DETAILED ACTION
Claims 1-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim(s) 1,4,5,14,15,16,17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated1 by SEPPI (US 2013/0012812 A1):
Claim(s) 2,3 is/are rejected under 35 U.S.C. 103 as being unpatentable over SEPPI (US 2013/0012812 A1) in view of Reiner et al. (US 2013/0309170 A1):
Claim(s) 6,7,8,9 is/are rejected under 35 U.S.C. 103 as being unpatentable over SEPPI (US 2013/0012812 A1) in view of ANDRESEN et al. (WO 2014/187962 A1):
Claim(s) 10,11 is/are rejected under 35 U.S.C. 103 as being unpatentable over SEPPI (US 2013/0012812 A1) in view of Boyden et al. (US 2022/0112553 A1) with Related U.S. Application Data: Provisional application No. 63/090,754, filed on Oct. 13, 2020:
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over SEPPI (US 2013/0012812 A1) in view of Cetinkaya (US 11,850,096 B1):
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over SEPPI (US 2013/0012812 A1) in view of Cetinkaya (US 11,850,096 B1) as applied in claim 12 further in view of LI et al. (WO 2015/191009 A1):
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 0: establish broadest reasonable interpretation as in footnotes;
Step 1: claim 1 is a process;
Step 2A, prong 1:
The claim(s) recite(s) an abstract idea (mental process: produce mentally):
generating2 a 3D image3:
1. An imaging method, comprising:
attaching image agents45 (i.e., image-things that act) to6 portions of an object;
expanding the portions of the object in three dimensions; and
generating a 3D image of the image agents7 (i.e., image-things that act) based on interactions of the image agents (i.e., image-things that act) with X-rays incident on the object after said attaching and said expanding are performed.
Step 2A, prong 2:
This judicial exception is not integrated into a practical application because the additional elements (“attaching” “expanding” “X-rays”) do not improve the technology of electronics8 (devices and circuits) in view of applicant’s disclosure [0021][0013][0022]:
[0021] The electronics layer 120 may include an electronic system 121 suitable for processing or interpreting signals generated by the radiation incident on the radiation absorption layer 110. The electronic system 121 may include an analog circuitry such as a filter network, amplifiers, integrators, and comparators, or a digital circuitry such as a microprocessor, and memory. The electronic system 121 may include one or more ADCs (analog to digital converters). The electronic system 121 may include components shared by the pixels 150 or components dedicated to a single pixel 150. For example, the electronic system 121 may include an amplifier dedicated to each pixel 150 and a microprocessor shared among all the pixels 150. The electronic system 121 may be electrically connected to the pixels 150 by vias 131. Space among the vias may be filled with a filler material 130, which may increase the mechanical stability of the connection of the electronics layer 120 to the radiation absorption layer 110. Other bonding techniques are possible to connect the electronic system 121 to the pixels 150 without using the vias 131.
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“count numbers of particles…shared by two different discrete regions 114”:
[0013] Each pixel 150 may be configured to detect radiation from a radiation source (not shown) incident thereon and may be configured to measure a characteristic (e.g., the energy of the particles, the wavelength, and the frequency) of the radiation. A radiation may include particles such as photons and subatomic particles. Each pixel 150 may be configured to count numbers of particles of radiation incident thereon whose energy falls in a plurality of bins of energy, within a period of time. All the pixels 150 may be configured to count the numbers of particles of radiation incident thereon within a plurality of bins of energy within the same period of time. When the incident particles of radiation have similar energy, the pixels 150 may be simply configured to count numbers of particles of radiation incident thereon within a period of time, without measuring the energy of the individual particles of radiation.
[0022] When radiation from the radiation source (not shown) hits the radiation absorption layer 110 including diodes, particles of the radiation may be absorbed and generate one or more charge carriers (e.g., electrons, holes) by a number of mechanisms. The charge carriers may drift to the electrodes of one of the diodes under an electric field. The electric field may be an external electric field. The electrical contact 119B may include discrete portions each of which is in electrical contact with the discrete regions 114. The term “electrical contact” may be used interchangeably with the word “electrode”. In an embodiment, the charge carriers may drift in directions such that the charge carriers generated by a single particle of the radiation are not substantially shared by two different discrete regions 114 (“not substantially shared” here means less than 2%, less than 0.5%, less than 0.1%, or less than 0.01% of these charge carriers flow to a different one of the discrete regions 114 than the rest of the charge carriers). Charge carriers generated by a particle of the radiation incident around the footprint of one of these discrete regions 114 are not substantially shared with another of these discrete regions 114. A pixel 150 associated with a discrete region 114 may be an area around the discrete region 114 in which substantially all (more than 98%, more than 99.5%, more than 99.9%, or more than 99.99% of) charge carriers generated by a particle of the radiation incident therein flow to the discrete region 114. Namely, less than 2%, less than 1%, less than 0.1%, or less than 0.01% of these charge carriers flow beyond the pixel 150.
Step 2B: The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements (“attaching” “expanding” “X-rays” “image agent” (i.e., an image-thing that acts) + chemical stuff: claims 2-13 & imaging stuff: claims 14-17) adhere to the conventional in view of applicant’s disclosure, [0002]:
BACKGROUND
[0002] A radiation9 detector is a device that measures a property of a radiation. Examples of the property may include a spatial distribution of the intensity, phase, and polarization of the radiation. The radiation10 may be one that has interacted1112 with an object. For example, the radiation measured by the radiation detector may be a radiation that has penetrated the object. The radiation may be an electromagnetic radiation such as infrared light, visible light, ultraviolet light, X-ray13, or γ-ray. The radiation may be of other types such as α-rays and β-rays. An imaging system may include one or more image sensors each of which may have one or more radiation detectors.
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) 1,4,5,14,15,16,17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated14 by SEPPI (US 2013/0012812 A1):
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Re 1., SEPPI discloses An imaging method, (likewise) comprising15:
attaching image agents (or likewise fig. 3: “iodine”-dots in fig 1:110) to portions of an object (or likewise: “By means of non-limiting examples, the agent may be administered to the patient using various methods, such as by injection, absorption, implant, or attachment (e.g., a material attached to a molecule, which through body function, attaches itself to cancer, hypoxic tissue, a particular tissue etc.).” [0023] 3rd S);
expanding (or likewise fig. 3: “scatter”) the portions of the object in three dimensions (or likewise: “The detector 804 detects projection16 data which is the integrated scattering data that is along the path of secondary x-ray 808 through the portion of the target volume 801 that is between the path of the incidental beam 802 and the detector 804.” [0054] 7th S); and
generating a 3D image (or likewise fig. 2: “detector”) of the image agents based on interactions of the image agents with X-rays incident on the object after said attaching and said expanding are performed (or likewise “In order to receive more projection data to reconstruct 3D CT image, the x-ray source 803 may move toward the detector 804 (See movement arrow pointing towards the detector 804 in FIG. 8 (A)). “ [0054] 8th S).
