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 .
DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of group I, claims 1-2, 4-5, 8-9, 11, 13-14 and 22-23, Fig. 2B in the reply filed on 05/20/2026 is acknowledged. Claim 6 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Thus, claims 1-2, 4-5, 8-9, 11, 13-14 and 22-23 are presently pending in this application.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 8-9, 11, 13-14 and 22-23 are rejected under 35 U.S.C. 102(a)(1) and 102 (a)(2) as being anticipated by Gill et al. (2013/0110253) “Gill”.
Regarding claims 1 and 11, Gill discloses a stent assembly 100 (Fig. 1) for implantation into a blood vessel (par. 0025), comprising: an inlet zone (proximal zone “alpha”; Fig. 1; par. 0033) including at least one inlet stent structure (struts 114; Fig. 1A), wherein the inlet stent structure is self-expanding (par. 0030 discloses a nitinol stent having shape memory, par. 0103 discloses stents expandable via removal of a sheath) and has an inlet radial force configured to at least partially conform to a non-circular cross-sectional shape of the vessel (par. 0024 discloses the stent can change shape in response to certain forces); and a patency zone (zone gamma; Fig. 1; par. 0033) having at least one patency stent structure (struts of annular portions 112; Fig. 1D) located distal of the inlet stent structure (zone gamma is located near distal end 104; Fig. 1), wherein the patency stent structure is self-expanding (par. 0030 discloses a nitinol stent having shape memory, par. 0103 discloses stents expandable via removal of a sheath) and has a patency radial force greater than the inlet radial force (par. 0033 discloses the gamma zone is harder than alpha zone and provides additional structure and support), and wherein the patency stent structure is coupled to the inlet stent structure such that the inlet stent structure is configured to be positioned upstream from a narrowing of a lumen along the blood vessel and the patency stent structure is configured to be positioned at the narrowing of the blood vessel lumen (the structural placement of the alpha zone and the distally located gamma zone is fully capable of performing this intended use when implanted in a narrowing lumen along a blood vessel);
a transition zone (beta zone; Fig. 1; par. 0033) between the inlet zone and the patency zone (Fig. 1), wherein the transition zone has a transition stent structure (Fig. 1D) having a transitional radial force greater than the inlet radial force of the inlet stent structure and less than the patency radial force of the patency stent structure (par. 0033 discloses the beta zone is an intermediate zone with properties falling between the alpha and gamma zones).
Regarding claim 8, Gill discloses wherein the patency stent structure has at least a generally circular cross-sectional shape in an unconstrained expanded state and a generally circular cross-sectional shape as it expands in contact with the blood vessel (par. 0029 discloses the stent including the patency or gamma zone has a cylindrical shape; Fig. 2B).
Regarding claim 9, Gill discloses wherein the patency radial force of the patency stent structure (gamma zone; Fig. 1) is configured to limit narrowing of the blood vessel when intracranial pressures increase that can cause extrinsic compression or enlargement of arachnoid granulations (the structure of the gamma zone provides additional structure and support to prevent deformation which is fully capable of performing this intended use depending on the implantation site).
Regarding claims 13-14, Gill discloses wherein the inlet stent structure comprises an inlet ring having struts and the patency stent structure comprises a patency ring having struts; and wherein the inlet stent structure comprises a plurality of inlet rings having struts and the patency stent structure comprises a plurality of patency rings having struts (inlet or alpha zone and patency or gamma zone have plurality of rings or annular portions 112; Figs. 1A and 1D).
Regarding claims 22-23, Gill discloses wherein the inlet stent structure is configured to be positioned in a superior sagittal sinus and the patency stent structure is configured to be positioned at least in part in a transverse sinus (the structure of the alpha and gamma zones are fully capable of performing this intended use depending on the implantation site); and wherein the patency zone includes at least one patency stent structure that is self-expanding (par. 0030 discloses a nitinol stent having shape memory, par. 0103 discloses stents expandable via removal of a sheath) and has a patency radial force configured to engage arachnoid granulations within a lumen of the blood vessel and expand to restore flow within the lumen of the blood vessel (the structure of the gamma zone is fully capable of performing this intended use depending on the implantation site; par. 0033).
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.
Claims 2 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Gill et al. (2013/0110253) “Gill” in view of Yachia et al. (2004/0167635) “Yachia”.
Regarding claim 2, Gill discloses the claimed invention of claim 1 including the inlet stent structure has at least a generally circular cross-sectional shape in an unconstrained expanded state and the patency stent structure has at least a generally circular cross-sectional shape in an unconstrained expanded state (par. 0029 and Fig. 2B disclose the stent including the alpha and gamma zones has a cylindrical shape); except for the inlet stent structure and the patency stent structure is configured to flex into a generally triangular shape as it expands in contact with the blood vessel. However, Yachia teaches a similar stent assembly 300 (Fig. 3A) having a stent structure configured to flex into a generally triangular shape as it expands in contact with the blood vessel (par. 0034 and Fig. 3A). It would have been an obvious matter of design choice to modify the stent in Gill to include the inlet stent structure and the patency stent structure is configured to flex into a generally triangular shape as it expands in contact with the blood vessel, since such a modification would have involved a mere change in the form or shape of a component to allow the stent to better conform to the anatomy at the implantation site (par. 0017 of Yachia). A change in form or shape is generally recognized as being within the level of ordinary skill in the art. MPEP 2144.04.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Gill et al. (2013/0110253) “Gill”.
Gill discloses the claimed invention of claim 1; except for wherein: the inlet radial force of the inlet stent structure is approximately 0.001 N/mm to 1.5 N/mm; and the patency radial force of the patency stent structure is approximately 0.3 N/mm to 2.0 N/mm. However, Gill does disclose inlet or alpha zone is softer and patency or gamma zone is harder and provides more structural support where each zone would obviously exhibit a certain radial force (par. 0033). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the inlet radial force of the inlet stent structure is approximately 0.001 N/mm to 1.5 N/mm; and the patency radial force of the patency stent structure is approximately 0.3 N/mm to 2.0 N/mm , since these are result effective variables that contribute to the overall expansion at the inlet and patency zones, 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. MPEP 2144.05.
Furthermore, since applicants have not disclosed that these modifications solve any stated problem or are for any particular purpose and it appears that the device would perform equally well with either designs, these modifications are a matter of design choice. Absent a teaching as to criticality, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. MPEP 2144.05.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YASHITA SHARMA whose telephone number is (571)270-5417. The examiner can normally be reached on 8am-5pm M-Th; 8am-4pm Fri (MT).
If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Jerrah Edwards, can be reached at 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YASHITA SHARMA/
Primary Examiner, Art Unit 3774
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