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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) is acknowledged.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 11, 21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In Claim 11, it is unclear what is meant by “sufficient number of registration points” since no basis for “sufficient” has been defined and it is a subjective term.
In Claim 21, “capturing registration points at each of a mastoid tip, a lateral orbital rim, a zygomatic root, and an upper orbital rim on the first lateral side of the head of the patient.” Is confusing because it does not maintain antecedent basis with “a first registration point” and “a second registration point” from claim 1. Are these points listed in claim 21 intended to further limit the first and second registration point and be used in the same manner as in claim 1?
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.
Claims 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20210174522 to Govari.
Regarding Claim 19, Govari teaches a system comprising:
(a) a field generating assembly operable to generate alternating magnetic fields around a head of a patient (magnetic field generators 36, Figure 1, par. 0028);
(b) a registration probe including a position sensor operable to generate signals indicating a real-time position of a distal tip of the registration probe (registration probe 16, Figure 1, par. 0024, 0029); and
(c) a processor, the processor being configured to:
(i) capture a first registration point at a first location on a first lateral side of the head of the patient, the first registration point being captured based on a signal from the position sensor of the registration probe as the registration probe is positioned at the first location, the signal from the position sensor indicating a real-time position of the position sensor in three-dimensional space, the patient lying on a second lateral side of the head of the patient as the first registration point is captured (at each landmark point on the patient’s head, e.g. first point 54, Figure 2, the registration probe captures a registration point indicating a 3D position with respect to the field generator frame of reference, par. 0030; the system of Govari is capable of detecting registration points while the patient is positioned on a second lateral side of the head, e.g. the patient’s head is turned on its side, as patient’s head tilt position has no effect on the structure (software operation or hardware) of the registration system),
(ii) capture a second registration point at a second location on the first lateral side of the head of the patient, the second registration point being captured based on a signal from the position sensor of the registration probe as the registration probe is positioned at the second location, the patient lying on the second lateral side of the head of the patient as the second registration point is captured (at each landmark point on the patient’s head, e.g. second point 54, Figure 2, the registration probe captures a registration point indicating a 3D position with respect to the field generator frame of reference, par. 0030; the system of Govari is capable of detecting registration points while the patient is positioned on a second lateral side of the head, e.g. the patient’s head is turned on its side, as patient’s head tilt position has no effect on the structure (software operation or hardware) of the registration system), and
(iii) register a real-time position of the patient with one or more pre-operative images, based on at least the first and second captured registration points with respect to a field generator assembly (registered to a CT image 48, Figure 1, based on registration points 54, Figure 2, par. 0030 with respect to the field generator 36),
wherein the first and second registration points are captured in preparation for a medical procedure to be performed on the same first lateral side of the head (the subsequent procedure is of no consequence to the structure requirements of the system (software or hardware); that is, a subsequent procedure performed on the same first lateral side of the head is capable of being performed in connection with the registration used in Govari. See MPEP 2114, “A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)”).
Regarding Claim 20, Govari further teaches the components of Claim 20 for the same reasoning as for Claim 19 above, with the additional components of (c) a medical instrument configured for insertion into the head of the patient via an ear of the patient on a first lateral side of the head of the patient, the medical instrument including a position sensor operable to generate signals indicating a real-time position of a distal tip of the medical instrument (instruments, such as catheters or guidewires, are tracked with magnetic detectors, par. 0024, 0029; small-sized surgical instruments such as catheters, guidewires are capable of insertion into the ear, Govari further teaches ENT (ear, nose, throat) procedures being performed by the instruments such as insertion into sinus passages, par. 0047 – thereby the instruments of Govari are capable of being inserted into the ear as required by the claim; the system of Govari is capable of detecting the tracked instrument while the patient is positioned on a second lateral side of the head, e.g. the patient’s head is turned on its side, as patient position of head orientation has no effect on the structure (software operation or hardware) of the tracking system); and (d)(iv) register a real-time position of the medical instrument, based on at least a signal from the position sensor of the medical instrument (par. 0029).
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 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, 3-8, 13-18, 21 are rejected under 35 U.S.C. 103 as being unpatentable over US 20210174522 to Govari in view of NPL “An Easy to use periosteal Flap for Cochlear Implantation: Experience from a Tertiary Care Centre” to Panda et al.