Re 4.,SEPPI discloses The method of claim 1, wherein the said expanding is performed after said attaching is performed (or likewise “[0023] In other embodiments, the material of interest may be an agent (or more than one agent) externally introduced into the tissue for enhancement of detection.“).
Re 5., SEPPI discloses The method of claim 1, wherein the image agents comprise an element with an atomic number of 23 or higher (or likewise “iodine…atomic number” via “ For example, if the administered agent is iodine17 and the energy of the excitation beam is at .about.59.9 keV from an .sup.241Am source in the radiation source 102, the energies of the fluorescence radiation photons K-alpha 1 (shown as peak 302 in FIG. 3) and K-beta 1 (shown as peak 304 in FIG. 3) from photo interaction of the incident radiation with the Iodine are .about.28.7 keV and 32.4 keV, respectively. The excitation beam 104 also interacts with the atoms of the tissue, but since the atomic number of the atoms of the tissue is lower, the emitted photons have the energy of <10 keV. The emitted radiation photons are emitted in all directions.” [0033] last Ss) .
Re 14., SEPPI discloses The method of claim 1, wherein said generating the 3D image of the image agents comprises:
capturing multiple 2D images of the image agents based on the interactions (or likewise “The reconstruction algorithm would be similar to those used in CT, MRI, and PET” [0048] last S); and
generating the 3D image of the image agents from the multiple 2D images using computed tomography18 (or likewise “Mounting multiple excitation beam sources 712 and multiple detectors 720 on a gantry, and collecting data from multiple directions or angles relative to the target volume 704 allows for reconstruction of volumetric image of the radioactive imaging agent distribution within the target volume 704. The reconstruction algorithm would be similar to those used in CT1920, MRI, and PET.” [0048]).
Re 15., SEPPI discloses The method of claim 14, wherein the interactions are emission of characteristic X-rays of the image agents caused by the X-ray incident on the object (or likewise “ The spatial, temporal, and functional attributes can be determined using: a) photo absorption of incidental excitation x-ray beam and subsequent emission of characteristic photons (e.g., K-alpha and K-beta radiation) by the material of interest, as well as b) secondary radiation generated from Compton scatter of incidental excitation x-ray beam interacting with tissue.” [0021] last S).
Re 16., SEPPI discloses The method of claim 14, wherein the interactions are attenuation of the X-ray incident on the object by the image agents (or likewise “[0003] The x-ray based imaging techniques, such as CT, detects the x-rays penetrated, attenuated, and/or scattered by the target region, on a medium that is opposite of the x-ray source, such as x-ray sensitive film or photonic detector.”).
Re 17., SEPPI discloses The method of claim 14, wherein said capturing the multiple 2D images comprises:
rotating a radiation source and a radiation detector around the object such that the image agents are disposed between the radiation source and the radiation detector (or likewise “[0053] Also, in other embodiments, the detector 120 may have an arc configuration. For example, in some cases, the arc of the detector 120 may partially circumscribe21 an object under examination, wherein the arc may extend at least 90.degree. circumferentially, or more preferably, at least 180.degree. circumferentially. In other embodiments, the detector 120 may extend 360.degree. circumferentially. In such cases, the detector 120 has a ring configuration with an opening in the middle for accommodating the object under examination…Also, the x-ray source 803 may rotate partially or completely (e.g., 180.degree.-360.degree.) around the target volume 801.” [0054] 11 S).
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) 2,3 is/are rejected under 35 U.S.C. 103 as being unpatentable over SEPPI (US 2013/0012812 A1) in view of Reiner et al. (US 2013/0309170 A1):
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Re 2., SEPPI teaches The method of claim 1, wherein said expanding is isotropic22.
SEPPI does not teach the difference of claim 2 of:
isotropic.
Reiner teaches the difference23 of claim 2 of:
isotropic (or likewise “isotropic” “CT datasets” [0190] 5th S:
[0190] For anatomic reference of PET signal, x-rays were projected over 360 degrees to create a computed tomographic (CT) image. X-ray projections had a cone beam angle of 9.3 degrees and a power of 80 keV. A 500 .mu.A anode source was located 347 mm from the center of rotation and x-rays were incident on a CCD detector containing 2048 transaxial and 3072 axial pixels. Projections were calibrated using 70 dark and 70 light images, interpolated bilinearly, processed through a Shepp-Logan filter, and then reconstructed using a filtered back projection algorithm. CT datasets were isotropic matrices with a total of 512.times.512.times.768 pixels measuring 110 .mu.m.sup.3. During CT acquisition, iodine contrast was infused into the tail vein at a rate of 35 .mu.L/min to enhance intravascular contrast. Projections were acquired at end expiration of the respiratory cycle using a BioVet gating system (M2M Imaging, Cleveland, Ohio) and total CT acquisition time was .about.10 minutes. PET-CT fusion and image analysis were performed using Inveon Research Workplace 3.0 (Siemens). Three-dimensional visualizations were produced with the DICOM viewer OsiriX (The OsiriX foundation, Geneva, Switzerland).
Since SEPPI teaches projection, one of skill in the art of projections could or would have done is refer to others and thus make SEPPI’s be as Reiner’s seeing in the change “Projections were calibrated…to enhance intravascular contrast”, Reiner [0190] 4th and 5th Ss, via explicit creative or even routine steps:
A) swap out SEPPI’s CT as shown in fig. 1 with Reiner’s “PET- CT” via [0189], 1st S
[0189] Images were acquired on the Siemens Inveon PET-CT. Each PET acquisition was 120 minutes in duration. PET was reconstructed from 600 million coincidental 511 keV photon counts on a series of LSO (lutetium oxyorthosilicate) scintillating crystals. Counts were rebinned in 3D by registering photons spanning no more than 3 consecutive rings and reconstructed into sinograms using a high resolution Fourier Rebin algorithm. Sinograms also yielded a 3D mapping of positron signal using a 2D filtered back-projection algorithm and a Ramp filter with a Nyquist cut-off of 0.5. Datasets were anisotropic matrices containing 128.times.128.times.159 pixels, measuring 0.796 mm/pixel in the z direction and 0.861 mm/pixel in the x and y directions. Calibration of PET signal preceded all scans by scanning an 8.0 cm in diameter cylindrical phantom containing a known amount of .sup.18F isotope. Data are expressed as standard uptake values (SUV), which normalizes activity measurements to body weight and injected activity.
