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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.
Status of Claims
The amendments and remarks filed on 11MAR2026 have been entered and considered.
Claims 1, 4-8 & 10-16 are currently pending.
Claim 1 has been amended.
Claims 2-3 have been canceled.
Claims 15-16 have been added.
No claims have been withdrawn.
No new matter has been added.
Claims 1, 4-8 & 10-16 are under examination.
Response to Arguments
Applicant's arguments filed 11MAR2026 regarding the rejections under 35 U.S.C 103 have been fully considered but are not persuasive. Parts deemed not persuasive discussed below:
Applicant argues (Page 6 of the Remarks):
Garrigue lacks: a two-part connector + insert structure, where in Garrigue, the element permanently anchored in the ventricular wall is the single tubular body + membrane + flanges + ring, and there is no distinct rigid insert introduced into a connector that itself defines a first opening and that insert defining a second opening for the pump. The pump body engages directly with tube 10; the installation/removal element 30 is only a temporary tool, not part of an implantable anchoring assembly;
However, the examiner maintains that the claimed elements are taught in Garrigue. While Garrigue discloses these functional components integrated into a singular device, it would have been obvious to one of ordinary skill in the art to split the part into two pieces for ease of manufacturing, as well as facilitating ease of replacement since the part is now modular. Because Garrigue’s device performs identical functions as the instant claims’ two piece design the modification is a standard rearrangement of parts.
Garrigue lacks: a support skirt on the connector, outside the heart, where Garrigue has flanges 18, 20 and a tubular membrane 16 that can lie along the ventricular wall, but it does not disclose a "support skirt extending from a joining flange and located outside the heart" in the claimed sense. The outer support function is provided by the retaining flange 20 contacting the outer wall, not by a separate skirt part of a connector;
However, the Examiner disagrees because the cited flanges 18, 20 show this support skirt based on its equivalent function to the claimed support skirt from the instant application. The flanges 18,20 provide the same structural support when they would rest on the wall of the heart. The reference does not need to use the same exact language as the instant application to disclose the claimed features.
Garrigue lacks: reinforcing flanges on connector and insert, pressed together, where Garrigue has flanges 18 and 20, but both are formed from the same tubular membrane 16, but there is no flange on a connector and another flange on a separate insert that are brought into mutual contact
However, the Examiner disagrees as even if the flanges 18,20 are formed of the same part as membrane 16 the flanges still form district regions on the device of Garrigue that serves a functional purpose as similarly required of the instant application, and the instant application only claims the device as a formed unit rather than distinct parts as well.
Garrigue lacks: a specific locking mechanism (lateral clamping / flange-joining element), where in Garrigue the proximal flange 20 is created by compressing membrane 16 with ring 15; the pump is secured by threaded engagement with internal surface 12, however, there is no clamping element that passes laterally through a reinforcing flange of a connector to clamp the body of an insert, nor fixing element configured to join together two distinct reinforcing flanges (one on connector, one on insert) .
However, the Examiner disagrees as the features of the instant claim are just minor predictable variations to what is shown as disclosed in Garrigue. Garrigue is shown to include the clamping flange element that serves the and identical purpose as the claimed locking mechanism which is oriented laterally without the proper orientation (lateral facing) The examiner maintains that rearranging parts of an invention involves only routine skill in the art, and the lateral orientation has not been shown to be anything more than a design choice. Someone may position the flange in a lateral orientation within the device to create a more condensed space saving design.
Jimenez fails to render these features obvious. Jimenez is used to supply mainly: A removable valved sheath (inner lumen with duckbill 3400/diaphragm 3500), and Generic material choices (including titanium). Which are not features in independent claim 1. For inventive step of claim 1, Jimenez would at best be relevant as general background on outer/inner lumens. However, structurally, Jimenez's teaching is: An outer lumen anchored in the wall, with optional ring/flange, An inner lumen/sheath (often flexible or collapsible) removable from the outer lumen, Locking via threads, pawl/ridge ratchets, bayonet-type engagements, etc., No disclosure of the above noted features of Applicant's claim 1. So, even if one skilled in the art combined/modified the anchored tube of Garrigue as the "connector" and looked to Jimenez for an "insert" concept, Jime.3333333
nez would lead to a valved inner sheath that is flexible/collapsible, not an entirely rigid insert with a proximal reinforcing flange.
