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 Arguments
This Office action is in response to the applicant’s communication filed on 11/24/2025. Each argument and/or amendment directed towards a maintained rejection is addressed below. Rejections/objections not repeated herein have been withdrawn.
Applicant’s arguments, see page 6, with respect to the claim amendments made in view of the previous objections to the drawings have been fully considered and are persuasive. The previous objections to the drawings have been withdrawn.
Applicant’s arguments, see page 6, with respect to the claim amendments made in view of the previous claim objections have been fully considered and are persuasive. The previous claim objections have been withdrawn.
Applicant’s arguments, see page 6, with respect to the claim amendments made in view of the previous 112 rejections have been fully considered and are persuasive. The previous 112 rejections have been withdrawn.
Applicant's arguments, see pages 7-9, alleging that Martinez (regarding claim 10) fails to disclose the proximal opening being configured to flex open during detachment tip insertion and flex closed during to retain the detachment tip during implant delivery have been fully considered but they are not persuasive. Martinez expressly discloses ([0035]; [0045]) that tabs 52 are expressly composed of resilient material that allows tabs 52 to flex both radially inward and radially outward. Proximal movement of the distal head 32 expressly deflects the resilient tabs 52 outwardly (i.e., are forced outward and resiliently desire to return inward), wherein “resilience” is defined as “the capability of a body to recover its size and shape after deformation caused especially by compressive stress” (see https://www.merriam-webster.com/dictionary/resilience). Additionally, and/or in the alternative, Applicant’s arguments appear to require a shape memory material to self-return to its closed position. Such a limitation is not recited in the rejected claims. The current claims only require the proximal opening to generically flex open and closed (by any means which may include any external assistance) to allow for insertion and retention of the distal detachment tip body (as shown in Figs 1-2 and 13-14; [0035]; [0045]). For at least these reasons, Applicant’s arguments are not persuasive.
Applicant's arguments, see pages 9-13, alleging that Martinez in view of Gandhi (regarding claim 1) and/or Martinez in view of Gandhi and Carter (regarding claim 18) fails to disclose or teach the proximal opening being configured to flex closed when the detachment tip body is within the detachment tip cavity have been fully considered but they are not persuasive. Martinez expressly discloses ([0035]; [0045]) that tabs 52 are expressly composed of resilient material that allows tabs 52 to flex both radially inward and radially outward. Proximal movement of the distal head 32 expressly deflects the resilient tabs 52 outwardly (i.e., are forced outward and resiliently desire to return inward), wherein “resilience” is defined as “the capability of a body to recover its size and shape after deformation caused especially by compressive stress” (see https://www.merriam-webster.com/dictionary/resilience). Additionally, and/or in the alternative, Applicant’s arguments appear to require a shape memory material to self-return to its closed position. Such a limitation is not recited in the rejected claims. The current claims only require the proximal opening to generically flex open and closed (by any means which may include any external assistance) to allow for insertion and retention of the distal detachment tip body (as shown in Figs 1-2 and 13-14; [0035]; [0045]). Applicant correctly points to paragraph [0045] of Martinez which supports the rejection in that the tabs 52 are configured to flex closed and retain the detachment tip body in the detachment tip cavity (whether tabs 52 resiliently collapse inward or are forced radially inward, this reads on the tabs being configured to flex closed and retain the detachment tip body in the detachment tip cavity, as shown in Figs. 1-2 and 13-14). For at least these reasons, Applicant’s arguments are not persuasive.
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.
Claims 1-20 are 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.
Claim 1 (and thereby dependent claims 2-9) recites the limitation "with proximal opening" in line 3. There is insufficient antecedent basis for this limitation in the claim (i.e., re-inserting the previously deleted “a” will moot this rejection; “with a proximal opening”). Appropriate correction is required.
Claim 10 (and thereby dependent claims 11-17) recites the limitation "with a proximal and a slot or cut" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim (i.e., re-inserting the previously deleted “opening” will moot this rejection; “with a proximal opening”). Appropriate correction is required.
Regarding claim 18 (and thereby dependent claims 19-20), the phrase "the distal to the detachment coupler" in lines 15-16. There is insufficient antecedent basis for this limitation in the claim (i.e., a minor amendment such as “the distal force to the detachment coupler” will moot this rejection). Appropriate correction is required.
Claim 20 recites the limitation "the length L" in line 4. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim Rejections - 35 USC § 102
Claim(s) 10-11 and 14-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Martinez et al. (US 2012/0109160).
