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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 October 20th 2025 has been entered.
Claim Objections
Claims 1-20 are objected to because of the following informalities:
Each independent claim uses both the terms “occlusive element” and “occlusive member” to describe the same structure. Only one of these terms should be used throughout the claims for consistency of claim terminology and clarity.
Appropriate correction is required.
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 non-obviousness.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Khairkhahan (US 2002/0111647) in view of Hedberg et al. (US 2013/0306232). Alternatively, claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Khairkhahan (US 2002/0111647) in view of Hedberg et al. (US 2013/0306232) and Case et al. (US 2004/0225348).
Regarding claim 1, Khairkhahan discloses a medical implant (10), comprising: an expandable framework (14/196; Figure 6) configured to shift between a collapsed configuration and an expanded configuration (¶[0045]), the expandable framework comprising a plurality of interconnected struts (17 and 196; ¶[0046]) defining a disc portion (11) and a body portion (194), the disc portion including a first side (at “17” and “14” - Figure 6) facing the body portion and an opposing second side (at “216”); and an occlusive element (15) extending over the opposing second side of the disc portion and extending between the disc portion and the body portion (¶[0047]; Figure 6).
Khairkhahan fails to disclose a plurality of securement members as claimed but suggests a variety of means for attaching the occlusive element to the framework (¶[0047]).
Hedberg et al. disclose a securement member (1000; Figure 10A) for securing an occlusive element (1008) to a framework (1006) which saves cost and labor (¶[0008]). The securement member having a base portion (e.g. from “1002” to “1002” in Figure 10A) projecting from an expandable frame work (1006) and a tip portion (1004) and a body portion (from “1002” to “1004” - Figure 10A) therebetween, wherein the securement member extends through an occlusive element to secure it to the framework (evident from Figure 10A). Note that Figures 5, 6A, 6B, 9B, 10B and 10C meet the above limitations as well; having portions extending through the occlusive element (e.g. see members 506 in Figure 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used a plurality of the securement members of Hedberg et al. to secure the occlusive element of Khairkhahan to the framework as claimed in order to save cost and labor.
Khairkhahan as modified by Hedberg et al. fails to disclose that the securement members are integrally formed with the expandable framework. Khairkhahan discloses that the securement member may be reflowed onto and/or adhesively bonded to the framework (¶[0065]).
Applicant has not disclosed any advantage gained by integrally forming the securement members with the framework over other attachment means (¶[0067] of the published Application) such as those disclosed by Khairkhahan.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have integrally formed the securement members of Hedberg et al. with the framework of Khairkhahan since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art. Howard v. Detroit Stove Works, 150 U.S. 164 (1893).
Alternatively or additionally, Case et al. teach that wires, clips, rings and other suitable means for attaching an occlusive element to a framework (e.g. see member 122 wrapped around strut 110 to attach it to graft 114 - Figure 4) may be integrally formed with or separately attached to the framework as suitable alternative attachment means (¶[0063]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention and in view of Case et al. to have integrally formed the securement members of Hedberg et al. with the framework of Khairkhahan since it has been held that substitution of equivalent means for performing the same function of a prior invention is not patentable (MPEP 2144.05 (ll)(A)).
Regarding claim 2, the occlusive member wraps around the disk portion and extends over at least a portion of the first side of the disc portion (evident from Figure 6 of Khairkhahan).
Regarding claim 3, the occlusive member extends far enough over the first side of the disc portion to be secured the plurality of securement members (evident from Figure 6 of Khairkhahan where the securement members would be positioned throughout both sides of the disk).
Regarding claim 4, the base portion of each of the plurality of securement members are attached to at least one of the plurality of struts defining the disc portion (as evident from Figure 10A of Hedberg et al. - member 1006 being analogous to the struts of Khairkhahan).
Regarding claim 5, the body portion of one or more of the plurality of securement members is aligned with at least one of the plurality of struts defining the disc portion (the side of the body portion facing the struts would be flush and aligned with the strut as evident from Figure 10A of Hedberg et al.).
Regarding claim 6, the expandable framework includes a central longitudinal axis, and wherein the body portion of one or more of the plurality of securement members extends toward the central longitudinal axis (evident from Figure 6 of Khairkhahan and Figure 10A of Hedberg et al.)
Regarding claim 7, the occlusive member includes one or more apertures extending from an inner surface of the occlusive member to an outer surface of the occlusive member, and wherein each of the one or more apertures is configured to receive one of the plurality of securement members (the securement members extend through the occlusive member as evident from Figure 10A of Hedberg et al. and would form apertures as claimed).
Regarding claim 8, at least one of the plurality of securement members extends through each of the one or more apertures, and wherein the plurality of securement members secures the occlusive member to the expandable framework (the securement members extend through the occlusive member as evident from Figure 10A of Hedberg et al. and would form apertures as claimed).
Regarding claim 9, part of the body portion of one or more of the plurality of securement members extends along the outer surface of the occlusive element (the portion on the side at “1008” in Figure 10A of Hedberg et al. can be considered as part of the body portion).
