DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
Applicant should note that the large number of references in the attached IDS, see IDS received on 11/18/2025, have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper filed of search. See MPEP 609.05(b). Applicant is requested to point out any particular references in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this Office Action.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Election/Restrictions
Applicant’s election without traverse of Species I,III,V,VIII,IX claims 1-10,12-20,22,24-35, 37-45,47-50,52,54-59 and 61-62 in the reply filed on 2/10/2026 is acknowledged. Claims 11,21,23,36,46,51,53 and 60 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/10/2026.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-10,12-20,22,24-35, 37-45,47-50,52,54-59 and 61-62 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 1 recites “the head region is configured to oppose forces that would otherwise cause the balloon to roll or fold upon itself along an angle with respect to the balloon's longitudinal axis, when the blood pump assembly is implanted in the descending aorta and the head region is disposed in the balloon.” It is unclear what structural features of the head region applicant is intending to encompass when reciting the head region is configured to oppose forces that would otherwise cause the balloon to roll or fold upon itself along an angle with respect to the balloon's longitudinal axis, when the blood pump assembly is implanted in the descending aorta and the head region is disposed in the balloon, clarification is required. The specification recites that by disposing a support structure into a blood. Claim 4 recites “the head region is configured to oppose forces that would otherwise cause the balloon to roll or fold upon itself along an angle with respect to the balloon's transverse axis.” It is unclear what structural features of the head region applicant is intending to encompass when reciting the head region is configured to oppose forces that would otherwise cause the balloon to roll or fold upon itself along an angle with respect to the balloon's transverse axis, clarification is required. Claim 14 recites the limitation "the cap" in line 1 and “the anti-backout port” in line 2. There is insufficient antecedent basis for these limitations in the claim. Claim 37 recites “the head region is configured to oppose forces that would otherwise cause the balloon to roll or fold upon itself along an angle with respect to at least one of the balloon's longitudinal and transverse axes.” It is unclear what structural features of the head region applicant is intending to encompass when reciting the head region is configured to oppose forces that would otherwise cause the balloon to roll or fold upon itself along an angle with respect to the balloon's longitudinal and transverse axes. clarification is required. Claim 61 recites “wherein the support structure comprises a sleeve” and then recites “[the sleeve being] configured to surround at least a portion of the support structure” it is unclear how the support structure comprises a sleeve and the sleeve is configured to surround a portion of the support structure. Is applicant stating the support structure includes a sleeve which is configured to surround at least a portion of itself? Clarification is required. Claims 2-10,12-20,22,24-35, 38-45,47-50,52,54-59 and 61-62 directly or indirectly depend from claims 1 and 37 and are also rejected to for the reasons stated above regarding claims 1 and 37. For the purposes of examination, as best understood, claims 1,4 and 37 have been interpreted to include support structures which oppose the balloon folding or rolling upon itself. For the purposes of examination, as best understood, claim 61 has been interpreted to include a support structure that includes a sleeve.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-7,9,22,28-29,33-34,37-43,52,55-56,61-62 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent No. 4,931,036 to Kanai et al. (Kanai) (cited by applicant).
