DETAILED ACTION
This action is pursuant to claims filed on 01/13/2026. Claims 1-25 are pending. An action on the merits of claims 1-25 is as follows.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/13/2026 has been entered.
Claim Objections
Claims 1, 13, 15, 17, 22, and 24-25 are objected to because of the following informalities:
In claim 1, line 1, “the stomach” should read “a stomach” as there is a lack of antecedent basis in the claims for this limitation
In claim 1, line 23, “the exterior” should read “an exterior” as there is a lack of antecedent basis in the claims for this limitation
In claim 13, line 2, “the intensity” should read “an intensity” as there is a lack of antecedent basis in the claims for this limitation
In claim 15, line 2, “the thickness” should read “a thickness” as there is a lack of antecedent basis in the claims for this limitation
In claim 15, line 3, “the antrum” should read “an antrum” as there is a lack of antecedent basis in the claims for this limitation
In claim 15, lines 3-4, “the lower esophageal sphincter” should read “a lower esophageal sphincter” as there is a lack of antecedent basis in the claims for this limitation
In claim 15, line 4, “the cardia” should read “a cardia” as there is a lack of antecedent basis in the claims for this limitation
In claim 15, line 4, “the angle of His” should read “an angle of His” as there is a lack of antecedent basis in the claims for this limitation
In claim 17, line 1, “the stomach” should read “a stomach” as there is a lack of antecedent basis in the claims for this limitation
In claim 17, line 18, “the exterior” should read “an exterior” as there is a lack of antecedent basis in the claims for this limitation
In claim 22, line 2, “the intensity” should read “an intensity” as there is a lack of antecedent basis in the claims for this limitation
In claim 24, line 2, “the thickness” should read “a thickness” as there is a lack of antecedent basis in the claims for this limitation
In claim 24, line 3, “the antrum” should read “an antrum” as there is a lack of antecedent basis in the claims for this limitation
In claim 24, lines 3-4, “the lower esophageal sphincter” should read “a lower esophageal sphincter” as there is a lack of antecedent basis in the claims for this limitation
In claim 24, line 4, “the cardia” should read “a cardia” as there is a lack of antecedent basis in the claims for this limitation
In claim 24, line 4, “the angle of His” should read “an angle of His” as there is a lack of antecedent basis in the claims for this limitation
In claim 25, lines 2-3, “near infrared fluorescent dye” should read “the near infrared fluorescent dye”
In claim 25, line 3, “the position” should read “a position” as there is a lack of antecedent basis in the claims for this limitation
Appropriate correction is required.
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.
Claims 1-25 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.
Regarding claim 1, the claim recites the limitation “the free end of said device” in line 7. There is insufficient antecedent basis for this limitation in the claim. Additionally, it is unclear what constitutes as the free end of the device, and if this is the same as the distal end of the device, or is a different end. The broad and indefinite scope of the limitation fails to inform a person of ordinary skill in the art with reasonable certainty of the metes and bounds of the claimed invention, therefore the claim is rendered indefinite. For purposes of examination, it is being interpreted as referring to the distal end of the device. Claims 2-16 are also rejected due to their dependence on claim 1.
Regarding claim 2, the claim recites the limitation “a near infrared fluorescent dye” in lines 1-2. It is unclear if this is meant to refer to the near infrared fluorescent dye from claim 1, line 14, or a different near infrared fluorescent dye. If it is referring to the dye form claim 1, it needs to refer back to it. If it is referring to a different dye, it needs to be distinguished from the dye from claim 1. For purposes of examination, it is being interpreted as referring to the near infrared fluorescent dye from claim 1. Claims 3-14 are also rejected due to their dependence on claim 2.
Regarding claim 16, the claim recites the limitation “a patient” in line 1. It is unclear if this limitation is meant to refer to the patient from claim 1, line 1, or a different patient. If it is referring to the patient from claim 1, it needs to refer back to it. If it is referring to a different patient, it needs to be distinguished from the patient from claim 1. For purposes of examination, it is being interpreted as referring to the patient from claim 1.
Further regarding claim 16, the claim recites the limitation “a bariatric procedure” in line 1. It is unclear if this limitation is meant to refer to the bariatric procedure from claim 1, line 1, or a different bariatric procedure. If it is referring to the procedure from claim 1, it needs to refer back to it. If it is referring to a different procedure, it needs to be distinguished from the procedure from claim 1. For purposes of examination, it is being interpreted as referring to the bariatric procedure from claim 1.
Regarding claim 17, the claim recites the limitation “the free end of said device” in line 7. There is insufficient antecedent basis for this limitation in the claim. Additionally, it is unclear what constitutes as the free end of the device, and if this is the same as the distal end of the device, or is a different end. The broad and indefinite scope of the limitation fails to inform a person of ordinary skill in the art with reasonable certainty of the metes and bounds of the claimed invention, therefore the claim is rendered indefinite. For purposes of examination, it is being interpreted as referring to the distal end of the device. Claims 18-25 are also rejected due to their dependence on claim 17.
Further regarding claim 17, the claim recites the limitation “said second section” in lines 18-19. It is unclear if this is meant to refer to the second portion from line 16, or a different second section. Additionally, if it is meant to read as “second section” and not “second portion”, there is improper antecedent basis for this limitation and it is unclear what it is meant to refer to. If it is meant to refer to the second portion introduced earlier in the claim, it should read “said second portion”. If it is meant to refer to a newly introduced second section, it needs to be properly introduced into the claim. The broad and indefinite scope of the limitation fails to inform a person of ordinary skill in the art with reasonable certainty of the metes and bounds of the claimed invention, therefore the claim is rendered indefinite. For purposes of examination, it is being interpreted as referring to the second portion. Claims 18-25 are also rejected due to their dependence on claim 17.
Regarding claim 19, the claim recites the limitation “a near infrared fluorescent dye” in lines 1-2. It is unclear if this limitation is meant to refer to the near infrared fluorescent dye from claim 17, line 8, or a different near infrared fluorescent dye. If it is referring to the dye from claim 17, it needs to refer back to it. If it is referring to a different dye, it needs to be distinguished from the dye from claim 17. For purposes of examination, it is being interpreted as referring to the near infrared fluorescent dye from claim 17. Claims 20-21 are also rejected due to their dependence on claim 19.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-5, 9-10, 12, 16-21, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Radl (US 20140148731) in view of Maegawa (US 20190144594) and Sherwinter (US 9375137).
