DETAILED ACTION
This Office action is responsive to communications filed on 02/23/2026. Claims 1, & 3-7 have been amended. Claim 2 is canceled. Presently, Claims 1, and 3-14 remain pending and are hereinafter examined on the merits.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/23/2026 has been entered.
Response to Arguments
Previous rejections under 35 USC § 112(b) are withdrawn in view of the amendments filed on 02/23/2026.
Previous claim objections directed to claim 8-14 are NOT withdrawn in view of the amendments filed on 02/23/2026.
The Applicant’s assert only claims 3-7 were objected to for failing to recite “The sensor-guided injection device of claim”. The Office action filed on 10/01/2025, indicated each claim was objected to for failing to recite “The sensor-guided injection device of claim”. Claim objections directed to each claim should recite in the preamble, “The sensor-guided injection device of claim”. Only claims 1-7 were amended to correct the informality. Claims 8-14, were not amended to obviate the objection. Accordingly, the claim objection is maintained.
Applicant’s arguments with respect to claim(s) have been considered but are moot because the new ground of rejection does not rely on Tang Q, Liang CP, Wu K, Sandler A, Chen Y. (Real-time epidural anesthesia guidance using optical coherence tomography needle probe. Quant Imaging Med Surg. 2015 Feb;5, herein Tang), in view of Samson (US 4,516,972) in view of Haffner et al (US 2014/0303544 A1 applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The new grounds of rejection now relied on, Tang Q, Liang CP, Wu K, Sandler A, Chen Y. (Real-time epidural anesthesia guidance using optical coherence tomography needle probe. Quant Imaging Med Surg. 2015 Feb;5, herein Tang), in view of Stergiopulos et al (US 20170348149 A1) in view of Badawi et al (US 20130253438 A1) in view of Haffner et al (US 2014/0303544 A1).
Claim Objections
The following claims are objected to because of the following informalities and should recite:
Claims 8-14, “The sensor-guided injection device of claim”. Appropriate correction is required.
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Tang Q, Liang CP, Wu K, Sandler A, Chen Y. (Real-time epidural anesthesia guidance using optical coherence tomography needle probe. Quant Imaging Med Surg. 2015 Feb;5, herein Tang), in view of Stergiopulos et al (US 20170348149 A1) in view of Badawi et al (US 20130253438 A1) in view of Haffner et al (US 2014/0303544 A1).
Claim 1: Tang teaches, A common-path (pg 119, right col, para 2: ‘laser power is split evenly into the sample and reference arms of a fiber-based Michelson interferometer. The reflected signals from the sample and reference arms form interference fringes’) swept source (pg 119, right col, para 2: ‘OCT system utilizes a wavelength-swept laser as light source’) optical coherence tomography (CP- SSOCT) distal sensor-guided injection device (pg 119, left col, last para to pg 119, right col, para 1: guiding epidural interventions using...OCT... Using micro-optics, OCT can be miniaturized into needle imaging devices to perform minimally invasive procedures) comprising:
an optical fiber (Fig 1A: GL [GRIN lens needle) at lower right; pg 119, right col, para 3: ‘gradient-index (GRIN) rod lens’) comprising a distal end, wherein the distal end of the optical fiber is configured to be proximate to or in contact with a selected portion of tissue (pg 120, left col, para 1: ‘insertion of the needle device by hand during experiments (see the photo inset in Figure 1A)’; pg 120, right col, para 2: ‘slowly inserted into different depths inside the tissue’; Fig 4, caption: ‘The bright horizontal line at the top of each OCT image indicates the tip of needle’),
-It is noted that the close proximity of the distal end of the optical fiber to the tissue is indicated in Fig 4B-F because only the very tip of the needle is evident in the images before the tissue layers.
