DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/05/2026 has been entered.
Response to Arguments
Applicant's arguments below filed 12/3/2025 have been fully considered but they are not persuasive | moot in view of the new grounds of rejection.
In response to the double patenting remarks, the claims remain rejected under double patenting.
Applicant’s arguments, see pages 14-17 of the remarks, filed 12/03/2025, with respect to claims 17, 34, and 39 have been fully considered and are persuasive. The 35 USC § 103 rejections of claims 17, 19, 21-29, 34-37, and 39-47 have been withdrawn.
The Applicant asserts on page 18 of the Response:
“Wenderow describes user controls (such as joysticks and buttons) that allow an operator to move percutaneous devices and, in some cases, to control certain imaging functions. Wenderow does not, however, disclose or suggest a user control that is positioned within an activation zone when in a resting position, nor does Wenderow disclose or suggest a user control that is configured to control initiation of image capture without causing movement of a percutaneous device within the patient when the user control is within the activation zone, but also control movement of the percutaneous device when the user control is outside the activation zone. At best, Wenderow discloses conventional user controls for device movement and imaging, without any disclosure, suggestion or even hint of dividing control functions based on the spatial relationship of the user control to an activation zone.”
In response the examiner respectfully asserts that as recited in the previous rejection Wenderow discloses user controls that may include buttons or joysticks and one with ordinary skill in the art would recognize that buttons and joysticks would have activation zones. One with ordinary skill in the art would recognize that if a joystick is used the activation zone for a joystick would be a certain radius around the joystick and the resting position would be at least partially within the activation zone. Wenderow also discloses a user control that is configured to control initiation of image capture and one with ordinary skill in the art would recognize this would require movement of the joystick within an activation zone. For clarification purposes Wenderow also discloses control of the percutaneous device such as in [0023] "Controls 16 allow the user to control bedside system 12 to perform a catheter based medical procedure". The examiner agrees that Wenderow does not teach a user control that is configured to control initiation of image capture without causing movement of a percutaneous device within the patient when the user control is within the activation zone, but also control movement of the percutaneous device when the user control is outside the activation zone as recited in the previous rejection.
The Applicant asserts on pages 18-19 of the Response:
“Paragraph [0053] of Fung, cited at page 27 of the Office Action, describes a joystick 114 for controlling "movement of the stage 106 and the activation of the X-ray source 220." However, as with Wenderow, Fung also does not disclose or suggest a user control that is positioned within an activation zone when in a resting position, nor does Fung disclose a user control that is configured to control initiation of image capture without causing movement of a percutaneous device within the patient when the user control is within the activation zone, but also control movement of the percutaneous device when the user control is outside the activation zone. Indeed, Fung does not disclose, suggest or even hint at the claimed division of control based on the position of the user control relative to an activation zone.
Further, the Office Action alleges that one of ordinary skill in the art would recognize that "when the interlock devices 182 184 are disengaged the joystick may only perform one function when there is movement in the activation zone such as initiating capture of images." Office Action, page 28. However, paragraph [0053] of Fung specifically describes that when the interlock devices 182, 184 are disengaged, one or more functions are disabled such as "the joystick 114 and the x-ray source 220." Thus, Fung does not disclose that the joystick may only perform one function but rather describes that the joystick may be either enabled or disabled.”
In response the examiner respectfully asserts that Fung is disclosing that one or more functions are disabled when the first access door 104 is opened and the joystick and the x-ray source are only examples. Therefore the joystick does not have to be disabled and only the x-ray source may be disabled. Therefore when the first access door 104 is opened the joystick may still be enabled to control movement of the stage.
The Applicant asserts on pages 18-19 of the Response:
“Paragraph [0053] of Fung, cited at page 27 of the Office Action, describes a joystick 114 for controlling "movement of the stage 106 and the activation of the X-ray source 220." However, as with Wenderow, Fung also does not disclose or suggest a user control that is positioned within an activation zone when in a resting position, nor does Fung disclose a user control that is configured to control initiation of image capture without causing movement of a percutaneous device within the patient when the user control is within the activation zone, but also control movement of the percutaneous device when the user control is outside the activation zone. Indeed, Fung does not disclose, suggest or even hint at the claimed division of control based on the position of the user control relative to an activation zone.
Further, the Office Action alleges that one of ordinary skill in the art would recognize that "when the interlock devices 182 184 are disengaged the joystick may only perform one function when there is movement in the activation zone such as initiating capture of images." Office Action, page 28. However, paragraph [0053] of Fung specifically describes that when the interlock devices 182, 184 are disengaged, one or more functions are disabled such as "the joystick 114 and the x-ray source 220." Thus, Fung does not disclose that the joystick may only perform one function but rather describes that the joystick may be either enabled or disabled.”
In response the examiner respectfully asserts that Fung is disclosing that one or more functions are disabled when the first access door 104 is opened and the joystick and the x-ray source are only examples. Therefore the joystick does not have to be disabled and only the x-ray source may be disabled. Therefore when the first access door 104 is opened the joystick may still be enabled to control movement of the stage.
The Applicant asserts on page 19 of the Response:
“The Office Action cites to Marar to allegedly describe "the user control being configured to control initiation of capture of medical images of the patient by a medical imaging system when within the activation zone and configured to cause the movement of the [...] device within the patient when outside of the activation zone." Office Action, page 27.
Marar describes a "two stage button-type switch" that has three configurations, not depressed, partially depressed, or fully depressed." Marar, paragraph [0031]. The button of Marar is configured to transition between an off, prep, and operating mode of an x-ray source. However, Marar is unrelated to movement of a percutaneous device and a person of ordinary skill in the art would not be motivated to modify any combination of Wenderow and Fang with the two-stage button of Marar at least because a button cannot control movement of a device and initiation of imaging as recited in claim 30.”
In response the examiner respectfully asserts that Wenderow teaches that user controls such as joysticks are used to control image capture and also discloses that user controls are used to control the catheter. Fung discloses a joystick Marar discloses a two-stage button with different functions for each stage. One with ordinary skill in the art would recognize joysticks can also have two-stages based on zones around the joystick and therefore one with ordinary skill in the art would find it obvious to use one user control with two stages to control the image capture and the movement of the catheter.
