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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/01/2026 has been entered.
Claims 1, 8, 10, 18, 23, 28, 32, and 37-38 have been amended. Claims 1-2, 5-8, 10, 12-13, 16-18, 22-23, 28, 32-34 and 37-38 are currently pending in the application.
Response to Arguments
Applicant’s arguments, see pg. 6, filed 09/01/2026, with respect to the rejections of claims 28 and 32-34 under 35 U.S.C. 112(b) have been fully considered and are persuasive. Therefore, the rejections have been withdrawn.
Applicant’s arguments, see pg. 6-8, filed 09/01/2026, with respect to the rejections of the claims under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Levenberg et al. (US 20140050766 A1).
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.
Claims 1, 2, 8 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Levenberg et al. (US 20140050766 A1) in view of Subramanian et al. (US 20130030455 A1).
Regarding claim 1, Levenberg discloses a heart patch device (the disclosed three-dimensional tissue construct can be used to regenerate heart muscle tissue, see [0042] and [0062]) comprising; a biodegradable polymeric mesh scaffold layer (see [0051]); and a biodegradable gel layer (the disclosed gel is made of fibrinogen and thrombin which are biodegradable, see [0045]), wherein the layers remain flexible after implantation (it is understood that the disclosed patch, which is made of the same flexible materials as the device of the instant application, remains flexible after implantation aside some teaching or suggestion that the patch changes in flexibility), wherein the gel layer includes one or more cells that express one or more of CD31 (PECAM1),CD144 (VE-Cadherin), and CD309 (VEGFR2) (the gel can further include one or more types of cells which may be HUVECs which are known to express CD31, CD144, and CD309, see [0013] and [0061]), and wherein the heart patch device is entirely biodegradable (Levenberg only discloses the patch being made of biodegradable materials).
Levenberg fails to teach the polymeric mesh scaffold layer has a tensile modulus of at least about 1 MPa.
Subramanian, in the same field of art, teaches a related heart patch device constructed of a polymeric material having a tensile modulus of at least 1 MPa (see [0084]), which provides the device with sufficient physical and mechanical properties for implantation (see [0086]).
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 device of Levenberg so that the mesh scaffold has a tensile modulus of at least about 1 MPa, as taught by Subramanian, since a tensile modulus in this range has been shown to provide the device with sufficient physical and mechanical properties for implantation.
Regarding the language “wherein the heart patch device is configured for implantation over a full-thickness defect in a free heart wall of a heart and further configured to mechanically support the free heart wall during beating of the heart and to repair the full-thickness defect by regenerating myocardium in the defect,” it is the Examiner’s position that the heart patch device of Levenberg and Subramanian, meeting all of the structural limitations of claim 1, is capable of performing the claimed function.
Regarding claim 2, Levenberg further discloses the polymeric mesh scaffold is made of a material comprising one or more of gelatin, polyurethane, and polycaprolactone (Levenberg discloses the polymeric mesh can be made of biodegradable polyurethane and polycaprolactone, see [0051]).
Regarding claim 8, Levenberg further discloses the gel layer further includes one or more stem cells (Levenberg discloses that the one or more cells in the gel can include stem cells, see [0013], [0061] and [0062]).
Regarding claim 37, Levenberg further discloses the one or more cells are present as a vascular structure within the gel layer prior to implantation over the full- thickness defect (the device can be incubated prior to implantation which blood vessel network/architecture to form, see [0096]).
Claims 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Levenberg and Subramanian, as applied to claim 2 above, and further in view of Kim et al. (US 20160115457 A1).
Regarding claim 5, the combination of Levenberg and Subramanian teaches the heart patch device of claim 2, wherein the gel comprises fibrinogen (see Levenberg [0045]) but fails to teach the gel further comprising one or more polyethylene glycol molecules.
Kim, in the same field of art, teaches a related gel which uses pegylated fibrinogen (fibrinogen with one or more polyethylene glycol molecules) since polyethylene glycol enhances the solubility of the gel, lowers toxicity and prolongs the circulation half life (see [0165] and [0172]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to substitute the fibrinogen of Levenberg with the pegylated fibrinogen of Kim since doing so would have yielded only predictable results, namely, the pegylated fibrinogen in the gel of Levenberg would have enhanced the solubility of the gel. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claim 6, Levenberg further discloses the gel further comprises thrombin (see [0045]).
