DETAILED ACTION
This action is a response to the filing on 2/23/2026. Examiner acknowledges the cancellation of claim 20.
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 without traverse of Group I, claims 1-19 in the reply filed on 2/23/2026 is acknowledged.
Claim Objections
Claim 5 is objected to because of the following informalities:
In claim 5, lines 3-4, “an engineered viruses” should be either –an engineered virus—or –engineered viruses--.
In claim 5, line 4, “a naturally occurring proteins” should be –a naturally occurring protein--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1-19 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 1 recites the limitation "the presence" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitations “a magnetocaloric vector” in line 5 and “magnetocaloric vector” in line 6. It is not clear if this is a new instance or refers to the magnetocaloric vector in line 2 of the claim.
Claim 1 recites the limitation “infiltrative tumor cells” in line 9. It is not clear if this is a new instance or refers to the cells instance mentioned in line 3
Claims 2-19 inherit the deficiencies of claim 1 and are likewise rejected.
Claim 7 recites the limitation “a second metal distribution” in line 6. It is not clear if this is a new instance or refers to the second metal distribution mentioned in lines 3-4 of the claim.
Claim 13 recites “retracting a scalp of the patient, after creating an incision” in line 3. This is unclear as there is no previously recited incision step.
Claims 14-15 inherit the deficiencies of claim 13 and are likewise rejected.
Claim 14 recites the limitation "the shortest path" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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)(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.
Claim(s) 1, 3-6, and 8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2005/0090732 (Ivkov et al., hereinafter Ivkov).
In regards to claim 1, Ivkov discloses a thermotherapy method via targeted delivery of nanoparticles (title and abstract; paragraphs [0013]-[0258]; figures 1-6). Ivkov discloses a method with the following steps:
administering a magnetocaloric vector to a patient in response to a determination of the presence of cells of an infiltrative tumor (paragraphs [0060]-[0258]), wherein administering a magnetocaloric treatment comprises:
preparing a magnetocaloric vector (paragraphs [0065]-[0116]);
delivering a dose of magnetocaloric vector to a target location (paragraph [0097] discloses methods for administration of probes/vectors );
waiting for the magnetocaloric vector to migrate to the infiltrative tumor cells (paragraph [0097]; required step to allow vector to reach target site); and
heating infiltrative tumor cells via application of a pulsed magnetic field to tissue of the patient surrounding the target location (paragraphs [0117]–[0119]).
In regards to claim 3, Ivkov discloses the limitation of claim 1. Ivkov further states controlling heat to a target temperature at a target location (paragraphs [0066]-[0070] and [0127]).
In regards to claim 4, Ivkov discloses the limitations of claim 1. Ivkov further shows that the magnetic field is controlled to heat a magnetocaloric substance for a target duration (paragraphs [0060], [00132], and [0164]; duration of activation is determined based on required parameters).
In regards to claim 5, Ivkov discloses the limitations of claim 1. Ivkov further states that the particle includes a targeting ligand such as a monoclonal antibody (paragraphs [0046], [0065], [0077], and [0081]).
In regards to claim 6, Ivkov discloses the limitations of claim 1. Ivkov further shows in paragraphs [0068]-[0075] the use of magnetocaloric metals such as iron oxide and magnetite.
In regards to claim 8, Ivkov discloses the limitations of claim 6. In addition, Ivkov shows in paragraphs [0039] and [0206]-[0228] that the probe can include chemotherapeutic agents/chemicals.
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.
Claim(s) 2 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2005/0090732 (Ivkov et al., hereinafter Ivkov).
In regards to claim 2, Ivkov discloses the limitations of claim 1. Ivkov further shows in figure 2 the generation of a magnetic field around the tissue of a patient surrounding a target location. Paragraph [0121] further shows identifying the presence of the magnetic particles/vector clusters and monitoring the temperature of the tissue. While Ivkov does not explicitly state the stopping of the magnetic field after a target temperature is reached, Ivkov does disclose preferred operating temperatures (paragraphs [0010], [0055], [0066], [0127], and [0164]). One of ordinary skill in the art would be motivated to perform said step due to potential safety issues that would arise if tissue temperatures stray outside of the target temperature.
In regards to claim 9, Ivkov discloses the limitations of claim 6. Ivkov states that the particle has a Curie temperature in the range of 40-150 C which overlaps the claimed range. Ivkov further states in paragraph [0066] that selection of materials with different Curie temperatures will vary depending on the optimization of treatment for particular tissue and target types. Applicant’s specification does not specify the criticality of the claimed range. Thus, it would have been obvious to one of ordinary skill in the art, before the filing date of the claimed invention to modify the method of Ivkov to have magnetocaloric metals with the claimed range, in order to tailor treatment to optimize treatment efficacy for specific tissue and target types.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2005/0090732 (Ivkov et al., hereinafter Ivkov) as applied to claim 1 above, and further in view of US 2021/0369630 (Dobson et al., hereinafter Dobson).