The Applicant asserts on pages 19-20 of the Response:
“None of Wenderow, Fung or Marar discloses or fairly suggests automatically initiating capture of medical images of the patient by a medical imaging system, without causing movement of the percutaneous device, in response to movement of the user control within the activation zone. In Wenderow, image capture and device movement are not functionally separated and there is no disclosure of a system in which movement of the user control within a defined activation zone results in initiation of image capture while not moving a percutaneous device. Similarly, Fung does not disclose or fairly suggest any such functional separation or initiation of image capture based on the position of the user control and Marar does not describe control of a percutaneous device as the cited portions are only related to x-ray imaging.”
In response the examiner respectfully asserts that Wenderow teaches that user controls such as joysticks are used to control image capture and also discloses that user controls are used to control the catheter. Fung discloses a single joystick to perform two functions. Marar discloses a two-stage button with different functions for each stage and each stage can be considered as a zone. One with ordinary skill in the art would recognize joysticks can also have two-stages based on zones around the joystick. Therefore one with ordinary skill in the art would find it obvious to combine the teachings of Wenderow, Fung, and Marar to teach automatically initiating capture of medical images of the patient by a medical imaging system, without causing movement of the percutaneous device, in response to movement of the user control within the activation zone.
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: “actuating mechanism” in claims 17, 30, 34, 39, 43, 44, and 45.
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 actuating mechanism is disclosed in [0037] as including a rotate actuator and an advance/retract actuator. Therefore the actuating mechanism will be interpreted as an actuator.
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 § 103
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 30-33 and 38 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Wenderow (WO 2010025338) and further in view of Fung (US 20070195927), Marar (US 20080292056) and Nagashima (JP2003110881A).
Regarding claim 30, Wenderow discloses a system (Title) comprising:
a bedside actuating mechanism configured to engage and to move a percutaneous device within a patient ([0023] – “bedside system 12 to perform various tasks using the various percutaneous intervention devices with which bedside system 12 may be equipped (e.g., to advance, retract, or rotate a guide wire, advance, retract, or rotate a working catheter”);
a user control positioned within an activation zone when in a resting position ([0024] – “Each of the dedicated controls may include one or more buttons, joysticks, touch screens, etc. that may be desirable to control the particular component to which the control is dedicated”, one with ordinary skill in the art would recognize joysticks and buttons can have one or multiple different activation zones and that if a joystick is used the activation zone can be a certain radius around the joystick where the resting position would be at least partially in the activation zone or the activation zone can be in a certain direction where the resting position would be at least partially in the activation zone); and
a controller configured to, in response to movement of the user control within the activation zone, automatically initiate the capture of medical images of the patient by the medical imaging system (0032] – “controls 16 may also be configured to allow the user positioned at workstation 14 to control various functions of imaging system 32 (e.g., image capture, magnification, collimation, c- arm positioning, etc.)”, one with ordinary skill in the art would recognize if a joystick or button is used as a controller for the image capture of the imaging system there would be an activation zone to initiate image capture when the joystick is moved in the particular activation zone)
wherein movement of the user control displaces the user control from the resting position (one with ordinary skill in the art would recognize movement of a joystick displaces the joystick from the resting position).
Conversely Wenderow does not teach the user control being configured to control initiation of capture of medical images of the patient by a medical imaging system when within the activation zone and configured to control movement of the percutaneous device within the patient when outside the activation zone;
in response to movement of the user control within the activation zone, automatically initiate capture of medical images of the patient by a medical imaging system without causing movement of the percutaneous device.
a size of the activation zone is configurable.
Fung discloses a dual function joystick including an imaging function as disclosed in paragraph [0053] of Fung.
Marar discloses the user control being configured to control initiation of capture of medical images of the patient by a medical imaging system when within the activation zone and configured to cause the movement of the […] device within the patient when outside of the activation zone ([0031] – “Exposure prep and hold switch 120 is selectively movable from the initial stage “off” position to an intermediate or first stage “prep” position by being depressed. Exposure prep and hold switch 120 is selectively movable from the first stage “prep” position to a final or second stage “operating” position by being further depressed”, therefore there is an activation zone for the “prep” stage and when the button is pushed further outside of that activation zone the x-ray is put into the operating stage, therefore it would be obvious for one of ordinary skill in the art to use an activation zone for one function and a zone outside of the activation zone to perform to another function such as movement of the device with one input device).
The disclosure of Marar is an analogous art considering it is in the field of control of an imaging device.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Wenderow to incorporate the two-stage switch of Marar to achieve the same results. One would have motivation to combine because it allows one to perform two different functions with one joystick, button, or switch.
Conversely Wenderow and Marar do not teach in response to movement of the user control within the activation zone, automatically initiate capture of medical images of the patient by a medical imaging system without causing movement of the percutaneous device.
a size of the activation zone is configurable.
However Fung discloses in response to movement of the user control within the activation zone, automatically initiate capture of medical images of the patient by a medical imaging system without causing movement of the percutaneous device (Fung discloses a dual function joystick in [0053] by reciting “joystick 114 to control the movement of the stage 106 and the activation of the X-ray source 220”, one with ordinary skill in the art would recognize when the interlock devices 182 184 are disengaged the joystick may only perform one function when there is movement in the activation zone such as initiating capture of images).
The disclosure of Fung is an analogous art considering it is in the field of controlling an imaging device with a joystick.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Wenderow to incorporate the dual function joystick of Fung to achieve the same results. One would have motivation to combine because it decreases the number of controls and therefore makes the system more user friendly.
Conversely Wenderow, Marar, and Fung do not teach a size of the activation zone is configurable.
However Nagashima discloses a size of the activation zone is configurable ([0041] – “if the value of the position signal exceeds the range of ±β, that is, if the value of the position signal becomes smaller than the threshold value 128-β or larger than the threshold value 128+β, it is determined that left/right operation of the joystick 20 has begun. The value of β can be set to any value”).
The disclosure of Nagashima is an analogous art considering it is in the field of controlling an imaging device with a joystick.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Wenderow to incorporate the size of the activation zone being configurable of Nagashima to achieve the same results. One would have motivation to combine because it would allow one to increase or decrease the movement/timing available to perform a first function of a controller.
Regarding claim 31, Wenderow, Marar, Fung, and Nagashima disclose all the elements of the claimed invention as cited in claim 30.
