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 .
Election/Restrictions
Applicant's election with traverse of Group I and species of astaxanthin; free of surface modifier, surfactant, agglomeration inhibitor, dispersion stabilizer, and viscosity modifier; and iron oxide nanoparticles in the reply filed on January 7, 2026 is acknowledged. The traversal is on the ground(s) that there is no undue burden on the Patent Office to search the art with regard to Groups I and II and the species. This is not found persuasive because group I down to a nanocapsule (a product), classified in A61K 9/51 and group II down to a method for treating and/or diagnosing diseases (a process of use), classified in A61L 49/1824. The groups I and II are shown to be distinct because the product can be used in a materially different process such as skincare. See MPEP § 860.05(h). The species are independent or distinct because different species recite the mutually exclusive characteristics of such species. There would be a serious search and/or examination burden if restriction were not required because the inventions have acquired a separate status in the art in view of their different classification, the inventions have acquired a separate status in the art due to their recognized divergent subject matter, and the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries).
The requirement is still deemed proper and is therefore made FINAL.
Drawings
The drawings are objected to because object because of the following informalities:
In FIG. 5, the X-axis and Y-axis lack descriptive labels and units of measurement. Without these labels, the technical significance of the data points and the relationship between the variables cannot be understood, failing to provide a clear understanding of the claimed invention.
Appropriate correction is required.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
The use of the term MagniSort® which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
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.
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.
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.
Claims 1, 3, 4, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Tran et al. (International Journal of Pharmaceutics, 2020; cited on IDS filed June 30, 2024) in view of Sridhar et al. (Antioxidants, 2021; cited on IDS filed June 30, 2024).
Regarding claim 1, Tran discloses multilayer nanocapsules comprising fucoidan for controlled drug delivery (page 4, column 1, ¶ 4). Tran discloses that the fucoidan nanocapsule can have hydrophilic drugs in the core (page 3, column 1, ¶ 1) and the shell can be comprised of a hydrophobic fucoidan structure (page 6, column 1, ¶ 2). This reads on a nanocapsule comprising a hydrophilic core and a hydrophobic shell containing multilayers of fucoidan. Regarding claims 4 and 11, Tran discloses that the nanocapsules can comprise iron oxide nanoparticles for biomedical applications (page 4, column 2, ¶ 4).
Regarding claims 1 and 3, Tran does not disclose a nanocapsule comprising carotenoids.
Sridhar discloses that carotenoids such as astaxanthin provide numerous health benefits such as antioxidant and anti-cancer properties, as well as the prevention of chronic disease like age-associated macular degeneration and cardiovascular disease (page 1, ¶ 1). Sridhar discloses that the carotenoids can be encapsulated using various nanosystems such as metal oxide nanoparticles to improve stability and biological activity of the carotenoids (abstract).
It would have been obvious to a person of ordinary skill in the art before the effective
filing date of the claimed invention to modify the nanocapsules of Tran to include carotenoids such as astaxanthin as taught by Sridhar in order to enhance therapeutic activity. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Sridhar teaches that carotenoids can be included in the nanocapsules and carotenoids can provide benefits such as antioxidant and prevention of some diseases. Incorporating carotenoids into the nanocapsules of Tran would simply involve applying a known therapeutic agent to a known nanocapsules to achieve the predictable result of enhanced therapeutic activity.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Tran et al. (International Journal of Pharmaceutics, 2020; cited on IDS filed June 30, 2024) and Sridhar et al. (Antioxidants, 2021; cited on IDS filed June 30, 2024) as applied to instant claims 1, 3, 4, and 11 as discussed above, and further in view of Kaminski et al. (European Journal of Pharmaceutical Sciences 2008; cited on PTO-892).
Tran and Sridhar are discussed above.
Tran and Sridhar do not disclose that the core comprises tissue plasminogen activator (tPA).
Kaminski discloses tPA is a most commonly used thrombolytic agent and tPA can be encapsulated into biodegradable magnetic microcarriers to improve stability and therapeutic efficiency (abstract; page 96, column 1, ¶ 1).
