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 .
Status of Claims and Rejections
Claims 1, 5, 7, 10, and 21 have been amended.
Claims 4 and 9 have been cancelled.
Claims 1-3, 5, 7, 10, 12-23, and 25-28 are pending.
In light of the claim amendments, the Section 112(b) rejection has been withdrawn.
In light of the claim amendments, the double patenting rejections have been withdrawn.
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.
Claims 1-3, 5, 7, 10, 13-15, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Appl. Publ. No. 2022/0249190 A1 (hereinafter “KELLY”), U.S. Patent Publ. No. US 2017/0368330 A1 to Silay et al. (hereinafter referred to as “SILAY”), U.S. Patent Appl. Publ. No. 2014/0330123 A1 (hereinafter “MANWARING”), and International Publ. No. WO 2021/050881 A1 to Gordon (hereinafter referred to as “GORDON”) or, alternatively, U.S. Patent No. 12,076,244 B1 (hereinafter “FOLSOM”).
With respect to claim 1, KELLY teaches a sonolucent cranial reconstruction device optimized for trans-cranioplasty ultrasound. KELLY at least partially concerns “cranial procedures” that may result “indentations and an inadequate cosmetic result….” ([0007]). With respect to the phrase, “optimized for trans-cranioplasty ultrasound,” Examiner is interpreting this as a statement within the preamble that recites the purpose or intended use of the claimed invention that does not result in a structural difference. (see MPEP 2111.02, II: “During examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference…between the claimed invention and the prior art.” (emphasis added)). Nevertheless, the KELLY-MANWARING device, as explained below, provides a sonic window for viewing the brain ultrasonically.
The device includes a tubular base member and an upper wall extending across a top of the tubular base member. Figure 21 shown here illustrates a “closed cap 2800” that may “facilitate closing a hole formed in the skull, e.g. the closed cap 2800 may be retained in the skull post-surgery.” ([0138]). In a first embodiment, the closed cap 2800 may be used alone and couple “directly with the hole in the skull 200.” In a second embodiment, the closed cap 2800 couples with a port 101 shown in Figure 1. When used alone the tubular base member is taught by the cap shaft 2910. When used with the port 101, the port 101 teaches the tubular base member. In either embodiment, the closed cap 2800 also teaches an upper wall with a “lip 2912” and “closed end 2920.” ([0138]). More specifically, “[a] lip 2912 may extend laterally form a first end of the cap shaft 2910 for abutting the port 101 around the opening 110 or the skull bone 206 around the hole of the skull 200…A closed end 2920 of the cap shaft 2910 may form a cover to extend over and close the hole.” ([0138]).
KELLY also teaches the tubular base member being shaped and dimensioned for positioning within an aperture defined by a cranial defect such that bone growth is prevented within the aperture defined by the cranial defect. “[T]he closed cap 2800 may be retained in the skull post-surgery.” ([0138], see also Figure 1 showing implants within hole of skull). KELLY also teaches that the tubular base member includes an annular frame member (“cap shaft 2910”) that includes an upper surface, a lower surface (bottom edge of cap shaft 2910), an inner sidewall extending between the upper surface and the lower surface (inwardly-facing surface of cap shaft 2910), and an outer sidewall extending between the upper surface and the lower surface of the annular frame member (outwardly-facing surface of cap shaft 2910). With respect to the “upper surface,” similar to Applicant’s “upper surface 18” of the annular frame member (see Figure 3 of Applicant’s disclosure), the upper surface is taught by the surface of the cap shaft 2910 that couples to the lip 2912 (i.e., corner). KELLY also teaches that the sonolucent upper wall (lip 2912 and closed end 2920) includes an upper surface, a lower surface, and a sidewall extending between the upper surface and the lower surface. (see annotated Figure 21).
KELLY also teaches that the annular frame member defines an outer perimeter of the tubular base member. The outwardly-facing surface of the cap shaft 2910 defines an outer perimeter of the closed cap 2800. KELLY teaches that the inner sidewall extends between the upper surface and the lower surface along a cavity defined by an interior of the annular frame member. (see Figure 21 in which the cap shaft 2910 defines a cavity that is closed by the closed end 2920).
KELLY does not explicitly teach that a distance from the upper surface of the annular frame member to the lower surface of the annular frame member is 7 mm to 9 mm in order to accommodate most full thickness defects. However, KELLY does teach “the cap shaft 2910 having a length of at least a thickness of the skull bone 206 in an embodiment.” A similar shaft 102 of a port 101 described in KELLY has a length that “is selected to be at least the thickness of the skull 200 of the patient to prevent bony ingrowth into the burr hole….” ([0091]).
However, in the same field of endeavor, SILAY describes “skull replacement systems” that include an implant. (Abstract). SILAY teaches that “the average human skull thickness [is] around 7 mm.”
It would have been obvious to one skilled in the art at the time of filing to select a distance from the upper surface of the annular frame member to the lower surface of the annular frame member to be 7 mm to 9 mm in order to accommodate a thickness of a skull. One would have been motivated to select this distance because, as taught in KELLY, the annular frame member has a height that can extend a thickness of a skull and SILAY teaches that the average human skull thickness is around 7 mm. There would have been a reasonable expectation of success because implants can be manufactured to accommodate different heights, including between 7 mm to 9 mm.
Moreover, it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.” (MPEP 2144.04, IV citing Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984)). Similarly, it has also been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). In this case, it would be routine optimization for one having ordinary skill in the art to size the implant for particular individuals. As the average skull thickness is 7 mm, it is inevitable that a particular patient’s skull would require a distance from the upper surface of the annular frame member to the lower surface of the annular frame member to be 7 mm to 9 mm. (MPEP 2144.05, II).
As to the phrase, “in order to accommodate most full thickness defects,” Examiner is interpreting this limitation as a functional limitation that is inherent in the prior art. (MPEP 2114: “If an examiner concludes that a functional limitation is an inherent characteristic of the prior art, then to establish a prima case of anticipation or obviousness, the examiner should explain that the prior art structure inherently possesses the functionally defined limitations of the claimed apparatus.”). More specifically, the combination of KELLY and SILAY teaches that the tubular base member is for the purpose of a cranial reconstruction and can be within 7 mm to 9 mm.
It is also not clear that KELLY explicitly teaches that the upper wall is sonolucent (i.e., material that allows ultrasound to pass through). However, KELLY does teach that the device 100 (shown above in Figure 1) “may include one or more guides that can be inserted and attached to the port providing the ability to secure instruments including…ultrasound probes…” ([0104]) and that “[i]n various embodiments, the plug 108 may be suitable to transmit light, electromagnetic or other radiation, ultrasound and/or electrical fields.” (emphasis added) ([0115]).
In the same field of endeavor, MANWARING teaches “implantable sonic windows.” (Title). For example, “the opening in the cranium can be closed with an implantable sonic window that provides protection to the brain and prevents deformation of the brain due to pressure changes but that also permits ultrasonic waves to freely pass into and out from the brain.” ([0023]). The material of the sonic window is a “porous sonically translucent material…, such as polyethylene, polystyrene, acrylic, or poly(methyl methacrylate) (PMMA).” ([0025]). The sonic windows may be “unitarily formed from a single piece of material,” ([0025]), or may have different materials. (see, e.g., materials 84 and 86 described in [0031]).
