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 . 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 § 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, 2, 5 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Yazdanpanah (US 2018/0078738) in view of Mickelsen (US 2017/0065343).
Regarding claims 1 and 2, Yazdanpanah discloses a catheter (which could be used to delivery any electrical energy including electroporation) that includes a shaft (204, fig. 3C), a plurality of electrodes (210) on a variable diameter loop (206, [0005]) controlled by a shaping wire (102, fig. 3D) and an activation wire (100) in a distinct lumen (not numbered). Yazdanpanah further discloses a plurality of electrical wires extending through the loop and shaft to the electrodes (not shown but necessary for the functions described in, for example, [0047]). Yazdanpanah does not disclose a multi-lumen arrangement that includes two lumens housing different subsets of electrical wires. It is noted that the fact that Yazdanpanah does not show the electrical wires at all is evidence that the level of ordinary skill in the art includes knowing how electrical wires are configurable in electrosurgical catheters, as well as evidence that there is no particular importance associated with the lumen/wire configuration. Further, lumens for wires are ubiquitous in the electrosurgical catheter art and there is no evidence that the lumen configuration produces an unexpected result (within the meaning of MPEP 716.02(a)). The fact that Applicant has disclosed numerous multi-lumen embodiments, several of which are mutually exclusive with each other (e.g. figs. 17 and 18), supports this conclusion. Mickelsen discloses another electrosurgical catheter system (schematically shown in fig. 1, note the use of electroporation, [0002]) which discloses the use of a multi-lumen arrangement (fig. 10) including two lumens housing different subsets of wires (10, 11, [0069]). It has been held that the combination of known elements according to known methods to yield predictable results is an obvious modification (MPEP 2141(III)). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to modify the catheter of Yazdanpanah to include any commonly known lumen/wire configuration, including using different lumens for different subsets of wires such as taught by Mickelsen resulting in a multi-lumen arrangement that extends through the shaft and loop, that would produce the predictable result of a functional electrosurgical catheter. The lumen having the shaping wire and activation wire in Yazdanpanah as modified can be considered a third lumen.
Regarding claim 5, the first and second lumens can be considered “proximate” any part of the circumference of the loop within the breadth of the term.
Regarding claim 18, the method of making the system of Yazdanpanah discussed above necessarily involves the claimed steps.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Yazdanpanah and Mickelsen, further in view of Maor (US 2009/0248012).
Regarding claim 3, Yazdanpanah does not disclose that the cross-sections of the lumens are “generally” kidney-shaped or teardrop-shaped. The fact that Applicant has disclosed several mutually exclusive cross-sectional shapes suggests that the shape of the lumens do not produce an expected result. The prior art is familiar with countless cross-sectional shapes for lumens including both “generally” kidney-shaped or teardrop-shaped, such as taught by Maor (fig. 11) which is noted is also an electroporation system ([0009]). It has been held that a change of shape is an obvious modification (MPEP 2144.04(IV)(B)). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the system of Yazdanpanah to include any commonly known lumen cross-sectional shapes, including the “generally” kidney-shaped or teardrop-shaped cross-sectional shapes taught by Maor, that would produce the predictable result of a catheter with lumens for electrical wires.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Yazdanpanah and Mickelsen, further in view of Imran (US 5,324,284).
Regarding claim 4, the system of Yazdanpanah does not include a dummy lumen. However, dummy lumens in a multi-lumen arrangement are common in the art such as taught by Imran (note empty lumens in figs. 3-5 which represent different embodiments of a shaft). It has been held that the combination of known elements according to known methods to yield predictable results is an obvious modification (MPEP 2141(III)). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to provide the multi-lumen arrangement of Yazdanpanah with at least one dummy lumen, such as taught by Imran, that would produce the predictable result of a system with a dummy lumen.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Yazdanpanah and Mickelsen, further in view of Byrd (US 2019/0307500).
Regarding claim 6, the system of Yazdanpanah does not disclose a thickness of insulation of the electrical wires. However, providing electrical wires with insulation of various thickness is common in the art. Byrd discloses a variable diameter electroporation catheter and teaches that the electrical wires can be provided with insulation having a thickness of 0.0015 inches ([0094]). It has been held that the combination of known elements according to known methods to yield predictable results is an obvious modification (MPEP 2141(III)). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to provide the electrical wires of Yazdanpanah with insulation of any commonly known thickness including 0.0015 inches as taught by Byrd that would produce the predictable result of preventing unwanted electrical behavior in the wires.
