DETAILED ACTION
Formal Matters
Claims 8-10 and 14-40 are cancelled. Claims 1-7 and 11-13 are pending and under examination.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
This application is a national stage entry of PCT/KR2023/011974 filed on 8/11/2023, which claims priority to KR10-2022-0102427 filed on 8/17/2022.
Information Disclosure Statements
The information disclosure statement (IDS) filed on 02/14/2025 has been considered by the examiner.
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 1-7 and 11-13 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.
Claims 1, 4 and 11 are indefinite for the recitation of “KxLyFe2(3)O4” as the Fe2(3)O4 can be construed as notation for Fe2 being present 3 times (via standard chemical notation). However, it is unclear if applicant means the 2 to be optional to 3 as in the portion being Fe2O4 or Fe3O4. For the purpose of compact prosecution, the examiner will consider this as KxLyFe2O4 or KxLyFe3O4.
Claims 1, 4 and 11 are indefinite for “K or L is a monovalent to trivalent cation metal including…..” as it is unclear if the group using “including” is closed to only those options of metals or if the claim is open to using cations outside of this group for these compounds. Applicant might consider saying “K or L is a monovalent to trivalent cation metal is….”
Claims 2-3, 5-7 and 12-13 are rejected as being dependent on an indefinite claim.
Claim 11 is indefinite for “suppressing a decrease in immune function or enhancing immune function, administered in combination with a chemotherapeutic anticancer drug” as it is unclear if the “administered in combination with a chemotherapeutic anticancer drug” applies to both the suppressing and enhancing options before it or if it only applies to the “enhancing immune function” portion just prior to the administered. For the purpose of compact prosecution, the examiner will read this as “suppressing a decrease in immune function or enhancing immune function when administered with a chemotherapeutic anticancer drug” so “suppressing a decrease in immune function” is a separate option that does not include “administered in combination with a chemotherapeutic anticancer drug”. Applicant should consider changing structure of this limitation to clarify what the exact options are.
Claims 12-13 are rejected for being dependent on an indefinite claim.
Claim 11 is indefinite for “or suppressing a decrease in immune function, caused by anticancer treatment or enhancing immune function” as it is unclear if the causes are both anticancer treatment and enhancing immune function or if the options are separately “suppressing a decrease in immune function caused by anticancer treatment” or “enhancing immune function”. For the purpose of compact prosecution the examiner will read this as “suppressing a decrease in immune function caused by anticancer treatment” or “enhancing immune function”. Applicant should consider changing structure of this limitation to clarify what the exact options are.
Claims 12-13 are rejected for being dependent on an indefinite claim.
Claim Rejections - 35 USC § 102
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 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-7 and 11-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pilgrimm US 5916539.
Pilgrimm teaches superparamagnetic particles and their use against tumors and increasing immunity (abstract). Pilgrimm teaches “several small superparamagnetic single-domain particles of iron oxide, iron mixed oxide or iron, with a particle size in a range between 3 and 20 nanometers” (abstract). Claim 3 of Pilgrimm provides “Superparamagnetic particles according to claim 1, characterized in that the superparamagnetic single-domain particles consist of .gamma.-Fe.sub.2 O.sub.3, Fe.sub.3 O.sub.4, of the iron mixed oxides corresponding to the general formula MO.Fe.sub.2 O.sub.3, wherein M represents the divalent metal ions Fe, Mg, Be, Mn, Zn, Co, Ba, Sr, Cu or mixtures thereof, of mixed oxides corresponding to the general formula mFe.sub.2 O.sub.3.nMe.sub.2 O.sub.3, wherein Me represents the trivalent metal ions Al, Cr, rare earth metals or mixtures thereof, or of iron.” Pilgrimm teaches “a method for destroying tumours and for increasing immunity, optionally under the influence of magnetic fields, the improvement which comprises, administering an effective amount of the pharmacologically active preparation according to claim 7, for said destroying tumors and said increasing immunity (claims 7 and 8 of Pilgrimm). Pilgrimm teaches pharmacological active substances including antitumor enzymes, antitumor proteins, alkylation reagents, vegetable alkaloids and others that are known as anticancer agents (claim 5 of Pilgrimm and column 7). Pilgrimm provides for immune stimulating superparamagnetic molecule complexes which lead to immune stimulation and destruction of biological material (column 10, lines 43-50). Example 22 of Pilgrimm provides for immunization and treatment of viral, bacterial and fungal infections with superparamagnetic particles. Thus, infectious diseases including viral, bacterial and fungal are seen as treatable with Pilgrimm’s method. Example 21 teaches administering parenterally into the body (also see examples 1-5 regarding making particles).
Although Pilgrimm did not examine the effects on immune cells, it also uses superparamagnetic iron oxide particles that are administered to a subject in vivo for destroying tumor cells and increasing immunity in a patient/subject. Thus, it would have the same immune cell effects as observed by applicant based on having a similar type and size of superparamagnetic particles (see MPEP 2112). Figure 4 of Perica teaches providing the treatment to a mouse model of tumors/cancer. Figure 4 shows that treatment attenuated tumor growth compared to controls.
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 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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-7 and 11-13 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Pilgrimm US 5916539 A and Perica et al (ACS Nano, 2014, volume 8, pages 2252-2260).
Pilgrimm teaches the claims as discussed above.
If Pilgrimm’s formulations can be shown objectively with evidence not to cause an increase in immune cells as part of Pilgrimm’s increased immunity, then prior art would be needed to teach this limitation of claims 2-3, 5-6 and 12-13.
Perica teaches “To enhance T cell activation, a magnetic field was used to drive aggregation of paramagnetic nano-aAPC, resulting in a doubling of TCR cluster size and increased T cell expansion in vitro and after adoptive transfer in vivo. T cells activated by nano-aAPC in a magnetic field inhibited growth of B16 melanoma, showing that this novel approach, using magnetic field-enhanced nano-aAPC stimulation, can generate large numbers of activated antigen-specific T cells and has clinically relevant applications for adoptive immunotherapy” (abstract). Figure 1 of Perica shows iron oxide in the superparamagnetic nanoparticles.
One of ordinary skill in the art before the time of filing would have used teachings of Perica to formulate superparamagnetic iron oxide nanoparticles that are capable of increase immune cells such as T cells in a subject by the combined teachings of Pilgrimm and Perica. There would have been a reasonable expectation of success in combining these teachings and achieving methods where administered superparamagnetic nanoparticles would help treat cancer in part by increasing immunity via increasing the number immune cells like T cells to fight the cancer cells.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARK V STEVENS whose telephone number is (571)270-7080. The examiner can normally be reached on M-F 9:00 am to 6:00 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong Kwon can be reached on (571)272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARK V STEVENS/
Examiner, Art Unit 1613