Martinez discloses (see Figs. 1-2 and 13-16) a detachment coupler mechanism comprising the following claim limitations:
(claim 10) A detachment coupler mechanism comprising: a detachment coupler (42/48, Figs. 1-2) having a detachment tip cavity (50, Fig. 2) with a proximal opening (as shown between tabs 52) and a slot or cut on each side of the cavity (i.e., one or more slots or cuts expressly shown in Figs. 1-2 between tabs 52 forming cavity 50) configured to (i.e., capable of) allow the proximal opening to flex open and closed ([0035]; tabs 52 expressly composed of resilient material that allows tabs 52 to flex radially inward and radially outward; [0045]; wherein proximal movement of the distal head 32 deflects resilient tabs 52 outwardly; “resilience” is defined as “the capability of a body to recover its size and shape after deformation caused especially by compressive stress”, see https://www.merriam-webster.com/dictionary/resilience); a pusher having a pusher wire (22, Figs. 1-2) with a distal detachment tip (32, Figs. 1-2) configured for insertion through the proximal opening and retainment within the detachment tip cavity (50) (as expressly shown in Figs. 1-2), wherein the slots or cuts flex the proximal opening open during insertion of the detachment tip (32) and flex to a closed position when the detachment tip body (32) is within the detachment tip cavity (50) to retain the detachment tip during implant delivery (as shown in Figs. 1-2; [0035]; [0045]); and a puller (24, Figs. 1-2 and 15-16) configured to (i.e., capable of) apply a distal force against the detachment coupler (42/48) to assist in detaching the detachment tip (32) from the detachment tip cavity (50) (as shown in Figs. 1-2 and 15-16; [0046]; puller 24 expressly disclosed to provide a counterforce on the proximal housing 42 when retracting pusher wire 22), wherein when the puller (24) applies the distal force to the detachment coupler (42/48) (as shown in Figs. 1-2 and 15-16; [0046]), the push wire (22) can apply an opposite proximal force to withdraw the detachment tip (32) from the detachment tip cavity (50) ([0032]-[0035]; [0046]);
(claim 11) wherein during withdrawal of the detachment tip (32) the proximal opening is configured to (i.e., capable of) flex open and flex closed when the withdrawal of the detachment tip (32) is complete (as shown in Figs. 1-2; [0035]; [0045]; as discussed in claim 10 above, the resilient material of the flexible tabs 52 expressly may deflected outward to allow for passage of the tip 32 therethrough);
(claim 14) wherein the detachment tip (32) includes a detachment tip body having a tapered distal end and a tapered proximal end (as shown in annotated Fig. 2 below);
(claim 15) wherein the proximal opening includes a proximal ramped portion, a reduced diameter portion, and a distal ramped portion coupled to the detachment tip cavity (50) (as shown in annotated Fig. 2 below);
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(claim 16) wherein the detachment tip (32) within the detachment tip cavity (50) permits axial movement through a delivery catheter (24, Figs. 1-2) ([0032]-[0034]; detachment coupler mechanism expressly disclosed for operation and use through catheters, endoscopes and the like); and
(claim 17) wherein the detachment tip (32) is configured to (i.e., capable of) rotate freely within the detachment coupler and does not require an external force to remain secured (as shown in Figs. 1-2; [0035]; tabs 52 are resilient and readily flex thereby tip 3 is fully capable of rotating therein, and tabs 52 are biased to retain the tip 32 therein without an external force).
Claim Rejections - 35 USC § 103
Claim(s) 1 and 4-9 are rejected under 35 U.S.C. 103 as being unpatentable over Martinez et al. (US 2012/0109160) in view of Gandhi et al. (US 6,478,773).
Martinez discloses (see Figs. 1-2 and 15-16) a detachment coupler mechanism comprising the following claim limitations:
(claim 1) A detachment coupler mechanism comprising: an implant (44, Figs. 1-2) coupled with a detachment coupler (42/48, Figs. 1-2) having a detachment tip cavity (50, Fig. 2) with a proximal opening (as shown between tabs 52) and a slot or cut (i.e., a slot or cut expressly shown in Figs. 1-2 between tabs 52 forming cavity 50) on each side of the cavity (50) configured to (i.e., capable of) allow the proximal opening to flex open and close ([0035]; tabs 52 expressly composed of resilient material that allows tabs 52 to flex radially inward and radially outward; [0045]; wherein proximal movement of the distal head 32 deflects resilient tabs 52 outwardly; “resilience” is defined as “the capability of a body to recover its size and shape after deformation caused especially by compressive stress”, see https://www.merriam-webster.com/dictionary/resilience); a pusher having a pusher wire (22, Figs. 1-2) coupled with a distal detachment tip (32, Figs. 1-2) configured for insertion through the proximal opening and retainment within the detachment tip cavity (50) (as expressly shown in Figs. 1-2), wherein the proximal opening is configured to (i.e., capable of) flex open during insertion of the detachment tip (32) and flex to a closed position when the detachment tip (32) is within the detachment tip cavity (50) to retain the detachment tip during implant delivery (as shown in Figs. 1-2; [0035]; [0045]); and a puller (24, Figs. 1-2 and 15-16) configured to (i.e., capable of) assist in detaching the detachment tip (32) from the detachment coupler (42/48) (as shown in Figs. 1-2 and 15-16; [0046]; puller 24 expressly disclosed to provide a counterforce on the proximal housing 42 when retracting pusher wire 22);
