DETAILED ACTION
Summary
Claims 1-20 are pending in the application. Claims 13-16 and 18-20 have been withdrawn from further consideration. Claims 1-8 are rejected under 35 USC 101. Claims 1-12 and 17 are rejected under 35 USC 103.
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 .
Election/Restrictions
Applicant’s election without traverse of Invention I and Species A in the reply filed on 12/2/2025 is acknowledged.
Claims 13-16, and 18-20 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention and nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/2/2025.
Applicant has stated that they believe claims 1-12 and 17-18 encompass the elected invention. However, claim 18 is drawn to a non-elected invention (Invention II), and is therefore withdrawn from further consideration.
Claim Objections
Claim 1 objected to because of the following informalities:
Claim 1 recites “the system” in line 18. It should recite “the catheter placement system”.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-8 rejected under 35 U.S.C. 101 because Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-8 rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 1 recites “a catheter inserted within a vasculature of a patient” in lines 2-3. This is positively reciting the human body as a patient must be part of the system for the catheter to be inserted within them. The Examiner recommends “configured to” language to make it clear the patient is not a part of the system (e.g. a catheter configured to be inserted within a vasculature of a patient).
All claims dependent from the above claims rejected under 35 USC 101 are also rejected, as the limitations of the dependent claims fail to cure the deficiencies identified above.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Flexman et al. (U.S PGPub 2018/0264227 A1) in view of Flexman et al. (U.S PGPub 2018/0014886 A1) (Flexman’886).
Regarding Claim 1, Flexman teaches a catheter placement system (Abstract) [0002], comprising:
an elongate medical device (Fig. 1, 108) disposed within a lumen (Fig. 1, 103) of a catheter (Fig. 1, 102) [0040] inserted within a vasculature of a patient [0031], wherein:
the elongate medical device includes a multi-core optical fiber extending along the elongate medical device [0042]-[0043],
the multi-core optical fiber includes a number of fiber-optic Bragg gratings disposed along the multi-core optical fiber [0044]-[0046], and
the fiber-optic Bragg gratings are configured to enable shape sensing of the elongate medical device [0044]-[0046];
a device hub (Fig. 2, 106) coupled with the elongate medical device at a location along the elongate medical device [0040]+[0049]; and
a system module (Fig. 1, 112) operatively coupled with the elongate medical device [0040], the system module including a processor (Fig. 1, 114) and memory having logic stored thereon (Fig. 1, 116) that, when executed by the processor [0040], performs operations that include:
determining a three-dimensional shape of the elongate medical device [0044]+[0046]+[0058]; and
depicting an image on a display (Fig. 1, 118) [0047] of the system [0058], wherein the image includes:
the three-dimensional shape (Fig. 6, 224) [0058]; and
a device handle icon (Fig. 6, 230) at a position along the three-dimensional shape [0058].
The system of Flexman is silent regarding the hub of the device being used as a device handle.
Flexman’886 teaches a medical device placement system (Abstract). This system contains a hub (Fig. 5, 105) [0051]+[0059] which can be used as a handle (Fig. 8, 105) [0033].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Flexman to use a handle as the hub, as recognized by Flexman’866, because this allows the user to obtain more information of the deployment of the elongate device, while allowing easier control of the deployment, thereby increasing the safety and efficacy of the procedure, as recognized by Flexman’866 [0028]+[0033].
Regarding Claim 2, the combination of references teaches the invention substantially as claimed. Flexman further teaches the fiber-optic Bragg gratings [0044] are configured to determine the location of the device hub along the elongate medical device [0024]+[0030]+p0049].
Flexman is silent regarding the shape being used to determine the location of the device handle.
Flexman’886 further teaches the shape template of the device handle is use to determine the position of the device handle [0058].
It would have been obvious to one of ordinary skill in the art before the effective filing date to substitute the device that is being determined the position of (i.e. the hub) of Flexman with a device handle, as taught by Flexman’866, as the substitution for one known device component with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of determining the position of the handle using the FBG are reasonably predictable.
Regarding Claim 3, the combination of references teaches the invention substantially as claimed. Flexman fails to explicitly teach wherein the device handle includes a locking mechanism configured for selective transitioning between: an unlocked state, wherein the device handle is positionable along the elongate medical device, and a locked state, wherein the location of the device handle along the elongate medical device is fixed.
Flexman’886 further teaches wherein the device handle includes a locking mechanism configured for selective transitioning [0052]-[0053] between: an unlocked state, wherein the device handle is positionable along the elongate medical device [0052] (unclamped), and a locked state, wherein the location of the device handle along the elongate medical device is fixed [0052]-[0053] (after clamping).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Flexman to include a locking system in the handle, as taught by Flexman’886, because this allows the system to better know the relative position of the device and the shape sensing coordinate system, thereby increasing the safety and efficacy of the procedure, as recognized by Flexman’886 [0002]+[0052].
