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 .
Information Disclosure Statement
A reference on the attached copy of the PTO-1449 was crossed out because no copy was provided.
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.
Claims 6-20 and 59-63 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 6 recites “optionally from about 20% to about 80% of the total of the conductive trace area and non-conductive area,” which is indefinite because it is not clear if the recitations after “optionally” are being positively claimed. Claim 6 is replete with unclear antecedent basis issues. The Examiner suggests the following amendments:
6. (Currently amended) A method of generating a fiber construct using an electrospinning system,
wherein the electrospinning system comprises an ejection device and a collector, wherein
the collector comprises a collection surface comprising
a conductive trace or a plurality of conductive traces; and
a non-conductive region or a plurality of non-conductive regions,
wherein the conductive trace or the plurality of conductive traces form(s) a pattern on the
collection surface,
wherein the collector has a conductive trace area from about 5% to about 99% of the total
of the conductive trace area and a non-conductive area,
wherein the ejection device comprises a reservoir and an ejector, and wherein the reservoir comprises a polymer solution contained therein;
the method comprising
(ia) selecting the collector, wherein the collector has [[a]] the collection surface comprising
[[a]] the pattern sufficient to generate the fiber construct having a grammage that is at least 5% higher
than a grammage of a fiber construct formed on an un-patterned collector under the same
conditions; and
(i) applying an electrostatic charge to the ejection device or a component thereof,
wherein following step (i), the polymer solution is extruded out of the ejection device via
the ejector, wherein the polymer solution is directed to the collection surface and forms the
fiber construct on the collection surface of the collector.
Claim 7 recites “optionally from about 20% to about 80% of the total of the conductive trace area and non-conductive area,” which is indefinite because it is not clear if the recitations after “optionally” are being positively claimed. The Examiner suggests the following amendments: “
Claims not listed above are rejected as being dependent upon a rejected claim.
For further examination purposes, the scope of the claims are read in light of the suggested Examiner amendments.
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.
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 CFR 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.
Claim(s) 6-10, 16, 20, 59-60, and 63 is/are rejected under 35 U.S.C. 103 as being unpatentable over JP 2006-283241.
(Claims 6, 7) JP 2006-283241 discloses a method of generating a fiber construct (web) using an electrospinning system (figs. 1-3; see English translation (whole document) attached to this Office Action),
wherein the electrospinning system comprises an ejection device (fig. 1) and a collector 20, wherein
the collector comprises a collection surface comprising
a conductive trace 20b or a plurality of conductive traces 20b (figs. 1-3, conductors); and
a non-conductive region 20c or a plurality of non-conductive regions 20c (figs. 1-3, non-conductors),
wherein the conductive trace or the plurality of conductive traces form(s) a pattern on the
collection surface (figs. 1-3; [0006], a conductor arranged in any pattern),
wherein the collector has a conductive trace area from about 5% to about 99% of the total of the conductive trace area and a non-conductive area, optionally from about 20% to about 80% of the total of the conductive trace area and non-conductive area (as shown in fig. 1, a conductive trace area is defined by all the areas defined by the conductive traces 20b, a non-conductive area is defined by all the areas defined by the non-conductive regions 20c, and conductive trace area defines a percentage (%) of the total of the conductive trace area and a non-conductive area; as to the specific claimed percentages, it would have been obvious to one of ordinary skill in the art, at the time the invention was made, to modify the method of JP 2006-283241 with the specific claimed percentages because such percentages would have been obvious in view of the “any pattern” teachings above (i.e., some patterns would result in such specific percentages; for example in figs. 1-3, a collector with a first pattern having 20 conductors 20b would have a conductive trace area which is a higher percent of the total
of the conductive trace area and a non-conductive area than a second pattern having 2 conductors 20b (i.e., the percentage is variable depending upon the pattern));
