Detailed Action
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/10/2025 has been entered.
Claim Interpretation
Claim 31 recites “the sensor lumen is positioned within an outer wall of the elongated body, and wherein the main lumen is defined by the outer wall of the elongated body”. The specification does not contain the term “outer wall”, and the term “main lumen” is only used to refer to the hub (See ¶0155 of the published application). The claim limitation “outer wall” is interpreted as referring to the “wall” of the sheath, as described in published ¶0139, ¶0141 and ¶0142. Although Item 614 “wall” was not found in the drawings, the sections refer to Figure 15 and thickness “T” as representative of the “outer wall”. ¶0139 also discloses a “first lumen” (Item 610), which is interpreted as the claimed “main lumen”.
Claim 31 recites the functional limitation “the embedding medium is inserted within the sensor lumen through the insertion opening”. Since Claim 31 is an apparatus/product claim, the claim covers what the apparatus/product is, not what the steps of making it are. The structure implied by the step is that there is an “opening extending from an exterior of the elongated body to the sensor lumen”. Thus, this portion of the claim is interpreted as requiring two openings.
Claim 31 recites “wherein the insertion opening is located….proximal to the sensor lumen opening.” The term “proximal” is interpreted as any location that is before (in the proximal direction) the sensor lumen opening along the length of the device. This is based on ¶0141 of “US20170296779A1”, which describes the “insertion opening” as “any suitable opening that is in communication with the sensor lumen, such as one at the proximal end of the medical device or through an opening formed at any suitable location along the length of the medical device that is in communication with the sensor lumen.” There is no recitation regarding the proximity of the sensor lumen opening and the insertion opening. The insertion opening is also not shown in the drawings.
Claim 31 recites “an embedding medium located in an interior of the sensor lumen and contacting the transmission line to secure the transmission line to the elongated body to fix the sensor at a desired position…” This limitation appears to draw support from published [0141]. This portion of the specification states that the embedding medium is used to secure the transmission line to the sheath, yet does not state that this results in the claimed maintaining of the sensor in the sensor lumen. Due to this, the maintaining limitation is interpreted as an inherent result of bonding the transmission line to the sensor lumen.
Claim 41 recites the functional limitation “the embedding medium is inserted within the sensor lumen through the insertion opening”. Since Claim 41 is an apparatus/product claim, the claim covers what the apparatus/product is, not what the steps of making it are. The structure implied by the step is that there is an “opening extending from an exterior of the elongated body to the sensor lumen”. Thus, this portion of the claim is interpreted as requiring two openings.
Claim 41 recites “wherein the insertion opening is located….proximal to the sensor lumen opening.” The term “proximal” is interpreted as any location that is before (in the proximal direction) the sensor lumen opening along the length of the device. This is based on ¶0141 of “US20170296779A1”, which describes the “insertion opening” as “any suitable opening that is in communication with the sensor lumen, such as one at the proximal end of the medical device or through an opening formed at any suitable location along the length of the medical device that is in communication with the sensor lumen.” There is no recitation regarding the proximity of the sensor lumen opening and the insertion opening. The insertion opening is also not shown in the drawings.
Claim 41 recites “an embedding medium within an interior of the sensor lumen and adjacent the line to secure the line to the elongated body to fix the sensor at a desired position…” This limitation appears to draw support from published [0141]. This portion of the specification states that the embedding medium is used to secure the transmission line to the sheath, yet does not state that this results in the claimed maintaining of the sensor in the sensor lumen. Due to this, the maintaining limitation is interpreted as an inherent result of bonding the transmission line to the sensor lumen.
Claim 41 recites “wherein the sensor lumen is positioned along an outer wall of the elongated body”. This is interpreted as the sensor lumen extending along a length of the outer wall within the material of the outer wall, as shown in Applicant’s Figure 15. It is noted that Figure 5A shows a different embodiment where the sensor lumen is on an outer wall of a first sheath (101). This embodiment, however, was not previously presented for examination. This embodiment also does not apply to the rest of the claim, specifically the limitation “an insertion opening extending from an exterior of the elongated body to the sensor lumen”. As such, the claim language is interpreted based on the embodiment of Figure 15, where the sensor lumen extends along a length of the outer wall material and within the outer wall.
