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 .
Information Disclosure Statement
Applicant should note that the large number of references in the attached information disclosure statement have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b).
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 recites “a sensor attached at least one of the distal and proximal ends”; this is grammatically incorrect and a suggested edit is “a sensor attached to at least one of the distal and proximal ends”.
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.
Claim(s) 1, 6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nitzan (US 20180185622 A1; 9/11/2003; cited in IDS).
Regarding claim 1, Nitzan teaches a circulatory assist device (Abstract) comprising:
a distal end and a proximal end (Fig. 1-3);
an impeller (Fig. 3, 310; [0133]);
a sensor attached at least one of the distal and proximal ends configured to receive electromagnetic frequencies for controlling the impeller, the impeller configured to move fluid in response to received electromagnetic frequencies ([0115] “electronic communication…pressure sensor”; [0117] “sensors…include radio frequency transmitters…sensor can be implanted in the patient as part of the pump”; [0142] “catheters can have one or more sensors of various types”; [0179] “control operation of the impeller…based on the pressure data acquired by the sensors”; [0259] “a component or feature of any one of the embodiments can be used in combination with any other component or feature of another embodiment”; [0260]); and
two or more chambers positioned proximally and distally relative to the impeller, the impeller being positioned between the two or more chambers (Fig. 3, impeller 310 is in between 302a and 302b; [0132]-[0133]).
Regarding claim 6, Nitzan teaches wherein the two or more chambers are positioned coaxially along a drive line of the impeller and connected thereto (Fig. 3, impeller 310 is in between 302a and 302b along 306 which reads on “drive line”; [0132]-[0133]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 3-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nitzan as applied to claim 1 above, in view of Kantrowitz (US 20090131741 A1; 5/21/2009).
Regarding claim 3, Nitzan does not teach further comprising a stent cage of a size and shape to be placed within a subject's blood vessel, the stent cage configured to expand within the subject's blood vessel. Note that Nitzan does teach stent(s) that expand and contract within blood vessel ([0128]] [0248]). However, Kantrowitz teaches in the same field of endeavor (Abstract) further comprising a stent cage of a size and shape to be placed within a subject's blood vessel, the stent cage configured to expand within the subject's blood vessel (Fig. 9-15; [0041]; [0065] “expandable stent-type cage”; [0067] “stent-type cage sheathing at least one inflatable chamber defining the pump”; [0069] “Appropriate sizing…of expandable stent-type cage or mesh tube”). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Nitzan to include these features as taught by Kantrowitz because this enables anchoring the device in a desired position (Fig. 9-15; [0041]; [0067]).
Regarding claim 4, in the combination of Nitzan and Kantrowitz, Kantrowitz teaches wherein the stent cage is configured to transition between an expanded position and a retracted position (Fig. 9-15; [0041]; [0065] “expandable stent-type cage”; [0067] “stent-type cage sheathing at least one inflatable chamber defining the pump”; [0069] “Appropriate sizing…of expandable stent-type cage or mesh tube”). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Nitzan to include these features as taught by Kantrowitz because this enables anchoring the device in a desired position (Fig. 9-15; [0041]; [0067]).
Regarding claim 5, in the combination of Nitzan and Kantrowitz, Kantrowitz teaches wherein the retracted position is circumferentially less than an inner circumference of a wall of the blood vessel, and the expanded position is circumferentially greater than or equal to the inner circumference of the wall of the blood vessel (Fig. 9-15; [0041]; [0065] “expandable stent-type cage”; [0067] “stent-type cage sheathing at least one inflatable chamber defining the pump”; [0069] “Appropriate sizing…of expandable stent-type cage or mesh tube”). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Nitzan to include these features as taught by Kantrowitz because this enables anchoring the device in a desired position (Fig. 9-15; [0041]; [0067]).
Claim(s) 7, 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nitzan as applied to claim 1 above, in view of Northrop (US 20210275779 A1; 9/9/2021).
