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 .
Detailed Action
This is in response to the non-provisional application filed 05/08/2025.
Claim Rejections - 35 USC § 102
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, 2, 5-7, 9, 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Publication Number 2021/0228268 (Urbanski et al.)
Regarding claims 1, 2, 5-7, 9, Urbanski et al. discloses as shown in Figure 3A, a system capable of perforating a tissue within a heart, the system comprising: a delivery device (sheath 20, see paragraph [0113]) comprising an elongated body having a body length, a proximal end and a distal end portion terminating in a distal tip, the elongated body defining a delivery lumen extending through the elongate body and dimensioned to slidingly receive at least one or more wires; a secondary device (dilator 30B, see paragraph [0143]) having a proximal end and a distal end portion terminating in a distal tip dimensioned to extend longitudinally within the delivery lumen of the delivery device towards the distal tip of the device; and a shapeable pre-formed member (stylet 60, see paragraph [0126]) longitudinally advanced through the elongated body of the delivery device, wherein the shapeable pre-formed member does not extend longitudinally within the delivery lumen of the delivery device, and wherein the pre-formed member maintains lumen patency of the delivery device, wherein the delivery device further includes at least one support lumens, wherein the at least one support lumens is adjacent the delivery lumen, and wherein the pre-formed member is longitudinally advanced through the at least one support lumens, wherein the pre-formed member allows flexibility to the device while minimizing kinking of the elongated body of the device, wherein the pre-formed member is conformed into a desired shape by a user, wherein the pre-formed member is longitudinally advanced through the at least one support lumens of the delivery device to achieve a specific device shape as the delivery device is advancing within the heart, wherein the delivery device is an elongated catheter, and wherein the elongated catheter is adapted to receive and allow longitudinal translation of the pre-formed member therein.
Regarding claim 11, Urbanski et al. discloses wherein the pre-formed member is selected from the group consisting of stainless steel and nitinol. See paragraph [0203]
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claim(s) 3, 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2021/0228268 (Urbanski et al.) in view of U.S. Patent Publication Number 2009/0312807 (Boudreadult et al.)
Regarding claim 3, Urbanski et al. fails to disclose wherein the elongated body of the delivery device further includes a device wall adjacent to the delivery lumen, and wherein the pre-formed member is longitudinally advanced through a portion of the wall of the elongated body.
Boudreadult et al., from a related field of endeavor teaches a similar system as shown in Figure 1, wherein the elongated body of the delivery device further includes a device wall adjacent to the delivery lumen, and wherein the pre-formed member is longitudinally advanced through a portion of the wall of the elongated body, for the purpose of allowing advancement of the pre-formed member and something else in the elongate body. See paragraph [0137].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the system disclosed by Urbanski et al to include the wall defining the stylet lumen taught by Boudreadult et al. such that the elongated body of the delivery device further includes a device wall adjacent to the delivery lumen, and wherein the pre-formed member is longitudinally advanced through a portion of the wall of the elongated body in order to allow multiple things to be advanced through the elongate body at the same time, a predictable use of known components to obtain expected ergonomic benefits. See KSR, 550 U.S. at 417; MPEP § 2143.
Regarding claim 8, Urbanski et al. discloses wherein the delivery device is a dilator. See paragraph [0113].
Urbanski fails to disclose at least one support lumens, and wherein the pre-formed member is longitudinally advanced through the at least one support lumens of the dilator.
Boudreadult et al., from a related field of endeavor teaches a similar system as shown in Figure 1, at least one support lumens, and wherein the pre-formed member is longitudinally advanced through the at least one support lumens of the dilator, for the purpose of allowing advancement of the pre-formed member and something else in the elongate body. See paragraph [0137].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the system disclosed by Urbanski et al to include at least one support lumens, and wherein the pre-formed member is longitudinally advanced through the at least one support lumens of the dilator in order to allow multiple things to be advanced through the elongate body at the same time, a predictable use of known components to obtain expected ergonomic benefits. See KSR, 550 U.S. at 417; MPEP § 2143.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2021/0228268 (Urbanski et al.) in view of U.S. Patent Publication Number 2009/0312807 (Boudreadult et al.) as applied to claim 3 above, and further in view of U.S. Patent Publication Number 2003/0060821 (Hall et al.)
Regarding claim 4, Urbanski in view of Boudradult fail to disclose wherein the pre-formed member is embedded into the wall of the delivery device.
Hall et al., from a related field of endeavor teaches a similar system as shown in Figure 1, where the pre-formed member is embedded into the wall of the delivery device. See paragraph [0006].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the system disclosed by Urbanski in view of Boudradult to embed the pre-formed member into the wall of the delivery to ensure that it does not fall out of the delivery device accidently, a predictable use of known components to obtain expected ergonomic benefits. See KSR, 550 U.S. at 417; MPEP § 2143.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2021/0228268 (Urbanski et al.) in view of U.S. Patent Publication Number 2011/0022057 (Eigler et al.)
Regarding claim Ubranski et al. fails to disclose wherein the pre-formed member is solid, and wherein the pre-formed member does not define a lumen.
Eigler et al., from a related field of endeavor teaches a similar system as shown in Figure 1, wherein the pre-formed member is solid, and wherein the pre-formed member does not define a lumen. See paragraph [0125].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify system disclosed by substituting the pre-formed member disclosed by Urbanski for the solid pre-formed member taught by Eigler because it would only require the simple substittion of one known alternative for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Claim(s) 12-15, 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2021/0228268 (Urbanski et al.) in view of U.S. Patent Publication Number 2009/0312807 (Boudreadult et al.)