B) see what happens (I foresee calibrated, enhanced intravascular contrast).
Re 3., SEPPI teaches The method of claim 1, wherein said expanding is performed before said attaching is performed.
SEPPI does not teach the difference of clam 3 of:
before.
Reiner teach the difference of clam 3 of:
before (or likewise “prior to” [0121]:
[0121] In addition, in vivo imaging can be used to assess the effect of an anti-cancer therapy on cells expressing PARP1, by using the compounds described herein, wherein the subject is imaged prior to, during, and/or after treatment with the therapy, and the corresponding signal/images are compared. For example, a subject with a cancer can be imaged prior to and after treatment with chemotherapy or radiation therapy to determine the response of the PARP1-expressing cancer cells to treatment.
Since SEPPI teaches “cancer” [0023] 3rd S:
[0023] In other embodiments, the material of interest may be an agent (or more than one agent) externally introduced into the tissue for enhancement of detection. The agent may be particle(s) or fluid. By means of non-limiting examples, the agent may be administered to the patient using various methods, such as by injection, absorption, implant, or attachment (e.g., a material attached to a molecule, which through body function, attaches itself to cancer, hypoxic tissue, a particular tissue etc.). The agent may be any material other than the tissue. An exemplary agent would be a contrast agent that has properties suitable for detection such that if the external radiation is an x-ray radiation at an appropriate energy level, the external radiation will interact with the agent to produce photo absorption-emission radiation and Compton scatter radiation.
one of skill in the art of cancer could or would have done is refer to others as the treatment of cancer and thus make SEPPI’s be as Reiner’s seeing in the change “treatment with chemotherapy or radiation therapy to determine the response of the PARP1-expressing cancer cells to treatment”, Reiner [0121] last S, via explicit creative or even routine steps:
A) obtain a preliminary scout CT image of patient before contrast agent injection via SEPPI’s CT scanner of fig. 1;
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B) Perform agent injections:
B1) inject SEPPI’s agent to the patient scanned via said CT; and/or
B1) inject Reiner’s needle of fig. 15B to the patient scanned via said CT:
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C) obtain CT with Reiner’s agent contrast and/or SEPPI’s agent of said patient via said SEPPI’s CT scanner;
D) see what happens (I foresee treatment with chemotherapy or radiation therapy to determine the response of the PARP1-expressing cancer cells to treatment).
Claim(s) 6,7,8,9 is/are rejected under 35 U.S.C. 103 as being unpatentable over SEPPI (US 2013/0012812 A1) in view of ANDRESEN et al. (WO 2014/187962 A1):
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Re 6., SEPPI teaches The method of claim 1, wherein said expanding the portions of the object comprises:
anchoring chemical linkers (i.e., molecules) on the object (or said likewise: “By means of non-limiting examples, the agent may be administered to the patient using various methods, such as by injection, absorption, implant, or attachment (e.g., a material attached to a molecule24, which through body function, attaches itself to cancer, hypoxic tissue, a particular tissue etc.).” [0023] 3rd S);
forming a polymer network that binds to the chemical linkers; and
expanding the portions by expanding the polymer network.
SEPPI does not teach the difference of claim 6 of:
a polymer network…
the polymer network.
ANDRESEN teach the difference of claim 6 of:
a polymer network (or likewise “form a hydrogel…comprised of cross-linked polymer networks that have…The organic x-ray contrast agent, such as iodinate…in figure 7”, starting pg. 22, line 28 and then to pg. 23, line 14)…
the polymer network (fig. 7:
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Since SEPPI suggests picking “an agent” such as “particle(s) or fluid” giving “contrast agent” as example via [0023]:
[0023] In other embodiments, the material of interest may be an agent (or more than one agent) externally introduced into the tissue for enhancement of detection. The agent may be particle(s) or fluid. By means of non-limiting examples, the agent may be administered to the patient using various methods, such as by injection, absorption, implant, or attachment (e.g., a material attached to a molecule, which through body function, attaches itself to cancer, hypoxic tissue, a particular tissue etc.). The agent may be any material other than the tissue. An exemplary agent would be a contrast agent that has properties suitable for detection such that if the external radiation is an x-ray radiation at an appropriate energy level, the external radiation will interact with the agent to produce photo absorption-emission radiation and Compton scatter radiation.
one of skill in the art of agents could or would have done is refer to others for the selection of an agent and thus make SEPPI’s be as ANDRESEN seeing in the change “An injectable matrix can thus be implanted in the human body with minimal surgical procedure”, ANDRESEN pg. 23,ll. 18,19, via explicit creative or routine steps:
A) goto agent store
A) pick ANDRESEN’s image contrast Iodine agent (said fig. 7) from the store
A) goto hospital/ER with computed tomography or imaging office with a patient;
B) inject ANDRESEN’s image contrast Iodine agent (said fig. 7) to the patient;
C) see what happens (I foresee: “An injectable matrix can thus be implanted in the human body with minimal surgical procedure).
Re 7., SEPPI of the combination of SEPPI-ANDRSEN teaches The method of claim 6, wherein the chemical linkers comprise compounds that bind to biomolecules25 of the object (or likewise “attaches…to…tissue” --i.e., attaches to a macromolecule-- via said likewise: “By means of non-limiting examples, the agent may be administered to the patient using various methods, such as by injection, absorption, implant, or attachment (e.g., a material attached to a molecule26, which through body function, attaches itself to cancer, hypoxic tissue27, a particular tissue etc.).” SEPPIS [0023] 3rd S).
Re 8., SEPPI of the combination of SEPPI-ANDRSEN teaches The method of claim 6, wherein the image agents is (“is” essentially means28 look at a figure: SEPPI’s fig. 1:110, reproduced below) as the chemical linkers (since the linked-atoms molecule of SEPPI is one and the same as fig. 1:110):
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Re 9., ANDRESEN of the combination of SEPPI-ANDRESEN teaches The method of claim 6, wherein the (tomographically) expanding the polymer network (for a CT image w/contrast) comprises:
adding water to the polymer network (via fig. 6: “[Water]” of ANDRESEN:
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Claim(s) 10,11 is/are rejected under 35 U.S.C. 103 as being unpatentable over SEPPI (US 2013/0012812 A1) in view of Boyden et al. (US 2022/0112553 A1) with Related U.S. Application Data: Provisional application No. 63/090,754, filed on Oct. 13, 2020:
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Re 10., SEPPI teaches The method of claim 1, wherein said (likewise-tomographic) expanding29 the portions of the object comprises30:
introducing a (likewise) swellable material into3132 the object (or likewise “Embodiments of the system and method described herein uses incidental excitation radiation from a source external to the material of interest, which may include the target tissue and/or an agent such as injected contrast agent and/or implanted objects33, to produce secondary radiation having different characteristics and different beam paths from the incident radiation.” [0020] 3rd S);
expanding (still for the ultimate end-result of expanding) the portions by causing the (likewise) swellable material to (likewise) swell34.
