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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05 December 2025 has been entered.
Priority
The application was filed on 03 August 2021 and claims priority to foreign application KR10-2020-0135139 filed on 19 October 2020 and provisional application no. 63/084,423 filed on 28 September 2020. Therefore, the effective filing date of the instant application is 28 September 2020.
Examiner’s Note
Applicant's amendments and arguments filed 05 December 2025 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections
and/or objections not reiterated from previous office actions are hereby withdrawn. The
following rejections and/or objections are either reiterated or newly applied. They constitute the
complete set presently being applied to the instant application. In the Applicant’s response, filed
05 December 2025, it is noted that claims 1, 8, and 17 have been amended and no new claims have been added. The amendments made are to exclude certain species of drugs or prodrugs. No new matter has been added.
Claim Objections
Claim 5 is objected to because of the following informalities: claim should recite “synthesized” instead of “synthesizing.” Appropriate correction is required.
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 (i.e., changing from AIA to pre-AIA ) 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.
Claim(s) 1, 2, 4-7, 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bi et al. (Layered Double Hydroxide-Based Nanocarriers for Drug Delivery, Pharmaceutics, 2014), Bhattacharyya et al. (Inorganic Nanoparticles in Cancer Therapy, Pharm Res., 2012), and Wen et al. (Recent advances in LDH-based nanosystems for cancer therapy, Materials and Design, 2020).
Bi et al. teach a layered double hydroxide (LDH) for controlled drug release and delivery (abs; entire teaching) with a generic formula as [M2+1-xM3+x(OH)2][An-]x/n zH2O where M2+ may be cations such as Mg2+, Zn2+, or Ni2+, M3+ may be Al3+, Ga3+, Fe3+, or Mn3+, and An- may be CO32-, NO3-, Cl-, or SO42- (pg. 300), and provide an example of [Zn0.72Al0.28(OH)2]Br0.28 0.69H2O (pg. 311), partially addressing claim 1. It would have been obvious to one skilled in the art to substitute a Bromide with Chloride since both of these anions contribute the same charge balance. The LDH materials, such as drug-LDH composite materials, can be formed by calcination-rehydration (pg. 301), addressing claims 2, 4, and 17. Bi et al. provide examples of anti-inflammatory drugs (pg. 307), chemotherapies (pg. 320), agrochemicals, vitamins, fragrances, and dyes (pg. 302), addressing claim 6. The heating limitation of claims 7 and 19 are interpreted as product-by-process limitations and are given minimal patentable weight. See MPEP 2113(I).
The limitations regarding the synthesis of the metal hydroxide and use of an anhydrous organic solvent in claims 5 and 18 are interpreted as product-by-process limitations. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Bi et al. do not teach Cobalt, Vanadium, or paclitaxel in their LDH compositions for the Applicant’s elections for claims 1 and 17.
Bhattacharyya teaches metal hydroxides are an important class of nanomaterials for drug delivery (pg. 252, right column), and that many periodic table metals are utilized to prepare a wide range of nanomaterials for cancer therapy, including layered double hydroxides (pg. 252, left column). Vanadium may cleave DNA, which is useful in cancer therapy (pg. 248), and cobalt complexes may sensitize hypoxic tissue towards radiation and cleave DNA (pg. 249).
Wen teaches that co-loading certain chemotherapy drugs, such as paclitaxel, in an LDH-based system had a synergistic result (pg. 5, section 2.3).
In regards to the Applicant’s election of Vanadium, Cobalt, and Bromide, it would have been prima facie obvious to a person of ordinary skill in the art to use the LDH composition comprising a poorly soluble drug from Bi et al. with the teaching of Vanadium and Cobalt’s uses in cancer therapy from Bhattacharyya in claims 1 and 17. A person of ordinary skill in the art would have been motivated to combine these teachings because both Bi and Bhattacharyya demonstrate LDH compositions and nanomaterials in general for cancer treatment. “Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (see MPEP § 2144.07).
Since Bi does not specifically teach using paclitaxel in their LDH composition in claims 1 and 17 but does teach chemotherapeutic drugs, one of ordinary skill in the art would have been led to use Wen’s teaching of a synergistic chemotherapeutic combination using paclitaxel and doxorubicin with a reasonable expectation of success. A skilled artisan would have been motivated by the benefit of a synergistic result and would have led to combine the teachings. “Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (see MPEP § 2144.07).
Claim(s) 8, 10-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barahuie et al. (Development of Drug Delivery Systems Based on Layered Hydroxides for Nanomedicine, Int. J. Mol. Sci, 2014), Costa et al. (Intercalation of Mg-Al layered double hydroxide by anionic surfactants: Preparation and characterization, Applied Clay Science, 2008), and Wen et al. (Recent advances in LDH-based nanosystems for cancer therapy, Materials and Design, 2020).