Regarding claims 12-15, 18, 19 Urbanski et al. discloses as shown in Figure 3A, a system capable of perforating a tissue within a heart, the system comprising: a delivery device (sheath 20, see paragraph [0113]) comprising an elongated body having a body length, a proximal end and a distal end portion terminating in a distal tip, the elongated body defining a delivery lumen extending through the elongate body and dimensioned to slidingly receive at least one or more wires; a secondary device (dilator 30B, see paragraph [0143]) having a proximal end and a distal end portion terminating in a distal tip dimensioned to extend longitudinally within the delivery lumen of the delivery device towards the distal tip of the device; and a shapeable pre-formed member (stylet 60, see paragraph [0126]) longitudinally advanced through the elongated body of the delivery device, wherein the shapeable pre-formed member does not extend longitudinally within the delivery lumen of the delivery device, and wherein the pre-formed member maintains lumen patency of the delivery device, wherein the delivery device further includes at least one support lumens, wherein the at least one support lumens is adjacent the delivery lumen, and wherein the pre-formed member is longitudinally advanced through the at least one support lumens, wherein the pre-formed member allows flexibility to the device while minimizing kinking of the elongated body of the device, wherein the pre-formed member is conformed into a desired shape by a user, wherein the pre-formed member is longitudinally advanced through the at least one support lumens of the delivery device to achieve a specific device shape as the delivery device is advancing within the heart, wherein the delivery device is an elongated catheter, and wherein the elongated catheter is adapted to receive and allow longitudinal translation of the pre-formed member therein, wherein the pre-formed member is longitudinally advanced through the at least one support lumens of the delivery device to achieve a specific device shape as the delivery device is advancing within the heart, wherein the delivery device is a dilator comprising at least one support lumens, and wherein the pre-formed member is longitudinally advanced through the at least one support lumens of the dilator, wherein the delivery device is an elongated catheter, and wherein the elongated catheter is adapted to receive and allow longitudinal translation of the pre-formed member therein, wherein the pre-formed member is longitudinally advanced through the entire elongated body of the delivery device, wherein the pre-formed member is longitudinally advanced through a portion of the elongated body of the delivery device
Urbanski fails to disclose at least one support lumens, and wherein the pre-formed member is longitudinally advanced through the at least one support lumens of the dilator.
Boudreadult et al., from a related field of endeavor teaches a similar system as shown in Figure 1, at least one support lumens, and wherein the pre-formed member is longitudinally advanced through the at least one support lumens of the dilator, for the purpose of allowing advancement of the pre-formed member and something else in the elongate body. See paragraph [0137].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the system disclosed by Urbanski et al to include at least one support lumens, and wherein the pre-formed member is longitudinally advanced through the at least one support lumens of the dilator in order to allow multiple things to be advanced through the elongate body at the same time, a predictable use of known components to obtain expected ergonomic benefits. See KSR, 550 U.S. at 417; MPEP § 2143.
Regarding claim 17, Urbanski et al. discloses wherein the pre-formed member is selected from the group consisting of stainless steel and nitinol. See paragraph [0203].
Regarding claim 20, Urbanski et al. discloses as shown in Figure 3A method for perforating a tissue within a heart, the method comprising: providing a delivery device (sheath 20, see paragraph [0113]) comprising an elongated body having a body length, a proximal end and a distal end portion terminating in a distal tip, the elongated body defining a delivery lumen extending through the elongate body and dimensioned to slidingly receive at least one or more wires; advancing a secondary device (dilator 30B, see paragraph [0143]) having a proximal end and a distal end portion terminating in a distal tip dimensioned to extend longitudinally within the delivery lumen of the delivery device towards the distal tip of the device; and advancing a shapeable pre-formed member (stylet 60, see paragraph [0126]) longitudinally advanced through the elongated body of the delivery device, and wherein the pre-formed member maintains lumen patency of the delivery device.
Urbanski et al. fails to disclose wherein the shapeable pre-formed member does not extend longitudinally within the delivery lumen of the delivery device.
Boudreadult et al., from a related field of endeavor teaches a method of using a similar system as shown in Figure 1, wherein the shapeable pre-formed member does not extend longitudinally within the delivery lumen of the delivery device, for the purpose of allowing advancement of the pre-formed member and something else in the elongate body. See paragraph [0137].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the system disclosed by Urbanski et al to include at least one support lumens, such that wherein the shapeable pre-formed member does not extend longitudinally within the delivery lumen of the delivery device in order to allow multiple things to be advanced through the elongate body at the same time, a predictable use of known components to obtain expected ergonomic benefits. See KSR, 550 U.S. at 417; MPEP § 2143.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2021/0228268 (Urbanski et al.) in view of U.S. Patent Publication Number 2009/0312807 (Boudreadult et al.) as applied to claim 12 above, and further in view of U.S. Patent Publication Number 2011/0022057 (Eigler et al.)
Regarding claim 16 Ubranski et al. fails to disclose wherein the pre-formed member is solid, and wherein the pre-formed member does not define a lumen.
Eigler et al., from a related field of endeavor teaches a similar system as shown in Figure 1, wherein the pre-formed member is solid, and wherein the pre-formed member does not define a lumen. See paragraph [0125].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify system disclosed by substituting the pre-formed member disclosed by Urbanski for the solid pre-formed member taught by Eigler because it would only require the simple substittion of one known alternative for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RICHARD G LOUIS whose telephone number is 571-270-1965. The examiner can normally be reached on Monday – Friday, 9:30 – 6:00 pm.
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/RICHARD G LOUIS/Primary Examiner, Art Unit 3771
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