Regarding independent claim 1, Radl teaches a sizing device for sizing the stomach of a patient for a bariatric procedure ([0044]: “one exemplary embodiment of a system 20 constructed in accordance with one exemplary preferred embodiment of this invention including a sizing device or instrument for performing a bariatric procedure on a patient.”), the stomach of the patient having a gastroesophageal junction and a wall including a lesser curvature and a greater curvature ([0008]: “The system comprises a sizing tube that is sufficiently flexible to be introduced through the esophagus into the stomach of the patient so that a portion of said sizing tube is disposed along a lesser curvature of the patient's stomach.”; [0069]: “during bariatric surgery it is necessary to mobilize the greater curvature of the stomach by separating it from the omentum and other parts of the anatomy where it is connected.”; [0105]: “The readily visually perceivable delineation line formed by the instrument of this invention is particularly useful for sealing the stomach in the vicinity of the gastro-esophageal junction GEJ”), said sizing device comprising:
an elongated sizing tube having a longitudinal axis extending along the length thereof, a distal end portion, a proximal portion ([0008]: “The sizing tube comprises an elongated tubular member having a hollow interior, a longitudinal axis, a distal free end and a proximal end portion.”), a passageway ([0045]: “the sizing tube 22 and 122 is an elongated flexible member having a central passageway”), an exterior periphery ([0008]: “The tubular member comprises a sidewall and a large plurality of apertures disposed in an array extending about the periphery of the sidewall”. The periphery of the sidewall is the exterior periphery.), a free end tip ([0047]: “The perforated tip 26 of the sizing tube 22 and 122 is located at the distal end”. The perforated tip is the free end tip.), and a plurality of apertures in fluid communication with said passageway and located at said distal end portion ([0047]: “The perforated tip 26 of the sizing tube 22 and 122 is located at the distal end 28 and comprises a plurality of small apertures 30 extending through the side wall of the tube 22 and in fluid communication with the tube's central passageway 22A”), said free end tip forming the free end of said device ([0047]: “The perforated tip 26 of the sizing tube 22 and 122 is located at the distal end”), said plurality of apertures located around said exterior periphery ([0053]: “The apertures 30 are of a constant diameter along their entire length, are small in size and are arranged in a symmetrical array 50 about the periphery of the distal end portion of the sizing tube closest to the distal or free end 28”).
However, Radl does not teach said elongated sizing tube being configured for producing near infrared fluorescent light projecting outward from said exterior periphery and introduction into the patient's stomach so that the position of said elongated sizing tube can be readily visualized laparoscopically from outside the wall of patient's stomach by transillumination of the near infrared fluorescent light produced by said elongated sizing tube passing through the wall of the stomach.
Maegawa discloses a fluorescent resin composition used in medical devices for visualization. Specifically, Maegawa teaches said medical device being configured for producing near infrared fluorescent light projecting outward from said exterior periphery and introduction into the patient's stomach so that the position of said elongated sizing tube can be readily visualized from outside the wall of patient's stomach by transillumination of the near infrared fluorescent light produced by said elongated sizing tube passing through the wall of the stomach ([0103]: “The fluorescent resin composition according to the present invention is excellent in compatibility and adhesiveness to a base material such as metal, and also allows for hydrophilic coating process, so that it can be applied to, for example, medical devices.”; [0104]: “the fluorescent dye of the present invention has a property of fluorescing with near infrared light within a wavelength region of 700 nm to 1300 nm, but the near infrared light within this wavelength region is easily transmitted through the living body”; [0002]: “Techniques for performing medical diagnosis and surgical operation are known including administering into a living body a fluorescent dye (near infrared fluorescent dye) which excites by undergoing irradiation with near infrared rays to emit near infrared fluorescence, and observing the fluorescence through the surface of the living body”. The fluorescent resin is coated on the medical device, which is the sizing device. The dye also allows the light to be transmitted through the living body, which includes being visible from outside the wall of the patient’s stomach.). Radl and Maegawa are analogous arts as they are both related to medical devices that involve viewing inside the human body.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the fluorescent resin composition from Maegawa into the device from Radl as it allows the device to be visualized during the procedure, which can ensure that the doctor conducting the procedure knows where the device is and if it is accurately placed.
The Radl/Maegawa combination teaches visualizing the procedure laparoscopically (Radl, [0060]: “The force applied to the stomach by the sizing tube with suction applied may also be considered independently of the positive pressure that is applied within the peritoneal cavity to facilitate laparoscopic surgery”; [0064]: “This action provides the surgeon with a clear line of delineation or demarcation of the instrument within the stomach, which can be readily seen by the surgeon via a laparoscope”), however the Radl/Maegawa combination does not teach specifically using the laparoscope to visualize light.
Sherwinter discloses a lighted gastric surgical bougie that includes a light source that uses a laparoscopic system. Specifically, Sherwinter teaches the elongated sizing tube can be readily visualized laparoscopically from outside the wall of patient's stomach by transillumination by said elongated sizing tube passing through the wall of the stomach (Column 2, lines 42-45: “The inventive bougie attaches a light to the tip of the bougie dilator detectable by a laparoscopic camera system through the visceral wall which will indicate the location of the tip of the bougie dilator.”; Maegawa, [0002]: “Techniques for performing medical diagnosis and surgical operation are known including administering into a living body a fluorescent dye (near infrared fluorescent dye) which excites by undergoing irradiation with near infrared rays to emit near infrared fluorescence, and observing the fluorescence through the surface of the living body.”; Radl, [0064]: “This action provides the surgeon with a clear line of delineation or demarcation of the instrument within the stomach, which can be readily seen by the surgeon via a laparoscope”). Radl, Maegawa, and Sherwinter are analogous arts as they are all related to medical devices that involve viewing inside the human body.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the laparoscopic visual of the elongated sizing tube from Sherwinter into the sizing device from the Radl/Maegawa combination, as it allows for the device to be seen and monitored while in use, which allows the procedure to be more closely monitored and easier for the doctors to perform.
