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 remarks filed on 02/11/2026.
The amendment filed 02/17/2026 has been entered. Claims 33-52 remain pending in the application.
The 112(b) rejection has been withdrawn in light of claim amendments.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 33-35, 40, 43-45, 48 and 52 are rejected under 35 U.S.C. 103 as being unpatentable over Zwierstra et al (US 20180250183 A1), hereinafter “Zwierstra”) in view of Schulte et al.(US 5730745 A, hereinafter “Schulte”).
Regarding claim 33, Zwierstra teaches a subject positioning apparatus, comprising:
a first part (100; fig 1) and a second part (150; fig. 1);
wherein the first part is configured to contact and conform with a region of the subject's head and/or neck, and to engage with and couple to the second part (the supine headset 100 is slid under the head 110 of the patient. The center restraint 150, left-side restraint 130, and right-side restraint 140 are secured around the head 110 to render the head 110 relatively immobile such that the patient's head 110 remains sufficiently restrained [0064]; fig. 2 shows the first part 100 and second part 150 coupled together, and conforming to the head);
the first part is configured to hold the subject, when coupled to the second part, in a fixed position relative to the apparatus (the supine headset 100 is slid under the head 110 of the patient. The center restraint 150, left-side restraint 130, and right-side restraint 140 are secured around the head 110 to render the head 110 relatively immobile such that the patient's head 110 remains sufficiently restrained [0064]; fig. 2 shows the first part 100 and second part 150 coupled together).
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Figs. 1 and 2 of Zwierstra reproduced above
Although Zwierstra teaches the first and second part together configured to clamp to further medical equipment (the supine headset 100 includes the baseplate 120 having a plurality of slots 172 into which the robotic pod 174 (e.g., a robotic pod including an ultrasound device, such as, but not limited to, a TCD device) can be placed [0066]; [0081] discloses clamping as a suitable fastening mechanism), Zwierstra does not teach the first and second part each further comprising a portion of a seal flange, the seal flange of [the first and second part together configured to clamp to further medical equipment] so that a region of the subject's head above the seal flange is received in the further medical equipment.
Schulte is considered analogous to the instant application as “ fixation apparatus” is disclosed (abstract).
Schulte teaches:
the first (202; fig. 11) and second part (208; fig. 11) each further comprising a portion of a seal flange (210, 214, and 204), the seal flange of the first (204) and second part (206) together configured to clamp to further medical equipment so that a region of the subject's head above the seal flange (The adaptor board 208 further includes a seal 214 having a circular cross-sectional shape and configured to sit within the groove 212. The seal 214 desirably has a diameter larger than the depth of the corresponding groove 212, such that the seal 214 extends above the surface of the adaptor board 208 when seated within the groove 212, Col. 12 lines 49-54; The adaptor board 208 further includes alignment holes 216 which cooperate with the guide pins 206 on the mounting frame 204. The alignment holes 216 are positioned with respect to the recess 210 and the groove 212 so as to position the mounting frame 204 over the seal 214 and the recess 210. In this manner, a substantially sealed cavity is formed between the mounting frame 204 and adaptor board 208 when the mounting frame 204 covers the recess 210, Col. 12 lines 55-63) is received in the further medical equipment (The adaptor board 12 desirably has a size and shape which is coextensive with conventional gurneys or hospital diagnostic and treatment tables. The adaptor board 12 can thus be placed onto of a diagnostic or treatment table or gurney when a medical procedure is preformed using the present stereotactic fixation apparatus 10. It is also contemplated that the adaptor board 12 can alternatively be integrally formed with a dedicated diagnostic or radiation therapy treatment table or gurney, Col. 4 lines 10-16).
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Fig. 11 of Schulte reproduced above
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 invention of Zwierstra to include the first and second part each further comprising a portion of a seal flange, the seal flange of the first and second part together configured to clamp to further medical equipment so that a region of the subject's head above the seal flange is received in the further medical equipment, as taught by Schulte. Doing so provides sufficient immobilization, allows accurate re-positioning, is well tolerated by a patient, is quickly released and does not interfere with the medical procedure (e.g., interfere with an external beam in radiotherapy), as suggested by Schulte (Col. 2 lines 21-35).