Regarding claim 10, the body portion of one or more of the plurality of securement members is offset radially outward from the tip portion, base portion or both the tip portion and the base portion of its respective securement member (the portion on the side at “1008” in Figure 10A of Hedberg et al. can be considered as part of the body portion).
Regarding claim 11, the body portion of one or more of the plurality of securement members extends radially inward from the tip portion, base portion or both the tip portion and the base portion of its respective securement member (see the portion at “1002” in Figure 10A, this portion in the Figure 10C embodiment of Hedberg et al. can be considered as part of the body portion and is radially inward of the tip).
Regarding claim 12, the tip portion of one or more of the plurality of securement members extends radially inward from the body portion, base portion or both the body portion and the base portion of its respective securement member (the portion on the side at “1008” in Figure 10A of Hedberg et al. can be considered as the body portion - the tip 1004 extends radially inward from this portion).
Regarding claim 13, the base portion of one or more of the plurality of securement members extends radially inward from the tip portion, body portion or both the tip portion and the body portion of its respective securement member (the base portion at “1000” in Figure 10A of Hedberg et al. extends radially inward from the tip portion 1004; note that the occlusive element of Khairkhahan can be external to the framework - ¶[0076]).
Regarding claim 14, one or more of the plurality of securement members each have a barb projecting circumferentially therefrom (e.g. member 1004 in Figure 10C of Hedberg et al. can be considered as a barb as claimed or one end 1004 of the head 1010 in Figure 10B can be considered as the barb as claimed).
Regarding claim 15, the barb projects from the body portion of its respective securement member (e.g. the barb in Figure 10B of Hedberg et al. projects from both the tip and the body portion).
Regarding claim 16, the limitations have been effectively addressed above.
Regarding claim 17, an inner surface of the occlusive element is in contact with an outer surface of the plurality of interconnected struts (the occlusive element can be on both sides of the struts - ¶[0047] of Khairkhahan; alternatively the occlusive element can be external to the struts - ¶[0076]), and a portion of the outer surface of the occlusive element lies against the body portion of the plurality of securement members (the portion of the securement member lying against the side at “1008” in Figure 10C of Hedberg et al. can be considered as the body portion and would lie against the outer surface of the occlusive element of Khairkhahan as claimed).
Regarding claim 18, the tip portion of one or more of the plurality of securement members is configured to pierce the occlusive element (the securement members of Hedberg et al. are made of metal - ¶[0066], and pointed - Figure 10A and would be capable of piercing the fabric occlusive element of Khairkhahan).
Regarding claim 19, the body portion of one or more of the plurality of securement members is offset radially outward from the tip portion, base portion or both the tip portion and the base portion of its respective securement member (the portion of the securement member on the side at “1008” in Figure 10A of Hedberg et al. can be considered as the body portion - the tip 1004 extends radially inward from this portion).
Regarding claim 20, in addition to the limitations already effectively addressed above in regard to previous claims, the occlusive member has an inner surface and an outer surface; wherein one or more of the plurality of securement members would extend through the occlusive member from the inner surface to the outer surface and wherein the same securement member extends through the occlusive member from the outer surface to the inner surface to secure the occlusive element to the first side of the disc portion of the framework (evident from the above combination and Figure 10A of Hedberg et al. showing the securement member extending out through the substrate 1008 and then back into the substrate).
Claims 1-13 and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Khairkhahan (US 2002/0111647) in view of Case et al. (US 2004/0225348).
Regarding claim 1, Khairkhahan discloses a medical implant (10), comprising: an expandable framework (14/196; Figure 6) configured to shift between a collapsed configuration and an expanded configuration (¶[0045]), the expandable framework comprising a plurality of interconnected struts (17 and 196; ¶[0046]) defining a disc portion (11) and a body portion (194), the disc portion including a first side (at “17” and “14” - Figure 6) facing the body portion and an opposing second side (at “216”); and an occlusive element (15) extending over the opposing second side of the disc portion and extending between the disc portion and the body portion (¶[0047]; Figure 6).
Khairkhahan fails to disclose a plurality of securement members as claimed but suggests a variety of means for attaching the occlusive element to the framework (¶[0047]).
Case et al. disclose a securement member (1104; Figures 18-21) for securing an occlusive element (1106) to a framework (1102) which helps clamp the occlusive element to the framework (¶[0087]). The securement member having a base portion (all portions of member 1104 beneath the graft 1106 in Figure 21) integrally formed with (¶[0063]) and projecting from an expandable frame work (1102) and a tip portion (all portions to the right of “1104” in Figure 21) and a body portion (all portions between “1104” and the base portion) therebetween.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used a plurality of the securement members of Case et al. to secure the occlusive element of Khairkhahan to the framework as a suitable prior art attachment means suitable for the intended purpose of Khairkhahan (MPEP 2144.03).
