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
Applicant’s claims filed on 03/30/2026 is acknowledged by the examiner. No amendments were filed.
Claim 3 remains cancelled.
Claims 1-2, 4-27, and 29-34 are currently pending.
Claims 1-2, 4-19, 27, 29-30 are currently under examination.
Response to Arguments
Applicant's arguments filed 03/30/2026 have been fully considered but they are not persuasive.
Applicant’s argument regarding claim 27: Claim 27 has been amended to further clarify a structural and functional aspect of the invention that was not previously explicit. This amendment clarifies that the pin assembly itself is load-bearing and that the camera mount system is supported on the patient’s head by the pin assembly, rather than being supported by a frame, head clamp structure, or other external support. Hladio does not disclose, expressly or inherently, this configuration. Hladio teaches that camera mounting structures are supported by a head clamp that is itself externally supported by an operating table or other support structure. Hladio describes the pin assemblies solely as immobilization elements used to secure the patient’s skull, not as load-bearing supports for camera mounting hardware.
Examiner’s response: The Examiner still believes that Hladio reads on the amended claim 27, as the pin assembly of Hladio is configured to rest on the patient’s head and support at least in part the weight of the camera mount system, as the pin assembly is tensioned and directly contacts the patient’s head, and thus the loads are transferred through the frame of the head clamp into the pin assemblies and then transferred into the patient’s skull, therefore, although the pin assemblies are not described as load-bearing supports for camera mounting hardware, the pin assemblies are still capable of this function as the pin assemblies are connected to the camera mount 306+camera 102 via the connector 202/302 and the frames. The claim is not specific as to how the camera mount is positioned relative to the frame of the head clamp and is not specific as to how the frame of the head clamp is positioned relative to the camera mount in order for the pin assemblies to support the weight of the camera mount.
Applicant’s argument regarding claims 1 and 15: The Examiner proposes to modify Hladio by relying on Schuele ‘604 and Schuele ‘592. However, neither Schuele ‘064 nor Schuele ‘592 contemplates mounting a camera to a frame in the first instance, much less mounting a camera at the specific location required by the claims. Schule ’64 is directed to head stabilization mechanisms, and Schuele ‘592 is concerned with accessory connectors (e.g., starburst interfaces), without any teaching or suggestion directed to camera placement, camera stability, or load path considerations in image-guided surgery. Here, the cited references do not suggest the desirability of relocating Hladio’s camera mounting arm from its centrally supported location to the first upper end of the frame adjacent the pin assembly, nor do they recognize any stability problem that would motivate such a modification. Absent such a suggestion, the Examiner’s proposed reconstruction rests solely on Applicant’s disclosure, relying on impermissible hindsight.
Examiner’s response: Schule ‘064 is only disclosed in the office action as a teaching reference for a base support and a selectively movable frame portion, therefore, the arguments regarding Schule ‘064 are moot, as the reference does not have to do with the camera mount portion of the claim. Although Schuele ‘592 does not specifically state that the starburst interface 124 is for camera mount, Schuele ‘592 still states that starburst interface 124 is an accessory attachment interface, and that “various accessories or other components can be mounted” (see [0024] of Schuele ‘592), which opens up the reference, and thus the combination still stands. Further, 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).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 27 and 29 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by HLADIO et al. (referred to as “HLADIO”) (US 2019/0183590 A1).
Regarding claim 27, HLADIO discloses a camera mount system (500) for facilitating image-guided surgery (see Fig. 5 and [0078]; camera-head-clamp assembly 500 is a fixed camera head clamp system for facilitating image-guided surgery), comprising:
a camera mount extending from a proximal end to a distal end (see Annotated Fig. 5 (1) of HLADIO below; the entire left portion of the camera-head-clamp assembly 500 is the camera mount as labeled and highlighted in Annotated Fig. 5 (1), including the frame portion and mounting arm 300, as this portion of camera-head-clamp assembly 500 is used to mount the camera 102, and the camera mount extends from a proximal end, which is the end that is closest to the patient’s head and thus the end with the pins, and a distal end which is the end furthest to the patient’s head and is the end with camera mount 306), wherein the proximal end of the camera mount comprises a pin assembly configured to rest on the patient’s head so as to support the weight of the camera mount system (500) (see Annotated Fig. 5 of HLADIO (1) below; the proximal end of the camera mount is the end that is closest to the patient’s head, and thus the proximal end comprises a pin assembly configured to rest on the patient’s head, as seen in Annotated Fig. 5, so as to support a weight of the camera-head-clamp assembly 500, as the pin assembly is tensioned and directly contacts the patient’s head and thus the pin assembly carries some forces and weight from the camera-head-clamp assembly 500 to keep the pins stable when contacting the patient’s head), wherein the distal end of the camera mount includes a camera receptacle (306) (see Figs. 3 and Annotated Fig. 5 (1) of HLADIO below; the distal end of the camera mount is where camera mount 306 is located, which is a camera receptacle as it is configured to receive camera 102); and
a localizing camera (102) selectively attached to the camera receptacle (306) (see [0079] and Figs. 3 and 5; the camera 102 may selectively be attached to the camera mount 306, as the camera mount 306 may be a releasable and repeatable connection).
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Annotated Fig. 5 (1) of HLADIO.