It would have been obvious to a person of ordinary skill in the art before the effective
filing date of the claimed invention to modify the nanocapsules of Tran and Sridhar to include tPA as taught by Kaminski in order to treat thrombosis efficiently. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Kaminski teaches that tPA can be encapsulated into the nanocapsules and Tran teaches the nanocapsules can house hydrophilic drugs in the core. Incorporating tPA into the nanocapsules of Tran and Sridhar would simply involve applying a known therapeutic agent to a known nanocapsules to achieve the predictable result of enhanced therapeutic activity.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Tran et al. (International Journal of Pharmaceutics, 2020; cited on IDS filed June 30, 2024) and Sridhar et al. (Antioxidants, 2021; cited on IDS filed June 30, 2024) as applied to instant claims 1, 3, 4, and 11 as discussed above, and further in view of Machala et al. (Chemistry of Materials, 2011; cited on PTO-892).
Tran and Sridhar are discussed above.
Tran and Sridhar do not disclose that the iron oxide is Fe304 or Fe2O3.
Machala discloses the use of iron oxide nanoparticles for biomedical applications (abstract). Machala disclose that iron (III) oxide (Fe2O3) is one of the most interesting and potentially useful phases of the iron oxides (abstract).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to use the nanocapsules of Tran and Sridhar comprising Fe2O3 as iron oxide for diagnostic imaging, as taught by Machala. A person of ordinary skill in the art would have been motivated to make this selection and reasonably would have expected success because Machala teaches that Fe2O3 can be used as diagnostic imaging agent. Applying the teaching of Machala to the nanocapsules of Tran and Sridhar to select Fe2O3 as iron oxide constitutes no more than the predictable use of prior art elements according to their established functions.
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Tran et al. (International Journal of Pharmaceutics, 2020; cited on IDS filed June 30, 2024) and Sridhar et al. (Antioxidants, 2021; cited on IDS filed June 30, 2024) as applied to instant claims 1, 3, 4, and 11 as discussed above, and further in view of Polyakov et al. (The Journal of Physical Chemistry B, 2010; cited on PTO-892).
In addition to the teachings of Tran and Sridhar discussed above, Sridhar discloses the preparation of carotenoid nanoparticles of varying sizes by adjusting the ratio of polyvinylpyrrolidone (carrier) to astaxanthin (page 25, ¶ 4).
Tran and Sridhar do not disclose the weight ratio of fucoidan to carotenoids is from 0.55 to 110 and the weight ratio of carotenoids to metal oxide nanoparticles is from 0.01 to 100.
Polyakov discloses the formation of complexes between carotenoid astaxanthin and metal ions (abstract). Polyakov discloses that carotenoid/metal complex can be formed at various ratios such as 1:1 and 1:2 and that these complexes exhibit different stabilities and characteristics (page 16976, conclusion).
It would have been obvious to a person of ordinary skill in the art before the effective
filing date of the claimed invention to form the nanocapsules of Tran and Sridhar using specific ratio ranges of fucoidan to carotenoids and carotenoids to metal oxide in order to achieve specific goals such as increasing stability, maximizing efficiency, or reducing costs. The weight ratio of fucoidan to carotenoids, the weight ratio of carotenoids to metal oxide nanoparticles, and the amount of a specific ingredient such as fucoidan, carotenoids, and metal oxide within the nanocapsule is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). MPEP § 2144.05.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Tran et al. (International Journal of Pharmaceutics, 2020; cited on IDS filed June 30, 2024) and Sridhar et al. (Antioxidants, 2021; cited on IDS filed June 30, 2024) as applied to instant claims 1, 3, 4, and 11 as discussed above, and further in view of Hu et al. (ACS Applied Materials and Interfaces, 2019; cited on PTO-892).
Tran and Sridhar are discussed above.
Tran and Sridhar do not disclose that the nanocapsule is free of surface modifier, surfactant, agglomeration inhibitor, dispersion stabilizer and/or viscosity modifier.
Hu discloses all-natural food-grade hydrophilic-hydrophobic core-shell microparticles (title). Hu discloses the method making the particles using all-natural food-grad materials without the use of toxic chemical agents and/or synthetic substance, ensuring the particles are biocompatible and edible for use in food, pharmaceutics, and biomedicines (page 11943, column 1, ¶ 4).