(claim 4) wherein the puller (24) is configured to (i.e., capable of) apply a distal force against the implant coupler (42/48) (as shown in Figs. 1-2 and 15-16; [0046]; puller 24 expressly disclosed to provide a counterforce on the proximal housing 42 when retracting pusher wire 22) while the push wire (22) applies a proximal force to withdraw the detachment tip (32) from the detachment tip cavity (50) ([0032]-[0035]; [0046]);
(claim 5) wherein the proximal opening is configured to (i.e., capable of) flex open during withdrawal of the detachment tip (32) and flex closed when the withdrawal of the detachment tip (32) is complete (as shown in Figs. 1-2; [0035]; flexible tabs 52 of resilient material expressly disclosed);
(claim 6) wherein the detachment (32) includes a detachment tip body having a tapered distal end and a tapered proximal end (as shown in annotated Fig. 2 below);
(claim 7) wherein the proximal opening includes a proximal ramped portion, a reduced diameter portion, and a distal ramped portion coupled to the detachment tip cavity (as shown in annotated Fig. 2 below);
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(claim 8) wherein inserting the detachment tip (32) within the detachment tip cavity (50) permits axial movement of the pusher (22) and implant (44) ([0032]-[0036]; axial movement of the pusher 22 and implant 40 expressly provides for actuation of the teeth 58 and rack 54 of the implant 44); and
(claim 9) wherein the detachment tip (32) is configured to (i.e., capable of) rotate freely within the detachment coupler and does not require an external force to remain secured (as shown in Figs. 1-2; [0035]; tabs 52 are resilient and readily flex thereby tip 3 is fully capable of rotating therein, and tabs 52 are biased to retain the tip 32 therein without an external force).
Martinez, as applied above, discloses a detachment coupler mechanism comprising all the limitations of the claim except for the implant comprising an embolic coil. Gandhi teaches a similar detachable vasoocclusive device that can comprise either a detachable surgical clip (col. 1, lines 29-34) and/or a detachable embolic coil (44, Fig. 3; col. 1, lines 29-34 and 57-60). Accordingly, Gandhi teaches that it is known that a detachable surgical clip and a detachable embolic coil are elements that are functional equivalents for providing a detachment mechanism for delivering one or more intravascular vasoocclusive devices. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have substituted the detachable embolic coil taught by Gandhi for the detachable surgical clip of Martinez because both elements were known equivalents for providing a detachment mechanism for delivering one or more intravascular vasoocclusive devices within the vascular interventional art. The substitution would have resulted in the predictable results of providing a detachment mechanism for delivering one or more intravascular vasoocclusive devices to the device Martinez in view of Gandhi.
Claim(s) 2-3, 12-13 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Martinez in view of Gandhi as applied to claims 1, 4 and 8-9 above and/or Martinez as applied to claim 10 above, and further in view of Carter et al. (US 2008/0051721).
Martinez in view of Gandhi and/or Martinez, as applied above respectively, discloses a detachment coupler mechanism comprising all the limitations of the claim except for wherein the slot or cut includes a "T" cut having a length L, width W and height H, wherein the force/friction strength of the flex for the proximal opening is modified by increasing or decreasing the length L of the "T" cut, wherein decreasing the length L of the "T" cut increases the force/friction strength and increasing the length L of the "T" cut decreases the force/friction strength.
However, Carter teaches (see Figs. 3A and 6B) a similar detachment coupler mechanism comprising either an enlarged distal head (see Fig. 3A) or a “T” cut having a length L, width W and height H (see Fig. 6B) wherein the force/friction strength of the flex for the proximal opening is modified by increasing or decreasing the length L of the "T" cut, wherein decreasing the length L of the "T" cut increases the force/friction strength and increasing the length L of the "T" cut decreases the force/friction strength (it is noted that changing one or more dimensions of the structure and/or cuts is not affirmatively claimed and/or adding/removing material from a living hinge will alter the material characteristics as claimed). Accordingly, Carter teaches that it is known that an enlarged distal head and a “T” cut having a length L, width W and height H are elements that are functional equivalents for providing a detachable coupling mechanism ([0040]-[0041]; [0051]). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have substituted a “T” cut having a length L, width W and height H taught by Carter for the enlarged distal head of Martinez and/or Martinez in view of Gandhi because both elements were known equivalents for providing a detachable coupling mechanism within the medical implant art. The substitution would have resulted in the predictable results of providing a detachable coupling mechanism to the device of Martinez in view of Gandhi and/or Martinez, further in view of Carter.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure, see:
Beckham et al. (US 2013/0138136);
King et al. (US 2018/0078261);
Ryan et al. (US 2018/0085122);
King et al. (US 2018/0098771); and
Estevez et al. (US 2018/0116677).
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 Robert Lynch whose telephone number is (571)270-3952. The examiner can normally be reached on Monday-Friday (9:00AM-6:00PM, with alternate Fridays off).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Elizabeth Houston, 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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/ROBERT A LYNCH/Primary Examiner, Art Unit 3771