Wenderow further discloses wherein the controller is configured to cause the movement of the percutaneous device in response to movement of the user control ([0026] – “guide catheter control 29, guide wire control 23, and working catheter control 25 are joysticks that allow the user to advance, retract, and rotate the component associated with the control”) […].
Conversely Wenderow does not teach wherein the controller is configured to cause the movement of the […] device in response to movement of the user control outside of the activation zone.
As cited above Fung discloses a dual function joystick including an imaging function.
Marar discloses wherein the controller is configured to cause the movement of the […] device in response to movement of the user control outside of the activation zone ([0031] – “Exposure prep and hold switch 120 is selectively movable from the initial stage “off” position to an intermediate or first stage “prep” position by being depressed. Exposure prep and hold switch 120 is selectively movable from the first stage “prep” position to a final or second stage “operating” position by being further depressed”, therefore there is an activation zone for the “prep” stage and when the button is pushed further outside of that activation zone the x-ray is put into the operating stage, therefore it would be obvious for one of ordinary skill in the art to use an activation zone for one function and a zone outside of the activation zone to perform to another function with one input device).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Wenderow to incorporate the two-stage switch of Marar to achieve the same results. One would have motivation to combine because it allows one to perform two different functions with one joystick, button, or switch.
Regarding claim 32, Wenderow, Marar, Fung, and Nagashima disclose all the elements of the claimed invention as cited in claims 30 and 31.
Wenderow further discloses wherein the controller is configured to cause the movement of the percutaneous device […] to stop in response to the user control returning to the resting position ([0026] – “guide catheter control 29, guide wire control 23, and working catheter control 25 are joysticks that allow the user to advance, retract, and rotate the component associated with the control”, it would have been obvious to one with ordinary skill in the art that movement of the percutaneous device would be stopped in response to the joystick returning to the resting position, as this is typical manner in which a joystick is utilized).
Conversely Wenderow does not teach wherein the controller is configured to cause the movement of the percutaneous device and the capture of medical images to stop in response to the user control returning to the resting position.
However Fung discloses wherein the controller is configured to cause the movement of the percutaneous device and the capture of medical images to stop in response to the user control returning to the resting position (As cited above Wenderow teaches a joystick to control movement of the percutaneous device Fung discloses a dual function joystick in [0053] by reciting “joystick 114 to control the movement of the stage 106 and the activation of the X-ray source 220”, it would have been obvious to one with ordinary skill in the art that the capturing of images and movement of the stage would both be stopped in response to the joystick returning to the resting position, as this is typical manner in which a joystick is utilized).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Wenderow to incorporate the dual function joystick of Fung to achieve the same results. One would have motivation to combine because it decreases the number of controls and therefore makes the system more user friendly.
Regarding claim 33, Wenderow, Marar, Fung, and Nagashima disclose all the elements of the claimed invention as cited in claim 30.
Conversely Wenderow does not teach wherein the movement of the user control within the activation zone is indicative of an upcoming movement of the percutaneous device within the patient.
However Marar discloses wherein the movement of the user control within the activation zone is indicative of an upcoming movement of the percutaneous device within the patient. ([0031] – “Exposure prep and hold switch 120 is selectively movable from the initial stage “off” position to an intermediate or first stage “prep” position by being depressed. Exposure prep and hold switch 120 is selectively movable from the first stage “prep” position to a final or second stage “operating” position by being further depressed”, therefore there is an activation zone for the “prep” stage and when the button is pushed further outside of that activation zone the x-ray is put into the operating stage, therefore it would be obvious for one of ordinary skill in the art to use an activation zone for one function and a zone outside of the activation zone to perform to another function such as movement of the device with one input device therefore movement of the controller in the first zone [activation zone] would be indicative of the second function being upcoming).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Wenderow to incorporate the two-stage switch of Marar to achieve the same results. One would have motivation to combine because it allows one to perform two different functions with one joystick, button, or switch.
Regarding claim 38, Wenderow, Marar, Fung, and Nagashima disclose all the elements of the claimed invention as cited in claim 30.
Wenderow further discloses further comprising: the medical imaging system configured to capture the medical images of the patient ([0032] – “Imaging system 32 is configured to take x-ray images of the appropriate area of patient 21”).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 17, 19, and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. US9320479B2 in view of Moll (US 20070197896).
Although the claims at issue are not identical, they are not patentably distinct from each other because each is directed to a system, with the instant claims being broader and therefore anticipated by the conflicting claims. The claims 17 and 19 additionally correspond to claim 1 of US9320479B2 with respect to the system, the bedside actuator configured to move the percutaneous device, a user interface, a sensor configured to detect the presence of the user's hand adjacent the user interface, and generating a first input generated by the sensor indicating that movement of the percutaneous device is to occur, and the initiation of image capture is in response to the first input, a controller to determine movement of the percutaneous device is to occur and initiating capture of the medical images by a medical imaging system in response to the determination by a medical imaging system [claim 17], initiating capture of medical images prior to movement of the percutaneous device [claim 19], the user interface is configured to detect a second input and control the system to cause the percutaneous device to move based on the second input [claim 21].
Regarding Claim 17, claim 1 of US9320479B2 does not teach that the capture of medical images are automatically controlled and that the control is based on movement of the percutaneous device, however this is obvious in view of Moll.
automatically initiate capture of medical images of the patient by a medical imaging system in response to determining that the movement of the percutaneous device within the patient is to occur (Fig. 148C, [0270] discloses what is shown in Fig. 148C by reciting that target tissue is observed to determine a path and the catheter is inserted and insertion is paused to acquire an image slice and location data and the procedure then continues with automated imaging and automated navigation of the device while continuing to pause to acquire image data along the path).
The disclosure of Moll is an analogous art considering it is in the field of a robotic catheter system.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of U.S. Patent No. US9320479B2 to incorporate the automatic capture of images based on movement of a device of Moll to achieve the same results. One would have motivation to combine because it would provide updated images as the device moves to visualize how the internal body movement may affect movement of the device.
Regarding claim 19, although claim 19 and claim 1 of US9320479B2 are not identical, they are not patentably distinct, one with ordinary skill in the art would find it obvious to perform a first control signal before a second control signal.
Regarding claim 21, although claim 21 and claim 1 of US9320479B2 are not identical, they are not patentably distinct, one with ordinary skill in the art would find it obvious to perform a first control signal before a second control signal.
Claim 22 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. US9320479B2 and Moll (US 20070197896), as applied to claim 17 above, and further in view of McGee (US 20060247521).
