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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/17/2026 has been entered.
Response to Amendments
The Amendment filed 3/19/2026 has been entered.
Claims 1-13 remain pending in the application.
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.
Claims 1-5, and 7-13 are rejected under 35 U.S.C. 103 as being unpatentable over Rajagopal et al. (U.S. Patent Pub. 20190015205), hereinafter Rajagopal, and further in view of Plowiecki et al. (U.S. Patent No. 3895632), hereinafter Plowiecki.
Regarding claim 1, Rajagopal discloses a tool (epicardial tether system 300; see FIGS. 8-15; the Examiner notes that all reference characters cited below refer to FIGS. 8-15 unless otherwise stated) for placement in a heart wall and pericardial space operable to provide access to the pericardial space from a chamber of a heart and/or operable to be an anchor for devices coupled thereto (“for positioning an anchor 302 in the pericardial space 304”, [0069]), comprising:
a body (catheter 306) defining a lumen (lumen 318) operable to extend through the heart wall (See FIG. 8);
a head at a distal end (distal end 312) of the body operable to extend into the pericardial space (FIG. 8), the head including movable elements (anchor 302, FIG. 13) operable to move from a low profile predeployed configuration to a high profile deployed configuration (“As illustrated in FIGS. 13 and 14, when the anchor 302 positioned on the distal end of the anchor delivery rod reaches the pericardial space 304, the anchor expands to its full size, thereby locking the anchor 302 in place”, [0074]), the head defining an eyelet (the Examiner notes J-wire 82 and CO2 gas enter the pericardial space 304 via lumen 318, hence an opening or eyelet must be present and the wire can be ) at the distal end and operable to extend into the pericardial space (see FIG. 11), the eyelet being in fluid communication with the lumen so as to define an access channel operable to provide a fluid passage between the chamber of the heart and the pericardial space (“fluid communication with the inner catheter lumen”, [0069]); and
a base (proximal end 316 of catheter 3062) further comprising a retention member (anchor delivery guide 52) operable to retain the base in the heart wall. However, Rajagopal does not expressly state wherein the eyelet is operable to resiliently deform between open and closed configurations.
Plowiecki teaches a catheter of a trocar provided with a moulded connector (Abstract) wherein the eyelet (tongue 26) is operable to resiliently deform between open and closed configurations (“plug 20 is in an operative position, the small tongue 26 blocking the inlet 22 of the chamber. The small tongue thus prevents any return flow of the liquid towards the supply”, Col 2 Lines 51-54).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify Rajagopal to include an eyelet operable to resiliently deform between open and closed configurations. Doing so protects the supply liquid from being contaminated, as taught by Plowiecki (Col 3 Lines 44-46).
Regarding claim 2, Rajagopal in view of Plowiecki teaches the claimed invention as discussed above concerning the rejection of claim 1, and Rajagopal further teaches wherein the movable elements (anchor 302) are operable to buttress a parietal pericardium when the movable members attain a high profile in the deployed configuration (see FIG. 15) and wherein the retention member cooperates to engage the movable elements into abutment with the parietal pericardium (“anchor delivery guide 52 is inserted over the J-wire 82 until the tip 60 at the distal end 56 of the anchor delivery guide is positioned at or adjacent an anchoring site 324 in the pericardial space 304. The anchor delivery rod 54 is inserted through the inner guide lumen of the anchor delivery guide 52 until the distal end 64 of the anchor delivery rod is positioned in the pericardial space 304. The anchor 302 of the epicardial tether system 300 is coupled to the distal end 64 of the anchor delivery rod 54.”, [0073-74]).
Regarding claim 5, Rajagopal in view of Plowiecki teaches the claimed invention as discussed above concerning the rejection of claim 1, and Rajagopal further teaches wherein the eyelet (the Examiner notes J-wire 82 and CO2 gas enter the pericardial space 304 via lumen 318, hence an opening or eyelet must be present) is operable to expel or withdraw fluid or gas from a pericardial space using a device in communication with the lumen (“fluid communication with the inner catheter lumen”, [0069]).
Regarding claim 7, Rajagopal in view of Plowiecki teaches the claimed invention as discussed above concerning the rejection of claim 1, and Rajagopal further teaches wherein the access channel is operable for receiving and allowing the passage of devices therethrough between a ventricular side of the heart to the pericardial space (“intracardiac anchors for anchoring medical devices, such as cardiac valves, to a cardiac wall, including for interventricular or epicardial implantation of a replacement valve into an intracardial wall.”, [0002]);
Regarding claim 8, Rajagopal in view of Plowiecki teaches the claimed invention as discussed above concerning the rejection of claim 1, and Plowiecki further teaches wherein in the closed configuration the access channel is occluded to prevent fluid passage through the access channel (“plug 20 is in an operative position, the small tongue 26 blocking the inlet 22 of the chamber. The small tongue thus prevents any return flow of the liquid towards the supply”, Col 2 Lines 51-54).
