DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim 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, 7-15, and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Belef et al. (US 6398755) in view of Stigall et al. (US 20140276016).
Regarding Claim 1, Belef teaches a system, (Abstract “system (2)”), for imaging a blood vessel, (Column 2 Lines 6-10 “Imagining [sic] using computer-assisted reconstruction algorithms enables physicians to view a representation of the patient's interior intravascular structures in two or three dimensions (i.e., so-called three-dimensional or longitudinal view reconstruction).”), the system comprising:
a) a catheter shaft (Column 4 Lines 55 “catheter 24”), having a proximal end region (Column 5 Line 18 “proximal end 50”);
b) a telescope assembly disposed at the proximal end region, (Fig. 1), the telescope assembly including a first telescope tube, (Column 5 Line 16 “telescoping portion 51”), and a second telescope tube (Column 4 Line 59 “catheter sheath 36” and Fig. 1); and
c) an imaging assembly slidably disposed within the catheter shaft, the imaging assembly including a drive shaft and an imaging device coupled to the drive shaft (Fig. 1 and Column 4 Lines 57-66 “Catheter 24 includes a catheter core 34, with an operative element 32 (typically an ultrasonic transducer) at its distal end, housed within a catheter sheath 36. Catheter drive unit 22 includes a housing 28 to which an LCD translation displacement display 30 is mounted. Display 30 provides the user with translation displacement information relating to the translational (that is, longitudinal or axial) position of operative element 32. Catheter core 34 is rotatable and translatable (longitudinally slidable) within sheath 36 of catheter 24.”).
However, Belef does not explicitly teach a flush port coupled to the telescope assembly; a distal opening in the catheter shaft, the distal opening in fluid communication with the flush port.
In an analogous flushing for imaging catheter field of endeavor, Stigall teaches a system for imaging a blood vessel, ([0024] “The imaging assembly 120 produces ultrasound energy and receives echoes from which real time ultrasound images of a thin section of the blood vessel are produced.”), the system comprising:
a) a flush port coupled to the telescope assembly ([0025] “The flush port 190 is connected to a lumen (not shown) that runs the length of the catheter 100”); and
b) a distal opening in the catheter shaft, the distal opening in fluid communication with the flush port (Figs. 2A-2D and Claim 1 “a flush port at a proximal end in fluidic communication with a plurality of openings at a distal end of the catheter.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify the teachings of Belef with the flush port of Stigall because it allows fluid communication between the ends of the system, for example, to allow the lumen of the catheter to fill with blood, as taught by Stigall in [0026].
Regarding Claim 2, the modified system of Belef teaches all limitations of Claim 1, as discussed above. Furthermore, Belef teaches wherein the telescope assembly includes a seal disposed between the first telescope tube and the second telescope tube (Column 6 Line 60 “There is a sliding seal between end 50 and portion 51”).
Regarding Claim 3, the modified system of Belef teaches all limitations of Claim 1, as discussed above. Furthermore, Belef teaches wherein the drive shaft is coupled to the first telescope tube (Fig. 1, where telescoping portion 51 is coupled to catheter drive unit 22 via hub 49.).
Regarding Claim 4, the modified system of Belef teaches all limitations of Claim 1, as discussed above. Furthermore, Belef teaches wherein the imaging device includes an ultrasound transducer (Column 4 Lines 57-59 “Catheter 24 includes a catheter core 34, with an operative element 32 (typically an ultrasonic transducer) at its distal end, housed within a catheter sheath 36.).
Regarding Claim 5, the modified system of Belef teaches all limitations of Claim 1, as discussed above. Furthermore, Belef teaches a sensor disposed adjacent to the telescope assembly (Fig. 4 and Column 6 Lines 15-16 “displacement sensor 110 positioned between clutch 104 and output 92,” where because the displacement sensor 110 is located within the drive unit 22 which is adjacent the catheter 24, therefore the displacement sensor 110 is adjacent to the telescope assembly of Belef).
Regarding Claim 7, the modified system of Belef teaches all limitations of Claim 1, as discussed above. Furthermore, Belef teaches a handle coupled to a proximal end region of the telescope assembly (Fig. 2, where housing 28 provides a handle coupled to the telescope assembly).
Regarding Claim 8, the modified system of Belef teaches all limitations of Claim 1, as discussed above. Furthermore, Stigall teaches wherein the flush port is disposed adjacent to a proximal end region of the telescope assembly (Claim 1 “having a flush port at a proximal end”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify the teachings of Belef with the flush port of Stigall because the design provides easy access to the catheter for clearance and maintenance.
Regarding Claim 9, the modified system of Belef teaches all limitations of Claim 1, as discussed above. Furthermore, Belef teaches a housing disposed at a proximal end region of the first telescope tube (Fig. 2 “housing 28”).
Regarding Claim 10, the modified system of Belef teaches all limitations of Claim 9, as discussed above. Furthermore, Belef teaches wherein the housing includes a seal (Column 5 Lines 15-17 “Sheath 36 includes a hub 49 which secures a telescoping portion 51 of sheath 36 to housing 28 of unit 22.”).
