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 Amendment
This office action is responsive to the amendment filed on 03/06/2026. As directed by the amendment: claims 1, 18-20, and 24 have been amended, claims 9-10 have been cancelled and claims 25-28 have been added. Thus, claims 1-8 and 11-28 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see pages 10-11, filed 03/06/2026, with respect to the rejection(s) of claim(s) 1-8 and 11-12 under 35 U.S.C. 103 as being unpatentable over Lorenzo (US 20190192167 A1), herein referenced to as “Lorenzo” in view of Quick et al (US 20140005714 A1), herein referenced to as “Quick” have been fully considered and are persuasive.
The applicant has amended claims 1, 18-20, and 24 to further recite “wherein a diameter of the support in the expanded configuration increases until a maximum is reached at a distal end of the support without decreasing in diameter”.
This overcomes the prior art of Lorenzo in view of Quick as in Quick as the maximum diameter of the support is not at the distal end of the support is not reached without decreasing in diameter.
Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Lorenzo in view of Miles et al (US 20100324588 A1).
Claim Objections
Claims 27-28 are objected to because of the following informalities:
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27
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body
body.
28
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10%.
Appropriate correction is required.
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 nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-8 and 11-28 are rejected under 35 U.S.C. 103 as being unpatentable over Lorenzo (US 20190192167 A1), herein referenced to as “Lorenzo” in view of Miles et al (US 20100324588 A1), herein referenced to as “Miles”.
Claim 1
Lorenzo discloses: An intravascular device 10 (see Figs. 1A-5B, [0078]) comprising: an expandable body 12 (see Figs. 1A-5B, [0078]) having an expanded configuration (see Fig. 5B, [0080], expanded configuration) and a contracted configuration (see Fig. 1B, [0062], a collapsed configuration for delivery), said expandable body 12 in said expanded configuration (see Fig. 5B) having a convex semi-spherical curved shape (see Figs. 5A-5B, 12 has a convex semi-spherical curved shape) having a continuous arch shaped cross section (see Figs. 5A-5B, 12 has a continuous arch-shaped cross section); a support 13 (see Figs. 5A-5B, [0062]) which provides a double layer (see Figs. 5A-5B, 13 overlaps at portions over the neck of the aneurysm, providing a second or double layer) to at least a portion the portion of 12 over the neck of the aneurysm of said expandable body 12 a connector 44 (see Figs. 1A-5B, [0062]); wherein said connector 44 is attached to said expandable body 12 and to said support 13, wherein the support 13 is nested within a volume the interior volume of 12 (see Figs. 5A-5B, 13 is nested within the volume of 12 as designed by 14) of the expandable body 12.
Lorenzo does not explicitly disclose: wherein in the expanded configuration the support has a convex semi-spherical curved shape having a continuous arch shaped cross section, and the expandable body and the support are arranged as concentric and parallel semi-spherical curved shapes, wherein a shape of the support follows a shape of the expandable body excluding a region of support adjacent to the connector, wherein within the region, a distance between the support and the expandable body is larger than the distance between the support and the expandable body external to the region, wherein a diameter of the support in the expanded configuration increases until a maximum is reached at a distal end of the support without decreasing in diameter, wherein a length of the region is about 1-20% of a width of the intravascular device in the expanded configuration, wherein the width is measured perpendicular to a long axis of the intravascular device, wherein the length is measured from a first end of the support connected to the connector to an inflection point where a curve of the region changes from concave down to concave up, wherein the region is shaped and biased in a spring-like manner for the support to apply a radial force against the expandable body.
However, Lorenzo teaches in the same field of invention an intravascular device 10 (see Figs. 1A-5B) with a mesh body 12. Lorenzo further teaches: a mesh body 12 has a convex semi-spherical curved shape (see Figs. 5A-5B, 12 has a convex semi-spherical curved shape) having a continuous arch shaped cross section (see Figs. 5A-5B, 12 has a continuous arch-shaped cross section).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lorenzo to incorporate the teachings of Lorenzo and have the support has a convex semi-spherical curved shape having a continuous arch shaped cross section. Motivation for such can be found in Lorenzo as it is stated that elements 12 and 13 can take on any other shape shown in the figures (see [0063] and [0074], including generally spherical shapes).
Furthermore, In reDailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.).
Lorenzo as modified above further teaches: and the expandable body 12 and the support 13 are arranged as concentric (see Figs. 5A-5B, 12 and 13 are concentric, and as modified, 13 is a semi-spherical curved shape), and parallel semi-spherical cured shapes (see Figs. 5A-5B, 12 and 13 are parallel in alignment, and as modified, 13 is a semi-spherical curved shape).
Lorenzo does not explicitly teach: wherein a shape of the support follows a shape of the expandable body excluding a region of support adjacent to the connector, wherein within the region, a distance between the support and the expandable body is larger than the distance between the support and the expandable body external to the region, wherein a diameter of the support in the expanded configuration increases until a maximum is reached at a distal end of the support without decreasing in diameter, wherein a length of the region is about 1-20% of a width of the intravascular device in the expanded configuration, wherein the width is measured perpendicular to a long axis of the intravascular device, wherein the length is measured from a first end of the support connected to the connector to an inflection point where a curve of the region changes from concave down to concave up, wherein the region is shaped and biased in a spring-like manner for the support to apply a radial force against the expandable body.