The sonic window 50 (Figures 3A and 3B) and the sonic window 70 (Figure 4B) are shown above. “[T]he sonic window 30 generally comprises a planar body 32 that is made of a sonically translucent polymeric material and that defines a peripheral portion 34 and a central portion 36. The peripheral portion 34 comprises multiple edges 38 and the central portion 36 comprises multiple edges 40.” ([0029]). The sonic window 70 has a similar construction but is made with two different materials 84, 86. ([0031]).
It would have been obvious to one skilled in the art to manufacture the closed cap 2800 of KELLY with a “sonically translucent polymeric material” as taught in MANWARING. One would be motivated to use the sonolucent material to allow ultrasound imaging through the material as taught in MANWARING ([0023]) and KELLY ([0104], [0115]). There would have been a reasonable expectation of success as MANWARING teaches that implants having a similar shape to those described in KELLY may be manufactured using a sonolucent material.
KELLY does not explicitly teach that a space defined by the cavity is filled with a highly ultrasound transmissive fluid, gel, or other material to enhance or otherwise control passage of ultrasound waves through the cranial reconstruction device.
In the same field of endeavor, GORDON teaches a cranial implant that includes “one or more sonolucent materials that permit transmission of mechanical waves through the sonolucent materials when the static cranial implant device is subgaleally implanted.” (Abstract). Like KELLY, the cranial implant may be inserted after making a bone flap during surgical procedure. “FIGS. 1A and 1 B schematically show the insertion of skull bone flap 104, which includes cranial implant device 105 implanted in a burr-hole 101 disposed through skull bone flap 104.” ([083]). GORDON teaches that the cranial implants may have “at least one adjustable or fixed external lens element configured to further focus the mechanical waves transmitted through the sonolucent material….” (emphasis added) ([016]). These lens elements “permit and/or enhance transcranial therapeutic ultrasound, diagnostic ultrasound, photoacoustic imaging, electromagnetic wave diagnostic imaging or electromagnetic wave therapeutic intervention.” ([082]).
Notably, the lens element comprise a sonolucent material and can be interchangeable with other lens elements. “The sonolucent materials typically form, and/or comprise, at least one lens element. The lens elements of in the cranial implant devices disclosed herein include various embodiments. In some embodiments, a focal point of the lens element is adjustable. In certain embodiments, the lens element is interchangeable with another lens element.” ([025]).
It would have been obvious to one skilled in the art at the time of invention to include a highly ultrasound transmissive fluid, gel, or other material (e.g., lens element) within a space defined by the cavity as taught in GORDON. One would have been motivated to position a lens element within the cavity of KELLY’s cap shaft to enhance or otherwise control passage of ultrasound waves through the cranial reconstruction device. There would have been a reasonable expectation of success because the cavity in KELLY can receive a lens element.
Alternatively, FOLSOM teaches a sonic window implant that is inserted into a hole of the cranium. (Abstract). “Sutures in the sonic window tent the dura mater to the bottom interior surface…The implant allows the use of ultrasound for imaging, diagnosis, and intraoperative treatment of the brain and allows ultrasound to be combined with pre-operative imaging from CT, MRI, PET, MEG, or EEG.” (Abstract).
FOLSOM teaches that “[i]mplanting the sonic window implant device includes forming a recessed bone ledge at a top of the cranial opening to engage the ledge of the sonic window implant device. The sonic window implant device is inserted into the cranial opening to the level of the dura mater and the ledge of the sonic window implant device is fastened to the recessed bone ledge. Any gap that forms between the bottom interior surface of the sonic window and the dura mater is filled with an ultrasound conductive liquid or gel.” (Col. 3, lines 54-62). “An implant, in order to enable sonic transmission, must enable direct contact to the subjacent dura mater or have a space which can be filled with ultrasound conductive fluid such as saline or conductive gel. For example, a gap between the inner mirror surface and dura which entraps air at time of placement in surgery will not be useful for ultrasound in either diagnostic or therapeutic modalities due to the severe attenuation.” (Col. 6, lines 17-24).
It would have been obvious to one skilled in the art at the time of invention to include a highly ultrasound transmissive fluid, gel, or other material within a space defined by the cavity as taught in FOLSOM. One would have been motivated to fill the cavity with an ultrasound-transmissive gel in order to enable sonic transmission and reduce attenuation, as taught in FOLSOM. There would have been a reasonable expectation of success because the cavity in KELLY can be filled with an ultrasound-transmissive gel.
With respect to claim 2, KELLY teaches that the tubular base member extends a thickness of a cranium to mechanically prevent bone remodeling in the cranial defect, thereby preserving acoustic pass-through. KELLY teaches that “the cap shaft 2910 [has] a length of at least a thickness of the skull bone 206 in an embodiment.” A similar shaft 102 of a port 101 described in KELLY has a length that “is selected to be at least the thickness of the skull 200 of the patient to prevent bony ingrowth into the burr hole….” ([0091]).
With respect to claim 3, KELLY teaches that the tubular base member is formed with a cross sectional profile selected from the group consisting of cylindrical, square, rectangular, oval, and polyhedral. As shown in Figure 21, the cap shaft 2910 has a cylindrical profile.
With respect to claim 5, KELLY teaches that the inner sidewall and the outer sidewall define consistent and continuous diameters. (see Figure 21 in which the cap shaft 2910 has a wall of uniform thickness such that the inner and outer sidewalls define consistent and continuous diameters).
With respect to claim 7, KELLY teaches that the sonolucent upper wall is coextensive with the upper surface of the annular frame member such that the sonolucent upper wall and the inner sidewall define a cavity of the cranial reconstruction device. With respect to the upper wall and the upper surface being “coextensive,” the upper surface is taught by the surface of the cap shaft 2910 that couples to the lip 2912 and the closed end 2920. Like Applicant’s upper surface 18 (shown in Figure 3 and described at [0058] of Applicant’s disclosure), the upper surface of KELLY is coextensive with the upper wall of KELLY defined by the lip 2912 and the closed end 2920.
With respect to claim 10, KELLY does not explicitly teach a lensing window [that] is integrated into the cavity of the tubular base member to manipulate or alter ultrasound wave.
However, in the same field of endeavor, GORDON teaches a cranial implant that includes “one or more sonolucent materials that permit transmission of mechanical waves through the sonolucent materials when the static cranial implant device is subgaleally implanted.” (Abstract). In some configurations, GORDON teaches cranial implants with “at least one adjustable or fixed external lens element configured to further focus the mechanical waves transmitted through the sonolucent material….” ([016]). These lens elements “permit and/or enhance transcranial therapeutic ultrasound, diagnostic ultrasound, photoacoustic imaging, electromagnetic wave diagnostic imaging or electromagnetic wave therapeutic intervention.” ([082]). “In certain of these embodiments, cranial implant housing 202 and lens element 206 are fabricated as an integral component (e.g., as an integrally molded part, etc.).” ([084]).
It would have been obvious to one skilled in the art at the time of invention to insert a lens element, as taught in GORDON, into the cavity of KELLY’s cap shaft. One would have been motivated to insert the lens element because the lens element can enhance transcranial therapeutic ultrasound, diagnostic ultrasound, and photoacoustic imaging as taught in GORDON. ([082]). There would have been a reasonable expectation of success because the cavity in KELLY can receive a lens element.