Regarding Claim 5, the combination of references teaches the invention substantially as claimed. Flexman fails to explicitly teach wherein: in the unlocked state the device handle is rotatable about the elongate medical device, and in the locked state the device handle is rotatably fixed to the elongate medical device.
Flexman’886 further teaches wherein: in the unlocked state the device handle is rotatable about the elongate medical device [0050]-[0052] (while the handle is unclamped, the handle is capable of rotating about the medical device), and in the locked state the device handle is rotatably fixed to the elongate medical device [0050]-[0052] (the handle would also be rotationally coupled to the guidewire when it is clamped).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Flexman to include a locking system in the handle, as taught by Flexman’886, because this allows the system to better know the relative position of the device and the shape sensing coordinate system, thereby increasing the safety and efficacy of the procedure, as recognized by Flexman’886 [0002]+[0052].
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Flexman in view of Flexman’886 as applied to claim 3 above, and further in view of Noonan et al. (U.S PGPub 2018/0279909 A1).
Regarding Claim 4, the combination of references teaches the invention substantially as claimed. The combination fails to explicitly teach wherein: the device handle defines a positioning shape of the elongate medical device when the locking mechanism is transitioned to the locked state, and the operations include determining the location of the device handle along the elongate medical device based on the positioning shape.
Noonan teaches a hub for an optical shaped sensing device (Abstract). The device handle defines a positioning shape of the elongate medical device [0006] when the locking mechanism is transitioned to the locked state [0008]+[0064], and the operations include determining the location of the device handle along the elongate medical device based on the positioning shape [0072].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to define the positions shape when locked, as taught by Noonan, because this allows the system to more accurately determine the location of a catheter, while also allowing the positioning system to be used on a variety of medical devices, thereby increasing the safety of the procedure for less cost, as recognized by Noonan [0027]+[0030]-[0031].
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Flexman and Flexman’886 as applied to claim 5 above, and further in view of Bydlon et al. (U.S PGPub 2019/0346319 A1).
Regarding Claim 6, the combination of references teaches the invention substantially as claimed. Flexman further teaches the operations include determining a rotational position of the device handle about a longitudinal axis of the elongate medical device based on the positioning shape [0062]-[0063].
The system of Flexman is silent regarding the hub of the device being used as a device handle.
Flexman’886 teaches a medical device placement system (Abstract). This system contains a hub (Fig. 5, 105) [0051]+[0059] which can be used as a handle (Fig. 8, 105) [0033].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Flexman to use a handle as the hub, as recognized by Flexman’866, because this allows the user to obtain more information of the deployment of the elongate device, while allowing easier control of the deployment, thereby increasing the safety and efficacy of the procedure, as recognized by Flexman’866 [0028]+[0033].
The combination is silent regarding the image includes an orientation of the device handle icon with respect to the three-dimension shape based on the rotational position of the device handle about the longitudinal axis of the elongate medical device.
Bydlon teaches a system for tracking an interventional device (Abstract). This system displays an image which includes an orientation of the device handle icon with respect to the three dimension based on the rotational position of the device handle [0082] (the color coded markers indicate an orientation of the device handle icon).
It would have been obvious to one of ordinary skill in the art to modify the combined system to indicate the orientation of the device handle, as taught by Bydlon, because this allows the user to better monitor the state of the shape-sensed guidewire, as recognized by Bydlon [0006].
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Flexman in view of Flexman’866 as applied to claim 1 above, and further in view of Ramachandran et al. (U.S PGPub 2019/0059743 A1).
Regarding Claim 7, the combination of references teaches the invention substantially as claimed. Flexman fails to explicitly teach wherein: the fiber-optic Bragg gratings are configured to enable sensing of a number of localized temperatures along the elongate medical device, including: a first localized temperature at a first point along the elongate medical device, the first point located outside the patient adjacent an insertion site of the patient; and a second localized temperature at a second point along the elongate medical device, the second point located inside the patient adjacent the insertion site, the operations include determining a location of the insertion site along the elongate medical device based on the first and second localized temperatures, and the image includes the insertion site at a position along the three-dimensional shape corresponding to the location of the insertion site along the elongate medical device.
