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 and amendments, see applicant's arguments, filed 0, with respect to the 35 U.S.C. 112(a) rejection of claim 19 and its dependent claims have been fully considered and are persuasive. The rejection of 11/26/2025 has been withdrawn.
With respect to Burchman only disclosing a prosthetic heart valve and not a “precision workstation” used in “constructing a heart valve or other repair structure used in cardiac surgery,” Examiner notes that claim 19 only discloses “an assembly for forming a cardiac repair structure” to which a heart valve will satisfy. Claiming a precision workstation and detailing what parts belong to the workstation and not the heart valve assembly detailed in parts of claim 19 will overcome the prior art. From here, examiner argues that, as Bruchman does teach a heart valve itself, and as a valve has blood passing through it, the frame itself will act as a reservoir for a blood fluid. Examiner notes that clarification on the fluid can overcome Burchman if said fluid is for use with the precision workstation and not a blood fluid. Examiner also notes that the rejection in view of Berchman was changed in view of the new limitations presented on 07/31/2026.
As the valve structure and platform surface are two separate parts, it stands to reason that a first portion of the cardiac repair structure can be removed. Part 150a is also on a first platform surface. Birchman also teaches a second platform surface is disposed upon a second part 131 and related frame in figure 4a. Additionally, part 150a is disposed on a first and second platform surface as per figure 4a, with part 150a defined in [0078]). With part 150a being a part on a first and second platform surface, Saar (US Pub No.: 2019/0069996) was brought in to teach an aperture.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, 34.36. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the manifold of Labib into Burchman for the purpose of providing a manifold that can be used with the heart valve and required implantation of Burchman that can suction fluid out of a patient’s body to relieve lymphedema in [0537]. Here, the manifold is used during implantation of the device of Burchman.
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.
Claim(s) 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burchman (US Pub No.: 2014/0163673) in view of Labib (US Pub No.: 2018/0200185) and McNamara (US Pub No.: 2012/0265296).
Regarding claim 19, Burchman (US Pub No.: 2014/0163673) discloses an assembly for forming a cardiac repair structure (in the abstract) from a portion of pericardial tissue (fabrication from biological tissue in [0002], [0005]), the assembly comprising:
a deck having a recess that is at least partially defined by top surface and one or more walls that extend away from the top surface to define a first fluid reservoir (being the two parts 131 in figure 3, that both extend upward with a bottom wall part 134 extends perpendicular to parts 131 at the apex of part 134 in figure 3, a normal displacement of part 134 is normal to parts 131);
a platform assembly removably disposed within a portion of the first fluid reservoir of the deck (being the leaflets part 140. The leaflets are defined as having an elastomer in [0034] and the elastomer is porous in [0022]-[0023] as the cardiac repair structure is the valve structure shown in figure 3 has the first platform surface, being the surface of the valve in figure 4A, placed on top of it, it stands to reason that a first portion of the cardiac repair structure can be removed. Part 150a is also on a first platform surface),
the platform assembly comprising:
a first platform segment defining a first volume (being one of the parts 140 in figure 1A), the first platform having a first platform surface,
wherein the first platform surface includes a first plurality of apertures (parts 150 shown in figure 1A), with each of the first plurality of apertures being in fluid communication with the first volume (shown visually in figures 1A and 1B, where parts 150 are on parts 140 that come into contact with a first volume),
wherein the first platform surface is planar (leaflets part 140 are assumed to be planar as per the structure of a heart valve leaflet),
wherein a first platform perimeter edge defining a portion of the first platform surface is non-linear and is configured to have the shape of a first perimeter edge of the cardiac repair structure (the edge of part 140 is depicted as being non-linear in figure 1B, where the cardiac repair structure is shown in figure 3);
a second platform segment defining a second volume (being about a second part 140 in figure 1A), the second platform having a second platform surface (being the surface of part 140),
wherein the second platform surface includes a second plurality of apertures (being parts 150 in figures 1A-1B), with each of the second plurality of apertures being in fluid communication with the second volume (shown visually in figures 1A and 1B, where parts 150 are on parts 140 that come into contact with a first volume),
wherein the second platform surface is planar (leaflets part 140 are assumed to be planar as per the structure of a heart valve leaflet),
wherein a second platform perimeter edge defining a portion of the second platform surface is non-linear and is configured to have the shape of a second perimeter edge of the cardiac repair structure (the edge of part 140 is depicted as being non-linear in figure 1B),
wherein a first portion of the cardiac repair structure is configured to be removably disposed on the first platform surface (as the cardiac repair structure is the valve structure shown in figure 3 has the first platform surface, being the surface of the valve in figure 4A, placed on top of it, it stands to reason that a first portion of the cardiac repair structure can be removed. Part 150a is also on a first platform surface)
and a second portion of the cardiac repair structure is configured to be disposed on the second platform surface (a second platform surface is disposed upon a second part 131 and related frame in figure 4a. Additionally, imageable element 150a is disposed on a first and second platform surface as per figure 4a, with part 150a defined in [0078]),
wherein a portion of the first platform is pivotably coupled to a portion of the second platform (different parts 140 interface with each other as per figures 1A and 1B) such that the platform is pivotable between a first position, in which the first platform surface is coplanar with the second platform surface, and a second position, in which at least a portion of the first platform surface is immediately adjacent to at least a portion of second platform surface (being the change in parts 140 from figure 1A to figure 1B).
However, Burchman does not disclose details with respect to a manifold assembly
Instead, Labib (US Pub No.: 2018/0200185) teaches a manifold assembly (in [0135]-[0136]) comprising: a first valve assembly comprising (the primary valves in [0229]):a first tube having a first end and a second end (being the tubular structure in [0140]), the first end being coupled to a portion of the first platform such that the first end of the first tube is in fluid communication with the first volume (the tubing with the manifold of Labib can be coupled with the platform of Burchman); a first valve having an open position and a closed position (it stands to reason that the valves in [0229] will have an open and closed position),
wherein an outlet of the first valve is in fluid communication with the second end of the first tube (as the valve controls the delivery of fluid in [0225] and as the tubes are used to introduce the fluid in [0533], the valve is used to control the passage of fluid),
and wherein an inlet of the first valve is configured to be coupled to a first vacuum source such that when the first valve is in the open position (the vacuum and connection details being present in [0437]), the first volume is in fluid communication with the first vacuum source and when the first valve is in the closed position, the first volume is not in fluid communication with the first vacuum source (in [0437]),
and when the first valve is in the open position, the first plurality of apertures is in fluid communication with the first volume and is configured to cooperate to provide a force on the;
and a second valve assembly (the secondary valves in [0229]) comprising: a second tube having a first end and a second end (as a plurality of tubes are present in [0147], a second tube is present in Labib), the first end being coupled to a portion of the second platform such that the first end of the second tube is in fluid communication with the second volume (the tubing of Labib can be made to interface with the second platform of Burchman); a second valve having an open position and a closed position (it stands to reason that the valves in [0229] will have an open and closed position),
wherein an outlet of the second valve is in fluid communication with the second end of the second tube (as the valve controls the delivery of fluid in [0225] and as the tubes are used to introduce the fluid in [0533], the valve is used to control the passage of fluid),
and wherein an inlet of the second valve is configured to be coupled to a second vacuum source such that when the second valve is in the open position (the vacuum and connection details being present in [0437]), the second volume is in fluid communication with the second vacuum source and when the second valve is in the closed position (in [0437]), the second volume is not in fluid communication with the second vacuum source,
and when the second valve is in the open position, the second plurality of apertures is in fluid communication with the second volume and is configured to cooperate to provide a force on the second portion of the cardiac repair structure to couple the second portion of the cardiac repair structure to the second platform surface (fluid communication details in [0459]-[0461]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the manifold of Labib into Burchman for the purpose of providing a manifold that can be used with the heart valve and required implantation of Burchman that can suction fluid out of a patient’s body to relieve lymphedema in [0537]. Here, the manifold is used during implantation of the device of Burchman.
Burchman in view of Labib also does not teach a forming of a cardiac repair structure from a portion of pericardial tissue.
Instead, McNamara (US Pub No.: 2012/0265296) teaches a formation of a cardiac repair structure from a portion of pericardial tissue (in [0127] and [0294])
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the pericardial tissue of McNamara into Burchman for the purpose of providing a material known in the art that can be used for a valve (in [0294]) where pericardial tissue is known in the art to have the durability and material properties of a natural human heart valve.
Regarding claim 20, Burchman in view of Labib and McNamara teach the assembly for forming the cardiac repair structure of claim 19, wherein Burchman discloses the platform assembly is removably secured to the deck (one of ordinary skill in the art can remove parts 140 from part 130 within Burchman).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burchman (US Pub No.: 2014/0163673) in view of Labib (US Pub No.: 2018/0200185) McNamara (US Pub No.: 2012/0265296) and Saar (US Pub No.: 2019/0069996).
Regarding claim 21, Burchman in view of Labib and McNamara teach the assembly for forming the cardiac repair structure of claim 19, with Burchman disclosing the platform assembly further comprising: a third platform segment defining a third volume (being the third leaflet part 140), the third platform having a third platform surface (being the surface of part 140),
wherein the third platform surface includes a third plurality of apertures (shown visually in figures 1A and 1B, where parts 150 are on parts 140 that come into contact with a first volume), with each of the third plurality of apertures being in fluid communication with the third volume (shown visually in figures 1A and 1B, where parts 150 are on parts 140 that come into contact with a fluid. The third volume would be the fluid that interacts with the third aperture),
wherein the third platform surface is planar (leaflets part 140 are assumed to be planar as per the structure of a heart valve leaflet),
wherein a third platform perimeter edge defining a portion of the third platform surface is non-linear and is configured to have the shape of a third perimeter edge of the cardiac repair structure (the edge of part 140 is depicted as being non-linear in figure 1B, where the additional leaflets will comprise a third platform. Additionally, another edge of part 140 by part 134 in figure 4A is also depicted as not being linear);
With respect to the presence of apertures Saar (US Pub No.: 2019/0069996) wherein the third platform surface includes a third plurality of apertures (part 92 in figure 8, defined as an aperture on a valve element in paragraph [0044]), with each of the third plurality of apertures being in fluid communication with the third volume (as the apertures are on a leaflet in [0044], a fluid communication is implied).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the aperture part 92 of into Burchman for the purpose of providing a small amount of fluid flow as per [0044] that creates a secondary fluid flow path in [0045] that prevents a stagnation of blood as per [0047].
Claim(s) 22-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burchman (US Pub No.: 2014/0163673) in view of Labib (US Pub No.: 2018/0200185) and McNamara (US Pub No.: 2012/0265296) in further view of Artof (US Pub No.: 2005/0075731).
Regarding claim 22, Burchman in view of Labib and McNamara teach the assembly for forming the cardiac repair structure of claim 19. However, Burchman in view of Labib does not teach details with respect to a first shaft and a plurality of pins.
Instead Artof (US Pub No.: 2005/0075731) teaches wherein a first shaft (shaft in [0053]) is pivotably coupled to a first portion of the deck and is rotatable between an engaged position and a disengaged position (as the shaft of Artof is disclosed for use in a valve (valve in [0001]), the shaft of Artof can be used to couple with the deck of Burchman), the first shaft having a first plurality of pins (plurality of pins in figure 37B, labeled in [0133])
such that (a) when the first shaft is in the engaged position, each of first plurality of pins engages a corresponding first portion of the platform assembly to secure the corresponding first portion of the platform assembly within the portion of the first fluid reservoir of the deck (pins 251 to engage with shaft 255 when the shaft is rotated, as per [0133]),
and (b) when the first shaft is in the disengaged position, each of first plurality of pins is remote from the corresponding first portion of the platform assembly (as the shaft has to be rotated to engage to the pins via plate 259 in [0133], it stands to reason that, if the shaft is not rotated, a pin contacting is not present).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the shaft and pin setup of Artov into Burchman for the purpose of providing an “expansion and contraction device for implanting the valve assemblies” as presented in Artov in [0127], where the expansion device would allow for a folded valve to be expanded in the body.
Regarding claim 23, Burchman in view of Labib, McNamara and Artov teach the assembly for forming the cardiac repair structure of claim 22. However, the current iteration of Artov does not teach details with respect to a second shaft.
However, Artov can be implemented into the combination of Burchman and Labib wherein a second shaft is pivotably coupled to a second portion of the deck and is rotatable between an engaged position and a disengaged position (as the shaft of Artof is disclosed for use in a valve (valve in [0001]), the shaft of Artof can be used to couple with the deck of Burchman), the second shaft having a second plurality of pins (plurality of pins in figure 37B, labeled in [0133])
such that (a) when the second shaft is in the engaged position, each of second plurality of pins engages a corresponding second portion of the platform assembly to secure the corresponding second portion of the platform assembly within the portion of the first fluid reservoir of the deck (pins 251 to engage with shaft 255 when the shaft is rotated, as per [0133]),
and (b) when the second shaft is in the disengaged position, each of second plurality of pins is remote from the corresponding second portion of the platform assembly (as the shaft has to be rotated to engage to the pins via plate 259 in [0133], it stands to reason that, if the shaft is not rotated, a pin contacting is not present).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the shaft and pin setup of Artov into Burchman for the purpose of providing an “expansion and contraction device for implanting the valve assemblies” as presented in Artov in [0127], where the expansion device would allow for a folded valve to be expanded in the body.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Beith (US Patent No.: 7,682,389) a cardiac or heart valve in the abstract, with a parabolic leaflet geometry in the abstract and figure 2a. Farritor (US Patent No.: 7,772,796) discloses manifold details with a fluid communication in column 2 lines 39-47.
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AREN PATEL whose telephone number is (571)272-0144. The examiner can normally be reached 7:00 - 4:30 M-Th.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah C. Edwards can be reached on (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AREN PATEL/Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774