Regarding Claim 1, Govari teaches a method, comprising:
(a) capturing a first registration point at a first location on a first lateral side of a head of the patient, the first registration point being captured based on a signal from a position sensor of a registration probe as the registration probe is positioned at the first location, the signal from the position sensor indicating a real-time position of the position sensor in three-dimensional space (at each landmark point on the patient’s head, e.g. first registration point 54, annotated Figure 2 below, the registration probe captures a registration point indicating a 3D position with respect to the field generator frame of reference, par. 0030);
(b) capturing a second registration point at a second location on the first lateral side of the head of the patient, the second registration point being captured based on a signal from the position sensor of the registration probe as the registration probe is positioned at the second location, the patient lying on the second lateral side of the head of the patient during the act of capturing the second registration point (at each landmark point on the patient’s head, e.g. second registration point 54, annotated Figure 2 below, the registration probe captures a registration point indicating a 3D position with respect to the field generator frame of reference, par. 0030); and
(c) registering a real-time position of the patient with an image guided surgery system, based on at least the first and second captured registration points, to thereby achieve registration of the patient with the image guided surgery system (registered to a CT image 48, Figure 1, based on registration points 54, Figure 2, par. 0030).
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While the system of Govari is capable of detecting registration points while the patient is positioned on a second lateral side of the head, e.g. the patient’s head is turned on its side, as patient’s head tilt position has no effect on the structure (software operation or hardware) of the registration system, Govari does not teach the first and second registration points are captured while the patient is lying on a second lateral side of the head, as required by claim 1. Instead, Govari generally references ENT (ear, nose, throat) procedures which benefit from the patient being positioned supine (e.g. sinus procedure, par. 0047), which one of ordinary skill would recognize gives the surgeon good access to the sinus areas.
Panda teaches an ENT procedure for implanting a cochlear implant. The patient is placed supine with the head turned opposite to the side of the operation, i.e. the patient’s head is turned on its side (“Method-Surgical Procedure” section, first sentence). One of ordinary skill in the art would recognize this positioning provides good access to the anatomy of interest for the surgeon.
As such, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to acquire the landmark registration points of Govari while the patient’s head was tilted to the side as in Panda, so as to provide the patient in a position with good access for the surgical procedure being done, e.g. cochlear implant procedure as in Panda.
Further, Govari teaches wherein the first and second registration points are captured in preparation for a medical procedure to be performed on the same first lateral side of the head (Examiner notes that the claim only requires the capability of such function, since no steps are recited; however, Govari teaches ear, nose, and throat procedures, e.g. sinus procedure, par. 0047, of which is performed on the same lateral side of the head as the registration points. For example, for the patient’s right sinus, it would be on the same lateral side as the first and second registration points annotated in the image above). In addition, Panda teaches a subsequent procedure being performed on the lateral side of the head (cochlear implant procedure), which in combination with Govari, would implicitly be utilizing the first and second registration points on the same lateral side (as annotated in the figure above). Examiner notes that Govari teaches registration points on both lateral sides, so a procedure performed on either lateral side of the head would read on the claim.
Regarding Claim 3, Govari in view of Panda further teaches capturing a third registration point at a third location on the first lateral side of the head of the patient, the third registration point being captured based on a signal from the position sensor of the registration probe as the registration probe is positioned at the third location, the patient lying on the second lateral side of the head of the patient during the act of capturing the third registration point, the act of registering the real-time position of the patient with the image guided surgery system being further based on at least the third captured registration point (the registration point corresponding to the cheekbone in Figure 2, par. 0034 of Govari, for the same reasoning as for claim 1 above).
Regarding Claim 4, Govari in view of Panda further teaches capturing a fourth registration point at a fourth location on the first lateral side of the head of the patient, the fourth registration point being captured based on a signal from the position sensor of the registration probe as the registration probe is positioned at the fourth location, the patient lying on the second lateral side of the head of the patient during the act of capturing the fourth registration point, the act of registering the real-time position of the patient with the image guided surgery system being further based on at least the fourth captured registration point (the registration point corresponding to the tip of the nose in Figure 2, par. 0034 of Govari, for the same reasoning as for claim 1 above).
Regarding Claim 5, Govari further teaches driving a display to visually indicate to an operator the first location and the second location (as in Figure 2, icons 54 are superimposed, par. 0036, which corresponds to the touched first and second locations, par. 0037).
