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
The amendments filed on 09/09/2025 have been entered. Claims 1-4 and 6-21 remain pending in the application.
Response to Arguments
Applicant’s arguments, see pages 7-8, filed 09/09/2025 with respect to the rejection(s) of claim(s) 1 and 15 under 35 USC 102(a)(1) in view of Oostman and in view of Piferi have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Kampen and Solar.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, 9, 10, and 12-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by van Kampen (US 2021/0169586).
Regarding claim 1, van Kampen discloses a surgical fiducial marker unit (100, FIGs 2-3C, [0032-0040]), comprising: a main body (102) having a top surface (112), a bottom surface (Bottom surface of legs 108), a length (“OD”, FIG 3B), a width (“OD” taken in a perpendicular direction, since the body is circular. FIG 3A or 3C for a width and height), and a thickness (Top to bottom dimension in FIG 3B), wherein the thickness is substantially less than both the length and the width (The frame is thin relative to its length and width, best illustrated in FIG 3B); a plurality of fiducial marker sites coupled to the main body ([0040] discloses fiducial markers 118 are embedded into the top surface of the main body. Therefore the indentations which receive the embedded markers are interpreted as the marker sites) and configured to host a plurality of surgical fiducial markers suitable for use with a separate augmented reality system (The sites host marker 118, [0040], FIG 3A, wherein CT scan forms the separate augmented reality system to be used to visualize the markers), each of the plurality of fiducial marker sites including a socket having a size and shape that corresponds to the size and shape of an entire surgical fiducial marker ([0040] discloses the markers are circular and embedded into the top surface 112. Side view FIG 3B shows the top surface is flat, therefore the markers are embedded to be flush with the top surface. Thus the holes which fully receive the circular markers are interpreted as sockets having a size and shape of an entire marker) and that is configured to receive the entire surgical fiducial marker therein (As FIG 3A-3B show the markers do not protrude from the top surface of the main body, therefore the entire marker is received within each marker site), each socket having a socket wall (Circumferential wall) that surrounds a recess (Circular opening which receives the marker embedded therein) and an open top (FIG 3A which shows the markers 118 are visible from the top) such that an upper surface of the surgical fiducial marker fitted within the recess is optically visible (FIG 3A, [0040]), wherein the plurality of fiducial marker sites are distributed across the top surface at fixed positions relative to each other (FIG 3A shows the marker are at the top surface in fixed positions which are predefined in the main body) to form a fixed positional arrangement that is asymmetrical (The inclusion of a reference marker makes the grid asymmetrical). [0040] “One of the pluralities of fiducial markers 118 has a bigger size than other fiducial markers 118 to indicate the north direction”); and an adhesive layer disposed on the bottom surface ([0036] discloses use of an adhesive to affix the legs 108, which form the bottom surface, to the body of the patient) wherein the adhesive layer is configured to securely adhere the main body to a patient during a surgical procedure ([0036]).
Regarding claim 2, van Kampen discloses the plurality of surgical fiducial markers coupled to the plurality of fiducial marker sites (FIG 2 shows markers 118 coupled to the frame at their respective sites).
Regarding claim 3, van Kampen discloses each of the plurality of surgical fiducial markers defines a circular disk ([0040] discloses the shape as being discs) having a flat upper surface (it is understood that a disc shaped marker has a flat upper surface) configured to be visible by a component of the separate augmented reality system when the circular disk is coupled to one of the fiducial marker sites ([0040] discloses the discs are radio-opaque markers highly visible on a CT scanner).
Regarding claim 9, van Kampen discloses the main body defines a curved shape that conforms to a curved shape of the forehead of the patient (As shown in FIG 2, 2B, and 3B, the bottom of legs 108 has at least some curvature which conforms to the head).