However, Miles in a similar field of invention teaches an intravascular device 40 (see Figs. 1-5C) with an expandable body 54 + 48 (see Figs. 1-5C) and a support 52 (see Figs. 1-5C) with a connector 90 (see Figs. 1-5C). Miles further teaches: wherein a shape the shape of 52 (see Figs. 3A-5C) of the support 52 follows a shape the shape of 54 + 48 (see Figs. 3A-5C) of the expandable body 54 + 48 excluding a region (see annotated Fig. 5A below) of support 52 adjacent to the connector 90, wherein within the region (see annotated Fig. 5A below), a distance (see annotated Fig. 5A below) between the support 52 and the expandable body 54 + 48 is larger than the distance (see annotated Fig. 5A below) between the support 52 and the expandable body 54 + 48 external to the region (see annotated Fig. 5A below), wherein a diameter (see annotated Fig. 5A below) of the support 52 in the expanded configuration (see annotated Fig. 5A below) increases until a maximum (see annotated Fig. 5A below) is reached at a distal end (see annotated Fig. 5A below, the definition of “end” according to Merriam-Webster online dictionary being “the part of an area that lies at the area”, hence an end part as noted) of the support 52 without decreasing in diameter (see annotated Fig. 5A below), wherein a length (see annotated Fig. 5A below) of the region is about 1-20% of a width (see annotated Fig. 5A below) of the intravascular device 40 in the expanded configuration, wherein the width (see annotated Fig. 5A below) is measured perpendicular to a long axis (see annotated Fig. 5A below) of the intravascular device 40, wherein the length (see annotated Fig. 5A below) is measured from a first end (see annotated Fig. 5A below) of the support 52 connected to the connector 90 to an inflection point (see annotated Fig. 5A below) where a curve of the region changes from concave down to concave up (see annotated Fig. 5A below), wherein the region is shaped and biased in a spring-like manner (see annotated Fig. 5A below, the region is an “S”-like curve) for the support 52 to apply a radial force against the expandable body (see [0108], the expander portion/support 52 assists in expanding the expandable body 48, hence applying an outward radial force).
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It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the intravascular device of Lorenzo to incorporate the teachings of Miles and teach an intravascular device with a shape of the support follows a shape of the expandable body excluding a region of support adjacent to the connector, wherein within the region, a distance between the support and the expandable body is larger than the distance between the support and the expandable body external to the region, wherein a diameter of the support in the expanded configuration increases until a maximum is reached at a distal end of the support without decreasing in diameter, wherein a length of the region, a width of the intravascular device in the expanded configuration, wherein the width is measured perpendicular to a long axis of the intravascular device, wherein the length is measured from a first end of the support connected to the connector to an inflection point where a curve of the region changes from concave down to concave up, wherein the region is shaped and biased in a spring-like manner for the support to apply a radial force against the expandable body. Motivation for such can be found in Miles as this biases the expander portion/support to assist in expanding the tissue growth member/expandable body (see [0108]), which assists in sequential expansion of the device following collapse and repositioning to better occlude target volumes due to variability in sizes and shapes of vascular structures such as LAAs or aneurysms (see [0006]).
The combination of Lorenzo and Miles does not explicitly teach: the length of the region is about 1-20% of the width of the intravascular device in the expanded configuration.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Lorenzo and Miles to have the length of the region is about 1-20% of the width of the intravascular device in the expanded configuration since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Lorenzo and Miles would not operate differently with the length of the region is about 1-20% of the width of the intravascular device in the expanded configuration. Further, applicant places no criticality on the range claimed, (see [0801] of applicant’s patent application publication) which recites alternatives including 1-20%, 5-20%, and 5-10% showing alternatives which indicates the range is not critical and can be altered.
Claim 2
The combination of Lorenzo and Miles teaches: The device according to claim 1, see 103 rejection above. Lorenzo further discloses: wherein the intravascular device 10 is set for expanding the expandable body 12 prior to expansion (see Figs. 4A-5B, the expandable body 12 begins to expand first before the support 13, as 13 is contained within 12 and 12 needs to expand first) of the support 13.
Claim 3
The combination of Lorenzo and Miles teaches: The device according to claim 1, see 103 rejection above. Lorenzo further discloses: wherein said expandable body 12 joins said connector 44 from a proximal end proximal end of 44 (see Fig. 2, 12 joins 44 at the proximal end, it doesn’t contact 44 otherwise, see [0073], 16 the proximal end of 12 contacts 44) of said connector 44.
Claim 4
The combination of Lorenzo and Miles teaches: The device according to claim 1, see 103 rejection above. Lorenzo further discloses: wherein said support 13 joins said connector 44 from a distal end distal end of 44 (see Fig. 2, 13 joins 44 at the distal end of 44, [0078]) of said connector 44.
Claim 5
The combination of Lorenzo and Miles teaches: The device according to claim 1, see 103 rejection above. Lorenzo further discloses: wherein one or both of said expandable body 12 and said support 13 include mesh (see [0062], 12 and 13 are made of mesh, 10 is made of multiple self-expanding multi-filament segments).
Claim 6
The combination of Lorenzo and Miles teaches: The device according to claim 1, see 103 rejection above. Lorenzo further discloses: wherein said expandable body 12, in said expanded configuration (see Fig. 5B) is sufficiently resilient to resist collapse within an aneurysm A (see Fig. 5B, when 12 is expanded it is used to support to aneurysm wall so that it avoids rupture).
Claim 7
The combination of Lorenzo and Miles teaches: The device according to claim 1, see 103 rejection above. Lorenzo further discloses: wherein the semi-spherical curved shape (see Figs. 5A-5B, the curved shape of 12) having the continuous arch shaped cross section excludes a straight portion and/or a concave portion (the cross section is only convex, it does not have a straight portion and/or concave portion).
Claim 8
The combination of Lorenzo and Miles teaches: The device according to claim 1, see 103 rejection above. Lorenzo further discloses: wherein a distal end 14 (see Figs. 5A-5B, [0062]) of the expandable body 12 is open (see [0062], 14 is open) and a distal end 18 (see Figs. 5A-5B, [0062]) of the support 13 is open (see [0062], 18 is open) and non-connected (see Fig. 5B, 18 the distal end of 13 is not connected to 14, the distal end of 12) to the open distal end 14 of the expandable body 12.
Claim 11
The combination of Lorenzo and Miles teaches: The device according to claim 1, see 103 rejection above. Lorenzo further discloses: wherein the expandable body 12 and the support 13 are non-anchored at distal ends 14 and 18 (see Figs. 1A-1B and 5A-5B, [0062], the ends are not anchored together, and they are both open) thereof when in the contracted configuration (see [0062], collapsed state), and made of a flexible material mesh (see [0065], the material has flexibility) selected for navigation through tortuous vasculature (see [0083], the device can track through tortuous path through the vasculature).
Claim 12
The combination of Lorenzo and Miles teaches: The device according to claim 1, see 103 rejection above. Lorenzo does not explicitly disclose: wherein the connector includes radiopaque material.
