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, see Remarks, filed 06/03/2026, with respect to the rejection(s) of claim(s) under 35 USC 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of LaRose in view of US 4014317 to Bruno.
Since the Bruno Reference was not previously provided, the action is being considered as 2nd non-final rejection, replacing the previously mailed non-final rejection.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claim(s) 1-3, 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable US Pat Pub No. 20090203957 to LaRose et al. (Hereinafter “LaRose” – previously presented) in view of US 4014317 to Bruno.
Regarding claim 1. (Original) LaRose discloses a ventricular assist device for a patient (para 0024 “ventricular assist device 10”), comprising: a cannula (para 0033 “outflow cannula”) including a lumen (para 0033 “hollow tube”); an inlet valve on the cannula and in communication with the lumen (para 0025, 0044 “inlet 21”); an outlet valve on the cannula and in communication with the lumen (para 0025 “outlet 23”, fig 3); a pump (para 0025, “pump 20”) connected to the cannula and adapted to draw blood through the inlet [] from a ventricle of the patient into the lumen and deliver blood from the lumen through the outlet [] into an aorta or pulmonary artery of the patient (para 0012 “inlet of the pump communicates with the left ventricle of the heart, and positioning an outflow cannula of the pump so that the outflow cannula extends from within the left ventricle through the aortic valve”, 0040, fig 17); and an anchor (para 0038 “anchoring element”) including (a) a graft adapted to receive and hold the cannula (para 0032 “fitting 100”, the claim does not provide any details regarding the “graft”, the specification at para [0017] recites the graft to be a “tube []”) and (b) an anchor retainer carried on a first end of the graft and adapted to secure the anchor to a wall of the ventricle (para 0038, 0047, fig. 10).
Regarding claim 2. (Original) LaRose discloses the ventricular assist device of claim 1, further including a cannula retainer carried on the cannula (para 0032 “member 60”, the claim does not provide any details regarding the “cannula retainer”, under its BRI, any component connected/attached to the cannula could reasonably be considered to be the cannula retainer. fig. 2).
LaRose fails to explicitly disclose the inlet to be an inlet valve and the outlet to be an outlet valve.
Bruno, from a similar field of endeavor teaches that it is known for the inlet to be a valve and for the outlet to be a valve to allow blood to be removed through the inlet valves and reinfused through outlet valves (Col 5, lns 46-54). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosure of LaRose, with the teachings of Bruno to provide the predictable result of transferring blood.
Regarding claim 3. (Original) LaRose as modified by Bruno renders obvious the ventricular assist device of claim 2, wherein the anchor further includes at least one tie fastening the graft to the cannula adjacent the cannula retainer (para 0039 “a spherical socket 84 adapted to engage the spherical ball 90 of elongate member 60”, fig. 2).
Regarding claim 9. (Original) LaRose as modified by Bruno renders obvious the ventricular assist device of claim 1, wherein the anchor retainer is a sewing mat that is stitched to the ventricle wall (para 0038 “sewing or stapling the ring to the heart wall”).
Regarding claim 10. (Original) LaRose as modified by Bruno renders obvious the ventricular assist device of claim 1, wherein the graft is a tube made from a medical grade synthetic material (para 0034).
Regarding claim 11. (Original) LaRose as modified by Bruno renders obvious the ventricular assist device of claim 10, wherein the cannula is received and held [] the tube (fig. 2, para 0032). It is noted that LaRose discloses the graft to be held in the cannula and not the other way around as claimed. However, such modification is understood to be an obvious matter of design choice. See In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Regarding claim 15. (Original) LaRose as modified by Bruno renders obvious the ventricular assist device of claim 1, further including a first retainer ring, a second retainer ring and a third retainer ring carried on the cannula (fig. 1, various sections of the device). It is noted that it would have been obvious to make the components separable, connected via retaining rings. See In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961).
Claim(s) 4-6, 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over LaRose and Bruno as applied to claims above and further in view of US Pat Pub No 20040193004 to Tsubouchi et al. (hereinafter “Tsubouchi” – previously presented).
Regarding claim 4. (Original) LaRose as modified by Bruno renders obvious the ventricular assist device of claim 2, but fails to disclose wherein the cannula retainer includes a first retainer ring and a second retainer ring carried on the cannula wherein the first retainer ring is positioned inside the ventricle wall and the second retainer ring is positioned outside the ventricle wall.
Tsubouchi, from a similar field of endeavor teaches having a plurality of ring member (110, 112, cuff 108, etc.) to allow for attaching the device to the heart to provide blood flow communication via the device. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosure of LaRose as modified by Bruno, with the teachings of Tsubouchi, because doing so would allow the predictable result of attaching the device to the tissue.
Regarding claim 5. (Original) LaRose as modified by Bruno and Tsubouchi renders obvious the ventricular assist device of claim 4, wherein the anchor further includes at least one tie fastening the graft to the cannula between the second retainer ring and a third retainer ring (LaRose , fig. 4, Tsubouchi, para 0031, 0036).
Regarding claim 6. (Original) LaRose as modified by Bruno and Tsubouchi renders obvious the ventricular assist device of claim 5, further including stitching connecting the anchor retainer to the ventricle wall (para 0038 “sewing or stapling the ring to the heart wall”).
Regarding claim 12. (Original) LaRose as modified by Bruno renders obvious the ventricular assist device of claim 1, wherein the inlet valve is a [] valve, the outlet valve is a [] valve and the lumen is a single lumen (para 0033 “outflow cannula”, para 0025, 0044 “inlet 21”, para 0025 “outlet 23”, fig 3) but fails to explicitly disclose the valves to be one-way valves.
Tsubouchi, from a similar field of endeavor teaches using one-way valves associated with the inflow and outflow ports of the LVAD provide for blood flow into the variable-volume chamber during expansion, and for blood flow out of this chamber (para 0004). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosure of LaRose as modified by Bruno, with the teachings of Tsubouchi, because doing so would allow for using the one-way valves to provide the predictable result of providing blood flow as desired.
Regarding claim 13. (Original) LaRose as modified by Bruno and Tsubouchi renders obvious the ventricular assist device of claim 12, wherein the pump is a valveless, single port diaphragm displacement pump (para 0025 “pump 20”).
Regarding claim 14. (Original) LaRose as modified by Bruno and Tsubouchi renders obvious the ventricular assist device of claim 13, further including a pump drive connected to the pump (para 0026).
Allowable Subject Matter
Claim 7-8 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SANA SAHAND whose telephone number is (571)272-6842. The examiner can normally be reached M-Th 8:30 am -5:30 pm; F 9 am-3 pm.
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/SANA SAHAND/Examiner, Art Unit 3796
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