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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 17, 2026 has been entered.
Response to Arguments
Applicant's arguments filed June 17, 2026 have been fully considered but they are not persuasive in view of the rejection set forth below addressing the amendments to the claims.
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 1-15 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 the limitation "each protrusion" in line 9 of the claim. There is insufficient antecedent basis for this limitation in the claim since the claim only previously recites “at least one protrusion” in line 9. Therefore, it is unclear if the claim requires more than one protrusion.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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, 2, 6-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fiorella et al (20130066348).
Regarding claim 1, Fiorella et al (US 2005096691) discloses a device, comprising: a first tubular member (124); and a radially expandable (100) feature having one or more metal wires (paragraph 0007) disposed around the first tubular member, the radially expandable feature configured to be selectively expanded from a first configuration to a second configuration (expandable configuration) to allow blood within a blood vessel of a patient to flow around the first tubular member from a point upstream of the radially expandable feature, around and/or through the one or more radially expandable feature, and to a point downstream of the radially expandable feature (paragraph 0007), a distal end of the radially expandable feature in contact with at least one surface of at least one protrusion at a distal end of the first tubular member, each protrusion extending radially outward from the first tubular member (132c protrudes radially outwardly from 124, figure 3).
Regarding claim 2, Fiorella discloses all of the limitations set forth in claim 1, wherein the one or more metal wires forms a cylindrical wire mesh around the first tubular member (figure 3).
Regarding claim 6, Fiorella discloses all of the limitations set forth in claim 2, wherein upon compression in the second configuration, the cylindrical wire mesh increases its outer diameter and decreases its axial length, and wherein in tension in the first configuration, the cylindrical wire mesh decreases its outer diameter and increases its axial length (figures 6B-6C).
Regarding claim 7, Fiorella discloses all of the limitations set forth in claim 1, wherein the one or more metal wires forms a stent around the first tubular member (figure 6B-6C).
Regarding claim 8, Fiorella discloses all of the limitations set forth in claim 1, wherein the one or more metal wires forms a wire basket around the first tubular member (figures 6B-6C).
Regarding claim 9, Fiorella discloses all of the limitations set forth in claim 1, wherein the one or more metal wires are configured to extend radially outward away from the first tubular member to expand a portion of a blood vessel (figure 8F).
Regarding claim 10, Fiorella discloses all of the limitations set forth in claim 1, further comprising a second tubular member (132c), the first tubular member being slidably received by the second tubular member (figure 3).
Regarding claim 11, Fiorella discloses all of the limitations set forth in claim 10, wherein the one or more metal wires are coupled to the first tubular member (figure 3, all components are coupled to one another to form the device).
Regarding claim 12, Fiorella discloses all of the limitations set forth in claim 10, wherein the one or more metal wires are coupled to the second tubular member (figure 3).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Fiorella et al (20130066348), as applied to claim 2 above, and further in view of Lashinski et al (US 20060020334).
Regarding claims 3-5, Fiorella discloses all of the limitations set forth in claim 2, wherein Fiorella further discloses the device is advanced and deployed through a patients vasculature for treatment of various vessels within the human body (paragraph 0007-0008), but does not specifically disclose the cylindrical wire mesh, in a first configuration, has an outer diameter no more than 12 Fr, in a second configuration, has an outer diameter no less than 20 Fr, and configured to have an outer diameter of 7 Fr to 23 Fr. Lashinski et al (hereafter Lashinski) teaches it know was known in the art at the time of the invention for catheters and filters advanced and deployed through a patients vasculature to have a diameter of about 8-24 French (paragraph 0402). Therefore, it was well known in the art at the time of the invention to make the cylindrical wire mesh of a filter have an outer diameter no more than 12 Fr in a first collapsed configuration, and an outer diameter no less than 20 F in a second expanded configuration, such that the diameter of the filter is configured to have an outer diameter of 7 Fr to 23 Fr, as taught as known in the art at the time of the invention by Lashinski, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claims 13-14 and 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Fiorella et al (20130066348), as applied to claim 10 above, and further in view of Groothuis et al (US 20050096691).
Regarding claim 13 and 24-25, Fiorella discloses all of the limitations set forth in claim 10, wherein a distal end of the second tubular member is configured to be in contact with a proximal end of the one or more metal wires (figure 3), that an inflation balloon can be used to expand the expandable device in a known manner (paragraph 0046) and that the expandable member can be collapsed from the expanded condition into the collapsed condition in any suitable manner (paragraph 0063), but does not specifically disclose compressing the one or more metal wires requires moving the second tubular member in a proximal or distal direction. However, Groothuis et al (US 2005096691) discloses a device, comprising: a first tubular member (hollow push rod, 104, fig 1-2, paragraph 0037); and a radially expandable (expandable filter 108, figure 1, 3, paragraph 0043) feature having one or more metal wires (filter 108, paragraph 0043) disposed around the first tubular member, the radially expandable feature configured to be selectively expanded from a first configuration (collapsed configuration) to a second configuration (expandable configuration) to allow blood within a blood vessel of a patient to flow around the first tubular member from a point upstream of the radially expandable feature, around and/or through the one or more radially expandable feature, and to a point downstream of the radially expandable feature (paragraph 0073), further comprising a second tubular member (outer tube 102, figure 1, 3, paragraph 0037), the first tubular member being slidably received by the second tubular member (push rod 104 being slidably disposed through outer tube 102, figure 3, paragraph 0041). Groothius further teaches a distal end of the second tubular member is configured to be in contact with a proximal end of the one or more metal wires such that compressing the one or more metal wires requires moving the second tubular member in a proximal or distal direction (paragraph 0046). Therefore, since Groothius teaches a known manner of expanding and collapsing the expandable device using an inflation balloon having the claimed limitations, it would have been obvious to one with ordinary skill in the art at the time of the invention to substitute the inflation mechanism of Fiorella with the second tubular member of Groothius, meeting the claimed limitations of claims 13-15, since it has been held that mere substitution of art-recognized equivalents at the time of the invention involves routine skill in the art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANH TIEU DANG whose telephone number is (571)270-3221. The examiner can normally be reached Monday-Thursday (9am-4pm EST).
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/ANH T DANG/ Primary Examiner, Art Unit 3771
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