DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 102
2. 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.
3. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
4. Claims 1-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Eberle et al., U.S. Patent No. 10,258,240 B1 (“Eberle”).
As to Claim 1, Eberle teaches the following:
An intraluminal sensing device (see “In an example, an apparatus includes an elongated assembly, at least a portion of which is sized, shaped, or otherwise configured to be inserted into a human body to measure a physiological parameter at an internal location within the body.” in Abstract), comprising:
a guidewire (“guidewire”) 4402 configured to be positioned within a body lumen of a patient (see “FIGS. 44A-44C depict another example of a guidewire in combination with an optical fiber pressure sensor. In FIG. 44A, an optical pressure sensor assembly 4400, e.g., assemblies 3900, 4000, and 4100 of FIGS. 39-41, can be delivered to a desired site using a guidewire, shown generally at 4402.” in col. 62, ll. 51-55), wherein the guidewire 4402 comprises:
a core wire (“core wire”) 4404 (see “The guidewire 4402 can include a core wire 4404, a proximal coil 4406, and a distal coil 4408.” in col. 62, ll. 56-57);
a sensor (“optical pressure sensor assembly”) 4400 configured to obtain medical data associated with the body lumen (see “In FIG. 44A, an optical pressure sensor assembly 4400, e.g., assemblies 3900, 4000, and 4100 of FIGS. 39-41, can be delivered to a desired site using a guidewire, shown generally at 4402.” in col. 62, ll. 52-55; and
a sensor housing (“tube assembly”) 4412 fixedly attached to the core wire 4404, wherein the sensor housing 4412 is a single component and defines an outer profile of the guidewire 4402, wherein the sensor housing 4412 comprises:
a core wire lumen (“a proximal end portion 4414 and a distal end portion 4416”) 4414/4416 configured to receive the core wire 4404 through an entire length of the sensor housing 4412 such that a cross section (see fig. 44C) of the core wire lumen 4414/4416 completely surrounds a cross section of the core wire 4404 (see fig. 44C) (see “As seen in FIG. 44A, the optical pressure sensor assembly 4400 can fit within the tube assembly 4412. The optical fiber 4424 can extend into and out of the tube assembly 4412. In contrast to the guidewire design in FIGS. 43A-43C, the tube assembly 4412 does not fit within the coils 4406, 4408. Instead, the coils 4406, 4408 can be affixed, respectively, to the proximal end portion 4414 and the distal end portion 4416 that extend from the proximal and distal ends 4418, 4420 respectively, of the tube assembly 4412. The pressure sensor assembly 4400 can be mounted to the core wire 4404 via a mounting material 4426, e.g., an epoxy, which can extend through the tube assembly 4412.” in col. 63, ll.1-12; and see “FIG. 44C depicts a cross-sectional view of the guidewire assembly shown in FIG. 44A. As seen in FIG. 44C, a portion of the diameter of the core wire 4404 can be reduced over a length of the tube assembly 4412 to provide sufficient room for mounting the pressure sensor assembly 4400.” in col. 63, ll. 13-17); and
an open sensor cavity (“main body”) 4422 different from the core wire lumen 4414/4416 and configured to receive the sensor 4400 (see “The guidewire 4402 can further include a tube assembly 4412 to provide stiffness around the sensor assembly 4400. The tube assembly 4412 is shown in more detail in FIG. 44B. The tube assembly includes a proximal end portion 4414 and a distal end portion 4416 that extend from the proximal and distal ends 4418, 4420, respectively, of a main body 4422 of the tube assembly 4412. A portion of the circumference of the main body 4422 of the main body 4422 can be removed to allow pressure signals to reach the pressure sensor assembly 4400.” in col. 62, ll. 58-67),
wherein the sensor cavity 4422 comprises an attachment platform fixedly attached to a fixed portion of the sensor 4400 such that a cantilevered portion of the sensor 4400 is suspended within the sensor cavity 4422 (see “As seen in FIG. 44A, the optical pressure sensor assembly 4400 can fit within the tube assembly 4412. The optical fiber 4424 can extend into and out of the tube assembly 4412. In contrast to the guidewire design in FIGS. 43A-43C, the tube assembly 4412 does not fit within the coils 4406, 4408. Instead, the coils 4406, 4408 can be affixed, respectively, to the proximal end portion 4414 and the distal end portion 4416 that extend from the proximal and distal ends 4418, 4420 respectively, of the tube assembly 4412. The pressure sensor assembly 4400 can be mounted to the core wire 4404 via a mounting material 4426, e.g., an epoxy, which can extend through the tube assembly 4412.” in col. 63, ll. 1-12).
