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 .
DETAILED ACTION
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 4–6, 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Azizian et al. US2013/0274596 and further in view of Kubo US2015/0016705.
For claim 1, Azizian discloses “A surgical camera system configured to capture image data indicative of a surgical implant comprising a fluorescent agent (0071-0072), the surgical camera system comprising:
a camera (CCD 105; fig 1; [0077]) comprising at least one sensor configured to capture image data comprising a first range of wavelengths (visual light source, e.g. white light) and a second range of wavelengths (narrow-band light source, e.g. near infrared);
an excitation light source (narrow-band source 102; [0077]) that emits an excitation emission at an excitation wavelength; and
a controller (image acquisition and control module 106; [0040, 0077]) in communication with the at least one sensor of the camera, the controller configured to:
process the image data from the at least one sensor ([0040, 0077]);
detect at least one fluorescent portion of the image data in response to a fluorescent emission generated by the fluorescent agent in the second range of wavelengths ([0040, 0077]);
identify a portion of the surgical implant in the image data where the at least one fluorescent portion is detected (0034, 0071, where displaying and highlighting on a display screen is interpreted as “identifying” since some portion of interest has been singled out and provided for visual display, i.e. identified);
and generate enhanced image data demonstrating a portion of the surgical implant visually distinguished from a remainder of the surgical implant ([0034, 0040, 0077])”.
Azizian does not disclose the controller configured to identify a portion of the surgical implant based on a “characteristic shape or pattern of the portion in the image data”. Kubo teaches in the same field of endeavor, providing a pattern for a fluorescent marker (marker F; fig 2A; 0025, provides a manner to further distinguish and specify significant portions or parts of an element by detecting differences in fluorescence intensity, i.e. providing the ability to further identify based intensity as a distinguishing feature, i.e. hatching, patterns) to indicate differences in fluorescence intensity. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Kubo into the invention of Azizian in order to configure the camera system e.g. as claimed because it provides a manner to communicate additional information in the form of differences in fluorescence intensity, i.e. further identifying substructures (0025).
For claim 4, Azizian discloses “The surgical camera system according to claim 1, wherein the fluorescent emission is transmitted from the fluorescent agent at an output wavelength different from the excitation wavelength (fig 4 shows emission spectra 401 is different from excitation spectra 400.
For claim 5, Azizian discloses “The surgical camera system according to claim 1, further comprising: a visible light source (light source 104) that emits light in the first range of wavelengths and wherein the excitation light source, the visible light source, and the camera are incorporated in an endoscope ([0062])”.
For claim 6, Azizian discloses “The surgical camera system according to claim 1, wherein the at least one sensor of the camera comprises a plurality of sensors comprising a first sensor configured to capture first data in the first range of wavelengths and a second sensor configured to capture second data in the second range of wavelengths ([0077] describes the CCD 105 can be two separate CCDs for each illumination type), wherein the controller is further configured to:
generate the enhanced image data by selectively applying an overlay defined by the second data from the second sensor over the first data from the first sensor (0075, 0077, 0087 describes the markers “can then be re-projected as an overlay” indicating an optionality and selectivity).
For claim 34, Azizian discloses “The system according to claim 1, wherein the fluorescent agent is formed as an insert of the portion of the surgical implant (0071: the fluorescence marker/color is added as a component of the device and is therefore considered “an insert”)”.
Claims 2, 3 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Azizian and Kubo as applied to claim 1 above, and further in view of Ito et al. US2019/0282135.
For claim 2 Azizian discloses “The surgical camera system according to claim 1, wherein the first range of wavelengths comprises wavelengths in the visible light range ([0092] describes the light source as a visible light source)”, but does not detail the “wavelengths comprises wavelengths from 400 nm to 650 nm”. Ito teaches in the same field of endeavor, visible light ranges from 400 nm to 700 nm ([0324]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the first range of wavelengths from 400 nm to 650 nm since it is known in the art to be in the range of a visible light source as taught by Ito.
For claim 3, Azizian discloses “The surgical camera system according to claim 2, wherein the second range of wavelengths comprises wavelengths ranging from 650 nm to 900 nm in a near-infrared range (excitation spectra 401; fig 4).
Claim(s) 11, 17, 19, 20, 26, 31-33, 36, 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Azizian and Kubo and further in view of Sendai US2003/0218137 and Gleich US20200397530.
For claim 11, Azizian discloses “A method for displaying a surgical assembly, the method comprising:
illuminating at least one fluorescent portion of the surgical assembly comprising a plurality of components of a surgical implant (0070 describes plural surgical tools, wherein a surgical tool is comprised of various connected components) in light comprising a first range of wavelengths corresponding to visible light and a second range of wavelengths comprising an excitation emission (narrow-band source 102; [0077]) wherein the surgical components are configured to form interconnected parts of the surgical assembly (a surgical tool is comprised of various connected components);
capturing first image data comprising the first range of wavelengths; capturing second image data comprising the second range of wavelengths demonstrating a fluorescent emission output from the fluorescent portion in response to the excitation emission ([0040, 0070, 0077-0078]);
Azizian does not disclose “identifying one or more portions of the plurality of surgical components forming portions of the surgical assembly as identified components, wherein a type or category of the identified components are identified based on a characteristic shape or pattern of the at least one fluorescent portion”.
