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 .
Response to Amendment
This Office action is responsive to the amendment filed June 14, 2026. As directed by the amendment, claims 6, 8, and 13 have been amended, claim 26 has been added. Thus, claims 1-13 and 19-26 are presently pending with claims 19-25 being previously withdrawn from further consideration.
The amendment to claims 6, 8 and 13 are sufficient to overcome the objection to claim 8 and the 35 U.S.C 112(b) rejections of claims 6, 8-10 and 13 from the previous Office action. The claim objection and 35 U.S.C 112(b) rejections from the previous Office action are hereby withdrawn.
Response to Arguments
Applicant' s argument that Campbell does not disclose a separate inner tubular member onto which a previously coated scaffold is latter positioned is found to be persuasive, it is noted that the aspect of coating the scaffold on inner and outer surfaces of the scaffold in an expanded configuration is disclosed by Campbel ([0072-0073] mesh 48 is formed and shaped set to an expanded shape and, once formed, elastomeric coating 50 is applied to the inner and outer surface of the mesh). As such, the prior art rejections of January 06, 2026 has been withdrawn. However, after further consideration, a new ground of rejection, further in view of Applicant cited Rothermel et al. (US 3152618) that is believed to address concerns raised by Applicant.
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.
Claims 1, 2, 4, 6, 12-13 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over previously cited Campbell et al. US 20110004046 A1 (“Campbell”) in view of Applicant cited Rothermel et al. US 3152618 (“Rothermel”).
Regarding claim 1, Campbell discloses a method of manufacturing ([0027]) an expandable and collapsible blood conduit (Fig. 1, cannula 40, [0066]) for a catheter blood pump (Fig. 1, blood pump 10), comprising: depositing a coating (Fig. 3, Fig. 4, coating 50) on inner and outer surfaces of a scaffold (Fig. 4, mesh 48) in an expanded configuration to create a coated scaffold ([0072-0073] mesh 48 is formed and shaped set to an expanded shape and, once formed, elastomeric coating 50 is applied to the inner and outer surface of the mesh to form expandable portion 44, e.g., by solution casting), the coated scaffold (Fig. 3, Fig. 4, expandable portion 44) comprising a plurality of coated elongate members that define a plurality of apertures (Fig. 3, Fig. 4, mesh 48 defines a plurality of apertures).
Campbell does not explicitly disclose positioning the coated scaffold about an inner tubular member; and adhering the coating on the coated scaffold to the inner tubular member to form a conduit.
Rothermel is in the field of reinforced flexible conduits (col. 1, Ins. 9-10) teaches a method (manufacture; col. 1, Ins. 63-64), comprising positioning (Fig. 1, Fig. 4, reinforcement 13 is positioned over the tube 12; col. 3, Ins. 11-14) the coated scaffold (Fig. 1, Fig. 4, reinforcement 13 is coated with layer 14; col. 3, Ins. 11-20) about an inner tubular member (Fig. 1, Fig. 4, tube 12); and adhering the coating (Fig. 1, Fig. 4, layer 14) on the coated scaffold (Fig. 1, Fig. 4, reinforcement 13 coated with layer 14) to the inner tubular member (Fig. 1, Fig. 4, tuber 12) to form a conduit (Fig. 1, Fig. 2, an integral bond takes place between the tube and the coating on the wire; col. 3, Ins. 25-43).
At the time of filing the claimed invention, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method of manufacture in Campbell to include an additional step of positioning the coated scaffold about an inner tubular member and adhering the coating on the coated scaffold to the inner tubular member to form the conduit, so as to ensure that the mesh 48 of Campbell ([0073] which is analogous to a reinforcement member) will not be exposed within the inner surface of the blood conduit(see Fig. 13D of Campbell) or in cases where complete embedment has resulted as required by Campbell in [0073], the blood conduit would not have a substantial thickness or result in a blood conduit that does not possess maximum degree of flexibility, as taught by Rothermel col. 1, Ins. 28-38.
Regarding claim 2, see [0073], Campbell teaches spray application of the coating, which would include an inner and outer surface of the scaffold.
Regarding claim 4, Campbell discloses an alternative embodiment in [0073] “spray application over a mandrel” is a process that would involve disposing the scaffold about a mandrel to apply the coating by spraying. Combining the embodiments of solution casting of the scaffold that would form a coating on the scaffold, followed by spray application of the coating over a mandrel of Campbell would have been obvious to one of ordinary skill in the art at the time of filing the claimed invention, because it has been held that combining two embodiments disclosed adjacent to each other in a prior art patent does not require a leap of inventiveness and involves only routine skill in the art, Boston Scientific v. Cordis Fed. Cir. 2009. In the modified method, depositing the coating occurs while the scaffold is disposed about a mandrel such that inner surfaces of elongate members of the scaffold are not in contact with the mandrel owing to the initial coating via solution coating that would form a layer between the mandrel and the inner surfaces of the elongate members of the scaffold.