In reference to at least claim 1
Kanai discloses a blood pump support apparatus for a blood pump assembly (e.g. “Fig. 1 shows a longitudinal section of an intra-aortic balloon pump”, Col. 4, ll. 4-6) having an inflatable balloon (e.g. balloon 1, Fig. 1) coupled to a driveline (e.g. catheter 3 in connection with drive tube 9, Col. 5, ll. 53-57), the driveline configured to shuttle a working fluid into and out of the inflatable balloon during operation such that when the blood pump assembly is implanted in the descending aorta of a patient, the blood pump assembly provides circulatory support to the patient (e.g. “A drive tube 9 of a drive unit (not shown, but having a construction as indicated at 30 in FIG. 4a)”, Col. 5, ll. 53-57), the blood pump support apparatus comprising: a support structure (e.g. the assembly of sleeve 4 and insertion member 6, Fig. 1) having a head region (e.g. sleeve 4, Fig. 1) and a tail region (e.g. portion of insertion member 6 reaching chuck 6b, Fig. 1), the support structure being configured to be removably disposable in the blood pump assembly such that the head region is disposed in the balloon (e.g. “At this time, the insertion member 6 is pulled out from the catheter 3, and thus is separated therefrom. Under this condition, the portion of the intra-aortic balloon pump which is to be inserted into the physical body of a patient, namely, part of the balloon 1 and the catheter 3, can be inserted into the aorta of the patient… If he then further drives the chuck 6b inward until such braking action is removed, the sleeve 4 is positioned in its position of use as illustrated in FIG. 1., Col. 5, ll. 13-38; “The only requirement is that the sleeve member is movable between a given position within the balloon and the retracted position away therefrom “, Col. 6, ll. 27-30); and the head region is configured to oppose forces that would otherwise cause the balloon to roll or fold upon itself along an angle with respect to the balloon's longitudinal axis (e.g. “The absence of the sleeve 4 within the balloon 1 enables the balloon 1 to be folded into a smaller diameter than the catheter 3.”, thus the sleeve 4 is configured to oppose forces that would otherwise cause the balloon to fold upon itself along an angle equal to 0 or 180 degrees with respect to the balloon’s longitudinal axis, Col. 5, ll. 11-13), when the blood pump assembly is implanted in the descending aorta and the head region is disposed in the balloon (e.g. “The only requirement is that the sleeve member…has the construction which prevents its blockage of a fluid channel formed therein if the balloon undergoes a deflating motion.”, Col. 6, ll. 27-33, thus the configuration of the sleeve member 4 as disclosed in Col 5, ll. 11-13 such that “The absence of the sleeve 4 within the balloon 1 enables the balloon 1 to be folded into a smaller diameter than the catheter 3”, also applied for the intended functioning of the balloon 1 when implanted in the descending aorta and sleeve member 4 is disposed inside balloon 1).
In reference to at least claim 2
Kanai discloses wherein the support structure is removably disposable in the blood pump assembly via implantation through the driveline (e.g. “At this time, the insertion member 6 is pulled out from the catheter 3, and thus is separated therefrom. Under this condition, the portion of the intra-aortic balloon pump which is to be inserted into the physical body of a patient, namely, part of the balloon 1 and the catheter 3, can be inserted into the aorta of the patient… If he then further drives the chuck 6b inward until such braking action is removed, the sleeve 4 is positioned in its position of use as illustrated in FIG. 1., Col. 5, ll. 13-38; “The only requirement is that the sleeve member is movable between a given position within the balloon and the retracted position away therefrom “, Col. 6, ll. 27-30).
In reference to at least claim 3
Kanai discloses wherein when the head region is disposed in the balloon (e.g. sleeve 4 is disposed in balloon 1, Fig. 1), the tail region is disposed in the driveline (e.g. portion of insertion member 6 reaching chuck 6b is disposed in the catheter 3, Fig. 1).
In reference to at least claim 4
Kanai discloses wherein, when the blood pump assembly is implanted in the descending aorta and the support structure is disposed in the blood pump assembly, the head region is configured to oppose forces that would otherwise cause the balloon to roll or fold upon itself along an angle with respect to the balloon's transverse axis (e.g. “The absence of the sleeve 4 within the balloon 1 enables the balloon 1 to be folded into a smaller diameter than the catheter 3.”, thus the sleeve 4 is configured to oppose forces that would otherwise cause the balloon to fold upon itself along an angle equal to 0 or 180 degrees with respect to the balloon’s transverse axis, Col. 5, ll. 11-13).
In reference to at least claim 5
Kanai discloses wherein the support structure comprises a wire (e.g. sleeve 4 and insertion element 6 may include a wire 5, Figs. 1, 2a-2b).
In reference to at least claim 6
Kanai discloses wherein the wire is one of Nitinol and stainless steel (e.g. “The wire 5 is formed of a stainless steel”, Col. 4, ll. 18-21).
In reference to at least claim 7
Kanai discloses wherein the head region comprises one of Nitinol and stainless steel (e.g. sleeve 4 may include a wire 5, Figs. 1, 2a, “The wire 5 is formed of a stainless steel”, Col. 4, ll. 18-21).
In reference to at least claim 9
Kanai discloses wherein when the head region is disposed in the balloon (e.g. sleeve 4 is disposed within balloon 1, Fig. 1), the tail region is disposed in the driveline (e.g. portion of insertion member 6 reaching chuck 6b is disposed within catheter 3, Fig. 1) and the proximal end of the tail region is external to the proximal end of the driveline (e.g. portion of insertion member 6 reaching chuck 6b which is external to catheter 3, Fig. 1).
