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 .
Status of Claims
Claims 1-20 are presently pending in this application.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim 20 recites “a means for contracting”. This will be interpreted as “contraction element 1200”, as described in Paragraph [0036]-[0038] of the instant specification.
Claim Rejections - 35 USC § 102
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 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.
Claims 1, 2, 16, 17, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Leasure (US Patent No. 7,172,551).
Regarding Claim 1, Leasure discloses a ventricular assist device (400, Fig. 7; Abstract) configured to be placed in a ventricle of a heart (Col. 1, Lines 42-62; Col. 5, Lines 6-11), the ventricular assist device comprising: a pumping pouch (wall 416 defining chamber 418, Fig. 7; Col. 5, Lines 3-21) having an opening (420, Fig. 7) and defining an internal volume (chamber 418, Fig. 7; Col. 5, Lines 3-21) configured to fill with blood in through the opening; a contraction element (actuators 440, Fig. 7; Col. 5, Lines 10-21) coupled to the pumping pouch (wall 416 defining chamber 418, Fig. 7; Col. 5, Lines 3-21), the contraction element (actuators 440, Fig. 7) capable of squeezing at least a portion of the pumping pouch to force at least a portion of the blood out through the opening (Col. 5, Lines 10-21); and a frame (struts 426 or member 422, Fig. 7; Col. 5, Lines 3-21) coupled to the pumping pouch (wall 416 defining chamber 418, Fig. 7; Col. 5, Lines 3-21), the frame configured to be coupled to a wall of the heart (Col. 1, Lines 42-62; Col. 5, Lines 6-11; Col. 2, Lines 62-65; see pump 100 in Fig. 1 coupled to ventricle).
Regarding Claim 2, Leasure discloses a ventricular assist device further wherein the contraction element (actuators 440, Fig. 7; Col. 5, Lines 10-21) includes an electroactive polymer (Col. 5, Lines 22-40).
Regarding Claim 16, Leasure discloses a ventricular assist device further wherein the pumping pouch (wall 416 defining chamber 418, Fig. 7; Col. 5, Lines 3-21) is made of an inelastic material (Col. 5, Lines 3-10; Col. 2, Line 65 – Col. 3, Line 1).
Regarding Claim 17, Leasure discloses a ventricular assist device further comprising: a stem (end 423, Fig. 7) coupled to the pumping pouch (wall 416 defining chamber 418, Fig. 7; Col. 5, Lines 3-21), the stem configured to be coupled to the wall of the heart (Col. 1, Lines 42-62; Col. 5, Lines 6-11; Col. 2, Lines 62-65; see pump 100 in Fig. 1 coupled to ventricle).
Regarding Claim 20, Leasure discloses a ventricular assist device (400, Fig. 7; Abstract) configured to be placed in a ventricle of a heart (Col. 1, Lines 42-62; Col. 5, Lines 6-11), the ventricular assist device comprising: a pumping pouch (wall 416 defining chamber 418, Fig. 7; Col. 5, Lines 3-21) having an opening (420, Fig. 7), the pumping pouch being flexible (Col. 5, Lines 3-10; Col. 2, Line 65 – Col. 3, Line 3) and defining an internal volume (chamber 418, Fig. 7; Col. 5, Lines 3-21) configured to fill with blood in through the opening; a means for contracting (actuators 440, Fig. 7; considered by the Examiner to be functionally equivalent to the “contraction element 1200”, see Claim Interpretation section above) coupled to the pumping pouch (wall 416 defining chamber 418, Fig. 7; Col. 5, Lines 3-21), the means for contracting (actuators 440, Fig. 7) capable of squeezing at least a portion of the pumping pouch to force at least a portion of the blood out through the opening (Col. 5, Lines 10-21); and a frame (struts 426 or member 422, Fig. 7; Col. 5, Lines 3-21) coupled to the pumping pouch, the frame configured to be coupled to a wall of the heart (Col. 1, Lines 42-62; Col. 5, Lines 6-11; Col. 2, Lines 62-65; see pump 100 in Fig. 1 coupled to ventricle).
Claims 1, 3, 5-8, 10-12, 14, 15, and 17-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Thanikachalam (US Patent No. 10,492,911).
