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 10/27/2025. As directed by the amendment: claims 23, 26-29, and 32-34 have been amended and claims 1-15, 25, and 31 have been cancelled. Thus, claims 23-24, 26-30, and 32-34 are presently pending in this application.
Election/Restrictions
Applicant’s election without traverse of Species M, Figs. 19, 20A, and 20B, directed to an occlusion device with a membrane between two or more layers in the reply filed on 10/27/2025 is acknowledged.
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.
In claims 23 and 29 the limitation “securing means” invokes 112(f) as “means” is modified by the functional language “securing” but is not further modified by sufficient structure. For the purpose of prior art examination this limitation will be interpreted as a mechanical restraint (see [0104] of applicant’s patent application publication).
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.
Claim(s) 16-20 and 22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Heisel et al (US 20140257374 A1), herein referenced to as “Heisel”.
Claim 16
Heisel discloses: A device 2 (see Figs. 1-2, [0024]-[0025]) for treating an aneurysm comprising an expandable mesh 20 + 22 (see Figs. 1-2, [0021], expanded state, [0025] and [0030]-[0031], collapsible) configured to be positioned in a cerebral aneurysm, the mesh 20 + 22 comprising at least two mesh layers 20 + 22 and a membrane 24 (see Figs. 1-2, [0035]) positioned between two of the at least two mesh layers 20 + 22.
The preamble, "for treating an aneurysm," merely recites intended uses of the apparatus. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Heisel meets the structural limitations of the claim, and is capable of being used to treat an aneurysm by occluding the aneurysm.
The language, "configured to be positioned in a cerebral aneurysm," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Heisel meets the structural limitations of the claim, and is capable of being placed into a cerebral aneurysm to occlude the aneurysm.
Claim 17
Heisel discloses: The device of Claim 16, see 102 rejection above. Heisel further discloses: wherein the mesh 20 + 22 is a braid (see [0027], tubular braid).
Claim 18
Heisel discloses: The device of Claim 16, see 102 rejection above. Heisel further discloses: wherein the mesh 20 + 22 has a bowl shape (see Figs. 1-2, is bowl-shaped as it has a concave part meeting the definition of bowl as defined by the online Merriam-Webster dictionary as “a bowl-shaped or concave part”).
Claim 19
Heisel discloses: The device of Claim 16, see 102 rejection above. Heisel further discloses: wherein the membrane 24 is fluid impermeable (see [0037], occlusive, hence prevents the passing of fluid).
Claim 20
Heisel discloses: The device of Claim 16, see 102 rejection above. Heisel further discloses: wherein the membrane 24 has a plurality of perforations (see [0037], semi-nonporous, meaning will have some pores).
Claim 22
Heisel discloses: The device of Claim 16, see 102 rejection above. Heisel further discloses: wherein the at least two mesh layers 20 + 22 comprise an inner layer 22 (see Fig. 2, [0025]) and an outer layer 20 (see Fig. 2, [0025]) that are continuous (see Fig. 2, 20 + 22 are continuous with one another) with one another at a distal end portion the distal end of 20 + 22 towards the bottom of Fig. 2 (distal and proximal are relative terms that are opposite of another) of the mesh.
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) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heisel in view of Warner et al (US 20190336132 A1), herein referenced to as “Warner”.
Claim 21
Heisel discloses: The device of Claim 16, see 102 rejection above. Heisel further discloses: wherein the membrane 24 comprises a polymer (see [0037], polyester, which is a polymer).
Heisel does not explicitly disclose: wherein the membrane comprises a fluoropolymer.
However, Warner in a similar field of invention teaches a device (see Fig. 23) for treating an aneurysm (see [0002] and [0028]) with mesh 300 + 320 (see Fig. 23, [0077]) with two layers 300 + 320 and membrane 310 (see Fig. 23, [0077]) positioned between (see [0077], sandwiched between) the two layers 300 + 320. Warner further teaches: wherein the membrane 320 comprises a fluoropolymer (see [0080], ePTFE, which is a fluoropolymer).
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 Heisel to incorporate the teachings of Warner and have a device for treating an aneurysm with the membrane comprising a fluoropolymer. This is due to fluoropolymer being used for membranes is common in the art (see [0080]), thus it would be obvious to combine. See in re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960) (2100).
