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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has complied with all conditions for receiving the benefit of an earlier filing date of 29 Nov 2022 under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c).
Information Disclosure Statement
The information disclosure statements (IDS) both submitted on 14 Feb 2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS has been considered by the Examiner. Examiner notes that the IDS lists duplicates of Sahatjian et al. (US Patent No. 5238004) and Horikawa et al. (US Patent No. 6508803).
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) for the following reasons:
In Fig. 1, reference characters "14" and "16" appear to refer to the same part and reference characters “24” and “26” appear to refer to another same part;
In Fig. 3, reference characters “12”, “14”, “16”, and “24” appear to refer to the same part;
In Fig. 4, reference characters “12”, “24”, and “36” appear to refer to the same part;
Between Fig. 3 and 4, reference characters “12” and “16” refer to different parts;
In Fig. 5-6, it is unclear to what part the reference character “38” is referring;
In Fig. 6, reference characters “42” and “50” appear to refer to the same part; and
In Fig. 7, it is unclear to what part(s) the reference characters “52” and “56” are referring.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
“obtain measure a diameter of a blood vessel” should read “obtain or measure a diameter of a blood vessel” ([00014], [00021]).
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites in the preamble “determining an effective diameter of a blood vessel at a deployment site” and in the body the limitation “obtain measure a diameter of a blood vessel”. First, it is unclear whether the diameters recited in the preamble and the body are referring to the same diameter of a same blood vessel or not. Second, it is unclear whether the limitation in the body of the claim should “obtain or measure a diameter of a blood vessel” or otherwise. Claims 2-10 inherit the deficiency by the nature of their dependency on claim 1. For purposes of the examination, the limitation in the body is being given a broadest reasonable interpretation as “determine the effective diameter of the blood vessel”.
Claim 10 recites the limitation “wherein the elongate shaft comprises a reinforcing element disposed within a polymeric shaft”. It is unclear whether “a polymeric shaft” in the limitation is the same or different from “the elongate shaft” also in the limitation. For purposes of the examination, the limitation is being given a broadest reasonable interpretation as “wherein the elongate shaft comprises a reinforcing element disposed within the elongate shaft, wherein the elongate shaft is polymeric”.
Claim 11 recites in the preamble “determining an effective diameter of a blood vessel at a deployment site” and in the body the limitation “obtain measure a diameter of a blood vessel”. First, it is unclear whether the diameters recited in the preamble and the body are referring to the same diameter of a same blood vessel or not. Second, it is unclear whether the limitation in the body of the claim should “obtain or measure a diameter of a blood vessel” or otherwise. Claims 12-17 inherit the deficiency by the nature of their dependency on claim 11. For purposes of the examination, the limitation in the body is being given a broadest reasonable interpretation as “determine the effective diameter of the blood vessel”.
Claim 17 recites the limitation “wherein the inner member comprises: a first grouping of fingers at a first axial position along the elongate shaft; and a second grouping of fingers at a second axial position along the elongate shaft that is spaced apart from the first grouping of fingers”. It is unclear whether “a first grouping of fingers” and “a second grouping of fingers” recited in the limitation are the same or different from “a plurality of fingers” recited in claim 11, to which claim 17 depends. For purposes of the examination, the limitation is being given a broadest reasonable interpretation as “wherein the inner member comprises: a first grouping of the plurality of fingers at a first axial position along the elongate shaft; and a second grouping of the plurality of fingers at a second axial position along the elongate shaft that is spaced apart from the first grouping of fingers”.
Claim 18 recites in the preamble “determining an effective diameter of a blood vessel at a deployment site” and in the body the limitation “obtain measure a diameter of a blood vessel”. First, it is unclear whether the diameters recited in the preamble and the body are referring to the same diameter of a same blood vessel or not. Second, it is unclear whether the limitation in the body of the claim should “obtain or measure a diameter of a blood vessel” or otherwise. Claims 19-20 inherit the deficiency by the nature of their dependency on claim 18. For purposes of the examination, the limitation in the body is being given a broadest reasonable interpretation as “determine the effective diameter of the blood vessel”.