Although the claims at issue are not identical, they are not patentably distinct from each other because each is directed to a system, with the instant claims being broader and therefore anticipated by the conflicting claims. The claims 17 and 19 additionally correspond to claim 1 of US9320479B2 with respect to the system, the bedside actuator configured to move the percutaneous device, a controller to control capture of medical images by a medical imaging system [claim 17].
Regarding claim 22, claim 1 of US9320479B2 does not teach the limitations of claim 22, however this is obvious in view of the teachings of McGee.
McGee discloses wherein the controller is configured to determine that the movement of the percutaneous device has ceased, and stop the capture of medical images by the medical imaging system in response to determining that the movement of the percutaneous device has ceased (determining movement using a processor is disclosed in [0063], [0068] – “the imaging device 122 is activated in a continuous manner during movement of the catheter 110 (i.e., the imaging device 122 is activated as long as the catheter 110 remains moving, and is deactivated when the catheter 110 stops moving)”).
The disclosure of McGee is an analogous art considering it is in the field of a navigating a device through the body.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of U.S. Patent No. US9320479B2 to incorporate stopping image capture when movement of the device has ceased of McGee to achieve the same results. One would have motivation to combine because “the amount of radiation to which the patient and medical personnel are exposed is further reduced, and the overall life (or maintenance levels) can be extended due to reduced “on time.”” (McGee – [0074]).
Claims 23-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. US9320479B2, Moll (US 20070197896) and McGee (US 20060247521), as applied to claim 22 above, and further in view of Wenderow (WO 2010025338).
Although the claims at issue are not identical, they are not patentably distinct from each other because each is directed to a system, with the instant claims being broader and therefore anticipated by the conflicting claims. The claims 17 and 19 additionally correspond to claim 1 of US9320479B2 with respect to the system, the bedside actuator configured to move the percutaneous device, a controller to control capture of medical images by a medical imaging system [claim 17].
Regarding claim 23, claim 1 of US9320479B2 does not teach the limitation of claim 23, however this is obvious in view of the teaching of Wenderow.
Wenderow discloses further comprising: a display device configured to display the medical images captured by the medical imaging system ([0029] – “first monitor 26 is configured to display a real-time image of a patient's heart during a catheterization procedure”).
The disclosure of Wenderow is an analogous art considering it is in the field of a navigating a device through the body.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of U.S. Patent No. US9320479B2 to incorporate a display to display the images captured by the medical imaging system of Wenderow to achieve the same results. One would have motivation to combine so that progress of the procedure can be visualized.
Regarding claim 24, claim 1 of US9320479B2 does not teach the limitations of claim 24, however this is obvious in view of the teaching of Moll.
Moll discloses wherein the controller is configured to cause the display device to continuously display a last medical image captured by the medical imaging system after the capture of medical images has stopped ([0306] – “a real-time or updated-as-acquired fluoroscopy image including a fluoroscopic representation of the location of an instrument may be overlaid with a real-time representation of where the computerized system expects the instrument to be relative to the surrounding anatomy”, therefore because images are displayed and updated-as-acquired it would be obvious to continue to display the last updated image after the capture of medical images has stopped).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of U.S. Patent No. US9320479B2 to incorporate a continuous display of the last image of Moll to achieve the same results. One would have motivation to combine because it would allow one to analyze the progress of the procedure while reducing radiation exposure to the patient when x-ray is used by stopping the medical imaging.
Claims 25, 27, 29, 34-35, 37, 39-41, and 46-48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. US9320479B2 and Moll (US 20070197896), as applied to claim 17 above, and further in view of Wenderow (WO 2010025338).
Although the claims at issue are not identical, they are not patentably distinct from each other because each is directed to a system, with the instant claims being broader and therefore anticipated by the conflicting claims. The claims 17, 34, 35, and 39 additionally correspond to claim 1 of US9320479B2 with respect to the system, the bedside actuator configured to move the percutaneous device, a controller to determine movement of the percutaneous device is to occur and initiating capture of the medical images by a medical imaging system in response to the determination by a medical imaging system [claim 17], the bedside actuating mechanism configured to move the percutaneous device, a medical imaging system configured to capture medical images, a user control, a controller to control capture of medical images by a medical imaging system, a controller to initiate capture of medical images and cause movement of the percutaneous device after capture of medical images [claim 34], output a first control signal to capture medical images and a second control signal to cause movement of the percutaneous device [claim 35], the robotic catheter procedure system, the bedside actuating mechanism configured to move the percutaneous device, the controller coupled to the user interface, the bedside system and the medical imaging system, the controller configured to cause movement of the percutaneous device after capture of medical images [claim 39], output a first control signal to capture medical images and a second control signal to cause movement of the percutaneous device [claim 48].
Regarding claim 25, claim 1 of US9320479B2 does not teach the limitation of claim 25, however this is taught by Wenderow. It would be obvious to use a controller to make things more automated.
Wenderow discloses wherein the controller is configured to control the movement of the percutaneous device via the bedside actuating mechanism ([0044] – “Controller 40 also includes a procedure control module…Procedure control module 50 allows the manipulation of controls 16 by the user to operate bedside system 12”, [0045] – “Bedside system 12 is operated to feed guide catheter 148 through the patient's arterial system”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of U.S. Patent No. US9320479B2 to incorporate controller being configured to control the movement of the percutaneous device via the bedside actuating mechanism of Wenderow to achieve the same results. One would have motivation to combine because it would make things more automated and therefore decrease user error.
Regarding claim 27, claim 1 of US9320479B2 does not teach the limitation of claim 27, however this is taught by Wenderow.
Wenderow further discloses wherein the controller is configured to automatically initiate the capture of medical images by the medical imaging system without requiring user interaction with a control specific to the medical imaging system ([0032] – “controls 16 may also be configured to allow the user positioned at workstation 14 to control various functions of imaging system 32 (e.g., image capture, magnification, collimation, c- arm positioning, etc.)”, controls 16 can also be used to control other aspects of the system therefore the controls are not specific to the medical imaging system).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of U.S. Patent No. US9320479B2 to incorporate the controller automatically initiating the capture of medical images of Wenderow to achieve the same results. One would have motivation to combine because it would make the system more user friendly having multiple controls in one user interface.