Regarding claim 10, van Kampen discloses the main body is formed from a rigid material configured to maintain the fixed positions of the plurality of fiducial marker sites ([0038] discloses frame 102 is sufficiently rigid to retain its shape during at least a single use. The frame is at least configured to maintain the fixed position of the marker sites in conjunction with the adhesive on the bottom surface).
Regarding claim 12, van Kampen discloses the plurality of fiducial marker sites includes at least four fiducial marker sites ([0040] discloses for example 10 markers).
Regarding claims 13-14, van Kampen an augmented reality system reference feature located on the top surface of the main body ([0040] discloses one of the pluralities of fiducial markers 118 has a bigger size than other fiducial markers 118 to indicate the north direction which means 0 degree of the ring angle as a pre-defined parameter. The one differently sized marker is interpreted as a reference feature), wherein the augmented reality system reference feature is separate from the plurality of reference marker sites (This reference marker is separate from the remainder of the smaller sized markers) wherein the augmented reality system reference feature includes a divot extending into the top surface (The socket formed in the top surface to receive the marker is interpreted as a divot), the divot being configured as a known reference point for registering a point of a separate handheld localizer device (FIG 3A shows the larger marker site, [0040] discloses the use of said references feature by the separate localizer device to establish a rotational orientation of the device).
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) 4 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over van Kampen (US 2021/0169586) in view of Shelton (US 2023/0102358).
Regarding claims 4 and 21, van Kampen discloses the invention substantially as claimed, as set forth above for claim 3.
Van Kampen is silent regarding each circular disk including a thin film formed from an infrared reflective material across its upper surface that is configured to be detected by the component of the separate augmented reality system.
However, Shelton teaches a fiducial marker (1320, FIGs 24-26) in the shape of circular discs (FIGs 24-26) each including a thin film formed from an infrared reflective material across its upper surface ([0202] teaches the markers are made of layers, for example FIG 26 has a top layer 1326 configured to be read using infrared light) that is configured to be detected by the component of the separate augmented reality system ([0202], the layer is configured to be detected using IR light).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the upper surface of each circular disc of the markers to comprise a film made of IR reflective material, as taught by Shelton, for the purpose of forming a layer of the marker which is visible using a particular type of light to correspond to the particular visualization technique of the system being used to image the device.
Claim(s) 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over van Kampen (US 2021/0169586) in view of Solar (US 2010/0063388).
Regarding claims 6 and 7, van Kampen discloses the invention substantially as claimed, as set forth above for claim 3.
Van Kampen is silent regarding each socket is oriented at an angle with respect to the top surface of the main body such that the flat upper surface of an entire circular disk received therein faces a different direction than the direction faced by the top surface of the main and all sockets at all fiducial marker sites are oriented at the same angle with respect to the top surface of the main body.
However, Solar teaches in the same field of endeavor a fiducial device (714, FIG 7B, [0078-0079]) configured for use with a surgical augmented reality system (Usable with a system of FIG 4), the fiducial device comprising: a surgical fiducial marker (716) defining a circular disk having a flat upper surface (FIG 7B, [0079-0080] disclose 716 is an imagable reflective surface in the shape of a circle, thereby forming a circular disk having a flat upper surface) configured to be detected by a detection component of the surgical augmented reality system (Camera of the optical positioning system 412, [0079]); and a socket (702) having a size and shape that corresponds to the surgical fiducial marker and that holds the entire surgical fiducial marker therein ([0079-0080], the marker 716 is affixed to the flat tup surface 718 of the pivoting head), wherein each socket is oriented at an angle with respect to the top surface of the main body such that the flat upper surface of an entire circular disk received therein faces a different direction than the direction faced by the top surface of the main (FIG 7B shows the tilting of the socket such that the flat disc shape marker 716 faces at an angled direction, [0079-0080]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify each fiducial marker site of van Kampen to comprise a pivotable head attached to the main body, as taught by Solar, such that each socket is oriented at an angle with respect to the top surface of the main body, thereby achieving the predictable result of aiming the flat upper surfaces of the fiducial markers in the correct direction of the augmented reality system to allow for detection of the maker sites. It would have been further obvious to orient all sockets at all fiducial marker sites at the same angle with respect to the top surface of the main body such that they can be equally visualized and registered by the augmented reality system.
