008).
It would have been prima facie obvious to an ordinary person skilled in the art before the effective filling date of the invention to modify the method as taught by Gibbings et al. with viral delivered miRNA as taught by Anand et al. to improve the efficiency of method. The ordinary person skilled in the art would have motivated to modify the method of Gibbings with viral miRNA as taught by Anand et al and have a
reasonable expectation of success that the modification would result in improving the method because Anand et al. explicitly taught viral vector comprising miRNA for treating cancer (para 0005-0008) and such a modification of the method is considered obvious over the cited prior art.
B. Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Gibbings et al. (WO 2009/147519) in view of Anand et al. (US 2017/0362590) as applied to claims 1, 9-10 and 19 above, and further in view of Nan et al. (Brain Research Vol. 1359, p. 14-21, (2010).
Gibbings et al. in view of Anand et al. teach a method for determining expression of at least one artificial miRNA produced by a viral delivered miRNA scaffold as discussed above in 6A. However, Gibbings et al. and Anand et al. did not specifically teach miRNA as miRNA-451.
Nan et al. teach a method for gene expression of miRNA in glioblastoma cells, wherein Nan et al. teach administering miRNA-451 to glioblastoma cells and measuring gene expression in said cells wherein Nan et al. teach that miRNA-451 plays a critical role as a tumor suppressor in human glioblastoma cells (page14, abstract, and page 15, paragraph 2 in the lefthand column).
It would have been prima facie obvious to an ordinary person skilled in the art before the effective filling date of the invention to modify the method as taught by Gibbings et al. and Anand et al. with miRNA-451 as taught by Nan et al. to improve the method. The ordinary person skilled in the art would have motivated to modify the method of Gibbings and Anand et al. with miRNA-451 as taught by Nana et al. and have a reasonable expectation of success that the modification would result in improving the
method because Nan et al. explicitly taught miRNA-451 as a tumor suppressor in treating cancer (page 14, abstract) and such a modification of the method is considered obvious over the cited prior art.
Response to Arguments:
With reference to the rejection of claims 1 and 9-10 under 35 USC 103 as being obvious to Gibbings et al. in view of Anand et al. and the rejection of claim 18 under 35 USC 103 as being obvious to Gibbings et al. in view of Anand et al. and further in view of Nan et al., the Applicant’s arguments have been fully considered and found unpersuasive. With reference to the Applicant’s arguments drawn to no teaching of a viral delivered miRNA patient’s brain cells the arguments were found unpersuasive. First, the recitation of said limitation in the preamble is not given any patentable weight as noted in MPEP 2111.02. Second, as discussed in the rejection, Gibbings et al. teach obtaining a sample comprising plasma or serum after treatment of a patient with miRNA, quantitating the mRNA by real-time amplification (example 3, on page 82-83), wherein the patient is treated for a neurodegenerative disease (brain disease), cancer, viral infection and macular degeneration (page 12, line 7-11, page 31, line 17 to line 11 on page 32) which is within the scope of the claims as presented. As discussed in the rejection it would be obvious to modify the method of Gibbings et al. with viral miRNA treatment as taught by Anand et al. Further, it would be obvious to modify the method with miRNA-451 as a tumor suppressor in glioblastoma cells as taught by Nan et al. to improve treatment of glioblastoma with specific miRNA-451. For all the above the rejection has been maintained and restated to address the amendment and include the new claim 19.
New Rejections Necessitated by the Amendment
Claim Objections
6. Claim 19 is incomplete. It does not end with a full stop or period. Appropriate correction is required.
Claim Rejections - 35 USC § 112
7. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 9-10 and 18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 1 recites ‘obtaining sample of CSF, serum or plasma, from a patient’. It is indefinite because it is not clear, whether a patient is the same patient recited in the preamble or is it referring to any patient being treated with the viral delivered miRNA scaffold.
Conclusion
No claims are allowable.
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.
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Suryaprabha Chunduru
Primary Examiner
Art Unit 1681
/SURYAPRABHA CHUNDURU/Primary Examiner, Art Unit 1681