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 .
Information Disclosure Statement
Applicant should note that the large number of references in the attached IDS, see IDS filed 7/10/2023, have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper filed of search. See MPEP 609.05(b). Applicant is requested to point out any particular references in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this Office Action.
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.
Claims 2 and 29 are 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. The term “substantially” in claims 2 and 29 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Claim 2 recites a “substantially constant inner cup volume” it is unclear what cup volumes would be considered “substantially constant”. The specification does not provide a range or values for what cup volumes would be considered “substantially constant”. Clarification is required. Claim 29 recites “substantially higher than a sensed heartbeat” it is unclear what frequency of pumping the control unit is arranged to set pumping frequency since “substantially higher than a sensed heartbeat” is a relative term that would vary based on user’s preference. Claims 30-31 recite the frequency of pumping being at least 2 times higher than the sensed heartbeat, does a pumping frequency at least 2 times higher than the sensed heartbeat constitute “substantially higher than a sensed heartbeat”. Clarification is required. For purposes of examination claim 2 has been interpreted to include a cup volume that is relatively the same during pump and filling operational modes and claim 29 has been interpreted to be a frequency of pumping at least 2 times higher than a sensed heartbeat as recited within claims 30-31.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-6,8-9,15,18,20,36-37 and 39 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2020/022905 to VanDort (VanDort) (cited by applicant).
In reference to at least claim 1
VanDort discloses a cardiac assist device (e.g. “heart support device”, abstract), comprising: a cup (e.g. chamber body 10) comprising: a cup wall defining an inner cup volume (e.g. chamber body 10 has a wall and inner cup volume); one or more in-flow openings to allow a first fluid to flow into the cup during operation (e.g. side openings 32); and an outflow element connected to the cup wall and having an aperture for expelling the first fluid during operation (e.g. first opening 12); an inner balloon (e.g. balloon 26) comprising a balloon wall defining an inner balloon volume, the inner balloon being positioned inside the cup (e.g. balloon 26 has an inner volume and is located inside chamber body 10); and a tube (e.g. catheter 16) connected to the inner balloon configured to inflate the inner balloon during a pumping operational mode and deflate the inner balloon during a filling operational mode (e.g. “A catheter 16 comprising at least one fluid lumen 18 is in fluid communication with the dynamic volume body 14 and is configured to deliver fluid (e.g. a liquid, or a gas such as Helium) to the dynamic volume body 14 to inflate and/or deflate the body 14.”, p. 5, ll. 10-16; “the dynamic volume body 12 can comprise an inflatable balloon 26 “, p. 6, ll. 29-38); wherein the cup is configured to counteract an outward directed force resulting from inflation of the inner balloon during the pumping operational mode (e.g. “The cup 28 is relatively rigid compared to the balloon 26, once it has been expanded to its expanded configuration”, p. 6, ll. 29-38, therefore the cup is “configured to counteract an outward directed force resulting from inflation of the inner balloon during the pumping operational mode).
In reference to at least claim 2
VanDort discloses wherein during the pumping and filling operational modes, the cup has a substantially constant inner cup volume (e.g. chamber body 10 has a constant inner volume, Figs. 2A-5).
In reference to at least claim 3
VanDort discloses wherein the cup comprises a skeleton structure integrated with the cup wall (e.g. support structure 24).
In reference to at least claim 4
VanDort discloses wherein the skeleton structure has a wire mesh structure (e.g. “the support structure can comprise a scaffold formed of a resilient material,”, p. 2, ll. 34-38).
In reference to at least claim 5
VanDort discloses wherein the cup wall comprises an inner layer, an outer layer, or both an inner layer and an outer layer (e.g. “the support structure can comprise a scaffold formed of a resilient material,”, p. 2, ll. 34-38).
In reference to at least claim 6
VanDort discloses wherein the cup further comprises a trans-valve section in communication with the outflow element (e.g. “the aortic valve when the pump is placed in the left ventricle.”, p. 2, ll. 35-37, p. 3, ll. 5-9).