Claim(s) 8 is rejected under 35 U.S.C. 103 as being unpatentable over van Kampen (US 2021/0169586).
Regarding claim 8, van Kampen discloses the invention substantially as claimed, as set forth above for claim 1. van Kampen further discloses the main body includes a central region that has at least some of the plurality of fiducial marker sites (The marker sites of 118 in FIG 3A are interpreted as being in a central region of the main body).
Van Kampen is silent regarding multiple extensions from the central region that collectively have at least some of the plurality of fiducial marker sites.
However, van Kampen teaches in the alternative embodiment of FIG 7, a main body (202) which has fiducial marker sites (218, [0048]) located at multiple extensions from the central region (FIG 7 shows the markers placed at radially outward extensions form the main body central region).
Therefore, it would have been an obvious matter of design choice to combine the fiducial marker site placement of the embodiment of FIG 7 with the embedment of FIG 3A, such that markers are placed both at a central region and a multiple extensions, for the purpose of creating additional reference points in order to better determine the rotational alignment and positioning of the device.
Claim(s) 11 is rejected under 35 U.S.C. 103 as being unpatentable over van Kampen (US 2021/0169586) in view of Oostman (US 2014/0276959).
Regarding claim 11, van Kampen discloses the invention substantially as claimed, as set forth above for claim 1.
Van Kampen is silent regarding the main body being formed from a flexible material configured to facilitate greater conformity between the main body and the patient when the main body is securely adhered to the patient.
However, Oostman teaches in the same field of endeavor of fiducial marker units (400, FIG 4A-4B)) for placement of the scalp of a patient ([0061]) wherein a main body (402) is formed from a flexible material ([0061] discloses frame 402 may be made of flexible material) configured to facilitate greater conformity between the main body and the patient when the main body is securely adhered to the patient ([0018] discloses the frame may be at least partially flexible to conform to the body surface of the patient). Oostman further contemplates that the same device can alternatively be made of a rigid material ([0061]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the rigid main body of van Kampen to be formed of a flexible material, as taught by Oostman, for the purpose of providing the main body with the ability to better conform to the shape of the scalp where the device is being adhered to.
Claim(s) 15 and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Solar (US 2010/0063388) in view of van Kampen (US 2021/0169586).
Regarding claim 15, Solar discloses a fiducial device (714, FIG 7B, [0078-0079]) configured for use with a surgical augmented reality system (Usable with a system of FIG 4), the fiducial device comprising: a surgical fiducial marker (716) defining a circular disk having a flat upper surface (FIG 7B, [0079-0080] disclose 716 is an imagable reflective surface in the shape of a circle, thereby forming a circular disk having a flat upper surface) configured to be detected by a detection component of the surgical augmented reality system (Camera of the optical positioning system 412, [0079]); and a holder (702) having a size and shape that corresponds to the surgical fiducial marker and that holds the entire surgical fiducial marker therein ([0079-0080], the marker 716 is affixed to the flat tup surface 718 of the pivoting head), wherein the holder is configured to be coupled to a separate surgical fiducial marker unit having multiple fiducial marker sites (Assembly is attachable to a separate surgical fiducial marker unit, such as 804, FIG 9, [0082], having multiple fiducial marker sites, such as receptacles 924 which each receive a locator assembly, [0087]).
Solar is silent regarding the holder being a socket having a socket wall that surrounds a recess and an open top such that an upper surface of the surgical fiducial marker fitted within the recess is optically visible.
