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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 17 - 31 in the reply filed on 9/22/2026 is acknowledged.
Claims 32 - 35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/22/2026.
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 17 - 31 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.
Claim 17 is indefinite for the following reasons:
It is unclear what is meant by “perform a registration of patient and navigation functions” (4th par.). The terminology appears to be missing words and/or contain a logical error. Is the claim trying to say that the patient is registered to the navigation functions? If so, the limitation does not appear to make sense. Is the claim trying to say that a patient registration is performed and navigation functions are performed?
There is unclear antecedent basis for “registration” (4th par.). It is unclear how this registration relates to the registration in line 1.
There is unclear antecedent basis for “navigation functions” (4th par.). It is unclear how these navigation functions relates to the navigation functions in line 1.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation “navigation functions” and the claim also recites limitations directed towards registration, as well as “output navigation guidance”, and “determine a combination patient tracker” which are the narrower statements of the range/limitation because each of these claim elements is considered to be a “navigation function”. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
There is unclear antecedent basis for “at least three markers in total” (2nd to last par.). It is unclear how these three markers relate to the total of at least three markers in the 10th paragraph.
There is unclear antecedent basis for “registration” (last par.). It is unclear how this registration relates to the previously recited registration(s). It is unclear how many registrations are performed.
Claim 18 is indefinite because there is insufficient antecedent basis for “the at least one second rigid body with markers”. The “at least one second rigid body with markers” has been set forth as comprising “at least one second marker” rather than markers. It is unclear how many markers the claim requires the at least one second rigid body to have.
Claim 25 is indefinite for the following reasons:
The claim recites an active state of markers in use (i.e., “are used” in lines 2). The claim is therefore a hybrid apparatus/method claim, which the Federal Circuit has held are indefinite under §112, second paragraph. See Rembrandt Data Techs., LP v. AOL, LLC, 641F.3d 1331, 1339 (Fed. Cir. 2011) (holding apparatus claim reciting active transmitting step indefinite). This is a critical defect because it is unclear whether the claim covers a device that is merely capable of performing the recited function or if the function must actually be performed.
There is unclear antecedent basis for “markers” in line 1 and 2. It is unclear how these three markers relate to the previously recited markers.
Claim 31 is indefinite because there is unclear antecedent basis for the “weighting”. It is unclear if this is the weighting in claim 30.
Examiner note: dependent claims that are listed in the rejection header above as being rejected while not having been specifically addressed are rejected by virtue of dependency.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 19 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 19 is directed to or encompassing a human organism because the claim recites the arrangement of the rigid bodies in terms of the patient, thereby requiring the patient to define the structural configuration of the system. Examiner suggests amending the claim top use “configured to” language (i.e., “… the first rigid body is configured to be arranged on a lateral side of the patient ...”, etc.)
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.
Claims 17 - 19, 25 - 27, and 29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cameron et al. (US 2020/0297435, of record).
Regarding claim 17, Cameron shows a navigation system with registration and navigation function for a surgical intervention on a patient (abstract), the navigation system comprising:
a visual display device (display 110, [0045] and fig. 1A - 1B) for visual navigation;
a navigation camera (camera 200, [0047] and fig. 1A - 1B) for optical detection and tracking of markers;
a control unit (computer, [0118]) adapted to process the optical detection of the navigation camera (tracking data, [0058]), to perform a registration (registration, [0056]) of patient and navigation functions, and to output navigation guidance via the visual display device (robotic trajectory guidance, [0043]; display this path and the planned path, [0078] - [0079]); and
a tracking surgery frame (stereotactic frame base 530, [0062] and figs. 5A - 5C), the tracking surgery frame being rigid (see figs. 5A - 5C and corresponding descriptions), and comprising:
a central opening or recess for entry to an intervention region ([0062] and fig. 5C showing the exposed upper region of anatomical feature 528), the central opening being arrangeable around an intervention region and being rigidly fixable with or to the patient, so that a geometrical relationship between the intervention region and the tracking surgery frame does not change (see figs. 5A - 5C and corresponding descriptions),
a first rigid body (reference array fixture 534, [0063] and fig. 5B and/or the arm of the frame reference array to which tracked markers 539 and/or arms thereof are directly attached) with at least one first marker (tracked markers 539, [0063] and fig. 5B) for being tracked by the navigation camera, the first rigid body being rigidly connected to the tracking surgery frame (see figs. 5A - 5C and corresponding descriptions); and
at least one second rigid body (auxiliary mounting arms 541 and/or dynamic reference frame 540, [0064] and fig. 5C) with at least one second marker (tracked markers 542, [0064] and fig. 5C) for being tracked by the navigation camera, the at least one second rigid body being rigidly connected to the tracking surgery frame (see figs. 5A - 5C and corresponding descriptions),
