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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on November 28th 2025 has been entered.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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 non-obviousness.
Claims 1, 13, 15, 17, 18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Wrobel et al. (US 2016/0235561) in view of Schmid et al. (US 2006/0136041).
Regarding claim 1, Wrobel et al. disclose an absorbable (¶[0077]) stent (10) to be inserted into a lumen of a blood vessel comprising: a flexible and elastic (¶[0076]) covering (28 or 26/28) having a central opening extending between a first end and a second end; and at least one belt (22, 24, 30 and other embodiments) disposed within the central opening between the first end and the second end, the at least one belt being a unitary single piece component (¶[0083]) and having an inside surface and an outside surface with the inside surface of the at least one belt exposed to the central opening (Figure 2A; ¶[0064]); wherein the first end and the second end are disposed within the same lumen of the blood vessel (Figure 8).
Wrobel et al. fail to disclose that the stent can radially expand and contract multiple times, the radial expansion in response to pressure exerted directly on the inside surface of the at least one belt by an expandable balloon and the radial contraction due to forces on the at least one belt while inside the lumen. The at least one belt of Wrobel et al. uses teeth (48 or 80/82) to secure the belt in an expanded state.
Schmid et al. teach constructing teeth on similar belts (1102; Figure 29) so that they can be expanded and contracted multiple times (and capable of being expanded by a balloon and contracted due forces while in a vessel lumen) in order to allow easier loading and securement of a stent on a balloon catheter (¶[0179]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention and in view of Schmid et al. to have constructed the teeth and belts of Wrobel et al. so that the belts can be expanded and contracted multiple times as claimed in order to allow easier loading and securement of the stent to a balloon catheter.
Regarding claims 13, 15 and 17, Wrobel et al. disclose a method of inserting an absorbable (¶[0077]) stent (10) in a blood vessel comprising: providing the stent and a catheter (66) having an expandable balloon (¶[0072]), the stent having a flexible and elastic (¶[0076]) covering (28 or 26/28) with a central opening extending between a first end and a second end and at least one belt (22, 24, 30 and other embodiments) disposed within the central opening between the first end and the second end (Figure 2A), the at least one belt being a unitary single piece component (¶[0083]) and having an inside surface and an outside surface and expanding radially in response to pressure exerted on the inside surface of the at least one belt by an expandable balloon (¶[0072]) and contracting radially due to forces on the at least one belt while inside the blood vessel (¶[0073]; Figure 11B); locating the stent on the expandable balloon on the catheter (¶[0072]); locating the stent and the expandable balloon in a blood vessel through a vessel opening (an opening in a vessel must be created in order to access the interior of a vessel), deflating the expandable balloon; and removing the expandable balloon from the blood vessel (necessary step in performing any catheter based stent delivery where the stent is not immediately removed - which is not disclosed).
Wrobel et al. fail to disclose that the stent can radially expand and contract multiple times, the radial expansion in response to pressure exerted directly on the inside surface of the at least one belt by an expandable balloon and the radial contraction due to forces on the at least one belt while inside the lumen. The at least one belt of Wrobel et al. uses teeth (48 or 80/82) to secure the belt in an expanded state.
Schmid et al. teach constructing teeth on similar belts (1102; Figure 29) so that they can be expanded and contracted multiple times (and capable of being expanded by a balloon and contracted due forces while in a vessel lumen) in order to allow easier loading and securement of a stent on a balloon catheter (¶[0179]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention and in view of Schmid et al. to have constructed the teeth and belts of Wrobel et al. so that the belts can be expanded and contracted multiple times as claimed in order to allow easier loading and securement of the stent to a balloon catheter.
Wrobel et al. fail to explicitly state that the inside surface of the belts are directly engaged by the balloon as claimed.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the balloon to directly engage the inside surface of the belts since they directly face the interior of the stent (Figure 2A) and the balloon would need to contact the entire interior of the stent in order to expand it.
Wrobel et al. fail to explicitly state expanding the stent so that an outside surface contacts the vessel at a lesion site as claimed.
However, the use of stents for treating a vessel lesion is notoriously well-known in the art. Wrobel et al. further disclose that their invention is related to treatment of stenoses by stents (¶[0003]) and that their stent can be coated with drugs known to treat vascular lesions (¶[0084]-[0086]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have deployed the stent at a lesion site as claimed in order to take advantage of this well-known medical use for stents; where such use is strongly suggested by Wrobel et al.