SEPPI does not teach the difference of claim 10 of:
swellable (material)35…36
causing the swellable (material) to swell.
Boyden teach the difference of claim 10 of:
swellable (material)37(or likewise “swellable material…isotropically”)…38
causing the swellable (material) to swell (or likewise “causes swelling… isotropically”, 63/090,754, pg. 16,ll.20-25:
Polymer and Nucleotide Expansion
20 The polymer (a non-limiting example of which is a hydrogel) within which linearized polynucleotide fragments are embedded is isotropically expanded. In some embodiments, a solvent or liquid is added to the complex and the solvent or liquid is absorbed by the swellable material and causes swelling. For example, if the mechanism of expansion is the polyelectrolyte effect, the gel may be dialyzed against water or an aqueous solution to expand. In one
25 embodiment, the addition of water allows the embedded sample to expand at least 3, 4, 5, or more times its original size in three dimensions. Thus, the sample may be increased I00-fold or more in volume. The labelled, linearized polynucleotide, having been fragmented, therefore expands isotropically along with the gel in at least a linear manner.
Since SEPPI suggests seeing images of other “molecules” such as “glucose” & seeing images of the “structure” of “angiogenesis”39 (cancer) “for diagnostic and/or treatment” via [0020]: bottom half & [0040]: bottom half:
[0020] This application provides for an apparatus and a method to measuring the spatial distribution, temporal attributes, and/or functional attributes of a material of interest. Unlike apparatus and methods that measure photonic information received directly opposite of the x-ray source, which measures the x-ray photons travelling through the material of interest, embodiments of the apparatus and method described herein measure the x-ray photons that are scattered or generated by the incident x-ray photons in the material of interest (such as tissue). Embodiments of the system and method described herein uses incidental excitation radiation from a source external to the material of interest, which may include the target tissue and/or an agent such as injected contrast agent and/or implanted objects, to produce secondary radiation having different characteristics and different beam paths from the incident radiation. This secondary radiation, having different attributes from that of the incident radiation, is produced by interaction of the incident radiation with the tissue and/or an agent such (as contrast agent, implanted material, or combination thereof). The secondary radiation is detected external to the material of interest, and may be analyzed to determine its source location, directionality, type, spatial distribution, or other attributes. Information about the incident radiation and detected secondary radiation (both of which may be of more that one type) may be used to determine positional, geometric, functional attributes, and temporal attributes of the material of interest. The spatial distribution may include the existence, density, location, function, and shape of the material of interest in the target volume being studied. The temporal attributes (which may be obtained by continuous monitoring or monitoring the same point of interest over different points in time) may include the rate of build-up and clearance, the pattern of flow, changes in existence of, density, location, function, shape and location of material nodules, and other attributes of the various types of molecules present in the material of interest. An example of detecting such temporal attributes may be accomplished by observing the change of the various types of molecules present over time (e.g., measuring the change of the amount of glucose in the tissue over time). The functional attributes may be determined by simultaneous observation of two or more attributes, such as by observing two or more types of secondary radiation emitted from the material of interest, projecting two or more types of excitation radiation onto the material of interest, injecting two or more types of contrast agent or tissue, or any combination thereof. For example, in some embodiments, functional attributes may be determined by observing the change in ratio or the function of two different types of tissue or structure (e.g., tissue, fat, bone, lung, angiogenesis liquid, solid) at a point of interest over time represents one or more human body function(s)) in the material of interest. The detected spatial distribution, temporal attributes and functional attributes can be arbitrarily combined in some embodiments.
[0040] The secondary analysis beam 414 has primarily two components. One of which is the scattered beam generated from photo absorption of the excitation pencil beam 402 by the imaging agent. The photo scattered beam has intensity that is proportional to the amount of imaging agent in the voxel, density of materials of the voxel, and intensity of the excitation beam 402. The photo scattered beam's quantum energy spectrum is dependent on the atomic number of materials in the voxel. Another component of the secondary radiation 414 is the Compton scatter radiation, which may be detected by the multi-energy detector in addition to the scattered beam. The Compton scatter is primarily dependent of the electron density in the voxel. Its quantum energy spectrum depends on the angle of scatter and incident beam quantum energy spectrum. In some embodiments, spatial and temporal information may be derived from detected secondary beams 414, which are analyzed to produce medical image for diagnostic and/or treatment. To acquire sufficient data for volumetric spatial and temporal information, the excitation beam 402 may raster scan the entire target volume voxel by voxel (the detector 420 and secondary beam collimator 416 may move dependently from the excitation beam source 412). In some embodiments, one or both of the incident source beam and the exit beam detection may be rastered. In other embodiments, individual point(s) of interest may be selected, in which case, the scanning may not be required.
one of skill in the art of molecules and cancer and imaging could or would of have done is look to others regarding molecules and cancer and imaging as diagnosis40/treatment thereof and thus make SEPPI’s be as Boyden’s seeing in the change that “determined genomic DNAs may assist in identifying a genomic variation or abnormality associated with the subject's disease or condition”, Boyden, 63/090,754, page 9, ll. 5,6, via explicit creative or even routine steps A) B) C) D) E) F):
Pre-Operative Steps:
A) Perform “non-invasive”, SEPPI [0002] 1st S, tomographic imaging to diagnose/treat cancer via SEPPI’s CT imaging;
B) observe the resulting CT images for “various types of molecules present in the material of interest”, SEPPI [0020]: bottom half;
Intra-Operative Steps:
C) perform a “biopsy”41 at the computed tomography material of interest obtaining a “biopsy specimen”, Boyden, pg. 23, ll. 13-15;
D) obtain a “cell”/”polynucleotides” from the “biopsy”, Boyden, pg. 23, ll. 12-13;
Post-Operative Steps:
E) input/process the biopsied, Computed Tomography (CT) polynucleotides using Boyden’s fig. 1, reproduced below, to create a plurality of biopsied, solid, CT, polynucleotide slices for viewing on a slide under a microscope:
E1) embed (via fig. 1:3rd box: “Overlay solid support with hydrogel, embedding42 immobilized polynucleotide”) Boyden’s swellable material into43 (i.e., to a point of contact with) the biopsied, CT polynucleotides;
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F) see what happens (I foresee: tomographically “determined genomic DNAs may assist in identifying a genomic variation or abnormality associated with the subject's disease or condition”).
