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 .
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.
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: “a control system configured to receive…” in claim 1.
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.
The “control system” has been interpreted as corresponding to one or more processors, as set forth in paragraph [0034] of Applicant’s PG-Pub, and equivalents thereof.
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 Objections
Claim 46 is objected to because of the following informalities:
In claim 46, in line 2, “a patient anatomy” should be changed to --- the patient anatomy ---.
Appropriate correction is required.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 9, 14-15, 27, 30, 44, 46, 60-61 and 65 is/are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Wang et al. (WO 2021/138096).
With regards to claims 1, 30 and 60, Wang et al. disclose a method, medical system comprising:
a control system (612) (paragraphs [0004], [0073], referring to the control system which includes programmed instructions to implement a plurality of operating modes including a navigation planning mode, a navigation mode and/or a procedure mode; Figure 9) configured to:
receive first imaging data of a patient anatomy (paragraph [0024], referring to the “image data” of the anatomical region that is displayed; Figure 2A, step 210);
identify an anatomical target (416, “C”) in the patient anatomy (paragraphs [0026]-[0028], referring to determining a target location in the anatomical region; Figures 2A, 3-4);
generate a treatment zone (418, 520) having a first axis (i.e. 546), wherein the treatment zone includes the anatomical target (416, “C”) (paragraph [0027], referring to, after the target location (416) is determined, a target border region (418) may be generated around the target location (416); paragraph [0036], referring to the target (520) and referring to the trajectory path (546) extending from the distal end (535) of the medical instrument (530) through the target (520), to an intersection point (555) on the surface of interest (510, wherein the direction of the trajectory path (546) corresponds to an orientation of the distal end (535) of the medical instrument (530) and the trajectory path (546) extends through the center C of the target (520); Figures 3-4, note that the trajectory path (546) which extends through the center C of the target border region (418, 520) defines a first axis of the treatment zone (418, 520)); and
determine a deployment position (i.e. position corresponding to the distal end (535) of the medical instrument) of an elongate device (530) configured to receive a medical instrument (i.e. biopsy tool/needle) for treatment of the anatomical target (paragraph [0036], referring to the medical instrument (530) being inserted into the portion (500) of the anatomical region in the vicinity of the target (520), wherein a biopsy tool/needle may extend from a distal end (535) of the medical instrument (530) towards the target (520); paragraphs [0042]-[0043], referring to more than one trajectory path being available to the medical instrument (530) to reach the anatomic target (520), wherein in such cases, the distal end (535) of the medical instrument (530) may be located in a different position and/or orientation with the patient anatomy depending on the chosen trajectory path, wherein a determination may be made that the trajectory path is unsafe and the trajectory path may be discarded, suppressed or otherwise not used in the determination of the zone boundary (540); paragraph [0044], referring to modifying/fine-tuning the trajectory path (546) such as by providing more space between the distal end (535) and the intersection point (555) to decrease the risk of the needle puncturing the surface (510) when the needle is extended; Figures 3-6), wherein the deployment position is aligned with the first axis of the treatment zone (paragraph [0036], referring to the direction of the trajectory path (546) corresponds to an orientation of the distal end (535) of the medical instrument (530) and the trajectory path (546) extends through the center C of the target (520); Figure 4A, wherein the position of the distal end (535) is aligned with the first axis (546) of the treatment zone (520)).
Further, with regards to claim 30, Wang et al. disclose that the method further comprises receiving information identifying the anatomical target in the patient anatomy (paragraphs [0026]-[0028], referring to the target location (416) being identified via a user input or may be determined without user input using, for example, image analysis techniques to determine target locations based on shape, density, location or other characteristics determined from computer analysis of the image data, wherein such image data/results from the image analysis corresponds to the received “information”) and determining the first axis (546) of the treatment zone to identify the deployment location of the elongate device (paragraph [0036], referring to the target (520) and referring to the trajectory path (546) extending from the distal end (535) of the medical instrument (530) through the target (520), to an intersection point (555) on the surface of interest (510, wherein the direction of the trajectory path (546) corresponds to an orientation of the distal end (535) of the medical instrument (530) and the trajectory path (546) extends through the center C of the target (520); Figures 4-6).
