DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Objections
Claim 26 is objected to because of the following informalities:
“the mean” in line 1 of claim 26 should read as “a mean”
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 12, 14, 19, 21, 26, and 27 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 13, 15-18, 20, 22-25, and 28-31 are further rejected due to their dependency to claim 12, 21, or 27.
Claims 12, 21, and 27 recite a magnetic marker and magnetic nanoparticles as separate components. However, [0011]-[0012] of the PGPUB recite that the magnetic marker includes the magnetic particles. Examiner suggests to amend the claims to clearly recite that the magnetic marker comprises magnetic nanoparticles.
Claim 14 recites the term “the plug” in line 2. There is insufficient antecedent basis for this limitation in the claim. It is unclear if this limitation is referring to the “solid metal plug” as mentioned in line 2 of claim 14. Clarification is requested.
The term “around” in claims 19 and 26 is a relative term which renders the claim indefinite. The term “around” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what range “around” encompasses as it is unclear what it means to be “around 60 nm.” Clarification is requested.
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 (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 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 negated by the manner in which the invention was made.
Claims 12-15 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Jones et al. ‘213 (US Pub No. 2004/0236213 – cited by Applicant) in view of Sirimanne et al. ‘195 (US Pub No. 2013/0066195).
Regarding claim 12, Jones et al. ‘213 teaches a tissue marking system (Title, Abstract) comprising:
a magnetic marker (Figs. 5, 6 short term markers 17 and [0041]) comprising a piece of magnetically detectable ferromagnetic material (radiopaque elements 28 and [0048]; It is noted that [0035] mentions that soft iron, ferrites, stainless steels, titanium, nickel and related alloys are ferromagnetic.); and
magnetic nanoparticles detectable using a susceptometer ([0048]; “detection by MRI”; One of ordinary skill would understand that an MRI can function as a magnetic resonance susceptometer. See https://pubmed.ncbi.nlm.nih.gov/1569876/),
wherein the magnetic marker and the magnetic nanoparticles are configured for delivery in or near a lesion (desired location 35 and [0049]; “The desired location 35 is typically a cavity from which a biopsy sample has been, or is to be, taken, or a lesion that has been or will be removed or otherwise treated.”),
wherein the magnetic marker has a magnetic susceptibility such that the magnetic marker is detectable using the susceptometer ([0048]; “detection by MRI”; One of ordinary skill would understand that an MRI can function as a magnetic resonance susceptometer.),
wherein the magnetic marker is retained in or near the lesion (desired location 35 and [0049]).
Jones et al. ‘213 teaches all of the elements of the current invention as mentioned above except for wherein the magnetic nanoparticles are configured to be taken up into a lymphatic system and migrate to one or more sentinel lymph nodes such that the one or more sentinel lymph nodes are magnetically localizable using the susceptometer.
Sirimanne et al. ‘195 teaches a method to remotely detect sentinel nodes (SN). This method includes the deposit, preferably by injection via a thin needle applicator or using a marker delivery device described herein, of a remotely detectable contrast agent that will migrate to the SN, allowing the exact location of the SN to be pinpointed and targeted for removal using minimally invasive techniques. This method eliminates the need for potentially toxic radioactive tracer material. In addition, the lack of toxicity of such agents obviates the need to remove the lesion and/or the SN on the same day ([0049]). These agents may be any biologically compatible agents capable of remote detection. Examples of such remote detection include, but are not limited to magnetism such as a magnetometer, Hall effect sensor, or magnetic resonance imaging (MRI) ([0050]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the magnetic nanoparticles of Jones et al. ‘213 to include being configured to be taken up into a lymphatic system and migrate to one or more sentinel lymph nodes such that the one or more sentinel lymph nodes are magnetically localizable using the susceptometer as Sirimanne et al. ‘195 teaches that this will aid in eliminating the need for potentially toxic radioactive tracer material and obviates the need to remove the lesion and/or the SN on the same day.
Regarding claim 13, Jones et al. ‘213 teaches wherein the piece of magnetically detectable ferromagnetic material is ferromagnetic stainless steel ([0048]; “detection by MRI”; One of ordinary skill would understand that an MRI can function as a magnetic resonance susceptometer. See https://pubmed.ncbi.nlm.nih.gov/1569876/).
