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 .
Note: all citations with respect to the specification of present application are citing the paragraph number in the Pre-Grant Publication US 2026/0090861 A1.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Limitation “coupling arrangement” in claim 1, 10 and 11.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
Regarding limitation “coupling arrangement” in claim 1, 10 and 11, the corresponding structural disclosure in the specification of present application is recited as: “The coupling arrangement can include one or more array magnetic components configured to form a magnetic coupling to one or more separate magnetic components of the surgical spinous process clamp or other separate surgical device” in [0046]; “This can involve loosening a thumbscrew, wing nut, or other coupling arrangement between a positioner coupling component and a corresponding coupling component of the clamp or other separate surgical component, for example” in [0055]; “This can involve loosening a thumbscrew, wing nut, or other coupling arrangement between a positioner coupling component and a corresponding coupling component of the clamp or other separate surgical component” in [0071]; “Surgical spinous process clamp 1200 can include clamp magnetic coupling arrangement 1250 including one or more magnetic components, while magnetically couplable fiducial marker array 1300 can include array magnetic coupling arrangement 1350 that includes one or more array magnetic components configured to form a magnetic coupling to the clamp magnetic components” in [0080]. Thus, the above limitation is interpreted as thumbscrew, wing nut, magnets or any reasonable equivalent component known to the people with ordinary skill in the art.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim 13 and 14 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 13 recites limitation “magnetically couplable half fiducial marker array”. It is unclear the above “half fiducial marker array” is a materially different marker array, or a portion of the “full marker array” as introduced earlier in claim 13. In addition, it is also unclear how a marker array can be considered as “half”.
Thus, the above limitation renders claim indefinite. For the purpose of examination, the above limitation is interpreted as any reasonable marker array.
Therefore, claim 13 and corresponding dependent claim 14 are rejected under 35 U.S.C. 112(b) as being indefinite.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 1 – 7, 10 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yang et al. (US 2021/0093394 A1; published on 04/01/2021) (hereinafter "Yang").
Regarding claim 1, Yang discloses a fiducial marker array ("… a removable marker assembly 100 … supporting tracking markers 150 ..." [0063]), comprising:
a rigid body configured to support a plurality of surgical fiducial markers at fixed positions relative to each other along the rigid body to form a fixed positional arrangement of surgical fiducial markers ("… includes a support member (140, 145) for supporting tracking markers 150 …" [0063]; see Fig.3 and Fig.5A), wherein at least a support portion of the rigid body is arranged along a surgical fiducial marker support plane ("… which are aligned in a plane defined by distal arc 145." [0063]; "… the marker plane, as defined by distal arc 145, is shown angled relative to longitudinal axis 130 ..." [0064]; see Fig.4) and the fixed positional arrangement of surgical fiducial markers is asymmetrical ("FIG. 5A provides a view of the example marker assembly attached to the medical instrument …" [0022]; see Fig.5A, two markers 150 are on the left side and one marker 150 is on the right side, which make the array asymmetrical); and
a coupling arrangement coupled to the rigid body ("Although connector 120 is shown provided as an integral portion marker assembly 100 … and may be separately interfaced or connected to marker assembly 100." [0063]; see Fig.3), wherein the coupling arrangement is configured to couple the fiducial marker array to a separate surgical device at a first fixed position relative to the separate surgical device ("… in which magnetic clamping is employed to secure an attachment assembly to a connection adapted attached to the shaft of a medical instrument." [0063]; "If the position of connection adapter 520 is not changed, the relationship between marker assembly 500 and the medical instrument 400 is well-defined and reproducible as required for the tracking of the instrument." [0089]).
Regarding claim 2, Yang discloses all claim limitations, as applied in claim 1, and Yang further discloses the plurality of surgical fiducial markers ("… for supporting tracking markers 150 …" [0063]; see Fig.3 and Fig.5A).
Regarding claim 3, Yang discloses all claim limitations, as applied in claim 1, and Yang further discloses wherein the separate surgical device is a surgical spinous process clamp ("The above embodiments can be combined to track an entire set of different medical instruments, for example, during surgery." [0099]; spinous process clamp is included in the "entire set"; see also cited pertinent art Elimelech).
