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 .
Election/Restrictions
Applicant's election with traverse of Species A (claims 1-8 and new claims 21-27) in the reply filed on 6/18/2026 is fully considered and is persuasive. The restriction requirement of Species A, B and C has been withdrawn.
Response to Amendment
In response to the amendment filed on 6/18/2026, Claims 14-20 have been cancelled, and Claims 1-13 and newly added Claims 21-27 are pending.
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.
Claims 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20220062619 Gross.
Regarding claim 1, Gross discloses a system for modulating blood flow (abstract, paragraph 9), the system comprising:
a first inflation device (94, Fig. 8-9) sized for placement at least partially within an inferior vena cava (IVC), superior vena cava (SVC) (as seen in Fig. 8-9, paragraph 233-234), or hepatic vein of a heart, the first inflation device being flexible to allow the first inflation device to expand and compress (Fig. 8-9, paragraph 224-234);
a first tube (98, Fig. 8-9) attached to the first inflation device (as seen in Fig. 8-9); and
a second inflation device (96, Fig. 8-9) connected to the first inflation device via the first tube (as seen in Fig. 8-9, paragraph 224), the second inflation device being sized for placement in a left atrium of the heart (the second inflation device 96 is seen in Fig. 8-9 as being placed in the left ventricle 50 of the heart, however the limitation of the second inflation device being sized for placement in a left atrium of the heart is an intended use and therefore the second inflation device 96 is capable of being positioned in the left atrium of the heart).
Regarding claim 2, Gross discloses the limitations of claim 1, and further discloses wherein the first inflation device (94) comprises a first balloon (paragraph 10, 13-15, 226) and the second inflation device (96) comprises a second balloon (the second inflation device 96 is an enclosed structure that is configured to hold fluid within and inflates/deflates and is therefore considered a balloon).
Regarding claim 3, Gross discloses the limitations of claim 1, and further discloses wherein the first tube comprises an inner lumen to convey a liquid or gas between the first inflation device and the second inflation device (paragraph 224).
Regarding claim 4, Gross discloses the limitations of claim 3, and further discloses wherein the second inflation device is flexible to allow the second inflation device to compress in response to increased pressure in the left atrium and wherein the first inflation device is flexible to allow the first inflation device to inflate in response to deflation of the second inflation device (paragraph 183-184, 224-234).
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.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Gross in view of US 20180228951 Schwammenthal et al. (hereinafter Schwammenthal).
Regarding claim 8, Gross discloses the limitations of claim 1, and further discloses further comprising a sensor (68, Fig. 5, paragraph 213; paragraph 214, two pressure sensors coupled to conduit 26) sized for placement within a right atrium or left atrium (the limitation of being sized for placement within a right atrium or left atrium is an intended use and the sensor of Gross is capable of being placed in a right atrium or left atrium).
Gross is silent on the sensor configured to transmit signals to the first inflation device in response to blood pressure changes.
However, Schwammenthal teaches an apparatus for controlling blood flow in a patient (abstract, paragraph 11) that comprises an inflation balloon (80, Fig. 5a) placed in a blood vessel and sensors (56/58/60) to sense blood pressure and wherein the inflation of balloon is controllable in response to blood pressure detected by sensors 56, 58, and/or 60 (paragraph 215).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gross with the teachings of Schwammenthal in order to provide automated control of the balloon inflation to modify and control its occlusive effect within the blood vessel.
Claims 9, 12-13, 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over Gross.
Regarding claim 9, Gross discloses an implant for modulating blood flow (abstract, paragraph 9), the implant comprising:
a first inflation device (94, Fig. 8-9) disposed at least partially within an IVC, SVC (as seen in Fig. 8-9, paragraph 233-234), or hepatic vein of a heart, the first inflation device being flexible to allow the first inflation device to expand and compress (Fig. 8-9, paragraph 224-234);
a first tube (98, Fig. 8-9) attached to the first inflation device (as seen in Fig. 8-9); and
a second inflation device (96, Fig. 8-9) connected to the first inflation device via the first tube (as seen in Fig. 8-9, paragraph 224), the second inflation device comprising a support device (504, Fig. 15a-b) enclosed by a membrane of the second inflation device (Fig. 15a-b, paragraph 273, an embodiment of a second inflation device 540 comprises a support device 504 that is enclosed by a membrane of the second inflation device (as seen in Fig. 15a-b, paragraph 280). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to substitute the second inflation device 96 taught by Gross with the second inflation device 540 comprising a support device 504 taught by Gross since it has been held that where the general conditions of a claim are disclosed in the prior art, the substitution of one known element for another yields predictable results to one of ordinary skill in the art; the second inflation device 540 comprising a support device 504 would be sufficient to provide support to the second inflation device).
Regarding claim 12, Gross teaches the limitations of claim 9, and further discloses wherein the support device includes joints (as seen in Fig. 15a-b, paragraph 275, support device 504 has joints in the form of bellows folds 507) to allow the support device to transition between an expanded configuration and a collapsed configuration in response to external pressure (Fig. 15a-b, paragraph 273, 279-281).
Regarding claim 13, Gross teaches the limitations of claim 9, and further discloses wherein the second inflation device is sized for placement within a left atrium (the second inflation device 96 is seen in Fig. 8-9 as being placed in the left ventricle 50 of the heart, however the limitation of the second inflation device being sized for placement in a left atrium of the heart is an intended use and therefore the second inflation device 96 is capable of being positioned in the left atrium of the heart).
