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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994)
The disclosure of the prior-filed application, Provisional Application No. 62/148,355 (filed 04/16/2015), fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The limitation “and a fluid in the distal portion of the elongate shaft that has a viscosity that decreases with an increasing shear rate corresponding to a speed rotation of the rotatable optical core” in claim 2, and all dependent claims thereof, does not have support in provisional application 62/148,355. While a fluid is disclosed in this provisional application, there is no mention of the fluid being a “fluid...that has a viscosity that decreases with an increasing shear rate corresponding to a speed rotation of the rotatable optical core.” The first disclosure of a “non-Newtonian fluid” (where “that has a viscosity that decreases with an increasing shear rate corresponding to a speed rotation of the rotatable optical core” is the definition of non-Newtonian”) appears in provisional application 62/322,182 (filed 04/13/2016). Therefore, claim 2 and all dependents thereof, is assigned the priority date of 04/13/2016.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 41 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 41 recites the limitation “wherein the non-Newtonian fluid is different than the fluid in the lumen of the elongate shaft.” However, no fluid within the lumen of the elongate shaft has been claimed so it is unclear what this limitation might be referring to.
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 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.
Claims 2-9, 11, 17, 21-23, 28, 32, 34, 36-40 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hasegawa et al. (US PG Pub. No. US 2015/0245768 A1, Sep. 3, 2015) (hereinafter “Hasegawa”).
Regarding claim 2: Hasegawa 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 (optical probe 10, [0020]-[0021]); a rotatable optical core comprising a proximal end and a distal end, the rotatable optical core optically and mechanically connecting with a console (optical fiber 11, [0025], figure 1, measurement unit 30); a probe connector positioned on the elongate shaft proximal end and surrounding at least a portion of the rotatable optical core (optical connector 12, figure 1); an optical assembly positioned in the elongate shaft distal portion and proximate the rotatable optical core distal end, the optical assembly configured to direct light to tissue and collect reflected light from the tissue, wherein the optical assembly comprises a single unitary gradient-index (GRIN) lens constructed and arranged to reflect light from a reflective surface of the single unitary GRIN lens (focusing optical system 13, deflection optical system 14, [0023]); and a non-Newtonian fluid in the distal portion of the elongate shaft that has a viscosity that decreases with an increasing shear rate corresponding to a speed rotation of the rotatable optical core ([0028] – it is noted that Applicant has previously argued on the record that “’silicone’ alone provides sufficient guidance provides sufficient guidance and structure as to what the makeup of a ‘shear-thinning fluid’ should be, see Remarks dated 06/07/2021 in parent application 15/566,041, where a shear-thinning fluid is non-Newtonian).
Regarding claim 3: Hasegawa discloses the imaging system according to claim 2, wherein the fluid is configured to reduce undesired rotational variances of the rotatable optical core ([0028]).
Regarding claim 4: Hasegawa discloses the imaging system according to claim 3, wherein the fluid is configured to avoid placing excessive loads on the rotatable optical core ([0028]).
Regarding claim 5: Hasegawa discloses the imaging system according to claim 2, wherein the imaging probe is configured to access blood vessels ([0009], [0016], [0043]). While Hasegawa is silent on the blood vessels being located in the brain, in the absence of any particular structural limitations, this is considered to be the intended use of the system.
Applicant is respectfully 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 the absence of any defining structural limitations, the probe of Hasegawa is considered to be capable of accessing blood vessels of the brain.
Regarding claim 6: Hasegawa discloses the imaging system according to claim 2, wherein the imaging probe further comprises at least one space reducing element positioned between the elongate shaft and the rotatable optical core (support tube 15, [0025]).
Regarding claim 7: Hasegawa discloses the imaging system according to claim 6, wherein the at least one space reducing element is configured to reduce rotational speed variances of the rotatable optical core (support tube 15, [0025]).
Regarding claim 8: Hasegawa discloses the imaging system according to claim 7, wherein the at least one space reducing element is configured to reduce rotational speed variances of the speed rotation of the rotatable optical core by increasing an amount of thinning of the non-Newtonian fluid (support tube 15, [0025]).