Regarding claim 34, modified Zwierstra teaches the apparatus of claim 33, as discussed above. Zwierstra further teaches wherein the first part and second part are together configured to fix the apparatus with a positional accuracy, relative to the subject's neurocranium, wherein the positional accuracy is defined as a distance the apparatus is able to move in any direction relative to the subject's neurocranium (For example, the robotic pod 174 can latch onto any given one of the slots 172 to lock into place, thereby providing adjustability of the robotic pod 174 with respect to the distance from the head 110, and thereby allowing the supine headset 100 to accommodate different sizes and shapes of subject heads. In some arrangements, the plurality of slots 172 are located along a lengthwise dimension of the baseplate 120, where the lengthwise dimension is greater than a widthwise dimension of the baseplate 120 [0066]).
While Zwierstra is silent on the with a positional accuracy, relative to the subject's neurocranium, of less than 5mm, it is noted that the Applicant’s specification does not impute any significance and/or criticality to the claimed 5 mm, therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date, to change the positional accuracy to less than 5 mm in order to accommodate for different sized heads. See MPEP 2144.04.IV.A.
Regarding claim 35, Zwierstra teaches the apparatus of claim 33, as discussed above. Zwierstra further teaches wherein the first part comprises a mating surface (120; fig. 2) that is configured to engage with a corresponding mating surface of the second part (the supine headset 100 includes a baseplate 120, as well as a left-side restraint 130 and a right-side restraint 140 attached to the baseplate 120 [0055]).
Regarding claim 40, modified Zwierstra teaches the apparatus of claim 33, as discussed above. Zwierstra further teaches the base flange configured to be received in a corresponding slot of a further medical apparatus (a system that combines one or more robotic pods (e.g., ultrasound pods) with a headset configured to lay on a surface while supporting a head of a patient who is in a supine or reclined position [0052]; the supine headset 100 includes the baseplate 120 having a plurality of slots 172 into which the robotic pod 174 (e.g., a robotic pod including an ultrasound device, such as, but not limited to, a TCD device) can be placed [0056]).
Regarding claim 43, modified Zwierstra teaches the apparatus of claim 33, as discussed above. Zwierstra further teaches wherein the first part is a neck part (100) and the first region of the subject's head comprises a posterior region of the subject's head (attaches to the posterior region of the subject’s head as shown in fig. 1), and the second part (150) is a face part configured to contact and conform with a region of the subject's face (150 conforms to the face as shown in figs. 1 and 2; the center restraint 150 includes a padding that makes contact with the head 110, and the padding is made from any suitable soft material, such as, but not limited to, closed cell foam, open cell foam, self-skinning open or closed cell foams, cast, aerated, or extruded silicone or urethane, polyurethane gels that are configured to distribute pressure efficiently, or the like [0065]).
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Figs. 1 and 2 of Zwierstra reproduced above
Regarding claim 44, modified Zwierstra teaches the apparatus of claim 33, as discussed above. Zwierstra further teaches the first part (150 [0065]) comprises a rigid portion consisting of a rigid material (the center restraint 150 is configured to pivot about a hinge so as to toggle between restraining/engaging the head 110 and disengaging/separating from the forehead [0065]; first part 150 is inherently rigid as it I used to stabilize the head) and a soft contact part comprising a softer material (the center restraint 150 includes a padding that makes contact with the head 110, and the padding is made from any suitable soft material, such as, but not limited to, closed cell foam, open cell foam, self-skinning open or closed cell foams, cast, aerated, or extruded silicone or urethane, polyurethane gels that are configured to distribute pressure efficiently, or the like [0065]).
Regarding claim 45, modified Zwierstra teaches the apparatus of claim 44, as discussed above. Zwierstra further teaches wherein the contact part of the first part is formed from a cast or impression of the shape of the subject (center restraint 150 includes a padding that makes contact with the head 110, and the padding is made from any suitable soft material, such as, but not limited to, closed cell foam, open cell foam, self-skinning open or closed cell foams, cast, aerated, or extruded silicone or urethane, polyurethane gels that are configured to distribute pressure efficiently, or the like [0065]).
