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 7/23/2026. 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 Rejections/objections not repeated herein have been withdrawn.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 pages 10-13, with respect to the deficiencies of the prior art of record in view of the present amendments to the respective independent claims have been fully considered and are persuasive. Therefore, previous prior art rejections have been withdrawn. However, upon further consideration, new ground(s) of rejection are made under Wilson et al. (US 2018/0000509), as set forth below.
Claim Rejections - 35 USC § 102
Claim(s) 21-24 and 42-44 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wilson et al. (US 2018/0000509).
Wilson discloses (see Figs. 3A-3B) a method and system for intraluminal tissue modification comprising the following claim limitations:
(claim 21) a catheter for lacerating a tissue (300, Figs. 3A-3B; [0035]), comprising one or more exposure windows (215, Figs. 3A-3B); one or more lacerators (330, Figs. 3A-3B), wherein the one or more lacerators (330) are configured to (i.e., capable of) lacerate the tissue and are deployed at or from the one or more exposure windows (as shown in Fig. 3A; [0047]); and one or more aligners (216, Figs. 3A-3B), wherein the one or more aligners (216) are deployable and configured to (i.e., capable of), when deployed, promote contact between the one or more lacerators (330) and the tissue (as shown in Figs. 3A-3B; [0047]; tissue expressly cut within capture regions 280), wherein at least a first aligner (i.e., “left” member 216 in Figs. 3A-3B) of the one or more aligners (216) is rotatably coupled to and laterally deployable from the catheter (as best shown in Figs. 2A-2B depicting capture members 216 rotatably hinging outward at joints 217a/217b/217c; [0042]-[0043]) and configured to (i.e., capable of), when deployed, contact the tissue to move the tissue into contact with a first lacerator (i.e., “left” blade 330 in Figs. 3A-3B) of the one or more lacerators (330) (as shown in Figs. 3A-3B; [0047]; capture members 216 contact and move tissue into the capture region 280 expressly to be cut by lacerators 330);
(claim 22) wherein: the one or more exposure windows (215) comprise a first exposure window (i.e., “right” slot 215 in Figs. 3A-3B); the first exposure window is arranged in the catheter to enable a second lacerator (i.e., “right” blade 330 in Figs. 3A-3B) of the one or more lacerators (330) to pierce the tissue to create an opening in the tissue (as shown in Figs. 3A-3B; [0047]; exposure windows 215 expressly arranged to allow lacerators 330 to deploy and cut/pierce tissue); and the first aligner (i.e., “left” member 216 in Figs. 3A-3B) is arranged to, when deployed, contact the tissue to move the tissue into contact with the first lacerator (“left” blade 330) when at least a part of the catheter is disposed in the opening of the tissue (as shown in Figs. 3A-3B; [0047]; capture members 216 expressly capable of contacting and moving tissue into the capture region 280 expressly to be cut by lacerators 330);
(claim 23) wherein: the one or more exposure windows (215) further comprise a second exposure window (i.e., “left” slot 215 in Figs. 3A-3B); and the second exposure window is arranged in the catheter to enable the first lacerator (“left” blade 330) to slice the tissue when the first lacerator is deployed at or from the second exposure window (“left” slot 215) of the catheter (100) (as shown in Figs. 3A-3B; [0047]; capture members 216 expressly capable of contacting and moving tissue into the capture region 280 expressly to be cut by lacerators 330 deployed from windows 215);
(claim 24) wherein: the one or more exposure windows (215) comprise a first exposure window (“left” slot 215) and a second exposure window (“right” slot 215); and the one or more lacerators (330) comprise: the first lacerator (“left” blade 330) advanceable through the catheter such that the first lacerator (“left” blade 330) is exposable through the first exposure window (“left” slot 215) (as shown in Figs. 3A-3B; [0047]; blades 330 expressly slide within slots 215 to cut tissue in the capture region 280); and a second lacerator (“right” blade 330) advanceable through the catheter such that the second lacerator (“right” blade 330) is exposable through the second exposure window (“right” slot 215) (as shown in Figs. 3A-3B; [0047]; blades 330 expressly slide within slots 215 to cut tissue in the capture region 280);
(claim 42) wherein the first aligner (“left” member 216) is configured to (i.e., capable of) prevent the tissue from moving laterally away from the first lacerator (“left” blade 330) while the first lacerator is slicing the tissue (as shown in Fig. 3B; [0043]; capture member 216 expressly hooks or captures targeted tissue within the capture region 280 for cutting);
(claim 43) wherein the one or more aligners (216) further comprise a second aligner (“right” member 216) defined by a distal-most end (208, Figs. 3A-3B) of the catheter (as expressly shown in Figs. 3A-3B); and
(claim 44) wherein, when the at least part of the catheter is disposed in the opening of the tissue and the catheter is caused to move longitudinally with respect to the tissue, the first aligner (“left” member 216) is configured to (i.e., capable of), when deployed, move the tissue into contact with the first lacerator (“left” blade 330) to create a lateral slice in the tissue originating at the opening of the tissue (as shown in Figs. 3A-3B; [0047]; device tip 250 is fully capable of being longitudinally moved through a previously cut opening to then deploy the first aligner 216 to moved tissue into the capture region 280 to get cut by the first lacerator 330).