The examiner maintains that the claim recites “a removable sheath having a non-return valve, or one-way valve, the sheath being configured to be mounted on at least the proximal end of the insert in order to prevent any loss of blood during the insertion or removal of a tool or of the cardiac pump”. The examiner further maintains that Jimenez teaches these claimed features in (Jimenez Delivery Techniques “With reference to FIG. 15 and FIG 16, an embodiment with an inner tube represented by a medical sheath 3100, which may be flexible, semi-flexible or rigid may be used to establish fluid communication between the tissue walls. The proximal end of the sheath may have one or multiple valves including but not limited to a duckbilled valve 3400 and/or a collapsible diaphragm valve 3500 of FIG. 15. In order to facilitate the insertion of a medical sheath 3200, it may be delivered mounted on a dilator 3210 with an axial orifice for a guidewire 3200 as shown in FIG. 16.”). It is further noted that Jimenez teaches variety of flow control mechanisms include a one-way valve such as a duckbilled valve (p27, lines 18-22). Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Applicant argues (Page 10-11 of the Remarks):
To reach claim 1 from the combination of Garrigue and Jimenez, the skilled person would have to: 1. split the single anchored tube of Garrigue into two separate components: a connector fixed in the wall and a distinct rigid insert; then 2. design a pair of reinforcing flanges, one on each, configured to be axially pressed together at the proximal side; and then 3. replace the internal thread-and-membrane compression scheme of Garrigue with a lateral clamp through the connector flange, or a fastener that directly joins the two flanges.
However, the Examiner is not persuaded. The splitting of Garrigues design to multiple components would be standard practice to achieve a design choice when the design serves an identical function split as it would have had as a unit and would only be a basic change. The choice would be predictable as it would allow for an ease of manufacturing. The use of flanges that join together is a standard practice of reinforcement and therefore the combination of references would have been obvious.
Neither Garrigue nor Jimenez suggests this architecture; both in fact rely on very different anchoring principles: Garrigue uses membrane deformation and axial compression with a ring to form a retaining flange and threaded pump attachment. Jimenez uses coils, rings, and internal ratchet/thread features for inner tube retention. There is no teaching that the problem to be solved is "improving a connector by adding an external reinforcing flange pair at the proximal side and locking them with a lateral clamp or flange-joining bolt," nor any hint that such a flange-and-clamp solution is desirable or obvious. Even allowing for a very flexible combination, Garrigue + Jimenez does not render obvious the particular two-piece connector/rigid insert with pressed reinforcing flanges and lateral clamping/fixing defined in claim 1. Under 35 U.S.C. §103 and BRI, a person of ordinary skill in the art, combining Garrigue and Jimenez, would not be led in an obvious way to the specific combination of " a connector configured to be mounted on said ventricular wall, the connector including a joining flange and a support skirt extending from the joining flange, the support skirt being configured to be placed outside the heart when the joining flange is joined to the ventricular wall, wherein the connector further includes a reinforcing flange placed at its proximal end, the insert also has a reinforcing flange, said reinforcing flanges being configured to be pressed against each other when the insert is mounted on the connector, locking/unlocking element is a clamping element passing laterally through the reinforcing flange of the connector in order to clamp the body of the insert, or a fixing element configured to join together the reinforcing flanges of the connector and of the insert" as in Applicant's claim 1. Those features define a distinct mechanical concept for apical VAD anchoring not taught or suggested by the cited art.
However, the Examiner is not persuaded. Both of the references have a shared endeavor of securement. One would understand that using a certain locking feature such as valves in Jimenez would be an obvious improvement to other devices of the same topic as it would provide a more reliable and safer device as the valves can serve as a safety feature. The combination of Jimenez and Garrigue provides a predictable mix of known engineering and design ideas directed towards the same goal and therefore would have been obvious to combine.
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 16 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.
Regarding Claim 16:
Claim 16 recites the limitation " wherein a removable sheath " in Line 1. There is insufficient antecedent basis for this limitation in the claim. Since Claim 1 recites “a removable sheath” and claim 16 depends from claim 1, it is unclear if the “a removable sheath” from claim 16 is introducing a new removable sheath, or if this is the removable sheath as recited in claim 1. For the purposes of examination, the examiner is interpreting this as the removeable sheath from claim 1. Correction is required.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 4-8, 10-12, & 15-16 are rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Garrigue et al. (FR Publication Number 3059907; Previously Cited) in view of Jimenez et al. (WO Publication Number 2012106422; Previously Cited).