It would have been obvious to a person of ordinary skill in the art before the effective
filing date of the claimed invention to modify the nanocapsules of Tran and Sridhar to be free of chemical agents such as surface modifier, surfactant, agglomeration inhibitor, dispersion stabilizer and/or viscosity modifier using the method of Hu in order to ensure the nanocapsules are biocompatible and edible. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Hu teaches that hydrophilic-hydrophobic core-shell microparticles can be made without toxic chemicals for pharmaceutical applications.
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Tran et al. (International Journal of Pharmaceutics, 2020; cited on IDS filed June 30, 2024) and Sridhar et al. (Antioxidants, 2021; cited on IDS filed June 30, 2024) as applied to instant claims 1, 3, 4, and 11 as discussed above, and further in view of Gao et al. (Antioxidant, 2020; cited on PTO-892).
In addition to the teachings of Tran and Sridhar discussed above, Tran discloses that the fucoidan multilayers can be formed via hydrogen bonds (page 2, column 1, ¶ 2).
Tran and Sridhar do not disclose that the carotenoids and metal oxide nanoparticles form non-covalent bonds, and the carotenoids and fucoidan form hydrogen bonds.
Gao discloses that carotenoids can interact with molecules in vesicles via non-covalent bonds such as hydrophobic forces, van der Waals interactions, and hydrogen bonds (page 6, ¶ 2). Gao discloses that carotenoids can bind to metal ion-substituted MCM-41 (mesoporous silica) and TiO2 (metal oxide) nanoparticles via hydrogen bonds (page 19, ¶ 3; page 13, ¶ 3). Gao discloses that carotenoids can act as hydrogen bond acceptors or donors, and that the chemical bonding of carotenoids in drug delivery systems significantly affects drug stability and activity (page 15, ¶ 7).
It would have been obvious to a person of ordinary skill in the art before the effective
filing date of the claimed invention to modify the nanocapsules of Tran and Sridhar to form hydrogen bonds among carotenoids, metal oxide nanoparticles, and fucoidan in order to improve their efficiency as drug delivery systems. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Gao teaches that the nanocapsules can form hydrogen bonds between carotenoids and other molecules such as metal oxides and vesicle matrices in the drug delivery systems, and that such bonding affects the therapeutic and diagnostic effectiveness.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No 18/353,440 (cited on PTO-892) in view of Sridhar et al. (Antioxidants, 2021; cited on IDS filed June 30, 2024), Kaminski et al. (European Journal of Pharmaceutical Sciences 2008; cited on PTO-892), Machala et al. (Chemistry of Materials, 2011; cited on PTO-892), Polyakov et al. (The Journal of Physical Chemistry B, 2010; cited on PTO-892), Hu et al. (ACS Applied Materials and Interfaces, 2008; cited on PTO-892), and Gao et al. (Antioxidant, 2020; cited on PTO-892).
Regarding claims 1, 3, 4, and 11, claim 1 of the ‘440 discloses a nanoparticle comprising a core comprising gadolinium agent, inner shell layer comprising superparamagnetic iron oxide, and outer shell layer comprising fucoidan and polyvinyl alcohol.
The claims of the ‘440 does not disclose a nanocapsule comprising carotenoids.
As discussed above, Sridhar discloses that carotenoids such as astaxanthin provide numerous health benefits such as antioxidant and anti-cancer properties, as well as the prevention of chronic disease like age-associated macular degeneration and cardiovascular disease (page 1, ¶ 1). Sridhar discloses that the carotenoids can be encapsulated using various nanosystems such as metal oxide nanoparticles to improve stability and biological activity of the carotenoids (abstract).
It would have been obvious to a person of ordinary skill in the art before the effective
filing date of the claimed invention to modify the nanocapsules of the ‘440 to include carotenoids such as astaxanthin as taught by Sridhar in order to enhance therapeutic activity. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Sridhar teaches that carotenoids can be included in the nanocapsules and carotenoids can provide benefits such as antioxidant and prevention of some diseases. Incorporating carotenoids into the nanocapsules of the ‘440 would simply involve applying a known therapeutic agent to a known nanocapsules to achieve the predictable result of enhanced therapeutic activity.
Regarding claim 2, the claims of the ‘440 and Sridhar do not disclose the core comprising tPA.
