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
The claims filed on September 22nd, 2025, have been entered. Claims 1-4 and 6-18 remain pending in the Application. Claim 5 has been canceled by the Applicant. Claim 18 has been added by the Applicant. The claim amendments overcome the previous 112(b) rejections.
Response to Arguments
Applicant's arguments filed September 22nd, 2025, have been fully considered but they are not persuasive.
Applicant argues that Qin et al. (Pub. No. 2019/0298387) does not disclose the limitation “a first loop; and…a plurality of second loops, each of the plurality of second loop having a respective minimum dimension less than a minimum dimension of the first loop, wherein three of the six sides in the deployed state each include an instance of the first loop and another three of the six sides in the deployed state each include a respective plurality of the second loops” because a person of ordinary skill in the art would have understood both sets of loops to have the same minimum dimensions. Examiner respectfully disagrees. While the posts 820 are the same diameter, the closed loops only extend over a single side of the cube and the open loops extend between multiple different sides, which means the open loops have a greater minimum length than the closed loops.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 18 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 18, the claim language of “three of the six sides include only the instance of the first loop” is unclear (particularly the wording “only the instance of”) because there are multiple possibilities for what is being claimed, and the claim is unclear as to which possibility is being claimed. For example, does the claim require that the three sides only have a single loop extending across all three of them, or that there is a single first loop for each of the three sides? Additionally, does the claim require that there is only a single loop of the first loop type, or that there is only a single loop of any type, or that there are only loops of the first loop type? Applicant should amend claim 18 to particularly point out what is being claimed. For the purposes of examination, the claim will be interpreted as having only loops of the first loop type, with at least one loop for each of the three sides.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 6-15, and 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Qin et al. (Pub. No. 2019/0298387).
Regarding claim 1, Qin et al. discloses an implant for vascular occlusion (850; FIGs. 8A-8B; [0089]), the implant comprising:
a coil (FIG. 8B: 850 is made of a coil) expandable from an elongated shape ([0082] coils formed by the mandrels of FIGS. 4A-16C can have a secondary shape which is formed after deployment, where the pre-deployment shape is shown in FIG. 3 as an elongated linear coil) to a deployed shape (FIG. 8B: 850 is shown in the deployed configuration), the coil in the elongated shape deliverable to a targeted vascular defect of a subject ([0079] the implant coil shown in FIG. 3 is delivered in the elongated shape to an aneurysm), the coil having the deployed shape in the targeted vascular defect of the subject ([0069] the coils change shape upon deployment to fit the aneurysm they are deployed within),
the coil, in the deployed shape, forming six sides ([0089] 850 is a cubic shape with six sides) collectively defining an interior portion therebetween in the absence of an external force on the coil (FIG. 8B: 850 defines an interior portion within the cube when not forced to be coiled around the delivery structure),
at least one side of the coil, in the deployed shape, comprising a first loop ([0089] open loops 870 and 880, on all six sides; FIG. 8B); and
at least one other side of the coil, in the deployed shape, comprises a plurality of second loops ([0089] closed loops 860, on three of the six sides; FIG. 8B), each of the plurality of second loops having a respective minimum dimension less than a minimum dimension of the first loop (FIG. 8B: 870 and 880 have a much greater minimum dimension extending over multiple sides than 860, which are limited to a portion of one side), wherein three of the six sides in the deployed state each include an instance of the first loop (FIG. 8B: each side of the six side have 870 and 880) and another three of the six sides in the deployed state each include a respective plurality of the second loops (FIG. 8B: three of the six sides have multiple 860).
Regarding claim 6, Qin et al. further discloses the coil in the deployed shape, in the absence of external force on the coil, transitions from a first side to an immediately adjacent second side for each of the six sides of the implant (FIGs. 3 and 8B: the deployment forces the linear coil to bend back to the default shape, which moves each side from a first position to a second position immediately adjacent to several other sides).
Regarding claim 7, Qin et al. further discloses the coil comprises a shape memory material ([0080] the strands making up the wires are shape memory materials).
Regarding claim 8, Qin et al. further discloses the shape memory material comprises a platinum tungsten alloy ([0080] the strands making up the wires can be platinum/tungsten alloys).
Regarding claim 9, Qin et al. further discloses the coil in the elongated shape is deliverable to the targeted vascular defect through an intraluminal device ([0075] the coils can be delivered by a catheter).
Regarding claim 10, Qin et al. further discloses with the coil in the deployed shape, at least two of the six sides are offset from one another by about 90 degrees ([0089] 850 is a cubic shape with six sides, where each side is offset to four other sides by 90 degrees).
Regarding claim 11, Qin et al. further discloses the deployed shape of the coil is generally cubic in the absence of external force on the coil ([0089] 850 is a cubic shape with six sides when in the deployed shape).
