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 .
Response to Arguments
Applicant’s arguments with respect to claims 1, 23, and 27 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
In response to applicant's argument that Pacetti (Pub. No.: 2016/0030211) and Bonitatebus et al. (Pub. No.: 2007/0122620) are nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, applicants’ invention provides claims to a biostable and biocompatible binder. Pacetti, at paragraph [0062], teaches that radiopaque particles 60 are retained in lumen 56 due to an external binder (such as a polymer binder) carrying the radiopaque particles and that polymer binder 61 includes a binder material to include silicones which is known in the art to be biostable and biocompatible; thus, being reasonably pertinent to the particular problem with which the inventor is concerned as one of ordinary skill in the art would be motivated to try implementation of the teaching.
Applicant further provides claims to radiopaque particles entrapped within a binder. Applicant’s specification teaches that radiopaque material prevents x-rays from penetrating through the radiopaque component, such that the radiopaque component is readily visible on an x-ray image. In some embodiments, the radiopaque material may be configured as particles (e.g., a powder, such as a finely divided powder). See Applicant’s specification at paragraph [0080]. Bonitatebus also teaches a core/shell nanoparticle 100 that is operable for use as an imaging agent in X-ray imaging (paragraph [0035], Fig. 1), wherein the nanoparticle comprises an active material to include tantalum (paragraph [0043]) having a radiopaque molecular structure (paragraph [0012]); thus, being reasonably pertinent to the particular problem with which the inventor is concerned as one of ordinary skill in the art would be motivated to try implementation of the teaching.
Applicant argues on pages 6 and 7 that the prior art of record fails to disclose the amended feature of a cured biostable and biocompatible silicone binder. However, newly found reference De Juan et al. (Pub. No.: WO 2013/040426) discloses a suture that can be overmolded with medical grade silicone and cured (paragraph [0426]).
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.
Claims 1, 2, 12, 15, 19, 20, 23, 24, 33, and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Jackson et al. (Pub. No.: US 2017/0188983) in view of De Juan et al. (Pub. No.: WO 2013/040426) and further in view of Rafiee et al. (Pub. No.: US 2018/0098850).
Consider claims 1, 12, Jackson discloses a radiopaque component (paragraph [0032], Fig. 1, Polyamide 6 sheath 16 having nanoparticle sized radiopaque material 18) for in vivo medical use (paragraph [0022], sutures used as an in vivo repair device),
the radiopaque component comprising a plurality of radiopaque particles entrapped within a binder (paragraph [0032], Fig. 1, suture 10 comprises a core 12 formed of an overcoated Polyamide 6 sheath 16 having nanoparticle sized radiopaque material 18).
Jackson does not specifically disclose a cured biostable and biocompatible silicone binder.
De Juan discloses a cured biostable and biocompatible silicone binder (paragraph [0426], a suture that can be overmolded with medical grade silicone and cured (as known in the art to be both biostable and biocompatible)).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace binder as disclosed by Jackson with the binder as taught by De Juan to form the silicone segments (which is known in the art to be both biostable and biocompatible) (De Juan, paragraph [0426]).
The combination of Jackson and De Juan does not specifically disclose wherein the radiopaque particles comprise at least 50%, by weight, of the radiopaque component.
Rafiee discloses wherein the radiopaque particles comprise at least 50%, by weight, of the radiopaque component (paragraph [0093], the sheath (also referred to as a “suture”, see paragraph [0092]) may be loaded with between about 20 and about 70% bismuth or barium sulfate by weight).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the radiopaque particles as disclosed by the combination of Jackson and De Juan with the radiopaque particles as taught by Rafiee to enhance radiopacity (Rafiee, paragraph [0093]).
Consider claim 2, the combination of Jackson, De Juan and Rafiee discloses wherein the radiopaque particles comprise tantalum (paragraph [0031], a sheath of nanoparticle radiopaque materials, such as tantalum)
Consider claim 15, the combination of Jackson, De Juan, and Rafiee discloses a polymer affixed to the radiopaque component (paragraph [0032], Fig. 1, the sheath 16 having nanoparticle sized radiopaque material 18 substantially uniformly dispersed throughout its thickness and length).
Consider claim 19, the combination of Jackson, De Juan, and Rafiee discloses wherein the polymer comprises a core and the radiopaque component is braided, wrapped, or encased about the polymer core to form a suture (paragraph [0031], the suture comprises a core of a plurality of twisted Polyamide 66 filaments encased within a sheath of Polyamide 6 in which nanoparticle radiopaque materials, such as tantalum, are substantially uniformly dispersed).
Consider claim 20, the combination of Jackson and De Juan does not specifically disclose wherein the polymer comprises ultra high molecular weight polyethylene.