Wrobel et al. fail to explicitly state that the vessel opening is closed.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have closed the vessel opening after withdrawal of the catheter as one skilled in the art would recognize that this would prevent excessive bleeding after the procedure.
Regarding claim 18, the blood vessel has a circumference and an outside surface of the flexible and elastic covering engages an inside surface of the blood vessel around the circumference of the blood vessel (capable of this function - ¶[0003], ¶[0084]-[0086] of Wrobel et al.).
Regarding claim 20, Wrobel et al. disclose that the at least one belt comprises at least two belts, the at least two belts being at a fixed distance from one another along the flexible covering before and after expansion of the at least two expanding belts (¶[0064], [0065] - the distance from one another is fixed in both states but not necessarily the same).
Claims 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Eidenschink et al. (US 20070135904) in view of Scanlon et al. (US 2015/0306282) and Schmid et al. (US 2006/0136041).
Regarding claims 1, 3 and 10-12, Eidenschink et al. disclose a stent (side branch stent 40) to be inserted into a lumen of a blood vessel comprising: a covering (70; Figure 7) having a central opening extending between a first end and a second end; and at least one belt (41) disposed within the central opening between the first end and the second end, the at least one belt being a unitary single piece component (as shown for any embodiment of Figures 10-15) and having an inside surface and an outside surface with the inside surface of the at least one belt exposed to the central opening (¶[0079] - “or without”) and expanding radially in response to pressure exerted directly on the inside surface of the at least one expanding belt by an expandable balloon (¶[0071], [0072], [0081], [0088]); wherein the first end and the second end are disposed within the same lumen of the blood vessel (they are capable of this at least before expansion).
Eidenschink et al. fail to disclose that the stent (the belt and/or the covering) is absorbable as claimed or that the cover is elastic. Eidenschink et al. disclose that the belt and covering can be made from a variety of materials including layered graft materials (¶[0029], [0079]).
Scanlon et al. disclose layered (¶[0031]) materials for constructing a stent and/or a graft (¶[0415]; Figure 49), including stents covered with inner or outer graft layers (¶[0415]), the materials providing high strength while allowing a controlled degradation rate (Abstract; ¶[0027]). The degradation allowing improved healing at the treatment site and reduction of late-stage thrombosis (¶[0021]). The materials including an extruded (¶[0030]) elastic (¶[0147]) copolymer as claimed (¶[0389]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the material of Scanlon et al. to construct the entirety of the stent of Eidenschink et al. in order to provide improved strength while improving healing at the treatment site and reduction of late-stage thrombosis.
Eidenschink et al. fail to disclose that the stent can radially expand and contract multiple times, the radial expansion in response to pressure exerted directly on the inside surface of the at least one belt by an expandable balloon and the radial contraction due to forces on the at least one belt while inside the lumen. The at least one belt of Eidenschink et al. uses teeth (50 or 88) to secure the belt in an expanded state.
Schmid et al. teach constructing teeth on similar belts (1102; Figure 29) so that they can be expanded and contracted multiple times (and capable of being expanded by a balloon and contracted due forces while in a vessel lumen) in order to allow easier loading and securement of a stent on a balloon catheter (¶[0179]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention and in view of Schmid et al. to have constructed the teeth and belts of Eidenschink et al. so that the belts can be expanded and contracted multiple times as claimed in order to allow easier loading and securement of the stent to a balloon catheter.
Regarding claim 2, the at least one expanding belt comprises three expanding belts, the three expanding belts disposed evenly and independently from one another within the central opening of the flexible covering (as evident from Figure 7 of Eidenschink et al., the side branch stent has at least three outer folds where a belt 41 is placed). The belts can move independently of eachother (especially since the connectors 43 can be flexible and stretchable - ¶[0074]). Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have not used the connectors (43) of Eidenschink et al. since the belts can be partially embedded into the graft interior (¶[0079]).
Regarding claim 4, in addition to the limitations addressed above, Eidenschink et al. further disclose that the at least one belt (Figures 10-11 or Figures 14-15) has a plurality of teeth (50 or formed by grooves 88, respectively) disposed along the outside surface to engage a pawl (51 or 22 respectively) disposed on the at least one expanding belt.
Regarding claims 5 and 6, the teeth have a first surface (formed by grooves 88 of Eidenschink et al.) with an angle of α1 to the outside surface and a second surface (surface of belt between grooves 88) having and angle of α2 to the outside surface wherein α1 is greater than α2.