Claim 42 recites “the transmission line”. This is interpreted as “a line” as introduced in Claim 41.
Claim 49 recites “the transmission line”. This is interpreted as “a line” as introduced in Claim 41.
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 31-39 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.
Claim 31 recites “the main lumen”. There is insufficient antecedent basis for this limitation.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 31-32, 34-39, 41-42, and 44-49 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Pinkernell (US20090177183A1) in view of Wallace (US6447462B1), further in view of Belleville (US20110066047A1).
As to claim 31, Pinkernell teaches an intraluminal medical device (Figure 7 teaches a device (10) that is configured to be inserted into a patient.) comprising: an elongated body having a first lumen and a sensor lumen (Figure 7 teaches an elongated body (10) that has a first (12) and second lumen. The second lumen has a sensor (14) that has its wire passing through it.), wherein the sensor lumen is separate from the first lumen and not in fluid communication with the first lumen (Figure 7 has a cross sectional view of the catheter where the first lumen (12) and the second are not in fluid communication.), the elongated body having a proximal end and a distal end (Figure 7 shows an overview of the catheter where it has two ends. The proximal end is interpreted as where the connectors (16) are, and the distal is where the sensor (14) is located.); wherein the sensor lumen is positioned with an outer wall of the elongated body and wherein the main lumen is defined by the outer wall of the elongated body (Figure 7 shows a side and cross sectional view of the catheter where the sensor lumen is within the material of the wall of the catheter, and that the wall of material defines the first/main lumen (12).) ; a transmission line and a sensor positioned within the sensor lumen (Figure 7 shows a sensor (14) that has a line (not labeled) that passes through the lumen. ¶0020 teaches the sensors are at the tip or in close proximity to the tip. ¶0022 teaches the sensors are placed at the tip, which is interpreted as being at the tip and within the sensor lumen. ¶0025 teaches that the sensor can be a pressure sensor, it can be a fiber optic pressure sensor, and a line can be a fiber optic line.), the transmission line being coupled to the sensor (Figure 7 shows a line (not labeled) connected to the sensor (14).); wherein the sensor lumen comprises a sensor lumen opening at or near the distal end of the elongated body (Figure 7 shows an opening to the sensor lumen at the end of the elongated body.), the sensor lumen opening providing direct access to an anatomical space within a subject in which the elongated body is positioned to permit the sensor to detect a parameter through the sensor lumen opening (Figure 7 shows the opening is at the very tip of the catheter, such that it is capable of allowing direct access to an anatomical space within a subject. ¶0022 teaches the sensors are located at the tip to measure directly at the source.); the sensor positioned within the sensor lumen at or adjacent the distal end of the elongated body (¶0022 teaches that the sensors are embedded at the tip of the catheter. The tip of the catheter is at or adjacent the distal end of the catheter (elongated body).); (Figure 4 shows that the catheter (10) can have multiple openings (where item 14 is located) on the exterior of the catheter with the openings being separate.); and an embedding medium located within an interior of the sensor lumen to secure the sensor at a desired position within the sensor lumen at or adjacent the distal end of the elongated body (¶0022 teaches the sensors are embedded at the distal tip of the catheter. This teaching of “embedded” is interpreted as teaching an embedding medium.).
Pinkernell does not explicitly disclose wherein an insertion opening extending from an exterior of the elongated body to the sensor lumen, the insertion opening being separate of the sensor lumen opening; an embedding medium located within an interior of the sensor lumen and contacting the transmission line to secure the transmission line to the elongated body; wherein the embedding medium is inserted within the sensor lumen through the insertion opening; and wherein the insertion opening is located at a position along a length of the elongated body between the sensor lumen opening and the proximal end of the elongated body and proximal to the sensor lumen opening.
