DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/13/2026 has been entered.
Response to Amendment
The amendment filed on 03/13/2026 has been entered. Claims 1, 11 and 17 are amended. Claim 2 is cancelled. Claims 1 and 3-20 remain pending, with Claims 11-20 withdrawn from further consideration.
Response to Arguments
On Pages 8-9 of Remarks, regarding amended Claim 1, Applicant argues that the newly added feature of depicting is not disclosed by reference Silverstein or Tata. This argument is moot in view of the new grounds of rejection which relies on the combination of reference Tata and Brannan (US 20220071706 A1) to disclose the limitation.
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.
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 is:
“an elongate medical device configured for …” in Claim 1.
A review of the Specification discloses that the corresponding structure for the “elongate medical device” may include “a guidewire, a stylet, a catheter or any medical device suitable for advancement along an anatomical pathway within patient, such as a vasculature” and “extends between a distal tip 123 and a console connector 133 at a proximal end 124” (Para 0038).
Because this claim limitation is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim 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 and 3-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
With regard to Claims 1 and 3-10:
Step 1: the claims are drawn to a system/apparatus, one of the four statutory categories.
Step 2A, Prong One:
The claims recite the limitations of tracking a position of the elongated medical device in Claim 1, defining a predicted anatomical pathway based on patient attributes in Claim 5, which are, under their broadest reasonable interpretation, limitations that cover performance of the limitation in the mind. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components and generic medical devices, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Step 2A, Prong Two:
This judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements – an elongate medical device, a console including a processor and a memory, and depicting image and data on a display in Claim 1, providing a notification in Claim 6, transmitting data to and from a network module in Claims 7 and 8, recoding position of an elongated medical device in Claim 8, a magnetic tracking system in Claim 9, and a fiber optic shape sensing system in Claim 10. The computer components and medical devices are recited at a high-level of generality (i.e., as a generic catheter device tracked by generic tracking tools and generic processor) such that it amounts no more than mere instructions to apply the exception using a generic computer component. The elements of depicting on a display, communicating with a network module, and recording results are insignificant extra-solution activities. Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea.
Step 2B:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of computer components and medical devices amount to no more than mere instructions to apply the exception using generic computer components and medical devices. Mere instructions to apply an exception using generic computer components and medical devices cannot provide an inventive concept.
For the reasons set forth above, Claim 1 and 3-10 are not patent eligible.
Claim Rejections - 35 USC § 103
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.
Claims 1, 5 and 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Silverstein et al (US 20120143029 A1; hereafter Silverstein), in view of Tata et al (US 20220354380 A1; hereafter Tata), further in view of Brannan et al (US 20220071706 A1; hereafter Brannan).
With regard to Claim 1, Silverstein discloses a medical system, comprising:
an elongate medical device (the catheter 72) configured for advancement along an anatomical pathway (the patient vasculature) within a patient (Silverstein, Para 0103; “FIG. 2 shows that the catheter 72 generally includes a proximal portion 74 that remains exterior to the patient and a distal potion 76 that resides within the patient vasculature after placement is complete”);
a tracking system (Silverstein, Para 0099; “… a tip location/navigation system ("TLS"), or magnetically-based tracking of the catheter tip during its advancement through the tortuous vasculature path to detect and facilitate correction of any tip malposition during such advancement.”) configured to track the elongate medical device within the patient, the tracking system comprising a console including a processor and a memory having logic stored thereon (Silverstein, Para 0104; “A processor 22, including non-volatile memory such as EEPROM for instance, is included in the console 20 for controlling system function during operation of the system 10”) that, when executed by the processor performs operations that include tracking a position of the elongate medical device with respect to an anatomical pathway stored in the memory (Silverstein, Para 0114; “The TLS enables the clinician to quickly locate and confirm the position and/or orientation of the catheter 72 …”) (Silverstein, Para 0306; “In a second real time phase of the procedure, a real rigid device, represented by a real device image 2716 is advanced along the same path as the virtual rigid device. During the second real time phase, the virtual path can be generated or maintained on the display device in a different color, pattern, or other contrasting way”).
Silverstein does not clearly and explicitly disclose:
predicting an anatomical pathway, including a vascular pathway, and
depicting on a display an image of the predicted anatomical pathway and one or more confidence levels for the predicted anatomical pathway.
