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 § 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 1-4, and 6-16 are rejected under 35 U.S.C. 103 as being unpatentable over Stigall et al. (US 2020/0054304; hereinafter Stigall), in view of Sakaguchi et al. (US 2018/0214120; hereinafter Sakaguchi).
Regarding claim 1, Stigall discloses a molded tip with extended guidewire lumen. Stigall shows an intraluminal imaging device (see fig. 1 and abstract), comprising: a flexible elongate member configured to be positioned within a body lumen of a patient (see par. [0008], [0029]), wherein the flexible elongate member (see abstract; fig. 1 and par. [0033], [0037], [0039], [0040], [0049]) comprises an outer member (see par. [0052]) and an inner member (see par. [0052]); an ultrasound scanner assembly configured to obtain ultrasound imaging data while positioned within the body lumen (see par. [0039]), wherein the ultrasound scanner assembly is positioned at a distal end of the flexible elongate member (see fig. 1); and a filler member positioned at the distal end of the flexible elongate member (see par. [0055]), wherein the filler member is coupled to the flexible elongate member to seal and bond a joint between the flexible elongate member and the ultrasound scanner assembly (see par. [0055]). Furthermore, Stigall teaches wherein the filler member contacts the outer member from inside of the outer member (the examiner notes that the claim does not limit that the filler member contacts the outer member from inside of the outer member via direct contacts; fig. 6 shows that the filler member indirectly contacts the outer member from inside of the outer member via indirect contact); and contacts the inner member from outside of the inner member (see par. [0055]; fig. 6 shows that the filler member 374 contacts the inner member 356 from outside of the inner member).
But, Stigall fails to explicitly state that the filler member is directly contacts the outer member from inside of the outer member, directly contact the inner member from outside of the inner member.
Sakaguchi discloses a catheter and teaches filler member is directly contacts an outer member from inside of the outer member, directly contact an inner member from outside of the inner member (see liquid seal member 55 in par. [0065], [0074]; par. [0107], fig. 5 and 13).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of filler member is directly contacts the outer member from inside of the outer member, directly contact the inner member from outside of the inner member in the invention of Stigall, as taught by Sakaguchi, to provide a liquid tight seal. The examiner notes that upon modifying the indention of Stigall to incorporate the liquid seal O-ring of Sakaguchi will provide directly contacts the outer member from inside of the outer member, directly contact the inner member from outside of the inner member.
Regarding claim 2, Stigall shows wherein the filler member comprises a lumen (see fig. 6 and par. [0055]).
Regarding claim 3, Stigall shows wherein the outer member comprises a lumen (see fig. 1, 5-7; par. [0044], [0049], [0054], [0055], [0059]); and wherein the inner member extends within the lumen of the outer member and the lumen of the filler member (see fig. 1, 5-7; par. [0044], [0049], [0054], [0055], [0059]).
Regarding claim 4, Stigall shows wherein the inner member comprises a lumen configured to receive a guidewire (see par. [0026], [0044], [0059]), and wherein the filler member is arranged such that, when the guidewire is received within the lumen of the inner member, the guidewire extends within the lumen of the filler member (see fig. 1, 5-7; par. [0044], [0049], [0054], [0055], [0059]).
Regarding claim 6, Stigall shows wherein the filler member is positioned at a proximal portion of the ultrasound scanner assembly (see fig. 6 and par. [0055]).
Regarding claim 7, Stigall shows wherein the distal end of the flexible elongate member is positioned over the proximal portion of the ultrasound scanner assembly and the filler member (see fig. 5-7 and 9; par. [0055]).
Regarding claim 8, Stigall shows wherein the distal end of the flexible elongate member comprises a flared portion of the outer member (see fig. 11C and 11D, and wherein the flared portion is coupled to the filler member (see fig. 6, 11C and 11D).
Regarding claim 9, Stigall shows wherein the ultrasound scanner assembly comprises a support member (see par. [0028], [0039], [0059], [0059] and fig. 7) and an array of acoustic elements positioned around the support member (see par. [0028], [0039], [0059], [0059] and fig. 7), and wherein the filler member is positioned around a proximal portion of the support member (see fig. 6 and 7).
