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 Arguments
Applicant’s arguments filed 4/30/2025 with respect to the rejection of Independent Claim 19 under 35 U.S.C. § 102(a)(1) as anticipated by U.S. Patent No. 5,139,517 A to Corral ("Corral") have been fully considered and are persuasive. The Examiner agrees that Corral does not disclose the amended Claim 19 limitation “wherein the catheter is configured to extend away from the dynamic volume body in the first direction.” Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of K. Chatterjee, "The Swan-Ganz Catheters: Past, Present, and Future," Circulation, Volume 119, Issue 1, 6 January 2009; Pages 147-152.
Applicant’s arguments with respect to the rejection of Independent Claim 42 under 35 U.S.C. § 103 as unpatentable over the combination of Corral and European Publication No. 3,398,626 Al to Siess ("Siess") have been fully considered and are persuasive. The Examiner agrees that the combination of Corral and Siess does not disclose the amended Claim 42 limitation “wherein the catheter is configured to extend away from the dynamic volume body in the first direction.” Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of K. Chatterjee, "The Swan-Ganz Catheters: Past, Present, and Future," Circulation, Volume 119, Issue 1, 6 January 2009; Pages 147-152.
Applicant’s arguments regarding dependent Claims 25-33, 36, 40, 48-54, 57, 59, 61, 62, 65 and 68-81 have been fully considered and are persuasive by virtue of Applicant’s persuasive arguments regarding the independent claims from which dependent Claims 25-33, 36, 40, 48-54, 57, 59, 61, 62, 65 and 68-81 respectively depend. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of K. Chatterjee, "The Swan-Ganz Catheters: Past, Present, and Future," Circulation, Volume 119, Issue 1, 6 January 2009; Pages 147-152.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 84 and 85 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding Claim 84, Claim 84 recites “wherein the one-way valve is physically uncoupled from the dynamic volume body.” The Present Specification does not provide support for this limitation.
The recited “one-way valve” is discussed at Para. [0061] of the Present Specification. The recited “dynamic volume body” is discussed at Para. [0046] of the Present Specification. The Present Specification is silent with respect to the manner in which the “one-way valve” and the “dynamic volume body” are coupled/uncoupled.
Regarding Claim 85, Claim 85 recites a similar limitation to Claim 84 and is not supported by the Present Specification for the same reasons.
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.
Claims 19, 25, 32, 61, 62, 65, 70-72, 74, 82 and 84 are rejected under 35 U.S.C. 103 as being unpatentable over previously cited US 5,139,517 A to Corral (“Corral”) in view of K. Chatterjee, "The Swan-Ganz Catheters: Past, Present, and Future," Circulation, Volume 119, Issue 1, 6 January 2009; Pages 147-152 (“Chatterjee”).
Regarding Independent Claim 19, Corral teaches:
A heart support device for circulatory assistance, the heart support device comprising: (Title, “Orthotopic intraventricular heart pump”);
a chamber body defining a chamber having an internal volume configured to be filled with blood, (Col. 5, Ln. 16-18, “The IVP's outer shell 44 is preferably semirigid and proportioned to approximate the natural shape of a normal ventricular chamber either left 30, or right 16;” Col. 5, Ln. 43-46, “The interior of the IVP is lined by a flexible, multilayered plastic sheet that is attached to the outer shell 44 at the inlet/outlet port area. The mobile lining of the inner liner 46 comes into direct contact with inflowing blood.”);
wherein the chamber body is dimensioned to be disposed within a heart chamber of the human heart, (Col. 5, Ln. 19-21, “The right (58) and left (40) IVP's outer shell will be individually shaped to conform with the natural shape of the respective ventricle 16 or 30.”);
the chamber body having a first outlet opening and an additional opening; (Col. 5, Ln. 43-45, “The interior of the IVP is lined by a flexible, multilayered plastic sheet that is attached to the outer shell 44 at the inlet/outlet port area.”);
a dynamic volume body positionable within the chamber and being expandable from an unexpanded state to an expanded state to alternately decrease or increase an available internal volume of the chamber; (Col. 6, Ln. 33-40, “The hydraulic catheters pass through the outer shell 44, and communicate with the hydraulic access chamber 52. This allows pressure to be applied to the access chamber to activate the inner liner 46 into a systolic contraction (see FIG. 3c). A second hydraulic catheter 64 may be used in conjunction with the right ventricular IVP which allows hydraulic pressure to be transmitted to the artificial balloon valve 66 for activation (discussed later).”);
Corral’s “hydraulic access chamber 52” is such a “dynamic volume body” as claimed.