However, Lorenzo teaches in the same field of invention an intravascular device 10 (see Figs. 1A-5B). Lorenzo further teaches with using radiopaque material for visualization (see [0067]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lorenzo to incorporate the teachings of Lorenzo and have wherein the connector includes radiopaque material. Motivation for such can be found in Lorenzo, as the connector 44 is used for tracking (see [0077]) and radiopacity would assist a surgeon in tracking (see [0067]).
Furthermore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lorenzo to incorporate the teachings of Lorenzo and have the connector (described within the specification as a tracking marker band which in the art is commonly a radiopaque marker band) with a radiopaque material (i.e. nitinol). This is due to using radiopaque material for marker bands is common in the art, thus it would be obvious to combine. See in re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960) (2100).
Claim 13
The combination of Lorenzo and Miles teaches: The device according to claim 1, see 103 rejection above. Lorenzo further discloses: wherein the connector 44 is configured for releasably connecting (see Figs. 5A-5B, [0081] and [0073], 54 is connected to 44 by 16, and when 54 is released from 30, 44 is also released), to a push wire 30 (see Figs. 1A-5B, [0081]).
Claim 14
The combination of Lorenzo and Miles teaches: The device according to claim 1, see 103 rejection above. Lorenzo further discloses: wherein distal ends 18 (see Figs. 5A-5B, [0078]) of the support 13 extend past distal ends 14 (see Figs. 5A-5B, [0078]) of the expandable body 12.
Claim 15
The combination of Lorenzo and Miles teaches: The device according to claim 1, see 103 rejection above. Lorenzo further discloses: wherein the expandable body 12 and the support 13 each include 72-288 wires (see [0064], 12 and 13 have between 4 to 96 wires which overlaps with 72 – 288 wires, hence 12 and 13 having 96 wires is within 72 -288 wires).
Claim 16
The combination of Lorenzo and Miles teaches: The device according to claim 1, see 103 rejection above. The combination of Lorenzo and Miles does not explicitly teach: wherein porosity of the intravascular device in the expanded configuration, by the expandable body and the support, is 60-75%.
As noted in Lorenzo it is necessary for the braided mesh of the segments of 12 and 13 to flexibly conform to a plurality of different shaped aneurysms (see [0064]). This correlates to porosity of the mesh and as such the porosity of the intravascular device in the expanded configuration is 60-75% is considered to be a result effective variable since the porosity directly affects the ability to conform to a plurality of different shaped aneurysms (see [0064]). Therefore, 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 device of Lorenzo by causing the porosity of the intravascular device in the expanded configuration is 60-75% as a matter of routine optimization since it has been held that ‘where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235, (CCPA 1955).
Claim 17
The combination of Lorenzo and Miles teaches: The device according to claim 1, see 103 rejection above. Lorenzo further discloses: wherein said connector 44 is attached (see Figs. 1-5B, 44 is attached to 12 at 16, and is attached to the proximal end of 13) to said expandable body 12 and to said support 13 and positioned within a center the center of the semi-spherical curved of 12 (see Figs. 5A-5B) of the convex semi-spherical curved shape (see Figs. 5A-5B).
Claim 18
Lorenzo discloses: An intravascular device 10 (see Figs. 1A-5B, [0078]) comprising: an expandable body 12 (see Figs. 1A-5B, [0078]) having an expanded configuration (see Fig. 5B, [0080], expanded configuration) and a contracted configuration (see Fig. 1B, [0062], a collapsed configuration for delivery), said expandable body 12 in said expanded configuration (see Fig. 5B) having a convex curved shape (see Figs. 5A-5B, 12 has a convex semi-spherical curved shape); a support 13 (see Figs. 5A-5B, [0062]) which provides a double layer (see Figs. 5A-5B, 13 overlaps at portions over the neck of the aneurysm, providing a second or double layer) to at least a portion the portion of 12 over the neck of the aneurysm of said expandable body 12; and a connector 44 (see Figs. 1A-5B, [0062]), wherein said expandable body 12 joins said connector 44 from a proximal end proximal end of 44 (see Fig. 2, 12 joins 44 at the proximal end, it doesn’t contact 44 otherwise, see [0073], 16 the proximal end of 12 contacts 44) of said connector 44, wherein said support 13 joins said connector 44 from a distal end distal end of 44 (see Fig. 2, 13 joins 44 at the distal end of 44, [0078]) of said connector 44; and wherein said connector 44 is attached to said expandable body 12 and to said support 13, wherein the support 13 is nested within a volume the interior volume of 12 (see Figs. 5A-5B, 13 is nested within the volume of 12 as designed by 14) of the expandable body 12.
Lorenzo does not explicitly disclose: wherein in the expanded configuration the support has a convex semi-spherical curved shape having a continuous arch shaped cross section, and the expandable body and the support are arranged as concentric and parallel semi-spherical curved shapes, wherein a shape of the support follows a shape of the expandable body excluding a region of support adjacent to the connector, wherein within the region, a distance between the support and the expandable body is larger than the distance between the support and the expandable body external to the region, wherein a diameter of the support in the expanded configuration increases until a maximum is reached at a distal end of the support without decreasing in diameter, wherein a length of the region is about 1-20% of a width of the intravascular device in the expanded configuration, wherein the width is measured perpendicular to a long axis of the intravascular device, wherein the length is measured from a first end of the support connected to the connector to an inflection point where a curve of the region changes from concave down to concave up, wherein the region is shaped and biased in a spring-like manner for the support to apply a radial force against the expandable body.
However, Lorenzo teaches in the same field of invention an intravascular device 10 (see Figs. 1A-5B) with a mesh body 12. Lorenzo further teaches: a mesh body 12 has a convex semi-spherical curved shape (see Figs. 5A-5B, 12 has a convex semi-spherical curved shape) having a continuous arch shaped cross section (see Figs. 5A-5B, 12 has a continuous arch-shaped cross section).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lorenzo to incorporate the teachings of Lorenzo and have the support has a convex semi-spherical curved shape having a continuous arch shaped cross section. Motivation for such can be found in Lorenzo as it is stated that elements 12 and 13 can take on any other shape shown in the figures (see [0063] and [0074], including generally spherical shapes).