The Radl/Maegawa/Sherwinter combination teaches whereupon said elongated sizing tube can be positioned so that a first portion of the periphery extends along the lesser curvature of the stomach (Radl, [0008]: “the tubular member comprises a sidewall and a large plurality of apertures disposed in an array extending about the periphery of the sidewall from a point adjacent the free end for a portion of the length of the sizing tube that is disposed along the lesser curvature of the patient's stomach.”; Figs. 4-7 show the left side of the sizing tube 22 extending along the lesser curvature of the stomach, which is the first portion), with a second portion of the periphery extending towards the greater curvature of the patient's stomach (Radl, Figs. 4-7 show the right side of the sizing tube 22 extending towards the greater curvature of the stomach, which is the second portion), and with said free end tip being located within the patient's stomach or pylorus (Radl, [0008]: “the free end for a portion of the length of the sizing tube that is disposed along the lesser curvature of the patient's stomach.”), said elongated sizing tube including a near infrared fluorescent dye disposed along said elongated sizing tube between said free end tip and a proximally located point adjacent the gastroesophageal junction for producing said near infrared fluorescent light so that the stomach wall adjacent the lesser curvature can be transilluminated along its entire length (Maegawa, [0103]: “The fluorescent resin composition according to the present invention is excellent in compatibility and adhesiveness to a base material such as metal, and also allows for hydrophilic coating process, so that it can be applied to, for example, medical devices.”; [0104]: “the fluorescent dye of the present invention has a property of fluorescing with near infrared light within a wavelength region of 700 nm to 1300 nm, but the near infrared light within this wavelength region is easily transmitted through the living body”. The fluorescent resin is coated on the medical device, which is the sizing device. The dye also allows the light to be transmitted through the living body, which includes being visible from outside the wall of the patient’s stomach. The coating can be applied to the entirety of the medical device, which can allow for the near infrared fluorescent dye to be disposed along the elongated sizing tube so that the stomach wall adjacent the lesser curvature can be transilluminated along its entire length.), said elongated sizing tube being for applying controlled suction to the interior of the patient's stomach via said plurality of apertures to pull the lesser curvature of the patient's stomach into engagement with said first portion of said periphery (Radl, [0016]: “The sizing tube is connected to a source of suction, whereupon controlled suction is applied from the source of suction via the array of apertures to bring adjacent portions of the patient's stomach into close engagement with portions of the periphery of the sizing tube”; [0008]: “The sizing tube is arranged to be coupled to a source of suction, whereupon controlled suction is applied to the hollow interior of the sizing tube to effect the drainage of gastric fluids from the patient's stomach through at least some of the apertures of the array of apertures and to bring adjacent portions of the patient's stomach into close engagement with portions of the periphery of the sizing tube at the location of the array of apertures to enable the patient's stomach to be sized”; [0072]: “prior to sizing and resecting the stomach the sizing is placed against the lesser curvature with suction applied to secure the device and provide the visually perceptible line of demarcation”) and to pull other portions of the patient's stomach adjacent to said second portion into engagement with said second portion of said periphery to anchor said elongated sizing tube in place (Radl, [0059]: “Suction applied to the sizing tube creates a negative pressure within the sizing tube and at the tube's apertures. The resulting force holds the sizing tube in place and anchors it to the stomach wall.”) and to produce a suction-created visually perceptible delineation line on the exterior of the patient's stomach along said second portion (Radl, [0025]: “Regulated suction is applied to the patient's stomach via the sizing tube while the sizing tube is in position along the lesser curvature of the patient's stomach to provide a visually perceptible delineation line along the sizing tube and to hold the sizing tube in position.).
Regarding claim 2, the Radl/Maegawa/Sherwinter combination teaches the sizing device of Claim 1, wherein said elongated sizing tube comprises a near infrared fluorescent dye (Maegawa, [0103]: “The fluorescent resin composition according to the present invention is excellent in compatibility and adhesiveness to a base material such as metal, and also allows for hydrophilic coating process, so that it can be applied to, for example, medical devices.”; [0104]: “the fluorescent dye of the present invention has a property of fluorescing with near infrared light within a wavelength region of 700 nm to 1300 nm, but the near infrared light within this wavelength region is easily transmitted through the living body”).
Regarding claim 3, the Radl/Maegawa/Sherwinter combination teaches the sizing device of Claim 2, wherein said elongated sizing tube comprises a resin composition containing said near infrared fluorescent dye (Maegawa, [0103]: “The fluorescent resin composition according to the present invention is excellent in compatibility and adhesiveness to a base material such as metal, and also allows for hydrophilic coating process, so that it can be applied to, for example, medical devices.”; [0104]: “the fluorescent dye of the present invention has a property of fluorescing with near infrared light within a wavelength region of 700 nm to 1300 nm, but the near infrared light within this wavelength region is easily transmitted through the living body”).
Regarding claim 4, the Radl/Maegawa/Sherwinter combination teaches the sizing device of Claim 2.
However, the Radl/Maegawa/Sherwinter combination is silent on the wavelength range that irradiates the near infrared fluorescent dye.
Maegawa teaches wherein said near infrared fluorescent dye emits fluorescence when irradiated with near infrared light within a wavelength range of approximately 700nm to 1300nm ([0103]: “The fluorescent resin composition according to the present invention is excellent in compatibility and adhesiveness to a base material such as metal, and also allows for hydrophilic coating process, so that it can be applied to, for example, medical devices.”; [0104]: “the fluorescent dye of the present invention has a property of fluorescing with near infrared light within a wavelength region of 700 nm to 1300 nm, but the near infrared light within this wavelength region is easily transmitted through the living body”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the wavelength range from Maegawa into the Radl/Maegawa/Sherwinter combination as the combination is silent on the wavelength range, and Maegawa discloses a suitable wavelength range in an analogous device.
Regarding claim 5, the Radl/Maegawa/Sherwinter combination teaches the sizing device of Claim 4.
However, the Radl/Maegawa/Sherwinter combination is silent on the wavelength that the fluorescent dye emits.
Maegawa teaches wherein said fluorescent dye emits fluorescence having a wavelength of approximately 830 nm when irradiated with near infrared light with a wavelength of approximately 800 nm ([0080]: “As the fluorescent dye, from the viewpoint of transmittance through a living tissue, it is preferable to use a cyanine compound (cyanine dye) that emits near infrared fluorescence within a wavelength region of 700 nm to 900 nm.”; [0084]: “Indocyanine green is excited by undergoing irradiation with near infrared light within a wavelength region of 760 nm to 780 nm and emits near infrared fluorescence within a wavelength region of 800 nm to 850 nm.”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the wavelength emitted from the dye from Maegawa into the Radl/Maegawa/Sherwinter combination as the combination is silent on the wavelength emitted, and Maegawa discloses a suitable wavelength in an analogous device.
Regarding claim 9, the Radl/Maegawa/Sherwinter combination teaches the sizing device of Claim 2, wherein said near infrared fluorescent dye is located in a coating on said elongated sizing tube (Maegawa, [0103]: “The fluorescent resin composition according to the present invention is excellent in compatibility and adhesiveness to a base material such as metal, and also allows for hydrophilic coating process, so that it can be applied to, for example, medical devices.”; [0104]: “the fluorescent dye of the present invention has a property of fluorescing with near infrared light within a wavelength region of 700 nm to 1300 nm, but the near infrared light within this wavelength region is easily transmitted through the living body”. The fluorescent resin is coated on the medical device, which is the sizing device.).
Regarding claim 10, the Radl/Maegawa/Sherwinter combination teaches the sizing device of Claim 2, wherein said near infrared fluorescent dye is located in a coating on a spring formed of metal, said spring being located in said passageway (Radl, 0085]: “the spring 126 is located within the distal end portion of the sizing tube … The spring 126 can be formed of any suitable material. One exemplary material is stainless steel 302”. The distal end portion is located in the passageway, therefore the spring is located in the passageway; Maegawa, [0103]: “The fluorescent resin composition according to the present invention is excellent in compatibility and adhesiveness to a base material such as metal, and also allows for hydrophilic coating process, so that it can be applied to, for example, medical devices.”; [0104]: “the fluorescent dye of the present invention has a property of fluorescing with near infrared light within a wavelength region of 700 nm to 1300 nm, but the near infrared light within this wavelength region is easily transmitted through the living body”. The fluorescent resin is coated on the medical device, which is the sizing device. The dye also allows the light to be transmitted through the living body, which includes being visible from outside the wall of the patient’s stomach. The coating can be applied to the entirety of the medical device, which include the spring.).