Regarding Claim 6, Govari further teaches the act of driving a display to visually indicate to an operator the first location and the second location comprising rendering a first indicator on a display screen and rendering a second indicator on the display screen, the first indicator representing the first location, the second indicator representing the second location (superimposed icon 54, par. 0036).
Regarding Claim 7, Govari further teaches the act of driving a display to visually indicate to an operator the first location and the second location further comprising displaying a three-dimensional rendering of the head of the patient, the first indicator and the second indicator each being overlaid on the three-dimensional rendering of the head of the patient (as shown in Figure 2; while Govari calls the image a “2D” rendering, it is also a 3D rendering since it is showing 3D depth/surface information from a 3D CT image, “true and realistic image of a face” par. 0033; since it is displayed on a flat display (NxM pixels) it is displayed in a 2D/flat form, par. 0036).
Regarding Claim 8, Govari further teaches generating instructions to an operator to register the first location and the second location in a predetermined sequence (iterations until all locations are acquired, as in loop 115, Figure 3; instructions are given to the operator, par. 0032).
Regarding Claim 13, Govari further teaches receiving a patient tracking signal from a tracking sensor, the tracking sensor being fixedly secured to the head of the patient, the patient tracking signal indicating a real-time position of the head of the patient (reference sensor 41, Figure 1, par. 0028 – to account for patient movements).
Regarding Claim 14, Govari further teaches the act of registering the real-time position of the patient with the image guided surgery system being further based on the patient tracking signal (par. 0028 – the information from the reference sensor 41 is sent to the processing unit for registration. One of ordinary skill recognizes that this is for accounting for patient movements.).
Regarding Claim 15, Govari further teaches receiving a signal from a position sensor of a medical instrument, the medical instrument being disposed in the head of the patient, the signal from the position sensor of the medical instrument indicating a real-time position of the position sensor of the medical instrument in three-dimensional space with respect to a field generator assembly (instruments, such as catheters or guidewires, are tracked with magnetic detectors and registered, par. 0024, 0029; Govari further teaches ENT (ear, nose, throat) procedures being performed by the instruments such as insertion into sinus passages, par. 0047; with respect to the field generator 36, Figure 1).
Regarding Claim 16, Govari teaches the signal from the position sensor of the medical instrument indicating a real-time position of a distal end of the medical instrument in three-dimensional space (par. 0047).
Regarding Claim 17, Govari further teaches (a) determining the real-time position of a position of the medical instrument relative to the real-time position of the patient and further relative to a corresponding position in one or more preoperative images, based on at least the registration of the patient with the image guided surgery system and the signal from the position sensor of the medical instrument; and (b) driving a display to render an indicator showing a real-time position of a portion of the medical instrument in relation to the one or more preoperative images (par. 0047 – the tracked instrument is also registered to the CT images for image-guided surgery which implicitly provides a display of the tracked position to the surgeon).
Regarding Claim 18, Govari further teaches a medical instrument being inserted into the head of the patient (sinuses, par. 0047). In combination with Panda for performing an alternate ENT procedure of cochlear implant, the surgical tools would be inserted into the ear areas.
Regarding Claim 21, Govari further teaches utilizing facial landmarks including forehead, tip of nose, protruding cheek bones, firm areas that do not compress under pressure from the probe (par. 0034). As shown in Figure 2 above, the registration points include the upper orbital rim on the first lateral side of the head of the patient and the zygomatic root. However, it is not explicit that the lateral orbital rim and mastoid tip are used. Given the teachings of Govari to utilize appropriate points that do not compress under pressure from the probe as landmarks (par. 0034), one of ordinary skill in the art before the effective filing date of the claimed invention would have found it a routine matter of design choice to also utilize additional registration points including the lateral orbital rims and mastoid tip, since these are other known bony points that do not compress under pressure from the probe. The motivation to do so is because additional registration points increase accuracy of the registration process. Examiner contends that selection of those specific points does not provide any critical or unexpected result, so long as they are suitable bony landmarks that do not move with respect to each other or compress under pressure from the probe.
Claims 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over US 20210174522 to Govari in view of US 20240153111 to Kaeseberg.
Regarding Claim 9, Govari does not teach the acts of capturing the first registration point and capturing the second registration point being performed while an operator traces the registration probe along a path on the lateral side of the head of the patient. Govari teaches selection of registration points from bony anatomy (firm areas that do not compress under pressure from the probe, par. 0034).