Regarding claim 1, Garrigue discloses an assembly for fitting a cardiac pump in place on a heart, the assembly comprising a medical device for anchoring the cardiac pump in an opening of a ventricular wall of the heart (Garrigue Abstract “The invention relates to a fixation device without suture on an opening of a ventricular wall,”), the medical device including a connector configured to be mounted on said ventricular wall, (Garrigue Brief Description of Drawings “Figure 6 is a longitudinal sectional view of an assembly / removal of a heart pump connected to the apex of a beating heart, according to a particular embodiment of the invention, this assembly being shown in a first configuration in which it comprises a tool for perforating and ablating part of the ventricular wall to produce an opening in said wall”) the connector including a joining flange (Garrigue Abstract “defines a first flange (18) extending radially from the hollow body, the other end of this tubular membrane (16) being capable of being deformed by the displacement of said ring (15); ) so as to form a retaining flange (20) whose position may vary with respect to said first (18) flange so as to fit ventricular walls of different thicknesses”; Brief Description “the ring so as to form a retaining flange whose position can vary within a predetermined range of distances from the first flange”; Part 18 of Figure 2) and a support skirt extending from the joining flange, (Garrigue Brief Description of Invention “this large dimension of the retaining flange intended to be thus formed, reinforces the support of the device on the ventricular wall and therefore ensures better holding in position, or stabilization, of the fixing device on this ventricular wall in particular during an intervention on the propulsive heart pump intended to be received in the channel of this main body”; Retaining Flange 20 seen in Figure 2) the support skirt being configured to be placed outside the heart when the joining flange is joined to the ventricular wall, (Garrigue Description “Said retaining flange (20) being intended to come into contact with the opposite face of said ventricular wall so that said flanges”; Detailed Description Of The Embodiment Of The Invention “retaining flange 20 whose position may vary within a predetermined range of distances d from the first flange 18 defined by the distal end 17 of the tubular membrane 16 in its second stable configuration.”); an insert , (Garrigue Abstract “a distal end (17) of this tubular membrane (16), placed on the side of this second end, being self-expanding between a first configuration in which it has a tubular shape, and a second configuration in which it defines a first flange (18) extending radially from the hollow body, the other end of this tubular membrane (16)”) the connector defining a first opening for the passage of a part of the body of the insert , the insert being entirely rigid and defining a second opening for the passage of the body of the cardiac pump, (Garrigue Abstract “the tubular membrane (16) covering it, passing through said ventricular wall through said opening, block in position said fixing device in said opening.”; Detailed Description Of The Embodiment Of The Invention “The ring 15 and the tube are made of rigid and inert materials, that is to say biocompatible with the human organism.”) the insert including a distal end configured to be placed inside the heart and a proximal end configured to be placed outside the heart when the insert is mounted on the connector (Garrigue Figure 8 Part 16; Description “formed by the part of the hollow body and the portion of the tubular membrane (16) covering it , passing through said ventricular wall through said opening, lock in position said fixation device in said opening”), and at least one element for positionally locking/ unlocking the insert with respect to the connector, when the insert has been introduced into the connector (Garrigue Description “Said retaining flange (20) being intended to come into contact with the opposite face of said ventricular wall so that said flanges and the assembly formed by the part of the hollow body and the portion of the tubular membrane (16) covering it , passing through said ventricular wall through said opening, lock in position said fixation device in said opening”; Brief Description of Drawings “This system for the introduction of a medical device comprises a main body 30 defining a longitudinal inner channel 31, or lumen, for receiving this medical device 32, this medical device being movable in translation in this inner channel 31 so that a part thereof can be placed in projection of this main body for its introduction into a ventricular wall 33 or in the channel delimited by the inner wall 12 of a sleeve fixed in the opening of the ventricular wall 33, such as that of an anchoring device described above.”) wherein the connector further includes a reinforcing flange placed at its proximal end, the insert also has a reinforcing flange, said reinforcing flanges being configured to be pressed against each other when the insert is mounted on the connector (Garrigue Brief Description of Invention “Advantageously, this ring makes it possible to compress the tubular membrane placed on the external surface of said hollow body.”; Pressing Ring Part 15 as shown in Figure 2), locking/unlocking element is a clamping element to clamp the body of the insert, or a fixing element configured to join together the reinforcing flanges of the connector and of the insert. (Garrigue Figure 4 showing the side profile of the clamping elements; Detailed Description Of The Embodiment Of The Invention “The opposite end, called the proximal end 19, of this tubular membrane 16 is capable of being gradually deformed by the movement of the ring 15 along the external surface 11 of the tube so as to form a second retaining flange 20 whose position may vary within a predetermined range of distances d from the first flange 18 defined by the distal end 17 of the tubular membrane 16 in its second stable configuration. This distance d makes it possible to compress the ventricular wall in order to ensure the tightness of the device and a reliable and durable maintenance.”).