and wherein the optical fiber is arranged to direct light to the selected portion of tissue (pg 119, right col, para 3: ‘the laser spot is ... delivered into tissues with special relay optics called gradient-index (GRIN) rod lens’) and to detect light reflected from the selected portion of the tissue (pg 119, right col, para 2: ‘reflected signals from the sample and reference arms form interference fringes ... interference fringes from different depths received by a balanced detector (BO) are encoded with different frequencies. Depth-resolved tomography can be obtained by analyzing the frequency spectrum of the interference fringes’) to provide information regarding a relative distance of the distal end of the optical fiber to the selected portion of the tissue (Fig 3C, 4B-4F; -it is noted that distance from the end of the optical fiber to the image features representing various tissue features is measured from the top of each of Fig 3C, 4B-4F, using the '0.25 mm' scale provided at the bottom right of each of Fig 3, 4; pg 119, right col, para 3: the lateral and axial resolutions in tissue are around 13 [micrometer]);
an injection needle (Fig 2: 'Inserted needle'; pg 120, left col, para 1: 18 gauge epidural needle) configured to deliver one or more therapeutic agents (pg 118, left col, para 1: ‘Epidural anesthesia ... treatment of acute lumbar radicular pain with epidural steroid injections’) to the selected portion of the tissue (pg 118, left col, para 1: epidural space), wherein the injection needle is operably coupled and substantially parallel to the optical fiber (pg 120, left col, para 1: ‘total outer diameter (0.D.) including the GRIN rod lens and the protective steel tubing is around 0.74 mm, which can be fitted into the clinically-used 18 gauge epidural needle’) such that the relative distance of the distal end of the optical fiber to the selected portion of the tissue as determined by the CP- SSOCT system provides a position of a tip of the injection needle relative to the selected portion of the tissue (pg 119, right col, para 1: ‘the probe can visualize artery, vein, and nerve structures in front of the needle in animal models in vivo’), wherein the tip comprises a distal end configured for insertion into the selected portion of the tissue (pg 118, left col, para 1: the epidural needle needs to penetrate several tissue layers such as fat, supraspinous ligaments, interspinous ligaments, and ligamentum flavum before reaching the epidural space (between ligamentum flavum and dura));
a translational stage (FIG 2: 'Motor stage'; pg 120, right col, para 2: ‘a motor stage which was controlled by a motor controller (ESP301, 3 Axis Motion Controller, Newport Corporation)’) configured to axially position the optical fiber and the injection needle at a relative distance to the selected portion of the tissue (pg 120, right col, para 2: ‘to obtain a smooth insertion process with constant speed and avoid bulk motion due to hand operation, the hand-held part of the OCT needle device was mounted on a motor stage’), wherein the optical fiber and the injection needle are operably coupled to the translational stage (pg 120, right col, para 2: ‘the hand- held part of the OCT needle device was mounted on a motor stage’); and
an articulated arm (Fig 2: 'Articulated arm'), wherein the translational stage is operably coupled to the articulated arm (pg 120, right col, para 2: ‘The motor stage was fixed on an articulated arm for easy adjustment and stability’).
Tang fails to disclose:
a flexible, expandable tube comprising:
a pair of thin, elongate strips of flexible material;
wherein the pair of thin, elongate strips of flexible material form the flexible, expandable tube, wherein an elongate lumen is defined between the pair of thin, elongate strips of flexible material and wherein the elongate lumen is configured to dispense an agent.
However, Stergiopulos in the context of treating intraocular pressures such as glaucoma discloses:
a flexible, expandable tube (FIG. 9A – element 70, ¶0074, ‘FIG. 9A, deformable structure 70 comprises two polymer sheets 71 and 72 welded together along opposing edges. In this embodiment, the deformable structure may be flat in its zero-stress state and inflates when filled with fluid.’)) comprising:
-This two-sheet structure is flat in its “zero-stress state” but “inflates when filled with fluid”, demonstrating its expandable nature, ¶0074. The flexible sheets are made from a thermosetting polymer, such as polyurethan, ¶0074.
a pair of thin, elongate strips of flexible material;
-Specifically, Stergiopulos teaches features of a “deformable structure” that functions as a tube formed by bonding or welding two flexible, flat sheets of biocompatible material together along their opposing edges, ¶0074. These two flexible sheets are a pair of thin, elongate strips of flexible material (i.e., 71, 72).
wherein the pair of thin, elongate strips of flexible material form the flexible, expandable tube, wherein an elongate lumen is defined between the pair of thin, elongate strips of flexible material and wherein the elongate lumen is configured to dispense an agent.
