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 claim(s) 1 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.
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.
Claim(s) 1, 3-4, 6, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over USPAP 2020/0155732 (Rangwala et al.) in view of US Patent App. USPAP 2015/0081000 (Hossainy et al.).
Rangwala discloses a stent formed of a single braided wire (112) that is a drawn filled tube ([0040]) defining a flared crown at each end of the stent. The flared crown comprises four long loops (114) and four short loops (118) that are distributed equally about the flared crown, as most clearly indicated by the braiding arrangements shown in Figures 6-9 (see description of four long and four short loops at [0048]; [0051]). The four short loops (118) are positioned radially equidistant between two adjacent long loops, as clearly shown in Figures 6-9 and 12. At least two of the long loops (114) on each end of the stent comprise coiled wire forming marking coils (132) (Fig. 2; [0011]; [0061]; [0066]) positioned opposite one another.
Rangwala discloses various examples of stent width (which corresponds with diameter [0057]) and the corresponding length of short loops and long loops at [0056]. One example is a stent having a diameter of 3 – 3.5 mm has long flares “sized about” 0.04 – 0.05 inch (or 1 – 1.27 mm). Rangwala fails to explicitly state that the dimensions given for the flared loops correspond with an unconstrained diameter relative to the stent diameter, but does set forth that the diameter of the flared crown is a result effective variable dependent on the vessel and stent body diameters. Rangwala teaches the flared crown should be slightly oversized relative to the vessel being treated in order to ensure proper anchoring with the vessel wall without collapsing too much ( [0055-0057]; [0049]). It would have been an obvious matter of design choice to configure the flared crowns of the Rangwala stent to be 1-2 mm greater diameter than the stent body, in order to optimize the stent for a particular patient’s anatomy, 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. In re Aller, 105 USPQ 233.
Although Rangwala fails to disclose the braid density is 15 - 21 PPI (picks per square inch), Rangwala teaches that the stent’s PPI is a result effective variable that achieves a desired size of pores for a particular purpose and/or a higher PPI for a scaffolding function (greater stiffness) [0098-0100]. Hossainy discloses another stent formed from braided wires. Similar to Rangwala, Hossainy teaches that the braid density of a stent can be varied to achieve desired mechanical properties [0345]. Hossainy teaches that it is known in the art for a stent to have a braid density in the range of 15-21 PPI [0048; 0227], wherein the braid density can be tailored to obtain a desired radial strength of the stent [0198; 0345]. It would have been obvious to one having ordinary skill in the art at the time the invention was made configure the Rangwala stent to have a braid density in the range of 15 to 21 PPI, as taught by Hossainy, for the purpose of achieving a desired porosity and/or mechanical properties of the stent for a particular patient’s needs, 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. In re Aller, 105 USPQ 233.
Although Rangwala does not explicitly state the stent is “configured to generate a chronic radially outward force and to generate a resistance radial force in a range of 0.3 N/mm to 0.5 mm/N when implanted”, Rangwala discloses the stent is oversized relative to the patient’s vessel so that it anchors with the vessel wall and therefore applies a chronic radial outward force to the vessel wall ([0049; 0054-0057; 0098-0100]. Hossainy teaches that a stent with a braid density in the range of 15-20 PPI may exhibit a radial strength of 0.7 N/mm – 2 N/mm [0048]. Hossainy further teaches that a stent may be configured to have an initial radial strength of 0.5 N/mm ([0146]) or in a range of 0.4 N/mm to 0.75 N/mm [0189]). Hossainy teaches that the radial strength or stiffness of the stent at deployment can be adjusted by various parameters, such as filament density, filament cross-section, number of filaments, etc. ([0198]) and braid pick count [0227]. It is noted that Applicant does not place criticality on the recited range 0f 0.3 – 0.5 N/mm resistive radial force, but merely states this range as one of many options as low as 0.02 N/mm and up to 0.7 N/mm [0077-0078], wherein the specification does not tie the particular braid density to the range of 0.3 – 0.5 N/mm resistive radial force.