Furthermore, In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.).
Lorenzo as modified above further teaches: and the expandable body 12 and the support 13 are arranged as concentric (see Figs. 5A-5B, 12 and 13 are concentric, and as modified, 13 is a semi-spherical curved shape), and parallel semi-spherical cured shapes (see Figs. 5A-5B, 12 and 13 are parallel in alignment, and as modified, 13 is a semi-spherical curved shape).
Lorenzo does not explicitly teach: wherein a shape of the support follows a shape of the expandable body excluding a region of support adjacent to the connector, wherein within the region, a distance between the support and the expandable body is larger than the distance between the support and the expandable body external to the region, wherein a diameter of the support in the expanded configuration increases until a maximum is reached at a distal end of the support without decreasing in diameter, wherein a length of the region is about 1-20% of a width of the intravascular device in the expanded configuration, wherein the width is measured perpendicular to a long axis of the intravascular device, wherein the length is measured from a first end of the support connected to the connector to an inflection point where a curve of the region changes from concave down to concave up, wherein the region is shaped and biased in a spring-like manner for the support to apply a radial force against the expandable body.
However, Miles in a similar field of invention teaches an intravascular device 40 (see Figs. 1-5C) with an expandable body 54 + 48 (see Figs. 1-5C) and a support 52 (see Figs. 1-5C) with a connector 90 (see Figs. 1-5C). Miles further teaches: wherein a shape the shape of 52 (see Figs. 3A-5C) of the support 52 follows a shape the shape of 54 + 48 (see Figs. 3A-5C) of the expandable body 54 + 48 excluding a region (see annotated Fig. 5A below) of support 52 adjacent to the connector 90, wherein within the region (see annotated Fig. 5A below), a distance (see annotated Fig. 5A below) between the support 52 and the expandable body 54 + 48 is larger than the distance (see annotated Fig. 5A below) between the support 52 and the expandable body 54 + 48 external to the region (see annotated Fig. 5A below), wherein a diameter (see annotated Fig. 5A below) of the support 52 in the expanded configuration (see annotated Fig. 5A below) increases until a maximum (see annotated Fig. 5A below) is reached at a distal end (see annotated Fig. 5A below, the definition of “end” according to Merriam-Webster online dictionary being “the part of an area that lies at the area”, hence an end part as noted) of the support 52 without decreasing in diameter (see annotated Fig. 5A below), wherein a length (see annotated Fig. 5A below) of the region is about 1-20% of a width (see annotated Fig. 5A below) of the intravascular device 40 in the expanded configuration, wherein the width (see annotated Fig. 5A below) is measured perpendicular to a long axis (see annotated Fig. 5A below) of the intravascular device 40, wherein the length (see annotated Fig. 5A below) is measured from a first end (see annotated Fig. 5A below) of the support 52 connected to the connector 90 to an inflection point (see annotated Fig. 5A below) where a curve of the region changes from concave down to concave up (see annotated Fig. 5A below), wherein the region is shaped and biased in a spring-like manner (see annotated Fig. 5A below, the region is an “S”-like curve) for the support 52 to apply a radial force against the expandable body (see [0108], the expander portion/support 52 assists in expanding the expandable body 48, hence applying an outward radial force).
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It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the intravascular device of Lorenzo to incorporate the teachings of Miles and teach an intravascular device with a shape of the support follows a shape of the expandable body excluding a region of support adjacent to the connector, wherein within the region, a distance between the support and the expandable body is larger than the distance between the support and the expandable body external to the region, wherein a diameter of the support in the expanded configuration increases until a maximum is reached at a distal end of the support without decreasing in diameter, wherein a length of the region, a width of the intravascular device in the expanded configuration, wherein the width is measured perpendicular to a long axis of the intravascular device, wherein the length is measured from a first end of the support connected to the connector to an inflection point where a curve of the region changes from concave down to concave up, wherein the region is shaped and biased in a spring-like manner for the support to apply a radial force against the expandable body. Motivation for such can be found in Miles as this biases the expander portion/support to assist in expanding the tissue growth member/expandable body (see [0108]), which assists in sequential expansion of the device following collapse and repositioning to better occlude target volumes due to variability in sizes and shapes of vascular structures such as LAAs or aneurysms (see [0006]).
The combination of Lorenzo and Miles does not explicitly teach: the length of the region is about 1-20% of the width of the intravascular device in the expanded configuration.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Lorenzo and Miles to have the length of the region is about 1-20% of the width of the intravascular device in the expanded configuration since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Lorenzo and Miles would not operate differently with the length of the region is about 1-20% of the width of the intravascular device in the expanded configuration. Further, applicant places no criticality on the range claimed, (see [0801] of applicant’s patent application publication) which recites alternatives including 1-20%, 5-20%, and 5-10% showing alternatives which indicates the range is not critical and can be altered.
Claim 19
Lorenzo discloses: An intravascular device 10 (see Figs. 1A-5B, [0078]) comprising: an expandable body 12 (see Figs. 1A-5B, [0078]) having an expanded configuration (see Fig. 5B, [0080], expanded configuration) and a contracted configuration (see Fig. 1B, [0062], a collapsed configuration for delivery), said expandable body 12 in said expanded configuration (see Fig. 5B) having a convex curved shape (see Figs. 5A-5B, 12 has a convex semi-spherical curved shape); a support 13 (see Figs. 5A-5B, [0062]) which provides a double layer (see Figs. 5A-5B, 13 overlaps at portions over the neck of the aneurysm, providing a second or double layer) to at least a portion the portion of 12 over the neck of the aneurysm of said expandable body 12 a connector 44 (see Figs. 1A-5B, [0062]) connected to the expandable body 12 and to the support 13; wherein said connector 44 is attached to said expandable body 12 and recessed (see Figs. 5A-5B, 44 is within the curved shape in 12) within said convex curved shape (see Figs. 5A-5B), wherein a distal end 14 (see Figs. 5A-5B, [0062]) of the expandable body 12 is open (see [0062], 14 is open) and a distal end 18 (see Figs. 5A-5B, [0062]) of the support 13 is open (see [0062], 18 is open) and non-connected (see Fig. 5B, 18 the distal end of 13 is not connected to 14, the distal end of 12) to the open distal end 14 of the expandable body 12, wherein the support 13 is nested within a volume the interior volume of 12 (see Figs. 5A-5B, 13 is nested within the volume of 12 as designed by 14) of the expandable body 12.