Re 11., SEPPI of the combination of SEPPI-Boyden teaches The method of claim 10, wherein the image agents is a part (or likewise as parts or any part via “the material of interest…may include44 …an agent such as injected contrast agent”, SEPPI [0020], 3rd S) of45 (via the combination of SEPPI-Boyden) the swellable material .
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over SEPPI (US 2013/0012812 A1) in view of Cetinkaya (US 11,850,096 B1):
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Re 12., SEPPI teaches The method of claim 1, wherein[[,]]46 before the step of the (tomographic) expanding the portions of the object, further comprises:
weakening bonds in the object {before the step of the expanding the portions of the object}.
SEPPI does not teach the difference of claim 12 of:
weaking (bonds)...{before…}47
Cetinkaya teach the difference of claim 12 of:
weaking (bonds) (or likewise “bonds, weakened”, c.16,ll. 1-5)...{before…}48
Since SEPPI suggests picking “an agent” such as “particle(s) or fluid” giving “contrast agent” as example via [0023]:
[0023] In other embodiments, the material of interest may be an agent (or more than one agent) externally introduced into the tissue for enhancement of detection. The agent may be particle(s) or fluid. By means of non-limiting examples, the agent may be administered to the patient using various methods, such as by injection, absorption, implant, or attachment (e.g., a material attached to a molecule, which through body function, attaches itself to cancer, hypoxic tissue, a particular tissue etc.). The agent may be any material other than the tissue. An exemplary agent would be a contrast agent that has properties suitable for detection such that if the external radiation is an x-ray radiation at an appropriate energy level, the external radiation will interact with the agent to produce photo absorption-emission radiation and Compton scatter radiation.
one of skill in the art of agents could or would have done is refer to others for the selection of an agent and thus make SEPPI’s be as Cetinkaya’s seeing in the change “a method, device and system for ultrasonic delivery of ligand-receptor based drugs and image enhancing contrast agents utilizing catch and slip bonds in a targeted part(s) of the patient's body or organs are described and disclosed. One of the objects of utilizing catch and slip bonds in target part(s) of the patient's body is to substantially reduce or eliminate cavitation and other side-effects associated with drugs and agents in the process.”, Cetinkaya, c. 14,ll. 50-55, via explicit creative or even routing steps A) B) C) D):
A) obtain ultrasound equipment as shown in Cetinkaya’s fig. 3
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B) engineer SEPPI’s imaging agent “with engineered receptors or ligands”, Cetinkaya, c.1,ll. 50:
B1) attach a square two-fingered hand (shown in fig. 1, below) to SEPPI’s imaging agent;
B2) measure the force that the hand can withstand while holding the contrast/imaging agent;
B3) create more receptors/ligands (i.e., fingers) if the square two-finger hand does not sufficiently hold the contrast agent:
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C) perform Cetinkaya’s fig. 4:
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D) see what happens (I foresee: a method, device and system for ultrasonic delivery of ligand-receptor based drugs and image enhancing contrast agents utilizing catch and slip bonds in a targeted part(s) of the patient's body or organs are described and disclosed. One of the objects of utilizing catch and slip bonds in target part(s) of the patient's body is to substantially reduce or eliminate cavitation and other side-effects associated with drugs and agents in the process.”)
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over SEPPI (US 2013/0012812 A1) in view of Cetinkaya (US 11,850,096 B1) as applied in claim 12 further in view of LI et al. (WO 2015/191009 A1):
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Re 13., SEPPI of the combination of SEPPI-Cetinkaya teaches The method of claim 12, wherein the weakening bonds in the object comprises:
using detergents, enzymes, and/or heat to weakening biomolecules of the object.
SEPPI of the combination of SEPPI-Cetinkaya does not teach the difference of claim 13 of:
using detergents, enzymes, and/or heat to weakening biomolecules.
LI teach the difference of claim 13 of:
using 49 heat to weakening biomolecules50 (or likewise “At a temperature above the LCST, the hydrogen bonds between the molecules and water weaken and the polymer chains aggregate with each other, forming a compact configuration.”, pg. 3,ll. 25-30: fig. 9A:
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Since Cetinkaya of the combination of SEPPI-Cetinkaya suggests that micelles51 are well known for a “long time as drug carriers, and recently as gene carriers” and provides other works to “See”, via c,7, last para:
Micelles Vesicles and Liposomes:
A micelle is an aggregation of surfactant molecules dispersed in a liquid colloid. A vesicle is a small membrane-enclosed sack that can store or transport substances. Liposomes are artificially prepared vesicles made of lipid bilayer. They have been used for a long time as drug carriers, and recently as gene carriers. Ultrasound applied in combination with gene-carrying liposomes has enhanced the transfection rate both in vitro (See Unger Ee, Fritz Ta, Matsunaga T, Ramaswami Vr, Yellowhair D, Wu G: Therapeutic Drug Delivery Systems. In; U. S. Patent Database Imarx Pharmaceutical Corp; United States of America: (1996):48; Unger E C, McCreery T P, Sweitzer R H. Ultrasound Enhances Gene Expression of Liposomal Transfection. Investigative Radiology. 1997; 32(12):723-727; Lawrie A, Brisken A F, Francis Se, Et al. Ultrasound Enhances Reporter Gene Expression after Transfection of Vascular Cells In Vitro. Circulation. 1999; 99(20):2617-2620; and Mccreery T P, Sweitzer R H, Unger E C: DNA Delivery to Cells in Culture Using Ultrasound. In: Methods in Molecular Biology Vol. 245. Heiser We, Ed. Humana Press; Totowa, New Jersey: (2004):287-291.) and in vivo. (See Mccreery T P, Sweitzer R H, Unger E C: DNA Delivery To Cells In Vivo By Ultrasound. In: Methods In Molecular Biology Vol. 245. Heiser We, Ed. Humana Press; Totowa, New Jersey: (2004):293-298.)