-Stergiopulos teaches by welding the two flat sheets of material together along their opposite edges, the space there between is constitutes as an elongate lumen, FIG. 9A. This two flat sheet structure is flat in its “zero-stress state” but “inflates when filled with fluid”, demonstrating its expandable nature, ¶0074. The elongate lumen is configured to dispense the fluid, the primary purpose of the defined lumen within this flexible tube is to dispose a fluid. The flexible tube is configured with an inlet end that communicates with an outlet that dispenses the fluid, ¶0023.
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the device of Tang to incorporate the teachings of Stergiopulos by including a flexible, expandable tube comprising: a pair of thin, elongate strips of flexible material; wherein the pair of thin, elongate strips of flexible material form the flexible, expandable tube, wherein an elongate lumen is defined between the pair of thin, elongate strips of flexible material and wherein the elongate lumen is configured to dispense an agent for the advantage of providing an improved apparatus with such an apparatus being able to flat in its zero-stress state and inflate when filled with fluid, as suggested by Stergiopulos, ¶0074.
Tang as modified above fails to explicitly disclose: a thin layer of elastic material jacketing the pair of thin, elongate strips of flexible material;
However, Badawi teaches an analogous device for accessing an eye for delivering a fluid composition therein (see Abstract) comprising a cannula that is advanced through an eye wall and anterior chamber (see para. [0058]). Badawi further teaches that it is advantageous to coat the cannula with a lubricious polymer to reduce friction between the ocular tissue and the cannula during the procedure (see para. [0058]) and that the lubricious polymers can include polytetrafluoroethylene (PTFE) (see para. [0058]), which is elastic. Specifically, Badawi teaches to coat the cannula to reduce friction between the ocular tissue and the cannula. The entire cannula is inserted into the eye the coating would be reasonable interpreted to cover the entire canula. Indeed, it is “A” surface coding, but that the surface means the entire outer surface, which defines jacketing. The claim does not constitute any particular type of jacketing.
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the device of modified Tang to incorporate the teachings of Badawi by coating the pair of thin, elongate strips of flexible material with a lubricious and elastic coating at least to reduce friction between the ocular tissue and the tube during the procedure, as taught by Badawi (see para. [0058]). The modified combination would disclose a thin layer of elastic material jacketing the pair of thin, elongate strips of flexible material including wherein the pair of thin, elongate strips of flexible material and the thin layer of elastic material jacketing the pair of thin, elongate strips of flexible material form the flexible, expandable tube, wherein an elongate lumen is defined between the pair of thin, elongate strips of flexible material and wherein the elongate lumen is configured to dispense an agent.
Tang as modified above fail to disclose; that the elongate lumen dispenses the one or more therapeutic agenda via the injection needle to the target location of the selected portion of the tissue –i.e., wherein the elongate lumen is configured to dispense the one or more therapeutic agents via the injection needle to a target location of the selected portion of the tissue, as required by the claim.
