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
This office action is responsive to the amendment filed on 8/6/2025. As directed by the amendment: claims 21 and 31 have been amended, claim 35 has been cancelled. Thus, claims 21-34 and 36-37 are presently pending in this application.
Response to Arguments
Applicant's arguments filed 8/6/2025 have been fully considered but they are not fully persuasive.
Regarding applicant’s argument regarding the preceding office actions 112(b) rejection on page 6-8:
Examiner notes that applicants arguments regarding preceding office actions 112(b) rejection pertaining to the term "substantial" are convincing.
For examination purposes the claim terms "substantial" and "substantially exclude" areto be interpreted in view of applicant's disclosure, particularly page 8 paragraph 3 and page 9 paragraph 5. Such that a person of ordinary skill in the art interpret that a "system configured to -- substantially exclude blood from a venous angle" excludes some amount of blood from a venous angle greater than zero. Further a person of ordinary skill in the art would understand that a "volumetric balloon configured to substantially fill a portion of the isolated volume of space" occupies some volume of space within the isolated volume greater than zero.
Regarding applicant’s argument regarding the preceding office actions 112(a) rejection on page 8-9:
Applicant's present amendment resolves the preceding office actions stated 112(a) rejection.
Regarding applicant’s argument regarding the independent claims and the prior art previously relied upon on page 9-14 of applicant's remarks filed 3/10/2025:
Applicants arguments regard the disposition of ports/orifices/inlets/outlets on the surface of the prior art catheters, disposed between the first occlusion balloon and second occlusion balloon, which open into the isolated volume.
Examiner notes that in the examiner's rejection as necessitated by the amendment, below, the prior art of record is still relied upon to reject the present claims in a manner similar to the preceding non-final office action, however the disclosed invention have been modified such that disclosed ports/orifices/inlets/outlets for distributing/removing fluid from the isolated volume are instead disposed on a secondary external catheter. Thus the claimed invention of a catheter having a volumetric balloon disposed between two occlusion balloons with neithers ports nor outlets on that catheter which open into the isolated volume is demonstrated by the modified invention.
Applicant further argues that modification of Kapur in view of Sterman would go against the teachings of Kapur and render it inoperable for its intended purpose of occluding the SVC for the disclosed therapeutic purposes.
Examiner notes that Kapur's paragraph 95 notes that the system and methods of Kapur may be utilized to treat lymphatic congestion and a number of other conditions whose treatment improves cardiac function, which do not necessitate disposal of the invention solely in the SVC. Thus implementing aspects of Sterman's teachings to relieve lymphatic congestion via draining to modify aspects of Kapur's system and method does not go against the teachings of Kapur nor render it unsatisfactory for its intended purpose, as relieving lymphatic congestion is a disclosed intended purpose of the invention. Further, Sterman notes on col 25 line 38-44 that lymphatic isolation and perfusion may be beneficial when performed in conjunction with similar treatment of heart tissue.
Accordingly, the examiner's rejection as necessitated by the amendment, below, in view of the some of the prior art of record stands.
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.
Claim 21-34 and 36-37 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 21,
There is a lack of antecedent basis for the claim term "the catheter" which renders the claim indefinite as it unclear whether the claim is referring to the aforementioned "at least one catheter", a distinct catheter, or is referring to a specific catheter of the "at least one catheter". For examination purposes the claim term is to be interpreted as pertaining to a first catheter belonging to the group of "at least one catheter", in view of page 9 paragraph 2 of applicant's disclosure which delineates a first catheter 303 and a second catheter 321 of fig 4.
There is a lack of antecedent basis for the claim term "the volumetric balloon" which renders the claim indefinite as it unclear whether the claim is referring to the aforementioned "at least one volumetric balloon", a distinct volumetric balloon, or is referring to a specific volumetric balloon of the "at least one volumetric balloon". For examination purposes the claim term is to be interpreted as pertaining to a first volumetric balloon belonging to the group of "at least one volumetric balloon", in view of page 8 paragraph 3 to page 9 paragraph 2 of applicant's disclosure which delineates a first catheter 303 and a second catheter 321 of fig 4.