Barahuie et al. teach that a general formula for layered hydroxide salt is M2+(OH)2-x(An-)x/n mH2O with an example of Zn2(OH)2(NO3)2 2H2O (pg. 7752). The layered hydroxide composition may include anti-inflammatory drugs (pg. 7758), chemotherapy or anticancer drugs (entire teaching), or vitamins (pg. 7768), addressing claim 13. The heating limitation of claim 12 is interpreted as product-by-process limitations and are given minimal patentable weight. See MPEP 2113(I).
Barahuie et al. do not teach a surfactant in claims 10 and 11. Barahuie does not teach paclitaxel in claim 8.
Costa et al. teach Mg-Al LDH compositions further comprising surfactants such as sodium dodecyl sulfate (pg. 155) to modify various properties of the composition, such as the interlayer distance or thermal decomposition (abs).
Wen teaches that co-loading certain chemotherapy drugs, such as paclitaxel, in an LDH-based system had a synergistic result (pg. 5, section 2.3).
In regards to claims 10 and 11, it would have been prima facie obvious to a person of ordinary skill in the art to use the LDH composition comprising a poorly soluble drug from Barahuie with the teaching of using sodium dodecyl sulfate as a surfactant from Costa et al. A person of ordinary skill in the art would have been motivated to combine these teachings because Costa teaches that LDH properties may be modified using a surfactant. One of ordinary skill in the art would have been motivated to modify their LDH composition to include a surfactant depending on the properties they wanted to change.
Since Bi does not specifically teach using paclitaxel in their LDH composition in claim 8 but does teach chemotherapeutic drugs, one of ordinary skill in the art would have been led to use Wen’s teaching of a synergistic chemotherapeutic combination using paclitaxel and doxorubicin with a reasonable expectation of success. A skilled artisan would have been motivated by the benefit of a synergistic result and would have led to combine the teachings. “Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (see MPEP § 2144.07).
Response to Arguments
Applicant's arguments filed 05 December 2025 have been fully considered but they are not persuasive.
The Applicant argues that the art does not teach amended claims 1, 8, and 17 (Remarks, pgs. 11-12).
Applicant’s argument is not found persuasive. Wen teaches that co-loading certain chemotherapy drugs, such as paclitaxel, in an LDH-based system had a synergistic result (pg. 5, section 2.3). Since Bi does not specifically teach using paclitaxel in their LDH composition in claims 1, 8, and 17, one of ordinary skill in the art would have been led to use Wen’s teaching of a synergistic chemotherapeutic combination using paclitaxel and doxorubicin with a reasonable expectation of success. A skilled artisan would have been motivated by the benefit of a synergistic result and would have led to combine the teachings. “Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (see MPEP § 2144.07).
The Applicant argues that Hu is not analogous art (Remarks, pgs. 12-13).
The teachings of Hu have been removed as prior art and the arguments against them will not be addressed.
The Applicant argues that there is no valid motivation to combine and modify the references and teachings of Bi, Barahuie, Hu, and O’Hare (Remarks, pg. 14).
Applicant’s argument is not found persuasive. The teachings from Hu and O’Hare have been removed as prior art and the argument against them will not be addressed.
In regards to the combination of Bi and Bhattacharyya, it would have been prima facie obvious to a person of ordinary skill in the art to use the LDH composition comprising a poorly soluble drug from Bi et al. with the teaching of Vanadium and Cobalt’s uses in cancer therapy from Bhattacharyya in claims 1 and 17. A person of ordinary skill in the art would have been motivated to combine these teachings because both Bi and Bhattacharyya demonstrate LDH compositions and nanomaterials in general for cancer treatment. “Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (see MPEP § 2144.07).
Additionally, the limitations regarding the synthesis of the metal hydroxide and use of an anhydrous organic solvent in claims 5 and 18 are interpreted as product-by-process limitations. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
The Applicant argues that the “broad disclosures” of chemotherapeutic drugs in Bi or Barahuie are insufficient (Remarks, pgs. 14-15).
Applicant’s argument is not found persuasive. Wen teaches that co-loading certain chemotherapy drugs, such as paclitaxel, in an LDH-based system had a synergistic result (pg. 5, section 2.3). Since Bi and Barauie do not specifically teach using paclitaxel in their LDH composition in claim 8 but do teach chemotherapeutic drugs, one of ordinary skill in the art would have been led to use Wen’s teaching of a synergistic chemotherapeutic combination using paclitaxel and doxorubicin with a reasonable expectation of success. A skilled artisan would have been motivated by the benefit of a synergistic result and would have led to combine the teachings. “Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (see MPEP § 2144.07).
The Applicant argues that O’Hare teaches away from the inclusion of paclitaxel or docetaxel (Remarks, pg. 15).
The teachings from O’Hare have been removed as prior art and the arguments against them will not be addressed.
The Applicant argues that evidentiary evidence, Cancer Research UK, does not suggest selecting any of the claimed drugs (Remarks, pgs. 15-16).
The teachings from evidentiary evidence, Cancer Research UK, have been removed and the arguments against them will not be addressed.
Conclusion
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/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613