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
Applicant's arguments filed 6/22/2026 have been fully considered. Regarding the rejection of claims 1-4, 6, 7, and 19-24 under 35 U.C.S. 103 as being unpatentable over Iflah in view of Dasnurkar, applicant argues Dasnurkar does not teach drawing the adhesive applicator progressively along the wall to apply an adhesive via the nozzle along the interior. This is persuasive and the examiner agrees that Dasnurkar does not disclose drawing an applicator along a wall of the implant.
Applicant argues Iflah drives a first anchor into tissue, withdraws the driver, and then drives the second anchor into tissue therefore Iflah does not suggest drawing Iflah’s driver progressively along the interior. This argument is persuasive and the examiner agrees Iflah does not disclose drawing an applicator along the wall. In Iflah the delivery channel 18 is drawn along the wall, but the system of Iflah includes a plurality of anchor drivers 36 (par.410; fig.2) that are separately inserted and withdrawn from the delivery channel 18 to place subsequent anchors. Since the anchor drivers 36, and not the delivery channel 18, are analogous to an adhesive-applicator, Iflah in view Dasnurkar does not disclose drawing an adhesive-applicator progressively along the wall and then applying the adhesive via the nozzle at locations along the interior.
Applicant argues Iflah does not teach or suggest continuous coupling along the interior and Iflah would not work if adhesive “was all along the interior”. These arguments in combination with the indefinite scope of “drawing the adhesive-applicator progressively along the wall to apply the adhesive via the nozzle along the interior” caused the rejections under 35 U.S.C. 112(a) and 35 U.S.C. 112(b) below. Applicant appears to imply that the new limitations require some continuous coupling all along the interior. As discussed further below in the rejection under 35 U.S.C. 112(b), it is unclear if “drawing the adhesive-applicator progressively along the wall to apply the adhesive via the nozzle along the interior” requires that the applicator is drawn along the wall while the adhesive is applied or if the applicator is progressively drawn along the wall and then adhesive is applied to a specific part of the interior. The arguments imply applicant intends this limitation to mean that the applicator is drawn continuously along the interior while adhesive is continuously applied all along the interior. The examiner fails to see support for the applicator simultaneously being drawn along the wall while applying the adhesive. Applicant states par. 114 provides support for the limitation, but “adhesive 52 may be applied throughout the interior of structure 20” does not sufficiently support simultaneously drawing the applicator along the wall while applying adhesive. For instance, adhesive applied throughout the interior of the structure could be caused by zero spacing between the adhesion sites such that adhesive extends for the entire length of the structure, or some other means of injecting the cement throughout the interior. The adhesive applicator of the invention is withdrawn and then repositioned before applying adhesive as show in application figs. 3C-3D and 4C-4E. Par. 123 of applicant’s specification specifically discloses “repositioning” the adhesive-applicator after retracting (see the arrows related to 18, 50 in figs. 4C and 4E). Pars.123-124 of the instant specification disclose periodic application of adhesive after moving the adhesive-applicator along the wall, with periodic withdraw and repositioning of the adhesive-applicator during the movement. The specification never discloses continuously applying adhesive while the applicator is continuously drawn along the wall. If applicant disagrees with the rejection under 35 U.S.C. 112(a) and believes the specification discloses simultaneously applying adhesive while progressively drawing the adhesive-applicator, specific support in the specification as originally filed should be provided.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-8, 10-15, 20-22, and 24-26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, the scope of “drawing the adhesive-applicator progressively along the wall to apply the adhesive via the nozzle along the interior” is unclear as discussed below. Applicant’s arguments imply that the adhesive-applicator is drawn along the wall while adhesive is applied (applicant argues in the first paragraph on page 8 of the arguments that “Iflah does not teach or suggest continuous coupling along the interior”). However, there is no support for drawing the adhesive-applicator progressively along the wall while applying the adhesive via the nozzle along the interior.
Regarding claim 24, the specification as originally filed does not disclose “at each of the successive parts of the wall, while the nozzle is disposed at the successive part of the wall: drawing the adhesive-applicator progressively along the wall to apply the adhesive via the nozzle along the interior surface”. Instead the specification discloses drawing the adhesive-applicator along the wall to successive parts of the wall and then applying adhesive via the nozzle.
Regarding claim 26, there is no support for “drawing the adhesive-applicator progressively along the wall to: apply the adhesive via the nozzle along the interior” when this limitation is interpreted to mean the adhesive is applied along the interior while the adhesive-applicator is drawn along the wall. See the rejection under 35 U.S.C. 112(b) for further information regarding this interpretation.
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 1-8, 10-15, 20-22, and 24-26 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.
Regarding claims 1 and 26, the scope of “drawing the adhesive-applicator progressively along the wall to apply the adhesive via the nozzle along the interior” is unclear. Does the limitation mean simultaneously drawing the adhesive-applicator while applying the adhesive along the interior? Or does the limitation mean drawing the adhesive-applicator along the wall in order to then apply the adhesive at locations along the interior? (It appears the specification does not disclose drawing the adhesive applicator while applying the adhesive along the interior as discussed in the rejection under 35 U.S.C. 112(a) above). Please clarify.
Regarding claims 4-6, 8, and 10, the claims each recite the limitation "using the adhesive-applicator to apply the adhesive via the nozzle into the interior". There is insufficient antecedent basis for this limitation in the claims. (Claim 1 was amended to delete the word “using” so this step is no longer in claim 1).
Regarding claim 24, the scope of “drawing the adhesive-applicator progressively along the wall to apply the adhesive via the nozzle along the internal surface” is unclear. Does the limitation mean simultaneously drawing the adhesive-applicator along the wall while applying the adhesive along the internal surface? Or does the limitation mean drawing the adhesive-applicator along the wall in order to then apply the adhesive at locations along the internal surface? (It appears the specification does not disclose drawing the adhesive applicator while applying the adhesive as discussed in the rejection under 35 U.S.C. 112(a) above). Please clarify.
Allowable Subject Matter
Claims 1-8, 10-15, 20-22, and 24-26 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, and 35 U.S.C. 112(a) set forth in this Office action.
Applicant may consider amending the limitation “drawing the adhesive-applicator progressively along the wall to apply the adhesive via the nozzle along the interior” such that the claim limitation is consistent with the specification pars. 123-124 as originally filed. For instance claim 1, lines 9-11 could be amended to recite --drawing the adhesive-applicator progressively along the wall and ing the adhesive via the nozzle to a plurality of sites along the interior”.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. WO2019/097289 discloses anchors or adhesive for securing a device to tissue of the heart.
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 MEGAN Y WOLF whose telephone number is (571)270-3071. The examiner can normally be reached Mon-Fri 8am-2pm.
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/MEGAN Y WOLF/Primary Examiner, Art Unit 3774