Regarding claim 22,
There is a lack of antecedent basis for the claim term "the catheter" which renders the claim indefinite as it unclear whether the claim is referring to the "at least one catheter", a distinct catheter, or is referring to a specific catheter of the "at least one catheter" as carrying at least one of the occlusion balloons. For examination purposes the claim term is to be interpreted as pertaining to the at least one catheter, in view of page 8 paragraph 3 to page 9 paragraph 2 of applicant's disclosure and fig 4.
Regarding claim 23
There is a lack of antecedent basis for the claim term "the catheter" which renders the claim indefinite as it unclear whether the claim is referring to the "at least one catheter", a distinct catheter, referring to a specific catheter of the "at least one catheter", or is referring to the second catheter of claim 22 as bearing the first and third occlusion balloon. For examination purposes the claim term is to be interpreted as pertaining to a first catheter belonging to the group of "at least one catheter", in view of page 8 paragraph 3 to page 9 paragraph 2 of applicant's disclosure and fig 4.
Regarding claim 24,
There is a lack of antecedent basis for the claim term "the catheter" which renders the claim indefinite as it unclear whether the claim is referring to the "at least one catheter", a distinct catheter, referring to a specific catheter of the "at least one catheter", or is referring to the second catheter of claim 22 as being dimensioned in the claimed manner. For examination purposes the claim term is to be interpreted as pertaining to a first catheter belonging to the group of "at least one catheter", in view of page 8 paragraph 3 to page 9 paragraph 2 of applicant's disclosure and fig 4.
There is a lack of antecedent basis for the claim term "the occlusion balloons" which renders the claim indefinite as it unclear whether the claim is referring to the aforementioned "plurality of occlusion balloons", a distinct set of occlusion balloons, or is referring to both the first, second , and third occlusion balloons. For examination purposes the claim term is to be interpreted as pertaining to the first, second, and third occlusions balloons, in view of page 8 paragraph 3 to page 9 paragraph 2 of applicant's disclosure.
Regarding claim 25
There is a lack of antecedent basis for the claim term "the volumetric balloons" which renders the claim indefinite as it unclear whether the claim is referring to the aforementioned "at least one volumetric balloon", a distinct set of volumetric balloons, or is referring to both the first and second volumetric balloons. For examination purposes the claim term is to be interpreted as pertaining to the first and second volumetric balloons, in view of page 9 paragraph 2 of applicant's disclosure.
Regarding claim 26
There is a lack of antecedent basis for the claim term "the occlusion balloons" which renders the claim indefinite as it unclear whether the claim is referring to the aforementioned "plurality of occlusion balloons", a distinct set of occlusion balloons, or is referring to both the first, second , and third occlusion balloons. For examination purposes the claim term is to be interpreted as pertaining to the first, second, and third occlusions balloons, in view of page 8 paragraph 3 to page 9 paragraph 2 of applicant's disclosure.
There is a lack of antecedent basis for the claim term "the region of depressurization" which renders the claim indefinite as it unclear whether the claim is referring to the aforementioned “region of reduced pressure” or is instead referring to a different region. For examination purposes the claim is to be interpreted as referring to the same region in view of page 8 paragraph 2 of applicant’s disclosure.
Regarding claim 27
There is a lack of antecedent basis for the claim term "the occlusion balloons" which renders the claim indefinite as it unclear whether the claim is referring to the aforementioned "plurality of occlusion balloons", a distinct set of occlusion balloons, or is referring to both the first, second , and third occlusion balloons. For examination purposes the claim term is to be interpreted as pertaining to the first, second, and third occlusions balloons, in view of page 8 paragraph 3 to page 9 paragraph 2 of applicant's disclosure.
