DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This office action is in response to the communications filed on 01/27/2026, concerning Application No. 17/398,778. The amendments to the claims filed on 01/27/2026 are acknowledged. Presently, claims 41, 44, and 46-56 are pending.
Claim Objections
Claim 49 is objected to because of the following informalities:
Claim 49, line 2, the limitation “having diameters in the range of 1 μm to 500 μm” should be changed to “having diameters in a range of 1 μm to 500 μm” because there is insufficient antecedent basis for this limitation in the claim.
Appropriate correction is required.
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 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.
Claims 41, 44, and 46-56 are rejected under 35 U.S.C. 103 as being unpatentable over Snow et al. (US Patent 6,749,554 B1, of record, hereinafter Snow) in view of Imran et al. (US 2019/0133937 A1, of record, hereinafter Imran).
Regarding claim 41, Snow discloses a method for manufacturing an ultrasound-detectable marker (see, e.g., Abstract, “A medical or surgical device or tool that is designed to be implanted or inserted inside the human or mammalian body, having at least part of its surface coated whereby the ultrasound visibility of said device or tool in vivo is enhanced, wherein the coating comprises one or more of the following: (i) a matrix material containing a plurality of contrast enhancing elements”, and Col. 16, lines 30-34, “An ultrasound contrast enhancing agent is any agent which when delivered to the treatment site serves to enhance the visibility of the radioactive source to ultrasound either alone or on reaction with a component of the coating of the source”, and Col. 18, lines 21-33, “the invention provides a coating composition adapted to provide improved ultrasound visibility in vivo for medical or surgical devices and tools that are designed to be implanted or inserted inside a patient's body, including radioactive sources for use in brachytherapy. The coating composition coats the device for at least a part of the time whilst it is in use and provides enhanced detectability by pulse echo ultrasound for at least a part of the time whilst the device is inside a patient's body. Such enhanced ultrasound visibility is useful to aid a physician in placement of the device or tool at the required position inside a patient's body and to monitor the progress of the medical procedure”, and Col. 19, lines 58-65, “the invention provides a method for improving the ultrasound visibility in vivo of medical or surgical devices that are designed to be implanted or inserted inside a patient's body, including radioactive sources for use in brachytherapy, the method comprising providing a composition in powdered form comprising a non-polymeric biocompatible compound, and fusing said composition to form a coating on the device”), comprising:
forming a body of a marker from a non-metallic material (see, e.g., Col. 6, lines 38-63, “The coating material may comprise a matrix material which contains a plurality of contrast enhancing elements such as bubbles or microbubbles of gas or a precursor to a gas, or ultrasound-reflecting particles, for example hollow or solid particles, either uniformly or non-uniformly distributed in the matrix. The contrast enhancing elements should contribute to enhanced ultrasound visibility and detectability of the source […] The matrix material may be a polymer…”, and Col. 7, lines 1-37, “Mixtures of polymers including compatible polymers and phase separating incompatible polymers may be used in the coating materials. […] Suitable coating materials for use in the invention also include matrix materials such as a fused or melted amino acid…”, and Col. 24, lines 57-62, “FIG. 1 illustrates in schematic form a radioactive source 1 according to the invention comprising a carrier and a radioisotope encapsulated in a metal container 2, for example a titanium or stainless steel seed. The outside of the container 2 is coated with a matrix material 3 containing domains of encapsulated bubbles or particles 4”); and
forming in the body, a plurality of features that are sized and shaped that when imaged using Doppler ultrasound will generate a twinkling artifact (see, e.g., Col. 6, lines 12-15, “the outer surface of the coating may be roughened, i.e., the coating material may be other than smooth in its surface features. Such roughening may further enhance the ultrasound visibility of the source”, and Col. 6, lines 38-45, “The coating material may comprise a matrix material which contains a plurality of contrast enhancing elements such as bubbles or microbubbles of gas or a precursor to a gas, or ultrasound-reflecting particles, for example hollow or solid particles, either uniformly or non-uniformly distributed in the matrix. The contrast enhancing elements should contribute to enhanced ultrasound visibility and detectability of the source”, and