In reference to at least claim 22
Kanai discloses wherein the profile of the head region tapers distally toward the distal end of the head region to form a nipple (e.g. distal end of the sleeve 4 tapers to form a nipple, Fig. 1).
In reference to at least claim 28
Kanai discloses one or more non- radiopaque materials is disposed at a location on the support structure (e.g. “A sleeve 4 and an insertion member 6, both formed of polyethylene,”, polyethylene is non-radiopaque, Col. 4, ll. 37-28) such that when the one or more non-radiopaque material are aligned with a predetermined location of the driveline, it is determined that head region is disposed in the balloon (e.g. “When the sleeve 4 enters the internal space of the balloon 1 and reaches a given position, its distal end 4a moves past the projection 5a formed on the wire, allowing the operator to perceive a temporary braking action through the chuck 6b. If he then further drives the chuck 6b inward until such braking action is removed, the sleeve 4 is positioned in its position of use as illustrated in FIG. 1.”, Col. 5, ll. 31-38).
In reference to at least claim 29
Kanai discloses wherein the one or more non-radiopaque materials are visual markers and the predetermined location of the driveline is a proximal end of the driveline (e.g. “When the sleeve 4 enters the internal space of the balloon 1 and reaches a given position, its distal end 4a moves past the projection 5a formed on the wire, allowing the operator to perceive a temporary braking action through the chuck 6b. If he then further drives the chuck 6b inward until such braking action is removed, the sleeve 4 is positioned in its position of use as illustrated in FIG. 1.”, Col. 5, ll. 31-38).
In reference to at least claim 33
Kanai discloses one or more non- radiopaque materials is disposed at a location on the support structure (e.g. “A sleeve 4 and an insertion member 6, both formed of polyethylene,”, polyethylene is non-radiopaque, Col. 4, ll. 37-28) such that when the one or more non-radiopaque material are aligned with a predetermined location of the driveline, it is determined that head region is disposed in the balloon (e.g. “When the sleeve 4 enters the internal space of the balloon 1 and reaches a given position, its distal end 4a moves past the projection 5a formed on the wire, allowing the operator to perceive a temporary braking action through the chuck 6b. If he then further drives the chuck 6b inward until such braking action is removed, the sleeve 4 is positioned in its position of use as illustrated in FIG. 1.”, Col. 5, ll. 31-38).
In reference to at least claim 34
Kanai discloses wherein the one or more non-radiopaque materials are visual markers and the predetermined location of the driveline is a proximal end of the driveline (e.g. “When the sleeve 4 enters the internal space of the balloon 1 and reaches a given position, its distal end 4a moves past the projection 5a formed on the wire, allowing the operator to perceive a temporary braking action through the chuck 6b. If he then further drives the chuck 6b inward until such braking action is removed, the sleeve 4 is positioned in its position of use as illustrated in FIG. 1.”, Col. 5, ll. 31-38).
In reference to at least claim 37
Kanai discloses a blood pump support method for a blood pump support apparatus for a blood pump assembly (e.g. “Fig. 1 shows a longitudinal section of an intra-aortic balloon pump”, Col. 4, ll. 4-6) having an inflatable balloon (e.g. balloon 1, Fig. 1) coupled to a driveline (e.g. catheter 3 in connection with drive tube 9, Col. 5, ll. 53-57), the driveline configured to shuttle a working fluid into and out of the inflatable balloon during operation such that when the blood pump assembly is implanted in the descending aorta of a patient, the blood pump assembly provides circulatory support to the patient (e.g. “A drive tube 9 of a drive unit (not shown, but having a construction as indicated at 30 in FIG. 4a)”, Col. 5, ll. 53-57), the blood pump support method comprising: implanting a support structure in the blood pump assembly (e.g. the assembly of sleeve 4 and insertion member 6, Fig. 1) such that having a head region of the support structure is disposed in the balloon (e.g. sleeve 4 is disposed within balloon 1, Fig. 1) and a tail region of the support structure is disposed in the driveline (e.g. portion of insertion member 6 reaching chuck 6b is disposed within catheter 3, Fig. 1), wherein when the blood pump assembly is implanted in the descending aorta and the head region is disposed in the balloon (e.g. “The only requirement is that the sleeve member…has the construction which prevents its blockage of a fluid channel formed therein if the balloon undergoes a deflating motion.”, Col. 6, ll. 27-33, thus the configuration of the sleeve member 4 as disclosed in Col 5, ll. 11-13 such that “The absence of the sleeve 4 within the balloon 1 enables the balloon 1 to be folded into a smaller diameter than the catheter 3”, also applied for the intended functioning of the balloon 1 when implanted in the descending aorta and sleeve member 4 is disposed inside balloon 1) the head region is configured to oppose forces that would otherwise cause the balloon to roll or fold upon itself along an angle with respect to the balloon's longitudinal axis and transverse axis (e.g. “The absence of the sleeve 4 within the balloon 1 enables the balloon 1 to be folded into a smaller diameter than the catheter 3.”, thus the sleeve 4 is configured to oppose forces that would otherwise cause the balloon to fold upon itself along an angle equal to 0 or 180 degrees with respect to the balloon’s longitudinal and transverse axis, Col. 5, ll. 11-13).