Regarding claim 48, Zwierstra teaches a method of locating a subject relative to medical equipment, comprising:
placing a first part (100; fig 1) in conformal contact with a first region of the subject's head and/or neck (the supine headset 100 is slid under the head 110 of the patient. The center restraint 150, left-side restraint 130, and right-side restraint 140 are secured around the head 110 to render the head 110 relatively immobile such that the patient's head 110 remains sufficiently restrained [0064]);
placing a second part (150; fig. 1) in contact with a second portion of the head and/or neck (the supine headset 100 is slid under the head 110 of the patient. The center restraint 150, left-side restraint 130, and right-side restraint 140 are secured around the head 110 to render the head 110 relatively immobile such that the patient's head 110 remains sufficiently restrained [0064];;
fixing the first part to the second part (the supine headset 100 is slid under the head 110 of the patient. The center restraint 150, left-side restraint 130, and right-side restraint 140 are secured around the head 110 to render the head 110 relatively immobile such that the patient's head 110 remains sufficiently restrained [0064]; fig. 2 shows the first part 100 and second part 150 fixed together).
wherein the first part and second part together form a subject positioning apparatus ([0064] discloses positioning/immobilizing the subject using first part 100 and second part 150), and
Although Zwierstra discloses a clamping mechanism and medical equipment (the supine headset 100 includes the baseplate 120 having a plurality of slots 172 into which the robotic pod 174 (e.g., a robotic pod including an ultrasound device, such as, but not limited to, a TCD device) can be placed [0066]; [0081] discloses clamping as a suitable fastening mechanism), Zwierstra, however, does not teach the method comprises slipping a seal assembly onto the subject's head adjacent to the subject positioning apparatus, and clamping the seal assembly between the subject positioning apparatus and the medical equipment.
Schulte is considered analogous to the instant application as “ fixation apparatus” is disclosed (abstract).
Schulte teaches slipping a seal assembly (seal 214, , Col. 4 lines 10-16) onto the subject's head adjacent to the subject positioning apparatus (The adaptor board 208 further includes a seal 214 having a circular cross-sectional shape and configured to sit within the groove 212. The seal 214 desirably has a diameter larger than the depth of the corresponding groove 212, such that the seal 214 extends above the surface of the adaptor board 208 when seated within the groove 212, Col. 12 lines 49-54; The adaptor board 208 further includes alignment holes 216 which cooperate with the guide pins 206 on the mounting frame 204. The alignment holes 216 are positioned with respect to the recess 210 and the groove 212 so as to position the mounting frame 204 over the seal 214 and the recess 210. In this manner, a substantially sealed cavity is formed between the mounting frame 204 and adaptor board 208 when the mounting frame 204 covers the recess 210, Col. 12 lines 55-63), and clamping the seal assembly between the subject positioning apparatus and the medical equipment (The adaptor board 12 desirably has a size and shape which is coextensive with conventional gurneys or hospital diagnostic and treatment tables. The adaptor board 12 can thus be placed onto of a diagnostic or treatment table or gurney when a medical procedure is preformed using the present stereotactic fixation apparatus 10. It is also contemplated that the adaptor board 12 can alternatively be integrally formed with a dedicated diagnostic or radiation therapy treatment table or gurney, Col. 4 lines 10-16).
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 invention of Zwierstra to include slipping a seal assembly onto the subject's head adjacent to the subject positioning apparatus, and clamping the seal assembly between the subject positioning apparatus and the medical equipment, as taught by Schulte. Doing so provides sufficient immobilization, allows accurate re-positioning, is well tolerated by a patient, is quickly released and does not interfere with the medical procedure (e.g., interfere with an external beam in radiotherapy), as suggested by Schulte (Col. 2 lines 21-35).
Regarding claim 52, modified Zwierstra teaches the method of claim 48, as discussed above. Zwierstra further teaches clamping the first part and second part to the medical equipment (the supine headset 100 includes the baseplate 120 having a plurality of slots 172 into which the robotic pod 174 (e.g., a robotic pod including an ultrasound device, such as, but not limited to, a TCD device) can be placed [0066]; [0081] discloses clamping as a suitable fastening mechanism).