wherein the ejection device comprises a reservoir (syringe 12, needle electrode 14) and an ejector (plunger 12a), and wherein the reservoir comprises a polymer solution ([0016], syringe 12 stores a spinning solution S such as a polymer solution) contained therein;
the method comprising
(Claim 6) (ia) selecting the collector, wherein the collector has a collection surface comprising
a pattern sufficient to generate the fiber construct having a grammage that is at least 5% higher
than a grammage of a fiber construct formed on an un-patterned collector under the same conditions ([0006], more fibers are deposited on the conductor and less fibers on a non-conductor; [0044], higher fiber deposit concentration on the conductor 20b than on non-conductor 20c; thus, it would have been obvious to one of ordinary skill in the art, at the time the invention was made, to modify the collector of JP 2006-283241 to have a collection surface comprising a pattern sufficient to generate the fiber construct having a grammage that is higher than a grammage of a fiber construct formed on an un-patterned collector under the same conditions because, in view of the teachings above, a pattern (made of conductors) would generate the fiber construct having a grammage that is higher (more deposited fibers, higher fiber deposit concentration) than a grammage of a fiber construct formed on an un-patterned collector (made of non-conductors) under the same conditions (less deposited fibers, lower fiber density); as to selecting the collector to have a pattern sufficient to generate a grammage that is at least 5% higher, it would have been obvious to further modify the method with selecting the collector to have a pattern sufficient to generate a grammage that is at least 5% higher because such selection would have been obvious in view of the “any pattern” teachings above (i.e., some patterns would result in a grammage that is at least 5% higher; for example in figs. 1-3, a collector with a first pattern having 20 conductors 20b would have more grammage than a second pattern having 2 conductors 20b, and both patterns would define a higher grammage than for an un-patterned collector; each pattern would result in a grammage amount (more deposited fibers, higher fiber deposit concentration) that is a percent higher than the grammage amount (less deposited fibers, lower fiber density) of the un-patterned collector; and the grammage percent of the first pattern would be higher than the second pattern (i.e., grammage percent is variable depending upon the pattern)); and
(i) applying an electrostatic charge to the ejection device or a component thereof ([0017], the needle electrode 14 is electrically connected to the positive electrode of a high-voltage DC power 16 and applied to the plus),
wherein following step (i), the polymer solution is extruded out of the ejection device (syringe 12, needle electrode 14) via the ejector (plunger 12a), wherein the polymer solution is directed to the collection surface 20b, 20c and forms the fiber construct (web) on the collection surface of the collector 20 [0018]-[0028],
(Claim 7) wherein the formed fiber construct has a grammage that is at least 5% higher than a grammage of a fiber construct formed on an un-patterned collector under the same conditions ([0006], more fibers are deposited on the conductor and less fibers on a non-conductor; [0044], higher fiber deposit concentration on the conductor 20b than on non-conductor 20c; thus, it would have been obvious to one of ordinary skill in the art, at the time the invention was made, to modify the method wherein the formed fiber construct has a grammage that is higher than a grammage of a fiber construct formed on an un-patterned collector under the same conditions because, in view of the teachings above, a pattern (made of conductors) would generate the fiber construct having a grammage that is higher (more deposited fibers, higher fiber deposit concentration) than a grammage of a fiber construct formed on an un-patterned collector (made of non-conductors) under the same conditions (less deposited fibers, lower fiber density); as to the grammage being at least 5% higher, it would have been obvious to further modify the method with the grammage being at least 5% higher because such grammage would have been obvious in view of the “any pattern” teachings above (i.e., some patterns would result in a grammage that is at least 5% higher; for example in figs. 1-3, a collector with a first pattern having 20 conductors 20b would have more grammage than a second pattern having 2 conductors 20b, and both patterns would define a higher grammage than for an un-patterned collector; each pattern would result in a grammage amount (more deposited fibers, higher fiber deposit concentration) that is a percent higher than the grammage amount (less deposited fibers, lower fiber density) of the un-patterned collector; and the grammage percent of the first pattern would be higher than the second pattern (i.e., grammage percent is variable depending upon the pattern)).