Regarding claim 10, Stigall shows wherein the proximal portion of the support member comprises a proximal flange defining a proximal end of the support member (see par. [0008], [0040], [0052], [0055]) and configured to receive the inner member (see par. [0008], [0040], [0052], [0055]; fig. 5-7, 9), and wherein the filler member is positioned around the proximal flange see par. [0008], [0040], [0052], [0055], fig. 5-7, 9).
Regarding claim 11, Stigall shows wherein the proximal portion of the support member comprises a proximal stand (see par. [0049], [0050]), wherein a diameter of the proximal stand is greater than a diameter of the proximal flange (see fig. 6), and wherein the filler member is positioned adjacent to the proximal stand (see fig. 6).
Regarding claim 12, Stigall shows wherein the proximal portion of the support member terminates at a proximal end of the support member, and wherein the proximal end of the filler member is positioned proximal of the proximal end of the support member (see fig. 6).
Regarding claim 13, Stigall further comprising: a plurality of conductors in communication with the ultrasound scanner assembly and extending along the flexible elongate member (see par. [0030], [0035], [0036], [0037]), wherein the ultrasound scanner assembly comprises a conductor interface (see par. [0030], [0035], [0036], [0037]), wherein the plurality of conductors are coupled to the conductor interface (see par. [0030], [0035], [0036], [0037]), and wherein the conductor interface is adjacent to at least one of the first polymer or the second polymer (see par. [0030], [0035], [0036], [0037]; fig. 1, 3 and 6).
Regarding claim 14, Stigall shows wherein the plurality of conductors are coupled to the conductor interface at a proximal portion of the conductor interface (see par. [0030], [0035], [0036], [0037]; fig. 1, 3 and 6)., and wherein the proximal portion of the conductor interface is positioned proximal of the filler member (see par. [0030], [0035], [0036], [0037], [0055]; fig. 1, 3 and 6)..
Regarding claim 15, Stigall shows wherein the flexible elongate member comprises a rapid-exchange catheter with a guidewire entry port (see par. [0031] and fig. 8), wherein the guidewire entry port is disposed at a distal portion of the flexible elongate member (see par. [0031], [0059], [0060] and fig. 8), and wherein the filler member is positioned distal of the guidewire entry port (see par. [0031], [0055], [0059], [0060] and fig. 6 and 8).
Regarding claim 16, Stigall shows an intravascular ultrasound ([VUS) imaging catheter (see par. [0008]), comprising: a catheter, wherein the body lumen comprises a blood vessel (see par. [0008], [0029], [0039]; 212 in fig. 3), wherein the ultrasound scanner assembly is configured for IVUS (see par. [0008]) and comprising a circumferential array of acoustic elements (see par. [0008], [0029], [0039]; 212 in fig. 3).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Stigall et al. (US 2020/0054304; hereinafter Stigall), in view of Sakaguchi et al. (US 2018/0214120; hereinafter Sakaguchi), as applied to claim 1 above and further in view of Stigall et al. (US 2019/0274658; hereinafter Stigall 658’).
Regarding claim 5, Stigall and Sakaguchi disclose the invention substantially as described in the 103 rejection above, , furthermore, Stigall shows wherein the outer member comprises a first polymer (see abstract; fig. 1 and par. [0033], [0037], [0039], [0040], [0049]); a filler member comprising a second polymer (see par. [0055]), wherein the inner member comprises a third polymer (see abstract; fig. 1 and par. [0033], [0037], [0039], [0040], [0049]), and wherein the filler member is coupled to the flexible elongate member via thermal bonding of the second polymer and the third polymer (see abstract; fig. 1 and par. [0033], [0037], [0039], [0040], [0049], [0055]). Stigall shows wherein the filler member is coupled to the flexible elongate member via thermal bonding of the first polymer and the second polymer to seal a joint between the flexible elongate member and the ultrasound scanner assembly (see par. [0055]), and indirectly coupled to the outer member (see fig. 6).
But, Stigall fails to explicitly state that the bonding is done via thermal reflow.