Regarding claim 12, the Radl/Maegawa/Sherwinter combination teaches the sizing device of Claim 2, wherein said near infrared fluorescent dye is located in a body located in said passageway (Radl, [0048]: “The slide valve includes a body 32 having a first coupling 34 which is tubular and arranged to be disposed (e.g., frictionally fit) within the hollow proximal end 30 of the sizing tube 22”. The body is in the hollow proximal end, which is in the passageway; Maegawa, [0103]: “The fluorescent resin composition according to the present invention is excellent in compatibility and adhesiveness to a base material such as metal, and also allows for hydrophilic coating process, so that it can be applied to, for example, medical devices.”; [0104]: “the fluorescent dye of the present invention has a property of fluorescing with near infrared light within a wavelength region of 700 nm to 1300 nm, but the near infrared light within this wavelength region is easily transmitted through the living body”. The fluorescent resin is coated on the medical device, which is the sizing device. The dye also allows the light to be transmitted through the living body, which includes being visible from outside the wall of the patient’s stomach. The coating can be applied to the entirety of the medical device, which can include the body.).
Regarding claim 16, the Radl/Maegawa/Sherwinter combination teaches a system for sizing the stomach of a patient for a bariatric procedure, said system comprising the sizing device of Claim 1 (see rejection of claim 1 above) and a suction controller (Radl, [0074]: “The system 120 makes use of a sizing tube or instrument 22 or 122 and valve 24 like those described above plus the addition of an integrated suction controller”), said suction controller being configured for connection to a source of suction and to said proximal portion of said sizing tube for applying controlled suction to the interior of the patient's stomach via said plurality of apertures (Radl, [0075]: “the suction controller 200 has a suction source side which is designated by the reference number 201 and is arranged to be connected to a source of suction such as a hospital's wall suction line”; [0016]: “The sizing tube is connected to a source of suction, whereupon controlled suction is applied from the source of suction via the array of apertures to bring adjacent portions of the patient's stomach into close engagement with portions of the periphery of the sizing tube”; [0008]: “The sizing tube is arranged to be coupled to a source of suction, whereupon controlled suction is applied to the hollow interior of the sizing tube to effect the drainage of gastric fluids from the patient's stomach through at least some of the apertures of the array of apertures and to bring adjacent portions of the patient's stomach into close engagement with portions of the periphery of the sizing tube at the location of the array of apertures to enable the patient's stomach to be sized”; [0072]: “prior to sizing and resecting the stomach the sizing is placed against the lesser curvature with suction applied to secure the device and provide the visually perceptible line of demarcation”).
Regarding independent claim 17, Radl teaches a method of sizing the stomach of a patient for a bariatric procedure ([0016]: “The subject invention also entails methods of sizing the stomach of a patient for a bariatric procedure”), the stomach of the patient having a gastroesophageal junction and a wall including a lesser curvature and a greater curvature ([0008]: “The system comprises a sizing tube that is sufficiently flexible to be introduced through the esophagus into the stomach of the patient so that a portion of said sizing tube is disposed along a lesser curvature of the patient's stomach.”; [0069]: “during bariatric surgery it is necessary to mobilize the greater curvature of the stomach by separating it from the omentum and other parts of the anatomy where it is connected.”; [0105]: “The readily visually perceivable delineation line formed by the instrument of this invention is particularly useful for sealing the stomach in the vicinity of the gastro-esophageal junction GEJ”), said method comprising:
providing an elongated sizing tube having a longitudinal axis extending along the length thereof, a distal end portion, a proximal portion ([0008]: “The sizing tube comprises an elongated tubular member having a hollow interior, a longitudinal axis, a distal free end and a proximal end portion.”), a passageway ([0045]: “the sizing tube 22 and 122 is an elongated flexible member having a central passageway”), an exterior periphery ([0008]: “The tubular member comprises a sidewall and a large plurality of apertures disposed in an array extending about the periphery of the sidewall”. The periphery of the sidewall is the exterior periphery.), a free end tip ([0047]: “The perforated tip 26 of the sizing tube 22 and 122 is located at the distal end”. The perforated tip is the free end tip.), and a plurality of apertures in fluid communication with said passageway and located at said distal end portion ([0047]: “The perforated tip 26 of the sizing tube 22 and 122 is located at the distal end 28 and comprises a plurality of small apertures 30 extending through the side wall of the tube 22 and in fluid communication with the tube's central passageway 22A”), said free end tip forming the free end of said device ([0047]: “The perforated tip 26 of the sizing tube 22 and 122 is located at the distal end”), said plurality of apertures located around said exterior periphery ([0053]: “The apertures 30 are of a constant diameter along their entire length, are small in size and are arranged in a symmetrical array 50 about the periphery of the distal end portion of the sizing tube closest to the distal or free end 28”).
However, Radl does not teach said elongated sizing tube including a near infrared fluorescent dye disposed along said elongated sizing tube between said free end tip and a proximally located point adjacent the gastroesophageal junction when said sizing tube is in place within the patient's stomach, said near infrared fluorescent dye of said elongated sizing tube being configured for producing near infrared fluorescent light projecting outward from at least a portion of said exterior periphery.
Maegawa discloses a fluorescent resin composition used in medical devices for visualization. Specifically, Maegawa teaches said elongated sizing tube including a near infrared fluorescent dye disposed along said elongated sizing tube between said free end tip and a proximally located point adjacent the gastroesophageal junction when said sizing tube is in place within the patient's stomach, said near infrared fluorescent dye of said elongated sizing tube being configured for producing near infrared fluorescent light projecting outward from at least a portion of said exterior periphery ([0103]: “The fluorescent resin composition according to the present invention is excellent in compatibility and adhesiveness to a base material such as metal, and also allows for hydrophilic coating process, so that it can be applied to, for example, medical devices.”; [0104]: “the fluorescent dye of the present invention has a property of fluorescing with near infrared light within a wavelength region of 700 nm to 1300 nm, but the near infrared light within this wavelength region is easily transmitted through the living body”; [0002]: “Techniques for performing medical diagnosis and surgical operation are known including administering into a living body a fluorescent dye (near infrared fluorescent dye) which excites by undergoing irradiation with near infrared rays to emit near infrared fluorescence, and observing the fluorescence through the surface of the living body”. The fluorescent resin is coated on the medical device, which is the sizing device. The dye also allows the light to be transmitted through the living body, which includes being visible from outside the wall of the patient’s stomach.). Radl and Maegawa are analogous arts as they are both related to medical devices that involve viewing inside the human body.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the fluorescent resin composition from Maegawa into the device from Radl as it allows the method to be visualized during the procedure, which can ensure that the doctor conducting the procedure knows where the device is and if it is accurately placed.