a catheter coupled to the dynamic volume body; (Col. 6, Ln. 24-33, “Hydraulic fluid is transmitted to the IVP by reinforced hydraulic catheters (tubes) 50 (left IVP), 62 (right IVP) or 64 (artificial valve). … The hydraulic catheters pass through the outer shell 44, and communicate with the hydraulic access chamber 52.”);
a directional flow structure in fluid communication with the first outlet opening and configured to direct a flow of blood from the chamber in a first direction in which blood naturally exits the heart chamber, (Col. 5, Ln. 43-57, “The interior of the IVP is lined by a flexible, multilayered plastic sheet that is attached to the outer shell 44 at the inlet/outlet port area. The mobile lining of the inner liner 46 comes into direct contact with inflowing blood. The inner liner 46 forms a chamber 48 which may hold blood received from the atria, either right 12 or left 26. Pumping is effected by diaphragmatic movement of the liner by applying hydraulic pressure. Pressure is introduced between the inner liner 46 and the external shell 44 (i.e., the hydraulic access chamber), which allows a circumferential, uniform compression to occur. The ventricular contraction effected by the IVP diaphragm strongly mimics the heart's natural contraction as shown in FIGS. 3c and 4b.”);
Corral’s “inner liner 46” is such a “directional flow structure” as claimed, is in fluid communication with Corral’s “outlet” as claimed, and is configured to direct blood flow in the manner claimed.
and a one-way valve structure associated with the additional opening and configured to alternately allow blood to flow through the additional opening into the internal volume of the chamber and inhibit blood from flowing through the additional opening out of the internal volume of the chamber. (Col. 7, Ln. 16-27, “As the IVP's ventricular filling cycle progresses through diastole, the artificial valve 66 begins to activate. Activation and subsequent closure of the valve 66 occurs when increasing hydraulic pressure is applied to the hydraulic access chamber. When hydraulic fluid is forced into the valve 66, the annular-shaped diaphragm expands which closes the opening to the right atrium 12. Building hydraulic pressure forces the walls of the valve 66 toward the center of the lumen comprising the inlet area, until it ultimately seals off. Valvular closure may be timed to antedate ventricular activation to minimize regurgitation.”).
Corral’s “artificial valve 66” is such a “one-way valve structure” as claimed, is associated with Corral’s “additional opening” (i.e., Corral’s “inlet area”), and alternately allows and inhibits blood flow in the manner claimed.
Corral does not disclose:
wherein the catheter is configured to extend away from the dynamic volume body in the first direction;
Chatterjee describes “pulmonary artery catheterization” (Pg. 147, Left Column, First Paragraph). Chatterjee is reasonable pertinent to the problem faced by the inventor, and is thus analogous art.
Chatterjee teaches:
wherein the catheter is configured to extend away from the dynamic volume body in the first direction; (Pg. 149, Right Column, Second Paragraph, “Because of the ease of catheter placement at the bedside and of the potential benefits, pulmonary artery catheterization with the use of balloon flotation catheters became almost a routine monitoring technique during cardiac and noncardiac surgery…”).
In the embodiment of Corral’s Figs. 4a and 4b to which the rejection in view of Corral pertains, Corral’s intraventricular heart pump is configured for use in connection with the right ventricle. As is further shown in Corral’s Figs. 4A and 4B, a catheter which extends “away from the dynamic volume body” “in a first direction in which blood naturally exits the heart chamber” would extend through the pulmonary artery (“PA 20” of Coral’s Figs. 4A and 4B).
Chatterjee teaches that such catheter placement is “used so frequently by residents and fellows in coronary care, medical, surgical, and other critical care units and during cardiac and noncardiac surgery that [its name] soon became a verb.” (Chatterjee at Pg. 148, Left Column, Second Paragraph).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Corral with the teachings of Chatterjee (i.e., to modify the device of Corral such that its catheter extends in the direction of the pulmonary artery) because such catheter placement is fast and easy (Chatterjee at Pg. 151, Right Column, Second Paragraph).
Regarding Claim 25, the combination of Corral and Chatterjee renders obvious the entirety of Claim 19 as explained above.
Corral additionally discloses:
further comprising a support structure configured to support the chamber body in an expanded configuration (Col. 5, Ln. 60-68, “A series of tethering cords 56 disposed between the outer shell 44 and the inner liner 46 within the hydraulic access chamber link the diaphragmatic liner 46 to the external shell 44. The cords 56 function to insure a uniform, consistent systolic ventricular shape after hydraulic pressure is applied. Once hydraulic pressure is withdrawn, the cords 56 provide an additional impetus to recoil back against the external shell 44, to a fully contracted state;” Col. 7, Ln. 28-34, “Tethering cords 56 are also used in the balloon valve 66 to shape the valve during closure and to pull the valve material back into diastolic position when the hydraulic fluid is removed. This aspect is particularly important with respect to the balloon valve 66, which must be fully opened at every cycle to allow blood to flow freely from the right atrium 12.”).
Regarding Claim 32, the combination of Corral and Chatterjee renders obvious the entirety of Claim 25 as explained above.
Corral additionally discloses:
wherein the support structure is inflatable (Col. 5, Ln. 60-68, “A series of tethering cords 56 disposed between the outer shell 44 and the inner liner 46 within the hydraulic access chamber link the diaphragmatic liner 46 to the external shell 44. The cords 56 function to insure a uniform, consistent systolic ventricular shape after hydraulic pressure is applied. Once hydraulic pressure is withdrawn, the cords 56 provide an additional impetus to recoil back against the external shell 44, to a fully contracted state;” Col. 7, Ln. 28-34, “Tethering cords 56 are also used in the balloon valve 66 to shape the valve during closure and to pull the valve material back into diastolic position when the hydraulic fluid is removed. This aspect is particularly important with respect to the balloon valve 66, which must be fully opened at every cycle to allow blood to flow freely from the right atrium 12.”).