Claim Rejections - 35 USC § 103
Claim(s) 26 is rejected under 35 U.S.C. 103 as being unpatentable over Wilson as applied to claim 21 above, and further in view of Schultheis (US 2022/0273324).
Wilson, as applied above, discloses a method and system for intraluminal tissue modification comprising all the limitations of the claim except for wherein at least one of the one or more lacerators comprises a thulium fiber laser configured to pass laser energy through or towards the tissue at or near the one or more exposure windows to lacerate the tissue.
Schultheis teaches a similar method and system for valve treatment wherein at least one of the one or more lacerators comprises a thulium fiber laser (see claim 21; [0040]; [0060]; [0080]-[0082]; [0106]-[0108]) configured to (i.e., capable of) pass laser energy through or towards the tissue at or near the one or more exposure windows to lacerate the tissue. Accordingly, Schultheis teaches that it is known that mechanical tissue cutters and thulium laser tissue cutters are elements that are functional equivalents for breaking up and lacerating/fracturing tissue. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have substituted the thulium laser tissue cutters taught by Schultheis for the mechanical tissue cutters of Wilson because both elements were known equivalents for breaking up and lacerating/fracturing tissue within the valve repair art. The substitution would have resulted in the predictable results of providing a means for breaking up and lacerating/fracturing tissue to the Wilson device.
Claim(s) 27, 33 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Wilson as applied to claim 21 above, and further in view of Miller et al. (US 2012/0302935) (i.e., regarding claim 27); and/or Wilson in view of Miller et al. (US 2012/0302935) (i.e., regarding claims 33 and 36).
Wilson discloses (see Figs. 3A-3B) a method and system for intraluminal tissue modification comprising the following claim limitations:
(claim 33) A system for lacerating a tissue, comprising: a catheter (300, Figs. 3A-3B; [0035]) comprising: one or more exposure windows (215, Figs. 3A-3B); one or more lacerators (330, Figs. 3A-3B), wherein the one or more lacerators (330) are configured to (i.e., capable of) lacerate the tissue and are deployed at or from the one or more exposure windows (as shown in Fig. 3A; [0047]); and one or more aligners (216, Figs. 3A-3B), wherein the one or more aligners (216) are deployable and configured to (i.e., capable of), when deployed, promote contact between the one or more lacerators (330) and the tissue when the one or more lacerators (330) are deployed at or from the one or more exposure windows (215) (as shown in Figs. 3A-3B; [0047]; tissue expressly cut within capture regions 280), wherein at least a first aligner (i.e., “left” member 216 in Figs. 3A-3B) of the one or more aligners (216) is rotatably coupled to and laterally deployable from the catheter (as best shown in Figs. 2A-2B depicting capture members 216 rotatably hinging outward at joints 217a/217b/217c; [0042]-[0043]) and configured to (i.e., capable of), when deployed, contact the tissue to move the tissue into contact with a first lacerator (i.e., “left” blade 330 in Figs. 3A-3B) of the one or more lacerators (330) (as shown in Figs. 3A-3B; [0047]; capture members 216 contact and move tissue into the capture region 280 expressly to be cut by lacerators 330).
Wilson, as applied above, discloses a method and system for intraluminal tissue modification comprising all the limitations of the claim except for an energy source couplable to the one or more lacerators comprising one or more electrodes configured to be activated to transmit energy to the tissue, the transmitted energy passing towards the tissue through the one or more lacerators deployed at or from the one or more exposure windows.
Miller teaches a similar method and system for tissue cutting comprising an energy source couplable to the first lacerator comprising one or more electrodes (see Abstract; [0037]; one or more electrodes expressly disclosed) configured to be (i.e., capable of) activated to transmit energy to the tissue, the transmitted energy passing towards the tissue through the at least one of the one or more lacerators to lacerate or cut tissue. Accordingly, Miller teaches that it is known that mechanical cutting blades and electrode cutters are elements that are functional equivalents for lacerating and cutting tissue. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have substituted the electrodes taught by Schultheis for the mechanical second lacerator of Wilson because all elements were known equivalents for lacerating and cutting tissue within the tissue repair art. The substitution would have resulted in the predictable results of providing a means for lacerating and cutting tissue to the Wilson device.
Allowable Subject Matter
Claims 25, 28-32 and 34-35 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 37-40 are allowed.
The following is an examiner’s statement of reasons for allowance: the art of record does not teach or render obvious a method as claimed that includes, in combination with the claim(s) as a whole, the steps of piercing the tissue at or near a first exposure window of the catheter to generate an opening in the tissue, advancing at least a portion of the catheter through the opening in the tissue, rotatably deploying a first aligner laterally from the catheter and deploying a first lacerator at or from a second window to slice tissue. The closest prior art appears to be Wilson et al. (US 2018/0000509) disclosing a method and system for intraluminal tissue modification, but failing to expressly disclose or teach the steps of piercing the tissue at or near a first exposure window of the catheter to generate an opening in the tissue, advancing at least a portion of the catheter through the opening in the tissue.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
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 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
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