Regarding claim 9, Rajagopal in view of Plowiecki teaches the claimed invention as discussed above concerning the rejection of claim 1, and Plowiecki further teaches wherein the head further includes an occluding element operable to resiliently move between open and closed positions, wherein in the closed position the access channel is occluded to prevent fluid passage through the access channel (“plug 20 is in an operative position, the small tongue 26 blocking the inlet 22 of the chamber. The small tongue thus prevents any return flow of the liquid towards the supply”, Col 2 Lines 51-54).
Regarding claim 10, Rajagopal in view of Plowiecki teaches the claimed invention as discussed above concerning the rejection of claim 1, and Plowiecki further teaches comprising an occluding plug operable to be placed in the access channel so as to occlude the access channel to prevent fluid passage through the access channel (“plug 20 is in an operative position, the small tongue 26 blocking the inlet 22 of the chamber. The small tongue thus prevents any return flow of the liquid towards the supply”, Col 2 Lines 51-54).
Regarding claim 11, Rajagopal in view of Plowiecki teaches the claimed invention as discussed above concerning the rejection of claim 1, and Rajagopal further teaches wherein the tool (system 300) is operable to couple with other devices or tissues of the heart (catheter 306, manifold 310, and pericardial space [0069]).
Regarding claim 12, Rajagopal discloses a method of implanting a tool (epicardial tether system 300; see FIGS. 8-15; the Examiner notes that all reference characters cited below refer to FIGS. 8-15 unless otherwise stated) for placement in a heart wall and pericardial space operable to provide access to the pericardial space from a chamber of a heart and/or operable to be an anchor for devices coupled thereto (“for positioning an anchor 302 in the pericardial space 304”, [0069]), comprising: providing the tool, comprising:
a body (catheter 306) defining a lumen (lumen 318) operable to extend through the heart wall (See FIG. 8);
a head at a distal end (distal end 312) of the body operable to extend into the pericardial space (FIG. 8), the head including movable elements (anchor 302) operable to move from a low profile predeployed configuration to a high profile deployed configuration (“As illustrated in FIGS. 13 and 14, when the anchor 302 positioned on the distal end of the anchor delivery rod reaches the pericardial space 304, the anchor expands to its full size, thereby locking the anchor 302 in place”, [0074]), the head defining an eyelet (the Examiner notes J-wire 82 and CO2 gas enter the pericardial space 304 via lumen 318, hence an opening or eyelet must be present) at the distal end and operable to extend into the pericardial space (see FIG. 11), the eyelet being in fluid communication with the lumen so as to define an access channel operable to provide a fluid passage between the chamber of the heart and the pericardial space (“fluid communication with the inner catheter lumen”, [0069]); and
a base (proximal end 316 of catheter 3062) further comprising a retention member (anchor delivery guide 52) operable to retain the base in the heart wall providing a delivery system operable for endovascular epicardial access, the delivery system including a steerable catheter and a delivery catheter (“illustrated in FIGS. 8-15, the assembly comprises an epicardial tether system 300 for positioning an anchor 302 in the pericardial space 304. In one aspect, the epicardial tether comprises a catheter 306”, [0069]);
inserting the delivery system into the patient using a transvenous, transarterial, transseptal, transartrial, or transaortic approach (“The anchors may be implanted into any cardiac wall including the interventricular septum”, Abstract);
advancing the delivery catheter onto which the tool is coupled into the myocardium and extending the head of the tool into the pericardial space (see FIG. 9). However, Rajagopal does not expressly state wherein the eyelet is operable to resiliently deform between open and closed configurations.
Plowiecki teaches a catheter of a trocar provided with a moulded connector (Abstract) wherein the eyelet (inlet 22) is operable to resiliently deform between open and closed configurations (“plug 20 is in an operative position, the small tongue 26 blocking the inlet 22 of the chamber. The small tongue thus prevents any return flow of the liquid towards the supply”, Col 2 Lines 51-54).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify Rajagopal to include an eyelet operable to resiliently deform between open and closed configurations. Doing so protects the supply liquid from being contaminated, as taught by Plowiecki (Col 3 Lines 44-46).
Regarding claim 13, Rajagopal in view of Plowiecki teaches the claimed invention as discussed above concerning the rejection of claim 12, and Rajagopal further teaches wherein the delivery system further includes a guidewire (J-wire 82) and/or needle, the method including: advancing the guidewire or needle through the delivery catheter and extending through the tool into the myocardium and into the pericardial space; and advancing the tool over the guidewire or needle (see FIGS. 8-9).
Claims 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Rajagopal et al. (U.S. Patent Pub. 20190015205), hereinafter Rajagopal, further in view of Plowiecki et al. (U.S. Patent No. 3895632), hereinafter Plowiecki, and further in view of Kudlik et al. (U.S. Patent Pub. 9668860), hereinafter Kudlik.
