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 Objections
Claim 13 is objected to because of the following informalities:
Claim 13 recites the limitation “the same volume of fluid” in line 7. There is insufficient antecedent basis for this limitation in the claim.
Appropriate correction is required.
Applicant is advised that should claim 9 be found allowable, claim 20 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-6 and 12-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 2, the limitation “wherein the treatment region is a region within a vessel containing a thrombus” renders the claim indefinite because the claim is unclear regarding whether the treatment region is positively claimed as a part of claimed invention. For examination purposes, examiner construes that the isovolumetric pump system is configured to operate in the treatment region wherein the treatment region is a region within a vessel containing a thrombus.
Claims 3-6 being dependent on claim 2 are also rejected.
Regarding claim 12, the limitation “wherein the user interface” renders the claim indefinite because the claim is unclear if “the user interface” is positively claimed as a part of the claimed invention. Claim 12 is dependent on claim 11 which does not positively recite “a user interface”. For examination purposes, examiner construes “user interface” as positively recited limitation.
Regarding claim 13, line 6, the limitation “a volume of fluid” renders the claim indefinite because the claim is unclear if “a volume of fluid” refers to “an infusion fluid” recited in claim 13, line 2, “fluid” recited in claim 13, line 4 or additional. For examination purposes, examiner construes “fluid” in line 6 as being referring to at least one of “an infusion fluid” and “fluid” recited in line 4.
Claims 14-19 being dependent on claim 13 are also rejected.
Regarding claim 20, the claim is unclear if the apparatus and method claims are being recited in a single claim because claim 20 recites “The method of claim 1” but claim 1 recites a structure of an isovolumetric pump system. For examination purposes, examiner construes claim 20 recites the structure since claim 20 depends on claim 1.
Claim Rejections - 35 USC § 102
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 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.
Claims 13, 14, 16 and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by MacMohan et al. (US 2003/0069549 A1).
Regarding claim 13, MacMohan teaches a method of removing a thrombus (figure 2B, paragraph 0020, lines 3-7, abstract) from a treatment region, comprising:
pumping (paragraph 0068, lines 1-11, paragraph 0069, lines 1-11) an infusion fluid to the treatment region using an infusion pump (structure formed by elements 1 and 22 or 24a and 22 or 90) of an isovolumetric pump system (figure 1 with embodiments of figures 3A and 4A, 4B, 6, 14);
suctioning fluid (paragraph 0068, lines 1-11, paragraph 0069, lines 1-11) from the treatment using a suction pump (structure formed by one of elements 3, 4, 24b and 23 or 91) of the isovolumetric pump system; and
adjusting (paragraph 0036, lines 5-24, paragraph 0035, lines 36-47) a volume of fluid in the treatment region,
wherein substantially the same volume of fluid (paragraph 0036, lines 5-24, paragraph 0035, lines 36-47) is suctioned from the treatment region and infused into the treatment region.
Regarding claim 14, MacMohan teaches wherein the treatment region is a region within a vessel containing a thrombus (figure 2B, “Clot”).
Regarding claim 16, MacMohan teaches further comprising removing the thrombus from the treatment region (abstract, “removal of concentrations of emboli”, paragraph 0065, lines 16-26).
Regarding claim 17, MacMohan discloses wherein walls of the vessel neither distend nor collapse while internal volume is exchanged in the treatment region (paragraph 0029, lines 21-26).
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 1-3, 5, 6, 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over MacMohan et al. (US 2003/0069549 A1) in view of Hahn et al. (US 2006/0093989 A1).
