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
Applicant's response filed 06/23/2026 has been considered. Rejections and/or objections not reiterated from the previous office action mailed 12/23/2025 are hereby withdrawn.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 06/23/2026, claims 19, 84-87, 89-90 and 96-99 are pending in the application and currently under examination.
Any rejection not reiterated in this Office Action is hereby withdrawn.
New Claim Rejections – necessitated by claim amendments
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 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 19, 84, 86, 87, 89-90 and 96-99 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kisseleva et al. (US 20150004133), Swayze et al. (US Patent No. 8,816,056 of record 892 12/23/2025), Das et al. ("Exosome as a novel shuttle for delivery of therapeutics across biological barriers." Molecular pharmaceutics 16.1 (2018): 24-40 of record 892 12/23/2025).
Regarding claim 19, Kisseleva et al. teach reducing the symptoms of liver fibrosis by targeting Stat3 (abstract). Kisseleva et al. teach using inhibitors such as siRNA (see 0089). Kisseleva et al.do not teach a siRNA having SEQ ID No. 5 and wherein the siRNA is in a lipid nanoparticle.
Regarding claims 19, 87, 89-90, 96 and 97, Swayze et al. teach the use of a inhibitory RNA having the instantly claimed SEQ ID No 5 that targets Stat3 (see alignment below) wherein the RNA can comprise modifications and is 18-30 nucleotides in length (col. 13). Swayze et al. teach Stat3 is expressed in most cell types and is useful for treating diseases (see col. 2). Swayze et al. teach the siRNA can be formulated for delivery via parenterally, intravenously, intramuscularly or subcutaneously (see col. 38).
Patent No. 8816056
APPLICANT: Eric E. Swayze
SEQ ID NO 245
LENGTH: 16
TYPE: DNA
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: Synthetic oligonucleotide
Query Match 100.0%; Score 16; Length 16;
Best Local Similarity 62.5%;
Matches 10; Conservative 6; Mismatches 0; Indels 0; Gaps 0;
Qy 1 CUAUUUGGAUGUCAGC 16
Db 1 CTATTTGGATGTCAGC 16
One of skill in the art, when looking for a siRNA to treat liver fibrosis as taught by Kisseleva et al., would have had a good reason to try using the inhibitory RNA taught by Swayze et al. given it was demonstrated that this siRNA reduced Stat3 by 97% (see Table 2 col. 79). Furthermore, KSR states an obvious to try rationale may be proper when the possible options for solving a problem are known, finite, and predictable, with a reasonable expectation of success. KSR, 550 U.S. at 418, 82 USPQ2d at 1396. Also, see MPEP § 2143.
Regarding claims 84 and 86, Das et al. teach the efficient use of exosomes for delivery of therapeutics across biological barriers for therapeutic treatment (see abstract). Das et al. teach methods for loading therapeutics such as inhibitory RNA into exosomes that had CD47 on the surface (see page 30 cols 1 and 2). Das et al. teach exosomes have better target specificity because they are less toxic (see page 32 first para) and are considered clinically safe and used in clinical trials (see page 33 second col.).
It would have been obvious to package the inhibitory RNA in an exome as taught by Das et al. because Das et al. teach advantages of such exosomes and have been proven safe as they have been used in clinical trials. There is an expectation of an advantage for using exosomes with a CD47 on the surface and thus a motivation to combine the prior art references for treatment of fibrosis using a nanoparticle comprising an inhibitory RNA targeted to Stat3 (see MPEP 2144). Conclusive proof of efficacy is not required to show a reasonable expectation of success and obviousness does not require absolute predictability, but at least some degree of predictability is required (MPEP 2143.02).
Regarding claims 98 and 99, Battaglia et al. teach using anti-microbial preservatives in lipid nanoparticles for certain routes of delivery to a subject to prevent irritation and microbial growth in the tissue or cell (see page 371). It would have been obvious to one of ordinary skill in the art to include an anti-microbial agent in the composition for delivery to a subject.
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.
Claim 85 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kisseleva et al. (US 20150004133), Swayze et al. (US Patent No. 8,816,056 of record 892 12/23/2025) and von Andrian et al. (US 20100092425 of record 892 12/23/2025).
Kisseleva et al. (US 20150004133) and Swayze et al. (US Patent No. 8,816,056 of record 892 12/23/2025) are relied upon as above, but don’t teach the nanoparticle with a growth factor on the surface.
Regarding claim 85, von Andrian et al. teach nanoparticles for delivery of RNA comprising targeting moieties that binds to an organ, cell or tissue to enhance delivery of the composition to the desired cell, organ or tissue (0243). von Andrian et al. teach the targeting moiety can be a cell surface receptor such as a growth factor (see 0244).
It would have been obvious to one of ordinary skill in the art to make the lipid nanoparticle comprising an inhibitory RNA with a cell surface receptor, such as a growth factor, for efficient targeted delivery to the desired cell, tissue or organ. There is an expectation of an advantage for using a nanoparticle comprising an inhibitory RNA with a cell surface receptor, such as a growth factor and thus a motivation to combine the prior art references for treatment of fibrosis (see MPEP 2144). Conclusive proof of efficacy is not required to show a reasonable expectation of success and obviousness does not require absolute predictability, but at least some degree of predictability is required (MPEP 2143.02).
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
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