Regarding claim 4, Yang discloses all claim limitations, as applied in claim 1, and Yang further discloses wherein the coupling arrangement includes one or more array magnetic components configured to form a magnetic coupling to one or more separate magnetic components of the separate surgical device ("To clamp medical instrument 400 to marker assembly 500, the instrument shaft 405 and connection adapter 520 are inserted through the bore 515 of within internal sleeve 525. As shown in the semi-transparent view of FIG. 21(b), connection adapter 520 is directly clamped to ring magnet 525 inside marker assembly 500." [0089]).
Regarding claim 5, Yang discloses all claim limitations, as applied in claim 4, and Yang further discloses wherein the magnetic coupling results in the fixed positional arrangement of surgical fiducial markers being set at a constant orientation and location with respect to the separate surgical device while the fiducial marker array remains magnetically coupled to the separate surgical device ("As shown in the semi-transparent view of FIG. 21(b), connection adapter 520 is directly clamped to ring magnet 525 inside marker assembly 500. If the position of connection adapter 520 is not changed, the relationship between marker assembly 500 and the medical instrument 400 is well-defined and reproducible as required for the tracking of the instrument." [0089]; "Connection adapter 550 has a non-cylindrically symmetric feature for locking an orientation of the medical instrument within the bore of the internal sleeve 560." [0094]).
Regarding claim 6, Yang discloses all claim limitations, as applied in claim 5, and Yang further discloses wherein the constant orientation and location is repeatable when the fiducial marker array is uncoupled from and recoupled to the separate surgical device such that recalibration of the fiducial marker array is unnecessary ("An additional calibration tool 600, described in further detail in FIG. 22, allows the positioning of connection adapter 520 at a well-defined distance along the shaft from the tip of the medical instrument, allowing exchanging of marker assembly 500 among multiple pre-calibrated medical instruments without the need for intraoperative re-calibration." [0086]).
Regarding claim 7, Yang discloses all claim limitations, as applied in claim 1, and Yang further discloses wherein the support portion of the rigid body is configured to support all of the plurality of surgical fiducial markers ("… includes a support member (140, 145) for supporting tracking markers 150 …" [0063]; see Fig.3 and Fig.5A).
Regarding claim 10, Yang discloses all claim limitations, as applied in claim 1, and Yang further discloses wherein the rigid body extends laterally in only one direction away from the coupling arrangement (see Fig.3 and Fig.5A).
Regarding claim 12, Yang discloses a magnetically couplable fiducial marker array ("… a removable marker assembly 100 … supporting tracking markers 150 ..." [0063]; "… in which magnetic clamping is employed to secure an attachment assembly to a connection adapted attached to the shaft of a medical instrument." [0063]), comprising:
a rigid body configured to support a plurality of surgical fiducial markers at fixed positions relative to each other along the rigid body to form a fixed positional arrangement of surgical fiducial markers ("… includes a support member (140, 145) for supporting tracking markers 150 …" [0063]; see Fig.3 and Fig.5A), wherein at least a support portion of the rigid body is arranged along a surgical fiducial marker support plane ("… which are aligned in a plane defined by distal arc 145." [0063]; "… the marker plane, as defined by distal arc 145, is shown angled relative to longitudinal axis 130 ..." [0064]; see Fig.4) and the fixed positional arrangement of surgical fiducial markers is asymmetrical ("FIG. 5A provides a view of the example marker assembly attached to the medical instrument …" [0022]; see Fig.5A, two markers 150 are on the left side and one marker 150 is on the right side, which make the array asymmetrical);
the plurality of surgical fiducial markers ("… for supporting tracking markers 150 …" [0063]; see Fig.3 and Fig.5A); and
a magnetic coupling arrangement formed at the rigid body ("… in which magnetic clamping is employed to secure an attachment assembly to a connection adapted attached to the shaft of a medical instrument." [0063]) and having one or more array magnetic components ("Ring magnet 530 is supported below counter piece 525 above end cap 535." [0087]: "clamped to ring magnet 525 inside marker assembly 500." [0089]), wherein the magnetic coupling arrangement is configured to form a magnetic coupling between the one or more array magnetic components and one or more separate magnetic components of a separate surgical spinous process clamp at a first fixed position relative to the separate surgical spinous process clamp ("… in which magnetic clamping is employed to secure an attachment assembly to a connection adapted attached to the shaft of a medical instrument." [0063]; "If the position of connection adapter 520 is not changed, the relationship between marker assembly 500 and the medical instrument 400 is well-defined and reproducible as required for the tracking of the instrument." [0089]; "The above embodiments can be combined to track an entire set of different medical instruments, for example, during surgery." [0099]; spinous process clamp is included in the "entire set"; see also cited pertinent art Elimelech).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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 8, 9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Yang, as applied in claim 1, and further in view of Kang et al. (US 2023/0172671 A1; published on 06/08/2023) (hereinafter "Kang").
