DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Claims 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/12/2026.
Applicant’s election without traverse of Group I, claims 1-16, in the reply filed on 1/12/2026 is acknowledged.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
Claims 1-16 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Li et al. (US 6,716,225 B2) in view of Scanlon et al. (US 2007/0207186 A1).
Regarding claims 1-3 and 7-8, Li discloses a compression and kink resistant implant (implant device 10) for nerve repair (column 2, lines 7-9), comprising a tubular biopolymeric membrane (tubular matrix 12 made of a biopolymeric material; column 1, lines 65-67), the tubular biopolymeric membrane having an outer surface (Fig. 1) and being biocompatible, resorbable, and semipermeable (column 4, lines 17-21), wherein the implant (10) has a kink resistance angle of 40 degrees to 150 degrees (column 10, lines 17-22). Li discloses the tubular biopolymeric membrane includes various types of collagen (column 4, lines 36-37).
Li fails to disclose a polymeric filament being a synthetic polymer, the polymeric filament being helical, in a crisscross arrangement, and located on the outer surface of the tubular biopolymeric membrane, wherein the implant has a compression resistance of 1 N to 10 N at 100% compression, and wherein the synthetic polymeric filament has a helical pitch of 1 mm to 2 mm.
However, Scanlon teaches an implant for nerve repair ([0161]; page 19, column 2, line 43) wherein the implant may be made of collagen ([0195]; page 25, column 2, line 31; wherein the expanded material of the implant may be made of collagen) and may include a polymeric filament (reinforcement 68) being in a helical and in a crisscross arrangement on the outer surface ([0082]) of the tubular member of the nerve repair implant (Fig. 34; [0126]). The filament may be made from polycaprolactone, a biodegradable synthetic polymer ([0271]).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the tubular biopolymeric membrane of Li to include the polycaprolactone helical and crisscross reinforcement filament of the nerve repair implant of Scanlon on the outer surface of the tubular biopolymeric membrane of Li for the purpose of increasing the strength of the implant as well as enabling the implant to have shape or size memory ([0248] of Scanlon).
Although the addition of the synthetic polymer filament of Scanlon to the implant of Li would increase the implant’s compression resistance, modified Li fails to explicitly disclose wherein the implant has a compression resistance of 1 N to 10 N, and wherein the synthetic polymeric filament has a helical pitch of 1 mm to 2 mm.
It is noted that the property of compression resistance is imparted by the polymeric filament that is wound around the outside of the tubular biopolymeric matrix in a helical path. The extent of compression resistance is a function of the pitch of the filament winding. For example, an implant having a polymeric filament wound with a small pitch, i.e., a tight winding, has a higher compression resistance as comparted to a similar implant having a winding with a larger pitch. For example, an implant having an inside diameter of 1.5 mm that is reinforced with a polymeric fiber wound with a 1 mm pitch has a compression resistance of 4 N. A similar implant in which the polymeric fiber is wound with a 2 mm pitch has a compression resistance of 2.5 N. The compression resistance imparted by a crisscross polymeric fiber is greater than that of a helical fiber given the same winding pitch ([0021] of applicant’s specification).
Li discloses the implant has an internal diameter of 1.5 mm (the implant has an internal diameter of 1.0 to 10 mm; column 2, lines 25-26). Scanlon teaches the helical filament may be wrapped around the central tube at various angles that may be modified by the user in order to customize the flexibility, manage the longitudinal shrinkage or expansion upon changing size and shape, minimize drag within a passageway or combinations thereof ([0100]). Therefore, the pitch of the filaments is disclosed to be a result effective variable in that changing the pitch of the filaments affects the flexibility, changing in size and shape, and drag of the implant.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the helical pitch of the filaments of modified Li to be between 1 mm to 2 mm for the purpose of customizing the flexibility, managing the longitudinal shrinkage or expansion upon changing size and shape, minimizing drag within a passageway or combinations thereof, as taught by Scanlon. 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. In re Aller, 105 USPQ 233. When the structure recited in the references is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. Modifying the 1.5 mm implant of Li to include the synthetic polymeric filament of Scanlon having a helical pitch of 1 mm as discussed above, would then inherently disclose a compression resistance of 4 N at 100% as disclosed by applicant’s specification.
Regarding claim 4, Li modified discloses the invention as claimed, and Li further discloses wherein the implant has an internal diameter of 1.0 mm to 10 mm (column 2, lines 25-26).
