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 .
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 1/15/2025 has been received and made of record. Note the acknowledged form PTO-1449 enclosed herewith.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: see reference numerals “174”, “182” and “186” in Figure 12B. It is further noted that reference numeral “182” also lacks any indicator line/arrow. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. 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 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.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as "configured to" or "so that"; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Currently no claims are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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(s) 1-2, 7, 9-13, 15-16 and 18-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Maschke et al. (US 2010/0063514).
Maschke discloses (see Fig. 1) a device and method for a medical intervention comprising the following claim limitations:
(claim 1) A method comprising: positioning an imaging element (4, Fig. 1) relative to a patient tissue structure (T, Fig. 1) (as shown in Fig. 1; [0009]-[0010]; [0014]; [0028]; [0030]-[0031]; [0033]; [0042]; preoperative and intraoperative use of a positioned imaging system, such as x-rays, is expressly disclosed); establishing, by moving a robotic arm (22, Fig. 1), registration between the imaging element (4) and a surgical instrument (2, Fig. 1) held by the robotic arm (22) (as shown in Fig. 1; [0034]; [0036]; [0042]; registering the progress of the surgical instrument 2 on the robotic arm 22 with the images from the imaging system 4 is expressly disclosed); and conducting, using the surgical instrument (2), an intervention on the patient tissue structure (T) while calculating an orientation of the surgical instrument (2) relative to the patient tissue structure (T) using the registration (see claim 58 and Fig. 1; [0034]; [0036]; [0042]; continuously tracking the movement progress of the surgical instrument 2 during the medical intervention is expressly disclosed);
(claim 2) comprising imaging the patient tissue structure (T) during the intervention ([0009]; [0030]-[0031]; [0033]-[0034]; continuously acquiring imaging during the intervention is expressly disclosed);
(claim 7) wherein the method is performed without optically tracking the patient tissue structure (T) ([0031]; optical tracking is disclosed as an alternative option for tissue imaging and position extrapolation);
(claim 9) wherein establishing the registration between the imaging element (4) and the surgical instrument (2) held by the robotic arm (22) comprises registering the robotic arm (22) to a coordinate system of the patient tissue structure ([0035]-[0036]; guiding of the robotic arm 22 holding the surgical instrument 2 via a coordinate system associated with the imaging system 4 is expressly disclosed);
(claim 10) wherein the imaging element (4) is an X-ray source (as shown in claim 49 and Fig. 1; [0009]-[0010]; [0014]; [0028]);
(claim 11) wherein the imaging element is an fluoroscopy panel detector ([0014]; [0042]; use of x-ray or fluoroscopic images expressly disclosed);
(claim 12) comprising controlling the robotic arm (22) based on the registration ([0035]-[0036]; guiding of the robotic arm 22 holding the surgical instrument 2 from the starting point to the destination point in the thoracic region of the patient P during the intervention is expressly disclosed);
(claim 13) an x-ray imaging device (4, Fig. 1) configured to (i.e., capable of) image a patient tissue structure (T, Fig. 1) (as shown in Fig. 1; [0009]-[0010]; [0014]; [0028]; [0030]-[0031]; [0033]; [0042]; preoperative and intraoperative use of a positioned imaging system, such as x-rays, is expressly disclosed); a robotic arm (22, Fig. 1); a surgical instrument (2, Fig. 1) supported by the robotic arm (22) (as shown in Fig. 1); and a controller (3, Fig. 1) for the robotic arm (22) programmed to: establish registration between the surgical instrument (2) and the x-ray imaging device (4) using movement of the robotic arm (22) (as shown in Fig. 1; [0034]; [0036]; [0042]; registering the progress of the surgical instrument 2 on the robotic arm 22 with the images from the imaging system 4 is expressly disclosed); and calculate, during an intervention on the patient tissue structure (T) using the surgical instrument (2), and orientation of the surgical instrument (2) using the registration (see claim 58 and Fig. 1; [0034]; [0036]; [0042]; continuously tracking the movement progress of the surgical instrument 2 during the medical intervention is expressly disclosed);
(claim 15) wherein the x-ray imaging device (4) is arranged to image the patient tissue structure (T) while the surgical instrument (2) moves at the patient tissue structure (T) (see claim 58 and Fig. 1; [0036]; [0042]; continuously tracking the movement progress of the surgical instrument 2 during the medical intervention is expressly disclosed);