However, Wallace teaches wherein an insertion opening extending from an exterior of the elongated body to the sensor lumen (Figures 4A-4B, Items 44a-44b), the insertion opening being separate of the sensor lumen opening (Figures 4A and 4B show that the two openings in the lumen are separate.); an embedding medium located within an interior of the sensor lumen to secure a line to the elongated body (Figures 4A-4B teach that the adhesive (32) surrounds the tubing (20b) before it reaches the opening (42a-b). This is a teaching of using adhesive to secure a line in place within the catheter interior.); wherein the embedding medium is inserted in the sensor lumen through an insertion opening (Figures 4A-4B teach an insertion opening (44a-44b) that is location proximal to another opening (42a-42b) where pressure measurement tubing (20a-20b) exits the sidewall of the outer tubing (12). The other opening (42a-42b) is interpreted as an analogous sensor lumen opening. Col. 7 Lines 60-65 teach the injection of curable adhesive into the fill ports (44a-44b) in order to embed the pressure tubing at the exit port (42a-42b) of the tubing.), the insertion opening being separate of the sensor lumen opening (Figures 4A-4B show the openings (44 and 42) are separate.); wherein the insertion opening is located at a position along a length of the elongated body between the sensor lumen opening and the proximal end of the elongated body and proximal to the sensor lumen opening (Figures 3A-3B show the overall view of the catheter (200) where the area with the openings is shown in Figure 3B as being closer to the distal end. The pressure lumen tubing is shown as extending from the proximal end towards the opening and curving up towards the opening in the sidewall of the outer tube (12). The views in Figures 4A-4B appear to be shown in the opposite orientation such that items 44a and 44b located closer to the proximal end than the openings 42a and 42b.).
One of ordinary skill would have been motivated to apply the known adhesive injection technique of Wallace to the sensor embedding method of Pinkernell in order to fix the ends of the sensors in place (See Wallace Col. 8, Lines 5-6) with a method that uses a UV-curable adhesive that allows for curing to be initiated in a very short time. (See Wallace Col. 8, Lines 1-4)
Therefore, it would have been obvious to one of ordinary skill in the art, at the time the invention was effectively filed to apply the known adhesive injection technique of Wallace to the sensor embedding method of Pinkernell because it has been held to be prima facie obvious to apply a known technique to a known method, ready for improvement, to yield predictable results. See MPEP 2143 (I)(D).
Pinkernell in view of Wallace does not explicitly disclose the embedding medium contacts the transmission line and is used to secure the transmission line to the elongated body to fix the sensor at a desired position. Pinkernell in view of Wallace does disclose that the sensor is secured in place (Pinkernell ¶0022 teaches the sensors can be embedded in some way.) and that the embedding medium secures more than just the tip of the embedded structure. (Figures 4A-4B of Wallace show that the adhesive fill material encapsulates a length of the pressure measurement tubing (20a/b) and connects it to the sidewalls of the lumen.)
However, Belleville teaches wherein the embedding medium contacts the transmission line and secures the transmission line to the elongated body such that a position of the sensor relative to the sensor lumen is maintained. (Figures 4 and 7 teach a sensor lumen (51) that houses a wire (17) connected to a pressure sensor (16). ¶0039 teaches that the wire (17) is secured near the sensor with an adhesive (21) in order to hold the sensor in place. Figure 4 shows the adhesive (21) surrounds the transmission line/wire (17) within a separate cavity from the first/main lumen (where the guide wire (25) is run).)
One of ordinary skill would have been motivated to apply the known transmission line securing technique of Belleville to the sensor embedding method of Pinkernell in view of Wallace in order to hold the sensor in place (See Belleville ¶0039). The act of securing the transmission line to the surrounding lumen also protects the connection between the transmission line and sensor from forces that could cause damage to said connection. (Basic engineering rationale)
Therefore, it would have been obvious to one of ordinary skill in the art, at the time the invention was effectively filed to apply the known transmission line securing technique of Belleville to the sensor embedding method of Pinkernell in view of Wallace because it has been held to be prima facie obvious to apply a known technique to a known method, ready for improvement, to yield predictable results. See MPEP 2143 (I)(D).