Additionally, with regards to claim 60, Wang et al. disclose that the medical system comprises a display system (610) (paragraph [0070]; Figure 9), an elongate device (100, 530) (paragraphs [0021], [0036], referring to the medical instrument (100, 530)); a medical instrument (i.e. biopsy tool/needle) configured to extend within the elongate device (100, 530); wherein the control system is communicatively coupled to the display system (paragraph [0004]; Figure 9), wherein the control system is configured to: display a graphical user interface via the display system, the graphical user interface including a virtual navigation view (paragraphs [0023]-[0024], referring to the graphical user interface (400); paragraph [0075], referring to the system including a virtual visualization system; Figures 1, 3-4) and display an image of the elongate device in the virtual navigation view and display an anatomical target (“C”) in the virtual navigation view (paragraphs [0024]-[0025], referring to the display of the image data (410) and information associated with planning the medical procedure; Figures 3-4).
With regards to claim 2, Wang et al. disclose that the deployment position includes a deployment location or a deployment orientation (paragraph [0036], referring to the location of the exit point/distal end (535) and referring to direction of the tractor path (546) corresponding to an orientation of the distal end (535) of the instrument (530); paragraphs [0042]-[0044], referring to an adjustment of an orientation at which the distal end (535) of the medical instrument approaches the anatomic target (520) and/or providing more space between the distal end (535) and the intersection point (555), thereby the deployment position is defined by a deployment location (i.e. location/position of the distal end (535)) or a deployment orientation (i.e. orientation at which the distal end (535) approaches the anatomic target (520); Figures 4-6).
With regards to claim 9, Wang et al. disclose that the control system is further configured to determine a deployment range of the elongate device (paragraphs [0042], [0058], referring to the depth (Dt) of the trajectory zone (830) being based on an extension length (i.e. deployment range) of a tool extendable from the medical instrument, wherein the depth Dt of the trajectory zone (830) may be set at the maximum extension length of the tool; Figure 8).
With regards to claim 14, Wang et al. disclose that an orientation of the deployment range is determined based on a major axis of the anatomical target (paragraphs [0036], [0042], referring to the direction of the trajectory path (546) corresponding to an orientation of the distal end (535) of the medical instrument (530) and the trajectory path (546) extends through the center C of the target (520); Figures 3-4, 6, note that that the target is circular, and thus any axis that passes through the center of the circle is considered to correspond to the major/longest axis of the circle).
With regards to claims 15 and 65, Wang et al. disclose that the control system is further configured to determine at least one ablation zone, wherein the at least one ablation zone covers the treatment zone (paragraph [0026], referring to the target location corresponding to a biopsy site; paragraph [0070], referring to the medical instrument including components for use in surgery, biopsy, “ablation”, etc., and thus the target location/border region/zone corresponds to an ablation zone). Further, with regards to claim 65, Wang et al. disclose that the control system is further configured to display the at least one ablation zone (418, 520) in the virtual navigation view (400) (see Figures 3-4).
With regards to claim 27, Wang et al. disclose that the control system is further configured to display an image of the treatment zone (418, 520) and an image of the anatomical target (416, “C”) via a display system including a graphical user interface (paragraph [0024], referring to displaying the image data (410) corresponding to the anatomical region (104) of a patient via graphical user interface (400), wherein the graphical user interface (400) displays information associated with planning a medical procedure; see Figures 3, 4).
With regards to claim 44, Wang et al. disclose that the method further comprises determining a deployment location for a medical instrument configured to extend within the elongate device, wherein at the deployment location a longitudinal axis of the medical instrument is aligned with the first axis of the treatment zone (paragraph [0036], referring to the medical instrument (530) being inserted into the portion (500) of the anatomical region in the vicinity of the target (520), wherein a biopsy tool/needle may extend from a distal end (535) of the medical instrument (530) towards the target (520); paragraphs [0042]-[0043], referring to more than one trajectory path being available to the medical instrument (530) to reach the anatomic target (520), wherein in such cases, the distal end (535) of the medical instrument (530) may be located in a different position and/or orientation with the patient anatomy depending on the chosen trajectory path, wherein a determination may be made that the trajectory path is unsafe and the trajectory path may be discarded, suppressed or otherwise not used in the determination of the zone boundary (540); paragraph [0044], referring to modifying/fine-tuning the trajectory path (546) such as by providing more space between the distal end (535) and the intersection point (555) to decrease the risk of the needle puncturing the surface (510) when the needle is extended; paragraph [0036], referring to the direction of the trajectory path (546) corresponds to an orientation of the distal end (535) of the medical instrument (530) and the trajectory path (546) extends through the center C of the target (520); Figure 4A, wherein the position of the distal end (535) is aligned with the first axis (546) of the treatment zone (520); Figures 3-6).