Regarding Claim 1, Thanikachalam discloses a ventricular assist device (Abstract, ventricular ejection device 1, Figs. 1C-D; 4C-D) configured to be placed in a ventricle of a heart (Col. 2, Lines 1-20; Abstract), the ventricular assist device comprising: a pumping pouch (recoiling part 5 including membrane 12, Figs. 1A-D, 5A-C) having an opening and defining an internal volume configured to fill with blood in through the opening (Col. 4, Lines 21-42); a contraction element (spring 9, Figs. 2, 5B, 5C) coupled to the pumping pouch (recoiling part 5 including membrane 12, Figs. 1A-D, 5A-C), the contraction element (spring 9, Figs. 2, 5B, 5C) capable of squeezing at least a portion of the pumping pouch to force at least a portion of the blood out through the opening (Col. 2, Lines 1-20; Col. 4, Lines 51-64); and a frame (anchoring stent 4, Figs. 1A-D, Fig. 2; 5A-C) coupled to the pumping pouch (recoiling part 5 including membrane 12, Figs. 1A-D, 5A-C), the frame configured to be coupled to a wall of the heart (device 1 coupled to wall of heart, Fig. 4D-E; Col. 4, Lines 7-20; Col. 6, Lines 39-56; Claim 3).
Regarding Claim 3, Thanikachalam discloses a ventricular assist device further wherein the contraction element (spring 9, Figs. 2, 5B, 5C) includes a shape memory alloy (made from shape memory alloy such as Nitonol, Col. 5, Lines 5-22, 40-46; Claim 11).
Regarding Claim 5, Thanikachalam discloses a ventricular assist device further wherein the contraction element (spring 9, Figs. 2, 5B, 5C) includes a twisted coil alloy (spring 9 is a ‘twisted’/helical coil, made from shape memory alloy or other alloys, Col. 5, Lines 5-22, 40-46).
Regarding Claim 6, Thanikachalam discloses a ventricular assist device further wherein the contraction element (spring 9, Figs. 2, 5B, 5C) includes a circumferential band coupled to a side wall of the pumping pouch, the circumferential band encircling the internal volume (spring 9 is a ‘twisted’/helical coil which is attached to and encircles the sidewall of recoiling part 5 including membrane 12, see Figs. 2, 5B, 5C; Col. 2, Lines 1-20; Col. 4, Lines 51-64).
Regarding Claim 7, Thanikachalam discloses a ventricular assist device further wherein the contraction element (spring 9, Figs. 2, 5B, 5C) includes a helix coupled to a side wall of the pumping pouch, the helix winding around the internal volume (spring 9 is a ‘twisted’/helical coil which is attached to and encircles the sidewall of recoiling part 5 including membrane 12, see Figs. 2, 5B, 5C; Col. 2, Lines 1-20; Col. 4, Lines 51-64).
Regarding Claim 8, Thanikachalam discloses a ventricular assist device further wherein the contraction element (spring 9, Figs. 2, 5B, 5C) includes a partial band coupled to a side wall of the pumping pouch, the partial band at least partially encircling the internal volume (spring 9 is a ‘twisted’/helical coil which is attached to and at least partially encircles the sidewall of recoiling part 5 including membrane 12, see Figs. 2, 5B, 5C; Col. 2, Lines 1-20; Col. 4, Lines 51-64).
Regarding Claim 10, Thanikachalam discloses a ventricular assist device further wherein the contraction element (spring 9, Figs. 2, 5B, 5C) includes a side strip coupled to a side wall of the pumping pouch, the side strip extending from an upper portion of the pumping pouch to a lower portion of the pumping pouch (spring 9 is a ‘twisted’/helical coil [which could be a considered a ‘side strip’] which is attached to and encircles the sidewall of recoiling part 5 including membrane 12, from an upper portion to a bottom portion, see Figs. 2, 5B, 5C; Col. 2, Lines 1-20; Col. 4, Lines 51-64).
Regarding Claim 11, Thanikachalam discloses a ventricular assist device further wherein the contraction element (spring 9, Figs. 2, 5B, 5C) includes a bottom strip coupled to a bottom wall of the pumping pouch (spring 9 is a ‘twisted’/helical coil [which could be a considered a ‘bottom strip’ at the bottom portion] which is attached to and encircles the sidewall of recoiling part 5 including membrane 12, through a bottom portion, see Figs. 2, 5B, 5C; Col. 2, Lines 1-20; Col. 4, Lines 51-64).
Regarding Claim 12, Thanikachalam discloses a ventricular assist device further wherein the contraction element (spring 9, Figs. 2, 5B, 5C) includes a spring coupled to a bottom wall of the pumping pouch (spring 9 is a ‘twisted’/helical coil which is attached to and encircles the sidewall of recoiling part 5 including membrane 12, through a bottom portion, see Figs. 2, 5B, 5C; Col. 2, Lines 1-20; Col. 4, Lines 51-64).