Regarding claim 29, HLADIO discloses the invention as discussed in claim 29. HLADIO further discloses wherein the pin assembly includes two or more pins for direct attachment to the patient’s head (see Annotated Fig. 5 (1) of HLADIO above, which has the pin assembly labeled, and the pin assembly includes two pins for direct attachment to the patient’s head as seen in Fig. 5, also see [0072] which discusses immobilizing a patient’s skull by clamping it with points of fixation 204).
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.
Claim(s) 1, 2, 4, 5, 7-11, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over HLADIO in view of Schule et al. (US 2010/0059064 A1) (referred to as “Schule ‘064”) further in view of Schuele (US 2016/0324592 A1) (referred to as “Schuele ‘592”).
Regarding claim 1, HLADIO discloses a head clamp (108) for facilitating image-guided surgery, comprising:
a camera mount (300) for rigidly securing a localizing camera to the head clamp (108) (see Figs. 2-3, 5, and 7, and [0073], [0079]; head clamp 108 is for facilitating image-guided surgery, as mounting arm 300 includes a camera mount 306 can rigidly secures camera 102 which is a localizing camera to the head clamp 108);
a frame, wherein the frame defines a central space dimensioned to receive a patient’s head (see Figs. 2, 5, and 7, and Annotated Fig. 5 of HLADIO; the frame of the head clamp is indicated by element 200 shown in Fig. 2, and the frame defines a central space dimensioned to receive a patient’s head as shown in Fig. 5 where the patient’s anatomy/head 112 is shown in a central space);
a first pin assembly secured to a first upper end of the frame portion (see Annotated Fig. 5 (2) of HLADIO; a first pin assembly is labeled in Annotated Fig. 5 (2), and a first upper end of the frame portion is also labeled in Annotated Fig. 5 (2), which is the entire upright portion of the arm, which is highlighted in Annotated Fig. 5 (2) of HLADIO, and thus a first pin assembly is secured to the first upper end of the frame portion); and
a second pin assembly secured to a second upper end of the frame portion (see Annotated Fig. 5 (2) of HLADIO; a second pin assembly is labeled in Annotated Fig. 5 (2), and a second upper end of the frame portion is also labeled in Annotated Fig. 5 (2), which is the entire upright portion of the arm which is highlighted in Annotated Fig. 5 (2) of HLADIO, and thus a second pin assembly is secured to the second upper end of the frame portion);
wherein the camera mount (300) extends from a proximal end to a distal end (see Figs. 3, 5, and 7; the mounting arm 300 extends from a proximal end, which is where connector 302 is located as it is the point of attachment, to a distal end, which is where camera mount 306 is located), wherein the distal end of the camera mount (300) includes a camera receptacle (306) configured to receive the localizing camera (102) (see Figs. 3,5, and 7; the distal end of mounting arm 300 is where camera mount 306 is located, which is a camera receptacle as it is configured to receive camera 102).
HLADIO is silent on a base support; a frame secured to the base support, wherein the frame comprises a fixed frame portion and a movable frame portion, wherein the movable frame portion is selectively movable relative to the fixed frame portion; a first pin assembly secured to a first upper end of the fixed frame portion; and a second pin assembly secured to a second upper end of the movable frame portion; and wherein the proximal end of the camera mount is selectively secured to the first upper end of the frame.
However, Schule ‘064 teaches an analogous head clamp (10) further comprising a base support (110) (see Fig. 3A-4C; the skull clamp 10 further comprises intermediary member 1100 which is interpreted as a base support as it is disposed at the base of skull clamp 10 and acts as a support when connected to base unit 810); the frame (110, 210) secured to the base support (1100) (see Figs. 3A-4C; the first arm 110 and second arm 210 make up a frame of the skull clamp 10, and the first arm 110 and second arm 210 are secured to intermediary member 1100 as seen in Fig. 3A), wherein the frame (110, 210) comprises a fixed frame portion (210) and a movable frame portion (110) (see [0028],[0077], and Figs. 1A-3A; when a user pulls/rotates knob 222, the feature disengages teeth 114 of insert portion 112, thereby permitting adjustment of the position of first arm 110 relative to second arm 210, and thus second arm 210 is a fixed frame portion and first arm 110 is a movable frame portion as insert portion 112 is placed inside recess 214 of receiving portion 212), wherein the movable frame portion (110) is selectively movable relative to the fixed frame portion (210) (see Figs. 1A-3A and [0028], [0077]; when a user pulls/rotates knob 222, the feature disengages teeth 114 of insert portion 112, thereby permitting adjustment of the position of first arm 110 relative to second arm 210, and thus first arm 110 is selectively movable relative to second arm 210), providing a support mechanism that further connects to a base unit for attaching the head clamp to an operating table making it easier for medical professionals to attach the device, and providing an easy way to adjust the head clamp to various user’s heads.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided a central portion of the frame of the head clamp of HLADIO with a base support (1100) as taught by Schule ‘064 and to have modified the frame of HLADIO to include a selectively movable frame portion (110) and a fixed frame portion (210) as taught by Schule ‘064 to have provided an improved head clamp that provides a support mechanism that further connects to an attachment section for attaching the head clamp to an operating table making it easier for medical professionals to attach the device, and that provides an easy way to adjust the head clamp to various user’s heads. Therefore, the combination of HLADIO in view of Schule ‘064 results in a first pin assembly secured to a first upper end of the fixed frame portion (210 of Schule ‘064) (see Annotated Fig. 5 (2) of HLADIO; a first pin assembly is labeled in Annotated Fig. 5 (2), and a first upper end of the frame portion is also labeled in Annotated Fig. 5 (2), which is the entire upright portion of the arm that is highlighted in Annotated Fig. 5 (2) of HLADIO, and as previously modified, the first pin assembly is secured to the first upper end of the fixed frame portion 210 of Schule ‘064); and a second pin assembly secured to a second upper end of the movable frame portion (see Annotated Fig. 5 (2) of HLADIO; a second pin assembly is labeled in Annotated Fig. 5 (2), and a second upper end of the frame portion is also labeled in Annotated Fig. 5, which is the entire upright portion of the arm that is highlighted in Annotated Fig. 5 (2) of HLADIO, and thus as previously modified above, a second pin assembly is secured to the second upper end of the movable frame portion 110 of Schule ‘064).