As to claim 32, Pinkernell in view of Wallace and Belleville teaches the device of Claim 31, wherein the embedding medium comprises at least one of the following: an epoxy, a methacrylate, and another type of adhesive (Wallace, Col. 8, Lines 1-4 teach the use of another type of adhesive.); wherein the embedding medium comprises a curable material (Wallace, Col. 8, Lines 1-4 teach the use of a curable adhesive.); wherein the sensor comprises a pressure sensor (Pinkernell Figure 7 shows a sensor (14). ¶0023-0024 describe the sensor as either a flow rate sensor or a pressure sensor. ¶0028 teaches the catheters can have either a pressure sensor, flow rate sensor, or both.); wherein the transmission line comprises a fiber optic line (¶0025 of Pinkernell teaches the use of a fiber optic sensor with a fiber optic sensing line).
As to claim 34, Pinkernell in view of Wallace and Belleville teaches the device of Claim 31, wherein the embedding medium comprises an adhesive. (Wallace, Col. 8, Lines 1-4 teach the use of a UV curable adhesive.)
As to claim 35, Pinkernell in view of Wallace and Belleville teaches the device of Claim 31, wherein the embedding medium comprises a curable material. (Wallace, Col. 8, Lines 1-4 teach the use of a UV curable adhesive.)
As to claim 36, Pinkernell in view of Wallace and Belleville teaches the device of Claim 35, wherein the curable material is configured to be curable using ultraviolet light. (Wallace, Col. 8, Lines 1-4 teach the use of a UV curable adhesive.)
As to claim 37, Pinkernell in view of Wallace and Belleville teaches the device of Claim 31, wherein the sensor comprises a fiber optic sensor. (¶0025 of Pinkernell teaches the use of a fiber optic sensor with a fiber optic sensing line.)
As to claim 38, Pinkernell in view of Wallace and Belleville teaches the device of Claim 31, wherein the sensor comprises a pressure sensor. (Pinkernell Figure 7 shows a sensor (14). ¶0023-0024 describe the sensor as either a flow rate sensor or a pressure sensor. ¶0028 teaches the catheters can have either a pressure sensor, flow rate sensor, or both.)
As to claim 39, Pinkernell in view of Wallace and Belleville teaches the device of Claim 31, wherein the transmission line comprises a fiber optic line. (¶0025 of Pinkernell teaches the use of a fiber optic sensor with a fiber optic sensing line.)
As to claim 41, Pinkernell teaches an intraluminal medical device (Figure 7 teaches a device (10) that is configured to be inserted into a patient.) comprising: an elongated body having a main lumen and a sensor lumen (Figure 7 teaches an elongated body (10) that has a main (12) and second lumen. The second lumen has a sensor (14) that has its wire passing through it.), wherein the sensor lumen is not in fluid communication with the main lumen (Figure 7 has a cross sectional view of the catheter where the main lumen (12) and the sensor lumen are not in fluid communication.), the elongated body having a proximal end and a distal end (Figure 7 shows an overview of the catheter where it has two ends. The proximal end is interpreted as where the connectors (16) are, and the distal is where the sensor (14) is located.); wherein the sensor lumen is positioned along an outer wall of the elongated body (Figure 7 shows the sensor lumen extends along and within the material of the outer wall of the main lumen (12).); a line and a sensor positioned within the sensor lumen, the line being operatively coupled to the sensor (Figure 7 shows a sensor (14) that has a line (not labeled) that passes through the lumen. ¶0020 teaches the sensors are at the tip or in close proximity to the tip. ¶0022 teaches the sensors are placed at the tip, which is interpreted as being at the tip and within the sensor lumen. ¶0025 teaches that the sensor can be a pressure sensor, it can be a fiber optic pressure sensor, and a line can be a fiber optic line.); wherein the sensor lumen comprises a sensor lumen opening at or near the distal end of the elongated body (Figure 7 shows an opening to the sensor lumen at the end of the elongated body.), the sensor lumen opening providing access to an anatomical space within a subject in which the elongated body is positioned (Figure 7 shows the opening is at the very tip of the catheter, such that it is capable of allowing direct access to an anatomical space within a subject. ¶0022 teaches the sensors are located at the tip to measure directly at the source.); and an embedding medium located within an interior of the sensor lumen to secure the sensor at a desired position within the sensor lumen at or adjacent the distal end of the elongated body (¶0022 teaches the sensors are embedded at the distal tip of the catheter. This teaching of “embedded” is interpreted as teaching an embedding medium.).
