DETAILED ACTION
Note: The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
1. Claims 1-23 are pending and currently under consideration for patentability.
Priority
2. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Information Disclosure Statement
3. The information disclosure statements (IDS) submitted on April 25, 2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claim Objections
4. Claim 5 is objected to because of the following informalities:
Lines 1-2 of claim 5 recites “…comprises a second a second sensor-retention structure…” which unnecessarily repeats the phrase “a second”, creating a minor informality.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
5. Claim(s) 1, 9 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al. (CN 111317516 A).
6. With regard to claim 1, Wang discloses a sensor implant device (sealing device, 10a; Fig. 5; abstract; [0005-0008]; [0055]) comprising: a shunt body (waist part, 130) that forms a fluid conduit (130 having hollow cylindrical structure; [0079]; [0062]); a first anchor structure (second blocking plate, 120) associated with a first axial end of the shunt body (130; Fig. 5; [0062-0064]); and a first sensor-retention structure (connector, 207) associated with a second axial end of the shunt body (130; Fig. 5; [0065]), the first sensor-retention structure (207) being configured to hold a first sensor device (pressure monitoring element, 200) in a sensing position (Fig. 5) in which a sensor transducer (pressure sensor, 201; [0060]; it is examiner’s position that all pressure sensors inherently include a transducer to convert physical pressure to a measurable signal) of the first sensor device is disposed at least partially radially outside of a channel area (hollow channel of 130) of the fluid conduit (Fig. 5; [0070]; [0079]).
7. With regard to claim 9, Wang discloses that the sensor implant device (10a; Fig. 5) is configured to be compressed into a compressed state in which the first sensor-retention structure (207) is disposed within the channel area of the fluid conduit (of 130; [0056]; [0092]; [0107-0108]; [0128]).
8. With regard to claim 10, Wang discloses that the first anchor structure (120) has a diameter that is greater than a diameter of the shunt body (130; Fig. 5; [0062]; [0070].
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
9. Claim(s) 2, 5 and 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Rowe et al. (WO 2020/123338 A1).
10. With regard to claim 2, While the sensor device (200) of Wang is shown having an axis aligned in parallel with an axis of the fluid conduit (130) in the sensing position (Figs. 5, 6), and Wang’s sensor device (200) is fully capable of being aligned with an axis of the fluid conduit (130) in the sensing position, by virtue of the tether-like first sensor-retention structure (207; Figs. 5, 6; [0070]), Wang fails to explicitly disclose that, when in the sensing position, the first sensor device is aligned with an axis of the fluid conduit.
However, within the same field of endeavor, Rowe discloses cardiac implant devices with integrated pressure sensing (abstract; Figs. 14A, 16A-C), wherein a sensor implant device (1400, 1600) is provided, comprising: a shunt body (shunt structure, 1620; best seen in Figs. 16A-C) forming a fluid conduit (barrel/conduit, 1622; best seen in Figs. 16A-C); a first anchor structure (arm members, 1321, 1621; best seen in Figs. 13, 16A-C) associated with the shunt body (1620; [0115]; [0117]); and a sensor-retention structure (conductor, 1427 or projections, 1627) configured to hold a first sensor device (sensor element, 1412, 1610) in a sensing position, in which the first sensor device (1412, 1610) is aligned with an axis of the fluid conduit (1622; [0115]; [0118-0123]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the positioning of the first sensor device disclosed by Wang to be aligned with an axis of the fluid conduit when in a sensing position, similar to that disclosed by Rowe, in order to provide sensor readings that can be used to indirectly measure flow across or throughout the shunt structure based at least in part on fluid momentum associated with fluid contacting the sensor elements, while also generating readings related to velocity of flow through the shunt to determine or indicate undesirable occlusion or closing-off of the shunt flow path, as suggested by Rowe in paragraph [0120].
11. With regard to claim 5, Wang is silent in regard to the first anchor structure comprising a second sensor-retention structure configured to hold a second sensor device such that a sensor transducer of the second sensor device is disposed at least partially radially outside of the channel area of the fluid conduit.
However, Rowe discloses an alternate embodiment in Figure 20 where the sensor implant device (299) includes two sensors with transducers (291, 292) attached via a sensor-retention structure (attachment member, 297), which are disposed at least partially radially outside of the channel area of the fluid conduit ([0128]). Additionally, the embodiment of Figure 16A includes the sensor implant device (1600) which includes two sensors (1612, 1613) attached via a sensor-retention structure (securement projections, 1627), which are disposed at least partially radially outside of the channel area of the fluid conduit (1620; [0119-0121]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the first anchor structure disclosed by Wang to include a second sensor-retention structure for holding a second sensor device, similar to that disclosed by Rowe, in order to utilize sensors positioned on opposite sides of the wall separating the heart chambers for measuring a desired physiological parameter, such as fluid pressure, or any other parameter, in its respective chamber or area of implant, as suggested by Rowe in paragraph [0128].
