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 .
Response to Amendment
The objection to Claim 5 has been withdrawn in light of the amendment to the claims filed on 19 December 2025.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “tool holder” & “handle” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-5 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. In particular, Claims 1 & 5 now recite “a handle of the surgical tool”; however, the instant specification fails to show possession of said handle because the instant specification does not describe “the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention” as laid out in MPEP § 2163.02. More specifically, the instant specification does not convey with reasonable clarity how one of ordinary skill in the art, as of the filing date sought, can show the inventor was in possession of said handle. Therefore, Claims 1 & 5 fail to meet the written description requirement of 35 U.S.C. 112(a).
Dependent claims are rejected by virtue of their dependency to abovementioned claims.
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 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.
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.
Claims 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Lang (US PGPUB 20170258526) in view of Yano et al. (“Development of a Surgical Knife Attachment with Proximity Indicators,” (14 May 2017), In: Marcus, A., Wang, W. (eds) Design, User Experience, and Usability: Designing Pleasurable Experiences. DUXU 2017. Lecture Notes in Computer Science(), vol 10289; hereinafter "Yano")
With regards to Claim 1, Lang discloses a surgical tool tracking array (an optical marker; see Lang ¶ [0426]) comprising:
a multi-faced reference array having a plurality of planar faces (cuboid optical marker with different 2D QR codes on one or more surfaces; see Lang ¶ [0419]);
a plurality of different optically coded patterns each on a different one of the planar faces (cuboid optical marker with different 2D QR codes on one or more surfaces; see Lang ¶ [0419]); and
wherein the multi-faced reference array is attached to a portion of a surgical tool to the surgical tool tracking array (wherein optical marker is attached to a surgical tool; see Lang ¶ [0426 & 0434-0438]),
Lang teaches of a magnetic base which is adhesively attached to the skin or surgical drape, said magnetic base for magnetically receiving the optical marker array (see Lang ¶ [0444 & 0446]). Lang also teaches of attaching the optical marker array to surgical tool (see Lang ¶ [0426]). While it would have been obvious to someone of ordinary skill to combine the magnetic base with the surgical tool to provide a tool holder, it appears that Lang may be silent to wherein the tool holder is configured to space the multi-faced reference array away from a handle of the surgical tool.
However, Yano teaches of surgical knife {i.e. surgical tool} attachment clamp {tool holder} with a cubicle array of markers (see Yano FIGS. 2-3). In particular, FIG. 3 clearly illustrates that the attachment clamp {i.e. tool holder} clearly spaces out the cuboid marker array from the handle {i.e. which is clearly held by the user} of the surgical knife at the distal tip.
Lang and Yano are both considered to be analogous to the claimed invention because they are in the same field of optical tracking surgical tools with navigation systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lang to incorporate the above teachings of Yano to provide at least wherein the tool holder is configured to space the multi-faced reference array away from a handle of the surgical tool. Doing so would aid in easy attachment to the knife or other surgical tools (see Yano pg. 609, ¶ 3).
With regards to Claim 21, modified Lang teaches of wherein:
the planar faces include a front square planar face configured to face away from the surgical tool when coupled to the tool holder, and a plurality of side square planar faces each extending from different side edges of the front square planar face and angled toward the surgical tool when coupled to the tool holder (cube/cuboid {i.e. plurality of side square planar faces} optical marker with different 2D QR codes {i.e. planar} on one or more surfaces; see Lang ¶ [0419]; one of ordinary skill in the art would understand that an attached cuboid optical marker would have at least one of the 6 faces oriented substantially away from the attached tool while all the other faces angled toward to the surgical tool, it should be appreciated that the instant specification fails to provide a special definition or scope of “fac[ing] away” as described in ¶ [0225] with relation to FIG. 23).
With regards to 31, modified Lang teaches of wherein:
the planar faces include a front square planar face configured to face away from the surgical tool when coupled to the tool holder, and four side square planar faces each extending from different ones of the four side edges of the front square planar face and angled toward the surgical tool when coupled to the tool holder (cube/cuboid {i.e. four side square planar faces} optical marker with different 2D QR codes {i.e. planar} on one or more surfaces; see Lang ¶ [0419]; one of ordinary skill in the art would understand that an attached cuboid optical marker would have at least one of the 6 faces oriented substantially away from the attached tool while all the other faces angled toward to the surgical tool, it should be appreciated that the instant specification fails to provide a special definition or scope of “fac[ing] away” as described in ¶ [0225] with relation to FIG. 23).