Regarding claim 14, Jones et al. ‘213 teaches wherein the piece of magnetically detectable ferromagnetic material is a solid metal plug (short term markers 17, radiopaque elements 28 and [0048]), wherein the plug is between 0.8 mm and 2.4 mm in diameter ([0043]), less than 15 mm in length ([0043]), and has a shape (Fig. 6 shows that radiopaque element 28 is a shape.).
Regarding claim 15, Jones et al. ‘213 teaches wherein the shape is a wire, a cylinder or a coil (radiopaque element 28 is a wire shape.) such that the magnetic marker marks a site at which the magnetic marker is placed and is not subject to migration (marker 17 and [0052]).
Claim 16 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Jones et al. ‘213 in view of Sirimanne et al. ‘195 further in view of Ramachandran ‘731 (US Pub No. 2010/0087731).
Regarding claim 16, Jones et al. ‘213 in view of Sirimanne et al. ‘195 teaches all of the elements of the current invention as mentioned above except for wherein the magnetic nanoparticles are superparamagnetic nanoparticles, wherein the superparamagnetic nanoparticles have a hydrodynamic diameter that ranges from 20 nm to 150 nm.
Ramachandran ‘731 teaches superparamagnetic agents may be composed of a magnetic iron oxide core surrounded by a coating that prevents aggregation and sedimentation of the particles in aqueous solutions, achieves high biological tolerance, and prevents toxic side effects…The core size ranges from 2 nm to less than 10 nm, and the hydrodynamic diameter ranges from 20 nm to about 150 nm. Particles with a relatively larger size, such as greater than 50 nm hydrodynamic diameter, are called superparamagnetic iron oxide (SPIO) particles ([0027]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the magnetic nanoparticles of Jones et al. ‘213 in view of Sirimanne et al. ‘195 to include superparamagnetic nanoparticles, wherein the superparamagnetic nanoparticles have a hydrodynamic diameter that ranges from 20 nm to 150 nm as Ramachandran ‘731 teaches that this will aid in preventing aggregation and sedimentation of the particles in aqueous solutions, achieves high biological tolerance, and prevents toxic side effects.
Claims 17 and 18 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Jones et al. ‘213 in view of Sirimanne et al. ‘195 further in view of Franklin-Ford, et al. (“Tracking Injectable Microspheres in Dynamic Tissues with Encapsulated Superparamagnetic Iron Oxide Nanoparticles” – 2012).
Regarding claims 17 and 18, Jones et al. ‘213 in view of Sirimanne et al. ‘195 teaches all of the elements of the current invention as mentioned above except for a bioabsorbable matrix,
wherein the magnetic nanoparticles are disposed in the bioabsorbable matrix, wherein the bioabsorbable matrix comprises a bioabsorbable gel.
Franklin-Ford et al. teaches encapsulating superparamagnetic iron oxide (SPIO) microspheres in an agarose gel phantom (page 1616, 2.2 In vitro Imaging in an Agarose Phantom), which would aid in detecting and tracking the SPIO nanoparticles at sites of in vivo injection (page 1620, 4. Conlclusion).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Jones et al. ‘213 in view of Sirimanne et al. ‘195 to include a bioabsorbable matrix, wherein the magnetic nanoparticles are disposed in the bioabsorbable matrix, wherein the bioabsorbable matrix comprises a bioabsorbable gel as Franklin-Ford et al. teaches that this will aid in detecting and tracking the SPIO nanoparticles at sites of in vivo injection.
Claim 19 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Jones et al. ‘213 in view of Sirimanne et al. ‘195 further in view of Asgari ‘885 (US Pub No. 2008/0175885).
Regarding claim 19, Jones et al. ‘213 in view of Sirimanne et al. ‘195 teaches all of the elements of the current invention as mentioned above except for wherein a mean particle size of the magnetic nanoparticles is around 60 nm.
Asgari ‘885 teaches to optimize the image producing properties, the average particle size of the magnetic signal producing agents may be provided to 5 .mu.m at maximum, such as from about 2 nm up to 1 .mu.m, e.g. from about 5 nm to 200 nm. The super paramagnetic signal producing agents can be chosen, for example, from the group of so-called SPIOs (super paramagnetic iron oxides) with a particle size larger than 50 nm or from the group of the USPIOs (ultra small super paramagnetic iron oxides) with particle sizes smaller than 50 nm ([0099]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the mean particle size of the magnetic nanoparticles of Jones et al. ‘213 in view of Sirimanne et al. ‘195 to include being around 60 nm as Asgari ‘885 teaches that this will aid in optimizing the imagine producing properties.
