-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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 17, 2025 has been entered.
Priority
This application is a continuation of 15/631,387 filed on 06/23/2017, which is a
continuation of 14/496,070 filed on 09/25/2014, and claims benefit in provisional application
61/882,504 filed on 09/25/2013.
Claim Status
Claims 1, 3, 11-13, 15, and 17-19 are pending and examined. Claims 2, 4-10, 14, 16, and 20-24 were canceled. Claim 1 was amended.
Withdrawn Claim Rejections-35 USC§ 103
Rejections of claims 1, 3-8, 11, 13, 15, and 17-19 over Anneaux (US 2011/0030885 Al Published February 10, 2011 - of record in IDS dated 05/10/2022) and Davis (WO 2005/120578 A2 Published December 22, 2005); rejection of claim 9 over Anneaux, Davis, and Xue (CN 101653624 A Published February 24, 2010 - English language machine translation appended thereto); and rejections of claims 10 and 12 over Anneaux, Davis, and Wood (US 2012/0015331 Al Published January 19, 2012) are withdrawn because claim 1 was amended to require the fibers to comprise co-electrospun poly(lactide-co-caprolactone) and poly(lactic-co-glycolic)acid or a blend of poly(lactide-co-caprolactone) and poly(lactic-co-glycolic)acid, which is not obvious over the cited references.
Withdrawn Double Patenting Rejections
All double patenting rejections of claims 1, 3-8, 11, 13, 15, and 17-19 are withdrawn because the rejections were obviated with claim amendments.
Claim Rejections-35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3, 11-13, 15, and 17-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 was amended to require poly(lactide-co-caprolactone) and poly(lactic-co-glycolic)acid. Applicant cited paragraph 0027 of the specification for support, which teaches polycaprolactone, polylactic acid, polyglycolic acid, or combinations thereof. Applicant stated that because the specification explicitly discloses lactic acid, glycolic acid, caprolactone, and combinations thereof that a copolymer is understood as a combination of the monomers.
Applicant’s arguments and cited paragraph were considered, however they are not sufficient to show that the application as filed has support for the two copolymers. Polycaprolactone, polylactic acid, and polyglycolic acid are three complete polymer molecules and not fractions or chemical moieties of a compound. The skilled artisan would have understood “combinations thereof” to mean a physical mixture of two or more polymers. The skilled artisan would not have interpreted “combinations thereof” to mean taking parts of the listed homopolymers and forming completely different copolymers from said parts. A copolymer of lactic acid and caprolactone is a completely different compound from polycaprolactone and polylactic acid. Similarly, a copolymer of lactic acid and glycolic acid is a completely different compound from polylactic acid and polyglycolic acid. There is no teaching in the application as filed that applicant contemplated copolymers of lactic acid and glycolic acid, and copolymers of lactic acid and caprolactone.
The examiner disagrees with applicant’s statement that the specification explicitly discloses caprolactone, glycolic acid, lactic acid, and combinations thereof because the specification was reviewed and no such teaching is present. Even if the specification had such teaching, it would not have been sufficient to give support for the two copolymers because caprolactone, glycolic acid, and lactic acid are three complete chemical compounds and the skilled artisan would have interpreted “combinations thereof” to mean a physical mixture of two or more. A copolymer of these monomers would require a chemical reaction of two different monomers, and the specification as filed does not teach copolymerizing these monomers to arrive at the claimed copolymers.
Claims 3, 11-13, 15, and 17-19 are rejected for new matter because the claims depend from claim 1 and require the new matter limitations of claim 1.
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 1, 3, 11-13, 15, and 17-19 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 1 was amended by deleting “and” between the first and the second “wherein” clauses, and by adding a third “wherein” clause. The claim is indefinite because it does not recite a conjunction between the last two “wherein” clauses and it is not clear if all three “wherein” clauses are required or if they are alternatives. For the purpose of applying prior art, the claim is interpreted as requiring all three “wherein” clauses.
