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 .
Response to Arguments
Applicant does not explicitly address the objection to the specification, and the objection to the specification remains unaddressed in terms of amendments. Therefore, the objection to the specification is maintained.
Applicant’s argument on Pages 5-6 regarding the rejection of Claims 1, 11, and 20 under 35 U.S.C. 103 over Belef in view of Stigall has been fully considered but is not persuasive. Applicant argues that Stigall “merely discloses a flush port 190 for flushing a catheter. The cited art does not teach or suggest a proximal member with a flush port in fluid communication with a telescope assembly such that a space between the first telescope tube and the second telescope tube can be flushed.” Examiner respectfully disagrees. Stigall teaches flush port 190, that is in fluid communication with a telescope assembly (Fig. 1) such that a space (lumen not shown that runs the length of the catheter 100, allowing fluid communication between the ex-corporal portion and the pull-back chamber 130) such that a space between the first telescope tube (external telescope section 165) and the second telescope tube (pull-back chamber 130, proximal shaft 140, transition shaft 150) can be flushed.
Regarding the rejection of all remaining corresponding claims, applicant’s argument submitted on Page 6 relies on the supposed deficiencies with respect to the rejection of parent Claims 1 and 11. Applicant’s argument is moot for the same reasons detailed above.
Therefore, the rejections of Claims 1-7, 9-16, and 18-20 under 35 U.S.C. 103 over Belef in view of Stigall and Claims 8 and 17 under 35 U.S.C. 103 over Belef in view of Stigall further in view of Havel are maintained.
Specification
The use of the term Boston Scientific CorporationTM (Page 11 Line 3) and Measurement SpecialtiesTM (Page 17 Line 15), which are trade names or marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding Claims 1, 11, and 20 the limitation “such that a space between the first telescope tube and the second telescope tube can be flushed” fails to comply with the written description requirement. The disclosure does not teach a space between the first telescope and second telescope to be flushed. Rather, the disclosure teaches that one or both of the telescoping pullback section 112 and distal section 110 can be flushed […] via a port 124 disposed within the telescoping section or can be placed elsewhere along the telescoping pullback section 112 or distal section 110 (Page 12 Lines 22-26). Regarding the figures containing port 124, there is no teaching which would reasonably suggest flushing of a space between first telescope tube 120 and second telescope tube 122, merely that the flushing occurs within both of them, along their shared axis.
Claims not explicitly addressed above are rejected as depending from a rejected claim and failing to cure deficiencies of the parent claim.
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 1-7, 9-16, and 18-20 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 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 Line 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 4 Line 16 “telescoping portion 51”), and a second telescope tube, (Column 4 Line 59 “catheter sheath 36” and Fig. 1), the telescope assembly including 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 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 proximal member coupled to the telescope assembly, the proximal member including a flush port.
In an analogous flushing for imaging catheters 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 proximal member coupled to the telescope assembly, the proximal member including a flush port (Fig. 1, where connector 170 has flush port 190 connected to it), in fluid communication with the telescope assembly, (Fig. 1), such that a space, (Fig. 1, and [0025] “lumen not shown that runs the length of the catheter 100, allowing fluid communication between the ex-corporal portion and the pull-back chamber 130.”), between the first telescope tube, (external telescope section 165), and the second telescope tube, (pull-back chamber 130, proximal shaft 140, transition shaft 150), can be flushed ([0025] “lumen not shown that runs the length of the catheter 100, allowing fluid communication between the ex-corporal portion and the pull-back chamber 130.”).
Stigall teaches flush port 190, that is in fluid communication with a telescope assembly (Fig. 1) such that a space such that a space between the first telescope tube and the second telescope tube can be flushed.
Regarding Claim 2, 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 3, the modified system of Belef teaches all limitations of Claim 1, as discussed above. Furthermore, Belef teaches wherein the seal is disposed between the first telescope tube and the second telescope tube (Fig. 1 and Column 6 Line 60 “There is a sliding seal between end 50 and portion 51”).