Regarding Claim 11, Belef teaches a system, (Abstract “system (2)”), for imaging a blood vessel, (Column 2 Lines 6-10 “Imagining [sic] using computer-assisted reconstruction algorithms enables physicians to view a representation of the patient's interior intravascular structures in two or three dimensions (i.e., so-called three-dimensional or longitudinal view reconstruction).”), the system comprising:
a) a catheter shaft (Column 4 Lines 55 “catheter 24”), having a proximal end region (Column 5 Line 18 “proximal end 50”);
b) a telescope assembly coupled to the catheter shaft, (Fig. 1), the telescope assembly including a first telescope tube, (Column 5 Line 16 “telescoping portion 51”), and a second telescope tube (Column 4 Line 59 “catheter sheath 36” and Fig. 1);
c) an imaging assembly slidably disposed within the catheter shaft, the imaging assembly including a drive shaft and an imaging device coupled to the drive shaft (Fig. 1 and Column 4 Lines 57-66 “Catheter 24 includes a catheter core 34, with an operative element 32 (typically an ultrasonic transducer) at its distal end, housed within a catheter sheath 36. Catheter drive unit 22 includes a housing 28 to which an LCD translation displacement display 30 is mounted. Display 30 provides the user with translation displacement information relating to the translational (that is, longitudinal or axial) position of operative element 32. Catheter core 34 is rotatable and translatable (longitudinally slidable) within sheath 36 of catheter 24.”).
However, Belef does not explicitly teach a flush port coupled to the first telescope tube.
In an analogous flushing for imaging catheter field of endeavor, Stigall teaches a system for imaging a blood vessel, ([0024] “The imaging assembly 120 produces ultrasound energy and receives echoes from which real time ultrasound images of a thin section of the blood vessel are produced.”), the system comprising: a flush port coupled to the first telescope tube ([0023] “The ex-corporal portion of catheter 100 also include a transition shaft 150 coupled to a coupling 160 that defines the external telescope section 165” and [0025] “The flush port 190 is connected to a lumen (not shown) that runs the length of the catheter 100”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify the teachings of Belef with the flush port of Stigall because it allows fluid communication between the ends of the system, for example, to allow the lumen of the catheter to fill with blood, as taught by Stigall in [0026].
Regarding Claim 12, the modified system of Belef teaches all limitations of Claim 11, as discussed above. Furthermore, Belef teaches wherein the telescope assembly includes a seal disposed between the first telescope tube and the second telescope tube (Column 6 Line 60 “There is a sliding seal between end 50 and portion 51”).
Regarding Claim 13, the modified system of Belef teaches all limitations of Claim 11, as discussed above. Furthermore, Belef teaches wherein the drive shaft is coupled to the first telescope tube (Fig. 1, where telescoping portion 51 is coupled to catheter drive unit 22 via hub 49.).
Regarding Claim 14, the modified system of Belef teaches all limitations of Claim 11, as discussed above. Furthermore, Belef teaches wherein the imaging device includes an ultrasound transducer (Column 4 Lines 57-59 “Catheter 24 includes a catheter core 34, with an operative element 32 (typically an ultrasonic transducer) at its distal end, housed within a catheter sheath 36.).
Regarding Claim 15, the modified system of Belef teaches all limitations of Claim 11, as discussed above. Furthermore, Belef teaches a sensor disposed adjacent to the telescope assembly (Fig. 4 and Column 6 Lines 15-16 “displacement sensor 110 positioned between clutch 104 and output 92,” where because the displacement sensor 110 is located within the drive unit 22 which is adjacent the catheter 24, therefore the displacement sensor 110 is adjacent to the telescope assembly of Belef).
Regarding Claim 17, the modified system of Belef teaches all limitations of Claim 11, as discussed above. Furthermore, Belef teaches a handle coupled to a proximal end region of the telescope assembly (Fig. 2, where housing 28 provides a handle coupled to the telescope assembly).
Regarding Claim 18, the modified system of Belef teaches all limitations of Claim 11, as discussed above. Furthermore, Stigall teaches wherein the flush port is disposed adjacent to a proximal end region of the telescope assembly (Claim 1 “having a flush port at a proximal end”).
Regarding Claim 19, Belef teaches a system (Abstract “system (2)”), for imaging a blood vessel, (Column 2 Lines 6-10 “Imagining [sic] using computer-assisted reconstruction algorithms enables physicians to view a representation of the patient's interior intravascular structures in two or three dimensions (i.e., so-called three-dimensional or longitudinal view reconstruction).”), the system comprising:
a) a catheter shaft (Column 4 Lines 55 “catheter 24”);
b) a telescope assembly coupled to the catheter shaft, (Fig. 1), the telescope assembly including a male telescope tube, (Column 5 Lines 16-19 “telescoping portion 51” […]. Telescoping portion 51 has a smaller diameter and slides within proximal end 50 of sheath 36.”), a female telescope tube, (Column 4 Line 59 “catheter sheath 36”), and a seal (Column 6 Line 60 “There is a sliding seal between end 50 and portion 51”); and
c) an imaging assembly slidably disposed within the catheter shaft, the imaging assembly including a drive shaft and an ultrasonic imaging device coupled to the drive shaft (Fig. 1 and Column 4 Lines 57-66 “Catheter 24 includes a catheter core 34, with an operative element 32 (typically an ultrasonic transducer) at its distal end, housed within a catheter sheath 36. Catheter drive unit 22 includes a housing 28 to which an LCD translation displacement display 30 is mounted. Display 30 provides the user with translation displacement information relating to the translational (that is, longitudinal or axial) position of operative element 32. Catheter core 34 is rotatable and translatable (longitudinally slidable) within sheath 36 of catheter 24.”).