Col. 16, lines 30-49, “An ultrasound contrast enhancing agent is any agent which when delivered to the treatment site serves to enhance the visibility of the radioactive source to ultrasound either alone or on reaction with a component of the coating of the source. […] the contrast enhancing agent may comprise a gas (e.g. perfluorobutane, N.sub.2 or CO.sub.2) or a gas precursor liquid such as perfluorooctylbromide which can form a gas when heated in the body. Bubbles of gas may thus be produced proximal to a source, so enhancing visibility of the source to ultrasound imaging techniques”, and Col. 30, lines 54-62, “Qualitative tests showed that the coated tubes were at least as echogenic as traditional tubes and retained that activity over a wider range of angles relative to the probe than did the polished tubes. In addition, using color doppler ultrasound mode, the presence of active microbubbles on the tube was determined by the flashing colours of bubbles breaking under the influence of the ultrasound energy…”),
wherein the plurality of features comprise at least one of internal features formed within the body (see, e.g., Col. 6, lines 38-45, “The coating material may comprise a matrix material which contains a plurality of contrast enhancing elements such as bubbles or microbubbles of gas or a precursor to a gas, or ultrasound-reflecting particles, for example hollow or solid particles, either uniformly or non-uniformly distributed in the matrix. The contrast enhancing elements should contribute to enhanced ultrasound visibility and detectability of the source”, and Col. 20, lines 47-67, “The coating and fusing steps may be repeated as required to produce a coating comprising two or more layers. During repeated coating steps, the outermost coating layer may optionally be treated one or more times at one or more locations with an etching step to create pits, bubbles or pores which may contain gas or gas precursor and which may then be over-coated with additional layer(s) of fused powder coating. Suitable etching methods include abrasion, solvent etching, and selective dissolution of part of the coating, for example dissolution of a salt from a hydrophobic or more high energy sugar coating in water. Preferably, etching of the outermost coating layer may be done after each layer is applied, up to and even including the final layer. […] the surface of the device to be coated is roughened prior to the coating step. This surface roughness may also serve to enhance the ultrasound visibility of the coated devices. In addition, a roughened exterior surface may serve to trap additional amounts of gas during the coating step”, where the gas bubbles are formed and distributed in the coating material/matrix material/polymer, such that there are internal holes/voids where the non-metallic material/polymer coating is not deposited and where the gas bubbles are formed) or external features formed in a surface of the body (see, e.g., Col. 6, lines 12-15, “the outer surface of the coating may be roughened, i.e., the coating material may be other than smooth in its surface features. Such roughening may further enhance the ultrasound visibility of the source”, and Col. 20, lines 47-67, “The coating and fusing steps may be repeated as required to produce a coating comprising two or more layers. During repeated coating steps, the outermost coating layer may optionally be treated one or more times at one or more locations with an etching step to create pits, bubbles or pores which may contain gas or gas precursor and which may then be over-coated with additional layer(s) of fused powder coating. Suitable etching methods include abrasion, solvent etching, and selective dissolution of part of the coating, for example dissolution of a salt from a hydrophobic or more high energy sugar coating in water. Preferably, etching of the outermost coating layer may be done after each layer is applied, up to and even including the final layer. […] the surface of the device to be coated is roughened prior to the coating step. This surface roughness may also serve to enhance the ultrasound visibility of the coated devices. In addition, a roughened exterior surface may serve to trap additional amounts of gas during the coating step”).
Snow does not specifically disclose wherein the body is formed using an additive manufacturing process, and wherein the at least one of the internal features or the external features are formed by using the additive manufacturing process. However, Examiner notes that Snow does disclose forming a body of a marker from a non-metallic material (i.e., a polymer), and discloses that the plurality of features (that generate a twinkling artifact when imaged) comprise at least one of internal features formed within the body (i.e., gas bubbles, pores, pits, internal holes, voids, etc.) or external features formed in a surface of the body (i.e., roughened outer surface, etc.), as set forth above.