The Radl/Maegawa combination teaches introducing said elongated sizing tube into the stomach (Radl, [0008]: “the free end for a portion of the length of the sizing tube that is disposed along the lesser curvature of the patient's stomach.”) and applying controlled suction to the interior of the patient's stomach via said plurality of apertures to pull the lesser curvature of the patient's stomach into engagement with a first portion of the exterior periphery (Radl, [0016]: “The sizing tube is connected to a source of suction, whereupon controlled suction is applied from the source of suction via the array of apertures to bring adjacent portions of the patient's stomach into close engagement with portions of the periphery of the sizing tube”; [0008]: “The sizing tube is arranged to be coupled to a source of suction, whereupon controlled suction is applied to the hollow interior of the sizing tube to effect the drainage of gastric fluids from the patient's stomach through at least some of the apertures of the array of apertures and to bring adjacent portions of the patient's stomach into close engagement with portions of the periphery of the sizing tube at the location of the array of apertures to enable the patient's stomach to be sized”; [0072]: “prior to sizing and resecting the stomach the sizing is placed against the lesser curvature with suction applied to secure the device and provide the visually perceptible line of demarcation”; [0008]: “the tubular member comprises a sidewall and a large plurality of apertures disposed in an array extending about the periphery of the sidewall from a point adjacent the free end for a portion of the length of the sizing tube that is disposed along the lesser curvature of the patient's stomach.”; Figs. 4-7 show the left side of the sizing tube 22 extending along the lesser curvature of the stomach, which is the first portion) and to pull portions of the patient's stomach closely-adjacent a second portion of the exterior periphery into engagement with said second portion of the exterior periphery to anchor said elongated sizing tube in place (Radl, [0059]: “Suction applied to the sizing tube creates a negative pressure within the sizing tube and at the tube's apertures. The resulting force holds the sizing tube in place and anchors it to the stomach wall.”; Figs. 4-7 show the right side of the sizing tube 22 extending towards the greater curvature of the stomach, which is the second portion) and to produce a suction- created visually perceptible delineation line on the exterior of the patient's stomach along said second section (Radl, [0025]: “Regulated suction is applied to the patient's stomach via the sizing tube while the sizing tube is in position along the lesser curvature of the patient's stomach to provide a visually perceptible delineation line along the sizing tube and to hold the sizing tube in position.), whereupon said visually perceptible delineation line can be readily visualized by a laparoscope (Radl, [0060]: “The force applied to the stomach by the sizing tube with suction applied may also be considered independently of the positive pressure that is applied within the peritoneal cavity to facilitate laparoscopic surgery”; [0064]: “This action provides the surgeon with a clear line of delineation or demarcation of the instrument within the stomach, which can be readily seen by the surgeon via a laparoscope”).
Sherwinter discloses a lighted gastric surgical bougie that includes a light source that uses a laparoscopic system. Specifically, Sherwinter teaches the elongated sizing tube can be readily visualized laparoscopically from outside the wall of patient's stomach by transillumination by said elongated sizing tube passing through the wall of the stomach (Column 2, lines 42-45: “The inventive bougie attaches a light to the tip of the bougie dilator detectable by a laparoscopic camera system through the visceral wall which will indicate the location of the tip of the bougie dilator.”; Maegawa, [0002]: “Techniques for performing medical diagnosis and surgical operation are known including administering into a living body a fluorescent dye (near infrared fluorescent dye) which excites by undergoing irradiation with near infrared rays to emit near infrared fluorescence, and observing the fluorescence through the surface of the living body.”; Radl, [0064]: “This action provides the surgeon with a clear line of delineation or demarcation of the instrument within the stomach, which can be readily seen by the surgeon via a laparoscope”; Maegawa, [0103]: “The fluorescent resin composition according to the present invention is excellent in compatibility and adhesiveness to a base material such as metal, and also allows for hydrophilic coating process, so that it can be applied to, for example, medical devices.”; [0104]: “the fluorescent dye of the present invention has a property of fluorescing with near infrared light within a wavelength region of 700 nm to 1300 nm, but the near infrared light within this wavelength region is easily transmitted through the living body”; [0002]: “Techniques for performing medical diagnosis and surgical operation are known including administering into a living body a fluorescent dye (near infrared fluorescent dye) which excites by undergoing irradiation with near infrared rays to emit near infrared fluorescence, and observing the fluorescence through the surface of the living body”. The fluorescent resin is coated on the medical device, which is the sizing device. The dye also allows the light to be transmitted through the living body, which includes being visible from outside the wall of the patient’s stomach.). Radl, Maegawa, and Sherwinter are analogous arts as they are all related to medical devices that involve viewing inside the human body.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the laparoscopic visual of the elongated sizing tube from Sherwinter into the sizing device from the Radl/Maegawa combination, as it allows for the device to be seen and monitored while in use, which allows the procedure to be more closely monitored and easier for the doctors to perform.
Regarding claim 18, the Radl/Maegawa/Sherwinter combination teaches the method of Claim 17, additionally comprising sealing a portion of the patient's stomach adjacent the suction-created visually perceptible delineation line by a device located outside the patient's stomach while said elongated sizing tube is anchored in place to form a sealed residual stomach portion about said elongated sizing tube (Radl, [0016]: “The sizing tube is connected to a source of suction, whereupon controlled suction is applied from the source of suction via the array of apertures to bring adjacent portions of the patient's stomach into close engagement with portions of the periphery of the sizing tube”; [0075]: “the suction controller 200 has a suction source side which is designated by the reference number 201 and is arranged to be connected to a source of suction such as a hospital's wall suction line”; [0059]: “Suction applied to the sizing tube creates a negative pressure within the sizing tube and at the tube's apertures. The resulting force holds the sizing tube in place and anchors it to the stomach wall.”; [0105]: “The readily visually perceivable delineation line formed by the instrument of this invention is particularly useful for sealing the stomach in the vicinity of the gastro-esophageal junction GEJ”; [0018]: “The resection line is located adjacent the delineation line, whereupon when the patient's stomach is resected along the resection line that action creates a residual portion of the patient's stomach. The residual portion of the patient's stomach can then be sealed along the resection line to produce a seal line”. The hospital’s wall suction line is the device located outside the patient’s stomach.).
Regarding claim 19, the Radl/Maegawa/Sherwinter combination teaches the method of Claim 17, wherein said elongated sizing tube comprises a near infrared fluorescent dye (Maegawa, [0103]: “The fluorescent resin composition according to the present invention is excellent in compatibility and adhesiveness to a base material such as metal, and also allows for hydrophilic coating process, so that it can be applied to, for example, medical devices.”; [0104]: “the fluorescent dye of the present invention has a property of fluorescing with near infrared light within a wavelength region of 700 nm to 1300 nm, but the near infrared light within this wavelength region is easily transmitted through the living body”).
Regarding claim 20, the Radl/Maegawa/Sherwinter combination teaches the method of Claim 19.