However, Haffner in the context of implants with controlled drug delivery using optical coherence tomography discloses:
wherein the elongate lumen (interior lumen 58) is configured to dispense the one or more therapeutic agents (62) via the injection needle ([0161], ‘the implant has an outer diameter that will permit the implant to fit within a 23-gauge needle during implantation. The implant can also have a diameter that is designed for insertion with larger needles. For example, the implant can also be delivered with 18-, 19-, or 20-gauge needles. In other embodiments, smaller gauge applicators, such as 23-gauge or smaller, are used. In some embodiments, the implant has a substantially constant cross-sectional shape through most of its length’; [0239], ‘the loading and/or recharging of a device is accomplished with a syringe/needle, through which the therapeutic agent is delivered’) to a target location of the selected portion of the tissue. ([0173], ‘the implant houses a drug 62 within the interior lumen 58 of the implant.’; [0216], ‘Drugs 62 may be positioned within one or more of said created lumens’; [0234], ‘A drug 62 is housed within the interior lumen 58 of the implant. The drug 62 comprises a therapeutically effective agent against a particular ocular pathology as well as any additional compounds needed to prepare the drug in a form with which the drug is compatible. In some embodiments, one or more of the internal lumens may contain a different drug or concentration of drug, which may be delivered simultaneously (combination therapy) or separately. In some preferred embodiments, an interior lumen is sized in proportion to a desired amount of drug to be positioned within the implant. The ultimate dimensions of an interior lumen of a given embodiment are dictated by the type, amount, and desired release profile of the drug or drugs to be delivered and the composition of the drug(s).’; [Abstract], ‘Disclosed herein are drug delivery devices and methods for the treatment of ocular disorders requiring targeted and controlled administration of a drug to an interior portion of the eye for reduction or prevention of symptoms of the disorder.’;’)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the device of modified Tang to be configured such that wherein the elongate lumen is configured to dispense one or more therapeutic agents via the injection needle to a target location of the selected portion of the tissue as suggested by Haffner, in order to improve the release of a drug to a desired intraocular target tissue, [0003] of Haffner, and such a configuration is advantageous in order to reduce the amount of tissue damage caused by the advancing distal end that occurs during the implantation procedures, [0177] of Haffner.
Claim 7: Modified Tang teaches the device of claim 1, Tang discloses: wherein the sensor-guided injection device is adapted to be at least one of held by a surgeon for performing manual surgery (pg 120, left col, para 1: enables insertion of the needle device by hand during experiments (see the photo inset in Figure 1A)) or to be attached to a robotic system for at least one of robotic or robot-assisted surgery (pg 120, right col, para 2: In order to obtain a smooth insertion process with constant speed and avoid bulk motion due to hand operation, the hand-held part of the OCT needle device was mounted on a motor stage which was controlled by a motor controller (ESP301, 3 Axis Motion Controller, Newport Corporation)).
Claim 8: Modified Tang teaches the device of claim 1, Tang discloses: wherein the articulated arm is operably coupled to a robotic system (pg 120, right col, para 2: In order to obtain a smooth insertion process with constant speed and avoid bulk motion due to hand operation, the hand-held part of the OCT needle device was mounted on a motor stage which was controlled by a motor controller (ESP301, 3 Axis Motion Controller, Newport Corporation). The motor stage was fixed on an articulated arm).
Claims 3-6, and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Tang Q, Liang CP, Wu K, Sandler A, Chen Y. (Real-time epidural anesthesia guidance using optical coherence tomography needle probe. Quant Imaging Med Surg. 2015 Feb;5, herein Tang), in view of Stergiopulos et al (US 20170348149 A1) in view of Badawi et al (US 20130253438 A1) in view of Haffner et al (US 2014/0303544 A1), as applied to claim 1 above, in further view of Price et al (US 2016/0074212 A1, herein Price).
Claim 3: Modified Tang discloses all the limitations of the device of claim 1; Tang fails to disclose: wherein the sensor-guided injection device is configured to move through a subretinal space of an eye.
However, in the context of a sensor-guided injection device, Price teaches, (abstract: apparatus for delivering therapeutic agent to an eye comprises a body, a cannula, a hollow needle, an actuation assembly, and a detection/visualization system), that the device is configured to move through a subretinal space of an eye (Fig 11A-11C: 30, 32, 306, 2030; para [0107]: features that provide an operator with real time feedback indicating when distal end (32) of needle (30, 2030) has passed through Bruch's membrane (i.e., the innermost layer of the choroid (306)) and into the subretinal space).
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the device of modified Tang so that the device is configured to move through a subretinal space of an eye, as taught by Price, to allow treatment of age-related macular degeneration as disclosed by Price (see Price at para [0004]).