Regarding claim 1, MacMohan teaches an isovolumetric pump system (figure 1 with embodiments of figures 3A and 4A, 4B, 6, 14) for removal of a thrombus (figure 2B, paragraph 0020, lines 3-7, abstract) from a treatment region, comprising:
an infusion pump (structure formed by elements 1 and 22 or 24a and 22 or 90) connected to an input (opening of element 2) of the treatment region, the infusion pump (paragraph 0068, lines 1-11, paragraph 0069, lines 1-11) operable to pump an infusion fluid into the treatment region;
a suction pump (structure formed by one of elements 3, 4, 24b and 23 or 91) connected to an output of the treatment region, the suction pump (paragraph 0068, lines 1-11, paragraph 0069, lines 1-11) operable to pump fluid out of the treatment region;
at least one drive 20, 30, 93 operatively connected to the infusion pump 1, 22 or 24a, 22 and the suction pump 3, 23, 4, 23 or 24b, 23; and
a controller (paragraph 0072, lines 2-7, “electronic system”) operatively connected to the infusion pump and the suction pump via the at least one drive 20, 30, 93 (examiner assumes that a mechanical structure such as elements 20, 30 is needed since electrical component alone cannot control the pump. If electrical system includes a mechanical component similar to elements 20, 30 to control the pump then examiner would conclude the mechanical component as “at least one drive”),
wherein the controller (paragraph 0072, lines 2-7, “electronic system”, alternatively element 94 could also be construed as “controller”) is operable to ensure that substantially the same volume of fluid (paragraph 0036, lines 5-24, paragraph 0035, lines 36-47) is maintained within the treatment region by controlling input and/or output pressures, volumetric flow rates, and/or fluid velocities from the suction pump and the infusion pump.
MacMohan is silent regarding at least one drive being at least one motor drive.
However, Hahn teaches a design of a therapeutic device (figure 3) capable to perform irrigation and suction comprising at least one motor drive 197 (figure 3) for the purpose of achieving controlled fluid regulation using electric control system (paragraph 0067).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the at least one drive of MacMohan to incorporate at least one motor drive as taught by Hahn for the purpose of achieving controlled fluid regulation using electric control system (paragraph 0067).
Regarding claim 2, MacMohan discloses wherein the treatment region is a region within a vessel containing a thrombus (figure 2B, “Clot”).
Regarding claim 3, MacMohan discloses further comprising a catheter system (figure 3A, paragraph 0067, lines 15-17) operable to be placed within the vessel and isolate the treatment region.
Regarding claim 5, MacMohan discloses wherein the isovolumetric pump system is operable to remove the thrombus from the treatment region (abstract, “removal of concentrations of emboli”, paragraph 0065, lines 16-26).
Regarding claim 6, MacMohan discloses wherein the isovolumetric pump system is operable to ensure that walls of the vessel neither distend nor collapse while internal volume is exchanged in the treatment region (paragraph 0029, lines 21-26).
Regarding claim 10, MacMohan is silent regarding wherein that at least one motor drive is a dual motor drive.
However, Hahn teaches wherein the at least one motor drive is a dual motor drive 197 (paragraph 0063, lines 1-4, the operation of element 197 could be reversed thereby making the motor drive as a dual motor drive, alternatively when MacMohan is modified in view of Hahn, the motor will drive both pumps together due to the arrangement and operation of the infusion and suction pumps of MacMohan) for the purpose of achieving controlled fluid regulation using electric control system (paragraph 0067).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the at least one drive of MacMohan to incorporate wherein that at least one motor drive is a dual motor drive as taught by Hahn for the purpose of achieving controlled fluid regulation using electric control system (paragraph 0067)
Regarding claim 11, MacMohan further discloses further comprising a housing 92 comprising: at least one compartment (hollow portion inside element 92 for holding elements 90, 91, 93 and hold portion of element 94) for containing the infusion pump 90, the suction pump 91, the at least one motor drive 93, and the controller 94; two or more openings (opening in element 92 that allows communication with elements 2 and “aspiration lumen”) on a side (side comprising element 2 and “aspiration lumen”) of the housing operable for receiving tubing (tubing could be connected) connected to the infusion pump and the suction pump; and an outer surface (any outer surface could be used to connect to an interface, for instance, surface of element 92 comprising element 94 could be construed as an external surface that is capable to support a user interface) operable for supporting a user interface.