Claim 20 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Jones et al. ‘213 in view of Sirimanne et al. ‘195 further in view of Kynor et al. ‘051 (US Patent No. 7,561,051 – cited by Applicant).
Regarding claim 20, Jones et al. ‘213 in view of Sirimanne et al. ‘195 teaches all of the elements of the current invention as mentioned above except for the susceptometer, wherein the susceptometer is a handheld susceptometry probe.
Kynor et al. ‘051 teaches a locating system 400 that includes a self-contained handheld locating probe 404 that is a magnet locating probe configured to sense the magnetic field emitted by magnets 408A-D. The magnets 408A-D function as fiducial markers bracketing a tumor 412 destined for excision from a breast 416 of a patient 420 (Fig. 4A and Column 15 Lines 1-20).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Jones et al. ‘213 in view of Sirimanne et al. ‘195 to include the susceptometer, wherein the susceptometer is a handheld susceptometry probe as Kynor et al. ‘051 teaches that this will aid in sensing markers that help a medical practitioner in locating a tumor in a patient destined for removal.
Claim 21 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Jones et al. ‘213 in view of Sirimanne et al. ‘195 further in view of Spoonhower et al. ‘113 (US Pub No. 2007/0008113).
Regarding claim 21, Jones et al. ‘213 in view of Sirimanne et al. ‘195 teaches all of the elements of the current invention as mentioned above except for a magnetic detection probe system comprising
a power module in electrical communication with the handheld susceptometry probe to supply current thereto,
a sense module in electrical communication with the handheld susceptometry probe to receive signals therefrom; and
a processing module in electrical communication with the power module and sense module,
wherein the processing module generates a waveform that controls the supply of current from the power module to the handheld susceptometry probe; wherein the processing module receives a signal from the sense module that indicates proximity to the handheld susceptometry probe.
Spoonhower et al. ‘113 teaches a magnetic detection probe system (Fig. 4) comprising
a power module in electrical communication with the handheld susceptometry probe (monitoring device 30, handheld device 56 and [0056]) to supply current thereto (kiosk computer 15 and [0059]; One of ordinary skill would understand that a computer includes a power module.),
a sense module in electrical communication with the handheld susceptometry probe to receive signals therefrom (proximity detector 17 and [0059]); and
a processing module in electrical communication with the power module and sense module (kiosk computer 15 and [0059]; One of ordinary skill would understand that a computer includes a processor.),
wherein the processing module generates a waveform that controls the supply of current from the power module to the handheld susceptometry probe (signal 3 and [0059]); wherein the processing module receives a signal from the sense module that indicates proximity to the handheld susceptometry probe ([0059]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Jones et al. ‘213 in view of Sirimanne et al. ‘195 to include a magnetic detection probe system comprising a power module in electrical communication with the handheld susceptometry probe to supply current thereto, a sense module in electrical communication with the handheld susceptometry probe to receive signals therefrom; and a processing module in electrical communication with the power module and sense module, wherein the processing module generates a waveform that controls the supply of current from the power module to the handheld susceptometry probe; wherein the processing module receives a signal from the sense module that indicates proximity to the handheld susceptometry probe as Spoonhower et al. ‘113 teaches that this will aid in monitoring internal bodily events ([0003]).
Claims 22, 24, and 25 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Jones et al. ‘213 in view of Ramachandran ‘731 further in view of Kynor et al. ‘051 further in view of Sirimanne et al. ‘195.