In reference to at least claim 8
VanDort discloses wherein the skeleton structure comprises shape-memory material (e.g. “As an example, the support structure 24 can comprise a shape memory material, e.g. in the form of a collapsible scaffold formed of nitinol or another shape memory material.”, p. 6, ll. 7-8).
In reference to at least claim 9
VanDort discloses wherein the outflow element comprises an outflow skeleton structure which is formed from an extension of the skeleton structure (e.g. “ the support device comprises a chamber 10 formed by a series of panels 34 supported by a support structure 24. The support structure 24 comprises a plurality of ribs 36 that are arranged in a helical fashion, extending from a first common end point 38 and, advantageously, meeting at a second common end point 40 (for example, as shown in FIG. 8).”, the support structure 24 extends into “outflow element” 12, Fig. 8, p. 9, ll. 6-11).
In reference to at least claim 15
VanDort discloses wherein the tube is a multi-lumen catheter (e.g. “A catheter comprising at least one lumen is provided in fluid communication with the dynamic volume body and is arranged to deliver fluid to the dynamic volume body to inflate the dynamic volume body.” p. 2, ll. 3-5, therefore a catheter can include multiple lumens).
In reference to at least claim 18
VanDort discloses wherein the inner balloon has a conical shape (e.g. balloon 26 has a conical shape, Figs. 2A-5).
In reference to at least claim 20
VanDort discloses wherein each of the one or more inflow openings comprises a one-way valve (e.g. “The additional side openings 32 can comprise one-way valve structures configured to allow the flow of fluid into the chamber 10 via the openings 32 (and prevent flow in the opposite direction)”, p. 8, ll. 15-17).
In reference to at least claim 36
VanDort discloses wherein the cup comprises one or more circumferential restraining elements (e.g. “the support structure can comprise a scaffold formed of a resilient material,”, p. 2, ll. 34-38, therefore the resilient material of the scaffold includes “restraining elements”).
In reference to at least claim 37
VanDort discloses wherein a portion of the skeleton structure is configured to pass through an aortic valve when at least a portion of the cup is positioned in a left ventricle of a patient (e.g. “the aortic valve when the pump is placed in the left ventricle.”, p. 2, ll. 35-37, p. 3, ll. 5-9, 30-37).
In reference to at least claim 39
VanDort discloses wherein the one or more in-flow openings are arranged in the cup wall (e.g. side openings 32 are arranged in the cup wall, Fig. 5).
Claim(s) 1-2,5-7,11,13,15,18-19,27-31 and 38-39 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent No. 5,169,378 to Figuera (Figuera) (cited by applicant).
In reference to at least claim 1
Figuera discloses a cardiac assist device (e.g. intraventricular expansion assist pump, Col. 1, ll. 7-8), comprising: a cup (e.g. pump body 1) comprising: a cup wall defining an inner cup volume (e.g. pump body 1 has a wall and inner cup volume); one or more in-flow openings to allow a first fluid to flow into the cup during operation (e.g. nozzles 5); and an outflow element connected to the cup wall and having an aperture for expelling the first fluid during operation (e.g. transvalvular segment 2 has an aperture); an inner balloon (e.g. balloon 3) comprising a balloon wall defining an inner balloon volume, the inner balloon being positioned inside the cup (e.g. balloon 3 has an inner volume and is located inside pump body 1); and a tube (e.g. catheter 4) connected to the inner balloon configured to inflate the inner balloon during a pumping operational mode and deflate the inner balloon during a filling operational mode (e.g. “A larger diameter conduit 4' is meant for the inflation and deflation of the internal balloon 3”, Col. 4, ll. 35-38); wherein the cup is configured to counteract an outward directed force resulting from inflation of the inner balloon during the pumping operational mode (e.g. “The chamber is of varying rigidity, not distendible, so that, on one hand, it avoids collapse when a vacuum is produced in the internal balloon and, on the other hand, protects the myocardium from the internal pressure provoked by the inflation of the balloon.”, Col. 4, ll. 54-60, therefore the pump body is “configured to counteract an outward directed force resulting from inflation of the inner balloon during the pumping operational mode).