The limitation “wherein the support structure is inflatable” is being interpreted to mean that the support structure contracts and expands in conjunction with fluid flow through the chamber body. This interpretation is made in light of the distinction between the “support structure” being inflatable as recited by Claim 32, and the “dynamic volume body compris[ing] an inflatable balloon” as recited by Claim 33, which appears to recite two distinct embodiments.
The embodiment of Claim 32 is believed to be reflected by Para. [0053] of the Present Specification, which states that “…the support structure 24 can be provided in fluid communication with at least one lumen of the catheter 16 to allow the support structure 24 to be inflated after it has been advanced into the heart lumen.” In the embodiment of Claim 32 and Para. [0053], the “support structure” is separate from the “dynamic volume body” (which dynamic volume body may be an inflatable balloon), and appears to be “inflatable” in the sense that it expands and contracts in conjunction with the fluid flow (Present Specification at Para. [0053], “…the support structure 24 can comprise an expandable scaffold that can be expanded with a supply of fluid or gas to the scaffold.”).
In the embodiment of Claim 33, the dynamic volume body (i.e., rather than the support structure) “comprises” an inflatable balloon. This embodiment appears to correspond to Para. [0056] of the Present Specification.
Regarding Claim 61, the combination of Corral and Chatterjee renders obvious the entirety of Claim 19 as explained above.
Corral additionally discloses:
wherein the catheter is coupled to the chamber body. (Col. 6, Ln. 24-33, “Hydraulic fluid is transmitted to the IVP by reinforced hydraulic catheters (tubes) 50 (left IVP), 62 (right IVP) or 64 (artificial valve). … The hydraulic catheters pass through the outer shell 44, and communicate with the hydraulic access chamber 52.”).
Regarding Claim 62, the combination of Corral and Chatterjee renders obvious the entirety of Claim 19 as explained above.
Corral additionally discloses:
wherein the catheter is configured to extend along a sidewall of the chamber (Col. 6, Ln. 26-40, “Hydraulic fluid is transmitted to the IVP by reinforced hydraulic catheters (tubes) 50 (left IVP), 62 (right IVP) or 64 (artificial valve). The catheters travel from the hydraulic motor located in the peritoneal cavity, through the diaphragm, to the apex of the heart. At the point of entry through the apex of the heart, the catheters are covered by DACRON sheathing 54. This allows for firm surgical attachment which ultimately leads to physical incorporation. The hydraulic catheters pass through the outer shell 44, and communicate with the hydraulic access chamber 52. This allows pressure to be applied to the access chamber to activate the inner liner 46 into a systolic contraction (see FIG. 3c).”)
The limitation “the catheter is configured to extend along a sidewall of the chamber” requires only that the recited catheter be structurally capable of so extending. The claim does not affirmatively require the catheter to extend along a sidewall. Corral’s catheter is structurally capable of so-extending, per Col. 6, Ln. 26-40.
Regarding Claim 65, the combination of Corral and Chatterjee renders obvious the entirety of Claim 19 as explained above.
Corral additionally discloses:
wherein the dynamic volume body is secured to the chamber body (Col. 5, Ln. 50-53, “Pressure is introduced between the inner liner 46 and the external shell 44 (i.e., the hydraulic access chamber), which allows a circumferential, uniform compression to occur.”).
Corral’s “dynamic body volume” (i.e., Corral’s “hydraulic access chamber”) is formed as the space between Corral’s “chamber body” (i.e., Corral’s “external shell 44”) and another component, and is thus “secured to” Corral’s chamber body as claimed.
Regarding Claim 70, the combination of Corral and Chatterjee renders obvious the entirety of Claim 19 as explained above.
Corral additionally discloses:
wherein the directional flow structure is configured to direct the flow of blood from the chamber into the aorta (Col. 6, Ln. 32-36, “The hydraulic catheters pass through the outer shell 44, and communicate with the hydraulic access chamber 52. This allows pressure to be applied to the access chamber to activate the inner liner 46 into a systolic contraction (see FIG. 3c);” Col. 4, Ln. 32-34, “Blood is then ejected from the ventricular cavity into the aorta 34. This phase is called systole.”).
Corral’s “directional flow structure” (i.e., Corral’s “hydraulic access chamber 52”) mimics systole, which corral explains to be the ejection of blood from the ventricular cavity into the aorta. Corral’s “directional flow structure” is thus configured to direct the flow of blood from the chamber into the aorta in the manner claimed.
Regarding Claim 71, the combination of Corral and Chatterjee renders obvious the entirety of Claim 19 as explained above.
