DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. 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.
Claim Rejections - 35 USC § 102
3. 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.
4. Claims 1-10 and 12-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Asirvatham U.S. 2017/0258521 (herein referred to as “Asirvatham 2017”).
5. Regarding Claim 1, Asirvatham 2017 teaches a method of improving a heart function in a heart of a subject having heart dysfunction (Figs. 1 and 25), the method comprising:
(a) accessing a pericardial cavity of the heart (Fig. 19A, para 0067, “dilator device 100 is configured and arranged to puncture pericardium 22 to gain access to the pericardial space of heart 20”);
(b) advancing a cutting device within the pericardial cavity to a first incision point (para 0122, “Pericardium slitter device 600 includes a shaft 610 and a reverse-cutting blade 620. Pericardium slitter device 600 can also include a control handle (not shown) such that a clinician operator can operate and control pericardium slitter device 600”);
(c) piercing at least a parietal layer of a pericardium of the heart (para 0121, “such that a distal end portion of pericardium slitter device 600 is positioned within the pericardial space (between the visceral and parietal layers of pericardium 22)”; para 0051);
(d) retracting the cutting device along a selected cut path (para 0142, “pericardial modification device 830 has been retracted into sheath 810”) so as to create a first incision having a selected length in at least the parietal layer (Figs. 19E, 19F, ref num 25c, 25d) to reduce pressure exerted on the hart by the pericardium (para 0153, “The pattern is made by creating multiple incisions, tears, or removals of pericardium 22 to create the multiple openings 28. This pattern can allow the volume contained by pericardium 22 to expand. In some embodiments, this method and pattern can be used to relieve pressure within pericardium 22”); and,
(e) repeating operations (b) thru (d) to create one or more additional incisions along respective additional cut paths, wherein each of the first and the additional incisions are one of isolated from each other or intersect each other (para 0176, “After a single cut or multiple cuts to pericardium 22 have been made, pericardectomy device 1000 can be repositioned to another area of pericardium 22 as desired. The actions can be repeated to cut (or tear, puncture, dissect, etc.) another portion of pericardium 22. By repeating the actions described herein, pericardium 22 can be removed to the extent desired—which may be a full or partial removal of pericardium 22”).
6. Regarding Claim 2, Asirvatham 2017 teaches creating the incision length is through one or more of the parietal layer, a fibrous layer, and adipose tissue of the pericardium (para 0052, “the parietal layer is fully removed and the visceral layer is modified, modulated, or partially removed”).
7. Regarding Claim 3, Asirvatham 2017 teaches accessing the pericardial cavity comprises puncturing the pericardium to access the pericardial cavity (para 0010, “a method of puncturing pericardium”; para 0067) and inserting a guidewire into and advancing a dilator over the guidewire and into the pericardial cavity (Figs. 1-3, para 0064).
8. Regarding Claim 4, Asirvatham 2017 teaches before puncturing the pericardium, providing subxiphoid access to the pericardium or transvascular access to the pericardium (para 0055, “The approach can be, for example, subxiphoidal”).
9. Regarding Claim 5, Asirvatham 2017 teaches after inserting a guidewire or dilator into the pericardial cavity, advancing a multi-lumen catheter over the guidewire into the pericardial cavity (Fig. 12, para 0099-0100), the multi-lumen catheter having a proximal end, a distal end, a longitudinal axis, and comprising the cutting device (see Fig. 12).
10. Regarding Claim 6, Asirvatham 2017 teaches retracting the cutting device comprises pulling the cutting device along the guidewire to create the first incision and the additional incisions (Figs. 19E, 19F, ref num 25c, 25d; para 0141-0142, it is understood that the cutting device is retracted along the guidewire, and that the additional incisions would be made when the method is repeated).
11. Regarding Claim 7, Asirvatham 2017 teaches the cutting device selected from a group consisting of a scalpel, a mechanical cutting device, and electrosurgical device, a reversibly retractable knife blade, and combinations thereof (see Figs. 12, ref num 500, Figs. 13-15, ref num 600).
12. Regarding Claim 8, Asirvatham 2017 teaches the cutting device comprises first and second cutting surfaces in a scissor-shaped configuration (Fig. 12, ref num 532, 534; para 0101, “like a scissors, upper jaw 534 and lower jaw 532 can be pivoted in relation to each other, and tissue positioned between upper jaw 534 and lower jaw 532 can be thereby sheared”), wherein piercing at least the parietal layer further comprises placing one cutting surface above the parietal layer and the second cutting surface below the parietal layer (para 0099, “such that a distal end portion of pericardium slitter device 500 is positioned within the pericardial space (between the visceral and parietal layers of pericardium 22)…”; para 0138), and wherein retracting the cutting device comprises retracting the cutting device such that the first and second cutting surfaces cut through the parietal layer (para 0116, “lower jaw extension 536 will need to be retracted in order to shear pericardium 22 essentially all the way to the location of the upper cul-de-sac areas of the pericardial space”).