(claim 16) wherein the surgical instrument (2) is configured to (i.e., capable of) provide an insertion motion ([0026]; [0043]; instrument 2 expressly disclosed as a needle wherein the force of its insertion motion is expressly measured and monitored);
(claim 18) wherein the orientation is calculated in a coordinate system of the patient tissue structure (T) ([0035]-[0036]; guiding of the robotic arm 22 holding the surgical instrument 2 via a coordinate system associated with the imaging system 4 is expressly disclosed); and
(claim 19) A method, comprising: imaging, with an x-ray device (4, Fig. 1), a patient tissue structure (T, Fig. 1) while a surgical instrument (2, Fig. 1) held by a robotic arm (22, Fig. 1) is positioned relative to the patient tissue structure (T) (as shown in Fig. 1; [0009]-[0010]; [0014]; [0028]; [0030]-[0031]; [0033]; [0042]; preoperative and intraoperative use of a positioned imaging system, such as x-rays, is expressly disclosed); establishing, by moving the robotic arm (22), registration between the x-ray device (4), the patient tissue structure (T), and the surgical instrument (2) held by the robotic arm (22) (as shown in Fig. 1; [0034]; [0036]; [0042]; registering the progress of the surgical instrument 2 on the robotic arm 22 with the images from the imaging system 4 is expressly disclosed); and conducting, using the surgical instrument (2), an intervention on the patient tissue structure (T) while calculating an orientation of the surgical instrument (2) relative to the patient tissue structure (T) using the registration (see claim 58 and Fig. 1; [0034]; [0036]; [0042]; continuously tracking the movement progress of the surgical instrument 2 during the medical intervention is expressly disclosed).
Claim(s) 1-4 and 7-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhao et al. (US 2009/0088634).
Zhao discloses (see Figs. 1A-5B and 16) systems and methods for image guided surgery comprising the following claim limitations:
(claim 1) A method comprising: positioning an imaging element (101C, Fig. 1A) relative to a patient tissue structure (P, Fig. 1A) (as shown in Fig. 1; [0032]; [0034]; [0043]; [0052]-[0053]; [0074]; [0079]-[0080]; [0191]-[0197]; imaging device use/insertion for imaging during surgery expressly disclosed); establishing, by moving a robotic arm (158A, Fig. 1A), registration between the imaging element (101C) and a surgical instrument (101A, Fig. 1A) held by the robotic arm (158A) (as shown in Figs. 1A and 16; see claim 20; [0046]; [0052]-[0053]; [0057]-[0061]; [0161]; [0191]-[0197]; registering the surgical instrument 101A and overlaying the instrument 101A into images from the imaging system 101C is expressly disclosed); and conducting, using the surgical instrument (101A), an intervention on the patient tissue structure (P) while calculating an orientation of the surgical instrument (101A) relative to the patient tissue structure (P) using the registration ([0001]; [0031]; [0057]-[0061]; [0080]; [0148]; acquisition and tracking of the position and orientation of robotic tools or instruments is expressly disclosed);
(claim 2) comprising imaging the patient tissue structure (P) during the intervention ([0191]; real time imaging expressly disclosed);
(claim 3) comprising calculating the orientation of the surgical instrument (101A) relative to the patient tissue structure (P) further based on a joint position of a joint 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);
(claim 4) comprising measuring the joint position with an encoder of the joint 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);
(claim 7) wherein the method is performed without optically tracking the patient tissue structure (P) ([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);
(claim 8) comprising maintaining the registration using data from joints 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);
(claim 9) wherein establishing the registration between the imaging element (101C) and the surgical instrument (101A) held by the robotic arm (158A) comprises registering the robotic arm (158A) to a coordinate system of the patient tissue structure (P) ([0031]; [0037]; [0052]; [0061]-[0062]; [0148]; [0161]; [0205]-[0206]; [0209] instrument 101A position registered to a coordinate system is expressly disclosed]);
(claim 10) wherein the imaging element is an X-ray source ([0052]; [0191]; imaging modalities including x-rays expressly disclosed);
(claim 11) wherein the imaging element is an fluoroscopy panel detector ([0032]; imaging modalities including fluoroscopy expressly disclosed);
(claim 12) comprising controlling the robotic arm (158A) based on the registration ([0001]; [0031]; [0033]-[0036]; [0045]; [0057]-[0061]; [0080]; [0148]; [0161]; [0167]-[0169]; [0203]; acquisition and tracking of the position and orientation of robotic tools or instruments is expressly disclosed);