HLADIO in view of Schule ‘064 discloses the invention as discussed above.
HLADIO in view of Schule ‘064 is silent on wherein the proximal end of the camera mount is selectively secured to the first upper end of the frame.
However, Schuele ‘592 teaches an analogous head clamp (10) (se Figs. 1-3; head fixation device or HFD 10 is a head clamp), wherein the analogous proximal end of an analogous mount (300) is selectively secured to the first upper end (106) of the frame (102) (see Figs. 1-3 and [0028], [0024]; the proximal end of navigation adapter 300 is where the navigation adapter 300 is mounted to starburst interface 124, as this is the point of attachment, as shown in Fig. 1, and thus proximal end is selectively secured to the upright portion 106 of arm 102, as seen in Fig. 1 via the starburst interface 124, which is best seen in Fig. 3), providing to allow for the accessory that is mounted to be closer to the points where the head clamp connects with or contacts the patient’s head (see [0024]), to provide for clearer images during surgery.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the first upper end of the frame in the device of HLADIO in view of Schule ‘064 to include starburst mechanism (124 of Schuele ‘592), as connector 302 of HLADIO is also a starburst mechanism, see [0073] of HLADIO, such that the proximal end of the camera mount is selectively secured to the first upper end of the frame as taught by Schuele ‘592 to have provided an improved head clamp device for facilitating image-guided surgery that allows for the accessory that is mounted to be closer to the points where the head clamp connects with or contacts the patient’s head (see [0024]) to provide for clearer images during surgery. Therefore, the combination of HLADIO in view of Schule ‘064 further in view of Schuele ‘592 results in wherein the proximal end of the camera mount (300 of HLADIO) is selectively secured to the first upper end of the frame (as previously modified above, the proximal end of mounting arm 300 of HLADIO, which is where connector 302 of HLADIO is located, is selectively secured to starburst mechanism 124 of Schuele ‘592, as HLADIO also discloses connector 302 of HLADIO is a starburst mechanism, and the starburst mechanism 124 of Schuele ‘592 is provided at the first upper end of the frame of HLADIO as previously modified above, also see Figs. 1-3 of Schuele ‘592 and Fig. 3 of HLADIO and [0073] of HLADIO).
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Annotated Fig. 5 (2) of HLADIO.
Regarding claim 2, HLADIO in view of Schule ‘064 further in view of Schuele ‘592 discloses the invention as discussed in claim 1. HLADIO in view of Schule ‘064 further in view of Schuele ‘592 further discloses a receptacle (124 of Schuele ‘592) disposed at the first upper end of the frame (as previously modified above, see claim 1, the first upper end of the frame of HLADIO, which is labeled in Annotated Fig. 5 (2) of HLADIO, is provided with starburst mechanism 124 of Schuele ‘592, which is a receptacle as it is a starburst mechanism that mates connector 302 of HLADIO and holds or contains connector 302 of HLADIO/mounting arm 300 of HLADIO), wherein the proximal end of the camera mount (300 of HLADIO) is selectively secured to the receptacle (124 of Schuele ‘592) of the frame (as previously modified above, see claim 1, the proximal end of the mounting arm 300 of HLADIO is where connector 302 of HLADIO is located, and thus the proximal end of the mounting arm 300 of HLADIO is selectively secured to starburst mechanism 124 of Schuele ‘592 as previously modified above, as connector 302 of HLADIO is also a starburst mechanism, see Fig. 3 of Schuele ‘592 and [0028] of Schuele ‘592 and see Fig. 3 of HLADIO and [0073] of HLADIO).
Regarding claim 4, HLADIO in view of Schule ‘064 further in view of Schuele ‘592 discloses the invention as discussed in claim 2. HLADIO in view of Schule ‘064 further in view of Schuele ‘592 further discloses wherein the fixed frame portion (210 of Schule ‘064) extends from the base support (1100 of Schule ‘064) to the first upper end (see Annotated Fig. 5 (2) of HLADIO; as previously modified above, see claim 1, second arm 210 of Schule ‘064 extends from intermediary member 1100 of Schule ‘064 to a portion of the first upper end which is the upright portion of the arm as labeled in Annotated Fig. 5 (2) of HLADIO); and wherein the movable frame portion (110 of Schule ‘064) extends from the fixed frame portion (210 of Schule ‘064) to the second upper end (see Annotated Fig. 5 (2) of HLADIO; as previously modified above, see claim 1, the first arm 110 of Schule ‘064 extends from the second arm 210 of Schule ‘064 to a portion of the second upper end which is the upright portion of the arm as labeled in Annotated Fig. 5 (2) of HLADIO).