Regarding Claim 14, Thanikachalam discloses a ventricular assist device further wherein the frame includes one or more tissue anchors (anchoring stent 4 includes anchoring elements 11, Figs. 2, 3B-C, 4D-E; Col. 5, Lines 5-40; Col. 6, Lines 5-35) configured to be coupled to the wall of the heart (Col. 2, Lines 1-25).
Regarding Claim 15, Thanikachalam discloses a ventricular assist device further wherein the pumping pouch (recoiling part 5 including membrane 12, Figs. 1A-D, 5A-C) is impermeable to blood (Col. 4, Lines 20-30, 64-67).
Regarding Claim 17, Thanikachalam discloses a ventricular assist device further comprising a stem (anchoring elements 11, Figs. 2, 3B-C, 4D-E; Col. 5, Lines 5-40; Col. 6, Lines 5-35) coupled to the pumping pouch (recoiling part 5 including membrane 12, Figs. 1A-D, 5A-C), the stem configured to be coupled to the wall of the heart (Col. 5, Lines 5-40; Col. 6, Lines 5-35; Col. 2, Lines 1-25).
Regarding Claim 18, Thanikachalam discloses a method for delivering a ventricular assist device (Abstract, ventricular ejection device 1, Figs. 1C-D; 4C-D) into a ventricle of the heart, the ventricular assist device including a pumping pouch (recoiling part 5 including membrane 12, Figs. 1A-D, 5A-C) coupled to a frame (anchoring stent 4, Figs. 1A-D, Fig. 2; 5A-C), the method comprising: introducing a catheter (16, Fig. 4A) into the ventricle of the heart (Col. 6, Lines 35-56); ejecting the ventricular assist device from the catheter (16, Fig. 4A; Col. 6, Lines 35-56) into the ventricle of the heart to allow the pumping pouch (recoiling part 5 including membrane 12, Figs. 1A-D, 5A-C) and the frame (anchoring stent 4, Figs. 1A-D, Fig. 2; 5A-C) to expand in the ventricle of the heart (16, Fig. 4A; Col. 6, Lines 35-56); and anchoring the frame to a wall of the heart (Col. 5, Lines 5-40; Col. 6, Lines 5-35; Col. 2, Lines 1-25).
Regarding Claim 19, Thanikachalam discloses the method for delivering a ventricular assist device further wherein the frame (anchoring stent 4, Figs. 1A-D, Fig. 2; 5A-C) includes a stem (anchoring stent 4 includes anchoring elements 11, Figs. 2, 3B-C, 4D-E; Col. 5, Lines 5-40; Col. 6, Lines 5-35), and wherein anchoring the frame includes attaching the stem to the wall of the heart (Col. 5, Lines 5-40; Col. 6, Lines 5-35; Col. 2, Lines 1-25).
Regarding Claim 20, Thanikachalam discloses a ventricular assist device (Abstract, ventricular ejection device 1, Figs. 1C-D; 4C-D) configured to be placed in a ventricle of a heart, the ventricular assist device comprising: a pumping pouch (recoiling part 5 including membrane 12, Figs. 1A-D, 5A-C) having an opening, the pumping pouch being flexible and defining an internal volume configured to fill with blood in through the opening (Col. 4, Lines 21-42); a means for contracting (spring 9 is considered by the Examiner to be functionally equivalent to the “contraction element 1200”, see Claim Interpretation section above, Figs. 2, 5B, 5C) coupled to the pumping pouch, the means for contracting (spring 9, Figs. 2, 5B, 5C) capable of squeezing at least a portion of the pumping pouch to force at least a portion of the blood out through the opening (Col. 2, Lines 1-20; Col. 4, Lines 51-64); and a frame (anchoring stent 4, Figs. 1A-D, Fig. 2; 5A-C) coupled to the pumping pouch, the frame (anchoring stent 4, Figs. 1A-D, Fig. 2; 5A-C) configured to be coupled to a wall of the heart (device 1 coupled to wall of heart, Fig. 4D-E; Col. 4, Lines 7-20; Col. 6, Lines 39-56; Claim 3).
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.
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 9 is rejected under 35 U.S.C. 103 as being unpatentable over Leasure (US Patent No. 7,172,551).
Regarding Claim 9, Leasure discloses a ventricular assist device (400, Fig. 7; Abstract) as described in detail with respect to Claim 1 above. However, the embodiment of Fig. 7 does not explicitly disclose wherein the contraction element includes a flap coupled to a side wall of the pumping pouch, the flap having a first end portion coupled to the pumping pouch, the flap having a second end portion that is free.
