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
The Amendment filed 10/06/25 has been entered. Claims 6 and 16 remain withdrawn. Claims 1-5, 7-15, and 17-20 are addressed in the following office action.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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 1-5, 7, 9-15, 17 and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bowman (US 2017/0224355), cited in previous office action.
As to claim 1, Bowman discloses an apparatus (apparatus of figure 10-12) for treating an aneurysm in a blood vessel (see paragraph 0113-0116), comprising: an occlusion device (35) configured to be releasably coupled (see paragraph 0154-155) to an elongate delivery shaft (48) [Note, the elongate delivery shaft is not part of the claimed invention], the occlusion device comprising an inverted mesh tube (see figure 11, top inverts) having an outer layer (the layer 31 surrounding layer 32) and an inner layer (layer making up 32), the outer layer transitioning to the inner layer at an inversion fold (see annotated figure below), wherein at least the outer layer is formed into an expanded shape having a proximal section (see figure below) having a proximal section maximum diameter (see annotated figure below), a distal section (see annotated figure below) having a distal section maximum diameter (see annotated figure below), and a waist portion (see annotated figure below) comprising a reduced diameter over a longitudinal length (see annotated figure below), thus providing a longitudinal space between an extreme distal end of the proximal section and an extreme proximal end of the distal section (see annotated figure below), when an angle A between the proximal section and the distal section is 180° (the longitudinal axis of the distal section and proximal section are aligned, hence the 180°, see figure 11), such that the distal section and the proximal section are able to move toward each other on a side of the occlusion device as the angle A between a proximal longitudinal axis of the proximal section and a distal longitudinal axis of the distal section is decreased (the devices are composed of braid forming multiple shaped sections which allow compressibility and elongation, allowing the devices to conform to the general shape of the aneurysm, see paragraph 0115, 0139, 0143), the waist portion having a waist portion maximum diameter (see annotated figure below), wherein the waist portion maximum diameter is less than the proximal section maximum diameter and the waist portion maximum diameter is less than the distal section maximum diameter (see annotated figure below), and wherein the distal section comprises a mushroom head shape (seen as mushroom shape) that is longitudinally bounded by a transverse proximal face extending inwardly to the waist portion (see annotated figure below) and by a dome-like distal face (see annotated figure below).
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As to claim 2, Bowman discloses the invention of claim 1, Bowman further discloses: wherein the waist portion is substantially cylindrical in shape (seen as substantially cylindrical, see paragraphs 0139 & 0142).
As to claim 3, Bowman discloses the invention of claim 1, Bowman further discloses: wherein the waist portion comprises a circumferential concavity (see annotated figure below).
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As to claim 4, Bowman discloses the invention of claim 1, Bowman further discloses: wherein the inner layer has an expanded shape which conforms with the expanded shape of the outer layer (both layers are made of a material that conforms, thus the inner layer can conform with the expanded shape of the outer layer when deployed, see figure 11 and paragraphs 0003, 0115 and 0190).
As to claim 5, Bowman discloses the invention of claim 1, Bowman further discloses: wherein the inversion fold is a circular shape (disc-shaped, see figure 11 and paragraph 0139) surrounding an orifice that communicates with an internal volume of the occlusion device (see annotated figure below).
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As to claim 7, Bowman discloses the invention of claim 1, Bowman further discloses: wherein the occlusion device is configured to be delivered in a collapsed configuration through an inner lumen of a delivery catheter (paragraphs 0127-0128, 0143, 0160).
As to claim 9, Bowman discloses the invention of claim 1, Bowman further discloses: wherein the proximal section maximum diameter and the distal section maximum diameter are substantially the same (see annotated figure below, seen as substantially the same).
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As to claim 10, Bowman discloses the invention of claim 1, Bowman further discloses: wherein the proximal section comprises a conical shape (see figure 11 and paragraph 0139).
As to claim 11, Bowman discloses an apparatus (apparatus of figure 10-12) for treating an aneurysm in a blood vessel (see paragraph 0113-0116), comprising: an occlusion device (35) configured to be releasably coupled (paragraph 0154-0155) to an elongate delivery shaft (48) [Note, the elongate delivery shaft is not part of the claimed invention], the occlusion device comprising an inverted mesh tube (see figure 11, top inverts) having an outer layer (the layer 31 surrounding layer 32) and an inner layer (layer making up 32), the outer layer transitioning to the inner layer at an inversion fold at a distal end of the occlusion device (see annotated figure below), wherein at least the outer layer is formed into an expanded shape having a proximal section (see annotated figure below) having a proximal section maximum diameter (see annotated figure below), a distal section (see annotated figure below) having a distal section maximum diameter (see annotated figure below), and a waist portion (see annotated figure below) comprising a reduced diameter over a longitudinal length, thus providing a longitudinal space between an extreme distal end of the proximal section and an extreme distal end of the distal section (see annotated figure below) when an angle A between the proximal section and the distal section is 180° (the longitudinal axis of the distal section and proximal section are aligned, hence the 180°, see figure 11), such that the distal section and the proximal section are able to move toward each other on a side of the occlusion device as the angle A between a proximal longitudinal axis of the proximal section and a distal longitudinal axis of the distal section is decreased (the devices are composed of braid forming multiple shaped sections which allow compressibility and elongation, allowing the devices to conform to the general shape of the aneurysm, see paragraph 0115, 0139, 0143), the waist portion having a waist portion maximum diameter (see annotated figure below), wherein the waist portion maximum diameter is less than the proximal section maximum diameter and the waist portion maximum diameter is less than the distal section maximum diameter (see annotated figure below), and wherein the distal section comprises a shape that is longitudinally bounded by a flat transverse proximal face extending substantially inwardly to the waist portion and by a convex distal face (see annotated figure below).