Corral additionally discloses:
wherein the directional flow structure is configured to provide a steady directional flow of blood toward the aorta when the device is in use (Col. 6, Ln. 32-36, “The hydraulic catheters pass through the outer shell 44, and communicate with the hydraulic access chamber 52. This allows pressure to be applied to the access chamber to activate the inner liner 46 into a systolic contraction (see FIG. 3c);” Col. 4, Ln. 32-34, “Blood is then ejected from the ventricular cavity into the aorta 34. This phase is called systole;” Col. 7, Ln. 12-15, “This extremely low-profile means that blood flow from the atria into the ventricle is virtually unobstructed, laminar, with minimal turbulence, and therefore less prone to develop clots.”).
Corral’s “directional flow structure” (i.e., Corral’s “hydraulic access chamber 52”) mimics systole, which corral explains to be the ejection of blood from the ventricular cavity into the aorta. Corral’s “directional flow structure” is thus configured to direct the flow of blood from the chamber into the aorta in the manner claimed. Corral’s description of the induced flow at Col. 7, Ln. 12-15 is such “steady directional flow” as claimed.
Regarding Claim 72, the combination of Corral and Chatterjee renders obvious the entirety of Claim 19 as explained above.
Corral as modified by Chatterjee is silent regarding the size of Corral’s directional flow structure.
Accordingly, the combination of Corral and Chatterjee does not disclose:
wherein the directional flow structure has a diameter that is less than or equal to the diameter of the aorta
However, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Corral as modified by Chatterjee such that its directional flow structure has a diameter that is less than or equal to the diameter of the aorta because such a modification entails a mere change in size/proportion, and such a change in size/proportion is a common practice which the court has held normally requires only ordinary skill in the art and hence is considered routine expedients. MPEP 2144.04(IV)(A); In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955) (Claims directed to a lumber package “of appreciable size and weight requiring handling by a lift truck” were held unpatentable over prior art lumber packages which could be lifted by hand because limitations relating to the size of the package were not sufficient to patentably distinguish over the prior art.); In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976) (“mere scaling up of a prior art process capable of being scaled up, if such were the case, would not establish patentability in a claim to an old process so scaled.” 531 F.2d at 1053, 189 USPQ at 148.).
Regarding Claim 74, the combination of Corral and Chatterjee renders obvious the entirety of Claim 19 as explained above.
Corral additionally discloses:
wherein the directional flow structure has a diameter smaller than the diameter of the chamber body (Col. 5, Ln. 43-57, “The interior of the IVP is lined by a flexible, multilayered plastic sheet that is attached to the outer shell 44 at the inlet/outlet port area. The mobile lining of the inner liner 46 comes into direct contact with inflowing blood. The inner liner 46 forms a chamber 48 which may hold blood received from the atria, either right 12 or left 26. Pumping is effected by diaphragmatic movement of the liner by applying hydraulic pressure. Pressure is introduced between the inner liner 46 and the external shell 44 (i.e., the hydraulic access chamber), which allows a circumferential, uniform compression to occur. The ventricular contraction effected by the IVP diaphragm strongly mimics the heart's natural contraction as shown in FIGS. 3c and 4b.”);
Corral’s “inner liner 46” is such a “directional flow structure” as claimed, and is contained within Corral’s chamber body (i.e., Corral’s “shell 44”). Accordingly, Corral’s “directional flow structure” (i.e., “inner liner 46”) has a diameter smaller than the diameter of the chamber body as claimed.
Regarding Claim 82, the combination of Corral and Chatterjee renders obvious the entirety of Claim 19 as explained above.
Corral additionally discloses:
wherein the one-way valve structure is configured to inhibit blood from flowing through the additional opening out of the chamber for at least a portion of the time when the dynamic volume body is expanded, and allow blood to flow through the additional opening into the chamber when the dynamic volume body returns to the unexpanded state. (Col. 7, Ln. 16-27, “As the IVP's ventricular filling cycle progresses through diastole, the artificial valve 66 begins to activate. Activation and subsequent closure of the valve 66 occurs when increasing hydraulic pressure is applied to the hydraulic access chamber. When hydraulic fluid is forced into the valve 66, the annular-shaped diaphragm expands which closes the opening to the right atrium 12. Building hydraulic pressure forces the walls of the valve 66 toward the center of the lumen comprising the inlet area, until it ultimately seals off. Valvular closure may be timed to antedate ventricular activation to minimize regurgitation.”).
Regarding Claim 84, the combination of Corral and Chatterjee renders obvious the entirety of Claim 19 as explained above.
The combination of Corral and Chatterjee is silent with regard to the manner by which the one-way valve attaches to the dynamic body volume.
The combination of Corral and Chatterjee thus does not disclose:
wherein the one-way valve is physically uncoupled from the dynamic volume body
However, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Corral and Chatterjee such that Corral’s one-way valve is physical uncoupled from the dynamic volume body because such a modification is merely “making separable.” See MPEP 2144.04(V)(C). Such making separable is a common practice which the court has held normally requires only ordinary skill in the art and is hence considered a routine expedient. MPEP 2144.04.
Independent Claim 42 and dependent Claims 26-31, 33, 48-54, 61, 62, 65, 68, 69, 75-79, 81, 83 and 85 are rejected under 35 U.S.C. 103 as being unpatentable over previously cited US 5,139,517 A to Corral (“Corral”) in view of previously cited EP 3,398,626 A1 to Siess et al. (“Siess”) and K. Chatterjee, "The Swan-Ganz Catheters: Past, Present, and Future," Circulation, Volume 119, Issue 1, 6 January 2009; Pages 147-152 (“Chatterjee”).