In reference to at least claim 38
Kanai discloses the method further comprising implanting the blood pump assembly in the descending aorta (e.g. “can be inserted into the aorta….When the balloon pump is inserted into the aorta of the patient”, the pump is inserted into the aorta which includes the descending aorta, Col. 5, ll. 16-24).
In reference to at least claim 39
Kanai discloses the method further comprising at least partially inflating the balloon prior to implanting the support structure (e.g. “At this time, the insertion member 6 is pulled out from the catheter 3, and thus is separated therefrom. Under this condition, the portion of the intra-aortic balloon pump which is to be inserted into the physical body of a patient, namely, part of the balloon 1 and the catheter 3, can be inserted into the aorta of the patient… If he then further drives the chuck 6b inward until such braking action is removed, the sleeve 4 is positioned in its position of use as illustrated in FIG. 1., Col. 5, ll. 13-38).
In reference to at least claim 40
Kanai discloses wherein implanting the support structure comprising implanting the support structure through the driveline (e.g. “ the sleeve 4 is initially positioned to its retracted position or within the internal space of the catheter 3, and the balloon 1 is previously folded.”, Col. 5, ll. 8-11, “The distal end of the insertion member 6 is then inserted through the opening of the connector 7 and is expelled in the direction of the arrow AR1 while holding the chuck 6b with hand. This moves the sleeve 4 in the same direction. When the sleeve 4 enters the internal space of the balloon 1 and reaches a given position, its distal end 4a moves past the projection 5a formed on the wire,” Col. 5, ll. 27-38).
In reference to at least claim 41
Kanai discloses wherein the support structure comprises a wire (e.g. sleeve 4 and insertion element 6 may include a wire 5, Figs. 1, 2a-2b).
In reference to at least claim 42
Kanai discloses wherein the wire is one of Nitinol and stainless steel (e.g. “The wire 5 is formed of a stainless steel”, Col. 4, ll. 18-21).
In reference to at least claim 43
Kanai discloses wherein implanting the support structure in the blood pump assembly comprises externalizing the proximal end of the tail region with respect to the proximal end of the driveline (e.g. portion of insertion member 6 reaching chuck 6b which is external to catheter 3, Fig. 1).
In reference to at least claim 52
Kanai discloses wherein the profile of the head region tapers distally toward the distal end of the head region to form a nipple (e.g. distal end of the sleeve 4 tapers to form a nipple, Fig. 1).
In reference to at least claim 55
Kanai discloses a non-radiopaque materials is disposed at a location on the support structure (e.g. “A sleeve 4 and an insertion member 6, both formed of polyethylene,”, polyethylene is non-radiopaque, Col. 4, ll. 37-28); and implanting the support structure in the blood pump assembly comprises advancing the support structure until the non-radiopaque materials is aligned with a predetermined location of the driveline (e.g. “When the sleeve 4 enters the internal space of the balloon 1 and reaches a given position, its distal end 4a moves past the projection 5a formed on the wire, allowing the operator to perceive a temporary braking action through the chuck 6b. If he then further drives the chuck 6b inward until such braking action is removed, the sleeve 4 is positioned in its position of use as illustrated in FIG. 1.”, Col. 5, ll. 31-38).
In reference to at least claim 56
Kanai discloses wherein the non-radiopaque material is a visual marker and the predetermined location of the driveline is a proximal end of the driveline (e.g. “When the sleeve 4 enters the internal space of the balloon 1 and reaches a given position, its distal end 4a moves past the projection 5a formed on the wire, allowing the operator to perceive a temporary braking action through the chuck 6b. If he then further drives the chuck 6b inward until such braking action is removed, the sleeve 4 is positioned in its position of use as illustrated in FIG. 1.”, Col. 5, ll. 31-38).
