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 Objections
This office action is responsive to the amendment filed on 01/12/2026. As directed by the amendment: claims 1, 5, 8, 15, 16, 20 and 22 have been amended, no additional claims have been cancelled and no new claims have been added. Thus, claims 1, 5, 7, 8, 10, 15-17 and 20-22 are presently pending in this application, and currently examined in the Office Action.
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, 5, 7, 8, 10, 15-17 and 20-22 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.
Regarding claims 1 and 16, both of which set forth, on lines 14-17, the parameter of the endovascular medical implant device/stent delivery catheter system comprising “the first end face inserted into one of the plurality of tubes and the second end face inserted into a different one of the plurality of tubes”; however, this parameter was never mentioned or suggested in the originally filed disclosure. Specifically, the originally filed specification never discloses that first and second end faces, of the one or more bent or curved non-biodegradable nitinol connectors, are ” inserted into” one of the plurality of tubes, which are composed of non-biodegradable nitinol and are connected to the plurality of biodegradable elongated segments. It is to be noted that the only time, in the entire specification as originally filed, “insertion” of parts to form the structural frame is ever mentioned is in paragraph [0077], stating “In certain embodiments, nitinol and magnesium are connected by inserting magnesium wire into a nitinol tube and then…” (emphasis added). To clarify, the “magnesium wire” is in reference to the biodegradable elongated segment, which can in certain embodiments, be inserted into the “nitinol tube”. However, this is completely different from what is claimed, in the above mentioned parameter of lines 14-17, of claims 1 and 16.
Regarding claim 8, which sets forth, on lines 14-16, the parameter of the method of preparing an endovascular device comprising “the first end face inserted into one of the plurality of tubes and the second end face inserted into a different one of the plurality of tubes”; however, this parameter was never mentioned or suggested in the originally filed disclosure. Specifically, the originally filed specification never discloses a method of preparing the endovascular device/structural frame including having the first and second end faces, of the one or more bent or curved non-biodegradable nitinol connectors, being ” inserted into” one of the plurality of tubes, which are composed of non-biodegradable nitinol and are connected to the plurality of biodegradable elongated segments. It is to be noted that the only time, in the entire specification as originally filed, “insertion” of parts to form the structural frame is ever mentioned is in paragraph [0077], stating “In certain embodiments, nitinol and magnesium are connected by inserting magnesium wire into a nitinol tube and then…” (emphasis added). To clarify, the “magnesium wire” is in reference to the biodegradable elongated segment, which can in certain embodiments, be inserted into the “nitinol tube”. However, this is completely different from what is claimed, in the above mentioned parameter of lines 14-16, of claim 8.
Examiner’s Notes
It is to be noted that in device/apparatus claims, such as claims 1, 5, 7, 16, 17 and 20-22, only the claimed structure of the final device bears patentable weight; intended use/functional language and/or method of manufacturing is considered to the extent that it further defines the claimed structure of the final device (see MPEP 2113 & 2114).
Examiner cites particular columns and line numbers in the references as applied to the claims below for the convenience of the applicant(s). Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant(s) fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
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.
Claims 1, 5, 7, 8, 10, 15, 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Case et al. (US PG Pub. 2005/0228486), as previously disclosed, hereinafter Case, in view of Mangiardi (US PG Pub. 2013/0236498), as previously disclosed.
