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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/30/2026 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 04/30/2026. As directed by the amendment: claim 1 have been amended claims 12-20 remain withdrawn. Thus, claims 1-20 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see pages 6-8, filed 04/30/2026, with respect to the rejection(s) of claim(s) 1-11 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” have been fully considered and are persuasive.
The applicant amended claim 1 to further recite “wherein the cup-shaped member includes an open end and extends between the inner layer and the outer layer to define a concave interior region”.
The applicant argues that Pecor does not explicitly teach that the cup-shaped member includes an open end and extends between the inner layer and the outer layer to define a concave interior region. The examiner agrees, that Pecor does not explicitly teach that the cup-shaped member defines a concave interior region.
Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Hallisey in view of Pecor and Rashidi (US 20230277184 A1), herein referenced to as “Rashidi”.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “wherein the cup-shaped member includes an open end and extends between the inner layer and the outer layer to define a concave interior region” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claim limitation “wherein the cup-shaped member includes an open end and extends between the inner layer and the outer layer to define a concave interior region” does not explicitly have support within the applicant’s written specification. Specifically, there is no specific indication that the cup-shaped member of the application has a concave interior region (see [0027] and [0051]-[0061] of published application). Additionally, the applicant’s specification notes that the drawings or figures represented within the published application are not necessarily drawn to scale unless specifically indicated and furthermore, the interior region of the cup-shaped member is not specifically shown in the figures. The closest is Fig. 3C, but only a distal open end is shown, without showing a concave interior region.
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” and Rashidi (US 20230277184 A1), herein referenced to as “Rashidi”.
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, wherein the cup-shaped member includes an open end and extends between the inner layer and the outer layer to define a concave interior region.
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, wherein the cup-shaped member 2416 includes an open end (see Fig. 19, 2416 has an open end positioned towards the distal end) and extends between the inner layer first portion of the mesh and the 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).
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, wherein the cup-shaped member includes an open end and extends between the inner layer and the outer layer. 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]).
The combination of Hallisey and Pecor does not explicitly teach: to define a concave interior region.
However, Rashid in a similar field of invention teaches an embolization device 100 (see Figs. 1A-1B and 3A-3C) with a braided lattice 102 (see Figs. 1A-1B and 3A-3C) with an inner layer 112 (see Figs. 1A-B and 3A-3C) and an outer layer 114 (see Figs. 1A-1B and 3A-3C) with a cup-shaped member 104 (see Figs. 1A-1B and 3A-3C) disposed between the inner layer 112 (see Figs. 1A-1B and 3A-3C) and the outer layer 114 (see Figs. 1A-1B and 3A-3C, [0083]) and having an open end (see Figs. 1A-1B and 3A-3C, 104 has an open distal end). Rashid further teaches: to define a concave interior region 116 part of the distal side of 104 (see Figs. 1B and 3A-3C, [0083], 104 conforms the shape of 116, [0078] which is defined by 112 and 114, [0079], and 112 serves as the inner concave surface of the bowl structure, hence the distal side of 104 conforms to 116, the distal/upper side of which 112 is concave).
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 cup-shaped member of Hallisey and Pecor to incorporate the teachings of Rashid and teach an embolization device with the cup-shaped member defines a concave interior region. Motivation for such can be found in Rashid as this helps shape a rounded, atraumatic shape to avoid tissue damage when introducing the mesh into an aneurysm or other tissue (see [0079]).
Claim 2
The combination of Hallisey, Pecor, and Rashid 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, Pecor, and Rashid 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, Pecor, and Rashid 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, Pecor, and Rashid 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, Pecor, and Rashid 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, Pecor, and Rashid 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.
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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, Pecor, and Rashid 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).
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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, Pecor, and Rashid 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).
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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, Pecor, and Rashid 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, Pecor, and Rashid 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kroeger et al (US 20200000476 A1), teaches a vascular embolization device with a positioning a layer within two other layers, and having an open end
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.
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RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/Examiner, Art Unit 3771
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