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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/16/25 has been entered.
Status of Claims
Claims 1, 4-7, 10-19, 23, and 25-28 are rejected. Claims 2-3, 8-9, 20-22, and 24 are canceled.
Response to Arguments
Provisional Rejection for Nonstatutory Double Patenting
The nonstatutory double patenting rejection is maintained until a Terminal Disclaimer is filed.
Claim Rejections - 35 USC § 112
The previous 112(b) rejection has been withdrawn in view of the amendment.
Claim Rejections - 35 USC § 103
Applicant's arguments filed 12/16/25 have been fully considered but they are not persuasive.
Applicant argues that the cited art does not teach a tapered portion being proximal of the inflatable balloon and spaced apart from the fiber proximal end and from the fiber distal end. However, the Examiner disagrees. Massimini teaches a portion being spaced apart from the fiber proximal end and from the fiber distal end (Figs. 6-7-a plurality of light diffusers spaced apart/along the length of the fiber (602, 604 and 606/702 or 704), wherein the optical fiber includes a first portion positioned proximal to a portion (Figs. 6-7-see the left side of the light guide before the plurality of fiber diffusers). While Massimini does not teach a tapered portion and the tapered portion being proximal of the inflatable balloon, Segalescu teaches this. Segalescu teaches the tapered portion being proximal of the inflatable balloon (Fig. 10a-balloon body 2 proximal to section 31; ¶93-still alternative optical designs (not illustrated) for emitting a radial confined light-energy are based on the usage of an optical fiber with a tapered thinner cross-section (core and/or cladding) for the radial light-energy emitting section 31 causing dispersion of a light wave in this thinner section; ¶65; ¶69). See the rejection below for further details.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 4-7, 10-19, 23, and 25-28 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The amended limitation of “the tapered portion being proximal of the inflatable balloon” in claims 1 and 25 and all their dependent claims is new matter, as it is not supported in the originally filed claims, specification, or drawings.
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.
Claims 1, 4-7, 10-19, 23, and 25-28 are 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.
In claims 1 and 25, the limitation of “the tapered portion being proximal of the inflatable balloon and spaced apart from the fiber proximal end and from the fiber distal end” seems unclear. Claims 1 and 25 additionally recite “a fiber distal end positioned within the inflatable balloon.” Therefore, it remains unclear how the tapered portion is proximal to the inflatable balloon since it is spaced apart from the fiber distal end and the fiber distal end is positioned within the inflatable balloon. For the purpose of examination, this limitation has been interpreted to include have the tapered portion being positioned within the balloon. Dependent claims 4-7, 10-19, 23, and 26-28 are indefinite for the same reason indicated for independent claims 1 and 25.
Claim Rejections - 35 USC § 103
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.
Claims 1, 4-6, 13, 16, 19, and 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Massimini (US 20200406010 filed on 6/17/20 as cited in the IDS) in view of Segalescu (US 20070282301 filed on 2/27/05).
Regarding claim 1, Massimini teaches a catheter system for treating a treatment site within or adjacent to a vessel wall or a heart valve, the catheter system comprising: an inflatable balloon (¶45-inflatable balloon; Fig. 1); an optical fiber having (i) a fiber proximal end (¶53-proximal portion 104 of light guide 110 in Fig. 1), and (ii) a fiber distal end positioned within the inflatable balloon (¶57-a balloon fluid 124 within balloon 122 at the distal portion 106; Fig. 1), the optical fiber being configured to receive an energy pulse to generate a plasma pulse within the inflatable balloon (¶55-the light source 116 of catheter system 100 can be configured to provide sub-millisecond pulses of light from the light source through the at least first light window and second light window, thereby inducing plasma formation in a balloon fluid, causing rapid bubble formation, and imparting pressure waves upon the treatment site), a portion being spaced apart from the fiber proximal end and from the fiber distal end (Figs. 6-7-a plurality of light diffusers spaced apart/along the length of the fiber (602, 604 and 606/702 or 704), wherein the optical fiber includes a first portion positioned proximal to a portion (Figs. 6-7-see the left side of the light guide before the plurality of fiber diffusers) and a second portion positioned distal to the portion (Figs. 6-7-see the right side of the light guide after the plurality of fiber diffusers), wherein the first portion includes a first constant diameter (Fig. 6-sections adjacent to the diffusers 602/604/606 (where light travels/remains within the fiber, shown by arrows) are of a constant diameter) and wherein the second portion includes a second constant diameter (Fig. 6-sections adjacent to the diffusers 602/604/606 (where light travels/remains within the fiber, shown by arrows) are of a constant diameter); and an energy source that is in optical communication with the fiber proximal end of the optical fiber (¶54-the light source 116 can be in optical communication with the first light guide 110; ¶55).