In reference to at least claim 61
Kanai discloses wherein the support structure comprises a sleeve configured to surround at least a portion of the support structure to facilitate implantation and explantation into the blood pump assembly (e.g. the assembly of sleeve 4 and insertion member 6, Fig. 1).
In reference to at least claim 62
Kanai discloses wherein implanting and explanting the support structure in the blood pump assembly comprises surrounding at least a portion of the support structure with a sleeve (e.g. the assembly of sleeve 4 and insertion member 6, Fig. 1).
Claim(s) 1-7,9-10, 12-13,15-17,37-45 and 47-48 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by JPH0724060 to Miyata et al. (Miyata) (cited by applicant- English translation provided by applicant).
In reference to at least claim 1
Miyata discloses a blood pump support apparatus for a blood pump assembly (e.g. blood pump assembly Figs. 1-3,6-7) having an inflatable balloon (e.g. balloon portion 22) coupled to a driveline (e.g. catheter tube 24), the driveline configured to shuttle a working fluid into and out of the inflatable balloon during operation such that when the blood pump assembly is implanted in the descending aorta of a patient, the blood pump assembly provides circulatory support to the patient (e.g. Figs. 1, 6; para. [0001]: the present invention relates to a balloon catheter to be used in the intra-aortic balloon pumping method for treating e.g. acute heart failure; para. [0020]: the balloon portion 22 is adapted to expand or contract by fluid pressure introduced into the balloon portion 22 via catheter tube 24; para. [0023]: pressure fluid inlet and outlet 28 in fluid communication with catheter tube 24 is connected to a pump device 8 as shown in Fig. 6), the blood pump support apparatus comprising: a support structure having a head region and a tail region, the support structure being configured to be removably disposable in the blood pump assembly such that the head region is disposed in the balloon (e.g. stylet tube 42; Figs. 1, 3 shows the head of stylet tube 42 disposed in balloon portion 22; Figs. 1, 2 show the rear end of stylet tube 42 attached to connector 40, which can be unscrewed from distal tip 26 of catheter 24); and the head region is configured to oppose forces that would otherwise cause the balloon to roll or fold upon itself along an angle with respect to the balloon's longitudinal axis , when the blood pump assembly is implanted in the descending aorta and the head region is disposed in the balloon (e.g. para. [ 0014], Figs. 1-3: the metal stylet 42 tube has a larger rigidity as compared to the flexible inner tube 30, the insertion of the stylet 42 improves the stiffness of the balloon catheter, reducing the risk of the latter being pushed back by the blood flow and preventing kink or bending; since the style 42 reaches the balloon portion 22, as shown in Fig. 3, the skilled reader understands the stylet 42 also improves the stiffness of the balloon portion 22, reducing the risk of the latter being pushed back by the blood flow and preventing kink or bending) when the blood pump assembly is implanted in the descending aorta and the head region is disposed in the balloon (e.g. para. [0032]-[0033]: it is after insertion of the balloon catheter 20 that the stylet tube 42 is inserted; this interpretation is further clear since measurement of the blood pressure fluctuations is disclosed with the stylet 42 inserted, para. [0033], [0031], Fig. 7 disclosing passage 70 for communicating the blood pressure measuring port 44 and the measurement port 32 shown in Fig. 1).
In reference to at least claim 2
Miyata discloses wherein the support structure is removably disposable in the blood pump assembly via implantation through the driveline (e.g. para. [0032]-[0033]: it is after insertion of the balloon catheter 20 that the stylet tube 42 is inserted within catheter tube 24, Figs. 1-2).
In reference to at least claim 3
Miyata discloses wherein when the head region is disposed in the balloon the tail region is disposed in the driveline (e.g. stylet tube 42; Figs. 1, 3 shows the head of stylet tube 42 disposed in balloon portion 22; Figs. 1, 2 show the rear end of stylet tube 42 disposed in catheter tube 24 and attached to connector 40).