As discussed above, Kaminski discloses tPA is a most commonly used thrombolytic agent and tPA can be encapsulated into biodegradable magnetic microcarriers to improve stability and therapeutic efficiency (abstract; page 96, column 1, ¶ 1).
It would have been obvious to a person of ordinary skill in the art before the effective
filing date of the claimed invention to modify the nanocapsules of the ‘440 and Sridhar to include tPA as taught by Kaminski in order to treat thrombosis efficiently. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Kaminski teaches that tPA can be encapsulated into the nanocapsules and Tran teaches the nanocapsules can house hydrophilic drugs in the core. Incorporating tPA into the nanocapsules of the ‘440 and Sridhar would simply involve applying a known therapeutic agent to a known nanocapsules to achieve the predictable result of enhanced therapeutic activity.
Regarding claim 5, the claims of the ‘440 and Sridhar do not disclose that the iron oxide is Fe304 or Fe2O3.
As discussed above, Machala discloses the use of iron oxide nanoparticles for biomedical applications (abstract). Machala disclose that iron (III) oxide (Fe2O3) is one of the most interesting and potentially useful phases of the iron oxides (abstract).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to use the nanocapsules of the ‘440 and Sridhar comprising Fe2O3 as iron oxide for diagnostic imaging, as taught by Machala. A person of ordinary skill in the art would have been motivated to make this selection and reasonably would have expected success because Machala teaches that Fe2O3 can be used as diagnostic imaging agent. Applying the teaching of Machala to the nanocapsules of the ‘440 and Sridhar to select Fe2O3 as iron oxide constitutes no more than the predictable use of prior art elements according to their established functions.
Regarding claims 6 and 7, the claims of the ‘440 and Sridhar do not disclose the weight ratio of fucoidan to carotenoids is from 0.55 to 110 and the weight ratio of carotenoids to metal oxide nanoparticles is from 0.01 to 100.
As discussed above, Polyakov discloses the formation of complexes between carotenoid astaxanthin and metal ions (abstract). Polyakov discloses that carotenoid/metal complex can be formed at various ratios such as 1:1 and 1:2 and that these complexes exhibit different stabilities and characteristics (page 16976, conclusion).
It would have been obvious to a person of ordinary skill in the art before the effective
filing date of the claimed invention to form the nanocapsules of the ‘440 and Sridhar using specific ratio ranges of fucoidan to carotenoids and carotenoids to metal oxide in order to achieve specific goals such as increasing stability, maximizing efficiency, or reducing costs. The weight ratio of fucoidan to carotenoids, the weight ratio of carotenoids to metal oxide nanoparticles, and the amount of a specific ingredient such as fucoidan, carotenoids, and metal oxide within the nanocapsule is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). MPEP § 2144.05.
Regarding claim 8, the claims of the ‘440 and Sridhar do not disclose that the nanocapsule is free of surface modifier, surfactant, agglomeration inhibitor, dispersion stabilizer and/or viscosity modifier.
As discussed above, Hu discloses all-natural food-grade hydrophilic-hydrophobic core-shell microparticles (title). Hu discloses the method making the particles using all-natural food-grad materials without the use of toxic chemical agents and/or synthetic substance, ensuring the particles are biocompatible and edible for use in food, pharmaceutics, and biomedicines (page 11943, column 1, ¶ 4).
It would have been obvious to a person of ordinary skill in the art before the effective
filing date of the claimed invention to modify the nanocapsules of the ‘440 and Sridhar to be free of chemical agents such as surface modifier, surfactant, agglomeration inhibitor, dispersion stabilizer and/or viscosity modifier using the method of Hu in order to ensure the nanocapsules are biocompatible and edible. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Hu teaches that hydrophilic-hydrophobic core-shell microparticles can be made without toxic chemicals for pharmaceutical applications.
Regarding claims 9 and 10, the claims of the ‘440 and Sridhar do not disclose the carotenoids and metal oxide nanoparticles form non-covalent bonds, and the carotenoids and fucoidan form hydrogen bonds.