Claims 3, 11-13, 15, and 17-19 are indefinite because the claims depend from an indefinite base claim.
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 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.
This application currently names joint inventors. In considering patentability of the
claims the examiner presumes that the subject matter of the various claims was commonly
owned as of the effective filing date of the claimed invention(s) absent any evidence to the
contrary. Applicant is advised of the obligation under 37 CPR 1.56 to point out the inventor and
effective filing dates of each claim that was not commonly owned as of the effective filing date
of the later invention in order for the examiner to consider the applicability of 35 U.S.C.
102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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.
Claims 1 and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over El-Kurdi (WO 2008/094971 A2 Published August 7, 2008).
The claims encompass a scaffold comprising:
at least one layer of electrospun polymer fibers having an orientation relative to one
another that is generally parallel, random, or a combination thereof;
wherein the scaffold has a conduit shape;
wherein the fibers are formed as drug eluting fibers; and
wherein the electrospun polymer fibers comprise co-electrospun poly(lactide-co-caprolactone) and poly(lactic-co-glycolic)acid or a blend of poly(lactide-co-caprolactone) and poly(lactic-co-glycolic)acid.
The teachings of El-Kurdi are related to a tubular tissue graft comprising a tubular tissue and a restrictive fiber matrix of a bioerodible polymer about a circumference of the tubular tissue. The matrix may be electrospun onto the tubular tissue (Abstract). In one embodiment, the device is prepared by electrospinning the polymer fibers onto the tubular tissue. The polymer fibers can comprise any useful bioerodible polymer composition. In other embodiments, the fibers comprise a polymer chosen from one or more of: a polymer derived from an alpha-hydroxy acid, a polylactide, a poly(lactide-co-glycolide ), and a poly(L-lactide-co-caprolactone ), among others (paragraph bridging pages 13-14). In yet another embodiment, one or both of a cell and a therapeutic agent (e.g., drug, cytokine, chemoattractant, antibiotic, anti-inflammatory, etc.) is associated with (attached to, absorbed into, adsorbed to, grown into, linked to, etc.) the matrix. Suitable cells include endothelial cells. In another embodiment, a growth factor is associated with the matrix, for example and without limitation, a growth factor chosen from one or more of basic fibroblast growth factor (bFGF), acidic fibroblast growth factor (aFGF), vascular endothelial growth factor (VEGF), hepatocyte growth factor (HGF), insulin-like growth factors (IGF), transforming growth factor-beta pleiotrophin protein, midkine protein and IGF-1 (paragraph bridging pages 14-15). A "fiber" is an elongated, slender, thread-like and/or filamentous structure. A "matrix" is any two- or three-dimensional arrangement of elements (e.g., fibers), either ordered (e.g. in a woven or non-woven mesh) or randomly arranged
(as is typical with a mat of fibers typically produced by electrospinning) (page 21 first paragraph in Detailed Description). Electrospinning may be performed using two or more nozzles, wherein each nozzle is a source of a different polymer solution. The nozzles may be biased with different biases or the same bias in order to tailor the physical and chemical properties of the resulting non-woven polymeric mesh (second full paragraph on page 23).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have formed a scaffold comprising at least one layer of electrospun polymer fibers having an orientation relative to one another that is random, wherein the scaffold has tubular shape and the fibers are drug eluting fibers, with a reasonable expectation of success because El Kurdi teaches a tubular tissue graft comprising a tubular tissue and a fiber matrix of a bioerodible polymer about a circumference of the tubular tissue wherein the matrix is electrospun onto the tubular tissue and comprises a therapeutic agent associated with the matrix, and wherein the fibers are randomly arranged in the matrix. The fibers are drug eluting fibers because El Kurdi teaches that the polymers release therapeutic agents when they degrade within the patient’s body (third full paragraph on page 29). It would have been obvious to have formed the fibers using a mixture of polymers because El Kurdi teaches forming the fibers from one or more polymers selected from a poly(lactide-co-glycolide) and a poly(L-lactide-co-caprolactone). It would have been obvious to have formed the fibers by co-electrospinning a poly(lactide-co-glycolide) and a poly(L-lactide-co-caprolactone) because El Kurdi an embodiment where electrospinning may be performed using two or more nozzles, wherein each nozzle is a source of a different polymer solution. Similarly, it would have been obvious to have formed the fibers using a blend of the two polymers because El Kurdi teaches that biodegradable polymers include blends of polymers (second full paragraph on page 27), and defines “polymer composition” as a composition comprising one or more polymers (third full paragraph on page 27). A person skilled in the art would have understood one or more polymers to mean one of more polymers that differ in structure. El Kurdi exemplifies forming the fiber from a blend of polymers (Table 2 on page 43).
