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 .
Priority
The instant application was filed 17 October 2023 and claims priority to provisional application 63/416,785 filed 17 October 2022. The effective filing date of the instant application is 17 October 2022.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-17, 26-30) in the reply filed on 17 November 2025 is acknowledged.
Claims 18-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 17 November 2025.
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.
Claim 27 is 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 27 contains the trademark/trade name Teflon. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe PTFE and, accordingly, the identification/description is indefinite.
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.
Claim(s) 1, 2, 4, 5, 7-12, 15, 26, 29, 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shastri et al. (US 20060085063 A1), as evidenced by Giannas (Antineoplastic Effect of Heparin on Colorectal Cancer: A Review of the Literature, Journal of Clinical Medicine, 2023), Li (Suppression of Hypoxia-Inducible Factor 1a by Low-Molecular-Weight Heparin Mitigates Ventilation-Induced Diaphragm Dysfunction in a Murine Endotoxemia Model, International Journal of Molecular Sciences, 2021), and Palayoor (Ibuprofen-mediated reduction of hypoxia-inducible factors HIF-1alpha and HIF-2alpha in prostate cancer cells, Clin Cancer Res., 2003).
Shastri teaches a drug delivery device (para. 174; entire teaching) comprising circumferential electrospun polymer nanofibers (para. 14), where one technique used to make the material is described using a coaxial spinneret system to produce hollow fibers (para. 200). NanoMesh in the instant claims is interpreted as a network or structure of layered nanofibers. The device may have multiple layers, where the layers may be made of different material (para. 141). The layers may also be electrospun with one or more additives or active agents, such as heparin (para. 215), which has antineoplastic properties (evidenced by Giannas, abs) and inhibits HIF-1a (evidenced by Li, abs), addressing claims 1 and 2. Other active agents include therapeutic agents that may control tumor growth (para. 64). Other agents may have anti-inflammatory properties, such as ibuprofen, which may have HIF-2a inhibiting properties (evidenced by Palayoor, abs), addressing claims 4 and 5.
Shastri teaches an embodiment where the polymer fibers may be compression molded (para. 93) or cut to form the body shape of the delivery device, such as a prosthesis, stent, scaffold (abs), or tissue construct (para. 129), then electrospun (para. 263), which is interpreted as addressing claims 7 and 15. Cutting to form the shape of the desired delivery device or PU films obtained from silicon wafers (para. 290) are interpreted as round, circular, or disc-shaped, addressing the disc shape of claims 7 and 15. Additionally, a drug delivery device to deliver all kinds of agents (para. 67), either topically or internally (para. 67), would be expected to take the form of different shapes, such as disc shapes, and is obvious to the skilled artisan. Furthermore, the limitations of a disc laser cut from the nanofibers in claims 7 and 15 are interpreted as product-by-process limitations and are given minimal patentable weight. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Given the broadness of Shastri’s teachings of its combination of multiple layers and multiple active agents, the drug delivery device is interpreted as capable of having one layer positioned outward from a first surface and another different layer positioned outward from a second surface in claim 8. The drug delivery device having multiple electrospun layers is interpreted as capable of having intermediate layers between the first, second, and third layers in claims 9 and 11. The layers may be made of polymer fibers, such as polyethylene (para. 89), which is hydrophobic, addressing claim 10. Since the device may include different therapeutic agents, such as ibuprofen or heparin, the combination of agents is interpreted as addressing claim 12.
The device may include a supplementary material, such as a coating, which may be added to the spinning solution to produce polymer fibers or added after spinning in order to change or enhance the properties of the polymer fibers (para. 101). The supplementary materials fibrin (para. 102), which is interpreted as a hydrophobic polymer. The device may comprise multiple layers, a side that surrounds the circumference of the device, which is interpreted as a sidewall extending around the perimeter with a hydrophobic coating, such as fibrin, with therapeutic agents electrospun into the nanofibers, addressing claim 26. Shastri teaches a uniform fiber deposition (para. 32), as well as non-woven fiber mats (para. 169), which is interpreted as homogeneously distributed, addressing claim 29. Since the nanofibers may be made of different polymers (paras. 89, 90), both hydrophobic and hydrophilic, and may optionally include active agents within these nanofibers, the combination is interpreted as addressing claim 30.
