DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
This office action is responsive to the amendment filed on 06/23/2026. As directed by the amendment: claims 37-43, 45-48 have been amended. Thus, claims 37-48 are presently pending in the application.
Response to Arguments
The amendment to claims 38, 46 to correct the indefinite limitation has overcome the previous 112b rejection from the non-final office action. Therefore, the 112(b) rejections have been withdrawn.
Applicant's arguments filed 06/23/2026 have been fully considered but they are not persuasive. Applicant argues on page 6, the prior art Opolski fails to disclose longitudinally locking the medical device to the delivery device via a holding structure enclosed within a sleeve of the delivery device. The examiner respectfully disagrees. Opolski teaches in an alternative embodiment as seen in Figures 5A-5B, a releasing element 500 enclosed within a sleeve 411 includes a locking mechanism (not shown) that is operatively associated with the releasing element 500 to prevent premature release of the implant 250 (see paragraphs [0056-0057]).
In light of the amendment to include “a delivery device via a holding structure” has overcome the 102 rejections over Opolski. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of 102 rejection is made in view of Opolski et al. U.S. Publication 2003/0181945 A1 and a new ground(s) of 103 rejection is made in view of Opolski U.S. Publication 2004/0176797 A1 in view of Cohn U.S. Publication 2009/0164004 A1.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 37-48 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Opolski et al. U.S. Publication 2003/0181945 A1.
Regarding Claim 37, Opolski et al. discloses a method of implanting a medical device (abstract and paragraph [0033]) comprising: connecting the medical device 3 to a delivery device 2 (paragraphs [0032-0033]); longitudinally locking the medical device 3 to the delivery device 2 via a holding structure 1, 35 enclosed within a sleeve 4 of the delivery device 2 (paragraphs [0032], [0034-0035] and [0041] as seen in Figures 2A-2D); moving the medical device intravascularly to a region of an intended implantation site (paragraph [0048]); delivering the medical device to the implantation site via movement of the delivery device along an axis of the delivery device (paragraphs [0006], [0010], [0048]); allowing the medical device to move in any one of a plurality of planes relative to the axis of the delivery device (paragraph [0008], [0015], [0036] and [0048]); and releasing the medical device from the delivery device (paragraphs [0010], [0041] and [0043]).
Regarding Claim 38, Opolski et al. discloses wherein connecting the medical device to a delivery device comprises: allowing the medical device 3 to rest at any one of a plurality of angles relative to the axis of the delivery device 2 (as seen in Figure 2D and paragraph [0040]); moving the delivery device 2 along its axis towards a connection point of the medical device 3 (as seen in Figures 2A-2D and paragraphs [0006], [0010], [0012]); capturing the delivery medical device with the delivery device (paragraphs [0041-0042], [0046]).
Regarding Claim 39, Opolski et al. discloses wherein the plurality of angles are in a range of 0 to 180 degrees relative to the axis of the delivery device (paragraphs [0011], [0040]).
Regarding Claim 40, Opolski et al. discloses wherein capturing the delivery medical device comprises the delivery device 2 capturing a connection point in the form of a rounded ball 22 disposed on the medical device (paragraphs [0038-0040] and [0042-0043]).
Regarding Claim 41, Opolski et al. discloses a method of delivering a medical device to a patient (abstract and paragraphs [0032-0033]) comprising: connecting the medical device 3 to a delivery system 2 (paragraphs [0032-0033]); longitudinally locking the medical device 3 to the delivery system 2 via a holding structure 1, 35 enclosed within a sleeve 4 of the delivery system 2 (paragraphs [0032], [0034-0035] and [0041] as seen in Figures 2A-2D); moving the medical device through a body lumen to a delivery site (paragraph [0048]); moving the delivery system 2 along a delivery system axis to the delivery site (paragraphs [0006], [0010], [0048]); allowing movement of the medical device 3 in a plurality of planes relative to the delivery system axis (paragraph [0008], [0015], [0036] and [0048]); and releasing the medical device 3 from the delivery system 2 (paragraphs [0010], [0041] and [0043]).