Regarding claim 5, Li modified discloses the invention as claimed, and Li further discloses wherein the implant has a length of 0.5 cm to 15 cm (column 2, lines 27-28).
Regarding claim 6, Li modified discloses the invention as claimed, and Li further discloses wherein the implant has a thickness of 0.1 mm to 1 mm (column 2, lines 27-28).
Regarding claims 9-10, Li modified discloses the invention as claimed, and Li further discloses wherein the tubular biopolymeric membrane is permeable to molecules having a molecular weight less than or equal to 500,000 daltons, wherein the molecular weight is less than or equal to 100,000 daltons (column 5, lines 20-30).
Regarding claims 11-13, Li discloses a shaped compression resistant implant (implant device 10) which is capable of being used for ridge augmentation in dental surgery (due to the sizes of the implant; column 2, lines 24-34), comprising an arcuate biopolymeric membrane (curved tubular matrix 12; column 1, lines 65-67; Fig. 1), the arcuate biopolymeric membrane (12) having an outer surface (Fig. 1) and being biocompatible, resorbable, and semipermeable (column 4, lines 17-21). Li discloses the arcuate biopolymeric membrane includes various types of collagen (column 4, lines 36-37).
Li fails to disclose a polymeric filament being a synthetic polymer and located on the outer surface of the arcuate biopolymeric membrane, and wherein the implant has a compression resistance of 1 N to 10 N.
However, Scanlon teaches an implant for nerve repair ([0161]; page 19, column 2, line 43), similar to that of Li, and/or for dental surgery ([0161]; page 19, column 1, lines 14-15), wherein the implant may be made of collagen (page 25, column 2, line 31 of para. [0195]; wherein the expanded material of the implant may be made of collagen) and may include a polymeric filament (reinforcement 68) being in a helical and in a crisscross arrangement on the outer surface ([0082]) of the implant (Fig. 34; [0126]). The filament may be made from polycaprolactone, a biodegradable synthetic polymer ([0271]).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the arcuate biopolymeric membrane of Li to include the polycaprolactone reinforcement filament of the implant of Scanlon on the outer surface of the arcuate biopolymeric membrane of Li for the purpose of increasing the strength of the implant as well as enabling the implant to have shape or size memory ([0248] of Scanlon).
Although the addition of the synthetic polymer filament of Scanlon to the implant of Li would increase the implant’s compression resistance, modified Li fails to explicitly disclose wherein the implant has a compression resistance of 1 N to 10 N.
It is noted that the property of compression resistance is imparted by the polymeric filament that is wound around the outside of the tubular biopolymeric matrix in a helical path. The extent of compression resistance is a function of the pitch of the filament winding. For example, an implant having a polymeric filament wound with a small pitch, i.e., a tight winding, has a higher compression resistance as comparted to a similar implant having a winding with a larger pitch. For example, an implant having an inside diameter of 1.5 mm that is reinforced with a polymeric fiber wound with a 1 mm pitch has a compression resistance of 4 N. A similar implant in which the polymeric fiber is wound with a 2 mm pitch has a compression resistance of 2.5 N. The compression resistance imparted by a crisscross polymeric fiber is greater than that of a helical fiber given the same winding pitch ([0021] of applicant’s specification).
Li discloses the implant has an internal diameter of 1.5 mm (the implant has an internal diameter of 1.0 to 10 mm; column 2, lines 25-26). Scanlon teaches the helical filament may be wrapped around the central tube at various angles that may be modified by the user in order to customize the flexibility, manage the longitudinal shrinkage or expansion upon changing size and shape, minimize drag within a passageway or combinations thereof ([0100]). Therefore, the pitch of the filaments is disclosed to be a result effective variable in that changing the pitch of the filaments affects the flexibility, changing in size and shape, and drag of the implant.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the helical pitch of the filaments of modified Li to be between 1 mm to 2 mm for the purpose of customizing the flexibility, managing the longitudinal shrinkage or expansion upon changing size and shape, minimizing drag within a passageway or combinations thereof, as taught by Scanlon. 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. In re Aller, 105 USPQ 233. When the structure recited in the references is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. Modifying the 1.5 mm implant of Li to include the synthetic polymeric filament of Scanlon having a helical pitch of 1 mm as discussed above, would then inherently disclose a compression resistance of 4 N at 100% as disclosed by applicant’s specification.