Regarding claim 9: Hasegawa discloses the imaging system according to claim 2, 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 (figure 1 - the outer diameter of the optical assembly is at least larger than the inner diameter of support tube 15, which is "a portion of the elongate shaft proximal to the optical assembly").
Regarding claim 11: Hasegawa 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 ([0027] - the transparent portion of jacket tube 16 located at distal end 11b, see figure 1).
Regarding claim 17: Hasegawa discloses the imaging system according to claim 2, further comprising a fluid interacting element in the distal portion and the lumen of the elongate shaft, wherein the fluid interacting element is configured to interact with the fluid to increase load on the rotatable optical core during rotation of the rotatable optical core (support tube 15, [0028]).
Regarding claim 21: Hasegawa discloses the imaging system according to claim 2, wherein the imaging probe of the imaging system is configured to provide to the console quantitative or qualitative information ([0029]-[0031]). Since the use of the information does not appear to be related in any way to the structure of the system, using the information “to determine the size of a flow diverter of an implant to be implanted in the patient or position a flow diverter in the patient” is considered to be the intended use of the system. Applicant is respectfully 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 the absence of any limitations indicating either what the information must be in order to be used as claimed, or any limitations indicating how the data is used, the system of Hasegawa is considered to be capable of providing information that could be used to determine the size of a flow diverter of an implant to be implanted in the patient or position a flow diverter in the patient.
Regarding claim 22: Hasegawa discloses the imaging system according to claim 21. Since the type of information acquired/provided by the imaging system does not appear to be in any way linked to the structure of the system, the type of acquired information is considered to be the intended use of the system. Applicant is respectfully 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 the absence of any limitations relating the structure of the system to the type of information acquired/transmitted, the system of Hasegawa is considered to be capable of acquiring information comprising information related to a parameter selected from the group consisting of: perforator location; perforator geometry; neck size; flow diverter mesh density; and combinations thereof.
Regarding claim 23: Hasegawa discloses the imaging system according to claim 2. Since the type of information provided by the imaging probe, and how the information is then used, does not appear to be linked in any way to the structure of the imaging probe/imaging system, the type of information provided is considered to be the intended use of the system. Applicant is respectfully 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 the absence of any limitations relating the structure of the system to the type of information acquired/transmitted, the system of Hasegawa is considered to be capable of provide implant site information, and wherein the implant site information is used to select a particular implantable device for implantation in the patient.
Regarding claim 28: Hasegawa discloses the imaging system according to claim 2, wherein the elongate shaft comprises an inner diameter that varies along the length of the elongate shaft (figure 1 – the inner diameter of the elongate shaft, where the elongate shaft comprises both the jacket tube 16 and the support tube 15, is different at locations 11a and 11b).
Regarding claim 32: Hasegawa 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 (support tube 15, [0025]).
Regarding claim 34: Hasegawa discloses the imaging system according to claim 2, further comprising a rotation assembly constructed and arranged to rotate the rotatable optical core ([0025]).
Regarding claims 36-39: Hasegawa discloses that the fluid is silicone oil (where “silicone” has been interpreted as a suitable non-Newtonian fluid, see above) ([0028]).
Regarding claim 40: Hasegawa discloses the imaging system according to claim 2, wherein the single unitary GRIN lens is constructed and arranged to reflect light from the reflective surface of the single unitary GRIN lens to another surface of the single unitary GRIN lens where the light is output from the single unitary GRIN lens (fig. 1, [0021], [0030]).
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 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.
Claims 10, 20, 26, 33, 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hasegawa in view of Suter et al. (US PG Pub. No. US 2009/0131801 A1, May 21, 2009) (hereinafter “Suter”).
Regarding claim 10: Hasegawa teaches the imaging system according to claim 2, wherein the imaging system includes a sensor that receives a signal related to the tissue, a processor that executes an algorithm configured to process the signal (optical detector 33, analyzer 36, [0029], [0031], [0020]). Hasegawa further teaches an image “displaying” information ([0034]) which at least implicitly discloses a display in order to provide the function of “displaying.” However, Hasegawa does not teach that the image is three dimensional or that the image data is acquired by retraction of the elongate shaft.