Claim(s) 16, 22-24, 26-27, 29-30, and 32-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen et al (US 20210129275 A1), herein referenced to as “Nguyen” in view of Heisel.
Claim 16
Nguyen discloses: A device 1000 (see Figs. 10A-10C, [0285]) for treating an aneurysm (see [0210]) comprising an expandable mesh 1000a + 1000b (see Figs. 10A-10C, [0285]) configured to be positioned in a cerebral aneurysm (see [0287], aneurysm), the mesh 1000a + 1000b comprising at least two mesh layers 1000a + 1000b (see Figs. 10A-10C, [0285]).
Nguyen does not explicitly disclose: a membrane positioned between two of the at least two mesh layers.
However, Heisel in a similar field of invention teaches a device 2 (see Figs. 1-2) for occluding a bodily lumen (see [0002]) with an expandable mesh 20 + 22 with at least two layers 20 + 22. Heisel further teaches: a membrane 24 (see Figs. 1-2, [0025] and [0035]) positioned between two 20 + 22 of the at least two mesh layers 20 + 22.
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 Nguyen to incorporate the teachings of Heisel and teach a device for treating an aneurysm with a membrane positioned between two of the at least two mesh layers. Motivation for such can be found in Heisel as this membrane can provide an immediate and a long-term benefit, immediately it provides an occlusive benefit, for long-term occlusion it provides cell seeding and tissue growth such that device stability and closure is facilitated (see [0037]).
Claim 22
The combination of Nguyen and Heisel teaches: The device of claim 16, see 103 rejection above. Nguyen further discloses: wherein the at least two mesh layers 1000a + 1000b comprise an inner layer 1000b (see Figs. 10B-10C, [0285]) and an outer layer 1000a (see Figs. 10B-C, [0285]) that are continuous with one another (see Figs. 10B-10C, 1000b and 1000a are continuous at 1010) at a distal end portion 1010 (see Figs. 10A-10C, [0285]) of the mesh.
Claim 23
Nguyen discloses: An occlusive device 1000 (see Figs. 10A-10C, [0285]) for treating an aneurysm (see [0210]), the device 1000 comprising: a mesh 1000 (see Figs. 10A-10C, [0285]) configured to be implanted in an aneurysm (see [0210]) and comprising a proximal end portion the proximal end of 1000 that is coupled via a proximal coupler (see Figs. 10B-10C, [0285]), a distal end portion 1010 (see Figs. 10B-10C, [0285]), and a longitudinal axis the longitudinal axis of 1000 that extends from the proximal end of the device to the distal end (see Figs. 10B-10C) extending therebetween, the mesh 1000 defining an opening 1008 (see Figs. 10A-10C, [0286]) at the distal end portion 1010 and outer 1000a (see Figs. 10A-10C, [0285]) and inner layers 1000b (see Figs. 10A-10C, [0285]) that are continuous (see Figs. 10B-10C, 1000a and 1000b are continuous distally at 1010) with one another distally at the distal end portion 1010 of the mesh and proximally (see [0288], the first and second ends of 1000 are secured at proximal coupler to form a double layer) at the proximal end portion the proximal end of 1000 that is coupled via a proximal coupler of the mesh via a securing means proximal coupler (see [0285] and [0288], meets the 112(f) interpretation of a mechanical restraint, as a proximal coupler is a mechanical restraint); wherein the mesh 1000 is configured to transition between a collapsed state (see [0288], low profile state) for delivery to an aneurysm (see [0210]) through an elongated shaft delivery catheter (see [0288]) and an expanded, unconstrained state (see Figs. 10A-10C, [0285]) wherein, in the expanded, unconstrained state (see Figs. 10B-10C): an inner surface (see annotated Figs. 10B-C below) of the outer layer 1000a and an inner surface (see annotated Figs. 10B-C below) of the inner layer 1000b are separated by a radial distance (see annotated Figs. 10B-C below) such that the inner surfaces (see annotated Figs. 10B-C below) of the outer 1000a and inner layers 1000b enclose a cavity (see annotated Figs. 10B-C below), the inner surface (see annotated Figs. 10B-C below) of the inner layer 1000b having a first region (see annotated Figs. 10B-C below) and a second region (see annotated Figs. 10B-C below) extending from the first region (see annotated Figs. 10B-C below), and wherein the first region (see annotated Figs. 10B-C below) extends proximally from the opening 1008 and is concave towards the inner surface (see annotated Figs. 10B-C below)of the outer layer 1000a, and wherein the second region (see annotated Figs. 10B-C below) is convex towards the inner surface (see annotated Figs. 10B-C below) of the outer layer 1000a.
