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 § 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.
1. Claim 7 is 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. .
In regards to claim 7, “an auxiliary medical device” has already been claimed, so it is unclear if this is a new auxiliary medical device or if this is the same one as previously claimed. For examination purposes, the Examiner is interpreting this to be the same auxiliary medical device.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
2. Claim(s) 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Anand (US 20210299431 A1).
In regards to claim 20, Anand discloses a method for treating the heart, the method comprising: advancing a medical device into the superior vena cava of the heart (Abstract), the medical device including:
a first catheter shaft having a first lumen; a second catheter shaft extending within the first lumen, wherein the second catheter shaft is configured to translate relative to the first catheter shaft (Par. 0054-0056 teach there being two elongate members [30a, 30b] with lumens, i.e. catheters. Fig 2 shows there being an end portion on these. Fig 7 shows them extending into one another [130, 160] and able to move relative to one another)
a first expandable member disposed on the first catheter shaft (Par. 0072 and Fig 3 teach a first expandable member [28a] extending from the first catheter); and
a second expandable member disposed on the second catheter shaft distal to the first expandable member (Par. 0070 teaches a second expandable member [28b] connected to the second catheter [30b]);
a first sensing member having a first end positioned adjacent the first expandable member, the first sensing member designed to sense a first parameter (Par. 0055 of Anand teaches a first sensing member [32a] that is adjacent to the first expandable member. See Fig 1 and 2 of Anand)
a second sensing member having a first end positioned adjacent the second expandable member, the second sensing member designed to sense a second parameter (Par. 0055 of Anand teaches a second sensing member [32b] that is adjacent to the second expandable member);
positioning the first expandable member within the superior vena cava (Par. 0072 and Fig 3 teach a first expandable member [28a] positioned in the superior vena cava)
translating the second catheter shaft toward the inferior vena cava, positioning the second expandable member within the inferior vena cava (Par 0059 and Fig 2 of Anand show the second expandable member [28b] situated in the inferior vena cava;
sensing a first parameter with the first sensing member, sensing a second parameter with the second sensing member (Par. 0059 teach the sensing members sensing a variety of parameters); and
expanding the first expandable member, the second expandable member or both the first and the second expandable members based on a change in the first parameter, a change in the second parameter, or a change in both the first and the second parameters (Par. 0065 of Anand teaches that the pump can inflate or delate the expandable members based on data received by a sensing member).
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.
3. Claim(s) 1-2, 4-9, and 11-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Anand (US 20210299431 A1) in view of Schultz (WO 2021062032 A1).
In regards to claim 1, Anand discloses a medical device system for treating a heart (Abstract), the system comprising:
a control system including a processor and a pump (Par. 0051 teaches a control system [14] with a processor [16] and pump [18]);
a first catheter shaft having a first lumen and a first end, a second catheter shaft extending within the first lumen and having a first end (Par. 0054-0056 teach there being two elongate members [30a, 30b] with lumens, i.e. catheters. Fig 2 shows there being an end portion on these. Fig 7 shows them extending into one another [130, 160])
a first expandable member disposed on the first catheter shaft, wherein the first expandable member is configured to be positioned in the superior vena cava (Par. 0072 and Fig 3 teach a first expandable member [28a] positioned in the superior vena cava and extending from the first catheter); and
a second expandable member disposed on the second catheter shaft distal to the first expandable member (Par. 0070 teaches a second expandable member [28b] connected to the second catheter [30b]), wherein the second expandable member is configured to translate relative to the first expandable member (The expandable members are connected so they would be moving/shifting relative to one another)
Anand does not disclose there being a hub coupled to the control system. However, in the same field of endeavor, Schultz discloses a venus infusion catheter system (Abstract) wherein the control system is coupled to a catheter which contains a hub (Par. 0159 and 0384-0386) in order to allow for the delivery of fluids through the catheter (Par. 0402).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Anand and modified them by having the system comprise a hub connected to the catheter, as taught and suggested by Schultz, in order to allow for the delivery of fluids through the catheter (Par. 0402 of Schultz).
In regards to claim 2, the combined teachings of Anand and Schultz as applied to claim 1 disclose the medical device system of claim 1, wherein the second expandable member is configured to be positioned in the inferior vena cava (Par. 0059 of Anand).