Tata in the same field of endeavor discloses:
predicting an anatomical pathway (Tata, Para 0029; “The anatomy model 12 can be created in various different ways, such as using previously acquired images 18 or anatomical data from the patient.”; Para 0030; “The anatomy model 12 can be a simplified model generated from rich image data … The anatomy model 12 can be rendered to show the approximate locations and dimensions of airway passages and surrounding tissue walls …”), including a vascular pathway (Tata, Para 0074; “While the present techniques are discussed in the context of endoscope navigation within airway passages, it should be understood that the disclosed techniques may also be useful in other types of airway management or clinical procedures … such as patient catheterization techniques. By way of example, contemplated techniques include cystoscopy, cardiac catheterization …”), and
depicting on a display an image of the predicted anatomical pathway and lower- and higher-confidence regions differently (Tata, Para 0072; “If the operator chooses to ignore the notification and advance within the airway, the portion of the model can be indicated as a lower confidence region, or can be updated using the available image signal.”; Para 0073; “FIG. 11 is an example display of the anatomy model 12 that includes portions 1002, rendered in solid lines, that have been validated and/or adjusted and portions 1004, rendered in dashed lines, that have not been validated and/or adjusted”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Silverstein, as suggested by Tata, in order to predict and display a vascular pathway and presenting portions of different prediction confidence differently. One of ordinary skill in the art would have been motivated to make the modification for the benefit of improving efficiency and safety in navigating medical devices into anatomical cavities that are not regularly shaped or sized (Tata, Para 0027; “… it can be difficult to determine which branch of a patient's lungs is the correct path to choose, and correcting wrong turns often involves backtracking to a familiar landmark, such as a carina, and starting over. This back-tracking and re-tracing of navigation through a patient's airway (or other cavity) lengthens the duration of the clinical procedure, which can increase the risk of a poor outcome for the patient as well as costs for the healthcare provider.”), particularly for vascular pathway in catheterization procedures.
Silverstein and Tata do not clearly and explicitly disclose displaying confidence level in a predicted map.
Brannan in the same field of endeavor discloses displaying confidence level in a predicted map (Brannan, Para 0048; “FIG. 2C illustrates predicted ablation zone 240 … may additionally have confidence interval 245 … A user may select the preferred method to visualize the confidence interval (see FIGS. 3-5), and may also select a desired confidence interval (for example, 80%, 90%, 95%, etc.)”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Silverstein and Tata, as suggested by Brannan, in order to display confidence level in a predicted map. One of ordinary skill in the art would have been motivated to make the modification for the benefit of improving the safety and efficiency of an interventional procedure by visually showing prediction confidence for more accurate decision.
With regard to Claim 5, Silverstein, Tata and Brannan disclose all the limitations of Claim 1 as discussed above, but do not clearly and explicitly disclose wherein the predicted anatomical pathway is defined based on a number of patient attributes.
Tata further discloses wherein the predicted anatomical pathway is defined based on a number of patient attributes (Tata, Para 0028; “it is beneficial to provide … a general or generic patient model representative of an average patient anatomy (which may be selected from an available set of models based on patient demographic, size, age, gender, etc.) of the anatomy that can be used for endoscope navigation to help locate the endoscope within the patient.”) (Tata, Para 0067 further discloses updating the anatomy model based on real-time position and image data acquired from patient.). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Silverstein, Tata and Brannan, as further suggested by Tata, in order to predict an anatomy model of the pathway based on patient’s demographic information and anatomic information. One of ordinary skill in the art would have been motivated to make the modification for the benefit of providing a relatively accurate anatomy model for guiding the device’s advancement (Tata, Para 0027; “… it may be difficult for the doctor, or any caregiver in the room, to know where the endoscope is positioned within the patient anatomy …”).
With regard to Claim 7, Silverstein, Tata and Brannan disclose all the limitations of Claim 5 as discussed above, but do not clearly and explicitly disclose wherein the operations further include: transmitting the patient attributes to a network module, and receiving the predicted anatomical pathway from the network module.