As discussed above, Gao discloses that carotenoids can interact with molecules in vesicles via non-covalent bonds such as hydrophobic forces, van der Waals interactions, and hydrogen bonds (page 6, ¶ 2). Gao discloses that carotenoids can bind to metal ion-substituted MCM-41 (mesoporous silica) and TiO2 (metal oxide) nanoparticles via hydrogen bonds (page 19, ¶ 3; page 13, ¶ 3). Gao discloses that carotenoids can act as hydrogen bond acceptors or donors, and that the chemical bonding of carotenoids in drug delivery systems significantly affects drug stability and activity (page 15, ¶ 7).
It would have been obvious to a person of ordinary skill in the art before the effective
filing date of the claimed invention to modify the nanocapsules of the ‘440 and Sridhar to form hydrogen bonds among carotenoids, metal oxide nanoparticles, and fucoidan in order to improve their efficiency as drug delivery systems. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Gao teaches that the nanocapsules can form hydrogen bonds between carotenoids and other molecules such as metal oxides and vesicle matrices in the drug delivery systems, and that such bonding affects the therapeutic and diagnostic effectiveness.
This is a provisional nonstatutory double patenting rejection.
Claims 1-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. US 10,736,964 B2 (cited on PTO-892) in view of Tran et al. (International Journal of Pharmaceutics, 2020; cited on IDS filed June 30, 2024), Sridhar et al. (Antioxidants, 2021; cited on IDS filed June 30, 2024), Kaminski et al. (European Journal of Pharmaceutical Sciences 2008; cited on PTO-892), Machala et al. (Chemistry of Materials, 2011; cited on PTO-892), Polyakov et al. (The Journal of Physical Chemistry B, 2010; cited on PTO-892), Hu et al. (ACS Applied Materials and Interfaces, 2008; cited on PTO-892) and Gao et al. (Antioxidant, 2020; cited on PTO-892).
Regarding claims 1, 3, 4, and 11, claim 1 of the ‘964 discloses a nanoparticle comprising a core, a shell comprising fucoidan and a plurality of superparamagnetic iron oxide nanoparticles, and an outer layer.
The claims of the ‘964 do not disclose an outer layer comprising fucoidan. The claims of the ‘964 does not disclose a nanocapsule comprising carotenoids.
As discussed above, Tran discloses multilayer nanocapsule shells comprising fucoidan for controlled drug delivery (page 4, column 1, ¶ 4).
As discussed above, Sridhar discloses that carotenoids such as astaxanthin provide numerous health benefits such as antioxidant and anti-cancer properties, as well as the prevention of chronic disease like age-associated macular degeneration and cardiovascular disease (page 1, ¶ 1). Sridhar discloses that the carotenoids can be encapsulated using various nanosystems such as metal oxide nanoparticles to improve stability and biological activity of the carotenoids (abstract).
It would have been obvious to a person of ordinary skill in the art before the effective
filing date of the claimed invention to modify the nanocapsules of the ‘964 to include multilayer fucoidan nanocapsules as taught by Tran and to include carotenoids such as astaxanthin as taught by Sridhar in order to enhance therapeutic activity. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Tran teaches that multilayer fucoidan nanocapsules can be formed. In addition, Sridhar teaches that carotenoids can be included in the nanocapsules and carotenoids can provide benefits such as antioxidant and prevention of some diseases.
Regarding claim 2, the claims of the ‘964, Tran, and Sridhar do not disclose the core comprising tPA.
As discussed above, Kaminski discloses tPA is a most commonly used thrombolytic agent and tPA can be encapsulated into biodegradable magnetic microcarriers to improve stability and therapeutic efficiency (abstract; page 96, column 1, ¶ 1).
It would have been obvious to a person of ordinary skill in the art before the effective
filing date of the claimed invention to modify the nanocapsules of the ‘964, Tran, and Sridhar to include tPA as taught by Kaminski in order to treat thrombosis efficiently. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Kaminski teaches that tPA can be encapsulated into the nanocapsules and Tran teaches the nanocapsules can house hydrophilic drugs in the core. Incorporating tPA into the nanocapsules of the ‘964, Tran, and Sridhar would simply involve applying a known therapeutic agent to a known nanocapsules to achieve the predictable result of enhanced therapeutic activity.
Regarding claim 5, the claims of the ‘964, Tran, and Sridhar do not disclose that the iron oxide is Fe304 or Fe2O3.
