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 Amendment
The amendment filed 03/05/2026 has been entered. Claim 87 has been amended. Claims 1-86, 90, 92 and 102 are cancelled. Claims 87-89, 91, 93-101 and 103 remain pending in this application.
Response to Arguments
The amendment to claim 94 overcomes the rejection under 35 USC §112(b). The 112(b) rejection is therefore withdrawn.
Applicant’s arguments with respect to claim(s) 87 have been considered but are moot because the new ground of rejection does not rely the same embodiment of Mesallum applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant argues that Mesallum does not teach a pump comprising an impeller within the central lumen positioned between the proximal inlet opening and the distal discharge opening, the second restrictor positioned at least partially overlapping the impeller, and wherein the pump is configured to pump fluid from the vein into the central lumen through the proximal inlet opening through the catheter shaft to the discharge opening to thereby create a low pressure zone within the vein between the first restrictor and the second restrictor. However, the embodiment of fig. 2 previously cited is no longer relied upon and a new grounds of rejection is made over the embodiment of fig. 4 of Mesallum.
Applicant argues that Mesallum fails to disclose, teach or suggest isolating an inlet opening. However, identical to the claimed invention, Mesallum discloses an opening between two restrictors.
Regarding the arguments directed towards Fulton, Fulton is no longer relied upon to teach such limitations recited in amended claim 87.
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 88-89 and 91 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.
Claim 88 recites “wherein the catheter shaft includes a single restrictor” while claim 87 recites a first restrictor coupled to the catheter shaft and a second restrictor coupled to the catheter shaft. Claim 88 will be interpreted as “wherein the catheter shaft includes the first restrictor and the second restrictor.
Claim 89 recites the limitation "the at least one restrictor" in ln. 1. There is insufficient antecedent basis for this limitation in the claim. Claim 89 will be interpreted as wherein the first restrictor and/or the second restrictor comprises a balloon.
Claim 91 recites the limitation "the at least one restrictor" in ln. 1. There is insufficient antecedent basis for this limitation in the 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 87-89, 93-96, 99, 101 and 103 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mesallum (Pub. No.: US 2015/0238671 A1).
Regarding claim 87, Mesallum discloses (fig. 4) a medical system (abstract), comprising:
A catheter shaft (catheter 402) configured to be positioned within a blood vessel (412) of a patient (¶ 0043);
A central lumen extending through a segment of the catheter shaft (fig. 4);
At least one proximal inlet opening (opening 408) formed through a sidewall of the catheter shaft into the central lumen (fig. 4, ¶ 0043);
At least one discharge opening (opening 406) configured to allow fluid in the central lumen to exit therethrough (fig. 4, ¶ 0043);
A first restrictor (second balloon 414) coupled to the catheter shaft and configured to be positioned within the blood vessel (fig. 4, ¶ 0043) and a second restrictor (first balloon 410) coupled to the catheter shaft at a location distal to the first restrictor such that the proximal inlet is positioned between the first and second restrictors (fig. 4), wherein the first e restrictor and second restrictor are configured to be being movable between an activated configuration in which the first and/or second restrictors has have a first diameter and a relaxed configuration in which the first and/or second restrictors has have a second diameter that is less than the first diameter (¶ 0043), the first and/or second restrictors being configured to occlude fluid flow through the vein when the first and/or second restrictor is in the activated configuration within the blood vessel (¶ 0043);
At least one inflation lumen extending through the catheter shaft, the at least one inflation lumen being in fluid communication with the first and second restrictor, such that movement of fluid through the at least one inflation lumen results in expansion of the first and/or second restrictor (¶ 0068, ¶ 0081); and
A pump (404) comprising an impeller (¶ 0043) within the central lumen catheter shaft positioned between the proximal inlet opening and the distal discharge opening (fig. 4, ¶ 0043), the second restrictor positioned at least partially overlapping the impeller (fig. 4), wherein the pump is configured to pump fluid from the blood vessel into the central lumen through the proximal inlet opening through the catheter shaft to the distal discharge opening to thereby create a low pressure zone within the blood vessel between the first restrictor and the second restrictor (¶ 0043, the flow control system is configured to manipulate flow characteristics such as direction, the flow control system can reverse flow).
Mesallum fails to disclose that the blood vessel is a vein.
However, such limitation relates to the intended use of the system, which, in this case, imparts no further limitations on the structure of the device. Further, Mesallum discloses embodiments wherein the catheter shaft is positioned within a vein of a patient (¶ 0047). Accordingly, the catheter shaft of Mesallum is capable of being positioned within a vein of a patient and using the device for this purpose requires only routine skill in the art (See § MPEP 2114 II).
Regarding claim 88, Mesallum discloses wherein the catheter shaft includes the first restrictor and the second restrictor (fig. 4, ¶ 0043).
Regarding claim 89, Mesallum discloses wherein the first restrictor and/or the second restrictor comprises a balloon (fig. 4, ¶ 0043).
Regarding claim 93, Mesallum discloses wherein the pump is configured to be positioned within the blood vessel (fig. 4, ¶ 0041).
Mesallum fails to disclose that the blood vessel is a vein.
However, such limitation relates to the intended use of the system, which, in this case, imparts no further limitations on the structure of the device. Further, Mesallum discloses embodiments wherein the pump is positioned within a vein of a patient (¶ 0047). Accordingly, the pump of Mesallum is capable of being positioned within a vein of a patient and using the device for this purpose requires only routine skill in the art (See § MPEP 2114 II).
Regarding claim 94, Mesallum discloses wherein the pump is implantable (fig. 4, ¶ 0043).
Regarding claim 95, Mesallum discloses a controller configured to actuate the pump (¶ 0043).
Regarding claim 96, Mesallum discloses wherein the controller is configured to actuate the pump in response to user operation of a control external to the body of the patient (¶ 0086, ¶ 0090).