Alternatively, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the teeth (50) of Eidenschink et al. with two different angles as claimed since one skilled in the art would recognize that providing a sharper angle on the back side of each tooth would help prevent reverse movement of the pawl over the teeth and unintended loosening of the belts.
Regarding claim 7, Eidenschink et al. fail to disclose that the flexible covering has a plurality of openings to allow liquid to move between the central opening and the lumen of the blood vessel. Eidenschink et al. disclose that the covering may be porous (¶[0079]). Scanlon et al. disclose that the graft material can be formed by braiding (¶[0048]; Figures 19 and 20) which provides a plurality of pores (247) of sufficient size for blood flow (¶[0126]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the covering of Eidenschink et al. using the braiding disclosed by Scanlon et al. as a suitable way to provide the covering with a controllable porosity.
Regarding claim 8, Eidenschink et al. disclose that the covering can be porous (¶[0079]). Eidenschink et al. disclose that their stent can be used to release drugs (¶[0089]). Scanlon et al. disclose that through-holes can be provided in their material for storage and release of drugs (¶[0307]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the through-holes of Scanlon et al. in the covering of Eidenschink et al. in order to allow for storage and release of a drug at the treatment site. Once the drug is released (or even partially released) the covering would have an opening as claimed.
Regarding claim 9, in addition to the modifications explained above in regard to claim 7, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the covering with the plurality of radiographic coatings (or markers) disclosed by Scanlon et al. (¶[0128]) in order to improve visibility of the stent during delivery and positioning.
Regarding claims 13 and 15, in addition to the limitations already addressed above, Eidenschink et al. further disclose locating the stent on an expandable balloon (¶[0071], [0072], [0081]) on a catheter (20); locating the stent and the expandable balloon at a lesion site in a blood vessel through a vessel opening (¶[0087]); expanding the expandable balloon while directly engaged with the inside surface of the at least one belt (necessarily occurring when belts 41 are inside of the covering 70), thereby expanding the stent at the lesion site (¶[0071], [0072], [0081]); deflating the expandable balloon; and removing the expandable balloon from the blood vessel and closing the vessel opening (recognized by one skilled in the art as a necessary part of balloon catheter stent delivery - also see ¶[0006]). The remaining limitations have been addressed above.
Regarding claim 14, Eidenschink et al. fail to disclose using a balloon catheter to compress the lesion site before locating the stent at the lesion site. However, Scanlon et al. teach that such a procedure can be done before placing a stent (¶[0410]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used a balloon catheter to compress the lesion site of Lentz et al. prior to deploying the stent since, in view of Scanlon et al., a skilled artisan would recognize that this step would allow extra room for maneuvering of the compressed stent within the lesion site.
Claims 3, 10-12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Wrobel et al. (US 2016/0235561) in view of Schmid et al. (US 2006/0136041), as applied to claim 1 or 13 above, and further in view of Scanlon et al. (US 2015/0306282).
Regarding claims 3 and 10-12, Wrobel et al. fail to disclose that the belt and support structure are made of absorbable materials (¶[0077], [0083]) but fail to disclose that the flexible covering is made of absorbable materials.
Scanlon et al. disclose layered (¶[0031]) materials for constructing a stent and/or a graft (¶[0415]; Figure 49), including stents covered with inner or outer graft layers (¶[0415]), the materials providing high strength while allowing a controlled degradation rate (Abstract; ¶[0027]). The degradation allowing improved healing at the treatment site and reduction of late-stage thrombosis (¶[0021]). The materials including an extruded (¶[0030]) elastic (¶[0147]) copolymer as claimed (¶[0389]).
Regarding claim 14, Wrobel et al. fail to disclose the step of using the balloon catheter to compress the lesion site before locating the stent at the lesion site.
However, Scanlon et al. disclose predilating a vessel prior to stent deployment (¶[0410]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention an in view of Scanlon et al. to have predilated the lesion site with the balloon catheter prior to stent deployment as one skilled in the art would recognize that this would allow the stent to better conform to the lesion since the stent is cylindrical.
Claims 2 and 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Wrobel et al. (US 2016/0235561) in view of Schmid et al. (US 2006/0136041), as applied to claim 1 above, and further in view of Eidenschink et al. (US 20070135904). Claims 16 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Wrobel et al. (US 2016/0235561) in view of Schmid et al. (US 2006/0136041) and Eidenschink et al. (US 20070135904).
