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 .
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.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 4/14/2026 has been entered. Claims 1-8, 14-16, and 18-21 are pending.
Response to Arguments
Applicant's arguments filed 4/14/2026 have been fully considered but they are not persuasive. Applicant argues that Kutryk fails to disclose PDA for use in coating scaffolds. However, Kutryk teaches PDA coatings for substrates/medical devices in paragraphs [0002] and [0081]. Specifically, paragraph [0002] states “The invention relates to medical devices…coated with polydopamine and antibodies” and paragraph [0081] states “In one embodiment, a PDA film can be formed by immersing a substrate/medical device into an aqueous dopamine solution.”
Applicant further argues that the combination of Slepian with Moshaverinia is technically incompatible because Slepian discloses a vascular nanofiber patch designed for medical strength and cell seeding, while Moshaverinia’s devices are for bone mineralization. However, both Slepian and Moshaverinia disclose devices used in tissue repair/engineering, which is also analogous to the claimed invention, and Moshaverinia teaches fibronectin coatings to enhance cellular attachment (see [0113]). Therefore, examiner maintains the position that it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Slepian’s biocompatible patch with a fibronectin on the surface of the biocompatible shell, as taught by Moshaverinia, as doing so would enhance cellular attachment to the patch, thereby promoting tissue regeneration and healing (see also [0048], [0099]).
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating
obviousness or nonobviousness.
Claims 1-8, 14-16, and 18-21 are rejected under 35 U.S.C. 103 as being unpatentable over Slepian et al. (US 2016/0040122) in view of Kutryk (US 2018/0296732) and Moshaverinia et al. (US 2019/0276787).
Regarding claim 1, Slepian discloses a biocompatible patch comprising a scaffold (see [0074]) comprising a plurality of coaxial nanofibers (see [0078]), wherein the nanofibers comprise a polymeric core and a biocompatible shell (see [0060]), and a surface of the scaffold is configured to contact a cell, a tissue, or an organ (see [0012], [0067], [0071]), wherein the biocompatible patch further comprises a growth factor (see [0122]), wherein the growth factor is incorporated into the biocompatible shell or on the surface of the biocompatible shell (on the surface; see [0120-0122]), and wherein the growth factor is selected from the group consisting of vascular endothelial growth factor (VEGF), basic fibroblast growth factor (bFGF), insulin-like growth factor (IGF), placental growth factor (PIGF), angiopoietin-1, platelet derived growth factor-BB (PDGF-BB), and transforming growth factor R (TGF-0) (see [0122]; basic fibroblast growth factor (bFGF)). Slepian fails to disclose the biocompatible patch is coated with polydopamine (PDA).
Kutryk also discloses a medical device or substrate (see [0002]). Kutryk teaches coating the medical device or substrate with polydopamine (PDA) (see [0002]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Slepian’s biocompatible patch coated with polydopamine (PDA) as taught by Kutryk. Doing so would provide the patch with a primer to enhance durability of coatings applied thereto and/or achieve better adhesion between coatings and the patch (see [0012], [0013]).
Slepian as modified by Kutryk fails to disclose fibronectin on the surface of the biocompatible shell. Moshaverinia also discloses a biocompatible patch (fibrous membrane; see [0009]). Moshaverinia teaches fibronectin coatings to enhance cellular attachment (see [0113]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Slepian’s modified biocompatible patch with a fibronectin on the surface of the biocompatible shell as taught by Moshaverinia. Doing so would enhance cellular attachment to the patch, thereby promoting tissue regeneration and healing (see also [0048], [0099]).
Regarding claim 2, Slepian as modified discloses the polymeric core comprises a material selected from the group consisting of polycaprolactone (PCL), poly(lactic-co- glycolic acid) (PLGA), polylactic acid (PLA), polyglycolide (PGA), and polyurethane (PU) (see [0005], [0056], [0061]; for example, polycaprolactone, poly(lactic-co- glycolic acid), polylactic acid, or polyurethane).
Regarding claim 3, Slepian as modified discloses the biocompatible shell comprises a material selected from the group consisting of gelatin, collagen, collagen type I, collagen type IV, Matrigel, elastin, silk, laminin, and polyvinyl alcohol (see [0062]; for example, gelatin, collagen, or laminin).
Regarding claim 4, Slepian as modified discloses the biocompatible shell comprises gelatin (see [0011], [0062]).
Regarding claim 5, Slepian as modified discloses the biocompatible shell comprises collagen (for example, see [0062]).