Tata further discloses wherein the operations further include: transmitting the patient attributes to a network module (Tata, Para 0061; “The endoscope controller 714 also forwards the image signal and the orientation signal to the controller 718, such as through the wireless transceivers on the two devices, and/or through wired connections and/or intermediary devices.”), and receiving the predicted anatomical pathway (the stored anatomy model 734) from the network module (Tata, Para 0058; “The endoscope controller 714 is connected by a wired or wireless (shown) connection to the graphics controller 718, which also includes … the stored anatomy model 734. … the display 716 is a hardware display screen fixedly or portably mounted in an environment of the patient. … the display 716 may be an augmented reality viewer … that display the anatomy model 734 overlaid on the patient.”) (Tata, Para 0061; “The block diagram of FIG. 8 shows the signal flow between the various devices.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Silverstein, Tata and Brannan, as further suggested by Tata, in order to transmit patient’s information to the graphics controller and then receive the predicted model from the controller. One of ordinary skill in the art would have been motivated to make the modification as necessary steps for predicting anatomical pathway or model for the benefit of better guiding the device’s advancement (Tata, Para 0027; “… it may be difficult for the doctor, or any caregiver in the room, to know where the endoscope is positioned within the patient anatomy …”).
With regard to Claim 8, Silverstein, Tata and Brannan disclose all the limitations of Claim 7 as discussed above, but do not clearly and explicitly disclose wherein the operations further include: making a record of the position of the elongate medical device after advancement along the anatomical pathway; and transmitting the record to the network module.
Tata further discloses wherein the operations further include: making a record of the position of the elongate medical device after advancement along the anatomical pathway; and transmitting the record to the network module (Tata, Para 0061 discloses that, for every small step (e.g. 1 mm) in its advancement, the position of the elongated device is recorded and transmitted to the controller 718; “For example, when the real-world endoscope 712 is moved distally by a distance of 1 mm inside the patient, this change in position is reported by the position sensor 756 through the position signal. The new position coordinates are received by the controller 718”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Silverstein, Tata and Brannan, as further suggested by Tata, in order to record and transmit the position of the device for the entire procedure including the end of the procedure. One of ordinary skill in the art would have been motivated to make the modification for the benefit of verifying arrival of the device to the desired anatomic location (Tata, Para 0070; “In embodiments, the anatomy model may be generally determined to be generally accurate in particular regions in view of the live image and position data.”).
With regard to Claim 9, Silverstein, Tata and Brannan disclose the system according to Claim 1 as discussed above. Silverstein further discloses wherein the tracking system includes a magnetic tracking system, comprising:
a number of magnetic elements disposed along the elongate medical device (Silverstein, Para 0115; “The magnetic assembly includes one or more magnetic elements 106 disposed adjacent one another proximate the stylet distal end 100B …”), the magnetic elements defining a number of magnetic fields (Silverstein, Para 0118; “a magnetic field produced by the magnetic elements 106”); and
a number of magnetometers placed on the patient (Silverstein, Para 0166; “The handheld probe 1140 includes a head 1180 … the head is placed against the patient's skin proximate the prospective insertion site 1173 (FIG. 19).” Para 0169; “the probe 1140 includes a sensor array 1190”) and coupled with console (Silverstein, Fig. 18 shows the coupling of sensor array 1190 and console 1120), the magnetometers configured to detect the magnetic fields (Silverstein, Para 0169; “The sensors 1192 are configured to detect a magnetic field associated with the needle 1200 …”),
wherein tracking the position of the elongate medical device includes determining positions of the magnetic elements in three-dimensional space with respect to the magnetometers (Silverstein, Para 0170; “… each of the sensors 1192 includes three orthogonal sensor coils for enabling detection of a magnetic field in three spatial dimensions”).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Silverstein, Tata and Brannan, in view of Glover et al (US 20200022587 A1; hereafter Glover).
With regard to Claim 3, Silverstein, Tata and Brannan disclose all the limitations of Claim 1 as discussed above, but do not clearly and explicitly disclose wherein the vascular pathway includes at least one of a lower one third of a superior vena cava, or a Cavo-atrial junction.
Glover in the same field of endeavor discloses wherein the vascular pathway includes at least one of a lower one third of a superior vena cava, or a Cavo-atrial junction (Glover, Para 0085; “In use of the PA catheter 1001, as illustrated in FIG. 4 (Prior Art), when the tip 1120 of the catheter 1001 is first introduced into the heart 500, e.g., through the superior vena cava as illustrated …”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Silverstein, Tata and Brannan, as suggested by Glover, in order to perform catheterization for the superior vena cava. One of ordinary skill in the art would have been motivated to make the modification for the benefit of monitoring patient’s hemodynamic status in surgery using right heart catheterization (Glover, Para 0085; “RHC may be used for monitoring and diagnosis, e.g. during TVT, and in the operating room (OR) for monitoring of important hemodynamic parameters during cardiac surgery or other high-risk surgery.”).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Silverstein, Tata and Brannan, in view of Hill et al (US 6006134 A; hereafter Hill).
