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 .
Detailed Action
This is in response to the amendment filed 12/09/2025.
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.
Claims 21, 22, 24-31 is/are rejected under 35 U.S.C. 103 as being obvious over U.S. Patent Publication Number 2008/0300616 (Que et al.)
Regarding claims 21, 22, 24-28, 31 Que discloses as shown in Figure 1A, a medical system capable of delivery and deploying an implant into a patient, the medical system compromising: a medical implant (occlusive element 12, see paragraph [0035]) having a proximal engagement loop (securing member 20, see paragraph [0038]); an implant delivery system having an implant pusher shaft (elongate pusher member 30, see paragraph [0040]), an engagement wire (elongate releasing member 60, see paragraph [0043]) , and a wire engagement interface (retaining member 40, see paragraph [0043]); wherein the implant pusher shaft has an elongated lumen with a distal end and a proximal end; wherein the engagement wire comprises a proximal end and a distal end, and slidably disposed within the elongated lumen of the implant pusher shaft; wherein the wire engagement interface fixedly joins to a distal portion of the implant pusher shaft with a distal end of the wire engagement interface aligning with the distal end of the implant pusher shaft, where the wire engagement interface partially blocks a distal luminal opening of the implant pusher shaft, and is configured to engage the distal end of the engagement wire; see paragraph [0042]; wherein the medical system has a first medical implant delivery configuration where the proximal engagement loop of the medical implant extends proximally from the distal end of the implant pusher shaft, loops over the wire engagement interface; and the engagement wire extends distally with the distal end of the engagement wire engages the wire engagement interface securing the engagement loop to the implant delivery system, wherein the medical system has a second medical implant deployment configuration where the engagement wire retracts proximally away from the wire engagement interface, thereby releasing the engagement loop of the medical implant from the implant pusher shaft, wherein the wire engagement interface has a generally tubular profile with a first end, a second end, and an axial lumen extending from the first end to the second end, and wherein in the first medical implant delivery configuration, the distal end of the engagement wire extends distally into the axial lumen of the wire engagement interface from its proximal end, wherein the distal end of the wire engagement interface aligns with the distal end of the implant pusher shaft, wherein the wire engagement interface joins the implant pusher shaft with the proximal end of the wire engagement interface joining the distal end of the implant pusher shaft, wherein the wire engagement interface has a generally tubular profile with a first end, a second end, and an axial lumen extending from the first end to the second end, and wherein in the first medical implant delivery configuration, the distal end of the engagement wire extends distally into the axial lumen of the wire engagement interface from its proximal end, wherein in both the first medical implant delivery configuration and the second medical implant deployment configuration, the distal end of the engagement wire remains inside the elongated lumen of the implant pusher shaft, wherein the wire engagement interface has a proximal end surface angled (perpendicular) from the longitudinal axis of the implant pusher shaft.
Que fails to disclose the proximal engagement loop of the medical implant extends proximally from the proximal end of the medical implant to the implant pusher shaft from the distal end of the implant pusher shaft into the elongated lumen.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the medical system disclosed by Que by rearranging the location of the retaining member 40 such that it was further or more proximally into the lumen of the elongate pusher member 30 such that the part of the recess 44 in which the proximal engagement loop 20 extends in the first medical implant delivery configuration was within the elongated lumen of the pusher shaft, such that the proximal engagement loop of the medical implant extends proximally from the proximal end of the medical implant to the implant pusher shaft from the distal end of the implant pusher shaft into the elongated lumen, because it would only require the rearrangement of parts, without changing how the device operates (retraction of elongate releasing member 60 would still allow occlusive element 12 to be released. See In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950)
To be clear, Figure 1A shows if a part (generally indicated as A) of the recess 44 in which the proximal engagement loop 20 extends in the first medical implant delivery configuration was within the lumen of the elongate pusher member 30, there would still be room to release securing member 20:
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Regarding claim 29, 30 Que et al. discloses as shown in Figure 5 a method of using a medical system, medical system for delivery and deploying an implant (occlusive element 12, see paragraph [0035]) into a patient, the medical system compromising: a medical implant having a proximal engagement loop (securing member 20, see paragraph [0038]); an implant delivery system having an implant pusher shaft (elongate pusher member 30, see paragraph [0040]), an engagement wire (elongate releasing member 60, see paragraph [0043]), and a wire engagement interface (retaining member 40, see paragraph [0043]); wherein the implant pusher shaft has an elongated lumen with a distal end and a proximal end; wherein the engagement wire comprises a proximal end and a distal end, and slidably disposed within the elongated lumen of the implant pusher shaft; wherein the wire engagement interface joins to a distal portion of the implant pusher shaft with a distal end of the wire engagement interface aligning with the distal end of the implant pusher shaft, where the wire engagement interface partially blocks a distal luminal opening of the implant pusher shaft, and is capable of engaging the distal end of the engagement wire; wherein the medical system has a first medical implant delivery configuration where the proximal engagement loop of the medical implant is capable of extending proximally from the distal ends of the implant pusher shaft; see paragraph [0057]; loops over the wire engagement interface; and the engagement wire extends distally with the distal end of the engagement wire engages the wire engagement interface securing the engagement loop to the implant delivery system, wherein the wire engagement interface joins the implant pusher shaft with the proximal end of the wire engagement interface joining the distal end of the implant pusher shaft, wherein the wire engagement interface has a generally tubular profile (at finger 46, see Figure 2E and paragraph [0050]) with a first end, a second end, and an axial lumen extending from the first end to the second end, and wherein in the first medical implant delivery configuration, the distal end of the engagement wire extends distally into the axial lumen of the wire engagement interface from its proximal end, wherein the distal end of the wire engagement interface aligns with the distal end of the implant pusher shaft, wherein in both the first medical implant delivery configuration and the second medical implant deployment configuration, the distal end of the engagement wire is capable of remaining inside the elongated lumen of the implant pusher shaft, wherein the medical system has a second medical implant deployment configuration where the engagement wire retracts proximally away from the wire engagement interface, thereby releasing the engagement loop of the medical implant from the implant pusher shaft, the method of using the medical system comprising delivering the medical implant to a site, wherein the medical system is at a first medical implant delivery configuration where the proximal engagement loop of the medical implant extends proximally from the distal end of the implant pusher shaft into the elongated lumen, loops over the wire engagement interface; and the engagement wire extends distally with the distal end of the engagement wire engages the wire engagement interface securing the engagement loop to the implant delivery system, retracting the engagement wire away from the wire engagement interface, thereby releasing the engagement loop of the medical implant from the implant pusher shaft.
Que fails to disclose the proximal engagement loop of the medical implant extends proximally from the proximal end of the medical implant to the implant pusher shaft from the distal end of the implant pusher shaft into the elongated lumen.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the medical system disclosed by Que by rearranging the location of the retaining member 40 such that it was further or more proximally into the lumen of the elongate pusher member 30 such that the part of the recess 44 in which the proximal engagement loop 20 extends in the first medical implant delivery configuration was within the elongated lumen of the pusher shaft, such that the proximal engagement loop of the medical implant extends proximally from the proximal end of the medical implant to the implant pusher shaft from the distal end of the implant pusher shaft into the elongated lumen, because it would only require the rearrangement of parts, without changing how the device operates (retraction of elongate releasing member 60 would still allow occlusive element 12 to be released. See In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950)
To be clear, Figure 1A shows if a part (generally indicated as A) of the recess 44 in which the proximal engagement loop 20 extends in the first medical implant delivery configuration was within the lumen of the elongate pusher member 30, there would still be room to release securing member 20:
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Response to Arguments
Applicant's arguments filed 06/02/2025, see pages 6-11 have been fully considered but they are not persuasive. The applicant argues Que fails to disclose the wire engagement interface partially blocks a distal luminal opening of the implant shaft because the proximal portion of the retaining member 40 is sized and shaped to fit along the entire inner luminal surface of the elongate pusher member and the distal portion of the retaining member 40 has the same overall size as the proximal portion of the retaining member.
In response, the Office respectfully disagrees. Retaining member 40 disclosed by Que necessarily partially blocks a distal luminal opening of the implant shaft because Que discloses it as capable of free movement within the elongate pusher member. In order to be able to freely move within the elongate pusher member, it would necessarily have to be slightly smaller than the elongate pusher member and thus necessarily partially block it as recited in the claim. Que simply does not disclose retaining member 40 more than partially blocks the elongate pusher member and the applicant’s argument is purely speculative because it references figures which are not disclosed to scale. Arguments presented by the applicant cannot take the place of evidence in the record. See In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965) and In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984).