In reference to at least claim 4
Miyata discloses wherein, when the blood pump assembly is implanted in the descending aorta and the support structure is disposed in the blood pump assembly, the head region is configured to oppose forces that would otherwise cause the balloon to roll or fold upon itself along an angle with respect to the balloon's transverse axis (e.g. para. [ 0014], Figs. 1-3: the metal stylet 42 tube has a larger rigidity as compared to the flexible inner tube 30, the insertion of the stylet 42 improves the stiffness of the balloon catheter, reducing the risk of the latter being pushed back by the blood flow and preventing kink or bending; since the style 42 reaches the balloon portion 22, as shown in Fig. 3, the skilled reader understands the stylet 42 also improves the stiffness of the balloon portion 22, reducing the risk of the latter being pushed back by the blood flow and preventing kink or bending).
In reference to at least claim 5
Miyata discloses wherein the support structure comprises a wire (e.g. para.[0028]: As the metal constituting the stylet tube 42 is not particularly limited, and examples thereof include stainless steel and tungsten, but stainless steel is preferably used.).
In reference to at least claim 6
Miyata discloses wherein the wire is one of Nitinol and stainless steel (e.g. para.[0028]: As the metal constituting the stylet tube 42 is not particularly limited, and examples thereof include stainless steel and tungsten, but stainless steel is preferably used.).
In reference to at least claim 7
Miyata discloses wherein the head region comprises one of Nitinol and stainless steel (e.g. para.[0028]: As the metal constituting the stylet tube 42 is not particularly limited, and examples thereof include stainless steel and tungsten, but stainless steel is preferably used.).
In reference to at least claim 9
Miyata discloses wherein when the head region is disposed in the balloon and the tail region is disposed in the driveline(e.g. stylet tube 42; Figs. 1, 3 shows the head of stylet tube 42 disposed in balloon portion 22; Figs. 1, 2 show the rear end of stylet tube 42 disposed in catheter tube 24 and attached to connector 40) and the proximal end of the tail region is external to the proximal end of the driveline (e.g. stylet tube 42; Figs. 1, 3 shows the head of stylet tube 42 disposed in balloon portion 22; Figs. 1, 2 show the rear end of stylet tube 42 disposed in catheter tube 24 and extending therefrom, Fig. 1).
In reference to at least claim 10
Miyata discloses further comprising a connector (e.g. y-connector that includes connector 40, Figs. 1-2) having a distal end that is removably coupleable to a proximal end of the driveline (e.g. connector 40 is removably coupled, Figs. 1-2) the connector being configured to secure the tail region of the support structure (e.g. rear end of stylet tube 42 attached to connector, Figs 1-2).
In reference to at least claim 12
Miyata discloses wherein the connector comprises a cap (e.g. cap containing port 44, Figs. 1-2) and a proximal end of the tail region terminates proximate an inside surface of a cap, thereby containing the proximal end of the tail region (e.g. rear end of stylet tube 42 includes a proximal portion contained within connector 40, Figs 1-2).
In reference to at least claim 13
Miyata discloses wherein the proximal end of the tail region includes a flange (e.g. rear end of stylet tube 42 includes a flange, Figs 1-2).
In reference to at least claim 15
Miyata discloses the driveline has a lumen (e.g. catheter tube 24 has a lumen), and the connector include a pneumatic port that is in fluid communication with the driveline lumen (e.g. para. [0023]: pressure fluid inlet and outlet 28 in fluid communication with catheter tube 24 is connected to a pump device 8, Fig. 6),
In reference to at least claim 16
Miyata discloses wherein when the head region is disposed in the blood pump assembly and the tail region is configured to be disposed in the driveline lumen (e.g. stylet tube 42; Figs. 1, 3 shows the head of stylet tube 42 disposed in balloon portion 22; Figs. 1, 2 show the rear end of stylet tube 42 within catheter tube 24 attached to connector 40)
In reference to at least claim 17
Miyata discloses wherein the connector is a y- connector (e.g. Y-shaped connector, Fig. 1).