Regarding claim 7, Nitzan does not teach wherein the two or more chambers contain a piezoelectric material positioned within the chambers. However, Northrop teaches in the same field of endeavor (Abstract; Fig. 4A) wherein the two or more chambers contain a piezoelectric material positioned within the chambers ([0082] “the first actuating element 120 may be a piezoelectric (piezo) element. In such cases, the medical device 100 may also include electrical wires connected to the first actuating element 120 for applying energy (e.g., current, voltage, etc.) to drive the piezoelectric element, causing the piezoelectric element to change size and/or shape… In further embodiments, the first actuating element 120 may be made from one or more electroactive polymers, which can exhibit a change in size and/or shape when stimulated by an electric field or current. In such cases, the medical device 100 may include electrical wires connected to the first actuating element 120 for applying a current to cause the first actuating element 120 to change size and/or shape. In still further embodiments, the first actuating element 120 may be a balloon.”; [0083] “In other embodiments, the first actuating element 120 may be actuatable in response to radiofrequency energy. In such cases, the first actuating element 120 may include a receiver configured to receive radiofrequency energy, and a converter configured to convert the radiofrequency energy into electrical energy (e.g., current or voltage). The electrical energy (e.g., current or voltage) may then be utilized by the first actuating element 120 to change its size and/or shape.”; [0084] “In other embodiments, the medical device 100 may have a plurality of actuating elements 120. For example, in other embodiments, instead of having one actuating element 120 in the opening 140 of the wall, the medical device 100 may have multiple actuating elements 120 stacked in the opening 140. Such configuration allows differing degrees of deflection by selectively actuating one or multiple one of the actuating elements simultaneously.”; [0130] “Each item may be an embodiment itself or may be a part of an embodiment. One or more items described below may be combined with other item(s) in an embodiment.”). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Nitzan to include these features as taught by Northrop because this enables efficient actuating of device within body ([0002]; [0004]; 0005]; [0082]-[0084]).
Regarding claim 9, Nitzan does not teach wherein the two or more chambers include a vibrational material positioned therein. However, Northrop teaches in the same field of endeavor (Abstract; Fig. 4A) wherein the two or more chambers include a vibrational material positioned therein ([0082] “the first actuating element 120 may be a piezoelectric (piezo) element. In such cases, the medical device 100 may also include electrical wires connected to the first actuating element 120 for applying energy (e.g., current, voltage, etc.) to drive the piezoelectric element, causing the piezoelectric element to change size and/or shape… In further embodiments, the first actuating element 120 may be made from one or more electroactive polymers, which can exhibit a change in size and/or shape when stimulated by an electric field or current. In such cases, the medical device 100 may include electrical wires connected to the first actuating element 120 for applying a current to cause the first actuating element 120 to change size and/or shape. In still further embodiments, the first actuating element 120 may be a balloon.”; [0083] “In other embodiments, the first actuating element 120 may be actuatable in response to radiofrequency energy. In such cases, the first actuating element 120 may include a receiver configured to receive radiofrequency energy, and a converter configured to convert the radiofrequency energy into electrical energy (e.g., current or voltage). The electrical energy (e.g., current or voltage) may then be utilized by the first actuating element 120 to change its size and/or shape.”; [0084] “In other embodiments, the medical device 100 may have a plurality of actuating elements 120. For example, in other embodiments, instead of having one actuating element 120 in the opening 140 of the wall, the medical device 100 may have multiple actuating elements 120 stacked in the opening 140. Such configuration allows differing degrees of deflection by selectively actuating one or multiple one of the actuating elements simultaneously.”; [0130] “Each item may be an embodiment itself or may be a part of an embodiment. One or more items described below may be combined with other item(s) in an embodiment.”). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Nitzan to include these features as taught by Northrop because this enables efficient actuating of device within body ([0002]; [0004]; 0005]; [0082]-[0084]).
Note that the piezoelectric material of Northrop reads on recited “vibrational material” since the structure is capable of performing the recited function of vibration. For the purposes of examination, Applicant is reminded that this is a product claim. Intended use/functional language does not require that reference specifically teach the intended use of the element. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Claim(s) 12-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nitzan (US 20180185622 A1; 9/11/2003; cited in IDS) in view of Kantrowitz (US 20090131741 A1; 5/21/2009), and further in view of Tuval (US 20220079457 A1; cited in IDS).
Regarding claim 12, Nitzan teaches a circulatory assist device for moving fluid through a subject's vein or artery (Abstract).
Nitzan does not teach a stent cage of a size and shape to be placed within an artery or vein of a subject. Note that Nitzan does teach stent(s) that expand and contract within blood vessel ([0128]] [0248]). However, Kantrowitz teaches in the same field of endeavor (Abstract) a stent cage of a size and shape to be placed within an artery or vein of a subject ((Fig. 9-15; [0041]; [0065] “expandable stent-type cage”; [0067] “stent-type cage sheathing at least one inflatable chamber defining the pump”; [0069] “Appropriate sizing…of expandable stent-type cage or mesh tube”). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Nitzan to include these features as taught by Kantrowitz because this enables anchoring the device in a desired position (Fig. 9-15; [0041]; [0067]).