Suter, in the same field of endeavor, teaches creating volumetric (three-dimensional) images ([0039], [0043]) from data acquired during retraction (“pullback”) of the elongate shaft ([0045], [0046]) where the data is processed and displayed by a system configured to acquire, process and display the image data ([0036], where “a system configured to...display image data” is considered to be a disclosure of a display). Suter further teaches that the three dimensional structure of the lumen can be better appreciated by the volumetric (3D) images acquired in this manner ([0039]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the time of filing to modify the system of Hasegawa by acquiring three-dimensional images during retraction (“pullback”) of the elongate shaft as taught by Suter in order to provide a more complete visualization of the lumen in three dimensions which may provide a better appreciation of the vessel structure in view of the further teachings of Suter.
Regarding claim 20: Hasegawa teaches the imaging system according to claim 2 but is silent on a retraction assembly constructed and arranged to retract the elongate shaft and the optical assembly, which occurs simultaneously with the imaging probe collecting data from a target area.
Suter, in the same field of endeavor, teaches a retraction (“pullback”) assembly (pullback device 130) constructed and arranged to retract the elongate shaft and the optical assembly, which occurs simultaneously with the imaging probe collecting data from a target area ([0045], [0046]). Suter further teaches that the three dimensional structure of the lumen can be better appreciated by the volumetric (3D) images acquired in this manner ([0039]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the time of filing to modify the system of Hasegawa by acquiring three-dimensional images during retraction (“pullback”) of the elongate shaft as taught by Suter in order to provide a more complete visualization of the lumen in three dimensions which may provide a better appreciation of the vessel structure in view of the further teachings of Suter.
Regarding claim 26: Hasegawa teaches the imaging system according to claim 2 but is silent on a guide catheter.
Suter, in the same field of endeavor, teaches an imaging system comprising an imaging probe which is provided through a guide catheter ([0016], [0051], claim 15).
It would have been prima facie obvious for one having ordinary skill in the art prior to the time of filing to modify the system of Hasegawa by providing a guide catheter as taught by Suter in order to provide a means of guiding the probe to the proper location within the body.
Regarding claim 33: Hasegawa teaches the imaging system according to claim 32, but is silent on a retraction assembly constructed and arranged to retract at least one of the rotatable optical core or the elongate shaft, and wherein the torque shaft distal end is positioned proximal to the retraction assembly.
Suter, in the same field of endeavor, teaches a retraction (“pullback”) assembly (pullback device 130) constructed and arranged to retract at least one of the rotatable optical core or the elongate shaft, and wherein the torque shaft distal end is positioned proximal to the retraction assembly (figure 1, [0045], [0046]). Suter further teaches that the three dimensional structure of the lumen can be better appreciated by the volumetric (3D) images acquired in this manner ([0039]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the time of filing to modify the system of Hasegawa by acquiring three-dimensional images during retraction (“pullback”) of the elongate shaft as taught by Suter in order to provide a more complete visualization of the lumen in three dimensions which may provide a better appreciation of the vessel structure in view of the further teachings of Suter.
Regarding claim 35: Hasegawa teaches the imaging system according to claim 2 wherein the console comprises a rotation assembly constructed and arranged to rotate the rotatable optical core ([0025]) but is silent on and a retraction assembly constructed and arranged to retract at least one of the rotatable optical core or the elongate shaft.
Suter, in the same field of endeavor, teaches a retraction assembly (pullback device 130) constructed and arranged to retract at least one of the rotatable optical core or the elongate shaft (figure 1, [0045], [0046]). Suter further teaches that the three dimensional structure of the lumen can be better appreciated by the volumetric (3D) images acquired in this manner ([0039]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the time of filing to modify the system of Hasegawa by acquiring three-dimensional images during retraction (“pullback”) of the elongate shaft as taught by Suter in order to provide a more complete visualization of the lumen in three dimensions which may provide a better appreciation of the vessel structure in view of the further teachings of Suter.
