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 .
Response to Arguments
Applicant’s arguments, see pg. 6, filed 6/26/2026, with respect to the claim objection have been fully considered and are persuasive. The claim objection of 3/26/2026 has been withdrawn.
Applicant’s arguments, see pages 6-7, filed 6/26/2026, with respect to the rejection(s) of claim(s) 1-20 under 102(a)(1) and (a)(2) and 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of US Patent Application Publicaiton 2021/0076949 to Smith who teaches a guidewire which extends both proximally and distally of the distal end of the imaging lumen, see Figs. 5A-B and the rejections below.
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.
Claim(s) 1-2 and 5-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 2022/0361743 to Chan (hereinafter “Chan”) in view of US Patent Application Publication 2021/0076949 to Smith et al (hereinafter “Smith”). Chan discloses an imaging catheter comprising:
In regards to Claim 1, a catheter shaft (Figs. 6A-D, Element 102, [0015]) configured to be disposed within a blood vessel, the catheter shaft having an imaging window region (Element 120) and an imaging lumen (Element 104); wherein the imaging lumen is configured to accommodate an imaging assembly therein (Elements 110 and 111, [0099]); a distal tip member (Element 124) coupled to the catheter shaft, the distal tip member having a guidewire lumen formed therein (Element 106, [0093]); wherein the imaging lumen has a distal end (Element number 124 points directly at the distal end of the imaging lumen) and wherein the imaging window region and the distal tip member axially overlap (Fig. 6A shows window 120 overlapping the axis of distal tip 124, Fig. 6D also shows Element 118 overlapping window 120)
However, Chan does not disclose wherein the guidewire lumen extends proximally and distally relative to the distal end of the imaging lumen. Smith discloses an intravascular imaging device wherein the guidewire lumen extends proximally and distally relative to the distal end of the imaging lumen (Fig. 5A-B, Element 580 is the guidewire lumen, Element 590 is the guidewire, [0059] [0060]). It would have been obvious before the effective filing date of the claimed invention to modify Chan to include that the guidewire lumen extends proximally and distally relative to the distal end of the imaging lumen such as that taught by Smith in order to anchor to an occlusion within the intravascular system of the patient (Smith [0004] [0060]).
In regards to claim 2, wherein the distal tip member includes a distal end region extending distally from the imaging window region and an overlap region where the imaging window region and the distal tip member axially overlap (See annotated Fig. 6D below)
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In regards to claim 5, wherein the overlap region has a length of about 300 millimeters or less ([0102], window is 5mm-150mm)
In regards to Claim 6, wherein the overlap region has a length of about 15-300 millimeters (([0102], window is 5mm-150mm, Fig. 6D shows an overlap of the window region)
In regards to Claim 7, wherein the imaging lumen is in fluid communication with the guidewire lumen ([0158])
In regards to claim 8, wherein the distal tip member has an axially-extending slit formed therein (Figs. 6A-D, Element 118)
In regards to claim 9, wherein the distal tip member has an axially-extending channel formed therein (Fig. 6A-D show a channel where Element 112 is inserted)
In regards to claim 10, wherein the distal tip member and the imaging window region are integrally formed ([0095], body 102 and tip 124 are made of same material and are constructed together)
In regards to claim 11, wherein the distal tip member, the imaging window region, or both include a coating ([0164])
Claim(s) 12 and 15-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chan in view of US Patent Application Publication 2014/0180127 to Meyer (hereinafter “Meyer”) and Smith.
In regards to Claim 12, Chan discloses an imaging catheter comprising:
a catheter shaft assembly (Figs. 6A-D, 100) including a catheter shaft extending distally therefrom (Element 102, [0015]); wherein the catheter shaft includes an imaging window region (Element 120) having an imaging lumen formed therein (Element 104) and a distal tip region (Element 124) having a guidewire lumen formed therein; wherein the imaging lumen has a distal end (Element number 124 points directly at the distal end of the imaging lumen) wherein the distal tip region includes an overlapping region disposed along a side surface of the imaging window region (see annotated Fig. 6D below); and an imaging core disposed within the imaging lumen (Element 113)
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However, Chan does not disclose that the catheter shaft assembly comprises a telescoping region or that the guidewire lumen has a proximal end disposed proximally of the distal end of the imaging lumen and a distal end disposed distally of the distal end of the imaging lumen.
In the analogous art of imaging catheters, Meyer discloses an imaging catheter comprising a telescoping region ([0010] [0029]). It would have been obvious before the effective filing date of the claimed invention to modify Chan to include a telescoping region such as that taught by Meyer in order to extend an imager into the distal end of the catheter while reducing cable buckling.
