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 Arguments
Applicant’s arguments with respect to the claim(s) have been considered but 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. The prior art of Rosenbluth is now being relied on as the claimed relative dimensions are more clearly illustrated in the prior art of Rosenbluth.
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) 2-8, 13, and 16-23 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Rosenbluth et al. (US 2014/0058436). Regarding claim 2, Rosenbluth discloses an occlusive device ([0056] – occludes a portion of an aneurysm) comprising a first enlarged diameter region (see below), a second enlarged diameter region (see below), a reduced diameter region between the first and second enlarged diameter regions (see below), and a cylindrical inner braid portion (portion of 16 labelled) comprising a passage extending at least a portion through the first enlarged diameter region, the second enlarged diameter region, and the reduced diameter region, wherein the passage has a substantially consistent diameter throughout, and a length of the cylindrical inner braid portion is less than a width of the first and second enlarged diameter regions. It is noted that the claimed cylindrical inner braid portion is considered only a portion of inner braid member 16 as labelled below. It is further noted that the claim requires that the inner braid portion comprises a passage extending at least a portion through the first and second enlarged diameter regions and the reduced diameter regions, but not entirely through these regions.
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Regarding claims 3 and 4, the first and second enlarged diameter regions have a first disc shape and a second disc shape, respectively (see fig. 8)
Regarding claim 5, the first enlarged diameter region is a substantially similar shape as the second enlarged diameter region (see fig. 8)
Regarding claim 6, the first enlarged diameter region and the second enlarged diameter region each comprise a substantially similar diameter (see fig. 8, where labelled 1st and 2nd enlarged diameter regions are considered to have a substantially similar diameter).
Regarding claim 7, the first enlarged diameter region and the second enlarged diameter region each comprise a substantially similar length (see fig. 8).
Regarding claim 8, the passage comprises a continuous lumen extending between and through the first enlarged diameter region, the second enlarged diameter region, and the reduced diameter region (see annotated figure below, which is relied upon for claim 8 only. Although patent drawings do not define precise proportions of the elements when there is no disclosure that the drawings are drawn to scale, they can be relied upon for what they would reasonably teach one of ordinary skill in the art. The length of the cylindrical inner braid portion labelled below, which forms a continuous lumen between and through the 1st and 2nd enlarged diameter regions, and reduced diameter region, is only about half the diameter of each of the 1st and 2nd enlarged diameter regions as illustrated and thus it is understood to be less than the diameters;).
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Regarding claim 13, discloses an occlusive device comprising a proximal neck bridge, a distal neck bridge, a linkage portion between the proximal and distal neck bridges (see annotated figure below) and a cylindrical inner braid portion (16 between dotted lines in annotated figure below) comprising a continuous lumen extending at least a portion through the proximal neck bridge, the distal neck bridge, and the linkage portion, wherein the continuous lumen has a substantially consistent diameter throughout.
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Regarding claims 16 and 17, in a delivery configuration, an embolic agent is able to be pushed through the continuous lumen into a treatment site, wherein the embolic agent comprises an embolic coil. Note that the embolic agent is not positively recited in combination with the device. Because an embolic coil could be pushed through the continuous lumen and pushed into a treatment site downstream of the device, it meets this recitation of intended use.
Regarding claim 18, each of the proximal neck bridge and the distal neck bridge comprises a larger width or diameter than the linkage portion (fig. 8).
Regarding claim 19, each of the proximal neck bridge and the distal neck bridge has a disc shape, and wherein the linkage portion comprises a cylindrical portion (fig. 8).
Regarding claim 20, Rosenbluth discloses an occlusive device comprising a proximal neck bridge, a distal neck bridge, a linkage means for connecting the proximal and distal neck bridges (see examiner-annotated figure above, noting that the portion labelled “linkage portion” is considered the “linkage means” of claim 20), and a cylindrical inner braid portion (portion of 16 between dotted lines in annotated figures) comprising a means for forming a continuous lumen (tubular braid, which corresponds to structure invoked by 35 USC 112f) extending at least a portion through the proximal neck bridge and the distal neck bridge, wherein the continuous lumen has a substantially consistent diameter throughout (see examiner-annotated fig. 8 above).
Regarding claim 21, the proximal neck bridge has a disc shape, wherein the distal neck bridge has a disc shape, and wherein the linkage means has a cylindrical portion having a diameter which is less than a width or diameter of each of the proximal neck bridge and the distal neck bridge (see fig. 8).
Regarding claim 22, the cylindrical inner braid portion comprises a consistent diameter along a longitudinal length of the occlusive device (fig. 8), wherein the consistent diameter is less than a first diameter of the first enlarged diameter region and a second diameter of the second enlarged diameter region.
