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 12/23/2025. As directed by the amendment: claims 3 and 6 has been amended and claims 12-20 remain withdrawn. Thus, claims 1-20 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see page 6, filed 12/23/2025, with respect to the claim objections have been fully considered and are persuasive. The applicant’s amendments to the claims overcome the minor informalities within the claims. The claim objections have been withdrawn.
Applicant's arguments, see pages 7-10, filed 12/23/2025 have been fully considered but they are not persuasive.
The applicant argues that the combination of Hallisey and Pecor do not teach the limitations of claim 1.
They specifically argue that Pecor fails to disclose a cup-shaped member. The examiner respectfully disagrees, as seen in Fig. 19 of Pecor, 2416 is a cup-shaped member. Specifically, according to the online Merriam-Webster definition as “something resembling a cup” which is “an open usually bowl-shaped drinking vessel”. 2416 is something resembling a cup as it is open and bowl-shaped, as it is rounded with an opening. Furthermore, Pecor discloses that 2400, which 2416 adapts to the shape of is “bowl shaped” (see [0138]).
They further argue that Hallisey and Pecor are incompatible as Pecor relies on a mesh structure in which a single mesh wall is folded or doubled back on itself where Hallisey disclosed unitary braided enclosures in which embolic material is later inserted.
In response to applicant's argument that it is unclear how Pecor’s folded-mesh configuration is to be imported into Hallisey, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Furthermore, they argue that this would fundamentally change the manner is in which embolic material is introduced and retained. The examiner respectfully disagrees. Pecor states that its device 2400 has a cavity between the first and second mesh portions in which an embolic composition can be received, similar to Hallisey (see [0138]).
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) 1-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hallisey et al (US 20220054139 A1), herein referenced to as “Hallisey” in view of Pecor et al (US 20240050099 A1), herein referenced to as “Pecor”.
Claim 1
Hallisey discloses: An embolization device 100 (see Figs. 1-5, [0020] and [0030]), comprising: an embolic structure 110 (see Figs. 1-5, [0021] and [0030]) comprising a plurality of enclosures 111 (see Figs. 1-5, [0022] and [0029]-[0030]) comprising a braided lattice (see [0021], braided lattice) of nitinol wires (see [0021], nickel-titanium alloy, which is nitinol) and an embolic member 150 (see Figs. 1-5, [0022] and [0030]) disposed in the at least one enclosure 111.
Hallisey does not explicitly disclose: at least one enclosure of the plurality of enclosures including an inner layer of the braided lattice of nitinol wires, an outer layer of the braided lattice of nitinol wires, and the embolic member is a cup-shaped member disposed in the at least one enclosure between the inner layer and the outer layer of the braided lattice of nitinol wires.
However, Pecor in a similar field of invention teaches an embolization device 2400 (see Fig. 19) with at least one enclosure 2402 (see Fig. 19, [0138]) comprising a braided lattice (see [0049]) and comprises an embolic member 2416 (see Fig. 19) disposed in the at least one enclosure 2402. Pecor further teaches: the at least one enclosure 2402 including an inner layer first portion of the mesh (see Fig. 19, [0139], the membrane 2416 is sandwiched between two portions of the wall of the mesh, hence inner and outer layers) of the braided lattice mesh (see [0139]), an outer layer second portion of the mesh (see Fig. 19, [0139], the membrane 2416 is sandwiched between two portions of the wall of the mesh, hence inner and outer layers) of the braided lattice mesh, and the embolic member 2416 (see Fig. 19) is a cup-shaped member 2416 (see Fig. 19, [0139], 2416 is cup shaped, to span a neck of an aneurysm) disposed in the at least one enclosure 2402 between (see Fig. 19, [0139]) the inner layer first portion of the mesh and the outer layer second portion of the mesh of the braided lattice mesh.
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 Hallisey to incorporate the teachings of Pecor and teach an embolization device with the plurality of enclosures including an inner layer of the braided lattice of nitinol wires, an outer layer of the braided lattice of nitinol wires, and the embolic member is a cup-shaped member disposed in the at least one enclosure between the inner layer and the outer layer of the braided lattice of nitinol wires. Motivation for such can be found in Pecor as by having two layers of braided lattice, an occlusive membrane can be secured by sandwiching instead of require additional steps of welding, adhering, or otherwise coupling (see [0139]), additionally a cup-shaped member can cover the neck of an aneurysm, hence ensuring fluid impermeability of the aneurysm (see [0139]).