Regarding Independent Claim 42, Corral discloses:
A heart support device for circulatory assistance, the heart support device comprising: (Title, “Orthotopic intraventricular heart pump”);
a chamber body defining a chamber having an internal volume configured to be filled with blood, (Col. 5, Ln. 16-18, “The IVP's outer shell 44 is preferably semirigid and proportioned to approximate the natural shape of a normal ventricular chamber either left 30, or right 16;” Col. 5, Ln. 43-46, “The interior of the IVP is lined by a flexible, multilayered plastic sheet that is attached to the outer shell 44 at the inlet/outlet port area. The mobile lining of the inner liner 46 comes into direct contact with inflowing blood.”);
wherein the chamber body is configured to be disposed within a heart chamber of the human heart, (Col. 5, Ln. 19-21, “The right (58) and left (40) IVP's outer shell will be individually shaped to conform with the natural shape of the respective ventricle 16 or 30.”);
the chamber body having a first outlet opening and an additional opening; (Col. 5, Ln. 43-45, “The interior of the IVP is lined by a flexible, multilayered plastic sheet that is attached to the outer shell 44 at the inlet/outlet port area.”);
a dynamic volume body positionable within the chamber and being expandable from an unexpanded state to an expanded state to alternately decrease or increase an available internal volume of the chamber; (Col. 6, Ln. 33-40, “The hydraulic catheters pass through the outer shell 44, and communicate with the hydraulic access chamber 52. This allows pressure to be applied to the access chamber to activate the inner liner 46 into a systolic contraction (see FIG. 3c). A second hydraulic catheter 64 may be used in conjunction with the right ventricular IVP which allows hydraulic pressure to be transmitted to the artificial balloon valve 66 for activation (discussed later).”);
Corral’s “hydraulic access chamber 52” is such a “dynamic volume body” as claimed.
a catheter coupled to the dynamic volume body; (Col. 6, Ln. 24-33, “Hydraulic fluid is transmitted to the IVP by reinforced hydraulic catheters (tubes) 50 (left IVP), 62 (right IVP) or 64 (artificial valve). … The hydraulic catheters pass through the outer shell 44, and communicate with the hydraulic access chamber 52.”);
a directional flow structure in fluid communication with the first outlet opening and configured to direct a flow of blood out of the chamber in a first direction in which blood naturally exits the heart chamber, (Col. 5, Ln. 43-57, “The interior of the IVP is lined by a flexible, multilayered plastic sheet that is attached to the outer shell 44 at the inlet/outlet port area. The mobile lining of the inner liner 46 comes into direct contact with inflowing blood. The inner liner 46 forms a chamber 48 which may hold blood received from the atria, either right 12 or left 26. Pumping is effected by diaphragmatic movement of the liner by applying hydraulic pressure. Pressure is introduced between the inner liner 46 and the external shell 44 (i.e., the hydraulic access chamber), which allows a circumferential, uniform compression to occur. The ventricular contraction effected by the IVP diaphragm strongly mimics the heart's natural contraction as shown in FIGS. 3c and 4b.”);
Corral’s “inner liner 46” is such a “directional flow structure” as claimed, is in fluid communication with Corral’s “outlet” as claimed, and is configured to direct blood flow in the manner claimed.
and a one-way valve structure associated with the additional opening and configured to alternately allow blood to flow through the additional opening into the internal volume of the chamber and inhibit blood from flowing through the additional opening out of the internal volume of the chamber,
wherein the chamber body includes a support structure comprising a scaffold formed of a resilient material expandable from a first configuration in which the chamber body has a first internal volume to a second configuration in which the chamber body comprises a second internal volume, the second internal volume being larger than the first internal volume.
Corral does not disclose:
wherein the catheter is configured to extend away from the dynamic volume body in the first direction;
formed of a resilient material
That is, Corral is silent regarding what material Corral’s “support structure comprising a scaffold” (i.e., Corral’s “tethering cords 56”) are formed from.
Chatterjee describes “pulmonary artery catheterization” (Pg. 147, Left Column, First Paragraph). Chatterjee is reasonable pertinent to the problem faced by the inventor, and is thus analogous art.
Chatterjee teaches:
wherein the catheter is configured to extend away from the dynamic volume body in the first direction; (Pg. 149, Right Column, Second Paragraph, “Because of the ease of catheter placement at the bedside and of the potential benefits, pulmonary artery catheterization with the use of balloon flotation catheters became almost a routine monitoring technique during cardiac and noncardiac surgery…”).
In the embodiment of Corral’s Figs. 4a and 4b to which the rejection in view of Corral pertains, Corral’s intraventricular heart pump is configured for use in connection with the right ventricle. As is further shown in Corral’s Figs. 4A and 4B, a catheter which extends “away from the dynamic volume body” “in a first direction in which blood naturally exits the heart chamber” would extend through the pulmonary artery (“PA 20” of Coral’s Figs. 4A and 4B).