As discussed above, Machala discloses the use of iron oxide nanoparticles for biomedical applications (abstract). Machala disclose that iron (III) oxide (Fe2O3) is one of the most interesting and potentially useful phases of the iron oxides (abstract).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to use the nanocapsules of the ‘964, Tran, and Sridhar comprising Fe2O3 as iron oxide for diagnostic imaging, as taught by Machala. A person of ordinary skill in the art would have been motivated to make this selection and reasonably would have expected success because Machala teaches that Fe2O3 can be used as diagnostic imaging agent. Applying the teaching of Machala to the nanocapsules of the ‘964, Tran, and Sridhar to select Fe2O3 as iron oxide constitutes no more than the predictable use of prior art elements according to their established functions.
Regarding claims 6 and 7, the claims of the ‘964, Tran, and Sridhar do not disclose the weight ratio of fucoidan to carotenoids is from 0.55 to 110 and the weight ratio of carotenoids to metal oxide nanoparticles is from 0.01 to 100.
As discussed above, Polyakov discloses the formation of complexes between carotenoid astaxanthin and metal ions (abstract). Polyakov discloses that carotenoid/metal complex can be formed at various ratios and that these complexes exhibit different stabilities and characteristics (page 16976, conclusion).
It would have been obvious to a person of ordinary skill in the art before the effective
filing date of the claimed invention to form the nanocapsules of the ‘964, Tran, and Sridhar using specific ratio ranges of fucoidan to carotenoids and carotenoids to metal oxide in order to achieve specific goals such as increasing stability, maximizing efficiency, or reducing costs. The weight ratio of fucoidan to carotenoids, the weight ratio of carotenoids to metal oxide nanoparticles, and the amount of a specific ingredient such as fucoidan, carotenoids, and metal oxide within the nanocapsule is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). MPEP § 2144.05.
Regarding claim 8, the claims of the ‘964, Tran, and Sridhar do not disclose that the nanocapsule is free of surface modifier, surfactant, agglomeration inhibitor, dispersion stabilizer and/or viscosity modifier.
As discussed above, Hu discloses all-natural food-grade hydrophilic-hydrophobic core-shell microparticles (title). Hu discloses the method making the particles using all-natural food-grad materials without the use of toxic chemical agents and/or synthetic substance, ensuring the particles are biocompatible and edible for use in food, pharmaceutics, and biomedicines (page 11943, column 1, ¶ 4).
It would have been obvious to a person of ordinary skill in the art before the effective
filing date of the claimed invention to modify the nanocapsules of the ‘964, Tran, and Sridhar to be free of chemical agents such as surface modifier, surfactant, agglomeration inhibitor, dispersion stabilizer and/or viscosity modifier using the method of Hu in order to ensure the nanocapsules are biocompatible and edible. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Hu teaches that hydrophilic-hydrophobic core-shell microparticles can be made without toxic chemicals for pharmaceutical applications.
Regarding claims 9 and 10, the claims of the ‘964, Tran, and Sridhar do not disclose the carotenoids and metal oxide nanoparticles form non-covalent bonds, and the carotenoids and fucoidan form hydrogen bonds.
As discussed above, Gao discloses that carotenoids can interact with molecules in vesicles via non-covalent bonds such as hydrophobic forces, van der Waals interactions, and hydrogen bonds (page 6, ¶ 2). Gao discloses that carotenoids can bind to metal ion-substituted MCM-41 (mesoporous silica) and TiO2 (metal oxide) nanoparticles via hydrogen bonds (page 19, ¶ 3; page 13, ¶ 3). Gao discloses that carotenoids can act as hydrogen bond acceptors or donors, and that the chemical bonding of carotenoids in drug delivery systems significantly affects drug stability and activity (page 15, ¶ 7).
It would have been obvious to a person of ordinary skill in the art before the effective
filing date of the claimed invention to modify the nanocapsules of the ‘964, Tran and Sridhar to form hydrogen bonds among carotenoids, metal oxide nanoparticles, and fucoidan in order to improve their efficiency as drug delivery systems. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Gao teaches that the nanocapsules can form hydrogen bonds between carotenoids and other molecules such as metal oxides and vesicle matrices in the drug delivery systems, and that such bonding affects the therapeutic and diagnostic effectiveness.
Conclusion
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/JONG HWAN BAEK/Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618