Regarding claim 5, HLADIO in view of Schule ‘064 further in view of Schuele ‘592 discloses the invention as discussed in claim 4. HLADIO in view of Schule ‘064 further in view of Schuele ‘592 further discloses wherein the first pin assembly includes two pins (see Annotated Fig. 5 (2) of HLADIO; the 1st pin assembly includes two pins, also see Fig. 2 of HLADIO pins 204 of HLADIO) and the second pin assembly includes one pin (see Annotated Fig. 5 (2) of HLADIO; the 2nd pin assembly includes one pin, see Fig. 2 of HLADIO pin 204 of HLADIO).
Regarding claim 7, HLADIO in view of Schule ‘064 further in view of Schuele ‘592 discloses the invention as discussed in claim 4. HLADIO in view of Schule ‘064 further in view of Schuele ‘592 further discloses wherein the proximal end of the camera mount (300 of HLADIO) includes a receptacle lock (302 of HLADIO) configured to engage the receptacle (124 of Schuele ‘592) of the frame to prevent rotation of the camera mount (300 of HLADIO) relative to the fixed frame portion (210 of Schule ‘064) of the frame (as previously modified above, see claims 1 and 4, the proximal end of mounting arm 300 of HLADIO includes connector 302 of HLADIO, which is interpreted as a receptacle lock as connector 302 of HLADIO is a complementary starburst mechanism that engages with starburst mechanism 124 of Schuele ‘592, as it is also a starburst mechanism, and when connector 302 of HLADIO is secured, the starburst mechanism provides a highly rigid structure that is unlikely to shift or rotate, see [0072] of HLADIO which discusses how starburst mechanism are rigid connections, and thus prevents rotation of the mounting arm 300 of HLADIO relative to the fixed frame portion 210 of Schule ‘064).
Regarding claim 8, HLADIO in view of Schule ‘064 further in view of Schuele ‘592 discloses the invention as discussed in claim 7.
Schuele ‘592 further teaches an analogous head clamp (10) and wherein the receptacle (124) of the frame includes a series of projections and a series of receptacle spaces disposed between the projections (126) (see Figs. 3 and 6, and [0028], [0032]; the starburst interface 124 of the frame includes a series of projections or teeth 126 in Fig. 3 or teeth 224 in Fig. 6, and in between the teeth 126/224 are a series of spaces in order to form the teeth, and thus are a series of receptacle spaces), providing a better connecting mechanism that allows complementary starburst mechanisms to better mate with one another.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the receptacle (124 of Schuele ‘592) in the device of HLADIO in view of Schule ‘064 further in view of Schuele ‘592 with a series of projections and a series of receptacle spaces disposed between the projections as taught by Schuele ‘592 to have provided an improved head clamp device that provides a better connecting mechanism that allows complementary starburst mechanisms to better mate with one another.
Regarding claim 9, HLADIO in view of Schule ‘064 further in view of Schuele ‘592 discloses the invention as discussed in claim 8. HLADIO in view of Schule ‘064 further in view of Schuele ‘592 further discloses wherein the receptacle lock (302 of HLADIO) of the proximal end of the camera mount (300 of HLADIO) includes one or more lock projections dimensioned to fit into one or more of the receptacle spaces (see Fig. 3 of HLADIO; the connector 302 of HLADIO of the proximal end of the mounting arm 300 of HLADIO includes one or more lock projections, which are a series of complementary teeth that are dimensioned to fit into one or more of the receptacle spaces of starburst interface 124 of Schuele ‘592 in order for the two starburst features to mate, as Schuele ‘592 discloses that teeth 126/224 of Schuele ‘592 engage with a complementary starburst interface, see [0028], [0032] of Schuele ‘592).
Regarding claim 10, HLADIO in view of Schule ‘064 further in view of Schuele ‘592 discloses the invention as discussed in claim 9.
Schuele ‘592 further teaches an analogous head clamp (10) (see Fig. 1), and further comprising a fastener including a bolt (352) and a knob (354) configured to secure the proximal end of the mount (300) to the receptacle (124) of the frame (see Figs. 1, 13, and 14; threaded rod 352 is a bolt as the definition of bolt is “any of several types of strong fastening rods, pins, or screws, usually threaded to receive a nut,” https://www.dictionary.com/browse/bolt, and actuator 354 is a knob as actuator 354 projects out from body 301 and is rotated like a knob, and threaded rod 352 and actuator 354 are configured to secure a proximal end of the navigation adapter 300, which is a mount, to starburst interface 124, see Fig. 1, 3, and [0042]), providing a connection between starburst interfaces that can be oriented in a desired position (see [0042]) and providing a sturdy connection between starburst interfaces.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the proximal end of the camera mount (connector 302 of HLADIO) in the device of HLADIO in view of Schule ‘064 further in view of Schuele ‘592 with a fastener including a bolt (352) and a knob (354) as taught by Schuele ‘592 to have provided an improved head clamp that provides a connection between starburst interfaces that can be oriented in a desired position (see [0042]) and that provides a sturdy connection between starburst interfaces. Therefore, the combination of HLADIO in view of Schule ‘064 further in view of Schuele ‘592 results in a fastener including a bolt (352 of Schuele ‘592) and a knob (354 of Schuele ‘592) configured to secure the proximal end (where connector 302 of HLADIO is located) of the camera mount (300 of HLADIO) to the receptacle (202 of HLADIO) of the frame (as previously modified above, see above, threaded rod 352 of Schuele ‘592 and actuator 354 of Schuele ‘592 make up a fastener and they are configured to secure connector 302 of HLADIO of mounting arm 300 of HLADIO, see Fig. 3 of HLADIO, to connector 202 of HLADIO of the frame).