Smith discloses an intravascular imaging device wherein the guidewire lumen extends proximally and distally relative to the distal end of the imaging lumen (Fig. 5A-B, Element 580 is the guidewire lumen, Element 590 is the guidewire, [0059] [0060]). It would have been obvious before the effective filing date of the claimed invention to modify Chan to include that the guidewire lumen extends proximally and distally relative to the distal end of the imaging lumen such as that taught by Smith in order to anchor to an occlusion within the intravascular system of the patient (Smith [0004] [0060]).
In regards to claim 15, Chan discloses that the imaging window region has an imaging lumen formed therein that is in fluid communication with the guidewire lumen (Fig. 6C, [0158])
In regards to claim 16, Chan discloses that the distal tip region has an axially-extending slit formed therein (Fig. 6D, Element 118)
In regards to Claim 17, Chan discloses that the distal tip region has an axially-extending channel formed therein (Channel comprising guide wire 112)
In regards to claim 18, Chan discloses that wherein the distal tip region and the imaging window region are integrally formed ([0095], body 102 and tip 124 are made of same material and are constructed together)
In regards to Claim 19, Chan discloses that the distal tip region and the imaging window region are formed from a single monolith of material ([0095] “In some variations, the catheter body 102 and nose cone 124 may comprise an optically transparent polymer with a refractive index of less than 1.60 may be used.”)
In regards to Claim 20, Chan discloses a method comprising:
disposing an intravascular imaging device within a blood vessel ([0015]), the intravascular imaging device comprising:
a catheter shaft assembly (Figs. 6A-D, 100) including a catheter shaft extending distally therefrom (Element 102, [0015]); wherein the catheter shaft includes an imaging window region (Element 120) having an imaging lumen formed therein (Element 104) and a distal tip region (Element 124) having a guidewire lumen formed therein; wherein the imaging lumen has a distal end (Element number 124 points directly at the distal end of the imaging lumen) wherein the distal tip region includes an overlapping region disposed along a side surface of the imaging window region (See Annotated Fig. 6D below); and an imaging core disposed within the catheter shaft assembly (Element 113)
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However, Chan does not disclose that the catheter shaft assembly comprises a telescoping region and wherein the guidewire lumen has a proximal end disposed proximally of the distal end of the imaging lumen and a distal end disposed distally of the distal end of the imaging lumen.
In the analogous art of imaging catheters, Meyer discloses an imaging catheter comprising a telescoping region ([0010] [0029]). It would have been obvious before the effective filing date of the claimed invention to modify Chan to include a telescoping region such as that taught by Meyer in order to extend an imager into the distal end of the catheter while reducing cable buckling.
Smith discloses an intravascular imaging device wherein the guidewire lumen extends proximally and distally relative to the distal end of the imaging lumen (Fig. 5A-B, Element 580 is the guidewire lumen, Element 590 is the guidewire, [0059] [0060]). It would have been obvious before the effective filing date of the claimed invention to modify Chan to include that the guidewire lumen extends proximally and distally relative to the distal end of the imaging lumen such as that taught by Smith in order to anchor to an occlusion within the intravascular system of the patient (Smith [0004] [0060]).
Claim(s) 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Chan in view of Smith. Chan discloses a length of the catheter shaft in paragraph [0096], but does not disclose that the distal end region has a length of about 5-25 millimeters or that the distal end region has a length of about 10-20 millimeters. Chan and Smith fail to explicitly disclose wherein the distal end region has a length of 5-25mm or 10-20mm. However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make/set the length of the distal end region of Chan and Smith to be 5-25mm or 10-20mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the distal end region would not operate differently with the claimed length. Further, Applicant places no criticality on the range claimed, indicating in [0062] that these lengths are just examples.
Claim(s) 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chan in view of Meyer and Smith. Chan, Meyer, and Smith do not disclose that the second portion has a length of 300 millimeters or 15-300 millimeters. Chan, Meyer, and Smith fail to explicitly disclose wherein the second portion has a length of 300 millimeters or 15-300 millimeters. However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make/set the length of the second portion of Chan in view of Meyer to be 300 millimeters or 15-300 millimeters since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the second portion would not operate differently with the claimed length. Further, Applicant places no criticality on the range claimed, indicating in [0062] that these lengths are just examples.
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 MICHAEL JAMES CAREY whose telephone number is (571)270-7235. The examiner can normally be reached Monday-Friday (8am-5pm).
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/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
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