With respect to claim 13, KELLY teaches that the sonolucent upper wall is further provided with outwardly extending tab members coextensive with the sonolucent upper wall. In KELLY, the embodiment of the closed cap 2800 shown in Figure 21 is described as a cover for a bone flap. “Thus, the cap 2800 forms a cover from which projects shaft 2910, the shafts 2910 for instance projecting perpendicularly from a plane of the cover. The cover therefore defines a closed end 2920 that may be an embodiment of the plate (bone flap 508).” (See prior figure, Figure 20A illustrating bone flap 508). Notably, “[i]n such embodiments, the cover is in unitary construction. The cap 2800 has the shaft 2910 selected in dimension as a function of the burr hole or skull opening. The shaft 2910 therefore serves a cetering function by causing the fastener holes circumferentially distributed in the lip 2912 or equivalent connector(s) (e.g., tabs) to be spaced sufficiently from the periphery of the skull opening.” ([0139]). As to the meaning of equivalent connector or tabs, KELLY teaches earlier in the document that a lip 104, which is similar in design and purpose to the lip 2912, may instead by “one or more laterally projecting tabs.” ([0086]).
With respect to claim 14, KELLY teaches that wherein the tubular base member and the sonolucent upper wall are integrally formed. In describing that the closed cap 2800 can be used as a cover for covering a hole in the skull, KELLY further describes “[i]n such embodiments, the cover is in unitary construction.” ([0139]).
With respect to claim 15, KELLY does not explicitly wherein the tubular base member and the sonolucent upper wall are manufactured from sonolucent poly (methyl methacrylate) (PMMA). However, both KELLY and MANWARING teach that the device may be unitarily formed (e.g., [0139] and [0025], respectively). Moreover, MANWARING teaches that the single piece of material to unitarily form the device may be “a polymeric material, such as polyethylene, polystyrene, acrylic, or poly(methyl methacrylate) (PMMA).” (emphasis added) ([0025]).
It would have been obvious to one skilled in the art to select PMMA as the material to unitarily form the device and also provide its sonolucent properties. As previously discussed with respect to claim 1, one skilled in the art would form the device using a sonolucent material to allow ultrasound imaging through the material as taught in MANWARING ([0023]) and KELLY ([0104], [0115]). One of the few materials taught in MANWARING as being both sonolucent and capable of forming a cranial implant is PMMA. There would have been a reasonable expectation of success as MANWARING teaches that implants having a similar shape to those described in KELLY may be manufactured using PMMA.
With respect to claim 20, KELLY does not explicitly teach further including an ultrasound transducer. However, MANWARING teaches using an ultrasound probe while the cranial implant is positioned within a patient’s skull. (see Figures 9 and 10 and [0037]). “[T]he tip of an ultrasound probe P can be positioned at the sonic window 170 after it has been implanted (and after the scalp has been closed) to transmit ultrasonic radiation UR through the window and into the brain.” ([0037]).
It would have been obvious to one skilled in the art to include an ultrasound transducer with the cranial reconstruction device. As discussed above, with respect to claim 1, one skilled in the art would form the device using a sonolucent material to allow ultrasound imaging through the material as taught in MANWARING ([0023]) and KELLY ([0104], [0115]). It naturally follows that it would be necessary to provide an ultrasound probe with the cranial reconstruction device in order to complete the ultrasound imaging. There would have been a reasonable expectation of success as MANWARING teaches that such implants may be used with ultrasound probes.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Appl. Publ. No. 2022/0249190 A1 (hereinafter “KELLY”), U.S. Patent Publ. No. US 2017/0368330 A1 to Silay et al. (hereinafter referred to as “SILAY”), U.S. Patent Appl. Publ. No. 2014/0330123 A1 (hereinafter “MANWARING”), and International Publ. No. WO 2021/050881 A1 to Gordon (hereinafter referred to as “GORDON”) or, alternatively, U.S. Patent No. 12,076,244 B1 (hereinafter “FOLSOM”) as applied to claim 1 above, and further in view of U.S. Patent Appl. Publ. No. 2020/0197180 A1 (hereinafter “CHRISTOPHER ‘180”).
With respect to claim 12, the cited art does not teach that the sidewall of the sonolucent upper wall is tapered inwardly along a lower portion thereof such that a diameter of the sidewall decreases as it extends from the upper surface toward the lower surface of the sonolucent upper wall.
However, in the same field of endeavor, CHRISTOPHER ‘180 teaches reconstructive cranial implants 110, 210. (Title, Abstract, and [0034]). “The implant body 112, 212 may take a variety of forms and are most commonly shaped and dimensioned for integration into the structure of a patient's skull; that is, the implant body 112, 212 has a geometry that substantially conforms to a resected portion of the patient's anatomy to which the implant is to be secured.” Notably, “the peripheral edge 112p, 212p” of the implant bodies 112, 212, respectively, have “a substantial taper for resting upon a matching taper formed along the skull.” ([0034]).
As such, CHRISTOPHER ‘180 teaches that the sidewall of the sonolucent upper wall is tapered inwardly along a lower portion thereof such that a diameter of the sidewall decreases as it extends from the upper surface toward the lower surface of the sonolucent upper wall in order to better match the resected portion of the patient’s skull.
It would have been obvious to one skilled in the art to provide a sidewall that is tapered as recited in claim 12. One would have been motivated to design the sidewall in this manner in order to better match a resected portion of a patient’s skull, as taught in CHRISTOPHER ‘180. (see, e.g., [0034]). There would have been a reasonable expectation of success as CHRISTOPHER ‘180 teaches implants with tapered sidewalls can be effectively used as skull implants.
Claims 1, 16, 17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Appl. Publ. No. 2022/0249190 A1 (hereinafter “KELLY”), U.S. Patent Publ. No. US 2017/0368330 A1 to Silay et al. (hereinafter referred to as “SILAY”), U.S. Patent Appl. Publ. No. 2014/0330123 A1 (hereinafter “MANWARING”), and International Publ. No. WO 2021/050881 A1 to Gordon (hereinafter referred to as “GORDON”) or, alternatively, U.S. Patent No. 12,076,244 B1 (hereinafter “FOLSOM”). NOTE: Compared to the other rejection of claim 1, this rejection is based on a modified embodiment of KELLY.
With respect to claim 1, KELLY teaches a sonolucent cranial reconstruction device optimized for trans-cranioplasty ultrasound. KELLY at least partially concerns “cranial procedures” that may result “indentations and an inadequate cosmetic result….” ([0007]). With respect to the phrase, “optimized for trans-cranioplasty ultrasound,” Examiner is interpreting this as a statement within the preamble that recites the purpose or intended use of the claimed invention that does not result in a structural difference. (see MPEP 2111.02, II: “During examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference…between the claimed invention and the prior art.” (emphasis added)).
The device includes a tubular base member and an upper wall extending across a top of the tubular base member. Figure 21 shown here illustrates a “closed cap 2800” that may “facilitate closing a hole formed in the skull, e.g. the closed cap 2800 may be retained in the skull post-surgery.” ([0138]). In an alternative embodiment, the closed cap 2800 couples with a port 101 shown in Figure 1. When used with the port 101, the port 101 teaches the tubular base member. The closed cap 2800 also teaches an upper wall with a “lip 2912” and “closed end 2920.” ([0138]). More specifically, “[a] lip 2912 may extend laterally form a first end of the cap shaft 2910 for abutting the port 101 around the opening 110 or the skull bone 206 around the hole of the skull 200…A closed end 2920 of the cap shaft 2910 may form a cover to extend over and close the hole.” ([0138]).