Regarding claim 8, Yang teaches all claim limitations, as applied in claim 1, except wherein the support portion of the rigid body includes a primary branch and multiple secondary branches extending from the primary branch at different locations, each secondary branch including at least one location configured to support one of the plurality of surgical fiducial markers.
However, in the same field of endeavor, Kang teaches wherein the support portion of the rigid body includes a primary branch and multiple secondary branches extending from the primary branch at different locations ("As shown in FIG. 6A, the tracker 47 may include a unique array S4 …" [0054]; see Fig.6A, the middle part with connector 1500 is the primary branch, and the four branches extending outwards are the secondary branches), each secondary branch including at least one location configured to support one of the plurality of surgical fiducial markers ("… include a unique array S4 of markers …" [0054]; see Fig.6A).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the removable marker assembly as taught by Yang with removable tracker as taught by Kang. By employing unique array of markers, it is possible that "the surgical system 10 is able to determine a point and/or an axis of the cylindrical portion (e.g., an axis H-H shown in FIG. 3B) based on the geometry of the tracker 47, specifically, the geometric relationship between the reflective spheres on the array S4 and the V-shaped groove on the first portion 1505 of the clamp 1500" (see Kang; [0054]).
Regarding claim 9, Yang in view of Kang teaches all claim limitations, as applied in claim 8, and Kang further teaches wherein the multiple secondary branches include at least four secondary branches (see Fig.6A, the four branches extending outwards are the secondary branches).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the removable marker assembly as taught by Yang with removable tracker as taught by Kang. By employing unique array of markers, it is possible that "the surgical system 10 is able to determine a point and/or an axis of the cylindrical portion (e.g., an axis H-H shown in FIG. 3B) based on the geometry of the tracker 47, specifically, the geometric relationship between the reflective spheres on the array S4 and the V-shaped groove on the first portion 1505 of the clamp 1500" (see Kang; [0054]).
Regarding claim 11, Yang teaches all claim limitations, as applied in claim 1, except wherein the rigid body extends laterally in exactly two opposite directions away from the coupling arrangement.
However, in the same field of endeavor, Kang teaches wherein the rigid body extends laterally in exactly two opposite directions away from the coupling arrangement ("As shown in FIG. 6A, the tracker 47 may include a unique array S4 …" [0054]; see Fig.6A, the middle part with connector 1500 is the primary branch, and the four branches extending outwards are the secondary branches).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the removable marker assembly as taught by Yang with removable tracker as taught by Kang. By employing unique array of markers, it is possible that "the surgical system 10 is able to determine a point and/or an axis of the cylindrical portion (e.g., an axis H-H shown in FIG. 3B) based on the geometry of the tracker 47, specifically, the geometric relationship between the reflective spheres on the array S4 and the V-shaped groove on the first portion 1505 of the clamp 1500" (see Kang; [0054]).
Claim 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Yang in view of Lakin et al. (US 2007/0016009 A1; published on 01/18/2007) (hereinafter "Lakin") and Ryan et al. (US 2018/0168740 A1; published on 06/21/2018) (hereinafter "Ryan").
