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 .
Claims 1, 3, 4, 7-10, 23, 24, 26, 28, 29, 32, 34-36 and 38 are presented for examination.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/27/2026 has been entered.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3, 7-10, 23, 24, 26 and 34 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Thaxton et al. (US 20150064255).
Thaxton teaches a nanostructures, compositions and methods for treating cancers and other conditions are provided. In some cases, the nanostructures and/or compositions may be used to treat cancers or other diseases or conditions at least in part by controlling cholesterol metabolism in cells. The nanostructures and compositions may be used, for example, to control cholesterol influx and/or efflux in cells. In some cases, the nanostructures or compositions may be used to kill the cells. Examples of
cancer cells that may be affected by the nanostructures and compositions described herein include
cancer those having scavenger receptor type B-I (SR-B1), B-cell lymphoma cells, non-Hodgkin's lymphoma cells, melanoma cells and/or others. In some embodiments, the nanostructures may be mimics of natural high-density lipoprotein (HDL). See the abstract and claim 4. The use of a nanostructure having a core and a shell is taught in Para [0012] and claims 34-39. Thaxton teaches that the core is covalently attached to the shell. See Para [0091]. The use of shell being monolayer or bilayer is taught in Para [0092]. The core trans-sectional dimension of 500 nm is taught in Para [0110] and Thaxton teaches the use of a phospholipid and an apolipoprotein in the shell. See claims 43-48. The use of phosphatidylethanolamine in the shell is taught in para [0118]. Thaxton in Para [0019] teaches the use of a metal, such as gold in the core. Thaxton makes clear that the claimed method of use is old and well known. The determination of identifying subject having a ferroptosis sensitive malignancy does not create a patentably distinct method of treatment.
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.
Claim(s) 1,3, 4, 7-10, 23-24, 26, 28-29, 32, 34-36 and 38 is/are rejected under 35 U.S.C. 103 as being
unpatentable over Thaxton et al. (US 20150064255) in view of Bradbury et al. (WO 2016/196201) and
further in view of Shen et al. (Emerging Strategies of Cancer Therapy Based on Ferroptosis).
Thaxton teaches nanostructures, compositions and methods for treating cancers and other conditions.
In some cases, the nanostructures and/or compositions may be used to treat cancers or other diseases
or conditions at least in part by controlling cholesterol metabolism in cells. The nanostructures and
compositions may be used, for example, to control cholesterol influx and/or efflux in cells as claimed In
some cases, the nanostructures or compositions may be used to kill the cells. Examples of cancer cells
that may be affected by the nanostructures and compositions described herein include those having
scavenger receptor type B-I (SR-B1), B-cell lymphoma cells, non-Hodgkin's lymphoma cells, melanoma
cells and/or others as claimed in claim 26. In some embodiments, the nanostructures may be mimics of
natural high-density lipoprotein (HDL). See the abstract and claim 4. The use of a nanostructure having
a core and a shell as claimed in claim 1 is taught in Para [0012] and claims 34-39. Thaxton teaches that
the core is covalently attached to the shell as claimed in claim 9. See Para [0091]. The use of shell
being monolayer or bilayer as claimed in claims 7 and 8 is taught in Para [0092]. The core trans-
sectional dimension of 500 nm as claimed in claim 10 is taught in Para [0110] and [0112]. Thaxton
teaches the use of a phospholipid and an apolipoprotein as claimed in claims 4, 7 and 8 in the shell. See
claims 43-48. The use of phosphatidylethanolamine in the shell as claimed in claim 23 is taught in para
[0118]. Thaxton in Para [0019] teaches the use of a metal, such as gold as claimed in claim 3 in the core.
The use of apolipoprotein in the shell is taught in Para [0021]. Thaxton makes clear that the claimed
nanostructure has been previously used for the treatment of the claimed type cancers. Thaxton differs from the claimed invention in identifying the subject having ferroptosis sensitive malignancy and
associating the treatment with ferroptosis.
Bradbury teaches the use of nanoparticles, e.g., ultrasmall nanoparticles, to modulate molecular-level
interactions (e.g., cellular/subcellular functions, e.g., cell death). In particular embodiments, the
invention relates to methods of treatment with ultrasmall nanoparticles (e.g., C or C dots) to selectively
induce cell death in nutrient-deprived cancer cells via ferroptosis. See Para [0003]. The treatment of
different cancers, such as lymphoma, gastric, ovarian and carcinoma is taught in Para [0045]. Bradbury
teaches that ultrasmall, 6 nm diameter silica-based particles with a fluorescent (e.g., Cy5 encapsulated)
core and polyethylene glycol (PEG) coating and alpha melanocyte-stimulating hormone (aMSH)-
modified exterior. See para [0058]. The size of nanoparticles being 15 nm is taught in claim 26. The use
of a targeting moiety in the nanoparticle is taught in claim 31. The addition of another agent, such as a
chemotherapeutic agent to the nanoparticles is taught in claim 39. A drug, nanoparticle conjugate is
taught in claim 15. Bradbury makes clear that the claimed cancer are ferroptosis sensitive malignancy.