Regarding claim 12, Qin et al. further discloses the coil includes a first end portion and a second end portion ([0089] 850 is a cubic shape with six sides), and the first end portion and the second end portion axially contract relative to one another as the coil flexes from the elongated shape to the deployed shape (FIGs. 3 and 8B: deployment of the coil causes the proximal and distal ends to axially move closer together as the coil changes shape).
Regarding claim 13, Qin et al. further discloses the coil includes a helical winding about a longitudinal axis defined by the first end portion and the second end portion of the coil (FIG. 3: the coil has a helical winding around the deployment device, defined by a distal first end and a proximal second end).
Regarding claim 14, Qin et al. further discloses the first end portion of the coil forms a portion of the first loop (FIGs. 3 and 8B: the distal first end of the coil forms some of the coils shown in the fully deployed device form, including the ).
Regarding claim 15, Qin et al. further discloses the second end portion of the coil forms a portion of one of the plurality of second loops (FIGs. 3 and 8B: the proximal second end of the coil forms some of the coils shown in the fully deployed device form).
Regarding claim 18, as best understood in view of the 35 USC 112b rejection above, Qin et al. further discloses three of the six sides include only the instance of the first loop (i.e., only loops of the first loop type; FIG. 8B: three of the sides have both open and closed loops, such as the one with labels 860, 870, 880, while the other three sides, such as the one with label 850, only have open loops).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 2-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Qin et al.
Regarding claim 2, Qin et al. discloses the invention as claimed in claim 1, as discussed above. Qin et al. does not explicitly disclose the minimum dimension of the first loop spans at least 70% of a width of a corresponding one of the six sides of the implant. However, it would have been obvious to one of ordinary skill before the effective filing date to have the minimum dimension of the first loop span at least 70% of a width of a corresponding one of the six sides of the implant because 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 relative 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, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device would not operate differently with the claimed ratio. Furthermore, Applicant places no criticality on the dimensions claimed, indicating that the diameter can be at least 70-80% of the width or other cross-sectional dimension of the side in which the loop is located (Present Spec [0040]).
Regarding claim 3, Qin et al. discloses the invention as claimed in claim 1, as discussed above. Qin et al. does not explicitly disclose the respective minimum dimension of each of the plurality of second loops spans less than 50% of a width of a corresponding one of the six sides of the implant. However, it would have been obvious to one of ordinary skill before the effective filing date to have disclose the respective minimum dimension of each of the plurality of second loops spans less than 50% of a width of a corresponding one of the six sides of the implant because 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 relative 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, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device would not operate differently with the claimed ratio. Furthermore, Applicant places no criticality on the dimensions claimed, indicating that the diameter can be less than 50%, 45%, 40%, 35%, 30%, 25%, 20%, etc. of the width or other cross-sectional dimension of the side in which the loop is located (Present Spec [0040]).
Regarding claim 4, Qin et al. discloses the invention as claimed in claim 1, as discussed above. Qin et al. does not explicitly disclose the respective minimum dimension of each of the plurality of second loops spans less than 40% of a width of a corresponding one of the six sides of the implant. However, it would have been obvious to one of ordinary skill before the effective filing date to have disclose the respective minimum dimension of each of the plurality of second loops spans less than 50% of a width of a corresponding one of the six sides of the implant because 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 relative 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, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device would not operate differently with the claimed ratio. Furthermore, Applicant places no criticality on the dimensions claimed, indicating that the diameter can be less than 50%, 45%, 40%, 35%, 30%, 25%, 20%, etc. of the width or other cross-sectional dimension of the side in which the loop is located (Present Spec [0040]).
Claim(s) 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Qin et al. in view of Le et al. (Pub. No. 2018/0271533).
Regarding claim 16, Qin et al. discloses the invention as claimed in claim 1, as discussed above. Qin et al. is silent regarding a tether releasably secured to the coil.
Le et al. teaches in the same field of endeavor of occlusive aneurysm devices ([0027]), and discloses a coil (130; [0037]; FIG. 3) and a tether (132) releasably attached to the coil ([0027] 132 is tied between 134 and 136, and releases 130).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have substituted the delivery system of Qin et al. (catheter) for the delivery system of Le et al. (tether) because both delivery systems are disclosed as equivalent structures for deploying the coil, and substitution of one for the other would have resulted in the predictable result of allowing for controlled deployment of the coil to the aneurysm.
Regarding claim 17, Qin et al. further discloses the tether includes a thermoplastic elastomer ([0037] 132 may be made of thermoplastic elastomers such as Engage).
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 JAMES RYAN MCGINNITY whose telephone number is (571)272-0573. The examiner can normally be reached M-Th 8 am-5:30 pm.
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/JRM/Examiner, Art Unit 3771
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771