Pinkernell does not explicitly disclose wherein an insertion opening extending from an exterior of the elongated body to the sensor lumen, the insertion opening being separate of the sensor lumen opening; an embedding medium located within an interior of the sensor lumen to secure the line to the elongated body; wherein the embedding medium is inserted within the sensor lumen through the insertion opening; and wherein the insertion opening is located at a position along a length of the elongated body between the sensor lumen opening and the proximal end of the elongated body and proximal to the sensor lumen opening.
However, Wallace teaches wherein an insertion opening extending from an exterior of the elongated body to the sensor lumen (Figures 4A-4B, Items 44a-44b), the insertion opening being separate of the sensor lumen opening (Figures 4A and 4B show that the two openings in the lumen are separate.); an embedding medium located within an interior of the sensor lumen to secure a line to the elongated body (Figures 4A-4B teach that the adhesive (32) surrounds the tubing (20b) before it reaches the opening (42a-b). This is a teaching of using adhesive to secure a line in place within the catheter interior.); wherein the embedding medium is inserted in the sensor lumen through an insertion opening (Figures 4A-4B teach an insertion opening (44a-44b) that is location proximal to another opening (42a-42b) where pressure measurement tubing (20a-20b) exits the sidewall of the outer tubing (12). The other opening (42a-42b) is interpreted as an analogous sensor lumen opening. Col. 7 Lines 60-65 teach the injection of curable adhesive into the fill ports (44a-44b) in order to embed the pressure tubing at the exit port (42a-42b) of the tubing.), the insertion opening being separate of the sensor lumen opening (Figures 4A-4B show the openings (44 and 42) are separate.); wherein the insertion opening is located at a position along a length of the elongated body between the sensor lumen opening and the proximal end of the elongated body and proximal to the sensor lumen opening (Figures 3A-3B show the overall view of the catheter (200) where the area with the openings is shown in Figure 3B as being closer to the distal end. The pressure lumen tubing is shown as extending from the proximal end towards the opening and curving up towards the opening in the sidewall of the outer tube (12). The views in Figures 4A-4B appear to be shown in the opposite orientation such that items 44a and 44b located closer to the proximal end than the openings 42a and 42b.).
One of ordinary skill would have been motivated to apply the known adhesive injection technique of Wallace to the sensor embedding method of Pinkernell in order to fix the ends of the sensors in place (See Wallace Col. 8, Lines 5-6) with a method that uses a UV-curable adhesive that allows for curing to be initiated in a very short time. (See Wallace Col. 8, Lines 1-4)
Therefore, it would have been obvious to one of ordinary skill in the art, at the time the invention was effectively filed to apply the known adhesive injection technique of Wallace to the sensor embedding method of Pinkernell because it has been held to be prima facie obvious to apply a known technique to a known method, ready for improvement, to yield predictable results. See MPEP 2143 (I)(D).
Pinkernell in view of Wallace does not explicitly disclose the embedding medium is used to secure the transmission line to the elongated body to fix the sensor at a desired position. Pinkernell in view of Wallace does disclose that the sensor is secured in place (Pinkernell ¶0022 teaches the sensors can be embedded in some way.) and that the embedding medium secures more than just the tip of the embedded structure. (Figures 4A-4B of Wallace show that the adhesive fill material encapsulates a length of the pressure measurement tubing (20a/b) and connects it to the sidewalls of the lumen.)
However, Belleville teaches wherein the embedding medium secures the transmission line to the elongated body such that a position of the sensor relative to the sensor lumen is maintained. (Figures 4 and 7 teach a sensor lumen (51) that houses a wire (17) connected to a pressure sensor (16). ¶0039 teaches that the wire (17) is secured near the sensor with an adhesive (21) in order to hold the sensor in place. ¶0039 also teaches the filling of the empty volume around the sensor will polymer.)