In light of Hossainy’s teachings, it is considered to be within an ordinary level of skill in the art before the effective filing date of the claimed invention to have configured the modified Rangwala stent to generate a chronic radially outward force sufficient to change blood flow within the cerebral dural venous sinus from pulsatile flow or turbulent flow to laminar flow and to generate a resistive radial force in the range of 0.3 N/mm to 0.5 mm/N when implanted, in order to tailor the mechanical properties of the implant for a particular patient’s needs.
The limitation “configured for implantation in a cerebral dural venous sinus” is a functional limitation that is not given full patentable weight. The prior art is not required to explicitly disclose the recited functions, but merely have the capability of performing the recited functions in order to meet the claim requirements. In this case, Rangwala discloses neurovascular applications [0004; [0031]; [0055]). Rangwala discloses the stent body diameter is in the range of body has a diameter of 2.5 – 5 mm [0055] and a length of 7 mm – 18.5 mm [0057], which Applicant has disclosed as suitable for cerebral dural venous sinus [0066].
Regarding claim 3: Rangwala teaches that the stent diameter is a result effective variable chosen relative to the patient’s vessel so that the stent makes proper contact and anchors with the vessel wall to prevent migration [0055-0056]. Hossainy teaches that a stent with a braid density in the range of 15-20 PPI may exhibit a radial strength of 0.7 N/mm – 2 N/mm [0048]. Hossainy further teaches that a stent may be configured to have an initial radial strength of 0.5 N/mm ([0146]) or in a range of 0.4 N/mm to 0.75 N/mm [0189]). Hossainy teaches that the radial strength or stiffness of the stent at deployment can be adjusted by various parameters, such as filament density, filament cross-section, number of filaments, etc. ([0198]) and braid pick count [0227]. It is noted that Applicant does not place criticality on the recited value of 0.36 N/mm resistive radial force, but merely states this value as one of many options as low as 0.02 N/mm and up to 0.7 N/mm [0077-0078], wherein the specification does not tie the particular braid density to the value of 0.036 N/mm resistive radial force.
In light of Hossainy’s teachings, it is considered to be within an ordinary level of skill in the art before the effective filing date of the claimed invention to have configured the modified Rangwala stent to generate a resistive radial force of at least 0.036 N/mm when implanted, in order to tailor the mechanical properties of the implant for a particular patient’s needs.
Regarding claim 4: Rangwala teaches that the stent diameter is a result effective variable chosen relative to the patient’s vessel so that the stent makes proper contact and anchors with the vessel wall to prevent migration [0055-0056]. Hossainy teaches that a stent with a braid density in the range of 15-20 PPI may exhibit a radial strength of 0.7 N/mm – 2 N/mm [0048]. Hossainy further teaches that a stent may be configured to have an initial radial strength of 0.5 N/mm ([0146]) or in a range of 0.4 N/mm to 0.75 N/mm [0189]). Hossainy teaches that the radial strength or stiffness of the stent at deployment can be adjusted by various parameters, such as filament density, filament cross-section, number of filaments, etc. ([0198]) and braid pick count [0227]. It is noted that Applicant does not place criticality on the recited range of 0.0197 to 0.0433 N/mm resistive radial force, but merely states this value as one of many options as low as 0.02 N/mm and up to 0.7 N/mm [0077-0078], wherein the specification does not tie the particular braid density to the recited range.
In light of Hossainy’s teachings, it is considered to be within an ordinary level of skill in the art before the effective filing date of the claimed invention to configured the modified Rangwala stent to generate a resistive radial force in the range of 0.0197 to 0.0433 N/mm when implanted, in order to tailor the mechanical properties of the implant for a particular patient’s needs.
Regarding claim 6: Rangwala discloses the wire diameter is 0.010-0.004 inch [0038], which overlaps the claimed range.
Regarding claim 9: Rangwala discloses the wire diameter is 0.010-0.004 inch [0038], which overlaps the claimed range.
Regarding claim 34: Rangwala discloses the DFT tubes are wires comprised of a platinum core with a Nitinol outer layer [0008]; [0049].