Rafiee discloses wherein the polymer comprises ultra high molecular weight polyethylene (paragraph [0085], Fig. 1A, core wire 30, encased in an elongate sheath 50 wherein sheath 50 can be made from a 1-2 mm ultra high molecular weight polyethylene (“UHMWPE”) (see paragraph [0093]) and wherein the core wire is formed of a tantalum loaded polymer, see paragraph [0102])).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the polymer as disclosed by the combination of Jackson and De Juan with the polymer as taught by Rafiee for improved creep resistance (Rafiee, paragraph [0093]).
Consider claim 23, Jackson discloses a radiopaque implantable medical device (paragraphs [0033], [0022], Fig. 3, polymeric mesh implant 30 with threads 32 forming the mesh including nanoparticle sized radiopaque material 18), comprising:
an implantable medical device (paragraphs [0033], [0022], Fig. 3, polymeric mesh implant 30); and
a radiopaque component attached to the implantable medical device (paragraph [0033], Fig. 3, polymeric mesh implant 30 (see paragraph [0022]) with threads 32 forming the mesh corresponding to the radiopaque sutures of FIG. 1 or 2 and, therefore, including nanoparticle sized radiopaque material 18),
the radiopaque component comprising a plurality of radiopaque particles entrapped within a binder (paragraph [0032], Fig. 1, Polyamide 6 sheath 16 having nanoparticle sized radiopaque material 18).
Jackson does not specifically disclose a cured biostable and biocompatible silicone binder.
De Juan discloses a cured biostable and biocompatible silicone binder (paragraph [0426], a suture that can be overmolded with medical grade silicone and cured (as known in the art to be both biostable and biocompatible)).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace binder as disclosed by Jackson with the binder as taught by De Juan to form the silicone segments (which is known in the art to be both biostable and biocompatible) (De Juan, paragraph [0426]).
The combination of Jackson and Pacetti does not specifically disclose wherein the radiopaque particles comprise at least 50%, by weight, of the radiopaque component.
Rafiee discloses wherein the radiopaque particles comprise at least 50%, by weight, of the radiopaque component (paragraph [0093], the sheath (also referred to as a “suture”, see paragraph [0092]) may be loaded with between about 20 and about 70% bismuth or barium sulfate by weight).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the radiopaque particles as disclosed by the combination of Jackson and De Juan with the radiopaque particles as taught by Rafiee to enhance radiopacity (Rafiee, paragraph [0093]).
Consider claim 33, the combination of Jackson and DeJuan does not specifically disclose wherein the polymer comprises polyester.
Rafiee discloses wherein the polymer comprises polyester (paragraph [0085], Fig. 1A, core wire 30, encased in an elongate sheath 50 that is preferably made from a knit or woven polyester wherein the core wire is formed of a tantalum loaded polymer, see paragraph [0102]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the polymer as disclosed by the combination of Jackson and De Juan with the polymer as taught by Rafiee to provide a suitable material that stretches over the core wires (Rafiee, paragraph [0085]).
Consider claim 34, the combination of Jackson, De Juan, and Rafiee discloses wherein the radiopaque component is woven and/or sewn into the implantable medical device (paragraph [0033], Fig. 3, polymeric mesh implant 30 (see paragraph [0022]) with threads 32 forming the mesh corresponding to the radiopaque sutures of FIG. 1 or 2).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Jackson, De Juan, and Rafiee in view of Pacetti (Pub. No.: US 2016/0030211).
Consider claim 24, the combination of Jackson, DeJuan, and Rafiee discloses wherein the radiopaque particles comprise tantalum (paragraph [0031], a sheath of nanoparticle radiopaque materials, such as tantalum) and the radiopaque component is attached to the implantable medical device via Polyamide 6 (paragraph [0033], Fig. 3, polymeric mesh implant 30 (see paragraph [0022]) with threads 32 forming the mesh corresponding to the radiopaque sutures of FIG. 1 or 2).
The combination of Jackson, De Juan, and Rafiee does not specifically disclose the radiopaque component is attached to the implantable medical device via silicone.
Pacetti discloses the radiopaque component is attached to the implantable medical device via silicone (claim 1, implantable prosthesis comprising: a strut having a lumen; radiopaque particles within the lumen; and a polymer binder surrounding the radiopaque particles wherein polymer binder 61 includes silicones, see paragraph [0085]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace binder as disclosed by the combination of Jackson, De Juan, and Rafiee with the binder as taught by Pacetti to provide a binder having material to include silicone (which is known in the art to be both biostable and biocompatible) (Pacettii, paragraph [0085]).