Claim 2
The combination of Hallisey and Pecor teaches: The embolization device of claim 1, see 103 rejection above. Pecor further teaches: wherein the cup-shaped member 2416 includes a material (see [0139]) including at least one of expanded polytetrafluoroethylene (see [0139], ePTFE), fabric (will not be examined due to being an optional claim limitation), polyester (will not be examined due to being an optional claim limitation), nylon (will not be examined due to being an optional claim limitation), or polyether block amide (will not be examined due to being an optional claim limitation).
Claim 3
The combination of Hallisey and Pecor teaches: The embolization device of claim 1, see 103 rejection above. Hallisey further discloses: wherein the at least one enclosure 111 includes a first end a first end of 111 (see Figs. 1-5) and a second end the second end of 111 (see Figs. 1-5).
Pecor further teaches: and the cup shaped member 2416 extends from the first end 2400a (see Fig. 19, [0138]-[0139]) at least halfway (see Fig. 19, [0139], 2416 spans to at least halfway as shown in Fig. 19, see [0139], it can extend all the way to 2400b or not, which includes halfway as shown in Fig. 19) to the second end 2400b (see Fig. 19, [0138]-[0139]).
Claim 4
The combination of Hallisey and Pecor teaches: The embolization device of claim 1, see 103 rejection above. Hallisey further discloses: wherein the at least one enclosure 111 is generally spherical (see Fig. 5, [0020], expanded shape is spherical).
Pecor further teaches: and the cup-shaped member 2416 is generally semispherical (see Fig. 19, [0139], 2416 is generally semispherical).
Claim 5
The combination of Hallisey and Pecor teaches: The embolization device of claim 1, see 103 rejection above. Hallisey further discloses: wherein: the plurality of enclosures 111 includes a first enclosure a first 111 (see Figs. 1-5) and a second enclosure a second 111 (see Figs. 1-5).
The combination of Hallisey and Pecor further teaches: the first enclosure including the inner layer of the braided lattice of nitinol wires, the outer layer of the braided lattice of nitinol wires (see rejection of claim 1, as combined, the enclosures of Hallisey are modified to have an inner and outer layer), and the cup-shaped member disposed in the first enclosure between the inner layer and the outer layer of the braided lattice of nitinol wires (see rejection of claim 1, as combined, Hallisey is modified to have a cup-shaped member disposed where the embolization material is, see also Hallisey [0022], the embolic material can be disposed within any number of the enclosures, including within only a subset of the total number of enclosures, hence a first enclosure can have the cup-shaped member).
Claim 6
The combination of Hallisey and Pecor teaches: The embolization device of claim 5, see 103 rejection above. The combination of Hallisey and Pecor further teaches: wherein the cup-shaped member (Hallisey is modified to have 2416 of Pecor, which as combined is disposed in the first enclosure, which a first enclosure is proximal to the second enclosure, the open end of the semi-spherical cup member is then open and oriented distally towards a second more distal enclosure) disposed in the first enclosure includes an open end oriented towards the second enclosure and a pointed tip 114 (see Fig. 1, [0021], 114 is a pointed tip) disposed at an end (the distal most end of the second more distal enclosure has the pointed tip, opposite the open end of the semi-spherical cup member) opposite the open end.
Claim 7
The combination of Hallisey and Pecor teaches: The embolization device of claim 6, see 103 rejection above. Hallisey further discloses: wherein the plurality of enclosures 111 includes a third enclosure a third 111 (see Figs. 1-5, [0020], three enclosures, this enclosure can be distal to both the second and first enclosures 111), the second enclosure a second enclosure 111 distal to the first enclosure 111 but proximal to the third enclosure 111 (see annotated Fig. 5 below) being disposed between the first enclosure a first 111 and the third enclosure a third 111.
PNG
media_image1.png
399
715
media_image1.png
Greyscale
The combination of Hallisey and Pecor further teaches: and the cup-shaped member being absent from the second enclosure and the third enclosure (Hallisey is modified to have 2416 of Pecor, which as combined is disposed in the first enclosure, and hence is absent from the second and third enclosure, as Hallisey states that the embolic material can be disposed in any number of subunits, hence only one of the subunits being included).
Claim 8
The combination of Hallisey and Pecor teaches: The embolization device of claim 6, see 103 rejection above. Hallisey further discloses: wherein the plurality of enclosures 111 includes a third enclosure a third 111 (see Figs. 1-5, [0020], three enclosures, this enclosure can be proximal to the first enclosure and the second enclosure), the first enclosure a first 111 being disposed between the third enclosure a third enclosure 111 and the second enclosure a second enclosure (see annotated Fig. 5 below).