a total of at least three markers of the first rigid body and of the at least one second rigid body being connected to the tracking surgery frame (see tracking markers 539 and 542 in fig. 5C),
the tracking surgery frame, the first rigid body and the at least one second rigid body being configured to provide access to and a view of the intervention region via the central opening or recess ([0062] and fig. 5C showing the exposed upper region of anatomical feature 528),
a distance between the first rigid body and the at least one second rigid body being greater than a distance between the first rigid body and a portion of the tracking surgery frame which is closest to the first rigid body and which forms the central opening or recess to the intervention region (DRB 540 in general may be attached as needed for allowing unhindered surgical and equipment access, [0064] and fig. 5C. Also see figs. 5A - 5C, in which the distance between first rigid body 534 and second rigid body 541 and/or 540 is greater than a distance between the first rigid body 534 and a portion of the tracking surgery frame 530 which is closest to the first rigid body and which forms the central opening or recess to the intervention region),
the control unit being further adapted to determine a combination patient tracker based on the first rigid body and the at least one second rigid body (“… navigate using both the FRA markers 539 and the DRB 540…”, [0064] and fig. 5C - the combined data by which the navigation is achieved is interpreted as a “combination patient tracker”), the tracking surgery frame comprising at least three markers in total (see tracking markers 539 and 542 in fig. 5C), and
the navigation system being adapted to perform a registration based on the combination patient tracker (registration, [0056]).
Regarding claim 18, Cameron discloses the claimed invention substantially as noted above. Cameron further shows the tracking surgery frame is configured as a head support for a neurosurgical intervention on the patient's brain that is trackable via the first rigid body and the at least one second rigid body (anatomical feature 528 of patient, e.g., the patient's head, [0062]).
Regarding claim 19, Cameron discloses the claimed invention substantially as noted above. Cameron further shows the first rigid body is arranged on a lateral side of the patient, and the at least one second rigid body is arranged on an opposite lateral side, in order to achieve a large distance between the at least one first marker and the at least one second marker (see figs. 5A - 5C and corresponding descriptions).
Regarding claim 25, Cameron discloses the claimed invention substantially as noted above. Cameron further shows passive infrared markers and/or active infrared LEDs and/or optical patterns are used as markers ([0047]).
Regarding claim 26, Cameron discloses the claimed invention substantially as noted above. Cameron further shows the first rigid body has a first adapter so that the first rigid body is decoupleable and recoupleable with the at least one first marker during operation and is exchangeable without changing a position of the at least one first marker; and/or the at least one second rigid body has a second adapter so that the at least one second rigid body is decoupleable and recoupleable with the at least one second marker during operation and is exchangeable without changing a position of the at least one second marker ([0063] - [0064]. The structural features that allow the coupling/decoupling of the first and second rigid bodies are mapped to the claimed adapters).
Regarding claim 27, Cameron discloses the claimed invention substantially as noted above. Cameron further shows the combination patient tracker comprises a single combination patient tracker that the control unit determines based on all of the at least three markers (“… navigate using both the FRA markers 539 and the DRB 540…”, [0064] and fig. 5C - the combined data by which the navigation is achieved is interpreted as a “single combination patient tracker”).
Regarding claim 29, Cameron discloses the claimed invention substantially as noted above. Cameron further shows the control unit is adapted to detect a change in position of a marker of the combination patient tracker (tracked in real time, [0063]) and output a warning message to a user via the visual display device (robotic trajectory guidance, [0043]; display this path and the planned path, [0078] - [0079] - any of the displayed data is/are interpreted as “a warning message”, lacking any further limiting features of the warning in the claim).
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.
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.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable Cameron et al. (US 2020/0297435, of record) in view of Franck et al. (US 6,529,765, of record).
Regarding claim 20, Cameron discloses the claimed invention substantially as noted above. Cameron further shows that the tracking surgery frame is detachably attachable to the patient's anatomy and is trackable via the rigid bodies ([0063] - [0063]).
Cameron fails to show the tracking surgery frame is configured as a spinal frame attachable to spinous processes.
Franck discloses stereotactic surgery. Franck teaches a tracking surgery frame that is configured as a spinal frame attachable to spinous processes (“apparatus for stereotactic surgery on a body, such as surgery on the brain or spine. A guidance fixture is used that includes a mounting base having a central axis …”, abstract).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Cameron to have the tracking surgery frame be configured as a spinal frame is configured as a spinal frame attachable to spinous processes, as taught by Franck, in order to facilitate performing surgery on the patient’s spine, as suggested by Franck (col. 3, lines 54 - 62).
