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 Objections
Claim 1 is objected to because of the following informalities: Line 4 should read “to accommodate an imaging assembly…”. Appropriate correction is required.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2 and 5-11 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by US Patent Application Publication 2022/0361743 to Chan (hereinafter “Chan”). In regards to claims 1-2 and 5-11, Chan discloses an imaging catheter comprising:
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 and 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]); 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)
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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wherein the overlap region has a length of about 300 millimeters or less ([0102], window is 5mm-150mm)
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)
wherein the imaging lumen is in fluid communication with the guidewire lumen ([0158])
wherein the distal tip member has an axially-extending slit formed therein (Figs. 6A-D, Element 118)
wherein the distal tip member has an axially-extending channel formed therein (Fig. 6A-D show a channel where Element 112 is inserted)
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)
wherein the distal tip member, the imaging window region, or both include a coating ([0164])
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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 et al (hereinafter “Meyer”).
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) and a distal tip region (Element 124) having a guidewire lumen formed therein; wherein the distal tip region has a first portion (See Annotated Fig. 6D below) disposed distally of the imaging window region and a second portion disposed along a side surface of the imaging window region (portion of channel 106 comprising guidewire 112); 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.
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.
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) and a distal tip region (Element 124) having a guidewire lumen formed therein; wherein the distal tip region has a first portion (See Annotated Fig. 6D below) disposed distally of the imaging window region and a second portion disposed along a side surface of the imaging window region (portion of channel 106 comprising guidewire 112); 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.
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.
Claim(s) 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Chan. 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 fails 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 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. Chan and Meyer do not disclose that the second portion has a length of 300 millimeters or 15-300 millimeters. Chan and Meyer 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
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/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795