Regarding claim 21, Gross discloses the limitations of claim 1, and further discloses wherein at least one of the first inflation device and the second inflation device comprises a support device (250a, Fig. 12a-b, paragraph 251, 253, an embodiment of a second inflation device 204 comprises a support device 250a; Fig. 15a-b, paragraph 273, an embodiment of a second inflation device 540 comprises a support device 504. Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to substitute the second inflation device 96 taught by Gross with either the second inflation device 204 that comprises a support device 250a of Fig. 12a-b or a second inflation device 540 that comprises a support device 504 of Fig. 15a-b, since it has been held that where the general conditions of a claim are disclosed in the prior art, the substitution of one known element for another yields predictable results to one of ordinary skill in the art; the second inflation device 204 or 540 comprising a support device 250a or 504 would be sufficient to provide support to the second inflation device).
Regarding claim 22, Gross teaches the limitations of claim 21, and further discloses wherein the support device is a stent disposed around the second inflation device (Fig. 12a-b, paragraph 251, 253, the embodiment of second inflation device 204 has a support device 250a which is a stent).
Regarding claim 23, Gross teaches the limitations of claim 21, and further discloses wherein the support device is disposed within the second inflation device (Fig. 15a-b, paragraph 273, the embodiment of second inflation device 540 comprises a support device 504 disposed within the second inflation device (as seen in Fig. 15a-b, paragraph 280)).
Regarding claim 24, Gross teaches the limitations of claim 23, and further discloses wherein the support device comprises a coil (250d, Fig. 15a-b, paragraph 273).
Claims 25-27 are rejected under 35 U.S.C. 103 as being unpatentable over Gross in view of US 20200246523 Ratz et al. (hereinafter Ratz).
Regarding claim 25, Gross discloses the limitations of claim 1.
Gross is silent on further comprising an anchor configured to hold the second inflation device within the left atrium.
However, Ratz teaches a system for treating atrial dysfunction (abstract, paragraph 12) comprising an inflation device (102, Fig. 2, 6, 8) within the left atrium (paragraph 41) and an anchor (800, Fig. 6, 8) configured to hold the inflation device within the left atrium (paragraph 53-55).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gross with the teachings of Ratz in order to secure the position of the inflation device within the left atrium of the heart as disclosed by Ratz (paragraph 53-55).
Regarding claim 26, the combination of Gross and Ratz teaches the limitations of claim 25, and Ratz teaches wherein the anchor is configured to be disposed within the right atrium in contact with the right atrium side of the septum (Fig. 8, paragraph 55).
Regarding claim 27, the combination of Gross and Ratz teaches the limitations of claim 25, and Ratz teaches wherein the first tube extends through the anchor to couple the second inflation device (Fig. 2, 6, 8, paragraph 42, 55, a feed line 110 extends through the anchor 800 to couple to the inflation device 102 as seen in Fig. 2, 6, 8).
Allowable Subject Matter
Claims 5-7, 10-11 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: No prior art references alone or in combination with other references teaches each and every limitation of the independent claims. The closest art of record is Gross.
Regarding claim 5, Gross discloses the limitations of claim 1, and further discloses wherein the first inflation device (94) is sized for placement at least partially within a first hepatic vein (the limitation of the first inflation device being sized for placement at least partially within a first hepatic vein is an intended use and therefore the first inflation device 94 is capable of being placed at least partially within a first hepatic vein). However, Gross does not disclose the system further comprising a third inflation device sized for placement in a second hepatic vein.
Regarding claim 6, Gross discloses the limitations of claim 1, and further discloses wherein the first inflation device (94) is sized for placement at least partially within the IVC (as seen in Fig. 9, paragraph 234) or the hepatic vein. However, Gross does not disclose further comprising: a second tube; and a third inflation device sized for placement at least partially within the SVC, and wherein the third inflation device is connected via the second tube to the second inflation device.
Regarding claim 7, Gross discloses the limitations of claim 1. However, Gross does not disclose further comprising a third inflation device sized for placement in the IVC or hepatic veins, wherein the third inflation device is connected via the first tube to the second inflation device.
Regarding claim 10, Gross teaches the limitations of claim 9, wherein the first inflation device (94) is sized for placement at least partially within a first hepatic vein (the limitation of the first inflation device being sized for placement at least partially within a first hepatic vein is an intended use and therefore the first inflation device 94 is capable of being placed at least partially within a first hepatic vein). However, Gross does not disclose the implant further comprising a third inflation device sized for placement in a second hepatic vein.
Regarding claim 11, Gross teaches the limitations of claim 9, and further discloses wherein the first inflation device (94) is sized for placement at least partially within the IVC (as seen in Fig. 9, paragraph 234) or the hepatic vein. However, Gross does not disclose further comprising: a second tube; and a third inflation device sized for placement at least partially within the SVC, and wherein the third inflation device is connected via the second tube to the second inflation device.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KHOA TAN LE whose telephone number is (703)756-1252. The examiner can normally be reached Monday - Friday 8am - 4:30pm.
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/KHOA TAN LE/Examiner, Art Unit 3771 /MOHAMED G GABR/Primary Examiner, Art Unit 3771
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