In reference to at least claim 2
Figuera discloses wherein during the pumping and filling operational modes, the cup has a substantially constant inner cup volume (e.g. pump body 1 has a constant inner volume, Figs. 2a-2e).
In reference to at least claim 5
Figuera discloses wherein the cup wall comprises an inner layer, an outer layer, or both an inner layer and an outer layer (e.g. pump body 10 has a layer therefore the pump body has an “inner layer” or “an outer layer”).
In reference to at least claim 6
Figuera discloses wherein the cup further comprises a trans-valve section in communication with the outflow element (e.g. transvalvular segment 2).
In reference to at least claim 7
Figuera discloses wherein the outflow element comprises a collapsible tubular element (e.g. “A transvalvular segment 2, "neck", or distal part of the pump comprises a tube of some 16 mm diameter, is constructed of plastic bio-compatible material, as that of the body pump, but with very thin walls, which implies that it can easily collapse”, Col. 3, ll. 65-68).
In reference to at least claim 11
Figuera discloses a control unit arranged to control fluid flow through the tube during operation (e.g. drive unit 10).
In reference to at least claim 13
Figuera discloses wherein the combination of the cup and the inner balloon is adjustable to a transport mode, in which the maximum diameter of the combination is less than 7mm (e.g. Fig. 3, “The pump 1 is wrapped to its two way conducting catheter 4, with the internal balloon 3 deflated and the transvalvular segment 2 also wrapped to the catheter. The compressor 10 of the drive unit is in the position of rest and the pressure of the circuit of expansibility at 0. Under the above described conditions, the pump 1 has been introduced into the left ventricle through the femoral artery 12,”, Col. 5, ll. 1-10, the device is introduced through the femoral artery, therefore the combination of the cup and inner ballon is adjustable to a transport mode in which a maximum diameter is less than 7mm).
In reference to at least claim 15
Figuera discloses wherein the tube is a multi-lumen catheter (e.g. catheter 4 has conduits 4’ and 4”).
In reference to at least claim 18
Figuera discloses wherein the inner balloon has a conical shape (e.g. balloon 3 has a conical shape, Figs. 1,2b).
In reference to at least claim 19
Figuera discloses wherein the inner balloon comprises a multi-stage balloon assembly (e.g. “the internal balloon 3, as shown in FIG. 2d, is also constructed with a bio-compatible material and has a pyriform shape. Its main characteristic is that the thickness of its wall increases from the narrower distal part to the wider proximal part. The reason for such a difference is to provoke an inflation, somewhat sequential, progressive, from the pointed end on”, Col. 4, ll. 12-18).
In reference to at least claim 27
Figuera discloses wherein the control unit is arranged to inflate and deflate the inner balloon at a frequency of pumping (e.g. functioning of the pump, Col. 5, l. 33 – Col. 6, l. 1).
In reference to at least claim 28
Figuera discloses wherein the control unit is arranged to set the frequency of pumping synchronously to a sensed heartbeat (e.g. “As mentioned above, the synchronization of the pump with the heart beat is not indispensable, though the drive unit 10 must be provided with such possibility as well as with all the elements that are necessary to maintain and control all its functions: inflation and deflation; high and low pressures; vacuum; expansibility pressures; ventricular flow; EKG, and so on. It must also have all the security measures common in these kinds of drive units.”, Col. 6, ll. 50-58).
In reference to at least claim 29
Figuera discloses wherein the control unit is arranged to set the frequency of pumping substantially higher than a sensed heartbeat (e.g. “As mentioned above, the synchronization of the pump with the heart beat is not indispensable, though the drive unit 10 must be provided with such possibility as well as with all the elements that are necessary to maintain and control all its functions: inflation and deflation; high and low pressures; vacuum; expansibility pressures; ventricular flow; EKG, and so on. It must also have all the security measures common in these kinds of drive units.”, Col. 6, ll. 50-58, therefore the control unit is “arranged to set the frequency of pumping substantially higher than a sensed heartbeat”).
