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 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(s) 1-5, 7-11, 13, 14, 16-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Asirvatham (US PGPub 2013/0012938)
Regarding Claim 1, Asirvatham teaches a pericardial transection device for use in a pericardial cavity of a heart (abstract), said device comprising:
an elongated member (32; Figure 3; Paragraph 0043) having a distal end (closest to delivery tip 130) and a proximal end and extending along a longitudinal axis, the proximal end coupled to an end of a catheter (16);
a plurality of extensions (26; Figure 3 and Figured 9-10) operably coupled to the distal end of the elongated member (32; Figures 3 and 9-10; Paragraph 0047-0051); and
a sheath (134; Figure 2) having a distal end encircling at least the distal end of the elongated member (32) an in a longitudinally slidable relation therewith (Paragraph 0043 and 0047), where in a first sliding position, at least the distal end of the elongated member and the plurality of extensions are encircled by the sheath (134; Paragraph 0013 and 0047; Figure 2), and in a second sliding position, the plurality of extensions (26) project from the distal end of the sheath (as seen in Figures 3, 9-10),
wherein each of the plurality of extensions (26) extend in a different plane from each of the other extensions in the second sliding position (Figures 3-10), and wherein the plurality of extensions (26) are structured such that, in the second sliding position of the sheath (134) when the device is deployed in the pericardial cavity, at least one of the plurality of extensions (26) extend radially outwardly to contact a surface below the pericardial cavity and at least one of the plurality of extensions extends radially outwardly to contact a surface above the pericardial cavity (as seen in Figures 7-8 but also seen in Figure 9 in which one of the extensions is placed above and above the pericardial cavity).
Regarding Claim 2, Asirvatham teaches the pericardial transection device of claim 1, wherein the at least one of the elongated member or one or more of the plurality of extensions are flexibly rigid (Paragraph 0047 discloses nitinol).
Regarding Claim 3, Asirvatham teaches the pericardial transection device of claim 1, wherein at least one of the one or more of the plurality of extensions or the elongated member comprises a shape memory material (Paragraph 0047 discloses nitinol).
Regarding Claim 4, Asirvatham teaches the pericardial transection device of claim 1, wherein each of the plurality of extensions (26) are spatially separated from each other in a plane in the second sliding position (Figure 9).
Regarding Claim 5, Asirvatham teaches the pericardial transection device of claim 1, wherein the at least one of the plurality of extensions that extends outwardly to contact the surface above the pericardial cavity is structured for cutting pericardial tissue (Figures 7-8).
Regarding Claim 7, Asirvatham teaches the pericardial transection device of claim 1, wherein at least one of the plurality of extensions comprises an incision member (35; electrodes) and at least two of the plurality of extensions are structured to provide any one of: stability (Paragraph 0088), fixation or increase surface contact in the second sliding position (Figures 7-8 and Figure 9-10).
Regarding Claim 8, Asirvatham teaches the pericardial transection device of claim 1, wherein at least two of the plurality of extensions extend either obtuse to each other or acute to each other in the second sliding position (Figure 9).
Regarding Claim 9, Asirvatham teaches the pericardial transection device of claim 1, wherein at least two of the plurality of extensions extend orthogonal to each other in the second sliding position (26 of one extension and 338 of another extension; Figures 7-8).
Regarding Claim 10, Asirvatham teaches the pericardial transection device of claim 1, wherein the sheath comprises a radiopaque material that is randomly dispersed or arranged in a pattern (Paragraph 0049).
Regarding Claim 11, Asirvatham teaches the pericardial transection device of claim 1, wherein at least one of the plurality of extensions comprises an incision member, and wherein said incision member comprises one or more of: a blade, an electrode, and a RF electrode capable of cutting pericardial tissue (Paragraph 0046 and Paragraph 0074-0075).
Regarding Claim 13, Asirvatham teaches the pericardial transection device of claim 2, wherein at least one of the plurality of extensions comprises an incision member coupled to a controller (36) at the proximal end of the elongated member (Paragraph 0046; Figure 1).
Regarding Claim 14, Asirvatham teaches a pericardial transection device for use in a pericardial cavity of a heart (abstract), said device comprising:
an elongated member (32; Figure 3; Paragraph 0043) having a distal end (closest to delivery tip 130) and a proximal end and extending along a longitudinal axis, the proximal end coupled to an end of a catheter (16);
a plurality of extensions (26; Figure 3 and Figured 9-10) operably coupled to the distal end of the elongated member (32; Figures 3 and 9-10; Paragraph 0047-0051); and
a sheath (134; Figure 2) having a distal end encircling at least the distal end of the elongated member (32) an in a longitudinally slidable relation therewith (Paragraph 0043 and 0047), where in a first sliding position, at least the distal end of the elongated member and the plurality of extensions are encircled by the sheath (134; Paragraph 0013 and 0047; Figure 2), and in a second sliding position, the plurality of extensions (26) project from the distal end of the sheath (as seen in Figures 3, 9-10),
wherein each of the plurality of extensions (26) extend in a different plane from each of the other extensions in the second sliding position (Figures 3-10), and wherein the plurality of extensions (26) are structured such that, in the second sliding position of the sheath (134) when the device is deployed in the pericardial cavity, at least one of the plurality of extensions (26) extend radially outwardly to contact a surface below the pericardial cavity and at least one of the plurality of extensions extends radially outwardly to contact a surface above the pericardial cavity (as seen in Figures 7-8 but also seen in Figure 9 in which one of the extensions is placed above and above the pericardial cavity), wherein the at least one of the plurality of extensions (26) structured to contact the surface above the pericardial cavity is structured for cutting pericardial tissue (electrodes can be used for ablation; see Paragraph 0075).