However, Massimini is silent to a tapered portion between the fiber proximal end and the fiber distal end that is tapered in a direction toward the fiber distal end, the tapered portion being proximal of the inflatable balloon, and the second constant diameter being smaller than the first constant diameter.
Segalescu relates to devices and methods that facilitate percutaneous endoluminal therapy of blood vessels or other anatomical structures. More particularly, the present invention relates to devices that are capable of dilating a stenotic vessel while reducing the risk of restenosis after the procedure (¶1). Segalescu further teaches the invention using the following steps:
the optical fiber including a tapered portion between the fiber proximal end and the fiber distal end that is tapered in a direction toward the fiber distal end (¶93-still alternative optical designs (not illustrated) for emitting a radial confined light-energy are based on the usage of an optical fiber with a tapered thinner cross-section (core and/or cladding) for the radial light-energy emitting section 31 causing dispersion of a light wave in this thinner section), the tapered portion being proximal of the inflatable balloon (Fig. 10a-balloon body 2 proximal to section 31; ¶93-still alternative optical designs (not illustrated) for emitting a radial confined light-energy are based on the usage of an optical fiber with a tapered thinner cross-section (core and/or cladding) for the radial light-energy emitting section 31 causing dispersion of a light wave in this thinner section; ¶65; ¶69), and the second constant diameter being smaller than the first constant diameter (the second diameter would have to be smaller, as the diffuser would be a tapered/thinner leading to a smaller diameter for the next non-emitting section; ¶93).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Massimini to include a tapered portion between the fiber proximal end and the fiber distal end that is tapered in a direction toward the fiber distal end, the tapered portion being proximal of the inflatable balloon, and the second constant diameter being smaller than the first constant diameter of Segalescu as a simple substitution of one known configuration of an optical fiber for another known configuration that provides the same function.
Regarding claim 4, the combination of Massimini and Segalescu teaches the catheter system of claim 1 wherein the optical fiber includes a first fiber member and a second fiber member that is coupled to the first fiber member (Massimini, ¶103-the longitudinal protection structure 1810 can be a first component fused between the distal tip 1814 of the proximal portion 1804 of the first light guide 1802 and the proximal tip 1816 of the continuation of the first light guide 1808; Fig. 18).
Regarding claim 5, the combination of Massimini and Segalescu teaches the catheter system of claim 4 wherein the second fiber member is positioned within the inflatable balloon (Massimini, ¶103-the proximal recess 1806 can be disposed within a balloon along a longitudinal surface 1812 of the elongate shaft 102; Fig. 18).
Regarding claim 6, the combination of Massimini and Segalescu teaches the catheter system of claim 4 wherein the first fiber member is fused to the second fiber member at a fused region (Massimini, ¶103-the longitudinal protection structure 1810 can be a first component fused between the distal tip 1814 of the proximal portion 1804 of the first light guide 1802 and the proximal tip 1816 of the continuation of the first light guide 1808; Fig. 18).
Regarding claim 13, the combination of Massimini and Segalescu teaches the catheter system of claim 4 wherein the first fiber member and the second fiber member are formed as a unitary structure (Massimini, ¶103-the longitudinal protection structure 1810 can be a first component fused between the distal tip 1814 of the proximal portion 1804 of the first light guide 1802 and the proximal tip 1816 of the continuation of the first light guide 1808; Fig. 18; by fusing the fibers together it is understood that it would become a unitary structure).
Regarding claim 16, the combination of Massimini and Segalescu teaches the catheter system of claim 4 wherein the first fiber member includes an endcap (Massimini, ¶99- the first protection structure 1410 can be an end cap disposed about the distal portion 1414 of the first portion 1404 of the light guide 1402; ¶107).