Regarding claims 14-16, Li discloses a shaped compression resistant implant (implant device 10) which is capable of being used for ridge augmentation in dental surgery (due to the sizes of the implant; column 2, lines 24-34), comprising an arcuate biopolymeric membrane (curved tubular matrix 12; column 1, lines 65-67; Fig. 1), the arcuate biopolymeric membrane (12) having an outer surface (Fig. 1) and being biocompatible, resorbable, and semipermeable (column 4, lines 17-21). Li discloses the arcuate biopolymeric membrane includes various types of collagen (column 4, lines 36-37).
Li fails to disclose a polymeric filament being a synthetic polymer, the arcuate biopolymeric membrane having two layers, and the polymeric filament being incorporated between the two layers of the arcuate biopolymeric membrane, wherein the implant has a compression resistance of 1 N to 10 N.
However, Scanlon teaches an implant for nerve repair ([0161]; page 19, column 2, line 43), similar to that of Li, and/or for dental surgery ([0161]; page 19, column 1, lines 14-15), wherein the implant may be made of collagen (page 25, column 2, line 31 of para. [0195]; wherein the expanded material of the implant may be made of collagen) and may include a polymeric filament (reinforcement 68) being in a helical and in a crisscross arrangement and incorporated between two layers of membrane of the implant ([0082]; Fig. 34; [0126]). Scanlon teaches the polymeric filament (68) may be positioned on the outside, inside, between two wall thicknesses, or between wall thicknesses comprised of two or more layers of the implant ([0082]). The filament may be made from polycaprolactone, a biodegradable synthetic polymer ([0271]).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the arcuate biopolymeric membrane of Li to include two layers such that the polycaprolactone reinforcement filament of the implant of Scanlon is incorporated between two layers of the arcuate biopolymeric membrane of Li for the purpose of increasing the strength of the implant as well as enabling the implant to have shape or size memory ([0248] of Scanlon). Further, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements by known methods (i.e. modifying the implant of modified Li from a single layer to being formed from two layers), and the combination would have yielded the predictable result of an implant with increased strength due to a polymeric filament.
Although the addition of the synthetic polymer filament of Scanlon to the implant of Li would increase the implant’s compression resistance, modified Li fails to explicitly disclose wherein the implant has a compression resistance of 1 N to 10 N.
It is noted that the property of compression resistance is imparted by the polymeric filament that is wound around the outside of the tubular biopolymeric matrix in a helical path. The extent of compression resistance is a function of the pitch of the filament winding. For example, an implant having a polymeric filament wound with a small pitch, i.e., a tight winding, has a higher compression resistance as comparted to a similar implant having a winding with a larger pitch. For example, an implant having an inside diameter of 1.5 mm that is reinforced with a polymeric fiber wound with a 1 mm pitch has a compression resistance of 4 N. A similar implant in which the polymeric fiber is wound with a 2 mm pitch has a compression resistance of 2.5 N. The compression resistance imparted by a crisscross polymeric fiber is greater than that of a helical fiber given the same winding pitch ([0021] of applicant’s specification).
Li discloses the implant has an internal diameter of 1.5 mm (the implant has an internal diameter of 1.0 to 10 mm; column 2, lines 25-26). Scanlon teaches the helical filament may be wrapped around the central tube at various angles that may be modified by the user in order to customize the flexibility, manage the longitudinal shrinkage or expansion upon changing size and shape, minimize drag within a passageway or combinations thereof ([0100]). Therefore, the pitch of the filaments is disclosed to be a result effective variable in that changing the pitch of the filaments affects the flexibility, changing in size and shape, and drag of the implant.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the helical pitch of the filaments of modified Li to be between 1 mm to 2 mm for the purpose of customizing the flexibility, managing the longitudinal shrinkage or expansion upon changing size and shape, minimizing drag within a passageway or combinations thereof, as taught by Scanlon. 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. In re Aller, 105 USPQ 233. When the structure recited in the references is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. Modifying the 1.5 mm implant of Li to include the synthetic polymeric filament of Scanlon having a helical pitch of 1 mm as discussed above, would then inherently disclose a compression resistance of 4 N at 100% as disclosed by applicant’s specification.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Zhang et al. (US 2010/0234863 A1) is noted for teaching a tubular implant (10) for nerve repair (abstract) with a compression strength from about 0.1 N to about 50 N at 50% compression ([0010]). Li (US 6,090,996) is noted for teaching collagen implants (column 3, lines 59-66).
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/SARAH A LONG/Primary Examiner, Art Unit 3771