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 .
Drawings
The drawings were received on 9/20/2024. These drawings are accepted for examination.
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) 1-3, 5-7, and 22-24 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jaffe et al (US 2009/0088648).
Regarding claims 1 and 2, Jaffe discloses and teaches a catheter device with elongated tubular sheath, a lumen therethrough, an elongate needle within the lumen, terminating at the distal end of the catheter (including a tip) which has a central axis in the tip portion, and an optical probe extending within the lumen and terminating at the distal end, adjacent the sheath (abstract, 0024-0039, Claims 10, 14-21). The distal end of the probe is configured to provide optical interrogation to tissues and receive reflected optical signals to create an imaging field. The lumen of Jaffe includes at least first and second channels within the lumen, allowing for both the needle and optical device to be placed in one of the channels (Abs).
Regarding claims 3, 5-7, and 22-24, Jaffe et al discloses and teaches the optical probe including an optical fiber and OCT probe with a transseptal needle for penetration of the septum of the heart (0004, 0006-0009, 0026-0033, 0098-0107, Claims 19-20). Jaffe specifically teaches the positioning of the catheter at the atrium of the heart, and locating a puncture site on the septum based on the optical signal detected/scattered from the interrogation in order to guide the needle through the septum, and advancing the catheter through the created hole (0004-0009, Claims 19-20, 0026, 0028, 0033, 0076-0078).
Claim(s) 1, 2, 4-6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stokes et al (US 2017/0014159).
Regarding claims 1-2, Stokes discloses and teaches a catheter device with elongated tubular sheath, a lumen therethrough, an elongate needle within the lumen, terminating at the distal end of the catheter (including a tip) which has a central axis in the tip portion, and an optical probe extending within the lumen and terminating at the distal end, adjacent the sheath (Fig 1a, 1b, 0042). The distal end of the probe is configured to provide optical interrogation to tissues and receive reflected optical signals to create an imaging field. The lumen of Stokes includes at least first and second channels within the lumen, allowing for both the needle and optical device to be placed in one of the channels (Fig 2, Claims 1-3, Fig 1b, both imaging and needle device within catheter).
Regarding claims 4-6, Stokes includes a steerable element (0042) and transseptal needle (0043), which is capable of being axially moved (Fig 2).
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.
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) 8, 9, 11, 12, 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stokes in view of Imam (US 2010/0094126). With respect to claims 8, 9, and 15 Stokes discloses what is listed above with respect to claim 1, and also discloses catheter arrangements for imaging, but fails to specify a light source, and an optical detector coupled to a probe configured to detect a signal from the field of view/interrogation. Attention is hereby directed to the teaching reference to Imam which expressly discloses a light source (Fig 3a, 313) coupled to an optical probe (3a), with detector (320) configured to interrogate a field of view and record the detected/reflected signal.
Imam’s transluminal catheter further discloses the signal processing (0051, Fig 3-5) and localization of internal anatomical locations with signal feedback (finding arteries/veins, 0041, 0046-0047). Stokes further discloses the identification of thickness from imaging properties including optical properties (0014, 0046-0048 Claims 1, 6, 11, 13) and the subsequent identification of the puncture site from that thickness data. It would have been obvious to one of ordinary skill in the art at the time of the invention to have utilized the teachings of Imam with those of Stokes to visualize and identify objects clearly seen and obfuscated in a field of interrogation (0005, Imam).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stokes in view of Imam (US 2010/0094126), and in further view of Jaffe (‘648, above). While Stokes in view of imam discloses what is listed above, they fail to disclose an OCT probe. Attention is directed to Jaffe as above in rejection of claim 7, disclosing and teaching the optical probe including an optical fiber and OCT probe with a transseptal needle for penetration of the septum of the heart (0004, 0006-0009, 0026-0033, 0098-0107, Claims 19-20). It would have been obvious to utilize and OCT probe as the visualization device to create optical images with high resolution (Jaffe, abs, background).
Claim(s) 13-14 and 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stokes in view of Imam (US 2010/0094126) and in further view of Cinbis (US 2013/0116522).
Stokes in view of Imam discloses what is listed above, and further discloses processing and interrogation with light waves (0014), but fails to disclose the processing link between optical tissue data and the identification of the thickness/properties for puncture locations.
Stokes does positively recite the identification of the thickness of the septum, identification of the fossa ovalis (0008), image generation for anatomical locations, and classify features in the images (0015, 0017, 0046-0047, fossa ovalis, thickness), but doesn’t disclose the filtering processing for display of features.
Attention is hereby directed to the teaching reference to Cinbis, which expressly discloses and teaches the filtering (0038-0039, 0060 (partial wavelengths) and processing of optical tissue data for identification of tissue properties (classifying thinnest portion (fossa), image generation, Fig 13 and associated disclosure), including anatomical and thickness properties for transsceptal procedures (0053-0056, Fig 13). It would have been obvious to one of ordinary skill in the art to have utilized the processing and display techniques of Cinbis with the teachings of Stokes in order to provide guidance for trans-sceptal procedures in the body (Abs, background, Cinbis).
Claim 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stokes in view of Imam (US 2010/0094126) as applied to claim 9 above, and in further view of Barbagli (US 2020/0008678).
Stokes in view of Imam discloses what is listed above, but fails to expressly disclose a localization system for tracking the catheter and mapping data for the catheter over time, whereby a visualization of a spatial map and identify elements of the map based on the detector signal and map data. Attention is hereby directed to Barbagli which discloses and teaches a tracking system or guiding the OCT imaging system during interrogation and the integration of OCT data with the tracking data (0041, 0045-0048, 0051) as a combined display. It would have been obvious to one of ordinary skill in the art at the time of the invention to have utilized the teachings of Barbagli with those of Stokes in view of Imam for the purpose of guiding an internal procedure accurately under OCT (abs, 0029, 0033-0034, 0041).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOEL M. LAMPRECHT whose telephone number is (571)272-3250. The examiner can normally be reached Mon - Fri 9:00-5:30.
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/JOEL LAMPRECHT/Primary Examiner, Art Unit 3798