Regarding claims 11 and 12, it would have been obvious to have formed the scaffold to comprise a cell selected from epithelial cells because El Kurdi teaches that the matrix is associated with one or both of a cell and a therapeutic agent, wherein the cell is selected from epithelial cells.
Regarding claim 13, it would have been obvious to have formed the scaffold to comprise a growth factor because El Kurdi teaches that the matrix is associated with a growth factor. Alternatively, it would have been obvious to have formed the scaffold to comprise a cytokine, an antibiotic, or an anti-inflammatory because El Kurdi teaches that the matrix is associated with a therapeutic agent selected from a cytokine, an antibiotic, and an anti-inflammatory.
Claims 1, 11-13, 15, and 17-19 are rejected under 35 U.S.C. 103 as being
unpatentable over Anneaux (US 2011/0030885 Al Published February 10, 2011 - of record in
IDS dated 05/10/2022) and El-Kurdi (WO 2008/094971 A2 Published August 7, 2008).
The claims encompass a scaffold comprising:
at least one layer of electrospun polymer fibers having an orientation relative to one
another that is generally parallel, random, or a combination thereof;
wherein the scaffold has a conduit shape;
wherein the fibers are formed as drug eluting fibers; and
wherein the electrospun polymer fibers comprise co-electrospun poly(lactide-co-caprolactone) and poly(lactic-co-glycolic)acid or a blend of poly(lactide-co-caprolactone) and poly(lactic-co-glycolic)acid.
The teachings of Anneaux are related to a prosthetic device including electrostatically
spun fibrous layer and method of making (Title and Abstract). The prosthetic device includes
tubular prosthetic devices comprising electrospun, also referred to as espin, fibers around a
central lumen of such devices. In certain embodiments, the central lumen can include expanded
PTFE. In certain embodiments, the espin fibers can include PTFE, however other materials can
be espun and used in addition to or in combination with espin PTFE. For example, other suitable materials that can be espun in accordance with the present disclosure include nylons, polyurethanes (PU), polyesters, fluorinated ethylene propylene (FEP), or the like. (paragraph 0014).
Advantages over conventional processes and devices include: 1) the ability to incorporate layers with vastly different pore structures and sizes, these different structural layers can be used to manipulate mechanical properties, cellular proliferation, cellular permeability, fluid permeability, adhesion to a structural frame, and/or incorporation of an active therapeutic component; 2) the ability to make a composite construction with vastly different components enabling a broader range of therapeutic uses and structures; 3) improved bonding of PTFE layers to structural frames and to other layers of the construct; 4) the ability to incorporate an espin layer that closely mimics that of the extracellular matrix affording greater control of cellular response; and 5) enabling the coating of complex geometries that otherwise could not be covered with ePTFE or other materials alone (paragraph 0017). The tubular structure can include bioactive agents such as growth factors and cells (paragraph 0018). Figure 2 is a cross section view of a device including an ePTFE layer 1, a frame 3, and an espin layer 2. Such a configuration may be used in an application where it is desirable to bond ePTFE to a formed structure such as a stent, occlusion device or other frame. The espin layer provides adhesion while also providing a substantially different pore size and structure on the luminal or abluminal surface depending on the application. In such a configuration, the espin layer can be applied directly to the surface of the frame or added as a preformed sheet that is combined with the ePTFE and frame as part of the sintering or curing process. In general, such a configuration could be utilized in any application where the encapsulation of a support frame is desirable. For instance, such a configuration could be used in connection with a conventional stent (paragraph 0021). The electro-spun layer is preferably applied directly to the frame through electrospinning methods understood by those skilled in the art; however, it could also be applied by lamination as well.