Regarding claims 1, 5, 21 and 22, Case discloses an endovascular medical implant device comprising a structural frame (500) structured to elastically deform from an original structure to a collapsed structure ([0058]) comprising a plurality of elongated segments (502&504) composed of biodegradable wire having an outer surface, each of the plurality of elongated segments having a first end and an opposite second end, and a length extending therebetween; a plurality of tubes (T1/T2) comprising an outer surface and an opening formed by the outer surface, composed of non-biodegradable material connected to the plurality of elongated segments (502&504); one or more bent or curved connectors (506) composed of non-biodegradable material, each of the connectors (506) comprising first and second opposite end faces (E1&E2) and a length extending therebetween, and structured to form the structural frame (500), illustrated in Figure 5A and modified figure 5A, below ([0025] & [0099]); and though it is not specifically disclosed that the first and second end faces are inserted into the plurality of tubes, it is stated that straight and arcuate portions can be joined by any suitable method ([0043], Last 3 Lines), that the non-biodegradable material is nitinol, and the biodegradable wire is a metallic wire composed of magnesium, iron and, alloys and mixtures thereof, it is stated that suitable materials to construct the frame include stainless steel and Nitinol ([0057], Lines 1-3), and further stated that bioabsorbable/biodegradable struts can be jointed to non-bioabsorbable/non-biodegradable struts by any suitable method ([0044], Last 3 Lines), and that in the embodiment of Figure 5A the one or more bent or curved connectors is in the form of a strut or wire, however such an example of the bent/curved connector (524/526) being formed of a strut/wire is described and illustrated in Figure 5C ([0101]); these parameters are deemed to be a mere matter of normal design choice, not involving a novel, inventive step and it would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine appropriate form/shapes of the material and methods of joining said materials to form the connectors, including being a strut/wire which is inserted into the tubes, since this is a mere change in the form/shape of the connectors, which is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results and also has been held that constructing a formerly integral structure in various elements involves only routine skill in the art (see MPEP 2144.04), and further obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine appropriate materials for the non-biodegradable tube and the biodegradable wire, including Nitinol and stainless steel (which is well known to one having ordinary skill in the art to be an iron alloy), respectively, as disclosed by Case, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use (see MPEP 2144.07); however, Case does not teach a coating of electrospun fiber comprising biodegradable polymer deposited on at least a portion of the outer surface of the biodegradable metal wire, such that at least a portion of the coating of electrospun fiber supports the structural frame when a portion of the biodegradable metal wire is degraded, wherein the total amount of the biodegradable polymer constitutes about 10% or less of the total mass of the device, the nitinol constitutes about 10% or less of the total mass of the device, and the biodegradable metal wire constitutes about 80% or greater of the total mass of the device.
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However, Mangiardi teaches endovascular medical implant device, in the same field of endeavor, comprising a biodegradable core (21) and a coating of electrospun fibers (23), comprising a biodegradable polymer, deposited on at least a portion of the outer surface of the biodegradable core (21), such that at least a portion of the coating of electrospun fibers (23) supports the structural frame/core when a portion of the biodegradable core (21) is degraded, wherein the biodegradable polymer is polycaprolactone, and/or polyglycolic acid and mixtures thereof, illustrated in Figures 3A and 3B; wherein the coating of electrospun fibers aids in controlled/reduced degradation rate (Mangiardi: [0060], Lines 1-7; [0063], Lines 3-10; [0083] & [0111], Last 2 Lines).
In view of the teachings of Mangiardi, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for a coating of electrospun fibers comprising a biodegradable polymer to be deposited on at least a portion of the outer surface of the biodegradable metal wire, of the medical implant device of Case, such that at least a portion of the coating of electrospun fibers supports the structural frame when a portion of the biodegradable metal wire is degraded, in order to aid in controlled/reduced degradation rates, as taught by Mangiardi, and further obvious and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate biodegradable polymer, including polycaprolactone, and/or polyglycolic acid and mixtures thereof, since these are well-known materials used in coatings of electrospun fibers coatings, as taught by Mangiardi, and it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use (see MPEP 2144.07). Furthermore, though it is not specifically disclosed that the total amount of the biodegradable polymer constitutes about 10% or less of the total mass of the device, the nitinol constitutes about 10% or less of the total mass of the device, and the biodegradable metal wire constitutes about 80% or greater of the total mass of the device, this parameter is deemed to be a mere matter or normal design choice, not involving a novel inventive step; it would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine appropriate weight percentages for the different materials/portions of the medical implant device, of Case in view of Mangiardi, including the biodegradable polymer constituting about 10% or less, the nitinol constituting about 10% or less, and the biodegradable stainless steel wire constituting about 80% or greater of the total mass of the device, based on patient need of appropriate degradation/support properties, and since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (see MPEP 2144.05).
Regarding claim 7, Case in view of Mangiardi disclose the endovascular medical implant device of claim 1, wherein Case further teaches the collapsed structure is configured to be placed in a delivery tube/catheter, deployed from the delivery tube/catheter into a patient body and upon being deployed, the collapsed structure is configured to recover to the original structure (Case: [0017]).
