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 Amendment
This Office action is responsive to the amendment file 01/22/2026. Claims 1, 8, 10, 17-18 and 22-23 have been amended. Claims 37 and 38 are newly added. 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, filed 01/22/2026, see pg. 6-11, with respect to the rejections of the claims under 35 U.S.C. 103 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 28 and 32-34 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.
Claim 28 depends from claim 24 which has been cancelled which renders the scope of the claim indefinite. For examination purposes, claim 28 has been interpreted as depending from claim 23. However, there is no support for the combination of the subject matter of claim 28 and the subject matter of claim 23 in the application as originally filed. There is support for the device including one or more mammalian cells that express one or more of CD31 (PECAMI), CD144 (VE-Cadherin), and CD309 (VEGFR2) (see Specification [0007], [0008] and [0009]). There is also support for the device including additionally or alternatively one or more mammalian stem cells (see Specification [0092] and [0093]). However, it is the Examiner’s position that there is no support for the one or more mammalian cells that express one or more of CD31, CD144 and CD309 specifically being stem cells.
Claims 32-34 are similarly rejected by virtue of their dependency from claim 28.
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.
Claims 1, 23, 37 and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Krupnick et al. (US 7,396,537) in view of Subramanian et al. (US 20130030455), and further in view of Naughton et al. (US 2003/0007954).
Regarding claim 1, Krupnick discloses a heart patch device comprising (see Abstract); a biodegradable polymeric mesh scaffold layer (the intermediate layer can be formed of a biodegradable polymer mesh, see col. 9, lines 5-12); and a biodegradable gel layer (a collagen hydrogel can be used which is understood to be biodegradable, see col. 8, line 66 – col. 9, line 4), 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 (the device is configured to replace myocardium, see Fig. 13 and col. 25, lines 34-41), wherein the layers remain flexible after implantation (it is understood that the disclosed patch, which is made of flexible materials, remains flexible after implantation absent some teaching or suggestion that it changes in flexibility).
Krupnick fails to teach wherein the polymeric mesh scaffold layer has a tensile modulus of at least about 1 MPa and the gel layer includes one or more cells that express one or more of CD31 (PECAMI), CD144 (VE-Cadherin), and CD309 (VEGFR2).
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 Krupnick 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.
The combination of Krupnick and Subramanian fails to teach wherein the gel layer includes one or more cells that express one or more of CD31 (PECAMI), CD144 (VE-Cadherin), and CD309 (VEGFR2).
However, it is noted that Krupnick teaches the gel layer may be seeded with one or more cells (see col. 6, line 66 – col. 7, line 3). Krupnick simply fails to the cells expressing one or more of CD31 (PECAMI), CD144 (VE-Cadherin), and CD309 (VEGFR2).
Naughton, in the same field of art teaches a related heart patch device which is seeded with HUVECs (see [0025] and [0081]) to promote vascularization and healing after cardiac surgery (see Abstract). HUVECs are cells known to express CD31 (PECAMI), CD144 (VE-Cadherin), and CD309 (VEGFR2).
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 biodegradable gel of Krupnick so that it includes HUVECs (i.e., cells that express CD31, CD144, and CD309), since doing so would promote vascularization and healing after cardiac surgery.
Regarding claim 23, Krupnick discloses a method of treating a subject having a heart defect (see Fig. 13), the method comprising: obtaining a heart patch device, the heart patch device comprising a biodegradable polymeric mesh scaffold layer (the intermediate layer can be formed of a biodegradable polymer mesh, see col. 9, lines 5-12); and a biodegradable gel layer (a collagen hydrogel can be used which is understood to be biodegradable, see col. 8, line 66 – col. 9, line 4); placing the heart patch device over the heart defect (see Fig. 13); connecting the heart patch device to the heart with one or more sutures (the patch is sutured to the myocardium, see col. 25, lines 34-41); and thereby providing mechanical support to the heart during beating and replacing a section of myocardium with the heart patch device (the device replaces myocardium, see col. 7, lines 1-3), and wherein the heart defect is a full-thickness defect in a free wall of the heart (the device is used to repair a defect in the free wall of the heart, see Fig. 13).
Krupnick fails to teach wherein the polymeric mesh scaffold layer has a tensile modulus of at least about 1 MPa and the gel layer includes one or more cells that express one or more of CD31 (PECAMI), CD144 (VE-Cadherin), and CD309 (VEGFR2).
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 Krupnick 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.