The technique involves pressing an espun layer onto a second material layer and heating to a complimentary temperature. In all configurations, the design can include or exclude a structural frame. These frames can take the form of stents, occlusion coils or frames, regenerative medicine scaffolds, structural reinforcements, pacing or monitoring leads, tissue anchors or tacks, biological stimulation devices, biomimetic implants, signal receivers or transmitters, orthopedic fixation devices or any other metallic, polymeric, ceramic or other therapeutic device (paragraph 0026). The diameter of fibers in the espin layer can range from about 10 nm to 2000 nm in size (paragraph 0030). Expanded PTFE is comprised of a microstructure consisting of solid nodes interconnected by fine, highly oriented fibrils. The expanded PTFE nodes and fibrils provide unique biocompatible porous structures. The microstructure of the material can be adjusted to provide a matrix for cellular attachment and in-growth. The expanded PTFE and electrospun PTFE microstructures are designed to enhance, inhibit or retard the migration of endothelium during the early phase of healing (paragraph 0032). Paragraph 0036 describes suitable fiberizing polymers, including polyethylene oxide, alginate, poly lactic acid, chitosan, and polyaniline.
Anneaux does not teach drug eluting fibers and the specific polymers required by claim 1.
The teachings of El Kurdi are summarized above.
The teachings of Anneaux and El Kurdi are related to tubular prosthetic devices comprising electrospun polymer fibers and it would have been obvious to have combined them because they are in the same field of endeavor.
Regarding claim 1, it would have been prima facie obvious to a person of ordinary skill
in the art before the effective filing date of the claimed invention to have formed a tissue
regeneration scaffold comprising expanded PTFE layer and a layer of electrospun polymer
fibers, with a reasonable expectation of success because Anneaux teaches a prosthetic device
suitable for tissue regeneration wherein the device is a scaffold comprising electrostatically spun
fibrous layer and an expanded PTFE layer. It would have been obvious to have formed the layer
having fibers in random orientation because Anneaux teaches an embodiment wherein the fibers
are in a random orientation. It would have been obvious to have formed the tissue regeneration
scaffold in the shape of a tube or a stent because Anneaux teaches that the prosthetic device
includes tubular prosthetic devices comprising electrospun, also referred to as espin, fibers
around a central lumen of such devices; and in one embodiment teaches positioning a stent over
a tubular polymeric structure followed by electrospinning nanofibers from a dispersion onto the
tubular frame to form a prosthetic device (paragraphs 008, 0019 and 0021). Anneaux further
teaches an implantable microporous tubular vascular prosthesis or tubular graft comprising espun
fibers in a random orientation around a central lumen. The tubular vascular prosthesis or tubular
graft may include one or more layers forming a composite structure of espun PTFE fibers around
a tubular structure such as tubular vascular prosthesis, tubular graft, tubular frame, or a
combination thereof (paragraph 0016). This embodiment renders the vascular implant obvious. A
tube is a conduit, which renders the claimed conduit obvious.
It would have been obvious to have formed the prosthetic device in the form of tubular
structure comprising a bioactive agent because Anneaux teaches that the tubular structure
includes a bioactive agent (paragraph 0018). Anneux does not teach how the bioactive agent is
incorporated into the tubular structure.
It would have been obvious to the skilled artisan to have formed the tubular prosthetic
device by incorporating the bioactive agent into the fibers in order to form bioactive agent
eluting fibers, with a reasonable expectation of success because it was known from El Kurdi that a therapeutic agent may be incorporated into a tubular prosthetic device made from fibers by associating the therapeutic agent with the fibers in the matrix and wherein the fibers release the therapeutic agent into the subject.