Regarding claims 8 and 15, Case discloses a method of preparing an endovascular device comprising forming a structural frame (500) structured to elastically deform from an original structure to a collapsed structure ([0058]) comprising obtaining a plurality of elongated segments (502&504) composed of biodegradable wire having an outer surface, each of the plurality of elongated segments having a first end and an opposite second end, and a length extending therebetween; obtaining a plurality of tubes (T1/T2) comprising an outer surface and an opening formed by the outer surface, composed of non-biodegradable material connected to the plurality of elongated segments (502&504); obtaining one or more bent or curved connectors (506) composed of non-biodegradable material, each of the connectors (506) comprising first and second opposite end faces (E1&E2) and a length extending therebetween, structured to form the structural frame (500), illustrated in Figure 5A and modified figure 5A, above ([0025] & [0099]); and though it is not specifically disclosed that the first and second end faces are inserted into the plurality of tubes, it is stated that straight and arcuate portions can be joined by any suitable method ([0043], Last 3 Lines), that the non-biodegradable material is nitinol, it is stated that suitable materials to construct the frame include stainless steel (which is known to be a bioabsorbable/biodegradable material) and Nitinol ([0057], Lines 1-3), and further states that bioabsorbable/biodegradable struts can be jointed to non-bioabsorbable/non-biodegradable struts by any suitable method ([0044], Last 3 Lines), and that in the embodiment of Figure 5A the one or more bent or curved connectors is in the form of a strut or wire, however such an example of the bent/curved connector (524/526) being formed of a strut/wire is described and illustrated in Figure 5C ([0101]); these parameters are deemed to be a mere matter of normal design choice, not involving a novel, inventive step and it would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine appropriate form/shapes of the material and methods of joining said materials to form the connectors, including being a strut/wire which is inserted into the tubes, since this is a mere change in the form/shape of the connectors, which is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results and also has been held that constructing a formerly integral structure in various elements involves only routine skill in the art (see MPEP 2144.04), and further obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate material for the non-biodegradable tube, including Nitinol, as disclosed by Case, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use (see MPEP 2144.07); however, Case does not teach depositing a coating of electrospun fiber comprising a biodegradable polymer on at least a portion of the outer surface of the biodegradable metal wire, such that at least a portion of the coating of electrospun fiber supports the structural frame when a portion of the biodegradable metal wire is degraded, wherein the total amount of the biodegradable polymer constitutes about 10% or less of the total mass of the device, the nitinol constitutes about 10% or less of the total mass of the device, and the biodegradable metal wire constitutes about 80% or greater of the total mass of the device.
However, Mangiardi teaches a method of preparing an endovascular device, in the same field of endeavor, depositing a coating of electrospun fibers (23), comprising a biodegradable polymer, on at least a portion of an outer surface of a biodegradable core (21), such that at least a portion of the coating of electrospun fibers (23) supports the structural frame/core when a portion of the biodegradable core (21) is degraded, illustrated in Figures 3A and 3B; wherein the coating of electrospun fibers aids in controlled/reduced degradation rate (Mangiardi: [0060], Lines 1-7; [0063], Lines 3-10 & [0111], Last 2 Lines).
In view of the teachings of Mangiardi, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the method of preparing an endovascular device of Case to further include depositing a coating of electrospun fibers, comprising a biodegradable polymer, on at least a portion of the outer surface of the biodegradable metal wire, such that at least a portion of the coating of electrospun fibers supports the structural frame when a portion of the biodegradable metal wire is degraded, in order to aid in controlled/reduced degradation rates, as taught by Mangiardi. Furthermore, though it is not specifically disclosed that the total amount of the biodegradable polymer constitutes about 10% or less of the total mass of the device, the nitinol constitutes about 10% or less of the total mass of the device, and the biodegradable metal wire constitutes about 80% or greater of the total mass of the device, this parameter is deemed to be a mere matter or normal design choice, not involving a novel inventive step; it would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine appropriate weight percentages for the different materials/portions of the medical implant device, of Case in view of Mangiardi, including the biodegradable polymer constituting about 10% or less, the nitinol constituting about 10% or less, and the biodegradable metal wire constituting about 80% or greater of the total mass of the device, based on patient need of appropriate degradation/support properties, and since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (see MPEP 2144.05).
Regarding claim 10, Case in view of Mangiardi disclose the method of claim 8, wherein Case further teaches inserting the collapsed structure in a delivery tube/catheter; deploying the collapsed structure from the delivery tube/catheter into a vascular target in a patient body; and recovering the original form of the structural frame in the vascular target (Case: [0017] & [0125]).
Claims 16, 17 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Case in view of Mangiardi and Dorn et al. (US PG Pub. 2002/0183826), as previously disclosed, hereinafter Dorn.