Regarding claim 6, Slepian as modified discloses the plurality of coaxial nanofibers are aligned (see [0019], [0077], [0078], [0096]).
Regarding claim 7, Slepian as modified discloses the plurality of coaxial nanofibers have a diameter between about 200 nm to about 1000 nm (see Table I listing nanofiber diameters that fall within the claimed range).
Regarding claim 8, Slepian as modified discloses the biocompatible patch has a tensile strength between about 0.5 MPa to about 3.0 MPa (see [0107] describing a tensile strength of 5.42+/- 1.95 MPa which includes 3.47 MPa which is considered “about” 3.0 MPa, thereby falling within the claimed range).
Regarding claim 14, Slepian as modified discloses the scaffold is configured to contact a cell, such as, a stem cell or a cardiac cell (see [0012], [0067], [0071] describing the nanofibers being suitable for use in the culture or growth of any number of cells, including stem cells).
Regarding claim 15, Slepian as modified discloses the scaffold is configured to contact a cell, such as, a stem cell selected from the group consisting of an induced pluripotent stem cell, a mesenchymal stem cell, and a cardiac progenitor cell (see [0012], [0067], [0071] describing the nanofibers being suitable for use in the culture or growth of any number of cells, including stem cells).
Regarding claim 16, Slepian as modified discloses the scaffold is configured to contact a tissue, such as, a cardiac tissue (see [0012], [0071] disclosing the heart organ and [0058] describing the implantable scaffold enables in vivo regeneration of vascular tissue).
Regarding claim 18, Slepian as modified discloses a method for treating a damaged cardiac tissue in a subject (see [0012], [0071] disclosing the heart organ and [0058] describing the implantable scaffold enables in vivo regeneration of vascular tissue) comprising transplanting the biocompatible patch of claim 1 to a site of the damaged cardiac tissue in the subject (see [0013] describing the step of contacting the cell, tissue, or organ with a surface of the core-shell nanofibers forming the scaffold/patch, and [0058] describing the patch being used in wound healing and tissue engineering).
Regarding claim 19, Slepian as modified discloses a cell in contact with the surface of the scaffold and culturing the cell and the scaffold of the biocompatible patch ex vivo for 7 days (see [0099]), but fails to disclose culturing the cell and the scaffold of the biocompatible patch ex vivo for at least 10 days prior to transplantation. However, there is no evidence of record that establishes that changing the cell and scaffold culture duration would result in a difference in function of Slepian’s device. Further, a person of ordinary skill in the art, being faced with modifying the cell and scaffold culture duration of Slepian, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended given the claimed culture duration. Lastly, applicant has not disclosed that the claimed culture duration solves any stated problem, indicating that the duration comprises at least 4 days, which Slepian discloses (7 days, see [0099]), and offering other acceptable culture durations (e.g., at least 5 days, at least 6 days, at least 7 days, at least 8 days, at least 9 days, at least 10 days, etc.; see page 17 of the specification) and, therefore, there appears to be no criticality placed on the culture duration claimed such that it produces an unexpected result. Therefore, 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 cell and scaffold culture duration of Slepian to be at least 10 days prior to transplantation as an obvious matter of design choice within the skill of the art..
Regarding claim 20, Slepian as modified discloses a method of differentiating a stem cell (see [0008]) comprising contacting a stem cell with a surface of the scaffold of the biocompatible patch of claim 1, and culturing the stem cell (see [0012], [0064], [0067], [0071], [0116], [0118]-[0122], [0125], [0136]).
Regarding claim 21, Slepian as modified discloses the claimed invention except for the stem cell being selected from the group consisting of an induced pluripotent stem cell, a mesenchymal stem cell, and a cardiac progenitor cell. Moshaverinia also discloses a method of differentiating a stem cell (see [0047-0048]). Moshaverinia teaches the stem cell being selected from the group consisting of an induced pluripotent stem cell, a mesenchymal stem cell, and a cardiac progenitor cell (see [0050], [0096], [0104], [0105] disclosing mesenchymal stem cells). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have performed Slepian’s method using a mesenchymal stem cell as taught by Moshaverinia. Doing so would provide the patch with cultured stem cells known in the art to provide successful tissue regeneration (see also [0005]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Thakor et al. (US Pub. No. 2022/0218875) discloses a scaffold comprising a growth factor (see paragraph [0114-0115]), a polydopamine (PDA) coating (see paragraph [0166]), and a fibronectin (see paragraph [0112]).
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/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
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