It would have been obvious to have formed Anneaux’ fibers by espinning polyesters and PTFE, with a reasonable expectation of success Anneaux teaches that the espin fibers include PTFE, however many other suitable materials can be espun and used in addition to or in combination with such espun PTFE. For example, other suitable materials that can be espun include nylons, polyurethanes, and polyesters (paragraph 0014). Anneaux does not teach examples of polyesters. It would have been obvious to have selected poly(lactide-co-glycolide) and a poly(L-lactide-co-caprolactone) as the polyesters because it was known from El Kurdi that these polyesters are as suitable for making fibers by electrospinning in the process of making tubular prosthetic. It would have been obvious to have formed the fibers using a mixture of polymers because El Kurdi teaches forming the fibers from one or more polymers selected from a poly(lactide-co-glycolide) and a poly(L-lactide-co-caprolactone). It would have been obvious to have formed the fibers by co-electrospinning a poly(lactide-co-glycolide) and a poly(L-lactide-co-caprolactone) because El Kurdi an embodiment where electrospinning may be performed using two or more nozzles, wherein each nozzle is a source of a different polymer solution. Similarly, it would have been obvious to have formed the fibers using a blend of the two polymers because El Kurdi teaches that biodegradable polymers include blends of polymers (second full paragraph on page 27), and defines “polymer composition” as a composition comprising one or more polymers (third full paragraph on page 27). A person skilled in the art would have understood one or more polymers to mean one of more polymers that differ in structure. El Kurdi exemplifies forming the fiber from a blend of polymers (Table 2 on page 43).
Selecting El Kurdi’s polyesters would have been obvious because the selection of a known material based on its suitability for its intended purpose supports obviousness, and combining prior art elements according to known methods to obtain predictable results
supports obviousness.
Regarding claim 3, it would have been obvious to have formed the device with ridges
because it is apparent from the cross-sectional view of device in Figures 3 and 4 of Anneaux that
the device comprises ridges. Since the ridges are present in the prior art structure, the increase in
kink resistance would have been necessarily present.
Regarding claims 11 and 13, it would have been obvious to have added cells and growth
factors to the device with a reasonable expectation of success because Anneaux teach adding
bioactive agents such as growth factors and cells to the device.
Regarding claim 12, it would have been obvious to have selected epithelial cells because El Kurdi teaches that epithelial cells are suitable for incorporating into a tubular prosthetic.
Regarding claim 15, it would have been obvious to have formed the fibers having a
diameter in the range of about 10 nm to 2000 nm, which renders the claimed range of fiber
diameters obvious because the ranges overlap. It would have been obvious to have formed the
layer having intemodal distance from about 0.1 to about 200 microns with porosity ranging from
about 20 to 90%, with a reasonable expectation of success because Anneaux teaches said
parameters as suitable for a tissue regeneration device. The claimed pore size range is obvious
because it overlaps prior art range.
Regarding claim 17, it would have been obvious to have formed the fibers to further comprise polyaniline, with a reasonable expectation of success because Anneaux teaches polyaniline as a suitable fiberizing polymer.
Regarding claims 18 and 19, Anneaux teaches that the device can be fastened into a
helical pattern or interlacing rings and fibers around the lumen of the device (paragraphs 0016
and 0023). As the helical or spiral fiber share the same structure as instantly claimed, it would
have been expected to have the same reinforcing quality as instantly claimed macroscopic radial
reinforcement.
Double Patenting Rejections
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 15, and 17 are rejected on the ground of nonstatutory double patenting as
being unpatentable over claims 1-11 of U.S. Patent No. 9,737,632 B2 (of record in IDS dated
05/10/2022) in view of Anneaux and El Kurdi.
Patented claims are drawn to a scaffold consisting of a layer of biocompatible electrospun polymer fibers having an orientation relative to one another that is generally parallel, random, or a combination thereof, the scaffold having a shape selected from an arteriovenous shunt, a vascular implant, a stent, a conduit, and a combination thereof. It would have been prima facie obvious to a person of ordinary skill in the to have modified the patented scaffold in view of the teachings of cited references in order to arrive at the claimed invention.
