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 .
Election/Restrictions
Claim 1-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group I, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/06/2026.
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) 12, 15-18, and 21-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shaltis (US 2015/0190615).
Regarding claim 12, Shaltis discloses an introducer catheter device (1, FIG 1, [0046-0049] specifically the embodiment of FIG 19-20, [0062]), comprising: an elongate shaft (14) having a distal portion (176); a device lumen (172) configured to receive a medical device ([0062] discloses that 172 is a device lumen); a guidewire lumen (170) having a first diameter (Defined as the diameter at the narrow spacing between detents 174 within the lumen); and a guidewire (100) configured to be disposed within the guidewire lumen (As shown in FIGs 19-20), the guidewire having a second diameter (Width of the majority of the guidewire, including a diameter taken at a point proximal to 102) smaller than the first diameter (The second diameter is smaller than the first in order to allow for this portion of the guidewire to be seating within the opening at the region of the first diameter), the guidewire also having at least one interference feature (102) having a third diameter (Width of 102) larger than the first diameter (As shown in FIG 20, the third diameter is greater than the first diameter), the interference feature being configured to create an interference fit with the guidewire lumen when the guidewire is moved relative to the guidewire lumen (When retracted to the position of FIG 20, the interference feature 102 creates an interference fit with the detents 174 of the guidewire lumen) for steering of the introducer catheter device in at least one direction ([0062] discloses further proximal retraction of the guidewire after 102 engages 174 results in steering of the distal end of the catheter; “Further movement of the guidewire 100 in a proximal direction when in the secured condition will deflect the leading catheter end segment 176 in the manner discussed hereinabove”).
Regarding claim 15, Shaltis discloses the guidewire lumen extends along the distal portion and the elongate shaft (As shown in FIG 19-20, extending along distal portion 176).
Regarding claim 16, Shaltis discloses the interference feature comprises a step-up portion that includes a transition from the second diameter to the third diameter (The proximal curved end of 102 which attaches to the guidewire body forms a step-up portion because it tapers from the size of the second diameter to the third diameter).
Regarding claim 17, Shaltis discloses the interference feature comprises a protrusion (Looped segment 102 is interpreted as porting a protrusion).
Regarding claim 18, Shaltis discloses the interference feature comprises a spherical shape (Looped segment 102 is interpreted as being spherical in shape).
Regarding claim 21, Shaltis discloses the interference feature is positioned distal to the guidewire lumen when the guidewire is disposed within the guidewire lumen (FIG 19).
Regarding claim 22, Shaltis discloses the interference feature is configured to provide an interference fit with the guidewire lumen when the guidewire is pulled proximally with respect to the introducer catheter (FIG 20, [0062]).
Regarding claim 23, Shaltis discloses the interference feature is positioned proximal to the guidewire lumen when the guidewire is disposed within the guidewire lumen (FIG 20 shows a state where the guidewire is disposed within the lumen and the interference feature 102 is proximal to at least some distal portion of the guidewire lumen).
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) 13 is rejected under 35 U.S.C. 103 as being unpatentable over Shaltis (US 2015/0190615) in view of Schilting (US 2012/0078232).
Regarding claim 13, Shaltis discloses the invention substantially as claimed, as set forth above for claim 12. Shaltis further discloses the catheter device can be used for an interventional procedure such as capturing occlusion material or removing aneurysm ([0064]).
Shaltis is silent regarding the distal portion includes a dilator portion configured to stretch or expand a tissue.
However, Schilting discloses a catheter device (FIG 1-3) in the same field of endeavor of occlusion removal (see stenosis 4 formed by occlusive material 2, FIG 2-3, [0029]) wherein the distal portion of the elongate shaft (5) includes a dilator portion (13, [0041]) configured to stretch or expand a tissue (When compressed against the tissue 2, the dilator is at least configured to apply some expanding force).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the distal portion of Shaltis to comprise a dilator portion, as taught by Schilting, for the purpose of aiding in fixing the distal end of the device relative to a stenosis for performing the desired treatment.
Claim(s) 14 is rejected under 35 U.S.C. 103 as being unpatentable over Shaltis (US 2015/0190615) in view of Buck et al. (US 2021/0186536).
Regarding claim 14, Shaltis discloses the invention substantially as claimed, as set forth above for claim 12. Shaltis further discloses the catheter device can be used for an interventional procedure such as capturing occlusion material or removing aneurysm ([0064]). Shaltis further discloses a guidewire port (16) for the guidewire lumen being located at the hub at the proximal end of the catheter (FIG 1, [0046]).
Shaltis is silent regarding the guidewire lumen extends along only the distal portion.
However, Buck discloses a catheter device (10, FIG 1A) in the same field of endeavor of occlusion removal ([0066]) wherein the shaft comprises a guidewire lumen (17, [0075]) extending along only the distal portion of the shaft ([0075] discloses the proximal guide wire port may be through a sidewall of the catheter 10 in a rapid exchange implementation, instead of the port being provided in the hub at the proximal end of the catheter).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the guidewire port to be located along the shaft towards the distal end of the catheter, as taught by Buck et al. (this placement is understood based on disclosure of a rapid exchange implementation), since Buck teaches that rapid exchange and over the wire configurations are interchangeably used in the art and would achieve the predictable result of allowing the catheter to be delivered over the guidewire to the target treatment site.
Claim(s) 19-22 and 24-26 is rejected under 35 U.S.C. 103 as being unpatentable over Shaltis (US 2015/0190615) in view of Vrancken (US 2020/0054864).
Regarding claim 19-20, Shaltis discloses the invention substantially as claimed, as set forth above for claim 12.
Shaltis is silent regarding the interference feature comprising an expandable balloon.
