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 Claims
The amendments and arguments filed 10 March 2026 are acknowledged and have been fully considered. Claims 1-2 and 10-11 are currently pending. Claim 1 is amended; claims 3-9 are cancelled; no claims are withdrawn; claim 11 is new.
Claims 1-2 and 10-11 are examined on the merits herein.
Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. In particular, the rejection of claims under 35 U.S.C. 102 are withdrawn in view of Applicant’s amendment to the claims. The following rejections and/or objections are either reiterated or newly applied, and constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 103
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.
Claims 1-2 and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Kyung et al. (KR 2013-0024254; of record) in view of Bhushan et al. (RSC Advances, 2015, Vol. 5, 12078).
Claim 1 is drawn to an oral nanoparticle comprising:
a bioactive compound present in a core portion; and
bile acid surrounding the bioactive compound,
wherein the bioactive compound and the bile acid are non-covalently bonded, and the bioactive compounds is niclosamide and the bile acid is cholic acid.
Kyung et al. teach a nanoparticle comprising a drug and a bile acid complex (Abstract) wherein the drug is encapsulated inside the self-assembled nanoparticle (Par. 2), indicating a non-covalent interaction between the drug in the core and the bile acid complex. Kyung et al. further teach in example 12 (Pg. 16) a nanoparticle comprising 5-β-cholanic acid and docetaxel.
As such, Kyung et al. teach a nanoparticle comprising a bioactive compound present in a core portion; and bile acid surrounding the bioactive compound, wherein the bioactive compound and the bile acid are non-covalently bonded.
The nanoparticle of Kyung et al. differs from the instantly claimed nanoparticle in the following ways:
the bioactive compound in the nanoparticle of Kyung et al. is not niclosamide; and
the bile acid in the nanoparticle of Kyung et al. is not cholic acid.
Yet, as to 1: Kyung et al. further teach the bile acid nanoparticle as being useful for improving the delivery of hydrophobic anti-cancer agents, including docetaxel (Pars.[0045-47]).
And as taught by Bhushan et al., niclosamide is an effective anti-cancer agent for a variety of types of cancer, but is limited by extremely low solubility in water (Pg. 12078-12079 bridging paragraph). Bhushan et al. further teach that the encapsulation of niclosamide in nanoparticles overcomes the poor solubility of the drug and leads to improved bioavailability (Abstract).
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the nanoparticle of Kyung et al. to encapsulate niclosamide as taught by Bhushan et al. It would have been obvious to substitute one anti-cancer agent with limited solubility for another to obtain the predictable result of a nanoparticle that improves the solubility of a hydrophobic anti-cancer agent, with a reasonable expectation of success.
And, as to 2: Kyung et al. further teach suitable bile acids including 5-β-cholanic acid and cholic acid (Par. [0039]).
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the nanoparticles of Kyung et al. to include cholic acid. It would have been obvious to substitute one bile acid suitable for encapsulation of active agents in nanoparticles for another to obtain the predictable result of an encapsulated active agent, with a reasonable expectation of success.
Based on all of the foregoing, claim 1 is rejected as prima facie obvious.
Claim 2 is drawn to the nanoparticle of claim 1, wherein the bioactive compounds is contained in an amount in a range of 10% to 90% by weight, and the bile acid is contained in an amount in a range of 10% to 90% by weight.
Kyung et al. teach in manufacturing example 6 (Pg. 15) a bile acid complex being formed by combining 4.8 g of PEGylated chitosan with 1.45 g of 5-β-cholanic acid. Kyung et al. further teach in Example 12 (Pg. 16) the nanoparticle being formed by combining 16 mg of this bile acid complex with 4 mg docetaxel. This preparation results in a nanoparticle comprising 20% by weight active agent and 18.6% bile acid as calculated by examiner, overlapping with the instantly claimed range.
As such, claim 2 is rejected as prima facie obvious.
Claim 10 is drawn to an oral nanoparticle composition containing the oral nanoparticle of claim 1.
Kyung et al. do not teach the nanoparticle composition being an oral composition. However, the recitation of “an oral composition” is a recitation of intended use and does not impose further structural limitation on the composition (MPEP 2111.02). As Kyung et al. and Bhushan et al. teach a composition comprising the instantly claimed nanoparticles, claim 10 is rejected as prima facie obvious for the same reasons applied to claim 1 above.
Claim 11 is drawn to a composition for anticancer applications, containing the oral nanoparticle of claim 1.
Claim 11 is an intended use claim and does not impose further structural limitation on the composition (MPEP 2111.02). Nevertheless, Kyung et al. teach the nanoparticles for treating cancer (Par. [0045]) and Bhushan et al. teach niclosamide as an anti-cancer agent (Abstract).
As such, claim 11 is rejected as prima facie obvious.
Response to Arguments
Applicant's arguments filed 10 March 2026 have been fully considered but they are not persuasive.
Applicant argues on pg. 4 of the remarks that neither Kyung et al. or Bhushan et al. teach the unexpected feature of improved bioavailability for niclosamide in the niclosamide-cholic acid nanoparticles.
It is well settled that a showing of unexpected results is generally sufficient to overcome a prima facie case of obviousness. In re Albrecht, 514 F.2d 1389 (CCPA 1975). However, as recognized by the court in In re Schulze, 346 F.2d 600 (CCPA 1965), mere arguments are not sufficient to demonstrate unexpected results. Rather, unexpected results must be established by factual evidence by comparing the claimed invention with that of the closest prior art. In re Burckel, 592 F.2d 1175 (CCPA 1979). As discussed by the court in In re De Blauwe, 736 F.2d 699 (Fed. Cir. 1994), “the absence of tests comparing [Applicant’s claimed invention] with those of the closest prior art… constitute mere argument”. In the instant case, Applicant has not appropriately compared the claimed invention with that of the closest prior art (i.e., Kyung et al.) and provided factual evidence which Applicant asserts establishes unexpected results of the claimed invention.
As such, Applicant’s argument of unexpected results is insufficient to overcome the prima facie case of obviousness.
Applicant argues on pg. 5 of the remarks that the nanoparticle of Kyung et al. is structurally very different from the instantly claimed nanoparticle.
Applicant argues on pg. 6 of the remarks that there is no teaching present in Bhushan et al. that would lead one of ordinary skill in the art to combine Kyung et al. and Bhushan et al. to obtain “pure bile acid-based nanoparticles having neither polymer nor protein.”
This argument is not persuasive. While the nanoparticle of Kyung et al. is structurally different from the nanoparticles disclosed in the instant specification, this argument is not commensurate in scope with the claims. The claims recite a nanoparticle comprising a bioactive compound present in a core and a bile acid surrounding the bioactive compound. As Kyung et al. teach a nanoparticle comprising a bioactive compound present in a core and a bile acid complex surrounding the core, it reads on the instant claim, regardless of the additional components of the bile acid complex taught by Kyung et al.
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). 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 Paul Hoerner whose telephone number is (571)270-0259. The examiner can normally be reached Monday - Friday 9:00am - 5:00pm eastern.
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, Bethany Barham can be reached at (571)272-6175. 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.
/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/PAUL HOERNER/Examiner, Art Unit 1611
Prosecution Insights