Regarding claims 16 and 20, Case discloses a stent delivery catheter system comprising a structural frame (500) structured to elastically deform from an original structure to a collapsed structure ([0058]) comprising a plurality of elongated segments (502&504) composed of biodegradable wire having an outer surface, each of the plurality of elongated segments having a first end and an opposite second end, and a length extending therebetween; a plurality of tubes (T1/T2) comprising an outer surface and an opening formed by the outer surface, composed of non-biodegradable material connected to the plurality of elongated segments (502&504); one or more bent or curved connectors (506) composed of non-biodegradable material, each of the connectors (506) comprising first and second opposite end faces (E1&E2) and a length extending therebetween, and structured to form the structural frame (500), illustrated in Figure 5A and modified figure 5A, above ([0025] & [0099]); and a delivery catheter structured to receive the collapsed structure ([0017]); and though it is not specifically disclosed that the first and second end faces are inserted into the plurality of tubes, it is stated that straight and arcuate portions can be joined by any suitable method ([0043], Last 3 Lines), that the non-biodegradable material is nitinol, it is stated that suitable materials to construct the frame include stainless steel (which is known to be a bioabsorbable/biodegradable material) and Nitinol ([0057], Lines 1-3), and further states that bioabsorbable/biodegradable struts can be jointed to non-bioabsorbable/non-biodegradable struts by any suitable method ([0044], Last 3 Lines), and that in the embodiment of Figure 5A the one or more bent or curved connectors is in the form of a strut or wire, however such an example of the bent/curved connector (524/526) being formed of a strut/wire is described and illustrated in Figure 5C ([0101]); these parameters are deemed to be a mere matter of normal design choice, not involving a novel, inventive step and it would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine appropriate form/shapes of the material and methods of joining said materials to form the connectors, including being a strut/wire which is inserted into the tubes, since this is a mere change in the form/shape of the connectors, which is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results and also has been held that constructing a formerly integral structure in various elements involves only routine skill in the art (see MPEP 2144.04), and further obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate material for the non-biodegradable tube, including Nitinol, as disclosed by Case, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use (see MPEP 2144.07); however, Case does not teach a coating of electrospun fibers comprising a biodegradable polymer deposited on at least a portion of the outer surface of the biodegradable metal wire, such that at least a portion of the coating of electrospun fibers supports the structural frame when a portion of the biodegradable metal wire is degraded, a pushrod configured to deploy the collapsed structure from the catheter, and wherein the total amount of the biodegradable polymer constitutes about 10% or less of the total mass of the device, the nitinol constitutes about 10% or less of the total mass of the device, and the biodegradable metal wire constitutes about 80% or greater of the total mass of the device.
However, Mangiardi teaches endovascular medical implant device, in the same field of endeavor, comprising a biodegradable core (21) and a coating of electrospun fibers (23), comprising a biodegradable polymer, deposited on at least a portion of the outer surface of the biodegradable core (21), such that at least a portion of the coating of electrospun fibers (23) supports the structural frame/core when a portion of the biodegradable core (21) is degraded, illustrated in Figures 3A and 3B; wherein the polymer coating aids in controlled/reduced degradation rate (Mangiardi: [0060], Lines 1-7; [0063], Lines 3-10 & [0111], Last 2 Lines). Furthermore, Dorn teaches a method of delivering a collapsible structure/stent (32), illustrated in Figures 1f and 1g, comprising a delivery catheter (16) for receiving the collapsible structure/stent (32), and a pushrod/elongate pusher configured to deploy the collapsed stent (32), from the delivery tube (16), into a vascular target (Dorn: [0061] — [0064]).
In view of the teachings of Mangiardi and Dorn, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for a coating of electrospun fibers comprising a biodegradable polymer to be deposited on at least a portion of the outer surface of the biodegradable metal wire, of the medical implant device of Case, such that at least a portion of the coating of electrospun fibers supports the structural frame when a portion of the biodegradable metal wire is degraded, in order to aid in controlled/reduced degradation rates, as taught by Mangiardi; and for the delivery catheter to further comprise a pushrod, in order to aid in advancing/delivering the structural frame at a target site in a minimally invasive way, as taught by Dorn. And though it is not specifically disclosed that the total amount of the biodegradable polymer constitutes about 10% or less of the total mass of the device, the nitinol constitutes about 10% or less of the total mass of the device, and the biodegradable metal wire constitutes about 80% or greater of the total mass of the device, this parameter is deemed to be a mere matter or normal design choice, not involving a novel inventive step; it would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine appropriate weight percentages for the different materials/portions of the structural frame of Case, including the biodegradable polymer constituting about 10% or less, the nitinol constituting about 10% or less, and the biodegradable stainless steel wire constituting about 80% or greater of the total mass of the device, based on patient need of appropriate degradation/support properties, and since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (see MPEP 2144.05).