Regarding claim 29, claim 1 of US9320479B2 does not teach the limitation of claim 29, however this is taught by Wenderow.
Wenderow discloses further comprising: one or more sensors configured to detect a distance that the percutaneous device has advanced into, or retracted out of, the patient ([0054] – “distance moved by the various percutaneous intervention devices during the procedure. This distance information may be obtained from…positional sensors located on the percutaneous intervention devices”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of U.S. Patent No. US9320479B2 to incorporate the sensors configured to detect a distance that the percutaneous device has traveled of Wenderow to achieve the same results. One would have motivation to combine because it would allow one to determine how close the device is to the intended target.
Regarding claim 34, claim 1 of US9320479B2 does not teach that the medical imaging system is configured to display medical images, a controller to automatically initiate capture and display of medical images, and cause movement of the device based on movement of the user control however this is obvious in view of the teachings of Wenderow and Moll.
Wenderow discloses a medical imaging system configured to capture and display medical images of the patient ([0032] – “Imaging system 32 is configured to take x-ray images of the appropriate area of patient 21 during a particular procedure… The image or images may be displayed”);
a controller configured to […] initiate the capture and a display of medical images by a medical imaging system (Fig. 2, [0044] – “Controller 40 also includes a procedure control module… Procedure control module 50 may also cause data appropriate for a particular procedure to be displayed…procedure control module 50 may also be configured to allow a user located at workstation 14 to operate imaging system 32”, paragraph [00229] discloses that the workstation can be used to control image capture); and
cause movement of the percutaneous device based on the movement of the user control ([0023] – “Controls 16 allow the user to control bedside system 12 to perform a catheter based medical procedure. Controls 16 may be configured to control movement of the percutaneous intervention devices”) […].
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of U.S. Patent No. US9320479B2 to incorporate the capture and display of medical images of Wenderow to achieve the same results. One would have motivation to combine because it would allow for progress of the procedure can be visualized.
Conversely claim 1 of US9320479B2 and Wenderow do not teach automatically initiate a capture and a display of medical images,
However Moll discloses automatically initiate a capture and a display of medical images by a medical imaging system (Fig. 148C, [0270] discloses what is shown in Fig. 148C by reciting that target tissue is observed to determine a path and the catheter is inserted and insertion is paused to acquire an image slice and location data and the procedure then continues with automated imaging and automated navigation of the device while continuing to pause to acquire image data along the path, [0306] – “a real-time or updated-as-acquired fluoroscopy image including a fluoroscopic representation of the location of an instrument may be overlaid with a real-time representation of where the computerized system expects the instrument to be”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of US9320479B2 to incorporate the automatic capture of images after movement of a device of Moll to achieve the same results. One would have motivation to combine because it would provide updated images as the device moves to visualize how the internal body movement may affect movement of the device.
Regarding claim 35, claim 1 of US9320479B2 does not teach that the control signal automatically initiates image capture and display of medical images and that the control to cause movement of the percutaneous device is in response to an indication from the medical imaging system that the capture and display of images has been initiated, this is obvious in view of the teachings of Moll.
Moll discloses wherein the controller is configured to output a first control signal to the medical imaging system to automatically initiate the capture and display of medical images, and output a second control signal to the bedside actuating mechanism to cause the movement of the percutaneous device in response to an indication from the medical imaging system that the capture and display of medical images has been initiated (Fig. 148C, [0270] discloses what is shown in Fig. 148C by reciting that the catheter is inserted and insertion is paused to acquire an image slice and location data and the procedure then continues with automated imaging and automated navigation of the device while continuing to pause to acquire image data along the path, therefore the automated imaging can be interpreted as the first control signal when the movement is paused and the automated navigation can be interpreted as the second control signal after each image has been captured, analyzed, [0306] discloses that the updated as acquired images are displayed).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of US9320479B2 to incorporate the first control signal and second control signal of Moll to achieve the same results. One would have motivation to combine because it would provide updated images as the device moves to visualize how the internal body movement may affect movement of the device.
Regarding claim 37, claim 1 of US9320479B2 does not teach the limitation of claim 37, however this is taught by Wenderow.
Wenderow discloses further comprising: the medical imaging system configured to capture the medical images of the patient ([0032] – “Imaging system 32 is configured to take x-ray images of the appropriate area of patient 21”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of US9320479B2 to incorporate the medical imaging system being configured to capture the medical images of the patient of Wenderow to achieve the same results. One would have motivation to combine because it would allow the operator to view the internal anatomy and to view how the percutaneous device may be affecting the anatomy.
Regarding claim 39, claim 1 of US9320479B2 does not teach that the controller is configured to cause movement of the percutaneous device based on a signal from the user input system and only after initiation of image capture, however this is obvious in view of the teachings of Wenderow and Moll.
Wenderow discloses the controller configured to cause movement of the percutaneous device via the bedside system based on a signal received from the user input system ([0023] – “Controls 16 allow the user to control bedside system 12 to perform a catheter based medical procedure. Controls 16 may be configured to control movement of the percutaneous intervention devices”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of US9320479B2 to incorporate the controller configured to cause movement of the percutaneous device via the bedside system based on a signal received from the user input system of Wenderow to achieve the same results. One would have motivation to combine because it would allow the operator to determine and control when to move the device within the patient.
Conversely claim 1 of US9320479B2 and Wenderow do not teach cause movement of the percutaneous device […] only after initiation of the capture of medical images by the medical imaging system.
However Moll discloses cause movement of the percutaneous device […] only after initiation of the capture of medical images by the medical imaging system (Fig. 148C, [0270] discloses what is shown in Fig. 148C by reciting that target tissue is observed to determine a path and the catheter is inserted and insertion is paused to acquire an image slice and location data and the procedure then continues with automated imaging and automated navigation of the device while continuing to pause to acquire image data along the path).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of US9320479B2 to incorporate the movement of a device after image capture of Moll to achieve the same results. One would have motivation to combine because it would provide updated images as the device moves to visualize how the internal body movement may affect movement of the device.
Regarding claim 40, claim 1 of US9320479B2 does not teach the limitation of claim 40, however this is obvious in view of the teachings of Moll.
