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 .
Claim Objections
Claim 12 and 14 are objected to because of the following informalities:
Claim 12 line 1 – 2, limitation "wherein implanting the pericardial anchor in the pericardium comprises" should read "wherein said implanting the pericardial anchor in the pericardium comprises".
Claim 12 line 2, limitation "the shaft" should read "the tubular shaft".
Claim 14 line 3, limitation "a patient's pericardial sac" should read "the patient's pericardial sac".
Appropriate correction is required.
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.
Claim 1 – 10 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 recites limitation “a pericardial anchor” in line 4. It is unclear the above anchor is a newly introduced element or it is reciting the “pericardial anchor” as introduced in claim 1 line 1.
Thus, the above limitation renders claim indefinite. For the purpose of examination, the above limitation is interpreted as any reasonable anchor or anchoring element.
Claim 6 recites limitation “a guidewire lumen” in line 2. It is unclear the above guidewire lumen is a newly introduced different lumen inside the extension shaft, or the same guidewire lumen of the tubular shaft as introduced in claim 1 line 3.
Thus, the above limitation renders claim indefinite. For the purpose of examination, the above limitation is interpreted as any reasonable guidewire lumen.
Therefore, claim 1, 6 and all corresponding dependent claim 2 – 5 and 7 – 10 are rejected under 35 U.S.C. 112(b) as being indefinite.
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 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 1, 5, 6 and 8 – 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ma et al. (US 2017/0072191 A1; published on 03/16/2017) (hereinafter "Ma").
Regarding claim 1, Ma discloses a pericardial anchor for positioning a cardiac assist system ("The present disclosure provides improved active helical fixation anchors 66 for use with implantable medical leads or leadless pulse generators." [0037]) over a patient's heart beneath the patient's sternum and ribs ("These unique features of the tube-cut helical fixation anchor 66 can solve challenges in fixating a device into cardiac tissue ..." [0038]; according to human anatomy, the cardiac tissue is beneath the sternum and ribs), said pericardial anchor comprising:
a tubular shaft having a guidewire lumen therethrough ("The lead body 52 is constructed to include a hollow interior extending from the proximal region 54 to the distal region 56. The hollow interior allows for the introduction of a stylet, guidewire or other device during implant …" [0053]); and
a pericardial anchor at a distal end of the tubular shaft ("As shown in FIG. 2B, the distal region 56 of the lead 6 includes a helical fixation anchor 66 distally extending from an extreme distal tip end 68 of the lead 6 when the helical fixation anchor 66 is in a deployed state." [0046]; see Fig.2B, the lead body 52 is part of the lead 6; see also [0042]);
wherein the pericardial anchor is configured to anchor in the patient's pericardium in response to manipulation of the tubular shaft ("A torqueable catheter can be used to rotate the housing and force the helical fixation anchor 66 into heart tissue …" [0062]).
Regarding claim 5, Ma discloses all claim limitations, as applied in claim 1, and further discloses an extension shaft configured to removably couple to the proximal end of the tubular shaft ("As indicated in FIG. 2B, the lead 10 may include a fixation sleeve 74 slidably mounted around the lead body 52 proximal the shock coil 35. As indicated in FIG. 2B, the lead 10 may include a fixation sleeve 74 slidably mounted around the lead body 52 proximal the shock coil 35." [0051]).
Regarding claim 6, Ma discloses all claim limitations, as applied in claim 5, and further discloses wherein the extension shaft has a guidewire lumen ("The hollow interior allows for the introduction of a stylet, guidewire or other device during implant …" [0053]).
Regarding claim 8, Ma discloses all claim limitations, as applied in claim 1, and further discloses wherein the pericardial anchor is a helical anchor with a flat distal face oriented in a plane orthogonal to an axis of the tubular shaft ("As shown in FIG. 6, the tube-cut anchor 66 includes a distal end 200, a proximal end 202, and helical turns 204 extending between the distal and proximal ends." [0066]; see Fig.6 – 14), wherein the helical anchor has a sharpened tip configured to penetrate a pericardial membrane with limited penetration into an underlying fat pad ("… the distal termination of the most distal helical turn of the tube-cut anchor 66 terminates as a distal tip 214, wherein the distal tip is sharpened or tapered to facilitate the distal tip 214 being able to pierce cardiac tissue." [0073]).