JP 2006-283241 further discloses the method:
(Claims 8, 59) further comprising loading the polymer solution into the reservoir of the ejection device prior to step (i), wherein the polymer solution comprises one or more polymers and a solvent, and optionally one or more active agent and/or one or more additive ([0023]-[0025], a polymer, two or more polymers, other optional additives include electrolytes, water, sodium hydroxide solution, and lithium chloride solution, which additives are also active agents for improving electrical properties of the spinning solution);
(Claim 9) wherein the system further comprises a power supply, a pressurization component, a temperature control component, a position control component, one or more sensors, a controller, or an output device, or a combination thereof ([0017]-[0018], power supply 16, pump 18 (pressurization component));
(Claims 10, 60) wherein the conductive trace or each conductive trace of the plurality of conductive traces is arranged such that during step (i), undisturbed electric field lines or blurred electric field lines align around the conductive trace or each conductive trace of the plurality of conductive traces ([0019]-[0027] a strong electric field is generated by conductors 20b, a weak or no electric field is generated by non-conductors 20c; such claimed undisturbed electric field lines or blurred electric field lines would have been obvious in view of the “any pattern” teachings above (i.e., some patterns would result in such undisturbed electric field lines or blurred electric field lines); for example, a pattern with no electric field from conductors 20c and with a single conductor 20b would result in undisturbed electric field lines from the single conductor 20b), OR a pattern with no electric field from conductors 20c and with conductors 20b spaced at distances wherein the electric fields of the conductors do not intersect would result in undisturbed electric field lines, OR a pattern with no electric field from conductors 20c and with conductors 20b spaced at distances wherein the electric fields of the conductors 20b at least slightly intersect would result in blurred electric field lines);
(Claim 16) further comprising mixing the polymer with the solvent to form the polymer solution and/or assembling the system prior to step (i) ([0023]-[0026], the syringe 12 is filled with a solution in which a polymer is dissolved in a solvent (i.e., the polymer and solvent are mixed enabling the dissolving, and then filled into the syringe which is prior to step (i); it would have been obvious to assembly the electrospinning system prior to operation of the system (i.e., prior to the system operation defined in step (i)); and
(Claims 20 and 63) wherein the pattern on the collector comprises lines, checkerboard, squares, spirals, helices, zigzags, sinusoidal curves, non-sinusoidal wave forms, or circles, or a combination thereof (figs. 1-2 show lines; [0006], pattern including straight lines, curved lines, and combinations thereof).
Claim(s) 11, 15, 17, 19, 61-62 is/are rejected under 35 U.S.C. 103 as being unpatentable over JP 2006-283241 as applied to claims 6-10, 16, 20, 59-60, and 63 above, and further in view of Limen et al. (US 2019/0151081).
JP 2006-283241 discloses the method substantially as claim, as mentioned above, except for the limitations of claims 11, 15, 17, 19, 61-62.
Limen et al. (US 2019/0151081) discloses an electrospinning method of forming a fiber construct including electrospinning a polymer solution including a polymer and solvent [0069];
(Claims 11, 61) wherein the polymer is a natural polymer or a synthetic polymer, or a combination thereof [0047]-[0049], and wherein the molecular weight of the natural polymer or
synthetic polymer is in a range from about 1x10³ g/mol to about 500x10³ g/mol ([0070], 50 kDa to 1,200 kDa, which equals 50,000 g/mol to 1,200,000 g/mol);
(Claim 15) wherein the electrospinning method is repeated to generate a fiber construct having at least two layers ([0064] microporous layers produced by electrospinning; [0082], the microporous layers may be made from the same material or from different materials; thus, when different materials, the electrospinning method is repeated with each different material to make each different material layer);
(Claims 17, 62) further comprising (ii) post-processing the fiber construct subsequent to step (i), wherein step (ii) comprises triggering cross-linking in the fiber construct, shaping the fiber construct, cutting the fiber construct, heating the fiber construct, depositing a coating material on the surface of the fiber construct, and/or adding one or more active agent(s) and/or one or more additive(s) onto/into the fiber construct ([0101], implant (fiber construct) can be shaped; fig. 6, [0088], shaping the fiber construct by engraved calendar; [0011], implant (fiber construct) can be cut; [0082], [0088], heating the fiber construct; [0055], implant (fiber construct) can be coated with bioactive agents (i.e., depositing a coating of bioactive agents on the implant (fiber construct)); [0051]-[0060], adding additives and/or active agents onto/into the implant (fiber construct), additives/active agents added to spinning solution or incorporated into the structure of the implant, additives/active agents added onto the implant by coating);
(Claim 19) wherein at least one of the one or more active agent(s) is associated with a carrier ([0051], [0055], adding active agents into the implant (fiber construct), active agents added to spinning solution or incorporated into the structure of the implant, bioactive agents may be included to provide for the delivery of an active agent (i.e., the bioactive agents define a carrier to enable delivery of an active agent)).