Garrigue does not disclose wherein a locking/unlocking element is a clamping element passing laterally through the reinforcing flange of the connector. Garrigue is shown to include the clamping flange element that serves the and identical purpose as the claimed locking mechanism which is oriented laterally without the proper orientation (lateral facing). It would have been obvious for someone of skill in the art to design a device with a locking/unlocking element is a clamping element passing laterally through the reinforcing flange of the connector since it has been held that rearranging parts of an invention involves only routine skill in the art, and the lateral orientation has not been shown to be anything more than a design choice. In re Japikse, 86 USPQ 70. Here, someone may position the flange in a lateral orientation within the device to create a more condensed space saving design.
Garrigue does not disclose a removable sheath having a non-return valve, or one-way valve, the sheath being configured to be mounted on at least the proximal end of the insert in order to prevent any loss of blood during the insertion or removal of a tool or of the cardiac pump. Jimenez in a similar field of endeavor of cardiac devices teaches a removable sheath having a non-return valve, or one-way valve, the sheath being configured to be mounted on at least the proximal end of the insert in order to prevent any loss of blood during the insertion or removal of a tool or of the cardiac pump (Jimenez Delivery Techniques “With reference to FIG. 15 and FIG 16, an embodiment with an inner tube represented by a medical sheath 3100, which may be flexible, semi-flexible or rigid may be used to establish fluid communication between the tissue walls. The proximal end of the sheath may have one or multiple valves including but not limited to a duckbilled valve 3400 and/or a collapsible diaphragm valve 3500 of FIG. 15. In order to facilitate the insertion of a medical sheath 3200, it may be delivered mounted on a dilator 3210 with an axial orifice for a guidewire 3200 as shown in FIG. 16.”). Jimenez further teaches variety of flow control mechanisms include a one-way valve such as a duckbilled valve (p27, lines 18-22).
Before the effective filing date, it would have been obvious to a person of skill in the art to modify Garrigue’s anchoring device with Jimenez’s removable sheath having a non-return valve, or one-way valve, the sheath being configured to be mounted on at least the proximal end of the insert in order to prevent any loss of blood during the insertion or removal of a tool or of the cardiac pump and an for the purposes of providing a fixing device to place and deposit a heart pump that is simple to use and reduces the risk of blood reflux (Garrigue Object of The Invention “).
Regarding claim 4, Claim 1 is obvious over Garrigue in view of Jimenez. Garrigue further discloses wherein the rigid insert has a tubular portion, the longitudinal dimension providing for the distal end of the insert(Garrigue Description “a distal end (17) of this tubular membrane (16), placed on the side of this second end, being self-expanding between a first configuration in which it has a tubular shape”; Detailed Description Of The Embodiment Of The Invention “The opposite end, called the proximal end 19, of this tubular membrane 16 is capable of being gradually deformed by the movement of the ring 15).
Regarding claim 5, Claim 1 is obvious over Garrigue in view of Jimenez. Garrigue further discloses wherein the connector and/or the insert include one or more grooves, each of the grooves receiving a seal, (Garrigue Brief Description of Invention “Preferably, the distal end of said guide element comprises a device for stabilizing a part of the heart, said stabilization device comprising a flared part comprising, preferably at its end of larger diameter, a groove, which has at the at least one suction port to create a vacuum in said groove when a portion of the ventricular wall is in contact with said stabilization device”) and the insert(Garrigue Detailed Description Of The Embodiment Of The Invention “In addition, the assembly of the pump body and the inner surface 12 of the tube is sealed to prevent any blood reflux through this channel.”; Detailed Description Of The Embodiment Of The Invention “This main body 30 also comprises a sealing element 34 placed inside this channel so that this sealing element 34 can be opened when the end of the medical device is pressed against it, in order to release the passage to the medical device 32 through this sealing element 34”).
Regarding claim 6, Claim 1 is obvious over Garrigue in view of Jimenez. Garrigue further discloses wherein the joining flange is made of a material configured to promote the growth or the attachment of cells, in order to reinforce the joining flange join with the ventricular wall. (Garrigue Detailed Description Of The Embodiment Of The Invention “The ring 15 and the tube are made of rigid and inert materials, that is to say biocompatible with the human organism. They are, for example, made of PEEK (polyetheretherketone), ceramic or titanium. These elements can be printed, i.e. they are then formed by a three-dimensional printing process”).
