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 .
Claim Rejections - 35 USC § 102(a)(1)
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 23, 25, and 26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Naimark et al. (US20030073979).
Regarding Claim 23, Naimark teaches the following:
A patch comprising a sheet made of natural polymers, synthetic polymers, or biological fabric (a culture patch)(para 47). The patch being an in vitro culture patch is an intended use of the invention. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim (see MPEP 2114). The patch would be capable of being used in vitro and therefore meets the claim.
The patch comprises a biologically active material (component required for growth of an object to be cultured) that is dispersed or embedded within a matrix layer of the patch (para 54). As the object to be cultured is not a positively recited limitation of the claim, the object to be cultured is selected from the group consisting of bacteria, parasites, cells separated from a tissue, or primary cultured cells is an intended use of the device. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim (see MPEP 2114). The patch of Naimark would be capable of being used to grow an object is selected from the group consisting of bacteria, parasites, cells separated from a tissue, or primary cultured cells and therefore meets the claim.
The patch is preferably of woven (intertwined) or braided fibers … made of a polymer including … gelatin … (para 47) and the preferable thickness of the patch is about 50 to 100 microns (para 56)(a three-dimensional gel mesh structural body, wherein the mesh structural body is a solid structure with a continuous distribution of intertwined micro-threads). Note: the patch has a length, width, and thickness which by definition makes it a three-dimensional patch.
The mesh structural body has a uniform distribution of micro needles (which are fluidically connected to the micro cavities to be able to deliver the biological material) which ensures a uniform delivery over the area of targeted tissue (para 65)(micro-cavities in which the component required for growth is contained)
The patch delivers doses of one or a combination of biologically active material (components) to body tissue (reaction region) in a sustained fashion (para 46)(configured to come into contact with a reaction region in which the object to be cultured is placed and provide at least a portion of the contained component required for growth to the reaction region).
Regarding Claim 25, Naimark teaches all of the limitations of Claim 23 (see above). Naimark further teaches wound healing agents and growth factors are suitable therapeutics to be placed on the patch (para 72) (the component required for growth is a nutrient for culturing the object to be cultured).
Regarding Claim 26, Naimark teaches all of the limitations of Claim 23 (see above). Naimark further teaches the biologically active material can be yeasts, proteins, hormones, etc. (para 76)(culture media). Note: culture media is the substance required for growing a microorganism. Naimark further teaches the delivery media can be formulated as needed to maintain cell function and viability (para 76).
Response to Arguments
Applicant's arguments filed 04/22/2026 have been fully considered but they are not persuasive.
In response to applicant's argument that Naimark does not disclose an in vitro cell culture patch on page 4, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding Applicant’s arguments that Naimark teaches a two dimensional textile, the patch has a length, width, and thickness which by definition makes it a three-dimensional patch and Naimark teaches the patch can be biostable and is preferably of woven (intertwined) or braided fibers … made of a polymer including … gelatin … (para 47). This is a three-dimensional gel based solid mesh body.
Regarding Applicant’s arguments that Naimark does not teach micro-cavities with components contained within, the mesh structural body has a uniform distribution of micro needles (which are fluidically connected to the micro cavities to be able to deliver the biological material) which ensures a uniform delivery over the area of targeted tissue (para 65).
The amendments to address the 112(b) rejections from the 10/23/2025 Office Action have been accepted and the 112(b) rejections from the 10/23/2025Office Action have been withdrawn.
The amendments to address the Claim objections from the 10/23/2025 Office Action have been accepted and the Claim objections from the 10/23/2025 Office Action have been withdrawn.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN E LEPAGE whose telephone number is (571)270-3971. The examiner can normally be reached 8:30-5:30 ET.
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/J.E.L./Examiner, Art Unit 1796
/LYLE ALEXANDER/Supervisory Patent Examiner, Art Unit 1797
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