(Claim 11, 61) It would have been obvious to one of ordinary skill in the art, at the time the invention was made, to further modify the method wherein the polymer is a natural polymer or a synthetic polymer, or a combination thereof, and wherein the molecular weight of the natural polymer or synthetic polymer is in a range from about 1x10³ g/mol to about 500x10³ g/mol, as disclosed by Limen et al. (US 2019/0151081), because such a modification is known in the art and would provide an alternative configuration for the method known to be operable in the art.
(Claim 15) It would have been obvious to one of ordinary skill in the art, at the time the invention was made, to further modify the method wherein the electrospinning method is repeated to generate a fiber construct having at least two layers, as disclosed by Limen et al. (US 2019/0151081), because such a modification is known in the art and would provide an alternative configuration for the method known to be operable in the art. Note repeating the electrospinning method would repeat steps (ia) and (i) or repeat step (i) at least one time to generate the fiber construct having the at least two layers.
(Claims 17, 62) It would have been obvious to one of ordinary skill in the art, at the time the invention was made, to further modify the method to further comprise (ii) post-processing the fiber construct subsequent to step (i), wherein step (ii) comprises triggering cross-linking in the fiber construct, shaping the fiber construct, cutting the fiber construct, heating the fiber construct, depositing a coating material on the surface of the fiber construct, and/or adding one or more active agent(s) and/or one or more additive(s) onto/into the fiber construct, as disclosed by Limen et al. (US 2019/0151081), because such a modification is known in the art and would provide an alternative configuration for the method known to be operable in the art.
(Claim 19) It would have been obvious to one of ordinary skill in the art, at the time the invention was made, to further modify the method wherein at least one of the one or more active agent(s) is associated with a carrier, as disclosed by Limen et al. (US 2019/0151081), because such a modification is known in the art and would provide an alternative configuration for the method known to be operable in the art.
Claim(s) 9, 12-15, 17 and 62 is/are rejected under 35 U.S.C. 103 as being unpatentable over JP 2006-283241 as applied to claims 6-10, 16, 20, 59-60, and 63 above, and further in view of Phaneuf et al. (US 2014/0271795).
The rejection of claim 9 is an alternative rejection which reads on other alternative claimed components, not disclosed by JP 2006-283241 above, for the electrospinning system of claim 9.
JP 2006-283241 discloses the method substantially as claim, as mentioned above, except for the limitations of claims 12-13.
Phaneuf et al. (US 2014/0271795) discloses an electrospinning method of forming a fiber construct including electrospinning a polymer solution including one or more polymer(s),
(Claim 9) the method including an electrospinning system, wherein the system further comprises a power supply , a pressurization component, a temperature control component, a position control component, one or more sensors, a controller, or an output device, or a combination thereof ([0056], [0069], [0142], controllable supply of power, syringe pump (pressurization component), perfusion rate at 3 mL/h at 25 degrees Celsius (temperature control component is obvious, if not inherent, in order to maintain temperature at 25 degrees Celsius), collecting surface set at a jet gap distance of 15 cm from the tip of the needle (position control component is obvious, if not inherent, in order to set the gap distance), and the system being computer-automated (controller) (note that sensors and output devices (i.e., for sending signals between sensors and the computer) would have been further obvious in view of the control teachings; for example in order to maintain the temperature at 25 degrees Celsius, it would have been obvious, if not inherent, that a sensor for measuring the temperature and an output device (for communicating the measured temperature) would be required to monitor such temperature);
(Claims 12-13) wherein the total concentration of the one or more polymer(s) is in a range from about 1% (w/v) to 90% (w/v) of the polymer solution, wherein the polymer solution comprises two or more polymers, and wherein each polymer is present at a concentration in a range from about 0.1% (w/v) to 89.9% (w/v) of the polymer solution ([0142] electrospinning a two polymer solution of PU at 7% (w/v) and PET at 3% (w/v) and electrospinning another two polymer solution of PCL at 15% (w/v) and PGA at 5% (w/v);
(Claim 14) wherein the polymer solution is extruded from the ejection system at an extrusion rate in a range from about 0.01 mL/h to about 50 mL/h ([0142], perfusion (ejection) rate of 3 mL/h);
(Claim 15) wherein the electrospinning method is repeated to generate a fiber construct having at least two layers ([0142], PCL-PGA solution was electrospun onto the existing, previously electrospun, nPU-PET polymer on the mandrel (collection surface) (i.e., the electrospinning method was repeated for each solution to generate a fiber construct having at least two layers);
(Claims 17, 62) further comprising (i) applying an electrostatic charge to an ejection device ([0056], voltage applied across the needle (ejection device)), (ii) post-processing the fiber construct subsequent to step (i), wherein step (ii) comprises triggering cross-linking in the fiber construct ([0008], cross-linkers were utilized post-spinning).