Moll discloses wherein the controller is configured to determine that image capture has been initiated based on a signal from the medical imaging system indicating that image capture has been initiated (Fig. 148C, [0270] discloses what is shown in Fig. 148C by reciting the catheter is inserted and insertion is paused to acquire an image slice and location data and the procedure then continues with automated imaging and automated navigation of the device while continuing to pause to acquire image data along the path, Fig. 148C shows that each image is analyzed to automatically navigate the device therefore there would be a signal from the medical imaging system indicating that image capture has been initiated).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of US9320479B2 to incorporate the signal from the imaging system indicating that image capture has been initiated of Moll to achieve the same results. One would have motivation to combine because it would allow for more automation while providing updated images as the device moves to visualize how the internal body movement may affect movement of the device.
Regarding claim 41, claim 1 of US9320479B2 does not teach the limitation of claim 41, however this is obvious in view of the teachings of Wenderow.
Wenderow discloses wherein the medical imaging system includes a digital x-ray imaging device ([0031] – “imaging system 32 is a digital x- ray imaging device”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of US9320479B2 to incorporate the controller configured to cause movement of the percutaneous device via the digital x-ray imaging device of Wenderow to achieve the same results. One would have motivation to combine because it allows one to easily adjust the field of view of the x-rays.
Regarding claim 46, claim 1 of US9320479B2 does not teach the limitation of claim 46, however this is obvious in view of the teachings of Wenderow. It would be obvious to include a rotate actuator for the guide wire to provide rotational control to the guide wire.
Wenderow discloses wherein the guide wire actuating mechanism includes a rotational actuator ([0023] – “bedside system 12 may be equipped (e.g., to…rotate a guide wire”, [0058] – “motors, actuators, encoders, etc. that are currently in use or in motion within bedside system”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of US9320479B2 to incorporate the rotational actuator for the guide wire of Wenderow to achieve the same results. One would have motivation to combine because it would provide rotational control to the guide wire.
Regarding claim 47, claim 1 of US9320479B2 does not teach the limitation of claim 47, however this is obvious in view of the teachings of Wenderow.
Wenderow discloses wherein the working catheter actuating mechanism includes a rotational actuator ([0023] – “bedside system 12 may be equipped (e.g., to…rotate a working catheter”, [0058] – “motors, actuators, encoders, etc. that are currently in use or in motion within bedside system”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of US9320479B2 to incorporate the rotational actuator for the guide wire of Wenderow to achieve the same results. One would have motivation to combine because it would provide rotational control to the guide wire.
Regarding claim 48, claim 1 of US9320479B2 does not teach that the control signal automatically initiates image capture a of medical images and that the control to cause movement of the percutaneous device is in response to an indication from the medical imaging system that the capture of images has been initiated, this is obvious in view of the teachings of Moll.
Moll discloses wherein the controller is configured to output a first control signal to the medical imaging system to automatically initiate the capture of medical images, and output a second control signal to the actuating mechanism to cause the movement of the percutaneous device in response to an indication from the medical imaging system that the capture of medical images has been initiated (Fig. 148C, [0270] discloses what is shown in Fig. 148C by reciting that the catheter is inserted and insertion is paused to acquire an image slice and location data and the procedure then continues with automated imaging and automated navigation of the device while continuing to pause to acquire image data along the path, therefore the automated imaging can be interpreted as the first control signal when the movement is paused and the automated navigation can be interpreted as the second control signal after each image has been captured and analyzed).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of US9320479B2 to incorporate the first control signal and second control signal of Moll to achieve the same results. One would have motivation to combine because it would provide updated images as the device moves to visualize how the internal body movement may affect movement of the device.
Claim 26 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of U.S. Patent No. US9320479B2 in view of Moll (US 20070197896) and Wenderow (WO 2010025338) as applied to claim 25 above.
Although the claims at issue are not identical, they are not patentably distinct from each other because each is directed to a system, with the instant claims being broader and therefore anticipated by the conflicting claims. The claim 26 additionally correspond to claim 3 of US9320479B2 with respect to the system, the bedside actuator configured to move the percutaneous device, a controller to control capture of medical images by a medical imaging system [claim 17 corresponding to claim 1 of US9320479B2], control the movement of the percutaneous device and actuation of the medical imaging system based on user interaction with a single control [claim 26 corresponding to claim 3 of US9320479B2].
Claim 26 is dependent on claims 17 and 25, as cited above Moll teaches what US9320479B2 does not teach in claim 17 and Wenderow teaches what US9320479B2 does not teach claim in 25.
Regarding claim 26, although claim 26 and claim 3 of US9320479B2 are not identical, they are not patentably distinct.
Claim 28 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. US9320479B2 in view of Moll (US 20070197896), Wenderow (WO 2010025338), and Besson (US 20080118023).
Regarding claim 28, claim 1 of US9320479B2 does not teach the limitations of claim 28, however this is taught by Wenderow and Besson.
Wenderow discloses further comprising: the medical imaging system ([0031] – “imaging system 32”),
wherein the medical imaging system includes an x-ray source configured to emit x-rays toward the patient ([0031] – “imaging system 32 is a digital x- ray imaging device including a C-arm that allows imaging system 32 to partially or completely rotate around patient 21”), and
the controller is configured to identify a leading edge of the percutaneous device in the medical images captured by the medical imaging system ([0069] – “distal tip 150 of guide wire 142 is configured to facilitate location by the user…distal tip 150 of guide wire 142 emits radiation that is detected by imaging system 32”), and
identification of the leading edge by the controller is based on loaded images of leading edges of percutaneous devices or training of the controller by a user ([0069] – “distal tip 150 of guide wire 142 is configured to facilitate location by the user…distal tip 150 of guide wire 142 emits radiation that is detected by imaging system 32”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of US9320479B2 to incorporate the imaging system to identify a leading edge of the percutaneous device of Wenderow to achieve the same results. One would have motivation to combine so that progress of the procedure can be visualized.
Conversely U.S. Patent No. US9320479B2 and Wenderow do not teach limit the x-rays from the x-ray source to an immediate vicinity of the leading edge of the percutaneous device as the percutaneous device moves within the patient,
However Besson discloses limit the x-rays from the x-ray source to an immediate vicinity of the leading edge of the percutaneous device as the percutaneous device moves within the patient ([0089] – “real-time localization of the device tip”, ([0122] – “High resolution and high image refresh rates are necessary only over a small field of view in the immediate neighborhood of the catheter distal end”),
The disclosure of Besson is an analogous art considering it is in the field of a navigating a device through the body while providing images.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of U.S. Patent No. US9320479B2 to incorporate collimation of x-rays to limit x-rays to an immediate vicinity of the distal end of the catheter of Besson to achieve the same results. One would have motivation to combine because “a factor of from four to twelve reduction in patient radiation dose is achieved relative to prior fluoroscopy systems” (Besson – [0122]).