Regarding claim 9, Ma discloses all claim limitations, as applied in claim 1, and further discloses a polymer sleeve configured to cover the tubular shaft ("The lead body 62 includes an outer insulation sheath 76 … The outer insulation sheath 76 is preferably fabricated of silicone rubber, polyurethane, silicone rubber-polyurethane-copolymer (SPC), or other suitable polymer." [0052]).
Regarding claim 10, Ma discloses all claim limitations, as applied in claim 1, and further discloses wherein the manipulation of the tubular shaft comprises rotation of the tubular shaft ("A torqueable catheter can be used to rotate the housing and force the helical fixation anchor 66 into heart tissue …" [0062]).
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 2 – 4 are rejected under 35 U.S.C. 103 as being unpatentable over Ma, as applied in claim 1, and further in view of Marshall et al. (US 2019/0117960 A1; published on 04/25/2019) (hereinafter "Marshall").
Regarding claim 2, Ma teaches all claim limitations, as applied in claim 1, except a removable handle at a proximal end of the tubular shaft.
However, in the same field of endeavor, Marshall teaches a removable handle at a proximal end of the tubular shaft ("The outer catheter 104 is deflected by rotating the handle 102." [0090]; see Fig.12; see also Fig.1A and 1B, the handle is removed in the final stage).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the cardiac device as taught by Ma with the cardiac implantable medical devices as taught by Marshall. Doing so would make it possible to "develop a medical electrical lead that minimizes trauma to the tissue and solely attaches to the epicardial tissue" (see Marshall; [0011]).
Regarding claim 3, Ma in view of Marshall teaches all claim limitations, as applied in claim 2, and Ma further teaches wherein the pericardial anchor is configured to anchor in the patient's pericardium in response to manipulation of the tubular shaft via the catheter ("A helical fixation anchor 66, can enable insertion of the device endocardially or epicardially through a guiding catheter. A torqueable catheter can be used to rotate the housing and force the helical fixation anchor 66 into heart tissue …" [0062])
And Marshall further teaches wherein the pericardial anchor is configured to anchor in the patient's pericardium in response to manipulation of the tubular shaft via the handle ("The outer catheter 104 is deflected by rotating the handle 102. The guiding catheter 100 includes an outer deflectable catheter 104 …" [0090]; considering the catheter 104 is equivalent to the torqueable catheter as taught by Ma).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the cardiac device as taught by Ma with the cardiac implantable medical devices as taught by Marshall. Doing so would make it possible to "develop a medical electrical lead that minimizes trauma to the tissue and solely attaches to the epicardial tissue" (see Marshall; [0011]).
Regarding claim 4, Ma in view of Marshall teaches all claim limitations, as applied in claim 2, and Marshall further teaches wherein the tubular shaft is configured to receive and anchor the cardiac assist system over the patient's heart beneath the patient's sternum and ribs after the handle is removed ("The lead 18 further includes a left ventricular pace/sense electrode 34 placed on the left ventricle, a right ventricular pace sense electrode 36." [0058]; see Fig.1A and 1B, the handle 102 is removed).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the cardiac device as taught by Ma with the cardiac implantable medical devices as taught by Marshall. Doing so would make it possible to "develop a medical electrical lead that minimizes trauma to the tissue and solely attaches to the epicardial tissue" (see Marshall; [0011]).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Ma, as applied in claim 1, and further in view of Datta et al. (US 2019/0021791 A1; published on 01/24/2019) (hereinafter "Datta").
Regarding claim 7, Ma teaches all claim limitations, as applied in claim 1, except wherein the tubular shaft is a slotted metal tube having controlled flexibility.