Claims 12 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hasegawa in view of Tearney et al. (US Patent No. US 10,285,568 B2, May 14, 2019) (hereinafter “Tearney”).
Regarding claims 12 and 13, as interpreted above: Hasegawa teaches the imaging system according to claim 11 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 or less than 15mm) 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, 105 USPQ 233.
Claim 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hasegawa in view of McWeeney et al. (US PG Pub. No. US 2005/0272975 A1, Dec. 8, 2005) (hereinafter “McWeeney”).
Regarding claim 14: Hasegawa teaches the imaging system according to claim 11, wherein the optically transparent window comprises nylon ([0027]), but is silent on the particular type of nylon used.
McWeeney, in the same problem solving area of in-vivo visualization, teaches an outer sleeve made from nylon 12 which is used to vary the stiffness of the catheter and to provide improved torque transfer and other desirable catheter properties ([0083]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the time of filing to select the nylon of the jacket tube 16 (“outer sleeve”), which comprises the optically transparent window, to be nylon 12 as taught by McWeeney in order to provide improved torque transfer and other desirable catheter properties in view of the further teachings of McWeeney.
Claim 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hasegawa in view of Bhagavatula et al. (US PG Pub. No. US 2014/0247454 A1, Sep. 4, 2014) (hereinafter “Bhagavatula”).
Regarding claim 15: Hasegawa teaches the imaging system according to claim 11 but is silent on a braided shaft.
Bhagavatula in the same field of endeavor, teaches wherein the elongate shaft comprises at least a first portion, positioned proximate the optically transparent window, and wherein the first portion comprises a braided shaft ([0063]). Bhagavatula further teaches that the braided portion reinforces the shaft and provides kink resistance ([0063]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the time of filing to incorporate the braided shaft of Bhagavatula into the system of Bhagavatula in order to provide reinforcement and kink resistance to the elongate shaft in view of the further teachings of Bhagavatula.
Claim 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hasegawa in view of Miyata et al. (US PG Pub. No. US 2002/0151823 A1, Oct. 17, 2002) (hereinafter “Miyata”).
Regarding claim 94: Hasegawa teaches the imaging system according to claim 11, wherein the elongate shaft further comprises a support tube such as the support tube taught by Miyata ([0026], [0005]).
Miyata, in the same field of endeavor, teaches a metal support tube (abstract, [0017]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the time of filing to implement the support tube of Hasegawa as disclosed by Miyata based on the explicit suggestion of Hasegawa to do so.
Claim 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hasegawa in view of Tearney and Suter.
Regarding claim 18: Hasegawa teaches the imaging system according to claim 2 wherein the rotatable optical core is constructed and arranged to rotate ([0025]), but is silent regarding the direction of rotation.
Tearney, in the same field of endeavor, teaches an optical core constructed and arranged to rotate in two directions (see directional arrow in figure 1).
Suter, in the same field of endeavor, teaches an optical core constructed and arranged to rotate in one direction (figures 1, 2A, 4A-4C all show single direction rotation of the optical core).
Since there are only two options available (rotating in a single direction or rotating in two directions), which can both be successfully applied to optical imaging within a patient, and in the absence of any evidence of criticality or unexpected result, it would have been prima facie obvious to one having ordinary skill in the art at the time of invention to rotate the optical core in only a single direction because a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense (KSR, 550 U.S. at 421, 82 USPQ2d at 139).
Claims 19 and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hasegawa in view of Madigan, Jeremy. "Vascular access: guide catheter selection, usage, and compatibility." In Interventional Neuroradiology, pp. 27-38. Springer, London, 2014 (hereinafter “Madigan”).
Regarding claims 19 and 29: Hasegawa teaches the imaging system according to claim 2, but is silent on the diameters of the optical assembly and the elongate shaft.
Madigan, in the same problem solving area of vascular access catheters, teaches that the inner and outer diameter of a sheath/catheter are results-effective variables and are chosen based on the application (pg. 28).
