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 .
DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/28/2026 has been entered. Claims 1-15 and 20-43 are currently pending and under examination.
Claim Rejections - 35 USC § 112
In view of the amendment filed on 4/28/2026 clarifying the language of claim 25 the 112(b) rejections made against claim 25 in the office action of 10/29/2025 have been withdrawn.
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 24-36 and 40-43 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. Independent claims 24 and 41 recite “the outer membrane having a first thickness, the inner membrane having a second thickness less than the first thickness.”, however the original disclosure does not provide support for the amended claim language. The drawings show an inner membrane (406 or 904) and an outer membrane (408 or 902) with a thickness but do not provide specifics regarding the thickness of each membrane including support for the inner membrane having a thickness less than an outer membrane. Therefore, 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. Claims 25-37, 40 and 42-43 directly or indirectly depend from claim 24 and 41 and are also rejected to for the reasons stated above regarding claims 24 and 41.
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 20 and 39 are 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. Claim 20 recites the limitation "the substantially cylindro-conically shaped proximal region" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Claim 39 ends with a comma making it difficult to determine the metes and bounds of the claims since it is unclear whether applicant intended to add more language to the claim or if the claim is complete, clarification is required. As best understood, for the purposes of examination, claim 20 has been interpreted to include the balloon having a tubular-shaped proximal end and claim 39 has been interpreted to be complete as stated.
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) 24-27, 32-36 and 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0360663 to Smith et al. (Smith) (previously cited).
In reference to at least claim 24
Smith discloses a blood pump assembly comprising:·a balloon (e.g. expandable member “balloon” 110) defining an elongated inflatable chamber (e.g. expandable member 110 has an inflatable chamber that includes interior space 317) having an interior volume (e.g. Figs. 3a, 3b), the balloon having a distal region (e.g. portion located at 315) with a distal end (e.g. Fig. 3b), a central region (e.g. portion between elements 315 and 313), and a proximal region (e.g. portion located at 313) with a proximal end (e.g. Fig. 3b), wherein the proximal end of the balloon has an opening (e.g. opening through which 120 is inserted, Fig. 3c); and wherein: the interior volume of the inflatable chamber is between approximately 20 cc and 60 cc (e.g. “the expandable member 110 can have a displacement volume between about 20 ml and about 60 ml” [0080]), inclusive, the proximal region of the balloon is substantially cylindro-conically shaped (e.g. Fig.3b), the proximal region of the balloon tapering toward the proximal end of the balloon (e.g. proximal region tapers, Fig. 3b ), the central region of the balloon is substantially cylindrically shaped with a substantially uniform exterior diameter (e.g. Figs. 3a, 3b), and the distal region of the balloon is substantially cylindro-conically shaped (e.g. Fig. 3b), the distal region of the balloon tapering toward the distal end of the balloon (e.g. Fig. 3b), and a driveline (e.g. 120) including a distal end (e.g. Fig. 3c), a proximal end (e.g. Fig. 4a), and a central lumen (e.g. 421), configured to communicate a working fluid for delivery to or from the elongated inflatable chamber (e.g. Fig. 3c, “To transition the expandable member 110 between the first state and the second state, the drive unit 150 can direct a fluid (gas or liquid, e.g., air) into an internal volume of the expandable member 110 via the first driveline 120”, para. [0030]), wherein: the driveline includes an outer membrane (e.g. outer membrane 428), an inner membrane (e.g. inner membrane 426), and a kink resistant element disposed therebetween (e.g. kink-resistant element 427), the outer membrane having a first thickness and the inner membrane having a second thickness ( outer membrane 428 and inner membrane 426 each have a thickness, Fig. 4B).
Smith discloses that the expandable member has a length (e.g. “The expandable member 110 can have a length between about 15 cm and about 30 cm. In some embodiments, for example, the expandable member 110 has a length greater than about 19 cm, such as about 20 cm or about 25 cm.”; para [0080]),
Smith fails to teach the proximal region being approximately 15-30% of the length of the balloon, the central region being approximately 55-65% of the length of the balloon the distal region being approximately 15-30% of the length of the balloon. To modify the expandable member to have the proximal region being approximately 15-30% of the length of the balloon, the central region being approximately 55-65% of the length of the balloon the distal region being approximately 15-30% of the length of the balloon would have been obvious before the effective filing date of the claimed invention as a matter of a change in size or shape of the device. It has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device, see MPEP 2144.04.The prior art device would not perform differently depending on the length of the various portions of the expandable member.
Additionally, it would have been an obvious matter of design choice to modify the Smith reference, to have the proximal region being approximately 15-30% of the length of the balloon, the central region being approximately 55-65% of the length of the balloon and the distal region being approximately 15-30% of the length of the balloon, since applicant has not disclosed that having the proximal region being approximately 15-30% of the length of the balloon, the central region being approximately 55-65% of the length of the balloon the distal region being approximately 15-30% of the length of the balloon solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Further, absent a teaching as to criticality that the proximal region being approximately 15-30% of the length of the balloon, the central region being approximately 55-65% of the length of the balloon and the distal region being approximately 15-30% of the length of the balloon, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement, see MPEP 2144.04.
Smith fails to disclose the inner membrane having a second thickness less than the first thickness of the outer membrane.