Claim 4: Modified Tang as modified discloses all the elements above in claim 3, Tang fails to disclose the following taught by Price, as relied upon above:
Price further teaches, wherein the sensor-guided injection device is configured to access a subretinal space of the eye transsclerally (Fig 9E, 9F, 10B: 20 316,301,304; para [0095], [0096]: The sclerotomy procedure forms a small incision (316) through sclera (304) of eye (301) ... provides access to the space between sciera (304) and choroid (306) ... As can be seen in FIG. 9F, cannula (20) is directed through guide loops (336) of suture loop assembly (330) and into incision (316) ... aid an operator in identifying the proper depth of insertion as cannula (20) is guided along an atraumatic path).
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the device of modified Tang so that the device is configured to access a subretinal space of the eye transsclerally, as taught by Price, to allow treatment of age-related macular degeneration as disclosed by Price (see Price at para [0004]).
Claim 5: Modified Tang discloses all the elements above in claim 1; however Tang does not teach specifically wherein the sensor-guided injection device is configured to deliver the one or more therapeutic agents to a subretinal space of an eye.
However, in the context of a sensor-guided injection device, Price teaches, (abstract: apparatus for delivering therapeutic agent to an eye comprises a body, a cannula, a hollow needle, an actuation assembly, and a detection/visualization system), that the device is configured to deliver one or more therapeutic agents to a subretinal space of an eye (para [0092]: procedure for subretinal delivery of therapeutic agent from a suprachoroidal approach).
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the device of modified Tang so that the device is configured to deliver the one or more therapeutic agents to a subretinal space of an eye, as taught by Price, to allow treatment in a highly localized fashion as disclosed by Price (see Price at para [0004]).
Claim 6: Modified Tang as modified discloses all the elements above in claim 5, Tang fails to disclose the following taught by Price, as relied upon above:
wherein the one or more therapeutic agents is selected from a gene, a cell, a biologic, and a small molecule therapeutic agent (para [0101]: drugs having smaller or large molecules, therapeutic cell solutions, certain gene therapy solutions).
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the device of modified Tang so that wherein the one or more therapeutic agents is selected from a gene, a cell, a biologic, and a small molecule therapeutic agent, as taught by Price, to allow treatment of age-related macular degeneration as disclosed by Price (see Price at para [0004]).
Claim 13: Modified Tang discloses all the elements above in claim 1; however Tang does not teach specifically the device further comprising a reservoir in fluid communication with the injection needle, wherein the reservoir is configured to move fluid through the injection needle to the selected portion of the tissue.
However, Price teaches, in the context of a sensor-guided injection device (abstract: apparatus for delivering therapeutic agent to an eye comprises a body, a cannula, a hollow needle, an actuation assembly, and a detection/visualization system), a reservoir in fluid communication with the injection needle (Fig 1OG, 11C: 341; para [0101]: therapeutic agent (341) may be infused by actuating a syringe or other fluid delivery device), wherein the reservoir is configured to move fluid through the injection needle (Fig 1OG, 11C: 30, 341; para [0102]: drive agent (341) out from needle (30)) to the selected portion of tissue (Fig 1OG, 11C: 341; para [0102]: the amount of therapeutic agent (341) that is ultimately delivered to the delivery site is approximately 50 micro L).
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the device of modified Tang so that the device includes a reservoir in fluid communication with the injection needle, wherein the reservoir is configured to move fluid through the injection needle to the selected portion of the tissue as taught by Price, to allow treatment in a highly localized fashion as disclosed by Price (see Price at para ([0004]).
Claim 14: Modified Tang as modified discloses all the elements above in claim 13, Tang fails to disclose the following taught by Price, as relied upon above:
Price further teaches, wherein the reservoir comprises a syringe or a microfluidic device (para [010]): actuating a syringe).
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the reservoir of modified Tang so that the device includes comprises a syringe as taught by Price, to allow treatment in a highly localized fashion as disclosed by Price (see Price at para ([0004]).