Claims 36-39 are rejected under 35 U.S.C. 103 as being unpatentable over Zwierstra et al (US 20180250183 A1), hereinafter “Zwierstra”) in view of Schulte et al.(US 5730745 A, hereinafter “Schulte”) and Nordgren et al. (US 20190290471 A1, hereinafter “Nordgren”).
Regarding claim 36, modified Zwierstra teaches the apparatus of claim 35, as discussed above. Zwierstra, however, does not teach wherein the first and second part each comprise a mating flange that comprises the mating surface of the respective part, and the mating flange and/or mating surfaces of the first part and second part are substantially parallel to a frontal or sagittal plane of the subject.
Nordgren is considered analogous to the instant application as “Easy on/easy off clips or clamps for mounting mask to body part fixation device” is disclosed (title).
Nordgren teaches wherein the first (130; fig. 2A) and second part (120) each comprise a mating flange (an upper surface of flange 140 [0031]; Mask frame 150 [0031]) that comprises the mating surface of the respective part, and the mating flange and/or mating surfaces of the first part and second part are substantially parallel to a frontal or sagittal plane of the subject (an upper surface of flange 140 includes multiple registration holes 200 (only one is viewable in FIG. 2A) for docking mask frame 150 to shell frame 130. Mask frame 150 may further include multiple pins (not shown) on an underside of the frame 150, that line up with, and can be inserted into, the registration holes 200. When docking mask frame 150 to shell frame 130, the registration holes ensure the proper positioning of mask frame 150 relative to flange 140 of shell frame 130 [0031]; the mating surfaces are parallel to the frontal plane of the subject, as subject is lying down, as shown in fig. 2A, reproduced below).
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Snippet of Fig. 2A of Nordgren reproduced above
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 invention of Zwierstra to include wherein the first and second part each comprise a mating flange that comprises the mating surface of the respective part, and the mating flange and/or mating surfaces of the first part and second part are substantially parallel to a frontal or sagittal plane of the subject, as taught by Nordgren. Doing so would for quickly and easily mounting, and fastening, the body part mask at a fixed position on the body part immobilization device, as suggested by Nordgren ([0023]).
Regarding claim 37, modified Zwierstra teaches the apparatus of claim 36, as discussed above. Zwierstra, however, does not teach wherein the mating flange of the first part and second part comprises at least one slot for receiving a fastener that is arranged to clamp the mating surfaces of the first part and second part together.
Nordgren, however, teaches wherein the mating flange of the first part and second part comprises at least one slot for receiving a fastener that is arranged to clamp the mating surfaces of the first part and second part together (an upper surface of flange 140 includes multiple registration holes 200 (only one is viewable in FIG. 2A) for docking mask frame 150 to shell frame 130. Mask frame 150 may further include multiple pins (not shown) on an underside of the frame 150, that line up with, and can be inserted into, the registration holes 200 [0031]; mask frame 150 includes multiple pivoting clamps 800 which, in combination with retention pins 810, fasten mask frame 150 to shell frame 130 [0041]).
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 invention of Zwierstra to include wherein the mating flange of the first part and second part comprises at least one slot for receiving a fastener that is arranged to clamp the mating surfaces of the first part and second part together, as taught by Nordgren. Doing so would for quickly and easily mounting, and fastening, the body part mask at a fixed position on the body part immobilization device, as suggested by Nordgren ([0023]).
Regarding claim 38, modified Zwierstra teaches the apparatus of claim 37, as discussed above. Zwierstra, however, does not teach at least one fastener for clamping the mating surfaces of the first part and second part together, wherein the apparatus is configured for quick release of engagement between the first part and second part by loosening at least one fastener and sliding it out of the slot in the mating flange.
