DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
CLAIM INTERPRETATION
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
No claim limitation has been interpreted under 35 U.S.C. 112(f) because each term (e.g., ‘inner guide member’) connotes sufficient structure to a POSITA. See MPEP § 2181. If applicant contends otherwise, please point to supporting disclosure.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 1 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Miller et al. (US 2002/0198491A1, “Miller”) in view of Ryan et al. (US 5,492,532, “Ryan”).
Regarding claims 1 and 2, Miller discloses a balloon dilation device including a handle having proximal and distal ends. The handle includes a first port (154; Fig. 2A) at the proximal end of the handle and a second port (164; Fig. 2) at the proximal end of the handle. An inner guide member (172; Fig. 2) includes a proximal portion and a distal portion. The proximal portion of the inner guide member is in the handle and extends through a recessed region. The distal portion of the inner guide member extends distally from the distal end of the handle. The inner guide member includes a lumen (152; Fig. 2) extending from a proximal end of the inner guide member to a distal end of the inner guide member. The first port is in fluid communication with the lumen at the proximal end of the inner guide member. A shaft (170; [0056]) is mounted about a periphery of the inner guide member. An inflatable balloon (160) is coupled to the shaft and disposed about the inner guide member. An inflation lumen (158) that extends from the second port to the inflatable balloon. A center axis of the first port is coaxial with a longitudinal axis of the proximal portion of the inner guide member in the handle. A center axis of the second port is at an acute angle on a proximal side. The handle includes a recessed region that receives the inner guide member, the shaft around the inner guide member, the first port and the second port. The recessed region has a Y-shape (Fig. 2; [0052]). However, the handle does not disclose a web structure that extends between the first port and the second port and defines a portion of the Y-shape of the recessed region.
In the same field of endeavor, balloon catheters, Ryan teaches a balloon catheter having a handle including a first port (16) and a second port (18) that define a Y-shape recessed region. The handle includes a web structure (12) that extends between the first port and the second port and defines a portion of the Y-shape of the recessed region. The cross-sectional shape of the web structure along the longitudinal axis is triangular (Fig.1). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have provided the handle of Miller with a web structure, as taught by Ryan, to provide easier grip and control while improving operator comfort by providing a single continuous structure that reduces a risk of separation when under mechanical stress during handling.
Claim(s) 3-5 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Miller in view of Ryan, as applied to claim 1 above, and further in view of Nardeo (US 2009/0216174A1).
Regarding claims 3 and 4, the combination of Miller and Ryan does not disclose that the handle includes an intermediate portion between proximal and distal portions, the distal portion tapers inwardly from the intermediate portion to the distal end of the handle, the proximal portion tapers outwardly from the intermediate portion to the proximal end of the handle. The combination of Miller and Ryan disclose that the recessed region includes a first segment, a second segment, and a third segment that define the Y-shape of the recessed region. A junction between the first segment, the second segment and the third segment is at an interface between the intermediate portion and the proximal portion of the handle (Fig. 2; Miller).
In the same field of endeavor, catheters, Nardeo teaches a handle (Fig. 6) of a catheter. The handle includes an intermediate portion (see annotated figure below) between proximal and distal portions. The distal portion tapers inwardly from the intermediate portion to the distal end of the handle and the proximal portion tapers outwardly from the intermediate portion to the proximal end of the handle. Therefore, it would have been obvious to one of ordinary skill in the art before the invention was made to have formed the handle of Miller with the intermediate portion, tapered inwardly distal portion and tapered outwardly proximal portion, as taught by Nardeo, to provide atraumatic maneuvering of the handle when facilitating a procedure.
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Regarding claim 5, the combination of Miller, Ryan and Nardeo discloses a handle (Fig. 6; Nardeo) having a top side, a bottom side, a first lateral side, and a second lateral side that extend between the proximal and distal ends of the handle. The top side is opposite the bottom side and the first lateral side is opposite the second lateral side. The first and second ports (50, 52; Nardeo) are centered between the first and second lateral sides. The first port is above the second port such that the first port is closer to the top side and the second port is closer to the bottom side.
Claim(s) 6-9 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Miller in view of Ryan, as applied to claim 1 above, and further in view of Kolff (US 5,370,640).
Regarding claims 6-9, the combination of Miller and Ryan does not disclose a light fiber extending from a distal tip to a proximal light connector.
In the same field of endeavor, catheters, Kolff teaches a catheter including a light fiber (14; Fig. 1) that extends from a distal tip (18) to a proximal light connection (22). The light fiber is capable of being disposed in a lumen of an inner guide member. The proximal light connector is capable of receiving light from a light source (24; C6:L6-20). The distal tip is capable of emitting the light received by the proximal light (Fig. 3). The portable light source (24; Fig. 3) is coupled to the proximal light connector and is capable of generating the light received by the proximal light connector. The portable light source is elongated along the longitudinal axis (Fig. 3) when longitudinally extended. A center axis of the portable light source is coaxial with the center axis of the first port when extended longitudinally. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have provided the lumen of the inner guide member of the device of the combination of Miller and Ryan with a light fiber, proximal light connector and portable light source, as taught by Kolff, to permit the surgeon to actually see the position of the catheter tip relative to its surroundings and enable the surgeon to position the catheter without stretching, tearing or puncturing walls or other delicate objects (abs; Kolff).
Claim(s) 10 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Miller in view of Ryan in view of Kolff, as applied to claim 7 above, and further in view of Perez (US 2005/0261622A1).
Regarding claims 10, the combination of Miller and Kolff does not disclose that the portable light source includes a battery-powered light emitting diode (LED) light source.
In the same field of endeavor, catheters, Perez teaches a portable light device that utilizes battery-powered LEDs (light emitting diodes) that emit light at one or more therapeutic wavelengths [0014]. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have provided the lumen of the inner guide member of the device of the combination of Miller, Ryan and Kolff with a portable light source includes a battery-powered light emitting diode (LED), as taught by Perez, to provide the benefits of energy efficiency, long lifespan and lightweight to the portable light source.
Claim(s) 11 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Miller in view of Ryan in view of Kolff, as applied to claim 7 above, and further in view of Duhaylongsod et al. (US 6,113,588, “Duhaylongsod”).
Regarding claims 11, the combination of Miller, Ryan and Kolff does not disclose that the portable light source is capable of generating the light as a red light.
In the same field of endeavor, catheters, Duhaylongsod teaches a light source(42) that is capable of generating a red light within the range of 600-650nanometers [0018Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have provided the portable light source of the combination of Miller, Ryan and Kolff with the means of generating a red light, as taught by Duhaylongsod, to provide means to illuminate blood present in blood vessels and only reflected by walls of the blood vessels.
Claim(s) 12 and 13 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Miller in view of Ryan in view of Kolff, as applied to claim 6 above, and further in view of Jenkins et al. (US 2010/0099946A1, “Jenkins”).
Regarding claims 12 and 13, the combination of Miller, Ryan and Kolff does not that the light fiber is a lighted guide wire.
In the same field of endeavor, catheters, Jenkins teaches a catheter that includes a lighted guide wire that is capable of being advanced through the lumen of the catheter to a position at which the distal tip of the light fiber is distal of a distal-most end. The light fiber is removable from the lumen [0072; Fig. 2] via device (212). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have provided the lumen of the inner guide member of the device of the combination of Miller, Ryan and Kolff with a light guidewire, as taught by Jenkins, to provide means for torquing, rotating, retracting the lighted guidewire while permitting the surgeon to actually see the position of the catheter tip relative to its surroundings and enable the surgeon to position the catheter without stretching, tearing or puncturing walls or other delicate objects.
Claim 14-16 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Miller et al. (US 2002/0198491A1, “Miller”) in view of Kolff (US 5,370,640).
Regarding claims 14-16, Miller discloses a balloon dilation device including a handle having proximal and distal ends. The handle includes a first port (154; Fig. 2A) at the proximal end of the handle and a second port (164; Fig. 2) at the proximal end of the handle. An inner guide member (172; Fig. 2) includes a proximal portion and a distal portion. The proximal portion of the inner guide member is in the handle and extends through a recessed region. The distal portion of the inner guide member extends distally from the distal end of the handle. The inner guide member includes a lumen (152; Fig. 2) extending from a proximal end of the inner guide member to a distal end of the inner guide member. The first port is in fluid communication with the lumen at the proximal end of the inner guide member. A shaft (170; [0056]) is mounted about a periphery of the inner guide member. An inflatable balloon (160) is coupled to the shaft and disposed about the inner guide member. An inflation lumen (158) that extends from the second port to the inflatable balloon. However, Miller does not disclose a light fiber extending from a proximal end to a distal tip and a portable light source coupled to the proximal end of the light fiber.
In the same field of endeavor, catheters, Kolff teaches a catheter including a light fiber (14; Fig. 1) that extends from a distal tip (18) to a proximal light connection (22). The light fiber is capable of being disposed in a lumen of an inner guide member. The proximal light connector is capable of receiving light from a light source (24; C6:L6-20). The distal tip is capable of emitting the light received by the proximal light (Fig. 3). The portable light source (24; Fig. 3) is coupled to the proximal light connector and is capable of generating the light received by the proximal light connector. The portable light source is elongated along the longitudinal axis (Fig. 3) when longitudinally extended. A center axis of the portable light source is coaxial with the center axis of the first port when extended longitudinally. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have provided the lumen of the inner guide member of the device of Miller with a light fiber, proximal light connector and portable light source, as taught by Kolff, to permit the surgeon to actually see the position of the catheter tip relative to its surroundings and enable the surgeon to position the catheter without stretching, tearing or puncturing walls or other delicate objects (abs; Kolff).
Claim(s) 17 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Miller in view of Kolff, as applied to claim 14 above, and further in view of Perez (US 2005/0261622A1).
Regarding claims 17, the combination of Miller and Kolff does not disclose that the portable light source includes a battery-powered light emitting diode (LED) light source.
In the same field of endeavor, catheters, Perez teaches a portable light device that utilizes battery-powered LEDs (light emitting diodes) that emit light at one or more therapeutic wavelengths [0014]. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have provided the lumen of the inner guide member of the device of the combination of Miller, Ryan and Kolff with a portable light source includes a battery-powered light emitting diode (LED), as taught by Perez, to provide the benefits of energy efficiency, long lifespan and lightweight to the portable light source.
Claim(s) 18 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Miller in view of Kolff, as applied to claim 14 above, and further in view of Duhaylongsod et al. (US 6,113,588, “Duhaylongsod”).
Regarding claims 18, the combination of Miller and Kolff does not disclose that the portable light source is capable of generating the light as a red light.
In the same field of endeavor, catheters, Duhaylongsod teaches a light source(42) that is capable of generating a red light within the range of 600-650nanometers [0018Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have provided the portable light source of the combination of Miller and Kolff with the means of generating a red light, as taught by Duhaylongsod, to provide means to illuminate blood present in blood vessels and only reflected by walls of the blood vessels.
Claim(s) 19 and 20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Miller in view of Kolff, as applied to claim 14 above, and further in view of Jenkins et al. (US 2010/0099946A1, “Jenkins”).
Regarding claims 19 and 20, the combination of Miller and Kolff does not that the light fiber is a lighted guide wire.
In the same field of endeavor, catheters, Jenkins teaches a catheter that includes a lighted guide wire that is capable of being advanced through the lumen of the catheter to a position at which the distal tip of the light fiber is distal of a distal-most end. The light fiber is removable from the lumen [0072; Fig. 2] via device (212). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have provided the lumen of the inner guide member of the device of the combination of Miller and Kolff with a light guidewire, as taught by Jenkins, to provide means for torquing, rotating, retracting the lighted guidewire while permitting the surgeon to actually see the position of the catheter tip relative to its surroundings and enable the surgeon to position the catheter without stretching, tearing or puncturing walls or other delicate objects.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Muessig et al. (US 2002/0120182A1) discloses a catheter including a light source that provides red light.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOCELIN C TANNER whose telephone number is (571)270-5202. The examiner can normally be reached M-F 8am-4pm.
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/JOCELIN C TANNER/Primary Examiner, Art Unit 3771
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