However, in the same field of endeavor, Datta teaches wherein the tubular shaft is a slotted metal tube ("The distal tip section 15 includes the hinged tube 50 having a hollow cylindrical body 51 with a lumen 56 … the body has an N plurality of transverse slots 52 defining an (N−1) plurality of hinges 53 therebetween … The slots 52 are cut or formed with electrical discharge machining (EDM) or laser machining. A suitable material for construction of the tube is metal and metal alloys, for example, nitinol." [0042]) having controlled flexibility ("So anchored, each of the puller wires 36A and 36B may be singly actuated by a user through manipulation of the deflection knob 13 (FIG. 1) on the control handle 16 to cause axial force on the puller wire in initially deflecting the distal tip section 15 for a distal deflection DD in a direction away from the spine 54 under a lesser actuation force and subsequently the intermediate section 14 for a proximal deflection PD under a greater actuation force either in the same direction (FIG. 3A), or in an opposition direction (FIG. 3B)." [0049]).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the flexible cardiac device as taught by Ma with the bending control mechanism on the cardiac catheter as taught by Datta. "The proximal deflection PD facilitates access to the right atrium of the heart for the catheter operator and also provides the operator with improved control over the tip dome electrode movement during ablation process" (see Datta; [0049]).
Claim 11 – 15 are rejected under 35 U.S.C. 103 as being unpatentable over Ma in view of Noriega et al. (WO 2020176670 A1; published on 09/03/2020) (hereinafter "Noriega").
Regarding claim 11, Ma teaches a method for positioning a cardiac assist system over a patient's heart beneath the patient's sternum and ribs ("As can be understood from FIG. 2B, the lead 6 is designed for intravenous insertion and contact with the endocardium ..." [0042]; according to human anatomy, the cardiac tissue is beneath the sternum and ribs), said method comprising:
advancing a pericardial anchor ("As can be understood from FIG. 2B, the lead 6 is designed for intravenous insertion and contact with the endocardium ..." [0042]) at a distal end of a tubular shaft ("As shown in FIG. 2B, the distal region 56 of the lead 6 includes a helical fixation anchor 66 distally extending from an extreme distal tip end 68 of the lead 6 when the helical fixation anchor 66 is in a deployed state." [0046]; see Fig.2B, the lead body 52 is part of the lead 6; see also [0042]) over the guidewire to position the pericardial anchor adjacent a preselected location on the patient's pericardium ("The hollow interior allows for the introduction of a stylet, guidewire or other device during implant, which is beneficial in allowing the surgeon to guide the otherwise flexible lead 6 from the point of venous insertion to the myocardium." [0053]);
implanting the pericardial anchor in the pericardium to stabilize the tubular shaft over the patient's heart ("The anchor 66 may be active in that it can serve as an electrode in addition to serving as a mechanism by which the distal end of the lead can be affixed or anchored to endocardial tissue." [0047]).
Although Ma does not explicitly teach the advancing of a guidewire, the taught medical device including a guidewire lumen is capable for procedure with guidewire.
Further, in the same field of endeavor, Noriega teaches percutaneously advancing a guidewire to a position over the patient's heart beneath the patient's ribs ("A guidewire and tapered dilator may be inserted into the intrapericardial space anterior to the heart at the apical site, and advanced to exit the pericardium at a superior location on the left side of the pericardium." [0010]); and
advancing the cardiac assist system over the tubular shaft to locate the cardiac assist system over the patient's heart beneath the patient's sternum and ribs ("The device comprises an implantable cardiac assist catheter, typically configured to be advanced over a guidewire to a position in the patient’s pericardial sac between a myocardial surface and an inner surface of the pericardium." [0007]).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the cardiac device implanting as taught by Ma with the cardiac assist device placement as taught by Noriega. Doing so would make it possible to provide "improved apparatus, systems and methods for providing cardiac assist to patients suffering from late stage heart failure" (see Noriega; [0005]).
Regarding claim 12, Ma in view of Noriega teaches all claim limitations, as applied in claim 11, and Ma further teaches wherein implanting the pericardial anchor in the pericardium comprises rotating the shaft to implant a helical anchor in the pericardium ("A torqueable catheter can be used to rotate the housing and force the helical fixation anchor 66 into heart tissue …" [0062]; "As shown in FIG. 6, the tube-cut anchor 66 includes a distal end 200, a proximal end 202, and helical turns 204 extending between the distal and proximal ends." [0066]; see Fig.6 – 14).