In reference to at least claim 37
Miyata discloses a blood pump support method for a blood pump assembly having an inflatable balloon coupled to a driveline (e.g. blood pump assembly Figs. 1-3,6-7), the driveline configured to shuttle a working fluid into and out of the inflatable balloon during operation such that when the blood pump assembly is implanted in the descending aorta of a patient, the blood pump assembly provides circulatory support to the patient (e.g. Figs. 1, 6; para. [0001]: the present invention relates to a balloon catheter to be used in the intra-aortic balloon pumping method for treating e.g. acute heart failure; para. [0020]: the balloon portion 22 is adapted to expand or contract by fluid pressure introduced into the balloon portion 22 via catheter tube 24; para. [0023]: pressure fluid inlet and outlet 28 in fluid communication with catheter tube 24 is connected to a pump device 8 as shown in Fig. 6), the blood pump support method comprising: implanting a support structure in the blood pump assembly such that a head region of the support structure is disposed in the balloon and a tail region of the support structure is disposed in the driveline (e.g. stylet tube 42; Figs. 1, 3 shows the head of stylet tube 42 disposed in balloon portion 22; Figs. 1, 2 show the rear end of stylet tube 42 with a catheter tube 24 attached to connector 40, which can be unscrewed from distal tip 26 of catheter 24), wherein when the blood pump assembly is implanted in the descending aorta and the head region is disposed in the balloon (e.g. para. [0032]-[0033]: it is after insertion of the balloon catheter 20 that the stylet tube 42 is inserted; this interpretation is further clear since measurement of the blood pressure fluctuations is disclosed with the stylet 42 inserted, para. [0033], [0031], Fig. 7 disclosing passage 70 for communicating the blood pressure measuring port 44 and the measurement port 32 shown in Fig. 1), the head region is configured to oppose forces that would otherwise cause the balloon to roll or fold upon itself along an angle with respect to at least one of the balloon's longitudinal and transverse axes (e.g. para. [ 0014], Figs. 1-3: the metal stylet 42 tube has a larger rigidity as compared to the flexible inner tube 30, the insertion of the stylet 42 improves the stiffness of the balloon catheter, reducing the risk of the latter being pushed back by the blood flow and preventing kink or bending; since the style 42 reaches the balloon portion 22, as shown in Fig. 3, the skilled reader understands the stylet 42 also improves the stiffness of the balloon portion 22, reducing the risk of the latter being pushed back by the blood flow and preventing kink or bending).
In reference to at least claim 38
Miyata discloses the method further comprising implanting the blood pump assembly in the descending aorta (e.g. Figs. 1, 6; para. [0001]-[0002]: the present invention relates to a balloon catheter to be used in the intra-aortic balloon pumping method for treating e.g. acute heart failure).
In reference to at least claim 39
Miyata discloses the method further comprising at least partially inflating the balloon prior to implanting the support structure (e.g. para. [0032]-[0033]: it is after insertion of the balloon catheter 20 that the stylet tube 42 is inserted within catheter tube 24, Figs. 1-2).
In reference to at least claim 40
Miyata discloses wherein implanting the support structure comprising implanting the support structure through the driveline (e.g. para. [0032]-[0033]: it is after insertion of the balloon catheter 20 that the stylet tube 42 is inserted within catheter tube 24, Figs. 1-2).
In reference to at least claim 41
Miyata discloses wherein the support structure comprises a wire (e.g. para.[0028]: As the metal constituting the stylet tube 42 is not particularly limited, and examples thereof include stainless steel and tungsten, but stainless steel is preferably used.).
In reference to at least claim 42
Miyata discloses wherein the wire is one of Nitinol and stainless steel (e.g. para.[0028]: As the metal constituting the stylet tube 42 is not particularly limited, and examples thereof include stainless steel and tungsten, but stainless steel is preferably used.).
In reference to at least claim 43
Miyata discloses wherein implanting the support structure in the blood pump assembly comprises externalizing the proximal end of the tail region with respect to the proximal end of the driveline (e.g. stylet tube 42; Figs. 1, 3 shows the head of stylet tube 42 disposed in balloon portion 22; Figs. 1, 2 show the rear end of stylet tube 42 disposed in catheter tube 24 and extending therefrom, Fig. 1).
In reference to at least claim 44
Miyata discloses installing a connector on a proximal end of the driveline (e.g. y-connector that includes connector 40, Figs. 1-2); and securing the tail region of the support structure using the connector (e.g. rear end of stylet tube 42 attached to connector, Figs 1-2).
In reference to at least claim 45
Miyata discloses the connector comprises an anti-backout port (e.g. y-connector includes an anti-backout port, Fig. 1), and securing the tail region comprises receiving the proximal end of the tail region of the support structure in the anti-backout port (e.g. rear end of stylet tube 42 includes a proximal portion contained within connector 40, Figs 1-2).
In reference to at least claim 47
Miyata discloses wherein the connector comprises a cap on a proximal end of the anti-backout port (e.g. cap containing port 44, Figs. 1-2) and securing the tail region comprises receiving the proximal end of the tail region of the support structure proximate an inside surface of the cap (e.g. rear end of stylet tube 42 includes a proximal portion contained within connector 40, Figs 1-2 and 7).