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 diameter for and sheath (including an inner diameter between 0.0165" and 0.027" or an outer diameter between 0.006" to 0.022"), where the outer diameter of the optical assembly is controlled by the diameter of the sheath and would therefore be between 80um-500um (0.00314961” - 0.019685) to fit inside the sheath, in order to optimize the sheath/catheter size for patient safety and procedure success in view of the teachings of Madigan that the inner and outer diameter of a sheath/catheter 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, 105 USPQ 233.
Claim 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hasegawa and Suter as applied to claim 26 above, and further in view of Madigan.
Regarding claim 27: Hasegawa and Suter teach the imaging system according to claim 26, but are silent on the diameter of the guide catheter.
Madigan, in the same problem solving area of vascular access catheters, teaches that the inner and outer diameter of a sheath/catheter are results-effective variables and are chosen based on the application (pg. 28).
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 diameter for and sheath/guide catheter (including an inner diameter between 0.0165" and 0.027") in order to optimize the sheath/catheter size for patient safety and procedure success in view of the teachings of Madigan that the inner and outer diameter of a sheath/catheter 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, 105 USPQ 233.
Claims 24 and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hasegawa in view of Petroff et al. (US PG Pub. No. 2014/0094697 A1, Apr. 3, 2014) (hereinafter “Petroff”).
Regarding claim 24: Hasegawa teaches the imaging system according to claim 23, including using the system to diagnose a lesion in a blood vessel and selecting a method of treatment ([0003]) but does not teach further comprising the implantable device for implantation in the patient, wherein the implantable device comprises a device selected from the group consisting of: stent; flow diverter; and combinations thereof.
Petroff, in the same field of endeavor, teaches an imaging system comprising an implantable device for implantation in the patient, wherein the implantable device comprises a device selected from the group consisting of: stent; flow diverter; and combinations thereof ([0026], [0135]-[0137]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the time of filing to modify the system of Hasegawa to include an implantable device as taught by Petroff in order to treat the diagnosed lesion to improve the health of the patient.
Regarding claim 25, as interpreted above: Hasegawa and Petroff teach the imaging system according to claim 24, wherein the imaging system selects the implantable device based on an implantable device parameter selected from the group consisting of: porosity; length; diameter; and combinations thereof (Petroff – [0134]-[0137] – the vessel diameter is used in the determination).
Claims 30 and 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hasegawa in view of Shiber (US Patent No. US 4,957,482, Sep. 18, 1990) (hereinafter “Shiber”).
Regarding claim 30: Hasegawa teach the imaging system according to claim 2, wherein the elongate shaft further comprises a middle portion (figure 1, any sheath having a proximal and distal ends has “a middle portion”), but are silent on wherein the elongate shaft distal portion comprises a larger inner diameter than an inner diameter of the elongate shaft middle portion.
Shiber, in the analogous art of atherectomy, teaches an elongate shaft (catheter) wherein the elongate shaft further comprises a middle portion, and wherein the elongate shaft distal portion comprises a larger inner diameter than an inner diameter of the elongate shaft middle portion (column 3, lines 34-40; figure 1; claim 3). Shiber further teaches that the smaller inner diameter and thicker wall toward the proximal end (which would include the "middle portion") is beneficial to more effectively dissipate torque (column 3, lines 34-40).
It would have been prima facie obvious for one having ordinary skill in the art prior to the time of filing to modify the system of Hasegawa by incorporating the smaller inner diameter and thicker wall toward the proximal end (which would include the "middle portion") in order to more effectively dissipate torque in view of the further teachings of Shiber.
Regarding claim 31: Hasegawa and Shiber teach the imaging system according to claim 108, wherein the elongate shaft distal portion comprises a wall thickness that is less than the elongate shaft middle portion wall thickness (Shiber - column 3, lines 34-40; figure 1; claim 3).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 2-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-40 and of U.S. Patent No. 11,278,206. Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims disclose every limitation of the instant claims.
Allowable Subject Matter
Claim 41 would be allowable over the prior art if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims. However, this claim is still subject to a Non-Statutory Double Patenting rejection.
Conclusion
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 on 9:00am - 5:00pm (Central Time), Monday - Friday.
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/CAROLYN A PEHLKE/Primary Examiner, Art Unit 3799