Nordgren, however, teaches at least one fastener for clamping the mating surfaces of the first part and second part together, wherein the apparatus is configured for quick release of engagement (The shell frame may additionally include an upper flange that permits “easy on/easy off” attachment of the mask frame to the flange [0024]; includes a body part immobilization table, upon which a body part is positioned, and to which a mask frame, such as a multi-piece mask frame, attaches using clips or clamps after form fitting the material of the mask to the body part being immobilized. [0025]) between the first part and second part by loosening at least one fastener and sliding it out of the slot in the mating flange (FIGS. 10A-10C depict a physical configuration of an exemplary implementation of pivoting clamp 800. … The width of clamping space 1010, therefore, permits mask frame 150 and upper flange 140 of shell frame 130 to fit within clamping space 1010, between upper clamping arm 930 and lower clamping arm 940, to tightly clamp and fasten mask frame 150 in place against the upper surface of upper flange 140 of shell frame 130 [0044]).
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 invention of Zwierstra to include at least one fastener for clamping the mating surfaces of the first part and second part together, wherein the apparatus is configured for quick release of engagement between the first part and second part by loosening at least one fastener and sliding it out of the slot in the mating flange, as taught by Nordgren. Doing so would for quickly and easily mounting, and fastening, the body part mask at a fixed position on the body part immobilization device, as suggested by Nordgren ([0023]).
Regarding claim 39, modified Zwierstra teaches the apparatus of claim 33, as discussed above. Zwierstra, however, does not teach wherein the first part and second part are customised to fit a specific subject.
Nordgren, however, teaches wherein the first part and second part are customised to fit a specific subject (The shell frame additionally may contain a cushion (e.g., head cushion) that is customized to fit the body part of the patient. For example, when the body part is a patient head, the depth of the shell frame enables the customized cushion to surround the head up to a mid-point of the head, providing a large contact surface area that permits a substantial area of support for the head [0024]; forming the mask to the shape of the face of the patient [0022]).
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 invention of Zwierstra to include wherein the first part and second part are customised to fit a specific subject, as taught by Nordgren. Doing so would for quickly and easily mounting, and fastening, the body part mask at a fixed position on the body part immobilization device, as suggested by Nordgren ([0023]).
Claims 41-42 and 51 are rejected under 35 U.S.C. 103 as being unpatentable over Zwierstra et al (US 20180250183 A1), hereinafter “Zwierstra”) in view of Schulte et al.(US 5730745 A, hereinafter “Schulte”) and Ramamurthy et al. (US 20230082109 A1, hereinafter “Ramamurthy”)
Regarding claim 41, modified Zwierstra teaches the apparatus of claim 33, as discussed above. Zwierstra, however, does not teach wherein the seal flange is configured to engage with a sealing assembly that encircles the subject's head.
Ramamurthy is considered analogous to the instant application as “Ultrasound transducer assembly” is disclosed (title).
Ramamurthy teaches wherein the seal flange (a rigid frame 14 [0052]) is configured to engage with a sealing assembly (fillable jacket 30 [0054]) that encircles the subject's head (frame 14 comprises padding 14A coupled to a section of an inside surface of frame 14 (see FIG. 1B). Padding 14A can provide more comfort to subject 3 when frame 14 is pressed against the face of subject 3 [0053]; sealing assembly 14 encircles head as shown in fig. 1A, reproduced below).
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Snippet of Fig. 1A of Ramamurthy, reproduced above
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 invention of Zwierstra to include wherein the seal flange is configured to engage with a sealing assembly that encircles the subject's head, as taught by Ramamurthy. Doing so would achieve good coupling of ultrasound energy between transducer elements of the ultrasound transducer assembly and brain tissue of a subject, as suggested by Ramamurthy ([0045])
Regarding claim 42, modified Zwierstra teaches the apparatus of claim 41, as discussed above. Zwierstra, however, does not teach wherein the seal flange is inclined at an angle of between 10 and 30 degrees to a transverse plane of the subject, and/or wherein the seal flange comprises one or more slots configured to receive a fastener for clamping the seal flange to a further medical apparatus.