Regarding claim 11, HLADIO in view of Schule ‘064 further in view of Schuele ‘592 discloses the invention as discussed in claim 10.
Schuele ‘592 further teaches an analogous head clamp (10) (see Fig. 1), wherein the bolt (352) of the fastener is configured to extend through a bore in the proximal end of the mount (300) and to engage a bore (128) of the receptacle (124) of the frame (see Figs. 1, 3, 13-14, [0042], [0028], and Annotated Fig. 14 of Schuele ‘592; the threaded rod 352 is configured to extend through a bore in the proximal end of the navigation adapter 300, as labeled in Annotated Fig. 14, and the bolt 352 engages threaded bore 128 of the starburst interface 124), providing a connection between starburst interfaces that can be oriented in a desired position (see [0042]) and providing a sturdy connection between starburst interfaces.
Therefore, 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 proximal end of the camera mount (connector 302 of HLADIO) in the device of HLADIO in view of Schule ‘064 further in view of Schuele ‘592 with a bore in the proximal end and to engage a bore (128) of the receptacle of the frame as taught by Schuele ‘592 to have provided an improved head clamp that provides a connection between starburst interfaces that can be oriented in a desired position (see [0042]) and provides a sturdy connection between starburst interfaces. Therefore, the combination of HLADIO in view of Schule ‘064 further in view of Schuele ‘592 results in the bolt (352 of Schuele ‘592) of the fastener is configured to extend through a bore in the proximal end (where connector 302 of HLADIO is located) of the camera mount (300 of HLADIO) and to engage a bore (128 of Schuele ‘592) of the receptacle (202 of HLADIO) of the frame (as previously modified above, see above, threaded rod 352 of Schuele ‘592 is configured to extend through a bore in the proximal end of mounting arm 300 of HLADIO and engages threaded bore 128 of Schuele ‘592 of connector 202 of HLADIO).
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Annotated Fig. 14 of Schuele ‘592.
Regarding claim 14, HLADIO in view of Schule ‘064 further in view of Schuele ‘592 discloses the invention as discussed in claim 4.
Schuele ‘592 further teaches an analogous head clamp (10) (see Fig. 1), wherein the receptacle (208) of the frame is detachably secured to the first upper end of the frame (see Figs. 1-6; starburst interface 208 is a receptacle as it is used to contain/hold any accessories, and starburst interface 208 is detachably secured to the first upper end of the frame, as starburst interface 208 is attached to rail 118 via clamp 200, see [0029] and [0023]), providing an easy attachment mechanism that allows a user to decide to attach or detach the receptacle whenever necessary.
Therefore, 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 receptacle (124 of Schuele ‘592) of the device of HLADIO in view of Schule ‘064 further in view of Schuele ‘592 to be in the form of a clamp (200) such that the receptacle is detachably secured to the first upper end of the frame as taught by Schuele ‘592 to have provided an improved head clamp device that provides an easy attachment mechanism that allows a user to decide to attach or detach the receptacle whenever necessary.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over HLADIO in view of Schule ‘064 in view of Schuele ‘592 further in view of Schuele (US 8,844,536 B1) (referred to as “Schuele ‘536”).
Regarding claim 6, HLADIO in view of Schule ‘064 further in view of Schuele ‘592 discloses the invention as discussed in claim 5.
HLADIO in view of Schule ‘064 further in view of Schuele ‘592 is silent on wherein the first pin assembly further includes a rotating base and a rotational lock; wherein the two pins of the first pin assembly are secured to the rotating base to selectively rotate the two pins; wherein in an engaged position the rotational lock prevents rotation of the rotating base.
However, Schuele ‘536 teaches an analogous head clamp (10) (see Fig. 1) and an analogous first pin assembly (60), wherein the first pin assembly (60) further includes a rotating base (200) and a rotational lock (400) (see Figs. 1-2 and Col. 9 lines 50-66; the dual pin fixture 60 includes arch member 200 which is a rotating base as arch member 200 is located at the base of dual pin fixture 60, and the rotational position of arch member 200 is able to be adjusted, see Col. 9 lines 62-66, and dual pin fixture 60 also includes rotating disc 400 which is a rotational lock as when rotating disc 400 is rotated in a certain direction and causes connector 300 to be translated towards arch member 200, the position of arch member 200 is locked, see Col. 9 lines 57-62); wherein the two pins (61) of the first pin assembly (60) are secured to the rotating base (200) to selectively rotate the two pin (61) (see Figs. 1-2 and Col. 10 lines 5-11; the two skull pins 61 of the dual pin fixture 60 are secured to arch member 200 to selectively rotate the two skull pins 61); wherein in an engaged position the rotational lock (400) prevents rotation of the rotating base (200) (see Figs. 1-2 and Col. 9 lines 50-66; when rotating disc 400 is rotated and in an engaged position such that connector 300 is translated toward arch member 200, teeth 341 of connector 300 engage teeth 229 of arch member 200, the position of arch member 200 is secured or locked in place, thus preventing rotation of the arch member 200), providing a locking mechanism for a pair of skull pins to be selectively secured so that the stabilizing fixture can be adjustably rotated to a desired position (see Abstract).