Claims 30-33 and 38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of U.S. Patent No. US9320479B2 in view of an Wenderow (WO 2010025338), Fung (US 20070195927), Marar (US 20080292056), and Nagashima (JP2003110881A).
Although the claims at issue are not identical, they are not patentably distinct from each other because each is directed to a system, with the instant claims being broader and therefore anticipated by the conflicting claims. The claims 30-31 and 33 additionally correspond to claim 6 of US9320479B2 which is dependent on claims 1, 2, 3, 4, and 5 with respect to the system, the bedside actuating mechanism configured to move the percutaneous device, in response to movement of the user control within an activation zone initiate capture of medical images without causing movement of the percutaneous device [claim 30 corresponding to limitations in claims 1, 5, and 6 of US9320479B2], cause movement of the percutaneous device in response to movement of the control out of the activation zone [claim 31 corresponding to claims 1, 5, and 6 of US9320479B2], and movement of the control within the activation zone is indicative of an upcoming movement of the percutaneous device [claim 33 corresponding to claims 1, 5, and 6 of US9320479B2].
Regarding claim 30, claim 30 and claims 1-5 of US9320479B2 are not identical, however all limitations of claim 30 can be taught by Wenderow, Fung, Marar, and Nagashima as recited in the 35 USC § 103 rejection of claim 30 recited above, therefore it would be obvious to combine the teachings of Wenderow, Marar, Fung, and Nagashima with US9320479B2 for any portion of the claim not taught by claims 1-5 of US9320479B2.
Regarding claim 31, claim 31 and claims 1-5 of US9320479B2 are not identical, however all limitations of claim 31 can be taught by Wenderow and Marar as recited in the 35 USC § 103 rejection of claim 31 recited above, therefore it would be obvious to combine the teachings of Wenderow and Marar with US9320479B2 for any portion of the claim not taught by claims 1-5 of US9320479B2.
Regarding claim 32, the limitations of claim 32 are not taught by claims 1-5 of US9320479B2 however as recited in the 35 USC § 103 rejection of claim 32 recited above, Wenderow and Fung both use joysticks for user control and it would be obvious to one with ordinary skill in the art that movement of a joystick to a resting position would stop its control.
Regarding claim 33, claim 33 and claims 1-5 of US9320479B2 are not identical, however all limitations of claim 33 can be taught by Marar as recited in the 35 USC § 103 rejection of claim 33 recited above, therefore it would be obvious to combine the teachings of Marar with US9320479B2 for any portion of the claim not taught by claims 1-5 of US9320479B2.
Regarding claim 38, claim 1 of US9320479B2 does not teach the limitation of claim 38, however this is taught by Wenderow as recited in the 35 USC § 103 rejection of claim 38 recited above. It would be obvious to use the medical imaging system to image the patient to view the internal anatomy and to view how the percutaneous device may be affecting the anatomy.
Claim 36 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. US9320479B2, Moll (US 20070197896), and Wenderow (WO 2010025338) as applied to claim 34 above, and further in view of Konen (US 6135946).
Regarding claim 36, claim 1 of US9320479B2 does not teach the limitations of claim 36, however this claim is obvious in view of the teaching of Moll and Konen.
Moll discloses wherein the controller is configured to determine that the movement of the percutaneous device within the patient is to occur by predicting a next movement of the percutaneous device based on a pattern of use of the user control (Fig. 130, paragraph [0257] discloses a description of Fig. 130 and how movement of the input device is used to determine a next position),
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of US9320479B2 to incorporate the prediction of a next movement based on movement of an input device of Moll to achieve the same results. One would have motivation to combine because it would provide for “transform for visualization orientation and preferred controls orientation, to facilitate “instinctive driving”” (Moll - [0257]).
Conversely US9320479B2 and Moll does not teach automatically initiate the capture and display of medical images by the medical imaging system based on the predicted next movement.
However Konen discloses automatically initiate the capture and display of medical images by the medical imaging system based on the predicted next movement (Col. 3 lines 21-23 – “the processed image data can be selected so as to relate to a next position of the endoscope when a movement of the endoscope is intended…user can see if the intended motion”, it would be obvious to use the next position determined in Moll to provide image data of the next position of Konen because it is a calculated position based on a user input to move the device).
The disclosure of Konen is an analogous art considering it is in the field of a navigating a device through the body while providing images.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of US9320479B2 to incorporate the capture and display of a next image of Konen to achieve the same results. One would have motivation to combine because “it is achieved that the user can see if the intended motion of the endoscope is safe” (Konen – Col. 3 lines 23-24).
Claim 42 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of U.S. Patent No. US9320479B2 in view of Moll (US 20070197896) and Wenderow (WO 2010025338).
Although the claims at issue are not identical, they are not patentably distinct from each other because each is directed to a system, with the instant claims being broader and therefore anticipated by the conflicting claims. The claim 42 additionally correspond to claim 11 of US9320479B2 with respect to the robotic catheter procedure system, the bedside actuating mechanism configured to move the percutaneous device, the controller coupled to the user interface, the bedside system and the medical imaging system, the controller configured to cause movement of the percutaneous device after capture of medical images [claim 39 corresponding to claim 1 of US9320479B2], wherein the controller is configured to communicate with a contrast injection system [claim 42 corresponding to claim 11 of US9320479B2].
Regarding claim 42, claim 1 of US9320479B2 in view of Moll and Wenderow can be combined to teach independent claim 39. Claim 42 is taught by claim 11 of US9320479B2.
Claims 43-44 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. US9320479B2 in view of Moll (US 20070197896) and Wenderow (WO 2010025338).