However, in the same field of endeavor of medical devices designed to be implanted/inserted/delivered inside the human body, Imran discloses forming a body of a marker using an additive manufacturing process, wherein the plurality of features comprise at least one of internal features formed within the body by the additive manufacturing process or external features formed in a surface of the body using the additive manufacturing process (see, e.g., Para. [0033-0034], and Para. [0222], “In one or more embodiments, tissue penetrating member 140 can be fabricated from various drugs and other therapeutic agents 101, one or more pharmaceutical excipients (e.g., disintegrants, stabilizers, etc.) and one or more biodegradable polymers. […] Referring now to FIGS. 18a-18f, in many embodiments, the penetrating member 140 can be formed to have a shaft 144 and a needle tip 145 or other pointed tip 145 so as to readily penetrate tissue of the intestinal wall as shown in the embodiment of FIG. 18a. […] In particular embodiments, feature 147 may correspond to an aperture or hole 148 going partly or all other way through tissue penetrating member 140 as is shown in FIG. 18g. Hole or aperture 149 allows the ingress of tissue fluids (e.g., serosal fluids) into the interior 140i of member 140. Feature 147 may also correspond to one or more channels or grooves 149 on a surface 140s of member 140 as is shown FIGS. 18h and 18i. Channel or groove 149 enhances the surface area of member 140 available for contact with tissue fluids and thus enhances the rate of dissolution and/or degradation of the tissue penetrating member”, and Para. [0223], “Tissue penetrating member 140 will also typically include one or more tissue retaining features 143 such as a barb or hook to retain the penetrating member within the tissue of the intestinal wall IW or peritoneum after advancement. Retaining features 143 can be arranged in various patterns 143p to enhance tissue retention such as two or more barbs symmetrically or otherwise distributed around and along member shaft 144 as is shown in the embodiments of FIGS. 18a and 18b. Additionally, in many embodiments, penetrating member will also include a recess or other mating feature 146 for attachment to a coupling component”, and Para. [0229], “Tissue penetrating member 140 can be fabricated using one or more polymer and pharmaceutical fabrication techniques known in the art. For example, drug 101 (with or without biodegradable material 105) can be in solid form and then formed into the shape of the tissue penetrating member 140 using molding, compaction or other like method with one or more binding agents added. The use of 3-D printing and related fabrication methods is also contemplated”, and Fig. 18a, 18G, and/or 18H, where 3D printing is a known additive manufacturing process, and where it is disclosed that a structure/member 140 (some type of body marker or structure that is inserted into the body) is fabricated using polymer and is formed into a shape with outer apertures/features/recesses/pores/holes/voids/cavities such as the disclosed features 143, 146, 147, and/or 149, such that the shape of the member 140 (including outer features 143, 146, 147, and/or 149) can be formed via using a 3D printing/additive manufacturing process, as taught in Para. [0229]).
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 Snow by including wherein the body is formed using an additive manufacturing process, and wherein the at least one of the internal features or the external features are formed by the additive manufacturing process (i.e., substitute one manufacturing process for creating holes/voids/pores/etc. within a structure for another manufacturing process), as disclosed by Imran. One of ordinary skill in the art would have been motivated to make this modification in order to desirably form the desired outer features in the surfaces of the respective member delivered into a human body, as recognized by Imran (see, e.g., Para. [0222-0223] and [0229]).
Regarding claim 44, Snow modified by Imran discloses the method of claim 41, as set forth above. Snow further discloses wherein the internal feature comprises a void where the non-metallic material is not deposited (see, e.g., Col. 6, lines 38-45, “The coating material may comprise a matrix material which contains a plurality of contrast enhancing elements such as bubbles or microbubbles of gas or a precursor to a gas, or ultrasound-reflecting particles, for example hollow or solid particles, either uniformly or non-uniformly distributed in the matrix. The contrast enhancing elements should contribute to enhanced ultrasound visibility and detectability of the source”, and Col. 20, lines 47-67, “The coating and fusing steps may be repeated as required to produce a coating comprising two or more layers. During repeated coating steps, the outermost coating layer may optionally be treated one or more times at one or more locations with an etching step to create pits, bubbles or pores which may contain gas or gas precursor and which may then be over-coated with additional layer(s) of fused powder coating. Suitable etching methods include abrasion, solvent etching, and selective dissolution of part of the coating, for example dissolution of a salt from a hydrophobic or more high energy sugar coating in water. Preferably, etching of the outermost coating layer may be done after each layer is applied, up to and even including the final layer. […] the surface of the device to be coated is roughened prior to the coating step. This surface roughness may also serve to enhance the ultrasound visibility of the coated devices. In addition, a roughened exterior surface may serve to trap additional amounts of gas during the coating step”, where the gas bubbles are formed and distributed in the coating material/matrix material/polymer, such that there are internal holes/voids where the non-metallic material/polymer coating is not deposited and where the gas bubbles are formed).