Regarding claim 2, the occlusive member wraps around the disk portion and extends over at least a portion of the first side of the disc portion (evident from Figure 6 of Khairkhahan).
Regarding claim 3, the occlusive member extends far enough over the first side of the disc portion to be secured the plurality of securement members (evident from Figure 6 of Khairkhahan where the securement members would be positioned throughout both sides of the disk).
Regarding claim 4, the base portion of each of the plurality of securement members are attached to at least one of the plurality of struts defining the disc portion (as evident from Figure 10A of Hedberg et al. - member 1006 being analogous to the struts of Khairkhahan).
Regarding claim 5, the body portion of one or more of the plurality of securement members is aligned with at least one of the plurality of struts defining the disc portion (the body portions would be aligned with all struts to which they are attached as evident from Figures 18 and 21 of Case et al.).
Regarding claim 6, the expandable framework includes a central longitudinal axis, and wherein the body portion of one or more of the plurality of securement members extends toward the central longitudinal axis (the occlusive element can be internal of the struts - ¶[0076] of Khairkhahan; therefore, the body portion as defined above would have a portion extending toward the central longitudinal axis as evident from Figure 21 of Case et al.)
Regarding claim 7, the occlusive member includes one or more apertures extending from an inner surface of the occlusive member to an outer surface of the occlusive member, and wherein each of the one or more apertures is configured to receive one of the plurality of securement members (the securement members extend through the occlusive member as evident from Figure 21 of Case et al. and would therefore form apertures as claimed).
Regarding claim 8, at least one of the plurality of securement members extends through each of the one or more apertures, and wherein the plurality of securement members secures the occlusive member to the expandable framework (the securement members extend through the occlusive member as evident from Figure 21 of Case et al. and would form apertures as claimed).
Regarding claim 9, part of the body portion of one or more of the plurality of securement members extends along the outer surface of the occlusive element (the occlusive element can be external of the struts - ¶[0076] of Khairkhahan).
Regarding claim 10, the body portion of one or more of the plurality of securement members is offset radially outward from the tip portion, base portion or both the tip portion and the base portion of its respective securement member (the occlusive element can be internal or external of the struts - ¶[0076] of Khairkhahan; therefore the body portion would be offset radially outward of the base or tip depending on whether the struts are internal or external - as evident from Figure 21 of Case et al.).
Regarding claim 11, the body portion of one or more of the plurality of securement members extends radially inward from the tip portion, base portion or both the tip portion and the base portion of its respective securement member (the occlusive element can be internal or external of the struts - ¶[0076] of Khairkhahan; therefore the body portion would extend radially inward of the base or tip depending on whether the struts are internal or external - as evident from Figure 21 of Case et al.).
Regarding claim 12, the tip portion of one or more of the plurality of securement members extends radially inward from the body portion, base portion or both the body portion and the base portion of its respective securement member (the occlusive element can be internal or external of the struts - ¶[0076] of Khairkhahan; therefore the tip portion would extend radially inward from the body and base when the occlusive element is internal - as evident from Figure 21 of Case et al.).
Regarding claim 13, the base portion of one or more of the plurality of securement members extends radially inward from the tip portion, body portion or both the tip portion and the body portion of its respective securement member (the occlusive element can be internal or external of the struts - ¶[0076] of Khairkhahan; therefore the base portion would extend radially inward from the tip and body when the struts are internal - as evident from Figure 21 of Case et al.).
Regarding claim 16, the limitations have been effectively addressed above.
Regarding claim 17, an inner surface of the occlusive element is in contact with an outer surface of the plurality of interconnected struts (the occlusive element can be on both sides of the struts - ¶[0047] of Khairkhahan; alternatively the occlusive element can be external to the struts - ¶[0076]), and a portion of the outer surface of the occlusive element lies against the body portion of the plurality of securement members (evident from Figure 21 of Case et al. given the structure of the body portion described above).
Regarding claim 18, the tip portion of one or more of the plurality of securement members is configured to pierce the occlusive element (the securement members of Case et al. are pointed - Figure 18, and would be made of metal - ¶[0046] of Khairkhahan; the securement members would therefore be capable of piercing the fabric occlusive element of Khairkhahan).
Regarding claim 19, the body portion of one or more of the plurality of securement members is offset radially outward from the tip portion, base portion or both the tip portion and the base portion of its respective securement member (the occlusive element can be internal or external of the struts - ¶[0076] of Khairkhahan; the body portion would be offset radially outward from the tip or base depending on whether the struts are internal or external as evident from Figure 21 of Case et al.).
Response to Arguments
Applicant has argued that Hedberg et al. disclose staples and therefore they would or could not be formed integrally with the framework of Khairkhahan. There is no disclosure in Hedberg et al. that the staple embodiments must be attached in any manner that would prevent being them being integrally formed with the framework. Furthermore, several of the embodiments, such as Figure 5, are readable by the claims and are disclosed as anchors rather than staples. The remainder of Applicant’s arguments are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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/THOMAS MCEVOY/Primary Examiner, Art Unit 3771