(claim 13) an x-ray imaging device (101C, Fig. 1A) ([0052]; [0191]; use of an alternative imaging modality, such as x-ray, is expressly disclosed) configured to (i.e., capable of) image a patient tissue structure (P, Fig. 1A); a robotic arm (158A, Fig. 1A); a surgical instrument (101A, Fig. 1A) supported by the robotic arm (158A) (as shown in Fig. 1A); and a controller (151, Fig. 1A) for the robotic arm (158A) programmed to: establish registration between the surgical instrument (101A) and the x-ray imaging device (101C) using movement of the robotic arm (158A) (as shown in Figs. 1A and 16; see Abstract; [0033]; [0046]-[0047]; [0049]; [0052]-[0053]; [0057]-[0061]; [0161]; [0191]-[0197]; registering the surgical instrument 101A and overlaying the instrument 101A into images from the imaging system 101C is expressly disclosed); and calculate, during an intervention on the patient tissue structure (P) using the surgical instrument (101A), and orientation of the surgical instrument (101A) using the registration ([0001]; [0031]; [0033]; [0046]-[0047]; [0049]; [0052]-[0053]; [0057]-[0061]; [0080]; [0148]; acquisition and tracking of the position and orientation of robotic tools or instruments is expressly disclosed);
(claim 14) wherein the robotic arm (158A) comprises a joint rotation sensing system, wherein the controller (151) is programmed to calculate the orientation of the surgical instrument (101A) using data from the joint rotation sensing system and without requiring optical tracking of the patient tissue structure (P) ([0037]; [0042]; each robotic arm and joint may include one or more displacement transducers, positional sensors, and/or orientational sensors to assist the controller 151 in acquisition and tracking of robotic instruments);
(claim 15) wherein the x-ray imaging device (101C) is arranged to image the patient tissue structure (P) while the surgical instrument (101A) moves at the patient tissue structure (P) ([0001]; [0031]; [0033]; [0046]-[0047]; [0049]; [0052]-[0053]; [0057]-[0061]; [0080]; [0148]; [0191]; acquisition and tracking of the position and orientation of robotic tools or instruments is expressly disclosed);
(claim 16) wherein the surgical instrument (101A) is configured to (i.e., capable of) provide an insertion motion (as shown in Figs. 1A, 5A-5B and 16; [0033]-[0035]; [0037]; [0041]; robotic arm 158A expressly provides for manipulating and inserting the surgical instruments 101A into and about the treatment site);
(claim 17) wherein the controller (151) is programmed to maintain the registration using data from a joint rotation sensing system ([0037]; [0042]; [0046]-[0047]; [0049]; 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);
(claim 18) wherein the orientation is calculated in a coordinate system of the patient tissue structure (P) ([0031]; [0037]; [0052]; [0061]-[0062]; [0148]; [0161]; [0205]-[0206]; [0209] instrument 101A position registered to a coordinate system is expressly disclosed]);
(claim 19) A method, comprising: imaging, with an x-ray device (101C, Fig. 1A) ([0052]; [0191]; use of an alternative imaging modality, such as x-ray, is expressly disclosed), a patient tissue structure (P, Fig. 1A) while a surgical instrument (101A, Fig. 1A) held by a robotic arm (158A, Fig. 1A) is positioned relative to the patient tissue structure (P) (as shown in Fig. 1; [0032]; [0034]; [0043]; [0052]-[0053]; [0074]; [0079]-[0080]; [0191]-[0197]; imaging device use/insertion for imaging during surgery expressly disclosed); establishing, by moving the robotic arm (158A), registration between the x-ray device (101C), the patient tissue structure (P), and the surgical instrument (101A) held by the robotic arm (158A) (as shown in Figs. 1A and 16; see claim 20; [0046]; [0052]-[0053]; [0057]-[0061]; [0161]; [0191]-[0197]; registering the surgical instrument 101A and overlaying the instrument 101A into images from the imaging system 101C is expressly disclosed); and conducting, using the surgical instrument (101A), an intervention on the patient tissue structure (P) while calculating an orientation of the surgical instrument (101A) relative to the patient tissue structure (P) using the registration ([0001]; [0031]; [0057]-[0061]; [0080]; [0148]; acquisition and tracking of the position and orientation of robotic tools or instruments is expressly disclosed); and
(claim 20) wherein calculating the orientation of the surgical instrument (101A) relative to the patient tissue structure (P) further comprises using joint rotation data for joints 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).
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.
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.
Claim(s) 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Maschke and/or Zhao as applied to claim 1 above, and further in view of Mittelstadt et al. (US 6,033,415).
Maschke and/or 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]; Zhao [0032]) 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 Maschke and/or 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 Maschke and/or Zhao.
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
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