13. Regarding Claim 9, Asirvatham 2017 teaches the first cutting surface is an electrode (para 0118, “one or more electrodes 533 can be located on either upper jaw 534 or lower jaw 532”) and the second cutting surface is a mechanical blade (para 0021, “The device may also include one or more electrodes attached to the blade member”), and wherein retracting the cutting device further comprises applying power to the electrode of the first cutting surface during retraction (para 0118, “the one or more electrodes 533 (supplied by RF energy, for example) can be actuated to burn a small portion of pericardium 22, and then the pivoting actuation between the jaws 532 and 534 can be actuated to shear pericardium 22 from the small, burned portion”).
14. Regarding Claim 10, Asirvatham 2017 teaches the first cutting surface comprises two or more electrodes (para 0118, “one or more electrodes 533 can be located on either upper jaw 534 or lower jaw 532”; this indicates there may be two or more electrodes on the first cutting surface).
15. Regarding Claim 12, Asirvatham 2017 fails to teach advancing the multi-lumen catheter into the pericardial space, stabilizing a portion of the multi-lumen catheter within the pericardial cavity, wherein the stabilizing comprises deploying one or more stabilizing members, the one or more stabilizing members projecting laterally from the multi-lumen catheter.
16. Regarding Claim 13, Asirvatham 2017 teaches detecting a phrenic nerve (para 0058, “the devices provided herein include electrode devices for stimulating or sensing the phrenic nerves”).
17. Regarding Claim 14, Asirvatham 2017 teaches retracting the cutting device along a selected cut path so as to create a first incision having a selected length in at least the parietal layer is selected (Figs. 19E, 19F, ref num 25c, 25d) so as to avoid cutting the phrenic nerve (para 0118, “the same electrodes 533 can also have pacing and/or recording functions to ensure there is no myocardial contact and/or no phrenic nerve contact”).
18. Regarding Claim 15, Asirvatham 2017 teaches the at least one incision length is chosen from: along a length or circumference of only the parietal layer of the pericardium; from an anterior to a posterior of a heart; from a posterior base to an apex of a heart; from a posterior right atrium to an apex of a heart; from a left ascending aorta to an apex of a heart; from a right ascending aorta to an apex of a heart; or transversely about a heart (see Figs. 19D, 19E, 19F).
19. Regarding Claim 16, Asirvatham 2017 teaches a method of improving a heart function in a heart of a subject having heart dysfunction (Figs. 1 and 5), the method comprising:
(a) accessing a pericardial cavity of the heart Fig. 19A, para 0067, “dilator device 100 is configured and arranged to puncture pericardium 22 to gain access to the pericardial space of heart 20”);
(b) advancing a cutting device within the pericardial cavity to a first incision point (para 0122, “Pericardium slitter device 600 includes a shaft 610 and a reverse-cutting blade 620. Pericardium slitter device 600 can also include a control handle (not shown) such that a clinician operator can operate and control pericardium slitter device 600”), wherein the cutting device comprises first and second cutting surfaces in a scissor-shaped configuration (Fig. 12, ref num 532, 534; para 0101, “like a scissors, upper jaw 534 and lower jaw 532 can be pivoted in relation to each other, and tissue positioned between upper jaw 534 and lower jaw 532 can be thereby sheared”);
(c) piercing at least a parietal layer of a pericardium of the heart (para 0121, “such that a distal end portion of pericardium slitter device 600 is positioned within the pericardial space (between the visceral and parietal layers of pericardium 22)”; para 0051);
(d) placing one cutting surface of the cutting device above the parietal layer and the second cutting surface below the parietal layer (para 0099, “such that a distal end portion of pericardium slitter device 500 is positioned within the pericardial space (between the visceral and parietal layers of pericardium 22)…”; para 0138);
(e) retracting the cutting device along a selected cut path such that the first and second cutting surfaces cut through the parietal layer (para 0142, “pericardial modification device 830 has been retracted into sheath 810”) and so as to create a first incision having a selected length in at least the parietal layer (Figs. 19E, 19F, ref num 25c, 25d) to reduce pressure exerted on the heart by the pericardium (para 0153, “The pattern is made by creating multiple incisions, tears, or removals of pericardium 22 to create the multiple openings 28. This pattern can allow the volume contained by pericardium 22 to expand. In some embodiments, this method and pattern can be used to relieve pressure within pericardium 22”); and,
(f) repeating operations (b) thru (e) to create one or more additional incisions along respective additional cut paths, wherein each of the first and the additional incisions are one of isolated from each other or intersect each other (para 0176, “After a single cut or multiple cuts to pericardium 22 have been made, pericardectomy device 1000 can be repositioned to another area of pericardium 22 as desired. The actions can be repeated to cut (or tear, puncture, dissect, etc.) another portion of pericardium 22. By repeating the actions described herein, pericardium 22 can be removed to the extent desired—which may be a full or partial removal of pericardium 22”).