Shastri does not teach an exact combination of layers and therapeutic agents in at least claim 1.
In regards to selecting the combination of different polymeric nanofiber layers and active agents, “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G.Pro, 425 U.S. 273, 282 (1976)). “When the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been obvious to have selected various combinations of various disclosed ingredients from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
Shastri teaches a drug delivery device comprising circumferential electrospun polymer nanofibers and active agents, whereas the claimed invention is directed a drug delivery device comprising a first layer of coaxially electrospun nanofibers, a second layer coaxially electrospun nanofibers, and therapeutic agents integrated in the layers. Since Shastri teaches the individual components of the claimed composition, it is obvious for one of ordinary skill in the art to select the different combinations of ingredients to arrive at the claimed invention with a reasonable expectation of success.
Claim(s) 1-17, 26, 29, 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shastri et al. (US 20060085063 A1), Domenech et al. (Hypoxia,: The Cornerstone of Glioblastoma, International Journal of Molecular Sciences, 2021), and Blakney (Delivery of multipurpose prevention drug combinations from electrospun nanofibers using composite microarchitectures, International Journal of Nanomedicine, 2014), as evidenced by Giannas (Antineoplastic Effect of Heparin on Colorectal Cancer: A Review of the Literature, Journal of Clinical Medicine, 2023), Li (Suppression of Hypoxia-Inducible Factor 1a by Low-Molecular-Weight Heparin Mitigates Ventilation-Induced Diaphragm Dysfunction in a Murine Endotoxemia Model, International Journal of Molecular Sciences, 2021), and Palayoor (Ibuprofen-mediated reduction of hypoxia-inducible factors HIF-1alpha and HIF-2alpha in prostate cancer cells, Clin Cancer Res., 2003).
In regards to claim(s) 1, 2, 4, 5, 7-12, 15, 26, 29, 30, Shastri et al., as applied supra, is herein applied in its entirety for its teachings of a drug delivery device comprising circumferential electrospun polymer nanofibers and active agents.
Shastri does not specifically teach acriflavine, PT2385, or temozolomide in claims 3, 6, 13, 14, 16, and 17.
Domenech teaches that acriflavine has inhibitory activity by blocking HIF-1 DNA binding and antitumoral activity in certain cancers (pg. 10; entire teaching), PT2385 has HIF-2 inhibition properties and antitumoral activity (pg. 12), and that inhibition of HIF-1a sensitizes cancer cells to temozolomide (pg. 6).
Blakney teaches that electrospun fabrics are an ideal topical delivery system for co-delivery of multiple agents because of their ability to encapsulate and deliver diverse drugs to modulate drug release kinetics over short and long timeframes (pg. 2968; entire teaching).
Since Shastri does not specifically teach acriflavine, PT2385, or temozolomide in claims 3, 6, 13, 14, 16, and 17, one of ordinary skill in the art would have been motivated to use Domenech’s teaching of the different anticancer drugs and Blakney’s teaching of using multiple agents in electrospun nanofibers with a reasonable expectation of success. A skilled artisan would have recognized the benefit of using multiple active agents to modulate drug release kinetics of different anticancer agents from the teachings to enhance Shastri’s drug delivery device comprising multiple nanofiber layers and therapeutic agents.
Claim(s) 1-17, 26-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shastri et al. (US 20060085063 A1), Domenech et al. (Hypoxia,: The Cornerstone of Glioblastoma, International Journal of Molecular Sciences, 2021), Blakney (Delivery of multipurpose prevention drug combinations from electrospun nanofibers using composite microarchitectures, International Journal of Nanomedicine, 2014), and Li (Waterproof-breathable PTFE nano-and Microfiber Membrane as High Efficiency PM2.5 Filter, Polymers, 2019), as evidenced by Giannas (Antineoplastic Effect of Heparin on Colorectal Cancer: A Review of the Literature, Journal of Clinical Medicine, 2023), Li (Suppression of Hypoxia-Inducible Factor 1a by Low-Molecular-Weight Heparin Mitigates Ventilation-Induced Diaphragm Dysfunction in a Murine Endotoxemia Model, International Journal of Molecular Sciences, 2021), and Palayoor (Ibuprofen-mediated reduction of hypoxia-inducible factors HIF-1alpha and HIF-2alpha in prostate cancer cells, Clin Cancer Res., 2003).