Regarding claim 6, Campbell as modified by Rothermel disclose positioning the coated scaffold about an inner tubular member but does not explicitly disclose that the inner tubular member is disposed on a mandrel, however, Campbell does teach the use of a mandrel to form the scaffold (mesh 48) to a desired shape [0072] as a means of supporting and/or holding the scaffold during manufacture. At the time of filing the claimed invention, it would have been obvious to one having ordinary skill in the art to position the coated scaffold and an inner member as discussed in claim 1 above about a mandrel, as a means of supporting and/or holding the coated scaffold and inner rube during the manufacturing step.
Regarding claim 12, Campbell teaches in [0073] fitting coating as a separate tube over the mesh and heat shrinking to form a tight fit, the separate tube undergoes heat shrinking, hence a heat shrink tubing. At the time of filing the claimed invention, it would have been obvious to one having ordinary skill in the art at the time of filing the claimed invention, to arrange a heat shrink tube over the coated scaffold, and heat shrink to form a tight fit so as to adjust the thickness of the coating to a desired thickness. In the modified method, the process of heat shrinking would cause bonding of the scaffold coating to the inner tubular member, as both the coating and inner tubular member are heat shrinkable materials.
Regarding claims 13 and 26, Campbell disclose that the scaffold (mesh) comprise struts ([0078] “Inlet struts 56 and discharge struts 58 can be part of mesh 48”), owing to the struts being part of the scaffold, it follows that the depositing step as discussed in claim 1 above would deposit the coating on the outer and/or inner surfaces of the struts.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Campbell in view of Rothermel as applied to claim 1 above, and further in view of previously cited Takahashi et al. US 20060105099 A1 (“Takahashi”).
Regarding claim 3, Campbell in view of Rothermel does not explicitly disclose wherein depositing the coating comprises spraying the coating while rotating the scaffold, however, Takahashi discloses in [0066] spin coating and spraying by using a spray as art recognized alternatives techniques of applying a coating.
Inasmuch as Takahashi disclose spin coating and spraying by using a spray as art recognized alternatives techniques of coating, it would have been obvious to one of ordinary skill in the exercise art at the time of filing the invention, to substitute one for the other, In re Fout, 675 F.2d 297, 301, 213 USPQ 532, 536 (CCPA 1982), in the instant case, substitute spray coating disclosed by Campbell in view of Rothermel with spin coating as taught by Takahashi, to perform the same function of depositing the coating and for the added advantage of more uniform coating that can be achieved by spin coating.
Claims 5 and 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over Campbell in view of Rothermel as applied to claim 1 above, and further in view of previously cited Korkuch et al. US 20200054861 A1 (“Korkuch”).
Regarding claims 5, 7 and 8, Campbell in view of Rothermel does not explicitly disclose a hydrophilic material and therefore fails to disclose limitations of claims 7-10. However, Korkuch teaches in [0035] that it was known in the prior art to coat inner and outer surface of a device that is inserted into a blood vessel with a hydrophilic coating, to permit a reduction of frictional forces and avoid clotting by allowing adequate blood flow ([0035]). It would have been obvious to one having ordinary skill in the art at the time of filing the claimed invention, to have modified the method of Campbell to include a hydrophilic material on the coating, or include a hydrophilic material with the inner tubular member or deposit a hydrophilic material on the conduit subsequent to the adhering step, so as to permit a reduction of frictional forces and avoid clotting by allowing adequate blood flow by the expandable and collapsible blood conduit during use.
Regarding claim 9, in view of the teachings of Korkuch in [0167], the presence of a hydrophilic coating would minimize or reduce a sheathing force owing to reduction of frictional forces, while Campbell in view of Korkuch does not explicitly disclose the size of sheath as being not greater than 14F, however this is a known and common size of a sheath used to place medical devices into the body, as such the sheath in this case would not be greater than 14F.
Regarding claim 10, Campbell disclose that the scaffold (mesh) comprise struts ([0078] “Inlet struts 56 and discharge struts 58 can be part of mesh 48”), owing to the struts being part of the scaffold, it follows that the depositing the hydrophilic material on the conduit would also deposit the hydrophilic material onto the one or more struts.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Campbell in view of Rothermel as applied to claim 1 above, and further in view of Martakos et al. US 20080118550 A1 (“Martakos”).
Regarding claim 11, Campbell in view of Rothermel does not explicitly disclose performing an etching process on the scaffold earlier in time than the depositing step. However, Martakos discloses in [0101] that it was known in the prior art to surface treat a mesh by etching prior to application of coating, to improve adhesive force between a mesh and coating, diminish coating flow and pooling, so as to achieve a more continuous coating in all areas of the mesh.
In view of these teachings, it would have been obvious to one having ordinary skill in the art at the time of filing the claimed invention, to perform etching on the scaffold of Campbell earlier in time that the deposition step, because etching would improve adhesive force between the scaffold and coating, diminish coating flow and pooling, thus resulting with a more continuous coating of the scaffold.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BONIFACE N NGANGA whose telephone number is (571)270-7393. The examiner can normally be reached Mon. - Thurs. 5:30 am - 4:00 pm.
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/BONIFACE N NGANGA/Primary Examiner, Art Unit 3797