Regarding claim 22, Jones et al. ‘213 teaches a method of tissue marking and localization (Abstract), the method comprising:
providing an implantable magnetic marker (Figs. 5, 6 short term markers 17 and [0041]) comprising a solid magnetically detectable ferromagnetic material (radiopaque elements 28 and [0048]; It is noted that [0035] mentions that soft iron, ferrites, stainless steels, titanium, nickel and related alloys are ferromagnetic.), wherein the marker is between 0.8 mm and 2.4 mm in diameter ([0043]), less than 15 mm in length ([0043]), and has a shape (Fig. 6 shows that radiopaque element 28 is a shape.);
providing magnetic nanoparticles ([0048]; “detection by MRI”; One of ordinary skill would understand that an MRI can function as a magnetic resonance susceptometer. See https://pubmed.ncbi.nlm.nih.gov/1569876/)
detecting, using a magnetic probe, the implantable magnetic marker ([0048]; “detection by MRI”; One of ordinary skill would understand that an MRI can function as a magnetic resonance susceptometer.) at a first tissue location, wherein the first tissue location is in or near a tumor, a lesion, or a biopsy location (desired location 35 and [0049]); and
Jones et al. ‘213 teaches all of the elements of the current invention as mentioned above except for wherein the magnetic nanoparticles have a hydrodynamic diameter that ranges from 20 nm to 150 nm.
Ramachandran ‘731 teaches superparamagnetic agents may be composed of a magnetic iron oxide core surrounded by a coating that prevents aggregation and sedimentation of the particles in aqueous solutions, achieves high biological tolerance, and prevents toxic side effects…The core size ranges from 2 nm to less than 10 nm, and the hydrodynamic diameter ranges from 20 nm to about 150 nm. Particles with a relatively larger size, such as greater than 50 nm hydrodynamic diameter, are called superparamagnetic iron oxide (SPIO) particles ([0027]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the magnetic nanoparticles of Jones et al. ‘213 to include a hydrodynamic diameter that ranges from 20 nm to 150 nm as Ramachandran ‘731 teaches that this will aid in preventing aggregation and sedimentation of the particles in aqueous solutions, achieves high biological tolerance, and prevents toxic side effects.
Jones et al. ’213 in view of Ramachandran ‘731 teaches all of the elements of the current invention as mentioned above except for wherein the magnetic probe is a handheld magnetic probe.
Kynor et al. ‘051 teaches a locating system 400 that includes a self-contained handheld locating probe 404 that is a magnet locating probe configured to sense the magnetic field emitted by magnets 408A-D. The magnets 408A-D function as fiducial markers bracketing a tumor 412 destined for excision from a breast 416 of a patient 420 (Fig. 4A and Column 15 Lines 1-20).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the magnetic probe of Jones et al. ‘213 in view of Ramachandran ‘731 to include a being handheld magnetic probe as Kynor et al. ‘051 teaches that this will aid in sensing markers that help a medical practitioner in locating a tumor in a patient destined for removal.
Jones et al. ‘213 in view of Ramachandran ‘731 further in view of Kynor et al. ‘051 teaches all of the elements of the current invention as mentioned above except for detecting, using the handheld magnetic probe, the magnetic nanoparticles at a second tissue location, wherein the second tissue location is a lymph node or a portion of a lymphatic system.
Sirimanne et al. ‘195 teaches a method to remotely detect sentinel nodes (SN). This method includes the deposit, preferably by injection via a thin needle applicator or using a marker delivery device described herein, of a remotely detectable contrast agent that will migrate to the SN, allowing the exact location of the SN to be pinpointed and targeted for removal using minimally invasive techniques. This method eliminates the need for potentially toxic radioactive tracer material. In addition, the lack of toxicity of such agents obviates the need to remove the lesion and/or the SN on the same day ([0049]). These agents may be any biologically compatible agents capable of remote detection. Examples of such remote detection include, but are not limited to magnetism such as a magnetometer, Hall effect sensor, or magnetic resonance imaging (MRI) ([0050]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the magnetic nanoparticles of Jones et al. ‘213 in view of Ramachandran ‘731 further in view of Kynor et al. ‘051 to include being configured to be taken up into a lymphatic system and migrate to one or more sentinel lymph nodes such that the one or more sentinel lymph nodes are magnetically localizable using the susceptometer as Sirimanne et al. ‘195 teaches that this will aid in eliminating the need for potentially toxic radioactive tracer material and obviates the need to remove the lesion and/or the SN on the same day.
Regarding claim 24, Jones et al. ‘213 in view of Ramachandran ‘731 further in view of Kynor et al. ‘051 further in view of Sirimanne et al. ‘195 teaches wherein the handheld magnetic probe comprises a susceptometer ([0048]; “detection by MRI”; One of ordinary skill would understand that an MRI can function as a magnetic resonance susceptometer.).