one of skill in the art of micelles could or would have done is take a look at these other teachings of carriers and thus make Cetinkaya’s of the combination of SEPPI-Cetinkaya be as LI’s seeing in the change:
“Advantageously, the presence of the hydrophobic polymer in the micellar particle may lower the critical micelle concentration (CMC) of the micellar particle as compared to another micellar particle without the same hydrophobic polymer. Hence, by having the hydrophobic polymer in the micellar particle, micellization of the particle is substantially promoted. In addition, the hydrophobic polymer may increase the stability of the micellar particle in an aqueous solution. As the stability of the micellar particle is increased, the tendency of the micellar particle to form inter micellar aggregates may be substantially reduced, even at an elevated temperature. At a temperature below the LCST, the high hydrophobicity of the hydrophobic polymer in the copolymer may provide stronger driving force for self-assembly and larger micelle core may be formed in an aqueous solution.”, LI, page 2, ll.10-20,
via additional explicit creative or even routine steps C1):
A) obtain ultrasound equipment as shown in Cetinkaya’s fig. 3
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B) engineer SEPPI’s imaging agent “with engineered receptors or ligands”, Cetinkaya, c.1,ll. 50:
B1) attach a square two-fingered hand (shown in fig. 1, below) to SEPPI’s imaging agent;
B2) measure the force that the hand can withstand while holding the contrast/imaging agent;
B3) create more receptors/ligands (e.g., five fingers) if the square two-finger hand does not sufficiently hold the contrast agent:
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C) perform Cetinkaya’s fig. 4:
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C1) At Centinkaya’s fig. 4: “Input:…drug type”, protect Cetinkaya’s drug type (i.e., cargo) against heat or “extremely high pressures and temperatures”, Centinkaya, c.18,ll. 20-25, “comprising the steps of:
(a) providing a micellar particle having a core-shell configuration, the core comprising a hydrophobic polymer and the shell comprising at least one of a hydrophilic polymer or a thermoresponsive polymer, the thermoresponsive polymer capable of becoming hydrophobic at a temperature above a low critical solution temperature of the thermoresponsive polymer; and
(b) immobilizing the cargo with the hydrophobic thermoresponsive polymer at the temperature stated in step (a) to thereby protect the cargo from thermal degradation.” (LI: pg. 2,ll.30-35).
D) see what happens (I foresee: (1) “a method, device and system for ultrasonic delivery of ligand-receptor based drugs and image enhancing contrast agents utilizing catch and slip bonds in a targeted part(s) of the patient's body or organs are described and disclosed. One of the objects of utilizing catch and slip bonds in target part(s) of the patient's body is to substantially reduce or eliminate cavitation and other side-effects associated with drugs and agents in the process.” and (2) “the hydrophobic polymer may increase the stability of the micellar particle in an aqueous solution. As the stability of the micellar particle is increased, the tendency of the micellar particle to form inter micellar aggregates may be substantially reduced, even at an elevated temperature. At a temperature below the LCST, the high hydrophobicity of the hydrophobic polymer in the copolymer may provide stronger driving force for self-assembly and larger micelle core may be formed in an aqueous solution”).
Conclusion
The prior art “nearest to the subject matter defined in the claims” (MPEP 707.05) made of record and not relied upon is considered pertinent to applicant's disclosure.
The following table lists several references that are relevant to the subject matter claimed and disclosed in this Application. The references are not relied on by the Examiner, but are provided to assist the Applicant in responding to this Office action.
Citation
Relevance
IDS (3/14/2024) cited Mayerich et al. (US 2020/0033266 A1): an X-reference
Mayerich teaches expanding polymers:
[0059] Expansion microscopy (ExM) is a technique in which fluorophores on fixed specimens are linked to a swellable polymer matrix that is physically expanded, enabling super-resolution microscopy with conventional microscopes. The matrices currently used in these applications are hydrogels, which are optically clear, water-swollen polymers.
as the closest to the claimed “expanding the portions of the object in three dimensions” of claim 1 and “expanding the portions by expanding the polymer network” of claim 6.
IDS (3/14/2024) cited KOHMAN (US 2018/0052081 A1)
KOHMAN teaches “X-ray film” [0089] and expanding a biological sample using a polymer matrix network:
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[0003] In expansion microscopy (ExM), 3-dimensional imaging with nanoscale precision is performed on cells and tissues. This is accomplished by physically expanding the biological sample using a dense polymer matrix (FIG. 1). The first step of this process involves treating the tissue with a fluorescent protein-binding-group (typically an antibody) that selectively binds to the protein being analyzed. Next the sample is infused with a monomer solution that permeates into the tissue. Free radical polymerization of this solution creates a polymer network that is physically connected to the protein-binding-groups through customized bioconjugation chemistry. Lastly, the tissue is digested and the hydrogel (and fluorescent dyes) expands uniformly.
as the closest to the claimed “expanding the portions of the object in three dimensions” of claim 1 and “expanding the portions by expanding the polymer network” of claim 6.
Lanza et al. (US 2020/0085392 A1): this reference is applicable to claim 1 under 35 USC 102
Lanza teaches Rituximab “antibodies52… act as” image “labeling agents” [0112] and “specimen…projection…into…3D” [0075] last Ss:
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[0075] In some embodiments, the sample specimen is mounted on a high-precision nano-positioning stage, an example of which is discussed above in connection with FIG. 1. The mounted sample specimen may be sequentially exposed to X-ray illuminations in a coded fashion as discussed above. The X-ray optical chain described above in connection with FIG. 6A focuses the X-ray beam on a high-resolution detector in order to provide a set of projection images of the sample specimen such as an IC chip. In some embodiments, these projection images are reconstructed into a 3D image stack of planar images using a tomosynthesis algorithm.
as the closest to the claimed “attaching [binding] image agents [Rituximab antibody labeling agents] to portions of an object [“malignant CD20” [0111]]…expanding the portions of the object in three dimensions” of claim 1.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DENNIS ROSARIO whose telephone number is (571)272-7397. The examiner can normally be reached Monday-Friday, 9AM-5PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Henok Shiferaw can be reached at 571-272-4637. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DENNIS ROSARIO/Examiner, Art Unit 2676
/Henok Shiferaw/Supervisory Patent Examiner, Art Unit 2676
1 MPEP 2131 Anticipation — Application of 35 U.S.C. 102 [R-08.2017], 2nd para, 2nd to last S: The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990).
2 generate: to bring into existence; cause to be; produce, wherein produce is defined: to bring into existence by intellectual or creative ability, wherein ability is defined: power or capacity to do or act physically, mentally, legally, morally, financially, etc . (Dictionary.com)
3 Applicant’s disclosure [0016] last S: “a 3D image is…something that can be seen by naked eyes”, wherein see is defined: to construct a mental image of; visualize. (Dictionary.com)
4 BROAD CLAIM LANGUAGE : agent: a person or thing that acts or has the power to act (Dictionary.com)
5 “image agents” (i.e., image-things that act) does NOT invoke 35 USC 112(f) in claim 1 since “image agents” (i.e., “image-things”) is not modified by functional language (“attaching”) and instead is the grammatical object of ”attaching”.