Therefore, 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 first pin assembly of HLADIO in view of Schule ‘064 further in view of Schuele ‘592 to include a rotating base (200) and a rotational lock (400) as taught by Schuele ‘536 such that the two pins of the first pin assembly are secured to the rotating baes to selectively rotate the two pins and when in an engaged position, the rotational lock prevents rotation of the rotating base to have provided an improved head clamp that provides a locking mechanism for a pair of skull pins to be selectively secured so that the stabilizing fixture can be adjustably rotated to a desired position (see Abstract).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over HLADIO in view of Schule ‘064 further in view of Lemieux et al. (US 2002/0109053 A1) (referred to as “Lemieux”).
Regarding claim 12, HLADIO in view of Schule ‘064 further in view of Schuele ‘592 discloses the invention as discussed in claim 4.
HLADIO in view of Schule ‘064 further in view of Schuele ‘592 is silent on wherein the camera receptacle at the distal end of the camera mount includes an upper surface having a plurality of ridges.
However, Lemieux teaches an analogous camera receptacle (1A) (see Fig. 1), wherein the camera receptacle (1A) includes an upper surface having a plurality of ridges (see Figs. 1-2; camera attachment plate 1A is a camera receptacle as it holds/contains camera 2, and an upper surface of the camera receptacle 1A has a plurality of ridges, as there are multiple concentric o-rings 1 on the upper surface of the camera receptacle 1A, and thus the areas in between the concentric o-rings 1 are considered to be a plurality of ridges, as the definition of a ridge is “an elevated body part or structure, or a raised strip,” https://www.merriam-webster.com/dictionary/ridge, and thus the areas in between the concentric o-rings 1 are an elevated structure or raised strip, as best seen in Fig. 2, as in Fig. 2 the o-ring grooves 1c are shown and the elevated strips in between are also better shown, see [0016]), providing a firm, non-slip engagement between the camera receptacle and the camera (see [0020]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided an upper surface of the camera receptacle (306 of HLADIO) in the device of HLADIO in view of Schule ‘064 further in view of Schuele ‘592 with a plurality of ridges as taught by Lemieux to have provided an improved head clamp that provides a firm, non-slip engagement between the camera receptacle and the camera. Therefore, the combination of HLADIO in view of Schule ‘064 in view of Schuele ‘592 further in view of Lemieux results in the camera receptacle (36 of HLADIO) at the distal end of the camera mount (300 of HLADIO) includes an upper surface having a plurality of ridges (as previously modified above, see above, an upper surface of the camera mount 306 of HLADIO located at the distal end of the mounting arm 300 of HLADIO has a plurality of ridges, see Figs. 1-2 of Lemieux which shows the raised/elevated strips between the concentric o-rings 1 of Lemieux).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over HLADIO in view of Schule ‘064 in view of Lemieux further in view of Olinger (US 2019/0368653 A1).
Regarding claim 13, HLADIO in view of Schule ‘064 in view of Schuele ‘592 further in view of Lemieux discloses the invention as discussed in claim 12.
Lemieux further teaches an analogous camera receptacle (1A), wherein the camera receptacle (1A) further includes a threaded bolt (1B) (see Fig. 1; screw thread 1B is a threaded bolt, as the definition of bolt is “any of several types of strong fastening rods, pins, or screws, usually threaded to receive a nut,” https://www.dictionary.com/browse/bolt), wherein the threaded bolt (1B) extends upwards beyond the plurality of ridges (see Figs. 1-2; the screw thread 1B extends upwards beyond the plurality of ridges, which are the areas in between the concentric ring grooves 1/1c), providing a secure attachment means between the camera receptacle and camera.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the camera receptacle (306 of HLADIO) in the device of HLADIO in view of Schule ‘064 in view of Schuele ‘592 further in view of Lemieux to further include a threaded bolt (1B) as taught by Lemieux that extends upwards beyond the plurality of ridges to have provided an improved head clamp that provides a secure attachment means between the camera receptacle and camera.
HLADIO in view of Schule ‘064 in view of Schuele ‘592 further in view of Lemieux discloses the invention as discussed above.
HLADIO in view of Schule ‘064 in view of Schuele ‘592 further in view of Lemieux is silent on wherein the camera receptacle further includes a knob.
However, Olinger teaches an analogous camera receptacle (see Figs. 1A-1C) wherein the camera receptacle further includes a knob (38) (see Figs. 1A-1C; the camera receptacle shown in Figs. 1A-1C further includes knob 38), providing an easy to grasp handle that allows a user to easily lock/unlock the camera from the desired position.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the camera receptacle (306 of HLADIO) in the device of HLADIO in view of Schule ‘064 in view of Schuele ‘592 further in view of Lemieux with a knob (38) as taught by Olinger to have provided an improved head clamp that provides an easy to grasp handle that allows a user to easily lock/unlock the camera from the desired position.
Claim(s) 15, 16, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schuele ‘592 in view of Schule ‘064 further in view of HLADIO.