Claims 7 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Yazdanpanah and Mickelsen, further in view of Yagi (US 2012/0065633).
Regarding claim 7, the system of Yazdanpanah does not disclose the use of an injected filler. However, using filler to seal lumens with leads is common in the art such as taught by Yagi (fig. 3, [0093]) and any process of filling the lumen with filler can be considered “injecting.” It has been held that the combination of known elements according to known methods to yield predictable results is an obvious modification (MPEP 2141(III)). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the system of Yazdanpanah to include a filler in the lumens such as taught by Yagi that would produce the predictable result of sealing the lumens.
Regarding claim 19, the method of making the system of Yazdanpanah discussed above necessarily involves the claimed steps.
Claims 8, 9 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Yazdanpanah and Mickelsen, further in view of Selkee (US 2014/0261985).
Regarding claim 8 and 9, the system of Yazdanpanah does not disclose the use of a seal at the edge of an electrode or that the wire extends out and circumferentially around before terminating at an electrode. However, these are both common features of electrosurgical catheters. Selkee, in fact, discloses both the use of a seal at the edge of an electrode (at least part of 28, fig. 1, [0049]), and that the wire (16, fig. 1) extends out and circumferentially around before terminating at an electrode (i.e. a conductor for applying energy to tissue which could include 22 and part of 28). It has been held that the combination of known elements according to known methods to yield predictable results is an obvious modification (MPEP 2141(III)). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the system of Yazdanpanah to include electrode seals and any commonly known connection arrangement between conductive elements, including by circumferential translation of a wire prior to a termination at an electrode, both taught by Selkee, that would produce the predictable result of a system that can be used to treat tissue in a desired manner.
Regarding claim 20, the method of making the system of Yazdanpanah discussed above necessarily involves the claimed steps.
Claims 10, 11, 14 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Yazdanpanah in view of Babkin (US 2019/0076179).
Regarding claims 10, 11 and 14, Yazdanpanah discloses a catheter (which could be used to delivery any electrical energy including electroporation) that includes a shaft (204, fig. 3C), a plurality of electrodes (210) on a variable diameter loop (206, [0005]) controlled by a shaping wire (102, fig. 3D) and an activation wire (100) in a distinct lumen (not numbered) and a plurality of electrical wires extending through the loop and shaft to the electrodes (not shown but necessary for the functions described in, for example, [0047]). Yazdanpanah does not disclose a tubing arrangement that includes isolating two subsets of electrical wires. It is noted that the fact that Yazdanpanah does not show the electrical wires at all is evidence that the level of ordinary skill in the art includes knowing how electrical wires are configurable in electrosurgical catheters, as well as evidence that there is no particular importance associated with the lumen/wire configuration. Further, lumens for wires are ubiquitous in the electrosurgical catheter art and there is no evidence that the lumen configuration produces an unexpected result (within the meaning of MPEP 716.02(a)). The fact that Applicant has disclosed numerous multi-lumen embodiments, several of which are mutually exclusive with each other (e.g. figs. 17 and 18), supports this conclusion. Babkin discloses an ablation catheter with a plurality of electrodes (887, fig. 24) that can be used for sensing or ablation ([0187]-[0188]) and which are connected using wires within a tubing arrangement that includes a plurality of biaxially arranged tubes (897, fig. 25) physically isolating various subsets of electrical wires (892). It has been held that the combination of known elements according to known methods to yield predictable results is an obvious modification (MPEP 2141(III)). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to modify the system of Yazdanpanah to include any commonly known structure for allowing electric wires to pass through the shaft and loop to connect to electrodes, including physically isolating subsets of wires by using at least two tubes such as taught by Babkin, that would produce the predictable result of a functional electrosurgical catheter.
Regarding claim 18, the method of making the system of Yazdanpanah discussed above necessarily involves the claimed steps.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Yazdanpanah and Babkin, further in view of Pomeranz (US 5,800,482).
Regarding claim 12, the system of Yazdanpanah does not disclose the use of a heat shrink material. However, using heat shrink materials to bundle electric wires is common in the art such as taught by Pomeranz (102, fig. 8, col. 9 lines 28-40). It has been held that the combination of known elements according to known methods to yield predictable results is an obvious modification (MPEP 2141(III)). Therefore, before the application was filed, it would have been obvious to further modify the system of Yazdanpanah to use any commonly known tube material, including a heat shrink material as taught by Pomeranz, that would produce the predictable result of a function electrosurgical catheter.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Yazdanpanah and Babkin, further in view of Schaer (US 6,595,989).