However, van Kampen discloses a surgical fiducial marker unit (100, FIGs 2-3C, [0032-0040]), comprising a fiducial marker holder ([0040] discloses fiducial markers 118 are embedded into the top surface of the main body. Therefore the indentations which receive the embedded markers are interpreted as the marker sites) configured to host a fiducial marker suitable for use with a separate augmented reality system (The sites host marker 118, [0040], FIG 3A, wherein CT scan forms the separate augmented reality system to be used to visualize the markers), the holder being formed as a socket having a size and shape that corresponds to the size and shape of an entire surgical fiducial marker ([0040] discloses the markers are circular and embedded into the top surface 112. Side view FIG 3B shows the top surface is flat, therefore the markers are embedded to be flush with the top surface. Thus the holes which fully receive the circular markers are interpreted as sockets having a size and shape of an entire marker) and that is configured to receive the entire surgical fiducial marker therein (As FIG 3A-3B show the markers do not protrude from the top surface of the main body, therefore the entire marker is received within each marker site), each socket having a socket wall (Circumferential wall) that surrounds a recess (Circular opening which receives the marker embedded therein) and an open top (FIG 3A which shows the markers 118 are visible from the top) such that an upper surface of the surgical fiducial marker fitted within the recess is optically visible (FIG 3A, [0040]). Van Kampen further teaches the fiducial marker can either be disc shaped and embedded in the surface, or they can be flat and printed on to the top surface ([0040]), thereby teaching that the two different designs are interchangable.
Therefore, it would have been obvious to one or ordinary skill in the art at the time of filing to modify the fiducial marker of Solar from being a flat circular marker printed on the top surface of the holder to instead be a three dimensional disc embedded in a socket formed by the holder, as taught by van Kampen, wherein the socket comprises a socket wall that surrounds a recess and an open top such that an upper surface of the surgical fiducial marker fitted within the recess is optically visible, since substitution of one fiducial marker type for the other would not require an inventive step and would achieve the predictable result of securing the fiducial marker to the marker site in a fixed manner.
Regarding claims 17-18, Solar /van Kampen disclose the invention substantially as claimed, as set forth above for claim 15. Solar further discloses the socket is further configured to be oriented at an angle with respect to a surface of the separate surgical fiducial marker unit (FIG 7B shows the socket is formed as a swiveling head, [0078-0080], therefore being configured to be angled relative to a surface of a marker unit such as when attached to frame of FIG 9) and further wherein the angle of orientation is adjustable ([0078] discloses the socket is swiveling and adjustably tiltable).
Regarding claim 19, Solar /van Kampen disclose the invention substantially as claimed, as set forth above for claim 15. Solar further discloses the socket is further configured to be able to coordinate with other similar sockets such that the fiducial device is configured to be part of an array of coordinated fiducial devices on the separate surgical fiducial marker unit (See array in FIG 9 wherein a plurality of fiducial devices can be affixed to marker unit 804, [0084-0087]).
Claim(s) 16 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Solar (US 2010/0063388) in view of van Kampen (US 2021/0169586), further in view of Shelton (US 2023/0102358).
Regarding claims 16 and 20, Solar /van Kampen discloses the invention substantially as claimed, as set forth above for claim 15.
Solar /Van Kampen is silent regarding each circular disk including a thin film formed from an infrared reflective material across its upper surface that is configured to be detected by the component of the separate augmented reality system.
However, Shelton teaches a fiducial marker (1320, FIGs 24-26) in the shape of circular discs (FIGs 24-26) each including a thin film formed from an infrared reflective material across its upper surface ([0202] teaches the markers are made of layers, for example FIG 26 has a top layer 1326 configured to be read using infrared light) that is configured to be detected by the component of the separate augmented reality system ([0202], the layer is configured to be detected using IR light).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the upper surface of each circular disc of the markers to comprise a film made of IR reflective material, as taught by Shelton, for the purpose of forming a layer of the marker which is visible using a particular type of light to correspond to the particular visualization technique of the system being used to image the device.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 5712727134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BROOKE LABRANCHE/ Primary Examiner, Art Unit 3771