Regarding claim 17, Case in view of Mangiardi and Dorn disclose the stent delivery catheter system of claim 16, and though it is not specifically disclosed the delivery catheter is a silicon tube; it would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate material for the delivery catheter, including silicon as claimed, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use (see MPEP 2144.07). Furthermore, it is to be noted that neither the claim, nor the originally filed specification gave any reason/benefit for, or criticality to, the parameter of the delivery catheter being made of silicon, as opposed to any other material.
Response to Arguments
Applicant's arguments filed 01/12/2026 have been fully considered but they are not persuasive. Applicant argues the rejections of independent claims 1, 8 and 16 as being unpatentable over the prior art of Case in view of Mangiardi (claims 1 and 8) and Case in view of Mangiardi and Dorn (claim 16), stating that Case does not teach the newly added parameter of the first and second end faces, of the bent/curved connectors, being inserted into the plurality of tubes, and that the plurality of tubes and bent/curved connectors are composed of non-biodegradable Nitinol. Examiner respectfully disagrees with Applicant’s assertions. Firstly, it is to be noted, as detailed above in the 112 new matter rejection section, nowhere in the originally filed disclosure of the current application at hand is there any mention, or suggestion, of first and second end faces, of the bent/curved connectors, being inserted into the plurality of tubes. What is disclosed is that the non-biodegradable/superelastic bent/curved connectors can be a “tube and/or strut” ([0055] of the originally filed specification of the current application at hand), meaning that the bent/curved connectors can be fully in a tube form, or can be fully in a strut form, or can be a combination of tubes connected/joined by a strut; however, the originally filed disclosure does not give any reason/benefit for, or criticality to, forming the non-biodegradable/superelastic bent/curved connectors in one way over another. Secondly, Case teaches a structural frame (500) comprising a plurality of elongated segments (502&504) composed of biodegradable wire having an outer surface, each of the plurality of elongated segments having a first end and an opposite second end, and a length extending therebetween; a plurality of tubes (T1/T2) comprising an outer surface and an opening formed by the outer surface, composed of non-biodegradable material connected to the plurality of elongated segments (502&504); one or more bent or curved connectors (506) composed of non-biodegradable material, each of the connectors (506) comprising first and second opposite end faces (E1&E2) and a length extending therebetween, and structured to form the structural frame (500), illustrated in Figure 5A and modified figure 5A, above (Case: [0099]); and though Case does not specifically disclose that in the embodiment of Figure 5A the one or more bent or curved connectors is in the form of a strut or wire, and that the first and second end faces are inserted into the plurality of tubes, Case does disclose an embodiment, illustrated in Figure 5C, wherein the bent/curved connector (524/526) is formed of a strut/wire ([0101]), and also states that straight/wire portions and arcuate portions can be joined by any suitable method ([0043], Last 3 Lines). Thus, it would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine appropriate form/shapes of the material and methods of joining said materials to form the connectors, including being a strut/wire which is inserted into the tubes, since this is a mere change in the form/shape of the connectors, which is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results and also has been held that constructing a formerly integral structure in various elements involves only routine skill in the art (see MPEP 2144.04). Lastly, Case discloses struts/elongated segments (502&504) which are connected/joined by curved elbow/bent or curved connectors (506), and further states “One or more struts or elbows 506 can comprise a bioabsorbable material, or a non-bioabsorbable material...or any combination thereof” (Case: [0099]). This disclosure by Case therefore includes the combination where the struts/elongated segments comprising a biodegradable material and the curved elbow/bent or curved connectors comprising a non-biodegradable material. Moreover, Case states that suitable materials to construct the frame include stainless steel (which is known to be a bioabsorbable/biodegradable material) and Nitinol (Case: [0057], Lines 1-3); thus, it would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine appropriate materials for the non-biodegradable curved elbow/bent or curved connectors, including Nitinol, as taught by Case, and since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use (see MPEP 2144.07). Therefore, the current rejections of independent claims 1, 8 and 16, as being unpatentable over the prior art of Case in view of Mangiardi (claims 1 and 8) and Case in view of Mangiardi and Dorn (claim 16) are deemed to be proper since all the structural limitations set forth in the claims are taught; hence, the rejections stand.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/DINAH BARIA/Primary Examiner, Art Unit 3774 02/17/2026