Regarding Claim 4, the modified system of Belef teaches all limitations of Claim 1, as discussed above. Furthermore, Belef teaches a handle coupled to the telescope assembly (Fig. 2, where housing 28 provides a handle coupled to the telescope assembly).
Regarding Claim 5, the modified system of Belef teaches all limitations of Claim 1, as discussed above. Furthermore, Belef teaches a pullback slider coupled to the drive shaft (Column 7 Line 33 “The invention is typically used in a pullback mode” and Figs. 2 and 3, where drive unit interface 82 is mounted to be slidable and is coupled to drive unit 22.).
Regarding Claim 6, the modified system of Belef teaches all limitations of Claim 1, as discussed above. Furthermore, Belef teaches wherein a portion of the telescope assembly is coupled to the drive shaft (Fig. 1 via hub 49).
Regarding Claim 7, the modified system of Belef teaches all limitations of Claim 1, as discussed above. Furthermore, Belef teaches wherein the first telescope tube is coupled to the drive shaft (Fig. 1, where telescoping portion 51 is coupled to catheter drive unit 22 via hub 49).
Regarding Claim 9, the modified system of Belef teaches all limitations of Claim 1, as discussed above. Furthermore, Stigall teaches wherein the catheter shaft includes an open distal end (Figs. 2A-2D and Claim 1 “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 Belef with the open distal end of Stigall because the modification allows for easy passage of fluids once the distal end is inserted properly into the patient.
Regarding Claim 10, the modified system of Belef teaches all limitations of Claim 1, as discussed above. Furthermore, Stigall teaches wherein the catheter shaft defines a lumen and wherein the flush port is in fluid communication with the lumen ([0025] “The flush port 190 is connected to a lumen (not shown) that runs the length of the catheter 100, allowing fluid communication between the ex-corporal portion and the pull-back chamber 130.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify Belef with the lumen of Stigall for the same reasons as Claim 1 above.
Regarding Claim 11, Belef teaches a system for imaging a blood vessel, the system comprising:
a) a catheter shaft having a lumen, (Fig. 1, where the sheath 36 is shown to have a lumen to house catheter core 34), formed therein and 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 4 Line 16 “telescoping portion 51”), and a second telescope tube, (Column 4 Line 59 “catheter sheath 36” and Fig. 1), the telescope assembly including a seal (Column 6 Line 60 “There is a sliding seal between end 50 and portion 51”);
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 housing coupled to the telescope assembly, the housing including a flush port in fluid communication with the telescope assembly.
In an analogous flushing for imaging catheters 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 housing coupled to the telescope assembly, ([0023] “The end of the telescope section is defined by the connector 170 which allows the catheter 100 to be interfaced to an interface module”), the housing including a flush port, (Fig. 1, where connector 170 has flush port 190 connected to it), in fluid communication with the telescope assembly ([0025] “The flush port 190 is connected to a lumen (not shown) that runs the length of the catheter 100, allowing fluid communication between the ex-corporal portion and the pull-back chamber 130.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify Belef with proximal member including a flush port of Stigall because it allows fluid communication between the ends of the catheter 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 seal is disposed between the first telescope tube and the second telescope tube (Fig. 1 and 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 a handle coupled to the telescope assembly (Fig. 2, where housing 28 provides a handle coupled to the telescope assembly).
Regarding Claim 14, the modified system of Belef teaches all limitations of Claim 11, as discussed above. Furthermore, Belef teaches a pullback slider coupled to the drive shaft (Column 7 Line 33 “The invention is typically used in a pullback mode” and Figs. 2 and 3, where drive unit interface 82 is mounted to be slidable and is coupled to drive unit 22.).
Regarding Claim 15, the modified system of Belef teaches all limitations of Claim 11, as discussed above. Furthermore, Belef teaches wherein a portion of the telescope assembly is coupled to the drive shaft (Fig. 1, where telescoping portion 51 is coupled to catheter drive unit 22 via hub 49).
Regarding Claim 16, the modified system of Belef teaches all limitations of Claim 11, as discussed above. Furthermore, Belef teaches wherein the first telescope tube is coupled to the drive shaft (Fig. 1, where telescoping portion 51 is coupled to catheter drive unit 22 via hub 49).