Chatterjee teaches that such catheter placement is “used so frequently by residents and fellows in coronary care, medical, surgical, and other critical care units and during cardiac and noncardiac surgery that [its name] soon became a verb.” (Chatterjee at Pg. 148, Left Column, Second Paragraph).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Corral with the teachings of Chatterjee (i.e., to modify the device of Corral such that its catheter extends in the direction of the pulmonary artery) because such catheter placement is fast and easy (Chatterjee at Pg. 151, Right Column, Second Paragraph).
Siess describes “an intravascular blood pump for percutaneous insertion into a patient's blood vessel” (Para. [0001]). Siess is analogous art.
Siess teaches:
formed of a resilient material (Para. [0016], “…the support member may comprise at least one elastic wire, preferably made of a shape memory material, such as Nitinol.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Corral and Chatterjee with the teachings of Siess (i.e., to form Corall’s “support structure comprising a scaffold” (i.e., Corral’s “tethering cords 56”) from a shape memory material such as Nitinol as taught by Siess) in order to impart the “ability to undergo a mechanical deformation due to an external force applied to the shape memory material, and then recover its original undeformed shape upon release of the external force” (Para. [0016]).
Regarding Claim 26, the combination of Corral and Chatterjee renders obvious the entirety of Claim 25 as explained above.
The combination of Corral and Chatterjee does not disclose:
wherein the support structure is collapsible to allow insertion of the heart support device through a vascular lumen
Siess describes “an intravascular blood pump for percutaneous insertion into a patient's blood vessel” (Para. [0001]). Siess is analogous art.
Siess teaches:
wherein the support structure is collapsible to allow insertion of the heart support device through a vascular lumen (Para. [0016], “In another embodiment, the support member may comprise at least one elastic wire, preferably made of a shape memory material, such as Nitinol;” Para. [0017], “The wire, which may be made of Nitinol as mentioned above, can be retracted from the ring seal in order to be able to collapse the ring seal. Upon retraction of the wire, it can be straightened by pulling it into a lumen of the catheter.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Corral and Chatterjee with the teachings of Siess (i.e., to form Corral’s “support structure comprising a scaffold” (i.e., Corral’s “tethering cords 56”) from a shape memory material such as Nitinol as taught by Siess, thereby rendering it collapsible in the manner of Siess) in order to impart the “ability to undergo a mechanical deformation due to an external force applied to the shape memory material, and then recover its original undeformed shape upon release of the external force” (Para. [0016]).
Regarding Claim 27, the combination of Corral, Chatterjee and Siess renders obvious the entirety of Claim 26 as explained above.
Siess additionally discloses:
wherein the support structure is collapsible into a guide tube for insertion of the heart support device through the vascular lumen (Para. [0016], “In another embodiment, the support member may comprise at least one elastic wire, preferably made of a shape memory material, such as Nitinol;” Para. [0017], “The wire, which may be made of Nitinol as mentioned above, can be retracted from the ring seal in order to be able to collapse the ring seal. Upon retraction of the wire, it can be straightened by pulling it into a lumen of the catheter.”).
This limitation is being interpreted similarly to Claim 25, as explained above. That the recited support structure is “collapsible into a guide tube,” which guide tube is not affirmatively recited, narrows the claim predominately in the sense that it requires the “support structure” to be “collapsible.” It is noted that the specifics of what being “collapsible” entails are not recited, and that no special definition is set forth in the Present Specification.
Regarding Claim 28, the combination of Corral and Chatterjee renders obvious the entirety of Claim 25 as explained above.
Corral additionally discloses:
wherein the support structure comprises a scaffold … expandable from a first configuration in which the chamber body has a first internal volume to the expanded configuration in which the chamber body comprises a second internal volume, the second internal volume being larger than the first internal volume. (Col. 5, Ln. 60-68, “A series of tethering cords 56 disposed between the outer shell 44 and the inner liner 46 within the hydraulic access chamber link the diaphragmatic liner 46 to the external shell 44. The cords 56 function to insure a uniform, consistent systolic ventricular shape after hydraulic pressure is applied. Once hydraulic pressure is withdrawn, the cords 56 provide an additional impetus to recoil back against the external shell 44, to a fully contracted state;” Col. 7, Ln. 28-34, “Tethering cords 56 are also used in the balloon valve 66 to shape the valve during closure and to pull the valve material back into diastolic position when the hydraulic fluid is removed. This aspect is particularly important with respect to the balloon valve 66, which must be fully opened at every cycle to allow blood to flow freely from the right atrium 12.”).
Corral is silent regarding what Corral’s Corral is silent regarding what material Corral’s “support structure comprising a scaffold” (i.e., Corral’s “tethering cords 56”) are formed from.
Accordingly, Corral does not disclose:
formed of a resilient material
Siess describes “an intravascular blood pump for percutaneous insertion into a patient's blood vessel” (Para. [0001]). Siess is analogous art.