However, the Radl/Maegawa/Sherwinter combination is silent on the wavelength range that irradiates the near infrared fluorescent dye.
Maegawa teaches wherein said method additionally comprises irradiating the fluorescent dye of said sizing tube with near infrared light within a wavelength range of approximately 700 nm to 1300 nm ([0103]: “The fluorescent resin composition according to the present invention is excellent in compatibility and adhesiveness to a base material such as metal, and also allows for hydrophilic coating process, so that it can be applied to, for example, medical devices.”; [0104]: “the fluorescent dye of the present invention has a property of fluorescing with near infrared light within a wavelength region of 700 nm to 1300 nm, but the near infrared light within this wavelength region is easily transmitted through the living body”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the wavelength range from Maegawa into the Radl/Maegawa/Sherwinter combination as the combination is silent on the wavelength range, and Maegawa discloses a suitable wavelength range in an analogous device.
Regarding claim 21, the Radl/Maegawa/Sherwinter combination teaches the method of Claim 20.
However, the Radl/Maegawa/Sherwinter combination is silent on the wavelength that the fluorescent dye emits.
Maegawa teaches wherein said fluorescent dye emits fluorescence with a wavelength of approximately 830 nm when irradiated with near infrared light with a wavelength of approximately 800 nm ([0080]: “As the fluorescent dye, from the viewpoint of transmittance through a living tissue, it is preferable to use a cyanine compound (cyanine dye) that emits near infrared fluorescence within a wavelength region of 700 nm to 900 nm.”; [0084]: “Indocyanine green is excited by undergoing irradiation with near infrared light within a wavelength region of 760 nm to 780 nm and emits near infrared fluorescence within a wavelength region of 800 nm to 850 nm.”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the wavelength emitted from the dye from Maegawa into the Radl/Maegawa/Sherwinter combination as the combination is silent on the wavelength emitted, and Maegawa discloses a suitable wavelength in an analogous device.
Regarding claim 25, the Radl/Maegawa/Sherwinter combination teaches the method of Claim 17.
However, the Radl/Maegawa/Sherwinter combination does not teach the laparoscope is configured to produce visible light of a desired wavelength in response to said near infrared fluorescent light produced by near infrared fluorescent dye associated with said elongated sizing tube to enable a user to readily visualize the position of said elongated sizing tube, the position of the elongated sizing tube with respect to internal anatomy of the patient, and said suction-created visually perceptible delineation line.
Maegawa teaches the laparoscope is configured to produce visible light of a desired wavelength in response to said near infrared fluorescent light produced by near infrared fluorescent dye associated with said elongated sizing tube to enable a user to readily visualize the position of said elongated sizing tube, the position of the elongated sizing tube with respect to internal anatomy of the patient, and said suction-created visually perceptible delineation line ([0103]: “The fluorescent resin composition according to the present invention is excellent in compatibility and adhesiveness to a base material such as metal, and also allows for hydrophilic coating process, so that it can be applied to, for example, medical devices.”; [0104]: “the fluorescent dye of the present invention has a property of fluorescing with near infrared light within a wavelength region of 700 nm to 1300 nm, but the near infrared light within this wavelength region is easily transmitted through the living body”; [0002]: “Techniques for performing medical diagnosis and surgical operation are known including administering into a living body a fluorescent dye (near infrared fluorescent dye) which excites by undergoing irradiation with near infrared rays to emit near infrared fluorescence, and observing the fluorescence through the surface of the living body”. The fluorescent resin is coated on the medical device, which can be the laparoscope; [0104]: “the fluorescent dye of the present invention has a property of fluorescing with near infrared light within a wavelength region of 700 nm to 1300 nm, but the near infrared light within this wavelength region is easily transmitted through the living body”. If the sizing tube emits near infrared light, it can cause the laparoscope to emit light in the range of 700nm-750nm, which includes visible light.).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the laparoscope being coated in the fluorescent dye from Maegawa into the Radl/Maegawa/Sherwinter combination as it will allow the laparoscope to be visualized as well, which can provide further information about the location of the tools during the procedure, which ensures that everything is in the correct location and the procedure is being performed correctly.
Claims 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over the Radl/Maegawa/Sherwinter combination as applied to claim 3 above, and further in view of Brister (US 20180125690).
Regarding claim 6, the Radl/Maegawa/Sherwinter combination teaches the sizing device of Claim 3, wherein said elongated sizing tube comprises two layers, with one of said layers being said resin composition containing said near infrared fluorescent dye (Radl, [0045]: “the sizing tube 22 and 122 is an elongated flexible member having a central passageway 22A (FIGS. 1 and 3B) formed, e.g., extruded, of any suitable material.”; Maegawa, [0103]: “The fluorescent resin composition according to the present invention is excellent in compatibility and adhesiveness to a base material such as metal, and also allows for hydrophilic coating process, so that it can be applied to, for example, medical devices.”; [0104]: “the fluorescent dye of the present invention has a property of fluorescing with near infrared light within a wavelength region of 700 nm to 1300 nm, but the near infrared light within this wavelength region is easily transmitted through the living body”).
However, the Radl/Maegawa/Sherwinter combination does not teach the layers being co-extruded.
Brister teaches an intragastric device. Specifically, Brister teaches the layers being co-extruded ([0144]: “The various layers in the composite wall can impart one or more desirable properties to the balloon 10 (e.g., fluid retention, resistance to moisture, resistance to acidic environment, wettability for processing, and structural strength). A list of polymer resins and coatings that can be combined into a multi-layer preformed system (“composite wall”) is provided in Tables 1a-b. These films can be adhesively bonded together, co-extruded, or adhered via tie layers or a combination thereof to obtain the desired combination of properties for the composite wall”). Radl and Brister are analogous arts as they are both related to devices for treating weight loss.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the layers being co-extruded from Brister into the Radl/Maegawa/Sherwinter combination as it is another known method of constructing layers of a device, therefore it would be a simple substitution.
Regarding claim 7, the Radl/Maegawa/Sherwinter/Brister combination teaches the sizing device of Claim 6, wherein said one of said layers being an outer layer (Brister, [0144]: “The various layers in the composite wall can impart one or more desirable properties to the balloon 10 (e.g., fluid retention, resistance to moisture, resistance to acidic environment, wettability for processing, and structural strength). A list of polymer resins and coatings that can be combined into a multi-layer preformed system (“composite wall”) is provided in Tables 1a-b. These films can be adhesively bonded together, co-extruded, or adhered via tie layers or a combination thereof to obtain the desired combination of properties for the composite wall”. The layers can be combined in an orientation that provides desirable properties to the device, therefore the resin layer can be the outer layer.).
