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 .
Specification
The disclosure is objected to because of the following informalities: The reaction scheme shown on pg.12 of present application is NOT legible. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
It is to be noted that the effective filing date of present application is not July 21, 2021 (on which the Korean document 10-2021-0095512 was filed) because applicant have not filed a certified English translation of their Korean priority document. Thus, the effective filing date of the present application is July 20, 2022 (371(c) date), which is why Jung et al (which became publicly available online on April 8, 2022) is being used as a prior art in the following paragraph.
Claim(s) 1-4 and 7-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jung et al (“H2O2-activatable hybrid prodrug nanoassemblies as a pure nanodrug for hepatic ischemia/reperfusion injury”, Biomaterials, vol.284 (April 8, 2022) 121515, pg.1-11, as obtained from the website: https://www.sciencedirect.com/science/article/pii/S0142961222001545?via%3Dihub ).
Jung first teaches (abstract) that self-assembling prodrugs are able to form stable nanoparticles without additional excipients and therefore have gained increasing interest in the field of drug delivery. Jung then specifically teaches (abstract) self-assembling RABA (instant retinoic acid prodrug) as a hybrid prodrug of atRA (all-trans retinoic acid) and HBA (hydroxybenzyl alcohol), and the chemical structure of RABA as shown below (see Jung’s Fig. 1(a) where Jung shows a synthesis scheme for RABA)
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teaches instant [Formula 1]. Thus, Jung teaches instant claims 1 and 2.
With respect to instant claims 3 and 4, Jung teaches (pg.2, right hand-column, the paragraph under section 2.2; pg.4, left hand-column, 2nd paragraph) that the RABA nanoassemblies were prepared by a reprecipitation method: RABA was dissolved in 1.00 mL of methanol and the solution was precipitated in 20.0 mL of water under continuous stirring. Jung teaches (pg.9, left-hand column, 2nd paragraph) that upon the addition into water, RABA self-assembles to form stable spherical nanostructures that have narrow size distribution. In the same paragraph, Jung further teaches that RABA nanoassemblies were composed exclusively of RABA without additional excipients and therefore have 100% drug loading capacity, which is highly desirable for translational nanomedicine. Thus, Jung teaches instant claims 3 and 4.
With respect to instant claims 7 and 8, in its Fig.1(b) as duplicated below (see also the last paragraph on pg.3, right-hand column and the first paragraph on pg.4, left-hand column), Jung shows H2O2 triggered degradation of RABA (to release atRA and HBA):
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. Jung teaches (pg.3, right-hand column, last paragraph) that the boronic acid of RABA undergoes H2O2-triggered self-immolation rapidly to generate QM (quinone methide) through 1,6-elimination. QM in turn instantaneously reacts with water to generate HBA (i.e., hydroxybenzyl alcohol which structure is
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). Thus, Jung teaches instant claims 7 and 8.
With respect to instant claim 9, Jung teaches (pg.2, left-hand column, last paragraph; pg.3, right-hand column, first paragraph, and Scheme 1; pg.4, left-hand column, last paragraph) that its RABA is able to self-assemble into well-defined nanoconstructs, scavenge H2O2, and exert multiple therapeutic actions in response to pathological stimuli. Although Jung does not explicitly teaches that the RABA also depletes (or scavenge) glutathione (GSH), since Jung’s RABA is the same as instant RABA, it would inherently deplete GSH as well. Thus, Jung teaches instant claim 9.
With respect to instant claims 10 and 11, although Jung does not explicitly teach that its RABA inhibit tumor growth, since Jung’s RABA is the same as instant RABA, it would inherently inhibit tumor growth. For the same reason, Jung’s H2O2-activatable hybrid prodrug RABA nanoassemblies (which was injected intravenously) would inherently be capable of being used as an anticancer composition as recited in instant claim 11. Thus, Jung teaches instant claims 10 and 11.
Claim Rejections - 35 USC § 103
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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.
Claim(s) 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Jung et al (“H2O2-activatable hybrid prodrug nanoassemblies as a pure nanodrug for hepatic ischemia/reperfusion injury”, Biomaterials, vol.284 (April 8, 2022) 121515, pg.1-11, as obtained from the website: https://www.sciencedirect.com/science/article/pii/S0142961222001545?via%3Dihub ) in view of Sallam et al (US 2015/0125533 A1).
With respect to instant claim 5, although Jung does not explicitly teach that the surface of the nanoparticles are coated with g-polyglutamic acid, as evidenced by Sallam et al ([0010]-[0011]), it is known in the art coating nanoparticles with polyglutamic acid helps attaching a targeting moiety to the nanoparticles. It would have been obvious to one skilled in the art to coat the nanoparticles formed of Jung’s H2O2-activatable hybrid prodrug RABA with g-polyglutamic acid in order to improve the attachment of the nanoparticles to a targeting moiety. Thus, Jung in view of Sallam renders obvious instant claim 5.
With respect to instant claim 6, since Jung in view of Sallam teaches instant nanoparticles of RABA that are coated with instant g-polyglutamic acid, such nanoparticles would inherently be capable of targeting cancer cells in which gamma glutamyl transferase (GGT) is overexpressed. Thus, Jung in view of Sallam renders obvious instant claim 6.
Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
It is to be noted that instant 102 and 103 rejections over Jung et al can be overcome by submitting a certified English translation of the foreign priority document (KR10-2021-0095512) (as long as instant claims are supported by the translation) or by submitting Rule 130(a) declaration of attribution (as long as such declaration is applicable in instant case).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SIN J. LEE whose telephone number is (571)272-1333. The examiner can normally be reached on M-F 9 am-5:30pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Kwon can be reached on 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SIN J LEE/
Primary Examiner, Art Unit 1613
December 10, 2025