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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5 September 2025 has been entered.
Status of Claims
The amendments and arguments filed 5 September 2025 are acknowledged and have been fully considered. Claims 1-19 and 32-37 are currently pending. Claim 1 is amended; claims 20-31 are cancelled; claims 12-19 are withdrawn; claims 32-37 are new.
Claims 1-11 and 32-37 are examined on the merits herein.
Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. In particular, the rejection of claims 1-11 under 35 U.S.C. is withdrawn in view of Applicant’s amendment to claim 1. The following rejections and/or objections are either reiterated or newly applied, and constitute the complete set presently being applied to the instant application.
Claim Interpretation
The instant claims are interpreted under their plain meaning, unless defined differently in the specification (see MPEP 2111.01). In particular, “biocompatible cardio patch” is interpreted as a biocompatible conductive scaffold for use in the treatment of the heart.
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 36 is rejected under 35 U.S.C. 103 as being unpatentable over Noshadi et al. (Scientific Reports, 2017, Vol. 7, 4345; of record) in view of Zhao et al. (Acta Biomaterialia, 2017, Vol. 49, 66-77; of record) and Zhang et al. (Tissue Engineering, 2007, Vol. 13, 2063-2071).
Claim 36 is drawn to a biocompatible cardio-patch comprising:
an electrospun biocompatible polymer fiber conjugated to a first ionic constituent of a bio-ionic liquid; and
one or more SDF-1 molecules, wherein at least one of the one or more SDF-1 molecules is covalently bound to the fiber.
Noshadi et al. teach electroconductive hydrogels produced by functionalizing polymer hydrogels with a choline-based bio-ionic liquid for use as a tissue engineering scaffold suited for the growth and function of cardiomyocytes (Abstract). Noshadi et al. further teach the polymer being gelatin methacryloyl (i.e., a biocompatible polymer, Pg. 2 “Synthesis of Bio-IL conjugated ECHs”) and being seeded with a population of cardiomyocytes (Pg. 7 last paragraph). While Noshadi et al. do not explicitly teach the scaffold being a cardio-patch, seeding the scaffold with cardiomyocytes indicates that it is intended to be used for treating the heart. As such, the biocompatible conductive scaffold intended for treating the heart reads on the instantly claimed cardio-patch.
As such, Noshadi et al. teach a biocompatible cardio-patch comprising: a biocompatible polymer conjugated to a first ionic constituent of a bio-ionic liquid.
The scaffold of Noshadi et al. differs from the instantly claimed invention in the following ways:
the scaffold of Noshadi et al. does not comprise biocompatible polymer fibers; and
the scaffold of Noshadi et al. does not comprise SDF-1 molecules covalently bound to the fiber.
Yet, as to 1: Zhao et al. teach scaffolds of gelatin methacryloyl fibers (Abstract, “Fabrication of electrospun GelMA fibers” on pg. 68). Zhao et al. further teach “Electrospun substitutes exhibit several fundamental features for rapid and functional wound healing which render them superior to hydrogels or sponges. Their ECM-like nanofibrous architectures provide a high surface-to-volume ratio which not only enables maximal cell-material interactions and material-mediated signaling, but also promotes rapid hemostasis. Additionally, the nanoporous nature of these mats aids in nutrient and waste exchange whilst creating a barrier to external pathogens” (Pg. 67 left column first paragraph). While Zhao et al. disclose nanoporous structures having limited 3D cellular infiltration (Pg. 67 left column second paragraph), Zhao et al. further teach that the GelMA fiber scaffold overcomes this issue (Pg. 74 right column second paragraph).
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the scaffold of Noshadi et al. to comprise polymer fibers as taught by Zhao et al. It would have been obvious to combine the conductive scaffold of Noshadi et al. with the fibrous scaffold of Zhao et al. to yield the predictable result of a conductive scaffold with a high surface-to-volume ratio to enable maximal cell-material interactions, with a reasonable expectation of success.
And, as to 2: Zhang et al. teach the use of a patch to deliver SDF-1 for the repair of heart tissue (Abstract), further teaching that SDF-1 increases c-kit+ cell homing (Abstract) which in turn can regenerate cardiomyocytes (Pg. 2069 left column third paragraph). Zhang et al. further teach the extended release of SDF-1 was achieved with minimal burst effect seen due to covalent linkage of SDF-1 to the patch (Pg. 2067 right column second paragraph).
And as discussed in MPEP 2144.06, “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose… [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
In the instant case, the fibrous cardio-patch of Noshadi et al. and Zhao et al. and the use of SDF-1 covalently linked to a scaffold taught by Zhang et al. are both known in the prior art to be useful for the growth of cardiomyocytes. Therefore, it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have combined the cardio-patch of Noshadi et al. and Zhao et al. with SDF-1 covalently linked to the cardio-patch to yield a cardio-patch further capable of stimulating the growth of cardiomyocytes, with a reasonable expectation of success.
Based on all of the foregoing, claim 36 is rejected as prima facie obvious.
Allowable Subject Matter
Claims 1-11 and 32-35 are allowed.
Claim 37 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant’s arguments, see pgs. 6-7 of the remarks, filed 5 September 2025, with respect to claims 1-11 have been fully considered and are persuasive. The rejection of claims 1-11 has been withdrawn.
Applicant’s argument that the prior art does not teach every limitation of claim 36 is moot in view of the new grounds of rejection set forth above.
Conclusion
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/PAUL HOERNER/Examiner, Art Unit 1611