DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 1-5 and 11-12 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Dave (US 2007/0202046) in view of Williams et al. (US 2005/0187615).
As to claims 1-2, Dave discloses a stent structure (see 0043, 0047) comprising a tube formed of one or more tubular segments, the tube is coated with an elastomeric polymer (see 0071 – device made from bulk erosion polymer and coated with surface erosion polymer; surface erosion polymers can be polyanhydrides - 0067 which are elastomeric). Dave teaches the polymeric substrate is coated with a biodegradable polymer (surface erosion polymer - see 0071).
Dave fails to teach a reduced diameter in segments as required by claim 1. The claim limitations of the base polymeric substrate formed via dip-coating is a product by process limitation and is not given patentable weight unless it results in structural or functional differences in the product. Dave does teach dip coating a mandrel to for the polymeric tube (see 0047).
Williams et al. discloses a polymeric endoprosthesis device that is comprised of at least one erodible polymer (see abstract). Williams further states that the device can have varied surfaces or wall thicknesses to enhance the device with increased strength or flexibility (see 0075). The varied inner diameter of the device decreased surface friction with further devices (see 0075).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the stent of Dave to include the varied wall thickness as taught by Williams et al. in order to increase strength or flexibility. One would have been motivated to do so since both are directed to forming polymeric stents, both teach varying the final tube diameter (see 0047 of Dave) and thickness where Williams et al. teaches the advantages of having sections of different diameters.
As to the limitation, “wherein the one or more tubular segments reduced in diameter are formed by machining or cutting the tubular-shaped base polymeric substrate” is a product by process limitation and is not given patentable weight unless it results in structural or functional differences in the product. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Williams teaches varied reduced thickness of the tubing (which would result in a decrease of the diameter in the inner portion of the tubing material) meeting the limitation of reduced thickness. Williams provides the reduction in thickness/diameter through the molding process, but this results in the same claimed structure of reduced thickness/diameter of the tube.
As to claim 2, the base polymeric substrate is formed upon a mandrel (see 0047).
As to claim 3, Dave teaches the polymeric substrate is coated with a biodegradable polymer (surface erosion polymer - see 0071). The claim limitations of the coating being formed by dip coating in a polymeric solution comprising a bioabsorable or biodegradable polymeric material, is a product by process limitation and is not given patentable weight unless it results in structural or functional differences in the product. Dave teaches a coating of a biodegradable polymer, Dave does not employ the same process, but produces the same stent having the same structural characteristics. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
As to claim 4, the stent comprises a first ring and a second ring connected by a strut (see 102 of Fig. 1 and 112 of Fig. 1).
As to claim 5, the strut has a width that is less than the circumference of the ring (see Fig. 1).
As to claims 11 and 12, the stent has a plurality of rings with interconnected struts in an alternating pattern (see Fig. 1 and 0023).
Claim 6-10 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Dave (US 2007/0202046) in view of Williams et al. (US 2005/0187615) as applied to claim 1 above, and further in view of Furst (US 2007/0288085).
The teachings of Dave and Williams et al. as applied to claim 1 are as stated above.
Dave modified by Williams et al. fails to teach the polymer is polycaprolactone, is part of a blend or co-polymer , the blend is 1-50% of the polymer, the blend /co-polymer comprises poly-L-lactide or the blend/copolymer has a glass transition temperature of 50-65C. as required by claims 6-10.
Furst discloses a medical device which can be formed of or coated with a variety of polymers to improve strength, durability, biocompatibility, friction or provide protection (see 0060). Furst states the polymer can be polycaprolactone, blends or copolymers comprising PLLA (see 0060).
It would have been obvious to one of ordinary skill in the art to coat the stent of Dave as with the material as taught by Furst. One would have been motivated to do so since both are directed to forming polymeric stents or providing polymeric coatings to stents, where Furst further teaches the benefits of protection, improved strength, and durability to using bioresorbable elastomeric polymers as coatings for stent.
As to the limitation of the blend comprising 1-50%, Dave teaches the polymer blend can be present at 50% (see 0090) and have a glass transition temp of 60C (see 0083). Furst teaches the polymers can be used for forming the stent or coating the stent. Therefore, it would have been obvious to one of ordinary skill in the art to such polymers/blends taught by Dave for forming the stent as coating materials in order to provide the stent with specific properties.
Claim 13 – 14 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Dave (US 2007/0202046) in view of Williams et al. (US 2005/0187615) as applied to claim 11 above in further view of Nikanorovet al. (US 2007/0191926).
The teachings of Dave and Williams et al. as applied to claim 11 are as stated above.
Dave fails to teach the spacing of the ring portions are required by claim 13 or that the distal end is more flexible as required by claim 14.
Nikanorov et al. discloses an expandable stent that has cylindrical rings and interconnecting links (see abstract). Nikanorov et al. stats the spacing between the rings at the distal end of the stent is greater than that on the main body of the stent in order to improve the stents retention on the delivery device to place the stent within the body.
It would have been obvious to one having ordinary skill in the art before the invention was made to modify the stent of Dave and Williams et al. to include the ring spacing as taught by Nikanorov et al. One would have been motivated to do so since both are directed to stents that are flexible while Nikanorov et al. further teaches the spacing at the distal ends should differ than the main body in order to retain the stent onto the delivery device during insertion of the stent.
Response to Arguments
Applicant's arguments filed 02/19/2026 have been fully considered but they are not persuasive. Applicant argues Dave fails to teach tubular segments reduced in diameter, and that Williams does not teach or suggest the claimed limitation of tubular segments reduced in diameter compared to the tube diameter along the base polymeric substrate. The rejection does not rely on Dave alone for this limitation, Rather, the rejection relies on Williams to teach structural variations along the tubular endoprosthesis. Williams discloses hat the polymeric endoprosthesis may include regions of varying wall thickness or varied surfaces in order to enhance the mechanical properties of the device, such as increased flexibility or strength (See Williams 0075). A person of ordinary skill in the art would understand that changes in wall thickness along a tubular structure necessarily correspond to localized differences in the internal or external diameter of the tube. Such dimensional variations inherently produce sections of tube having a reduced diameter relative to other portions of the tube. Furthermore, Williams expressly teaches that the device may include sections of different diameters or profiles along the length to achieve mechanical properties, thereby suggesting structural regions that are narrower relative to other regions of the tube. Accordingly, Williams teaches or at least suggests segments of reduced diameter along the length of the tubular device, which corresponds to the claimed limitation of one or more tubular segments reduced in diameter compared to the tube diameter.
Applicant further argues that Williams does not teach teaches the base polymeric substrate comprising the one or more tubular segments reduced in diameter is coated by one or more polymer layers, wherein at least one of the polymer layers comprises elastomeric polymer. This argument is not persuasive because the rejection relies on Dave for this limitation. Dave teaches a polymeric stent structure formed from biodegradable polymeric materials and further teaches coating the device with a surface erosion polymer layer. Dave further discloses that such polymers may include polyanhydrides which are elastomeric biodegradeable polymers.
Conclusion
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/CACHET I. PROCTOR/
Examiner
Art Unit 1712
/CACHET I PROCTOR/Primary Examiner, Art Unit 1712