Claim 4 is are rejected under 35 U.S.C. 103 as being unpatentable over MacMohan et al. (US 2003/0069549 A1) in view of Hahn et al. (US 2006/0093989 A1) and further in view of Drasler et al. (US 6,258,061 B1).
Regarding claim 4, MacMohan/Hahn (hereinafter referred as “modified MacMohan”) discloses the claimed invention substantially as claimed, as set forth above in claims 1-3. Modified MacMohan is silent regarding the catheter system is connected to the infusion pump and the suction pump through tubing. However, it would be obvious that though, MacMohan does not explicitly recite the connection between the catheter and the infusion pump and the suction pump, one would construe that some form of tubing has to be present in order to connect to the catheter system.
Additionally, Drasler teaches a design of a tissue removal device 10 (figure 1) comprising the catheter system 12 is connected to the infusion pump 56 and the suction pump 42 through tubing 28, 60 for the purpose of using a well-known technique to connect the catheter system with the infusion pump and the suction pump (figure 1, column 8, lines 18-21, column 7, lines 62-65).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the connection between the catheter system and the infusion pump and the suction pump of modified MacMohan to incorporate wherein the catheter system is connected to the infusion pump and the suction pump through tubing as taught by Drasler for the purpose of using a well-known technique to connect the catheter system with the infusion pump and the suction pump (figure 1, column 8, lines 18-21, column 7, lines 62-65).
Claims 7-9 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over MacMohan et al. (US 2003/0069549 A1) in view of Hahn et al. (US 2006/0093989 A1) and further in view of Costin (US 5,733,256).
Regarding claim 7, modified MacMohan discloses the claimed invention substantially as claimed, as set forth above in claim 1. Modified MacMohan is silent regarding further comprising a pressure sensor connected to the infusion pump, the suction pump and/or the controller.
However, Costin teaches a design of an integrated phacoemulsification system (figures 1-4) further comprising a pressure sensor 104, 106 (column 2, lines 37-42) connected to the infusion pump, the suction pump and/or the controller 102 for the purpose of having a precise control over the fluid flow and/or the pressure at the treatment site (column 2, lines 37-42, column 6, lines 45-50).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the isovolumetric pump of modified MacMohan to incorporate further comprising a pressure sensor connected to the infusion pump, the suction pump and/or the controller as taught by Costin for the purpose of having a precise control over the fluid flow and/or the pressure at the treatment site (column 2, lines 37-42, column 6, lines 45-50).
Regarding claim 8, modified MacMohan discloses the claimed invention substantially as claimed, as set forth above in claim 1. Modified MacMohan is silent regarding wherein the pressure sensor and the controller are operable to perform pressure compensation within the treatment region and control the infusion pump and the suction pump automatically.
However, Costin teaches wherein the pressure sensor and the controller are operable to perform pressure compensation within the treatment region and control the fluid flow automatically (column 6, lines 56-64) for the purpose of automatically control the fluid flow and/or the pressure at the treatment site accurately (column 2, lines 37-42, column 6, lines 45-50).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the isovolumetric pump of modified MacMohan to incorporate wherein the pressure sensor and the controller are operable to perform pressure compensation within the treatment region and control the infusion pump and the suction pump automatically as taught by Costin for the purpose of automatically control the fluid flow and/or the pressure at the treatment site accurately (column 2, lines 37-42, column 6, lines 45-50).
Modified MacMohan modified in view of Costin will result in a modified isovolumetric pump comprising wherein the pressure sensor and the controller are operable to perform pressure compensation within the treatment region and control the infusion pump and the suction pump automatically.
Regarding claim 9, modified MacMohan discloses the claimed invention substantially as claimed, as set forth above in claim 1. Modified MacMohan is silent regarding further comprising a flow sensor connected to the infusion pump, the suction pump, and/or the controller, the flow sensor operable to monitor volumetric flow and/or fluid velocity into and out of the treatment region.