Regarding claim 13, Ma in view of Noriega teaches all claim limitations, as applied in claim 12, and Ma further teaches wherein the helical anchor has a flat distal face oriented in a plane orthogonal to an axis of the tubular shaft ("As shown in FIG. 6, the tube-cut anchor 66 includes a distal end 200, a proximal end 202, and helical turns 204 extending between the distal and proximal ends." [0066]; see Fig.6 – 14), wherein the helical anchor has a sharpened tip configured to penetrate a pericardial membrane with limited penetration into an underlying fat pad ("… the distal termination of the most distal helical turn of the tube-cut anchor 66 terminates as a distal tip 214, wherein the distal tip is sharpened or tapered to facilitate the distal tip 214 being able to pierce cardiac tissue." [0073]).
Regarding claim 14, Ma in view of Noriega teaches all claim limitations, as applied in claim 11, and Noriega further teaches wherein the cardiac assist system ("Referring now to Fig. 10, the cardiac assist system 10 of Fig. 1 may be implanted in a patient as illustrated." [0071]) comprises:
a pneumatic effector configured to be implanted beneath a patient's pericardial sac and over a myocardial surface overlying the patient's left ventricle ("In particular, the balloon or other pneumatic effector 20 is introduced into the pericardial sac between an inner surface of the pericardium P and an outer surface of the myocardium M. The pneumatic effector 20 will preferably be located generally over the left ventricle so that inflation or other actuation of the effector compresses the left ventricle, as shown in broken line in Fig. 10." [0071]);
an implantable port configured to receive a percutaneously introduced cannula ("Port 24 is connected to the balloon by catheter body 18 and accessed percutaneously by cannula 14." [0071]), wherein said port is connected to supply a driving gas received from the cannula to the pneumatic effector ("The external drive unit 48 delivers actuating gas through connecting tube 46 and cannula 14 to the port 24 in order to actuate the pneumatic effector ..." [0071]);
an external drive unit ("The external drive unit 48 …" [0071]; "… an external drive unit which includes …" [0016]) including:
(a) a pump assembly ("… a pump assembly …" [0016]); and
(b) control circuitry ("… and control circuitry." [0016]) configured to operate the pump to actuate the pneumatic effector in response to the patient's sensed heart rhythm ("The control circuitry is typically configured to operate the pump to actuate the pneumatic effector in response to the patient’s sensed heart rhythm." [0016]); and
a connecting tube having a pump end attachable to the pump assembly and a cannula end attached to the cannula ("Usually, the connecting tube has a pump end which is attachable to the pump of the pump assembly and a cannula end attached to the cannula." [0016]).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the cardiac device implanting as taught by Ma with the cardiac assist device placement as taught by Noriega. Doing so would make it possible to provide "improved apparatus, systems and methods for providing cardiac assist to patients suffering from late stage heart failure" (see Noriega; [0005]).
Regarding claim 15, Ma in view of Noriega teaches all claim limitations, as applied in claim 11, and Noriega further teaches locking the cardiac assist system in position with respect to the tubular shaft to prevent one or more of axial or transverse movement of the cardiac assist system with respect to the heart after the cardiac assist system has been advanced over the tubular shaft to locate the cardiac assist system over the patient's heart beneath the patient's sternum and ribs ("… the distal tip of the implantable cardiac assist catheter may further comprise an anchoring balloon or other anchoring structure. Such anchoring structures can be used by advancing the distal catheter tip outwardly through the pericardium, After the pneumatic effector is properly positioned, typically over the patient’s left ventricle, the anchor may be deployed (e.g. by balloon inflation) to stabilize the catheter position for subsequent use." [0034]).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the cardiac device implanting as taught by Ma with the cardiac assist device placement as taught by Noriega. Doing so would make it possible to provide "improved apparatus, systems and methods for providing cardiac assist to patients suffering from late stage heart failure" (see Noriega; [0005]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Koop et al. (US 2017/0326372 A1; published on 11/16/2017) teach a cardiac pacemaker for over the wire delivery.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHAO SHENG whose telephone number is (571)272-8059. The examiner can normally be reached Monday to Friday, 8:30 am to 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne M. Kozak can be reached at (571) 270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHAO SHENG/ Primary Examiner, Art Unit 3797
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