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.
Claims 1-7, 9, 11-16, and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zadno-Azizi (WIPO Pub No. WO2001/12104A1, a copy attached to this Office action) – hereinafter referred to as Zadno-Azizi.
Regarding claim 1, Zadno-Azizi discloses an apparatus for deployment at a blood vessel at a deployment site (at least Fig. 14), the apparatus comprising:
an outer member (Fig. 14: second elongate member 126) defining a garage disposed within the outer member (pg. 8, lines 28-33: first elongate member 124 surrounded by second elongate member 126);
an inner member (Fig. 14: first elongate member 124) slidingly disposed within the garage (pg. 8, lines 28-33: first elongate member 124 surrounded by second elongate member 126),
the inner member (Fig. 14: first elongate member 124) adapted to be advanced distally from the garage into the blood vessel in which the apparatus is disposed (Fig. 14 and pg., 7, line 35 - pg. 8, line 6: first elongate member is pushed through a second elongate member),
the inner member (Fig. 14: first elongate member 124) comprising:
an elongate shaft having a distal region (Fig. 14: portion of first elongate member 124 at which membrane 122, ribs 120, and guidewire tip 128 are positioned); and
an expandable member (Fig. 14: membrane 122 and ribs 120) extending from the distal region (Fig. 14 and pg. 8, lines 28-30: membrane 122 expands with ribs 120 to form a seal),
the expandable member (Fig. 14: membrane 122 and ribs 120) biased to extend radially outwardly from the distal region when not constrained by being within the garage (Fig. 14 and pg. 8, lines 28-33: membrane 122 and ribs 120 expand from first elongate member 124, ribs 120 are made of shape memory material; pg. 7, line 32 - pg. 8, line 27: first elongate member is pushed through second elongate member, or the second elongate member is retracted over the first elongate member to allow membrane and ribs to expand).
It is noted that the preamble of claim 1 as well as the body of the claim recites the intended use of “determining an effective diameter of a blood vessel at a deployment site” and “in order to obtain measure a diameter of a blood vessel in which the apparatus is disposed “of the claimed apparatus, respectively. A review of the specification of the instant application discloses that the determination of an effective diameter of a blood vessel at a deployment site is based on imaging of the claimed apparatus at the deployment site (see [0050] of the specification of the instant application). However, neither the claim nor the specification discloses the imaging technique performed with the claimed apparatus in determining the effective diameter that a limited patentable weight is being given to the intended use of the claimed apparatus. Further, while Zadno-Azizi does not explicitly disclose that its apparatus is for determination of an effective diameter of a blood vessel, Zadno-Azizi’s apparatus is capable of being imaged at its deployment site under at least ultrasound and fluoroscopic imaging due to its material composition (pg. 8, lines 30-33: ribs 120 made of shape memory material such as Nitinol or stainless steel). As noted below in claims 2 and 3, it is well known in the art that nitinol and stainless steel are visible under ultrasound imaging and stainless steel is visible under fluoroscopic imaging.
Regarding claim 2, Zadno-Azizi discloses all limitations of claim 1, as discussed above, and Zadno-Azizi further discloses:
wherein the expandable member (Fig. 14: membrane 122 and ribs 120) is adapted to be visible via ultrasound imaging (pg. 8, lines 30-33: ribs 120 made of shape memory material such as Nitinol or stainless steel).
As noted above in claim 1, it is well known in the art that nitinol and stainless steel are visible under ultrasound imaging.
Regarding claim 3, Zadno-Azizi discloses all limitations of claim 1, as discussed above, and Zadno-Azizi further discloses:
wherein the expandable member (Fig. 14: membrane 122 and ribs 120) is adapted to be visible via fluoroscopic imaging (pg. 8, lines 30-33: ribs 120 made of shape memory material such as stainless steel).