It would have been an obvious matter of design choice to modify the Smith reference, to have the inner membrane having a second thickness less than the first thickness of the outer membrane, since applicant has not disclosed that having the inner membrane having a second thickness less than the first thickness of the outer membrane solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs, i.e. the thicknesses shown within Smith or the claimed thicknesses. Additionally, MPEP 2144.04 states “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.” Therefore, absent a teaching as to criticality that the inner membrane having a second thickness less than the first thickness of the outer membrane, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement, see MPEP 2144.04.
In reference to at least claim 25
Smith discloses wherein the combined length of the proximal and central regions of the balloon is between approximately 100 mm and 220 mm, inclusive (e.g. “The expandable member 110 can have a length between about 15 cm and about 30 cm. In some embodiments, for example, the expandable member 110 has a length greater than about 19 cm, such as about 20 cm or about 25 cm.”; para [0080]).
In reference to at least claim 26
Smith discloses wherein the distal end of the balloon is one of: rounded, nipple-shaped, or bullet-shaped (e.g. nipple 316, Fig. 3b).
In reference to at least claim 27
Smith discloses the pump assembly further comprising a connection element (e.g. 429), wherein: the distal end of the driveline is coupleable to the proximal end of the balloon at the opening (e.g. driveline 120 is coupled to the proximal end 312, Fig. 3c), the connection element is disposed at and secured to the proximal end of the driveline (e.g. Fig. 4a, 4b), the connection element is sized and shaped to receive a corresponding connection element associated with a delivery dilator (e.g. delivery dilator 280, “The connection element 429 can be a threaded female connection element that is sized and shaped to receive a corresponding threaded male connection element on the elongated delivery dilator 280.”, para. [0083]) configured to pull the driveline through a patient's vasculature, and the connection element that is secured to the proximal end of the driveline has a channel configured to permit the fluid to pass there through and into or out of the central lumen (para [0049]). It should be noted that modified Smith fails to specifically teach wherein the separation force required to separate the connection element from the proximal end of the driveline exceeds at least approximately 12 to 30 pounds force. Smith does teaches connecting and disconnecting the driveline (e.g. para [0037], [0054]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the intra-aortic balloon pump of Smith to any separation force that exceeds at least approximately 12 to 30 pounds, since it has been held where the general conditions of a claimed are disclosed in the prior art (connecting and disconnecting the driveline), discovering the optimum or workable ranges involves only routine skill in the art, see MPEP 2144.05.
In reference to at least claim 32
Smith discloses the pump assembly wherein the kink-resistant element (e.g. 427) is disposed between the outer membrane and the inner membrane along a first length of the driveline (e.g. Fig. 4b), and radiopaque material (e.g. nitinol; para [0082], is radio opaque), is disposed between the outer membrane and the inner membrane along a second length of the driveline (e.g. can extend the entirely of the driveline; para [0082]).
In reference to at least claim 33
Smith discloses wherein: the second length of the driveline is proximate to or at the distal end of the driveline (can extend the entirely of the driveline; para [0082]), the radio opaque material has the same thickness as the kink-resistant element (e.g. Figs. 4a, 4b), and the radio opaque material is a ring (e.g. see cross-section showing 427 is ring shaped).
In reference to at least claim 34
Smith discloses wherein the balloon has a wall (e.g. Fig. 3c), the inner surface of said wall defining the elongated inflatable chamber (e.g. 317), the wall having a non-uniform thickness (e.g. para [0077]).
In reference to at least claim 35
Smith discloses wherein: the driveline has a stiffness, and the wall thickness at a portion of the proximal region of the balloon exceeds the wall thickness at the central region to minimize at least one of strain on or kinking in said portion of the proximal region of the balloon during operation of the blood pump assembly caused by the driveline stiffness (e.g. “In some embodiments, the first end portion 312 can have a greater material thickness relative to other portions of the expandable member 110. Without being bound by theory, the thicker material is expected to reduce kinking and stretching at the interface between the expandable member 110 and the first driveline 120.”, para. [0077]).
In reference to at least claim 36
Smith discloses wherein: the balloon is sized and shaped to receive a blood pump support structure, configured to oppose buoyancy forces acting on the balloon when the blood pump assembly is implanted in the descending aorta (blood pump support structure is not positively claimed; the balloon comprises an interior space fully capable of receiving a blood pump support structure), ·and the wall thickness at a portion of the distal region of the balloon exceeds the wall thickness at the central region of the balloon (e.g. formation of nipple 316) such that during operation of the blood pump assembly, a strain on said portion of the distal region of the balloon caused by the blood pump support structure is minimized (the balloon comprises an interior space fully capable of receiving a blood pump support structure for minimizing strain).
