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 .
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.
Claim 24 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 24 recites a “second heat shrink tube”. Claim 24 depends from claim 18 which does not previously mention a heat shrink tube. It is not clear if claim 24 is requiring two heat shrink tubes or only one. This is being interpreted as requiring only one tube for claim 24.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 18-20 and 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Aboulhosn (EP3437668A1, made of record on the IDS dated 10/6/2025, see copy provided.)
Regarding claim 18, Aboulhosn meets the claimed, A method for manufacturing a cannula, the method comprising: thermoforming an inner layer of the cannula over a mandrel, the inner layer comprising an inner material and an inner diameter and outer diameter; (Aboulhosn [0028] describes forming a base layer 10 over a mandrel 7, see Figure 3 showing the base layer 10 has an inner and outer diameter) thermoforming an outer layer of the cannula over the inner layer, the outer layer extending along a longitudinal length and comprising an outer material; (Aboulhosn [0030] describe applying additional layers of additional material on top of base layer 10, see Figure 3 showing the additional layers extending along the length of the mandrel) and thermoforming a first outer end reinforcement layer to extend over the outer layer at a proximal end of the cannula to form a first reinforced portion of the cannula, (Aboulhosn [0027] and [0031] describes adding additional layers in the axial sections such that a canula having stiff portions connected by flexing portions is created.)
The embodiment described in Aboulhosn Figure 3 does not show placing a shape memory coil over the outer diameter of the inner material, and outer layer covering the coil however a different embodiment of Aboulhosn meets the claimed, placing a shape memory coil over the outer diameter of the inner material; and outer layer covering the coil (Aboulhosn [0035] describes applying a stiffening structure 16 in a helical shape between the previously created layers and subsequent layers.)
It would have been obvious to a person of ordinary skill in the art before the filing date to combine the method shown in Figure 4 with the method of adding a stiffening helix as described in Aboulhosn [0035] in order to provide extra stiffening to the structure, se Aboulhosn [0035]
Aboulhosn does not explicitly describe the stiffness in the reinforced portion as being tow times as stiff and does not explicitly meet the claimed, the first reinforced portion of the cannula being at least two times as stiff as a medial portion of the cannula, the medial portion being distal of the first reinforced portion of the cannula, however, Aboulhosn [0026] describes the ends of the cannula where the cannula connects to a blood pump should be more stiff to prevent cracks while the other portions of the cannula should be softer to prevent damage to tissue. Aboulhosn describes the stiffness as a result effective variable which affects the ability of the cannula to respond to load during operation and ultimately the ability of the cannula to easily crack during use. It would have been obvious to a person of ordinary skill in the art before the filing date to modify the stiffness of the canula through routine optimization to arrive at a stiffness which would not crack during use, see Aboulhosn [0026] and MPEP §2144.05(II)(B).
Regarding claim 19, Aboulhosn meets the claimed, The method of claim 18, further comprising bonding the cannula to a pump housing and an inflow cage of an intravascular blood pump, the pump housing being configured to at least partially enclose a rotor (Aboulhosn [0025]-[0026] describe attaching cannula 4 to a pumping device housing 1a at one end and a blood flow inlet 2 at the other end, see Figure 1.)
Regarding claim 20, Aboulhosn meets the claimed, The method of claim 19, wherein a distal end of the cannula is bonded to the inflow cage, and a-the proximal end of the cannula is bonded to the pump housing (Aboulhosn [0025]-[0026] describe attaching cannula 4 to a pumping device housing 1a at one end and a blood flow inlet 2 at the other end, see Figure 1.)
Regarding claim 25, Aboulhosn does not explicitly meet the claimed, The method of claim 18, wherein the first reinforced portion of the cannula is at least four times as stiff as the medial portion of the cannula however, Aboulhosn [0026] describes the ends of the cannula where the cannula connects to a blood pump should be stiffer to prevent cracks while the other portions of the cannula should be softer to prevent damage to tissue. Aboulhosn describes the stiffness as a result effective variable which affects the ability of the cannula to respond to load during operation and ultimately the ability of the cannula to easily crack during use. It would have been obvious to a person of ordinary skill in the art before the filing date to modify the stiffness of the canula through routine optimization to arrive at a stiffness which would not crack during use, see Aboulhosn [0026] and MPEP §2144.05(II)(B).
Regarding claim 26, Aboulhosn meets the claimed, The method of claim 18, further comprising thermoforming a second outer end reinforcement layer to extend over the outer layer at the distal end of the cannula to form a second reinforced portion of the cannula, and wherein the medial portion is proximal of the second reinforced portion of the cannula (Aboulhosn [0027] and [0031] describes adding additional layers in the axial sections such that a canula having stiff portions connected by flexing portions is created.)
Claim 21-22 rejected under 35 U.S.C. 103 as being unpatentable over Aboulhosn as applied to claim 20 above, and further in view of Watts (EP0689847A1, see copy provided.)
Regarding claim 21, Aboulhosn meets the claimed, The method of claim 20, wherein bonding the distal end of the cannula to the inflow cage, to an interface between the distal end of the cannula and the inflow cage; (Aboulhosn [0025]-[0026] describe attaching cannula 4 to a pumping device housing 1a at one end and a blood flow inlet 2 at the other end, see Figure 1.)
Aboulhosn does not describe using epoxy and does not meet the claimed, applying an epoxy and heat curing the epoxy. Analogous in the field of assembling cannula devices, Watts describes using heat-curing epoxy to attach a cannula to another device and meets the claimed, applying an epoxy and heat curing the epoxy (Watts [0016] describe heat curing an epoxy to attach a cannula to the distal end of a barrel for a fluid communication pathway.)