With regards to Claim 41, modified Lang teaches of wherein the optically coded patterns are two dimensional barcode patterns (cuboid optical marker with different 2D QR codes on one or more surfaces; see Lang ¶ [0419]) which optically encode planar face identifiers (QR codes can be used to determine the orientation of select surfaces or faces of the geometric shape, i.e. optical encode planar face identifiers; see Lang ¶ [0419]).
With regards to Claim 5, Lang discloses a surgical tool tracking array (an optical marker; see Lang ¶ [0426]) comprising:
a multi-faced reference array (cuboid optical marker with different 2D QR codes on one or more surfaces; see Lang ¶ [0419]);
attachment means which couples a portion of a surgical tool to the surgical tool tracking array (wherein optical marker is attached to a surgical tool; see Lang ¶ [0426 & 0434-0438], wherein the presence of an attachment amounts to an attachment means),
wherein the multi-faced reference array includes a plurality of planar faces, the plurality of planar faces comprise a front square planar face configured to face away from the surgical tool when coupled to the tool holder (cuboid {i.e. four side square planar faces} optical marker with different 2D QR codes {i.e. planar} on one or more surfaces; see Lang ¶ [0419]; one of ordinary skill in the art would understand that an attached cuboid optical marker would have at least one of the 6 faces oriented substantially away from the attached tool while all the other faces angled toward to the surgical tool, it should be appreciated that the instant specification fails to provide a special definition or scope of “fac[ing] away” as described in ¶ [0225] with relation to FIG. 23);
wherein the planar faces further comprise a plurality of side square planar faces each extending from different side edges of the front square planar face and angled toward the surgical tool when coupled to the tool holder (cuboid {i.e. four side square planar faces} optical marker with different 2D QR codes {i.e. planar} on one or more surfaces; see Lang ¶ [0419]; one of ordinary skill in the art would understand that an attached cuboid optical marker would have at least one of the 6 faces oriented substantially away from the attached tool while all the other faces angled toward to the surgical tool, it should be appreciated that the instant specification fails to provide a special definition or scope of “fac[ing] away” as described in ¶ [0225] with relation to FIG. 23);
wherein the surgical tool tracking array is operationally coupled to a camera tracking system (using a camera system to localize the optical marker; see Lang ¶ [0437]) and a surgical robot (the instruments are attached to robotic arms; see Lang ¶ [0156 & 1368]).
Lang teaches of a magnetic base which is adhesively attached to the skin or surgical drape, said magnetic base for magnetically receiving the optical marker array (see Lang ¶ [0444 & 0446]). Lang also teaches of attaching the optical marker array to surgical tool (see Lang ¶ [0426]). While it would have been obvious to someone of ordinary skill to combine the magnetic base with the surgical tool to provide a tool holder, it appears that Lang may be silent to wherein the tool holder is configured to space the multi-faced reference array away from a handle of the surgical tool.
However, Yano teaches of surgical knife {i.e. surgical tool} attachment clamp {tool holder} with a cubicle array of markers (see Yano FIGS. 2-3). In particular, FIG. 3 clearly illustrates that the attachment clamp {i.e. tool holder} clearly spaces out the cuboid marker array from the handle {i.e. which is clearly held by the user} of the surgical knife at the distal tip.
Lang and Yano are both considered to be analogous to the claimed invention because they are in the same field of optical tracking surgical tools with navigation systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lang to incorporate the above teachings of Yano to provide at least wherein the tool holder is configured to space the multi-faced reference array away from a handle of the surgical tool. Doing so would aid in easy attachment to the knife or other surgical tools (see Yano pg. 609, ¶ 3).
Response to Arguments
Applicant’s arguments with respect to the rejection under 35 U.S.C. 103 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
In particular, Applicant argues that Lang does not teach of a tool holder that is configured to space the multi-faced reference array away from a handle of the surgical tool. The Office agrees. More specifically, the Office contends that it would be obvious to combine Lang’s magnetic base to Lang’s surgical tool for simple reattachment means; however, Lang does not teach of a handle let alone the magnetic base configured to be spaced away from the handle. Therefore, the Office relies on Yano to remedy the deficiencies of Lang.
It should be appreciated that the drawings fail to designate the tool holder and handle. Therefore, one of ordinary skill in the art would not be able to recognize how the tool holder would space the reference array from the handle. Moreover, amending both the instant specification and the drawings to support a handle may raise a 35 U.S.C. 112(a) rejection for the introduction of new matter.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHISH S. JASANI whose telephone number is (571)272-6402. The examiner can normally be reached M-F 8:00 am - 4:00 pm (CST).
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, Keith M. Raymond can be reached on (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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/ASHISH S. JASANI/Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798