In reference to at least claim 41
Smith discloses a balloon defining an elongated inflatable chamber (e.g. expandable member 110 has an inflatable chamber that includes interior space 317) having an interior volume (e.g. Figs. 3a, 3b), the balloon having a distal region (e.g. portion located at 315) with a distal end (e.g. Fig. 3b), a central region (e.g. portion between elements 315 and 313), and a proximal region (e.g. portion located at 313) with a proximal end (e.g. Fig. 3b), wherein the proximal end of the balloon has an opening (e.g. opening through which 120 is inserted, Fig. 3c); and wherein: the proximal region of the balloon is substantially cylindro-conically shaped (e.g. Fig.3b), the proximal region of the balloon tapering toward the proximal end of the balloon (e.g. proximal region tapers, Fig. 3b ), the central region of the balloon is substantially cylindrically shaped (e.g. Figs. 3a, 3b), and the distal region of the balloon is substantially cylindro-conically shaped (e.g. Fig. 3b), the distal region of the balloon tapering toward the distal end of the balloon (e.g. Fig. 3b), a driveline (e.g. 120) configured to be coupled to the balloon (e.g. driveline 120 is coupled to the balloon, Fig. 3A) and provide a conduit through which fluid can be conveyed to and from the balloon via the opening (e.g. “The first driveline 120 is an elongated structure having a lumen extending therethrough for delivering inflation gases to the expandable member 110.”, para. [0031], “the first driveline 120 can be coupled to the expandable member 110 to deliver inflation gases thereto.”, para. [0034], “and a lumen extending through the first driveline 120 (described below with reference to FIGS. 4A-4B) is in fluid communication with an interior space 317 of the expandable member 110.”, para. [0076]), the driveline including an outer membrane (e.g. outer membrane 428), an inner membrane (e.g. inner membrane 426), and a kink resistant element disposed therebetween (e.g. kink-resistant element 427), the outer membrane having a first thickness and the inner membrane having a second thickness ( outer membrane 428 and inner membrane 426 each have a thickness, Fig. 4B).
However, Smith fails to disclose the inner membrane having a second thickness less than the first thickness of the outer membrane.
It would have been an obvious matter of design choice to modify the Smith reference, to have the inner membrane having a second thickness less than the first thickness of the outer membrane, since applicant has not disclosed that having the inner membrane having a second thickness less than the first thickness of the outer membrane solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs, i.e. the thicknesses shown within Smith or the claimed thicknesses. Additionally, MPEP 2144.04 states “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.” Therefore, absent a teaching as to criticality that the inner membrane having a second thickness less than the first thickness of the outer membrane, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement, see MPEP 2144.04.
Claim(s) 1-7, 11-15, 20-23, 38-40 and 42-43 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0360663 to Smith et al. (Smith) (previously cited) in view of US 2018/0055981 to Smith et al. (Smith ‘981) and US Patent No. 4,657,024 to Coneys (Coneys).
In reference to at least claim 1
Smith discloses a blood pump assembly comprising:·a balloon (e.g. expandable member “balloon” 110) defining an elongated inflatable chamber (e.g. expandable member 110 has an inflatable chamber that includes interior space 317) having an interior volume (e.g. Figs. 3a, 3b), the balloon having a distal region (e.g. portion located at 315) with a distal end (e.g. Fig. 3b), a central region (e.g. portion between elements 315 and 313), and a proximal region (e.g. portion located at 313) with a proximal end (e.g. Fig. 3b), the proximal end of the balloon having an opening (e.g. opening through which 120 is inserted, Fig. 3c); the proximal region of the balloon tapering toward the proximal end of the balloon (e.g. proximal region tapers, Fig. 3b ), the distal region of the balloon tapering toward the distal end of the balloon (e.g. Fig. 3b), a driveline (e.g. 120) configured to be coupled to the proximal end of the balloon (e.g. driveline 120 is coupled to the balloon at the proximal end, Fig. 3A) to fluidically couple a lumen of the driveline with the opening of the balloon (e.g. “The first driveline 120 is an elongated structure having a lumen extending therethrough for delivering inflation gases to the expandable member 110.”, para. [0031], “the first driveline 120 can be coupled to the expandable member 110 to deliver inflation gases thereto.”, para. [0034], “and a lumen extending through the first driveline 120 (described below with reference to FIGS. 4A-4B) is in fluid communication with an interior space 317 of the expandable member 110.”, para. [0076]), the driveline including an outer membrane (e.g. outer membrane 428), an inner membrane (e.g. inner membrane 426), a kink resistant element disposed between the outer membrane and the inner membrane along a first length of the driveline (e.g. kink-resistant element 427).
However, Smith fails to disclose a radiopaque material distinct from the kink resistant element, the radiopaque material disposed between the outer membrane and the inner membrane along a second length of the driveline different than the first length.
Smith ‘981 discloses a blood pump assembly (e.g. Fig. 1) that includes a driveline (e.g. inflation tube 21) that includes a radiopaque ring (e.g. 35) disposed at a coupling site with a balloon portion (e.g. 15, Figs. 10-16) of the blood pump assembly (e.g. Optionally, radiopaque ring 35 may be disposed at the coupling site.”, para. [0068], claim 10) providing visual markers to ensure correct placement (e.g. para. [0098]).
Coneys discloses that it is known in the art that radiopaque material is chemically reactive with body tissues and/or is rough or coarse when exposed to an exterior surface of a catheter providing a relatively high coefficient of friction which causes irritation or impairs insertion of a catheter into a tissue and when exposed to an interior of the tube provide a rough surface frequently causing bruising of the blood which in turn causes clotting (e.g. Col. 1, ll. 45-68). Coneys further discloses embedding the radiopaque material (e.g. 14/14’/14”) so that the radiopaque material is completed embedded within and surrounded by an inner and outer plastic material (e.g. Figs. 2-4, “In other words, the plastic material 12 defines the inner tubular bore surface as well as the exterior surface of the tube. Further, the flexible material includes an integrally extruded radiopaque layer 14 completely embedded within and surrounded by the plastic material 12 and extending along the tube between the ends thereof.”, Col. 3, ll. 23-29) thereby “thereby providing a catheter having surfaces with a low coefficient of friction yet providing a catheter having a very high concentration of the radiopaque material and chemical inertness which has been unattainable in the prior constructions.” Col. 4, ll. 29-38).