Ramamurthy, however, teaches wherein the seal flange comprises one or more slots configured to receive a fastener for clamping the seal flange to a further medical apparatus (Frame 14 may be integrally formed with or detachably coupled to mechanical substructure 12 (e.g. by snap fit mechanisms, hinges, etc.). Frame 14 may include a locking hinge mechanism that helps secure mechanical substructure 12 to head 2 of subject 3… When locked in place, frame 14 applies pressure on the bony areas (e.g. areas below the temples) of the face of subject 3 to constrain movement of ultrasound transducer assembly 10 relative to head 2. [0052]; Ultrasound transducer assembly 10 comprises a fillable jacket 30 that is coupled to the inner surface 12A of mechanical substructure 12. [0054]).
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 invention of Zwierstra to include wherein the seal flange comprises one or more slots configured to receive a fastener for clamping the seal flange to a further medical apparatus, as taught by Ramamurthy. Doing so would achieve good coupling of ultrasound energy between transducer elements of the ultrasound transducer assembly and brain tissue of a subject, as suggested by Ramamurthy ([0045]).
Regarding claim 51, modified Zwierstra teaches the method of claim 48, as discussed above. Zwierstra further teaches wherein the medical equipment comprises a …. at least one ultrasonic transducer (the supine headset 100 includes the baseplate 120 having a plurality of slots 172 into which the robotic pod 174 (e.g., a robotic pod including an ultrasound device, such as, but not limited to, a TCD device) can be placed [0066]), Zwierstra is silent regarding [wherein the medical equipment] comprises a cap comprising [at least one ultrasonic transducer], and/or wherein the seal assembly is configured to form a seal with the subject's head and with the medical equipment, and the method comprises filling a space between the subject's head and the medical equipment with liquid and using the seal assembly to retain the liquid in contact with the medical equipment and the subject's head.
Ramamurthy is considered analogous to the instant application as “Ultrasound transducer assembly” is disclosed (title).
Ramamurthy teaches:
wherein the medical equipment comprises a cap comprising at least one ultrasonic transducer (a cap supporting one or more ultrasound transducer elements [0028]),
the method comprises filling a space between the subject's head and the medical equipment with liquid and using the seal assembly (frame 14 comprises padding 14A coupled to a section of an inside surface of frame 14 (see FIG. 1B). Padding 14A can provide more comfort to subject 3 when frame 14 is pressed against the face of subject 3 [0053]; sealing assembly 14 encircles head as shown in fig. 14A, reproduced below) to retain the liquid in contact with the medical equipment and the subject's head (a port in fluid communication with the deformable chamber, and a valve for controlling fluid flow through the port to thereby control the volume of the acoustic transmission fluid in the deformable chamber [0017]; the fillable jacket is acoustically coupled to the mechanical substructure [0018] The deformable receptacle holds a volume of an acoustic transmission fluid in a deformable chamber [0028]).
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 combined invention of Zwierstra to include wherein the medical equipment] comprises a cap comprising [at least one ultrasonic transducer, and the method comprises filling a space between the subject's head and the medical equipment with liquid and using the seal assembly to retain the liquid in contact with the medical equipment and the subject's head, as taught by as taught by Ramamurthy. Doing so would achieve good coupling of ultrasound energy between transducer elements of the ultrasound transducer assembly and brain tissue of a subject, as suggested by Ramamurthy ([0045]).
Claims 46-47 and 49-50 are rejected under 35 U.S.C. 103 as being unpatentable over Zwierstra et al (US 20180250183 A1), hereinafter “Zwierstra”) in view of Schulte et al.(US 5730745 A, hereinafter “Schulte”) and Rincker et al. (US 20150297176 A1, hereinafter “Rincker”).
Regarding claim 46, modified Zwierstra teaches the apparatus of claim 33, as discussed above. Zwierstra, however, is silent regarding a positioning cap, configured to temporarily engage with the first part or the second part, so as to better position the subject for the first and second parts to be coupled together.
Rincker is considered analogous to the instant application as “Ultrasound head frame for emergency medical services” is disclosed (title).