Regarding claim 7, Levenberg further discloses wherein the polymeric mesh scaffold comprises biodegradable polyurethane (see [0051]).
Claims 10, 12-13, 16-18 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Levenberg in view of Hunter et al. (US 20050175703 A1), and further in view of Subramanian.
Regarding claim 10, Levenberg discloses a method for making a heart patch device (the disclosed three-dimensional tissue construct can be used to regenerate heart muscle tissue, see [0042] and [0062]), comprising; forming a mesh scaffold, wherein the mesh scaffold comprises a biodegradable polymer (see [0051]), forming a gel layer, wherein the gel is biodegradable (the disclosed gel is made of fibrinogen and thrombin which are biodegradable, see [0045]); and combining the mesh scaffold with the gel layer to form a flexible heart patch device (the mesh scaffold and gel are combined in one device, see [0042]), wherein the gel layer includes one or more cells that express one or more of CD31 (PECAM1),CD144 (VE-Cadherin), and CD309 (VEGFR2) (the gel can further include one or more types of cells which may be HUVECs which are known to express CD31, CD144, and CD309, see [0013] and [0061]), and wherein the heart patch device is entirely biodegradable (Levenberg only discloses the patch being made of biodegradable materials).
Levenberg fails to expressly teach forming the mesh by electrospinning.
Hunter, in the same field of art, teaches a related method of making a heart patch (see [0008]) including a polymer mesh scaffold which is formed by electrospinning to produce a non-woven mesh (see [1484]).
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 method of Levenberg by including the step of forming the polymer mesh by electrospinning since electrospinning was a known method of forming a mesh, as taught by Hunter, and doing so would have yielded only predictable results, namely, a non-woven polymer mesh.
The combination of Levenberg and Hunter fails to teach the mesh scaffold has a tensile modulus of at least about 1MPa.
Subramanian, in the same field of art, teaches a related heart patch device constructed of a polymeric material having a tensile modulus of at least 1 MPa (see [0084]), which provides the device with sufficient physical and mechanical properties for implantation (see [0086]).
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 method of Levenberg and Hunter so that the mesh scaffold has a tensile modulus of at least about 1 MPa, as taught by Subramanian, since a tensile modulus in this range has been shown provide the device with sufficient physical and mechanical properties for implantation.
Regarding the language “wherein the heart patch device is configured for implantation over a full-thickness defect in a free heart wall of a heart and further configured to mechanically support the free heart wall during beating of the heart while remaining flexible and to repair the full-thickness defect by regenerating myocardium in the defect,” it is the Examiner’s position that the heart patch device of Levenberg, Hunter and Subramanian, meeting all of the structural limitations of claim 1, is capable of performing the claimed function.
Regarding claim 12, the combination of Levenberg, Subramanian and Hunter teaches the method of claim 10, wherein the polymeric mesh scaffold is electrospun in the presence of polycaprolactone (Levenberg discloses that the mesh scaffold can be made of polycaprolactone, see [0051]).
Regarding claim 13, Levenberg further discloses the gel comprises one or more of fibrin and polyethylene glycol (see [0045]).
Regarding claim 16, Levenberg further discloses the gel further comprises thrombin (see [0045]).
Regarding claim 17, Levenberg further discloses the gel the polymeric mesh scaffold comprises biodegradable polyurethane (see [0051]).
Regarding claim 18, Levenberg further discloses the gel layer further includes one or more stem cells (Levenberg discloses that the one or more cells in the gel can include stem cells, see [0013], [0061] and [0062]).
Regarding claim 22, Levenberg further discloses the patch is incubated in culture media for from 24 to 336 hours, creating within the patch a vascular structure comprising the one or more cells (the patch can be incubated from 1-7 days to create a blood vessel network/architecture, see [0096]).
Claims 23, 28, and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Levenberg in view of Anderson et al. (US 20110184439 A1) and further in view of Subramanian.
