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
Acknowledgement is made of applicant’s amendment which was received by the office on October 10, 2025. Claims 1-15 and 20-37 are currently pending and under examination.
Claim Rejections - 35 USC § 112
In view of the amendment filed on 10/10/2025 clarifying the language of claims 6,8 and 27-28 the 112 rejections made against claims 6-15 and 27-31 in the office action of 4/10/2025 have been withdrawn.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 1-15 and 20-37 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 1 and 24 have been amended to recite “the outer membrane having a first thickness, the inner membrane having a second thickness greater 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 greater 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 2-15, 20-23 and 25-37 directly or indirectly depend from claim 1 or claim 24 and are also rejected to for the reasons stated above regarding claims 1 and 24.
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 25 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 25, line 3 recites “inclusive, and” which is unclear since there is no language provided after the “and”, clarification is required. Claim 25 is also missing a period making it unclear whether applicant intended to include more language after the “and”, clarification is required. For the purposes of examination it has been interpreted to be a combined length of between approximately 100mm and 220 mm.
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) 1-7, 11-15, 20-27 and 32-36 s/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 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), 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 (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) having a distal end (e.g. Fig. 3c), a proximal end (e.g. Fig. 4a), and a central lumen (e.g. 421), the central lumen 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).
However, Smith fails to disclose the inner membrane having a second thickness greater 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 greater than the first thickness of the outer membrane, since applicant has not disclosed that having the inner membrane having a second thickness greater 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 greater 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 2
Smith further discloses wherein the distal end of the balloon is rounded (e.g. Fig. 3b).
In reference to at least claim 3
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 further discloses wherein the distal end of the balloon is bullet-shaped (e.g. Fig. 3b).
In reference to at least claim 5
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 further 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]) 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 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 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 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 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 14
Smith further discloses wherein the radio opaque material is a ring (e.g. see cross-section showing 427 is ring shaped).
In reference to at least claim 15
Smith further discloses wherein the radio opaque material has substantially the same thickness as the kink-resistant element (e.g. Figs. 4a, 4b).
In reference to at least claim 20
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 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 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 further 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 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 also fails to disclose the inner membrane having a second thickness greater 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 greater than the first thickness of the outer membrane, since applicant has not disclosed that having the inner membrane having a second thickness greater 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 greater 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).
Claim(s) 8-10 and 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 8
Smith 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 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 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).
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 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 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 ballon 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
Applicant's arguments filed 10/10/2025 have been fully considered but they are not persuasive. Applicant argues “the cited references fail to disclose or suggest a “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 greater than the first thickness,” as recited by amended independent claims | and 24. Accordingly, Applicant respectfully asserts that amended independent claims 1 and 24, and their respective dependent claims, are patentable over the cited references. 12”, see pg. 12 of the response filed 10/10/2025, the examiner respectfully disagrees. It is noted that the 103 rejection using Smith has been amended in view of the claim amendments. Smith discloses a driveline (e.g. 120) that 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 has a first thickness and the inner membrane has a second thickness ( outer membrane 428 and inner membrane 426 each have a thickness, Fig. 4B). Regarding, the inner membrane having a second thickness greater than the first thickness of the outer membrane, 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 greater than the first thickness of the outer membrane, since applicant has not disclosed that having the inner membrane having a second thickness greater 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 greater 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.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/JG/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796