Regarding Claim 42, Opolski et al. discloses wherein connecting the medical device to a delivery system (paragraphs [0016], [0018], [0031]) comprises: resting the medical device at any one of a plurality of angles relative to the delivery system axis (as seen in Figure 2D and paragraph [0040]); moving the delivery system 2 along its axis towards the medical device 3 (as seen in Figures 2A-2D and paragraphs [0006], [0010], [0012]); capturing the medical device 3 with the delivery system 2 (paragraphs [0041-0042], [0046]).
Regarding Claim 43, Opolski et al. discloses wherein the plurality of angles are in a range of 0 to 180 degrees relative to the delivery system axis (paragraphs [0011], [0040]).
Regarding Claim 44, Opolski et al. discloses wherein capturing the medical device 3 comprises the delivery system 2 capturing a connection point in the form of a rounded ball 22 disposed on the medical device 3 (as seen in Figures 2A-2D and paragraphs [0038-0040] and [0042-0043]).
Regarding Claim 45, Opolski et al. discloses a method of deploying a medical device 3 in a patient (abstract and paragraphs [0032-0033]) comprising connecting the medical device 3 to a delivery device 2 (paragraphs [0032-0033]); longitudinally locking the medical device 3 to the delivery device 2 via a holding structure 1, 35 enclosed within a sleeve 4 of the delivery device 2 (paragraphs [0032], [0034-0035] and [0041] as seen in Figures 2A-2D); sliding the medical device percutaneously to a region of an implantation site (paragraphs [0003], [0005], [0048]); moving the medical device to the implantation site by urging the delivery device along an axis of the delivery device 2 (as seen in Figures 2A-2D and paragraphs [0006], [0010], [0048]); the medical device being free to move in any one of a plurality of planes relative to the axis of the delivery device 2 (paragraph [0008], [0011], [0015], [0036], [0040] and [0048]); and releasing the medical device from the delivery device (paragraphs [0010], [0041] and [0043]).
Regarding Claim 46, Opolski et al. discloses wherein connecting the medical device 3 to a delivery device 2 (paragraphs [0016], [0018], [0031-0032]) comprises: resting the medical device 3 at any one of a plurality of angles relative to the delivery system axis (as seen in Figure 2D and paragraph [0040]); moving the delivery device 2 along its axis towards the medical device (as seen in Figures 2A-2D and paragraphs [0006], [0010], [0012]); capturing the medical device 3 with the delivery device 2 (paragraphs [0032], [0041-0042], [0046]).
Regarding Claim 47, Opolski et al. discloses wherein the plurality of angles are in a range of 0 to 180 degrees relative to the axis of the delivery device 2 (paragraphs [0011], [0040]).
Regarding Claim 48, Opolski et al. discloses wherein capturing the medical device 3 comprises the delivery device 2 capturing a connection point in the form of a rounded ball 22 disposed on the medical device 3 (as seen in Figures 2A-2D and paragraphs [0038-0040] and [0042-0043]).
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained through the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 37-48 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Opolski U.S. Publication 2004/0176797 A1 in view of Cohn U.S. Publication 2009/0164004 A1.
Regarding Claim 37, Opolski discloses a method of implanting a medical device (paragraphs [0010], [0013], [0015-0016], [0035]) comprising: connecting the medical device 250 to a delivery device 100 (paragraph [0043], [0045]); moving the medical device intravascularly to a region of an intended implantation site; delivering the medical device to the implantation site via movement of the delivery device 100 along an axis of the delivery device 100 (paragraphs [0005], [0010], [0013] and [0015]); allowing the medical device to move in any one of a plurality of planes relative to the axis of the delivery device (paragraphs [0047-0048]); and releasing the medical device from the delivery device and wherein the medical device is enclosed within a sleeve 145 of the delivery device 100 (paragraph [0039]). However, in the embodiment used in the rejection above, Figures 2A-2D does not expressly disclose longitudinally locking the medical device to the delivery device enclosed within a sleeve of the delivery device. In an alternative embodiment as seen in Figures 5A-5B, Opolski teaches a delivery device 500 enclosed within a sleeve 411 and coupled to an implant 250, wherein the delivery device further includes a locking mechanism (not shown) that is operatively associated with the releasing element 500 to prevent premature release of the implant 250 (see paragraphs [0056-0057]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the delivery device of Figures 2A-2D to further include a locking mechanism coupled to the implant as taught in Figures 5A-5B to prevent premature release of the implant. However, Opolski does not expressly disclose longitudinally locking the medical device via a holding structure. Cohn teaches a method of implanting a device within a heart (abstract), the method comprising connecting the medical device 300 to a delivery device 510 (paragraphs [0072]), the method comprises longitudinally locking the medical device 300 to the delivery device 510 via a holding structure 515 enclosed within a sleeve 505 (paragraphs [0084] and [0094], Cohn discloses the holding structure 515 deforms between an open and closed position to grasp the medical device or release the medical device) for the purpose of releasably securing the prosthesis to the delivery apparatus (paragraph [0078] and [0094]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Opolski’s delivery device to further include a holding structure that locks the medical device to the delivery device as taught by Cohn for the purpose of releasably securing the prosthesis to the delivery apparatus.
