DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status
The current office action is a second, non-final office action since Applicant’s arguments alone overcame the previous prior art rejections.
Response to Arguments
This Office action is in response to the applicant’s communication filed on 8/14/2026. Each argument and/or amendment directed towards a maintained rejection is addressed below. Rejections/objections not repeated herein have been withdrawn.
Applicant’s arguments, see page 6, with respect to Applicant’s amendments to the drawings made in view of the previous objections to the drawings have been fully considered and are persuasive. The previous objections to the drawings have been withdrawn.
Applicant’s arguments, see pages 6-9, with respect to the deficiencies of Maschke and/or Zhao failing to expressly disclose establishing registration specifically between a surgical instrument and an imaging element via moving the robotic arm holding the instrument have been fully considered and are persuasive. Therefore, the previous prior art rejections made under Maschke and/or Zhao have been withdrawn. However, upon further consideration, new ground(s) of rejection are made under Graumann et al. (US 2004/0024310), as set forth below.
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 19-20 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 19 (and thereby dependent claim 20) is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: establishing registration specifically between the x-ray device and the patient tissue structure. The language of claim 19 sets forth that moving the robotic arm somehow further provides for registration between the x-ray device and the patient tissue structure, but movement of the robotic arm appears to be independent of and separate from registration occurring between the x-ray device and the patient tissue structure. It can be seen how movement of the robotic arm may establish registration between the arm/instrument and other components (e.g., the x-ray device and/or the patient tissue structure), but it appears a step is missing for establishing registration specifically between the x-ray device and the patient tissue structure via movement of the robotic arm. Appropriate correction is required, either by way of clarification and/or claim amendment.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 1-4 and 7-20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Graumann et al. (US 2004/0024310) in view of Zhao (US 2009/0088634).
Graumann discloses (see Fig. 1) a system and method for image guided surgery comprising the following claim limitations:
(claim 1) A method comprising: positioning an imaging element (9/10, Fig. 1) relative to a patient tissue structure (K, Fig. 1) (as shown in Fig. 1; [0022]-[0023]; C-arm moved about patient to multiple 2D images acquired to reconstruct and generate 3D images); establishing registration between the imaging element (9/10) and a surgical instrument (22, Fig. 1) by movement of the surgical instrument (22) (as shown in Fig. 1; [0028]; the steps of establishing registration expressly includes taking an initial position of the medical instrument 22, imaging element 9/10, and the patient’s anatomy K while taking further movement positions of the surgical instrument 22); and conducting, using the surgical instrument (22), an intervention on the patient tissue structure (K) while calculating an orientation of the surgical instrument (22) relative to the patient tissue structure (K) using the registration ([0028]; orientation of the medical instrument 22 during a procedure is continuously and immediately provided at display image 23 in Fig. 1);
(claim 2) comprising imaging (at display image 14, Fig. 1) the patient tissue structure (K) during the intervention (as shown in Fig. 1; [0028]; continuously and immediately acquiring and providing imaging during the intervention is expressly disclosed);
(claim 7) wherein the method is performed without optically tracking the patient tissue structure (K) ([0032]; optical tracking is expressly disclosed as not being required, and may be switched out for alternative tracking options such as magnetic systems for determining relative positions of components);
(claim 9) wherein establishing the registration between the imaging element (9/10) and the surgical instrument (22) comprises registering the surgical instrument (22) to a coordinate system of the patient tissue structure (K) ([0004]-[0005]; [0037]; conversion to a spatial coordinate system expressly disclosed);
(claim 10) wherein the imaging element (9/10) is an X-ray source (as shown in Fig. 1; see claims 2-5, 9 and 15; [0011]; [0022]-[0023]);
(claim 13) an x-ray imaging device (9/10, Fig. 1) configured to (i.e., capable of) image a patient tissue structure (K, Fig. 1) (as shown in Fig. 1; [0022]-[0023]; C-arm moved about patient to multiple 2D images acquired to reconstruct and generate 3D images); a surgical instrument (22, Fig. 1) (as shown in Fig. 1); and a controller (13/21, Fig. 1) programmed to: establish registration between the surgical instrument (22) and the x-ray imaging device (4) using movement of the surgical instrument (22) (as shown in Fig. 1; [0028]; the steps of establishing registration expressly includes taking an initial position of the medical instrument 22, imaging element 9/10, and the patient’s anatomy K while taking further movement positions of the surgical instrument 22); and calculate, during an intervention on the patient tissue structure (K) using the surgical instrument (22), and orientation of the surgical instrument (22) using the registration (see Fig. 1; [0028]; continuously tracking the movement progress of the surgical instrument 22 in immediate, real-time via registration is expressly disclosed);
(claim 15) wherein the x-ray imaging device (9/10) is arranged to image the patient tissue structure (K) while the surgical instrument (22) moves at the patient tissue structure (K) (as shown in Fig. 1; [0028]; continuously tracking the movement progress of each registered component, including the surgical instrument 22, during the medical intervention is expressly disclosed);
(claim 16) wherein the surgical instrument (22) is configured to (i.e., capable of) provide an insertion motion ([0024]; [0028]; instrument 22 expressly depicted as providing an insertion motion into the patient’ s thigh K);
(claim 18) wherein the orientation is calculated in a coordinate system of the patient tissue structure ([0004]-[0005]; [0037]; conversion to a spatial coordinate system expressly disclosed); and
(claim 19) A method, comprising: imaging, with an x-ray device (9/10, Fig. 1), a patient tissue structure (K, Fig. 1) while a surgical instrument (22, Fig. 1) is positioned relative to the patient tissue structure (K) (as expressly shown in Fig. 1; [0007]; [0024]; [0028]); establishing, by moving the surgical instrument (22), registration between the x-ray device (9/10), the patient tissue structure (KJ), and the surgical instrument (22) (as shown in Fig. 1; [0028]; the steps of establishing registration expressly includes taking an initial position of the medical instrument 22, imaging element 9/10, and the patient’s anatomy K while taking further movement positions of the surgical instrument 22); and conducting, using the surgical instrument (22), an intervention on the patient tissue structure (K) while calculating an orientation of the surgical instrument (22) relative to the patient tissue structure (K) using the registration ([0028]; orientation of the medical instrument 22 during a procedure is continuously and immediately provided at display image 23 in Fig. 1).