6 “to” is a transition word under 35 USC 112(f)
7 “the image agents” is modified by acts plural (i.e., “based on…attaching and said expanding” are verb- acts) and thus also does NOT invoke 35 USC 112(f).
8 electronics: (functioning as singular) the science and technology concerned with the development, behaviour, and applications of electronic devices and circuits (Dictionary.com)
9 radiation:
1 a. Streams of photons, electrons, small nuclei, or other particles. Radiation is given off by a wide variety of processes, such as thermal activity, nuclear reactions (as in fission), and by radioactive decay.
b. The emission or movement of such particles through space or a medium, such as air.
2 The use of such energy, especially x-rays, in medical diagnosis and treatment, wherein electron is defined: An elementary particle with a negative charge and a very small mass. Electrons are normally found in orbits around the nucleus of an atom. The chemical reactions that an atom undergoes depend primarily on the electrons in the outermost orbits (the valence electrons), wherein chemical reaction is defined: Chemistry. reaction, wherein reaction is defined: Also called chemical reaction. Chemistry. the reciprocal action of chemical agents upon each other; chemical change, wherein emission is defined: something that is emitted; discharge; emanation, wherein emanation is defined: an act or instance of emanating, wherein emanating is defined: to flow out, issue, or proceed, as from a source or origin; come forth; originate, wherein out is defined: so as to project or extend, wherein extend is defined: to stretch out in various or all directions; expand; spread out in area. (Dictionary.com)
10 AGENT features: radiation: something that is radiated. (Dictionary.com)
11 AGENT features: interact: to act one upon another. (Dictionary.com)
12 IMAGE AGENT (i.e., image X-ray radiation): “something…that has…acted”, wherein AGENT is defined: a person or thing that acts or has the power to act (Dictionary.com)
13 X-ray: A high-energy stream of electromagnetic radiation having a frequency higher than that of ultraviolet light but less than that of a gamma ray (in the range of approximately 10 16 to 10 19 hertz). X-rays are absorbed by many forms of matter, including body tissues, and are used in medicine and industry to produce images of internal structures, where absorb is defined: to swallow up the identity or individuality of; incorporate, wherein incorporate is defined: to put or introduce into a body or mass as an integral part or parts, wherein integral is defined: consisting or composed of parts that together constitute a whole, wherein together is defined: into or in union, proximity, contact, or collision, as two or more things, wherein union is defined: the act of uniting two or more things, wherein unite is defined: to cause to adhere, wherein adhere is defined: to stay attached; stick fast; cleave; cling (usually followed byto ). (Dictionary.com)
14 MPEP 2131 Anticipation — Application of 35 U.S.C. 102 [R-08.2017], 2nd para, 2nd to last S: The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990).
15 BROAD CLAIM LANGUAGE: -ing (of “comprising): a suffix of nouns formed from verbs, expressing the action of the verb or its result, product, material, etc. (the art of building; a new building; cotton wadding )., wherein etc. is defined: and others; and so forth; and so on (used to indicate that more of the same sort or class might have been mentioned, but for brevity have been omitted)., wherein so is defined: likewise or correspondingly; also; too. (Dictionary.com)
16 projection: a causing to jut or protrude. wherein jut is defined: to extend beyond the main body or line; project; protrude (often followed byout ), wherein extend is defined: to stretch out in various or all directions; expand; spread out in area. (Dictionary.com)
17 iodine: A shiny, grayish-black element of the halogen group. It is corrosive and poisonous and occurs in very small amounts in nature except for seaweed, in which it is abundant. Iodine compounds are used in medicine, antiseptics, and dyes. Atomic number 53; atomic weight 126.9045; melting point 113.5°C; boiling point 184.35°C; specific gravity (solid, at 20°C) 4.93; valence 1, 3, 5, 7. (Dictionary.com)
18 tomography: Any of several radiologic techniques for making detailed three-dimensional images of a plane section of a solid object, such as the body, while blurring out the images of other planes. (Dictionary.com)
19 CT: computed tomograph, wherein tomograph is defined: a machine for making an x-ray of a selected plane of the body. (Dictionary.com: AMERICAN)
20 CT: computerized tomography See also CT scanner, wherein computerized tomography is defined: Also called (esp US): computed tomography. CT. med a radiological technique that produces images of cross sections through a patient's body using low levels of radiation See also CT scanner, wherein computed tomography is defined: computerized axial tomography. CT, wherein computerized axial tomography is defined: Tomography in which computer analysis of a series of cross-sectional x-ray images made along a single axis of a bodily structure or tissue is used to construct a three-dimensional image of that structure. The technique is used in diagnostic studies of internal bodily structures, as in the detection of tumors or brain aneurysms. (Dictionary.com: BRITISH: AMERICAN: SCIENTIFIC)
21 circumscribe: to draw a line around; encircle, wherein encircle is defined: to form a circle around; surround; encompass, wherein around is defined: with a rotating course or movement. (Dictionary.com)
22 isotropic: Identical in all directions; invariant with respect to direction. For example, isotropic scattering of light by a substance entails that the intensity of light radiated is the same in all directions. (Dictionary.com: SCIENTIFIC)
23 THE CLAIMED INVENTION AS A WHOLE regarding “isotropic”:
This first disclosed problem (pixelated image) is “not substantially shared by two different discrete regions 114” in a pixel array via applicant’s disclosure:
[0022] When radiation from the radiation source (not shown) hits the radiation absorption layer 110 including diodes, particles of the radiation may be absorbed and generate one or more charge carriers (e.g., electrons, holes) by a number of mechanisms. The charge carriers may drift to the electrodes of one of the diodes under an electric field. The electric field may be an external electric field. The electrical contact 119B may include discrete portions each of which is in electrical contact with the discrete regions 114. The term “electrical contact” may be used interchangeably with the word “electrode”. In an embodiment, the charge carriers may drift in directions such that the charge carriers generated by a single particle of the radiation are not substantially shared by two different discrete regions 114 (“not substantially shared” here means less than 2%, less than 0.5%, less than 0.1%, or less than 0.01% of these charge carriers flow to a different one of the discrete regions 114 than the rest of the charge carriers). Charge carriers generated by a particle of the radiation incident around the footprint of one of these discrete regions 114 are not substantially shared with another of these discrete regions 114. A pixel 150 associated with a discrete region 114 may be an area around the discrete region 114 in which substantially all (more than 98%, more than 99.5%, more than 99.9%, or more than 99.99% of) charge carriers generated by a particle of the radiation incident therein flow to the discrete region 114. Namely, less than 2%, less than 1%, less than 0.1%, or less than 0.01% of these charge carriers flow beyond the pixel 150.