Regarding claim 99, Mesallum discloses at least one sensor (¶ 0073).
Regarding claim 101, Mesallum fails to disclose wherein the vein comprises an internal jugular vein or subclavian vein.
However, such limitation of claim 101 relates to the intended use of the system, which, in this case, imparts no further limitations on the structure of the device. The catheter shaft disclosed by Mesallum is capable of being configured to be positioned within an internal jugular vein or subclavian vein and using the device for this purpose requires only routine skill in the art (See § MPEP 2114 II).
Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter shaft of Mesallum such that it is positioned within an internal jugular vein or subclavian vein in order to manage blood flow in an internal jugular vein or subclavian vein.
Regarding claim 103, Mesallum discloses wherein the fluid comprises a gas (¶ 0068).
Claim(s) 97-98, 100 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mesallum, as applied to claim 97 and 95 above, and further in view of Fulton, III et al. (Pub. No.: US 2013/0331814 A1), hereinafter Fulton.
Regarding claim 97, Mesallum fails to disclose a pressure sensor configured to be implanted in the body of the patient, the controller configured to actuate the pump in response to a pressure measured by the pressure sensor exceeding a predefined threshold.
Fulton teaches (fig. 5A, 6, 8) a medical system (recovery device 138) and thus in the same field of endeavor, comprising:
A catheter shaft (recovery catheter 76) configured to be positioned within a vein of a patient (inferior vena cava, fig. 6);
A pump (21) configured to pump fluid through the catheter shaft to an outlet positioned distal to the at least one restrictor (¶ 0080);
A controller configured to actuate the pump (¶ 0103); and
A pressure sensor configured to be implanted in the body of the patient, the controller being configured to actuate the pump in response to a pressure measured by the pressure sensor exceeding a predefined threshold (¶ 0103).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the medical system of Mesallum such that it comprises a pressure sensor configured to be implanted in the body of the patient, the controller configured to actuate the pump in response to a pressure measured by the pressure sensor exceeding a predefined threshold, as taught by Fulton, in order to allow the pump to be regulated based on pressure (Fulton, ¶ 0103).
Regarding claim 98, Mesallum fails to disclose a pressure sensor configured to be implanted in the body of the patient, the controller configured to control a speed of operation of the pump depending on a pressure measured by the pressure sensor.
Fulton teaches (fig. 5A, 6, 8) a medical system (recovery device 138) and thus in the same field of endeavor, comprising:
A catheter shaft (recovery catheter 76) configured to be positioned within a vein of a patient (inferior vena cava, fig. 6);
A pump (21) configured to pump fluid through the catheter shaft to an outlet positioned distal to the at least one restrictor (¶ 0080);
A controller configured to actuate the pump (¶ 0103); and
A pressure sensor configured to be implanted in the body of the patient, the controller configured to control a speed of operation of the pump depending on a pressure measured by the pressure sensor (¶ 0103).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the medical system of Mesallum such that it comprises a pressure sensor configured to be implanted in the body of the patient, the controller configured to control a speed of operation of the pump depending on a pressure measured by the pressure sensor, as taught by Fulton, in order to allow the pump to be regulated based on pressure by controlling the speed of the pump (Fulton, ¶ 0103).
Regarding claim 100, Mesallum fails to disclose a flexible membrane attached to a distal portion of the catheter shaft, the flexible membrane being a collapsible, tube-like member having a lumen extending therethrough, the at least one restrictor being formed over a portion of the flexible membrane.
Fulton teaches (fig. 5A, 6, 8) a medical system (recovery device 138) and thus in the same field of endeavor, comprising:
A catheter shaft (recovery catheter 76) configured to be positioned within a vein of a patient (inferior vena cava, fig. 6);
At least one restrictor (balloons 180, 181) coupled to the catheter shaft and configured to be positioned within the vein (fig. 6, ¶ 0074), the at least one restrictor being movable between an activated configuration in which the at least one restrictor has a first diameter and a relaxed configuration in which the at least one restrictor has a second diameter that is less than the first diameter, the at least one restrictor being configured to occlude fluid flow through the vein when the at least one restrictor is in the activated configuration within the vein (¶ 0074); and
A flexible membrane (elastomeric covering 97) attached to a distal portion of the catheter shaft, the flexible membrane being a collapsible, tube-like member having a lumen extending therethrough, the at least one restrictor being formed over a portion of the flexible membrane (fig. 6, ¶ 0067).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the medical system of Mesallum such that it comprises a flexible membrane attached to a distal portion of the catheter shaft, the flexible membrane being a collapsible, tube-like member having a lumen extending therethrough, the at least one restrictor being formed over a portion of the flexible membrane, as taught by Fulton, in order to provide a shaft that is expandable for easier insertion (Fulton, ¶ 0052, ¶ 0067).
Claim(s) 91 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mesallum, as applied to claim 87 above, and further in view of Campbell et al. (Pub. No.: US 2011/0004046 A1).
Regarding claim 91, Mesallum fails to disclose wherein the at least one restrictor includes a stent.
Campbell teaches (fig. 1) a medical system (blood pump 10, ¶ 0058) and thus in the same field of endeavor, comprising at least one restrictor, wherein the at least one restrictor includes a stent (see expandable portion 44, ¶ 0069).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the at least one restrictor of Mesallum such that it includes a stent, as taught by Campbell, in order to provide a restrictor with bending characteristics (Campbell ¶ 0069).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Keren et al. (Pat. No.: US 7,780,628 B1) discloses a medical system, comprising: a first restrictor and a second restrictor.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 MEAGAN NGO whose telephone number is (571)270-1586. The examiner can normally be reached M - TH 8:00 - 4:00 PT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached on (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MEAGAN NGO/Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781
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