As noted above in claim 1, it is well known in the art that stainless steel is visible under fluoroscopic imaging.
Regarding claim 4, Zadno-Azizi discloses all limitations of claim 1, as discussed above, and Zadno-Azizi further discloses:
wherein the expandable member (Fig. 14: membrane 122 and ribs 120) comprises a plurality of fingers (Fig. 14: ribs 120) extending from the distal region of the elongate shaft (Fig. 14 and pg. 8, lines 9-33: membrane and ribs are secured to first elongate member, and membrane 122 and ribs 120 expand from first elongate member 124),
each of the plurality of fingers (Fig. 14: ribs 120) biased to extend radially outwardly from the distal region of the elongate shaft (Fig. 14 and pg. 8, lines 21-33: membrane 122 and ribs 120 expand from first elongate member 124 outside of second elongate member 126),
each of the plurality of fingers constrained from extending radially outwardly when the inner member is disposed within the garage (Fig. 14 and pg. 7, line 32 - pg. 8, line 33: either first elongate member is pushed through second elongate member, or the second elongate member is retracted over the first elongate member, thus membrane and ribs attached to the first elongate member would be constrained when the second elongate member surrounds the first elongate member).
Regarding claim 5, Zadno-Azizi discloses all limitations of claim 4, as discussed above, and Zadno-Azizi further discloses:
wherein each of the plurality of fingers (Fig. 14: ribs 120) comprises:
a spring element (Fig. 14: ribs 120) biased to extend radially outwardly (pg. 8, lines 21-33: ribs 120 made of shape memory material to expand from the first elongate member 124 when urged out of second elongate member); and
a polymeric sleeve (Fig. 14: membrane 122; pg. 11, lines 31-34: membrane of PET, elastomeric, or plastic material) extending over the spring element (Fig. 14 and pg. 8, line 28-33: membrane 122 surrounds ribs 120).
It is noted that a broadest reasonable interpretation has been given to “spring element” to include any element that returns to its original shape when the element is no longer subject to a constraint, including Zadno-Azizi’s ribs of shape memory material that expand when they are no longer disposed within the second elongate member. A review of the specification of the instant application discloses in [0052] that the spring element may be formed of a shape memory material.
Regarding claim 6, Zadno-Azizi discloses all limitations of claim 4, as discussed above, and Zadno-Azizi further discloses:
wherein the expandable member (Fig. 14: membrane 122 and ribs 120) comprises at least three fingers (pg. 8, lines 30: at least three ribs 120).
Regarding claim 7, Zadno-Azizi discloses all limitations of claim 4, as discussed above, and Zadno-Azizi further discloses:
wherein the expandable member (Fig. 14: membrane 122 and ribs 120) comprises at least four fingers (Fig. 14: at least four ribs 120 shown).
Regarding claim 9, Zadno-Azizi discloses all limitations of claim 1, as discussed above, and Zadno-Azizi further discloses:
wherein the expandable member comprises:
a plurality of spring elements (Fig. 14: ribs 120; pg. 8, lines 28-32: ribs 120 of shape memory material and configured to expand with membrane 122) extending from the distal region of the elongate shaft; and
a polymeric web (Fig. 14: membrane 122; pg. 11, lines 31-34: membrane of PET, elastomeric, or plastic material) enveloping each of the plurality of spring elements (Fig. 14 and pg. 8, lines 28-32: ribs 120 surrounded by membrane 122).
It is noted that a broadest reasonable interpretation has been given to “spring element” to include any element that returns to its original shape when the element is no longer subject to a constraint, including Zadno-Azizi’s ribs of shape memory material that expand when they are no longer disposed within the second elongate member. A review of the specification of the instant application discloses in [0052] that the spring element may be formed of a shape memory material.