Sendai teaches in the same field of endeavor a fluorescence intensity calculating section 412 which calculates multiple levels of fluorescence in tissues and generates color information for the various intensity levels [0140] and categorizing based on the fluorescence intensity, including the color information and the brightness information with an adjustable or customizable threshold level of intensity (0140). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Sendai into the invention of Azizian in order to configure the method for displaying a surgical implement e.g. as claimed, specifically, allowing the attribution of different colors to the fluorescence intensity in the color coding scheme of Azizian because it provides the customization of the threshold levels for detection and categorization (0140).
Additionally, Gleich teaches in the same field of endeavor, providing markers having a shape or attenuation pattern in order to provide type identification (0094). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Gleich into the invention of Azizian in order to configure the method e.g. as claimed, specifically, by using a shape or pattern characteristic of a marker to denote additional information, e.g. type identification because it allows communication of additional information.
Modified Azizian further discloses:
“generating enhanced image data demonstrating the first image data with at least one overlay or graphic demonstrating the fluorescent portion defined by the second image data overlaid on the first image data, wherein at least one overlay or graphic visually distinguishes the portion of the surgical assembly demonstrating each of the plurality of surgical components with a different color or identifying pattern (Azizian: [0040, 0047, 0070, 0077-0078]), and
communicating the enhanced image data for display on a display device, wherein the enhanced image data visually distinguishes the surgical components ([0040, 0070, 0077-0078])”.
For claim 17, Azizian discloses “The method according to claim 11, further comprising: detecting the fluorescent emission output from the fluorescent agent through fluid clouded by blood or particulates in a patient cavity. ([0070] mentions blood as tissue)”.
For claim 19, Azizian discloses “A surgical camera system configured to capture image data indicative of a surgical implement comprising a plurality of surgical components (0070 describes plural surgical tools) comprising a plurality of sutures (0089-0091 describes the marking of sutures, in particular suture knots and positions), the surgical camera system comprising:
a camera (CCD 105; fig 1; [0077]) comprising at least one sensor configured to capture image data comprising a first range of wavelengths and a second range of wavelengths; .
an excitation light source (narrow-band source 102; [0077]) that emits an excitation emission at an excitation wavelength; and
a controller (image acquisition and control module 106; [0040, 0077]) in communication with the sensor of the camera, the controller configured to:
process image data from the at least one image sensor comprising the first range of wavelengths and the second range of wavelengths ([0040, 0071-0077])”.
Azizian does not disclose:
“identify one of a plurality of surgical components in response to a characteristic shape or characteristic pattern of at least one fluorescent emissions output from the plurality of surgical components in the second range of wavelengths, wherein the surgical components form an interconnected assembly and the one of the plurality of surgical components is identified as a component type or category;
assign a distinctive color or pattern to the plurality of sutures distinguishing the plurality of surgical components of the interconnected assembly in response to the at least one fluorescent emission; and
generate enhanced image data demonstrating the plurality of surgical components in a plurality of distinct colors or patterns, wherein the distinct colors or patterns visually distinguish plurality of surgical components in the enhanced image data”.
To this end, Azizian teaches spraying, painting, attaching, and other modes for color identifying multiple different structures (0074), including sutures and portions of sutures as the plurality of surgical components (0089 describes detecting knot sections in the sutures and portions of the sutures themselves) using any marker which provides sufficient fluorescence, including mixing fluorescent dyes, suggesting the ability to generate various colors and shades (0071-0077). Additionally, Sendai teaches in the same field of endeavor a fluorescence intensity calculating section 412 which calculates multiple levels of fluorescence in tissues and generates color information for the various intensity levels [0140] and categorizing based on the fluorescence intensity, including the color information and the brightness information with an adjustable or customizable threshold level of intensity (0140). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Sendai into the invention of Azizian in order to configure the method for displaying a surgical implement e.g. as claimed, specifically, allowing the attribution of different colors to the fluorescence intensity in the color coding scheme of Azizian because it provides the customization of the threshold levels for detection and categorization (0140).
Additionally, Gleich teaches in the same field of endeavor, providing markers having a shape or attenuation pattern in order to provide type identification (0094). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Gleich into the invention of Azizian in order to configure the method e.g. as claimed, specifically, by using a shape or pattern characteristic of a marker to denote additional information, e.g. type identification because it allows communication of additional information.
For claim 20, modified Azizian discloses “The surgical camera system according to claim 19, wherein the enhancement of the image data comprises overlaying the distinct color or pattern over the fluorescent portion distinguishing a first suture from a second suture of the plurality of sutures (Azizian:[0047, 0075, 0089] describes different portions of a suture being identified and tracked, i.e. knots and sections of sutures; Sendai: [0140])”.