Regarding claim 46, Snow modified by Imran discloses the method of claim 41, as set forth above. Snow further discloses wherein the external features comprise a texture formed on at least a portion of the body of the marker (see, e.g., Col. 6, lines 12-15, “the outer surface of the coating may be roughened, i.e., the coating material may be other than smooth in its surface features. Such roughening may further enhance the ultrasound visibility of the source”, and Col. 6, lines 38-45, “The coating material may comprise a matrix material which contains a plurality of contrast enhancing elements such as bubbles or microbubbles of gas or a precursor to a gas, or ultrasound-reflecting particles, for example hollow or solid particles, either uniformly or non-uniformly distributed in the matrix. The contrast enhancing elements should contribute to enhanced ultrasound visibility and detectability of the source”, and Col. 20, lines 47-67, “The coating and fusing steps may be repeated as required to produce a coating comprising two or more layers. During repeated coating steps, the outermost coating layer may optionally be treated one or more times at one or more locations with an etching step to create pits, bubbles or pores which may contain gas or gas precursor and which may then be over-coated with additional layer(s) of fused powder coating. Suitable etching methods include abrasion, solvent etching, and selective dissolution of part of the coating, for example dissolution of a salt from a hydrophobic or more high energy sugar coating in water. Preferably, etching of the outermost coating layer may be done after each layer is applied, up to and even including the final layer. […] the surface of the device to be coated is roughened prior to the coating step. This surface roughness may also serve to enhance the ultrasound visibility of the coated devices. In addition, a roughened exterior surface may serve to trap additional amounts of gas during the coating step”, and Col. 30, lines 54-62, “Qualitative tests showed that the coated tubes were at least as echogenic as traditional tubes and retained that activity over a wider range of angles relative to the probe than did the polished tubes. In addition, using color doppler ultrasound mode, the presence of active microbubbles on the tube was determined by the flashing colours of bubbles breaking under the influence of the ultrasound energy…”).
Regarding claim 47, Snow modified by Imran discloses the method of claim 46, as set forth above. Snow further discloses wherein forming the texture further comprises mechanically creating the texture using at least one of coating etching (see, e.g., Col. 6, lines 12-15, “the outer surface of the coating may be roughened, i.e., the coating material may be other than smooth in its surface features. Such roughening may further enhance the ultrasound visibility of the source”, and Col. 20, lines 47-67, “The coating and fusing steps may be repeated as required to produce a coating comprising two or more layers. During repeated coating steps, the outermost coating layer may optionally be treated one or more times at one or more locations with an etching step to create pits, bubbles or pores which may contain gas or gas precursor and which may then be over-coated with additional layer(s) of fused powder coating. Suitable etching methods include abrasion, solvent etching, and selective dissolution of part of the coating, for example dissolution of a salt from a hydrophobic or more high energy sugar coating in water. Preferably, etching of the outermost coating layer may be done after each layer is applied, up to and even including the final layer. […] the surface of the device to be coated is roughened prior to the coating step. This surface roughness may also serve to enhance the ultrasound visibility of the coated devices. In addition, a roughened exterior surface may serve to trap additional amounts of gas during the coating step”), additive manufacturing, photolithography, or a laser.
Regarding claim 48, Snow modified by Imran discloses the method of claim 41, as set forth above. Snow further discloses wherein the plurality of features comprise pores (see, e.g., Col. 6, lines 38-45, “The coating material may comprise a matrix material which contains a plurality of contrast enhancing elements such as bubbles or microbubbles of gas or a precursor to a gas, or ultrasound-reflecting particles, for example hollow or solid particles, either uniformly or non-uniformly distributed in the matrix. The contrast enhancing elements should contribute to enhanced ultrasound visibility and detectability of the source”, and Col. 20, lines 47-67, “The coating and fusing steps may be repeated as required to produce a coating comprising two or more layers. During repeated coating steps, the outermost coating layer may optionally be treated one or more times at one or more locations with an etching step to create pits, bubbles or pores which may contain gas or gas precursor and which may then be over-coated with additional layer(s) of fused powder coating. Suitable etching methods include abrasion, solvent etching, and selective dissolution of part of the coating, for example dissolution of a salt from a hydrophobic or more high energy sugar coating in water. Preferably, etching of the outermost coating layer may be done after each layer is applied, up to and even including the final layer. […] the surface of the device to be coated is roughened prior to the coating step. This surface roughness may also serve to enhance the ultrasound visibility of the coated devices. In addition, a roughened exterior surface may serve to trap additional amounts of gas during the coating step”, where the gas bubbles are formed and distributed in the coating material/matrix material/polymer, such that there are internal holes/voids where the non-metallic material/polymer coating is not deposited and where the gas bubbles are formed) having diameters between 0.5 mm and 1 mm (see, e.g., Col. 6, lines 38-48, “The coating material may comprise a matrix material which contains a plurality of contrast enhancing elements such as bubbles or microbubbles of gas or a precursor to a gas, or ultrasound-reflecting particles, for example hollow or solid particles, either uniformly or non-uniformly distributed in the matrix. The contrast enhancing elements should contribute to enhanced ultrasound visibility and detectability of the source. The contrast enhancing elements are preferably about 0.1-500 .mu.m in size (i.e. in diameter, length or width), more preferably 1-50 .mu.m and most preferably 5-10 .mu.m in size”, where it is a known conversion that 500 μm equals 0.5 mm).