Rincker teaches a positioning cap (122), configured to temporarily engage with the first part (150), so as to better position the subject for the first and second parts to be coupled together (The back-of-the-head support 118 includes an upstanding, conformal outer rim 122. Both extend upward to surround an upper part of the back 120 of the head 106. In particular, the base 118 and/or the neck support 110 are shaped conformally with the back of correspondingly the head 106 and/or the neck 112 [0028]; 122 does not attach to the first part 150, and can be removed during position, as shown in figs. 1A and 1B and described in [0028]).
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Fig. 1A of Rincker reproduced above
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 invention of Zwierstra to include a positioning cap, configured to temporarily engage with the first part, so as to better position the subject for the first and second parts to be coupled together, as suggested by Rincker. Doing so would allow for both the imaging and therapy probe(s) are to be held steadily and tightly coupled to the patients head for the duration of the treatment, as suggested by Rincker ([0015]).
Regarding claim 47, modified Zwierstra teaches the apparatus of claim 46, as discussed above. Zwierstra, however, does not teach wherein the positioning cap comprises a head part that is configured to conform with the subject's upper cranium
Rincker, however, teaches wherein the positioning cap comprises a head part that is configured to conform with the subject's upper cranium (The back-of-the-head support 118 includes an upstanding, conformal outer rim 122. Both extend upward to surround an upper part of the back 120 of the head 106. In particular, the base 118 and/or the neck support 110 are shaped conformally with the back of correspondingly the head 106 and/or the neck 112 [0028]; the cap/support 118 extends to the upper part of the cranium as shown in fig. 1A).
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Fig. 1A of Rincker reproduced above
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 invention of Zwierstra to include wherein the positioning cap comprises a head part that is configured to conform with the subject's upper cranium, as suggested by Rincker. Doing so would allow for both the imaging and therapy probe(s) are to be held steadily and tightly coupled to the patients head for the duration of the treatment, as suggested by Rincker ([0015])
Regarding claim 49, modified Zwierstra teaches method of claim 48, as discussed above. Zwierstra, however, does not teach wherein prior to fixing the first part to the second part, a positioning cap is coupled to the first part or second part, the positioning cap conforming with a top portion of the subject's cranium.
Rincker is considered analogous to the instant application as “Ultrasound head frame for emergency medical services” is disclosed (title).
Rincker teaches prior to fixing the first part (150 [0029]) to the second part (152 [152]), a positioning cap is coupled to the first part (The back-of-the-head support 118 includes an upstanding, conformal outer rim 122. Both extend upward to surround an upper part of the back 120 of the head 106. In particular, the base 118 and/or the neck support 110 are shaped conformally with the back of correspondingly the head 106 and/or the neck 112 [0028]; 122 does not attach to the first part 150, and can be removed during position, as shown in figs. 1A and 1B and described in [0028])., the positioning cap conforming with a top portion of the subject's cranium (The back-of-the-head support 118 includes an upstanding, conformal outer rim 122. Both extend upward to surround an upper part of the back 120 of the head 106. In particular, the base 118 and/or the neck support 110 are shaped conformally with the back of correspondingly the head 106 and/or the neck 112 [0028]; the cap/support 118 extends to the upper part of the cranium as shown in fig. 1A).
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Fig. 1A of Rincker reproduced above
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 combined invention of Zwierstra to include wherein prior to fixing the first part to the second part, a positioning cap is coupled to the first part or second part, the positioning cap conforming with a top portion of the subject's cranium, as suggested by Rincker. Doing so would allow for both the imaging and therapy probe(s) are to be held steadily and tightly coupled to the patients head for the duration of the treatment, as suggested by Rincker ([0015]).
Regarding claim 50, modified Zwierstra teaches the method of claim 48, as discussed above. Zwierstra, however, does not teach after fixing the first part to the second part, the positioning cap is detached from the first part or second part.
Rincker, however, teaches after fixing the first part to the second part, the positioning cap is detached from the first part or second part (The back-of-the-head support 118 includes an upstanding, conformal outer rim 122. Both extend upward to surround an upper part of the back 120 of the head 106. In particular, the base 118 and/or the neck support 110 are shaped conformally with the back of correspondingly the head 106 and/or the neck 112 [0028]; 122 does not attach to the first part 150, and can be removed during position, as shown in figs. 1A and 1B and described in [0028]).