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Tang Q, Liang CP, Wu K, Sandler A, Chen Y. (Real-time epidural anesthesia guidance using optical coherence tomography needle probe. Quant Imaging Med Surg. 2015 Feb;5, herein Tang), in view of Stergiopulos et al (US 20170348149 A1) in view of Badawi et al (US 20130253438 A1) in view of Haffner et al (US 2014/0303544 A1), as applied to claim 8 above, in further view of Kang et al. US 2013/0123759 A1 herein, Kang.
Claim 9: Modified Tang discloses all the elements above in claim 8; however, Tang does not teach specifically wherein the robotic system comprises a hand-held robotic system.
However, Kang teaches, in the context of a robotic surgical injection device (Fig 2: 102, 122; para [0010]: surgical tool for a motion-compensating surgical tool system; para (0026): surgical tool 102. In this example, the moveable component 106 is an inner needle 122 that has an optical fiber 124), that the robotic system comprises a hand-held robotic system (para [0022]: compact hand-held microsurgical tool capable of surface tracking and motion compensation).
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the device of modified Tang so that the robotic system comprises a hand-held robotic system, as taught by Kang, to provide highly accurate incision depth control, uniform incision depth, and virtually eliminates hand tremor as disclosed by Kang (see Kang at para (0041)).
Claim 10: Modified ang in view of Kang teaches the device of claim 9, Tang fails to disclose the following taught by Kang, as relied upon above:
Kang further teaches wherein the hand-held robotic system comprises a steady-hand robotic system (para [0041]: the smart tool provides highly accurate incision depth control, uniform incision depth, and virtually eliminates the hand tremor).
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the device of modified Tang so that the hand-held robotic system comprises a steady-hand robotic system, as taught by Kang, to provide highly accurate incision depth control, uniform incision depth, and virtually eliminates hand tremor as disclosed by Kang (see Kang at para (0041)).
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Tang Q, Liang CP, Wu K, Sandler A, Chen Y. (Real-time epidural anesthesia guidance using optical coherence tomography needle probe. Quant Imaging Med Surg. 2015 Feb;5, herein Tang), in view of Stergiopulos et al (US 20170348149 A1) in view of Badawi et al (US 20130253438 A1) in view of Haffner et al (US 2014/0303544 A1), as applied to claim 1 above, in further view of Kalpin et al. US 2011/0237937 A1, herein, Kalpin.
Claim 11: Modified Tang teaches the device of claim 1. Tang does not teach specifically the device further comprising a graphical user interface.
However, Kalpin teaches, in the context of tissue visualization in surgery discloses, the device further comprising a graphical user interface ([0144], ‘Display device 14 to provide guidance information as well as an interactive user interface, as will be described in greater detail below. ‘)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the device of modified Tang to include a graphical user interface, as taught by Taylor, to allow the user to command the device using a familiar user interface, as being the use of a known interface mechanism as disclosed by Kalpin to obtain a certain image quality.
Claim 12: Modified Tang teaches the device of claim 11. Tang does not teach specifically the device wherein the graphical user interface is configured to provide a value of the relative distance of the distal end of the optical fiber to the selected portion of the tissue or a relative position of the tip of the injection needle to the selected portion of the tissue.
However, Kalpin teaches, in the context of tissue visualization in surgery discloses wherein the graphical user interface is configured to provide a value of a relative position of the tip of the injection needle to the selected portion of the tissue. (FIG. 22-23; [0170], ‘Having the first ring 5092 surrounding target location 5032 of target port 32 can provide visual confirmation to the user that at least a distal end of the selected needle 4058 of the tracked instrument 61, 61'' is over or above target port 32. If the trajectory of tracked instrument 61, 61'' has already been aligned with axis X of target port 32, then the guidance rings 5080 can be concentric about an axis parallel to axis X of target port 32 and surrounding target location 5032, as shown for example in FIG. 23.’)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the user interface of modified Tang to provide a value of a relative position of the tip of the injection needle to the selected portion of the tissue as taught by Kalpin. The motivation to do this yields predictable results such as improving surgical needle guidance.
Conclusion
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/N.A.R./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798