Regarding Claim 18, the modified system of Belef teaches all limitations of Claim 11, as discussed above. Furthermore, Stigall teaches wherein the catheter shaft includes an open distal end (Figs. 2A-2D and Claim 1 “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 Belef with the open distal end of Stigall because the modification allows for easy passage of fluids once the distal end is inserted properly into the patient.
Regarding Claim 19, the modified system of Belef teaches all limitations of Claim 11, as discussed above. Furthermore, Stigall teaches wherein the flush port is in fluid communication with the lumen ([0025] “The flush port 190 is connected to a lumen (not shown) that runs the length of the catheter 100, allowing fluid communication between the ex-corporal portion and the pull-back chamber 130.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify Belef with the lumen of Stigall for the same reasons as Claim 1 above.
Regarding Claim 20, Belef teaches a medical device for imaging a blood vessel, (Fig. 1), the medical device comprising:
a) a catheter shaft having a lumen, (Fig. 1, where the sheath 36 is shown to have a lumen to house catheter core 34), formed therein and having a proximal end region (Column 5 Line 18 “proximal end 50”);
b) a telescope assembly coupled to the proximal end region, (Fig. 1), the telescope assembly including a seal, (Column 6 Line 60 “There is a sliding seal between end 50 and portion 51”), a first telescope tube, (Column 4 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 the telescope assembly including a housing, and a flush port coupled to the housing; wherein the flush port is in fluid communication with the telescope assembly such that a space between the first telescope tube and the second telescope tube can be flushed.
In an analogous flushing for imaging catheters field of endeavor, Stigall teaches a medical device 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 medical device comprising: a telescope assembly, (Fig. 1), including a housing and a flush port coupled to the housing ([0023] “The end of the telescope section is defined by the connector 170 which allows the catheter 100 to be interfaced to an interface module”), the housing, ([0023] “The end of the telescope section is defined by the connector 170 which allows the catheter 100 to be interfaced to an interface module”), including a flush port (Fig. 1, where connector 170 has flush port 190 connected to it); wherein the flush port is in fluid communication with the telescope assembly such that a space, (Fig. 1, and [0025] “lumen not shown that runs the length of the catheter 100, allowing fluid communication between the ex-corporal portion and the pull-back chamber 130.”), between the first telescope tube, (external telescope section 165), and the second telescope tube, (pull-back chamber 130, proximal shaft 140, transition shaft 150), can be flushed ([0025] “lumen not shown that runs the length of the catheter 100, allowing fluid communication between the ex-corporal portion and the pull-back chamber 130.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify Belef with proximal member including a flush port of Stigall because it allows fluid communication between the ends of the catheter system, for example, to allow the lumen of the catheter to fill with blood, as taught by Stigall in [0026].
Claims 8 and 17 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 1 and 11, further in view of Havel et al. (US 20150094595).
Regarding Claims 8 and 17, the modified system of Belef teaches all limitations of Claims 1 and 11, as discussed above. However, the modified system of Belef teaches wherein the drive shaft includes a coil.
In an analogous over-the-wire ultrasound field of endeavor, Havel teaches a system for imaging a blood vessel, (Abstract “Disclosed are embodiments of devices and methods for imaging the inside of a body part, such as a blood vessel.”), wherein the drive shaft includes a coil ([0065] “Coil 80 is a conductor which is wrapped or coiled multiple times about the rotation axis. In the embodiment of FIG. 1, coil 80 is positioned in the axial direction (relative to the rotation axis) between motor 32 and transducer 28 and adjacent to wall 24 of catheter 22.”).
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 coil of Havel because the coil can be energized in order to pivot the imaging assembly within the catheter, thereby allowing for effective cross sectional imaging, as taught by Havel in [0009] and [0066].
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIA CHRISTINA TALTY whose telephone number is (571)272-8022. The examiner can normally be reached M-Th 8:30-5:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mike Carey can be reached at (571) 270-7235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARIA CHRISTINA TALTY/Examiner, Art Unit 3797
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
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