Regarding claim 13, Yang teaches a method of using a magnetically couplable fiducial marker array ("The aforementioned marker assemblies and related devices may be employed for tracking medical instruments, for example, for computer-aided navigation of, or for, various medical methods and procedures." [0111]), comprising:
removably coupling a plurality of surgical fiducial markers to a magnetically couplable full fiducial marker array at fixed positions relative to each other ("… a removable marker assembly 100 … includes a support member (140, 145) for supporting tracking markers 150 …" [0063]; see Fig.3 and Fig.5A) to form an asymmetrical fixed positional arrangement of surgical fiducial markers ("FIG. 5A provides a view of the example marker assembly attached to the medical instrument …" [0022]; see Fig.5A, two markers 150 are on the left side and one marker 150 is on the right side, which make the array asymmetrical);
forming a magnetic coupling between the magnetically couplable full fiducial marker array and a separate surgical component ("… in which magnetic clamping is employed to secure an attachment assembly to a connection adapted attached to the shaft of a medical instrument." [0063]);
calibrating the locations of the plurality of surgical fiducial markers while the magnetically couplable full fiducial marker array is magnetically coupled to the separate surgical component ("As further described below, an integrated magnet within handle 505 secures magnetic connection adapter 520 via an attractive magnetic force, thereby removably attaching marker assembly 510 to the medical instrument. An additional calibration tool 600, described in further detail in FIG. 22, allows the positioning of connection adapter 520 at a well-defined distance along the shaft from the tip of the medical instrument ..." [0086]);
removing the magnetically couplable full fiducial marker array from the separate surgical component ("… thereby removably attaching marker assembly 510 to the medical instrument … allowing exchanging of marker assembly 500 …" [0086]).
Yang fails to explicitly teach forming a magnetic coupling between a magnetically couplable half fiducial marker array and the separate surgical component; and reading automatically surgical fiducial markers on the magnetically couplable half fiducial marker array by an augmented reality system while the magnetically couplable half fiducial marker array is magnetically coupled to the separate surgical component.
However, in the same field of endeavor, Lakin teaches forming a magnetic coupling (considering the magnetic coupling as taught by Yang) between a magnetically couplable half fiducial marker array and the separate surgical component ("Array coupling member 520 is disposed at one end of frame 502 and assists in releasably and interchangeably connecting or attaching the tracking array to at least two different surgical components, one of which being surgical component 540, for instance. While tracking array 500 is generally “T-shaped,” other frame configurations having at least three markers attached may be used in accordance with the teachings of the present invention. Such alternate configurations include, but are not limited to, Y-shaped, F-shaped, X-shaped, V-shaped, U-shaped and L-shaped structures." [0052]; here the T-shaped and X-shaped is exchangeable; and the T-shaped array is considered as half of the X-shaped array; "Moreover, in further exemplary embodiments, one or more of the arm members (such as 706) forming the tracking array may be removable from the tracking array ..." [0059]).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the usage of removable marker assembly as taught by Yang with the using of exchangeable and reconfigurable markers array as taught by Lakin. Doing so would make it possible to provide a navigation method "that reduces the number of arrays required during a surgical procedure" (see Lakin; [0006]).
In addition, in the same field of endeavor, Ryan teaches reading automatically surgical fiducial markers on the magnetically couplable half fiducial marker array by an augmented reality system ("… tracking and recognition of visual markers and IMUs. This data is used to determine relative and/or absolute orientation and position of multiple items in the work view (1002). External data (1004) is brought into the algorithm. Algorithms are used to process the data for specific use cases (1006) and determine the required output (1008). This data is used in an augmented reality AR or virtual reality VR output display (1010) to assist the medical professional." [0148]) while the magnetically couplable half fiducial marker array is magnetically coupled to the separate surgical component (considering the magnetic coupling as taught by Yang).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the tracking as taught by Yang with the augmented reality as taught by Ryan. By using a mixed reality surgical navigation system, it is possible to provide "projection of feedback necessary for the procedure(s) visually into the user's field of view that does not require an unnatural motion or turning of the user's head to view an external screen" (see Ryan; [0004]).
Regarding claim 14, Yang in view of Lakin and Ryan teaches all claim limitations, as applied in claim 13, and Yang further teaches wherein the separate surgical component is a surgical spinous process clamp ("The above embodiments can be combined to track an entire set of different medical instruments, for example, during surgery." [0099]; spinous process clamp is included in the "entire set"; see also cited pertinent art Elimelech).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Elimelech et al. (US 2023/0329801 A1; published on 10/19/2023) teach a spinous process clamp with exchangeable markers array and an augmented reality system to assist surgical procedure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHAO SHENG whose telephone number is (571)272-8059. The examiner can normally be reached Monday to Friday, 8:30 am to 5:00 pm.
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, Anne M. Kozak can be reached at (571) 270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHAO SHENG/ Primary Examiner, Art Unit 3797
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