Lorenzo does not explicitly disclose: wherein in the expanded configuration the support has a convex semi-spherical curved shape having a continuous arch shaped cross section, and the expandable body and the support are arranged as concentric and parallel semi-spherical curved shapes, wherein a shape of the support follows a shape of the expandable body excluding a region of support adjacent to the connector, wherein within the region, a distance between the support and the expandable body is larger than the distance between the support and the expandable body external to the region, wherein a diameter of the support in the expanded configuration increases until a maximum is reached at a distal end of the support without decreasing in diameter, wherein a length of the region is about 1-20% of a width of the intravascular device in the expanded configuration, wherein the width is measured perpendicular to a long axis of the intravascular device, wherein the length is measured from a first end of the support connected to the connector to an inflection point where a curve of the region changes from concave down to concave up, wherein the region is shaped and biased in a spring-like manner for the support to apply a radial force against the expandable body.
However, Lorenzo teaches in the same field of invention an intravascular device 10 (see Figs. 1A-5B) with a mesh body 12. Lorenzo further teaches: a mesh body 12 has a convex semi-spherical curved shape (see Figs. 5A-5B, 12 has a convex semi-spherical curved shape) having a continuous arch shaped cross section (see Figs. 5A-5B, 12 has a continuous arch-shaped cross section).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lorenzo to incorporate the teachings of Lorenzo and have the support has a convex semi-spherical curved shape having a continuous arch shaped cross section.
Motivation for such can be found in Lorenzo as it is stated that elements 12 and 13 can take on any other shape shown in the figures (see [0063] and [0074], including generally spherical shapes).
Furthermore, In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.).
Lorenzo as modified above further teaches: and the expandable body 12 and the support 13 are arranged as concentric (see Figs. 5A-5B, 12 and 13 are concentric, and as modified, 13 is a semi-spherical curved shape), and parallel semi-spherical cured shapes (see Figs. 5A-5B, 12 and 13 are parallel in alignment, and as modified, 13 is a semi-spherical curved shape).
Lorenzo does not explicitly teach: wherein a shape of the support follows a shape of the expandable body excluding a region of support adjacent to the connector, wherein within the region, a distance between the support and the expandable body is larger than the distance between the support and the expandable body external to the region, wherein a diameter of the support in the expanded configuration increases until a maximum is reached at a distal end of the support without decreasing in diameter, wherein a length of the region is about 1-20% of a width of the intravascular device in the expanded configuration, wherein the width is measured perpendicular to a long axis of the intravascular device, wherein the length is measured from a first end of the support connected to the connector to an inflection point where a curve of the region changes from concave down to concave up, wherein the region is shaped and biased in a spring-like manner for the support to apply a radial force against the expandable body.
However, Miles in a similar field of invention teaches an intravascular device 40 (see Figs. 1-5C) with an expandable body 54 + 48 (see Figs. 1-5C) and a support 52 (see Figs. 1-5C) with a connector 90 (see Figs. 1-5C). Miles further teaches: wherein a shape the shape of 52 (see Figs. 3A-5C) of the support 52 follows a shape the shape of 54 + 48 (see Figs. 3A-5C) of the expandable body 54 + 48 excluding a region (see annotated Fig. 5A below) of support 52 adjacent to the connector 90, wherein within the region (see annotated Fig. 5A below), a distance (see annotated Fig. 5A below) between the support 52 and the expandable body 54 + 48 is larger than the distance (see annotated Fig. 5A below) between the support 52 and the expandable body 54 + 48 external to the region (see annotated Fig. 5A below), wherein a diameter (see annotated Fig. 5A below) of the support 52 in the expanded configuration (see annotated Fig. 5A below) increases until a maximum (see annotated Fig. 5A below) is reached at a distal end (see annotated Fig. 5A below, the definition of “end” according to Merriam-Webster online dictionary being “the part of an area that lies at the area”, hence an end part as noted) of the support 52 without decreasing in diameter (see annotated Fig. 5A below), wherein a length (see annotated Fig. 5A below) of the region is about 1-20% of a width (see annotated Fig. 5A below) of the intravascular device 40 in the expanded configuration, wherein the width (see annotated Fig. 5A below) is measured perpendicular to a long axis (see annotated Fig. 5A below) of the intravascular device 40, wherein the length (see annotated Fig. 5A below) is measured from a first end (see annotated Fig. 5A below) of the support 52 connected to the connector 90 to an inflection point (see annotated Fig. 5A below) where a curve of the region changes from concave down to concave up (see annotated Fig. 5A below), wherein the region is shaped and biased in a spring-like manner (see annotated Fig. 5A below, the region is an “S”-like curve) for the support 52 to apply a radial force against the expandable body (see [0108], the expander portion/support 52 assists in expanding the expandable body 48, hence applying an outward radial force).
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It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the intravascular device of Lorenzo to incorporate the teachings of Miles and teach an intravascular device with a shape of the support follows a shape of the expandable body excluding a region of support adjacent to the connector, wherein within the region, a distance between the support and the expandable body is larger than the distance between the support and the expandable body external to the region, wherein a diameter of the support in the expanded configuration increases until a maximum is reached at a distal end of the support without decreasing in diameter, wherein a length of the region, a width of the intravascular device in the expanded configuration, wherein the width is measured perpendicular to a long axis of the intravascular device, wherein the length is measured from a first end of the support connected to the connector to an inflection point where a curve of the region changes from concave down to concave up, wherein the region is shaped and biased in a spring-like manner for the support to apply a radial force against the expandable body. Motivation for such can be found in Miles as this biases the expander portion/support to assist in expanding the tissue growth member/expandable body (see [0108]), which assists in sequential expansion of the device following collapse and repositioning to better occlude target volumes due to variability in sizes and shapes of vascular structures such as LAAs or aneurysms (see [0006]).