Regarding claim 49, Snow modified by Imran discloses the method of claim 41, as set forth above. Snow further discloses wherein the plurality of features comprise pores (see, e.g., Col. 6, lines 38-45, “The coating material may comprise a matrix material which contains a plurality of contrast enhancing elements such as bubbles or microbubbles of gas or a precursor to a gas, or ultrasound-reflecting particles, for example hollow or solid particles, either uniformly or non-uniformly distributed in the matrix. The contrast enhancing elements should contribute to enhanced ultrasound visibility and detectability of the source”, and Col. 20, lines 47-67, “The coating and fusing steps may be repeated as required to produce a coating comprising two or more layers. During repeated coating steps, the outermost coating layer may optionally be treated one or more times at one or more locations with an etching step to create pits, bubbles or pores which may contain gas or gas precursor and which may then be over-coated with additional layer(s) of fused powder coating. Suitable etching methods include abrasion, solvent etching, and selective dissolution of part of the coating, for example dissolution of a salt from a hydrophobic or more high energy sugar coating in water. Preferably, etching of the outermost coating layer may be done after each layer is applied, up to and even including the final layer. […] the surface of the device to be coated is roughened prior to the coating step. This surface roughness may also serve to enhance the ultrasound visibility of the coated devices. In addition, a roughened exterior surface may serve to trap additional amounts of gas during the coating step”, where the gas bubbles are formed and distributed in the coating material/matrix material/polymer, such that there are internal holes/voids where the non-metallic material/polymer coating is not deposited and where the gas bubbles are formed) having diameters in the range of 1 μm to 500 μm (see, e.g., Col. 6, lines 38-48, “The coating material may comprise a matrix material which contains a plurality of contrast enhancing elements such as bubbles or microbubbles of gas or a precursor to a gas, or ultrasound-reflecting particles, for example hollow or solid particles, either uniformly or non-uniformly distributed in the matrix. The contrast enhancing elements should contribute to enhanced ultrasound visibility and detectability of the source. The contrast enhancing elements are preferably about 0.1-500 .mu.m in size (i.e. in diameter, length or width), more preferably 1-50 .mu.m and most preferably 5-10 .mu.m in size”).
Regarding claim 50, Snow modified by Imran discloses the method of claim 41, as set forth above. Snow further discloses the method further comprising embedding microspheres in the body to enhance the twinkling artifact generated by the marker (see, e.g., Col. 6, lines 12-15, “the outer surface of the coating may be roughened, i.e., the coating material may be other than smooth in its surface features. Such roughening may further enhance the ultrasound visibility of the source”, and Col. 6, lines 38-45, “The coating material may comprise a matrix material which contains a plurality of contrast enhancing elements such as bubbles or microbubbles of gas or a precursor to a gas, or ultrasound-reflecting particles, for example hollow or solid particles, either uniformly or non-uniformly distributed in the matrix. The contrast enhancing elements should contribute to enhanced ultrasound visibility and detectability of the source”, and Col. 8, lines 14-20, “Suitable contrast enhancing particles include particles of metal (for example titanium or aluminium), glass, silica, iron oxide, sand, clays, plastics such as teflon, carbon particles such as graphite, porous uniformly-sized non-aggregated particles […], hollow microcapsules or solid microspheres”, and Col. 16, lines 30-34, “An ultrasound contrast enhancing agent is any agent which when delivered to the treatment site serves to enhance the visibility of the radioactive source to ultrasound either alone or on reaction with a component of the coating of the source”, and Disclosed Claim 8, “wherein the coating comprises a matrix material and the matrix material comprises particles of metal, glass, silica, iron oxide, sand, clay, plastic, or are hollow microcapsules or solid microspheres”).
Regarding claim 51, Snow modified by Imran discloses the method of claim 50, as set forth above. Snow further discloses wherein the microspheres comprise metallic microspheres (see, e.g., Col. 8, lines 14-20, “Suitable contrast enhancing particles include particles of metal (for example titanium or aluminium), glass, silica, iron oxide, sand, clays, plastics such as teflon, carbon particles such as graphite, porous uniformly-sized non-aggregated particles […], hollow microcapsules or solid microspheres”, and Disclosed Claim 8, “wherein the coating comprises a matrix material and the matrix material comprises particles of metal, glass, silica, iron oxide, sand, clay, plastic, or are hollow microcapsules or solid microspheres”).