Regarding claim 23, the occlusion device further comprises: a third enlarged diameter region; and a second reduced diameter region between the second enlarged diameter region and the third enlarged diameter region, wherein the passage (defined by the cylindrical inner braid portion) is through the third enlarged region and the second reduced diameter region. See the examiner-annotated figure below, which is being relied upon for only claim 23. (Although patent drawings do not define precise proportions of the elements when there is no disclosure that the drawings are drawn to scale, they can be relied upon for what they would reasonably teach one of ordinary skill in the art. Note that the length of the cylindrical inner braid portion labelled below is illustrated as only about half the diameter of the 1st and 2nd enlarged diameter regions and thus it is understood that its length is less than the diameter of the 1st and 2nd enlarged diameter regions.)
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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.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable Rosenbluth. Regarding claim 12, Rosenbluth discloses the invention substantially as stated above including that the reduced diameter region has a cylindrical shape having a diameter which is less than the diameter of each of the first enlarged diameter region and the second enlarged diameter region (see 1st annotated figure above). Rosenbluth does not expressly disclose that the diameter of the reduced diameter region is less than half of the diameter of each of the first and second enlarged diameter regions. However, such a modification to the prior art of Rosenbluth would have been considered obvious to one of ordinary skill in the art since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984, cert. denied, 468 U.S. 830, 225,SPQ 232 (1984). Additionally, the figures of Rosenbluth suggest a large diameter difference between the reduced diameter region and the first and second enlarged diameter region, and thus one skilled in the art would have had a reasonable expectation of success when making such a modification to the prior art of Rosenbluth.
Claim(s) 9, 10, 14, and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable Rosenbluth in view of Bashiri (US 2005/0131523). Rosenbluth discloses the invention substantially as stated above including that the cylindrical inner braid portion forms the continuous lumen, but does not expressly disclose that the continuous lumen connects to a capsule comprising a degradable linkage.
Bashiri discloses that it is known to connect an expandable medical device such as a stent to a capsule (32) of the delivery device, the capsule comprising a degradable linkage (see figs. 3, 4 and par. [0055], [0057] – electrolytic corrosion or bioabsorption). In this manner, the stent can be advanced to the intended target site via the delivery device and released from the delivery device once proper positioning is attained. It would have been obvious to one of ordinary skill in the art to have modified the prior art of Rosenbluth to include a capsule comprising a degradable linkage as taught by Bashiri in order to facilitate delivery and release of the occlusive device of Rosenbluth. Because the capsule is connected to the occlusive device as taught by Bashiri, it is considered connected to all parts of the occlusive device including the cylindrical inner braid portion of the device of Rosenbluth.
Claim(s) 24-26 is/are rejected under 35 U.S.C. 103 as being unpatentable Rosenbluth in view of Lorenzo (US 2015/0272589). Rosenbluth discloses the invention substantially as stated above including that the cylindrical inner braid portion comprises a passage, but does not expressly disclose that the passage separately connects to the lumen of a catheter through a capsule, or that the occlusive device detachably connects to the catheter at the first enlarged diameter region.
Lorenzo discloses that it is known to deliver an occlusive device (20) with a catheter (14), the occlusive device having a passage that connects to the lumen of a catheter through a capsule (fingers 32,34; figs. 2, 5), the occlusive device being detachably connected to the catheter at a proximal end of the occlusive device (figs. 2, 5). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Rosenbluth to include a catheter detachably connected to the occlusive device at a distal end through a capsule as taught by Lorenzo in order to facilitate a low-profile, minimally invasive delivery of the expandable occlusive device of Rosenbluth. With such a modification, the occlusive device of Rosenbluth detachably connects to the catheter at the first enlarged diameter region since the first enlarged diameter region can be considered the proximal end region of the device of Rosenbluth that includes the proximal-most enlarged region (28d).
Regarding claim 25, when in a delivery configuration, an embolic agent is configured to be delivered to a treatment site via the passage at a distal end of the second enlarged diameter region of the prior art of Rosenbluth as modified by Lorenzo. Noting that this is a recitation of intended use, the prior art must only be capable of performing this function. Since the passage of the occlusive device of Rosenbluth extends through the entire length of the occlusive device, embolic agent may be delivered to a treatment site via the passage at a distal end of the second enlarged diameter region.
Regarding claim 26, the limitation “wherein the treatment site corresponds to an aneurysm of a patient using the occlusive device, wherein the embolic agent comprises an embolic coil, and wherein when in the delivery configuration, the second enlarged diameter region being configured to prevent the embolic coil from falling out of the aneurysm” is a recitation of intended and the embolic agent is not positively recited in combination with the device. Because the prior art device of Rosenbluth in view of Lorenzo is capable of being placed in an aneurysm in a manner in which the second enlarged diameter region prevents an embolic coil that has been delivered to the aneurysm via the passage from falling out of the aneurysm (e.g., if positioned within an aneurysm in a similar manner to figs. 1, 12, or 36 of the instant application), it meets this recitation of intended use.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 KATHLEEN SONNETT HOLWERDA whose telephone number is (571)272-5576. The examiner can normally be reached M-F, 8-5, with alternate Fridays off.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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KSH 2/25/2026
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771