In regards to claim 4, the combined teachings of Anand and Schultz as applied to claim 1 disclose the medical device system of claim 1, wherein the second expandable member is configured to translate relative to the first expandable member while the first expandable member is maintained in a fixed position within the superior vena cava (Fig 1 of Anand shows that the first expandable member [26a] can be moved or translated without the movement of 26b since they are not attached to one another).
In regards to claim 5, the combined teachings of Anand and Schultz as applied to claim 1 disclose the medical device system of claim 1, wherein the second expandable member is spaced apart from the first expandable member by a variable distance, and wherein the variable distances is 12 inches to 18 inches (Fig 1-4 of Anand show the two expandable members being spaced apart from one other by a variable distance).
At the time the invention was made, it would have been an obvious matter of design choice to a person of ordinary skill in the art to have the distance be 12-18 inches because Applicant has not disclosed that this provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Anand and applicant' s invention, to perform equally well since they are both spaced apart by some degree and would perform the same function of equally well. Therefore, it would have been prima facie obvious to modify Anand to obtain the invention as specified in the claim because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Anand.
In regards to claim 6, the combined teachings of Anand and Schultz as applied to claim 1 disclose the medical device system of claim 1, wherein the first lumen is configured to permit an auxiliary medical device to pass through the first lumen into the right atrium of the heart (Par. 0054-0055 of Anand teach that the elongate member 30a can have a lumen that allows for a sensing member to pass through it and reach the right atrium [see Fig 2 of Anand]).
In regards to claim 7, the combined teachings of Anand and Schultz as applied to claim 6 disclose the medical device system of claim 6, wherein the first lumen is configured to permit an auxiliary medical device to pass from the first lumen into the right atrium of the heart while the second expandable member is positioned in the inferior vena cava (Par. 0054-0055 of Anand teach that the elongate member 30a can have a lumen that allows for a sensing member to pass through it and reach the right atrium [see Fig 2]). Par 0059 and Fig 2 of Anand show the second expandable member [28b] situated in the inferior vena cava)
In regards to claim 8, the combined teachings of Anand and Schultz as applied to claim 6 disclose the medical device system of claim 6, wherein the pump is designed to expand or contract the first expandable member, the second expandable member, or both the first and the second expandable members based on a change in a first parameter sensed by the auxiliary medical device (Par. 0065 of Anand teaches that the pump can inflate or delate the expandable member based on data received by a sensing member)
In regards to claim 9, the combined teachings of Anand and Schultz as applied to claim 8 disclose the medical device system of claim 8, wherein the first parameter is selected from the group consisting of a cardiac output of the heart, a blood flow in the pulmonary artery of the heart, and a blood pressure of the pulmonary artery of the heart (Par. 0066 of Anand teaches the sensed parameter can be blood pressure).
In regards to claim 11 and 12, the combined teachings of Anand and Schultz as applied to claim 8 disclose the medical device of claim 8, further comprising a first sensing member having a first end positioned adjacent the first expandable member and a second end coupled to the control system (Par. 0055 of Anand teaches a first sensing member [32a] that is adjacent to the first expandable member and connected to the control system [14]. See Fig 1 and 2 of Anand)
wherein the first sensing member is designed to sense a second parameter, and wherein the pump is designed to expand or contract the first expandable member based on a change in the first parameter, the second parameter, or a change in both the first and the second parameters (Par. 0059 of Anand teach the sensing members can sense a variety of parameters, including pressure. Par. 0065 of Anand teaches that the pump can inflate or delate the expandable members based on data received by a sensing member).
In regards to claim 13 and 14, the combined teachings of Anand and Schultz as applied to claim 11 disclose the medical device of claim 11, further comprising a second sensing member having a first end positioned adjacent the second expandable member and a second end coupled to the control system (Par. 0055 of Anand teaches a second sensing member [32b] that is adjacent to the second expandable member and connected to the control system [14]. See Fig 1 and 2 of Anand),
wherein the second sensing member is designed to sense a third parameter, and wherein the pump is designed to expand or contract the second expandable member based on a change in the first parameter, the second parameter, the third parameter, or a change in both the first and the second parameters, a change in both the first and the third parameters, or a change in both the second and the third parameters (Par. 0059 of Anand teach the sensing members can sense a variety of parameters, including pressure. Par. 0065 of Anand teaches that the pump can inflate or delate the expandable members based on data received by a sensing member).