12. With regard to claim 6, Wang, as modified by the teachings of Rowe, teaches the device of claim 5; however, while the sensor device (200) of Wang is shown having an axis aligned in parallel with an axis of the fluid conduit (130) in the sensing position (Figs. 5, 6), and Wang’s sensor device (200) is fully capable of being aligned with an axis of the fluid conduit (130) in the sensing position, by virtue of the tether-like first sensor-retention structure (207; Figs. 5, 6; [0070]), Wang is silent in regard to the first sensor device and the second sensor device being axially aligned with the shunt body.
Rowe discloses an embodiment (Fig. 16A) wherein the first sensor device (first sensor element, 1612) and the second sensor device (second sensor element, 1613) being axially aligned with the shunt body (1620; aligned at least in parallel; [0119]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the positioning of the first and second sensor devices disclosed by Wang in view of Rowe to be axially aligned with the shunt body when in a sensing position, similar to that disclosed by Rowe, in order to provide sensor readings that can be used to indirectly measure flow across or throughout the shunt structure based at least in part on fluid momentum associated with fluid contacting the sensor elements, while also generating readings related to velocity of flow through the shunt to determine or indicate undesirable occlusion or closing-off of the shunt flow path, as suggested by Rowe in paragraph [0120].
13. With regard to claims 7 and 8, Wang, as modified by the teachings of Rowe, teaches the device of claim 5; however, while Wang discloses that the shunt body (130) has a first portion of a circumference of the shunt body (at 110) and a second portion of the circumference of the shunt body (at 120) that is diametrically opposite the first portion (Fig. 5); wherein the first sensor-retention structure (207) is associated with the first portion of a circumference of the shunt body (at 110; [0065]; [0070]), Wang is silent in regard to the second sensor-retention structure is associated with a second portion of the circumference of the shunt body that is diametrically opposite the first portion; and that the sensor transducer of the first sensor device and the sensor transducer of the second sensor device face in opposite directions.
Rowe discloses within an embodiment (Fig. 16A) that the first sensor-retention structure (1627 retaining 1612) is associated with a first portion of a circumference of the shunt body (1620), and the second sensor-retention structure (1627 retaining 1613) is associated with a second portion of the circumference of the shunt body that is diametrically opposite the first portion (Fig. 16A; [0119-0120]); and that the sensor transducer of the first sensor device (1612) and the sensor transducer of the second sensor device (1613) face in opposite directions (Fig. 16A; [0119-0123]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the sensor implant device disclosed by Wang to include a second sensor-retention structure for holding a second sensor device facing in diametrically opposed position to the first sensor, similar to that disclosed by Rowe, in order to utilize sensors positioned on opposite sides of the wall separating the heart chambers for measuring a desired physiological parameter, such as fluid pressure, or any other parameter, in its respective chamber or area of implant, as suggested by Rowe in paragraph [0128].
14. Claim(s) 3-4 and 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Bak-Boychuk et al. (WO 2020/163112 A1; hereafter referred to as Bak).
15. With regard to claims 3-4 and 11-13, While Wang discloses that sensor implant device as being formed by woven metal wire or metal net ([0092]), Wang is silent in regard to the shunt body being formed of a first plurality of winds of coil, and the first sensor-retention structure is formed of a second plurality of winds of coil wrapped around the first sensor device; wherein the coil form is coaxial with the shunt body; wherein the first plurality of winds of coil and the second plurality of winds of coil are part of a common wireform; and wherein the first anchor structure comprises a spiraled arm that is an integrated form with first plurality of winds of coil of the shunt body.
However, Bak discloses direct cardiac pressure monitoring (abstract; Figs. 14-16) comprising a shunt body (220) being formed of a first plurality of winds of coil (distal and proximal large-diameter portions, 222, 224); the shunt body (220) including a first sensor-retention structure (intermediate smaller-diameter helical portion, 223) comprising a second plurality of winds of coil configured to wrap around a first sensor device (210; Figs. 14-16; [0111]); wherein the coil form is coaxial with the shunt body (220; Figs. 14-16); wherein the first plurality of winds of coil (222, 224) and the second plurality of winds of coil (223) are part of a common wireform ([0111]); and wherein the first anchor structure (223) comprises a spiraled arm that is an integrated form with first plurality of winds of coil (222, 224) of the shunt body (220; [0111-0115]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the first sensor-retention structure disclosed by Wang to comprise a coil form configured to wrap around the first sensor device, similar to that disclosed by Bak, in order to utilize alternative known means of holding, securing and maintaining the sensor device in a relative position through interreference fit, where the shunt body and sensor-retention structure can be advantageously formed as a single unitary wire formed into a complex helical coil stack, as suggested by Bak in paragraphs [0111-0114].