Regarding claim 52, Snow modified by Imran discloses the method of claim 50, as set forth above. Snow further discloses wherein the microspheres comprise polymer microspheres (see, e.g., Col. 8, lines 14-20, “Suitable contrast enhancing particles include particles of metal (for example titanium or aluminium), glass, silica, iron oxide, sand, clays, plastics such as teflon, carbon particles such as graphite, porous uniformly-sized non-aggregated particles […], hollow microcapsules or solid microspheres”, where “Teflon” is a known synthetic polymer, and Disclosed Claim 8, “wherein the coating comprises a matrix material and the matrix material comprises particles of metal, glass, silica, iron oxide, sand, clay, plastic, or are hollow microcapsules or solid microspheres”).
Regarding claim 53, Snow modified by Imran discloses the method of claim 41, as set forth above. Snow further discloses wherein the internal features comprise one or more hollow tubes formed within the body (see, e.g., Col. 6, lines 38-45, “The coating material may comprise a matrix material which contains a plurality of contrast enhancing elements such as bubbles or microbubbles of gas or a precursor to a gas, or ultrasound-reflecting particles, for example hollow or solid particles, either uniformly or non-uniformly distributed in the matrix. The contrast enhancing elements should contribute to enhanced ultrasound visibility and detectability of the source”, and Col. 20, lines 47-67, “The coating and fusing steps may be repeated as required to produce a coating comprising two or more layers. During repeated coating steps, the outermost coating layer may optionally be treated one or more times at one or more locations with an etching step to create pits, bubbles or pores which may contain gas or gas precursor and which may then be over-coated with additional layer(s) of fused powder coating. Suitable etching methods include abrasion, solvent etching, and selective dissolution of part of the coating, for example dissolution of a salt from a hydrophobic or more high energy sugar coating in water. Preferably, etching of the outermost coating layer may be done after each layer is applied, up to and even including the final layer. […] the surface of the device to be coated is roughened prior to the coating step. This surface roughness may also serve to enhance the ultrasound visibility of the coated devices. In addition, a roughened exterior surface may serve to trap additional amounts of gas during the coating step”, where the gas bubbles are formed and distributed in the coating material/matrix material/polymer, such that there are internal/hollow holes/voids/tubes where the non-metallic material/polymer coating is not deposited and where the gas bubbles are formed).
Regarding claim 54, Snow modified by Imran discloses the method of claim 53, as set forth above. Snow further discloses wherein the one or more hollow tubes are contained completely within an inner volume of the body (see, e.g., Col. 6, lines 38-45, “The coating material may comprise a matrix material which contains a plurality of contrast enhancing elements such as bubbles or microbubbles of gas or a precursor to a gas, or ultrasound-reflecting particles, for example hollow or solid particles, either uniformly or non-uniformly distributed in the matrix. The contrast enhancing elements should contribute to enhanced ultrasound visibility and detectability of the source”, and Col. 20, lines 47-67, “The coating and fusing steps may be repeated as required to produce a coating comprising two or more layers. During repeated coating steps, the outermost coating layer may optionally be treated one or more times at one or more locations with an etching step to create pits, bubbles or pores which may contain gas or gas precursor and which may then be over-coated with additional layer(s) of fused powder coating. Suitable etching methods include abrasion, solvent etching, and selective dissolution of part of the coating, for example dissolution of a salt from a hydrophobic or more high energy sugar coating in water. Preferably, etching of the outermost coating layer may be done after each layer is applied, up to and even including the final layer. […] the surface of the device to be coated is roughened prior to the coating step. This surface roughness may also serve to enhance the ultrasound visibility of the coated devices. In addition, a roughened exterior surface may serve to trap additional amounts of gas during the coating step” (emphasis added), where the gas bubbles are formed and distributed in the coating material/matrix material/polymer, such that there are internal/hollow holes/voids/tubes where the non-metallic material/polymer coating is not deposited and where the gas bubbles are formed).
Regarding claim 55, Snow modified by Imran discloses the method of claim 53, as set forth above. Snow further discloses wherein the one or more hollow tubes extend to an outer surface of the body to form an aperture at the outer surface (see, e.g., Col. 6, lines 38-45, “The coating material may comprise a matrix material which contains a plurality of contrast enhancing elements such as bubbles or microbubbles of gas or a precursor to a gas, or ultrasound-reflecting particles, for example hollow or solid particles, either uniformly or non-uniformly distributed in the matrix. The contrast enhancing elements should contribute to enhanced ultrasound visibility and detectability of the source”, and Col. 20, lines 47-67, “The coating and fusing steps may be repeated as required to produce a coating comprising two or more layers. During repeated coating steps, the outermost coating layer may optionally be treated one or more times at one or more locations with an etching step to create pits, bubbles or pores which may contain gas or gas precursor and which may then be over-coated with additional layer(s) of fused powder coating. Suitable etching methods include abrasion, solvent etching, and selective dissolution of part of the coating, for example dissolution of a salt from a hydrophobic or more high energy sugar coating in water. Preferably, etching of the outermost coating layer may be done after each layer is applied, up to and even including the final layer. […] the surface of the device to be coated is roughened prior to the coating step. This surface roughness may also serve to enhance the ultrasound visibility of the coated devices. In addition, a roughened exterior surface may serve to trap additional amounts of gas during the coating step”, where the gas bubbles are formed and distributed in the coating material/matrix material/polymer, such that there are internal/hollow holes/voids/tubes where the non-metallic material/polymer coating is not deposited and where the gas bubbles are formed).