Regarding claim 11, Zadno-Azizi discloses an apparatus for deployment at a blood vessel at a deployment site (at least Fig. 14), the apparatus comprising:
an outer member (Fig. 14: second elongate member 126) defining a lumen disposed within the outer member (pg. 8, lines 28-33: first elongate member 124 surrounded by second elongate member 126);
an inner member (Fig. 14: first elongate member 124) slidingly disposed within the lumen (pg. 8, lines 28-33: first elongate member 124 surrounded by second elongate member 126),
the inner member (Fig. 14: first elongate member 124) adapted to be advanced distally from the lumen into the blood vessel in which the apparatus is disposed (Fig. 14 and pg. 7, line 35 - pg. 8, line 6: first elongate member is pushed through a second elongate member),
the inner member (Fig. 14: first elongate member 124) comprising:
an elongate shaft having a distal region (Fig. 14: portion of first elongate member 124 at which membrane 122, ribs 120, and guidewire tip 128 are positioned); and
a plurality of fingers (Fig. 14: ribs 120) extending from the distal region of the elongate shaft (Fig. 14 and pg. 8, lines 9-33: ribs are secured to first elongate member, and ribs 120 expand from first elongate member 124),
each of the plurality of fingers (Fig. 14: ribs 120) biased to extend radially outwardly from the distal region of the elongate shaft (Fig. 14 and pg. 8, lines 28-33: ribs 120 expand from first elongate member 124, ribs 120 are made of shape memory material; pg. 7, line 32 - pg. 8, line 27: first elongate member is pushed through second elongate member, or the second elongate member is retracted over the first elongate member to allow ribs to expand),
each of the plurality of fingers (Fig. 14: ribs 120) constrained from extending radially outwardly when the inner member is disposed within the lumen (Fig. 14 and pg. 7, line 32 - pg. 8, line 33: either first elongate member is pushed through second elongate member, or the second elongate member is retracted over the first elongate member, thus ribs attached to the first elongate member would be constrained when the second elongate member surrounds the first elongate member).
It is noted that the preamble of claim 11 as well as the body of the claim recites the intended use of “determining an effective diameter of a blood vessel at a deployment site” and “in order to obtain measure a diameter of a blood vessel in which the apparatus is disposed “ of the claimed apparatus, respectively. A review of the specification of the instant application discloses that the determination of an effective diameter of a blood vessel at a deployment site is based on imaging of the claimed apparatus at the deployment site (see [0050] of the specification of the instant application). However, neither the claim nor the specification discloses the imaging technique performed with the claimed apparatus in determining the effective diameter that a limited patentable weight is being given to the intended use of the claimed apparatus. Further, while Zadno-Azizi does not explicitly disclose that its apparatus is for determination of an effective diameter of a blood vessel, Zadno-Azizi’s apparatus is capable of being imaged at its deployment site under at least ultrasound and fluoroscopic imaging due to its material composition (pg. 8, lines 30-33: ribs 120 made of shape memory material such as Nitinol or stainless steel). As noted below in claims 13 and 14, it is well known in the art that nitinol and stainless steel are visible under ultrasound imaging and stainless steel is visible under fluoroscopic imaging.
Regarding claim 12, Zadno-Azizi discloses all limitations of claim 11, as discussed above, and Zadno-Azizi further discloses:
wherein each of the plurality of fingers (Fig. 14: ribs 120) comprises:
a spring element (Fig. 14: ribs 120) biased to extend radially outwardly (pg. 8, lines 21-33: ribs 120 made of shape memory material to expand from the first elongate member 124 when urged out of second elongate member); and
a polymeric web (Fig. 14: membrane 122; pg. 11, lines 31-34: membrane of PET, elastomeric, or plastic material) enveloping each of the plurality of spring elements (Fig. 14 and pg. 8, lines 28-32: ribs 120 surrounded by membrane 122).
It is noted that a broadest reasonable interpretation has been given to “spring element” to include any element that returns to its original shape when the element is no longer subject to a constraint, including Zadno-Azizi’s ribs of shape memory material that expand when they are no longer disposed within the second elongate member. A review of the specification of the instant application discloses in [0052] that the spring element may be formed of a shape memory material.