Graumann, as applied above, discloses a system and method for image guided surgery comprising establishing registration between the surgical instrument and imaging element by movement of the surgical instrument ([0028]; the steps of establishing registration expressly includes taking an initial position of the medical instrument 22, imaging element 9/10, and the patient’s anatomy K while taking further movement positions of the surgical instrument 22). Graumann fails to expressly disclose the surgical instrument being both held and moved by a robotic arm wherein the orientation of the surgical instrument is calculated based on data and/or a joint position via an encoder of a joint rotation sensing system of the robotic arm, controlling the robotic arm based on the registration, and the imaging element being a fluoroscopy panel detector.
However, Zhao teaches similar systems and methods for image guided surgery comprising the surgical instrument (101A, Fig. 1A) being both held and moved by a robotic arm (158A, Fig. 1A) wherein the orientation of the surgical instrument (101A) is calculated based on data and/or a joint position via an encoder of a joint rotation sensing system of the robotic arm (158A) ([0037]; [0042]; each robotic arm and joint may include one or more displacement transducers, positional sensors, and/or orientational sensors to assist in acquisition and tracking of robotic instruments), and controlling the robotic arm (158A) based on the registration (see claims 14 and 16; [0001]; [0031]; [0050]; [0054]; [0057]-[0061]; [0080]; [0148]; [0192]; [0206]; acquisition and tracking of the position and orientation of robotic tools or instruments as well as autonomous operating features are expressly disclosed; [0195]-[0196]; tool tracking systems can be used along with other active sensors/cameras listened in the alternative include use of electromagnetic sensors instead of cameras shown used in Fig. 1) in order to beneficially provide for a remote telerobotic surgical intervention with the surgeon being removed/distanced from the operating table while further beneficially providing for autonomous robotic operating features with non-optical tracking/guidance ([0002]; [0031]-[0032]; [0195]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system/method of Graumann to have the surgical instrument being both held and moved by a robotic arm wherein the orientation of the surgical instrument is calculated based on data and/or a joint position via an encoder of a joint rotation sensing system of the robotic arm, and controlling the robotic arm based on the registration in order to beneficially provide for a remote telerobotic surgical intervention with the surgeon being removed/distanced from the operating table while further beneficially providing for autonomous robotic operating features with non-optical tracking/guidance, as taught by Zhao.
Regarding claim 11, Zhao teaches similar systems and methods for image guided surgery including the imaging element comprising a fluoroscopy panel detector ([0032]; a plurality of equivalent imaging modalities are expressly taught, including specifically fluoroscopy). Accordingly, Zhao teaches that it is known that an x-ray imaging element and a fluoroscopic imaging element are elements that are functional equivalents for providing image guided surgical interventions. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have substituted the fluoroscopic imaging element taught by Zhao for the x-ray imaging element of Graumann because both elements were known equivalents for providing image guided surgical interventions within the surgical arts. The substitution would have resulted in the predictable results of providing image guided surgical interventions to the methods and systems of Graumann.
Claim(s) 5-6 are rejected under 35 U.S.C. 103(a) as being unpatentable over Graumann in view of Zhao as applied to claim 1 above, and further in view of Mittelstadt et al. (US 6,033,415).
Graumann in view of Zhao, as applied above, discloses systems and methods for image guided surgery comprising all the limitations of the claim except for wherein conducting, using a bone cutting instrument, the intervention on the patient tissue structure comprises conducting a step of a joint replacement operation.
However, Mittelstadt teaches a similar method for image guided surgery comprising an intervention using a bone cutting instrument to conduct a robotic joint replacement operation (col. 1, lines 29-34 and 54-59; col. 4, lines 33-39; col. 8, lines 1-9; col. 9, lines 9-23). Accordingly, Mittelstadt teaches that it is known that using a bone cutting instrument in a robotic joint replacement operation and open surgery, neurosurgical procedures, and/or endoscopic procedures (see Maschke [0003]; [0043]) are elements that are functional equivalents for providing medical interventions within the robotic surgical arts. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have substituted the use of a bone cutting instrument in a joint replacement operation taught by Mittelstadt for the open surgery, neurosurgical procedures, and/or endoscopic procedures of Graumann in view of Zhao because both elements were known equivalents for providing medical interventions within the robotic surgical arts. The substitution would have resulted in the predictable results of providing a medical intervention (i.e., joint replacement) within the robotic surgical arts to be performed by the method of Graumann in view of Maschke.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert Lynch whose telephone number is (571)270-3952. The examiner can normally be reached on Monday-Friday (9:00AM-6:00PM, with alternate Fridays off).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Elizabeth Houston, at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT A LYNCH/Primary Examiner, Art Unit 3771