Regarding claim 56, Snow modified by Imran discloses the method of claim 41, as set forth above. Snow further discloses wherein the external features comprise ridges formed on an outer surface of the body to create a coiled appearance (see, e.g., Col. 3, lines 51-65, “Efforts have been made to enhance the ultrasound visibility of relatively large surgical apparatus, such as surgical needles, solid stylets and cannulae by suitable treatment of their surfaces such as roughening, scoring, etching or coating. […] Sound waves that strike the grooves are diffracted or scattered as secondary wave fronts in many directions, and a percentage of those waves are detected by the ultrasound transducer. The diffraction grating is provided for use at the leading edge of a surgical instrument for insertion within a body or for use along a surface of an object the position of which is to be monitored while in the body”, and Col. 6, lines 12-15, “the outer surface of the coating may be roughened, i.e., the coating material may be other than smooth in its surface features. Such roughening may further enhance the ultrasound visibility of the source”, and Col. 17, lines 4-29, “The coating material for the radioactive sources of the invention may also be wrapped over part of the surface of the carrier. For example, a narrow strip made of Teflon.TM. or some other suitable biocompatible material with suitable acoustic properties (i.e. materials in which the speed of sound is different to that in water, or with an acoustic impedance different from that of water) may be wound around the outside of a carrier in a helical type fashion in order to introduce transverse surface irregularities. Such irregularities serve to enhance the ultrasound visibility of the source […] a helical coating of a polymer may be applied by direct polymerization of polymer or by regional crosslinking of polymer in a helical form. An irregular plastic coating might be fixed in place by glue, by melting or molding, or by designing the coating as a tightly fitting tube with a suitable pattern of wall thickness irregularities such as a helical array of grooves” (emphasis added), and Col. 20, lines 47-67, “The coating and fusing steps may be repeated as required to produce a coating comprising two or more layers. During repeated coating steps, the outermost coating layer may optionally be treated one or more times at one or more locations with an etching step to create pits, bubbles or pores which may contain gas or gas precursor and which may then be over-coated with additional layer(s) of fused powder coating. Suitable etching methods include abrasion, solvent etching, and selective dissolution of part of the coating, for example dissolution of a salt from a hydrophobic or more high energy sugar coating in water. Preferably, etching of the outermost coating layer may be done after each layer is applied, up to and even including the final layer. […] the surface of the device to be coated is roughened prior to the coating step. This surface roughness may also serve to enhance the ultrasound visibility of the coated devices. In addition, a roughened exterior surface may serve to trap additional amounts of gas during the coating step”).
Response to Arguments
Applicant's arguments, see Remarks filed 01/27/2026, have been fully considered but they are not persuasive.
Regarding Snow (US Patent 6,749,554 B1) in view of Imran (US 2019/0133937 A1, of record), Applicant argues that “The Office's rejection improperly combines Snow and Imran because Imran fails to teach or suggest the claimed limitation of "forming in the body, a plurality of features that are sized and shaped that when imaged using Doppler ultrasound will generate a twinkling artifact" using an additive manufacturing process” (see Page 5 of the Remarks filed 01/27/2026).