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As to claim 12, Bowman discloses the invention of claim 11, Bowman further discloses: wherein the waist portion is substantially cylindrical in shape (seen as substantially cylindrical, see paragraphs 0139 & 0142).
As to claim 13, Bowman discloses the invention of claim 11, Bowman further discloses: wherein the waist portion comprises a circumferential concavity (see annotated figure above).
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As to claim 14, Bowman discloses the invention of claim 11, Bowman further discloses: wherein the inner layer has an expanded shape which conforms with the expanded shape of the outer layer (both layers are made of a material that conforms, thus the inner layer can conform with the expanded shape of the outer layer when deployed, see figure 11 and paragraphs 0003, 0115 and 0190).
As to claim 15, Bowman discloses the invention of claim 11, Bowman further discloses: wherein the inversion fold is a circular shape (disc-shaped, see figure 11 and paragraph 0139) surrounding an orifice that communicates with an internal volume of the occlusion device (see annotated figure below).
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As to claim 17, Bowman discloses the invention of claim 11, Bowman further discloses: wherein the occlusion device is configured to be delivered in a collapsed configuration through an inner lumen of a delivery catheter (paragraphs 0127-0128, 0143, 0160).
As to claim 19, Bowman discloses the invention of claim 11, Bowman further discloses: wherein the proximal section maximum diameter and the distal section maximum diameter are substantially the same (see annotated figure below, seen as substantially the same).
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As to claim 20, Bowman discloses the invention of claim 11, Bowman further discloses: wherein the proximal section comprises a conical shape (see figure 11 and paragraph 0139) .
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 8 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Bowman (US 2017/0224355) as applied to claims 7 and 17 above, further in view of Lorenzo (US 2018/0242979), cited in previous office action.
As to claim 8, Bowman discloses the invention of claim 7, Bowman fails to directly disclose: wherein the occlusion device comprises a plurality of filaments comprising a shape memory alloy.
In the same field of endeavor, namely aneurysm treatment devices, Lorenzo teaches that its well known to make an aneurysm device out of shape memory filaments (nitinol, paragraph 0081).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the device of Bowman out of nitinol filaments as disclosed in Lorenzo because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. MPEP 2143. Here all elements of the claim are well known in the art of aneurysm treatment devices. Modifying Bowman to have nitinol filaments would not change the device’s function of being implanted in a patient’s vasculature. Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to make the device of Bowman out of nitinol filaments, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
As to claim 18, Bowman discloses the invention of claim 17, Bowman fails to directly disclose: wherein the occlusion device comprises a plurality of filaments comprising a shape memory alloy.
In the same field of endeavor, namely aneurysm treatment devices, Lorenzo teaches that its well known to make an aneurysm device out of shape memory filaments (nitinol, paragraph 0081).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the device of Bowman out of nitinol filaments as disclosed in Lorenzo because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. MPEP 2143. Here all elements of the claim are well known in the art of aneurysm treatment devices. Modifying Bowman to have nitinol filaments would not change the device’s function of being implanted in a patient’s vasculature. Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to make the device of Bowman out of nitinol filaments, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Response to Arguments
Applicant's arguments filed 10/06/25 have been fully considered but they are not persuasive.
Applicant argues that the office action of record does not establish that previously cited prior art reference Bowman discloses "wherein the distal section comprises a mushroom head shape that is longitudinally bounded by a flat transverse proximal face extending inwardly to the waist portion and by a dome-like distal dome” in claim 1, and “longitudinally bound by a flat transverse proximal face extending substantially inwardly to the waist portion and by a convex distal face” in claim 11. Examiner respectfully disagrees.
Concerning claim 1, Bowman discloses wherein a distal section (see annotated figure below) comprises a mushroom head shape (seen as mushroom shape) that is longitudinally bounded by a transverse proximal face extending inwardly to the waist portion (see annotated figure below) and by a dome-like distal face (see annotated figure below).
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Concerning claim 11, Bowman discloses wherein a distal section (see annotated figure below) comprises a shape that is longitudinally bounded by a flat transverse proximal face extending substantially inwardly to the waist portion and by a convex distal face (see annotated figure below).
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Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Chima Igboko whose telephone number is (571)272-8422. The examiner can normally be reached on Monday-Friday 9:00am-6:00pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jackie Ho, at (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.U.I/ Examiner, Art Unit 3771
/ASHLEY L FISHBACK/Primary Examiner, Art Unit 3771 October 29, 2025