As to Claim 2, Eberle teaches the following:
wherein the guidewire 4402 further comprises a pillow (“cradle”) 4510 disposed beneath the cantilevered portion of the sensor 4400 (see “The cradle 4510 can have varying inside dimensions to provide the ability to secure the sensor in varying ways. For example, in some embodiments, it may be advantageous to mount the sensor at its proximal portion only and to allow the rest of the sensor to be cantilevered in the cavity such that it cannot be touched during normal use of the guidewire.” in col. 63, ll. 40-45).
As to Claim 3, Eberle teaches the following:
wherein the pillow comprises trapped air (see col. 63, ll. 40-45).
As to Claim 4, Eberle teaches the following:
wherein the sensor housing 4412 further comprises an adhesive flow channel or an adhesive flow recess configured to receive an excess of an adhesive, wherein the attachment platform is fixedly attached to the fixed portion of the sensor by the adhesive (see “The pressure sensor assembly 4300 can be mounted to the core wire 4304 via a mounting material 4316, e.g., an epoxy, which can extend through the cradle 4312.” in col. 62, ll. 42-45).
As to Claim 5, Eberle teaches the following:
wherein the sensor housing 4412 further comprises a fluid flow channel (“pressure communication channel”, not labeled) configured to permit access to a sensing element of the sensor 4400 by a fluid within the body lumen of the patient (see “In addition, a slight spreading of the coil loops over the location of the pressure communication channel can be included. The channel can be a straight through hole, but a wide variety of channels as well as starting and ending locations of the channel from the outside of the core wire through to the inside of the pressure sensor housing cavity can be utilized.” in col. 64, l. 65, to col. 65, l. 5).
As to Claim 6, Eberle teaches the following:
wherein the sensor housing 4412 further comprises at least one core wire solder hole configured to receive solder or adhesive, such that the core wire is fixedly attached to the sensor housing by the solder or adhesive (see “The coil 4606 and the cradled enlarged portion of the core wire can be joined together to form a solid protection means. The joining process could be a suitable adhesive, solder or braze.” in col. 64, ll. 44-47).
As to Claim 7, Eberle teaches the following:
wherein the guidewire 4402 further comprises a shaping ribbon extending distally from the sensor housing 4412 into a flexible tip coil, wherein the flexible tip coil is fixedly attached to the sensor housing 4412 at a distal end of the sensor housing 4412 (see “Instead of the filament members described above and depicted in FIG. 47, the fiber pressure sensor assembly 4800 of FIG. 48 can include a ribbon member 4810, e.g., tape-like member, that can be wrapped around the core wire 4804, and define a channel 4812 within which the optical fiber 4808 can be positioned. The ribbon member 4810 can have a dimension, e.g., thickness, that is greater than the outer diameter of the optical fiber 4808, thereby preventing the coil 4806 from contacting the optical fiber 4808. In some example configurations, the ribbon member 4810 can be of uniform thickness. In other example configurations, the ribbon member 4810 can be of varying thickness, which can accommodate tapers in the core wire 4804. In some examples, the ribbon member 4810 can be substantially flat.” in col. 68, ll. 14-17).
As to Claim 8, Eberle teaches the following:
wherein the sensor housing 4412 further comprises:
a channel for receiving the shaping ribbon; or at least one shaping ribbon attachment hole configured to receive solder or adhesive, such that the shaping ribbon is fixedly attached to the sensor housing 4412 by the solder or adhesive (see “The ribbon member 4810 can create stand-offs or channels that can protect the optical fiber 4808 from being touched by the coil 4806, and thus prevent microbends. The ribbon member 4810 may be of flexible materials, e.g., metallic or polymeric, that can prevent the coil 4806 from physically contacting the optical fiber 4808 without substantially changing the mechanical performance characteristics of the guidewire 4802. By using a ribbon member 4810 that has a thickness greater than the outer diameter of the optical fiber 4808, the ribbon member 4810 can prevent the coil 4806 from contacting the optical fiber 4808. Alternatively, the ribbon member design can be accomplished by casting in place a suitable layer of, for example, flexible polymer material. Once the layer of polymer material is in place, the channels for the optical fiber can be created by selective removal of the polymer material using scribing techniques or laser ablation. The polymer material may be of uniform thickness, or may be of variable thickness, or may be of uniform or variable outer diameter.” in col. 68, ll. 28-46).