Regarding Claim 16, Asirvatham teaches the pericardial transection device of claim 14, wherein at least one of the plurality of extensions comprises an incision member (35; electrodes) and at least two of the plurality of extensions are structured to provide any one of: stability (Paragraph 0088), fixation or increase surface contact in the second sliding position (Figures 7-8 and Figure 9-10).
Regarding Claim 17, Asirvatham teaches the pericardial transection device of claim 14, wherein at least two of the plurality of extensions extend either obtuse to each other or acute to each other in the second sliding position (Figure 9).
Regarding Claim 18, Asirvatham teaches the pericardial transection device of claim 14, wherein at least one of the plurality of extensions comprises an incision member, and wherein said incision member comprises one or more of: a blade, an electrode, and a RF electrode capable of cutting pericardial tissue (Paragraph 0046 and Paragraph 0074-0075)..
Regarding Claim 19, Asirvatham teaches a pericardial transection device for use in a pericardial cavity of a heart (abstract), said device comprising:
an elongated member (32; Figure 3; Paragraph 0043) having a distal end (closest to delivery tip 130) and a proximal end and extending along a longitudinal axis, the proximal end coupled to an end of a catheter (16);
a plurality of extensions (26; Figure 3 and Figured 9-10) operably coupled to the distal end of the elongated member (32; Figures 3 and 9-10; Paragraph 0047-0051); and
a sheath (134; Figure 2) having a distal end encircling at least the distal end of the elongated member (32) an in a longitudinally slidable relation therewith (Paragraph 0043 and 0047), where in a first sliding position, at least the distal end of the elongated member and the plurality of extensions are encircled by the sheath (134; Paragraph 0013 and 0047; Figure 2), and in a second sliding position, the plurality of extensions (26) project from the distal end of the sheath (as seen in Figures 3, 9-10),
wherein the plurality of extensions (26) are structured such that, in the second sliding position when the device is deployed in the pericardial cavity, (i) at least two of the plurality of extensions extend radially outwardly to contact a surface below the pericardial cavity and are structured to provide any one of: stability, fixation or increase surface contact in the second sliding position (as seen in Figures 7-8 but also seen in Figure 9 in which one of the extensions is placed above and above the pericardial cavity ) and (ii) at least one of the plurality of extensions extends radially outwardly to contact the surface above the pericardial cavity, wherein the at least one of the plurality of extensions structured to contact the surface above the pericardial cavity is structured for cutting pericardial tissue (electrodes can be used for ablation; see Paragraph 0075)..
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.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Asirvatham (US PGPub 2013/0012938) as applied to claim 1 above, and further in view of Amit (US PGPub 2015/0105770).
Regarding Claim 12, Asirvatham teaches the pericardial transection device of claim 1, but fails to disclose wherein the device is sterilized.
Amit teaches a cardiac ablation catheter (abstract) wherein the catheter is sterilized before use (Paragraph 0019).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to sterilize the device, as taught by Amit, for the advantage of minimizing infection.
Claim(s) 6, 15, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Asirvatham (US PGPub 2013/0012938) as applied to claim 1 above, and further in view of Haissaguerre (US Patent 5,916,213)
Regarding Claim 6, 15, and 20, Asirvatham teaches the pericardial transection device of claim 1, but fails to disclose wherein the plurality of extensions each extend radially outwardly to collectively form a X-or Y-or T-shape in the second sliding position.
Haissaguerre teaches a tissue mapping and ablation catheter comprising a plurality of extensions (170/172; Figures 19A-19B) in which the extensions (170/172) are configured to be biased away in the second sliding position to collectively formed a y-shaped distal end (Column 13, Lines 42-61).
It would have been obvious to one of ordinary skill in the art to modify the plurality of extensions taught by Asirvatham, to collectively form a Y-shape in the second sling position, as taught by Haissaguerre, for the advantage of facilitating uniform contact with heart tissue (Column 13, Lines 57-59; Haissaguerre).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMED GAMIL GABR whose telephone number is (571)272-0569. The examiner can normally be reached M-F 9am-5pm.
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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 270-5953. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MOHAMED G GABR/Primary Examiner, Art Unit 3771
Prosecution Insights