16. With regard to claim 14, while Wang is silent in regard to the shunt body further comprising a cover disposed outside at least a portion of the first plurality of winds of coil, Bak discloses the use of a cover (one or more sleeves/cuffs, 2039) disposed outside at least a portion of the shunt body (2012; Fig. 20; [0134]; [0127]), while also noting the use of first plurality of winds of coil (222, 224) from the embodiment of Figures 14-16 can be applicable to other embodiments ([0111]; [0115]; [0135]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the first plurality of winds of coil disclosed by Wang in view of Bak to include a cover, similar to that disclosed by Bak, in order to utilize a bio-resorbable bio-spun polymer cloth serving to hold the sensor while also acting to encourage tissue ingrowth and can degrade over time, leaving just regrown tissue within the central frame portion, as suggested by Bak in paragraphs [0127] and [0134].
17. Claim(s) 15 is rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Bak, as applied to claim 11 above, and further in view of McNamara et al. (US PGPUB 2015/0148731).
18. With regard to claim 15, while Bak discloses the use of a cover (one or more sleeves/cuffs, 2039) disposed outside at least a portion of the shunt body (2012; Fig. 20; [0134]; [0127]), while also noting the use of first plurality of winds of coil (222, 224) from the embodiment of Figures 14-16 can be applicable to other embodiments ([0111]; [0115]), Wang and Bak are silent in regard to a cover disposed within at least a portion of the first plurality of winds of coil.
However, McNamara discloses methods and device for intra-arterial shunts having adjustable sizes (abstract; Figs. 36, 40A-D) wherein the intra-atrial shunt (3201) includes a plurality of winds of coil (tightly wound coil, 3601; [0311]) and a cover (internal sheath, 4005) disposed within at least a portion of the plurality of winds of coil (3601; [0325-0326]; [0216]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the first plurality of winds of coil disclosed by Wang in view of Bak to include an internal cover, similar to that disclosed by McNamara, in order to assist in directing fluid flow through the shunt device, as suggested by McNamara in paragraph [0216].
19. Claim(s) 16, 22 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of McNamara.
20. With regard to claim 16, Wang discloses a sensor implant device (sealing device, 10a; Fig. 5; abstract; [0005-0008]; [0055]) comprising: a wireform (100) comprising, in a deployed configuration: a barrel portion (130) formed of a plurality of winds of wire of the wireform (Fig. 5; [0092]); and a first sensor-support structure (110) emanating from a first axial end of the barrel portion (130; [0060]; [0065]), the first sensor-support structure (110) including a sensor-retention means (207) holding a first sensor device (200) outside of a channel area of the barrel portion (within 130; Fig. 5; [0070]; [0079]).
However, While Wang discloses that sensor implant device as being formed by woven metal wire or metal net ([0092]), Wang is silent in regard to a coil wireform comprising a barrel portion formed of a first plurality of winds of coil of the coil wireform.
McNamara, within the same field of endeavor, discloses methods and device for intra-arterial shunts having adjustable sizes (abstract; Fig. 36) wherein the intra-atrial shunt (3201) includes a coil wireform comprising a barrel portion formed of a plurality of winds of coil (tightly wound coil, 3601; [0311-0314]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the wireform barrel portion disclosed by Wang to be formed as a coil wireform made up of a plurality of winds of coil, similar to that disclosed by McNamara, in order to allow the practitioner to adjust the internal diameter of the shunt by winding or unwinding of the coil, as suggested by McNamara in paragraph [0313], while also serving the well-known function of allowing collapse of the shunt for transport within a delivery catheter and expansion upon deployment, as suggested by McNamara in paragraph [0314].
21. With regard to claims 22 and 23, Wang, as modified by McNamara above, discloses the coil wireform of claim 16. Further, McNamara discloses that the coil wireform (3601; Fig. 36) comprises shape memory material (nitinol) configured to assume the deployed configuration when deployed from a delivery catheter ([0083]; [0105-0106]; [0220]; [0312]; [0314]); and that the coil wireform (3601) is configured to be compressed into a delivery configuration in which the first plurality of winds of coil (3601) have a diameter that is smaller than a diameter of the first plurality of winds of coil in the deployed configuration ([0312]; [0314]).