Siess teaches:
formed of a resilient material (Para. [0016], “…the support member may comprise at least one elastic wire, preferably made of a shape memory material, such as Nitinol.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Corral and Chatterjee with the teachings of Siess (i.e., to form Corall’s “support structure comprising a scaffold” (i.e., Corral’s “tethering cords 56”) from a shape memory material such as Nitinol as taught by Siess) in order to impart the “ability to undergo a mechanical deformation due to an external force applied to the shape memory material, and then recover its original undeformed shape upon release of the external force” (Para. [0016]).
Regarding Claim 29, the combination of Corral, Chatterjee and Siess renders obvious the entirety of Claim 28 as explained above.
Corral additionally discloses:
wherein the support structure is biased into the expanded configuration. (Col. 5, Ln. 60-68, “A series of tethering cords 56 disposed between the outer shell 44 and the inner liner 46 within the hydraulic access chamber link the diaphragmatic liner 46 to the external shell 44. The cords 56 function to insure a uniform, consistent systolic ventricular shape after hydraulic pressure is applied. Once hydraulic pressure is withdrawn, the cords 56 provide an additional impetus to recoil back against the external shell 44, to a fully contracted state;” Col. 7, Ln. 28-34, “Tethering cords 56 are also used in the balloon valve 66 to shape the valve during closure and to pull the valve material back into diastolic position when the hydraulic fluid is removed. This aspect is particularly important with respect to the balloon valve 66, which must be fully opened at every cycle to allow blood to flow freely from the right atrium 12.”).
The limitation “biased into” is quite broad. The Present Specification provides no special definition of the term, and does not provide any additional insight into what “biased into” entails. In accordance with the broadest reasonable interpretation of the phrase, the limitation “biased into the expanded configuration.” is being interpreted to mean that some force causes the support structure to be in its expanded configuration.
Regarding Claim 30, the combination of Corral, Chatterjee and Siess renders obvious the entirety of Claims 28 and 29 as explained above (Claim 30 depends on Claims 28 and 29 in the alternative).
Siess additionally discloses:
wherein the support structure comprises Nitinol (Para. [0016], “In another embodiment, the support member may comprise at least one elastic wire, preferably made of a shape memory material, such as Nitinol.”).
Regarding Claim 31, the combination of Corral, Chatterjee and Siess renders obvious the entirety of Claim 28 as explained above.
Corral additionally discloses:
wherein the dynamic volume body is configured to expand the support structure from the first configuration to the expanded configuration, thereby increasing the internal volume of the chamber (Col. 6, Ln. 33-40, “The hydraulic catheters pass through the outer shell 44, and communicate with the hydraulic access chamber 52. This allows pressure to be applied to the access chamber to activate the inner liner 46 into a systolic contraction (see FIG. 3c). A second hydraulic catheter 64 may be used in conjunction with the right ventricular IVP which allows hydraulic pressure to be transmitted to the artificial balloon valve 66 for activation (discussed later);” Col. 5, Ln. 60-68, “A series of tethering cords 56 disposed between the outer shell 44 and the inner liner 46 within the hydraulic access chamber link the diaphragmatic liner 46 to the external shell 44. The cords 56 function to insure a uniform, consistent systolic ventricular shape after hydraulic pressure is applied. Once hydraulic pressure is withdrawn, the cords 56 provide an additional impetus to recoil back against the external shell 44, to a fully contracted state;” Col. 7, Ln. 28-34, “Tethering cords 56 are also used in the balloon valve 66 to shape the valve during closure and to pull the valve material back into diastolic position when the hydraulic fluid is removed. This aspect is particularly important with respect to the balloon valve 66, which must be fully opened at every cycle to allow blood to flow freely from the right atrium 12.”).
Corral’s “dynamic volume body” (i.e., Corral’s “hydraulic access chamber 52”) moves from an expanded configuration to a contracted configuration and back again. Corral’s “support structure” (i.e., Corral’s “tethering cords 56”) move in conjunction with Corral’s “dynamic volume body.”
Regarding Claim 33, the combination of Corral and Chatterjee renders obvious the entirety of Claim 19 as explained above.
Corral does not disclose:
wherein the dynamic volume body comprises an inflatable balloon and the catheter comprises a lumen therethrough, the lumen being in fluid communication with the inflatable balloon.
Siess describes “an intravascular blood pump for percutaneous insertion into a patient's blood vessel” (Para. [0001]). Siess is analogous art.
Siess teaches:
wherein the dynamic volume body comprises an inflatable balloon and the catheter comprises a lumen therethrough, the lumen being in fluid communication with the inflatable balloon. (Para. [0023], “The ring seal 10 comprises a flexible membrane 11 that forms a balloon-like element. The flexible membrane 11 encloses a support member 12, which comprises a foam in this embodiment, in particular a polyurethane foam. The foam is biased to the expanded configuration to provide self-expanding and self-holding properties for the ring seal 10. Preferably, the interior of the ring seal 10 is under atmospheric pressure, when in the expanded configuration. A vacuum line 14 may be provided to remove fluid, such as a liquid or gas, from the ring seal 10 to bring the ring seal 10 actively into the collapsed configuration, e.g. during insertion of the pumping device 2 or for removal of the pumping device 2 from the patient's heart H.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Corral and Chatterjee with the teachings of Siess (i.e., to modify the “dynamic body volume” of Corral (i.e., Corrals’ “hydraulic access chamber 52”) such that it comprises an inflatable balloon and Corral’s catheter such that it is in fluid communication via a vacuum line with the inflatable balloon) in order to provide protection against high pressure difference along the blood vessel (Siess at Para. [0005]).