Regarding claim 19, the combination of Massimini and Segalescu teaches the catheter system of claim 1 wherein the energy source includes a laser (Massimini, ¶19- where the light source includes a laser).
Regarding claim 25, Massimini teaches a catheter system for treating a treatment site within or adjacent to a vessel wall or a heart valve, the catheter system comprising: an inflatable balloon (¶45-inflatable balloon; Fig. 1); an optical fiber that is configured to receive an energy pulse to generate a plasma pulse within the inflatable balloon (¶55-the light source 116 of catheter system 100 can be configured to provide sub-millisecond pulses of light from the light source through the at least first light window and second light window, thereby inducing plasma formation in a balloon fluid, causing rapid bubble formation, and imparting pressure waves upon the treatment site), the optical fiber including (i) a first fiber member including a fiber proximal end ¶53-proximal portion 104 of light guide 110 in Fig. 1), (ii) a second fiber member including a fiber distal end that is positioned within the inflatable balloon (¶57-a balloon fluid 124 within balloon 122 at the distal portion 106; Fig. 1), (iii) a fused region wherein the first fiber member is fused to the second fiber member such that the second fiber member extends distally from the first fiber member (¶103-the longitudinal protection structure 1810 can be a first component fused between the distal tip 1814 of the proximal portion 1804 of the first light guide 1802 and the proximal tip 1816 of the continuation of the first light guide 1808; Fig. 18), a portion being spaced apart from the fiber proximal end and from the fiber distal end (Figs. 6-7-a plurality of light diffusers spaced apart/along the length of the fiber (602, 604 and 606/702 or 704), wherein the optical fiber includes a first portion positioned proximal to a portion (Figs. 6-7-see the left side of the light guide before the plurality of fiber diffusers) and a second portion positioned distal to the portion (Figs. 6-7-see the right side of the light guide after the plurality of fiber diffusers), wherein the first portion includes a first constant diameter (Fig. 6-sections adjacent to the diffusers 602/604/606 (where light travels/remains within the fiber, shown by arrows) are of a constant diameter) and wherein the second portion includes a second constant diameter (Fig. 6-sections adjacent to the diffusers 602/604/606 (where light travels/remains within the fiber, shown by arrows) are of a constant diameter).
However, Massimini is silent to (iv) a tapered portion between the fiber proximal end and the fiber distal end that is tapered in a direction toward the fiber distal end, the tapered portion being proximal of the inflatable balloon, and the second constant diameter being smaller than the first constant diameter.
Segalescu teaches (iv) a tapered portion between the fiber proximal end and the fiber distal end that is tapered in a direction toward the fiber distal end (¶93-still alternative optical designs (not illustrated) for emitting a radial confined light-energy are based on the usage of an optical fiber with a tapered thinner cross-section (core and/or cladding) for the radial light-energy emitting section 31 causing dispersion of a light wave in this thinner section), the tapered portion being proximal of the inflatable balloon (Fig. 10a-balloon body 2 proximal to section 31; ¶93-still alternative optical designs (not illustrated) for emitting a radial confined light-energy are based on the usage of an optical fiber with a tapered thinner cross-section (core and/or cladding) for the radial light-energy emitting section 31 causing dispersion of a light wave in this thinner section; ¶65; ¶69), and the second constant diameter being smaller than the first constant diameter (the second diameter would have to be smaller, as the diffuser would be a tapered/thinner leading to a smaller diameter for the next non-emitting section; ¶93).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Massimini to include (iv) a tapered portion between the fiber proximal end and the fiber distal end that is tapered in a direction toward the fiber distal end, the tapered portion being proximal of the inflatable balloon, and the second constant diameter being smaller than the first constant diameter of Segalescu as a simple substitution of one known configuration of an optical fiber for another known configuration that provides the same function.
Regarding claim 26, the combination of Massimini and Segalescu teaches the catheter system of claim 25 wherein the first fiber member has a first fiber member distal region (Massimini, Fig. 18), and the second fiber member has a second fiber member proximal region (Massimini, Fig. 18); and wherein the first fiber member distal region is fused to the second fiber member proximal region within the fused region such that the second fiber member extends distally from the first fiber member (Massimini, ¶103-the longitudinal protection structure 1810 can be a first component fused between the distal tip 1814 of the proximal portion 1804 of the first light guide 1802 and the proximal tip 1816 of the continuation of the first light guide 1808; Fig. 18).
Claims 7, 11, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Massimini in view of Segalescu as applied to claims 6 and 25 above, and further in view of Yu (US 20180042677 filed on 8/11/17).
Regarding claim 7, the combination of Massimini and Segalescu teaches the catheter system of claim 6. However, the combination of Massimini and Segalescu does not teach a ferrule that encircles the fused region.
Yu teaches a ferrule that encircles the fused region (Yu, ¶51-the portion of optical fiber 612 with diffused cladding 617 may be inserted into passage 650 of ferrule 644, and may be fused with ferrule 644).
Yu relates generally to treating subjects using lasers. More specifically, the present disclosure relates to systems, devices, and related methods for laser lithotripsy (¶2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Massimini to include a ferrule that encircles the fused region of Yu in order for the concentration of laser energy 306 increasing the overall energy delivered to targeted material 333, thereby speeding up treatment times, allowing harder materials to be broken down, and/or giving the user precise control over aiming of laser energy 306 (Yu, ¶37).
Regarding claim 11, the combination of Massimini, Segalescu, and Yu teaches the catheter system of claim 7 wherein the ferrule is configured to encircle only the optical fiber (Yu,¶51-the portion of optical fiber 612 with diffused cladding 617 may be inserted into passage 650 of ferrule 644, and may be fused with ferrule 644).
Regarding claim 27, the combination of Massimini and Segalescu teaches the catheter system of claim 25. However, the combination of Massimini and Segalescu does not teach wherein the optical fiber further includes a ferrule that encircles at least the fused region.
Yu teaches wherein the optical fiber further includes a ferrule that encircles at least the fused region (¶51-the portion of optical fiber 612 with diffused cladding 617 may be inserted into passage 650 of ferrule 644, and may be fused with ferrule 644).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Massimini to include wherein the optical fiber further includes a ferrule that encircles at least the fused region of Yu in order for the concentration of laser energy 306 increasing the overall energy delivered to targeted material 333, thereby speeding up treatment times, allowing harder materials to be broken down, and/or giving the user precise control over aiming of laser energy 306 (Yu, ¶37).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Massimini in view of Segalescu and further in view of Yu as applied to claim 7 above, and further in view of HYAKUTAKE (JP 2008083273 filed on 9/27/06), hereinafter referred to as Hyak.
Regarding claim 10, the combination of Massimini, Segalescu, and Yu teaches the catheter system of claim 7. However, the combination of Massimini, Segalescu, and Yu does not teach wherein the ferrule is formed from one of a plastic and a metal.
Hyak teaches wherein the ferrule is formed from one of a plastic and a metal (Hyak, ¶21-the ferrule 10 can be obtained from a metal such as zirconia ceramics, SUS, or hard plastic).
Hyak relates to a ferrule that optically connects two optical fibers, and more particularly to a ferrule that can realize an optical subassembly that can be used in common with optical connectors made in accordance with different standards (¶1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Massimini to include wherein the ferrule is formed from one of a plastic and a metal of Hyak in order for a ferrule that can realize an optical subassembly that can be used in common with optical connectors made in accordance with different standards (Hyak, ¶1).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Massimini in view of Segalescu and further in view of Yu as applied to claim 7 above, and further in view of Luther (US 20100316333 filed on 8/3/10).
Regarding claim 12, the combination of Massimini, Segalescu, and Yu teaches the catheter system of claim 7. However, the combination of Massimini, Segalescu, and Yu does not teach wherein the ferrule is one of a multi-fiber MT ferrule and an MTP ferrule.
Luther teaches wherein the ferrule is one of a multi-fiber MT ferrule and an MTP ferrule (Luther, ¶26-the term “MTP connector” refers to a multi-fiber connector that contains up to twelve optical fibers within a single ferrule. The design allows the use of ribbonized fiber to achieve very high density. TIA/EIA-604-5, Fiber Optic Intermateability Standard, Type MPO (FOCIS 5) describes the dimensions and tolerances required for intermateability between manufacturers' products, MPO and MTP connectors that are compliant to FOCIS 5 can intermate; ¶27-multi-fiber ferrule).
Luther relates generally to a fiber optic adapter and mating dissimilar multi-fiber connectors, and more particularly, to a fiber optic adapter that allows a TIA FOCIS 5 compliant MTP connector to mate with a dissimilar connector having a pocket at least large enough to accept the FOCIS 5 compliant MTP connector (¶3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Massimini to include wherein the ferrule is one of a multi-fiber MT ferrule and an MTP ferrule of Luther in order to have a fiber optic adapter and mating dissimilar multi-fiber connectors, and more particularly, to a fiber optic adapter that allows a TIA FOCIS 5 compliant MTP connector to mate with a dissimilar connector having a pocket at least large enough to accept the FOCIS 5 compliant MTP connector (Luther, ¶3).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Massimini in view of Segalescu as applied to claim 4 above, and further in view of Hilal (US 20030144654 filed on 1/25/02).
Regarding claim 14, the combination of Massimini and Segalescu teaches the catheter system of claim 4. However, the combination of Massimini and Segalescu does not teach wherein the first fiber member has a first fiber member distal region that is positioned outside of the inflatable balloon.
Hilal teaches wherein the first fiber member has a first fiber member distal region that is positioned outside of the inflatable balloon (Hilal, ¶74-the distal tip 117 of the optical fiber 127e is also carried on the outer surface of the balloon wall 123).
Hilal relates generally to electrosurgery and more specifically to the efficient control of electrosurgical cutting coagulation cautery and fulguration (¶2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Massimini to include wherein the first fiber member has a first fiber member distal region that is positioned outside of the inflatable balloon of Hilal in order for the distal tip 117e to direct laser energy outwardly from the wall 123e of the balloon 121e in order to create the energized pathway 156e (Hilal, ¶75).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Massimini in view of Segalescu as applied to claim 4 above, and further in view of Boll (US 20040210278 filed on 12/4/03).
Regarding claim 15, the combination of Massimini and Segalescu teaches the catheter system of claim 4. However, the combination of Massimini and Segalescu does not teach wherein the second fiber member has a second fiber member proximal region that is positioned outside of the inflatable balloon.
Boll teaches wherein the second fiber member has a second fiber member proximal region that is positioned outside of the inflatable balloon (Boll, ¶42-a fiber working channel 48 on the sheath 19, proximal to and outside of the balloon 38).
Boll relates to laser apparatus for providing endoscopic laser treatments for dealing with abnormal mucosal tissue, particularly esophageal dysplasia, otherwise known as Barrett's Esophagus, utilizing a delivery apparatus, for example, a laser delivery apparatus, to permit clear visualization of the esophagus, eliminating or reducing reflux during that visualization process, delivering a laser or other treatment of the esophagus, and reducing the movement of the esophageal wall to permit accurate laser dosimetry (¶5).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Massimini to include wherein the second fiber member has a second fiber member proximal region that is positioned outside of the inflatable balloon of Boll in order for providing endoscopic laser treatments for dealing with abnormal mucosal tissue, particularly esophageal dysplasia, otherwise known as Barrett's Esophagus, utilizing a delivery apparatus, for example, a laser delivery apparatus, to permit clear visualization of the esophagus, eliminating or reducing reflux during that visualization process, delivering a laser or other treatment of the esophagus, and reducing the movement of the esophageal wall to permit accurate laser dosimetry (Boll, ¶5).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Massimini in view of Segalescu as applied to claim 1 above, and further in view of McGowan ‘499 (US 20150051499 filed on 8/13/14).
Regarding claim 17, the combination of Massimini and Segalescu teaches the catheter system of claim 1. However, the combination of Massimini and Segalescu does not teach wherein the optical fiber is tapered from a diameter of at least 150 micrometers (μm) down to a diameter of less than 120 micrometers (μm).
McGowan ‘499 teaches wherein the optical fiber is tapered from a diameter of at least 150 micrometers (μm) down to a diameter of less than 120 micrometers (μm) (McGowan ‘499, ¶39-the distal end of the third optical fiber 212 may be tapered, the first end of the third optical fiber 212 may have a core diameter that is 150 μm while the other end of the third optical fiber 212 may have a core diameter that that approximates or otherwise is substantially the same as the core outer diameter of the optical fiber 208, the optical fiber 208 may have a core with an outer diameter of about 40-80 μm, or about 50-70 μm, or about 62.5 μm).
McGowan ‘499 relates to medical devices/systems, and methods for manufacturing medical devices. More particularly, the present disclosure pertains to medical device systems that include optical fibers having a tapered core (¶2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Massimini to include wherein the optical fiber is tapered from a diameter of at least 150 micrometers (μm) down to a diameter of less than 120 micrometers (μm) of McGowan ‘499 in order for receiving substantially all of a signal passing through the optical fiber. Hence, the tapered optical fiber allows for good communication even when there is a bit of offset (McGowan ‘499, ¶34).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Massimini in view of Segalescu as applied to claim 1 above, and further in view of Kasmatsu (JP 2014123147 filed on 2/17/14).
Regarding claim 18, the combination of Massimini and Segalescu teaches the catheter system of claim 1. However, the combination of Massimini and Segalescu does not teach wherein the tapered portion has a tapered portion length of at least 2 millimeters (mm).
Kasmatsu teaches wherein the tapered portion has a tapered portion length of at least 2 millimeters (mm) (Kasmatsu, ¶51-the taper length L which is the length of a taper part can be 2 mm or more and 10 mm or less, for example).
Kasmatsu relates to an optical connector, and more particularly to an optical connector for optically coupling an optical fiber on a light source side and an optical fiber on a light receiving side, and an endoscope system using the same (¶1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Massimini to include wherein the tapered portion has a tapered portion length of at least 2 millimeters (mm) of Kasmatsu so that a tapered portion is formed such that the diameter of the core portion becomes larger as it approaches the end face of the fiber (Kasmatsu, ¶8).
Claims 23 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Massimini in view of Segalescu as applied to claims 6 and 25 above, and further in view of Tun (US 20120143131 filed on 12/6/11 as cited in the IDS).
Regarding claim 23, the combination of Massimini and Segalescu teaches the catheter system of claim 6. However, the combination of Massimini and Segalescu does not teach wherein the fused region is outside of the inflatable balloon.
Tun teaches wherein the fused region is outside of the inflatable balloon (¶34-the proximal waist 50 of the outer balloon 23 can be bonded, fused, or otherwise connected to the outer surface of the outer tubular member 44).
Tun relates generally to medical devices and, more particularly, to dual balloon catheters (¶2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Massimini to include wherein the fused region is outside of the inflatable balloon of Tun in order for a suitable bonding process for the balloon assembly and catheter shaft (Tun, ¶34).
Regarding claim 28, the combination of Massimini and Segalescu teaches the catheter system of claim 25. However, the combination of Massimini and Segalescu does not teach wherein the fused region is outside of the inflatable balloon.
Tun teaches wherein the fused region is outside of the inflatable balloon (¶34- the proximal waist 50 of the outer balloon 23 can be bonded, fused, or otherwise connected to the outer surface of the outer tubular member 44).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Massimini to include wherein the fused region is outside of the inflatable balloon of Tun in order for a suitable bonding process for the balloon assembly and catheter shaft (Tun, ¶34).
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 1, 4-7, 10-19, 23, 25-28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 10-19, and 22-24 of copending Application No. 17/673221 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. See the table below.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented and claims of the copending Application anticipates the claims of the instant application according to the mapping provided in the table below.
Claims of the Instant Application (17/666172)
Claims of Copending Application (17/673221)
1
1
4
4
5
5
6
6
7
7
10
10
11
11
12
12
13
13
14
14
15
15
16
16
17
17
18
18
19
19
23
22
25
1, 6, and 23
26
23
27
7, 11
28
22
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA HODGE whose telephone number is (571) 272-7101. The examiner can normally be reached M-F: 8:00 am-5:00 pm.
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/L.N.H./Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792