It would have been obvious to one having ordinary skill in the art to modify the assembly of Smith to include a radiopaque material distinct from the kink resistant element such as a radiopaque marker along a second length of the driveline different than the first length, as taught by Smith ‘981, in order to provide visualization to the proximal end of the balloon element for correct placement. Further, regarding the radiopaque material being disposed between the outer membrane and the inner membrane, it would have been obvious to one having ordinary skill in the art to further modify the assembly of Smith modified by Smith ‘981 to include the radiopaque material distinct from the kink resistant element such as the radiopaque marker being disposed between the outer membrane and the inner membrane, as taught by Coneys, in order to provide a blood pump assembly with a very high concentration of the radiopaque material and chemical inertness preventing irritation or impairment of insertion of the blood pump assembly into the body (Col. 4, ll. 37-38).
In reference to at least claim 2
Smith modified by Smith ‘981 and Coneys renders obvious a blood pump assembly according to claim 1. Smith further discloses wherein the distal end of the balloon is rounded (e.g. Fig. 3b).
In reference to at least claim 3
Smith modified by Smith ‘981 and Coneys renders obvious a blood pump assembly according to claim 1. Smith further discloses wherein the distal end of the balloon is nipple-shaped (e.g. nipple 316).
In reference to at least claim 4
Smith modified by Smith ‘981 and Coneys renders obvious a blood pump assembly according to claim 1. Smith further discloses wherein the distal end of the balloon is bullet-shaped (e.g. Fig. 3b).
In reference to at least claim 5
Smith modified by Smith ‘981 and Coneys renders obvious a blood pump assembly according to claim 1. Smith further discloses wherein the length of the distal region of the balloon is less than approximately 40% of the combined length of the proximal and central regions of the balloon (e.g. Fig. 3b). Additionally, it has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device, see MPEP 2144.04.The prior art device would not perform differently depending on the length of the various portions of the expandable member.
In reference to at least claim 6
Smith modified by Smith ‘981 and Coneys renders obvious a blood pump assembly according to claim 1. Smith further discloses the pump assembly further comprising a connection element (e.g. 429), wherein: the connection element is disposed at and secured to the proximal end of the driveline (e.g. Fig. 4a, 4b), the connection element is sized and shaped to receive a corresponding connection element associated with a delivery dilator (e.g. delivery dilator 280, “The connection element 429 can be a threaded female connection element that is sized and shaped to receive a corresponding threaded male connection element on the elongated delivery dilator 280.”, para. [0083]) the connection element and the corresponding connection element associated with the delivery dilator both configured to pull the driveline through a patient's vasculature, and the connection element has a channel configured to permit the fluid to pass there through and into or out of the central lumen (para [0049]). It should be noted that modified Smith fails to specifically teach wherein a separation force required to separate the connection element from the proximal end of the driveline exceeds at least approximately 12 to 30 pounds force. Smith does teach connecting and disconnecting the driveline (e.g. para [0037], [0054]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the intra-aortic balloon pump of Smith to any separation force that exceeds at least approximately 12 to 30 pounds, since it has been held where the general conditions of a claimed are disclosed in the prior art (connecting and disconnecting the driveline), discovering the optimum or workable ranges involves only routine skill in the art, see MPEP 2144.05
In reference to at least claim 7
Smith modified by Smith ‘981 and Coneys renders obvious a blood pump assembly according to claim 1. Smith further discloses wherein the driveline has an outer diameter that is substantially uniform (e.g. Fig. 3a).
In reference to at least claim 11
Smith modified by Smith ‘981 and Coneys renders obvious a blood pump assembly according to claim 1. Smith further discloses wherein the kink-resistant element is a helically wound Nitinol coil (e.g. “The coil 427 can be composed of nitinol or another suitable kink-resistant material.” para [0082]).
In reference to at least claim 12
Smith modified by Smith ‘981 and Coneys renders obvious a blood pump assembly according to claim 1. Smith further discloses wherein the outer membrane comprises a biocompatible and anti-thrombogenic material (e.g. “the outer membrane 428 can be composed of an antithrombogenic material, such as elastin-s, to reduce and/or prevent clot formation on the first driveline 120 when it is implanted in a patient's vasculature.”, para [0082]).
In reference to at least claim 13
Smith modified by Smith ‘981 and Coneys renders obvious a blood pump assembly according to claim 1. The modified device with Smith ‘981 and Coneys discloses the second length of the driveline is proximate to or at the distal end of the driveline (e.g. ‘981, Optionally, radiopaque ring 35 may be disposed at the coupling site.”, para. [0068], claim 10)
In reference to at least claim 14
Smith modified by Smith ‘981 and Coneys renders obvious a blood pump assembly according to claim 1. The modified device with Smith ‘981 and Coneys discloses wherein the radio opaque material is a ring (e.g. ‘981, radiopaque ring 35).