An alternative embodiment of Leasure teaches wherein the contraction element includes a flap (balloon/portions 322, 336, 334; Fig. 6) coupled to a side wall of the pumping pouch (320, 326, 316, Fig. 6), the flap having a first end portion (portions 332, 336 connected to pouch/elements 320, 326, 316, Fig. 6) coupled to the pumping pouch, the flap having a second end portion that is free (free end 334, 322, Fig. 6; Col. 4, Line 51-Col. 5, Line 2).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include a flap in the contraction element, the flap coupled to a side wall of the pumping pouch, the flap having a first end portion coupled to the pumping pouch, the flap having a second end portion that is free, as taught in the alternative embodiment of Leasure, in order to increase the overall pumping force or redundancy of the design, since Leasure discloses that “the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention” (Col. 2, Lines 25-32), and since the substitution of one known element for another yields predictable results to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Leasure (US Patent No. 7,172,551)/Thanikachalam (US Patent No. 10,492,911) in view of Vidlund (US Patent No. 10,639,145).
Regarding Claim 4, both Leasure and Thanikachalam disclose the ventricular assist device as described above with respect to Claim 1. Leasure discloses a ventricular assist device further wherein the contraction element (actuators 440, Fig. 7; Col. 5, Lines 10-21) includes an electroactive polymer (Col. 5, Lines 22-40). Thanikachalam discloses a ventricular assist device further wherein the contraction element (spring 9, Figs. 2, 5B, 5C) includes a shape memory alloy (made from shape memory alloy such as Nitonol, Col. 5, Lines 5-22, 40-46; Claim 11). However, neither Leasure nor Thanikachalam explicitly disclose wherein the contraction element includes a shape memory ceramic.
Vidlund et al. teaches a cardiac assist device (Abstract) comprising contraction elements including a shape memory ceramic (Col. 39, Lines 50-61). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the contraction element as disclosed by Leasure or Thanikachalam to include a shape memory ceramic, as taught by Vidlund et al., in order to “provide sufficient structural integrity to withstand the intracardiac forces without dislocating, permanently deforming or fracturing”, as also taught by Vidlund et al. (Col. 39, Lines 50-61), and since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Leasure (US Patent No. 7,172,551)/Thanikachalam (US Patent No. 10,492,911) in view of Buckner et al. (US Patent No. 7,758,491).
Regarding Claim 13, both Leasure and Thanikachalam disclose the ventricular assist device as described above with respect to Claim 1. Leasure discloses a ventricular assist device further comprising a frame including struts (struts 426 and member 422, Fig. 7; Col. 5, Lines 3-21) which are attached to circular sections of the pumping pouch (circular top and bottom of wall 416 defining chamber 418, Fig. 7; Col. 5, Lines 3-21). Thanikachalam discloses a ventricular assist device further comprising a frame (anchoring stent 4, Figs. 1A-D, Fig. 2; 5A-C) coupled to the pumping pouch (recoiling part 5 including membrane 12, Figs. 1A-D, 5A-C), which includes an upper ring coupled to an upper portion of the pumping pouch (see Figs. 1C-D).
However, neither Leasure nor Thanikachalam explicitly disclose wherein the frame includes an upper ring coupled to an upper portion of the pumping pouch, a lower ring coupled to a lower portion of the pumping pouch, and one or more struts coupling the upper ring to the lower ring.
Buckner et al. teaches a ventricular cardiac assist device (Abstract, Col. 3, Lines 15-60) comprising a frame (bistable cage 10, Fig. 1) including an upper ring (top band 20, Fig. 1) coupled to an upper portion of the device, a lower ring (bottom band 15, Fig. 1) coupled to a lower portion of the device, and one or more struts (30, 32, 31, Fig. 1) coupling the upper ring to the lower ring (Col. 8, Line 56 – Col. 9, Line 23). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include an upper ring coupled to an upper portion of the pumping pouch, a lower ring coupled to a lower portion of the pumping pouch, and one or more struts coupling the upper ring to the lower ring, as taught by Buckner et al., in the frame of the ventricular assist devices disclosed by Leasure or Thanikachalam, in order to increase the mechanical stability of the device due to the ring/cage structure, as also taught by Buckner et al. (Abstract; Col. 8, Line 56 – Col. 9, Line 25; Col. 3, Lines 35-55).
Conclusion
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/PAMELA M. BAYS/Primary Examiner, Art Unit 3796