The combination of Krupnick and Subramanian fails to teach wherein the gel layer includes one or more cells that express one or more of CD31 (PECAMI), CD144 (VE-Cadherin), and CD309 (VEGFR2).
However, it is noted that Krupnick teaches the gel layer may be seeded with one or more cells (see col. 6, line 66 – col. 7, line 3). Krupnick simply fails to the cells expressing one or more of CD31 (PECAMI), CD144 (VE-Cadherin), and CD309 (VEGFR2).
Naughton, in the same field of art teaches a related heart patch device which is seeded with HUVECs (see [0025] and [0081]) to promote vascularization and healing after cardiac surgery (see Abstract). HUVECs are cells known to express CD31 (PECAMI), CD144 (VE-Cadherin), and CD309 (VEGFR2).
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 biodegradable gel of Krupnick so that it includes HUVECs (i.e., cells that express CD31, CD144, and CD309), since doing so would promote vascularization and healing after cardiac surgery.
Regarding claims 37 and 38, the combination of Krupnick, Subramanian and Naughton teaches the heart patch device of claim 1 and the method of claim 23, wherein the one or more cells are present as a vascular structure within the gel layer since there are HUVECs within the gel layer which promote vascularization.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Krupnick, Subramanian, and Naughton, as applied to above, and further in view of Poff et al. (US 6,123,667).
Regarding claim 2, the combination of Krupnick, Subramanian and Naughton teaches the heart patch device of claim 1, but fails to teach wherein the polymeric mesh scaffold is made of a material comprising one or more of gelatin, polyurethane, and polycaprolactone.
Poff, in the same field of art, teaches a related heart patch device comprised of a polymeric mesh scaffold comprised of biodegradable polyurethane (see col. 5, lines 35-60).
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 Krupnick, Subramanian and Naughton so that the polymeric mesh scaffold comprises biodegradable polyurethane, as taught by Poff, since substituting one known biodegradable material for another in a heart patch device would have yielded nothing more than predictable results.
Claims 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over Krupnick, Subramanian, Naughton, and Poff, as applied to claim 2 above, and further in view of Zhang (US 2005/0118144).
Regarding claims 5 and 6, the combination of Krupnick, Subramanian, Naughton and Poff teaches the heart patch device of claim 2, but fails to teach the gel comprises polyethylene glycol molecules conjugated to fibrinogen and wherein the gel further comprises thrombin.
However, it is noted that Krupnick discloses the gel comprises a collagen hydrogel, but may alternatively be any suitable hydrogel (see col. 8, line 66- col. 9, line 4).
Zhang, in the same field of art, discloses a biodegradable gel comprising PEGylated fibrinogen (i.e., fibrinogen with one or more polyethylene glycol molecules) and thrombin (see [0006]) that can be delivered to the heart to restore heart function (see [0005]).
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 biodegradable gel of Krupnick with the biodegradable gel of Zhang since doing so would have yielded nothing more than predictable results, namely, the biodegradable gel of Zhang in the device of Krupnick would have aided in restoring heart function. KSR International Co. V. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claim 7, Krupnick, Subramanian, Naughton, Poff and Zhang teach the heart patch device of claim 6. Poff further teaches wherein the polymeric mesh scaffold comprises biodegradable polyurethane (see Poff col. 5, lines 35-60).
Regarding claim 8, Krupnick, Subramanian, Naughton, Poff and Zhang teach the heart patch device of claim 7. Naughton further teaches wherein the one or more cells are selected from a stem cell, an endothelial cell, and mixtures thereof (Naughton teaches the layer including HUVECs which are a specific type of endothelial cell, see Naughton [0025] and [0081]).
Claims 10 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Krupnick, Subramanian, and Naughton, and further in view of Hunter et al. (US 2005/0175703).
Regarding claim 10, Krupnick discloses method for making a heart patch device (see Abstract and Fig. 1), comprising; forming a mesh scaffold, wherein the mesh scaffold comprises a biodegradable polymer (the intermediate layer can be formed of a biodegradable polymer mesh, see col. 9, lines 5-12); forming a gel layer, wherein the gel is biodegradable (a collagen hydrogel can be used which is understood to be biodegradable, see col. 8, line 66 – col. 9, line 4); and combining the mesh scaffold with the gel layer to form a flexible heart patch device (the two layers are combined in one device and the device is understood to be flexible since it is made of flexible material), 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 (the patch is configured to replace myocardium, see Fig. 13 and col. 25, lines 34-41) while remaining flexible and to repair the full-thickness defect by regenerating myocardium in the defect (it is understood that the disclosed patch remains flexible after implantation absent some teaching or suggestion that it changes in flexibility).