However, Belef does not explicitly teach a flush port coupled to the male telescope tube.
In an analogous flushing for imaging catheter field of endeavor, Stigall teaches a system for imaging a blood vessel, ([0024] “The imaging assembly 120 produces ultrasound energy and receives echoes from which real time ultrasound images of a thin section of the blood vessel are produced.”), the system comprising: a flush port coupled to the male telescope tube ([0023] “The ex-corporal portion of catheter 100 also include a transition shaft 150 coupled to a coupling 160 that defines the external telescope section 165” and [0025] “The flush port 190 is connected to a lumen (not shown) that runs the length of the catheter 100”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify the teachings of Belef with the flush port of Stigall because it allows fluid communication between the ends of the system, for example, to allow the lumen of the catheter to fill with blood, as taught by Stigall in [0026].
Regarding Claim 20, the modified system of Belef teaches all limitations of Claim 19, as discussed above. Furthermore, Belef teaches wherein the drive shaft is coupled to the male telescope tube (Fig. 1, where telescoping portion 51 is coupled to catheter drive unit 22 via hub 49.).
Claims 6 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Belef et al. (US 6398755) in view of Stigall et al. (US 20140276016), as applied to Claims 5 and 15, further in view of Corl et al. (US 20140187963).
Regarding Claims 6 and 16, the modified system of Belef teaches all limitations of Claims 5 and 15, as discussed above. However, the modified system of Belef does not explicitly teach wherein the sensor is an optical, resistive, capacitive, inductive, or magnetic sensor.
In an analogous rotational intravascular ultrasound field of endeavor, Corl teaches a system for imaging a blood vessel, ([0002] “The present disclosure relates generally to intravascular ultrasound (IVUS) imaging inside the living body and, in particular, to a control system for an IVUS imaging system”), wherein the sensor is an optical, ([0046] “Sensors 455 may include optical detectors and signals”), resistive, capacitive, inductive, or magnetic sensor ([0046] “Sensors 455 may include […] electromagnetic sensors and signals. […] sensors 455 include at least one Hall-effect sensor that measures the magnetic field produced by opposite poles (e.g., North N, and South, S) in magnet 460.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the sensor of Corl because the choice of sensor type may depend on the physical attributes of the device and its application. Optical sensors offer a number of advantages, such as increased sensitivity compared to existing techniques, having ability to be lightweight and very small in size, low attenuation, low power, and wide bandwidth, all of which are beneficial when designing an assembly configured to be inserted into a patient. Furthermore, magnetic sensors provide advantages such as being low-cost, small in size, having a long operational period, the ability to detect through various materials and are reliable even with fast processes. Each sensor type provides its won specific advantages that may be beneficial in the design of the system, depending on its place of use, patient, materials available, or size.
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 1-4, 11-14, 17, and 19-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-4, 6-7, 11-13, 15-16, and 18-19 of copending Application No. 19/077,171 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because while the reference application is more specific than the instant application in that it requires more specific limitations, the instant application may be applied in order to achieve the same concept.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
In Claims 1, 11, and 18-19 of the instant application and Claims 1 and 9 of the reference application, a system for imaging a blood vessel comprises a catheter shaft having a proximal region; a telescope assembly disposed at the proximal end region, the telescope assembly including a first telescope tube (male telescope tube in Claim 19 of the instant application) and a second telescope tube (female telescope tube in Claim 19 of the instant application), the telescope assembly including a seal; (a proximal member including, in the reference application) a flush port coupled (in fluid communication with, in the reference application) to the telescope assembly; a distal opening in the catheter shaft (Claims 9 and 18 of the reference application), the distal opening in fluid communication with the flush port; and an imaging assembly slidably disposed within the catheter shaft, the imaging assembly including a drive shaft and an imaging device coupled to the drive shaft.
Claims 2 and 12 of the instant application and Claims 3 and 12 of the reference application include a seal disposed between the first telescope tube and the second telescope tube.
Claims 3, 13, and 20 of the instant application and Claims 6-7 and 15-16 of the reference application include wherein the (a portion of in Claims 6 and 16 of the reference application) drive shaft is coupled to the first telescope tube (male telescope tube in Claim 20 of the instant application).
Claims 4 and 14 of the instant application and Claims 2 and 11 of the reference application include wherein the imaging device includes an ultrasound transducer.
Claims 7 and 17 of the instant application and Claims 4 and 13 of the reference application include a handle coupled to the (proximal end region of in the instant application) telescope assembly.
Conclusion
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/MARIA CHRISTINA TALTY/Examiner, Art Unit 3797
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
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