Regarding Claim 38, Opolski discloses wherein connecting the medical device 250 to a delivery device 2 comprises: allowing the medical device 250 to rest at any one of a plurality of angles relative to the axis of the delivery device (paragraphs [0015], [0047-0048]); moving the delivery device along its axis towards a connection point of the medical device (paragraph [0010], [0013], [0015-0016], [0034-0035]); capturing the medical device with the delivery device (paragraphs [0043] and [0070-0071]).
Regarding Claim 39, Opolski discloses wherein the plurality of angles are in a range of 0 to 180 degrees relative to the axis of the delivery device (paragraphs [0012], [0047]).
Regarding Claim 40, Opolski discloses wherein capturing the delivery device 100 comprises the medical device capturing a connection point in the form of a rounded ball disposed on the medical device (as seen in Figures 2A and 2C and paragraphs [0005], [0040], [0050]).
Regarding Claim 41, Opolski discloses a method of delivering a medical device to a patient (paragraphs [0010], [0013], [0015-0016], [0035]) comprising: connecting the medical device 250 to a delivery system 100 (paragraphs [0015-0016], [0040], [0047]); moving the medical device through a body lumen to a delivery site (paragraph [0010], [0013], [0015-0016], [0034-0035]); moving the delivery system 100 along a delivery system axis 261 to the delivery site (as seen in Figure 2C and paragraphs [0034], [0038-0040] and [0047-0048]); allowing movement of the medical device in a plurality of planes 266 relative to the delivery system axis 261 (as seen in Figure 2C and paragraphs [0047-0048]); and releasing the medical device 250 from the delivery system 100 (paragraphs [0015-0016], [0044] and [0048]). However, in the embodiment used in the rejection above, Figures 2A-2D does not expressly disclose longitudinally locking the medical device to the delivery device enclosed within a sleeve of the delivery device. In an alternative embodiment as seen in Figures 5A-5B, Opolski teaches a delivery device 500 enclosed within a sleeve 411 and coupled to an implant 250, wherein the delivery device further includes a locking mechanism (not shown) that is operatively associated with the releasing element 500 to prevent premature release of the implant 250 (see paragraphs [0056-0057]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the delivery device of Figures 2A-2D to further include a locking mechanism coupled to the implant as taught in Figures 5A-5B to prevent premature release of the implant. However, Opolski does not expressly disclose longitudinally locking the medical device via a holding structure. Cohn teaches a method of implanting a device within a heart (abstract), the method comprising connecting the medical device 300 to a delivery device 510 (paragraphs [0072]), the method comprises longitudinally locking the medical device 300 to the delivery device 510 via a holding structure 515 enclosed within a sleeve 505 (paragraphs [0084] and [0094], Cohn discloses the holding structure 515 deforms between an open and closed position to grasp the medical device or release the medical device) for the purpose of releasably securing the prosthesis to the delivery apparatus (paragraph [0078] and [0094]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Opolski’s delivery device to further include a holding structure that locks the medical device to the delivery device as taught by Cohn for the purpose of releasably securing the prosthesis to the delivery apparatus.