However, Costin teaches further comprising a flow sensor 104, 106 (column 2, lines 37-42) connected to the infusion pump, the suction pump, and/or the controller 102, the flow sensor operable to monitor volumetric flow and/or fluid velocity into and out of the treatment region for the purpose of having a precise control over the fluid flow and/or the pressure at the treatment site (column 2, lines 37-42, column 6, lines 45-50).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, to modify the isovolumetric pump system of modified MacMohan to incorporate further comprising a flow sensor connected to the infusion pump, the suction pump, and/or the controller, the flow sensor operable to monitor volumetric flow and/or fluid velocity into and out of the treatment region as taught by Costin for the purpose of having a precise control over the fluid flow and/or the pressure at the treatment site (column 2, lines 37-42, column 6, lines 45-50).
Regarding claim 20, modified MacMohan discloses the claimed invention substantially as claimed, as set forth above in claim 1. Modified MacMohan is silent regarding further comprising monitoring volumetric flow and/or fluid velocity into and out of the treatment region using a flow sensor connected to the infusion pump, the suction pump, and/or the controller.
However, Costin teaches further comprising monitoring volumetric flow and/or fluid velocity into and out of the treatment region using a flow sensor 104, 106 (column 2, lines 37-42) connected to the infusion pump, the suction pump, and/or the controller 102, for the purpose of having a precise control over the fluid flow and/or the pressure at the treatment site (column 2, lines 37-42, column 6, lines 45-50).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, to modify the isovolumetric pump system of modified MacMohan to incorporate further comprising monitoring volumetric flow and/or fluid velocity into and out of the treatment region using a flow sensor connected to the infusion pump, the suction pump, and/or the controller as taught by Costin for the purpose of having a precise control over the fluid flow and/or the pressure at the treatment site (column 2, lines 37-42, column 6, lines 45-50).
Claim(s) 12 is rejected under 35 U.S.C. 103 as being unpatentable over MacMohan et al. (US 2003/0069549 A1) in view of Hahn et al. (US 2006/0093989 A1) in view of Isaacson (US 2008/0132763 A1) and further in view of Steuer et al. (US 4,504,263).
Regarding claim 12, modified MacMohan discloses the claimed invention substantially as claimed, as set forth above in claims 1 and 11. Modified MacMohan is silent regarding wherein the user interface comprises: an LCD screen connected to the controller and operable for displaying inflow and outflow rates from the infusion pump and the suction pump; a speed knob switch operatively connected to the at least one motor drive; and an on/off switch.
However, Isaacson teaches a design of an apparatus of an endoscope pump comprising a speed knob switch operatively connected to the at least one motor drive (paragraph 0039, lines 4-10, paragraph 0057, lines 1-4) and displays the flow rates (markings around elements 13a, 13b in figure 2) for the purpose of controlling the flow speed of the suction and irrigation (paragraph 0039, lines 4-10).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to modify the user interface of modified MacMohan to incorporate a speed knob switch operatively connected to the at least one motor drive as taught by Isaacson for the purpose of controlling the flow speed of the suction and irrigation (paragraph 0039, lines 4-10).
Modified MacMohan and Isaacson is further silent regarding an LCD screen connected to the controller and operable for displaying inflow and outflow rates from the infusion pump and the suction pump and an on/off switch.
However, Steuer teaches a design of a flow rate monitor comprising an LCD screen 50 (figure 1) connected to the controller 12 and operable for displaying flow rates (column 20, lines 36-47) and an on/off switch 116 (column 7, lines 52-58) for the purpose of displaying the information in digital manner to the user (column 20, lines 36-47) and to turn the system on or off (column 7, lines 52-58).
Modified MacMohan and Isaacson already teaches the use of knob and displaying flow rates on the user interface but Steuer teaches displaying the information using LCD screen therefore, modified MacMohan modified in view of Isaacson and Steuer will result in having an LCD screen connected to the controller and operable for displaying inflow and outflow rates from the infusion pump and the suction pump.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, modifying the user interface of modified MacMohan and Isaacson to incorporate an LCD screen connected to the controller and operable for displaying inflow and outflow rates from the infusion pump and the suction pump and on/off switch as taught by Steuer for the purpose of displaying the information in digital manner to the user (column 20, lines 36-47) and to turn the system on or off (column 7, lines 52-58).
Claim(s) 15 is rejected under 35 U.S.C. 103 as being unpatentable over MacMohan et al. (US 2003/0069549 A1) in view of Drasler et al. (US 6,258,061 B1).
Regarding claim 15, MacMohan discloses the claimed invention substantially as claimed, as set forth above in claims 13, 14. MacMohan further discloses a catheter system (figure 3A, paragraph 0067, lines 15-17) is operable to be placed within the vessel and isolate the treatment region but is silent regarding a catheter system is connected to the infusion pump and the suction pump through tubing. However, it would be obvious that though, MacMohan does not explicitly recite the connection between the catheter and the infusion pump and the suction pump, one would construe that some form of tubing has to be present in order to connect to the catheter system.
Additionally, Drasler teaches a design of a tissue removal device 10 (figure 1) comprising the catheter system 12 is connected to the infusion pump 56 and the suction pump 42 through tubing 28, 60 for the purpose of using a well-known technique to connect the catheter system with the infusion pump and the suction pump (figure 1, column 8, lines 18-21, column 7, lines 62-65).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the connection between the catheter system and the infusion pump and the suction pump of modified MacMohan to incorporate wherein the catheter system is connected to the infusion pump and the suction pump through tubing as taught by Drasler for the purpose of using a well-known technique to connect the catheter system with the infusion pump and the suction pump (figure 1, column 8, lines 18-21, column 7, lines 62-65).
Claim(s) 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over MacMohan et al. (US 2003/0069549 A1) and further in view of Costin (US 5,733,256).
Regarding claim 18, MacMohan discloses the claimed invention substantially as claimed, as set forth above in claim 13. MacMohan is silent regarding further comprising monitoring pressure into and out of the treatment region using a pressure sensor connected to the infusion pump, the suction pump and/or the controller.
However, Costin teaches a design of an integrated phacoemulsification system (figures 1-4) further comprising monitoring pressure into and out of the treatment region using a pressure sensor 104, 106 (column 2, lines 37-42) connected to the infusion pump, the suction pump and/or the controller 102 for the purpose of having a precise control over the fluid flow and/or the pressure at the treatment site (column 2, lines 37-42, column 6, lines 45-50).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the isovolumetric pump of modified MacMohan to incorporate further comprising monitoring pressure into and out of the treatment region using a pressure sensor connected to the infusion pump, the suction pump and/or the controller as taught by Costin for the purpose of having a precise control over the fluid flow and/or the pressure at the treatment site (column 2, lines 37-42, column 6, lines 45-50).
Regarding claim 19, MacMohan discloses the claimed invention substantially as claimed, as set forth above in claim 13. MacMohan is silent regarding further comprising automatically controlling the infusion pump and the suction pump, via the controller, to compensate for pressure in the treatment region based on the monitored pressure from the pressure sensor.
However, Costin teaches further comprising automatically (column 6, lines 56-64) controlling the fluid flow, via the controller, to compensate for pressure in the treatment region based on the monitored pressure from the pressure sensor for the purpose of automatically control the fluid flow and/or the pressure at the treatment site accurately (column 2, lines 37-42, column 6, lines 45-50).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the isovolumetric pump of modified MacMohan to incorporate automatically controlling the infusion pump and the suction pump, via the controller, to compensate for pressure in the treatment region based on the monitored pressure from the pressure sensor as taught by Costin for the purpose of automatically control the fluid flow and/or the pressure at the treatment site accurately (column 2, lines 37-42, column 6, lines 45-50).
MacMohan modified in view of Costin will result in a modified method comprising automatically controlling the infusion pump and the suction pump, via the controller, to compensate for pressure in the treatment region based on the monitored pressure from the pressure sensor.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM EST.
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/NILAY J SHAH/Primary Examiner, Art Unit 3783