In regards to claim 16, Ivkov discloses the limitations of claim 1. Ivkov does disclose the use of various substance categories as part of the magnetocaloric vector for pharmaceutical therapies and chemotherapy but does not state that one of them is a proteasome inhibitor. In a related area, Dobson discloses the use of magnetic particles that deliver biologically active agents (title and abstract). Paragraph [0076] describes several compounds/anti-cancer drugs that can be incorporated into the particle, one of which is a proteasome inhibitor. Thus, it would have been obvious to one of ordinary skill in the art, before the filing date of the claimed invention to modify the method of Ivkov to include a proteasome inhibitor as into the magnetocaloric vector as taught by Dobson in order to enable treatment of cancers.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2005/0090732 (Ivkov et al., hereinafter Ivkov) as applied to claim 1 above, and further in view of US 2006/0246143 (Ege).
In regards to claim 17, Ivkov discloses the limitations of claim 1 but does not state the steps of removing a tissue sample from the patient and analyzing the tissues sample. In a related area, Ege discloses a targeted therapy system that uses magnetic particles (title and abstract). Ege shows in paragraph 67 the procedure of performing a biopsy of a tumor (removal of tissue from a patient) and performing a standard histopathologic and detailed genetic analysis to determine if the tissue sample contains cells from an infiltrative tumor (paragraph [0067]) in order to allow for determination of specific cancer profiles to design treatments with the particles that are specific to the particular cancer. Thus, it would have been obvious to one of ordinary skill in the art, before the filing date of the claimed invention, to modify the method of Ivkov to include the step of removing a tissue sample from the patient and analyze the tissue sample as taught by Ege in order to allow for determination of specific cancer profiles to design treatments with the particles that are specific to the particular cancer.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2005/0090732 (Ivkov et al., hereinafter Ivkov) as applied to claim 1 above, and further in view of US 2010/0234726 (Sirimanne et al., hereinafter Sirimanne).
In regards to claim 18, Ivkov discloses the limitations of claim 1 but does not state the step of waiting 4-14 days for the magnetocaloric vector to migrate to the infiltrative tumor cells. In a related area, Sirimanne discloses devices and methods for marking a biopsy cavity. Of note is paragraph [0182] which discloses the method of marking locations for cancer. Sirimanne states that the wait of 1 day to 1 month (which encompasses the claimed range) following injection allows for agents to migrate through the lymphatic system to reach areas that could also contain cancers. Thus, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the method of Ivkov to allow for a wait time as taught by Sirimanne in order to allow for agents to reach other areas that would contain cancers.
Ivkov and Sirimanne discloses the general wait conditions and the reasons for using them but not the claimed range. At the time the invention was made, it would have been an obvious matter of design choice to a person of ordinary skill in the art to use the claimed range because Applicant has not specified how the claimed range provides an advantage, is used for a particular purpose, or solves a stated problem (some of Applicant’s wait times in the specification have ranges between 1-28 days). One of ordinary skill in the art, furthermore, would have expected Ivkov and Sirimanne’s range and Applicant’s invention to perform equally well with either wait period because both perform the same function of allowing for the agents to migrate to the tumor cell locations.
Thus, it would have been prima facie obvious to modify Ivkov and Sirimanne to obtain the invention as specified in claim 18 because such a modification would have been a mere design consideration which fails to patentably distinguish over the prior art of Ivkov and Sirimanne.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2005/0090732 (Ivkov et al., hereinafter Ivkov) as applied to claim 1 above, and further in view of US 2015/0112168 (Conrad et al., hereinafter Conrad).
In regards to claim 19, Ivkov discloses the limitations of claim 1 but does not show that the magnetic field is generated by a magnetic field generator in physical contact with the patient. In a related area, Conrad discloses modulation of space of magnetic particles in a vasculature using an external magnetic field (title and abstract). Of particular note are figures 11A-B, 12A-B, 13A-B, 17A-B, 20A-C, 23A-B, 24A-B, and 25A-B and paragraphs [0058]-[0181] which shows a magnetic field generator (1270, 1370) in physical contact with the patient where the magnetic field can be used to heat the particles (paragraphs [0058] and [0148]). This configuration has the magnetic field generator as part of a wearable device that can measure the presence of the particles in the vasculature and administer treatment. Thus, it would have been obvious to one of ordinary skill in the art, before the filing date of the claimed invention, to modify the device of Ivkov to incorporate the magnetic field generator into a wearable device as taught by Conrad in order to allow for mobile treatment and analysis.
Allowable Subject Matter
Claims 7 and 10-12 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
In regards to claim 7, the prior art of record does not teach or suggest a method, as claimed by Applicant, with a combination of steps that includes:
until a difference between the first metal distribution and a second metal distribution is below a threshold:
administering a second magnetocaloric treatment;
observing a second metal distribution using imaging; and
comparing the difference between the first metal distribution and the second metal distribution to a threshold.
In regards to claim 10, the prior art of record does not teach or suggest a method, as claimed by Applicant, with a combination of steps that includes:
processing the tissue sample to isolate stem cells; and
inducing the stem cells to phagocytize the magnetocaloric metal.
Claims 11-12 are dependent on allowable matter from claim 10 and would be allowable once the 112 rejections are overcome.
Conclusion
The examiner notes that, though no art has been applied against claims 13-15 at this time, they are not presently allowable. The question of prior art will be revisited upon resolution of the numerous issues noted above.
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/JOSHUA DARYL D LANNU/Examiner, Art Unit 3791
/CARRIE R DORNA/Primary Examiner, Art Unit 3791
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