DETAILED ACTION
Claims 1-19 are pending in the instant application.
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 instant application claims priority to Republic of Korea 10-2023-0183725 filed December 15, 2023.
Information Disclosure Statement
The information disclosure statement (IDS) are in compliance with the provisions of 37 CFR 1.97, except where noted. Accordingly, the information disclosure statement was considered by the examiner. Please see attached initialed Forms 1449.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 1 does not mention any use of the nanoparticle. Claims 2-3 mention the use of NIR laser irradiation used in “combination”. The Examiner cannot determine what the combination is used with.
Claim 15 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 15 adds a method step to the composition claim 12.
Claims 17 and 19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 17 should recite “in a subject in need thereof”. Claims 17 and 19 include a typo “administrating”.
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.
Claims 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Khang et al. (US 2021/0008118 A1), Felder et al. (WO 2021/011753 A1), Lee et al. (Targeted chemo-photothermal treatments of rheumatoid arthritis using gold half-shell multifunctional nanoparticles. ACS Nano. 2013), Abdel-Hakem et al. (Therapeutic outcomes and biodistribution of gold nanoparticles in collagen-induced arthritis animal model, Journal of Drug Delivery Science and Technology, Volume 67, 2022).
Khang discloses a method for improving the migration ability of stem cells into cancer cells comprising educating the stem cells by treating the stem cells with an in vitro cell culture medium of cancer cells (Abstract). In another aspect of the present invention, there is provided a method of treating cancer in a subject in need of treatment comprising administering a stem cell-nano anticancer drug complex in which a carbon nanotube (CNT) or gold nanoparticle (AuNP) loaded with an anti-cancer drug is coupled to the surface of a stem cell, wherein the stem cell is educated in order to improve its migration ability into cancer cells by treating the stem cell with an anion channel activator and a cell culture medium of in vitro cell culture of cancer cells obtained from the subject ([0013]). The drug can be a chemical agent or a biologic agent; biologic agent can be immune check-point inhibitor or antibody or a functional fragment ([0048]).
Khang does not explicitly mention steroids.
Felder discloses metal nanoparticles having a steroid core structure (Abstract). In some embodiments, the transition metal nanoparticles are gold nanoparticles ([0011]). In some embodiments, the particle consists essentially of the compound having a steroid core structure or a salt or ester thereof, and the transition metal nanoparticles ([0012]). A steroid core structure is selected from triamcinolone, prednisolone, dexamethasone ([0053]). Steroids are useful for treating rheumatoid arthritis or rhematic disorders ([0102]).
Above references do not explicitly mention near-infrared laser irradiation.
Lee discloses that various near-infrared (NIR) resonant nanomaterials, such as Au nanoshells, Au nanorods, and carbon nanotubes, have been widely studied because they strongly absorb NIR light and produce localized cytotoxic heat upon NIR irradiation (pg 50, left col). For treatment of rheumatoid arthritis (RA), Lee et al. developed MTX-loaded polymer-Au half-shell nanoparticles (MTX-PLGA-Au) and conjugated RGD peptide to the surface of the Au half-shell, where the RGD peptide is a targeting moiety for inflammation (pg 51, right col). MTX-PLGA-Au was then exposed to NIR light for 10 min using a laser diode (808 nm) (col 53, right col). MTX-PLGA-Au nanoparticle-based treatment combined with NIR irradiation had greater therapeutic efficacy with a much smaller dosage of MTX in the nanoparticles. These results demonstrate that the targeted chemo-photothermal treatment using multifunctional nanoparticles is a useful and effective strategy for maximizing the therapeutic efficacy and minimizing dosage-related side effects in the treatment of RA (pg 55, right col).
Above references do not explicitly mention PEG coating on gold nanoparticles.
Abdel-Hakem discloses the effect of AuNPs on collagen-induced arthritis and the impact of particle size (Abstract). PEG-AuNPs were nontoxic when internalized in the human cervical cancer cell nucleus (pg 8, left col, 2nd to last paragraph). The data confirm the anti-arthritic properties of AuNPs and their potentiality to reduce pathological manifestations without significant toxic side effects. Among the evaluated sizes, AuNPs with a diameter of 25 nm represents the most effective treatment with a significant reduction of inflammation, decrease in bone and cartilage erosion, and prevention of pannus formation (pg 8, Conclusion).