Kaeseberg teaches using a touch pointer for registering surface points on the head to a frame of reference for image-guided surgery. Kaeseberg teaches moving the registration pointer along a path to measure the surface contours of the head (as shown in Figure 1). Kaeseberg further teaches the registration accuracy increases when the points are selected from those with underlying bone close to the skin surface (points 200, Figure 2A) compared to points with underlying bone further away from the surface (points 100, Figure 2A; par. 0049).
There were design incentives for implementing the claimed variation of paths on the lateral side of the head for registration of the surface contour. Specifically, as taught by both Govari and Kaeseberg, it is advantageous to select areas where underlying bone is close to the skin surface to increase accuracy, as would be the case on the lateral side of the head. Additional design incentives, as would be done in Panda’s cochlear implant procedure, would be registration of the areas nearest to the surgical site (i.e. ear area).
Therefore, as of the effective filing date of the claimed invention, the use of paths of the registration pointer along the lateral side of the head of the patient would have been recognized as predictable to one of ordinary skill in the art to provide the technical benefit of increased accuracy of registration to the surgical site. See MPEP 2143(I)(F).
Regarding Claims 10-11, Govari further teaches wherein the path is predetermined by the image guided surgery system or determined ad hoc by the operator and the processor automatically capturing a plurality of registration points along the path (par. 0034 wherein the landmark positions are selected either by the physician or automatically; in combination with the teachings of Kaeseberg, these landmarks would be paths and captured automatically), the processor further providing feedback to the operator indicating when a sufficient number of registration points have been captured(as in Kaeseberg, the registration points are displayed to the operator as feedback and therefore the operator can visually determine if they are sufficient).
Regarding Claim 12, Kaeseberg further teaches wherein capturing a plurality of additional registration points along the path, the act of registering the real-time position of the patient with the image guided surgery system being further based on at least the captured additional registration points (points along the paths as collected as landmark points and registered as a surface contour to the image data, Figure 1 points along the paths, par. 0050).
Response to Arguments
Applicant's arguments filed April 6, 2026 have been fully considered but they are not persuasive. Regarding the prior art, Applicant argues Govari’s registration is performed on the anterior face regardless of where the subsequent medical procedure is to be performed, e.g. a point below the tip of the patient’s nose, the left and right sides of the patient’s face besides the eyes, and a point between the eyes, as shown in Figure 2 of Govari. As such, Applicant argues that Govari does not teach the claim limitation “wherein the first and second registration points are captured in preparation for a medical procedure to be performed on the same first lateral side of the head” because Govari does not teach performing registration on a lateral side of the head. However, Applicant utilizes several of the same points as Govari, e.g. those listed in claim 21, including the upper orbital rim. All of the points listed can be considered to be on a lateral side because they are positioned with respect to the left and right (i.e. lateral) halves of the human body. Further, Govari implicitly teaches performing surgery on the lateral side of the head at which the points were captured, since the points were captures on both lateral sides and the surgery must be performed somewhere. Lastly, the claim does not require the procedure to be performed, only that the system (claim 19) is capable of permitting a procedure to be performed. The method claim also does not require any step of performing the procedure to be performed. With respect to claim 19, see MPEP 2114, “A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)”). There is nothing in Govari that would preclude a procedure from being performed on a lateral side of the head. Govari is specifically configured to be used in preparation of ENT procedures on the head, of which are implicitly done on a lateral side (i.e. with respect to the centerline left/right of the head); for example, a sinus procedure is done on a lateral right or left sinus.
Applicant also argues that Kaeseberg does not teach or suggest ad hoc path, but instead, the path of Kaeseberg is driven by the needs of a deformation correction algorithm. While it is agreed an algorithm is used, the algorithm does not seem to specify a requirement of specific points or paths. Rather, the algorithm utilizes relative shifts between the points collected. As such, it is not dependent on a specific path being performed or specific points acquired along the path. It will weigh the bony points higher since they are more accurate but seems to accept any points or path as input (i.e. ad hoc).
Examiner notes that the specific path used by Applicant may have criticality as shown in Figure 5. Further clarifying how it is advantageous and clarifying the path of Figure 5 in the claim would serve to advance prosecution.
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 ANGELA MARIE HOFFA whose telephone number is (571)270-7408. The examiner can normally be reached Monday - Friday 9:30 am - 6:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached at (571)270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ANGELA M. HOFFA
Primary Examiner
Art Unit 3799
/Angela M Hoffa/Primary Examiner, Art Unit 3799
Prosecution Insights