With regards to claim 46, Wang et al. disclose that the method further comprises receiving second imaging data of a patient anatomy (paragraph [0055], referring to the image data may include data obtained using one “or more” imaging technologies, such as CT, MRI, fluoroscopy, etc., wherein the image data may include multiple images of the three-dimensional anatomical region and thus second imaging data may be received); and generating a second treatment zone (i.e. region corresponding to “C2”) based on the second imaging data (paragraphs [0050]-[0051], referring to “TARGET 2”, wherein the image data may include a center C2 of the target region (564), etc., which, as depicted in Figure 7C, correspond to a second treatment zone).
With regards to claim 61, Wang et al. disclose that the control system is further configured to display at least one of the treatment zone (418, 520), the deployment location or a deployment range of the medical instrument in the virtual navigation view (see Figures 3, 7).
Claim(s) 3, 16, 24-25, 36-37, 68 and 70 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. as applied to claims 1, 30 and 60 above, and further in view of Munrow et al. (US Pub No. 2014/0073911).
With regards to claims 3 and 36, as discussed above, Wang et al. meet the limitaitons of claims 1 and 30. Further, Wang et al. disclose that the control system is further configured to identify one or more critical structures in the patient anatomy (paragraphs [0020], [0028], [0030], referring to the identification of the vulnerable anatomic structures or surfaces, for example, pulmonary pleurae or fissures, etc., wherein a candidate path identified during a planning procedure may be identified as invalid when it passes within a threshold distance of a vulnerable portion of the anatomy or breaches a vulnerable portion of the anatomy).
However, Wang et al. do not specifically disclose that the control system is further configured to alter/adjust the treatment zone based on the one or more critical structures.
Munrow et al. disclose a system for deploying needles in tissue including a controller and a visual display, wherein when a virtual treatment boundary (TB) and associated safety boundary (SB) indicates a risk that the treatment would affect more sensitive tissue surrounding the uterus, the size of both the safety and treatment boundaries (SB and TB) are reduced (Abstract; paragraph [0080]; Figure 11). The physician thus has confirmation that the treatment boundary completely surrounds the fibroid and that the treatment will be safe (paragraph [0080]; Figure 11).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the control system of the above combined references be further configured to alter the treatment zone based on the one or more critical structures, as taught by Munrow et al., in order to provide confirmation that the treatment boundary completely surrounds the fibroid and that the treatment will be safe (paragraph [0080]).
With regards to claim 16, as discussed above, Wang et al. meet the limitations of claim 15. However, Wang et al. do not specifically disclose that determining the at least one ablation zone further includes minimizing a size of an ablation region of the at least one ablation zone beyond the treatment zone.
Munrow et al. disclose a system for deploying needles in tissue for ablating or treating a fibroid, wherein the system includes a controller and a visual display, wherein when a virtual treatment boundary (TB) and associated safety boundary (SB) indicates a risk that the treatment would affect more sensitive tissue surrounding the uterus, the size of both the safety and treatment boundaries (SB and TB) are reduced (Abstract; paragraph [0080], note that adjusting the treatment boundary to be reduced results in minimizing a size of an ablation region beyond the previous designated treatment zone (i.e. previously defined treatment boundary); Figure 11). The physician thus has confirmation that the treatment boundary completely surrounds the fibroid and that the treatment will be safe (paragraph [0080]; Figure 11).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the determining the at least one ablation zone further include minimizing a size of an ablation region of the at least one ablation zone beyond the treatment zone, as taught by Munrow et al., in order to provide confirmation that the treatment boundary completely surrounds the fibroid and that the treatment will be safe (paragraph [0080]).
With regards to claim 24, Munrow et al. disclose that the control system is further configured to receive a user input adjusting a size of the at least one ablation zone (paragraph [0025], referring to the controller adjusting the position and size of the treatment/safety boundaries based on the power, time, and/or other treatment parameters which have been selected by the physician, and therefore the physician input of the power, time and or other treatment parameters ultimately results in adjustment of a size of the ablation zone corresponding to the adjusted treatment boundary).