Regarding claim 8, the Radl/Maegawa/Sherwinter/Brister combination teaches the sizing device of Claim 6, wherein said one of said layers being an inner layer (Brister, [0144]: “The various layers in the composite wall can impart one or more desirable properties to the balloon 10 (e.g., fluid retention, resistance to moisture, resistance to acidic environment, wettability for processing, and structural strength). A list of polymer resins and coatings that can be combined into a multi-layer preformed system (“composite wall”) is provided in Tables 1a-b. These films can be adhesively bonded together, co-extruded, or adhered via tie layers or a combination thereof to obtain the desired combination of properties for the composite wall”. The layers can be combined in an orientation that provides desirable properties to the device, therefore the resin layer can be the inner layer.).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over the Radl/Maegawa/Sherwinter combination as applied to claim 2 above, and further in view of Woo (US 20040133147).
Regarding claim 11, the Radl/Maegawa/Sherwinter combination teaches the sizing device of Claim 2, additionally comprising a spring (Radl, [0085]: “the spring 126 is located within the distal end portion of the sizing tube … The spring 126 can be formed of any suitable material”), and wherein said spring includes said near infrared fluorescent dye (Maegawa, [0103]: “The fluorescent resin composition according to the present invention is excellent in compatibility and adhesiveness to a base material such as metal, and also allows for hydrophilic coating process, so that it can be applied to, for example, medical devices.”; [0104]: “the fluorescent dye of the present invention has a property of fluorescing with near infrared light within a wavelength region of 700 nm to 1300 nm, but the near infrared light within this wavelength region is easily transmitted through the living body”. The fluorescent resin is coated on the medical device, which is the sizing device. The dye also allows the light to be transmitted through the living body, which includes being visible from outside the wall of the patient’s stomach. The coating can be applied to the entirety of the medical device, which include the spring.).
However, the Radl/Maegawa/Sherwinter combination does not teach the spring formed of a polymer.
Woo discloses an intestinal bypass device. Specifically, Woo teaches the spring being formed of a polymer ([0033]: “Several biocompatible materials like titanium alloys, stainless steel alloys or elastic biocompatible polymers can be used for constructing the spring”). Radl and Woo are analogous arts as they are both devices used to treat weight loss.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the spring being formed of a polymer from Woo into the Radl/Maegawa/Sherwinter combination as Radl states that the spring can be formed of any suitable material, and Woo discloses a suitable material for a spring.
Claims 13-14 and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over the Radl/Maegawa/Sherwinter combination as applied to claims 2 and 17 above, and further in view of Thorwarth (US 11543350).
Regarding claim 13, the Radl/Maegawa/Sherwinter combination teaches the sizing device of Claim 2.
However, the Radl/Maegawa/Sherwinter combination does not teach wherein said near infrared fluorescent dye is in the form of a fluorescent dye-enhanced matrix and wherein the intensity of the light emitted from said fluorescent dye-enhanced matrix is increased by including dispersed reflective nano-particles or micro-particles that increase apparent opacity of the device, by increasing scattering of incident light.
Thorwarth discloses a calibration target for analyzing biomolecules detected by fluorescence signals. Specifically, Thorwarth teaches wherein said near infrared fluorescent dye is in the form of a fluorescent dye-enhanced matrix and wherein the intensity of the light emitted from said fluorescent dye-enhanced matrix is increased by including dispersed reflective nano-particles or micro-particles that increase apparent opacity of the device, by increasing scattering of incident light (Claim 1: “A calibration target for calibrating an optoelectronic device for analyzing biomolecules by detecting fluorescence signals from a sample, the calibration target comprising: a substrate; and a solid fluorescent layer that is disposed on the substrate and capable of being excited by laser light, wherein the fluorescent layer has an optically inactive matrix having embedded therein a carbon-based component that is excitable to light emission, wherein the optically inactive matrix includes a material having a refractive index greater than 1.4, wherein the optically inactive matrix has a colloidal structure, wherein the optically inactive matrix includes titanium dioxide”. Titanium dioxide is a scattering agent, which means that it can increase scattering of incident light.). Radl, Maegawa, and Thorwarth are analogous arts as all are related to medical devices using light to view the human body.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the reflective materials from Thorwarth into the device from the Radl/Maegawa/Sherwinter combination as it allows the elongated sizing tube to become more reflective and being more visible, making the procedure easier, as being able to see the device even clearer can lead to an easier, quicker procedure.
Regarding claim 14, the Radl/Maegawa/Sherwinter/Thorwarth combination teaches the sizing device of Claim 13, wherein said particles are titanium dioxide(TiO2), cellulose or reflective materials that are easily dispersed in a polymer or in a resin (Thorwarth, Claim 1: “A calibration target for calibrating an optoelectronic device for analyzing biomolecules by detecting fluorescence signals from a sample, the calibration target comprising: a substrate; and a solid fluorescent layer that is disposed on the substrate and capable of being excited by laser light, wherein the fluorescent layer has an optically inactive matrix having embedded therein a carbon-based component that is excitable to light emission, wherein the optically inactive matrix includes a material having a refractive index greater than 1.4, wherein the optically inactive matrix has a colloidal structure, wherein the optically inactive matrix includes titanium dioxide”).
Regarding claim 22, the Radl/Maegawa/Sherwinter combination teaches the method of Claim 17.
However, the Radl/Maegawa/Sherwinter combination does not teach wherein said near infrared fluorescent dye is in the form of a fluorescent dye-enhanced matrix and wherein the intensity of the light emitted from said fluorescent dye-enhanced matrix is increased by including dispersed reflective nano-particles or micro-particles that increase apparent opacity of the device, by increasing scattering of incident light.
Thorwarth teaches wherein said near infrared fluorescent dye is in the form of a fluorescent dye-enhanced matrix and wherein the intensity of the light emitted from said fluorescent dye- enhanced matrix is increased by including dispersed reflective nano-particles or micro-particles that increase apparent opacity of the device, by increasing scattering of incident light (Claim 1: “A calibration target for calibrating an optoelectronic device for analyzing biomolecules by detecting fluorescence signals from a sample, the calibration target comprising: a substrate; and a solid fluorescent layer that is disposed on the substrate and capable of being excited by laser light, wherein the fluorescent layer has an optically inactive matrix having embedded therein a carbon-based component that is excitable to light emission, wherein the optically inactive matrix includes a material having a refractive index greater than 1.4, wherein the optically inactive matrix has a colloidal structure, wherein the optically inactive matrix includes titanium dioxide”. Titanium dioxide is a scattering agent, which means that it can increase scattering of incident light.).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the reflective materials from Thorwarth into the device from the Radl/Maegawa/Sherwinter combination as it allows the elongated sizing tube to become more reflective and being more visible, making the procedure easier, as being able to see the device even clearer can lead to an easier, quicker procedure.
Regarding claim 23, the Radl/Maegawa/Sherwinter/Thorwarth combination teaches the method of Claim 22, wherein said particles are titanium dioxide (TiO2), cellulose or reflective materials that are easily dispersed in a polymer or in a resin (Thorwarth, Claim 1: “A calibration target for calibrating an optoelectronic device for analyzing biomolecules by detecting fluorescence signals from a sample, the calibration target comprising: a substrate; and a solid fluorescent layer that is disposed on the substrate and capable of being excited by laser light, wherein the fluorescent layer has an optically inactive matrix having embedded therein a carbon-based component that is excitable to light emission, wherein the optically inactive matrix includes a material having a refractive index greater than 1.4, wherein the optically inactive matrix has a colloidal structure, wherein the optically inactive matrix includes titanium dioxide”).
Claims 15 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over the Radl/Maegawa/Sherwinter combination as applied to claims 1 and 17 above, and further in view of Thompson (WO 2015095333).
Regarding claim 15, the Radl/Maegawa/Sherwinter combination teaches the sizing device of Claim 1 that determines its location based on the light being detected (Maegawa, [0103]: “The fluorescent resin composition according to the present invention is excellent in compatibility and adhesiveness to a base material such as metal, and also allows for hydrophilic coating process, so that it can be applied to, for example, medical devices.”; [0104]: “the fluorescent dye of the present invention has a property of fluorescing with near infrared light within a wavelength region of 700 nm to 1300 nm, but the near infrared light within this wavelength region is easily transmitted through the living body”; [0002]: “Techniques for performing medical diagnosis and surgical operation are known including administering into a living body a fluorescent dye (near infrared fluorescent dye) which excites by undergoing irradiation with near infrared rays to emit near infrared fluorescence, and observing the fluorescence through the surface of the living body”).
However, the Radl/Maegawa/Sherwinter combination does not specify the specific features that are being located through this measurement.
Thompson discloses a resection line guide for a medical procedure. Specifically, Thompson teaches wherein said transillumination has an intensity which is configured to be inversely proportional to the thickness of the wall of the stomach, wherein the wall thickness may be used to infer location of a ridge that may delineate the antrum, the lower esophageal sphincter, or the cardia at the angle of His ([00175]: “embodiments of the present invention may include a light source configured to cooperate with a light collector or sensor to provide an indication of tissue thickness … the amount of light received at the sensors 190 may have a determinable correlation to the thickness of the tissue through which the light is transmitted. In this regard, the resection line guide 180 may be operatively coupled to a controller or other processor (not shown) capable of determining the tissue thickness based upon the amount of light emitted by the light source 188 and that received by sensors 190”; [0008]: “the thickness of the stomach tissue varies at the antrum”; [0007]: “At the top of the staple line, it is important to not divide part of the esophagus or the 'sling fibers' of the cardia, which participate in the physiologic anti-reflux action of the lower esophageal sphincter. Surgeons must use visual cues to ensure that the staple line is a safe distance away from the gastroesophageal junction”. It is obvious that the transillumination intensity would be inversely proportional to the thickness of the wall of the stomach as when there is a thicker wall, the light has to go through more tissue, so it will be less visible.). Radl, Maegawa, and Thompson are analogous arts as all are related to medical devices using light to view the human body.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the specific features that are being detected from Thompson into the Radl/Maegawa/Sherwinter combination as it provides specific features that are being located, which can be important during the procedure to ensure the correct locations for the surgery.
Regarding claim 24, the Radl/Maegawa/Sherwinter combination teaches the method of Claim 17 that determines its location based on the light being detected (Maegawa, [0103]: “The fluorescent resin composition according to the present invention is excellent in compatibility and adhesiveness to a base material such as metal, and also allows for hydrophilic coating process, so that it can be applied to, for example, medical devices.”; [0104]: “the fluorescent dye of the present invention has a property of fluorescing with near infrared light within a wavelength region of 700 nm to 1300 nm, but the near infrared light within this wavelength region is easily transmitted through the living body”; [0002]: “Techniques for performing medical diagnosis and surgical operation are known including administering into a living body a fluorescent dye (near infrared fluorescent dye) which excites by undergoing irradiation with near infrared rays to emit near infrared fluorescence, and observing the fluorescence through the surface of the living body”).
However, the Radl/Maegawa/Sherwinter combination does not specify the specific features that are being located through this measurement.
Thompson discloses a resection line guide for a medical procedure. Specifically, Thompson teaches wherein said transillumination has an intensity which is configured to be inversely proportional to the thickness of the wall of the stomach, wherein the wall thickness may be used to infer location of a ridge that may delineate the antrum, the lower esophageal sphincter, or the cardia at the angle of His ([00175]: “embodiments of the present invention may include a light source configured to cooperate with a light collector or sensor to provide an indication of tissue thickness … the amount of light received at the sensors 190 may have a determinable correlation to the thickness of the tissue through which the light is transmitted. In this regard, the resection line guide 180 may be operatively coupled to a controller or other processor (not shown) capable of determining the tissue thickness based upon the amount of light emitted by the light source 188 and that received by sensors 190”; [0008]: “the thickness of the stomach tissue varies at the antrum”; [0007]: “At the top of the staple line, it is important to not divide part of the esophagus or the 'sling fibers' of the cardia, which participate in the physiologic anti-reflux action of the lower esophageal sphincter. Surgeons must use visual cues to ensure that the staple line is a safe distance away from the gastroesophageal junction”. It is obvious that the transillumination intensity would be inversely proportional to the thickness of the wall of the stomach as when there is a thicker wall, the light has to go through more tissue, so it will be less visible.). Radl, Maegawa, and Thompson are analogous arts as all are related to medical devices using light to view the human body.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the specific features that are being detected from Thompson into the Radl/Maegawa/Sherwinter combination as it provides specific features that are being located, which can be important during the procedure to ensure the correct locations for the surgery.
Response to Arguments
All of applicant’s argument regarding the rejections and objections previously set forth have been fully considered and are persuasive unless directly addressed subsequently.
Applicant's arguments filed 01/13/2026 have been fully considered but they are not persuasive. Applicant argues that Sherwinter does not teach the location of the fluorescent dye, as Sherwinter confines the illumination to the tip of the device, however Sherwinter is not relied on to teach the location of the illumination, it is only relied upon to teach the laparoscope viewing the illumination, therefore this argument is not persuasive. Maegawa is relied on completely to teach the location and type of illumination ([0103]: “The fluorescent resin composition according to the present invention is excellent in compatibility and adhesiveness to a base material such as metal, and also allows for hydrophilic coating process, so that it can be applied to, for example, medical devices.”; [0104]: “the fluorescent dye of the present invention has a property of fluorescing with near infrared light within a wavelength region of 700 nm to 1300 nm, but the near infrared light within this wavelength region is easily transmitted through the living body”; [0002]: “Techniques for performing medical diagnosis and surgical operation are known including administering into a living body a fluorescent dye (near infrared fluorescent dye) which excites by undergoing irradiation with near infrared rays to emit near infrared fluorescence, and observing the fluorescence through the surface of the living body”. The fluorescent resin is coated on the medical device, which is the sizing device. The dye also allows the light to be transmitted through the living body, which includes being visible from outside the wall of the patient’s stomach.), therefore the argument against Sherwinter is not applicable to the rejection.
Conclusion
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/E.K.M./Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791