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
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) 2-6, 9, 11, 13-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tashiro, et al. (JP 2012229976, Nov. 22, 2012) (hereinafter “Tashiro”) in view of Drexler, Wolfgang, et al. "Optical coherence tomography today: speed, contrast, and multimodality." Journal of biomedical optics 19.7 (2014): 071412-071412 (hereinafter “Drexler”). The English-language equivalent of Tashiro, US 2014/0031679, is used for citation purposes.
Regarding claims 2-6: Tashiro discloses an imaging system for a patient comprising: an imaging probe comprising: an elongate shaft for insertion into the patient and comprising a proximal end, a distal portion, and a lumen extending between the proximal end and the distal portion (figs. 1 and 2, outer sheath 15 where the lumen is shown but not labeled); a rotatable optical core comprising a proximal end and a distal end, the rotatable optical core configured to optically and mechanically connect with a console (figs. 1 and 2, optical fiber 11); a probe connector positioned on the elongate shaft proximal end and surrounding at least a portion of the rotatable optical core (fig. 1, probe scanning device 30); and an optical assembly positioned in the elongate shaft distal portion and proximate the rotatable optical core distal end, the optical assembly comprising a single unitary gradient-index (GRIN) lens (fig. 2, GRIN lens 13), the optical assembly configured to direct light from a light source that provides a power and a frequency parameter for the directed light that permits the directed light to be transmitted through a wall of a first blood vessel to tissue and collect reflected light from the tissue ([0021]-[0022], [0031] – “near infrared light having a property of propagating through a living tissue” where “near infrared” refers to the wavelength which is inversely proportional to frequency and is therefore also descriptive of the frequency; while Tashiro does not describe imaging through a blood vessel wall, Tashiro does disclose the claimed characteristics of the light which would make this possible); wherein the imaging probe is constructed and arranged to collect image data from a patient site based on the directed light and the reflected light ([0031], [0035]), wherein the optical assembly is configured to be positioned within a first blood vessel proximate a patient site, and includes an optical component constructed to receive the light from the light source providing the at least one of the power or frequency parameter for the directed light ([0021]-[0022], [0031] – “near infrared light having a property of propagating through a living tissue” where “near infrared” refers to the wavelength which is inversely proportional to frequency and is therefore also descriptive of the frequency; while Tashiro does not describe imaging through a blood vessel wall, Tashiro does disclose the claimed characteristics of the light which would make this possible).
While Tashiro discloses that the imaging system is an OCT system ([0018]-[0020]) and that it may be used for any type of OCT ([0037]), Tashiro is silent on the power parameter being approximately 20mW and the frequency parameter being approximately 1300nm.
Drexler, in the same field of endeavor, discloses that a power parameter of approximately 20mW and a frequency parameter (wavelength) of approximately 1300nm is well-known and conventional in the art of biomedical OCT imaging (table 1, see at least entries 1-3 and 5-6).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to use a conventionally known power and frequency (wavelength) to perform the OCT imaging of Tashiro because the claimed elements (the probe of Tashiro and the conventional power and frequency parameters disclosed by Drexler) were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results (KSR, 550 U.S. at 416, 82 USPQ2d at 1395).
With respect to the limitations “the optical assembly configured to direct light…through a wall of a first blood vessel”; “an optical component constructed to receive the light from the light source … then directs the light through a wall of the first blood vessel to the patient site, receives the reflected light from the patient site through the wall of the first blood vessel”; and “wherein the patient site comprises a blood vessel outside of the first blood vessel within which the optical assembly is positioned,” it is noted that the specific imaging target is the intended use of the claimed system.
Applicant is reminded that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In this case, the claim recites an imaging system comprising an imaging probe comprising an elongate shaft, a rotatable optical core, a probe connector, and an optical assembly configured to transmit/receive the light having “at least one of a power or frequency parameter for the directed light that permits the directed light to be transmitted through a wall of a first blood vessel to tissue.”