Regarding claim 13, Zadno-Azizi discloses all limitations of claim 11, as discussed above, and Zadno-Azizi further discloses:
wherein each of the plurality of fingers (Fig. 14: ribs 120) are adapted to be visible via ultrasound imaging (pg. 8, lines 30-33: ribs 120 made of shape memory material such as Nitinol or stainless steel).
As noted above in claim 11, it is well known in the art that nitinol and stainless steel are visible under ultrasound imaging.
Regarding claim 14, Zadno-Azizi discloses all limitations of claim 11, as discussed above, and Zadno-Azizi further discloses:
wherein each of the plurality of fingers (Fig. 14: ribs 120) are adapted to be visible via fluoroscopic imaging (pg. 8, lines 30-33: ribs 120 made of shape memory material such as stainless steel).
As noted above in claim 11, it is well known in the art that stainless steel is visible under fluoroscopic imaging.
Regarding claim 15, Zadno-Azizi discloses all limitations of claim 11, as discussed above, and Zadno-Azizi further discloses:
wherein the inner member (Fig. 14: first elongate member 124, membrane 122, and ribs 120) comprises at least three fingers (pg. 8, lines 30: at least three ribs 120).
Regarding claim 16, Zadno-Azizi discloses all limitations of claim 11, as discussed above, and Zadno-Azizi further discloses:
wherein the inner member (Fig. 14: first elongate member 124, membrane 122, and ribs 120) comprises at least four fingers (Fig. 14: at least four ribs 120 shown).
Regarding claim 18, Zadno-Azizi discloses an apparatus for deployment at a blood vessel at a deployment site (at least Fig. 14), the apparatus comprising:
an outer member (Fig. 14: second elongate member 126) defining a lumen disposed within the outer member (pg. 8, lines 28-33: first elongate member 124 surrounded by second elongate member 126);
an inner member (Fig. 14: first elongate member 124) slidingly disposed within the lumen (pg. 8, lines 28-33: first elongate member 124 surrounded by second elongate member 126),
the inner member (Fig. 14: first elongate member 124) adapted to be advanced distally from the lumen into the blood vessel in which the apparatus is disposed (Fig. 14 and pg. 7, line 35 - pg. 8, line 6: first elongate member is pushed through a second elongate member),
the inner member (Fig. 14: first elongate member 124) comprising:
an elongate shaft having a distal region (Fig. 14: portion of first elongate member 124 at which membrane 122, ribs 120, and guidewire tip 128 are positioned); and
a plurality of spring elements (Fig. 14: ribs 120; pg. 8, lines 21-32: ribs 120 are made of shape memory material and are configured to expand when urged out of second elongate member) extending from the distal region of the elongate shaft (Fig. 14 and pg. 8, lines 9-33: ribs are secured to first elongate member, and ribs 120 expand from first elongate member 124),
a polymeric web (Fig. 14: membrane 122; pg. 11, lines 31-34: membrane of PET, elastomeric, or plastic material) enveloping each of the plurality of spring elements (Fig. 14 and pg. 8, line 28-33: membrane 122 surrounds ribs 120).
It is noted that the preamble of claim 18 as well as the body of the claim recites the intended use of “determining an effective diameter of a blood vessel at a deployment site” and “in order to obtain measure a diameter of a blood vessel in which the apparatus is disposed “ of the claimed apparatus, respectively. A review of the specification of the instant application discloses that the determination of an effective diameter of a blood vessel at a deployment site is based on imaging of the claimed apparatus at the deployment site (see [0050] of the specification of the instant application). However, neither the claim nor the specification discloses the imaging technique performed with the claimed apparatus in determining the effective diameter that a limited patentable weight is being given to the intended use of the claimed apparatus. Further, while Zadno-Azizi does not explicitly disclose that its apparatus is for determination of an effective diameter of a blood vessel, Zadno-Azizi’s apparatus is capable of being imaged at its deployment site under at least ultrasound and fluoroscopic imaging due to its material composition (pg. 8, lines 30-33: ribs 120 made of shape memory material such as Nitinol or stainless steel). As noted below in claims 19 and 20, it is well known in the art that nitinol and stainless steel are visible under ultrasound imaging and stainless steel is visible under fluoroscopic imaging.