In regards to claim 15, the combined teachings of Anand and Schultz as applied to claim 13 disclose the system of claim 13, wherein the second parameter, the third parameter, or both the second parameter and the third parameter is a blood pressure (Par. 0062 of Anand teaches the sensing members can sense a change in blood pressure).
In regards to claim 16, the combined teachings of Anand and Schultz as applied to claim 13 disclose the system of claim 13, wherein the first sensing member, the second sensing member, or both the first sensing member and the second sensing member includes a pressure wire (Par. 0060 of Anand teaches the sensing member being an wire with a pressure MEMS sensor attached to the wire).
In regards to claim 17, the combined teachings of Anand and Schultz as applied to claim 13 disclose the system of claim 13, wherein the first sensing member, the second sensing member, or both the first sensing member and the second sensing member includes a fluid-filled sensing catheter (Par. 0008 of Anand teaches there being a fluid-filled sensing catheter).
In regards to claim 18, Anand teaches a medical device system for treating a heart (Abstract) the system comprising:
a control system including a processor and a pump (Par. 0051 teaches a control system [14] with a processor [16] and pump [18]);
a first catheter shaft having a first lumen and a first end; a second catheter shaft extending within the first lumen and having a first end (Par. 0054-0056 teach there being two elongate members [30a, 30b] with lumens, i.e. catheters. Fig 2 shows there being an end portion on these. Fig 7 shows them extending into one another [130, 160])
wherein the second catheter shaft is configured to telescope relative to the first catheter shaft (Fig 1 of Anand shows that the first expandable member [26a] can be moved or telescoped)
a first expandable member disposed on the first catheter shaft, wherein the first expandable member is configured to be positioned in the superior vena cava (Par. 0072 and Fig 3 teach a first expandable member [28a] positioned in the superior vena cava and extending from the first catheter); and
and a second expandable member disposed on the second catheter shaft distal to the first expandable member (Par. 0070 teaches a second expandable member [28b] connected to the second catheter [30b]),
wherein the second expandable member is configured to be positioned in the inferior vena cava while the first expandable member is held in a fixed position within the superior vena cava (Fig 1 of Anand shows that the second expandable member [26b] can be moved or translated while 26a remains in the superior vena cava since they are not attached to one another).
In regards to claim 19, the combined teachings of Anand and Schultz as applied to claim 18 disclose the medical device system of claim 18, wherein the first lumen is configured to permit an auxiliary medical device to pass through the first lumen into the right atrium of the heart (Par. 0054-0055 of Anand teach that the elongate member 30a can have a lumen that allows for a sensing member to pass through it and reach the right atrium [see Fig 2]).
4. Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Anand and Schultz, and in view of Kaiser (US 20160199554 A1).
In regards to claim 3, the combined teachings of Anand and Schultz as applied to claim 1 disclose the medical device system of claim 1, except for wherein the second expandable member is configured to be positioned adjacent to a renal artery.
However, in the same field of endeavor, Kaiser teaches a system for optimizing intracardiac filling pressures and cardiac output (Abstract) wherein they place an expandable member by the renal vein (Par. 0030) in order to improve renal function and thus increase cardiac output (Par. 0009).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Anand and Schultz and modified them by having the system place the expandable member by the renal vein, as taught and suggested by Kaiser, in order to improve renal function and thus increase cardiac output (Par. 0009 of Kaiser).
5. Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Anand and Schultz, and in view of Olson (US 20170333671 A1).
In regards to claim 10, the combined teachings of Anand and Schultz as applied to claim 6 disclose the medical device system of claim 6, except for wherein the auxiliary medical device includes a thermodilution catheter.
However, in the same field of endeavor, Olson teaches a catheter system that is used to measure and control cardiac output (Abstract and Par. 0002-0008) wherein a thermodilution catheter is used (Par. 0009 and 0041) in order to more accurately measure cardiac output (Par. 0003 and 0009-10).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Anand and Schultz and modified them by having the system include a thermodilution catheter, as taught and suggested by Olson, in order to more accurately measure cardiac output (Par. 0003 and 0009-10 of Olson).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SKYLAR LINDSEY CHRISTIANSON whose telephone number is (571)272-0533. The examiner can normally be reached Monday-Friday, 7:30-5:30 EST.
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/S.L.C./Examiner, Art Unit 3792
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
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