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 01/12/2026. As directed by the amendment: claims 1 and 7 have been amended, claims 12-20 remain withdrawn, and claims 21-22 have been added. Thus, claims 1-22 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see pages 6-9, filed 01/12/2026, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 102(a)(2) as being anticipated by Guo et al (US 20230329719 A1), herein referenced to as “Guo” have been fully considered and are persuasive.
The applicant has amended claim 1 to further recite “and exhibiting a generally cylindrical shape”. The examiner agrees that Guo does not explicitly teach that the elongated sleeve exhibits a generally cylindrical shape but a fusiform shape.
Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Guo in view of Hebert et al (US 20160206419 A1), herein referenced to as “Hebert”.
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) 1-9, 11, and 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over by Guo et al (US 20230329719 A1), herein referenced to as “Guo”, in view of Hebert et al (US 20160206419 A1), herein referenced to as “Hebert”.
Claim 1
Guo discloses: An embolization device 10 (see Figs. 1-6, [0063]), comprising: a plurality of wires filaments (see [0083], braided tube is formed of filaments) braided together to form an elongated sleeve 11 (see Figs. 1-6, [0063]) defining an interior region the inner cavity formed by 11 (see Figs. 1-6, [0072], inner cavity defined by the expandable mesh structure 11); wherein the elongated sleeve 11 is configured to switch between an elongated configuration linear shape with a minimized radial size (see [0076], collapsed configuration) and a deployed configuration expanded configuration (see Figs. 1-6, [0076]).
Guo does not explicitly disclose: and exhibiting a generally cylindrical shape.
However, Hebert in a similar field of invention teaches an embolization device 10 (see Figs. 1-3A) with a plurality of wires the braided polyester filaments that form 12 (see Figs. 1-3A, [0073] and [0130]) defining an interior region the interior region of 12 (see Figs. 4A-4C) with an elongated configuration (see Fig. 1) and a deployed configuration (see Fig. 3A). Hebert further teaches: and exhibiting a generally cylindrical shape (see Fig. 1, [0128] and [0130], a crimped tubular generally cylindrical shape).
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 Guo to incorporate the teachings of Hebert and teach an embolization device with a generally cylindrical shape. Motivation for such can be found in Hebert as this crimped tubular/cylindrical shape is formed to increase the flexibility of the tubular structure (see [0031]) and increase wall thickness and fabric density to have a high surface area for increased blood absorption to enhance packing of the aneurysm (see [0128]).
Claim 2
The combination of Guo and Hebert teaches: The embolization device of claim 1, see 103 rejection above. Guo further discloses: wherein the plurality of wires filaments includes 15 wires (will not be examined here due to being an optional claim limitation in the alternative) or more (see [0054], the device has 48 filaments, which is more than 15 wires).
Claim 3
The combination of Guo and Hebert teaches: The embolization device of claim 1, see 103 rejection above. Guo further discloses: wherein the plurality of wires filaments is at least partially formed from one or more shape memory materials (see [0083], the filaments are fabricated from shape memory materials, including double-layer composite metal wires, which are two different shape memory materials or nitinol, which is one shape memory material).
Claim 4
The combination of Guo and Hebert teaches: The embolization device of claim 1, see 103 rejection above. Guo further discloses: wherein the plurality of wires filaments exhibit an average lateral dimension outer diameter of the filaments (see [0083]) of about 20 µm to about 75 µm (see [0083], outer diameter of 0.0005-0.002 inches, which is 12.7 micrometers to 50 micrometers which includes values between 20 micrometers to 75 micrometers).
Claim 5
The combination of Guo and Hebert teaches: The embolization device of claim 1, see 103 rejection above. Guo further discloses: wherein the elongated sleeve 11 exhibits an outer lateral dimension outer diameter of the expandable mesh structure 11(see [0023]) of about 2 mm to about 4 mm (see [0023], the outer diameter may be 2.0-8.0 mm, which includes values between 2 mm to 4 mm).