Khang teaches stem cell gold nanoparticle complex as a drug delivery system. Felder teaches that steroids can be encapsulated within gold nanoparticles. Lee teaches the advantages of NIR treatment for arthritis. Abdel-Hakem discloses that gold nanoparticles can be coated with PEGs. Therefore, it would have been obvious to one of ordinary person in the art before the effective filing date of the claimed invention to combined teachings of above to create a stem cell gold nanoparticle complex bound to the surface of stem cells. This is taking some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Regarding claim 2, photothermal therapy is discussed above.
Regarding claim 3, NIR treatment is taught above.
Regarding claim 4, PEG coated gold nanoparticles are taught above.
Regarding claim 5, Felder discloses that the composite particles comprise the compound having a steroid core structure in an amount of about 70 wt% to about 99wt% ([0054]), and the gold can be present in an amount of about 1 wt% to about 30 wt% ([0067]). Similarly, one of ordinary skill in the art would routinely experiment with different amounts (including weight ratios) of an active ingredient and gold nanoparticles.
Regarding claim 6, steroids are taught above.
Regarding claims 7-8, Khang discloses he stem cells may be embryonic stem cells or mesenchymal stem cells, and the mesenchymal stem cells are bone marrow-derived mesenchymal stem cells, adipose-derived mesenchymal stem cells, umbilical cord-derived mesenchymal stem cells ([0044]).
Regarding claims 9-10, Khang discloses a method of improving the migration ability of stem cells into cancer cells comprising: educating the stem cells by treating the stem cells with a cell culture medium of in vitro cell culture of cancer cells ([0008]). Furthermore, one of ordinary skill in the art would recognize that educated mesenchymal stem cells are versatile stem cells that change their gene activity and behavior after interacting with signals from diseased tissues, such as tumors or sites of inflammation. Depending on the purpose of the “educated” MSCs, one would consider various education mediums.
Regarding claims 11-12, Khang discloses that stem cell-gold nanoparticle can be active ingredient ([0012]).
Regarding claim 13, steroids useful for arthritis are taught above.
Regarding claim 14, regardless of an arthritis severity score, gold nanoparticles comprising a steroid would be useful in treating arthritis.
Claims 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over Khang et al. (US 2021/0008118 A1), Felder et al. (WO 2021/011753 A1), Lee et al. (Targeted chemo-photothermal treatments of rheumatoid arthritis using gold half-shell multifunctional nanoparticles. ACS Nano. 2013), Abdel-Hakem et al. (Therapeutic outcomes and biodistribution of gold nanoparticles in collagen-induced arthritis animal model, Journal of Drug Delivery Science and Technology, Volume 67, 2022), as applied to claims 1-14 above, and further in view of Peilin et al. (Size-dependent gold nanoparticles induce macrophage M2 polarization and promote intracellular clearance of Staphylococcus aureus to alleviate tissue infection, Materials Today Bio, June 2023).
Peilin discloses that gold nanoparticles with a diameter of 50 nm can induce M2 polarization (Abstract). Gold nanoparticle can induce M2 polarization of macrophages to inhibit inflammatory responses (pg 2, left col, last paragraph).
Therefore, it would have been obvious to one of ordinary person in the art before the effective filing date of the claimed invention to have used gold nanoparticles to repolarize from M1 macrophages to M2 macrophages, which in turn would help with reducing inflammation for a rhematic disease patient. This is taking some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Regarding claim 16, a gold nanoparticle comprising a steroid would help relieve pain caused by joint inflammation.
Regarding claims 17 and 19, steroids are useful in treating arthritis and a gold nanoparticle comprising steroids would be useful in similar ways.
Regarding claim 18, arthritis is taught above.
Conclusion
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/JOHN SEUNGJAI KWON/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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