Regarding claim 28
There is a lack of antecedent basis for the claim term "the occlusion balloons" which renders the claim indefinite as it unclear whether the claim is referring to the aforementioned "plurality of occlusion balloons" and/or "at least one volumetric balloons", or a distinct set of balloons. For examination purposes the claim term is to be interpreted as pertaining to the plurality of occlusions balloons, in view of page 9 paragraph 3 of applicant's disclosure.
Regarding claim 31
There is a lack of antecedent basis for the claim term "the catheter" which renders the claim indefinite as it unclear whether the claim is referring to the aforementioned "first catheter" or a distinct catheter. For examination purposes the claim term is to be interpreted as pertaining to a first catheter", in view of page 9 paragraph 2 of applicant's disclosure which delineates a first catheter 303 and a second catheter 321 of fig 4.
Regarding claims 29-30, 32-34, and 36-37,
The aforementioned dependent claims are at least rejected for being dependent upon the rejected claims which they depend from.
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.
Claims 21 and 26-30 are rejected under 35 U.S.C. 103 as being unpatentable over US 20100280451 A1, henceforth written as Teeslink, and in view of US 5090960 A, henceforth written as Don.
Regarding Claim 21,
Teeslink discloses:
A system for treating edema, the device comprising:
(paragraph 65; catheter assembly 100; fig 1)
a plurality of occlusion balloons configured to occlude a plurality of veins upstream and downstream of a lymphatic duct so as to isolate a volume of space in the region of the lymphatic duct;
(paragraph 65+77; occluding balloon 210 250 are configured such that they are functionally capable of occluding the veins in vicinity of the lymphatic duct as claimed; claim language of “configured to” implies a functional language and the prior art must only be capable of performing the recited function; fig 2)
at least one catheter connected at least to a first one of the occlusion balloons and a second one of the plurality occlusion balloons;
(catheter 150 has a proximal occluding balloon 250 and a distal occluding balloon 210; fig 2)
at least one volumetric balloon disposed along the catheter between the first and second occlusion balloons, wherein the catheter comprises an inflation lumen opening into an interior of the volumetric balloon and configured to allow for inflation and deflation of the volumetric balloon, wherein the volumetric balloon is configured to substantially fill a portion of the isolated volume of space between the first occlusion balloon and the second occlusion balloon when in an inflated state;
(paragraph 77; space-occupying balloon 230 and inflation lumen 330; fig 2-6; fig 12 demonstrates that balloon 230 occupies some of space of the isolated volume while inflated)
and at least one inflation lumen operable to inflate and deflate the plurality of occlusion balloons.
(paragraph 66; lumen 310 inflates the occluding balloons 210 250 and lumen 330 corresponds to that of space-occupying balloon 230; fig 9)
Teeslink discloses the elements of the present claim, as described above. Yet, its present embodiment is silent on:
wherein the catheter extends continually between the first and second occlusion balloons with no ports or outlets opening into the isolated volume of space
However Don teaches that a multi-balloon catheter which isolates a volume of vasculature (catheter 2 has balloons 12 13 which isolate a volume of vasculature therebetween; fig 1) and is used in conjunction with a fluid conveying catheter external to the balloon catheter (the disclosed embodiment of catheter 3 not having balloon 13’; fig 1) which has the advantages of the lumen of the fluid conveying catheter being capable of being made larger than what could be provided within the dimensions of the multi-balloon catheter, and consequently improving the volume of media which can be transferred to/from the space between the balloons (col 4 line 9-12). Additionally, agent dispensing catheters, distinct from the multi-balloon catheter, may be utilized to aid in dispensing agents such as contrast dye (col 5 line 40-57) in a multitude of positions relative to the balloons to determine certain treatment characteristics, such as direction and degree of blood flow.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to implement Don’s teachings of disposing suction and dispensing lumens external to a multi-balloon catheter by disposing ports 420 440 of Teeslink on separate suction and agent delivery catheters, therein minimizing a number of lumens required to fit within the catheter of Teeslink, improving its gage and thus vascular navigability, advantageously enabling larger agent delivery/removal lumens which improve the rate of agent delivery/removal as compared to embedded delivery/removal lumens, see col 4 line 9-12 of Don, and enabling greater positionability of the visualizing agent delivery which consequently improves therapeutic care quality by supporting a greater degree of anatomical and flow visualization by a clinician, see col 5 line 40-57 of Don.