The applicant argues it would not be obvious to modify Que as claimed because it would make it unfunctional. In response, the Office respectfully disagrees. Figure 1A shows if a part (generally indicated as A) of the recess 44 in which the proximal engagement loop 20 extends in the first medical implant delivery configuration was within the lumen of the elongate pusher member 30, there would still be room to release securing member 20:
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The applicant’s remarks do not address this point.
The components of the delivery system disclosed by Que are disclosed as moveable relative to one another. There is nothing to suggest if the parts of Que were rearranged as articulated by the office, it would not continue to work as intended. This position if further supported by paragraph [0065] of Que which states that one of ordinary skill in the art would understand various modifications as within the scope of the invention.
Response to Arguments
Applicant's arguments filed 12/09/2025, see pages 6-11 have been fully considered but they are not persuasive.
The applicant argues Que fails to disclose the distal end of the wire engagement interface aligning with the distal end of the implant pusher shaft as claimed because Que shows in multiple figures that the clasp portion 42 of the retaining member is outside the distal end 34 of the elongate pusher member.
In response, the Office respectfully disagrees. Retaining member 40 is clearly aligned the distal end of the implant pusher shaft 30 because it is concentric with it. Figure 1A clearly shows Retaining member 40 is aligned with distal end of the implant pusher shaft 30 because they are parallel.
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The Office does not dispute that Que shows in several figures that the clasp portion 42 of the retaining member is outside the distal end 34 of the elongate pusher member. However, this does not mean changing the configuration is undesirable or would render he resulting system inoperable. As explained in the prior action, Que specifically discloses that the disclosed embodiments are not meant to me interpreted as limiting in paragraph [0065].
Applicant further argues that based on the viewing angles shows in Figures 2A-B, the proximal portion of retaining member 40 takes up all the interior space of the distal end portion of the elongate pusher member 30 and that should the retaining member 40 be relocated more proximally, the size of finger 46 would prevent loop, hoop or ring-shaped securing member from being placed inside the recess, as well as exiting the recess.
In response, the office respectfully disagrees. Applicant is merely speculating that the size of finger 46 would prevent loop, hoop or ring-shaped securing member from being placed inside the recess, as well as exiting the recess. Arguments presented by applicant cannot take the place of evidence in the record. See In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984)
In this case, the evidence supports the Office’s position. Clearly, loop, hoop or ring-shaped securing member could be placed in the recess before retaining member 40 was relocated more proximally. Second, the Office’s position was that it only be relocated partially within the lumen of the elongate pusher member 30. Figure 1A shows if a part (generally indicated as A) of the recess 44 in which the proximal engagement loop 20 extends in the first medical implant delivery configuration was within the lumen of the elongate pusher member 30, there would still be room to release securing member 20:
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The applicant speculates that if the clasp 42 is places inside the inner lumen of the elongate pusher member 30, the coil runs the risk of being unreleasable because finger 46 could catch on the securing member as it exit the recess.
In response, the Office respectfully disagrees. The risk of finger 46 catching on the securing member as it exist the recess already exists:
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The Federal Circuit has held that “the fact that the motivating benefit comes at the expense of another benefit, however, should not nullify its use as a basis to modify the disclosure of one reference with the teachings of another. Instead, the benefits, both lost and gained, should be weighed against one another”. see Winner International Royalty Corp. v. Wang, 53 USPQ2d 1580 (Fed. Cir. 2000).
In this case, any increased risk of the finger 46 catching on the securing member would be outweighed by the benefit of creating a more stabilized overall system.
Regarding claim 31 the Office interprets Que as disclosing wherein the wire engagement interface has a proximal end surface angled (perpendicular) from the longitudinal axis of the implant pusher shaft.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RICHARD G LOUIS whose telephone number is (571)270-1965. The examiner can normally be reached on Monday – Friday, 9:30 am – 6 pm.
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/RICHARD G LOUIS/Primary Examiner, Art Unit 3771