The combination of Nitzan and Kantrowitz does not teach an impeller, positioned within the stent cage and configured to move fluid. Note that Nitzan does teach impeller (Fig. 3, 310; [0133]). However, Tuval teaches in the same field of endeavor (Abstract) teach an impeller, positioned within the stent cage and configured to move fluid (Fig. 2; Fig. 6D-6E; [0008]; [0180]). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Nitzan and Kantrowitz to include this feature as taught by Tuval because this enables anchoring and separating impeller from body (Fig. 2; Fig. 6D-6E; [0008]; [0175]; [0180]).
In the combination of Nitzan, Kantrowitz, and Tuval, Nitzan teaches two or more chambers positioned proximally and distally relative to the impeller, the impeller being situated between the two or more chambers (Fig. 3, impeller 310 is in between 302a and 302b; [0132]-[0133]).
Regarding claim 13, in the combination of Nitzan, Kantrowitz, and Tuval, Tuval teaches wherein the impeller comprises a helical impeller ([0008] “impeller…helical elongate elements”). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Nitzan and Kantrowitz to include this feature as taught by Tuval because this enables efficient blood pumping ([0008]).
Regarding claim 14, in the combination of Nitzan, Kantrowitz, and Tuval, Nitzan teaches a sensor for receiving electromagnetic frequencies for controlling the impeller ([0115] “electronic communication…pressure sensor”; [0117] “sensors…include radio frequency transmitters…sensor can be implanted in the patient as part of the pump”; [0142] “catheters can have one or more sensors of various types”; [0179] “control operation of the impeller…based on the pressure data acquired by the sensors”; [0259] “a component or feature of any one of the embodiments can be used in combination with any other component or feature of another embodiment”; [0260]).
Regarding claim 15, in the combination of Nitzan, Kantrowitz, and Tuval, Nitzan teaches wherein the impeller is wirelessly connected to the sensor is configured to control the impeller in response to the received electromagnetic frequencies ([0115] “electronic communication…pressure sensor”; [0117] “sensors…include radio frequency transmitters…sensor can be implanted in the patient as part of the pump…communication line such as…wireless line”).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nitzan, Kantrowitz, and Tuval as applied to claim 12 above, and further in view of Anagnostopoulos (US 20160136343 A1; 5/19/2016).
Regarding claim 19, the combination of Nitzan, Kantrowitz, and Tuval does not teach wherein each of the two chambers comprises a body portion and an attachment portion, the body portion comprising a tear drop shape and the attachment portion comprising an annular shape. Note that Nitzan teaches that chamber/balloon with body and attachment portions can be in different shapes such as doughnut ([0145]). However, Anagnostopoulos teaches in the same field of endeavor (Abstract; Fig. 1a-1b) the chamber/balloon comprises a body portion and an attachment portion, the body portion comprising a tear drop shape and the attachment portion comprising an annular shape ([0200] “The apparatus of claim 72 wherein said collateral inflatable balloon means is having a spherical, reverse cone or any 3D shape and a diameter smaller, compared to the annular diameter of said valvular centering means.”; [0201] “The apparatus of claim 71 wherein said collateral inflatable balloon means further comprising a disc shaped balloon, having a diameter equal or smaller, compared to the diameter of said valvular centering means, fused into the central portion of said valve means, thereby preventing valvular opening during balloon means inflation.”). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Nitzan, Kantrowitz, and Tuval to include these features as taught by Anagnostopoulos such that each of the two chambers have the shape as claimed because this is a suitable shape to use ([0200]-[0201]); MPEP 2144.04 changes in size/shape; MPEP 2144.07 art recognized suitability for an intended purpose.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nitzan (US 20180185622 A1; 9/11/2003; cited in IDS) in view of Northrop (US 20210275779 A1; 9/9/2021).
Regarding claim 20, Nitzan teaches a circulatory assist device for placement within a blood vessel of a patient (Abstract), the circulatory assist device comprising:
an impeller (Fig. 3, 310; [0133]).