An annotated figure is shown above that is based on a portion of Figure 8 and the description of the closed cap 2800 in [0138]. KELLY teaches the tubular base member being shaped and dimensioned for positioning within an aperture defined by a cranial defect such that bone growth is prevented within the aperture defined by the cranial defect. “[T]he closed cap 2800 may be retained in the skull post-surgery.” ([0138], see also above showing within hole of skull). KELLY also teaches that the tubular base member includes an annular frame member (in the alternative embodiment, the annular frame member is taught by “port 101”) that includes an upper surface (top surface of port 101), a lower surface (bottom edge of port 101), an inner sidewall extending between the upper surface and the lower surface (inwardly-facing surface of port 101), and an outer sidewall extending between the upper surface and the lower surface of the annular frame member (outwardly-facing surface of port 101). KELLY also teaches that the sonolucent upper wall (closed cap 2800) includes an upper surface, a lower surface, and a sidewall extending between the upper surface and the lower surface. (see annotated figure above).
KELLY also teaches that the annular frame member defines an outer perimeter of the tubular base member. The outwardly-facing surface of the cap shaft 2910 defines an outer perimeter of the closed cap 2800. KELLY teaches that the inner sidewall extends between the upper surface and the lower surface along a cavity defined by an interior of the annular frame member. (see Figure 21 in which the cap shaft 2910 defines a cavity that is closed by the closed end 2920).
KELLY does not explicitly teach that the a distance from the upper surface of the annular frame member to the lower surface of the annular frame member is 7 mm to 9 mm in order to accommodate most full thickness defects. However, KELLY does teach “the cap shaft 2910 having a length of at least a thickness of the skull bone 206 in an embodiment.” A similar shaft 102 of a port 101 described in KELLY has a length that “is selected to be at least the thickness of the skull 200 of the patient to prevent bony ingrowth into the burr hole….” ([0091]).
However, in the same field of endeavor, SILAY describes “skull replacement systems” that include an implant. (Abstract). SILAY teaches that “the average human skull thickness [is] around 7 mm.”
It would have been obvious to one skilled in the art at the time of filing to select a distance from the upper surface of the annular frame member to the lower surface of the annular frame member to be 7 mm to 9 mm in order to accommodate a thickness of a skull. One would have been motivated to select this distance because, as taught in KELLY, the annular frame member has a height that can extend a thickness of a skull and SILAY teaches that the average human skull thickness is around 7 mm. There would have been a reasonable expectation of success because implants can be manufactured to accommodate different heights, including between 7 mm to 9 mm.
It is also not clear that KELLY explicitly teaches that the upper wall is sonolucent (i.e., material that allows ultrasound to pass through). However, KELLY does teach that the device 100 (shown above in Figure 1) “may include one or more guides that can be inserted and attached to the port providing the ability to secure instruments including…ultrasound probes…” ([0104]) and that “[i]n various embodiments, the plug 108 may be suitable to transmit light, electromagnetic or other radiation, ultrasound and/or electrical fields.” (emphasis added) ([0115]).
In the same field of endeavor, MANWARING teaches “implantable sonic windows.” (Title). For example, “the opening in the cranium can be closed with an implantable sonic window that provides protection to the brain and prevents deformation of the brain due to pressure changes but that also permits ultrasonic waves to freely pass into and out from the brain.” ([0023]). The material of the sonic window is a “porous sonically translucent material…, such as polyethylene, polystyrene, acrylic, or poly(methyl methacrylate) (PMMA).” ([0025]). The sonic windows may be “unitarily formed from a single piece of material,” ([0025]), or may have different materials. (see, e.g., materials 84 and 86 described in [0031]).
The sonic window 50 (Figures 3A and 3B) and the sonic window 70 (Figure 4B) are shown above. “[T]he sonic window 30 generally comprises a planar body 32 that is made of a sonically translucent polymeric material and that defines a peripheral portion 34 and a central portion 36. The peripheral portion 34 comprises multiple edges 38 and the central portion 36 comprises multiple edges 40.” ([0029]). The sonic window 70 has a similar construction but is made with two different materials 84, 86. ([0031]).
It would have been obvious to one skilled in the art to manufacture the closed cap 2800 of KELLY with a “sonically translucent polymeric material” as taught in MANWARING. One would be motivated to use the sonolucent material to allow ultrasound imaging through the material as taught in MANWARING ([0023]) and KELLY ([0104], [0115]). There would have been a reasonable expectation of success as MANWARING teaches that implants having a similar shape to those described in KELLY may be manufactured using a sonolucent material.
KELLY does not explicitly teach that a space defined by the cavity is filled with a highly ultrasound transmissive fluid, gel, or other material to enhance or otherwise control passage of ultrasound waves through the cranial reconstruction device.
In the same field of endeavor, GORDON teaches a cranial implant that includes “one or more sonolucent materials that permit transmission of mechanical waves through the sonolucent materials when the static cranial implant device is subgaleally implanted.” (Abstract). Like KELLY, the cranial implant may be inserted after making a bone flap during surgical procedure. “FIGS. 1A and 1 B schematically show the insertion of skull bone flap 104, which includes cranial implant device 105 implanted in a burr- hole 101 disposed through skull bone flap 104.” ([083]). GORDON teaches that the cranial implants may have “at least one adjustable or fixed external lens element configured to further focus the mechanical waves transmitted through the sonolucent material….” (emphasis added) ([016]). These lens elements “permit and/or enhance transcranial therapeutic ultrasound, diagnostic ultrasound, photoacoustic imaging, electromagnetic wave diagnostic imaging or electromagnetic wave therapeutic intervention.” ([082]).
Notably, the lens element comprise a sonolucent material and can be interchangeable with other lens elements. “The sonolucent materials typically form, and/or comprise, at least one lens element. The lens elements of in the cranial implant devices disclosed herein include various embodiments. In some embodiments, a focal point of the lens element is adjustable. In certain embodiments, the lens element is interchangeable with another lens element.” ([025]).
It would have been obvious to one skilled in the art at the time of invention to include a highly ultrasound transmissive fluid, gel, or other material (e.g., lens element) within a space defined by the cavity as taught in GORDON. One would have been motivated to position a lens element within the cavity of KELLY’s cap shaft to enhance or otherwise control passage of ultrasound waves through the cranial reconstruction device. There would have been a reasonable expectation of success because the cavity in KELLY can receive a lens element.
Alternatively, FOLSOM teaches a sonic window implant that is inserted into a hole of the cranium. (Abstract). “Sutures in the sonic window tent the dura mater to the bottom interior surface…The implant allows the use of ultrasound for imaging, diagnosis, and intraoperative treatment of the brain and allows ultrasound to be combined with pre-operative imaging from CT, MRI, PET, MEG, or EEG.” (Abstract).