The system of Tashiro comprises an imaging probe comprising an elongate shaft, a rotatable optical core, a probe connector, and an optical assembly which is configured to transmit light that is disclosed as being capable of propagating through living tissue by virtue of its wavelength (where wavelength is inversely proportional to frequency and is therefore also descriptive of a “frequency parameter”). There is no evidence of a structural difference between the instantly claimed system and the system of Tashiro that would preclude the optical assembly of Tashiro from directing/receiving light to/from tissue outside of a blood vessel in which the probe is positioned. It is noted that the instant disclosure indicates at paragraph [0143] that the imaging probe is “constructed and arranged to collect image data from tissue selected from the group consisting of: wall tissue of a blood vessel of the patient site; thrombus proximate the patient site; occlusive matter proximate the patient site; a blood vessel outside of blood vessel in which optical assembly 130 is positioned; tissue outside of blood vessel in which optical assembly 130 is positioned; extracellular deposits outside of the lumen of the blood vessel in which optical assembly 130 is positioned (e.g. within and/or outside of the blood vessel wall); and combinations of one or more of these.” It is additionally noted that there does not appear to be any description of a particular structure of the imaging probe that would render it specially configured to image a vessel outside of the vessel where the optical assembly is positioned as opposed to any other tissue or the inside of vessel. There is no description of any particular structural configuration of the optical assembly which would render it “configured to direct light…through a wall of a first blood vessel”; “constructed to receive the light from the light source … then directs the light through a wall of the first blood vessel to the patient site, receives the reflected light from the patient site through the wall of the first blood vessel”; or used to image a patient site “wherein the patient site comprises a blood vessel outside of the first blood vessel within which the optical assembly is positioned,”
The structure of the optical assembly 130 is described at paragraph [0165] of the instant disclosure as including “lens 131, and a reflecting surface, reflector 132.” The structure of the optical assembly 130 is again described at paragraph [0167] as comprising “a lens 131 with an OD that is greater than the diameter of lumen 112” and that “OD of lens 131 being greater than the diameter of lumen 112 prevents optical assembly 130 from translating within lumen 112.” The disclosure indicates that the lens 131 may be a GRIN lens and/or a ball lens, and lists some possible focal lengths of a GRIN lens (paragraph [0179]), however there is no link between the type/focal length of the lens and the imaging target. There is no indication as to what the structure of the lens and the reflector must be in order to render the optical assembly constructed to or configured to image a particular target.
In the absence of any evidence of a structural difference between the claimed imaging probe/optical assembly and the imaging probe/optical assembly of Tashiro, the imaging probe/optical assembly of Tashiro considered to be capable of performing the claimed functions. This analysis additionally applies to the limitations of claims 3-6, which merely further limit the intended use of the probe by specifying the location in which it is to be used.
Regarding claim 9: Tashiro in view of Drexler discloses the imaging system according to claim 2, wherein the elongate shaft distal portion comprises an optically transparent window, and wherein the optical assembly is positioned within the optically transparent window (fig. 2, the shaft 15 surrounding the optical assembly is optically transparent – [0027]).
Regarding claim 11: Tashiro in view of Drexler discloses the imaging system according to claim 2, but is silent on wherein the rotatable optical core is constructed and arranged to rotate in a single direction.
It is noted that for a rotational scanning probe such as the probe of Tashiro, only two options exist for the rotation — the rotatable core can rotate in one direction or it can rotate in two directions. A person having ordinary skill in the art prior to the effective filing date of the claimed invention could have implemented either single direction or two direction rotation with a reasonable expectation of success. Additionally, single direction rotation would present a somewhat simplified approach as compared to two direction rotation because components such as the motor and rotary junction would only be required to measure one rotational direction.
Therefore, it would have been prima facie obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to configure the rotatable optical core to rotate only in a single direction in order to simplify the rotational aspects of the system because a person of ordinary skill has good reason to pursue the known options within his or her technical grasp (KSA, 550 U.S. at 421, 82 USPQ2d at 139).
Regarding claims 13-15: Tashiro in view of Drexler discloses the imaging system according to claim 2. The remaining limitations, regarding the imaging probe being “configured to provide” various types of information and how that information is to be used, is considered to be the intended use of the claimed system. The probe is capable only of emitting light to an imaging site and collecting the reflected light. The nature of the data that can be generated from the collected reflected light is not related to the structure of the probe. Applicant is reminded that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 16: Tashiro in view of Drexler discloses the imaging system according to claim 2, wherein the imaging probe further comprises a torque shaft with a proximal end and a distal end, and wherein the torque shaft is fixedly attached to the rotatable optical core such that rotation of the torque shaft rotates the rotatable optical core (fig. 1, [0023]; in the absence of any further structural limitations, the rotary joint 31 is considered to be a “torque shaft” by virtue of having two ends, being “fixedly attached” to the optical core and performing the claimed function).
Regarding claim 17: Tashiro in view of Drexler discloses the imaging system according to claim 2, further comprising a rotation assembly constructed and arranged to rotate the rotatable optical core (fig. 1, radial scan motor 32).
Claim(s) 7 is is/are rejected under 35 U.S.C. 103 as being unpatentable over Tashiro and Drexler as applied to claim 2 above and further in view of Murashima et al. (US 2016/0116683 A1, Apr. 28, 2016) (hereinafter “Murashima”).
Regarding claim 7: Tashiro in view of Drexler discloses the imaging system according to claim 2, but is silent on wherein the optical assembly comprises an outer diameter that is greater than an inner diameter of at least a portion of the elongate shaft proximal to the optical assembly.
Murashima, in the same field of endeavor, discloses an imaging probe comprising an elongate shaft (tube housing 41) having a lumen containing an optical core and an optical assembly ([0025]) where the elongate shaft has a narrowed portion near the proximal end with a small inner diameter (fig. 7, D2) where the narrowed portion has sufficiently small diameter as to serve as a support for the optical core (fig. 7, D2, support 41a; [0038]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the elongate shaft of Tashiro and Drexler to include a narrowed portion as taught my Murashima in order to provide additional support to the optical core. It is noted that this arrangement, and a narrowed portion/support proportional to that shown in Murashima would result in the claimed condition of the optical assembly having an outer diameter larger than the inner diameter of a portion of the elongate shaft (see the size of the optical core 11 and the optical assembly 12/13 in fig. 2 of Tashiro).