Claims 16 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over the combination Jackson, DeJuan, and Rafiee in view of Bonitatebus et al. (Pub. No.: 2007/012260).
Consider claim 16, the combination of Jackson and DeJuan discloses wherein a core and a polymer is braided, wrapped, or encased about the core to form a radiopaque suture (e.g., a radiopaque suture with respect to the polymer) (paragraph [0032], Fig. 1, suture 10 comprises a core 12 formed of an overcoated Polyamide 6 sheath 16 having nanoparticle sized radiopaque material 18).
The combination of Jackson and DeJuan does not specifically disclose wherein the radiopaque component comprises a core and a polymer is braided, wrapped, or encased about the radiopaque component core to form a radiopaque suture (e.g., a radiopaque suture with respect to the core).
Rafiee also discloses wherein the radiopaque component comprises a core (paragraph [0102], Fig. 1AN, core wire formed of a tantalum loaded polymer) and a polymer is braided, wrapped, or encased about the radiopaque component core to form a radiopaque suture (e.g., a radiopaque suture with respect to the core) (paragraph [0102], Fig. 1AN, braided tether with inserted core wire formed of a tantalum loaded polymer wherein the sheath/tether material 50 is referred to as a “suture,” see paragraph [0092]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the core as disclosed by the combination of Jackson and De Juan with the core as taught by Rafiee to enhance radiopacity (Rafiee, paragraph [0102]).
The combination of Jackson, De Juan, and Rafiee does not specifically disclose the radiopaque core comprising a plurality of radiopaque particles.
Bonitatebus discloses the radiopaque core (paragraph [0041], Figs. 1, 2, nanoparticle core 201 comprising tantalum) comprising a plurality of radiopaque particles (paragraph [0043], Figs. 1, 2, nanoparticle core 201).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the core as disclosed by the combination of Jackson, De Juan, and Rafiee with the nanoparticle core as taught by Bonitatebus to be operable for use as an imaging agent (Bonitatebus, paragraph [0041]).
Consider claim 27, Jackson discloses a radiopaque suture (paragraph [0032], Fig. 1, radiopaque suture 10) for in vivo use (paragraph [0022], sutures used as an in vivo repair device), the radiopaque suture comprising:
Jackson does not specifically disclose a radiopaque core, the radiopaque core comprising a plurality of radiopaque material entrapped within a binder.
Rafiee discloses a radiopaque core (Fig. 1A, core wire 40), the radiopaque core comprising a plurality of radiopaque material entrapped within a binder (paragraph [0102], Fig. 1AN, core wire formed of a tantalum loaded polymer).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the core as disclosed by Jackson with the radiopaque core as taught by Rafiee to enhance radiopacity (Rafiee, paragraph [0102]).
The combination of Jackson and Rafiee does not specifically disclose radiopaque particles.
Bonitatebus discloses radiopaque particles (paragraph [0041], Figs. 1, 2, nanoparticle core 201 comprising tantalum).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the core as disclosed by the combination of Jackson and Rafiee with the nanoparticle core as taught by Bonitatebus to be operable for use as an imaging agent (Bonitatebus, paragraph [0041]).
The combination of Jackson, Rafiee, and Bonitatebus does not specifically disclose a cured biostable and biocompatible silicone binder.
De Juan discloses a cured biostable and biocompatible silicone binder (paragraph [0426], a suture that can be overmolded with medical grade silicone and cured (as known in the art to be both biostable and biocompatible)).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace binder as disclosed by the combination of Jackson, Rafiee, and Bonitatebus with the binder as taught by De Juan to form the silicone segments (which is known in the art to be both biostable and biocompatible) (De Juan, paragraph [0426]).
The combination of Jackson, Bonitatebus, and De Juan does not specifically disclose wherein the radiopaque particles comprise at least 50%, by weight, of the radiopaque core; a polymer braided, wrapped, or encased about the radiopaque core to form a radiopaque suture.
Rafiee discloses wherein the radiopaque particles comprise at least 50%, by weight, of the radiopaque core (paragraph [0093], the sheath (also referred to as a “suture”, see paragraph [0092]) may be loaded with between about 20 and about 70% bismuth or barium sulfate by weight); a polymer braided, wrapped, or encased about the radiopaque core to form a radiopaque suture (paragraph [0088], Fig. 1A, suture wrap 60 can be a PTFE impregnated braided polyester fiber nonabsorbable surgical suture wherein core wire is formed of tantalum loaded polymer, see paragraph [0102]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the radiopaque particles as disclosed by the combination of Jackson, Bonitatebus, and De Juan with the radiopaque particles as taught by Rafiee to enhance radiopacity (Rafiee, paragraphs [0093], [0102]).