In regards to claim(s) 1-17, 26, 29, 30, Shastri et al., as applied supra, is herein applied in its entirety for its teachings of a drug delivery device comprising circumferential electrospun polymer nanofibers and active agents.
Shastri does not specifically teach using Teflon as a coating in claim 27 or coating twice in 28.
Li teaches that coating a membrane with PTFE may increase filtration efficiency and hydrophobic properties of the PTFE membrane, therefore improving the performance of the membrane (pgs. 2, 3; entire teaching).
Since Shastri does not specifically teach using Teflon as a coating in claim 27, one of ordinary skill in the art would have been motivated to use Li’s teaching of using a PTFE coating to increase the filtration efficiency and properties of the membrane with a reasonable expectation of success. A skilled artisan would have recognized the benefit of using a PTFE coating to improve and enhance the nanofiber layers in Shastri’s teaching. Furthermore, it would have been obvious to a skilled artisan to coat the layers more than once in claim 28 in order to further enhance and improve the performance of the layers for drug delivery.
Claim(s) 1-17, 26-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shastri et al. (US 20060085063 A1), Domenech et al. (Hypoxia,: The Cornerstone of Glioblastoma, International Journal of Molecular Sciences, 2021), Blakney (Delivery of multipurpose prevention drug combinations from electrospun nanofibers using composite microarchitectures, International Journal of Nanomedicine, 2014), Li (Waterproof-breathable PTFE nano-and Microfiber Membrane as High Efficiency PM2.5 Filter, Polymers, 2019), and Vlachou (Electrospinning and Drug Delivery, Electrospinning and Electrospraying – Techniques and Applications, 2019), as evidenced by Giannas (Antineoplastic Effect of Heparin on Colorectal Cancer: A Review of the Literature, Journal of Clinical Medicine, 2023), Li (Suppression of Hypoxia-Inducible Factor 1a by Low-Molecular-Weight Heparin Mitigates Ventilation-Induced Diaphragm Dysfunction in a Murine Endotoxemia Model, International Journal of Molecular Sciences, 2021), and Palayoor (Ibuprofen-mediated reduction of hypoxia-inducible factors HIF-1alpha and HIF-2alpha in prostate cancer cells, Clin Cancer Res., 2003).
In regards to claim(s) 1-17, 26-30, Shastri et al., as applied supra, is herein applied in its entirety for its teachings of a drug delivery device comprising circumferential electrospun polymer nanofibers and active agents.
Shastri does not specifically teach alternating coaxially electrospun nanofiber layers and homogeneously electrospun nanofiber layers in claim 31.
Vlachou teaches that homogeneously or blending electrospinning is simple and improves the mechanical and physicochemical properties to enhance drug release (section 2.2.2.1; entire teaching). Additionally, coaxial electrospinning is useful in multidrug delivery systems, controlled drug release, and prolonged release of therapeutic agents (section 2.2.2.2).
Since Shastri does not specifically teach alternating coaxially electrospun nanofiber layers and homogeneously electrospun nanofiber layers in claim 31, one of ordinary skill in the art would have been motivated to use Vlachou’s teaching of the benefits of homogeneously electrospinning and coaxially electrospinning nanofibers with a reasonable expectation of success. A skilled artisan would have recognized the improved drug delivery properties by utilizing both types of electrospun nanofibers in Shastri’s drug delivery device, especially since Shastri’s teaching is broad to the number of layers, active agents, and the way in which the layers are electrospun. For example, the layers may be co-electrospun sequentially or simultaneously (para. 216).
Conclusion
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/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613