PNG
media_image1.png
575
1025
media_image1.png
Greyscale
Nguyen does not explicitly disclose: and a membrane positioned between the outer and inner layers.
However, Heisel in a similar field of invention teaches a device 2 (see Figs. 1-2) for occluding a bodily lumen (see [0002]) with an expandable mesh 20 + 22 with at least two layers 20 + 22. Heisel further teaches: a membrane 24 (see Figs. 1-2, [0025] and [0035]) positioned between two 20 + 22 of the at least two mesh layers 20 + 22.
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 Nguyen to incorporate the teachings of Heisel and teach a device for treating an aneurysm with a membrane positioned between two of the at least two mesh layers. Motivation for such can be found in Heisel as this membrane can provide an immediate and a long-term benefit, immediately it provides an occlusive benefit, for long-term occlusion it provides cell seeding and tissue growth such that device stability and closure is facilitated (see [0037]).
Claim 24
The combination of Nguyen and Heisel teaches: The device of claim 23, see 103 rejection above. Nguyen further discloses: wherein the mesh 1000 comprises a plurality of braided filaments 1002 (see Figs. 10A-10C, [0288]).
Claim 26
The combination of Nguyen and Heisel teaches: The device of claim 23, see 103 rejection above. Heisel further teaches: wherein the membrane 24 is fluid impermeable (see [0037], occlusive, hence prevents the passing of fluid).
Claim 27
The combination of Nguyen and Heisel teaches: The device of claim 23, see 103 rejection above. Heisel further teaches: wherein the membrane 24 has a plurality of perforations (see [0037], semi-nonporous, meaning will have some pores).
Claim 29
Nguyen discloses: An occlusive device 1000 (see Figs. 10A-10C, [0285]) for treating an aneurysm (see [0210]), the device 1000 comprising: a mesh 1000 (see Figs. 10A-10C, [0285]) configured to be implanted in an aneurysm (see [0210]) and having a proximal end portion the proximal end of 1000 that is coupled via a proximal coupler (see Figs. 10B-10C, [0285]), a distal end portion 1010 (see Figs. 10B-10C, [0285]), and a longitudinal axis the longitudinal axis of 1000 that extends from the proximal end of the device to the distal end (see Figs. 10B-10C) extending therebetween, the mesh 1000 further comprising an opening 1008 (see Figs. 10A-10C, [0286]) at the distal end portion 1010 and outer 1000a (see Figs. 10A-10C, [0285]) and inner layers 1000b (see Figs. 10A-10C, [0285]) that meet distally at the distal end portion 1010 of the mesh 1000 and proximally (see [0288], the first and second ends of 1000 are secured at proximal coupler to form a double layer) at the proximal end portion the proximal end of 1000 that is coupled via a proximal coupler of the mesh 1000 via a securing means proximal coupler (see [0285] and [0288], meets the 112(f) interpretation of a mechanical restraint, as a proximal coupler is a mechanical restraint), wherein the mesh 1000 comprises a collapsed state (see [0288], low profile state) for delivery through an elongated shaft delivery catheter (see [0288]) to the aneurysm and an expanded, unconstrained state (see Figs. 10A-10C, [0285]), and wherein, in the expanded, unconstrained state (see Figs. 10A-10C, [0285]): an inner surface (see annotated Figs. 10B-10C below) of the outer layer 1000a and an inner surface (see annotated Figs. 10B-10C below) of the inner layer 1000b are separated by a radial distance (see annotated Figs. 10B-10C below) such that the inner surfaces (see annotated Figs. 10B-10C below) of the outer 1000a and inner layers 1000b enclose a first cavity (see annotated Figs. 10B-10C below), and the outer layer 1000a defines a diameter (see annotated Figs. 10B-10C below) that increases then decreases along the longitudinal axis the longitudinal axis of 1000 that extends from the proximal end of the device to the distal end of the mesh 1000 between the proximal the proximal end of 1000 that is coupled via a proximal coupler and distal end portions 1010.