FOLSOM teaches that “[i]mplanting the sonic window implant device includes forming a recessed bone ledge at a top of the cranial opening to engage the ledge of the sonic window implant device. The sonic window implant device is inserted into the cranial opening to the level of the dura mater and the ledge of the sonic window implant device is fastened to the recessed bone ledge. Any gap that forms between the bottom interior surface of the sonic window and the dura mater is filled with an ultrasound conductive liquid or gel.” (Col. 3, lines 54-62). “An implant, in order to enable sonic transmission, must enable direct contact to the subjacent dura mater or have a space which can be filled with ultrasound conductive fluid such as saline or conductive gel. For example, a gap between the inner mirror surface and dura which entraps air at time of placement in surgery will not be useful for ultrasound in either diagnostic or therapeutic modalities due to the severe attenuation.” (Col. 6, lines 17-24).
It would have been obvious to one skilled in the art at the time of invention to include a highly ultrasound transmissive fluid, gel, or other material within a space defined by the cavity as taught in FOLSOM. One would have been motivated to fill the cavity with an ultrasound-transmissive gel in order to enable sonic transmission and reduce attenuation, as taught in FOLSOM. There would have been a reasonable expectation of success because the cavity in KELLY can be filled with an ultrasound-transmissive gel.
With respect to claim 16, KELLY teaches wherein the sonolucent upper wall and the tubular base member are distinct pieces that are selectively assembled and/or disassembled As taught in KELLY, “[t]he closed cap 2800 may couple with the port 101…” as opposed to “directly” coupling with the skull. ([0138]).
With respect to claim 17, KELLY does not teach wherein the tubular base member and the sonolucent upper wall are formed from different materials offering optimal physical characteristics for their intended purposes.
However, MANWARING teaches that, unlike an earlier embodiment, “at least part of the central portion 76 is made of a lower-density, higher-porosity material 84 through which ultrasound waves can easily pass while the peripheral portion 74 is made of a high-density, lower-porosity material 86 through which ultrasound waves cannot easily pass but that is stronger than the higher-porosity material. In some embodiments, the material 84 of the central portion 76 is a polymeric material such polyethylene, polystyrene, acrylic, or PMMA while the material 86 of the peripheral portion 74 is made of silicone, polyoxymethylene (POM), high grade polytetrafluoroethylene (PTFE), or a biocompatible metal, such as titanium or stainless steel.” ([0031]).
As to the phrase, “offering optimal physical characteristics for their intended purposes,” Examiner is interpreting this limitation as a functional limitation that is inherent in the prior art. (MPEP 2114: “If an examiner concludes that a functional limitation is an inherent characteristic of the prior art, then to establish a prima case of anticipation or obviousness, the examiner should explain that the prior art structure inherently possesses the functionally defined limitations of the claimed apparatus.”). More specifically, MANWARING teaches that the tubular base member and the upper wall may be formed from different materials in which one is better for ultrasound and the other is stronger for supporting the ultrasound-transmissive material.
It would have been obvious to one skilled in the art to manufacture the closed cap and the port of KELLY using different materials because the two elements could serve different purposes. The closed cap provides the sonic window that enables ultrasound imaging and therefore should comprise a material that is more suitable for ultrasound. On the other hand, the port supports the closed cap and is also designed to prevent bony ingrowth and therefore should comprise a stronger material. There would have been a reasonable expectation of success as MANWARING teaches that different materials can be used.
With respect to claim 19, KELLY does not teach wherein the sonolucent upper wall is made of PMMA.
However, MANWARING teaches that, unlike an earlier embodiment, “at least part of the central portion 76 is made of a lower-density, higher-porosity material 84 through which ultrasound waves can easily pass while the peripheral portion 74 is made of a high-density, lower-porosity material 86 through which ultrasound waves cannot easily pass but that is stronger than the higher-porosity material. In some embodiments, the material 84 of the central portion 76 is a polymeric material such polyethylene, polystyrene, acrylic, or PMMA while the material 86 of the peripheral portion 74 is made of silicone, polyoxymethylene (POM), high grade polytetrafluoroethylene (PTFE), or a biocompatible metal, such as titanium or stainless steel.” ([0031]).
It would have been obvious to one skilled in the art to select PMMA as the material to provide the sonic window. As previously discussed with respect to claim 1, one skilled in the art would form the device using a sonolucent material to allow ultrasound imaging through the material as taught in MANWARING ([0023]) and KELLY ([0104], [0115]). One of the few materials taught in MANWARING as being both sonolucent and capable of forming a cranial implant is PMMA. There would have been a reasonable expectation of success as MANWARING teaches that implants having a similar shape to those described in KELLY may be manufactured using PMMA.
Claims 18 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Appl. Publ. No. 2022/0249190 A1 (hereinafter “KELLY”), U.S. Patent Publ. No. US 2017/0368330 A1 to Silay et al. (hereinafter referred to as “SILAY”), U.S. Patent Appl. Publ. No. 2014/0330123 A1 (hereinafter “MANWARING”), and International Publ. No. WO 2021/050881 A1 to Gordon (hereinafter referred to as “GORDON”) or, alternatively, U.S. Patent No. 12,076,244 B1 (hereinafter “FOLSOM”) as applied to claim 17, and further in view of U.S. Patent Appl. Publ. No. 2019/0209328 A1 to CHRISTOPHER et al. (hereinafter referred to as “CHRISTOPHER ’328”).
CHRISTOPHER ‘328 teaches low-profile intercranial assemblies that include a mounting plate and a cranial implant. The different possible materials for the mounting plate 12 [tubular base member] and for the static cranial implant 16 [sonolucent upper wall] (see, e.g., [0059] and [0064]). The list of materials are identical: “clear and/or opaque PMMA (Poly(methyl methacrylate)), PEEK (Polyether ether ketone), PEKK (Polyetherketoneketone), porous polyethylene, titanium alloy, allograft, autograft, xenograft, and/or various other tissue-engineered constructs.” (emphasis added) (Id.).
It would have been obvious to one having ordinary skill in the art at the time of invention to select different materials that provide optimal physical characteristics for their intended purposes for the mounting plate and the static cranial implant, and, more particularly, to select porous polyethylene for the tubular base member. As taught in CHRISTOPHER ‘328, the mounting plate and the static cranial implant may be optimized based on various parameters ([0054], [0058], [0062]). One material repeatedly suggested for the mounting plate is porous polyethylene. ([0013], [0059]). There would be a reasonable expectation of success because, as taught by CHRISTOPHER ‘328, the different materials can be successfully used to create an implant.
Claims 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Appl. Publ. No. 2022/0249190 A1 (hereinafter “KELLY”), U.S. Patent Publ. No. US 2017/0368330 A1 to Silay et al. (hereinafter referred to as “SILAY”), U.S. Patent Appl. Publ. No. 2014/0330123 A1 (hereinafter “MANWARING”), and International Publ. No. WO 2021/050881 A1 to Gordon (hereinafter referred to as “GORDON”) or, alternatively, U.S. Patent No. 12,076,244 B1 (hereinafter “FOLSOM”).
With respect to claim 21, KELLY teaches a method for preventing bone growth within a cranial defect (see, e.g., Abstract: “Apparatus for providing repeated cranial access.”). The method includes forming a cranial defect (see, e.g., [0126]: “Burr holes 506 have been drilled into the skull to allow the surgeon to cut a bone flap 508, which is removed to get access to the brain”) and implanting a cranial reconstruction device within the cranial defect such that the cranial reconstruction device covers the entire internal surface of the cranial defect (see, e.g., Figures 13A-13B and [0126]: “[B]one flap 508 may be fixed in place by inserting a device 100 into each of the burr holes 506, and securing the devices 100 to the skull bone 206 with screws 106…The insertion of device 100 into the central hole 510 in the bone flap 508 permits direct access to the brain of the patient post-surgery….”; see also Figure 2 in which the cranial reconstruction device covers the entire internal surface of the cranial defect).