It would have been obvious to a person of ordinary skill in the art before the filing date to combine the method of attaching the cannula to the inflow cage as described in Aboulhosn with the method of attaching the cannula using epoxy and heat curing as described in Watts in order to form a fluid connection with the cannula, see Watts [0016].
Regarding claim 22, Aboulhosn meets the claimed, The method of claim 20, wherein bonding the proximal end of the cannula to the pump housing comprises: to an interface between the proximal end of the cannula and the pump housing; (Aboulhosn [0025]-[0026] describe attaching cannula 4 to a pumping device housing 1a at one end and a blood flow inlet 2 at the other end, see Figure 1.)
Aboulhosn does not describe using epoxy and does not meet the claimed, applying an epoxy and heat curing the epoxy. Analogous in the field of assembling cannula devices, Watts describes using heat-curing epoxy to attach a cannula to another device and meets the claimed, applying an epoxy and heat curing the epoxy (Watts [0016] describe heat curing an epoxy to attach a cannula to the distal end of a barrel for a fluid communication pathway.)
It would have been obvious to a person of ordinary skill in the art before the filing date to combine the method of attaching the cannula to pump housing as described in Aboulhosn with the method of attaching the cannula using epoxy and heat curing as described in Watts in order to form a fluid connection with the cannula, see Watts [0016].
Claims 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Aboulhosn as applied to claim 18 above, and further in view of Snow (US 2001/0010247, made of record on the IDS dated 10/16/2024.)
Regarding claim 23, Aboulhosn meets the claimed, The method of claim 18, wherein thermoforming the inner layer comprises: placing an inner extruded sleeve comprising the inner material on the mandrel; (Aboulhosn [0028] describes the base layer 10 has been extruded onto the mandrel.)
Aboulhosn does not describe heat shrinking and does not meet the claimed, placing a first heat shrink tube around the inner extruded sleeve; heating the inner extruded sleeve and the first heat shrink tube to soften the sleeve and cause the first heat shrink tube to apply force on the sleeve towards the mandrel; and removing the first heat shrink tube.
Analogous in the field of cannula manufacturing, Snow meets the claimed, placing a first heat shrink tube around the inner extruded sleeve; heating the inner extruded sleeve and the first heat shrink tube to soften the sleeve and cause the first heat shrink tube to apply force on the sleeve towards the mandrel; and removing the first heat shrink tube (Snow [0054] describes using a heat shrink tube to heat a coating 209 on a mandrel and then removing the heat shrink tube after heating.)
It would have been obvious to a person of ordinary skill in the art before the filing date to combine the method of forming a first inner layer on the mandrel as described in Aboulhosn with the step of using a heat shrink tube to heat a coating layer 209 as described in Snow in order to promote bonding, see Snow [0054].
Regarding claim 24, Aboulhosn meets the claimed, The method of claim 18, wherein thermoforming the outer layer comprises: placing an outer extruded sleeve comprising the outer material over the inner layer and the coil; (Aboulhosn [0035] describes applying a stiffening structure 16 in a helical shape between the previously created layers and subsequent layers.)
Aboulhosn does not describe heat shrinking and does not meet the claimed, placing a second heat shrink tube around the outer extruded sleeve; heating the sleeve and the second heat shrink tube to soften the sleeve and cause the second heat shrink tube to apply force on the sleeve towards the inner layer and coil, embedding the coil in the outer material; and removing the second heat shrink tube (Snow [0074]-[0075] describes a method of making a cannula in which an additional layer 225 is coated over a helical elongate member 207N which is embedded in coating 209N. A heat shrink tube is then positioned over the layer 225N and heated to fuse the materials together.)
It would have been obvious to a person of ordinary skill in the art before the filing date to combine the method of forming a first inner layer on the mandrel as described in Aboulhosn with the step of using a heat shrink tube to heat a coating layer 209 as described in Snow in order to fuse the layers together and form a single integral structure, see Snow [0075].
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Aboulhosn as applied to claim 18 above, and further in view of Corbett (US 2017/0049947.)
Regarding claim 27, Aboulhosn meets the claimed, The method of claim 18, wherein the thermoforming the first outer end reinforcement layer comprises thermoforming the first outer end reinforcement layer to extend over the outer layer at the proximal end of the cannula to form the first reinforced portion of the cannula (Aboulhosn [0027] and [0031] describes adding additional layers in the axial sections such that a canula having stiff portions connected by flexing portions is created.)
Aboulhosn only describes the cannula and pump being connected and does not specify that the reinforcement layer extending over the distal end of the pump and does not meet the claimed, the first outer end reinforcement layer to extend over a distal end of a pump housing of an intravascular blood pump.
Analogous in the field of cannulas, Corbett meets the claimed, first outer end reinforcement layer to extend over a distal end of a pump housing of an intravascular blood pump (Corbett [0036] describes a sheath assembly which is inserted over a percutaneous pump.)
It would have been obvious to a person of ordinary skill in the art before the filing date to combine the method of manufacturing and assembling the cannula with the pump as described in Aboulhosn with the method of connecting the sheath over the pump as described in Corbett in order to plug a larger gap and prevent bleeding, see Corbett [0036].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 5,951,539: see Figure 2 and the accompanying description beginning at col. 10 line 17 describing making a catheter on a mandrel 200, placing tubing 202 on the mandrel, adding a ribbon 204 wrapped around the liner 202, and adding additional tubing sections on the outer surface
US 4,516,972: see Figure 3 and the description beginning at col. 3 line 35 describing adding an inner liner 12 to a wire-like mandrel 31, adding a ribbon 16 to wrap around the liner 12
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/V.B./Examiner, Art Unit 1744
/XIAO S ZHAO/Supervisory Patent Examiner, Art Unit 1744