Regarding claim 7, Claim 1 is obvious over Garrigue in view of Jimenez. Garrigue further discloses wherein the distal end of the insert is chamfered in order to facilitate its insertion through an orifice formed in the ventricular wall. (Garrigue Abstract “the other end of this tubular membrane (16) being capable of being deformed by the displacement of said ring (15); ) so as to form a retaining flange (20) whose position may vary with respect to said first (18) flange so as to fit ventricular walls of different thicknesses”; Detailed Description Of The Embodiment Of The Invention “The opposite end, called the proximal end 19, of this tubular membrane 16 is capable of being gradually deformed by the movement of the ring 15 along the external surface 11 of the tube so as to form a second retaining flange 20 whose position may vary within a predetermined range of distances d from the first flange 18 defined by the distal end 17 of the tubular membrane 16 in its second stable configuration. This distance d makes it possible to compress the ventricular wall in order to ensure the tightness of the device and a reliable and durable maintenance.”).
Regarding claim 8, Claim 1 is obvious over Garrigue in view of Jimenez. Garrigue further discloses wherein the insert(Garrigue Description “formed by the part of the hollow body and the portion of the tubular membrane (16) covering it , passing through said ventricular wall through said opening, lock in position said fixation device in said opening”; Description “Said retaining flange (20) being intended to come into contact with the opposite face of said ventricular wall so that said flanges and the assembly formed by the part of the hollow body and the portion of the tubular membrane (16) covering it , passing through said ventricular wall through said opening, lock in position said fixation device in said opening”).
Regarding claim 10, Claim 1 is obvious over Garrigue in view of Jimenez. Garrigue further discloses wherein the removable sheath is made of a flexible material being configured to seal at least the proximal end of the insert. (Garrigue Brief Description of The Drawings “Between this ring 15 and the second end 14 of the tube is placed a tubular membrane 16 covering the external surface 11 of the tube.”; Description “Said retaining flange (20) being intended to come into contact with the opposite face of said ventricular wall so that said flanges and the assembly formed by the part of the hollow body and the portion of the tubular membrane (16) covering it).
Regarding claim 11, Claim 1 is obvious over Garrigue in view of Jimenez. Garrigue further discloses wherein the removable sheath has a purge chamber, the non- return valve being placed at the proximal end of the sheath. (Garrigue Detailed Description Of The Embodiment Of The Invention “The proximal end of the main body 30 comprises a grip 35 and the distal end of the main body advantageously comprises a purge valve (not shown) in order to eliminate any presence of air in the part io of the inner channel placed in downstream of the sealing element 34.”).
Regarding claim 12, Claim 1 is obvious over Garrigue in view of Jimenez. Garrigue further discloses wherein the removable sheath has a purge orifice for the evacuation of air, and a closure element configured to close the purge orifice. (Garrigue Detailed Description Of The Embodiment Of The Invention “This main body 30 also comprises a sealing element 34 placed inside this channel so that this sealing element 34 can be opened when the end of the medical device is pressed against it, in order to release the passage to the medical device 32 through this sealing element 34”; Sealing element 34 as seen in Figure 6; Garrigue Detailed Description Of The Embodiment Of The Invention “The proximal end of the main body 30 comprises a grip 35 and the distal end of the main body advantageously comprises a purge valve (not shown) in order to eliminate any presence of air in the part io of the inner channel placed in downstream of the sealing element 34.”).
Regarding claim 15, Claim 1 is obvious over Garrigue in view of Jimenez. Garrigue discloses the inner surface of the support skirt then comprising grooves , (Garrigue Brief Description of Invention “Preferably, the distal end of said guide element comprises a device for stabilizing a part of the heart, said stabilization device comprising a flared part comprising, preferably at its end of larger diameter, a groove, which has at the at least one suction port to create a vacuum in said groove when a portion of the ventricular wall is in contact with said stabilization device”). Garrigue does not further disclose wherein the clamping element is a screw. Jimenez further teaches wherein the clamping element is a screw (Jimenez Delivery Techniques “According to other embodiments, instead of threads, the distal end may include other attachment means for securing an attaching device 820 to the outer lumen 810, such as, but not limited to, mechanical means, such as tabs, pins, screws, clamps, threads, hooks, interference fit, friction fit, etc.,”), Before the effective filing date, it would have been obvious to a person of skill in the art to modify Garrigue’s anchoring device with Jimenez’s wherein the clamping element is a screw or a bayonet clamping system. Jimenez further teaches wherein the clamping element is a screw, for the purposes of providing a fixing device that is efficient and low maintenance.