Although the claims at issue are not identical, they are not patentably distinct from each other because each is directed to a system, with the instant claims being broader and therefore anticipated by the conflicting claims. The claims 43 additionally correspond to claim 7 of US9320479B2 with respect to the robotic catheter procedure system, the bedside actuating mechanism configured to move the percutaneous device, the controller coupled to the user interface, the bedside system and the medical imaging system, the controller configured to cause movement of the percutaneous device after capture of medical images [claim 39 corresponding to claim 1 of US9320479B2], wherein the actuating mechanism can impart movement to a guide wire, a working catheter, or a guide catheter [claim 43 corresponding to claim 7 of US9320479B2], and wherein the actuating mechanism can impart movement to a guide wire, a working catheter, and a guide catheter [claim 44 corresponding to claim 7 of US9320479B2]
Regarding claim 43, claim 1 of US9320479B2 in view of Moll and Wenderow can be combined to teach independent claim 39. Claim 7 of US9320479B2 does not teach actuating mechanisms for each of the devices however this is obvious in view of the teachings of Wenderow.
Wenderow discloses wherein the actuating mechanism is a guide wire actuating mechanism, a working catheter actuating mechanism, or a guide catheter actuating mechanism ([0023] – “bedside system 12 may be equipped (e.g., to advance, retract, or rotate a guide wire, advance, retract, or rotate a working catheter, advance, retract, or rotate a guide catheter”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of US9320479B2 to incorporate the different actuating mechanisms of Wenderow to achieve the same results. One would have motivation to combine so that each device can be controlled individually.
Regarding claim 44, claim 1 of US9320479B2 in view of Moll and Wenderow can be combined to teach independent claim 39. Claim 7 of US9320479B2 does not teach that the actuating mechanism includes actuating mechanisms for all three of the devices however this is obvious in view of the teachings of Wenderow. It would be obvious to use a different actuating devices so that each device can be controlled individually.
Wenderow discloses wherein the actuating mechanism includes a guide wire actuating mechanism, a working catheter actuating mechanism, and a guide catheter actuating mechanism ([0023] – “the user may operate guide wire control 23, working catheter control 25, and/or guide catheter control 29 at the same time to advance, retract, and/or rotate a guide wire, a working catheter, and/or a guide catheter at the same time”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of US9320479B2 to incorporate the different actuating mechanisms of Wenderow to achieve the same results. One would have motivation to combine so that each device can be controlled individually.
Claim 45 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. US9320479B2 in view of Moll (US 20070197896), Wenderow (WO 2010025338) [hereinafter Wenderow 338 within this rejection], and Wenderow (US 20100069833) [hereinafter Wenderow 833 within this rejection].
Regarding claim 45, claim 1 of US9320479B2 does not teach the limitations of claim 45, however this claim is obvious in view of the teaching of Wenderow 833.
Wenderow 833 discloses wherein the bedside system comprises: a cassette including the actuating mechanism ([0047] – “cassette 24 will be at an angle relative to a horizontal plane in an operative position to direct the guide catheter, guide wire and working catheter”).
The disclosure of Wenderow 833 is an analogous art considering it is in the field of a robotic catheter system.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of US9320479B2 to incorporate the cassette of Wenderow 833 to achieve the same results. One would have motivation to combine because it allows for the device to be disengaged from the robot and to be disposed after a single use to “maintain a sterility of robotic vascular catheter system 10 components and prevent patient-to-patient transmission of infections” (Wenderow 833 – [0044]).
Claims 17, 19, and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. US10299867B2 in view of Moll (US 20070197896).
The claims of US10299867B2 and US9320479B2 are nearly identical therefore see the double patenting rejections above regarding claims 17, 19, and 21.
Claim 22 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. US10299867B2 and Moll (US 20070197896), as applied to claim 17 above, and further in view of McGee (US 20060247521).
The claims of US10299867B2 and US9320479B2 are nearly identical therefore see the double patenting rejections above regarding claim 22.
Claims 23-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. US10299867B2, Moll (US 20070197896) and McGee (US 20060247521), as applied to claim 22 above, and further in view of Wenderow (WO 2010025338).
The claims of US10299867B2 and US9320479B2 are nearly identical therefore see the double patenting rejections above regarding claims 23-24.
Claims 25, 27, 29, 34-35, 37, 39-41, and 46-48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. US10299867B2 in view of Moll (US 20070197896) and Wenderow (WO 2010025338).
The claims of US10299867B2 and US9320479B2 are nearly identical therefore see the double patenting rejections above regarding claims 25, 27, 29, 34-35, 37, 39-41, and 46-48.
Claim 26 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of U.S. Patent No. US10299867B2 in view of Moll (US 20070197896).
The claims of US10299867B2 and US9320479B2 are nearly identical therefore see the double patenting rejections above regarding claim 26.
Claim 28 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. US10299867B2 in view of Moll (US 20070197896), Wenderow (WO 2010025338), and Besson (US 20080118023).
The claims of US10299867B2 and US9320479B2 are nearly identical therefore see the double patenting rejections above regarding claim 28.
Claims 30-33 and 38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of U.S. Patent No. US10299867B2 in view of an Wenderow (WO 2010025338), Fung (US 20070195927), Marar (US 20080292056), and Nagashima (JP2003110881A).
The claims of US10299867B2 and US9320479B2 are nearly identical therefore see the double patenting rejections above regarding claims 30-33 and 38.
Claim 36 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. US10299867B2 in view of Moll (US 20070197896), Wenderow (WO 2010025338), and Konen (US 6135946).
The claims of US10299867B2 and US9320479B2 are nearly identical therefore see the double patenting rejections above regarding claim 36.
Claim 42 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of U.S. Patent No. US10299867B2 in view of Moll (US 20070197896) and Wenderow (WO 2010025338).
The claims of US10299867B2 and US9320479B2 are nearly identical therefore see the double patenting rejections above regarding claim 42.
Claims 43-44 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. US10299867B2 in view of Moll (US 20070197896) and Wenderow (WO 2010025338).
The claims of US10299867B2 and US9320479B2 are nearly identical therefore see the double patenting rejections above regarding claims 43-44.
Claim 45 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. US10299867B2 in view of Moll (US 20070197896), Wenderow (WO 2010025338) [hereinafter Wenderow 338 within this rejection], and Wenderow (US 20100069833) [hereinafter Wenderow 833 within this rejection].
The claims of US10299867B2 and US9320479B2 are nearly identical therefore see the double patenting rejections above regarding claim 45.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RENEE C LANGHALS whose telephone number is (571)272-6258. The examiner can normally be reached Mon.-Thurs. alternate Fridays 8:30-6.
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, Christopher Koharski can be reached on 571-272-7230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/R.C.L./ Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/ Supervisory Patent Examiner, Art Unit 3797