One of ordinary skill would have been motivated to apply the known transmission line securing technique of Belleville to the sensor embedding method of Pinkernell in view of Wallace in order to hold the sensor in place (See Belleville ¶0039). The act of securing the transmission line to the surrounding lumen also protects the connection between the transmission line and sensor from forces that could cause damage to said connection. (Basic engineering rationale)
Therefore, it would have been obvious to one of ordinary skill in the art, at the time the invention was effectively filed to apply the known transmission line securing technique of Belleville to the sensor embedding method of Pinkernell in view of Wallace because it has been held to be prima facie obvious to apply a known technique to a known method, ready for improvement, to yield predictable results. See MPEP 2143 (I)(D).
As to claim 42, Pinkernell in view of Wallace and Belleville teaches the device of Claim 41, wherein the embedding medium comprises at least one of the following: an epoxy, a methacrylate, and another type of adhesive (Wallace, Col. 8, Lines 1-4 teach the use of another type of adhesive.); wherein the embedding medium comprises a curable material (Wallace, Col. 8, Lines 1-4 teach the use of a curable adhesive.); wherein the sensor comprises a pressure sensor (Pinkernell Figure 7 shows a sensor (14). ¶0023-0024 describe the sensor as either a flow rate sensor or a pressure sensor. ¶0028 teaches the catheters can have either a pressure sensor, flow rate sensor, or both.); wherein the transmission line comprises a fiber optic line (¶0025 of Pinkernell teaches the use of a fiber optic sensor with a fiber optic sensing line.); and wherein the main lumen is colinear with the centerline of the elongated body. (Pinkernell, Figure 7 teaches that the main lumen (12) is colinear with the centerline.)
As to claim 44, Pinkernell in view of Wallace and Belleville teaches the device of Claim 41, wherein the embedding medium comprises an adhesive. (Wallace, Col. 8, Lines 1-4 teach the use of a UV curable adhesive.)
As to claim 45, Pinkernell in view of Wallace and Belleville teaches the device of Claim 41, wherein the embedding medium comprises a curable material. (Wallace, Col. 8, Lines 1-4 teach the use of a UV curable adhesive.)
As to claim 46, Pinkernell in view of Wallace and Belleville teaches the device of Claim 45, wherein the curable material is configured to be curable using ultraviolet light. (Wallace, Col. 8, Lines 1-4 teach the use of a UV curable adhesive.)
As to claim 47, Pinkernell in view of Wallace and Belleville teaches the device of Claim 41, wherein the sensor comprises a fiber optic sensor. (¶0025 of Pinkernell teaches the use of a fiber optic sensor with a fiber optic sensing line.)
As to claim 48, Pinkernell in view of Wallace and Belleville teaches the device of Claim 41, wherein the sensor comprises a pressure sensor. (Pinkernell Figure 7 shows a sensor (14). ¶0023-0024 describe the sensor as either a flow rate sensor or a pressure sensor. ¶0028 teaches the catheters can have either a pressure sensor, flow rate sensor, or both.)
As to claim 49, Pinkernell in view of Wallace and Belleville teaches the device of Claim 41, wherein the transmission line comprises a fiber optic line. (¶0025 of Pinkernell teaches the use of a fiber optic sensor with a fiber optic sensing line.)
Claim 33 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Pinkernell (US20090177183) in view of Wallace (US6447462) and Belleville (US20110066047A1), as applied in claim 31, further in view of Millar (US6394986).
As to claim 33, Pinkernell in view of Wallace and Belleville teaches the device of Claim 31, wherein the embedding medium comprises an adhesive. (Wallace Col. 5 teaches the use of a UV curable adhesive OR an RTV adhesive.)
Pinkernell in view of Wallace and Belleville does not explicitly disclose methacrylate or an epoxy.