With regards to claim 25, Munrow et al. disclose that the control system is further configured to adjust ablation parameters based on a proximity of the at least one ablation zone to one or more critical structures (paragraph [0025], [0028]-[0029], , referring to the controller adjusting the position and size of the treatment/safety boundaries based on the power, time, and/or other treatment parameters which have been selected by the physician; paragraph [0080], referring to the adjustment of the treatment boundaries based on the proximity to sensitive tissue, which would accordingly result in an adjustment of the ablation parameters; paragraph [0061], referring to rotation of the knob (30) determining the length of and/or power delivery during a treatment protocol, wherein the knob may also be used to virtually size the treatment/safety region, etc.).
With regards to claim 37, Wang et al. disclose that adjusting the treatment zone includes shifting the first axis of the treatment zone laterally from a major axis of the anatomical target, and wherein the shifted first axis is parallel to the major axis (paragraphs [0042]-[0044]; Figure 6, which depicts different treatment zones by shifting the first axis of the treatment zone laterally from a major axis (note that for a circle, any axis going through the center of the circle corresponds to the longest/major axis) of the anatomical target, and wherein the shifted first axis is parallel to the major axis (i.e. which is any axis passing through the center of the circle)).
‘With regards to claim 68, as discussed above, Wang et al. meet the limitations of claim 65. However, Wang et al. do not specifically disclose that the control system is further configured to receive a user input adjusting one or more ablation parameters based on: a proximity of the at least one ablation zone to one or more critical structures; or a proximity of the at least one ablation zone to one or more anatomical passageways in close proximity to the anatomical target.
Munrow et al. disclose a system for deploying needles in tissue including a controller and a visual display, wherein when a virtual treatment boundary (TB) and associated safety boundary (SB) indicates a risk that the treatment would affect more sensitive tissue surrounding the uterus, the size of both the safety and treatment boundaries (SB and TB) are reduced (Abstract; paragraph [0080]; Figure 11). The physician thus has confirmation that the treatment boundary completely surrounds the fibroid and that the treatment will be safe (paragraph [0080]; Figure 11). A controller adjusts the position and size of the treatment/safety boundaries based on the power, time, and/or other treatment parameters which have been selected by the physician, and therefore the physician input of the power, time and or other treatment parameters ultimately results in adjustment of a size of the ablation zone corresponding to the adjusted treatment boundary (paragraphs [0025], [0028]-[0029]; Figure 11). The system is configured to control the projected treatment size based upon both an energy level and the position of the stop elements, which are under the control of the user/physician, and which may be tracked by sensors on the treatment probe (paragraphs [0028]-[0029]).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the control system of Wang et al. be further configured to receive a user input adjusting one or more ablation parameters based on: a proximity of the at least one ablation zone to one or more critical structures; or a proximity of the at least one ablation zone to one or more anatomical passageways in close proximity to the anatomical target, as taught by Munrow et al., in order to provide confirmation that the treatment boundary completely surrounds the fibroid and that the treatment will be safe (paragraph [0080]).
With regards to claim 70, as discussed above, Wang et al. meets the limitations of claim 60. However, Wang et al. do not specifically disclose that the control system is further configured to determine a safety margin surrounding the treatment zone, wherein the safety margin is sized and shaped based on potential movement of a position of the medical instrument.
Munrow et al. disclose a system for deploying needles in tissue including a controller and a visual display, wherein when a virtual treatment boundary (TB) and associated safety boundary (SB) indicates a risk that the treatment would affect more sensitive tissue surrounding the uterus, the size of both the safety and treatment boundaries (SB and TB) are reduced (Abstract; paragraph [0080]; Figure 11, note that the safety boundary/margin surrounds the treatment zone/boundary and the reduction of the safety boundary/margin corresponds to the size and shape of the safety margin being set based on potential movement of a position of the medical instrument (i.e. such as potential movement of the medical instrument into the sensitive tissue)). The physician thus has confirmation that the treatment boundary completely surrounds the fibroid and that the treatment will be safe (paragraph [0080]; Figure 11).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the control system of Wang et al. be further configured to determine a safety margin surrounding the treatment zone, wherein the safety margin is sized and shaped based on potential movement of a position of the medical instrument., as taught by Munrow et al., in order to provide confirmation that the treatment boundary completely surrounds the fibroid and that the treatment will be safe (paragraph [0080]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE L FERNANDEZ whose telephone number is (571)272-1957. The examiner can normally be reached Monday-Friday 9:00 AM - 5:30 PM (ET).
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/KATHERINE L FERNANDEZ/Primary Examiner, Art Unit 3798
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