Regarding claim 13, the system of Yazdanpanah does not disclose the tubes are coaxial. However, Schaer not only teaches that the lumens that pass through medical devices for holding various elements including electric wires can be provided coaxially or biaxially, but that such and other configurations of lumens are within the level of ordinary skill in the art (col. 12 lines 12-20), which is understood to be a teaching that at least coaxial and biaxial lumen configurations are functional equivalents (MPEP 2144.06). Therefore, before the application was filed, it would have been obvious to further modify the system of Yazdanpanah to have any commonly known arrangement of lumens by placing the tubes either biaxially or coaxially as taught by Schaer that would produce the predictable result of a functional electrosurgical system.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Yazdanpanah and Babkin, further in view of Byrd.
Regarding claim 15, the system of Yazdanpanah does not disclose a thickness of insulation of the electrical wires. However, providing electrical wires with insulation of various thickness is common in the art. Byrd discloses a variable diameter electroporation catheter and teaches that the electrical wires can be provided with insulation having a thickness of 0.0015 inches ([0094]). It has been held that the combination of known elements according to known methods to yield predictable results is an obvious modification (MPEP 2141(III)). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to provide the electrical wires of Yazdanpanah with insulation of any commonly known thickness including 0.0015 inches as taught by Byrd that would produce the predictable result of preventing unwanted electrical behavior in the wires.
Claims 16 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Yazdanpanah and Babkin, further in view of Yagi.
Regarding claim 16, the system of Yazdanpanah does not disclose the use of a injected filler. However, using filler to seal lumens with leads is common in the art such as taught by Yagi (fig. 3, [0093]) and any process of filling the lumen with filler can be considered “injecting.” It has been held that the combination of known elements according to known methods to yield predictable results is an obvious modification (MPEP 2141(III)). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the system of Yazdanpanah to include a filler in the lumens such as taught by Yagi that would produce the predictable result of sealing the lumens.
Regarding claim 19, the method of making the system of Yazdanpanah discussed above necessarily involves the claimed steps.
Claims 17 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Yazdanpanah and Mickelsen, further in view of Selkee.
Regarding claim 17, the system of Yazdanpanah does not disclose the use of a seal at the edge of an electrode. However, this is a common feature of electrosurgical catheters. Selkee, for example, discloses a seal at the edge of an electrode (at least part of 28, fig. 1, [0049]). It has been held that the combination of known elements according to known methods to yield predictable results is an obvious modification (MPEP 2141(III)). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the system of Yazdanpanah to include electrode seals as taught by Selkee, that would produce the predictable result of a system that can be used to treat tissue in a desired manner.
Regarding claim 20, the method of making the system of Yazdanpanah discussed above necessarily involves the claimed steps.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Regarding the general teaching that a medical device can include lumens formed integrally with a tube material or by independent tubes, see col. 12 lines 34-60 of US 6,283,959 to Lalonde. Regarding the general teaching that wires can be placed in a lumen or not, see paragraph [0039] of US 2012/0197246 to Mauch. Regarding another catheter which puts lead wires in different lumens, see figure 15 of US 2006/0184106 to McDaniel and fig. 2 of US 2019/0357790 to Masuda. Regarding the general teaching that lumens can have numerous arrangements, including coaxial and biaxial among others, see figures 2A-E of US 2011/0218528 to Ogata and figures 6A-H of US 2007/0129719 to Kendale. Regarding a teaching to use a protective sheath around wires in a lumen, see element 39 in fig. 4 of US 6,183,463 to Webster. Regarding the general teaching that a single lumen with wires can be employed, or a plurality of lumens having different cross-sectional shapes can be employed, see paragraph [0028] of US 2004/0231683 to Eng. Regarding the general teaching that leads can be routed through “at least one lumen (not shown),” see paragraph [0022] of US 2012/0143182 to Ullrich.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL WAYNE FOWLER whose telephone number is (571)270-3201. The examiner can normally be reached Monday-Friday (9-5).
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, 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.
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.
/DANIEL W FOWLER/Primary Examiner, Art Unit 3794