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 Arguments
Applicant’s arguments combined with the claim amendments have been fully considered and are found persuasive with respect to the previous rejection(s); however, upon further search and consideration due to the change in scope, an updated grounds of rejection is presented below, necessitated by amendment.
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 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.
In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
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 of this title, 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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Zeroni et al. (US 2013/0220524; hereinafter “Zeroni”) in view of Grothe et al. (US 2022/0354532; hereinafter “Grothe”).
Regarding claim 1, Zeroni discloses catheter pump system comprising: a catheter assembly having a proximal end, a distal end, and an elongate body extending therebetween, the elongate body defining at least an inner lumen (e.g. ¶¶ 32 – “lumen 23 of the catheter body”); a shaft assembly extending at least partially within the inner lumen of the elongate body of the catheter assembly (e.g. ¶¶ 32 – “helical drive shaft 25 contained within the lumen 23 of the catheter body”) and defining a center lumen (e.g. ¶¶ 44 – “lumen running down the center and a thin tube of polymer over which a helix is formed”), said shaft assembly comprising: an outer filar layer and an inner filar layer disposed radially within said outer filar layer (e.g. ¶¶ 33 – “multiple layers of wire wound in alternating right and left hand layers”); and a polymer layer disposed between said outer filar layer (e.g. ¶¶ 45, 39 – “the extruded polymer fin flows into spaces or gaps between adjacent filars”, etc.); and a motor assembly configured to rotate the shaft assembly (e.g. ¶¶ 31 – motor #11).
Zeroni fails to expressly disclose a center lumen positioned radially within the inner filar layer, where the inner filar layer forms a seal and inhibits a flow of fluid therethrough. In the same field of endeavor, Grothe discloses a center lumen positioned radially within the inner filar layer, wherein the inner filar layer forms a seal and prevents fluid flow (e.g. ¶¶ 45-54 – based on whether the rotating device is rotating or not). It would have been obvious to one of ordinary skill in the art, prior to the effective filing date, to incorporate a similar central lumen positioned radially within the inner filar layer, forming a seal to prevent fluid flow, as taught by Grothe, to the known device of Zeroni, in order to yield the predictable results of providing effective fluid transfer to the target location on demand.
Regarding claim 11, Zeroni discloses a shaft assembly for a catheter pump system (e.g. ¶¶ 30, 71, etc.), said shaft assembly comprising: an outer filar layer configured to extend at least partially within an inner lumen defined by an elongate body of a catheter assembly and an inner filar layer disposed radially within said outer filar layer and defining a center lumen (e.g. ¶¶ 33 – “multiple layers of wire wound in alternating right and left hand layers”; ¶¶ 32 – “helical drive shaft 25 contained within the lumen 23 of the catheter body”; ¶¶ 44 – “lumen running down the center and a thin tube of polymer over which a helix is formed”); and a polymer layer at least partially disposed between said outer filar layer and said inner filar layer and configured to inhibit a flow of fluid therethrough (e.g. ¶¶ 45, 39 – “the extruded polymer fin flows into spaces or gaps between adjacent filars”, etc.), wherein said shaft assembly is configured to be rotated by a motor assembly (e.g. ¶¶ 31 – motor #11).
Zeroni fails to expressly disclose a center lumen positioned radially within the inner filar layer, where the inner filar layer forms a seal and inhibits a flow of fluid therethrough. In the same field of endeavor, Grothe discloses a center lumen positioned radially within the inner filar layer, wherein the inner filar layer forms a seal and prevents fluid flow (e.g. ¶¶ 45-54 – based on whether the rotating device is rotating or not). It would have been obvious to one of ordinary skill in the art, prior to the effective filing date, to incorporate a similar central lumen positioned radially within the inner filar layer, forming a seal to prevent fluid flow, as taught by Grothe, to the known device of Zeroni, in order to yield the predictable results of providing effective fluid transfer to the target location on demand.
Regarding claim 20, Zeroni teaches a method for manufacturing a shaft assembly for a catheter pump system (e.g. ¶¶ 30, 71, etc.), said method comprising positioning, radially within an outer filar layer configured to extend at least partially within an inner lumen defined by an elongate body of a catheter assembly and an inner filar layer defining a center lumen (e.g. ¶¶ 33 – “multiple layers of wire wound in alternating right and left hand layers”; ¶¶ 32 – “helical drive shaft 25 contained within the lumen 23 of the catheter body”; ¶¶ 44 – “lumen running down the center and a thin tube of polymer over which a helix is formed”); and positioning a polymer layer at least partially between the outer filar layer and the inner filar layer, the polymer layer configured to inhibit a flow of fluid therethrough (e.g. ¶¶ 45, 39 – “the extruded polymer fin flows into spaces or gaps between adjacent filars”, etc.), wherein the shaft assembly is configured to be rotated by a motor assembly (e.g. ¶¶ 31 – motor #11).
Zeroni fails to expressly disclose a center lumen positioned radially within the inner filar layer, where the inner filar layer forms a seal and inhibits a flow of fluid therethrough. In the same field of endeavor, Grothe discloses a center lumen positioned radially within the inner filar layer, wherein the inner filar layer forms a seal and prevents fluid flow (e.g. ¶¶ 45-54 – based on whether the rotating device is rotating or not). It would have been obvious to one of ordinary skill in the art, prior to the effective filing date, to incorporate a similar central lumen positioned radially within the inner filar layer, forming a seal to prevent fluid flow, as taught by Grothe, to the known device of Zeroni, in order to yield the predictable results of providing effective fluid transfer to the target location on demand.
Regarding claims 2-3 and 12-13, Zeroni discloses said polymer layer encapsulates said outer filar layer and inner filar layer (e.g. ¶¶ 45, 39 – “the extruded polymer fin flows into spaces or gaps between adjacent filars”, etc.).
Regarding claims 4 and 14, Zeroni discloses said polymer layer comprises a polymer film disposed between said outer filar layer and said inner filar layer (e.g. ¶¶ 45, 39 – “the extruded polymer fin flows into spaces or gaps between adjacent filars”, etc.).
Regarding claims 5 and 15, Zeroni discloses said polymer layer comprises at least one of high-density polyethylene (HDPE) or polytetrafluoroethylene (PTFE) (e.g. ¶¶ 29).
Regarding claims 6 and 16, Zeroni discloses said shaft assembly is configured to maintain a static pressure column of fluid within the center lumen (e.g. ¶¶ 51).
Regarding claims 8 and 17, Zeroni discloses said outer filar layer comprises wire wound in a first direction, and wherein said inner filar layer comprises wire wound in a second direction (e.g. ¶¶ 33 – “multiple layers of wire wound in alternating right and left hand layers”).
Regarding claims 9 and 18, Zeroni discloses said outer filar layer and said inner filar layer comprise stainless steel (e.g. ¶¶ 30 – “stainless steel coil”).
Regarding claims 10 and 19, Zeroni discloses said polymer layer is configured to resist rotational movement of said outer filar layer with respect to said inner filar layer (e.g. ¶¶ 50-51).
Regarding claim 7, Zeroni discloses a guidewire at least partially disposed within the center lumen of said shaft assembly (e.g. ¶¶ 71).
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael D’Abreu whose telephone number is (571) 270-3816. The examiner can normally be reached on 7AM-4PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL J D'ABREU/Primary Examiner, Art Unit 3796