Claim(s) 8, 12, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tashiro and Drexler as applied to claim 2 above and further in view of Kemp (US 2014/0100454 A1, Apr. 10, 2014) (hereinafter “Kemp”).
Regarding claims 8, 12, and 18: Tashiro in view of Drexler discloses the imaging system according to claim 2, wherein the imaging system includes a sensor that receives a signal related to the tissue, the console configured to process the signal, and a display configured to display an image (fig. 1) and a rotation assembly constructed and arranged to rotate the rotatable optical core (radial scanning motor 32). However Tashiro is silent on a 3D image and a retraction of the elongate shaft; a retraction assembly constructed and arranged to retract the elongate shaft and the optical assembly while the imaging probe collects data from a target area; and a retraction assembly constructed and arranged to retract at least one of the rotatable optical core or the elongate shaft.
Kemp, in the same field of endeavor, discloses an intravascular OCT system comprising an imaging probe comprising an elongate shaft and a rotatable optical core with a retraction assembly constructed and arranged to retract at least one of the rotatable optical core or the elongate shaft while the imaging probe collects data from a target site (pullback motor 865, fig. 6; [0044], [0066]) and generating and displaying a 3D image in response to the retraction ([0009]-[0010], [0034], [0069]-[0070]). Kemp further teaches that imaging catheter pullback (“retraction”) is the conventional method of obtaining intravascular OCT images ([0072] – existing OCT systems have a default pullback, [0062], [0055] – a list of references including conventional pullback techniques, [0005]) and that the particular method disclosed by Kemp provides the benefit improved parameter setting and image quality as opposed to prior systems ([0005]-[0008], [0062]).
It would have been prima facie for one having ordinary skill in the art to modify the system of Tashiro and Drexler by providing pullback (“retraction”) and 3D images as taught by Kemp in order to provide quality images of the entire tissue volume in view of the further teachings of Kemp.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tashiro and Drexler as applied to claim 9 above and further in view of Tearney et al. (US Patent No. US 10,285,568 B2, May 14, 2019) (hereinafter “Tearney”).
Regarding claim 10: Tashiro in view of Drexler discloses the imaging system according to claim 9, but is silent on the length of the optically transparent window.
Tearney, in the same field of endeavor, teaches that the length of an imaging window is a results-effective variable (column 7, lines 23-26 — “[t]he length of an imaging window... can define the length of the tissue scanned during imaging).
Therefore, in the absence of any evidence of criticality or unexpected result, it would have been prima facie obvious for one having ordinary skill in the art prior to the time of filing to select any appropriate length for the window (including less than 20mm) in order to optimize the length of the section of tissue scanned during imaging in view of the teachings of Tearney that window length is a results-effective variable, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only ordinary skill in the art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim(s) 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tashiro and Drexler as applied to claim 2 above and further in view of Follmer et al. (US Patent No. US 5,827,242, Oct. 27, 1998) (hereinafter “Follmer”’).
Regarding claims 20-21: Tashiro discloses the imaging system according to claim 2 but is silent on the probe diameter, including that the imaging probe has an outer diameter of less than 1mm, less than 0.7mm, less than or equal to 0.635mm, less than or equal to 0.4064mm, or less than or equal to 0.3556mm.
Follmer, in the same field of endeavor, teaches that the outer diameter of a catheter is a results effective variable and that for certain procedures, catheters with an outer diameter less than 1mm, less than 0.7mm, less than or equal to 0.635mm, less than or equal to 0.4064mm, or less than or equal to 0.3556mm must be used (column 1, lines 22-27; column 1, lines 33-37; column 1, lines 39-42 —“a primary requirement is size”, “blood vessels in the brain are frequently several millimeters or less in diameter, and useful catheters must be as small as 1 French (1 French; 0.33 mm) or below”; column 3, lines 36-42).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to implement the imaging probe of Tashiro to have an outer diameter less than 1mm, less than 0.7mm, less than or equal to 0.635mm, less than or equal to 0.4064mm, or less than or equal to 0.3556mm (where 0.33 mm is smaller than all of the claimed diameters) in order to perform certain vascular procedures where the size of the vessel constrains the diameter of the catheter in view of the teachings of Follmer, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only ordinary skill in the art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Response to Arguments
Applicant’s arguments with respect to prior art rejections of all pending claims, filed 01/21/2026, have been fully considered but are moot in view of the updated grounds of rejection necessitated by amendment.
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 CAROLYN A PEHLKE whose telephone number is (571)270-3484. The examiner can normally be reached 9:00am - 5:00pm (Central Time), Monday - Friday.
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/CAROLYN A PEHLKE/Primary Examiner, Art Unit 3799