Regarding claim 2, Wrobel et al. disclose that there can be three or more independent belts (¶[0062]) but fails to explicitly state that the belts are evenly disposed within the stent.
However, Eidenschink et al. depict similar belts (41) distributed evenly along the length of a stent (Figures 2, 4 and 9).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention and in view of Eidenschink et al. to have provided the three or more belts of Wrobel et al. with equal spacing along the length of the stent as one skilled in the art would recognize that this would facilitate a more uniform expansion of the stent.
Regarding claims 4 and 16, Wrobel et al. disclose an absorbable (¶[0077], [0083]) stent (10) to be inserted into a lumen of a blood vessel (capable as evident from Figure 2A and ¶[0003]) comprising: a flexible and elastic (¶[0076]) covering (28) having a central opening extending between a first end and a second end; and a plurality of belts (22, 24, 30 or other embodiments) disposed within and spaced independently from one another along the central opening between the first end and the second end (Figure 2A), each of the plurality of belts being a unitary single piece component (¶[0083]) and having an inside surface and an outside surface, each of the plurality of belts expanding radially in response to pressure directly exerted on the inside surface of the plurality of belts and contracting radially due to forces on the at least one belt (¶[0072]), wherein the first end and the second end are disposed within the same lumen of the blood vessel (Figure 2A).
Wrobel et al. fail to disclose that the belts have a plurality of teeth disposed along the outside surface to engage a pawl disposed on each of the plurality of belts. Wrobel et al. disclose various embodiments (Figures 3-6) of the belts using a ratchet mechanism to lock the belts in an expanded state which are “non-limiting” examples of such mechanisms (¶[0066]).
Eidenschink et al. disclose an expandable belt (41; embodiments of Figures 10-11 or 14-15) having a plurality of teeth (50 or teeth formed by grooves 88, respectively) disposed along an outside surface thereof to engage a pawl (51 or 22, respectively) disposed on each belts.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the belts of Eidenschink et al. to serve as the belts of Wrobel et al. as a simple substitution of one known belt locking mechanism used in stent expansion for another to obtain predictable results (MPEP 2143 (I)(B)).
Wrobel et al. fail to disclose that the stent can radially expand and contract multiple times, the radial expansion in response to pressure exerted directly on the inside surface of the at least one belt by an expandable balloon and the radial contraction due to forces on the at least one belt while inside the lumen. The at least one belt of Wrobel et al. uses teeth (48 or 80/82) to secure the belt in an expanded state.
Schmid et al. teach constructing teeth on similar belts (1102; Figure 29) so that they can be expanded and contracted multiple times (and capable of being expanded by a balloon and contracted due forces while in a vessel lumen) in order to allow easier loading and securement of a stent on a balloon catheter (¶[0179]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention and in view of Schmid et al. to have constructed the teeth and belts of Wrobel et al. so that the belts can be expanded and contracted multiple times as claimed in order to allow easier loading and securement of the stent to a balloon catheter.
Regarding claims 5 and 6, Wrobel et al. teach that providing the teeth of the belts with opposing surfaces having different angles will help prevent loosening of the belts after expansion (¶[0071; Figure 6). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention when combining the belt of Eidenschink et al. to have provided the teeth with surfaces having different angles as claimed in order to prevent unwanted loosening of the belts after expansion.
Regarding claim 19, the inside surface of the plurality of belts is exposed to the central opening (Figure 2A of Wrobel et al.).
Response to Arguments
Applicant's arguments filed November 28th 2025 have been fully considered but they are not persuasive. Applicant has argued that providing the belt structure of Schmid et al. within the stents of Wrobel et al. or Eidenschink et al. would require a change in the principle of operation of either or both inventions. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Schmid et al. teach providing a tooth structure which allows two-way ratcheting. This can be accomplished without significant modifications to the teeth of Wrobel et al. or Eidenschink et al. The detailed structure of the belts of Schmid et al. need not be bodily incorporated into either reference to implement this teaching. Applicant has argued that the ends of the Eidenschink et al. stent must reside in different vessels. Without conceding that this is true, the claims do not require the ends to be within the same vessel when the stent is expanded. For the above reasons, the previous grounds of rejection are respectfully maintained.
Conclusion
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/THOMAS MCEVOY/Primary Examiner, Art Unit 3771