Regarding claim 23, Levenberg discloses a method of treating a subject having a heart defect (the disclosed three-dimensional tissue construct can be used to regenerate heart muscle tissue, see [0042] and [0062]), the method comprising: obtaining a heart patch device, the heart patch device comprising a biodegradable polymeric mesh scaffold layer(see [0051]); and a biodegradable gel layer (the disclosed gel is made of fibrinogen and thrombin which are biodegradable, see [0045]); wherein the biodegradable gel layer includes one or more mammalian cells that express one or more of CD31 (PECAMI), CD144 (VE-Cadherin), and CD309 (VEGFR2) (the gel can further include one or more types of cells which may be HUVECs which are known to express CD31, CD144, and CD309, see [0013] and [0061]), and wherein the heart patch device is entirely biodegradable (Levenberg only discloses the patch being made of biodegradable materials).
Levenberg fails to expressly teach connecting the heart patch to the heart with one or more sutures and the defect is a full-thickness defect in a free wall of the heart.
Anderson, in the same field of art, teaches a related method of treating a subject having a heart defect (see Fig. 10A-10B) where a heart patch device is placed over the defect and connected to the heart patch device to the heart with suture (see [0080]), thereby providing mechanical support to the heart during beating and replacing a section of myocardium with the heart patch device, wherein the heart defect is a full-thickness defect in a free wall of the heart (the device is for repairing a free wall rupture, see [0023]).
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 method of Levenberg to include the step of connecting the heart patch device to the heart with suture and over a full-thickness defect, as taught by Anderson, since all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results, i.e., one skilled in the art would have recognized that the step of connecting the heart patch device to the heart disclosed by Anderson would have provided for the attachment of the heart patch device to the heart in the method of Levenberg. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
The combination of Levenberg and Anderson fails to teach the polymeric mesh scaffold layer has a tensile modulus of at least about 1 MPa.
Subramanian, in the same field of art, teaches a related heart patch device constructed of a polymeric material having a tensile modulus of at least 1 MPa (see [0084]), which provides the device with sufficient physical and mechanical properties for implantation (see [0086]).
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 device of Levenberg so that the mesh scaffold has a tensile modulus of at least about 1 MPa, as taught by Subramanian, since a tensile modulus in this range has been shown to provide the device with sufficient physical and mechanical properties for implantation.
Regarding claim 28, Levenberg further discloses the gel layer further includes one or more stem cells (Levenberg discloses that the one or more cells in the gel can include stem cells, see [0013], [0061] and [0062]).
Regarding claim 38, Levenberg discloses the one or more cells are present as a vascular structure within the heart patch device prior to placing the heart patch device over the heart defect (the device can be incubated prior to implantation which blood vessel network/architecture to form, see [0096]).
Claims 32-34 are rejected under 35 U.S.C. 103 as being unpatentable over Levenberg, Anderson and Subramanian, as applied to claim 23 above, and further in view of Kim.
Regarding claim 32, the combination of Levenberg, Anderson and Subramanian teaches the method of claim 23, wherein the gel comprises fibrinogen (see Levenberg [0045]), but fails to expressly teach polyethylene glycol molecules conjugated to the fibrinogen.
Kim, in the same field of art, teaches a related gel which uses pegylated fibrinogen (fibrinogen with one or more polyethylene glycol molecules) since polyethylene glycol enhances the solubility of the gel, lowers toxicity and prolongs the circulation half-life (see [0165] and [0172]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to substitute the fibrinogen of Levenberg with the pegylated fibrinogen of Kim since doing so would have yielded only predictable results, namely, the pegylated fibrinogen in the gel of Levenberg would have enhanced the solubility of the gel. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claim 33, Levenberg further discloses the gel further comprises thrombin (see [0045]).
Regarding claim 34, Levenberg further discloses wherein the polymeric mesh scaffold comprises biodegradable polyurethane (see [0051]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Dvir et al. (US 20150202348 A1) teaches prevascularization of a cardiac patch “is essential for its proper integration with the host myocardium after implantation” (see [0364]).
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/SERENITY A MILLER/Examiner, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771
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