Regarding Claim 48, the combination of Corral, Chatterjee and Siess renders obvious the entirety of Claim 42 as explained above.
Corral additionally discloses:
wherein the support structure is configured to support the chamber body in an expanded configuration. (Col. 5, Ln. 60-68, “A series of tethering cords 56 disposed between the outer shell 44 and the inner liner 46 within the hydraulic access chamber link the diaphragmatic liner 46 to the external shell 44. The cords 56 function to insure a uniform, consistent systolic ventricular shape after hydraulic pressure is applied. Once hydraulic pressure is withdrawn, the cords 56 provide an additional impetus to recoil back against the external shell 44, to a fully contracted state;” Col. 7, Ln. 28-34, “Tethering cords 56 are also used in the balloon valve 66 to shape the valve during closure and to pull the valve material back into diastolic position when the hydraulic fluid is removed. This aspect is particularly important with respect to the balloon valve 66, which must be fully opened at every cycle to allow blood to flow freely from the right atrium 12.”).
Regarding Claim 49, the combination of Corral, Chatterjee and Siess renders obvious the entirety of Claim 48 as explained above.
Siess additionally discloses:
wherein the support structure is collapsible to allow insertion of the heart support device through a vascular lumen (Para. [0016], “In another embodiment, the support member may comprise at least one elastic wire, preferably made of a shape memory material, such as Nitinol;” Para. [0017], “The wire, which may be made of Nitinol as mentioned above, can be retracted from the ring seal in order to be able to collapse the ring seal. Upon retraction of the wire, it can be straightened by pulling it into a lumen of the catheter.”).
Claim 49 is being interpreted similarly Claim 26 above. The explanations regarding Claim 26 apply equally to Claim 49.
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Corral and Chatterjee with the teachings of Siess (i.e., to form Corral’s “support structure comprising a scaffold” (i.e., Corral’s “tethering cords 56”) from a shape memory material such as Nitinol as taught by Siess, thereby rendering it collapsible in the manner of Siess) in order to impart the “ability to undergo a mechanical deformation due to an external force applied to the shape memory material, and then recover its original undeformed shape upon release of the external force” (Para. [0016]).
Regarding Claim 50, the combination of Corral, Chatterjee and Siess renders obvious the entirety of Claim 49 as explained above.
Siess additionally discloses:
wherein the support structure is collapsible into a guide tube for insertion of the heart support device through the vascular lumen(Para. [0016], “In another embodiment, the support member may comprise at least one elastic wire, preferably made of a shape memory material, such as Nitinol;” Para. [0017], “The wire, which may be made of Nitinol as mentioned above, can be retracted from the ring seal in order to be able to collapse the ring seal. Upon retraction of the wire, it can be straightened by pulling it into a lumen of the catheter.”).
This limitation is being interpreted similarly to Claim 27, as explained above.
Regarding Claim 51, the combination of Corral, Chatterjee and Siess renders obvious the entirety of Claim 42 as explained above.
Corral additionally discloses:
wherein the support structure is biased into the expanded configuration (Col. 5, Ln. 60-68, “A series of tethering cords 56 disposed between the outer shell 44 and the inner liner 46 within the hydraulic access chamber link the diaphragmatic liner 46 to the external shell 44. The cords 56 function to insure a uniform, consistent systolic ventricular shape after hydraulic pressure is applied. Once hydraulic pressure is withdrawn, the cords 56 provide an additional impetus to recoil back against the external shell 44, to a fully contracted state;” Col. 7, Ln. 28-34, “Tethering cords 56 are also used in the balloon valve 66 to shape the valve during closure and to pull the valve material back into diastolic position when the hydraulic fluid is removed. This aspect is particularly important with respect to the balloon valve 66, which must be fully opened at every cycle to allow blood to flow freely from the right atrium 12.”).
This limitation is being interpreted similarly to that of Claim 29, above.
Regarding Claim 52, the combination of Corral, Chatterjee and Siess renders obvious the entirety of Claim 42 as explained above.
Siess additionally discloses:
wherein the support structure comprises Nitinol (Para. [0016], “In another embodiment, the support member may comprise at least one elastic wire, preferably made of a shape memory material, such as Nitinol.”).
Regarding Claim 53, the combination of Corral, Chatterjee and Siess renders obvious the entirety of Claim 42 as explained above.
Corral additionally discloses:
wherein the dynamic volume body is configured to expand the support structure from the first configuration to the expanded configuration, thereby increasing the internal volume of the chamber. (Col. 6, Ln. 33-40, “The hydraulic catheters pass through the outer shell 44, and communicate with the hydraulic access chamber 52. This allows pressure to be applied to the access chamber to activate the inner liner 46 into a systolic contraction (see FIG. 3c). A second hydraulic catheter 64 may be used in conjunction with the right ventricular IVP which allows hydraulic pressure to be trans