Regarding claim 26, the modified device of Teeslink in view of Don discloses:
The system of claim 21, wherein the at least one volumetric balloon is configured to collapse to a relative smaller volume and, when so collapsed, effects a region of reduced pressure between said occlusion balloons, said reduced pressure causing a flow of lymphatic fluid into the region of depressurization.
Teeslink: (space-occupying balloon 230 is configured such that it is functionally capable of collapsing to a smaller volume, such that when the claimed plurality of occlusions are positioned per claim 21 there is a depressurization of the region around the lymphatic duct and consequent lymphatic fluid drainage; claim language of “configured to” implies a functional language and the prior art must only be capable of performing the recited function collapsing to a smaller volume such that a region of reduced pressure is produced which sucks lymphatic fluid into the region)
Regarding claim 27, the modified device of Teeslink in view of Don discloses:
The system of claim 21, wherein the occlusion balloons are configured to be inflated and deflated cyclically.
Teeslink: (paragraph 66; occluding balloon 210 250 are functionally capable of being inflated and deflated cyclically)
Regarding claim 28, the modified device of Teeslink in view of Don discloses:
The system of claim 21, wherein when the system is in an inflated configuration each balloon occludes its upstream or downstream vessel.
Teeslink: (paragraph 65-66; occluding balloon 210 250 occludes vessels and are respectively positioned up/down stream from one another)
Regarding claim 29, the modified device of Teeslink in view of Don discloses:
The system of claim 28, wherein the upstream vessels comprise one or more of an internal jugular vein, subclavian vein, or external jugular vein, and the downstream vessels comprise the innominate vein and or the superior vena cava.
Teeslink: (paragraph 109; catheter 100 is insertable into any of the blood vessels of cardiovascular system i.e. including the jugular, subclavian, and innominate veins, as well the superior vena cava)
Regarding claim 30, the modified device of Teeslink in view of Don discloses:
The system of claim 29, further comprising a control mechanism to control the cycle of inflation and deflation.
Teeslink: (paragraph 12+77+103; balloons 210 250 and 230 are inflated via their respective lumens 310 330 receiving fluid from receiving fluid from inflation sources (not enumerated/illustrated) at their respective ports 510 530; fig 9)
Claims 22-25 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Teeslink in view of Don, as applied to claim 21 above, in view of US 6699231 B1, henceforth written as Sterman.
Regarding Claim 22,
Teeslink in view of Don discloses all of the elements of the current invention which the present claim is dependent upon, as described above, including the following limitations of the present claim:
The system of claim 21, wherein the catheter carries at least one of the occlusion balloons,
(occluding balloon 210 250 on catheter 100; fig 2)
[and a volumetric balloon]
(space-occupying balloon 230 on catheter 100; fig 2)
However, Teeslink in view of Don is silent regarding:
the system further comprising a second catheter bearing: a second occlusion balloon, and a second volumetric balloon.
However, Sterman teaches a method for draining an isolated thoracic duct:
the system further comprising a second catheter:
(col 25 line 17-65; multiple balloon occlusion catheters 322 324 may be introduced to facilitate isolation, and consequent drainage, of a lymphatic duct; fig 17)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to duplicate the catheter disclosed Teeslink in view of Don in light of Sterman's multi-catheter lymphatic duct isolation/drainage teachings, thus arriving at a second catheter having what is considered the second occlusion balloon and the second volumetric balloon, in order to occlude multiple venous locations and more effectively isolating the critical anatomy to facilitate lymphatic duct perfusion, see MPEP 2144.04(vi)(b).