The combination of Lorenzo and Miles does not explicitly teach: the length of the region is about 1-20% of the width of the intravascular device in the expanded configuration.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Lorenzo and Miles to have the length of the region is about 1-20% of the width of the intravascular device in the expanded configuration since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Lorenzo and Miles would not operate differently with the length of the region is about 1-20% of the width of the intravascular device in the expanded configuration. Further, applicant places no criticality on the range claimed, (see [0801] of applicant’s patent application publication) which recites alternatives including 1-20%, 5-20%, and 5-10% showing alternatives which indicates the range is not critical and can be altered.
Claim 20
Lorenzo discloses: An intravascular device 10 (see Figs. 1A-5B, [0078]) comprising: an expandable body 12 (see Figs. 1A-5B, [0078]) having an expanded configuration see Fig. 5B, [0080], expanded configuration) and a contracted configuration (see Fig. 1B, [0062], a collapsed configuration for delivery), said expandable body 12 in said expanded configuration (see Fig. 5B) having a convex semi-spherical curved shape (see Figs. 5A-5B, 12 has a convex semi-spherical curved shape); a support 13 (see Figs. 5A-5B, [0062]) which provides a double layer (see Figs. 5A-5B, 13 overlaps at portions over the neck of the aneurysm, providing a second or double layer) to at least a portion the portion of 12 over the neck of the aneurysm of said expandable body 12; and a connector 44 (see Figs. 1A-5B, [0062]) connected to the expandable body 12 and to the support 13 (see Figs. 5A-5B, 44 is connected to both 12 and 13); wherein the intravascular device 10 is set for expanding the expandable body 12 prior to expansion (see Figs. 4A-5B, the expandable body 12 begins to expand first before the support 13, as 13 is contained within 12 and 12 needs to expand first) of the support 13, wherein the support 13 is nested within a volume the interior volume of 12 (see Figs. 5A-5B, 13 is nested within the volume of 12 as designed by 14) of the expandable body 12.
Lorenzo does not explicitly disclose: wherein in the expanded configuration the support has a convex semi-spherical curved shape having a continuous arch shaped cross section, and the expandable body and the support are arranged as concentric and parallel semi-spherical curved shapes, wherein a shape of the support follows a shape of the expandable body excluding a region of support adjacent to the connector, wherein within the region, a distance between the support and the expandable body is larger than the distance between the support and the expandable body external to the region, wherein a diameter of the support in the expanded configuration increases until a maximum is reached at a distal end of the support without decreasing in diameter, wherein a length of the region is about 1-20% of a width of the intravascular device in the expanded configuration, wherein the width is measured perpendicular to a long axis of the intravascular device, wherein the length is measured from a first end of the support connected to the connector to an inflection point where a curve of the region changes from concave down to concave up, wherein the region is shaped and biased in a spring-like manner for the support to apply a radial force against the expandable body.
However, Lorenzo teaches in the same field of invention an intravascular device 10 (see Figs. 1A-5B) with a mesh body 12. Lorenzo further teaches: a mesh body 12 has a convex semi-spherical curved shape (see Figs. 5A-5B, 12 has a convex semi-spherical curved shape) having a continuous arch shaped cross section (see Figs. 5A-5B, 12 has a continuous arch-shaped cross section).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lorenzo to incorporate the teachings of Lorenzo and have the support has a convex semi-spherical curved shape having a continuous arch shaped cross section. Motivation for such can be found in Lorenzo as it is stated that elements 12 and 13 can take on any other shape shown in the figures (see [0063] and [0074], including generally spherical shapes).
Furthermore, In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.).
Lorenzo as modified above further teaches: and the expandable body 12 and the support 13 are arranged as concentric (see Figs. 5A-5B, 12 and 13 are concentric, and as modified, 13 is a semi-spherical curved shape), and parallel semi-spherical cured shapes (see Figs. 5A-5B, 12 and 13 are parallel in alignment, and as modified, 13 is a semi-spherical curved shape).
Lorenzo does not explicitly teach: wherein a shape of the support follows a shape of the expandable body excluding a region of support adjacent to the connector, wherein within the region, a distance between the support and the expandable body is larger than the distance between the support and the expandable body external to the region, wherein a diameter of the support in the expanded configuration increases until a maximum is reached at a distal end of the support without decreasing in diameter, wherein a length of the region is about 1-20% of a width of the intravascular device in the expanded configuration, wherein the width is measured perpendicular to a long axis of the intravascular device, wherein the length is measured from a first end of the support connected to the connector to an inflection point where a curve of the region changes from concave down to concave up, wherein the region is shaped and biased in a spring-like manner for the support to apply a radial force against the expandable body.
However, Miles in a similar field of invention teaches an intravascular device 40 (see Figs. 1-5C) with an expandable body 54 + 48 (see Figs. 1-5C) and a support 52 (see Figs. 1-5C) with a connector 90 (see Figs. 1-5C). Miles further teaches: wherein a shape the shape of 52 (see Figs. 3A-5C) of the support 52 follows a shape the shape of 54 + 48 (see Figs. 3A-5C) of the expandable body 54 + 48 excluding a region (see annotated Fig. 5A below) of support 52 adjacent to the connector 90, wherein within the region (see annotated Fig. 5A below), a distance (see annotated Fig. 5A below) between the support 52 and the expandable body 54 + 48 is larger than the distance (see annotated Fig. 5A below) between the support 52 and the expandable body 54 + 48 external to the region (see annotated Fig. 5A below), wherein a diameter (see annotated Fig. 5A below) of the support 52 in the expanded configuration (see annotated Fig. 5A below) increases until a maximum (see annotated Fig. 5A below) is reached at a distal end (see annotated Fig. 5A below, the definition of “end” according to Merriam-Webster online dictionary being “the part of an area that lies at the area”, hence an end part as noted) of the support 52 without decreasing in diameter (see annotated Fig. 5A below), wherein a length (see annotated Fig. 5A below) of the region is about 1-20% of a width (see annotated Fig. 5A below) of the intravascular device 40 in the expanded configuration, wherein the width (see annotated Fig. 5A below) is measured perpendicular to a long axis (see annotated Fig. 5A below) of the intravascular device 40, wherein the length (see annotated Fig. 5A below) is measured from a first end (see annotated Fig. 5A below) of the support 52 connected to the connector 90 to an inflection point (see annotated Fig. 5A below) where a curve of the region changes from concave down to concave up (see annotated Fig. 5A below), wherein the region is shaped and biased in a spring-like manner (see annotated Fig. 5A below, the region is an “S”-like curve) for the support 52 to apply a radial force against the expandable body (see [0108], the expander portion/support 52 assists in expanding the expandable body 48, hence applying an outward radial force).