PNG
media_image2.png
399
715
media_image2.png
Greyscale
The combination of Hallisey and Pecor further teaches: and the cup-shaped member being absent from the second enclosure and the third enclosure (Hallisey is modified to have 2416 of Pecor, which as combined is disposed in the first enclosure, and hence is absent from the second and third enclosure, as Hallisey states that the embolic material can be disposed in any number of subunits, hence only one of the subunits being included).
Claim 9
The combination of Hallisey and Pecor teaches: The embolization device of claim 6, see 103 rejection above. Hallisey further discloses: wherein the plurality of enclosures 111 includes a third enclosure a third 111 (see Figs. 1-5, [0020], three enclosures, this enclosure can be proximal to the first enclosure and the second enclosure); the first enclosure a first 111 being disposed between the third enclosure a third enclosure 111 and the second enclosure a second enclosure (see annotated Fig. 5 below).
PNG
media_image2.png
399
715
media_image2.png
Greyscale
The combination of Hallisey and Pecor further teaches: wherein the third enclosure third 111 includes an inner layer (the enclosures of Hallisey were modified by Pecor to include the inner and outer layers of mesh, which with Hallisey is a braided lattice of nitinol wires, see 103 rejection of claim 1) of the braided lattice of nitinol wires, an outer layer (the enclosures of Hallisey were modified by Pecor to include the inner and outer layers of mesh, which with Hallisey is a braided lattice of nitinol wires, see 103 rejection of claim 1) of the braided lattice of the braided lattice of nitinol wires, and a cup-shaped member (Hallisey notes that the embolic material 150, which modified by Pecor to be a cup-shaped member, can be disposed in any number of subunits 111, see [0022] of Hallisey, hence the third enclosure can additionally have a cup-shaped member with the same shape, with an open end orientated distally, towards the first enclosure, the member between the inner and outer layers of the braided lattice mesh) disposed in the third enclosure between the inner layer and the outer layer of the braided lattice of nitinol wires of the third enclosure, and the cup-shaped member of the third enclosure includes an open end oriented towards the first enclosure.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to have a second cup-shaped member in the third enclosure, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art, additionally as noted by Hallisey (see [0022]). See In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). See MPEP 2144.04 (VI-B)
Claim 10
The combination of Hallisey and Pecor teaches: The embolization device of claim 6, see 103 rejection above. The combination of Hallisey and Pecor further teaches: wherein the second enclosure second 111 includes an inner layer (the enclosures of Hallisey were modified by Pecor to include the inner and outer layers of mesh, which with Hallisey is a braided lattice of nitinol wires, see 103 rejection of claim 1) of the braided lattice of nitinol wires, an outer layer (the enclosures of Hallisey were modified by Pecor to include the inner and outer layers of mesh, which with Hallisey is a braided lattice of nitinol wires, see 103 rejection of claim 1) of the braided lattice of the braided lattice of nitinol wires, and a cup-shaped member (Hallisey notes that the embolic material 150, which modified by Pecor to be a cup-shaped member, can be disposed in any number of subunits 111, see [0022] of Hallisey, hence the second enclosure can additionally have a cup-shaped member with the same shape, with an open end orientated distally, away from the first enclosure which is proximal to the second enclosure, the member between the inner and outer layers of the braided lattice mesh) disposed in the second enclosure between the inner layer and the outer layer of the braided lattice of nitinol wires of the second enclosure, with an open end of the cup-shaped member of the second enclosure orientated away from the first enclosure.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to have a second cup-shaped member in the second enclosure, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art, additionally as noted by Hallisey (see [0022]). See In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). See MPEP 2144.04 (VI-B)
Claim 11
The combination of Hallisey and Pecor teaches: The embolization device of claim 5, see 103 rejection above. The combination of Hallisey and Pecor further teaches: wherein the cup-shaped member (Hallisey as modified by Pecor has the cup-shaped member in a first enclosure 111) disposed in the first enclosure a first 111 includes an open end oriented away from the second enclosure (see Figs. 1-5, [0022], the embolic material, which was modified to be the cup-shaped member can be present in any of the subunits of 111, hence the first enclosure 111 can be distal to a second enclosure 111, and since the cup-shaped member faces distally, the open end would be oriented away from the second enclosure 111), the cup-shaped member being absent from the second enclosure (see Figs. 1-5, [0022], the embolic material can be absent from any number of the subunits of 111, hence the cup-shaped member would be absent from those subunits).
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 RAIHAN R KHANDKER whose telephone number is (571)272-6174. The examiner can normally be reached Monday - Friday 7:00 PM - 3:00 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771