However, Vrancken et al. teaches in the same field of endeavor of using a guidewire (20) to steer the distal end of a catheter (10), wherein a guidewire lumen (13) has a diameter greater than a second diameter of the guidewire (See diameter of guidewire in FIGs 6-6a when received within the lumen) and the guidewire lumen is smaller than a third diameter of an interference feature of the guidewire (wherein 21 is the interference feature and FIG 6-6a shows in phantom lines the third diameter which is larger than the guidewire lumen, [0091-0092]), such that an interference fit between the guidewire lumen allows the guidewire to steer the catheter device (Figs 7a-7d, [0105-0109]), wherein the interference feature comprises an expandable balloon (21 is disclosed as an expandable tip part, which is interpreted as also meeting the limitations of a balloon because it is formed of a flexible expandable material which expands and contracts in diameter).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to substitute the interference feature of Shaltis with the expandable balloon interference feature taught by Vrancken et al., for the purpose of substituting a mechanism commonly known in the art for releasably securing the distal end of a guidewire within the guidewire lumen of a catheter thereby achieving the predictable result of allowing for controlled advancement of the catheter along the guidewire or steering of the distal tip of the catheter when engaged with the interference feature.
Regarding claim 21 and 24, Shaltis discloses the invention substantially as claimed, as set forth above for claim 12.
Shaltis is silent regarding the interference feature is configured to provide an interference fit with the guidewire lumen when the guidewire is pushed distally with respect to the introducer catheter.
However, Vrancken et al. teaches in the same field of endeavor of using a guidewire (20) to steer the distal end of a catheter (10), wherein a guidewire lumen (13) has a diameter greater than a second diameter of the guidewire (See diameter of guidewire in FIGs 6-6a when received within the lumen) and the guidewire lumen is smaller than a third diameter of an interference feature of the guidewire (wherein 21 is the interference feature and FIG 6-6a shows in phantom lines the third diameter which is larger than the guidewire lumen, [0091-0092]), such that an interference fit between the guidewire lumen allows the guidewire to steer the catheter device (Figs 7a-7d, [0105-0109]), wherein the interference feature is positioned distal to the guidewire lumen when the guidewire is disposed within the guidewire lumen (Phantom lines shown in FIG 6-6a) and wherein the interference feature is configured to provide an interference fit with the guidewire lumen when the guidewire is pushed distally with respect to the introducer catheter (Due to 21 being expanded within the lumen 13 and engaging with either rim 19a,b).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to replace the detents in the guidewire lumen of Shaltis with at least one rim taught by Vrancken, and to substitute the interference feature of Shaltis with the expandable interference feature taught by Vrancken et al., for the purpose of substituting a mechanism commonly known in the art for releasably securing the distal end of a guidewire within the guidewire lumen of a catheter thereby achieving the predictable result of allowing for controlled advancement of the catheter along the guidewire or steering of the distal tip of the catheter when engaged with the interference feature. In the device as modified, the interference feature is configured to provide an interference fit with the guidewire lumen when the guidewire is pushed distally with respect to the introducer catheter because 21 can be expanded within the lumen proximal to the rim and therefore provide an interference fit with the guidewire lumen when the guidewire is pushed distally.
Regarding claim 22, 25, and 26, Shaltis discloses the invention substantially as claimed, as set forth above for claim 12.
Shaltis is silent regarding a second interference feature positioned proximal to the guidewire lumen when the guidewire is disposed within the guidewire lumen wherein the second interference feature is configured to provide an interference fit with the guidewire lumen when the guidewire is pushed distally with respect to the introducer catheter.
However, Vrancken et al. teaches in the same field of endeavor of using a guidewire (20) to steer the distal end of a catheter (10), wherein a guidewire lumen (13) has a diameter greater than a second diameter of the guidewire (See diameter of guidewire in FIGs 6-6a when received within the lumen) and the guidewire lumen is smaller than a third diameter of an interference feature of the guidewire (wherein 21 is the interference feature and FIG 6-6a shows in phantom lines the third diameter which is larger than the guidewire lumen, [0091-0092]), such that an interference fit between the guidewire lumen allows the guidewire to steer the catheter device (Figs 7a-7d, [0105-0109]), wherein the interference feature is configured to provide an interference fit with the guidewire lumen when the guidewire is pulled proximally with respect to the introducer catheter ([0010]), and comprising a second interference feature (19a) positioned proximal to the guidewire lumen (FIG 6a shows 19a is positioned proximal to at least a distal segment of the lumen) when the guidewire is disposed within the guidewire lumen (FIG 6a) wherein the second interference feature is configured to provide an interference fit with the guidewire lumen when the guidewire is pushed distally with respect to the introducer catheter(Due to 21 being expanded within the lumen 13 and engaging with either rim 19a,b).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to replace the detents in the guidewire lumen of Shaltis with at least one rim/second interference feature taught by Vrancken, and to substitute the interference feature of Shaltis with the expandable interference feature taught by Vrancken et al., for the purpose of substituting a mechanism commonly known in the art for releasably securing the distal end of a guidewire within the guidewire lumen of a catheter thereby achieving the predictable result of allowing for controlled advancement of the catheter along the guidewire or steering of the distal tip of the catheter when engaged with the interference feature. In the device as modified, the interference feature is configured to provide an interference fit with the guidewire lumen when the guidewire is pushed distally with respect to the introducer catheter because 21 can be expanded within the lumen proximal to the rim and therefore provide an interference fit with the guidewire lumen when the guidewire is pushed distally.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
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, Elizabeth Houston can be reached at 5712727134. 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.
/BROOKE LABRANCHE/Primary Examiner, Art Unit 3771