However, Millar teaches that when mounting a sensor to a catheter lumen, it is known to use epoxy OR an RTV adhesive. (See Col. 6 Lines 18-20)
One of ordinary skill in the art would have been motivated to substitute the known epoxy of Millar for the adhesive of Wallace since it is shown in the prior art that they are interchangeable for the sealing of sensors in catheters and each produce the same predictable result. Additionally, the epoxy of Millar is used to provide a smooth contour for the sensor area that will be compatible with the requirements for introduction into body vessels. (See Col. 6, Lines 43-46)
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of invention, to substitute the known epoxy of Millar for the RTV of Wallace because it has been held to be prima facie obvious to substitute one known element for another to yield predictable results. See MPEP 2143 (I)(B).
Claim 43 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Pinkernell (US20090177183) in view of Wallace (US6447462) and Belleville (US20110066047A1), as applied in claim 41, further in view of Millar (US6394986).
As to claim 43, Pinkernell in view of Wallace and Belleville teaches the device of Claim 41, wherein the embedding medium comprises an adhesive. (Wallace Col. 5 teaches the use of a UV curable adhesive OR an RTV adhesive.)
Pinkernell in view of Wallace and Belleville does not explicitly disclose methacrylate or an epoxy.
However, Millar teaches that when mounting a sensor to a catheter lumen, it is known to use epoxy OR an RTV adhesive. (See Col. 6 Lines 18-20)
One of ordinary skill in the art would have been motivated to substitute the known epoxy of Millar for the adhesive of Wallace since it is shown in the prior art that they are interchangeable for the sealing of sensors in catheters and each produce the same predictable result. Additionally, the epoxy of Millar is used to provide a smooth contour for the sensor area that will be compatible with the requirements for introduction into body vessels. (See Col. 6, Lines 43-46)
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of invention, to substitute the known epoxy of Millar for the RTV of Wallace because it has been held to be prima facie obvious to substitute one known element for another to yield predictable results. See MPEP 2143 (I)(B).
Response to Arguments
Applicant's arguments filed 06/10/2025 have been fully considered but are not persuasive.
Applicant argues that the references do not disclose “a medium positioned within an interior of a sensor lumen along a line to secure the line (e.g., transmission line) to a lumen (e.g., pressure lumen) of the elongated body, as claimed herein”. Applicant is essentially arguing that the references do not disclose all of the limitations as claimed.
Examiner respectfully asserts that the combination of references as outlined in the rejection above teach this feature and that the rejection is proper. Pinkernell teaches the elongated body with openings where sensors are located (See Figures 4 or 7) and that the sensors can be held in place by embedding (See ¶0022). To teach the structure of the insertion opening and embedding medium within the lumen, Wallace is relied upon. Specifically, Figures 4A and 4B show openings (44a-44b) that are used to insert the embedding medium (32) that surround the tubing (20b) inside of the lumen prior to the tubing reaching the opening (42a-b) which is separate from the insertion opening. Wallace therefore teaches the use of an insertion opening to insert adhesive/embedding material to secure a line in place within a lumen. Wallace does not explicitly disclose a “transmission” line. Belleville is then relied upon to show that a transmission line (wire, 17) is secured in place using adhesive (21) within the cavity proximal to where the sensor (16) is located. Thus, the combination of references teach the use of sensors within a sensor lumen that are connected to transmission lines that extend to the proximal end of the catheter (Pinkernell), using adhesive inserted through an insertion opening separate from the sensor opening to secure a line in place (Wallace), and using adhesive that contacts the transmission line to secure a transmission line in place within a cavity of a catheter (Belleville). All references are analogous to each other and to the problem being solved by the applicant. Based on the above teachings found in the prior art, the rejection is proper.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure can be found on the PTO-892 Notice of References Cited Form.
US20120035642A1 (Priority to 03-09-2009): Figure 6 teaches wires (28) that are connected to a pressure sensor (21) within a lumen (22) that are secured to the lumen (22) using an adhesive (29). See ¶0160. The reference teaches that this technique allows the avoidance of stresses on the wires from being transmitted to the sensor.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael W Hotchkiss whose telephone number is (571)272-3854. The examiner can normally be reached Monday-Friday from 0800-1600.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sunil K Singh can be reached on 571-272-3460. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHAEL W HOTCHKISS/Primary Examiner, Art Unit 3726