Additionally, it is noted that a broadest reasonable interpretation has been given to “spring element” to include any element that returns to its original shape when the element is no longer subject to a constraint, including Zadno-Azizi’s ribs of shape memory material that expand when they are no longer disposed within the second elongate member. A review of the specification of the instant application discloses in [0052] that the spring element may be formed of a shape memory material.
Regarding claim 19, Zadno-Azizi discloses all limitations of claim 18, as discussed above, and Zadno-Azizi further discloses:
wherein at least a portion of the inner member (Fig. 14: ribs 120) is adapted to be visible via ultrasound imaging (pg. 8, lines 30-33: ribs 120 made of shape memory material such as Nitinol or stainless steel).
As noted above in claim 18, it is well known in the art that nitinol and stainless steel are visible under ultrasound imaging.
Regarding claim 20, Zadno-Azizi discloses all limitations of claim 18, as discussed above, and Zadno-Azizi further discloses:
wherein at least a portion of the inner member (Fig. 14: ribs 120) is adapted to be visible via fluoroscopic imaging (pg. 8, lines 30-33: ribs 120 made of shape memory material such as stainless steel).
As noted above in claim 20, it is well known in the art that stainless steel is visible under fluoroscopic imaging.
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.
Claims 8 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Zadno-Azizi, as applied to claims 1 and 11 above, respectively, and further in view of Aboytes (US PG Pub No. 2011/0213403) – hereinafter referred to as Aboytes – as evidenced by Janardhan et al. (US PG Pub No. 2019/0133747) – hereinafter referred to as Janardhan.
Regarding claim 8, Zadno-Azizi discloses all limitations of claim 1, as discussed above, and Zadno-Azizi does not disclose:
wherein the expandable member comprises:
a first grouping of fingers at a first axial position along the elongate shaft; and
a second grouping of fingers at a second axial position along the elongate shaft that is spaced apart from the first grouping of fingers.
In the same field of deploying an apparatus in a blood vessel, Aboytes, however, teaches:
a first grouping of fingers (Fig. 4A-B: one of first portion 350 and second portion 352 of expandable member 326; [0086]: expandable member 326 of shape-memory material and with a mesh or braided material, thus each wire of mesh/braid representing a finger) at a first axial position along the elongate shaft (Fig. 4A-B and [0085]: one of first portion 350 and second portion 352 along tubular member 322/elongate member 324); and
a second grouping of fingers (Fig. 4A-B: other one of first portion 350 and second portion 352 of expandable member 326; [0086]: expandable member 326 of shape-memory material and with a mesh or braided material, thus each wire of mesh/braid representing a finger) at a second axial position along the elongate shaft that is spaced apart from the first grouping of fingers (Fig. 4A-B and [0085]: other one of first portion 350 and second portion 352 along tubular member 322/elongate member 324; [0086]: first portion 350 and second portion 352 spaced apart by annular capture region 342).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Zadno-Azizi’s apparatus to include Aboytes’s groupings of fingers. One of ordinary skill in the art would have combined the elements as claimed by known methods (i.e., arranging groupings of fingers along the elongate shaft, as disclosed by Aboytes), and the combination would have yielded a reasonable expectation of success since both Zadno-Azizi and Aboytes are directed to deploying an apparatus in a blood vessel where the apparatus expands across the diameter of the blood vessel. The motivation for the combination would have been to allow “"A tapered configuration of the distal portion 1100 can allow for adequate and safe deployment of the distal portion 1100 across blood vessels with multiple and/or varying diameters (e.g., vasculature that progressively reduces in size)", as evidenced by Janardhan ([0579] of Janardhan).