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It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the intravascular device of Lorenzo to incorporate the teachings of Miles and teach an intravascular device with a shape of the support follows a shape of the expandable body excluding a region of support adjacent to the connector, wherein within the region, a distance between the support and the expandable body is larger than the distance between the support and the expandable body external to the region, wherein a diameter of the support in the expanded configuration increases until a maximum is reached at a distal end of the support without decreasing in diameter, wherein a length of the region, a width of the intravascular device in the expanded configuration, wherein the width is measured perpendicular to a long axis of the intravascular device, wherein the length is measured from a first end of the support connected to the connector to an inflection point where a curve of the region changes from concave down to concave up, wherein the region is shaped and biased in a spring-like manner for the support to apply a radial force against the expandable body. Motivation for such can be found in Miles as this biases the expander portion/support to assist in expanding the tissue growth member/expandable body (see [0108]), which assists in sequential expansion of the device following collapse and repositioning to better occlude target volumes due to variability in sizes and shapes of vascular structures such as LAAs or aneurysms (see [0006]).
The combination of Lorenzo and Miles does not explicitly teach: the length of the region is about 1-20% of the width of the intravascular device in the expanded configuration.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Lorenzo and Miles to have the length of the region is about 1-20% of the width of the intravascular device in the expanded configuration since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Lorenzo and Miles would not operate differently with the length of the region is about 1-20% of the width of the intravascular device in the expanded configuration. Further, applicant places no criticality on the range claimed, (see [0801] of applicant’s patent application publication) which recites alternatives including 1-20%, 5-20%, and 5-10% showing alternatives which indicates the range is not critical and can be altered.
Claim 21
The combination of Lorenzo and Miles teaches: The intravascular device according to claim 1, see 103 rejection above. Miles further teaches: wherein in the expanded configuration (see annotated Fig. 5A below) the shape of the region (see annotated Fig. 5A below) of the support 52 is arranged as a substantially horizontal "S" (see annotated Fig. 5A below), wherein a first curve of the "S" (see annotated Fig. 5A below) is attached to the connector 90 and a second curve of the "S" (see annotated Fig. 5A below)is integrated with the arch shaped cross section the arch-shaped cross section of 52, wherein the "S" extends radially from the connector 90 and is rotated around the connector 90 (see Fig. 5C, the S is rotated to be symmetrical around the connector).
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Claim 22
The combination of Lorenzo and Miles teaches: The intravascular device according to claim 1, see 103 rejection above. Lorenzo further discloses: wherein a material the material of 12 (see Fig. 1A) of the expandable body 12 enters into the connector 44 in a first direction (see annotated Fig. 1A below) and a material the material of 13 of the support 13 enters into the connector 44 in a second direction (see annotated Fig. 1A below), wherein the first direction and the second direction are generally opposite at about 180 degrees to each other (see annotated Fig. 1A below).
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Claim 23
The combination of Lorenzo and Miles teaches: The intravascular device according to claim 1, see 103 rejection above. Miles further teaches: wherein in use when the intravascular device is deployed in an aneurysm, the support including the region and the expandable body are designed to direct an applied force towards a region in proximity to a neck of the aneurysm.
The language, "wherein in use when the intravascular device is deployed in an aneurysm, the support including the region and the expandable body are designed to direct an applied force towards a region in proximity to a neck of the aneurysm," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Lorenzo and Miles meets the structural limitations of the claim, and is capable of the support including the region when in the expanded form to apply a radially outward force towards the region proximate to the neck of the aneurysm as the support including its region is designed to assist in radial expansion (see [0108] of Miles).
Furthermore, wherein in product and apparatus claims, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See MPEP 2112.01 I.
Claim 24
Lorenzo discloses: An intravascular device 10 (see Figs. 1A-5B, [0078]) comprising: an expandable body 12 (see Figs. 1A-5B, [0078]) having an expanded configuration see Fig. 5B, [0080], expanded configuration) and a contracted configuration (see Fig. 1B, [0062], a collapsed configuration for delivery), said expandable body 12 in said expanded configuration (see Fig. 5B) having a convex semi-spherical curved shape (see Figs. 5A-5B, 12 has a convex semi-spherical curved shape) having a continuous arch shaped cross section (see Figs. 5A-5B, 12 has a continuous arch-shaped cross section); a support 13 (see Figs. 5A-5B, [0062]) which provides a double layer (see Figs. 5A-5B, 13 overlaps at portions over the neck of the aneurysm, providing a second or double layer) to at least a portion the portion of 12 over the neck of the aneurysm of said expandable body 12; and a connector 44 (see Figs. 1A-5B, [0062]) connected to the expandable body 12 and to the support 13 (see Figs. 5A-5B, 44 is connected to both 12 and 13); wherein the intravascular device 10 is set for expanding the expandable body 12 prior to expansion (see Figs. 4A-5B, the expandable body 12 begins to expand first before the support 13, as 13 is contained within 12 and 12 needs to expand first) of the support 13, wherein the support 13 is nested within a volume the interior volume of 12 (see Figs. 5A-5B, 13 is nested within the volume of 12 as designed by 14) of the expandable body 12.
Lorenzo does not explicitly disclose: the expandable body and the support are arranged as concentric and parallel semi-spherical curved shapes, wherein a shape of the support follows a shape of the expandable body excluding a region of support adjacent to the connector, wherein within the region, a distance between the support and the expandable body is larger than the distance between the support and the expandable body external to the region, wherein the region is shaped and biased in a spring-like manner for the support to apply a radial force against the expandable body, wherein a diameter of the support inf the expanded configuration increases until a maximum is reached at a distal end of the support without decreasing in diameter.