KELLY also teaches that the cranial reconstruction device includes a tubular base member and a sonolucent upper wall extending across a top of the tubular base member. Figure 21 shown here illustrates a “closed cap 2800” that may “facilitate closing a hole formed in the skull, e.g. the closed cap 2800 may be retained in the skull post-surgery.” ([0138]). In a first embodiment, he closed cap 2800 may be used alone and couple “directly with the hole in the skull 200.” In a second embodiment, the closed cap 2800 couples with a port 101 shown in Figure 1. When used alone the tubular base member is taught by the cap shaft 2910. When used with the port 101, the port 101 teaches the tubular base member. In either embodiment, the closed cap 2800 also teaches an upper wall with a “lip 2912” and “closed end 2920.” ([0138]). More specifically, “[a] lip 2912 may extend laterally form a first end of the cap shaft 2910 for abutting the port 101 around the opening 110 or the skull bone 206 around the hole of the skull 200…A closed end 2920 of the cap shaft 2910 may form a cover to extend over and close the hole.” ([0138]).
KELLY also teaches the tubular base member being shaped and dimensioned for positioning within an aperture defined by a cranial defect such that bone growth is prevented within the aperture defined by the cranial defect. “[T]he closed cap 2800 may be retained in the skull post-surgery.” ([0138], see also Figure 1 showing implants within hole of skull). KELLY also teaches that the tubular base member includes an annular frame member (“cap shaft 2910”) that includes an upper surface, a lower surface (bottom edge of cap shaft 2910), an inner sidewall extending between the upper surface and the lower surface (inwardly-facing surface of cap shaft 2910), and an outer sidewall extending between the upper surface and the lower surface of the annular frame member (outwardly-facing surface of cap shaft 2910). With respect to the “upper surface,” similar to Applicant’s “upper surface 18” of the annular frame member (see Figure 3 of Applicant’s disclosure), the upper surface is taught by the surface of the cap shaft 2910 that couples to the lip 2912 (i.e., corner). KELLY also teaches that the sonolucent upper wall (lip 2912 and closed end 2920) includes an upper surface, a lower surface, and a sidewall extending between the upper surface and the lower surface. (see annotated Figure 21).
KELLY does not explicitly teach that the a distance from the upper surface of the annular frame member to the lower surface of the annular frame member is 7 mm to 9 mm in order to accommodate most full thickness defects. However, KELLY does teach “the cap shaft 2910 having a length of at least a thickness of the skull bone 206 in an embodiment.” A similar shaft 102 of a port 101 described in KELLY has a length that “is selected to be at least the thickness of the skull 200 of the patient to prevent bony ingrowth into the burr hole….” ([0091]).
However, in the same field of endeavor, SILAY describes “skull replacement systems” that include an implant. (Abstract). SILAY teaches that “the average human skull thickness [is] around 7 mm.”
It would have been obvious to one skilled in the art at the time of filing to select a distance from the upper surface of the annular frame member to the lower surface of the annular frame member to be 7 mm to 9 mm in order to accommodate a thickness of a skull. One would have been motivated to select this distance because, as taught in KELLY, the annular frame member has a height that can extend a thickness of a skull and SILAY teaches that the average human skull thickness is around 7 mm. There would have been a reasonable expectation of success because implants can be manufactured to accommodate different heights, including between 7 mm to 9 mm.
Moreover, it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.” (MPEP 2144.04, IV citing Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984)). Similarly, it has also been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). In this case, it would be routine optimization for one having ordinary skill in the art to size the implant for particular individuals. As the average skull thickness is 7 mm, it is inevitable that a particular patient’s skull would require a distance from the upper surface of the annular frame member to the lower surface of the annular frame member to be 7 mm to 9 mm. (MPEP 2144.05, II).
As to the phrase, “in order to accommodate most full thickness defects,” Examiner is interpreting this limitation as a functional limitation that is inherent in the prior art. (MPEP 2114: “If an examiner concludes that a functional limitation is an inherent characteristic of the prior art, then to establish a prima case of anticipation or obviousness, the examiner should explain that the prior art structure inherently possesses the functionally defined limitations of the claimed apparatus.”). More specifically, the combination of KELLY and SILAY teaches that the tubular base member is for the purpose of a cranial reconstruction and can be within 7 mm to 9 mm.
It is also not clear that KELLY explicitly teaches that the upper wall is sonolucent (i.e., material that allows ultrasound to pass through). However, KELLY does teach that the device 100 (shown above in Figure 1) “may include one or more guides that can be inserted and attached to the port providing the ability to secure instruments including…ultrasound probes…” ([0104]) and that “[i]n various embodiments, the plug 108 may be suitable to transmit light, electromagnetic or other radiation, ultrasound and/or electrical fields.” (emphasis added) ([0115]).
In the same field of endeavor, MANWARING teaches “implantable sonic windows.” (Title). For example, “the opening in the cranium can be closed with an implantable sonic window that provides protection to the brain and prevents deformation of the brain due to pressure changes but that also permits ultrasonic waves to freely pass into and out from the brain.” ([0023]). The material of the sonic window is a “porous sonically translucent material…, such as polyethylene, polystyrene, acrylic, or poly(methyl methacrylate) (PMMA).” ([0025]). The sonic windows may be “unitarily formed from a single piece of material,” ([0025]), or may have different materials. (see, e.g., materials 84 and 86 described in [0031]).
The sonic window 50 (Figures 3A and 3B) and the sonic window 70 (Figure 4B) are shown above. “[T]he sonic window 30 generally comprises a planar body 32 that is made of a sonically translucent polymeric material and that defines a peripheral portion 34 and a central portion 36. The peripheral portion 34 comprises multiple edges 38 and the central portion 36 comprises multiple edges 40.” ([0029]). The sonic window 70 has a similar construction but is made with two different materials 84, 86. ([0031]).
It would have been obvious to one skilled in the art to manufacture the closed cap 2800 of KELLY with a “sonically translucent polymeric material” as taught in MANWARING. One would be motivated to use the sonolucent material to allow ultrasound imaging through the material as taught in MANWARING ([0023]) and KELLY ([0104], [0115]). There would have been a reasonable expectation of success as MANWARING teaches that implants having a similar shape to those described in KELLY may be manufactured using a sonolucent material.
KELLY does not explicitly teach that a space defined by the cavity is filled with a highly ultrasound transmissive fluid, gel, or other material to enhance or otherwise control passage of ultrasound waves through the cranial reconstruction device.
In the same field of endeavor, GORDON teaches a cranial implant that includes “one or more sonolucent materials that permit transmission of mechanical waves through the sonolucent materials when the static cranial implant device is subgaleally implanted.” (Abstract). Like KELLY, the cranial implant may be inserted after making a bone flap during surgical procedure. “FIGS. 1A and 1 B schematically show the insertion of skull bone flap 104, which includes cranial implant device 105 implanted in a burr- hole 101 disposed through skull bone flap 104.” ([083]). GORDON teaches that the cranial implants may have “at least one adjustable or fixed external lens element configured to further focus the mechanical waves transmitted through the sonolucent material….” (emphasis added) ([016]). These lens elements “permit and/or enhance transcranial therapeutic ultrasound, diagnostic ultrasound, photoacoustic imaging, electromagnetic wave diagnostic imaging or electromagnetic wave therapeutic intervention.” ([082]).