Regarding claim 25, Jones et al. ‘213 in view of Ramachandran ‘731 further in view of Kynor et al. ‘051 further in view of Sirimanne et al. ‘195 teaches wherein the shape is a wire, a cylinder or a coil (radiopaque element 28 is a wire shape.).
Claim 23 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Jones et al. ‘213 in view of Ramachandran ‘731 further in view of Kynor et al. ‘051 further in view of Sirimanne et al. ‘195 further in view of Madru et al. (“99mTc-Labeled Superparamagnetic Iron Oxide Nanoparticles for Mutlimodality SPECT/MRI of Sentinel Lymph Nodes” – 2012).
Regarding claim 23, Jones et al. ‘213 in view of Ramachandran ‘731 further in view of Kynor et al. ‘051 further in view of Sirimanne et al. ‘195 teaches all of the elements of the current invention as mentioned above except for mapping the portion of the lymphatic system using the magnetic nanoparticles disposed therein and the handheld magnetic probe.
Madru et al. teaches mapping the sentinel lymph node (SLN) in vivo using multimodality SPECT/MRI contrast agents (Abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Jones et al. ‘213 in view of Ramachandran ‘731 further in view of Kynor et al. ‘051 further in view of Sirimanne et al. ‘195 to include mapping the portion of the lymphatic system using the magnetic nanoparticles disposed therein and the handheld magnetic probe as Madru et al. teaches that this will aid in cancer staging and for selecting choice of therapy for patients with breast cancer and malignant melanoma (page 459, 2nd column; page 463, Conclusion).
Claim 26 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Jones et al. ‘213 in view of Ramachandran ‘731 further in view of Kynor et al. ‘051 further in view of Sirimanne et al. ‘195 further in view of Asgari ‘885.
Regarding claim 26, Jones et al. ‘213 in view of Ramachandran ‘731 further in view of Kynor et al. ‘051 further in view of Sirimanne et al. ‘195 teaches all of the elements of the current invention as mentioned above except for wherein a mean particle size of the magnetic nanoparticles is around 60 nm.
Asgari ‘885 teaches to optimize the image producing properties, the average particle size of the magnetic signal producing agents may be provided to 5 .mu.m at maximum, such as from about 2 nm up to 1 .mu.m, e.g. from about 5 nm to 200 nm. The super paramagnetic signal producing agents can be chosen, for example, from the group of so-called SPIOs (super paramagnetic iron oxides) with a particle size larger than 50 nm or from the group of the USPIOs (ultra small super paramagnetic iron oxides) with particle sizes smaller than 50 nm ([0099]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the mean particle size of the magnetic nanoparticles of Jones et al. ‘213 in view of Ramachandran ‘731 further in view of Kynor et al. ‘051 further in view of Sirimanne et al. ‘195 to include being around 60 nm as Asgari ‘885 teaches that this will aid in optimizing the imagine producing properties.
Claims 27-29 and 31 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Jones et al. ‘213 in view of Sirimanne et al. ‘195 further in view of Kynor et al. ‘051.
Regarding claim 27, Jones et al. ‘213 teaches a method of tissue marking and localization (Abstract), the method comprising:
providing an implantable magnetic marker (Figs. 5, 6 short term markers 17 and [0041]);
providing magnetic nanoparticles ([0048]; “detection by MRI”; One of ordinary skill would understand that an MRI can function as a magnetic resonance susceptometer. See https://pubmed.ncbi.nlm.nih.gov/1569876/)
detecting the implantable magnetic marker ([0048]; “detection by MRI”; One of ordinary skill would understand that an MRI can function as a magnetic resonance susceptometer.) at a tissue location, wherein the tissue location is in or near a tumor, a lesion, or a biopsy location (desired location 35 and [0049]); and
Jones et al. ‘213 teaches all of the elements of the current invention as mentioned above except for detecting, using the susceptometry probe, the magnetic nanoparticles that have migrated to one or more sentinel lymph nodes; and determining, using the susceptometry probe, a location of the one or more sentinel lymph nodes connected via a lymphatic system to the tissue location.