Claim 6
The combination of Guo and Hebert teaches: The embolization device of claim 1, see 103 rejection above. Guo further discloses: wherein the elongated sleeve 11 exhibits an outer lateral dimension outer diameter of the expandable mesh structure 11 (see [0022]-[0023]) of about 1 mm (see [0022]-[0023], the outer diameter of the expandable mesh structure may be 1/3 of the outer diameter of the largest spiral turn, so when the outer diameter of the largest spiral turn is 3.0 mm as in [0023], the outer diameter of the expandable mesh structure/elongated sleeve would be 1.0 mm) or less (will not be examined here due to being an optional claim limitation in the alternative).
Claim 7
The combination of Guo and Hebert teaches: The embolization device of claim 1, see 103 rejection above. Guo further discloses: wherein the deployed configuration expanded configuration (see Figs. 1-6) of the elongated sleeve 11 exhibits a generally spiral shape (see Figs. 1-6, [0076], in which it recovers a spiral shape) that extends from a distal terminal end 14 (see Figs. 1-6, [0063], the distal terminal end 14 extends proximally into a spiral shape) of the elongated sleeve 11.
Claim 8
The combination of Guo and Hebert teaches: The embolization device of claim 1, see 103 rejection above. Guo further discloses: further comprising at least one end cap 13 (see Figs. 1-6, [0094]) attached to a terminal end 112 (see Figs. 1-6, [0094]) of the elongated sleeve 11, the at least one end cap band 13 formed from an at least partially image-opaque material (see [0094], radiopaque ring).
Claim 9
The combination of Guo and Hebert teaches: The embolization device of claim 1, see 103 rejection above. Guo further discloses: further comprising a first attachment device 20 (see Figs. 1-6, [0077], push rood, detachably coupled to 11) attached to the elongated sleeve 11, the first attachment device 20 configured to be reversibly attached (see [0077], detachably coupled, hence it can decouple after being attached, thus meeting reversibly attached) to a medical device 10.
Claim 11
The combination of Guo and Hebert teaches: The embolization device of claim 1, see 103 rejection above. Guo further discloses: further comprising a mandrel 12 (see Figs. 1-6, [0072]) disposed in the interior region inner cavity (see Figs. 1-6, [0072]).
Claim 21
The combination of Guo and Hebert teaches: The embolization device of claim 1, see 103 rejection above. Guo further discloses: wherein the deployed configuration (see Fig. 2 and 3B) of the elongated sleeve 11 exhibits a spiral shape the spiral shape of 11 (see Fig. 3B) that is continuous from a distal terminal end 14 (see Fig. 1, 2, and 3b, [0063]) of the elongated sleeve 11 to a proximal terminal end 13 (see Fig. 1, 2, and 3B, [0063]) of the elongated sleeve 11.
Claim 22
The combination of Guo and Hebert teaches: The embolization device of claim 1, see 103 rejection above. Guo further discloses: wherein the deployed configuration (see Fig. 3B) of the elongated sleeve 11 exhibits a spiral shape the spiral shape of 11 (see Fig. 3B) having a spacing (see annotated Fig. 3b below) between adjacent portions adjacent spirals of 11 don’t touch (see Fig. 3B) of the elongated sleeve 11.
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Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Guo in view of Hebert as applied to claim 1 above, and further in view of Hewitt et al (US 20180206849 A1), herein referenced to as “Hewitt”.
Claim 10
The combination of Guo and Hebert teaches: The embolization device of claim 1, see 103 rejection above. Guo further discloses: wherein the plurality of wires filaments define a plurality of pores mesh openings (see Figs. 1-6, [0054]) therebetween.
The combination of Guo and Hebert does not explicitly teach: and, further comprising a plurality of fibers disposed in at least some of the plurality of pores.
However, Hewitt in a similar field of invention teaches an embolization device 10 (see Fig. 36) with a plurality of wires 14 (see Figs. 36-37) defining a plurality of pores the pores defined by 14 (see Fig. 37). Hewitt further teaches: further comprising a plurality of fibers 200 (see Figs. 36-37, [0210], non-structural fibers/microfibers) disposed in at least some of the plurality of pores the pores defined by 14 (see Fig. 37, [0210]).
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 Guo to incorporate the teachings of Hewitt and teach an embolization device with a plurality of fibers disposed in at least some of the plurality of pores. Motivation for such can be found in Hewitt as these additional non-structural fibers facilitate fixation, healing, fibrosis, or thrombosis (see [0209]).
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