Regarding claim 1, it would have been obvious to have formed the fibers in patented
claims as drug eluting fibers by incorporating the drug into the fiber, with a reasonable expectation of success because it was known from El Kurdi that scaffolds formed from electrospun biodegradable fibers are useful for delivering a drug to a subject wherein the drug is released into the subject when they degrade within patient’s body (page 30 first full paragraph). It would have been further obvious to have modified the fibers in patented claims by replacing the polymers in patented claim 3, such as polycaprolactone, polylactic acid, and glycolic acid, with a mixture of a poly(lactide-co-glycolide ) and a poly(L-lactide-co-caprolactone ), with a reasonable expectation of success because El Kurdi teaches polycaprolactone, polylactic acid, glycolic acid, a poly(lactide-co-glycolide), and a poly(L-lactide-co-caprolactone) are bioerodible polymers suitable for making fibers by electrospinning. Replacing one equivalent with another to obtain predictable results supports obviousness. It would have been obvious to co-electrospin the copolymers or form the fibers from a blend of the copolymers for reasons described above. It would have been obvious to form the fibers randomly oriented relative to one another because El Kurdi teaches randomly oriented fibers.
Regarding claim 3, it would have been obvious to have formed the patented scaffold with
ridges because having ridges in a vascular graft was known from Anneaux, which would have
been an obvious design choice.
Regarding claim 13, it would have been obvious to have selected antibiotics, anti-inflammatories, or growth factors as the active agent intended to be incorporated into the bioerodible fibers because El Kurdi teaches embedding these active agents into the bioerodible fibers (paragraph bridging pages 30-31).
Regarding claim 15, patented claim 5 teaches a fiber diameter and pore size that overlaps
with claimed ranges.
Regarding claim 17, it would have been obvious to have formed the layer with fibers
made from polyaniline because polyaniline was known from Anneaux as a suitable material for
making fibers intended for construction of vascular grafts.
Claims 1, 3, 11-13, 15, and 17-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 10,233,427 B2 in view of Anneaux and El Kurdi.
Patented claims are drawn to an implantable artificial organ scaffold comprising: one or more electrospun fibers, each fiber comprising a polymer and a radio opaque compound; wherein the one or more electrospun fibers are formed into a layer having a fiber orientation selected from the group consisting of substantially parallel, randomly oriented, and a combination thereof, wherein the layer has a fiber spacing from about 2 μm to about 50 μm; and wherein the implantable artificial organ scaffold is formed into a luminal structure having an interior surface that is smooth on the microscale
Regarding claim 1, it would have been obvious to have formed the fibers in patented claims as drug eluting fibers by incorporating the drug into the fibers, with a reasonable expectation of success because it was known from El Kurdi that scaffolds formed from electrospun biodegradable fibers are useful for delivering a drug to a subject wherein the drug is released into the subject when they degrade within patient’s body (page 30 first full paragraph). Patented claims do not teach suitable polymers for making the fibers. It would have been obvious to have formed the fibers in patented claims using a mixture of a poly(lactide-co-glycolide) and a poly(L-lactide-co-caprolactone), with a reasonable expectation of success because El Kurdi teaches a poly(lactide-co-glycolide) and a poly(L-lactide-co-caprolactone) as bioerodible polymers suitable for making fibers by electrospinning. The selection of a known material based on its suitability for its intended purpose supports obviousness. It would have been obvious to co-electrospin the copolymers or form the fibers from a blend of the copolymers for reasons described above. It would have been obvious to form the fibers randomly oriented relative to one another because El Kurdi teaches randomly oriented fibers.
Regarding claim 3, it would have been obvious to have formed the patented scaffold with
ridges because having ridges in a vascular graft was known from Anneaux, which would have been an obvious design choice.
Regarding claims 11 and 12, patented claims teach incorporating cells into the scaffold wherein the cells include epithelial cells.