Regarding claim 17, Zadno-Azizi discloses all limitations of claim 11, as discussed above, and Zadno-Azizi does not disclose:
wherein the inner member comprises:
a first grouping of fingers at a first axial position along the elongate shaft; and
a second grouping of fingers at a second axial position along the elongate shaft that is spaced apart from the first grouping of fingers.
In the same field of deploying an apparatus in a blood vessel, Aboytes, however, teaches:
a first grouping of fingers (Fig. 4A-B: one of first portion 350 and second portion 352 of expandable member 326; [0086]: expandable member 326 of shape-memory material and with a mesh or braided material, thus each wire of mesh/braid representing a finger) at a first axial position along the elongate shaft (Fig. 4A-B and [0085]: one of first portion 350 and second portion 352 along tubular member 322/elongate member 324); and
a second grouping of fingers (Fig. 4A-B: other one of first portion 350 and second portion 352 of expandable member 326; [0086]: expandable member 326 of shape-memory material and with a mesh or braided material, thus each wire of mesh/braid representing a finger) at a second axial position along the elongate shaft that is spaced apart from the first grouping of fingers (Fig. 4A-B and [0085]: other one of first portion 350 and second portion 352 along tubular member 322/elongate member 324; [0086]: first portion 350 and second portion 352 spaced apart by annular capture region 342).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Zadno-Azizi’s apparatus to include Aboytes’s groupings of fingers. One of ordinary skill in the art would have combined the elements as claimed by known methods (i.e., arranging groupings of fingers along the elongate shaft, as disclosed by Aboytes), and the combination would have yielded a reasonable expectation of success since both Zadno-Azizi and Aboytes are directed to deploying an apparatus in a blood vessel where the apparatus expands across the diameter of the blood vessel. The motivation for the combination would have been to allow “"A tapered configuration of the distal portion 1100 can allow for adequate and safe deployment of the distal portion 1100 across blood vessels with multiple and/or varying diameters (e.g., vasculature that progressively reduces in size)", as evidenced by Janardhan ([0579] of Janardhan).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Zadno-Azizi, as applied to claim 1 above, respectively, and further in view of Aboytes.
Regarding claim 10, Zadno-Azizi discloses all limitations of claim 1, as discussed above, and Zadno-Azizi does not disclose:
wherein the elongate shaft comprises a reinforcing element disposed within a polymeric shaft.
In the same field of deploying an apparatus in a blood vessel, Aboytes, however, teaches:
wherein the elongate shaft comprises a reinforcing element ([0063]: core wire) disposed within a polymeric shaft ([0063]: core wire movably disposed within a lumen of hypotube).
It is noted that a review of the specification of the instant application discloses “reinforcing element” includes a coil and “polymeric (elongate) shaft” includes hypotube (see [0048] of the specification of the instant application).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Zadno-Azizi’s apparatus to include Aboytes’s polymeric elongate shaft comprising a reinforcing member. One of ordinary skill in the art would have combined the elements as claimed by known methods (i.e., arranging the polymeric elongate shaft with the reinforcing member, as disclosed by Aboytes), and the combination would have yielded a reasonable expectation of success since both Zadno-Azizi and Aboytes are directed to deploying an apparatus in a blood vessel where the apparatus expands across the diameter of the blood vessel. The motivation for the combination would have been to control positioning and maneuvering of the expandable member within the blood vessel ([0044] of Aboytes).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Herzog (US PG Pub No. 2018/0153555) discloses an apparatus comprising polymeric web separating each finger (Fig. 5: lobes 116 of polymeric tip 114 separating tips of metal frame 128).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Younhee Choi whose telephone number is (571)272-7013. The examiner can normally be reached M-F 9AM-5PM EST.
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/Y.C./Examiner, Art Unit 3797
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
12/22/25