Regarding claim 16, Claim 1 is obvious over Garrigue in view of Jimenez. Garrigue does not further disclose wherein a removable sheath having a non- return valve , or one-way valve, the sheath being configured to be mounted on at least the proximal end of the insert in order to prevent any loss of blood during the insertion or removal of a tool or of the cardiac pump. Jimenez further teaches wherein a removable sheath having a non- return valve , or one-way valve, the sheath being configured to be mounted on at least the proximal end of the insert in order to prevent any loss of blood during the insertion or removal of a tool or of the cardiac pump (Jimenez Delivery Techniques “With reference to FIG. 15 and FIG 16, an embodiment with an inner tube represented by a medical sheath 3100, which may be flexible, semi-flexible or rigid may be used to establish fluid communication between the tissue walls. The proximal end of the sheath may have one or multiple valves including but not limited to a duckbilled valve 3400 and/or a collapsible diaphragm valve 3500 of FIG. 15. In order to facilitate the insertion of a medical sheath 3200, it may be delivered mounted on a dilator 3210 with an axial orifice for a guidewire 3200 as shown in FIG. 16.”). Before the effective filing date, it would have been obvious to a person of skill in the art to modify Garrigue’s anchoring device with Jimenez’s in a removable sheath having a non- return valve, or one-way valve, the sheath being configured to be mounted on at least the proximal end of the insert in order to prevent any loss of blood during the insertion or removal of a tool or of the cardiac pump., for the purposes of providing a fixing device to place and deposit a heart pump that is simple to use, and reduces the risk of blood reflux (Garrigue Object of The Invention “).
Claims 13-14 are rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Garrigue et al. (FR Publication Number 3059907; Previously Cited) in view of Jimenez et al. (WO Publication Number 2012106422; Previously Cited) as applied to claims 1, 4-8, 10-12, & 15-16 above, and further in view of Schorgl et al. (US Publication No. 20030069587).
Regarding claim 13, Claim 1 is obvious over Garrigue in view of Jimenez. Garrigue further discloses a cardiac pump comprising a casing configured to be introduced through the second opening defined by the insert, while ensuring a seal with one or more sealing elements carried by the insert. (Garrigue Brief Description of Invention “Thus, and advantageously, the fixing device on an opening of a ventricular wall provides a seal after placement without carrying out any suture”; Preferably, this sealing element comprising a valve whose seat is inclined at 45 ° to facilitate the passage of the medical device, while preventing the passage of blood in the other direction when this valve valve is in its position. shutter. This check valve thus defines a non-return valve”; Sealing element 34 as seen in Figure 6). Garrigue in view of Jimenez does not further disclose a kit for the treatment of heart disease. Garrigue further discloses a kit for the treatment of heart disease. Schorgl in a similar field of endeavor of cardiac devices teaches a kit for the treatment of heart disease (Schorgl ¶0025 “Referring to FIG. 8, the implant may be provided as part of a sterile, sealed package or kit. An exemplary kit 100 may include a suitable container 102, flexible conduits of varying lengths and inner diameters 104, a housing 106, a securing material 108 such as collagen or another suitable polymer, and instructions 110”).
Before the effective filing date, one of ordinary skill in the art would be motivated to put the elements of Garrigue in view of Jimenez into a kit form as taught by Schorgl since packaging medical plants in a kit form would allow convenient mnway of providing medical implants in a sterile, sealed format for medical professionals.
Regarding claim 14, Claims 1 & 13 are obvious over Garrigue in view of Jimenez and Schorgl. Garrigue further discloses wherein the cardiac pump has a turbine, movable in rotation with respect to the casing, and an inductor (Garrigue Background “State-of-the-art implantable heart pumps are thus typically equipped with an integrated electric motor to ensure their operation, the speed of rotation of the pump providing the force necessary to circulate the blood from the weakened ventricle to the circulation”; Detailed Description of Embodiments “Once, this anchoring device 10 secured to the ventricular wall, it is possible to introduce into the channel delimited by the inner surface 12 of the tube, a propellant heart pump”; Showing the turbine and the circuitry needed to run it which includes inductors). Conclusion
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/MEGAN T FEDORKY/Examiner, Art Unit 3796
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792
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