Regarding claim 35: Rangwala discloses a stent length of 7 mm – 18.5 mm [0029], which overlaps the claimed range.
Claim(s) 5, 8, and 31-33 are rejected under 35 U.S.C. 103 as being unpatentable over USPAP 2020/0155732 (Rangwala et al.) in view of US Patent App. USPAP 2015/0081000 (Hossainy et al.), and further in view of USPAP 2013/0245745 (Vong et al.).
Regarding claims 5 and 8: Rangwala discloses a stent length of 7 mm – 18.5 mm [0057] and fails to disclose the stent length is 45 mm or 60 mm. Vong discloses a similar braided stent with flared ends for anchoring the stent with in the vessel, and teaches that the stent length can be in the range of 5-100 mm in order to extend being the mouth of an aneurysm (150) (see Fig. 9; [0067]). Since it is well known in the art for patient anatomy to vary widely based on age, health, height, weight, etc., one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the Rangwala stent to have a length of 45 mm or 60 mm, as taught by Vong, in order to configure the implant according to a particular patient’s needs. Such a modification would have involved a mere change in size of a component, which is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
In regards to claims 31-33:
As discussed above, Rangwala discloses marking coils (132) on the stent. the phrase “configured to releasably couple the stent device to an insertion device” is a functional recitation that is not given full patentable weight, wherein the phrase is not a positive recitation of the insertion device. The prior art is not required to expressly disclose the coiled wires couple the stent to the insertion device, wherein the capability of the coiled wires (132) of the modified Rangwala stent to assist at least some degree to releasably coupling to an insertion device meets the functional claim requirements.
Rangwala discloses an insertion device with a catheter (140) enclosing the stent and a pusher rod (142) (see Figure 11), a stent body coil (reinforcement 154), and a radiopaque pusher body (144 and 146) coupled to a portion of the pusher rod (142) [0068]. Rangwala explains the coils (132) are positioned between bands (144 and 146) and aid in enhancing pushing force to deliver the stent [0072]. Rangwala fails to disclose all the components of the delivery device.
Vong teaches a delivery device can include a support rod (138), a stent body coil (106), a radiopaque pusher body coil (134), a polymer tube (136) coupled to the pusher rod (138) between the stent body coil (106) and the pusher body coil (134), and a catheter (133) [0068-0074]. One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to substitute the delivery device taught by Vong to deliver the modified Rangwala stent, as the modification merely involves a substitution of one known stent delivery catheter for another that obtains predictable results.
In regards to claim 32, the phrase “…releasably coupled to the insertion device by friction between the two marking coils, the polymer tube, and an inner surface of the catheter” is a functional recitation that is not given full patentable weight. The modified Rangwala assembly comprises all the structural features and would have at least some degree of friction between the components in the delivery configuration. Rangwala teaches that the coils (132) are placed between bands (144 and 146) in the insertion configuration and assist in releasably coupling the stent to the insertion device. It would have been further obvious to position the coils of modified Rangwala such that they aid in releasably coupling the stent to the insertion device.
In regards to claim 33, the phrase “…configured to be resheathable into the catheter when approximately 90% or less of the braided body has been deployed outside the catheter” is a functional recitation that is not given full patentable weight. The prior art is not required to expressly recite resheathing of the stent, but merely have the capability of being manipulated in the recited manner to meet the claim requirement. The modified Rangwala assembly comprises all the structural features and would have at least some degree of friction between the components in the delivery configuration. Vong teaches the concept of resheathing the stent (can be retracted if it was not fully deployed [0074]). Therefore, it would have been further obvious to arrange components of the modified Rangwala device for resheathing, as taught by Vong, in order to aid in repositioning the stent. Modified Rangwala comprises all of the claimed structural components is therefore considered to be capable of being resheathed in a catheter when 90% or less of the body has been deployed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH WEBB ALEMAN whose telephone number is (571)272-5749. The examiner can normally be reached M, Tu, Th, Fr 9am - 3pm.
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/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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