As to Claim 9, Eberle teaches the following:
wherein the guidewire 4402 further comprises at least one conductor in electrical communication with the sensor, wherein the sensor housing further comprises a conductor support configured to reduce a transference of mechanical stress from the at least one conductor to the sensor (see “As indicated above, the guidewire 2102 can be fabricated with a groove 2132 (FIG. 21B) to which the optical fiber 2104 can be attached. A portion of the optical fiber 2104 can extend underneath the mechanical joint 2136. To allow the received pressure to reach the optical fiber 2104, a portion of the mechanical joint 2136 can be removed in order to define a sensor window, shown generally at 2138. The sensor window 2138 can be covered with the sensor membrane 2140.” in col. 41, ll. 4-12).
As to Claim 10, Eberle teaches the following:
wherein the at least one conductor comprises at least two conductors, and wherein the conductor support further comprises a separation tine for separating two conductors of the at least two conductors (see col. 41, ll. 4-12).
As to Claim 11, Eberle teaches the following:
wherein the sensor cavity 4422 is configured to receive the sensor 4400 such that a sensing element of the sensor, positioned on the cantilevered portion of the sensor, is facing radially inward toward the core wire, such that a gap exists between the sensing element and a bottom surface of the sensor cavity (see “Optical pressure sensor assembly 4600 can be seen mounted on the cradle 4610 in a cantilevered way. The degree of cantilever can be varied by varying the length of the mount which attaches to the proximal body of 4600. The rest of the cavity can be formed such that there is a gap around the distal body and the sensitive distal end of 4600. The core wire 4604, in the section defining the sensor mount, can be varied in size and shape. For example, the outside diameter of the cradle 4610 can have a constant diameter section and one or more tapered sections. The coil 4606 can, for example, be attached to the cradle 4610 at the constant diameter section and not at the tapered section such that the effect is to minimize the relatively stiff length of the construction in this area. This can be helpful in providing enhancements to the mechanical performance of the guidewire.” in col. 64, ll. 20-35).
As to Claim 12, Eberle teaches the following:
wherein the sensor cavity 4422 is configured to receive the sensor 4400 such that a sensing element of the sensor 4400 is facing radially outward, away from the core wire 4404 (see col. 64, ll. 20-35).
As to Claim 13, Eberle teaches the following:
wherein the sensor housing 4412 further comprises a bridge element extending laterally across the sensor cavity, such that a bottom surface of the bridge element is not in contact with a bottom surface of the sensor cavity 4422 (see “The external pressure sensor can be one that is compliant with the requirements of the published specification ANSI/AAMI BP22:1994/(R) 2011, which relates to a standard bridge type sensor that typically has a sensitivity of 5 μV/V/mmHg. Depending on the configuration of the system there can be a provision for this type of input built directly into the FFR console or it will be supplied from another piece of equipment.” in col. 86, l. 62, to col. 87, l. 3).
As to Claim 14, Eberle teaches the following:
wherein the bottom surface of the bridge element is configured to apply a downward pressure to a top surface of the fixed portion of the sensor (see “The external pressure sensor can be one that is compliant with the requirements of the published specification ANSI/AAMI BP22:1994/(R) 2011, which relates to a standard bridge type sensor that typically has a sensitivity of 5 μV/V/mmHg. Depending on the configuration of the system there can be a provision for this type of input built directly into the FFR console or it will be supplied from another piece of equipment.” in col. 86, l. 62, to col. 87, l. 3).
As to Claim 15, Eberle teaches the following:
wherein the bridge element is configured to provide a space between the bottom surface of the bridge element and a top surface of the cantilevered portion of the sensor (see col. 86, l. 62, to col. 87, l. 3).
Conclusion
5. Any inquiry concerning this communication or earlier communications from the examiner should be directed to NAVIN NATNITHITHADHA whose telephone number is (571)272-4732. The examiner can normally be reached Monday - Friday 8:00 am - 8:00 am - 4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason M Sims can be reached at 571-272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NAVIN NATNITHITHADHA/Primary Examiner, Art Unit 3791 06/09/2026
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