In reference to at least claim 15
Smith modified by Smith ‘981 and Coneys renders obvious a blood pump assembly according to claim 1. The modified device with Smith ‘981 and Coneys discloses wherein the radio opaque material has substantially the same thickness as the kink-resistant element (e.g. ‘981, Optionally, radiopaque ring 35 may be disposed at the coupling site.”, para. [0068], claim 10). Alternatively, it would have been an obvious matter of design choice to modify the Smith reference, to have the radio opaque material has substantially the same thickness as the kink-resistant element, since applicant has not disclosed that having radio opaque material has substantially the same thickness as the kink-resistant element solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs, i.e. the thicknesses shown within Smith or the claimed thicknesses. Additionally, MPEP 2144.04 states “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.” Therefore, absent a teaching as to criticality that the radio opaque material has substantially the same thickness as the kink-resistant element, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement, see MPEP 2144.04.
In reference to at least claim 20
Smith modified by Smith ‘981 and Coneys renders obvious a blood pump assembly according to claim 1. Smith further discloses wherein the substantially cylindro-conically shaped proximal region of the balloon includes a tubular-shaped proximal end (e.g. Figs. 3b, 3c).
In reference to at least claim 21
Smith modified by Smith ‘981 and Coneys renders obvious a blood pump assembly according to claim 1. Smith further discloses wherein the balloon has a wall (e.g. Fig. 3c), the inner surface of said wall defining the elongated inflatable chamber (e.g. 317), the wall having a non-uniform thickness (e.g. para (0077]).
In reference to at least claim 22
Smith modified by Smith ‘981 and Coneys renders obvious a blood pump assembly according to claim 21. Smith further discloses wherein: the driveline has a stiffness, and the wall thickness at a portion of the proximal region of the balloon exceeds the wall thickness at the central region to minimize at least one of strain on or kinking in said portion of the proximal region of the balloon during operation of the blood pump assembly caused by the driveline stiffness (e.g. “In some embodiments, the first end portion 312 can have a greater material thickness relative to other portions of the expandable member 110. Without being bound by theory, the thicker material is expected to reduce kinking and stretching at the interface between the expandable member 110 and the first driveline 120.”, Fig. 3c, para. [0077]).
In reference to at least claim 23
Smith modified by Smith ‘981 and Coneys renders obvious a blood pump assembly according to claim 21. Smith further discloses wherein: the balloon is sized and shaped to receive a blood pump support structure, configured to oppose buoyancy forces acting on the balloon when the blood pump assembly is implanted in the descending aorta (blood pump support structure is not positively claimed; the balloon comprises an interior space fully capable of receiving a blood pump support structure), and the wall thickness at a portion of the distal region of the balloon exceeds the wall thickness at the central region of the balloon (e.g. formation of nipple 316) such that during operation of the blood pump assembly, a strain on said portion of the distal region of the balloon caused by the blood pump support structure is minimized (the balloon comprises an interior space fully capable of receiving a blood pump support structure for minimizing strain).
In reference to at least claim 38
Smith modified by Smith ‘981 and Coneys renders obvious a blood pump assembly according to claim 1. Smith further discloses wherein: the first length of the driveline is defined between a proximal end of the driveline to a region proximate to a distal end of the driveline (e.g. first length including kink-resistant element 427 which is from a proximal end of the driveline to a region proximate to a distal end of the driveline). The modified device with Smith ‘981 and Coneys would place the radiopaque maker at a coupling site which is a second length of the driveline defined between the region proximate to the distal end of the driveline and the distal end of the driveline (e.g. ‘981, Optionally, radiopaque ring 35 may be disposed at the coupling site.”, para. [0068], claim 10).
In reference to at least claim 39
Smith modified by Smith ‘981 and Coneys renders obvious a blood pump assembly according to claim 1. Smith further discloses wherein: the interior volume of the inflatable chamber is between approximately 20 cc and 60 cc, inclusive (e.g. “the expandable member 110 can have a displacement volume between about 20 ml and about 60 ml” [0080]), the proximal region of the balloon is substantially cylindro-conically shaped (e.g. Fig.3b), the proximal region of the balloon tapering toward the proximal end of the balloon (e.g. proximal region tapers, Fig. 3b ), the central region of the balloon is substantially cylindrically shaped (e.g. Figs. 3a, 3b), and the distal region of the balloon is substantially cylindro-conically shaped (e.g. Fig. 3b).
In reference to at least claim 40
Smith renders obvious a pump according to claim 32. Smith further discloses wherein: the first length of the driveline is defined between a proximal end of the driveline to a region proximate to a distal end of the driveline (e.g. first length including kink-resistant element 427 which is from a proximal end of the driveline to a region proximate to a distal end of the driveline).
However, Smith fails to disclose a radio opaque material disposed between the outer membrane and the inner membrane along a second length of the driveline, the second length of the driveline defined between the region proximate to the distal end of the driveline and the distal end of the driveline.
Smith ‘981 discloses a blood pump assembly (e.g. Fig. 1) that includes a driveline (e.g. inflation tube 21) that includes a radiopaque ring (e.g. 35) disposed at a coupling site with a balloon portion (e.g. 15, Figs. 10-16) of the blood pump assembly (e.g. Optionally, radiopaque ring 35 may be disposed at the coupling site.”, para. [0068], claim 10) providing visual markers to ensure correct placement (e.g. para. [0098]).