Regarding claim 15, Schuele ‘592 discloses a fixed camera head clamp system (10) for facilitating image-guided surgery (see Figs. 1-3 and [0024]; head fixation device, or HFD 10 is a head clamp system that includes starburst interface 124 to mount various accessories or other components, such as a fixed camera to facilitate image-guided surgery), comprising:
a frame (102), wherein the frame (102) comprises a first arm (104,106) and a second arm (104,106) (see Figs. 1-2; arms 102 make up the frame of HFD 10, and arms 102 each have a lateral portion 104 and an upright portion 106, which each makes up the first arm and second arms); wherein the first arm (104, 106) comprises a first upper end (see Figs. 1-2; the upright portion 106 on a left side makes up a first upper end of the first arm 104, 106), and the second arm (104, 106) comprises a second upper end (see Figs. 1-2; the upright portion 106 on a right side makes up a second upper end of the second arm 104, 106), with a receptacle (124) disposed at the first upper end (see Figs. 1-3 and [0024]; starburst interface 124 is a receptacle as starburst interface 124 is configured to receive various accessories or other components, and thus holds of contains the various accessories when they are attached to starburst interface 124, and starburst feature 124 is disposed at the upright portion 106 on left side, as best seen in Figs. 2-3); wherein the frame (102) defines a central space dimensioned to receive a patient’s head (see Figs. 1-3; arms 102 define a central space dimensioned to receive a patient’s head);
a first pin assembly (112) secured to the first upper end of the frame (102) (see Figs. 1-2; rocker arm 112 includes dual skull pins 114 and are secured to the upright portion 106 of arm 102 on the left side, and thus is secured to the first upper end);
a second pin assembly (116) secured to the second upper end of the frame (102) (see Figs. 1-2; skull pin 116 is secured to the upright portion 106 of arm 102 on the right side, and thus is secured to the second upper end).
Schuele ‘592 is silent on a base support; a frame secured to an upper end of the base support, and a camera mount extending from a proximal end to a distal end, wherein the proximal end of the camera mount is selectively secured to the receptacle of the frame, wherein the distal end of the camera mount includes a camera receptacle; and a localizing camera selectively attached to the camera receptacle.
However, Schule ‘064 teaches an analogous head clamp (10) further comprising a base support (1100) (see Fig. 3A-4C; the skull clamp 10 further comprises intermediary member 1100 which is interpreted as a base support as it is disposed at the base of skull clamp 10 and acts as a support when connected to base unit 810); a frame (110, 210) secured to an upper end of the base support (1100) (see Figs. 3A-4C; first arm 110 and second arm 210 make up a frame of the skull clamp 10, and first arm 110 and second arm 210 are secured to an upper end of intermediary member 1100 as seen in Fig. 3A), providing a support mechanism that further connects to a base unit for attaching the head clamp to an operating table making it easier for medical professionals to attach the device.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided a central portion of the frame of the head clamp (10) of Schuele ‘592 with a base support (1100) as taught by Schule ‘064 to have provided an improved head clamp that provides a support mechanism that further connects to an attachment section for attaching the head clamp to an operating table making it easier for medical professionals to attach the device.
Schuele ‘592 in view of Schule ‘064 discloses the invention as discussed above.
Schuele ‘592 in view of Schule ‘094 is silent on a camera mount extending from a proximal end to a distal end, wherein the proximal end of the camera mount is selectively secured to the receptacle of the frame, wherein the distal end of the camera mount includes a camera receptacle; and a localizing camera selectively attached to the camera receptacle.
However, HLADIO teaches an analogous head clamp (108) (see Fig. 5; head clamp 108 holds the patient’s anatomy/head 112 and thus is a head clamp), and a camera mount (300) extending from a proximal end to a distal end (see Figs. 3, 5, and 7; the mounting arm 300 extends from a proximal end, which is where connector 302 is located as it is the point of attachment, to a distal end, which is where camera mount 306 is located), wherein the proximal end of the camera mount (300) is selectively secured to an analogous receptacle (202) of the frame (see Figs. 3, 5, and 7; the proximal end of mounting arm 300 is where connector 302 is located, and thus is selectively secured to the connector 202, which is a starburst mechanism of the frame via connector 302, see [0073], and thus connector 202 is a receptacle as connector 202 holds and contains the mounting arm 300); and a localizing camera (102) selectively attached to the camera receptacle (306) (see [0079] and Figs. 3 and 5; the camera 102 may selectively be attached to the camera mount 306, as the camera mount 306 may be a releasable and repeatable connection), providing a camera mount to allow for visualization of a medical image of the patient anatomy in a sterile environment (see [0002]) to allow for safer surgical procedures.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the receptacle (starburst interface 124 of Schuele ‘592) in the device of Schuele ‘592 in view of Schule ‘064 with a camera mount (300) that extends from a proximal to a distal end, wherein the proximal end of the camera mount is selectively secured to the receptacle of the frame, wherein the distal end of the camera mount includes a camera receptacle; and a localizing camera selectively attached to the camera receptacle as taught by HLADIO, as Schuele ‘592 contemplates the attachment of various accessories or other components mounted to the starburst interface 124, see [0024] of Schuele ‘592, to have provided an improved head clamp system that provides a camera mount to allow for visualization of a medical image of the patient anatomy in a sterile environment (see [0002]) to allow for safer surgical procedures.
Regarding claim 16, Schuele ‘592 in view of Schule ‘064 further in view of HLADIO discloses the invention as discussed in claim 15.