In reference to at least claim 48
Miyata discloses wherein: the connector comprises a removable cap disposed on a proximal end of the anti-backout port (e.g. cap containing port 44, Figs. 1-2).
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) 8, 27 and 54 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent No. 4,931,036 to Kanai et al. (Kanai) in view of US 2018/0055981 to Smith et al. (Smith) and US 2007/0244544 to Birdsall et al. (Birdsall).
In reference to at least claim 8
Kanai discloses a blood pump according to claim 1 but does not explicitly teach the support structure is radiopaque. The use of a radiopaque marker "material" to visualize certain elements of an implanted device or catheter to provide visualization was well known in the art as evidence by Smith (e.g. para. [0098]) or Birdsall (e.g. para. [0039]), therefore 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 support apparatus of Kanai to include the support structure being radiopaque in order to provide visualization of the support structure during the insertion procedure for accurate positioning within the balloon.
In reference to at least claim 27
Kanai discloses a blood pump according to claim 1 but does not explicitly teach one or more radiopaque markers is disposed along the support structure. The use of a radiopaque marker "material" to visualize certain elements of an implanted device or catheter to provide visualization was well known in the art as evidence by Smith (e.g. para. [0098]) or Birdsall (e.g. para. [0039]), therefore 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 support apparatus of Kanai to include one or more radiopaque markers is disposed along the support structure in order to provide visualization of the support structure during the insertion procedure for accurate positioning within the balloon.
In reference to at least claim 54
Kanai discloses a blood pump support method according to claim 37 but does not explicitly teach one or more radiopaque markers are disposed along the support structure, and implanting the support structure in the blood pump assembly comprises advancing the support structure until at least one of the one or more radiopaque markers are aligned with one or more corresponding radiopaque markers on the blood pump assembly. The use of a radiopaque marker "material" to visualize certain elements of an implanted device or catheter to provide visualization was well known in the art as evidence by Smith (e.g. para. [0098]) or Birdsall (e.g. para. [0039]), therefore 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 support apparatus of Kanai to include one or more radiopaque markers disposed along the support structure and blood pump assembly and advancing the support structure until at least one of the one or more radiopaque markers are aligned with one or more corresponding radiopaque markers on the blood pump assembly in order to provide visualization of the support structure and blood pump assembly during the insertion procedure for accurate positioning within the balloon.
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent No. 4,931,036 to Kanai et al. (Kanai) in view of US Patent No 5,759,175 to Ariola et al. (Ariola).
In reference to at least claim 30
Kanai discloses a blood pump according to claim 1 but does not explicitly teach wherein the head region comprises a flexible tip portion and a non-flexible body portion, the flexible tip portion comprising the distal portion of the head region and the non-flexible body portion comprising the proximal portion of the head region.
Ariola discloses an intra-aortic balloon catheter which discloses providing an inner tube, i.e. support structure, within a balloon catheter structure that has varying flexibility along its length (e.g. Fig. 4) with the inner tube having the most flexibility nearest its distal tip (“The present invention relates to an improved intra-aortic balloon catheter having an outer tube and an inner tube. The inner tube is constructed utilizing kink-resistant superelastic metal material having varying flexibility of the length thereof and a high degree of pushability. The inner tube is most flexible nearest its distal tip. The flexible tip improves the steerability of the catheter and reduces the likelihood of vessel trauma during placement”, Col. 2, ll. 33-41) providing steerability of the catheter reducing the likelihood of vessel trauma while also providing a high degree of pushability (e.g. “The flexibility of the tip end of the improved intra-aortic balloon catheter inner tube can be designed to approach that of prior plastic inner tubes, while the proximal end can have the pushability of prior catheters having metallic inner tubes.”, Col. 2, ll. 41-45).
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 apparatus of Kanai to include the head region having varying flexibility including a flexible tip portion and a non-flexible body portion, as taught by Ariola, in order to provide steerability of the balloon catheter reducing the likelihood of vessel trauma while also providing a high degree of pushability (‘175, Col. 2, ll. 41-45).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US Patent No. 6,497,678 to Schock which discloses an intra-aortic balloon having a variable diameter that contains an inner tube that provides a support structure. US Patent No. 5,116,305 to Milder et al. which discloses a curved intra aortic balloon with a non-folding inflated balloon membrane.
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/JENNIFER L GHAND/Examiner, Art Unit 3796
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