However, Lorenzo teaches in the same field of invention an intravascular device 10 (see Figs. 1A-5B) with a mesh body 12. Lorenzo further teaches: a mesh body 12 has a convex semi-spherical curved shape (see Figs. 5A-5B, 12 has a convex semi-spherical curved shape) having a continuous arch shaped cross section (see Figs. 5A-5B, 12 has a continuous arch-shaped cross section).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lorenzo to incorporate the teachings of Lorenzo and have the support has a convex semi-spherical curved shape having a continuous arch shaped cross section. Motivation for such can be found in Lorenzo as it is stated that elements 12 and 13 can take on any other shape shown in the figures (see [0063] and [0074], including generally spherical shapes).
Furthermore, In reDailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.).
Lorenzo as modified above further teaches: and the expandable body 12 and the support 13 are arranged as concentric (see Figs. 5A-5B, 12 and 13 are concentric, and as modified, 13 is a semi-spherical curved shape), and parallel semi-spherical cured shapes (see Figs. 5A-5B, 12 and 13 are parallel in alignment, and as modified, 13 is a semi-spherical curved shape).
Lorenzo does not explicitly teach: wherein a shape of the support follows a shape of the expandable body excluding a region of support adjacent to the connector, wherein within the region, a distance between the support and the expandable body is larger than the distance between the support and the expandable body external to the region, wherein the region is shaped and biased in a spring-like manner for the support to apply a radial force against the expandable body, wherein a diameter of the support inf the expanded configuration increases until a maximum is reached at a distal end of the support without decreasing in diameter.
However, Miles in a similar field of invention teaches an intravascular device 40 (see Figs. 1-5C) with an expandable body 54 + 48 (see Figs. 1-5C) and a support 52 (see Figs. 1-5C) with a connector 90 (see Figs. 1-5C). Miles further teaches: wherein a shape the shape of 52 (see Figs. 3A-5C) of the support 52 follows a shape the shape of 54 + 48 (see Figs. 3A-5C) of the expandable body 54 + 48 excluding a region (see annotated Fig. 5A below) of support 52 adjacent to the connector 90, wherein within the region (see annotated Fig. 5A below), a distance (see annotated Fig. 5A below) between the support 52 and the expandable body 54 + 48 is larger than the distance (see annotated Fig. 5A below) between the support 52 and the expandable body 54 + 48 external to the region (see annotated Fig. 5A below), wherein the region is shaped and biased in a spring-like manner (see annotated Fig. 5A below, the region is an “S”-like curve) for the support 52 to apply a radial force against the expandable body (see [0108], the expander portion/support 52 assists in expanding the expandable body 48, hence applying an outward radial force), wherein a diameter (see annotated Fig. 5A below) of the support 52 in the expanded configuration (see annotated Fig. 5A below) increases until a maximum (see annotated Fig. 5A below) is reached at a distal end (see annotated Fig. 5A below, the definition of “end” according to Merriam-Webster online dictionary being “the part of an area that lies at the area”, hence an end part as noted) of the support 52 without decreasing in diameter (see annotated Fig. 5A below).
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It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the intravascular device of Lorenzo to incorporate the teachings of Miles and teach an intravascular device with a shape of the support follows a shape of the expandable body excluding a region of support adjacent to the connector, wherein within the region, a distance between the support and the expandable body is larger than the distance between the support and the expandable body external to the region, wherein the region is shaped and biased in a spring-like manner for the support to apply a radial force against the expandable body, wherein a diameter of the support inf the expanded configuration increases until a maximum is reached at a distal end of the support without decreasing in diameter. Motivation for such can be found in Miles as this biases the expander portion/support to assist in expanding the tissue growth member/expandable body (see [0108]), which assists in sequential expansion of the device following collapse and repositioning to better occlude target volumes due to variability in sizes and shapes of vascular structures such as LAAs or aneurysms (see [0006]).
Claim 25
The combination of Lorenzo and Miles teaches: The intravascular device according to claim 1, see 103 rejection above. Miles further teaches: wherein said support 52 ends with wire tips attached to each other (will not be examined here due to being an optional claim limitation) and/or rounded (see Fig. 5A, the ends of 52 are wire tips that are rounded).
Claim 26
The combination of Lorenzo and Miles teaches: The intravascular device according to claim 1, see 103 rejection above. Miles further teaches: wherein said support 52 has the shape of a cup (see annotated Fig. 3A below) or flattened cup (see annotated Fig. 3A below) with a width greater than a height thereof (see annotated Fig. 3A below).
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Claim 27
The combination of Lorenzo and Miles teaches: The intravascular device according to claim 1, see 103 rejection above. The combination of Lorenzo and Miles does not explicitly teach: wherein a separation between a contour of the body and a contour of the region is at most 10% of a height of said body.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Lorenzo and Miles to have a separation between a contour of the body and a contour of the region is at most 10% of a height of said body since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Lorenzo and Miles would not operate differently with a separation between a contour of the body and a contour of the region is at most 10% of a height of said body. Further, applicant places no criticality on the range claimed, (see [0802] of applicant’s patent application publication) which recites alternatives including 0.1-20%, 0.5-10%, and 1-10% showing alternatives which indicates the range is not critical and can be altered.
Claim 28
The combination of Lorenzo and Miles teaches: The intravascular device according to claim 1, see 103 rejection above. The combination of Lorenzo and Miles does not explicitly teach: wherein a cross-section of the tubular shape of the support is constant along a length of the walls and varies at most by 10%.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Lorenzo and Miles to have a cross-section of the tubular shape of the support is constant along a length of the walls and varies at most by 10% since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Lorenzo and Miles would not operate differently with a cross-section of the tubular shape of the support is constant along a length of the walls and varies at most by 10%. Further, applicant places no criticality on the range claimed, (see [0319] of applicant’s patent application publication) which recites alternatives including 5% or lower showing alternatives which indicates the range is not critical and can be altered, including values between 5 and 10 that are not necessary in the embodiment of 5% or lower.
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 RAIHAN R KHANDKER whose telephone number is (571)272-6174. The examiner can normally be reached Monday - Friday 7:00 PM - 3:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771
Prosecution Insights