The solution is to (photon) count (not claimed) shared/equal number of charge carriers in the pixel array:
[0013] Each pixel 150 may be configured to detect radiation from a radiation source (not shown) incident thereon and may be configured to measure a characteristic (e.g., the energy of the particles, the wavelength, and the frequency) of the radiation. A radiation may include particles such as photons and subatomic particles. Each pixel 150 may be configured to count numbers of particles of radiation incident thereon whose energy falls in a plurality of bins of energy, within a period of time. All the pixels 150 may be configured to count the numbers of particles of radiation incident thereon within a plurality of bins of energy within the same period of time. When the incident particles of radiation have similar energy, the pixels 150 may be simply configured to count numbers of particles of radiation incident thereon within a period of time, without measuring the energy of the individual particles of radiation.
“isotropic” is preprocessing to help balanced charge carriers across the pixel array: The lack of the disclosed shared/equal “count” in claim 2 is an indication of obviousness
24 molecule: A group of two or more atoms linked together by sharing electrons in a chemical bond. Molecules are the fundamental components of chemical compounds and are the smallest part of a compound that can participate in a chemical reaction. (Dictionary.com)
25 biomolecule: an organic molecule occurring in living organisms, such as an amino acid or protein. (Dictionary.com)
26 molecule: A group of two or more atoms linked together by sharing electrons in a chemical bond. Molecules are the fundamental components of chemical compounds and are the smallest part of a compound that can participate in a chemical reaction. (Dictionary.com)
27 tissue: Biology. an aggregate of similar cells and cell products forming a definite kind of structural material with a specific function, in a multicellular organism, wherein cell is defined: The basic unit of living matter in all organisms, consisting of protoplasm enclosed within a cell membrane. All cells except bacterial cells have a distinct nucleus that contains the cell's DNA as well as other structures (called organelles) that include mitochondria, the endoplasmic reticulum, and vacuoles. The main source of energy for all of a cell's biological processes is ATP, wherein DNA is defined: Genetics. deoxyribonucleic acid: an extremely long macromolecule that is the main component of chromosomes and is the material that transfers genetic characteristics in all life forms, constructed of two nucleotide strands coiled around each other in a ladderlike arrangement with the sidepieces composed of alternating phosphate and deoxyribose units and the rungs composed of the purine and pyrimidine bases adenine, guanine, cytosine, and thymine: the genetic information of DNA is encoded in the sequence of the bases and is transcribed as the strands unwind and replicate. . . (Dictionary.com)
28 Dictionay.com: “is”: be: (used as a copula to connect the subject with its predicate adjective, or predicate nominative, in order to describe, identify, or amplify the subject).
29 -ing (of “expanding”): a suffix of nouns (“said expanding”) formed from verbs (expand), expressing the action of the verb or its result, product, material, etc. [ultimate end-result of expanding] (the art of building; a new building; cotton wadding ), wherein etc is defined: and others; and so forth; and so on (used to indicate that more of the same sort or class might have been mentioned, but for brevity have been omitted), wherein so is defined: likewise or correspondingly; also; too. (Dictionary.com)
30 comprise: to include or contain, wherein include is defined: to contain as a subordinate element; involve as a factor (Dictionary.com)
31 Regarding the claimed “into” via Applicant’s disclosure:
[0077] While various aspects and embodiments have been disclosed herein, other aspects and embodiments will be apparent to those skilled in the art. The various aspects and embodiments disclosed herein are for purposes of illustration and are not intended to be limiting, with the true scope and spirit being indicated by the following claims., wherein scope is defined: Linguistics, Logic. the range of words (e.g., “introducing a swellable material”) or elements of an expression (claim 10) over which a modifier (e.g., a patent examiner) or operator (e.g., or me) has control. (Dictionary.com)
32 into: to a point of contact with; against. (Dictionary.com)
33 object: anything that is visible or tangible and is relatively stable in form. (Dictionary.com)
34 BROAD CLAIM LANGUAGE: swell: to grow in amount, degree, force, etc., wherein etc is defined: and others; and so forth; and so on (used to indicate that more of the same sort or class might have been mentioned, but for brevity have been omitted), wherein so is defined: likewise or correspondingly; also; too. (Dictionary.com)
(Dictionary.com)
35 (italics) represent claim limitations already taught
36 ellipses (…) represent claim limitations already taught
37 (italics) represent claim limitations already taught
38 ellipses (…) represent claim limitations already taught
39 angiogenesis: The formation of new blood vessels, especially blood vessels that supply oxygen and nutrients to cancerous tissues. (Dictionary.com)
40 diagnosis: the identification of diseases by the examination of symptoms and signs and by other investigations (Dictionary.com)
41 biopsy: the removal for diagnostic study of a piece of tissue from a living body. (Dictionary.com)
42 embed: Histology. to infiltrate (a biological tissue) with molten paraffin or other plastic material that later solidifies, enabling the preparation to be sliced very thin for viewing under a microscope, wherein infiltrate is defined: to filter into or through; permeate, wherein into is defined: (1) to the inside of; in toward (3) to a point of contact with; against. (Dictionary.com)
43 into: (3) to a point of contact with; against . (Dictionary.com)
44 include: to contain, as a whole does parts or any part or element. (Dictionary.com)
45 of: (used to indicate possession, connection, or association). (Dictionary.com)
46 This comma is interpreted as a deleted comma to make grammatical sense of claim 12 establishing order to the sequential elements of claim 12
47 {curly brackets} are used to establish order to the sequential elements of claim 12.
48 {curly brackets} are used to establish order to the sequential elements of claim 12.
49 The crossed out text “is not limiting the scope of” claim 13
50 biomolecule: an organic molecule occurring in living organisms, such as an amino acid or protein. (Dictionary.com)
51 micelle: Physical Chemistry. an electrically charged particle formed by an aggregate of molecules and occurring in certain colloidal electrolyte solutions, as those of soaps and detergents. wherein detergent is defined: A cleaning agent that increases the ability of water to penetrate fabric and break down greases and dirt. Detergents act like soap but, unlike soaps, they are derived from organic acids rather than fatty acids. Their molecules surround particles of grease and dirt, allowing them to be carried away. . (Dictionary.com)
52 antibody: any of numerous Y -shaped protein molecules produced by B cells as a primary immune defense, each molecule and its clones having a unique binding site that can combine with the complementary site of a foreign antigen, as on a virus or bacterium, thereby disabling the antigen and signaling other immune defenses. Ab (Dictionary.com)
Prosecution Insights