HLADIO further teaches a drape (904) configured to cover the localizing camera (102 of HLADIO) while the localizing camera (102 of HLADIO) is attached to the camera receptacle (306 of HLADIO) (see Fig. 9 of HLADIO and [0084]; drape 904 is configured to cover camera 102 while the camera 102 is attached to camera mount 306 as seen in Fig. 9), providing a drape around the camera in order to keep the field sterile when necessary.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the camera (102 of HLADIO) in the device of Schuele ‘592 in view of Schule ‘064 further in view of HLADIO with a drape (904) while the localizing camera is attached to the camera receptacle as taught by HLADIO to have provided an improved head clamp device that provides a drape around the camera in order to keep the field sterile when necessary.
Regarding claim 19, Schuele ‘592 in view of Schule ‘064 further in view of HLADIO discloses the invention as discussed in claim 15.
Although Schuele ‘592 in view of Schule ‘064 further in view of HLADIO does not explicitly disclose wherein the localizing camera is positioned 15 cm or less from the first pin assembly when attached to the camera receptacle, it is noted that the applicant does not indicate that the claimed dimension is used for a particular purpose, solves a stated problem, or is otherwise critical (see [0031] of applicant’s specification). Therefore, in Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit 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, and thus 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 position of the localizing camera (102 of HLADIO) in the device of Schuele ‘592 in view of Schule ‘064 further in view of HLADIO to be 15 cm or less from the first pin assembly when attached to the camera receptacle (306 of HLADIO) in order to position the camera close enough to have a clear view of the procedure site, as the mounting arm 300 of HLADIO, which holds the localizing camera 102 of HLADIO, provides six degrees of positional alignment via angular joint 308 and ball joint 304 and thus can be positioned to one’s needs, and as the localizing camera 102 of HLADIO may be positioned to a desired alignment with the surgical site subject, see [0102] of HLADIO.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schuele ‘592 in view of Schuele ‘064 in view of HLADIO further in view of Fung et al. (US 2015/0235335 A1) (referred to as “Fung”).
Regarding claim 17, Schuele ‘592 in view of Schule ‘064 further in view of HLADIO discloses the invention as discussed in claim 15.
Schuele ‘592 in view of Schule ‘064 further in view of HLADIO is silent on wherein the localizing camera has a field of view of at least 120 degrees.
However, Fung teaches an analogous localizing camera (camera 208), wherein the localizing camera (208) has a field of view of at least 120 degrees (see [0046]; camera 208 may be configured to have a field of view of 120-170 degrees, and thus is at least 120 degrees as claimed), providing a camera that has a wide enough field of view to sufficiently capture what is necessary.
Therefore, 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 localizing camera (102 of HLADIO) in the device of Schuele ‘592 in view of Schule ‘064 further in view of HLADIO to have a field of view of at least 120 degrees as taught by Fung to have provided an improved fixed camera head clamp system that provides a camera that has a wide enough field of view to sufficiently capture what is necessary.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schuele ‘592 in view of Schule ‘064 in view of HLADIO further in view of Harvey (US 4,652,104).
Regarding claim 18, Schuele ‘592 in view of Schule ‘064 further in view of HLADIO discloses the invention as discussed in claim 15.
Schuele ‘592 in view of Schule ‘064 further in view of HLADIO is silent on wherein the localizing camera has a view range of 1 cm to 75 cm.
However, Harvey teaches an analogous camera that has a view range of 1 cm to 75 cm (see Fig. 7 and Col. 2 lines 48-51 and Col. 5 lines 2-4; the lens in the camera has a telephoto limit of 80 mm or 8 cm which provides the camera with a view range of 8 cm, which is within the claimed range), providing a camera that has a close view range such that a medical professional is able to easily and sufficiently see the necessary areas during a procedure.
Therefore, 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 view range of the localizing camera (102 of HLADIO) in the device of Schuele ‘592 in view of Schule ‘064 further in view of HLADIO to be 1 cm to 75 cm as taught by Harvey to have provided an improved fixed camera head clamp system that provides a camera that has a close view range such that a medical professional is able to easily and sufficiently see the necessary areas during a procedure.
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over HLADIO in view of Lemieux.
Regarding claim 30, HLADIO discloses the invention as discussed in claim 27.
HLADIO is silent on wherein the camera receptacle of the camera mount includes an upper surface having a plurality of ridges.
However, Lemieux teaches an analogous camera receptacle (1A) (see Fig. 1), wherein the camera receptacle (1A) of the camera mount includes an upper surface having a plurality of ridges (see Figs. 1-2; camera attachment plate 1A is a camera receptacle as it holds/contains camera 2, and an upper surface of the camera receptacle 1A of the camera mount, which is the entire device shown in Fig. 1, has a plurality of ridges, as there are multiple concentric o-rings 1 on the upper surface of the camera receptacle 1A, and thus the areas in between the concentric o-rings 1 are considered to be a plurality of ridges, as the definition of a ridge is “an elevated body part or structure, or a raised strip,” https://www.merriam-webster.com/dictionary/ridge, and thus the areas in between the concentric o-rings 1 are an elevated structure or raised strip, as best seen in Fig. 2, as in Fig. 2 the o-ring grooves 1c are shown and the elevated strips in between are also better shown, see [0016]), providing a firm, non-slip engagement between the camera receptacle and the camera (see [0020]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided an upper surface of the camera receptacle (306 of HLADIO) in the device of HLADIO with a plurality of ridges as taught by Lemieux to have provided an improved head clamp that provides a firm, non-slip engagement between the camera receptacle and the camera.
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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/ROBIN HAN/Examiner, Art Unit 3786
/ALIREZA NIA/Supervisory Patent Examiner, Art Unit 3786
