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 .
Application Status
In order to clarify a typographical error in the previous office action, the Final Office action mailed 10/10/2025 has been replaced with this action.
Claim Objections
Claims 3 and 4 are objected to because of the following informalities: it is noted that the values/ranges recited in these claims are outside the range of claim 1. Appropriate correction is required.
Response to Arguments
Applicant's arguments filed 10/10/2025 have been fully considered but they are not persuasive. Applicant argues that the combination of Vong, Ringwala and Hossainy fail to render obvious the limitation that 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”. The Examiner recognizes a typographical error was made in the rejection of claim 1, and the rejection has been updated to address the correct claimed range.
Applicant argues that the claimed range is disclosed as having criticality, but the Examiner disagrees. The original specification 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 any particular braid density to the range of 0.3 – 0.5 N/mm resistive radial force. Applicant argues that the passage “…resistive radial force of the stent device 100 can be optimized to ensure that the stent device 100 remains patent following implantation with the stent device 100 applying excess pressure on the wall of the blood vessel within which the stent device 100 is implanted” is a disclosure of a critical range, but this passage only states a benefit of tailoring/ adjusting the resistive radial force for a particular blood vessel. The passage does not place criticality of the particular range of 0.3 N/mm to 0.5 mm/N alone or in combination with a braid density in a range of 15-21 PPI.
Applicant argues that Hossainy only discloses a radial strength in the range of 0.7 N/mm – 2 N/mm [0048], and therefore the claimed range of 0.3 N/mm to 0.5 mm/N is not rendered obvious by the prior art. The rejection below has been updated to clarify that Hossainy discloses various range for the radial strength of the stent, including that a stent may 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]. Therefore, one of ordinary skill in the art would have found it obvious to modify various parameters of the stent structure to achieve a resistive radial force of 0.3 -0.5 N/mm and the rejection under a combination of Vong, Ringwala, and Hossainy has been maintained.
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, 3-11 and 31-33 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent App. 2013/0245745 (Vong et al.) in view of US Patent App. Pub. No. 2021/0137715 (Ringwala et al.), and further in view of US Patent App. USPAP 2015/0081000 (Hossainy et al.).
Vong discloses a stent formed of a single braided wire (102) (abstract; [0052]) defining a flared crown at each end of the stent.
Vong fails to disclose that the single wire is a drawn filled tube. Vong does disclose marker bands (106) made from a radiopaque material [0060]. Ringwala teaches that forming a stent from a wire composed of drawn filled tube (DFT) provides the entire stent with radiopacity and eliminates the need for additional markers [0049]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to form the Vong stent from a single wire of drawn filled tube, as taught by Ringwala, as the modification merely involves a substitution of known materials for forming a stent in order to obtain the predictable result of a stent with radiopacity.
Vong does disclose the stent body diameter is in the range of 2-10 mm [0067] and the length is in the range of 30-100 mm [0065]. It is understood from the drawings that the crowns have a diameter larger than the body on the order of millimeters, but Vong fails to specify the unconstrained diameter of the crown is 1-2 mm larger than the diameter of the body. Vong sets forth that the diameter of a stent is a result effective variable, as Vong teaches the stent (100) preferably has a diameter sized for a vessel in the body [0067]. It would have been an obvious matter of design choice to configure the flared end of the modified Vong 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 Vong fails to disclose the braid density is 15 - 21 PPI (picks per square inch), Vong teaches that PPI is a result effective variable that achieves a desired porosity of the stent [0098-0099]. Hossainy discloses another stent formed from braided wires. Similar to Vong, 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 Vong 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 Vong 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”, Vong discloses the stent is oversized relative to the patient’s vessel so that it “pushes into”, or applies a chronic radial outward force to, the vessel [0100]. Vong discloses the stent (100) alone had an average radial force of 0.13 N and a dual layer stent had an average radial force of 0.26N [0097]. 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 Vong 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, Vong disclose the stent body diameter is in the range of 2-10 mm [0067], which Applicant has disclosed as suitable for cerebral dural venous sinus [0066].
Regarding claim 3: Vong teaches that the stent diameter is a result effective variable chosen relative to the patient’s vessel so that the stent “pushes into”, or applies a chronic radial outward force to, the vessel [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 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 Vong 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: Vong teaches that the stent diameter is a result effective variable chosen relative to the patient’s vessel so that the stent “pushes into”, or applies a chronic radial outward force to, the vessel [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 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 Vong 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 5: Vong discloses the stent length is 5-100 mm [0067], which encompasses the claimed range.
Regarding claim 6: Vong discloses the wire diameter is 0.001-0.01 inch [0076], which encompasses the claimed range.
Regarding claim 8: Vong discloses the stent length is 5-100 mm [0067], which encompasses the claimed range.
Regarding claim 9: Vong discloses the wire diameter is 0.001-0.01 inch [0076], which encompasses the claimed range.
In regards to claim 11: Vong discloses the stent may include at least one wire (106) wound about the stent body (102) at proximal and distal ends (see Figure 3; [0054-0061]). Since modified Vong is formed of a DFT wire, as taught by Ringwala, it would have been further obvious to form the coils (106) of the same material, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
It is noted that the phrase “configured to releasably couple the stent device to an insertion device” is a functional recitation that is not given full patentable weight. The prior art is not required to disclose an insertion device, as the insertion device is not positively recited here. Claim 1 is directed to a stent device only, and the insertion device is not positively recited as part of the stent device. Rather, it is recited as part of the manner in which the stent is intended to be used.
Nevertheless, Vong does disclose an insertion device (135) (see Figure 8; [0068]), wherein the coils (106) releasably couple with the insertion device [0072].
In regards to claims 31-33: since claim 11 does not positively recite an insertion device (it is only recited as part of the intended use of the stent), the limitations directed towards the structure of the insertion device are not given patentable weight. Claim 1 is directed towards a stent, and claim 11 only recites an insertion device as part of the intended use of the stent. The limitations regarding specific structures of the insertion device are not required to be disclosed by the prior art. Rather, the capability of the modified Vong stent to be coupled with such an insertion device meets the functional claim requirements.
Nevertheless, Vong discloses an insertion device with 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) and between the stent body coil (106) and the pusher body coil (134), and a catheter (133) [0068-0074].
In regards to claim 32, the phrase “…releasably coupled to the insertion device by friction between the at least one coil, the polymer tube, and an inner surface of the catheter” is a functional recitation that is not given full patentable weight. As explained above, the catheter is not positively recited and not required be disclosed by prior art in order to anticipate the claims. Claim 1 is directed towards a stent, and claim 11 only recites an insertion device as part of the intended use of the stent. Nevertheless, the stent of modified Vong is releasably coupled to the insertion device by friction between the coil (106), polymer tube (136) and inner surface of catheter (133).
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. As explained above, the catheter is not positively recited and not required be disclosed by prior art in order to anticipate the claims. Claim 1 is directed towards a stent, and claim 11 only recites an insertion device as part of the intended use of the stent. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Vong teaches the concept of resheathing the stent (can be retracted if it was not fully deployed [0074]). Therefore, the modified Vong stent is considered to be capable of being resheathed in a catheter when 90% or less of the body has been deployed.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/SARAH W ALEMAN/Primary Examiner, Art Unit 3774