Stigall 658’ discloses an intracardiac echocardiography catheter and teaches bonding via thermal reflow (see par. [0066], [0077], [0084]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of using thermal reflow in the invention of Stigall and Sakaguchi, as taught by Stigall 658’, to provide a better bonding by reshaping the bonding elements through process of heating and melting for better fitting between the elements.
Response to Arguments
Applicant's arguments filed 04/13/2026 have been fully considered but they are not persuasive.
In response to Applicant’s arguments, pages 7-9, with respect to prior art rejection of claims 1 and 5, the examiner respectfully disagrees. The examiner maintains that combined invention of Stigall and Sakaguchi does disclose all the claim limitation set forth in claim 1, particularly a filler member positioned at the distal end of the flexible elongate member, wherein the filler member is coupled to the flexible elongage member to seal and bond a joint between the flexible elongate member and the ultrasound scanner assembly, wherein the filler member directly contacts the outer member from inside the outer member; and directly contacts the inner member from outside of the inner member. The examiner has relied on prior art Stigall to teach a filler member positioned at the distal end of the flexible elongate member (see par. [0055]), wherein the filler member is coupled to the flexible elongate member to seal and bond a joint between the flexible elongate member and the ultrasound scanner assembly (see par. [0055]). Furthermore, Stigall teaches wherein the filler member contacts the outer member from inside of the outer member (the examiner notes that the claim does not limit that the filler member contacts the outer member from inside of the outer member via direct contacts; fig. 6 shows that the filler member indirectly contacts the outer member from inside of the outer member via indirect contact); and contacts the inner member from outside of the inner member (see par. [0055]; fig. 6 shows that the filler member 374 contacts the inner member 356 from outside of the inner member). The examiner has relied on prior art Sakaguchi to merely teach that a filler member is directly contacts an outer member from inside of the outer member, directly contact an inner member from outside of the inner member (see liquid seal member 55 in par. [0065], [0074]; par. [0107], fig. 5 and 13).
The Applicant argues on page 7 that the filler member occupies the same longitudinal position...as a portion of the inner member and a portion of the outer member, however, this limitation is not recited in claim 1. Furthermore, the examiner notes that claim 1 does not explicitly limit how the bonding is done and the material of the filler. Furthermore in par. [0065], Sakaguchi does mention that the seal member is configured with an O ring but can, but is not limited to this and can be any other configuration or material. Therefore, the examiner maintains that seal member 55 of Sakaguchi does read on the claim 1 and prior art Sakaguchi was not provided to actually teach the seal member since base reference already teaches the seal member, prior art Sakaguchi was provided to merely teaching that a filler member can be directly contacts an outer member from inside of the outer member, directly contact an inner member from outside of the inner member.
With regards to claim 5, the examiner maintains that combined invention of Stigall, Stakaguchi and Stigall 658’ does disclose all the claim limitation set forth in claim 5. The examierer maintains that prior art Stigall does show wherein the outer member comprises a first polymer (see abstract; fig. 1 and par. [0033], [0037], [0039], [0040], [0049]); a filler member comprising a second polymer (see par. [0055]), wherein the inner member comprises a third polymer (see abstract; fig. 1 and par. [0033], [0037], [0039], [0040], [0049]), and wherein the filler member is coupled to the flexible elongate member via thermal bonding of the second polymer and the third polymer (see abstract; fig. 1 and par. [0033], [0037], [0039], [0040], [0049], [0055]). The examiner notes that prior art Stigall shows wherein the filler member is coupled to the flexible elongate member via thermal bonding of the first polymer and the second polymer to seal a joint between the flexible elongate member and the ultrasound scanner assembly (see par. [0055]), and indirectly coupled to the outer member (see fig. 6). The examiner merely relied on prior art Stigall 658’ to teach an intracardiac echocardiography catheter and teaches bonding via thermal reflow (see par. [0066], [0077], [0084]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAHDEEP MOHAMMED whose telephone number is (571)270-3134. The examiner can normally be reached Monday to Friday, 9am to 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, 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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/SHAHDEEP MOHAMMED/ Primary Examiner, Art Unit 3797
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