20. Regarding Claim 17, Asirvatham 2017 teaches the first cutting surface is an electrode (para 0118, “one or more electrodes 533 can be located on either upper jaw 534 or lower jaw 532”) and the second cutting surface is a mechanical blade (para 0021, “The device may also include one or more electrodes attached to the blade member”), and wherein retracting the cutting device further comprises applying power to the electrode of the first cutting surface during retraction (para 0118, “the one or more electrodes 533 (supplied by RF energy, for example) can be actuated to burn a small portion of pericardium 22, and then the pivoting actuation between the jaws 532 and 534 can be actuated to shear pericardium 22 from the small, burned portion”).
21. Regarding Claim 18, Asirvatham 2017 teaches stabilizing the cutting device within the pericardial cavity by deploying one or more stabilizing members into the pericardial cavity (para 0170, “a stabilizing device (not shown) can also be used to reduce movement of pericardium 22 in preparation for cutting”).
22. Regarding Claim 19, Asirvatham 2017 teaches the at least one incision length is chosen from: along a length or circumference of only the parietal layer of the pericardium; from an anterior to a posterior of a heart; from a posterior base to an apex of a heart; from a posterior right atrium to an apex of a heart; from a left ascending aorta to an apex of a heart; from a right ascending aorta to an apex of a heart; or transversely about a heart (see Figs. 19D, 19E, 19F).
23. Regarding Claim 20, Asirvatham 2017 teaches detecting a phrenic nerve (para 0058, “the devices provided herein include electrode devices for stimulating or sensing the phrenic nerves”) and wherein retracting the cutting device along a selected cut path so as to create a first incision having a selected length in at least the parietal layer is selected (Figs. 19E, 19F, ref num 25c, 25d) so as to avoid cutting the phrenic nerve (para 0118, “the same electrodes 533 can also have pacing and/or recording functions to ensure there is no myocardial contact and/or no phrenic nerve contact”).
Claim Rejections - 35 USC § 103
24. 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
25. Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Asirvatham and in view of Saadat U.S. 2009/0187074 (herein referred to as “Saadat”).
26. Regarding Claim 11, Asirvatham 2017 fails to teach the multi-lumen catheter further comprises a fiberscope and the method further comprises obtaining visual information before, during, or after creating the at least incision length through the pericardium.
Saadat teaches a method of analogous art (para 0013), wherein the method comprises a fiberscope (para 0013, “the tissue may be directly visualized, either via the fiberscope or electronic imager”) that comprises obtaining visual information before, during, or after creating an incision (para 0013, “The device in its low-profile tapered delivery configuration may be introduced through the incision and superiorly into the thoracic cavity until the frame assembly is adjacent to the pericardial sac of the heart. Once desirably positioned, the frame assembly may be deployed into its open configuration and opening may be placed against the exterior surface of the pericardial sac and the tissue may be directly visualized, either via the fiberscope or electronic imager”). This allows the procedure to be performed under the guidance of direct visualization (para 0015). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Asirvatham 2017 to utilize a fiberscope within the multi-lumen catheter in order to provide visualization and guidance before, during, or after the procedure.
Conclusion
27. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure is as follows:
Asirvatham U.S. 2016/0015410 teaches a method of improving a heart function in a heart of a subject having a heart dysfunction comprising accessing a pericardial cavity of the heart, advancing a cutting device, piercing the target layer and making an incision (see Figs. 1 and 8A-8F).
28. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNIE L SHOULDERS whose telephone number is (571)272-3846. The examiner can normally be reached Monday-Friday (alternate Fridays) 8AM-5PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at 571-272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANNIE L SHOULDERS/Examiner, Art Unit 3794
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