Krupnick fails to teach forming the mesh by electrospinning, wherein the polymeric mesh scaffold layer has a tensile modulus of at least about 1 MPa and the gel layer includes one or more cells that express one or more of CD31 (PECAMI), CD144 (VE-Cadherin), and CD309 (VEGFR2).
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 Krupnick 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.
The combination of Krupnick and Subramanian fails to teach wherein the gel layer includes one or more cells that express one or more of CD31 (PECAMI), CD144 (VE-Cadherin), and CD309 (VEGFR2).
However, it is noted that Krupnick teaches the gel layer may be seeded with one or more cells (see col. 6, line 66 – col. 7, line 3). Krupnick simply fails to the cells expressing one or more of CD31 (PECAMI), CD144 (VE-Cadherin), and CD309 (VEGFR2).
Naughton, in the same field of art teaches a related heart patch device which is seeded with HUVECs (see [0025] and [0081]) to promote vascularization and healing after cardiac surgery (see Abstract). HUVECs are cells known to express CD31 (PECAMI), CD144 (VE-Cadherin), and CD309 (VEGFR2).
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 biodegradable gel of Krupnick so that it includes HUVECs (i.e., cells that express CD31, CD144, and CD309), since doing so would promote vascularization and healing after cardiac surgery.
The combination of Krupnick, Subramanian and Naughton fails to teach the mesh being formed 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 Krupnick 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.
Regarding claim 18, Krupnick, Subramanian, Naughton, and Hunter teach the method of claim 10. Naughton further teaches wherein the one or more cells are selected from a stem cell, an endothelial cell, and mixtures thereof (Naughton teaches the layer including HUVECs which are a specific type of endothelial cell, see Naughton [0025] and [0081]).
Claims 12 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Krupnick, Subramanian, Naughton, and Hunter, as applied to claim 10 above, and further in view of Poff.
Regarding claim 12, the combination of Krupnick, Subramanian, Naughton, and Hunter teaches the method of claim 10, but fails to teach wherein the polymeric mesh scaffold is electrospun in the presence of polycaprolactone.
Poff, in the same field of art, teaches a related heart patch device comprised of a polymeric mesh scaffold comprised of polycaprolactone (see col. 5, line 59 -col. 6, line 4).
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 Krupnick, Subramanian and Naughton so that the polymeric mesh scaffold comprises polycaprolactone, as taught by Poff, since substituting one known biodegradable material for another in a heart patch device would have yielded nothing more than predictable results.
Regarding claim 17, the combination of Krupnick, Subramanian, Naughton, and Hunter teaches the method of claim 10, but fails to teach wherein the polymeric mesh scaffold comprises biodegradable polyurethane.
Poff, in the same field of art, teaches a related heart patch device comprised of a polymeric mesh scaffold comprised of biodegradable polyurethane (see col. 5, lines 35-60).
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 Krupnick, Subramanian and Naughton so that the polymeric mesh scaffold comprises biodegradable polyurethane, as taught by Poff, since substituting one known biodegradable material for another in a heart patch device would have yielded nothing more than predictable results.
Claims 13 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Krupnick, Subramanian, Naughton, Hunter, and Poff, as applied to claim 12 above, and further in view of Zhang.
Regarding claims 13 and 16, the combination of Krupnick, Subramanian, Naughton, Hunter and Poff teaches the method of claim 12, but fails to teach the gel comprises polyethylene glycol molecules conjugated to fibrinogen and wherein the gel further comprises thrombin.
However, it is noted that Krupnick discloses the gel comprises a collagen hydrogel, but may alternatively be any suitable hydrogel (see col. 8, line 66- col. 9, line 4).
Zhang, in the same field of art, discloses a biodegradable gel comprising PEGylated fibrinogen (i.e., fibrinogen with one or more polyethylene glycol molecules) and thrombin (see [0006]) that can be delivered to the heart to restore heart function (see [0005]).
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 biodegradable gel of Krupnick with the biodegradable gel of Zhang since doing so would have yielded nothing more than predictable results, namely, the biodegradable gel of Zhang in the device of Krupnick would have aided in restoring heart function. KSR International Co. V. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
All of the documents cited in the attached PTO-892 teach related heart patch devices and methods.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 SERENITY MILLER whose telephone number is (571)272-1155. The examiner can normally be reached Monday-Friday 8:00am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at (571)272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SERENITY A MILLER/Examiner, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771
Prosecution Insights