Coneys discloses that it is known in the art that radiopaque material is chemically reactive with body tissues and/or is rough or coarse when exposed to an exterior surface of a catheter providing a relatively high coefficient of friction which causes irritation or impairs insertion of a catheter into a tissue and when exposed to an interior of the tube provide a rough surface frequently causing bruising of the blood which in turn causes clotting (e.g. Col. 1, ll. 45-68). Coneys further discloses embedding the radiopaque material (e.g. 14/14’/14”) so that the radiopaque material is completed embedded within and surrounded by an inner and outer plastic material (e.g. Figs. 2-4, “In other words, the plastic material 12 defines the inner tubular bore surface as well as the exterior surface of the tube. Further, the flexible material includes an integrally extruded radiopaque layer 14 completely embedded within and surrounded by the plastic material 12 and extending along the tube between the ends thereof.”, Col. 3, ll. 23-29) thereby “thereby providing a catheter having surfaces with a low coefficient of friction yet providing a catheter having a very high concentration of the radiopaque material and chemical inertness which has been unattainable in the prior constructions.” Col. 4, ll. 29-38).
It would have been obvious to one having ordinary skill in the art to modify the assembly of Smith to include a radiopaque material distinct from the kink resistant element such as a radiopaque marker along a second length of the driveline different than the first length, as taught by Smith ‘981, in order to provide visualization to the proximal end of the balloon element for correct placement. Further, regarding the radiopaque material being disposed between the outer membrane and the inner membrane, it would have been obvious to one having ordinary skill in the art to further modify the assembly of Smith modified by Smith ‘981 to include the radiopaque material distinct from the kink resistant element such as the radiopaque marker being disposed between the outer membrane and the inner membrane, as taught by Coneys, in order to provide a blood pump assembly with a very high concentration of the radiopaque material and chemical inertness preventing irritation or impairment of insertion of the blood pump assembly into the body (Col. 4, ll. 37-38). The modified device with Smith ‘981 and Coneys would place the radiopaque maker at a coupling site which is a second length of the driveline defined between the region proximate to the distal end of the driveline and the distal end of the driveline (e.g. ‘981, Optionally, radiopaque ring 35 may be disposed at the coupling site.”, para. [0068], claim 10).
In reference to at least claim 42
Smith renders obvious a pump according to claim 41. However, Smith fails to disclose a radiopaque marker separate from and disposed adjacent to the kink resistant element between the inner membrane and the outer membrane.
Smith ‘981 discloses a blood pump assembly (e.g. Fig. 1) that includes a driveline (e.g. inflation tube 21) that includes a radiopaque ring (e.g. 35) disposed at a coupling site with a balloon portion (e.g. 15, Figs. 10-16) of the blood pump assembly (e.g. Optionally, radiopaque ring 35 may be disposed at the coupling site.”, para. [0068], claim 10) providing visual markers to ensure correct placement (e.g. para. [0098]).
Coneys discloses that it is known in the art that radiopaque material is chemically reactive with body tissues and/or is rough or coarse when exposed to an exterior surface of a catheter providing a relatively high coefficient of friction which causes irritation or impairs insertion of a catheter into a tissue and when exposed to an interior of the tube provide a rough surface frequently causing bruising of the blood which in turn causes clotting (e.g. Col. 1, ll. 45-68). Coneys further discloses embedding the radiopaque material (e.g. 14/14’/14”) so that the radiopaque material is completed embedded within and surrounded by an inner and outer plastic material (e.g. Figs. 2-4, “In other words, the plastic material 12 defines the inner tubular bore surface as well as the exterior surface of the tube. Further, the flexible material includes an integrally extruded radiopaque layer 14 completely embedded within and surrounded by the plastic material 12 and extending along the tube between the ends thereof.”, Col. 3, ll. 23-29) thereby “thereby providing a catheter having surfaces with a low coefficient of friction yet providing a catheter having a very high concentration of the radiopaque material and chemical inertness which has been unattainable in the prior constructions.” Col. 4, ll. 29-38).
It would have been obvious to one having ordinary skill in the art to modify the assembly of Smith to include a radiopaque material distinct from the kink resistant element such as a radiopaque marker disposed adjacent the kink resistant element, as taught by Smith ‘981, in order to provide visualization to the proximal end of the balloon element for correct placement. Further, regarding the radiopaque material being disposed between the inner membrane and the outer membrane, it would have been obvious to one having ordinary skill in the art to further modify the assembly of Smith modified by Smith ‘981 to include the radiopaque material distinct from the kink resistant element such as the radiopaque marker being disposed between the inner membrane and the outer membrane, as taught by Coneys, in order to provide a blood pump assembly with a very high concentration of the radiopaque material and chemical inertness preventing irritation or impairment of insertion of the blood pump assembly into the body (Col. 4, ll. 37-38).
In reference to at least claim 43
Smith modified by Smith ‘981 and Coneys renders obvious a blood pump assembly according to claim 42. The modified device with Smith ‘981 and Coneys discloses wherein the radiopaque marker is disposed distal to the kink resistant element (e.g. ‘981, Optionally, radiopaque ring 35 may be disposed at the coupling site.”, para. [0068], claim 10). The modified device with Smith ‘981 and Coneys would place the radiopaque maker at a coupling site which is distal to the kink resistant element (e.g. ‘981, Optionally, radiopaque ring 35 may be disposed at the coupling site.”, para. [0068], claim 10).
Claim(s) 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0360663 to Smith et al. (Smith) in view of US 2018/0055981 to Smith et al. (Smith ‘981) and US Patent No. 4,657,024 to Coneys (Coneys) as applied to claim 1 further in view of US 2020/0182387 to Morrissey (Morrissey) (previously cited).