In reference to at least claim 30
Figuera discloses wherein the control unit is arranged to set the frequency of pumping to at least 2 times higher than a sensed heartbeat (e.g. “As mentioned above, the synchronization of the pump with the heart beat is not indispensable, though the drive unit 10 must be provided with such possibility as well as with all the elements that are necessary to maintain and control all its functions: inflation and deflation; high and low pressures; vacuum; expansibility pressures; ventricular flow; EKG, and so on. It must also have all the security measures common in these kinds of drive units.”, Col. 6, ll. 50-58, therefore the control unit is “arranged to set the frequency of pumping to at least 2 times higher than a sensed heartbeat).
In reference to at least claim 31
Figuera discloses wherein the control unit is arranged to set the frequency of pumping to at least a factor of 2-10 times higher than a sensed heartbeat (e.g. “As mentioned above, the synchronization of the pump with the heart beat is not indispensable, though the drive unit 10 must be provided with such possibility as well as with all the elements that are necessary to maintain and control all its functions: inflation and deflation; high and low pressures; vacuum; expansibility pressures; ventricular flow; EKG, and so on. It must also have all the security measures common in these kinds of drive units.”, Col. 6, ll. 50-58, therefore the control unit is “arranged to set the frequency of pumping to at least a factor of 2-10 times higher than a sensed heartbeat).
In reference to at least claim 38
Figuera discloses wherein the control unit is arranged to set the frequency of pumping to at least 2 times higher than a sensed heartbeat (e.g. “As mentioned above, the synchronization of the pump with the heart beat is not indispensable, though the drive unit 10 must be provided with such possibility as well as with all the elements that are necessary to maintain and control all its functions: inflation and deflation; high and low pressures; vacuum; expansibility pressures; ventricular flow; EKG, and so on. It must also have all the security measures common in these kinds of drive units.”, Col. 6, ll. 50-58, therefore the control unit is “arranged to set the frequency of pumping to at least 2 times higher than a sensed heartbeat).
In reference to at least claim 39
Figuera discloses wherein the one or more in-flow openings are arranged in the cup wall (e.g. nozzles 5 are arranged in the pump body 1, Figs, 1,2a, 2d, 2e, 2f).
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.
Claim(s) 10 and 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2020/022905 to VanDort (VanDort) in view of US Patent No. 5,169,378 to Figuera (Figuera).
In reference to at least claim 10
VanDort discloses a cardiac assist device according to claim 9 and further discloses the outflow element comprising a tubular element fixed to the outflow skeleton structure (e.g. the outflow element 12 is a tubular element and the support structure 24 extends into outflow element 12, Fig. 8, p. 9, ll. 6-11).
However, VanDort does not explicitly disclose the tubular element being collapsible.
Figuera discloses a cardiac assist device (e.g. intraventricular expansion assist pump, Col. 1, ll. 7-8), comprising: a cup (e.g. pump body 1) comprising: a cup wall defining an inner cup volume (e.g. pump body 1 has a wall and inner cup volume); one or more in-flow openings to allow a first fluid to flow into the cup during operation (e.g. nozzles 5); and an outflow element connected to the cup wall and having an aperture for expelling the first fluid during operation (e.g. transvalvular segment 2 has an aperture); an inner balloon (e.g. balloon 3) comprising a balloon wall defining an inner balloon volume, the inner balloon being positioned inside the cup (e.g. balloon 3 has an inner volume and is located inside pump body 1); and a tube (e.g. catheter 4) connected to the inner balloon. Figuera further discloses wherein the outflow element comprises a collapsible tubular element (e.g. “A transvalvular segment 2, "neck", or distal part of the pump comprises a tube of some 16 mm diameter, is constructed of plastic bio-compatible material, as that of the body pump, but with very thin walls, which implies that it can easily collapse”, Col. 3, ll. 65-68) and that the collapsing allows the transvalvular segment 2 which is the tubular element to adapt or conform itself to the situation or position of the aortic valve without interfering in function thereof (e.g. Col. 5, ll. 57-62).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Johnson to include the tubular element being collapsible, as taught by Figuera, in order to allow the tubular element to adapt or conform itself to the situation or position of the aortic valve without interfering in function thereof (‘378, Col. 5, ll. 57-62).
In reference to at least claim 40
VanDort discloses a cardiac assist device (e.g. “heart support device”, abstract), comprising: a cup (e.g. chamber body 10) comprising: a cup wall defining an inner cup volume (e.g. chamber body 10 has a wall and inner cup volume) and including a cup skeleton structure (e.g. support structure 24); one or more in-flow openings to allow a first fluid to flow into the cup during operation (e.g. side openings 32); and a tubular outflow element connected to the cup wall, wherein the outflow element includes an aperture for expelling the first fluid during operation (e.g. first opening 12) and an outflow skeleton structure from an extension of the cup skeleton structure (e.g. “ the support device comprises a chamber 10 formed by a series of panels 34 supported by a support structure 24. The support structure 24 comprises a plurality of ribs 36 that are arranged in a helical fashion, extending from a first common end point 38 and, advantageously, meeting at a second common end point 40 (for example, as shown in FIG. 8).”, the support structure 24 extends into “outflow element” 12, Fig. 8, p. 9, ll. 6-11); an inner balloon (e.g. balloon 26) comprising a balloon wall defining an inner balloon volume, the inner balloon being positioned inside the cup (e.g. balloon 26 has an inner volume and is located inside chamber body 10); and a tube (e.g. catheter 16) connected to the inner balloon configured to inflate the inner balloon during a pumping operational mode and deflate the inner balloon during a filling operational mode (e.g. “A catheter 16 comprising at least one fluid lumen 18 is in fluid communication with the dynamic volume body 14 and is configured to deliver fluid (e.g. a liquid, or a gas such as Helium) to the dynamic volume body 14 to inflate and/or deflate the body 14.”, p. 5, ll. 10-16; “the dynamic volume body 12 can comprise an inflatable balloon 26 “, p. 6, ll. 29-38); wherein the cup is configured to counteract an outward directed force resulting from inflation of the inner balloon during the pumping operational mode (e.g. “The cup 28 is relatively rigid compared to the balloon 26, once it has been expanded to its expanded configuration”, p. 6, ll. 29-38, therefore the cup is “configured to counteract an outward directed force resulting from inflation of the inner balloon during the pumping operational mode).
However, VanDort does not explicitly disclose the tubular element being collapsible.
Figuera discloses a cardiac assist device (e.g. intraventricular expansion assist pump, Col. 1, ll. 7-8), comprising: a cup (e.g. pump body 1) comprising: a cup wall defining an inner cup volume (e.g. pump body 1 has a wall and inner cup volume); one or more in-flow openings to allow a first fluid to flow into the cup during operation (e.g. nozzles 5); and an outflow element connected to the cup wall and having an aperture for expelling the first fluid during operation (e.g. transvalvular segment 2 has an aperture); an inner balloon (e.g. balloon 3) comprising a balloon wall defining an inner balloon volume, the inner balloon being positioned inside the cup (e.g. balloon 3 has an inner volume and is located inside pump body 1); and a tube (e.g. catheter 4) connected to the inner balloon. Figuera further discloses wherein the outflow element comprises a collapsible tubular element (e.g. “A transvalvular segment 2, "neck", or distal part of the pump comprises a tube of some 16 mm diameter, is constructed of plastic bio-compatible material, as that of the body pump, but with very thin walls, which implies that it can easily collapse”, Col. 3, ll. 65-68) and that the collapsing allows the transvalvular segment 2 which is the tubular element to adapt or conform itself to the situation or position of the aortic valve without interfering in function thereof (e.g. Col. 5, ll. 57-62).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Johnson to include the tubular element being collapsible, as taught by Figuera, in order to allow the tubular element to adapt or conform itself to the situation or position of the aortic valve without interfering in function thereof (‘378, Col. 5, ll. 57-62).
Conclusion
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/JENNIFER L GHAND/Examiner, Art Unit 3796