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 invention of Zwierstra to include after fixing the first part to the second part, the positioning cap is detached from the first part or second part, as suggested by Rincker. Doing so would allow for both the imaging and therapy probe(s) are to be held steadily and tightly coupled to the patients head for the duration of the treatment, as suggested by Rincker ([0015]).
Response to Arguments
Applicant's arguments filed 02/17/2026 have been fully considered but they are not persuasive.
Regarding the 35 USC 103 rejection of claim 33, the applicant argues the following on pages 7-8:
“Schulte Does Not Disclose the Claimed Seal Flange or Seal Assembly Features… Claim 33 requires that each of the first part and second part includes a portion of a protruding flange structure, with the portions together forming a seal flange that clamps to further medical equipment. Schulte's groove 212 is explicitly described as a recessed feature… The seal 214 is an O-ring that sits within this recessed groove, not a flange structure”
Furthermore, Schulte does not disclose first and second parts that each comprise "a portion of a seal flange"… which is structurally and functionally different from the claimed seal flange that is configured to clamp to further medical equipment”.
In response, the examiner respectfully disagrees. The portions of the seal flange figured to clamp the medical device are cited as parts 210, 214, and 204, and all of these portions protrude outward and attach together, i.e. form a “seal” as disclosed in Col. 12 lines 55-63 of Schulte, which is cited above. Although there is a groove 212, this is used to attach the different portions of the device together.
On page 9-10 of remarks, the applicant argues the following: “Zwierstra and Schulte Disclose Fundamentally Incompatible Apparatus Structures.. Zwierstra discloses a supine headset system for positioning a patient's head during ultrasound procedures…Schulte, by contrast, discloses a vacuum-assisted stereotactic fixation apparatus for focal radiation treatment procedures…These are fundamentally different apparatus structures designed for completely different medical procedures….. Such modifications constitute a complete structural redesign, not a simple or obvious modification”.
In response, the examiner respectfully disagrees. Both devices are used for fixing the head in place during a medical procedure. In response to applicant's argument that , the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
On pages 9-10 of remarks “The Office Action Has Not Established a Reasonable Motivation to Combine the References… The cited motivation is a general statement of design objectives for stereotactic fixation devices, not a teaching that one should incorporate Schulte's specific groove structure into a completely different type of apparatus like Zwierstra's supine headset… The proposed combination lacks a reasonable articulated motivation”
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the way the head is held in place is crucial for both references for the procedure within the device as a whole, and this is explicitly state in Schulte throughout the specification, but in particular the cited portion above (Schulte- Col. 2 lines 21-35)
Pages 10-11 “The Proposed Combination Reflects Improper Hindsight”
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Accordingly, these arguments are not persuasive and the 35 USC 103 rejection to claim 1 is maintained.
Regarding the 35 USC 103 rejection of claim 48, the applicant argues the following on page 8:
“With respect to claim 48, Schulte similarly does not disclose "slipping a seal assembly onto the subject's head adjacent to the subject positioning apparatus, and clamping the seal assembly between the subject positioning apparatus and the medical equipment... Schulte's mounting frame 204 is not slipped onto the subject's head; rather, it is positioned over the subject's face and secured to an adaptor board via guide pins and vacuum pressure"
In response, the examiner respectfully disagrees. The seal assembly has the be placed/i.e. “slipped” on the patient’s face and each of the flanges/parts 210, 214, and 204 are attached/aligned through the guide pins. The vacuum seal is used for radiotherapy purposes.
Accordingly, these arguments are not persuasive and the 35 USC 103 rejection to claim 48 is maintained.
Applicant’s arguments on pages 11-12 are premised upon the assertion that the remaining dependent claims are allowable by virtue of dependency on claims 33 and 48. The applicant respectfully disagrees for the reasons stated above.
Conclusion
THIS ACTION IS MADE FINAL. 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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/N.B./ Examiner, Art Unit 3798
/PASCAL M BUI PHO/ Supervisory Patent Examiner, Art Unit 3798
Prosecution Insights