For claim 26, Azizian discloses “The method according to claim 11, wherein the plurality of like surgical components comprise a plurality of sutures, a plurality of surgical tools, or a plurality of implants (0089-0091)”.
For claim 31, Azizian discloses “The method according to claim 11, wherein the plurality of surgical components comprise a plurality of sutures forming portions of the surgical assembly (0089-0091 describes multiple components and sutures)”.
For claim 32, modified Azizian disclose “The method according to claim 11, further comprising: providing visual instructions to a viewer via a display screen based on the different colors or identifying patterns, wherein the different colors or identifying patterns distinguish the surgical component (Kubo: marker F; fig 2A; 0025)”.
For claim 33, Azizian discloses “The method according to claim 11, wherein the characteristic shape is a defining feature of the surgical implant (Gleich: 0094) and the method that distinguishes a first portion of the surgical implant from a second portion of the surgical implant (0071; marking the portion is considered itself a defining feature which distinguishes from a different portion since portions are in fact different portions and therefore distinguishable based on their difference) in response to the characteristic shape (Gleich: 0094)”.
For claim 36, Azizian discloses “The system according to claim 19, wherein the surgical components comprise a plurality of sutures (0089-0091 describes components as sutures and components of sutures such as knots and considered to include individual stitches of sutures)”.
Modified Azizian discloses for claim 37, “The system according to claim 1, wherein the portion of the surgical implant is identified as a type or category of surgical implement based on the characteristic shape or pattern of the portion in the image data (Gleich: 0094)”.
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Azizian and Kubo as applied to claim 1 above, and further in view of Tsai et al. US2016/0136393.
For claim 27, Azizian does not disclose “The surgical camera system according to claim 1, wherein the characteristic shape of the surgical implant is identified as a head portion of a surgical anchor or a fastener engaged by a surgical tool in a surgical procedure”.
To this end though, Azizian discloses identifying the surgical implement, but not disclose specifically the surgical implement as the head of a surgical anchor or fastener, i.e.:
identify the surgical implement as a portion of a surgical implant in response to detecting the at least one fluorescent portion, wherein the portion of the surgical implant corresponds to “a head of a surgical anchor or a fastener engaged by” a surgical tool in a surgical procedure; and generate enhanced image data demonstrating identifying the at least one fluorescent portion of the surgical implement in the image data “as the head”.
Tsai teaches in the same field of endeavor a surgical hook 462 having fluorescent markers to aid in visualization 0075. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Tsai into the invention of Azizian in order to configure the surgical camera system e.g. as claimed, including identifying the specific surgical element that is being tracked and targeted because it aids in visualization of the element that is being tracked and targeted (Tsai 0075).
Claim(s) 28, 29, 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Azizian and Kubo as applied to claim 1 above, and further in view of Reed US5868749.
For claim 28, Azizian does not disclose “The system according to claim 1, wherein the engagement portion of the surgical implant forms a recessed portion of a drive head of the surgical anchor or fastener”.
Reed teaches in the same field of endeavor, a bone screw with a recessed portion in the head as a surgical implant (figs 1-8). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Reed into the invention of Azizian in order to configure the system e.g. as claimed because it allows identification of bone screws.
For claim 29, modified Azizian discloses “The system according to claim 28, wherein the at least one fluorescent portion is formed in the recessed portion (Reed: fig 1-8) and a fluorescent emission is output from within the recessed portion distinguishing the recessed portion from the remainder of the surgical implant (Azizian: 0040, 0071, 0077)”.
For claim 35, modified Azizian as in claim 28 discloses “The system according to claim 1, wherein the fluorescent agent is implemented in an embedded structure of the portion of the surgical implant (Reed: figs 1-8 shows recessed structures considered to be “embedded”)”.
Response to Arguments
Applicant's arguments filed 10/28/2025 have been fully considered but they are not persuasive.
Applicant’s argument with respect to claim 1 is found to be not persuasive. The detection, highlighting, and displaying amounts to the claimed identifying. The detected fluorescence on the object of interest amounts to the characteristic shape of the object since the shape of the detected fluorescence is directly related to the form and shape of the object, e.g. the fluorescence portion reflects the surface structure of the object as the characteristic shape. Applicant’s additional arguments with respect to the claim appears to delve into claim scope which has not been explicitly claimed, i.e. “type or category identification”, but is referenced in the specification. This is further supported by the addition of new claim 37 which appears to explicitly claim this feature. As such, this argument with respect to claim 1 does not address the claimed subject matter and is therefore not persuasive.
Applicants’ other arguments are moot considering the new grounds of rejection, in particular with respect to the type/category identification using a marker’s shape/pattern, additional references that may be of interest to the applicant are listed in the PTO892.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO892.
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 JAE K WOO whose telephone number is (571)272-0837. The examiner can normally be reached M-F 8:30-2:30p, 6p-9p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at (571) 272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jae Woo/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
02/19/26