Claims 6, 10, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Jackson, De Juan, and Rafiee in view of Vayser et al. (Pub. No.: US 2020/0261742).
Consider claim 6, the combination of Jackson, De Juan, and Rafiee does not specifically disclose wherein the radiopaque component is conformable.
Vayser discloses wherein the radiopaque component is conformable (paragraph [0081], discrete markers may be short segments of the radiopaque suture filaments wherein a marker may include a solid core that is flexible allowing the marker to conform to the site of interest, see paragraph [0087]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the radiopaque component as disclosed by the combination of Jackson, De Juan, and Rafiee with the core as taught by Vayser to allow the physician to determine the treatment plan or region without requiring extrapolation of the area or volume based on the markers, (Vayser, paragraph [0087]).
Consider claim 10, the combination of Jackson, De Juan, and Rafiee does not specifically disclose wherein the radiopaque component has a thickness of less than 0.6 mm.
Vayser discloses wherein the radiopaque component has a thickness of less than 0.6 mm (paragraph [0081], discrete markers may be short segments of the radiopaque suture filaments wherein filament diameters are larger than 0.4 mm, see paragraph [0041]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the radiopaque component as disclosed by the combination of Jackson, De Juan, and Rafiee with the radiopaque suture filaments as taught by Vayser to identify a plurality of surgical planes (Vayser, paragraph [0041]).
Consider claim 11, the combination of Jackson, De Juan, and Rafiee does not specifically disclose wherein the radiopaque component has a thickness of less than 0.2 mm.
Vayser discloses wherein the radiopaque component has a thickness of less than 0.2 mm (paragraph [0081], discrete markers may be short segments of the radiopaque suture filaments wherein filament diameters can range, for example, between 0.1 mm and 0.3 mm).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the radiopaque component as disclosed by the combination of Jackson, De Juan, and Rafiee with the radiopaque suture filaments as taught by Vayser to identify a plurality of surgical planes (Vayser, paragraph [0041]).
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Jackson, De Juan, and Rafiee in view of Burgermeister et al. (Pub. No.: US 2008/0132995).
Consider claims 13, 14, the combination of Jackson, De Juan, and Rafiee does not disclose wherein the radiopaque particles comprise at least 80%, (also 90%) by weight, of the radiopaque component.
Burgermeister discloses wherein the radiopaque particles comprise at least 60%, by weight, of the radiopaque component (paragraph [0113], the amount of radiopaque materials may range from 0-99 percent (wt percent)).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to the radiopaque particles as disclosed by the combination of Jackson, De Juan, and Rafiee with the radiopaque particles as taught by Burgermeister to enhance the radiopacity (Burgermeister, paragraph [0113]).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Jackson, De Juan, and Rafiee in view of Sloan et al. (Pub. No.: US 2022/0002943).
Consider claim 7, the combination of Jackson, De Juan, and Rafiee does not specifically disclose wherein the radiopaque component has an equivalent aluminum thickness of at least 8 mm under x-ray.
Sloan discloses wherein the radiopaque component has an equivalent aluminum thickness of at least 8 mm under x-ray (paragraph [0086], core-sheath structures (including sutures, see paragraph [0147]) may range from about 20 µm to about 8 mm).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the radiopaque component as disclosed by the combination of Jackson, De Juan, and Rafiee with core-sheath structure as taught by Sloan to be useful in various applications including medical cords to include sutures having core-sheath structures (Sloan, paragraph [0132]).
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Jackson, Bonitatebus, De Juan, and Rafiee in view of Vayser.
Consider claim 32, the combination of Jackson, Bonitatebus, De Juan, and Rafiee does not specifically disclose wherein the radiopaque suture has a diameter within a range of 0.03 mm to 0.6 mm.
Vayser discloses disclose wherein the radiopaque suture has a diameter within a range of 0.03 mm to 0.6 mm (paragraph [0081], discrete markers may be short segments of the radiopaque suture filaments wherein filament diameters can range, for example, between 0.1 mm and 0.3 mm).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the radiopaque suture as disclosed by the combination of Jackson, Bonitatebus, De Juan, and Rafiee with the radiopaque suture as taught by Vayser to identify a plurality of surgical planes (Vayser, paragraph [0041]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Unknown Inventor (Pub. No. JP 2008513118 A) discloses a biocompatible elastic matrix 2 comprising various biocompatible elastic binders and a radiopaque material 3 distributed therein in an amount sufficient to produce a radiopaque image.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GERALD JOHNSON whose telephone number is (571)270-7685. The examiner can normally be reached Monday-Friday 8am-5pm EST.
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/Gerald Johnson/
Primary Examiner, Art Unit 3797
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