In reference to at least claim 8
Smith modified by Smith ‘981 and Coneys renders obvious a device according to claim 6. Smith further discloses a connection element (e.g. 429) a hose barb fitting (e.g. para. [0069]) but does not explicitly teach wherein: the connection element is a hose barb fitting disposed at least partially within the driveline at the proximal end of the driveline, and the hose barb fitting includes: a longitudinal axis, a transverse axis, at least one barb on an exterior surface, an interior surface defining the channel, and a flange, the channel is disposed substantially along the longitudinal axis, the at least one barb extends circumferentially outward from the interior surface substantially along the transverse axis, the at least one barb being sized to be embedded into an inner wall of the driveline, and a flange disposed at the proximal end of the hose barb fitting and extending circumferentially outward and substantially along the transverse axis, the flange being located external to the driveline and extending substantially to the outer edge of the proximal end of the driveline, an exterior-facing surface of the flange being configured to be mated with an exterior surface of the corresponding connection element associated with the delivery dilator.
Morrissey discloses a connection element with common barbs (e.g. 16) for a secure connection (e.g. para [0006]) and a flange for providing a stop/flange (e.g. 8) against further penetration of the barbs (e.g. para [0017]).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date to apply this known improvement technique of barbs and flanges in the same manner to the prior art connection element of Smith and the results would have been predictable in order to provide a secure connection between the connection element and the device.
In reference to at least claim 9
Smith modified by Smith ‘981, Coneys and Morrissey renders obvious a device according to claim 8. Morrissey further discloses wherein the exterior-facing surface of the flange is: rounded at the outer-most edge (e.g. Figs. 1, 2) to mitigate against vascular injury when the driveline is being pulled through the patient’s vasculature, and shaped and sized to male flush with and at least substantially create a vacuum with the exterior surface of the corresponding connection element associated with the delivery dilator (e.g. the flat surface of stop 8, Fig. 1, 2 is fully capable of mating flush with the flat surface of driveline 120, Figs. 4a,4b disclosed within Smith).
In reference to at least claim 10
Smith modified by Smith ‘981, Coneys and Morrissey renders obvious a device according to claim 8. Smith further discloses wherein: the driveline includes an outer membrane (e.g. 428), an inner membrane (e.g. 426), and a kink-resistant element (e.g. 427) disposed between the outer membrane and the inner membrane along a first length of the driveline (e.g. Fig. 4b), and the at least one barb is embedded into the inner membrane of the driveline (e.g. barb 16 of Morrissey).
Claim(s) 28-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0360663 to Smith et al. (Smith) in view of US 2020/0182387 to Morrissey (Morrissey) (previously cited).
In reference to at least claim 28
Smith renders obvious a device according to claim 27. Smith further discloses a connection element (e.g. 429) a hose barb fitting (e.g. para. [0069]) but does not explicitly teach wherein: the connection element that is secured to the proximal end of the driveline is a hose barb fitting disposed at least partially within the driveline at the proximal end of the driveline, and the hose barb fitting includes: a longitudinal axis, a transverse axis, at least one barb on an exterior surface, an interior surface defining the channel, and a flange, the channel is disposed substantially along the longitudinal axis, the at least one barb extends circumferentially outward from the interior surface substantially along the transverse axis, the at least one barb being sized to be embedded into an inner wall of the driveline, and a flange disposed at the proximal end of the hose barb fitting and extending circumferentially outward and substantially along the transverse axis, the flange being located external to the driveline and extending substantially to the outer edge of the proximal end of the driveline, an exterior-facing surface of the flange being configured to be mated with an exterior surface of the corresponding connection element associated with the delivery dilator.
Morrissey discloses a connection element with common barbs (e.g. 16) for a secure connection (e.g. para [0006]) and a flange for providing a stop/flange (e.g. 8) against further penetration of the barbs (e.g. para [0017]).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date to apply this known improvement technique of barbs and flanges in the same manner to the prior art connection element of Smith and the results would have been predictable in order to provide a secure connection between the connection element and the device.
In reference to at least claim 29
Smith modified by Morrissey renders obvious a device according to claim 28. Smith further discloses wherein: the kink-resistant element (e.g. 427) is disposed between the outer membrane and the inner membrane along a first length of the driveline (e.g. Fig. 4b), and the at least one barb is embedded into the inner membrane of the driveline (e.g. barb 16 of Morrissey).
In reference to at least claim 30
Smith modified by Morrissey renders obvious a device according to claim 29. Smith further discloses wherein: radio opaque material is disposed between the outer membrane and the inner membrane along a second length of the driveline (nitinol is radio opaque), and the second length of the driveline is proximate to or at the distal end of the driveline (e.g. can extend the entirely of the driveline; para [0082]; Fig. 4b).
In reference to at least claim 31
Smith modified by Morrissey renders obvious a device according to claim 30. Smith further discloses wherein the radio opaque material has substantially the same thickness as the kink-resistant element (e.g. Figs. 4a, 4b).
Claim(s) 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0360663 to Smith et al. (Smith) in view of US 2018/0055981 to Smith et al. (Smith ‘981) and US Patent No. 4,657,024 to Coneys (Coneys) as applied to claim 1 further in view of US 2007/0005010 to Mori et al. (Mori) and US 2019/0192164 to Parekh et al. (Parekh) (both previously).