Regarding Claim 42, Opolski discloses wherein connecting the medical device 250 to a delivery system 100 comprises: resting the medical device 250 at any one of a plurality of angles relative to the axis 261 of the delivery device 100 (paragraphs [0015], [0047-0048]); moving the delivery system 100 along its axis towards a medical device (paragraph [0010], [0013], [0015-0016], [0034-0035]); capturing the medical device with the delivery system (paragraphs [0043] and [0070-0071]).
Regarding Claim 43, Opolski discloses wherein the plurality of angles are in a range of 0 to 180 degrees relative to the axis 261 of the delivery device 100 (paragraphs [0012], [0047]).
Regarding Claim 44, Opolski discloses wherein capturing the delivery device 100 comprises the delivery device capturing a connection point in the form of a rounded ball disposed on the medical device (as seen in Figures 2A and 2C and paragraphs [0005], [0040], [0050]).
Regarding Claim 45, Opolski discloses method of deploying a medical device in a patient (paragraphs [0010], [0013], [0015-0016], [0035]) comprising: connecting the medical device 250 to a delivery device 100 (paragraph [0043], [0045]); sliding the medical device 250 percutaneously to a region of an implantation site (paragraphs [0034],[0038-0040]) ; moving the medical device to the implantation site by urging the delivery device along an axis 261 of the delivery device 100 (as seen in Figure 2C and paragraphs [0038-0040] and [0047-0048]); the medical device 250 being free to move in any one of a plurality of planes 266 relative to the axis of the delivery device 100 (as seen in Figure 2C and paragraphs [0012], [0047-0048]); and releasing the medical device 250 from the delivery device 100 (paragraphs [0015-0016], [0044] and [0048]). However, in the embodiment used in the rejection above, Figures 2A-2D does not expressly disclose longitudinally locking the medical device to the delivery device enclosed within a sleeve of the delivery device. In an alternative embodiment as seen in Figures 5A-5B, Opolski teaches a delivery device 500 enclosed within a sleeve 411 and coupled to an implant 250, wherein the delivery device further includes a locking mechanism (not shown) that is operatively associated with the releasing element 500 to prevent premature release of the implant 250 (see paragraphs [0056-0057]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the delivery device of Figures 2A-2D to further include a locking mechanism coupled to the implant as taught in Figures 5A-5B to prevent premature release of the implant. However, Opolski does not expressly disclose longitudinally locking the medical device via a holding structure. Cohn teaches a method of implanting a device within a heart (abstract), the method comprising connecting the medical device 300 to a delivery device 510 (paragraphs [0072]), the method comprises longitudinally locking the medical device 300 to the delivery device 510 via a holding structure 515 enclosed within a sleeve 505 (paragraphs [0084] and [0094], Cohn discloses the holding structure 515 deforms between an open and closed position to grasp the medical device or release the medical device) for the purpose of releasably securing the prosthesis to the delivery apparatus (paragraph [0078] and [0094]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Opolski’s delivery device to further include a holding structure that locks the medical device to the delivery device as taught by Cohn for the purpose of releasably securing the prosthesis to the delivery apparatus.
Regarding Claim 46, Opolski discloses wherein connecting the medical device 250 to a delivery device 100 comprises: allowing the medical device 250 to rest at any one of a plurality of angles 266 relative to the axis of the delivery device 100 (paragraphs [0012], [0044], [0047-0048]); moving the delivery device along its axis towards a connection point of the medical device; capturing the medical device with the delivery device (as seen in Figures 2A and 2C and paragraphs [0005], [0040], [0043], [0050] and [0070-0071]).
Regarding Claim 47, Opolski discloses wherein the plurality of angles are in a range of 0 to 180 degrees relative to the axis of the delivery device (paragraphs [0012], [0047]).
Regarding Claim 48, Opolski discloses wherein capturing the medical device 250 comprises the delivery device capturing a connection point in the form of a rounded ball disposed on the medical device (as seen in Figures 2A and 2C and paragraphs [0005], [0040], [0050]).
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 SEEMA MATHEW whose telephone number is (571) 270-1452. The examiner can normally be reached on Monday-Friday 9 am – 5 pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, SPE, Melanie Tyson at (571) 272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEEMA MATHEW/
Primary Examiner, Art Unit 3774
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