Accordingly, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the coil wireform barrel portion disclosed by Wang in view of McNamara to be formed of shape memory material, similar to that disclosed by McNamara, in order to utilize the super-elastic properties of shape memory materials, allowing the practitioner to advance the coil wireform through a delivery catheter, then recover its initial coiled configuration upon exiting the catheter tip, as suggested by McNamara in paragraph [0314].
22. Claim(s) 17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of McNamara, as applied to claim 16 above, and further in view of Rowe.
23. With regard to claim 17, Wang and McNamara are silent in regard to a second sensor-support structure emanating from a second axial end of the barrel portion, the second sensor-support structure holding a second sensor device outside of the channel area of the barrel portion.
However, Rowe discloses an embodiment in Figure 20 where the sensor implant device (299) includes two sensors with transducers (291, 292) attached via a sensor-retention structure (attachment member, 297), which are disposed at least partially radially outside of the channel area of the fluid conduit ([0128]). Additionally, the embodiment of Figure 16A includes the sensor implant device (1600) which includes two sensors (1612, 1613) attached via a sensor-retention structure (securement projections, 1627), which are disposed at least partially radially outside of the channel area of the fluid conduit (1620; [0119-0121]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the barrel portion disclosed by Wang in view of McNamara to include a second sensor-retention structure for holding a second sensor device, similar to that disclosed by Rowe, in order to utilize sensors positioned on opposite sides of the wall separating the heart chambers for measuring a desired physiological parameter, such as fluid pressure, or any other parameter, in its respective chamber or area of implant, as suggested by Rowe in paragraph [0128].
24. With regard to claim 19, Wang and McNamara are silent in regard to the sensor-retention means comprises a mechanical clip.
However, Rowe suggests multiple options for sensor-retention means (one or more retention features, 629; Fig. 6), and specifically discloses a mechanical clip ([0082]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the sensor-retention means disclosed by Wang in view of McNamara to comprise a mechanical clip, similar to that disclosed by Rowe, in order to attach the sensor to the implant device through suitable or desireable means to circumferentially encase or retain the sensor through mechanical force, as suggested by Rowe in paragraph [0082], avoiding potential detachment of the sensor during use.
25. Claim(s) 18, 20 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of McNamara, as applied to claim 16 above, and further in view of Bak.
26. With regard to claim 18, Wang and McNamara are silent in regard to the sensor-retention means comprising one or more winds of coil.
However, Bak discloses direct cardiac pressure monitoring (abstract; Figs. 14-16) comprising a shunt body (220) being formed of a first plurality of winds of coil (distal and proximal large-diameter portions, 222, 224); the shunt body (220) including a sensor-retention means (intermediate smaller-diameter helical portion, 223) comprising one or more winds of coil configured to wrap around a first sensor device (210; Figs. 14-16; [0111-0115]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the sensor-retention means disclosed by Wang in view of McNamara to comprise one or more winds of coil, similar to that disclosed by Bak, in order to utilize alternative known means of holding, securing and maintaining the sensor device in a relative position through interreference fit, where the shunt body and sensor-retention structure can be advantageously formed as a single unitary wire formed into a complex helical coil stack, as suggested by Bak in paragraphs [0111-0114].
27. With regard to claims 20 and 21, Wang and McNamara are silent in regard to a sealing means associated with the barrel portion; wherein the sealing means comprises a fabric layer.
However, Bak discloses the use of a sealing means (one or more sleeves/cuffs, 2039; Fig. 20) associated with the barrel portion (frame, 2012; [0134]); wherein the sealing means comprises a fabric layer ([0135]; [0127].
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the first plurality of winds of coil disclosed by Wang in view of Bak to include a cover, similar to that disclosed by Bak, in order to utilize a bio-resorbable fiber cloth serving to hold the sensor while also acting to encourage tissue ingrowth and can degrade over time, leaving just regrown tissue within the central frame portion, as suggested by Bak in paragraphs [0127] and [0134].
Conclusion
28. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Brenner et al. (US PGPUB 2018/0035971) discloses a system for noninvasive measurement of pressure inside a body.
Zou et al. (US PGPUB 2021/0045691) discloses an implantable intracardiac apparatus.
29. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW J MENSH whose telephone number is (571)270-1594. The examiner can normally be reached M-F 9 a.m. - 6 p.m..
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/ANDREW J MENSH/Primary Examiner, Art Unit 3781