Sirimanne et al. ‘195 teaches a method to remotely detect sentinel nodes (SN). This method includes the deposit, preferably by injection via a thin needle applicator or using a marker delivery device described herein, of a remotely detectable contrast agent that will migrate to the SN, allowing the exact location of the SN to be pinpointed and targeted for removal using minimally invasive techniques. This method eliminates the need for potentially toxic radioactive tracer material. In addition, the lack of toxicity of such agents obviates the need to remove the lesion and/or the SN on the same day ([0049]). These agents may be any biologically compatible agents capable of remote detection. Examples of such remote detection include, but are not limited to magnetism such as a magnetometer, Hall effect sensor, or magnetic resonance imaging (MRI) ([0050]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Jones et al. ‘213 to include detecting, using the handheld susceptometry probe, the magnetic nanoparticles that have migrated to one or more sentinel lymph nodes; and determining, using the handheld susceptometry probe, a location of the one or more sentinel lymph nodes connected via a lymphatic system to the tissue location as Sirimanne et al. ‘195 teaches that this will aid in eliminating the need for potentially toxic radioactive tracer material and obviates the need to remove the lesion and/or the SN on the same day.
Jones et al. ’213 in view of Sirimanne et al. ‘195 teaches all of the elements of the current invention as mentioned above except for wherein the susceptometry probe is a handheld susceptometry probe.
Kynor et al. ‘051 teaches a locating system 400 that includes a self-contained handheld locating probe 404 that is a magnet locating probe configured to sense the magnetic field emitted by magnets 408A-D. The magnets 408A-D function as fiducial markers bracketing a tumor 412 destined for excision from a breast 416 of a patient 420 (Fig. 4A and Column 15 Lines 1-20).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the magnetic probe of Jones et al. ‘213 in view of Sirimanne et al. ‘195 to include a being handheld magnetic probe as Kynor et al. ‘051 teaches that this will aid in sensing markers that help a medical practitioner in locating a tumor in a patient destined for removal.
Regarding claim 28, Jones et al. ‘213 teaches wherein the implantable magnetic marker is a solid metal plug (short term markers 17, radiopaque elements 28 and [0048]) comprising ferromagnetic material (radiopaque elements 28 and [0048]; It is noted that [0035] mentions that soft iron, ferrites, stainless steels, titanium, nickel and related alloys are ferromagnetic.).
Regarding claim 29, Jones et al. ‘213 teaches wherein the implantable magnetic marker is between 0.8 mm and 2.4 mm in diameter ([0043]), less than 15 mm in length ([0043]), and has a shape (Fig. 6 shows that radiopaque element 28 is a shape.), wherein the shape is a wire, a cylinder or a coil (radiopaque element 28 is a wire shape.).
Regarding claim 31, Jones et al. ‘213 teaches wherein the ferromagnetic material is ferromagnetic stainless steel ([0048]; “detection by MRI”; One of ordinary skill would understand that an MRI can function as a magnetic resonance susceptometer. See https://pubmed.ncbi.nlm.nih.gov/1569876/).
Claim 30 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Jones et al. ‘213 in view of Sirimanne et al. ‘195 further in view of Kynor et al. ‘051 further in view of Ramachandran ‘731.
Regarding claim 30, Jones et al. ‘213 in view of Sirimanne et al. ‘195 further in view of Kynor et al. ‘051 teaches all of the elements of the current invention as mentioned above except for wherein the magnetic nanoparticles have a hydrodynamic diameter that ranges from 20 nm to 150 nm.
Ramachandran ‘731 teaches superparamagnetic agents may be composed of a magnetic iron oxide core surrounded by a coating that prevents aggregation and sedimentation of the particles in aqueous solutions, achieves high biological tolerance, and prevents toxic side effects…The core size ranges from 2 nm to less than 10 nm, and the hydrodynamic diameter ranges from 20 nm to about 150 nm. Particles with a relatively larger size, such as greater than 50 nm hydrodynamic diameter, are called superparamagnetic iron oxide (SPIO) particles ([0027]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the magnetic nanoparticles of Jones et al. ‘213 in view of Sirimanne et al. ‘195 further in view of Kynor et al. ‘051 to have a hydrodynamic diameter that ranges from 20 nm to 150 nm as Ramachandran ‘731 teaches that this will aid in preventing aggregation and sedimentation of the particles in aqueous solutions, achieves high biological tolerance, and prevents toxic side effects.
Conclusion
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/AURELIE H TU/ Primary Examiner, Art Unit 3791
