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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/04/2026 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 05/04/2026. As directed by the amendment: claims 1, 7, and 21-22 have been amended and claims 12-20 remain withdrawn. Thus, claims 1-22 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see pages 6-9, filed 05/04/2026, with respect to the rejection(s) of 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” have been fully considered and are persuasive.
The applicant has amended claim 1 to further recite “wherein the embolization device exhibits a conical helix shape in the deployed configuration”. The applicant argues that the combination of Guo and Hebert does not explicitly teach this amended limitation. Specifically, that Guo teaches a cylindrical shape, which is a non-conical shape as the outer diameter of the first spiral shape is equal to the outer diameter of third spiral shape. They further argue that Herbert does not teach a conical shape.
The examiner agrees.
Therefore, the rejection has been withdrawn.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 and Jayaraman (US 20050187564 A1).
Applicant's arguments, see pages 9-10, filed 05/04/2026 have been fully considered but they are not persuasive. In regards to the USC 103 rejection of claim 11, see arguments above in regards to claim 1, which claim 11 is dependent on. The applicant further argues that Guo in view of Herbert does not teach “a mandrel disposed in the interior region”. They argue that the guide structure 12, is not a mandrel as described in claim 11. The examiner respectfully disagrees.
Firstly, the guide structure 12, is in an interior region of 11 (see Figs. 1-6, a portion of 12 is within the inner cavity, see [0072], hence 12 is in an interior region of 11). Secondly, the guide structure 12 meets the definition of mandrel according to the online Merriam-Webster dictionary as “a metal bar that serves as a core around which material (such as metal) may be cast, molded, forged, bent, or otherwise shaped” as the guide structure 12 is a cylindrical linear member (see [0078]) formed of spring coil, which is a metal, with 11 shaped/braided around 12.
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” and Jayaraman (US 20050187564 A1), herein referenced to as “Jayaraman”.
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, wherein the embolization device exhibits a conical helix shape in the deployed configuration.
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]).
The combination of Herbert and Guo does not explicitly teach: wherein the embolization device exhibits a conical helix shape in the deployed configuration.
However, Jayaraman in a similar field of invention teaches an embolization device 10 (see Figs. 1-5) with a wire 20 (see Figs. 1-5) with an elongated configuration (see [0020], unexpanded shape is substantially linear) and a deployed configuration (see Figs. 1-5, [0020], expanded shape). Jayaraman further teaches: wherein the embolization device 10 exhibits a conical helix shape (see Figs. 1-5, [0020], substantially conical, [0074], a conical helix shape, as the coil is a helix, in a conical shape with tapering from one end to the other) in the deployed configuration (see Figs. 1-5, [0020] and [0074]).
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 embolization device in the deployed configuration of Herbert to incorporate the teachings of Jayaraman and teach an embolization device with a conical helix shape in the deployed configuration. Motivation for such can be found in Jayaraman as coils that randomly form expanded shapes result in an indeterminate number of coils required to close a given defect (see [0008]) and that by choosing the shape of a device, such as helical/conical shape allows better results when the proper shape is applied to a complementary defect (see [0017]) and for example, a conical shape is most appropriate for a PDA congenital defect (see [0094]).
Claim 2
The combination of Guo, Hebert, and Jayaraman 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, Hebert, and Jayaraman 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, Hebert, and Jayaraman 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, Hebert, and Jayaraman 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, Hebert, and Jayaraman 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, Hebert, and Jayaraman teaches: The embolization device of claim 1, see 103 rejection above. The combination of Guo and Jayaraman further teaches: wherein the conical helix shape (Guo as modified by Jayaraman, see Figs. 1-5, has a conical shape) that extends from a distal terminal end 14 (the modification results in the shape starting from Guo’s distal terminal end, which begins the shape of Guo as well, 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, Hebert, and Jayaraman 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, Hebert, and Jayaraman 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, Hebert, and Jayaraman teaches: The embolization device of claim 1, see 103 rejection above. Guo further discloses: further comprising a mandrel 12 (see Figs. 1-6, [0072], the guide structure 12 meets the definition of mandrel according to the online Merriam-Webster dictionary as “a metal bar that serves as a core around which material (such as metal) may be cast, molded, forged, bent, or otherwise shaped” as the guide structure 12 is a cylindrical linear member (see [0078]) formed of spring coil, which is a metal, with 11 shaped/braided around 12) disposed in the interior region inner cavity (see Figs. 1-6, [0072]).
Claim 21
The combination of Guo, Hebert, and Jayaraman teaches: The embolization device of claim 1, see 103 rejection above. The combination of Guo and Jayaraman further teaches: wherein the conical helix shape (Guo as modified see Figs. 1-5 of Jayaraman) of the elongated sleeve 11 in the deployed configuration 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 (see also Jayaraman, Figs. 1-5, the conical helix shape is continuous and uninterrupted).
Claim 22
The combination of Guo, Hebert, and Jayaraman teaches: The embolization device of claim 1, see 103 rejection above. The combination of Guo and Jayaraman further teaches: wherein the conical helix shape (Guo as modified see Figs. 1-5 of Jayaraman) of the elongated sleeve 11 in the deployed configuration (see Fig. 3B) of the elongated sleeve 11 has 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 (furthermore the conical helix shape of Jayaraman has spacings in between the turns, see Figs. 1-5).
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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 and Jayaraman 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, Hebert, and Jayaraman 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, Hebert, and Jayaraman 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Jayaraman (US 20020010481 A1) teaches an embolization device with a conical helix shape in the deployed configuration (see Figs. 1-5)
Maitland et al (US 20190015108 A1) teaches an embolization device with a conical helix shape in the deployed configuration (see Fig. 10)
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 8:00 AM - 5:00 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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
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