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 .
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 06 July 2026 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and/or objections not reiterated from previous office actions are hereby withdrawn.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
06 July 2026, it is noted that claims 1, 5, 8, and 17 have been amended, claim 2 has been canceled, and no new claims have been added. The amendments made are to exclude certain species of drugs or prodrugs or for clarification purposes. No new matter has been added.
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 Zou et al. (Synergistic inhibition of colon cancer cell growth with nanoemulsion-loaded paclitaxel and PI3K/mTOR dual inhibitor BEZ235 through apoptosis, Int J Nanomedicine, 2016).
Bi et al. teach a layered double hydroxide (LDH) for controlled drug release and delivery (abs; entire teaching) with a generic formula of [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). Bi provides 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 1, 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).
Zou suggests a synergistic effect regarding combining paclitaxel with other chemotherapeutic drugs and teaches that layered double hydroxide systems performed even more effectively in terms of anticancer findings (pg. 1948).
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 Zou’s teaching of a synergistic chemotherapeutic combination using paclitaxel and other chemotherapeutic drugs 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 Zou et al. (Synergistic inhibition of colon cancer cell growth with nanoemulsion-loaded paclitaxel and PI3K/mTOR dual inhibitor BEZ235 through apoptosis, Int J Nanomedicine, 2016).
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).
Zou suggests a synergistic effect regarding combining paclitaxel with other chemotherapeutic drugs and teaches that layered double hydroxide systems performed even more effectively in terms of anticancer findings (pg. 1948).
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 Zou’s teaching of a synergistic chemotherapeutic combination using paclitaxel and other chemotherapeutic drugs 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 06 July 2026 have been fully considered but they are not persuasive.
The Applicant argues that Wen is not available as prior art (Remarks, pg. 10).
Wen has been removed as prior art and the arguments against them will not be addressed.
The Applicant argues that Wen does not teach or suggest amended claim 1 (Remarks, pg. 10).
Applicant’s argument is not found persuasive. Zou suggests a synergistic effect regarding combining paclitaxel with other chemotherapeutic drugs and teaches that layered double hydroxide systems performed even more effectively in terms of anticancer findings (pg. 1948). 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 Bi is relied upon for general LDH drug-delivery materials and calcination-rehydration.
Applicant’s argument is not found persuasive. 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), as well as a method of calcination of LDH (pg. 7754). 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 deficiencies in Barahuie are cured by Costa and Zou. Regarding Costa, 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.
The Applicant argues that Bhattacharyya does not teach the claimed composite or the amended drug limitation (Remarks, pg. 11).
Applicant’s argument is not found persuasive. 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).
The Applicant argues that the rejection requires multiple selections from separate references (Remarks, pgs. 11-12).
Applicant’s argument is not found persuasive. It must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
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.
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/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613
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