(Claims 9) It would have been obvious to one of ordinary skill in the art, at the time the invention was made, to further modify the electrospinning system with an system comprising a power supply , a pressurization component, a temperature control component, a position control component, one or more sensors, a controller, or an output device, or a combination thereof, as disclosed by Phaneuf et al. (US 2014/0271795), because such a modification is known in the art and would provide an alternative configuration for the system known to be operable in the art.
(Claims 12-13) It would have been obvious to one of ordinary skill in the art, at the time the invention was made, to further modify the method wherein the total concentration of the one or more polymer(s) is in a range from about 1% (w/v) to 90% (w/v) of the polymer solution, wherein the polymer solution comprises two or more polymers, and wherein each polymer is present at a concentration in a range from about 0.1% (w/v) to 89.9% (w/v) of the polymer solution, as disclosed by Phaneuf et al. (US 2014/0271795), because such a modification is known in the art and would provide an alternative configuration for the method known to be operable in the art.
(Claims 14) It would have been obvious to one of ordinary skill in the art, at the time the invention was made, to further modify the method wherein the polymer solution is extruded from the ejection system at an extrusion rate in a range from about 0.01 mL/h to about 50 mL/h, as disclosed by Phaneuf et al. (US 2014/0271795), because such a modification is known in the art and would provide an alternative configuration for the method known to be operable in the art.
(Claim 15) It would have been obvious to one of ordinary skill in the art, at the time the invention was made, to further modify the method wherein the electrospinning method is repeated to generate a fiber construct having at least two layers, as disclosed by Phaneuf et al. (US 2014/0271795), because such a modification is known in the art and would provide an alternative configuration for the method known to be operable in the art. Note repeating the electrospinning method would repeat steps (ia) and (i) or repeat step (i) at least one time to generate the fiber construct having the at least two layers.
(Claims 17, 62) It would have been obvious to one of ordinary skill in the art, at the time the invention was made, to further modify the method to further comprise (ii) post-
processing the fiber construct subsequent to step (i), wherein step (ii) comprises triggering cross-linking in the fiber construct, as disclosed by Phaneuf et al. (US 2014/0271795), because such a modification is known in the art and would provide an alternative configuration for the method known to be operable in the art.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over JP 2006-283241 as applied to claims 6-10, 16, 20, 59-60, and 63 above, and further in view of Bowlin et al. (US 2002/0042128).
JP 2006-283241 discloses the method substantially as claim, as mentioned above, except for the limitations of claim 18.
Bowlin et al. (US 2002/0042128) discloses an electrospinning method to produce a fiber construct comprising (i) applying an electrostatic charge to a needle (ejection device) by a power supply 26, loading an electrospinning solution or suspension into a first reservoir, and loading an active agent solution or suspension in a second reservoir prior to step (i) (fig. 2; [0017], [0042]-[0043], [0162]; the first and second reservoirs are defined by the first and second syringes 22, and the solution or suspension can include active agents (active fragments, drugs)).
It would have been obvious to one of ordinary skill in the art, at the time the invention was made, to further modify the method with loading an active agent solution or suspension in a second reservoir prior to step (i), as disclosed by Bowlin et al. (US 2002/0042128), because such a modification is known in the art and would provide an alternative configuration for the method known to be operable in the art. Since the loading is prior to step (i), the combination would result in loading an active agent solution or suspension in a second reservoir prior to step (ia) (which is prior to step (i)) or subsequent to step (ia) and prior to step (i) (which is prior to step (i)).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH S LEYSON whose telephone number is (571)272-5061. The examiner can normally be reached M-F 8am-4:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sam Xiao Zhao can be reached at 5712705343. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.S.L/Examiner, Art Unit 1744
/XIAO S ZHAO/Supervisory Patent Examiner, Art Unit 1744