Regarding claim 3, Rajagopal in view of Plowiecki teaches the claimed invention as discussed above concerning the rejection of claim 1, and Rajagopal further teaches wherein the movable elements (anchor delivery rod 54 and anchor 302, FIG. 13) include an expander member operable to abut the pericardium (“the anchor 302 positioned on the distal end of the anchor delivery rod reaches the pericardial space 304, the anchor expands to its full size, thereby locking the anchor 302 in place”, [0074]) operable to enlarge a pericardial space (the Examiner notes FIG. 13 demonstrates the distal end 64 of the delivery rod 54 pushes against the pericardium. The more the distal end is pushed the more enlarged the pericardial space will become. It would have been obvious one of ordinary skill in the art to push the distal end of the rod forward so the entirety of the anchor can be inserted into the desired placement site and expand fully within the pericardial space). However, Rajagopal does not expressly state wherein the moveable elements include [a plurality of] expander members.
Kudlik teaches a device and system for treating a heart valve (Abstract) wherein the moveable elements include [a plurality of] expander members (“an anchor portion 51 comprising a central hub 52 from which extend a plurality of loops 54 and 56”, Col 4 Lines 31-33).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the expander member of Rajagopal to be a plurality of members. Doing so increases the surface area that is abutted by the anchors, further enlarging the pericardial space. Further it will provides multiples planes for anchor placement, as taught by Kudlik (see Col 2 Lines 60-64).
Regarding claim 3, Rajagopal in view of Plowiecki teaches the claimed invention as discussed above concerning the rejection of claim 2, and Rajagopal further teaches wherein the movable elements (anchor delivery rod 54 and anchor 302, FIG. 13) include an expander member operable to abut the pericardium (“the anchor 302 positioned on the distal end of the anchor delivery rod reaches the pericardial space 304, the anchor expands to its full size, thereby locking the anchor 302 in place”, [0074]) operable to enlarge a pericardial space (the Examiner notes FIG. 13 demonstrates the distal end 64 of the delivery rod 54 pushes against the pericardium. The more the distal end is pushed the more enlarged the pericardial space will become. It would have been obvious one of ordinary skill in the art to push the distal end of the rod forward so the entirety of the anchor can be inserted into the desired placement site and expand fully within the pericardial space). However, Rajagopal does not expressly state wherein the moveable elements include [a plurality of] expander members.
Kudlik teaches a device and system for treating a heart valve (Abstract) wherein the moveable elements include [a plurality of] expander members (“an anchor portion 51 comprising a central hub 52 from which extend a plurality of loops 54 and 56”, Col 4 Lines 31-33).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the expander member of Rajagopal to be a plurality of members. Doing so increases the surface area that is abutted by the anchors, further enlarging the pericardial space. Further it will provides multiples planes for anchor placement, as taught by Kudlik (see Col 2 Lines 60-64).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Rajagopal et al. (U.S. Patent Pub. 20190015205), hereinafter Rajagopal, further in view of Plowiecki et al. (U.S. Patent No. 3895632), hereinafter Plowiecki, and further in view of Sham et al. (U.S. Patent Pub. 20150289815), hereinafter Sham.
Regarding claim 6, Rajagopal in view of Plowiecki teaches the claimed invention as discussed above concerning the rejection of claim 1, however, Rajagopal in view of Plowiecki does not expressly state wherein the eyelet is operable to be a pressure port operable to measure pressure with a pressure sensing device.
Sham teaches intravascular diagnosis apparatus and methods including a monitoring guidewire (Abstract) wherein the eyelet (aperture, see [0069]) is operable to be a pressure port operable to measure pressure with a pressure sensing device (“pressure sensor disposed in the distal region of the core wire, and computing fractional flow reserve based on the pressure measurements from the pressure sensor and based on pressure measurements received at a communications port.”, [0028]; “insert the monitoring guidewire 402 into the aperture until the monitoring guidewire 402 is fully inserted into connector 406.”, [0069])
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify Rajagopal in view of Plowiecki to include an eyelet operable to be a pressure port operable to measure pressure with a pressure sensing device. Doing so provides computations using the processor based on communications and pressure measurements received from the monitoring guidewire, as taught by Sham (see [0029-20029]).
Response to Arguments
Applicant’s arguments, see Remarks, filed 03/19/2026, with respect to the rejection(s) of claim(s) 1-13 under 35 U.S.C. 102(a)(1) to Rajagopal (U.S. Patent Pub. 20190015205) have been fully considered but they are not persuasive.
In regards to the Applicant’s argument that “The Office Action acknowledges that Rajagopal does not teach the "eyelet" as recited in claim 1 and instead cites Plowiecki's "tongue 26" as teaching the "eyelet" as recited in claim 1”.
This is not accurate for the following reasons:
The Final dated 1/23/2026 states that Rajagopal discloses “an eyelet (the Examiner notes J-wire 82 and CO2 gas enter the pericardial space 304 via lumen 318, hence an opening or eyelet must be present and the wire can be) that is in fluid communication with the lumen so as to define an access channel operable to provide a fluid passage between the chamber of the heart and the pericardial space (“fluid communication with the inner catheter lumen”, [0069])” in the rejection of claims 1 and 12.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NELSON ALVARADO whose telephone number is (703) 756-5301. The examiner can normally be reached on M-F 8:30am-5pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached on (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is (571)-273-8300. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/Nelson Alvarado/
Junior Examiner , Art Unit 3783
4/22/2026 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights