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 .
Response to Amendment
This office action is responsive to the amendment filed on 31 March 2026. As directed by the amendment: claims 1, 3-9, 14, and 16-18 have been amended; no claims have been canceled or added. Thus, claims 1-20 are presently pending in this application.
Response to Arguments
Applicant's arguments filed 31 March 2026 have been fully considered but they are not persuasive. Applicant argues that a) Zemel fails to teach a catheter shaft because a needle is not a catheter, b) Zemel would not be obvious to modify in view of Smith as Zemel already uses a near-IR light in its invention, and c) the instant invention yields the benefit of finding a blood vessel at a relatively early stage and as such the modification of the length of the shaft cannot be a result based on routine optimization. Examiner respectfully disagrees.
Regarding a), the needle of Zemel is interpreted as a catheter with a shaft because the definition of a catheter, to a person of ordinary skill in the art, is a tubular medical device for injecting or removing fluids. To a person of ordinary skill in the art, the needle of Zemel meets this definition and can therefore be interpreted as a catheter, as the claim does not specify any other feature of the catheter that distinguishes it over Zemel.
Regarding b), although the modification combining the teachings of Zemel in view of Smith cites general benefits of having a near-IR emitting material, the actual modification being made is a simple substitution of one known element for another known element to obtain predictable results, which is a rationale supported by the court for a conclusion of obviousness. For more details, see MPEP 2143.
Regarding c), although applicant has a specific reason for the claimed range of length of the shaft, i.e. making it easier for a user to find a blood vessel at a relatively early stage, this reason is not sufficiently presented to be an unexpected result that could not be achieved with routine optimization. Both the device of Zemel and the instant invention are concerned with visualizing a device during a procedure, where the length of the device depends on the needs of a user. There are several factors that may affect the length of shaft that are not related to the benefits detailed by the instant specification, which would not require the length to be a result-effective variable. Applicant is pulling details and requirements from the specification that are not explicitly stated in the claims so the rejection relying on routine optimization is maintained due to the breadth of the claims.
As such, the rejections are upheld as detailed below.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-7, 10, 11, 13, 16-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Zemel (US 2011/0009738) in view of Smith et al (US 2019/0350672).
Regarding claim 1, Zemel discloses:
A catheter (Fig. 4) comprising: a shaft (206) to be inserted into a blood vessel (Fig. 2), the shaft (206) being flexible (the shaft is fully capable of being slightly flexed) and having a tubular shape (Fig. 4); wherein: the shaft (206) comprises: a light portion (210) that is located at a distal end portion (208) of the shaft (206) and is configured to emit near-infrared light by being irradiated with light (¶0032), and a non-light portion (uncoated area) that extends from the light portion (210) toward a proximal end side of the shaft (206) and does not emit the near-infrared light (¶0029).
Zemel discloses all of the elements of the claim but is silent regarding “a light emitting portion… comprising a fluorescent material or a phosphorescent material,” “a non-light emitting portion,” and “a length of the light emitting portion in an extending direction of the shaft is 7 mm or less.”
Regarding the “emitting” and “non-emitting” portions, Smith teaches a medical device (Abstract), thus being in the same field of endeavor, that uses materials that can emit near-IR wavelengths when exposed to a near-IR light source (20; Fig. 2A) (¶0113), specifically a fluorescent material (¶0081). Doing so reduces the risk of physical damage from the light source and makes locating the device within the body easier (¶0011-0012). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have changed the light-emitting coating of Zemel to be a light emitting device material as taught by Smith because doing so would be the result of a simple substitution of one known element (the light-emitting material of Smith) for another known element (the regular material coated by a light-reflecting material of Zemel) to obtain predictable results (making locating the device within the body easier).
Regarding the “length,” it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Zemel to have a light-emitting portion of 7 mm or less since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Zemel would not operate differently with the claimed length and since the light producing portion is intended to be long enough for a user to locate, having a length of 7 mm or less would allow the device to function appropriately.
Regarding claim 2, Zemel in view of Smith discloses:
The catheter according to claim 1, wherein: the non-light emitting portion (length of shaft 206 not including distal end 210) is disposed over an entire length from a proximal end of the light emitting portion (210) to a proximal end of the shaft (206).
Regarding claim 3, Zemel in view of Smith discloses:
The catheter according to claim 1, wherein: the shaft (206) comprises a shaft body; the non-light emitting portion (length of shaft 206 not including distal end 210) is formed by a portion of the shaft body (206); and the light emitting portion (210).
The teaching in view of Smith in the rejection of claim 1 teaches that the light-emitting portion may be in the form of “a light emitting layer comprising the fluorescent material or the phosphorescent material on at least one of an inner surface or an outer surface of a distal end portion of the shaft body” or incorporated into the device itself (¶0109). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have provided the light-emitting portion of Smith in the form of a light emitting layer in order to provide sufficient structure for the device, as taught by Smith.
Regarding claim 4, Zemel in view of Smith discloses:
The catheter according to claim 3, wherein: the light emitting portion (210) comprises a light emitting wall portion (210) formed by inclusion of the florescent material (taught by Smith in the rejection of claim 1) or the phosphorescent material in a distal end portion of the shaft body (206).
Regarding claim 5, Zemel in view of Smith discloses:
The catheter according to claim 1, wherein: the shaft (206) comprises a shaft body; the non-light emitting portion (length of shaft 206 not including distal end 210) is formed by a portion of the shaft body (206); and the light emitting portion (210).
The teaching in view of Smith in the rejection of claim 1 teaches that the light-emitting portion may be in the form of “inclusion of the fluorescent material or the phosphorescent material in a distal end portion of the shaft body” or as a layer of material (¶0109). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have provided the light-emitting portion of Smith in the form of a light emitting material incorporated into the device in order to provide sufficient structure for the device, as taught by Smith.
Regarding claim 6, Zemel in view of Smith discloses the catheter according to claim 3, wherein: the light emitting material taught by Smith in the rejection of claim 1 includes the fluorescent material (¶0081).
Regarding claim 7, Zemel in view of Smith discloses the catheter according to claim 5, wherein: the light emitting material taught by Smith in the rejection of claim 1 includes the fluorescent material (¶0081).
Regarding claim 10, Zemel in view of Smith discloses:
The catheter according to claim 1, wherein: the non-light emitting portion includes a material that absorbs light (¶0029).
Regarding claim 11, Zemel in view of Smith discloses the catheter according to claim 1, wherein: a peak wavelength of the near-infrared light emitted by the light emitting portion taught by Smith in the rejection of claim 1 is within a range of 700 nm or more and 1000 nm or less (¶0072).
Regarding claim 13, Zemel in view of Smith discloses:
A catheter system comprising: the catheter (Fig. 4) according to claim 1; an irradiation unit (30; Fig. 1) configured to irradiate a living body site including a blood vessel into which the catheter is inserted with light (¶0028); a light receiving unit (36) configured to receive the light guided from the living body site and the near-infrared light emitted by the light emitting portion (¶0028); and an image display unit (38) configured to display a received light image created on a basis of the light and the near-infrared light received by the light receiving unit (36).
Regarding claim 16, Zemel in view of Smith discloses:
A catheter (Fig. 4) comprising: a shaft (206) to be inserted into a blood vessel (Fig. 2), the shaft (206) being flexible (the shaft is fully capable of being slightly flexed) and having a tubular shape (Fig. 4), wherein: the shaft (206) comprises: a light portion (210) that is located at a distal end portion (208) of the shaft (206) and is configured to emit near-infrared light by being irradiated with light (¶0032), and a non-light portion (uncoated area) that extends from the light portion (210) toward a proximal end side of the shaft (206) and does not emit the near-infrared light (¶0029)
Zemel discloses all of the elements of the claim but is silent regarding “a light emitting portion… comprising a fluorescent material or a phosphorescent material,” “a non-light emitting portion,” and “a length of the light emitting portion in an extending direction of the shaft is six times or less an outer diameter of the non-light emitting portion in an extending direction of the shaft.”
Regarding the “emitting” and “non-emitting” portions, Smith teaches a medical device (Abstract), thus being in the same field of endeavor, that uses materials that can emit near-IR wavelengths when exposed to a near-IR light source (20; Fig. 2A) (¶0113), specifically a fluorescent material (¶0081). Doing so reduces the risk of physical damage from the light source and makes locating the device within the body easier (¶0011-0012). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have changed the light-emitting coating of Zemel to be a light emitting device material as taught by Smith because doing so would be the result of a simple substitution of one known element (the light-emitting material of Smith) for another known element (the regular material coated by a light-reflecting material of Zemel) to obtain predictable results (making locating the device within the body easier).
Regarding the “length,” it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Zemel to have a light-emitting portion of with a length of six times or less an outer diameter of the non-light emitting portion since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Zemel would not operate differently with the claimed length and since the light producing portion is intended to be long enough for a user to locate, having a length of six times or less an outer diameter of the non-light emitting portion would allow the device to function appropriately.
Regarding claim 17, Zemel in view of Smith discloses:
The catheter according to claim 16, wherein: the shaft (206) comprises a shaft body; the non-light emitting portion (length of shaft 206 not including distal end 210) is formed by a portion of the shaft body (206); and the light emitting portion (210).
The teaching in view of Smith in the rejection of claim 1 teaches that the light-emitting portion may be in the form of “a light emitting layer comprising the fluorescent material or the phosphorescent material on at least one of an inner surface or an outer surface of a distal end portion of the shaft body” or incorporated into the device itself (¶0109). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have provided the light-emitting portion of Smith in the form of a light emitting layer in order to provide sufficient structure for the device, as taught by Smith.
Regarding claim 18, Zemel in view of Smith discloses:
The catheter according to claim 16, wherein: the shaft (206) comprises a shaft body; the non-light emitting portion (length of shaft 206 not including distal end 210) is formed by a portion of the shaft body (206); and the light emitting portion (210).
The teaching in view of Smith in the rejection of claim 1 teaches that the light-emitting portion may be in the form of “inclusion of the fluorescent material or the phosphorescent material in a distal end portion of the shaft body” or as a layer of material (¶0109). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have provided the light-emitting portion of Smith in the form of a light emitting material incorporated into the device in order to provide sufficient structure for the device, as taught by Smith.
Regarding claim 20, Zemel in view of Smith discloses:
A catheter system comprising: the catheter (Fig. 4) according to claim 16; an irradiation unit (30; Fig. 1) configured to irradiate a living body site including a blood vessel into which the catheter is inserted with light (¶0028); a light receiving unit (36) configured to receive the light guided from the living body site and the near-infrared light emitted by the light emitting portion (¶0028); and an image display unit (38) configured to display a received light image created on a basis of the light and the near-infrared light received by the light receiving unit (36).
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Zemel in view of Smith further in view of Sipple et al (US 2022/0409100).
Regarding claim 8, Zemel in view of Smith discloses the catheter according to claim 3 but is silent regarding “the light emitting material includes the phosphorescent material.” However, Sipple teaches a trackable medical device (Abstract), thus being in the same field of endeavor, that uses optical detection and can result in a fluorescent or phosphorescent emission of light (¶0040). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the material of Zemel in view of Smith to be a phosphorescent material as taught by Sipple as such a modification would be the result of a simple substitution of one known element (the phosphorescent material of Sipple) for another known material (the fluorescent material of Smith) to obtain predictable results (detecting a device within a patient’s body).
Regarding claim 9, Zemel in view of Smith discloses the catheter according to claim 5 but is silent regarding “the light emitting material includes the phosphorescent material.” However, Sipple teaches a trackable medical device (Abstract), thus being in the same field of endeavor, that uses optical detection and can result in a fluorescent or phosphorescent emission of light (¶0040). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the material of Zemel in view of Smith to be a phosphorescent material as taught by Sipple as such a modification would be the result of a simple substitution of one known element (the phosphorescent material of Sipple) for another known material (the fluorescent material of Smith) to obtain predictable results (detecting a device within a patient’s body).
Claims 12, 14-15, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Zemel in view of Smith further in view of Sugarman (US 4311138).
Regarding claim 12, Zemel in view of Smith discloses the catheter assembly but is silent regarding “the catheter according to claim 1; and a needle body inserted into the catheter.” Instead, Zemel teaches a catheter in the form of a needle. However, Sugarman teaches a light-emitting venipuncture device (Fig. 1), thus being in the same field of endeavor, in the form of a catheter (30) guided by a needle (22) for placing within a patient (Col. 2:45-47) in order to provide an illuminated vessel without risking tissue damage. It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the device of Zemel to be in the form of a catheter guided by a needle body as taught by Sugarman in order to prevent needle stick while providing sufficient structure for tracking the device.
Regarding claim 14, Zemel in view of Smith discloses the catheter assembly but is silent regarding “the catheter according to claim 13; and a needle body inserted into the catheter.” Instead, Zemel teaches a catheter in the form of a needle. However, Sugarman teaches a light-emitting venipuncture device (Fig. 1), thus being in the same field of endeavor, in the form of a catheter (30) guided by a needle (22) for placing within a patient (Col. 2:45-47) in order to provide an illuminated vessel without risking tissue damage. It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the device of Zemel to be in the form of a catheter guided by a needle body as taught by Sugarman in order to prevent needle stick while providing sufficient structure for tracking the device.
Regarding claim 15, Zemel in view of Smith and Sugarman discloses the catheter system according to claim 14 but is silent regarding “the irradiation unit and the light receiving unit are disposed so as to face each other with the living body site interposed therebetween.” However, Smith further teaches providing the tracked medical device (1; Fig. 2A) between an irradiation unit (20) and a light receiving unit (77). Smith further teaches an embodiment of the irradiation unit and light receiving unit being on the same side of the device (Fig. 9) similar to the configuration disclosed by Zemel (Fig. 1). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have arranged the irradiation unit and light receiving unit of Zemel to be on either side of the living body site as taught by Smith because such a modification is the result of a simple substitution of one known element (the arrangement of Fig. 2A of Smith) for another known element (the arrangement of Fig. 1 of Zemel) to obtain predictable results (visualizing a medical device within a patient).
Regarding claim 19, Zemel in view of Smith discloses the catheter assembly but is silent regarding “the catheter according to claim 16; and a needle body inserted into the catheter.” Instead, Zemel teaches a catheter in the form of a needle. However, Sugarman teaches a light-emitting venipuncture device (Fig. 1), thus being in the same field of endeavor, in the form of a catheter (30) guided by a needle (22) for placing within a patient (Col. 2:45-47) in order to provide an illuminated vessel without risking tissue damage. It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the device of Zemel to be in the form of a catheter guided by a needle body as taught by Sugarman in order to prevent needle stick while providing sufficient structure for tracking the device.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TASNIM M AHMED whose telephone number is (571)272-9536. The examiner can normally be reached M-F 9am-5pm Pacific time.
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/TASNIM MEHJABIN AHMED/Primary Examiner, Art Unit 3783
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