Shen et al. teach Ferroptosis, a new form of regulated cell death that is iron- and reactive oxygen species
dependent, has attracted much attention in the research communities of biochemistry, oncology, and
especially material sciences. Since the first demonstration in 2012, a series of strategies have been
developed to induce ferroptosis of cancer cells, including the use of nanomaterials, clinical drugs,
experimental compounds, and genes. The use of lipid nanoparticles as ferroptosis agents for the
treatment of cancer is taught by Shen et al. See the abstract and part 3 of the article.
It would have been obvious to a person skilled in the art to use the claimed nanostructure for the
treatment ferroptosis sensitive malignancy, considering that Thaxton teaches the use of the claimed
compounds for the treatment of the claimed cancers in general, which covers the treatment of
ferroptosis sensitive cancer in the absence of evidence to the contrary. Bradbury confirms that the
claimed cancer are ferroptosis sensitive cancers. Bradbury further confirms that nanoparticles can be conjugated with a drug for treating ferroptosis sensitive cancers. The interval of administration is
considered to be within the skill of artisan in the absence of evidence to the contrary. Shen teaches the
use of lipid nanoparticles for inducing ferroptosis treatment of cancer. The combination of relied upon
references make clear that that claimed nanostructures have been previously used for the treatment of
cancer and ferroptosis induced treatment of cancer is old and well known. The determination of patient
population having ferroptosis sensitive malignancy does not create a patentably distinct method of use or a composition in the absence of evidence to the contrary.
Response to arguments
Applicant’s arguments have been noted. Applicant in his remarks argues that “Thaxton describes HDL-NP for use in cancer treatment. As the examiner acknowledges, Thaxton does not disclose that the subject to be treated with the particles of the invention has a ferroptosis-sensitive malignancy. Thaxton discusses evidence that the mechanism of action of the nanoparticles may derive from cholesterol metabolism. Thaxton does not mention or suggest ferroptosis”. It is the examiner’s position that Thaxton teaches the use of the claimed nanoparticles for the treatment of cancer. Thaxton teaches in some embodiments, the cancer is non-Hodgkin lymphoma. In some cases, the cancer is characterized by B-cell lymphoma cells, or wherein the cancer cells are B-cell lymphoma cells. In some embodiments, the cancer is leukemia. In other embodiments, the cancer is melanoma. In certain embodiments, the cancer is characterized by cells having SR-B1. In some embodiments, the cancer is characterized by cells having ABCA1 and/or ABCG1, or wherein the cancer cells have ABCA1 and/or ABCG1. See Para [0016]. Therefore, Thaxton teaches using the claimed compounds for the treatment of cancer overlapping with the claimed cancers. The selection of a patient population does not create a patentably new composition and method of use. The use of the claimed compound for the treatment of cancers, such as B-cell lymphoma taught by the prior art is expected to treat B-cell lymphoma caused by any mechanism in the absence of evidence to the contrary. There is no evidence of record that B-cell lymphoma in a subject being ferroptosis sensitive is treated differently than any other B-cell lymphoma. Additionally, Bradly confirms that the claimed cancers are ferroptosis sensitive cancers. Bradbury further confirms that nanoparticles can be conjugated with a drug for treating ferroptosis sensitive cancers. Applicant in his remarks further argues that One of skill would not have recognized that Thaxton contemplated the species of ferroptosis sensitive cancers. The mere fact that this species is within the larger genus does not necessarily anticipate the species. The specification must be examined to see if a disclosure of the claimed species has been made or whether the prior art reference merely invites further experimentation to find the species. Applicant submits that Thaxton makes no reference to the present species of cancers or treating this subpopulation”. It is the mechanism by which cancer is created does not create a patentably distinct composition and method of use as long as the same composition is used for the treatment of cancer. The use of the claimed compound in the body for the treatment of cancers, such as B-cell lymphoma as taught by Thaxton , would inherently treat the claimed B-cell lymphoma regardless of the mechanism by which it is treated. Identifying the patient population and administering the same drug as the prior art and treating the same type of cancer as the prior art does not create a patentably distinct composition and method of use regardless of the mechanism by which the cancer is treated. Furthermore, Bradbury teaches that the claimed type of cancers are associates with ferroptosis. Bradbury also teaches a drug which is ferroptosis inducer can be added to a nanoparticle, which reads on claim 38. Shen is used to show Ferroptosis is a new form of regulated cell death that is iron- and reactive oxygen species dependent, has attracted much attention in the research communities of biochemistry, oncology, and especially material sciences. Since the first demonstration in 2012, a series of strategies have been developed to induce ferroptosis of cancer cells, including the use of nanomaterials. Applicant in his response additionally argues that “Further, as stated above, Karner, Tahsin and Verma describe that tumor cells can differ in their ferroptosis sensitivity and multiple factors contribute to ferroptosis sensitivity. One of skill would not have been able to predict if the nanoparticles herein would be useful on ferroptosis sensitive cancers until the present disclosure”. It is the examiner’s position that applicant is using the same compounds for the treatment of the same disorders and argues that the mechanism by which such compounds treat cancer. Applicant’s attention is drawn to In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990), where the court states “Products of identical chemical composition cannot have mutually exclusive properties." A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZOHREH A FAY whose telephone number is (703)756-1800. The examiner can normally be reached Monday-Friday 9:30AM-6:00.
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/ZOHREH A FAY/Primary Examiner, Art Unit 1617