With regard to Claim 4, Silverstein, Tata and Brannan disclose all the limitations of Claim 1 as discussed above, but do not clearly and explicitly disclose wherein the vascular pathway includes an azygos vein.
Hill in the same field of endeavor discloses wherein the vascular pathway includes an azygos vein (Hill, Column 8, Lines 21-23; “… catheters of the present invention could be inserted into the azygos or accessory hemizygous veins to stimulate the sympathetic nerves for increasing heart rate or altering DFT efficacy for antiarrhythmic and hemodynamic benefits.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Silverstein, Tata and Brannan, as suggested by Hill, in order to perform catheterization for an azygos vein. One of ordinary skill in the art would have been motivated to make the modification for the benefit of stimulating the sympathetic nerves for antiarrhythmic and hemodynamic benefits as disclosed above.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Silverstein, Tata and Brannan, in view of McMichael et al (US 20210030480 A1; hereafter McMichael).
With regard to Claim 6, Silverstein, Tata and Brannan disclose all the limitations of Claim 1 as discussed above, but do not clearly and explicitly disclose wherein the operations further include providing a notification when the position the elongate medical device deviates from the predicted anatomical pathway.
McMichael in the same field of endeavor discloses wherein the operations further include providing a notification when the position the elongate medical device deviates from the predicted anatomical pathway (McMichael, Abstract; “… a notification alert that the medical device has deviated from a predetermined path.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Silverstein, Tata and Brannan, as suggested by McMichael, in order to notify the operator when the actual path of the device deviates from the predicted path. One of ordinary skill in the art would have been motivated to make the modification for the benefit of avoiding injury caused by improper placement or advancement of medical device inside patient’s body (McMichael, Para 0004; “Erroneous placement of the catheter tip may injure or harm the patient.”).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Silverstein, Tata and Brannan, in view of Leo (US 20180339134 A1; hereafter Leo).
With regard to Claim 10, Silverstein, Tata and Brannan disclose all the limitations of Claim 9 as discussed above. Silverstein further discloses wherein the tracking system further includes a fiber optic shape sensing system comprising an optical fiber extending along the elongate medical device (Silverstein, Para 0214; “other suitable sensors and gauges can optionally be used for measuring needle/stylet bending, including … fiber optic-based strain gauges/sensors. Also, the sensor/gauge may be placed directly on the needle/medical component …”).
Silverstein, Tata and Brannan do not clearly and explicitly disclose wherein:
the optical fiber is operatively coupled with the console,
the optical fiber includes a number of optical fiber cores, each optical fiber core including a plurality of fiber optic Bragg gratings configured to determine a strain in the optical fiber, and
tracking the position the elongate medical device further includes determining a three-dimensional shape of the elongate medical device based on the strain.
Leo in the same field of endeavor discloses wherein:
the optical fiber is operatively coupled with the console (Leo, Para 0061; “The force sensing manipulator system 170 may also be controlled and monitored by a controller or microprocessor 176.”),
the optical fiber includes a number of optical fiber cores (Leo, Para 0072; “The flexing portion 26 may be divided into segments 210, each segment 210 … including three core segments 212a, 212b and 212c …”), each optical fiber core including a plurality of fiber optic Bragg gratings configured to determine a strain in the optical fiber (Leo, Para 0030; “The distal fiber Bragg grating(s) 50 may be utilized to determine a force component or components exerted on the distal portion 30 …”), and
tracking the position the elongate medical device further includes determining a three-dimensional shape of the elongate medical device based on the strain (Leo, Para 0072; “Strain values for each flexing portion fiber Bragg grating 48 contained in the segment 210 may be used to compute a direction μ of the bend angle θ and a bend radius r for each of the segments 210.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Silverstein, Tata and Brannan, as suggested by Leo, in order to use the abovementioned fiber optic shape sensing system. One of ordinary skill in the art would have been motivated to make the modification for the benefit of assisting positioning of catheters inside the body of patient (Leo, Para 0008; “The inferred shape may also provide knowledge of the position of the distal extremity of the elongate flexible body.”).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEI ZHANG whose telephone number is (571)272-7172. The examiner can normally be reached Monday-Friday 8am-5pm E.T..
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/L.Z./ Examiner, Art Unit 3798
/PASCAL M BUI PHO/ Supervisory Patent Examiner, Art Unit 3798