Claims 21 - 24 are rejected under 35 U.S.C. 103 as being unpatentable Cameron et al. (US 2020/0297435, of record).
Regarding claim 21, Cameron discloses the claimed invention substantially as noted above. Cameron further shows in a top view of the central opening or recess surrounding the intervention region, around the central opening or recess on a virtual circle, the first rigid body ([0063] and fig. 5B: the arm of the frame reference array to which tracked markers 539 and/or arms thereof are directly attached) and the at least one second rigid body (second rigid body 541 and/or 540) are arrangeable in an equally distributed manner1 on the virtual circle (“Unlike the FRA fixture 534, which mounts in only one way for unambiguous localization of the stereotactic frame base 530, the DRB 540 in general may be attached as needed for allowing unhindered surgical and equipment access”, [0064] and fig. 5C. Note that DRB 540 is moveable to the claimed arrangement).
However, Cameron doesn’t explicitly state that the recited arrangement is used.
However, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Cameron to employ the recited arrangement, in order to mount the DRB 540 as needed for allowing unhindered surgical and equipment access, as suggested by Cameron ([0064]), when it would provide best access to the patient to have the first and second rigid bodies on opposite sides of the patient.
Regarding claim 22, Cameron discloses the claimed invention substantially as noted above. Cameron further shows the first rigid body ([0063] and fig. 5B: the arm of the frame reference array to which tracked markers 539 and/or arms thereof are directly attached) and the at least one second rigid body (second rigid body 541 and/or 540) total two rigid bodies. The first and second rigid bodies are arrangeable to lie diagonally opposite each other with respect to the central opening or recess and form a virtual straight line through the intervention region in connection (“Unlike the FRA fixture 534, which mounts in only one way for unambiguous localization of the stereotactic frame base 530, the DRB 540 in general may be attached as needed for allowing unhindered surgical and equipment access”, [0064] and fig. 5C. Note that DRB 540 is moveable to the claimed arrangement).
However, Cameron doesn’t explicitly state that the recited arrangement is used.
However, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Cameron to employ the recited arrangement, in order to mount the DRB 540 as needed for allowing unhindered surgical and equipment access, as suggested by Cameron ([0064]), when it would provide best access to the patient to have the first and second rigid bodies on opposite sides of the patient.
Regarding claim 23, Cameron discloses the claimed invention substantially as noted above. Cameron further shows the first rigid body ([0063] and fig. 5B: the arm of the frame reference array to which tracked markers 539) and the at least one second rigid body (second rigid body 541 and 540) total three rigid bodies that form a virtual triangle in connection with each other with respect to the central opening or recess (see fig. 5C in which a virtual triangle may be formed as recited).
Regarding claim 24, Cameron discloses the claimed invention substantially as noted above. Cameron further shows the first rigid body (two arms directly attached to two of markers 539 in figs. 5B - 5C) and the at least one second rigid body (second rigid body 541 and 540) total four rigid bodies that form a virtual rectangle in connection with each other with respect to the central opening or recess (see fig. 5C in which a virtual rectangle may be formed as recited).
Allowable Subject Matter
Claims 28 and 30 - 31 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 28, the prior art of record, singly and/or in combination, fails to teach or reasonably suggest the navigation system according to claim 17, wherein the control unit is configured to: calculate a first transformation matrix for registration of the patient based on the first rigid body, wherein the at least one first marker comprises at least three first markers, calculate a second transformation matrix for registration of the patient based on the at least one second rigid body, wherein the at least one second marker comprises at least three second markers, and calculate an averaged transformation matrix for the combination patient tracker based on the first transformation matrix and the second transformation matrix for registration of the patient in order to minimize a registration error via redundancy.
Regarding claims 30 - 31, the prior art of record, singly and/or in combination, fails to teach or reasonably suggest the navigation system according to claim 17, wherein the control unit is adapted to perform weighting for the first rigid body and the at least one second rigid body in order to shift a center of gravity of the combination patient tracker toward the intervention region and perform weighting of one of the first rigid body and the at least one second rigid body that is antiproportional to the markers.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMELIE R DAVIS whose telephone number is (571)270-7240. The examiner can normally be reached Monday-Friday, 9:30 - 6:00 PST.
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, Pascal Bui-Pho can be reached at (571)272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMELIE R DAVIS/Primary Examiner, Art Unit 3798
1 It is noted that the term “equally distributed manner” is interpreted in light of applicant’s disclosure which states that the term means “diagonally opposite each other” ([0062], as published).