Notably, the lens element comprise a sonolucent material and can be interchangeable with other lens elements. “The sonolucent materials typically form, and/or comprise, at least one lens element. The lens elements of in the cranial implant devices disclosed herein include various embodiments. In some embodiments, a focal point of the lens element is adjustable. In certain embodiments, the lens element is interchangeable with another lens element.” ([025]).
It would have been obvious to one skilled in the art at the time of invention to include a highly ultrasound transmissive fluid, gel, or other material (e.g., lens element) within a space defined by the cavity as taught in GORDON. One would have been motivated to position a lens element within the cavity of KELLY’s cap shaft to enhance or otherwise control passage of ultrasound waves through the cranial reconstruction device. There would have been a reasonable expectation of success because the cavity in KELLY can receive a lens element.
Alternatively, FOLSOM teaches a sonic window implant that is inserted into a hole of the cranium. (Abstract). “Sutures in the sonic window tent the dura mater to the bottom interior surface…The implant allows the use of ultrasound for imaging, diagnosis, and intraoperative treatment of the brain and allows ultrasound to be combined with pre-operative imaging from CT, MRI, PET, MEG, or EEG.” (Abstract).
FOLSOM teaches that “[i]mplanting the sonic window implant device includes forming a recessed bone ledge at a top of the cranial opening to engage the ledge of the sonic window implant device. The sonic window implant device is inserted into the cranial opening to the level of the dura mater and the ledge of the sonic window implant device is fastened to the recessed bone ledge. Any gap that forms between the bottom interior surface of the sonic window and the dura mater is filled with an ultrasound conductive liquid or gel.” (Col. 3, lines 54-62). “An implant, in order to enable sonic transmission, must enable direct contact to the subjacent dura mater or have a space which can be filled with ultrasound conductive fluid such as saline or conductive gel. For example, a gap between the inner mirror surface and dura which entraps air at time of placement in surgery will not be useful for ultrasound in either diagnostic or therapeutic modalities due to the severe attenuation.” (Col. 6, lines 17-24).
It would have been obvious to one skilled in the art at the time of invention to include a highly ultrasound transmissive fluid, gel, or other material within a space defined by the cavity as taught in FOLSOM. One would have been motivated to fill the cavity with an ultrasound-transmissive gel in order to enable sonic transmission and reduce attenuation, as taught in FOLSOM. There would have been a reasonable expectation of success because the cavity in KELLY can be filled with an ultrasound-transmissive gel.
With respect to claim 22, KELLY teaches wherein the cranial reconstruction device is sonolucent (see, e.g., [0115] “In various embodiments, the plug 108 may be suitable to transmit light, electromagnetic or other radiation, ultrasound and/or electrical fields”; the plug may be “constructed from PEEK.” ([0019])).
With respect to claim 23, KELLY does not explicitly teach a step of passing ultrasound through the cranial reconstruction device. KELLY does describe the plug 108 being suitable to transmit ultrasound and comprising PEEK (a sonolucent material according to the Applicant).
However, MANWARING teaches using an ultrasound probe while the cranial implant is positioned within a patient’s skull to pass ultrasound through the cranial device. (see Figures 9 and 10 and [0037]). “[T]he tip of an ultrasound probe P can be positioned at the sonic window 170 after it has been implanted (and after the scalp has been closed) to transmit ultrasonic radiation UR through the window and into the brain.” ([0037]).
It would have been obvious to one skilled in the art to pass ultrasound through the cranial reconstruction device using an ultrasound transducer. As discussed above, with respect to claim 1, one skilled in the art would form the device using a sonolucent material to allow ultrasound imaging through the material as taught in MANWARING ([0023]) and KELLY ([0104], [0115]). It naturally follows that it would be necessary to provide an ultrasound probe with the cranial reconstruction device in order to complete the ultrasound imaging by passing ultrasound therethrough. There would have been a reasonable expectation of success as MANWARING teaches that such implants may be used with ultrasound probes.
Claims 25-28 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Appl. Publ. No. 2022/0249190 A1 (hereinafter “KELLY”), U.S. Patent Publ. No. US 2017/0368330 A1 to Silay et al. (hereinafter referred to as “SILAY”), U.S. Patent Appl. Publ. No. 2014/0330123 A1 (hereinafter “MANWARING”), and International Publ. No. WO 2021/050881 A1 to Gordon (hereinafter referred to as “GORDON”) or, alternatively, U.S. Patent No. 12,076,244 B1 (hereinafter “FOLSOM”) as applied to claim 22, and further in view of Del Bene et al. “Cranial sonolucent prosthesis: a window of opportunity for neuro-oncology (and neuro-surgery).” Journal of Neuro-Oncology 156.3 (2022): 529-540 (hereinafter referred to as “DEL BENE”).
With respect to claim 25 (depending from claim 22), KELLY does not explicitly teach further including a step of acting upon and/or monitoring a contrast agent as it travels within the brain.
In the same field of endeavor, DEL BENE demonstrates the feasibility of using a cranioplasty prosthesis as “an artificial acoustic window.” (Abstract). DEL BENE disclosed that the artificial acoustic window can be used to interact with an ultrasound contrast agent. (p.530, right column, second full paragraph). DEL BENE was “able to perform real-time [contrast-enhanced ultrasound (CEUS)] imaging with a spatial and temporal resolution superimposable to the intra-operative setting…” (p.535, right column, last paragraph).
It would have been obvious to one having ordinary skill in the art at the time of invention to modify Kelly to add a step of acting upon and/or monitoring a contrast agent as it travels within the brain using the cranial implants of KELLY because the sonolucent nature of the implants in KELLY permit ultrasonic monitoring of the brain and because contrast-enhanced ultrasound, as taught in DEL BENE, can be monitored through the implant. One would have been motivated to monitor a contrast agent as it travels within the brain because, as disclosed in DEL BENE, the contrast-enhanced ultrasound can provide information on tumor presence, perfusion pattern, histopathological features, and vascularization. There would be a reasonable expectation of success as both the cranial implants and contrast-enhanced ultrasound with the cranial implants has been demonstrated by DEL BENE.
With respect to claim 26 (depending from claim 25), KELLY does not explicitly teach further including a step selected from a group consisting of imaging confirmation of blood flow immediately after surgery, imaging confirmation of blood flow during follow-up examinations, imaging confirmation of blood flow to desired locations within the brain, imaging visualization of, and guidance during, interventional procedures to guide a wire and/or catheter, and activating a contrast agent as it passes a particular point of interest and is subjected to ultrasound for activation thereof.
In the same field of endeavor, DEL BENE demonstrates the feasibility of using a cranioplasty prosthesis as “an artificial acoustic window.” (Abstract). DEL BENE disclosed that the artificial acoustic window can be used to interact with an ultrasound contrast agent. (p.530, right column, second full paragraph).