PNG
media_image2.png
575
1096
media_image2.png
Greyscale
Nguyen does not explicitly disclose: and a membrane positioned between the outer and inner layers.
However, Heisel in a similar field of invention teaches a device 2 (see Figs. 1-2) for occluding a bodily lumen (see [0002]) with an expandable mesh 20 + 22 with at least two layers 20 + 22. Heisel further teaches: a membrane 24 (see Figs. 1-2, [0025] and [0035]) positioned between two 20 + 22 of the at least two mesh layers 20 + 22.
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 Nguyen to incorporate the teachings of Heisel and teach a device for treating an aneurysm with a membrane positioned between two of the at least two mesh layers. Motivation for such can be found in Heisel as this membrane can provide an immediate and a long-term benefit, immediately it provides an occlusive benefit, for long-term occlusion it provides cell seeding and tissue growth such that device stability and closure is facilitated (see [0037]).
Claim 30
The combination of Nguyen and Heisel teaches: The device of claim 29, see 103 rejection above. Nguyen further discloses: wherein the mesh 1000 comprises a plurality of braided filaments 1002 (see Figs. 10A-10C, [0288]).
Claim 32
The combination of Nguyen and Heisel teaches: The device of claim 29, see 103 rejection above. Heisel further teaches: wherein the membrane 24 is fluid impermeable (see [0037], occlusive, hence prevents the passing of fluid).
Claim 33
The combination of Nguyen and Heisel teaches: The device of claim 29, see 103 rejection above. Heisel further teaches: wherein the membrane 24 has a plurality of perforations (see [0037], semi-nonporous, meaning will have some pores).
Claim(s) 28 and 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen in view of Heisel as applied to claim 23 and claim 29 above, and further in view of Warner.
Claim 28
The combination of Nguyen and Heisel teaches: The device of claim 23, see 103 rejection above. Heisel further teaches: wherein the membrane 24 comprises a polymer (see [0037], polyester, which is a polymer).
The combination of Nguyen and Heisel does not explicitly teach: wherein the membrane comprises a fluoropolymer.
However, Warner in a similar field of invention teaches a device (see Fig. 23) for treating an aneurysm (see [0002] and [0028]) with mesh 300 + 320 (see Fig. 23, [0077]) with two layers 300 + 320 and membrane 310 (see Fig. 23, [0077]) positioned between (see [0077], sandwiched between) the two layers 300 + 320. Warner further teaches: wherein the membrane 320 comprises a fluoropolymer (see [0080], ePTFE, which is a fluoropolymer).
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 Nguyen and Heisel to incorporate the teachings of Warner and have a device for treating an aneurysm with the membrane comprising a fluoropolymer. This is due to fluoropolymer being used for membranes is common in the art (see [0080]), thus it would be obvious to combine. See in re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960) (2100).
Claim 34
The combination of Nguyen and Heisel teaches: The device of claim 29, see 103 rejection above. Heisel further teaches: wherein the membrane 24 comprises a polymer (see [0037], polyester, which is a polymer).
The combination of Nguyen and Heisel does not explicitly teach: wherein the membrane comprises a fluoropolymer.
However, Warner in a similar field of invention teaches a device (see Fig. 23) for treating an aneurysm (see [0002] and [0028]) with mesh 300 + 320 (see Fig. 23, [0077]) with two layers 300 + 320 and membrane 310 (see Fig. 23, [0077]) positioned between (see [0077], sandwiched between) the two layers 300 + 320. Warner further teaches: wherein the membrane 320 comprises a fluoropolymer (see [0080], ePTFE, which is a fluoropolymer).
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 Nguyen and Heisel to incorporate the teachings of Warner and have a device for treating an aneurysm with the membrane comprising a fluoropolymer. This is due to fluoropolymer being used for membranes is common in the art (see [0080]), thus it would be obvious to combine. See in re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960) (2100).
Conclusion
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