Nitzan does not teach at least one portion of piezoelectric and/or vibrational material, the piezoelectric and/or vibrational material configured to vibrate or resonate in response to application of an electric, electromagnetic, and/or magnetic field. However, Northrop teaches in the same field of endeavor (Abstract; Fig. 4A) at least one portion of piezoelectric and/or vibrational material, the piezoelectric and/or vibrational material configured to vibrate or resonate in response to application of an electric, electromagnetic, and/or magnetic field ([0082] “the first actuating element 120 may be a piezoelectric (piezo) element. In such cases, the medical device 100 may also include electrical wires connected to the first actuating element 120 for applying energy (e.g., current, voltage, etc.) to drive the piezoelectric element, causing the piezoelectric element to change size and/or shape… In further embodiments, the first actuating element 120 may be made from one or more electroactive polymers, which can exhibit a change in size and/or shape when stimulated by an electric field or current. In such cases, the medical device 100 may include electrical wires connected to the first actuating element 120 for applying a current to cause the first actuating element 120 to change size and/or shape. In still further embodiments, the first actuating element 120 may be a balloon.”; [0083] “In other embodiments, the first actuating element 120 may be actuatable in response to radiofrequency energy. In such cases, the first actuating element 120 may include a receiver configured to receive radiofrequency energy, and a converter configured to convert the radiofrequency energy into electrical energy (e.g., current or voltage). The electrical energy (e.g., current or voltage) may then be utilized by the first actuating element 120 to change its size and/or shape.”; [0084] “In other embodiments, the medical device 100 may have a plurality of actuating elements 120. For example, in other embodiments, instead of having one actuating element 120 in the opening 140 of the wall, the medical device 100 may have multiple actuating elements 120 stacked in the opening 140. Such configuration allows differing degrees of deflection by selectively actuating one or multiple one of the actuating elements simultaneously.”; [0130] “Each item may be an embodiment itself or may be a part of an embodiment. One or more items described below may be combined with other item(s) in an embodiment.”). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Nitzan to include these features as taught by Northrop because this enables efficient actuating of device within body ([0002]; [0004]; 0005]; [0082]-[0084]).
Note that the piezoelectric material of Northrop reads on recited “configured to vibrate or resonate” since the structure is capable of performing the recited function. For the purposes of examination, Applicant is reminded that this is a product claim. Intended use/functional language does not require that reference specifically teach the intended use of the element. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Allowable Subject Matter
Claim(s) 2, 8, 10-11, 16-18 is/are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The prior art of record does not disclose or fairly suggest either singly or in combination the claimed invention of claim 2 when taken as a whole, comprising, in addition to the other recited claim elements, wherein the two or more chambers include vibrational or piezoelectric materials positioned in walls therein and configured to move or vibrate in response to receiving one or more of the electromagnetic frequencies. Note that this is the same “electromagnetic frequencies” from claim 1 that controls the impeller.
The prior art of record does not disclose or fairly suggest either singly or in combination the claimed invention of claim 8 when taken as a whole, comprising, in addition to the other recited claim elements, wherein the piezoelectric material is configured to receive the electromagnetic frequencies and move based upon the received electromagnetic frequencies. Note that this is the same “electromagnetic frequencies” from claim 1 that controls the impeller.
The prior art of record does not disclose or fairly suggest either singly or in combination the claimed invention of claim 10 and its dependent claim 11 when taken as a whole, comprising, in addition to the other recited claim elements, wherein the vibrational material enhances vibrations from a drive shaft.
The prior art of record does not disclose or fairly suggest either singly or in combination the claimed invention of claim 16 and its dependent claims 17-18 when taken as a whole, comprising, in addition to the other recited claim elements, wherein the two or more chambers each comprise a balloon comprising a flexible material configured to vibrate based at least in part upon movement of the impeller.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Sell (US 20050273130 A1; cited in IDS) teaches balloon catheter with magnetic responsive material within balloon that responds to externally applied magnetic field for orienting the distal end of device within subject ([0009]; [0011]; [0066]; claim 1). This is relevant to what is claimed in instant claim 2 however, magnetic materials are not the same as piezoelectric materials which couple mechanical stress with electrical charge. Further, Sell does not teach vibrating the device with the externally applied magnetic field.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan T Kuo whose telephone number is (408)918-7534. The examiner can normally be reached M-F 10 a.m. - 6 p.m. PT.
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/JONATHAN T KUO/Primary Examiner, Art Unit 3792
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