Regarding claim 13, patented claim 1 teaches a radio opaque compound.
Regarding claim 15, it would have been obvious to have formed the fibers in the patented claims having a range of diameters and a range of pore sizes as taught by Anneaux as described in detail above because Anneaux is concerned with tubular scaffolds formed from electrospun polymer fibers. The claimed ranges are obvious because they overlap with their respective prior art ranges.
Regarding claim 17, it would have been obvious to have formed the fibers to further comprise polyaniline, with a reasonable expectation of success because Anneaux teaches polyaniline as a suitable fiberizing polymer.
Regarding claims 18 and 19, Anneaux teaches that the device can be fastened into a
helical pattern or interlacing rings and fibers around the lumen of the device (paragraphs 0016
and 0023). As the helical or spiral fiber share the same structure as instantly claimed, it would
have been expected to have the same reinforcing quality as instantly claimed macroscopic radial
reinforcement.
Claims 1, 3, 11-13, 15, and 17-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-54 of U.S. Patent No. 12,167,853 B2 in view of Anneaux and El Kurdi.
Patented claims are drawn to a resorbable hybrid-scale fiber matrix for use in facilitating nerve repair and regeneration, the matrix comprising: an inner fiber layer comprising uniaxially-aligned or longitudinally-aligned fibers; and an outer fiber layer comprising randomly-aligned fibers, wherein the hybrid-scale fibers comprise fibers having a range of fiber diameters between 10 nm-10,000 nm (claim 1), wherein a mean pore size of the matrix is less than 300μ.sup.2. (claim 18), wherein the matrix comprises a shape geometry of a conduit (claim 16), and wherein the hybrid-scale fibers comprising a resorbable polymer selected from a group of polymers consisting of polycaprolactone, polylactic acid, and polyglycolic acid (claim 17).
Regarding claim 1, it would have been obvious to have formed the fibers in patented
claims as drug eluting fibers by incorporating the drug into the fiber, with a reasonable expectation of success because it was known from El Kurdi that scaffolds formed from electrospun biodegradable fibers are useful for delivering a drug to a subject wherein the drug is released into the subject when they degrade within patient’s body (page 30 first full paragraph). It would have been further obvious to have modified the fibers in patented claims by replacing the polymers in patented claim 17, such as polycaprolactone, polylactic acid, and glycolic acid, with a mixture of a poly(lactide-co-glycolide ) and a poly(L-lactide-co-caprolactone ), with a reasonable expectation of success because El Kurdi teaches polycaprolactone, polylactic acid, glycolic acid, a poly(lactide-co-glycolide), and a poly(L-lactide-co-caprolactone) are bioerodible polymers suitable for making fibers by electrospinning. Replacing one equivalent with another to obtain predictable results supports obviousness. It would have been obvious to co-electrospin the copolymers or form the fibers from a blend of the copolymers for reasons described above. It would have been obvious to form the fibers randomly oriented relative to one another because El Kurdi teaches randomly oriented fibers.
Regarding claim 3, it would have been obvious to have formed the patented scaffold with
ridges because having ridges in a vascular graft was known from Anneaux, which would have been an obvious design choice.
Regarding claims 11 and 12, it would have been obvious to have modified the matrix by associating the matrix with a cell such as an epithelial cell because it was known from El Kurdi that cells such as epithelial cells may be added to a tubular scaffold intended to tissue repair.
Regarding claim 13, it would have been obvious to have selected antibiotics, anti-inflammatories, or growth factors as the active agent intended to be incorporated into the bioerodible fibers because El Kurdi teaches embedding these active agents into the bioerodible fibers (paragraph bridging pages 30-31).
Regarding claim 15, the claimed diameter range is obvious because it overlaps with the patented diameter range in claim 2. The claimed pore size range is obvious because it overlaps with less than 300 microns.
Regarding claim 17, it would have been obvious to have formed the layer with fibers
made from polyaniline because polyaniline was known from Anneaux as a suitable material for
making fibers intended for construction of vascular grafts.