As taught in DEL BENE, “[c]ontrast-enhanced ultrasound (CEUS), relying on harmonic imaging, represents the signal originated by an exogenous contrast medium (microbubbles containing low-diffusion gasses) providing information on tumor presence, perfusion pattern, histopathological features, and vascularization.” (p.530, left column, first paragraph). DEL BENE was “able to perform real-time [contrast-enhanced ultrasound] imaging with a spatial and temporal resolution superimposable to the intra-operative setting…” (p.535, right column, last paragraph).
It would have been obvious to one having ordinary skill in the art at the time of invention to modify KELLY to activate a contrast agent as it passes a particular point of interest and is subjected to ultrasound, as taught by DEL BENE, because the sonolucent nature of the implants in KELLY permit ultrasonic monitoring of the brain and because contrast-enhanced ultrasound, as taught in DEL BENE, can be monitored through the implant. One would have been motivated to do so because the cranial implants can be used for contrast-enhanced ultrasound, which provides information on tumor presence, perfusion pattern, histopathological features, and vascularization. There would be a reasonable expectation of success as both the cranial implants and contrast agent activation using the cranial implants has been demonstrated by DEL BENE.
With respect to claim 27 (depending from claim 22), KELLY does not explicitly teach further including a step of utilizing ultrasound in conjunction with drug delivery.
In the same field of endeavor, DEL BENE also disclosed that the artificial acoustic window can be used for drug delivery. (p.530, right column, second full paragraph). One application is “blood–brain barrier (BBB) disruption for therapeutic and diagnostic purposes. This technique relies on the mechanical stimulation of the cerebral blood vessels to induce their temporary permeability…BBB disruption to enhance drug delivery is of particular interest for brain tumors.” (p.530, left column, first full paragraph). DEL BENE demonstrated that it is possible to burst the microbubbles for BBB disruption. (p.536, right column, first paragraph).
It would have been obvious to one having ordinary skill in the art at the time of invention to deliver drugs to particular regions of the brain using the cranial implants of KELLY. One would have been motivated to use the cranial implants for drug delivery because, as disclosed in DEL BENE, the cranial implants offer an acoustic window that enables blood-brain barrier disruption through mechanical stimulation of the cerebral blood vessels. There would be a reasonable expectation of success as both the cranial implants and blood-brain barrier disruption using the cranial implants has been demonstrated by DEL BENE.
With respect to claim 28 (depending from claim 27), the cited art does not explicitly teach further including a step selected from the group consisting of subjecting a drug to ultrasound at a specific location within the brain so that the drug is active at a highly specific location, subjecting a drug to ultrasound at a specific location within the brain to enhance effectiveness of the drug through delivery of ultrasound, subjecting the drug to ultrasound at a specific location within the brain to assist the drug in passing through the brain blood barrier, and therapeutically releasing nano-encapsulated drugs through the application of ultrasound wherein the ultrasound breaks down the encapsulation material to release the drug.
In the same field of endeavor, DEL BENE also disclosed that the artificial acoustic window can be used for drug delivery. (p.530, right column, second full paragraph). One application is “blood–brain barrier (BBB) disruption for therapeutic and diagnostic purposes. This technique relies on the mechanical stimulation of the cerebral blood vessels to induce their temporary permeability…BBB disruption to enhance drug delivery is of particular interest for brain tumors.” (p.530, left column, first full paragraph). DEL BENE demonstrated that it is possible to burst the microbubbles for BBB disruption. (p.536, right column, first paragraph). NOTE: Page 33 (middle bullet point) recites “subjecting the drug to ultrasound at a specific location within the brain to assist the drug in passing through the brain blood barrier” and describes the meaning of this recitation with “such as by causing brain cells to open up to permit larger sized molecules to pass.” In other words, “subjecting the drug to ultrasound” may include subjecting the anatomy where the drug is present to ultrasound. The drug is not necessarily activated. DEL BENE teaches directing ultrasound within the brain to induce the permeability of the blood vessels. As such, DEL BENE teaches subjecting a drug to ultrasound at a specific location within the brain (which includes subjecting the specific location to ultrasound while the drug is present) to enhance effectiveness of the drug through delivery of ultrasound.
It would have been obvious to one having ordinary skill in the art at the time of invention to subject a drug to ultrasound at a specific location within the brain to assist the drug in passing through the brain blood barrier, as taught by DEL BENE (p.530, left column, middle paragraph), using the cranial implants of KELLY. One would have been motivated to subject a specific location within the brain to ultrasound (while the drug is present), as disclosed in DEL BENE, because the ultrasound mechanically stimulates the blood vessels, thereby enhancing drug delivery to brain tumors as taught by DEL BENE. (p.530, left column, middle paragraph). There would be a reasonable expectation of success as both the cranial implants and blood-brain barrier disruption using the cranial implants has been demonstrated by DEL BENE.
RESPONSE TO APPLICANT’S ARGUMENTS
Applicant's arguments filed January 22, 2026 have been fully considered but they are not persuasive.
On page 12 of the Response, Applicant argues that “claims 1 and 21 now require the provision of an ultrasound transmissive fluid, gel, or other material within the space defined by the cavity. If the device as proposed based upon the modification of Kelly in view of Manwaring were to be modified to include a cavity as filled in accordance with the amended claims, the purpose behind the device of Kelly, that is, the provision of a passageway through the skull for access to the neuroanatomy, would ultimately be destroyed as the passageway would be filled with the ultrasound transmissive fluid, gel, or other material.” (emphasis added).
While KELLY does describe some embodiments that provide passageways through the skull for access to the neuroanatomy, KELLY’s teachings are not limited to only those embodiments. “A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art….” (emphasis added) (MPEP 2123). “The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.” In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)). (MPEP 2123).
For example, KELLY teaches that the closed cap “may facilitate closing a hole formed in the skull, e.g. the closed cap 2800 may be retained in the skull post-surgery.” ([0138]). Moreover, KELLY does not require that the closed cap be attached to the port 101 and, in fact, teaches that the closed cap may attach directly to the skull. “The closed cap 2800 may couple with the port 101 or directly with the hole in the skull 200.” ([0138]). Furthermore, the closed cap may have a length that is “at least a thickness of the skull bone 206.” In this case, the “closed cap” is clearly not limited to being a cap but the device itself that closes or plugs the hole.
Accordingly, KELLY teaches (or at the very least reasonably suggests) that embodiments can be used alone to enclose a hole formed in the skull. This reasonable suggestion would be further bolstered by MANWARING and FOLSOM, which teach similar designs for closing the hole in the skull that can also be used as sonic windows.
In addition to using the closed cap alone for closing a hole in a skull, KELLY generally teaches that the various embodiments may be used to not only cover the hole but maintain the hole in order to allow repeated access. (Abstract). KELLY also teaches that various embodiments may be used to ultrasonically access the brain through the holes. ([0104] and [0115]). As such, the combination of KELLY and MANWARING and/or FOLSOM teach using devices having distinct pieces that can be assembled together to form sonic windows.
Prior Art Made of Record
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Unsgård, Geirmund, Ole Solheim, and Tormod Selbekk. "Intraoperative ultrasound in neurosurgery." Intraoperative imaging and image-guided therapy. New York, NY: Springer New York, 2013. 549-565 (hereinafter “UNSGARD”). UNSGARD teaches that a sterile ultrasound-transmissive gel may be applied between the probe and the dura to ensure good beam penetration.
Conclusion
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/JASON P GROSS/Examiner, Art Unit 3797
/SERKAN AKAR/Primary Examiner, Art Unit 3797
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