Regarding claim 23, the modified device of Teeslink in view of Don and Sterman discloses:
The system of claim 22, wherein catheter comprises the first occlusion balloon
Teeslink: (occluding balloon 210 on catheter 150)
and a third occlusion balloon.
Teeslink: (occluding balloon 250 on catheter 150)
Examiner notes that in light of the modification made in claim 22 above, the claimed second occlusion balloon is disposed on the secondary catheter 150, and the first and third occlusions balloons are disposed on the initial catheter 150 of Teeslink.
Regarding claim 24, the modified device of Teeslink in view of Don and Sterman teaches:
The system of claim 23, wherein the catheter is dimensioned for insertion into a jugular vein and
Teeslink: (paragraph 109; catheter 100 is insertable into any of the blood vessels of cardiovascular system i.e. including the jugular, subclavian, and innominate veins, as well the superior vena cava)
the second catheter is dimensioned for insertion into a subclavian vein, and
Examiner notes that in light of the modification made in claim 22 above, the claimed second catheter is a duplication of catheter 100, and accordingly is likewise dimensioned to be insertable into any of the blood vessels of the cardiovascular system
wherein when the catheter and the second catheter are so inserted and the first, second, and third occlusion balloons are inflated, the occlusion balloons sequester the volume of space about the region of the lymphatic duct,
Sterman: (See Sterman's fig 17 for a representation of the positioning of the two catheter 100s of Teeslink, isolating a volume of space about the lymphatic duct)
wherein when the occlusion balloons are inflated, the first and second volumetric balloons can be inflated to displace blood from the volume of space.
(inflation of Teeslink's space-occupying balloon 230 displaces fluid upon inflation, see paragraph 116+118+120 of Teeslink, therein wherein positioned per Sterman’s teachings with the claimed duplicate catheter of Teeslink blood is displaced from the volume)
Regarding claim 25, the modified device of Teeslink in view of Don and Sterman discloses:
The system of claim 24, wherein when the volumetric balloons are deflated, the volume of space is depressurized, which urges lymph through a valve outlet of the lymphatic duct.
Teeslink: (when space-occupying balloon 230 is deflated, and the claimed plurality of occlusions are positioned per claim 24, there is a depressurization of the region around the lymphatic duct and consequent lymphatic fluid drainage; this depressurization is a consequence of deflating balloons 230 in an isolated volume, therein reducing the volume in the space and therein reducing pressure in the space)
Regarding Claim 31,
Teeslink discloses:
A method of treating edema, the method comprising: using a system configured to inhibit blood flow through, and substantially exclude blood from, a venous angle,
(paragraph 77; catheter assembly 100 is functionally capable of being utilized to apply treatment to the vasculature and vessels of the lymphatic system, therein functionally capable of excluding blood from a venous angle; fig 2)
the system comprising at least a first catheter comprising a first occlusion balloon, a second occlusion balloon, and a volumetric balloon positioned between the first and second occlusion balloons,
(paragraph 65-67; catheter 100 having occluding balloon 210 250 with space-occupying balloon 230 therebetween; fig 2)
wherein the catheter comprises an inflation lumen opening into an interior of the volumetric balloon and configured to allow for inflation and deflation of the volumetric balloon,
(paragraph 66; lumen 310 inflates the occluding balloons 210 250 and lumen 330 corresponds to that of space-occupying balloon 230; fig 9)
wherein the volumetric balloon is configured to substantially fill a portion of the isolated volume of space between the first occlusion balloon and the second occlusion balloon, --
(paragraph 77; space-occupying balloon 230 and inflation lumen 330; fig 2-6; fig 12 demonstrates that balloon 230 occupies some of space of the isolated volume while inflated)
--wherein the first and second occlusion balloons are configured to occlude a plurality of veins upstream and downstream of a lymphatic duct so as to isolate a volume of space in the region of the lymphatic duct;
(claim language of “configured to” implies a functional language and the prior art must at least be capable of performing the recited function of being capable of occluding a plurality of veins upstream and downstream of a lymphatic duct so as to isolate a volume of space in the region of the lymphatic duct; paragraph 77+96+109 of Teeslink notes that the invention is functionally capable of being disposed in the vasculature/vessels of the lymphatic system such that it is functionally capable being disposed in the claimed manner isolating a lymphatic duct)
and deflating at least the volumetric balloon to cause active transport of lymphatic fluid out of the thoracic duct and into systemic circulation.
(claim language of “configured to” implies a functional language and the prior art must at least be capable of performing the recited function of deflating the volumetric balloon to cause transport of fluid out of a thoracic duct and into systemic circulation; paragraph 66 notes that the balloons of the invention may be inflated and deflated independently, such that upon the occluding balloons 210 250 forming a isolated volume around a lymphatic duct, as noted above, a deflation of the balloon 230 produces a region of low pressure which may permit thoracic duct to open and drain lymphatic fluid into systemic circulation)
However, Teeslink remains silent regarding:
wherein the first catheter extends continually between the first and second occlusion balloons with no ports or outlets opening into the isolated volume of space,
However Don teaches that a multi-balloon catheter which isolates a volume of vasculature (catheter 2 has balloons 12 13 which isolate a volume of vasculature therebetween; fig 1) and is used in conjunction with a fluid conveying catheter external to the balloon catheter (the disclosed embodiment of catheter 3 not having balloon 13’; fig 1) which has the advantages of the lumen of the fluid conveying catheter being capable of being made larger than what could be provided within the dimensions of the multi-balloon catheter, and consequently improving the volume of media which can be transferred to/from the space between the balloons (col 4 line 9-12). Additionally, agent dispensing catheters, distinct from the multi-balloon catheter, may be utilized to aid in dispensing agents such as contrast dye (col 5 line 40-57) in a multitude of positions relative to the balloons to determine certain treatment characteristics, such as direction and degree of blood flow.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to implement Don’s teachings of disposing suction and dispensing lumens external to a multi-balloon catheter by disposing ports 420 440 of Teeslink on separate suction and agent delivery catheters, therein minimizing a number of lumens required to fit within the catheter of Teeslink, improving its gage and thus vascular navigability, advantageously enabling larger agent delivery/removal lumens which improve the rate of agent delivery/removal as compared to embedded delivery/removal lumens, see col 4 line 9-12 of Don, and enabling greater positionability of the visualizing agent delivery which consequently improves therapeutic care quality by supporting a greater degree of anatomical and flow visualization by a clinician, see col 5 line 40-57 of Don.
Claims 32-34 and 36-37 are rejected under 35 U.S.C. 103 as being unpatentable over Teeslink in view of Don and Sterman, and further in view of US 20220105319 A1, henceforth written as Salerno, and US 20190126014 A1, henceforth written as Kapur.
Regarding Claim 32,
The modified device/method of Teeslink in view of Don discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, Teeslink in view of Don is silent regarding:
wherein the method further comprises the steps of: inserting the first catheter such that the first occlusion balloon is inserted into an internal jugular vein and the second occlusion balloon is inserted into an innominate vein; inserting a second catheter comprising a third occlusion balloon and a second volumetric balloon into a subclavian or brachial vein, wherein the second volumetric balloon is configured to substantially fill a portion of the isolated volume of space between the second occlusion balloon and the third occlusion balloon; inflating one or more of the first, second, and third occlusion balloons and one or more of the first and second volumetric balloons; volumetrically displacing blood, via the inflated first or second volumetric balloons, in the respective volume of space filled by the first or second volumetric balloon between the respective first, second, and third occlusion balloons in advance of sealing engagement of the respective first, second, and third occlusion balloons; deflating the first or second volumetric balloon while maintaining sealing engagement with the respective first, second and third occlusion balloons; holding at least a partial vacuum on the first or second volumetric balloon for a period so as to depressurize the lymphatic outflow; collapsing the first, second and third occlusion balloons while maintaining the position of the first and second catheters; and allowing a second period to elapse with the first, second and third occlusion balloons collapsed, wherein the method is performed for a defined therapy duration.
However, Sterman teaches a method for draining an isolated thoracic duct:
wherein the method further comprises the steps of: inserting the first catheter such that the first occlusion balloon is inserted into an internal jugular vein and the second occlusion balloon is inserted into an innominate vein; inserting a second catheter comprising a third occlusion balloon and a second volumetric balloon into a subclavian or brachial vein, --
(See examiner’s annotation of Sterman’s fig 17 as viewed by a person of ordinary skill in the art and in light of Sterman’s col 25 line 17-65, below, providing the positioning of occluding catheters in the claimed regions)
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--inflating one or more of the first, second, and third occlusion balloons and one or more of the first and second volumetric balloons; --
(Fig 17 and col 25 line 18-62 demonstrates that isolation of the thoracic duct entails inflation of the balloons to occlude the vasculature surrounding the duct)
wherein the method is performed for a defined therapy duration.
(col 25 line 18-62; method is performed until a satisfactory therapeutic perfusion of the lymphatic duct is complete)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to implement the method of isolating a lymphatic duct with multiple balloon catheters taught by Sterman, with the multi-catheter system disclosed by Teeslink in view of Don, by replacing Sterman’s catheter’s 330 331 322 324 with the modified catheter system of Teeslink in view of Don, in order to advantageously arrive at method of draining a lymphatic duct which simultaneously enables a treatment of the surrounding tissue with a therapeutic agent that utilizes a minimal amount of therapeutic agent by the nature of the volumetric balloon of Teeslink filling the isolated volume defined by its occluding balloons, see paragraph 109 of Teeslink.
However the modified system and method of Teeslink in view of Don and Sterman remains silent regarding:
volumetrically displacing blood, via the inflated first or second volumetric balloons, in the respective volume of space filled by the first or second volumetric balloon between the respective first, second, and third occlusion balloons in advance of sealing engagement of the respective first, second, and third occlusion balloons;
However, Salerno discloses a method of inflating a multi-balloon catheter:
volumetrically displacing blood, via the volumetric balloon, between the occlusion balloons in advance of sealing engagement of the occlusion balloons;
(paragraph 97; core balloon 41 is fully inflated prior to occlusion elements 42 43 reaching their full size in order to ensure the vessel segment bound by the occlusion elements is fully emptied; fig 10)
Examiner notes, that where the isolated vessel is emptied aside from the volume contained within the core balloon 41, the pressure on the surrounding collateral vessels 8, see fig 10, is primarily dependent on the pressure in core balloon 41 as there is no additional fluid adjacent the collateral vessel 8 to impose pressure thereon. Consequently, pressure on collateral vessel 8 is nearly solely dependent on the pressure in core balloon 41, and not blood pressure of the primary vessel.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the balloon filling order methodology taught by Salerno to the modified apparatus and method of using disclosed by Teeslink in view of Don and Sterman, such that the claimed volumetric balloon fills prior to the occluding balloons, in order to empty the venous angle of blood and therein more directly control the pressure on the thoracic duct by controlling pressure/volume of the volumetric balloon.
However the modified system and method of Teeslink in view of Don, Sterman, and Salerno remains silent regarding:
deflating the first or second volumetric balloon while maintaining sealing engagement with the respective first, second and third occlusion balloons; holding at least a partial vacuum on the first or second volumetric balloon for a period so as to depressurize the lymphatic outflow
However, Kapur teaches a method of using a multi-balloon catheter comprising:
deflating the volumetric balloon while maintaining sealing engagement with the occlusion balloon and holding at least a partial vacuum on the volumetric balloon for a period so as to depressurize the vessel outflow.
(paragraph 178-179; balloon 143 can be deflated, therein holding at least a partial vacuum so as to removal fluid from balloon 143, to facilitate fluid flow in a particular direction)
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the balloon emptying order methodology taught by Kapur to the modified apparatus and method of using disclosed by Teeslink in view of Don, Sterman, and Salerno, such that the Teeslink’s volumetric balloons may be deflated to elicit lymphatic outflow from the lymphatic duct isolated by Sterman’s method, therein improving the manner by which flow may be selectively driven to/from the lymphatic duct, see paragraph 178-179 of Kapur.
However the modified system and method of Teeslink in view of Don, Sterman, and Salerno remains silent regarding:
collapsing the first, second and third occlusion balloons while maintaining the position of the first and second catheters; and allowing a second period to elapse with the first, second and third occlusion balloons collapsed
However, Kapur further teaches a method of using a multi-balloon catheter comprising:
collapsing the occlusion balloons while maintaining the position of the catheter; and allowing a second period to elapse with the occlusion balloons collapsed,
(paragraph 104-105+120+138-140+179 details that its controller 33 can deflate the occluding elements, balloons 142 143, for certain periods to support circulatory requirements of the surrounding tissues, and repeating inflation/duration a multitude of times)
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the balloon emptying methodology taught by Kapur to the modified apparatus and method of using disclosed by Teeslink in view of Don, Sterman, Salerno, and Kapur, such that the Teeslink’s occlusion balloons may be deflated to promote vascular circulation, therein reducing risks associated with obstructing blood flow over long periods, such as worsening condition and death.
Regarding Claim 33,
The modified device/method of Teeslink in view of Don, Sterman, Salerno, and Kapur discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However Teeslink in view of Don, Sterman, Salerno, and Kapur silent regarding:
The method of claim 32, further comprising removing the first and second catheter from the patient after the therapy duration has expired.
However, Sterman further teaches:
removing the first and second catheter from the patient after the therapy duration has expired.
(col 16 line 46-48 + col 18 line 51-52 + col 20 line 35-39; catheters may be removed after therapy is no longer required)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to apply the catheter removal teachings of Sterman to the method disclosed by Kapur in view of Sterman and Salerno, in order to advantageously arrive at a method of treating edema which does not place undue burden on patient after therapy is no longer required.
Regarding claim 34, modified device/method of Teeslink in view of Don, Sterman, Salerno, and Kapur teaches:
The method of claim 32, further comprising repeating the steps for the duration of therapy.
Examiner notes in light of the modification made in claim 32 above, Kapur’s teachings of intermittently deflating the balloons to support circulatory requirements as needed are implemented in the modified method such that after the intermittent deflation is completed, the device would return to normal operation such that the steps enumerated in claim 32 are necessarily repeated.
Regarding claim 36, modified device/method of Teeslink in view of Don, Sterman, Salerno, and Kapur teaches:
The method of claim 32, wherein the step of volumetrically displacing blood between the occlusion balloons comprises inflating at least one volumetric balloon before the occlusion balloons.
Examiner notes in light of the modification made in claim 32 above, implementing Salerno’s teaching result in the volumetric balloons of the modified invention being inflated prior to the occlusion balloons.
Regarding claim 37, modified device/method of Teeslink in view of Don, Sterman, Salerno, and Kapur teaches:
The method of claim 32, further comprising allowing normal flow to be restored to the region of the venous angle.
Examiner notes in light of the modification made in claim 32 above, Kapur’s teachings of intermittently deflating the balloons to support circulatory requirements as needed are implemented in the modified method such that upon the intermittent deflation occurring, normal flow is restored to the venous angle.
Conclusion
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/FORREST B DIPERT/ Examiner, Art Unit 3783
/MICHAEL J TSAI/ Supervisory Patent Examiner, Art Unit 3783