Regarding claims 18 and 19, Anneaux teaches that the device can be fastened into a
helical pattern or interlacing rings and fibers around the lumen of the device (paragraphs 0016
and 0023). As the helical or spiral fiber share the same structure as instantly claimed, it would
have been expected to have the same reinforcing quality as instantly claimed macroscopic radial
reinforcement.
Claims 1, 3, 11-13, 15, and 17-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-43 of U.S. Patent No. 10,227,568 B2 in view of Anneaux and El Kurdi.
Patented claims are drawn to an implantable artificial organ comprising: a scaffold comprising at least one layer of electrospun fibers having an orientation, a diameter, and a fiber spacing configured to control the orientation, growth, or differentiation of biological cells seeded thereon, the scaffold formed into a replica of a biological organ selected from the group consisting of an esophagus, a small intestine, a large intestine, a duodenum, and a jejunum; wherein the scaffold has an interior surface that is smooth on the microscale; wherein the electrospun fibers comprise a radiopaque material; and wherein the electrospun fibers have a fiber spacing of about 2 micrometers to about 50 micrometers (claim 1), wherein the electrospun fibers comprise one or more of a polycaprolactone, a polylactic acid, and a polyglycolic acid (claim 3), wherein the electrospun fibers have a diameter from about 100 nanometers to about 1000 nanometers (claim 4), wherein the electrospun fibers have an orientation selected from the group consisting of substantially mutually parallel, randomly oriented, and a combination thereof (claim 7), wherein the electrospun fibers comprise a mixture of multiple materials (claim 9), wherein the electrospun fibers further comprise one or more of an elutable drug (claim 10).
It would have been obvious to have modified the fibers in patented claims by replacing the polymers in patented claim 3, such as polycaprolactone, polylactic acid, and glycolic acid, with a mixture of a poly(lactide-co-glycolide ) and a poly(L-lactide-co-caprolactone ), with a reasonable expectation of success because El Kurdi teaches polycaprolactone, polylactic acid, glycolic acid, a poly(lactide-co-glycolide), and a poly(L-lactide-co-caprolactone) are bioerodible polymers suitable for making fibers by electrospinning. Replacing one equivalent with another to obtain predictable results supports obviousness. It would have been obvious to co-electrospin the copolymers or form the fibers from a blend of the copolymers for reasons described above.
Regarding claim 3, it would have been obvious to have formed the patented scaffold with
ridges because having ridges in a vascular graft was known from Anneaux, which would have been an obvious design choice.
Regarding claims 11 and 12, it would have been obvious to have modified the matrix by associating the matrix with a cell such as an epithelial cell because it was known from El Kurdi that cells such as epithelial cells may be added to a tubular scaffold intended to tissue repair. The intended purpose of patented scaffold is cell seeding.
Regarding claim 13, it would have been obvious to have selected antibiotics, anti-inflammatories, or growth factors as the active agent intended to be incorporated into the bioerodible fibers because El Kurdi teaches these active agents as useful for embedding and delivery by the bioerodible fibers (paragraph bridging pages 30-31).
Regarding claim 15, the claimed diameter range is obvious because it overlaps with the patented diameter range in claims 4 and 5. The claimed pore size range is obvious because it overlaps with the range of 2 microns to 50 microns. Fiber spacing in the patented claims reads on pore size.
Regarding claim 17, it would have been obvious to have formed the layer with fibers
made from polyaniline because polyaniline was known from Anneaux as a suitable material for
making fibers intended for construction of vascular grafts.
Regarding claims 18 and 19, Anneaux teaches that the device can be fastened into a
helical pattern or interlacing rings and fibers around the lumen of the device (paragraphs 0016
and 0023). As the helical or spiral fiber share the same structure as instantly claimed, it would
have been expected to have the same reinforcing quality as instantly claimed macroscopic radial
reinforcement.
Conclusion
No claims are allowed.
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/ALMA PIPIC/Primary Examiner, Art Unit 1617