Ramachandran teaches a system of using shape sensing fibers to measure temperature (Abstract). The system contains fiber-optic Bragg gratings [0024]-[0025] which are configured to enable sensing of a number of localized temperatures along the elongate medical device [0021]+[0025], including: a first localized temperature at a first point along the elongate medical device (Fig. 2, 212), the first point located outside the patient adjacent an insertion site of the patient [0033]; and a second localized temperature at a second point along the elongate medical device (Fig. 2, 216), the second point located inside the patient adjacent the insertion site [0033], the operations include determining a location of the insertion site (Fig. 2, 208) along the elongate medical device based on the first and second localized temperatures [0033]+[0037]+[0045], and the image includes the insertion site at a position along the three-dimensional shape corresponding to the location of the insertion site along the elongate medical device (Fig. 2, 208) [0033].
It would have been obvious to one of ordinary skill in the art to modify the combined system to use temperature to determine and entry point, as taught by Ramachandran, because this better allows the user to determine which portion of the instrument is inserted into the body, thereby improving image registration, as recognized by Ramachandran [0003]+[0016].
Claims 8-12 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Flexman’886 in view of Noonan.
Regarding Claim 8, Flexman’886 teaches a medical device (Abstract), comprising:
a device handle (Fig. 1, 105) configured for selective attachment to an elongate medical device (Fig. 1, 103) [0033]+[0052]-[0053], the device handle including a housing (Fig. 1, 105) having a passageway extending through the housing [0052], the passageway configured to receive the elongate medical device therethrough [0052], wherein:
the elongate medical device includes a multi-core optical fiber extending along the elongate medical device [0040],
the multi-core optical fiber includes a number of fiber-optic Bragg gratings disposed along the multi-core optical fiber [0038]-[0039].
While Flexman’886 teaches the handle can enable the fiber-optic Bragg gratings to detect a position of the device handle along the elongate medical device [0059], Flexman’886 fails to explicitly teach the template is used with the clamping mechanism.
Noonan teaches a hub for an optical shaped sensing device (Abstract). The device handle enable the fiber-optic Bragg gratings [0049] to detect a position of the device handle along the elongate medical device [0072].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Flexman’886 to define the positions shape when locked, as taught by Noonan, because this allows the system to more accurately determine the location of a catheter, while also allowing the positioning system to be used on a variety of medical devices, thereby increasing the safety of the procedure for less cost, as recognized by Noonan [0027]+[0030]-[0031].
Regarding Claim 9, the combination of references teaches the invention substantially as claimed. Flexman’886 further teaches wherein the housing is transitional between an open state and a closed state [0052]-[0053] (unclamped and clamped), wherein: in the closed state, the elongate medical device is laterally constrained within the passageway [0052], and in the open state, the elongate medical device is laterally displaceable into and out of the passageway [0050]+[0052]-[0053].
Regarding Claim 10, the combination of reference teaches the invention substantially as claimed. Flexman’886 further teaches wherein the device handle includes a locking mechanism configured for selective transitioning [0052]-[0053] between: an unlocked state, wherein the device handle is positionable along the elongate medical device [0052] (unclamped), and a locked state, wherein the location of the device handle along the elongate medical device is fixed [0052]-[0053] (after clamping).
Regarding Claim 11, the combination of references teaches the invention substantially as claimed. Flexman’886 further teaches wherein transitioning the housing from the open state to the closed state transitions the locking mechanism from the unlocked state to the locked state [0052]-[0053].
Regarding Claim 12, the combination of references teaches the invention substantially as claimed. Flexman’886 further teaches wherein the device handle is rotatable about the elongate medical device in the unlocked state [0050]-[0052] (while the handle is unclamped, the handle is capable of rotating about the medical device), and the device handle is rotatably fixed to the elongate medical device in the locked state [0050]-[0052] (the handle would also be rotationally coupled to the guidewire when it is clamped).
Regarding Claim 17, the combination of references teaches the invention substantially as claimed. Flexman’886 fails to teaches teach wherein: the locking mechanism forms a positioning shape of the elongate medical device when the locking mechanism is transitioned to the locked state, and the positioning shape enables the fiber-optic Bragg gratings to identify the position of the device handle along the elongate medical device.
Noonan teaches a hub for an optical shaped sensing device (Abstract). The locking mechanism forms a positioning shape of the elongate medical device [0006] when the locking mechanism is transitioned to the locked state [0008]+[0064], and the positioning shape enables the fiber-optic Bragg gratings to identify the position of the device handle along the elongate medical device [0072].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to define the positions shape when locked, as taught by Noonan, because this allows the system to more accurately determine the location of a catheter, while also allowing the positioning system to be used on a variety of medical devices, thereby increasing the safety of the procedure for less cost, as recognized by Noonan [0027]+[0030]-[0031].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Denissen et al. (U.S PGPub 2016/0228200 A1), which teaches a method for reconstructing a 3D shape of an elongate device.
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/SEAN D MATTSON/ Primary Examiner, Art Unit 3798
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