Examiner respectfully disagrees and emphasizes that Snow modified by Imran does disclose each and every feature as claimed in independent claim 41, as set forth above. Examiner emphasizes that:
[1] Snow discloses forming in the body, a plurality of features that are sized and shaped that when imaged using Doppler ultrasound will generate a twinkling artifact (see, e.g., Col. 6, lines 12-15, “the outer surface of the coating may be roughened, i.e., the coating material may be other than smooth in its surface features. Such roughening may further enhance the ultrasound visibility of the source”, and Col. 6, lines 38-45, “The coating material may comprise a matrix material which contains a plurality of contrast enhancing elements such as bubbles or microbubbles of gas or a precursor to a gas, or ultrasound-reflecting particles, for example hollow or solid particles, either uniformly or non-uniformly distributed in the matrix. The contrast enhancing elements should contribute to enhanced ultrasound visibility and detectability of the source”, and Col. 16, lines 30-49, “An ultrasound contrast enhancing agent is any agent which when delivered to the treatment site serves to enhance the visibility of the radioactive source to ultrasound either alone or on reaction with a component of the coating of the source. […] the contrast enhancing agent may comprise a gas (e.g. perfluorobutane, N.sub.2 or CO.sub.2) or a gas precursor liquid such as perfluorooctylbromide which can form a gas when heated in the body. Bubbles of gas may thus be produced proximal to a source, so enhancing visibility of the source to ultrasound imaging techniques”, and Col. 30, lines 54-62, “Qualitative tests showed that the coated tubes were at least as echogenic as traditional tubes and retained that activity over a wider range of angles relative to the probe than did the polished tubes. In addition, using color doppler ultrasound mode, the presence of active microbubbles on the tube was determined by the flashing colours of bubbles breaking under the influence of the ultrasound energy…”);
[2] Snow does not specifically disclose wherein the body is formed using an additive manufacturing process, and wherein the at least one of the internal features or the external features are formed by using the additive manufacturing process; however, Examiner notes that Snow does disclose forming a body of a marker from a non-metallic material (i.e., a polymer), and discloses that the plurality of features (that generate a twinkling artifact when imaged) comprise at least one of internal features formed within the body (i.e., gas bubbles, pores, pits, internal holes, voids, etc.) or external features formed in a surface of the body (i.e., roughened outer surface, etc.), as set forth above; and
[3] Snow is then modified by Imran, where Imran discloses forming a body of a marker using an additive manufacturing process, wherein the plurality of features comprise at least one of internal features formed within the body by the additive manufacturing process or external features formed in a surface of the body using the additive manufacturing process (see, e.g., Para. [0033-0034], and Para. [0222], “In one or more embodiments, tissue penetrating member 140 can be fabricated from various drugs and other therapeutic agents 101, one or more pharmaceutical excipients (e.g., disintegrants, stabilizers, etc.) and one or more biodegradable polymers. […] Referring now to FIGS. 18a-18f, in many embodiments, the penetrating member 140 can be formed to have a shaft 144 and a needle tip 145 or other pointed tip 145 so as to readily penetrate tissue of the intestinal wall as shown in the embodiment of FIG. 18a. […] In particular embodiments, feature 147 may correspond to an aperture or hole 148 going partly or all other way through tissue penetrating member 140 as is shown in FIG. 18g. Hole or aperture 149 allows the ingress of tissue fluids (e.g., serosal fluids) into the interior 140i of member 140. Feature 147 may also correspond to one or more channels or grooves 149 on a surface 140s of member 140 as is shown FIGS. 18h and 18i. Channel or groove 149 enhances the surface area of member 140 available for contact with tissue fluids and thus enhances the rate of dissolution and/or degradation of the tissue penetrating member”, and Para. [0223], “Tissue penetrating member 140 will also typically include one or more tissue retaining features 143 such as a barb or hook to retain the penetrating member within the tissue of the intestinal wall IW or peritoneum after advancement. Retaining features 143 can be arranged in various patterns 143p to enhance tissue retention such as two or more barbs symmetrically or otherwise distributed around and along member shaft 144 as is shown in the embodiments of FIGS. 18a and 18b. Additionally, in many embodiments, penetrating member will also include a recess or other mating feature 146 for attachment to a coupling component”, and Para. [0229], “Tissue penetrating member 140 can be fabricated using one or more polymer and pharmaceutical fabrication techniques known in the art. For example, drug 101 (with or without biodegradable material 105) can be in solid form and then formed into the shape of the tissue penetrating member 140 using molding, compaction or other like method with one or more binding agents added. The use of 3-D printing and related fabrication methods is also contemplated”, and Fig. 18a, 18G, and/or 18H, where 3D printing is a known additive manufacturing process, and where it is disclosed that a structure/member 140 (some type of body marker or structure that is inserted into the body) is fabricated using polymer and is formed into a shape with outer apertures/features/recesses/pores/holes/voids/cavities such as the disclosed features 143, 146, 147, and/or 149, such that the shape of the member 140 (including outer features 143, 146, 147, and/or 149) can be formed via using a 3D printing/additive manufacturing process, as taught in Para. [0229]).
Examiner emphasizes that Snow is utilized to teach forming in the body, a plurality of features that are sized and shaped that when imaged using Doppler ultrasound will generate a twinkling artifact; and that Snow is modified by Imran, where Imran is utilized to teach generally forming a body of a marker using an additive manufacturing process. Therefore, the combination of Snow modified by Imran does disclose each and every feature as claimed in independent claim 41, as set forth above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/T.D./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798
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