In reference to at least claim 37
Smith modified by Smith ‘981 and Coneys renders obvious a pump according to claim 1. Smith further discloses a combined length of the proximal and central regions of the balloon is between approximately 100 mm and 220 mm (e.g. “The expandable member 110 can have a length between about 15 cm and about 30 cm. In some embodiments, for example, the expandable member 110 has a length greater than about 19 cm, such as about 20 cm or about 25 cm.”, para [0080]) and that the expandable member has a substantially uniform diameter (e.g. Figs. 3a, 3b, para (0077]-[0078]).
However, Smith fails to disclose the central region of the balloon has a substantially uniform exterior diameter being approximately 12 mm to 20 mm, and the length of the distal region of the balloon is greater than approximately 15% of the combined length of the proximal and central regions of the balloon.
As to the limitation of the central region of the balloon with substantially uniform exterior diameter of approximately 12 mm to 20 mm. Mori discloses an intra-aortic balloon catheter that includes a balloon (e.g. extraction/contraction portion 3a) that has an inner volume of 20 to 50 cc and preferably has an outer diameter that is 12 to 20 mm (e.g. “For example, when an inner volume of the extraction/contraction portion 3a is 20 to 50 cc, it is preferable that the outer diameter is 12 to 20 mm”, para. [0051]) to assist cardiac function by improving the blood pressure in the aorta (e.g. para. [0002])
Since Smith discloses the expandable member has a diameter, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the central region of Smith to include a substantially uniform exterior diameter of approximately 12 mm to 20 mm, as taught by Mori, in order to assist cardiac function by improving the blood pressure in the aorta (‘101, para. [0002]).
As to the limitation of the length of the distal region of the balloon is greater than approximately 15% of the combined length of the proximal and central regions of the balloon. Parekh discloses an intra-aortic balloon pump with a distal region of the balloon being greater than approximately 15% of the combined length of the proximal and central regions of the balloon (e.g. Fig. 2; para [0037], [0040]). The length of the distal region aids positioning of the balloon to the appropriate location (e.g. para [0037]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the intra-aortic balloon pump of Smith to any usable length including a distal region of the balloon being greater than approximately 15% of the combined length of the proximal and central regions of the balloon, as taught by Parekh, in order to aid in positioning of the balloon to the appropriate location (‘164, para (0037]).
Response to Arguments
Claim Rejections under 35 USC 112
Applicant argues “ Claims 1-15 and 20-37 are supported by the disclosure of the application as originally filed. Specifically, FIGS. 9-12 clearly distinguish the outer membrane having a thickness greater than a thickness of the inner membrane, signifying that the invention is complete as evidenced by a reduction to drawings sufficiently detailed to show the inventor was in possession of the claimed invention. In fact, all of the figures that show a cross-section of the driveline (i.e., FIGS. 9-12) are consistent in distinguishing thicknesses of the inner and outer membranes. Further, FIGS. 9-12 provide clear differences in thickness of the inner and outer membranes that distinguish the claimed invention from the cited references, as applied by the Examiner, and would lead one of skill in the art to conclude that the inventor was sufficiently in possession of the claimed invention (see MPEP § 2163(II)(A)(3)(a)(i)).”, see pgs. 12-13 of the response filed 4/28/2026. This is not persuasive. As stated above, the original disclosure does not provide support for the claim language. The drawings show an inner membrane (406 or 904) and an outer membrane (408 or 902) with a thickness but do not provide specifics regarding the thickness of each membrane including support for the inner membrane having a thickness less than an outer membrane. There is no indication within the original disclosure that the drawings are to scale and the original disclosure is silent as to the dimensions within the drawings, therefore the features in the drawings are not evidence of actual proportions.
Claim Rejections under 35 USC 103
Amended Independent Claim1 and its Dependents are Allowable
Applicant’s arguments with respect to claim(s) 1, see pgs. 13-14 of response filed 4/28/2026, have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Amended Independent Claim 24 and its Dependents are Allowable
Applicant argues that Smith fails to teach or suggest "the driveline includes an outer membrane, an inner membrane, and a kink resistant element disposed therebetween, the outer membrane having a first thickness, the inner membrane having a second thickness less than the first thickness" as recited by amended claim 24… These reinforcements permit navigation of the tortuous curvature from the axillary artery to the thoracic aorta (or vice-versa)" to which indicates significance to the particular arrangement of the inner membrane having a second thickness less than the first thickness ([Applicant's Specification, paragraph [0092]).”, see pg. 14-15 ore response filed 4/28/2026. This is not persuasive. Applicant points to paragraph [0092] as showing support for significance to the particular arrangement of the inner membrane having a second thickness less than the first thickness, however paragraph [0092] does not recite anything related to the thickness of the membranes. As stated within the rejection, it would have been an obvious matter of design choice to modify the Smith reference, to have the inner membrane having a second thickness less than the first thickness of the outer membrane, since applicant has not disclosed that having the inner membrane having a second thickness less than the first thickness of the outer membrane solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs, i.e. the thicknesses shown within Smith or the claimed thicknesses.
New Independent Claim 41 and its Dependents are Allowable
Separate arguments are not provided for independent claim 41, therefore claim 41 is believed to be fully addressed in the response to arguments regarding independent claim 24 above.
Conclusion
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